Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 56169-56356 [2015-21921]
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Vol. 80
Thursday,
No. 180
September 17, 2015
Part III
Department of Health and Human Services
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Food and Drug Administration
21 CFR Parts 11, 16, 117, et al.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals; Final Rule
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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6246,
email: jenny.murphy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11, 16, 117, 500, 507, and
579
[Docket No. FDA–2011–N–0922]
RIN 0910–AG10
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for
Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is adding
regulations for the Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals. These
regulations will, for the first time,
establish requirements for the current
good manufacturing practice (CGMP) for
food for animals. In addition, we are
adding requirements for certain
domestic and foreign animal food
facilities to establish and implement
hazard analysis and risk-based
preventive controls for food for animals.
We are taking this action to provide
greater assurance that animal food is
safe and will not cause illness or injury
to humans and animals and to
implement new statutory provisions in
the FDA Food Safety Modernization Act
(FSMA). The rule is intended to build
an animal food safety system for the
future that makes modern science- and
risk-based preventive controls the norm
across all sectors of the animal food
system.
SUMMARY:
This rule is effective November
16, 2015, except for paragraph (2) of the
definition of ‘‘qualified auditor’’ in
§ 507.3, and §§ 507.12(a)(1)(ii),
507.105(a)(2), 507.105(c),
507.110(d)(2)(ii), 507.130(d), 507.135(d),
507.175(c)(2), and 507.175(c)(13). FDA
will publish a document in the Federal
Register announcing the effective dates
of paragraph (2) of the definition of
‘‘qualified auditor’’ in § 507.3,
§§ 507.12(a)(1)(ii), 507.105(a)(2),
507.105(c), 507.110(d)(2)(ii), 507.130(d),
507.135(d), 507.175(c)(2), and
507.175(c)(13). Certain provisions have
later compliance dates as discussed in
section LIII ‘‘Effective and Compliance
Dates.’’
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DATES:
FOR FURTHER INFORMATION CONTACT:
Jeanette Murphy, Center for Veterinary
Medicine (HFV–200), Food and Drug
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Table of Contents
Executive Summary
Purpose and Coverage of the Rule
Summary of the Major Provisions of the Rule
Costs and Benefits
I. Background
A. FDA Food Safety Modernization Act
B. Stages in the Rulemaking for the Animal
Food Preventive Controls Rule
C. Summary of the Major Provisions of
Proposed Rule for Preventive Controls
for Food for Animals
D. Draft Risk Assessment
E. Public Comments
II. Legal Authority
A. Current Good Manufacturing Practice
Regulations
B. Hazard Analysis and Risk-Based
Preventive Controls
III. General Comments on the Proposed Rule
IV. Definitions in the Section 415
Registration Regulations (21 CFR Part 1,
Subpart H)
A. Definitions That Impact a Determination
of Whether an Establishment Is a ‘‘Farm’’
B. Proposed Revisions to the Definition of
Farm
C. Proposed Revisions to Definitions of
Harvesting, Holding, Manufacturing/
Processing, Mixed-Type Facility, and
Packing
D. Comments on Feed Mills Associated
With Fully Vertically Integrated Farming
Operations
V. Comments on the Organizing Principles
for How the Status of a Food as a Raw
Agricultural Commodity or as a
Processed Food Affects the Requirements
Applicable to a Farm Under Sections 415
and 418 of the FD&C Act
VI. Rulemaking Required by Section 103(c) of
FSMA: On-Farm Activities
A. Section 103(c)(1)(C) of FSMA
B. Comments on Qualitative Risk
Assessment of On-Farm Activities
Outside of the Farm Definition
C. Comments Regarding an Exemption for
Small and Very Small Farm Mixed-Type
Facilities Under Section 421 of the FD&C
Act
VII. Subpart A: Comments on Proposed
§ 507.1—Applicability and Status
A. Comments on Proposed § 507.1(a)—
Applicability
B. Comments on Proposed § 507.1(b)—
Prohibited Act
C. Comments on Proposed § 507.1(c)—
Specific CGMP Requirements
D. Comments on Proposed § 507.1(d)—
Human Food Facilities That Manufacture
Animal Food
VIII. Subpart A: Comments on Proposed
§ 507.3—Definitions
A. Definitions We Proposed To Establish in
Part 507
B. Comments Asking FDA To Establish
Additional Definitions or Otherwise
Clarify Terms Not Defined in the Rule
C. Additional Definitions To Clarify Terms
Not Defined in the Proposed Rule
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IX. Subpart A: Comments on Qualifications
of Individuals Who Manufacture,
Process, Pack, or Hold Animal Food
A. Applicability and Qualifications of All
Individuals Engaged in Manufacturing,
Processing, Packing, or Holding Animal
Food (Final § 507.4(a), (b), and (d))
B. Additional Requirements Applicable to
Supervisory Personnel (Final § 507.4(c))
X. Subpart A: Comments on Proposed
§ 507.5—Exemptions
A. General Comments on the Proposed
Exemptions
B. Proposed § 507.5(a)—Exemption for
Facilities Not Required To Register
Under Section 415 Regulations
C. Proposed § 507.5(b)—Exemption
Applicable to Food Subject to 21 CFR
part 113—Thermally Processed LowAcid Foods Packaged in Hermetically
Sealed Containers
D. Proposed § 507.5(c)—Exemption
Applicable to Activities Subject to
Standards for Produce Safety in Section
419 of the FD&C Act
E. Proposed § 507.5(d)—Exemption
Applicable to a Qualified Facility
F. Proposed § 507.5(e) and (f)—Exemptions
Applicable to On-Farm Low-Risk
Activity/Animal Food Combinations
Conducted by a Small or Very Small
Business
G. Proposed § 507.5(g)—Exemption
Applicable to Facilities Solely Engaged
in Storage of Raw Agricultural
Commodities Other Than Fruits and
Vegetables Intended for Further
Distribution or Processing
H. Proposed § 507.5(h)—Exemption
Applicable to the Holding or
Transportation of One or More Raw
Agricultural Commodities
I. Comments Requesting Additional
Exemptions
XI. Subpart A: Comments on Proposed
§ 507.7—Requirements That Apply to a
Qualified Facility
A. Comments on Submission of a
Certification Statement
B. General Comments on Requirements
That Apply to a Qualified Facility
C. Proposed § 507.7(a)—Documentation To
Be Submitted
D. Proposed § 507.7(b)—Procedure for
Submission
E. Proposed § 507.7(c)—Frequency of
Determination and Submission
F. Proposed § 507.7(d)—Notification to
Consumers (Final § 507.7(e))
G. Proposed § 507.7(e)—Records (Final
§ 507.7(f))
XII. Subpart A: Comments on Proposed
§ 507.10—Applicability of Part 507 to a
Facility Solely Engaged in the Storage of
Unexposed Packaged Animal Food
XIII. Subpart A: Comments on Proposed
§ 507.12—Applicability of Part 507 to the
Holding and Distribution of Human Food
By-Products for Use as Animal Food
XIV. Subpart B: General Comments on
Proposed Subpart B—Current Good
Manufacturing Practice
XV. Subpart B: Comments on Proposed
§ 507.14—Personnel
A. Proposed § 507.14(a)(1)—Personal
Cleanliness (Final § 507.14(b)(1))
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B. Proposed § 507.14(a)(2)—Hand Washing
(Final § 507.14(b)(2))
C. Proposed § 507.14(a)(3)—Unsecured
Jewelry and Other Objects (Final
§ 507.14(b)(3))
D. Proposed § 507.14(a)(4)—Storing
Clothing and Personal Belongings (Final
§ 507.14(b)(4))
E. Proposed § 507.14(a)(5)—Taking Other
Necessary Precautions (Final
§ 507.14(b)(5))
XVI. Subpart B: Comments on Proposed
§ 507.17—Plant and Grounds
A. Proposed § 507.17(a)—Grounds
Surrounding an Animal Food Plant
B. Proposed § 507.17(b)(1)—Adequate
Space Between Equipment, Walls, and
Stored Materials
C. Proposed § 507.17(b)(2)—Dripping and
Condensation
D. Proposed § 507.17(b)(3)—Ventilation
E. Proposed § 507.17(b)(4)—Lighting
F. Proposed § 507.17(b)(5)—Glass
G. Proposed § 507.17(b)(6)—Outdoor
Storage
XVII. Subpart B: Comments on Proposed
§ 507.19—Sanitation
A. Proposed § 507.19(a)—Buildings
B. Proposed § 507.19(b)—Cleaning
C. Proposed § 507.19(b)(1)—Wet Cleaning
D. Proposed § 507.19(b)(2)—Wet
Processing
E. Proposed § 507.19(c)—Cleaning
Compounds and Sanitizing Agents
F. Proposed § 507.19(d)(1)—Toxic
Materials
G. Proposed § 507.19(d)(2)—Identification,
Use, and Storage of Toxic Materials
H. Proposed § 507.19(e)—Pest Control
I. Proposed § 507.19(f)—Trash and Garbage
XVIII. Subpart B: Comments on Proposed
§ 507.20—Water Supply and Plumbing
A. Proposed § 507.20(a)—Water Supply
B. Proposed § 507.20(b)—Plumbing
C. Proposed § 507.20(c)—Sewage
D. Proposed § 507.20(d)—Toilet Facilities
E. Proposed § 507.20(e)—Hand-Washing
Facilities
XIX. Subpart B: Comments on Proposed
§ 507.22—Equipment and Utensils
A. Proposed § 507.22(a)(1)—Plant
Equipment and Utensils
B. Proposed § 507.22(a)(2)—Design of
Equipment and Utensils
C. Proposed § 507.22(a)(3)—Equipment
Installation
D. Proposed § 507.22(a)(4)—Animal Food
Contact Surfaces
E. Proposed § 507.22(a)(5)—Non-Animal
Food Contact Equipment (Final
§ 507.22(a)(1))
F. Proposed § 507.22(b)—System Design
and Construction
G. Proposed § 507.22(c)—Monitoring Cold
Storage Temperatures
H. Proposed § 507.22(d)—Instruments
I. Proposed § 507.22(e)—Compressed Air
XX. Subpart B: Comments on Proposed
§ 507.25—Plant Operations
A. Proposed § 507.25(a)(1)—CGMPs
B. Proposed § 507.25(a)(2)—Identifying
Contents of Containers
C. Proposed § 507.25(a)(3)—Labeling of
Finished Product (Final § 507.27(b))
D. Proposed § 507.25(a)(4)—Animal Food
Packaging Material (Final § 507.25(a)(3))
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E. Proposed § 507.25(a)(5)—Responsibility
for Overall Plant Cleanliness (Final
§ 507.25(a)(4))
F. Proposed § 507.25(a)(6)—Contamination
Precautions (Final § 507.25(a)(5))
G. Proposed § 507.25(a)(7)—Testing
Procedures (Final § 507.25(a)(6))
H. Proposed § 507.25(a)(8)—Contaminated
Product (Final § 507.25(a)(7))
I. Proposed § 507.25(a)(9)—Protecting
Against Contamination (Final
§ 507.25(a)(8))
J. Proposed § 507.25(b)(1)—Raw Materials
and Ingredients
K. Proposed § 507.25(b)(1)(i)—Shipping
Containers
L. Proposed § 507.25(b)(1)(ii)—Raw
Materials
M. Proposed § 507.25(b)(1)(iii)—Raw
Materials
N. Proposed § 507.25(b)(2)—Raw Materials
Susceptible to Mycotoxins
O. Proposed § 507.25(b)(3)—Raw Materials
and Rework (Final § 507.25(b)(1)(iii))
P. Proposed § 507.25(b)(4)—Frozen Raw
Materials (Final § 507.25(b)(3))
Q. Proposed § 507.25(c)(1)—Appropriate
Conditions for Animal Food
R. Proposed § 507.25(c)(2)—Control of
Undesirable Microorganisms
S. Proposed § 507.25(c)(3)—Work-inProcess and Rework
T. Proposed § 507.25(c)(4)—Processing
Steps
U. Proposed § 507.25(c)(5)—Processing
Operations
V. Proposed § 507.25(c)(6)—Controlling
Water Activity (aw)
W. Proposed § 507.25(c)(7)—Controlling
pH
X. Proposed § 507.25(c)(8)—Ice
XXI. Subpart B: Comments on Proposed
§ 507.27—Holding and Distribution
A. Proposed § 507.27(a)—Holding and
Distribution
B. Proposed § 507.27(a)(1)—Containers
C. Proposed § 507.27(a)(2)—Protection
From Contamination
D. Proposed § 507.27(a)(3)—Labeling of
Animal Food Held for Distribution (Final
§ 507.27(b))
E. Proposed § 507.27(b)—Shipping
Containers (Final § 507.27(c))
F. Proposed § 507.27(c)—Returned Animal
Food (Final § 507.27(d))
G. Proposed § 507.27(d)—Unpackaged Bulk
Animal Food (Final § 507.27(e))
XXII. Subpart B: Comments on Proposed
§ 507.28—Holding and Distribution of
Human Food By-Products for Use as
Animal Food
A. Proposed § 507.28(a)—Contamination
B. Proposed § 507.28(a)(1)—Containers
C. Proposed § 507.28(a)(2)—Protection
From Contamination
D. Proposed § 507.28(a)(3)—Labeling
E. Proposed § 507.28(b)—Shipping
Containers
XXIII. Subpart C: Comments on Overall
Framework for Hazard Analysis and
Risk-Based Preventive Controls
XXIV. Subpart C: Comments on Proposed
§ 507.31—Food Safety Plan
A. Proposed § 507.31(a)—Requirement for
a Food Safety Plan
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B. Proposed § 507.31(b)—Preparation of the
Food Safety Plan by a Preventive
Controls Qualified Individual
C. Proposed § 507.31(c)—Contents of a
Food Safety Plan
D. Proposed § 507.31(d)—Records
E. Comments on Potential Requirements
for Submission of a Facility Profile to
FDA
XXV. Subpart C: Comments on Proposed
§ 507.33—Hazard Analysis
A. Proposed § 507.33(a)—Requirement for
a Written Hazard Analysis
B. Proposed § 507.33(b)—Hazard
Identification
C. Proposed § 507.33(c) and (d)—
Evaluation of Whether a Hazard Requires
a Preventive Control
XXVI. Subpart C: Comments on Proposed
§ 507.36—Preventive Controls (Final
§ 507.34)
A. Proposed § 507.36(a)—Requirement To
Identify and Implement Preventive
Controls (Final § 507.34(a))
B. Proposed § 507.36(b)—Requirement for
Written Preventive Controls (Final
§ 507.34(b))
C. Proposed § 507.36(c)(1)—Process
Controls (Final § 507.34(c)(1))
D. Proposed § 507.36(c)(2)—Sanitation
Controls (Final § 507.34(c)(2))
E. Proposed § 507.36(c)(3)—Supply-Chain
Controls (Final § 507.34(c)(3))
F. Proposed § 507.36(c)(4)—Recall Plan
(Final § 507.34(c)(4))
G. Proposed § 507.36(c)(5)—Other Controls
(Final § 507.34(c)(5))
XXVII. Subpart C: Circumstances in Which
the Owner, Operator, or Agent in Charge
of a Manufacturing/Processing Facility Is
Not Required To Implement a Preventive
Control (Final §§ 507.36 and 507.37)
XXVIII. Subpart C: Comments on Proposed
§ 507.38—Recall Plan
A. Proposed § 507.38(a)—Requirement for
a Written Recall Plan
B. Proposed § 507.38(b)—Procedures That
Describe the Steps To Be Taken, and
Assign Responsibility for Taking Those
Steps
XXIX. Comments on Proposed § 507.39—
Preventive Control Management
Components
A. Proposed § 507.39(a)—Flexible
Requirements for Monitoring, Corrective
Actions and Corrections, and
Verification
B. Proposed § 507.39(b)—Applicability of
Preventive Control Management
Components to Supply-Chain Program
C. Proposed § 507.39(c)—Recall Plan is Not
Subject to Preventive Control
Management Components
XXX. Subpart C: Comments on Proposed
§ 507.40—Monitoring
A. Our Tentative Conclusion To Require
Monitoring of the Performance of
Preventive Controls
B. Proposed § 507.40(a) and (b)—Flexibility
in Requirements for Monitoring
C. Proposed § 507.40(c)—Records
XXXI. Subpart C: Comments on Proposed
§ 507.42—Corrective Actions and
Corrections
A. Proposed § 507.42(a)(1)(i)—Requirement
To Establish and Implement Corrective
Action Procedures
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B. Proposed § 507.42(a)(2)—Content of
Corrective Action Procedures
C. Proposed § 507.42(b)—Corrective Action
in the Event of an Unanticipated
Problem
D. Proposed § 507.42(c)—Corrections
E. Proposed § 507.42(d)—Records
XXXII. Subpart C: Comments on Proposed
§ 507.45—Verification
A. Flexibility in Requirements for
Verification
B. Proposed § 507.45(a)—Verification
Activities
C. Proposed § 507.45(b)—Documentation of
Verification Activities
D. Comments on Potential Requirements
Regarding Complaints
XXXIII. Subpart C: Comments on Proposed
§ 507.47—Validation
A. Flexibility in the Requirements To
Validate Preventive Controls
B. Proposed § 507.47(b)(1)—When
Validation Must Be Performed and Role
of Preventive Controls Qualified
Individual in Validation
C. Proposed § 507.47(b)(2)—What
Validation Must Include
D. Proposed § 507.47(b)(3)—Preventive
Controls for Which Validation Is Not
Required
XXXIV. Subpart C: Comments on Proposed
§ 507.49—Verification of Implementation
and Effectiveness
A. Flexibility in the Requirements To
Conduct Activities To Verify
Implementation and Effectiveness
B. Proposed § 507.49(a)(1)—Calibration
C. Comments Directed to Proposed
Requirements for Both Product Testing
(Proposed § 507.49(a)(2) and (b)(2)) and
Environmental Monitoring (Proposed
§ 507.49(a)(3) and (b)(3))
D. Proposed § 507.49(a)(2)—Product
Testing
E. Proposed § 507.49(a)(3)—Environmental
Monitoring
F. Proposed § 507.49(a)(4)—Review of
Records
G. Proposed § 507.49(b)—Written
Procedures
XXXV. Subpart C: Comments on Proposed
§ 507.50—Reanalysis
A. Proposed § 507.50(a)—Circumstances
Requiring Reanalysis
B. Proposed § 507.50(b)—Timeframe To
Complete Reanalysis
C. Proposed § 507.50(c)—Requirement To
Revise the Written Food Safety Plan or
Document Why Revisions Are Not
Needed
D. Proposed § 507.50(d) —Requirement for
Oversight of Reanalysis by a Preventive
Controls Qualified Individual
E. Proposed § 507.50(e)—Reanalysis on the
Initiative of FDA
XXXVI. Subpart C: Comments on Proposed
§ 507.51—Modified Requirements That
Apply to a Facility Solely Engaged in the
Storage of Unexposed Packaged Animal
Food
A. Proposed § 507.51(a)—Modified
Requirements for Unexposed
Refrigerated Packaged Animal Food That
Requires Time/Temperature Controls
B. Proposed § 507.51(b)—Records
XXXVII. Subpart C: Comments on Proposed
§ 507.53—Requirements Applicable to a
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Preventive Controls Qualified Individual
and a Qualified Auditor
A. Proposed § 507.53(a) and (b)—What a
Preventive Controls Qualified Individual
or Qualified Auditor Must Do or Oversee
B. Proposed § 507.53(c)—Qualification
Requirements
C. Proposed § 507.53(d)—Records
XXXVIII. Subpart C: Comments on Proposed
§ 507.55—Implementation Records
XXXIX. Subpart D: Comments on Proposed
New Provisions for Withdrawal of a
Qualified Facility Exemption
A. Proposed § 507.60—Circumstances That
May Lead FDA To Withdraw a Qualified
Facility Exemption
B. Proposed § 507.62—Issuance of an Order
To Withdraw a Qualified Facility
Exemption
C. Proposed § 507.65—Contents of an
Order To Withdraw a Qualified Facility
Exemption
D. Proposed § 507.67—Compliance With,
or Appeal of, an Order To Withdraw a
Qualified Facility Exemption
E. Proposed § 507.69—Procedure for
Submitting an Appeal
F. Proposed § 507.71—Procedure for
Requesting an Informal Hearing
G. Proposed § 507.73—Requirements
Applicable to an Informal Hearing
H. Proposed § 507.85—Reinstatement of a
Qualified Facility Exemption That Was
Withdrawn
I. Conforming Amendment to 21 CFR Part
16
J. Other Comments on the Withdrawal
Provisions
XL. Subpart E: General Comments on
Proposed Requirements Applicable to a
Supply-Chain Program
XLI. Subpart E: Comments on Requirement
To Establish and Implement a SupplyChain Program
A. Requirement for a Written Supply-Chain
Program (Final § 507.105(a)(1) and (b))
B. Circumstances That Do Not Require a
Written Supply-Chain Program (Final
§ 507.105(a)(2))
C. Exemption for Animal Food Supplied
for Research or Evaluation (Final
§ 507.105(a)(3))
D. Additional Requirements for NonSuppliers (Final § 507.105(c))
E. Proposed General Requirements for the
Supply-Chain Program That We Are Not
Including in the Final Rule (Proposed
§ 507.37(a)(4) and (5))
XLII. Subpart E: Comments on General
Requirements for the Supply-Chain
Program
A. Description of What the Supply-Chain
Program Must Include (Final
§ 507.110(a))
B. Appropriate Supplier Verification
Activities ((Final § 507.110(b))
C. Purpose of Supplier Verification
Activities for Raw Materials and Other
Ingredients (Final § 507.110(c))
D. Factors That Must Be Considered When
Approving Suppliers and Determining
Appropriate Supplier Verification
Activities for Raw Materials and Other
Ingredients (Final § 507.110(d))
E. Supplier Non-Conformance (Final
§ 507.110(e))
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XLIII. Subpart E: New Requirement
Specifying the Responsibilities of the
Receiving Facility (Final § 507.115)
XLIV. Subpart E: Comments on Using
Approved Suppliers and Determining
Appropriate Supplier Verification
Activities
A. Using Approved Suppliers (Final
§ 507.120)
B. Determining Appropriate Verification
Activities (Final § 507.125)
XLV. Subpart E: Comments on Conducting
Supplier Verification Activities for Raw
Materials and Other Ingredients
A. Requirement To Conduct One or More
Supplier Verification Activities (Final
§ 507.130(a))
B. Requirement for an Onsite Audit as a
Verification Activity When a Hazard Has
a Reasonable Probability of Resulting in
Serious Adverse Health Consequences or
Death to Humans or Animals (Final
§ 507.130(b))
C. Alternative Verification Activity When
the Supplier Is a Qualified Facility (Final
§ 507.130(c))
D. Alternative Verification Activity When
the Supplier Is a Produce Farm That Is
Not a ‘‘Covered Farm’’ for the Purposes
of the Future Produce Safety Rule (Final
§ 507.130(d))
E. Alternative Verification Activity When
the Supplier Is a Shell Egg Producer That
Has Less Than 3,000 Laying Hens (Final
§ 507.130(e))
F. Independence of Persons Who Conduct
Supplier Verification Activities (Final
§ 507.130(f))
XLVI. Subpart E: Comments on Onsite Audit
A. Requirements Applicable to an Onsite
Audit (Final § 507.135(a) and (b))
B. Substitution of Inspection by FDA or an
Officially Recognized or Equivalent Food
Safety Authority
C. Onsite Audit by a Third-Party Auditor
Accredited for the Purposes of Section
808 of the FD&C Act
XLVII. Subpart E: Comments on Records
Documenting the Supply-Chain Program
A. Applicability of the Recordkeeping
Requirements of Subpart F (Final
§ 507.175(a))
B. Requirement To Review Records of the
Supply-Chain Program (Final
§ 507.175(b))
C. Documentation Demonstrating Use of
the Written Procedures for Receiving
Raw Materials and Other Ingredients
(Final § 507.175(c)(5))
D. Documentation of the Conduct of an
Onsite Audit (Final § 507.175(c)(7))
E. Documentation of Sampling and Testing
(Final § 507.175(c)(8))
F. Documentation of Other Appropriate
Supplier Verification Activity (Final
§ 507.175(c)(10))
G. Documentation of an Alternative
Verification Activity for a Supplier That
Is a Farm That Is Not a ‘‘Covered Farm’’
for the Purposes of the Future Produce
Safety Rule (Final § 507.175(c)(13))
XLVIII. Subpart F: Comments on Proposed
New Recordkeeping Requirements
A. Proposed § 507.200—Records Subject to
the Requirements of Subpart F and
Requirements for Official Review
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B. Proposed § 507.202—General
Requirements Applying to Records
C. Proposed § 507.206—Additional
Requirements Applying to the Food
Safety Plan
D. Proposed § 507.208—Requirements for
Record Retention
E. Proposed § 507.212—Use of Existing
Records
F. Final § 507.215—Special Requirements
Applicable to a Written Assurance
XLIX. Comments by Foreign Governments
and Foreign Businesses
L. Editorial and Conforming Changes
LI. Comments on FSMA’s Rulemaking
Provisions
A. Comments on Section 418(m) of the
FDA&C Act Regarding Modified
Requirements for Facilities Solely
Engaged in the Production of Food for
Animals Other Than Man
B. Comments on Requirements in Section
418(n)(3) of the FD&C Act Regarding
Content
LII. Comments on Proposed Conforming
Amendments
LIII. Effective and Compliance Dates
A. Effective and Compliance Dates for Part
507
B. Effective Dates for Conforming
Amendments
C. Delayed Effective Dates for Provisions
That Refer to the Forthcoming Rules for
Produce Safety and Third-Party
Certification
LIV. Compliance and Enforcement
LV. Executive Order 13175
LVI. Economic Analysis of Impacts
LVII. Analysis of Environmental Impact
LVIII. Paperwork Reduction Act of 1995
LIX. Federalism
LX. References
Executive Summary
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Purpose and Coverage of the Rule
This rule is part of FDA’s
implementation of FSMA, which
intends to better protect public (human
and animal) health by, among other
things, adopting a modern, preventive,
and risk-based approach to food safety
regulation. This rule establishes new
requirements for the production of
animal food by registered food facilities
in two ways.
First, this rule creates new CGMP
regulations that specifically address the
manufacturing, processing, packing, and
holding of food for animals. These
requirements apply to establishments
that are required to register with FDA as
a food ‘‘facility.’’ Second, this rule
creates new requirements for certain
domestic and foreign facilities to
establish and implement hazard
analysis and risk-based preventive
controls for food for animals. As with
the CGMPs, these requirements apply to
establishments that are required to
register with FDA as a food facility. This
portion of the rule requires registered
animal food facilities to maintain a food
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safety plan, perform a hazard analysis,
and institute preventive controls for the
mitigation of those hazards, unless an
exemption applies. Facilities must also
monitor their controls, conduct
verification activities to ensure the
controls are effective, take appropriate
corrective actions, and maintain records
documenting these actions.
This final rule is the result of
significant stakeholder engagement,
beginning before the proposed rule. In
response to extensive stakeholder input
on the proposed rule, we revised key
provisions in a supplemental notice of
proposed rulemaking. After the
supplemental notice of proposed
rulemaking, we conducted even more
outreach to the stakeholder community
to ensure that the risk-based, preventive
requirements in this final rule are
practical and protective of public
(human and animal) health.
Summary of the Major Provisions of the
Rule
The final rule establishes CGMP
provisions to ensure the safety and
suitability of animal food. Specifically,
the rule establishes requirements in the
following areas:
• Personnel;
• Plant and grounds;
• Sanitation;
• Water supply and plumbing;
• Equipment and utensils;
• Plant operations;
• Holding and distribution; and
• Holding and distribution of human
food by-products for use as animal food.
We have added flexibility and clarity
to the CGMPs in response to comments.
These CGMPs establish baseline
standards for producing safe animal
food that take into consideration the
unique aspects of the animal food
industry and provide flexibility for the
wide diversity in types of animal food
facilities. In addition, the CGMPs in this
final regulation allow human food
facilities subject to and in compliance
with CGMPs for human food and in
compliance with all applicable FDA
human food safety requirements to only
follow the specific CGMPs for the
holding and distribution of human food
by-products for use as animal food, as
long as they do not further process the
by-product. Under this final rule, all
other requirements of part 507,
including the hazard analysis,
preventive controls and supply-chain
program provisions, would not apply to
these by-products of human food
production.
The final rule implements the
requirements of FSMA for covered
facilities to establish and implement a
food safety system that includes a
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56173
hazard analysis and risk-based
preventive controls. Specifically, the
rule establishes requirements for:
• A written food safety plan;
• Hazard analysis;
• Preventive controls;
• Monitoring;
• Corrective actions and corrections;
• Verification;
• Supply-chain program;
• Recall plan; and
• Associated records.
We have added flexibility and clarity
to these provisions in response to
comments. Although there are
similarities between these requirements
of FSMA and the requirements of food
safety systems known as Hazard
Analysis and Critical Control Point
(HACCP) systems, not every provision
in FSMA is identical to the provisions
of HACCP systems, and we have revised
much of our terminology to distinguish
FSMA’s requirements for hazard
analysis and risk-based preventive
controls from HACCP requirements. A
facility subject to the rule must conduct
a hazard analysis to identify and
evaluate known or reasonably
foreseeable hazards for each type of
animal food manufactured, processed,
packed, or held at the facility to
determine whether there are any
hazards requiring preventive controls.
The first step of a hazard analysis is
hazard identification, which must
consider known or reasonably
foreseeable hazards, including
biological, chemical, and physical
hazards. The hazard analysis must
consider hazards that may be present in
the animal food because they occur
naturally, are unintentionally
introduced, or are intentionally
introduced for purposes of economic
gain. We continue to believe that
hazards that may be intentionally
introduced for economic gain will need
preventive controls in rare
circumstances, usually in cases where
there has been a pattern of economically
motivated adulteration in the past.
Economically motivated adulteration
that affects product integrity or quality,
for example, but not animal food safety,
is out of the scope of this rule.
A facility subject to the rule must
identify and implement preventive
controls to provide assurances that any
hazards requiring a preventive control
will be significantly minimized or
prevented and the animal food
manufactured, processed, packed, or
held by the facility will not be
adulterated. The rule establishes
preventive control management
components (monitoring, corrective
actions and corrections, and
verification) as appropriate to ensure the
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effectiveness of the preventive controls.
One way we have clarified the riskbased flexibility of these requirements is
by clearly stating in the final rule that
a facility must take into account the
nature of the preventive control and the
facility’s food safety system when
considering which activities are
appropriate for that facility.
We have also added flexibility and
made risk-based modifications for
specific preventive control management
components. For example, the final rule
allows flexibility for the specific records
required to document monitoring of
refrigeration controls during storage of
an animal food that requires time/
temperature control for safety. These
records can be either affirmative records
demonstrating temperature is controlled
or ‘‘exception records’’ demonstrating
loss of temperature control. As another
example, the rule includes tailored, less
burdensome requirements for
corrections. A correction is defined in
this rule as an action to identify and
correct a problem that occurred during
the production of animal food, without
other actions associated with a
corrective action procedure (such as
actions to reduce the likelihood that the
problem will recur, evaluate all affected
food for safety, and prevent affected
animal food from entering commerce).
The final rule clarifies that corrections
must be taken in a timely manner and
must be recorded when appropriate, but
they do not, for example, need to be
included in a written plan or
accompanied by a reanalysis of the
written food safety plan.
As a third example, the final rule
provides flexibility for which
verification activities must occur. In
general, a facility is required to conduct
verification activities, as appropriate to
the nature of the preventive control and
its role in the facility’s food safety
system, including validation,
verification of monitoring, verification
of corrective actions, verification of
implementation and effectiveness, and
reanalysis. Validation is not required for
all controls. For example, the rule
specifies that validation is not required
for certain types of preventive controls
(i.e., sanitation controls, supply-chain
controls, and the recall plan) and
provides flexibility for the facility to not
validate other preventive controls with
a written justification based on factors
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such as the nature of the hazard, and the
nature of the preventive control and its
role in the facility’s food safety system.
Product testing and environmental
monitoring are listed as possible
verification activities, but, like other
preventive control management
components in general, they are only
required as appropriate to the animal
food, facility, the nature of the
preventive control, and the preventive
control’s role in the facility’s food safety
system. In many cases, neither product
testing nor environmental monitoring
will be appropriate. For example, there
would be little or no benefit to product
testing or environmental monitoring in
facilities that pack or hold raw
agricultural commodities that are rarely
consumed unprocessed, such as
soybeans.
A facility must reanalyze the food
safety plan as a whole at least once
every 3 years. The final rule provides
the flexibility for a facility to only
reanalyze the applicable portion of the
food safety plan under certain other
circumstances, such as when a facility
becomes aware of new information
about potential hazards associated with
an animal food.
The final rule also adds flexibility to
the preventive controls requirements
and recognizes the reality of modern
distribution chains by not requiring a
manufacturing/processing facility to
implement a preventive control in
certain circumstances when the hazard
requiring a preventive control will be
controlled by another entity in the
distribution chain. For example, if a
facility’s customer (or another entity in
the distribution chain) will control the
hazard, then that facility can rely on its
customer to provide written assurance
that the identified hazard will be
controlled by an entity in the
distribution chain, with flexibility for
how the customer provides that written
assurance depending on whether the
customer, or an entity subsequent to the
customer, will control the hazard. We
have identified four specific
circumstances in which a
manufacturing/processing facility can
rely on another entity in the distribution
chain to control a hazard, with practical
solutions explained further in section
XXVII. We also have provided flexibility
for a facility to establish, document, and
implement an alternative system that
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ensures adequate control, at a later
distribution step, of the hazards in the
food product distributed by a
manufacturing/processing facility such
that the facility would not need to
implement a preventive control.
We revised the proposed provisions
for a supplier program to add flexibility,
recognizing that the receiving facility
and the supplier may be separated by
several entities in a supply chain. We
are allowing entities such as
distributors, brokers, and aggregators to
determine, conduct, and document
appropriate supplier verification
activities as a service to the receiving
facility, provided that the receiving
facility reviews and assesses applicable
documentation provided by the other
entity and documents that review and
assessment. However, because the
approval of suppliers is ultimately the
responsibility of the receiving facility,
the rule specifies that only a receiving
facility can approve suppliers. To
improve clarity and readability we
redesignated the proposed provisions
into eight distinct sections of regulatory
text in a newly established subpart E
(Supply-Chain Program).
Each facility subject to the rule must
have a recall plan for an animal food
with a hazard requiring a preventive
control.
Many activities required by the final
rule must be conducted (or overseen) by
a preventive controls qualified
individual, a new term we are coining
here. A preventive controls qualified
individual is a qualified individual who
has successfully completed certain
training in the development and
application of risk-based preventive
controls or is otherwise qualified
through job experience to develop and
apply a food safety system.
The rule establishes several
exemptions (including modified
requirements in some cases) from the
requirements for hazard analysis and
risk-based preventive controls. All of
these exemptions are expressly
authorized by FSMA. A facility that
manufactures, processes, packs, or holds
food and that is required to register with
FDA would be required to comply with
the requirements for hazard analysis
and risk-based preventive controls
unless it is covered by an exemption, as
shown in the following table.
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56175
PROPOSED EXEMPTIONS FROM THE NEW REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE
CONTROLS
Who or what is exempt from the requirements for hazard analysis and
risk-based preventive controls
Notes
‘‘Qualified Facility’’ as defined by FSMA:
Business with average annual sales of <$500,000 and at least half
the sales to consumers or local retailers or restaurants (within
the same state or within 275 miles); or
• Very small business, which the rule defines as a business
(including any subsidiaries or affiliates) averaging less than
$2,500,000, adjusted for inflation, per year, during the 3year period preceding the applicable calendar year in sales
of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held
for a fee or supplied to a farm without sale)
• Low-risk, on-farm activities performed by small business (<500 fulltime equivalent employees).
Modified requirements apply—i.e., a qualified facility is required to:
• Notify FDA about its status and either:
Æ Notify FDA that it is addressing hazards through preventive
controls and monitoring; or
Æ Notify FDA that it complies with applicable non-Federal food
safety regulations, and notify consumers of the name and
complete business address of the facility where the animal
food was manufactured or processed.
• The notification is in the form of an attestation, and must be
submitted every 2 years, during the same timeframe as the facility is required to update its facility registration.
Small and very small on-farm businesses conducting only the specified
low-risk activities are exempt from the requirements for hazard analysis and risk-based preventive controls.
-or• Low-risk, on-farm activities performed by a very small business (dollar threshold of $2,500,000, as described previously).
Activities that are subject to the ‘‘low-acid canned food’’ requirements
of part 113 (21 CFR part 113).
Activities of a facility that are subject to section 419 of the Federal
Food, Drug, and Cosmetic Act (Standards for Produce Safety) (21
U.S.C. 350h).
Facilities that are solely engaged in the storage of raw agricultural
commodities (other than fruits and vegetables) intended for further
distribution or processing.
A facility solely engaged in the storage of unexposed packaged animal
food that does not require time/temperature control to significantly
minimize or prevent the growth of, or toxin production by, pathogens.
We define the low-risk, on-farm activities that qualify for the exemption,
including the specific animal foods to which they relate (such as repacking roughage products, or cracking grains).
• The exemption applies only with respect to microbiological hazards
regulated under part 113.
• The facility must be in compliance with part 113.
These activities will be established in FDA’s forthcoming rule for
produce safety.
A facility that stores raw agricultural commodities that are fruits and
vegetables is not exempt.
The rule includes procedures for
withdrawing a qualified facility
exemption, in the event of an active
investigation of a foodborne illness
outbreak that is directly linked to the
facility, or if FDA determines that it is
necessary to protect the public (human
and animal) health and prevent or
mitigate a foodborne illness outbreak
based on relevant conditions or conduct
associated with the qualified facility.
The final rule provides procedures for a
facility to appeal an order to withdraw
a qualified facility exemption, for a
facility to request an informal hearing,
for the conduct of an informal hearing,
for an appeal, for revoking an order to
withdraw a qualified facility exemption,
Modified requirements apply for the storage of unexposed packaged
animal food that requires time/temperature control to significantly
minimize or prevent the growth of, or toxin production by, pathogens.
and for reinstating an exemption that
was withdrawn.
The rule finalizes recordkeeping
provisions associated with the new
provisions for hazard analysis and riskbased preventive controls. These
records allow facilities to show, and
FDA to determine, compliance with the
new requirements. To meet these
requirements, a facility may use existing
records as appropriate.
Costs and Benefits
This final regulation requires
domestic and foreign facilities to adopt
a food safety plan, perform a hazard
analysis, and to institute preventive
controls for the mitigation of those
hazards identified as requiring a
preventive control. It also includes
requirements for facilities to institute
risk-based environmental monitoring,
product testing, and a supply-chain
program as appropriate to the animal
food, the facility and the nature of the
preventive controls, as well as a
requirement to institute controls to help
prevent hazards associated with
economically motivated adulteration.
The total annualized costs are estimated
at $139.0 to $170.7 million per year
(over 10 years at a 7 percent discount
rate), and $135.6 to $166.7 million per
year (over 10 years at a 3 percent
discount rate). The total annualized
benefits to pets are estimated at $10.1–
$138.0 million.
ESTIMATED TOTAL COSTS AND BENEFITS
[Millions]
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One-time
Total Costs .......................................................................
Total Benefits to Pets ......................................................
Annual
$135.6 to $160.1
2 N/A
$119.7 to $147.9
$10.1 to $138.0
Total
annualized
cost at 7% 1
$139.0 to $170.7
$10.1 to $138.0
1 Total
2 N/A
annualized cost equal to annualized one-time cost plus annual cost.
= Not applicable
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Total
annualized
cost at 3% 1
$135.6 to $166.7
$10.1 to $138.0
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TABLE OF ABBREVIATIONS AND ACRONYMS
Abbreviation/Acronym
What it means
AAFCO ................................................................
AFSS ...................................................................
BAM ....................................................................
Bioterrorism Act ..................................................
Association of American Feed Control Officials.
Animal Feed Safety System.
Bacteriological Analytical Method.
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L.
107–188).
Critical Control Point.
Code of Federal Regulations.
Current Good Manufacturing Practice.
Codex Alimentarius Commission.
Compliance Policy Guide.
Center for Veterinary Medicine.
U.S. Environmental Protection Agency.
European Union.
U.S. Food and Drug Administration.
Federal Food, Drug, and Cosmetic Act.
Freedom of Information Act.
Food Safety and Inspection Service of the U.S. Department of Agriculture.
FSIS’ Compliance Guidelines on HACCP Systems Validation.
FDA Food Safety Modernization Act.
Food Safety Preventive Controls Alliance.
Foreign Supplier Verification Programs.
Good Agricultural Practices.
Global Food Safety Initiative.
Generally Recognized as Safe.
Hazard Analysis and Critical Control Point.
U.S. Department of Health and Human Services.
International Organization for Standardization.
Thermally processed low-acid foods packaged in hermetically sealed contain (commonly called
‘‘low-acid canned foods’’).
Not Applicable.
The National Advisory Committee on Microbiological Criteria for Foods (advisory committee
chartered under the USDA).
National Institute of Food and Agriculture of the U.S. Department of Agriculture.
Office of Management and Budget.
British Standards Institute ‘‘Publically Available Specification 222:2011’’.
Partnership for Food Protection.
Public Health Service Act.
Paperwork Reduction Act.
Protein Surveillance Assignment.
Risk Assessment.
Raw Agricultural Commodity.
Reportable Food Registry.
Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside
the Farm Definition) Conducted in a Facility Co-Located on a Farm.
Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the
Farm Definition) Conducted in a Facility Co-Located on a Farm (Final).
Time/Temperature Control for Safe Animal Food.
U.S. Department of Agriculture.
CCP ....................................................................
CFR .....................................................................
CGMP .................................................................
Codex ..................................................................
CPG ....................................................................
CVM ....................................................................
EPA .....................................................................
EU .......................................................................
FDA .....................................................................
FD&C Act ............................................................
FOIA ....................................................................
FSIS ....................................................................
FSIS Validation Guidelines .................................
FSMA ..................................................................
FSPCA ................................................................
FSVP ...................................................................
GAP ....................................................................
GFSI ....................................................................
GRAS ..................................................................
HACCP ...............................................................
HHS ....................................................................
ISO ......................................................................
LACF ...................................................................
N/A ......................................................................
NACMCF .............................................................
NIFA ....................................................................
OMB ....................................................................
PAS .....................................................................
PFP .....................................................................
PHS .....................................................................
PRA .....................................................................
PSA .....................................................................
RA .......................................................................
RAC ....................................................................
RFR .....................................................................
Section 103(c)(1)(C) draft RA .............................
Section 103(c)(1)(C) RA .....................................
TCS .....................................................................
USDA ..................................................................
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I. Background
A. FDA Food Safety Modernization Act
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353), signed
into law by President Obama on January
4, 2011, is intended to allow FDA to
better protect public (human and
animal) health by helping to ensure the
safety and security of the food supply.
FSMA enables us to focus more on
preventing food safety problems rather
than relying primarily on reacting to
problems after they occur. The law also
provides new enforcement authorities to
help achieve higher rates of compliance
with risk-based, prevention-oriented
safety standards and to better respond to
and contain problems when they do
occur. In addition, the law contains
important new tools to better ensure the
safety of imported foods and encourages
partnerships with State, local, tribal,
and territorial authorities. A top priority
for FDA are those FSMA-required
regulations that provide the framework
for industry’s implementation of
preventive controls and enhance our
ability to oversee their implementation
for both domestic and imported animal
food. To that end, we proposed the
seven foundational rules listed in table
1 and requested comments on all
aspects of these proposed rules.
TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA
Title
Abbreviation
Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Food for Animals.
2013 proposed rule for preventive
controls for animal food.
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Publication
78 FR 64736, October 29, 2013.
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TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA—Continued
Title
Abbreviation
Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food.
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption.
Foreign Supplier Verification Programs (FSVP) for Importers of Food
for Humans and Animals.
Accreditation of Third-Party Auditors/Certification Bodies to Conduct
Food Safety Audits and to Issue Certifications.
Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration.
Sanitary Transportation of Human and Animal Food .............................
2013 proposed rule for preventive
controls for human food.
2013 proposed produce safety rule
78 FR 3504, January 16, 2013.
2013 proposed FSVP rule .............
78 FR 45730, July 29, 2013.
2013 proposed third-party certification rule.
2013 proposed intentional adulteration rule (human food only).
2014 proposed sanitary transportation rule.
78 FR 45782, July 29, 2013.
We also issued a supplemental notice
of proposed rulemaking for the rules
listed in table 2 and requested
comments on specific issues identified
Publication
78 FR 3646, January 16, 2013.
78 FR 78014, December 24, 2013.
79 FR 7006, February 5, 2014.
in each supplemental notice of
proposed rulemaking.
TABLE 2—PUBLISHED SUPPLEMENTAL NOTICES OF PROPOSED RULEMAKING FOR THE FOUNDATIONAL RULES FOR
IMPLEMENTATION OF FSMA
Abbreviation
Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Food for Animals.
Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food.
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption.
Foreign Supplier Verification Programs (FSVP) for Importers of Food
for Humans and Animals.
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Title
2014 supplemental notice .............
As FDA finalizes these seven
foundational rulemakings, we are
putting in place a framework for food
safety that is modern and brings to bear
the most recent science on provisions to
enhance food safety, that is risk-based
and focuses effort where the hazards are
reasonably likely to occur, and that is
flexible and practical given our current
knowledge of food safety practices. To
achieve this, FDA has engaged in a great
deal of outreach to the stakeholder
community to find the right balance in
these regulations of flexibility and
accountability.
Since FSMA was enacted in 2011, we
have been involved in approximately
600 engagements on FSMA and the
proposed rules, including public
meetings, Webinars, listening sessions,
farm tours, and extensive presentations
and meetings with various stakeholder
groups (Refs. 1 and 2). As a result of this
stakeholder dialogue, FDA decided to
issue the four supplemental notices of
proposed rulemaking to share our
thinking on key issues and get
additional stakeholder input on those
issues. As we move forward into the
next phase of FSMA implementation,
we intend to continue this dialogue and
collaboration with our stakeholders,
through guidance, education, training,
and assistance, to ensure that everyone
understands and engages in their role in
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2014 supplemental human preventive controls notice.
2014 supplemental produce safety
notice.
2014 supplemental FSVP notice ...
food safety. FDA believes these seven
foundational final rules, when
implemented, will fulfill the paradigm
shift toward prevention that was
envisioned in FSMA and be a major step
forward for food safety that will protect
consumers into the future.
B. Stages in the Rulemaking for the
Animal Food Preventive Controls Rule
With regard to this rulemaking, we
published proposed provisions in the
2013 proposed animal food preventive
controls rule and we published new and
re-proposed provisions in the 2014
supplemental notice. In the 2014
supplemental notice, we reopened the
comment period only with respect to
specific proposed provisions. In
addition, we emphasized that the reproposed provisions we included in the
regulatory text were based on a
preliminary review of the comments.
In this document, we use the broad
term ‘‘proposed animal food preventive
controls rule’’ to refer to the complete
proposed regulatory text, including both
the proposed provisions we published
in the 2013 proposed animal food
preventive controls rule and the new
and re-proposed provisions we
published in the 2014 supplemental
notice. We use the narrow terms ‘‘2013
proposed preventive controls rule for
animal food’’ and ‘‘2014 supplemental
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79 FR
2014.
79 FR
2014.
79 FR
2014.
79 FR
2014.
58476, September 29,
58524, September 29,
58434, September 29,
58574, September 29,
notice’’ to refer to specific text
published in the Federal Register of
October 29, 2013 (78 FR 64736) and
September 29, 2014 (79 FR 58476),
respectively. We use the terms ‘‘final
preventive controls rule for animal
food’’ and ‘‘this rule’’ to refer to the
regulations we are establishing as a
result of this rulemaking.
C. Summary of the Major Provisions of
Proposed Rule for Preventive Controls
for Food for Animals
As part of our implementation of new
statutory provisions in FSMA, we
proposed to add, in newly established
part 507, regulations for CGMPs. In
addition, we proposed to add
requirements for certain domestic and
foreign facilities to establish and
implement hazard analysis and riskbased preventive controls for food for
animals. As directed by FSMA (see
section 418 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
350g)), these new provisions would
apply to domestic and foreign facilities
that are required to register under
section 415 of the FD&C Act (21 U.S.C.
350d) and our regulation for
Registration of Food Facilities (21 CFR
part 1, subpart H; the section 415
registration regulations). As directed by
FSMA (see section 418(l) and (m) of the
FD&C Act), we proposed to establish
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modified requirements for certain
facilities. We requested comment on all
aspects of the proposed requirements,
including an opportunity for public
comment on potential requirements for
product testing, environmental
monitoring, a supplier program, and
hazards that may be intentionally
introduced for purposes of economic
gain.
We proposed to establish the
requirements for CGMPs, for hazard
analysis and risk-based preventive
controls, and related requirements in
new 21 CFR 507 as shown in table 3:
TABLE 3—PROPOSED SUBPARTS IN
NEW PART 507
Subpart
Title
A ............
B ............
General Provisions.
Current
Good
Manufacturing
Practice.
Hazard Analysis and Risk-Based
Preventive Controls.
Withdrawal of an Exemption Applicable to a Qualified Facility.
Reserved.
Requirements
Applying
to
Records That Must be Established and Maintained.
C ............
D ............
E ............
F .............
D. Draft Risk Assessment
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We issued for public comment a
‘‘Draft Qualitative Risk Assessment of
Risk of Activity/Animal Food
Combinations for Activities (Outside the
Farm Definition) Conducted in a
Facility Co-Located on a Farm’’ (the
section 103(c)(1)(C) draft risk
assessment (RA)) (78 FR 64428, October
29, 2013). The purpose of the section
103(c)(1)(C) draft RA was to provide a
science-based risk analysis of those
activity/animal food combinations that
would be considered low risk when
conducted in a facility co-located on a
farm. We used the tentative conclusions
of the section 103(c)(1)(C) draft RA to
propose to exempt food facilities that
are small or very small businesses that
are engaged only in specific types of onfarm manufacturing, processing,
packing, or holding activities from the
requirements for hazard analysis and
risk-based preventive controls. We are
including the final risk assessment (the
section 103(c)(1)(C) RA) in the docket
established for this document (Ref. 3).
E. Public Comments
We received more than 2400 public
submissions on the 2013 proposed
preventive controls rule for animal food,
and more than 140 public submissions
on the 2014 preventive controls
supplement notice, each containing one
or more comments. We received
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submissions from diverse members of
the public, including animal food
facilities (including facilities co-located
on a farm); farms; cooperatives;
coalitions; trade organizations;
consulting firms; law firms; academia;
public health organizations; public
advocacy groups; consumers; pet
owners, consumer groups; Congress,
Federal, State, local, and foreign
Government Agencies; and other
organizations. Some submissions
included signatures and statements from
multiple individuals. Comments
address virtually every provision of the
proposed animal preventive controls
rule. In the remainder of this document,
we describe these comments, respond to
them, and explain any revisions we
made to the proposed preventive
controls rule for animal food.
Some comments address issues that
are outside the scope of this rule. For
example, some comments ask for more
inspections of pet food facilities. Other
comments express concern about the
use of bioengineered animal food
ingredients, and ask that animal foods
containing such ingredients not be used
in pet food. Other comments have
concerns with FDA’s general obligations
for the outcome of regulations it issues
and implements, general concerns with
FDA’s regulation and oversight of
industry, concerns about banning
specific products or imports from
specific countries, testing procedures at
the borders, and concerns about animal
food marketing. We do not discuss such
comments in this document.
II. Legal Authority
The proposed rule contained an
explanation of its legal basis under
authorities in FSMA, the FD&C Act, and
the Public Health Service Act (the PHS
Act). After considering comments
received in response to the 2013
proposed rule and the 2014
supplemental notice, we made changes
in the final rule. The legal authorities
relied on for the final rule are generally
the same as in the proposed rule unless
otherwise described.
A. Current Good Manufacturing Practice
Regulations
The CGMP regulations finalized in
this document establish current good
manufacturing practice requirements for
the manufacturing, processing, packing
and holding of animal food. FDA’s legal
authority to require current good
manufacturing practice derives from
sections 402(a)(3) and (4) and 701(a) of
the FD&C Act (21 U.S.C. 342(a)(3) and
(4), and 371(a)). Section 402(a)(3) of the
FD&C Act provides that a food is
adulterated if it consists in whole or in
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part of any filthy, putrid, or
decomposed substance, or if it is
otherwise unfit for food. Section
402(a)(4) of the FD&C Act provides that
a food is adulterated if it has been
prepared, packed, or held under
insanitary conditions whereby it may
have become contaminated with filth, or
whereby it may have been rendered
injurious to health. Under section 701(a)
of the FD&C Act, FDA is authorized to
issue regulations for the efficient
enforcement of the FD&C Act. The
CGMP regulations we are establishing
are necessary to prevent animal food
from containing filthy, putrid, or
decomposed substances, being
otherwise unfit for food, or being
prepared, packed, or held under
insanitary conditions whereby it may
have become contaminated with filth, or
whereby it may have been rendered
injurious to health.
In addition to the FD&C Act, FDA’s
legal authority for establishing CGMP
requirements derives from the PHS Act
to the extent such measures are related
to communicable disease. Authority
under the PHS Act is derived from the
provisions of sections 311, 361, and 368
(42 U.S.C. 243, 264, and 271) that relate
to communicable disease. The PHS Act
authorizes the Secretary to make and
enforce such regulations as ‘‘are
necessary to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the States * * * or from
one State * * * into any other State’’
(section 361(a) of the PHS Act). (See sec.
1, Reorg. Plan No. 3 of 1966 at 42 U.S.C.
202 for transfer of authority from the
Surgeon General to the Secretary.) The
CGMP regulations are necessary to
prevent the spread of communicable
disease.
The CGMP regulations finalized in
this document include limited labeling
requirements. These requirements are
partly to help prevent accidental comingling or mix-ups of products at the
facility, which could result in
contaminated animal food. Thus, FDA’s
legal authority for these requirements
derives from its authority to require
current good manufacturing practice.
The labeling requirements also are
intended to enable animal producers
and owners, and facilities receiving the
animal food for further manufacture, to
use the animal food appropriately.
Accordingly, the requirements are
supported by section 403(a)(1) of the
FD&C Act, which states that a food is
misbranded if its labeling is false or
misleading in any particular, and by
section 403(i) of the FD&C Act, which
states that a food is misbranded unless
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its label bears the common or usual
name of the food or its ingredients.
B. Hazard Analysis and Risk-Based
Preventive Controls
Section 103 of FSMA, Hazard
Analysis and Risk-Based Preventive
Controls, amends the FD&C Act to
create a new section 418, which
mandates rulemaking. Section
418(n)(1)(A) of the FD&C Act requires
that the Secretary issue regulations ‘‘to
establish science-based minimum
standards for conducting a hazard
analysis, documenting hazards,
implementing preventive controls, and
documenting the implementation of the
preventive controls. . . .’’ Section
418(n)(1)(B) of the FD&C Act requires
that the regulations define the terms
‘‘small business’’ and ‘‘very small
business,’’ taking into consideration the
study of the food processing sector
required by section 418(l)(5) of the
FD&C Act. Further, section 103(e) of
FSMA creates a new section 301(uu) in
the FD&C Act (21 U.S.C. 331(uu)) to
prohibit ‘‘(t)he operation of a facility
that manufactures, processes, packs, or
holds food for sale in the United States
if the owner, operator, or agent in charge
of such facility is not in compliance
with section 418 (of the FD&C Act).’’
In addition to rulemaking
requirements, section 418 contains
requirements applicable to the owner,
operator, or agent in charge of a facility
required to register under section 415.
Section 418(a) is a general provision
that requires the owner, operator, or
agent in charge of a facility to evaluate
the hazards that could affect food
manufactured, processed, packed, or
held by the facility, identify and
implement preventive controls, monitor
the performance of those controls, and
maintain records of the monitoring.
Section 418(a) specifies that the purpose
of the preventive controls is to ‘‘prevent
the occurrence of such hazards and
provide assurances that such food is not
adulterated under section 402 (of the
FD&C Act). . . .’’ In addition to the
general requirements in section 418(a)
of the FD&C Act, sections 418(b) to (i)
contain more specific requirements
applicable to facilities. These include
hazard analysis (section 418(b)),
preventive controls (section 418(c)),
monitoring (section 418(d)), corrective
actions (section 418(e)), verification
(section 418(f)), recordkeeping (section
418(g)), a written plan and
documentation (section 418(h)), and
reanalysis of hazards (section 418(i)).
Section 103(c)(2)(C) of FSMA requires
that the Secretary adopt a final rule with
respect to the requirements under
sections 418 and 421 of the FD&C Act
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from which the Secretary may issue
exemptions or modifications of the
requirements for certain types of
facilities. Sections 418(j) to (m) of the
FD&C Act and sections 103(c)(1)(D) and
(g) of FSMA provide authority for
certain exemptions and modifications to
the requirements of section 418 of the
FD&C Act. These include provisions
related to low-acid canned food (section
418(j)); activities of facilities subject to
section 419 of the FD&C Act (Standards
for Produce Safety) (section 418(k));
qualified facilities (section 418(l));
facilities that are solely engaged in the
production of food for animals other
than man, the storage of raw agricultural
commodities (other than fruits and
vegetables) intended for further
distribution or processing, or the storage
of packaged foods that are not exposed
to the environment (section 418(m));
and facilities engaged only in certain
low-risk on-farm activities on certain
foods conducted by small or very small
businesses (section 103(c)(1)(D) of
FSMA). In sections X, XI, XII, and
XXXVI we discuss provisions that
implement these exemptions and
modified requirements.
In the supplemental notice, we
included potential requirements for a
supplier program, environmental
monitoring, and product testing. We are
including provisions for such activities
in the final rule. Section 418(o)(3) of the
FD&C Act provides supplier verification
activities and an environmental
monitoring program as examples of
preventive controls. Section 418(f)(4) of
the FD&C Act provides for the use of
environmental and product testing
programs as part of required verification
that the preventive controls are
effectively and significantly minimizing
or preventing the occurrence of
identified hazards.
In certain circumstances, the final
rule does not require a manufacturing/
processing facility to implement a
preventive control for a hazard requiring
a preventive control. Instead, the facility
is permitted to rely on a subsequent
entity in the distribution chain to
significantly minimize or prevent the
hazard. In such a circumstance, a
facility must disclose in documents
accompanying the animal food, that the
food is ‘‘not processed to control
[identified hazard].’’ This requirement is
supported by sections 418 and 701(a) of
the FD&C Act (21 U.S.C. 350g and
371(a)). The requirement that facilities
apply preventive controls to
significantly minimize or prevent
hazards is fundamental to the public
health benefits of the rule. To
accommodate the realities of modern
food production, the rule allows a
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facility to rely on a subsequent entity in
the distribution chain rather than
requiring that facility to apply the
control. An animal food may pass
through multiple entities in the
distribution chain before it reaches
consumers. Further, ordinarily it is not
apparent from visual examination of the
animal food whether a hazard requiring
a preventive control has been addressed.
Consequently, without labeling, a
facility might not know that a facility
upstream in the supply chain has not
applied a preventive control and is
relying on a downstream entity to do so.
Therefore, the agency concludes that
information that animal food has not
been processed to control an identified
hazard is necessary for a facility to fulfil
its obligation under section 418 when a
facility is relying on a subsequent entity
to control the hazard. The agency also
concludes that such labeling is
necessary for the efficient enforcement
of the FD&C Act because the labelling is
critical for FDA to hold facilities
responsible for their obligations under
this regulatory scheme. Further, when
the hazard can cause a communicable
disease, FDA concludes that the
requirement is necessary to prevent the
spread of communicable disease from
one state into another state and relies on
sections 311, 361, and 368 of the PHS
Act.
FDA concludes that the provisions in
subpart C and related requirements in
subparts A, E and F should be
applicable to activities that are intrastate
in character. Facilities are required to
register under section 415 of the FD&C
Act regardless of whether the food from
the facility enters interstate commerce
(§ 1.225(b) (21 CFR 1.225(b))). The plain
language of section 418 of the FD&C Act
applies to facilities that are required to
register under section 415 (section
418(o)(2) of the FD&C Act) and does not
exclude a facility from the requirements
because food from such a facility is not
in interstate commerce. Further, the
prohibited act provision associated with
section 418 (section 301(uu) of the
FD&C Act) does not require interstate
commerce for a violation.
FDA also is issuing the provisions in
subpart C and related requirements in
subparts A, E and F, under sections
402(a)(3) and (4), and 701(a) of the
FD&C Act to the extent such
requirements are necessary to prevent
animal food from being held under
insanitary conditions whereby it may
become contaminated with filth or
rendered injurious to health, or being
unfit for food. FDA also is finalizing
those provisions under sections 311,
361, and 368 of the PHS Act relating to
communicable disease to the extent
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those provisions are necessary to
prevent the interstate spread of
communicable disease.
III. General Comments on the Proposed
Rule
(Comment 1) Several comments ask
us to develop guidance to accompany
the rule, particularly with respect to the
new requirements for hazard analysis
and risk-based preventive controls. For
example, comments ask us to provide
guidance on topics such as hazard
analysis, environmental monitoring, and
validation. Some of these comments ask
that drafts of the guidance first be made
available for public comment. Some of
these comments request that the
guidance be available as soon as
possible and before the rule becomes
effective. Some comments request
guidance specific to small businesses.
Several comments suggest FDA revisit
some current compliance policy
guidances in light of FSMA and the
proposed rules.
Other comments emphasize the
importance of education and outreach
and ask us to provide support for
ongoing education and outreach,
including an active role in providing
needed instructional examples and
lessons learned from current
investigations and foodborne outbreaks.
Some comments ask us to convene a
scientific workgroup that includes
experts in food and laboratory science,
public health, proficiency testing,
quality control, and other areas on at
least an annual basis to assess what
hazards should be addressed in food
safety plan. Other comments ask us to
engage universities and extension in
education and training efforts.
Some comments ask that funding and
information on funding for training be
provided. Other comments assert that
we must make available adequate
resources to support outreach and
technical assistance delivered by State
regulatory Agencies, as well as
Cooperative Extension programs and
non-governmental organizations that
work directly with farmers and
facilities.
(Response 1) We are developing
several guidance documents, including
general guidance on hazard analysis and
preventive controls, as well as guidance
for complying with the CGMP
requirements of subpart B (Ref. 4). We
will develop and issue this guidance in
accordance with our good guidance
practices regulation, which establishes
criteria for when we issue a guidance
document as an initial draft, invite
public comment, and prepare a final
version of the guidance document that
incorporates suggested changes, when
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appropriate (§ 10.115(g)) (21 CFR
10.115(g)). The public may submit
comments on any guidance document at
any time (§ 10.115(g)(5)). In addition, we
intend to review current guidance
documents and make a determination
whether they need to be withdrawn or
revised based on this final rule.
We agree with comments that stress
the importance of education and
outreach. A central element of our
strategy to gain industry compliance is
to help make available to facilities
subject to this rule the education and
technical assistance they need to
understand and implement the
requirements (Ref. 5). Within the
Agency we are establishing a Food
Safety Technical Assistance Network
and seeking funding to increase FDA
staffing to provide a central source of
information to support industry
understanding and implementation of
FSMA standards (Ref. 5). This will
allow us to respond in a timely and
consistent way to industry questions on
preventive controls technical and
compliance issues (Ref. 5).
We also are working in collaboration
with the Food Safety Preventive
Controls Alliance (FSPCA) to develop
training materials and establish training
and technical assistance programs (Refs.
5 and 6). The Alliance includes
members from FDA, State food
protection Agencies, the food (human
and animal) industry, and academia. It
is funded by a grant to the Illinois
Institute of Technology’s Institute for
Food Safety and Health, a nationally
recognized leader in food safety. In
addition to developing a standardized
preventive controls training curriculum,
the FSPCA is developing selected
sections of model food safety plans for
several food types that will provide
needed instructional examples.
Although we have provided funding to
the FSPCA to develop a standardized
preventive controls training curriculum,
we are unable to fund training for
individual groups who might need
particular training materials.
We also are partnering with the
National Institute of Food and
Agriculture (NIFA) of the U.S.
Department of Agriculture (USDA) to
administer the FSMA-mandated
National Food Safety Training,
Education, Extension, Outreach, and
Technical Assistance Program, a grant
program to provide technical assistance
for FSMA compliance to owners and
operators of small and medium-size
farms and small food processors (Ref. 7).
Such efforts will help ensure
widespread voluntary compliance by
encouraging greater understanding and
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adoption of established food safety
standards, guidance, and protocols.
(Comment 2) Some comments ask us
to explain how we will enforce the rule,
particularly with respect to coordination
with State and local authorities and
with other Federal Agencies. For
example, some comments ask whether
FDA or the States will pay for
inspections, whereas other comments
ask us to coordinate inspection of
imports with USDA’s Food Safety and
Inspection Service (FSIS) or ask us to
combine our inspections with those of
USDA where possible. Some comments
express concern about the time gap
between the effective date of this rule
and the time it will take to incorporate
applicable provisions into State law.
(Response 2) We are working through
the Partnership for Food Protection
(PFP) (a group of dedicated
professionals from Federal, State, local,
tribal, and territorial governments with
roles in protecting the food supply and
public health) to develop and
implement a national Integrated Food
Safety System consistent with FSMA’s
emphasis on establishing partnerships
for achieving compliance (see section
209(b) of FSMA). For an example of our
current thinking on establishing
partnerships for achieving compliance,
see the ‘‘best practices’’ document made
available by PFP (Ref. 8). This ‘‘best
practices’’ document provides
information to FDA field and State
programs on a variety of issues,
including how to coordinate compliance
activities. Our document entitled
‘‘Operational Strategy for Implementing
FSMA’’ also recognizes the importance
of developing operational partnerships
with States and other government
counterparts to optimize the
effectiveness, efficiency, and
consistency of FSMA implementation
domestically (Ref. 9).
We are implementing a new
inspection paradigm focused on
whether firms are implementing
systems that effectively prevent food
contamination, requiring fundamentally
different approaches to food safety
inspection and compliance (Ref. 10).
This new paradigm involves a major
reorientation and retraining, for which
we are seeking funding, of more than
2,000 FDA inspectors, compliance
officers, and other staff involved in food
safety activities, as well as thousands of
State, local, and tribal inspectors (Ref.
10).
(Comment 3) Some comments ask us
to reevaluate the proposed animal food
preventive controls rule, compare it
with existing programs, and identify a
mechanism for integrating compliance
verification with existing industry and
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governmental programs. These
comments note that many handlers/
processors use and understand
voluntary food safety management
systems such as HACCP and HACCPbased certification programs and ask us
why we proposed to create a separate
inspection framework for FSMA,
without integrating that inspection
framework with existing programs.
(Response 3) We decline this request.
As previously discussed, we are
establishing this rule as required by
section 103 of FSMA (78 FR 64736 at
64743 through 64745 and 64817 through
64818). However, where compliance
with this rule mirrors compliance with
existing regulatory requirements, there
is no need to duplicate existing records,
which may be supplemented as
necessary to include all of the required
information. (See also Response 2
regarding implementation of a national
Integrated Food Safety System.)
(Comment 4) Some comments ask us
to make the various rules we are
establishing to implement FSMA
consistent with each other. One
comment specifically asks us to
harmonize the human and animal food
preventive controls final rules to avoid
confusion by firms that produce both
human and animal food.
(Response 4) We have aligned the
provisions of the various rules to the
extent practicable. For example, we use
the same definitions of ‘‘farm’’ and the
same terms used in the definition of
‘‘farm’’ (i.e., packing, holding, and
manufacturing/processing) in this rule,
the human food preventive controls
rule, and the proposed produce safety
rule. However, the statutory direction is
not the same for all the rules, and this
difference in statutory direction does
lead to some differences between the
rules. For example, section 418(l) of the
FD&C Act (which relates to this rule)
provides for modified requirements for
facilities that are very small businesses
in addition to facilities that satisfy
criteria for sales to qualified end-users,
but section 419(f) of the FD&C Act
(which relates to the proposed produce
safety rule) only provides for modified
requirements for direct farm marketing.
Likewise, we have worked to align the
provisions of this rule with the
provisions of the Foreign Supplier
Verification Program (FSVP) rule.
Again, however, there are statutory
differences that lead to some differences
between the rules. For example, section
805 of the FD&C Act (21 U.S.C. 348a),
applies to an importer, whereas section
418 of the FD&C Act applies to a facility
that is required to register under section
415 of the FD&C Act. Except in the
circumstance where an importer is also
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a manufacturer/processor, an importer
must conduct a hazard analysis as part
of the foreign supplier verification
requirements, whereas a facility that is
a manufacturer/processor must conduct
a hazard analysis to determine whether
the requirements of the animal food
preventive controls rule apply to it. As
another example, section 805 of the
FD&C Act does not provide an
exemption for small or very small
entities, whereas section 418 of the
FD&C Act provides an exemption for
‘‘qualified facilities,’’ which include
very small businesses.
To the extent possible, we have
attempted to harmonize the animal food
preventive controls final rule with the
human food preventive controls final
rule. The CGMP (subpart B)
requirements address the
manufacturing, processing, packing, and
holding practices at animal food plants,
but are similar to those for human food,
where appropriate. Furthermore,
§ 507.1(d) contains provisions for a
human food facility that also
manufactures, processes, packs, or holds
animal food. This is intended to reduce
confusion and increase flexibility for
facilities that produce both human and
animal food.
(Comment 5) Some comments express
concern that we will enforce the rule
more strictly for domestic facilities than
for foreign facilities, e.g., because we
lack the funds and manpower to enforce
the rule for foreign facilities. Other
comments assert that it is
unprecedented for importing countries
to regulate the production processes in
exporting countries and that no
scientific evidence supports such
regulation. These comments express
concern that this regulatory requirement
will greatly increase trading costs and
might constitute a barrier to trade for
exporting countries.
(Response 5) We intend to enforce
this rule in a consistent manner to
ensure that imported and domestically
produced animal foods are in full
compliance with the requirements of
this rule. We note that the forthcoming
FSVP rule will require importers to help
ensure that animal food imported into
the United States is produced in
compliance with processes and
procedures, including reasonably
appropriate risk-based preventive
controls, that provide the same level of
public (human and animal) health
protection as those required under this
rule. The implementation of these
supplier verification programs by U.S.
importers will thus provide assurances
that imported animal food is in
compliance with this regulation.
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We disagree that we are seeking to
‘‘regulate the production processes in
exporting countries’’ inappropriately.
This rule provides for a flexible set of
principles and a framework for hazard
analysis and risk-based preventive
controls to be applied to a given
production process in order to ensure
the production of safe animal food
destined for the United States.
Mandating that a finished animal food
is manufactured under general methods
applicable to all animal foods (e.g., good
manufacturing practices) is a widely
accepted regulatory practice and
fundamentally different than mandating
that animal food be produced in a
certain way. We note that other
countries have adopted animal food
safety regulations that mandate certain
principles and conditions be applied to
animal food manufacturing. Because the
requirements being implemented by
FDA under this regulation are flexible
and not prescriptive, we do not agree
that this regulation will significantly
increase costs or impede trade.
We also disagree that there is no
scientific evidence supporting this rule.
In the 2013 proposed preventive
controls rule for human and animal
food, we provided an extensive
background discussing the scientific
evidence upon which this rule is based
(78 FR 3646 at 3659 through 3667,
January 16, 2013 and 78 FR 64736 at
64745, October 29, 2013). In addition,
the Appendix to the 2013 proposed
preventive controls rule provided
additional scientific information on
activities such as product testing and
environmental monitoring to support
their role in ensuring safe food and how
these align with international standards
such as those of Codex Alimentarius (78
FR 64736 at 64834 through 64836).
(Comment 6) Many comments from
pet owners are generally supportive of
the rule; however, some request
additional regulations and oversight for
pet food. Many comments state that pet
food should meet the same standards as
human food. Some comments request
that pet food be required to be tested for
safety.
(Response 6) The CGMP requirements
in subpart B are intended to serve as
baseline standards for producing safe
animal food across all types of animal
food facilities, including pet food
facilities. For discussion of the
relevance of the CGMP requirements to
pet food, see Response 163. Many pet
food facilities (as well as facilities
producing other animal food) will be
subject to the preventive controls
requirements of subpart C. These
provisions require the pet food
manufacturer to identify and evaluate
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potential hazards for the pet food to
determine whether a preventive control
is required (see § 507.33). These could
be hazards to the pet consuming the pet
food or the person handling the pet food
(e.g., Salmonella). The preventive
controls provisions also include
requirements for product testing for
pathogens or other hazards and
environmental monitoring for pathogens
under certain circumstances (see
§ 507.49), in order to help ensure the
safety of the pet (animal) food.
Currently, low-acid canned animal food
in a hermetically sealed container (such
as canned pet food) is subject to the
requirements of § 500.23 (21 CFR
500.23) and part 113 to control
microbiological hazards.
(Comment 7) Some comments request
communication and coordination with
state regulators throughout the FSMA
implementation phase. Some comments
specifically request training of FDA staff
and regulatory partners to inspect
animal food facilities because there are
differences between animal food and
human food facilities. Some comments
request that inspectors receive training
on the broad range of animal food
manufacturing. At least one comment
requests we establish a national
advisory committee to provide ongoing
input throughout FSMA
implementation and enforcement. Some
comments request that we provide
methods for communication with State
and other regulatory partners, including
possibly a call center or other directcontact resource for regulators and
industry to obtain information on
FSMA.
(Response 7) As discussed in
Response 1, we are working in
collaboration with the FSPCA to
develop training materials and programs
to be used by industry and regulators.
The training will be specific to human
or animal food and will include
information on developing a food safety
plan tailored to each facility’s unique
hazards. We will consider these and
other recommendations for the content
of such training as part of that
collaborative effort.
As discussed in Responses 1 and 2,
we are working through two working
groups (FSCPA and PFP) that involve
State and local regulators in order to
implement this final rule. We will
continue to work through these groups,
as well as use other methods of
communication and coordination (e.g.,
arranged teleconference meetings with
the States (i.e., 50-State calls) to
collaborate with State and local
regulatory officials to implement this
final rule. We will consider these
recommendations as we communicate
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with State and local regulatory partners
during the implementation of this final
rule.
(Comment 8) Some comments request
that this final rule have a provision
similar to the proposed produce safety
rule that allows a state or foreign
country to request a variance from the
rule’s requirements due to procedures,
processes, and practices that ensure a
product is not adulterated.
(Response 8) We are implementing
these regulations according to the
statutory direction of FSMA. A variance
request and review process is specified
for produce in section 419(c)(2) of the
FD&C Act; however, there are no similar
provisions in FSMA directing FDA to
create a variance process for facilities
subject to the preventive controls
regulations and we therefore are
declining to do so.
(Comment 9) Some comments ask us
to take a ‘‘BASE’’ approach to
implementing FSMA. These comments
describe this approach as follows: B
stands for borders, a critical area where
FDA should be focusing its attention
and resources; A stands for audits,
recognizing that FDA will need to
actively audit states and foreign
suppliers; S stands for standard,
representing the standards FDA will set
by which firms will be audited; and E
stands for education, ensuring that all
stakeholders know their roles and
responsibilities required by the rules.
(Response 9) While we do not intend
to follow the BASE approach described
in the comment, we expect that some of
our implementation efforts will be
similar to the approach described. For
discussion of our implementation
planning, see Responses 1 and 2. To the
extent this comment is referring to
animal food from foreign suppliers
presented for import, this is a subject of
the forthcoming FSVP rule.
(Comment 10) Some comments
requested exceptions or reduced
requirements that were not previously
proposed. One comment requests a
narrower scope of requirements for
facilities involved in the production of
chemicals used as food additives or in
accordance with generally recognized as
safe (GRAS) standards.
(Response 10) We decline these
requests. The CGMPs in subpart B and
preventive controls in subpart C are
written to serve as baseline standards
for producing safe animal food across all
types of animal food facilities, including
those producing food additives or other
ingredients.
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IV. Definitions in the Section 415
Registration Regulations (21 CFR Part
1, Subpart H)
A. Definitions That Impact a
Determination of Whether an
Establishment Is a ‘‘Farm’’
The 2013 proposed rule for human
food preventive controls contained a
description (78 FR 3646 at 3675 through
3676) of the current legal and regulatory
framework that governs the
determination of when an establishment
is required to register as a food facility
in accordance with the section 415
registration regulations. That
description focused on the framework
that governs whether an establishment
that grows and harvests crops or raises
animals satisfies the definition of
‘‘farm,’’ because the facility registration
requirements of section 415 of the FD&C
Act do not apply to ‘‘farms.’’ Under that
framework, a key factor in whether an
establishment falls within the definition
of ‘‘farm,’’ even with respect to crops it
grows and harvests itself, is whether the
activities conducted by the
establishment fall within definitions of
‘‘harvesting,’’ ‘‘packing,’’ or ‘‘holding’’
(which are within the ‘‘farm’’
definition). Another key factor is
whether activities conducted by the
establishment fall within the definition
of manufacturing/processing (which
have been outside the ‘‘farm’’
definition).
In the 2014 supplemental human
preventive controls notice, comments
were described regarding proposed
revisions to the definitions of ‘‘farm,’’
‘‘harvesting,’’ ‘‘packing’’ and ‘‘holding,’’
as well as comments regarding the
triggers for an activity to be considered
manufacturing/processing (79 FR 58524
at 58530 through 58538). Additional
revisions were proposed to the
definitions of ‘‘farm,’’ ‘‘harvesting,’’
‘‘packing’’ and ‘‘holding’’ to address
these comments.
Even after the revisions we proposed
in the 2014 supplemental human
preventive controls notice, some
comments assert that the overall ‘‘farm’’
definition still presents an unrealistic
and incomplete understanding of how
most farms in America are structured
with regard to their physical location(s)
and business models. See table 4 for
revised definitions that are being
finalized in the human food preventive
controls for the section 415 registration
regulations and the section 414
recordkeeping regulations.
In section IV of the final rule for
preventive controls for human food,
published elsewhere in this issue of the
Federal Register, comments on the
proposed changes to the section 415
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section 414 recordkeeping regulations
are discussed.
TABLE 4—REVISIONS TO THE PROPOSED DEFINITIONS IN THE SECTION 415 REGISTRATION REGULATIONS AND THE
SECTION 414 RECORDKEEPING REGULATIONS
Definition
Revision
Farm ............................................
Primary production farm ..............
•
•
•
•
•
•
•
•
Secondary activities farm ............
•
•
Harvesting ...................................
Holding ........................................
Manufacturing/Processing ...........
•
•
•
A farm is an ‘‘operation’’ rather than an ‘‘establishment.‘‘
There are two types of farms: (1) Primary production farm; and (2) secondary activities farm.
A primary production farm is ‘‘under one management’’ rather than ‘‘under one ownership.’’
Although a primary production farm continues to be ‘‘in one general physical location,’’ we have clarified
that ‘‘one general physical location is ‘‘not necessarily contiguous.’’
A primary production farm is an operation devoted to the growing of crops, the harvesting of crops, the
raising of animals (including seafood), or any combination of these activities. Although some primary production farms both grow and harvest crops, other primary production farms grow crops but do not harvest
them, and other primary production farms harvest crops but do not grow them.
Treatment to manipulate the ripening of raw agricultural commodities (RACs), and packaging and labeling
the treated RACs, without additional manufacturing/processing, is within the ‘‘farm’’ definition.
We added an example of drying/dehydrating RACs to create a distinct commodity that would fall within the
‘‘farm’’ definition (i.e., drying/dehydrating grapes to produce raisins), as well as an example of additional
manufacturing/processing that would cause an operation that dries/dehydrates RACs to create a distinct
commodity to fall outside the ‘‘farm’’ definition (i.e., slicing).
We added an example of additional manufacturing/processing that can cause an operation that packages
and labels RACs to fall outside the ‘‘farm’’ definition (i.e., irradiation).
A ‘‘secondary activities farm’’ is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.
A secondary activities farm may also conduct those additional activities allowed on a primary production
farm.
We added additional examples of harvesting activities.
We added additional examples of holding activities.
We added additional examples of manufacturing/processing activities.
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B. Proposed Revisions to the Definition
of Farm
In the human food proposed
preventive controls rule, we proposed to
revise the ‘‘farm’’ definition to (1)
Provide for on-farm packing and
holding of RACs to remain within the
farm definition regardless of ownership
of the RACs; (2) include, within the
‘‘farm’’ definition, a description of
packing activities that include
packaging RACs grown or raised on a
farm without additional manufacturing/
processing; and (3) provide for drying/
dehydrating RACs to create a distinct
commodity (such as the on-farm drying
of grapes to produce raisins), and
packaging and labeling such
commodities, without additional
manufacturing/processing, to remain
within the farm definition. See section
IV.B of the final rule for preventive
controls for human food, published
elsewhere in this issue of the Federal
Register, for a full discussion of
comments and responses on the
proposed revisions to the farm
definition.
In the final rule for preventive
controls for human food, published
elsewhere in this issue of the Federal
Register, we have revised the definition
of farm to replace the term ‘‘under one
ownership’’ with the term ‘‘under one
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management.’’ As discussed in section
IV.B of the final rule for preventive
controls for human food, although the
original phrase ‘‘under one ownership’’
was not referring to a single owner, the
‘‘farm’’ definition should reflect modern
business models (such as cooperatives,
on-farm packinghouses under
ownership by multiple growers, food
aggregators, and food hubs) and use
language that the modern farming
community understands. The term
‘‘under one management’’ refers to the
control structure of the business, that is,
the management of the business entity
that is the farm operation. Thus, for
example, a primary production farm
that hires another company as a contract
harvester to perform harvesting services
on the primary production farm’s behalf
is not ‘‘under one management’’ with
the primary production farm just
because the primary production farm is
directing the contractor’s activities
performed on the primary production
farm’s behalf. The primary production
farm and the contract harvester have
separate and independent management
structures because they are separate and
independent businesses. (See Response
25 in the final rule for preventive
controls for human food). As another
example, if a poultry processing
company contracts with a primary
production farm to raise chickens on the
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poultry processor’s behalf, the poultry
processor and the primary production
farm are not ‘‘under one management,’’
even if their contract strictly controls
almost all aspects of the raising of the
poultry. The poultry processor and the
primary production farm have separate
and independent management
structures because they are separate and
independent businesses.
In the final rule for preventive
controls for human food, we also
revised the farm definition to add a new
category: A ‘‘secondary activities farm.’’
(See Response 25 in the final rule for
preventive controls for human food). An
important limitation on the types of
operations that fit within this category
is that they must be majority owned (or
majority jointly owned) by the primary
production farm(s) that grows, harvests,
and/or raises the majority of the RACs
the secondary activities farm harvests,
packs, and/or holds. Thus, both product
and majority ownership must link a
secondary activities farm to a primary
production farm(s).
For example, a primary production
farm may own a majority interest in a
separate business that holds RACs and
processes them into animal food (e.g., a
feed mill). If the majority of the RACs
held by the feed mill come from the
primary production farm that owns the
feed mill’s majority interest, the feed
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mill is a secondary activities farm and
may manufacture/process animal food
within the farm definition, but only to
the extent that the animal food
manufactured is consumed at the feed
mill or on another farm whose ‘‘one
management’’ is the same management
as the feed mill. However, if the feed
mill in this example manufactures/
processes animal food that is consumed
on farms that are not under the same
management as the feed mill, that
manufacturing/processing is outside the
farm definition, the feed mill is subject
to registration under section 415 of the
FD&C Act, and its manufacturing/
processing of animal food for
consumption on farms not under the
same management is subject to the
requirements of this rule.
To further clarify, a feed mill that is
not majority owned by a primary
production farm(s) cannot be a
secondary activities farm. Also, a feed
mill that does not receive more than half
of the RACs it holds from primary
production farm(s) that own a majority
interest in the feed mill cannot be a
secondary activities farm. For example,
a feed mill owned by a poultry
processing company will be required to
register as a food facility, unless the feed
mill otherwise meets the definition of
‘‘farm.’’ When a feed mill is owned by
a company such as a poultry processor,
it is not majority owned by the primary
production farm(s) that supply the
majority of the RACs it holds, and
therefore the feed mill cannot be a
secondary activities farm.
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C. Proposed Revisions to Definitions of
Harvesting, Holding, Manufacturing/
Processing, Mixed-Type Facility, and
Packing
See section VIII. for a discussion of
comments and responses and revisions
to the definitions in part 507 of
harvesting, holding, manufacturing/
processing, mixed-type facility, and
packing. For a discussion of comments
and responses to these definitions in the
section 415 registration regulations and
the section 414 recordkeeping
regulations, see section IV.C through
IV.G of the final rule for preventive
controls for human food, published
elsewhere in this issue of the Federal
Register.
D. Comments on Feed Mills Associated
With Fully Vertically Integrated Farming
Operations
In the 2014 supplemental notice for
animal food, we requested comment on
whether feed mills that are part of fully
vertically integrated farming operations,
including cooperatives that fit this
model, that meet the farm definition
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should be required to register under
section 415 of the FD&C Act (and thus
would be subject to the rule). For
comments that supported applying the
final preventive controls rule to feed
mills that are part of fully vertically
integrated farming operations, we
requested input on how the farm
definition should be modified. If they
were required to register, we also
requested comment on whether there
should be exemptions from registration
under section 415 based on size, such as
number of animals being fed or the
amount of animal food being fed (based
on tonnage, monetary value, or some
other factor). Lastly, since there would
be no total annual sales figure for the
animal food produced by these feed
mills, we requested comment on how to
value the animal food being fed to
animals for purposes of determining
whether the feed mill would be a
qualified facility (proposed § 507.7) and
in particular a very small business.
(Comment 11) Some comments
generally agree with our recognition that
there are different types of farm models
for raising animals but request
additional clarification on what we
mean by a fully vertically integrated
farming operation and the depth of
integration within an operation.
(Response 11) Feed mills that are part
of fully vertically integrated farming
operations, or certain cooperative
farming operations that meet the
definition of a farm (see § 1.227, as
revised by the final rule for preventive
controls for human food published
elsewhere in this Federal Register), are
not subject to this final rule because
they are not required to register under
section 415 of the FD&C Act (see
§ 507.5(a)). Because expanding on the
characteristics of a fully integrated
farming operation is beyond the scope
of this rule, we decline to further clarify
the fully vertically integrated farming
operation farming model discussed in
the 2014 supplemental notice.
(Comment 12) Some comments do not
support modifying the farm definition to
subject feed mills that are part of fully
vertically integrated farming operations
to the requirements of this final rule.
These comments state that these feed
mills are currently making safe animal
food and that some are following
industry best practices that would meet
or exceed the requirements of our
proposed CGMPs. Some comments also
state that these feed mills are producing
a narrower range of animal food when
compared to independent feed mills
because these integrated feed mills
typically provide animal food to a single
species and therefore utilize fewer
ingredients, resulting in less chance of
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harmful error. Some comments note that
for large farming operations, feeding of
the animals is overseen by dedicated
individuals, such as a nutritionist,
which ensures an extra layer of
oversight for the safety of animal food.
Some comments express concern that
feed mills associated with contract
farming operations (contract feed mills)
will be treated differently because, as
proposed in the 2013 proposed rule,
they would need to comply with the
rule unlike the feed mills that are part
of fully vertically integrated farming
operations. These comments
recommend modifications to the farm
definition to incorporate the contract
feed mills into the farm definition,
resulting in the contract feed mills no
longer being required to register under
section 415 and therefore no longer
being subject to the requirements of this
rule. Some comments (including ones
that support and ones that oppose
modifying the farm definition) generally
agree there is no evidence that the safety
of animal food varies depending on
whether a feed mill is associated with
vertically integrated or contract farming.
These comments also state that the farm
definition as proposed has the potential
to create disparity in regulatory
requirements that feed mills must
follow based solely on the type of
farming model with which they are
associated (i.e., some will be subject to
CGMP and preventive controls
requirements, while some will be
subject to neither).
Some comments support modifying
the farm definition to subject feed mills
that are part of fully vertically integrated
farming operations to the requirements
of this final rule, and some of those
comments also support providing an
exclusion if it is limited to small onfarm animal food mixers. Other
comments contend that some of the feed
mills that are part of fully vertically
integrated farming operations produce
large volumes of animal food that feed
a substantial portion of the U.S. foodproducing animal population and that
these feed mills should be subject to the
final rule to ensure continual
production of safe animal food. Some
comments state concern that the feed
mills that are part of fully vertically
integrated farming operations could
introduce food safety hazards into the
human food supply because they are not
being adequately controlled due to the
feed mills’ exemption from this rule.
Comments that support modifying the
farm definition to subject feed mills that
are part of fully vertically integrated
farming operations to the requirements
of this final rule recommend that any
exemption from this final rule
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applicable to farms be limited based on
the volume of the animal feed produced
or animal equivalency units.
(Response 12) The farm definition in
21 CFR part 1 has been modified based
on other comments received to both the
2014 supplemental notice for human
food preventive controls and to the 2014
supplemental notice for animal food
preventive controls (see section IV.B of
the final rule for preventive controls for
human food published elsewhere in this
issue of the Federal Register). However,
feed mills that are part of fully vertically
integrated farming operations still meet
the definition of farm. As a result, they
are not required to register as a food
facility under section 415 and are not
subject to the requirements of this rule
including CGMPs (subpart B) and
Hazard Analysis and Risk-Based
Preventive Controls (subpart C), and
supply-chain program (subpart E). We
remain concerned that this leaves a gap
in the protection of public (human and
animal) health because these feed mill
operations manufacture significant
amounts of animal food. While some of
these feed mills may be voluntarily
implementing some type of animal food
safety measures, not all feed mills that
are part of vertically integrated farming
operations do. In addition, the voluntary
measures adopted by some feed mills
may not meet the standards of the food
safety requirements in this rule.
Moreover, we do not and cannot enforce
compliance with purely voluntary
practices. Finally, we recognize that
other feed mills not part of a ‘‘farm’’ as
defined in part 1 will have to comply
with the requirements of this rule
(unless they qualify for an exemption).
As we have previously stated, we do not
have evidence that the safety of animal
food varies depending on whether a
feed mill is part of vertically integrated
or contract farming. Therefore, we
intend to publish a proposed rule that
would require some feed mill operations
that currently are part of a farm to
comply with the CGMPs (subpart B) of
this rule.
The animal food CGMP requirements
help ensure that animal food is
protected from contamination during
manufacturing, processing, packing, and
holding (see sections XIV to XXII for
further discussion of the animal food
CGMP). By implementing these CGMPs,
we believe that feed mills not currently
covered by this rule would be able to
provide a baseline level of animal food
safety, thus further protecting the public
(human and animal) health. We will
continue to review the comments
received from the 2014 supplemental
proposed rule and other available data
in considering a proposed rule for feed
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mills that are part of fully vertically
integrated farming operations that are
not required to register under section
415, but produce a large volume of
animal food. One reason we are not
finalizing new food safety requirements
for feed mills that are part of fully
integrated farming operations in this
rulemaking is that we need more
information to help guide the scope of
the requirements. As part of the future
rulemaking process we will seek input
on the best way to subject vertically
integrated feed mills that produce large
volumes of animal food to food safety
requirements while avoiding
overburdening on-farm feed mixers that
produce a small amount of food for a
small number of animals. The proposed
rulemaking would not change the
applicability of subpart C, ‘‘Hazard
Analysis and Risk-Based Preventive
Controls,’’ for feed mills that are part of
a farm. Because farms meeting the
definition of § 1.227 are not required to
register under section 415 of the FD&C
Act, § 507.5(a) exempts them from
compliance with subpart C, as required
by FSMA.
V. Comments on the Organizing
Principles for How the Status of a Food
as a Raw Agricultural Commodity or as
a Processed Food Affects the
Requirements Applicable to a Farm
Under Sections 415 and 418 of the
FD&C Act
In the 2014 supplemental notice (79
FR 58476 at 58482), we referred to the
2014 supplemental human preventive
controls notice that discussed comments
on the organizing principles that formed
the basis for proposed revisions to
section 415 registration regulations and
the section 414 recordkeeping
regulations (79 FR 58524 at 58538). We
also explained how its proposed
revisions to the ‘‘farm’’ definition would
require FDA to reconsider those
organizing principles (79 FR 58524 at
58538).
For discussion of comments, see
section V of the final rule for preventive
controls for human food, published
elsewhere in this issue of the Federal
Register.
VI. Rulemaking Required by Section
103(c) of FSMA: On-Farm Activities
A. Section 103(c)(1)(C) of FSMA
We previously described provisions of
FSMA that direct us to conduct a
science-based risk analysis to cover
specific types of on-farm packing,
holding, and manufacturing/processing
activities that would be outside the
‘‘farm’’ definition and, thus, subject to
the requirements for hazard analysis
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and risk-based preventive controls (see
section 103(c)(1)(C)) of FSMA and 78 FR
64736 at 64751 and 64752 through
64754). Consistent with this statutory
direction, we developed the section
103(c)(1)(C) draft RA and made it
available for public comment (Ref. 11
and 78 FR 64428). We are including the
final risk assessment (the section
103(c)(1)(C) RA) in the docket
established for this document (Ref. 3).
We previously described provisions of
FSMA that direct us to consider the
results of the science-based risk analysis
and exempt facilities that are small or
very small businesses from the
requirements for hazard analysis and
risk-based preventive controls (or
modify these requirements, as we
determine appropriate), if such facilities
are engaged only in specific types of onfarm activities that we determine to be
low risk involving specific animal foods
that we determine to be low risk (see
section 103(c)(1)(D) of FSMA and 78 FR
64736 at 64751, 64753 through 64754,
and 64763 through 64764). In section
X.F, we discuss the provisions we are
establishing in § 507.5(e) and (f), based
on the results of the section 103(c)(1)(C)
RA, to exempt farm mixed-type facilities
that are small or very small businesses
from requirements for hazard analysis
and risk-based preventive controls if the
only activities that the business
conducts that are subject to those
requirements are low-risk activity/
animal food combinations.
We also previously described
provisions of FSMA that direct us to: (1)
Identify high risk-facilities and allocate
resources to inspect facilities according
to the known safety risks of the facilities
(as determined by several factors) and
immediately increase the frequency of
inspection of all facilities (see the
discussion of section 421 of the FD&C
Act at 78 FR 64736 at 64754) and (2)
consider a possible exemption from or
modification of requirements of section
421 of the FD&C Act as we deem
appropriate (see the discussion of
section 103(c)(1)(D) of FSMA at 78 FR
64736 at 64744). We tentatively
concluded that we should not exempt or
modify the frequency requirements
under section 421 based solely upon
whether a facility only engages in lowrisk activity/animal food combinations
and is a small or very small business
and requested comment on this
tentative conclusion.
B. Comments on Qualitative Risk
Assessment of On-Farm Activities
Outside of the Farm Definition
(Comment 13) Some comments
address the qualitative nature of the
section 103(c)(1)(C) draft RA and assert
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that it is based on professional judgment
rather than data. These comments ask us
to update the section 103(c)(1)(C) draft
RA when more data become available.
Some comments assert that we should
not rely on data from the Food
Processing Sector Study (Ref. 12), but
instead collect data from large-scale
surveys of actual farm mixed-type
facilities and their activities. Other
comments ask us to collect, analyze, and
interpret data about the levels of
hazards from animal food samples taken
from small and very small mixed-type
facilities and use consumption to
estimate the likelihood of exposure to
hazards in animal food from such
facilities. Some comments ask us to
consult with subject matter experts to
ensure that the final risk assessment
reflects sufficient geographic diversity.
(Response 13) We have acknowledged
the limitations of the section
103(c)(1)(C) draft RA (Ref. 11 and 78 FR
64428; see section I.F in that document).
Rather than limit public input to subject
matter experts, we requested comment
from all interested persons, and
received a number of comments about
activity/animal food combinations
conducted on farms and farm mixedtype facilities, including comments from
diverse geographic areas comprising
both areas where farms and farm mixedtype facilities tend to be small and
where they tend to be large. We disagree
that we need to conduct large scale
surveys, or enter into agreements with
agencies/organizations, to collect
additional information in light of the
previous opportunity for broad public
input regarding the activity/animal food
combinations conducted on farms and
farm mixed-type facilities.
(Comment 14) Some comments assert
that we should revise the section
103(c)(1)(C) draft RA and then make it
available for additional public comment
before finalizing the rule.
(Response 14) We subjected the
section 103(c)(1)(C) draft RA to peer
review in accordance with the
requirements of the Final Information
Quality Bulletin for Peer Review (issued
by the Office of Management and
Budget to implement the Information
Quality Act (Pub. L. 106–554)) before
we made it available for broader public
comment during a time period that
exceeded 10 months. The additional
iterative process recommended by these
comments is not necessary and would
go beyond the processes we routinely
apply for public input on a risk
assessment.
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C. Comments Regarding an Exemption
for Small and Very Small Farm MixedType Facilities Under Section 421 of the
FD&C Act
1. Request for Comment on Data
Submission Requirements
We requested comment on whether
we should establish data submission
requirements that would allow us to
identify types of facilities in order to
exempt them from the inspection
frequencies, or modify the inspection
frequencies that apply to them, under
section 421 of the FD&C Act. We
provided examples of such data
elements, including identification of a
facility as a farm mixed-type facility,
annual monetary value of sales, number
of employees, and animal food category/
activity type. We also requested
comment on any other criteria that may
be appropriate for the purposes of
allocating inspection resources to these
facilities.
Comments did not support these data
submission requirements. We are not
establishing any data submission
requirements that would allow us to
identify types of facilities in order to
exempt them from the inspection
frequencies, or modify the inspection
frequencies that apply to them, under
section 421 of the FD&C Act.
2. Request for Comment on an
Exemption From the Requirements of
Section 421 of the FD&C Act
We received no comments that
disagreed with our tentative conclusion
that we should not exempt or modify
the frequency requirements under
section 421 based solely upon whether
a facility only engages in low-risk
activity/animal food combinations and
is a small or very small business. We are
not establishing any exemption from, or
modification to, the frequency
requirements under section 421 for
facilities that only engage in low-risk
activity/animal food combinations and
are a small or very small business.
VII. Subpart A: Comments on Proposed
§ 507.1—Applicability and Status
We proposed in § 507.1 to establish
the significance of this part in
determinations of whether animal food
is adulterated. We also proposed a
provision relevant to FSMA’s statutory
provisions for a prohibited act under
section 301(uu) of the FD&C Act. We
proposed that animal food covered by
specific CGMPs would also be subject to
those requirements. For facilities
required to comply with CGMPs and
preventive controls for both the
proposed preventive controls rule for
animal food and the proposed
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preventive controls rule for human food,
we proposed that the facility must
comply with either rule for the animal
food, as long as the food safety plan
addresses hazards unique to animal
food. Some comments support the
proposed provisions without change.
Some comments that support the
proposed provisions ask us to clarify
how we will interpret the provisions.
In the following paragraphs, we
discuss comments that ask us to clarify
the proposed requirements, disagree
with, or suggest one or more changes to,
the proposed requirements. After
considering these comments, we have
revised the proposed requirements
along with editorial and conforming
changes as shown in table 31.
A. Comments on Proposed § 507.1(a)—
Applicability
We proposed that the criteria and
definitions in part 507 apply in
determining whether a food is
adulterated: (1) Within the meaning of
section 402(a)(3) of the FD&C Act in that
the food has been manufactured under
such conditions that it is unfit for food;
or (2) Within the meaning of section
402(a)(4) of the FD&C Act in that the
food has been prepared, packed, or held
under insanitary conditions whereby it
may have become contaminated with
filth, or whereby it may have been
rendered injurious to health. We also
proposed that the criteria and
definitions in part 507 also apply in
determining whether an animal food is
in violation of section 361 of the PHS
Act.
(Comment 15) Some comments note
that FSMA granted FDA mandatory
recall authority for adulterated food.
These comments express concern that
theoretically we could use a violation of
the requirements for hazard analysis
and risk-based preventive controls to
determine that food is adulterated,
thereby providing the basis for a
mandatory recall of that food. These
comments raise three issues relevant to
how we will apply § 507.1(a), with
consequences for a potential mandatory
recall of food.
First, these comments note that the
regulatory text stating that the ‘‘criteria
and definitions’’ apply in making a
determination of adulteration appears to
encompass the entirety of the rule. As
a result, farms or facilities that violate
any of the requirements in the proposed
rules, including components not
directly related to the safety of the food
(such as recordkeeping requirements),
could face a risk that we would deem
their food adulterated.
Second, these comments assert that
the regulatory text suggests that we
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would not automatically consider a food
adulterated as a result of a violation of
the proposed rule, because it states that
the criteria and definitions ‘‘apply in
determining’’ whether a food will be
considered adulterated, rather than that
the food ‘‘is’’ adulterated.
Third, these comments state that it is
not clear how the exemption applicable
to qualified facilities is included in the
‘‘criteria and definitions’’ used in
making a determination of adulteration.
These comments ask us to clarify that
we will not just automatically assume
that qualified facilities are selling
adulterated food because they are by
definition exempt from the
requirements for hazard analysis and
risk-based preventive controls.
(Response 15) The comments are
correct that the criteria and definitions
‘‘apply in determining’’ whether an
animal food will be considered
adulterated, rather than that the animal
food ‘‘is’’ adulterated. In determining
whether an animal food that is
manufactured, processed, packed, or
held in violation of part 507 (including
a violation of the recordkeeping
requirement) is adulterated, we would
consider the totality of the available
data and information about the violation
and the animal food before reaching a
conclusion that the animal food is
adulterated.
Although this rule does not address
the mandatory recall provisions of
FSMA, the statutory provisions
establish two basic criteria. (See section
423(a) of the FD&C Act (21 U.S.C.
3501).) First, we must determine that
there is a ‘‘reasonable probability’’ that
the animal food is adulterated under
section 402 of the FD&C Act. A violation
of part 507 would be relevant to
determining whether an animal food is
adulterated under section 402 of the
FD&C Act. Second, we must determine
that there is a reasonable possibility that
the use of, or exposure to, that animal
food will cause serious adverse health
consequences or death to humans or
animals. Not all animal food that is
adulterated has a reasonable probability
of causing serious adverse health
consequences or death to humans or
animals. For examples of animal food
contamination with a reasonable
probability of causing serious adverse
health consequences or death to humans
or animals, see the annual reports of the
Reportable Food Registry (RFR) (Refs.
13, 14, 15, and 16).
A facility that is exempt from any
requirement of part 507, including the
requirements for hazard analysis and
risk-based preventive controls, would
not be in violation of part 507 if it did
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not comply with provisions that it is not
subject to.
B. Comments on Proposed § 507.1(b)—
Prohibited Act
We proposed that the operation of a
facility that manufactures, processes,
packs, or holds animal food for sale in
the United States is a prohibited act
under section 301(uu) of the FD&C Act
if the owner, operator, or agent in charge
of such facility is required to comply
with, and is not in compliance with,
section 418 of the FD&C Act or subparts
C, D, or F of part 507 and § 507.7
(proposed § 507.1(b)).
(Comment 16) Some comments from
State regulatory Agencies note that this
new provision is not covered under the
applicable state statute and that making
any changes to the state statute can be
a lengthy process that takes up to 3
years to complete.
(Response 16) See Response 2 for a
discussion of our approach to working
with our food safety partners in the
States.
C. Comments on Proposed § 507.1(c)—
Specific CGMP Requirements
We proposed § 507.1(c) would
establish that animal food covered by
specific current good manufacturing
practice regulations also be subject to
the requirement of those regulations. We
received no comments that disagreed
with our proposal, and are finalizing the
proposed provision without change.
D. Comments on Proposed § 507.1(d)—
Human Food Facilities That
Manufacture Animal Food
We proposed in § 507.1(d) that a
facility that would be required to
comply with subpart B of part 507 and
would be required to comply with
subpart B of proposed part 117 for
human food, may choose to comply
with part 117 for the animal food. We
also proposed that a facility that would
be required to comply with subpart C of
part 507 and would be required to
comply with subpart C of proposed part
117 for human food, may choose to
comply with part 117 for the animal
food as long as the food safety plan also
addressed hazards that are reasonably
likely to occur in the animal food. We
also proposed that when applying the
requirements of part 117 to animal food,
the term ‘‘food’’ in part 117 would
include animal food.
Based on comments received in the
2014 supplemental notice, we proposed
in § 507.12 that human food by-products
held by the human food processor for
distribution for use as animal food
without additional manufacturing/
processing by the human food processor
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would only need to comply with
proposed § 507.28 in part 507 and
proposed § 117.95 in part 117 (79 58476
at 58487 to 58489). (See section XIII for
a discussion of comments received on
proposed § 507.12.) We are finalizing
the proposed provisions in 507.1(d)
with the exceptions in § 507.12.
For further discussion of comments
on applicability and status, see section
VIII in the final rule for preventive
controls for human food published
elsewhere in this issue of the Federal
Register.
VIII. Subpart A: Comments on
Proposed § 507.3—Definitions
We proposed definitions in the
preventive controls rule for animal food
to be consistent with the proposed
preventive controls rule for human food
with some minor differences and
clarifications applicable to animal food
(e.g., adding ‘‘animal’’ before ‘‘food’’).
Some comments support one or more of
these proposed definitions without
change. For example, some comments
state that they support the proposed
definitions for ‘‘microorganism’’ and
‘‘subsidiary’’ with no suggested
revisions. Some comments support our
proposal in the 2014 supplemental
notice to use the phrase ‘‘chemical
(including radiological)’’ in the
definition of ‘‘hazard,’’ noting that doing
so is consistent with FSMA, current
industry practice, and Codex and global
HACCP standards. Some comments that
support a proposed definition suggest
alternative or additional regulatory text,
such as adding examples to make the
definition clearer. Some comments that
support a proposed definition ask us to
clarify how we will interpret the
definition. Comments generally ask that
we maintain consistency of terms
among the FSMA rules to avoid
confusion and ensure regulatory
compliance.
We did not receive comment on the
following terms and therefore, are
finalizing them as proposed: ‘‘calendar
day,’’ ‘‘FDA,’’ ‘‘pest,’’ ‘‘water activity,’’
and ‘‘you.’’
We removed some proposed
definitions because the final rule does
not use them. The proposed definitions
that are removed in this final rule are
‘‘batter,’’ ‘‘blanching,’’ ‘‘packaging,’’
‘‘quality control operation,’’ ‘‘safe
moisture level,’’ ‘‘should,’’ and
‘‘significant hazard.’’
In the following sections, we discuss
comments that ask us to clarify
proposed definitions or that disagree
with, or suggest one or more changes to,
a proposed definition. After considering
these comments, we have revised the
proposed requirements with editorial
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and conforming changes as shown in
table 31.
We also discuss definitions for
additional terms (i.e., ‘‘audit,’’
‘‘correction,’’ ‘‘full-time equivalent
employee,’’ ‘‘hazard requiring a
preventive control,’’ ‘‘qualified facility
exemption,’’ ‘‘raw agricultural
commodity,’’ ‘‘supply-chain-applied
control,’’ ‘‘unexposed packaged animal
food,’’ and ‘‘written procedures for
receiving raw materials and other
ingredients’’) that we are establishing in
the final rule to simplify the regulatory
text throughout the regulations and
improve clarity. We also discuss a new
name (i.e., ‘‘preventive controls
qualified individual’’) for the definition
of a term that we had proposed to name
‘‘qualified individual,’’ and are
establishing a new definition for the
term ‘‘qualified individual.’’ Finally, we
also discuss definitions that comments
ask us to add, but that we did not add,
to the final rule.
A. Definitions We Proposed To Establish
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1. Adequate
We proposed to define the term
‘‘adequate’’ to mean that which is
needed to accomplish the intended
purpose in keeping with good public
health practice.
(Comment 17) Some comments
express concern that there is no
standard or definition for ‘‘good public
health practice’’ and, for animal food
establishments, the term ‘‘good public
health practice’’ creates more
uncertainty than it removes. The
comments request that we remove from
the definition the term ‘‘good public
health practice.’’ Other comments ask us
to develop guidance on thresholds and
processes that qualify as ‘‘adequate.’’
Other comments assert that the word
‘‘adequate’’ must be used in
combination with the word
‘‘reasonable’’ to properly describe the
intended measures and precautions.
(Response 17) We disagree that there
is no standard for ‘‘good public health
practice.’’ However, we have revised the
definition to add after public ‘‘(human
and animal)’’ to clarify it includes both.
Our intent in using the term ‘‘adequate’’
is to provide flexibility for an animal
food establishment to comply with the
requirement in a way that is most
suitable for its establishment. We
decline the request to develop guidance
to explicitly address ‘‘thresholds’’ or to
describe processes that qualify as
adequate. The CGMPs and preventive
controls requirements established in
this rule are broadly applicable
procedures and practices rather than
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very specific procedures and practices
where additional interpretation from
FDA might be appropriate.
2. Affiliate and Subsidiary
We proposed to define the term
‘‘affiliate’’ to mean any facility that
controls, is controlled by, or is under
common control with another facility.
We proposed to define the term
‘‘subsidiary’’ to mean any company
which is owned or controlled directly or
indirectly by another company. These
proposed definitions would incorporate
the definition in section 418(l)(4)(A) and
(D) of the FD&C Act and would make
the meanings of these terms clear when
used in the proposed definition of
‘‘qualified facility.’’
(Comment 18) Some comments ask us
to clarify that a facility that has no
material connection with another food
processing operation would not be
considered as an ‘‘affiliate’’ of that
operation.
(Response 18) It is not clear what the
comments mean by ‘‘no material
connection with another food
processing operation.’’ To the extent
that a facility does not control, is not
controlled by, or is not under common
control with another facility, we agree
that the facility would not be considered
an affiliate of that food processing
operation.
(Comment 19) Some comments assert
that the definitions of ‘‘affiliate’’ and
‘‘subsidiary’’ fail to account for the legal
differences between a piece of property
(i.e., a facility) and a business entity or
person. These comments ask us to
consider amending the proposed
definition of ‘‘qualified facility’’ to
clarify what sales to include in
determining whether a facility so
qualifies.
(Response 19) See Response 57.
3. Animal Food
We proposed to define the term
‘‘animal food’’ to mean food for animals
other than man that includes pet food,
animal feed, and raw materials and
ingredients.
(Comment 20) Several comments
voice concerns about including within
the definition of animal food the term
‘‘raw materials.’’ The main concern is
whether firms producing raw materials
for animal food must register and create
animal food safety plans. The comments
fear firms would dispose of the raw
material products due to the high cost
of developing and maintaining safety
plans, and disposal of those raw
material products would have a
significant economic impact due to a
considerable increase in the cost of
animal food in the United States.
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(Response 20) We decline to change
the definition. We do not expect that the
inclusion of the term ‘‘raw materials’’ in
the definition for animal food will
change current practices, noting that a
facility producing raw materials for
animal food is already required to
register. The definition of ‘‘animal food’’
is intended to clarify that the rule refers
to ‘‘food for animals’’ and not ‘‘food
derived from animals.’’
4. Critical Control Point
We proposed to define the term
‘‘critical control point’’ (CCP) to mean a
point, step, or procedure in a food
process at which control can be applied
and is essential to prevent or eliminate
a food safety hazard or reduce such
hazard to an acceptable level.
(Comment 21) Some comments
oppose the use of ‘‘critical control
point’’ in the rule because the term is
confusing and not understood by the
relevant industry in the context of
FSMA and the required preventive
controls. The comments suggest critical
control point is a HACCP term and not
appropriate for use in this rule where
the scope is defined differently by the
statute.
(Response 21) We decline to modify
or remove the definition as these
comments request because we believe
the term is helpful to industry. The
proposed definition matches the
statutory definition in section 418(o)(1)
of the FD&C Act and is consistent with
definitions in the Federal HACCP
regulations for seafood, juice, and meat
and poultry (parts 123 and 120 (21 CFR
part 123 and 120) and 9 CFR part 417
respectively). By specifying that a point,
step, or procedure in an animal food
safety process would reduce a hazard to
an ‘‘acceptable level,’’ the definition
provides flexibility for a facility to
determine an appropriate level in a
particular circumstance.
(Comment 22) Some comments
request that we define the term ‘‘control
point.’’ The comments suggest defining
this term as a point, step, or procedure
in the production of an animal food at
which a control may be applied.
(Response 22) We decline this
request. We define ‘‘critical control
point’’ as a point, step, or procedure in
a food process at which control can be
applied and is essential to prevent or
eliminate a food safety hazard or reduce
such hazard to an acceptable level. Also,
‘‘control point’’ is not a term used in the
regulatory text of the rule and therefore
does not need to be defined.
5. Environmental Pathogen
We proposed to define the term
‘‘environmental pathogen’’ to mean a
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pathogen capable of surviving and
persisting within the manufacturing,
processing, packing, or holding
environment such that food for animals
may be contaminated and may result in
foodborne illness if that animal food is
not treated to significantly minimize or
prevent the environmental pathogen.
We also proposed to specify that
environmental pathogen does not
include the spores of pathogenic
sporeformers. By ‘‘pathogenic
sporeformers,’’ we mean ‘‘pathogenic
sporeforming bacteria,’’ and we are
substituting the term ‘‘pathogenic
sporeforming bacteria’’ for ‘‘pathogenic
sporeformers’’ in the definition of
‘‘environmental pathogen’’ to make that
clearer.
(Comment 23) Some comments ask us
to include Salmonella spp. and Listeria
monocytogenes in the regulatory text as
examples of environmental pathogens.
Other comments believe the definition
is too broad because it would include
any pathogen that is capable of
surviving or persisting in the
environment, and the definition should
be limited to the pathogenic bacteria
that are more appropriate for protecting
animal food safety.
(Response 23) We agree that
Salmonella spp. and L. monocytogenes
are useful examples of environmental
pathogens and have added these two
examples to the proposed definition,
which had not included examples.
Adding these two examples to the
definition does not mean that these two
pathogens are the only environmental
pathogens that a facility must consider
in its hazard analysis. New
environmental pathogens can emerge at
any time, and other pathogens can also
be environmental pathogens.
Salmonella spp in pet food have been
involved in foodborne illness outbreaks
in humans (78 FR 64736 at 64747). In
addition, there have been recalls of pet
food found to contain L.
monocytogenes, though no human or
animal illnesses were associated with
these recalls to date (Refs. 17 and 18).
(Comment 24) Some comments ask us
to clarify the meaning of the term
‘‘persisting’’ as used in the definition,
such as whether it means that a
sanitation process will not remove the
microorganism.
(Response 24) We use the term
‘‘persisting’’ to mean that a pathogen
can get established if cleaning is not
adequate. Once a pathogen gets
established, appropriate sanitation
measures can remove the pathogen.
However, sanitation procedures
necessary to eliminate an environmental
pathogen that has become established
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generally are more aggressive than
routine sanitation procedures.
6. Facility
We proposed to define the term
‘‘facility’’ to mean a domestic facility or
a foreign facility that is required to
register under section 415 of the FD&C
Act in accordance with the
requirements of part 1, subpart H.
Comments directed to the meaning of
the term ‘‘facility’’ address its meaning
as established in the section 415
registration regulations, rather than this
definition established in part 507.
For a discussion of comments on
definitions in part 1, see section IV of
the final rule for preventive controls for
human food published elsewhere in this
issue of the Federal Register.
7. Farm
We proposed to define the term
‘‘farm’’ by reference to the definition of
that term in § 1.227(b) rather than by
repeating the full text of the ‘‘farm’’
definition in part 507. For a discussion
of comments to the farm definition and
of the ‘‘farm’’ definition that we are
establishing in § 1.227, see section IV of
the final rule for preventive controls for
human food published elsewhere in this
issue of the Federal Register.
8. Food
We proposed to define the term
‘‘food’’ to mean food as defined in
section 201(f) of the FD&C Act and to
include raw materials and ingredients.
Under section 201(f), the term ‘‘food’’
means: (1) Articles used for food or
drink for man or other animals, (2)
chewing gum, and (3) articles used for
components of any such article.
(Comment 25) Some comments ask us
to include examples in the definition.
These comments also ask us to clarify
whether the definition applies to food
for human consumption, animal
consumption, or both.
(Response 25) We decline the request
to include examples in the definition.
There are many examples of food and
adding a limited list of examples could
be confusing rather than helpful.
Although the definition of food includes
food for both human consumption and
animal consumption, the provisions of
the rule are clearly directed to food for
animal consumption.
(Comment 26) Some comments ask us
to consider fundamental and important
differences between food additives and
GRAS substances and finished food.
These comments explain that food
additives and GRAS substances may be
synthesized using various chemical and
biochemical processes, or may be
extracted, hydrolyzed or otherwise
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modified from their natural sources, and
result in food safety hazards that are
quite different from finished food
preparations. These comments also
explain that food additives and GRAS
substances are often produced using
processes that minimize microbial
contamination hazards and are almost
always used in food products that
undergo further downstream processing.
These comments assert that food
additives and GRAS substances
generally present a significantly lower
public health hazard compared to
finished food and should be regulated
accordingly.
(Response 26) Substances such as
food additives and GRAS substances are
food and are subject to the requirements
of this rule. Both the CGMP
requirements in subpart B and the
requirements for hazard analysis and
risk-based preventive controls in
subparts C and E provide flexibility to
address all types of food. (As discussed
in section XL, the final rule establishes
the requirements for a supply-chain
program in subpart E, rather than within
subpart C as proposed. As a result, this
document refers to subparts C and E
when broadly referring to the
requirements for preventive controls.) A
manufacturer of a food additive or
GRAS substance has flexibility to
comply with the requirements of the
rule based on the nature of the
production processes and the outcome
of the hazard analysis for that animal
food substance.
9. Food-Contact Surfaces
We proposed to define ‘‘food-contact
surfaces’’ to mean those surfaces that
contact animal food and those surfaces
from which drainage, or other transfer,
onto the food or onto surfaces that
contact the food ordinarily occurs
during the normal course of operations.
‘‘Food-contact surfaces’’ include foodcontact surfaces of utensils and
equipment.
(Comment 27) Several comments state
that the terms ‘‘drainage’’ and ‘‘utensils’’
are not widely used or understood
within animal feed and pet food
industry and that the definition for
‘‘food-contact surfaces’’ should be
revised by deleting ‘‘drainage, or other,’’
and by replacing ‘‘utensils’’ with
‘‘tools.’’
(Response 27) We decline these
requests. See our discussion of the term
‘‘utensils’’ in Response 169. We believe
the term ‘‘drainage’’ is commonly
understood.
10. Harvesting
We proposed to define the term
‘‘harvesting’’ to apply to farms and farm
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mixed-type facilities and to mean
activities that are traditionally
performed by farms for the purpose of
removing RACs from the place they
were grown or raised and preparing
them for use as food. We proposed that
harvesting be limited to activities
performed on RACs on a farm, and that
harvesting does not include activities
that transform a RAC into a processed
food. The proposed definition included
examples of activities that would be
harvesting.
In this final rule, we added or
modified several examples of harvesting
(see Response 28). As noted in table 31,
we have reorganized the listed examples
of harvesting to present them in
alphabetical order.
We are defining the term ‘‘harvesting’’
to apply to farms and farm mixed-type
facilities and to mean activities that are
traditionally performed on farms for the
purpose of removing RACs from the
place they were grown or raised and
preparing them for use as animal food.
The definition includes examples of
activities that are harvesting, as
described in this section. Harvesting is
also limited to activities performed on
RACs, or on processed foods created by
drying/dehydrating a RAC without
additional manufacturing/processing,
on a farm.
(Comment 28) Some comments ask us
to provide more examples of harvesting
activities, in the regulatory text and in
guidance. Examples of the requested
activities include braiding; bunching;
cutting the edible portion of the crop
from the plant; hydro-cooling;
maintaining hydration of product;
refrigerating; removing foliage;
removing free water from (e.g.
spinning); removing or trimming roots;
trimming the tops of bunches of allium
crops such as leeks, chives, or garlic and
root crops such as carrots, beets,
turnips, parsnips, etc. to prepare them
for sale; and trimming the lower stems
of harvested herb crops such as parsley,
basil, or cilantro, or the lower stems of
leafy greens. Other comments ask us to
specify that harvesting also
encompasses seed conditioning (i.e.,
cleaning the seed, including removal of
leaves, stems, and husks to prepare for
marketing), ripening (artificial or
natural) of fruit, and waxing or coating
of RACs.
(Response 28) We have added or
modified several examples of harvesting
in the regulatory text (i.e., cutting (or
otherwise separating) the edible portion
of the RAC from the crop plant,
removing or trimming part of the RAC
(e.g., foliage, husks, roots or stems) and
field coring and hulling). In table 1 in
the Appendix to the 2014 supplemental
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notice (79 FR 58476 at 58520 through
58521), we provided a more extensive
list of examples of harvesting activities,
including examples that are not in the
regulatory text. We have classified some
of these activities in more than one way
(see 79 FR 58476 at 58520 through
58521). For example, trimming of outer
leaves from RACs can be a harvesting
activity, as well as a manufacturing/
processing activity. Artificial ripening of
fruit is manufacturing/processing (not
harvesting), but is now within the
‘‘farm’’ definition.
(Comment 29) Some comments ask us
to periodically review the list of
harvesting activities to ensure that it
reflects current practices.
(Response 29) If particular activities
present questions in the future about
whether the activity is a harvesting
activity within the ‘‘farm’’ definition, or
a manufacturing/processing activity that
is outside the ‘‘farm’’ definition, we will
consider issuing guidance or updating
any existing guidance to clarify our
recommended classification of the
activity.
(Comment 30) Some comments note
that the proposed definition for
‘‘harvesting’’ seems to be much more
inclusive than FDA’s original proposed
regulation, but is significantly more
restrictive than the current regulation in
part 1 because it excludes future
technological developments. The
comment further notes as technology
and harvesting techniques advance, the
risk of tying the definition to traditional
activities will have a negative effect on
agriculture’s ability to adapt.
Furthermore, harvesting is merely the
first step in transforming a RAC into
processed food.
(Response 30) The comment did not
make a specific request or provide any
suggestions as to how future
technological developments should be
handled; therefore, we are finalizing the
definition with the changes previously
described.
11. Hazard
We proposed to define the term
‘‘hazard’’ to mean any biological,
chemical (including radiological), or
physical agent that is reasonably likely
to cause illness or injury in humans or
animals in the absence of its control.
(Comment 31) Some comments
express concern that the rule would
refer to four levels of ‘‘hazard,’’ i.e.,
‘‘hazard,’’ ‘‘known or reasonably
foreseeable hazard,’’ ‘‘significant
hazard,’’ and ‘‘serious adverse health
consequences or death to humans or
animals’’ hazard. These comments ask
us to provide sufficient clarity to be able
to distinguish between these types of
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hazards and to provide examples in
guidance as to how these terms will be
applied in determining compliance with
the rule. Other comments express
concern that the definitions do not
establish a meaningful distinction
between ‘‘hazard’’ and ‘‘significant
hazards’’ and do not sufficiently
distinguish between the hazards
identified in the first and second steps
of the hazard analysis (first narrowing
hazards to ‘‘known or reasonably
foreseeable hazards’’ and then
narrowing the ‘‘known or reasonably
foreseeable hazards’’ to ‘‘significant
hazards’’).
(Response 31) The rule uses three of
these terms (i.e., ‘‘hazard,’’ ‘‘known or
reasonably foreseeable hazard,’’ and the
proposed term ‘‘significant hazard’’) to
establish a tiered approach to the
requirements for hazard analysis and
risk-based preventive controls. The term
‘‘hazard’’ is the broadest of these three
terms—any biological, chemical
(including radiological), or physical
agent has the potential to cause illness
or injury. To conduct its hazard
analysis, a facility starts by first
narrowing down the universe of all
potential hazards to those that are
‘‘known or reasonably foreseeable’’ for
each type of food for animals
manufactured, processed, packed, or
held at its facility. The outcome of the
facility’s hazard analysis is a
determination of ‘‘significant hazards,’’
i.e., the subset of those known or
reasonably foreseeable hazards that
require a preventive control.
To make this clearer, we have: (1)
Revised the proposed definitions of
‘‘hazard’’ and (2) changed the term
‘‘significant hazard’’ to ‘‘hazard
requiring a preventive control’’
(formerly ‘‘significant hazard’’). See
Responses 32 and 62.
The rule does not define the term
‘‘serious adverse health consequences or
death to humans or animals’’ hazard.
However, the requirements for a supplychain program refer to a hazard for
which there is a reasonable probability
that exposure to the hazard will result
in serious adverse health consequences
or death to humans or animals (see
§ 507.130(b)). For additional
information on how we interpret
‘‘serious adverse health consequences or
death to humans or animals,’’ see our
guidance regarding the RFR (Refs. 19
and 20), which addresses statutory
requirements regarding ‘‘reportable
foods.’’ As explained in that guidance,
a ‘‘reportable food’’ is an article of food
for which there is a reasonable
probability that the use of, or exposure
to, such article of food will cause
serious adverse health consequences or
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death to humans or animals. The
guidance includes examples of
circumstances under which food might
be reportable.
(Comment 32) Some comments assert
that the distinction between the
definitions of ‘‘hazard’’ and ‘‘significant
hazard’’ is not discernable because the
proposed definition of ‘‘hazard’’
currently takes into account whether or
not a ‘‘hazard’’ is or is not controlled.
These comments ask us to delete the
phrase ‘‘in the absence of its control’’
from the definition of ‘‘hazard’’ to
clarify that hazards are simply the
agents that are reasonably likely to
cause illness or injury. Likewise, other
comments assert that any hazard that is
‘‘reasonably likely to cause illness or
injury in the absence of its control’’ will,
if known or reasonably foreseeable,
likely be controlled by any
knowledgeable person.
(Response 32) We have deleted the
phrase ‘‘in the absence of its control’’
from the definition of ‘‘hazard.’’ We
agree that deleting this phrase from the
definition of ‘‘hazard’’ will more clearly
distinguish between the terms ‘‘hazard’’
and ‘‘hazard requiring a preventive
control’’ that we are establishing in this
rule.
We also replaced the phrase ‘‘that is
reasonably likely to cause illness or
injury’’ with ‘‘that has the potential to
cause illness or injury’’ to more clearly
distinguish ‘‘hazard’’ from ‘‘known or
reasonably foreseeable hazard.’’ This
increases the alignment of the definition
of ‘‘hazard’’ in this rule with the Codex
definition of ‘‘hazard.’’
(Comment 33) Some comments ask us
to include ‘‘in the intended species’’ in
the definition of ‘‘hazard.’’
(Response 33) We decline this
request. During the hazard analysis the
facility must identify and evaluate,
based on experience, illness data,
scientific reports, and other information,
known or reasonably foreseeable
hazards for each type of animal food
manufactured, processed, packed, or
held at the facility to determine whether
there are hazards requiring a preventive
control (§ 507.33(a)). During the hazard
evaluation, the facility must consider
the effect of the intended or reasonably
foreseeable use on the safety of the
finished animal food for the intended
animal (§ 507.33(d)(8)).
12. Holding
We proposed to define ‘‘holding’’ to
mean storage of food, including
activities performed incidental to
storage of a food (e.g., activities
performed for the safe or effective
storage of that food and activities
performed as a practical necessity for
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the distribution of that food (such as
blending of the same RAC and breaking
down pallets)), but not including
activities that transform a RAC into a
processed food. We proposed that
holding facilities could include
warehouses, cold-storage facilities,
storage silos, grain elevators, and liquidstorage tanks.
(Comment 34) Some comments ask us
to provide more examples of holding
activities, in the regulatory text and in
guidance. Examples of the requested
activities include fumigating RACs;
application of chemicals (including
fungicides, sanitizers, and antioxidants); and ‘‘coating’’ grain RACs
with diatomaceous earth to control
insects. According to these comments,
these activities are incidental to storage
and do not transform RACs into
processed food. Other comments
wanted examples of holding of humanfood by-products destined for animal
food (for example wet pasta that dries
naturally while being held).
(Response 34) We have added or
modified several examples of holding in
the regulatory text (i.e., fumigating
animal food during storage, and drying/
dehydrating RACs when the drying/
dehydrating does not create a distinct
commodity (such as drying/dehydrating
hay or alfalfa)). In table 1 in the
Appendix to the 2014 supplemental
notice (79 FR 58476 at 58520 through
58521), we provided a more extensive
list of examples of holding activities,
including examples that are not in the
regulatory text. We have previously
classified some of these activities in
more than one way (see 79 FR 58476 at
58520 through 58521) depending on
when the activity occurs. For example,
sorting, culling, and grading RACs can
be either a holding activity or a packing
activity. Drying/dehydrating RACs is
holding when the drying/dehydrating
does not create a distinct commodity,
but is manufacturing/processing when
the drying/dehydrating creates a distinct
commodity (see section IV). Holding of
certain human food by-products for use
as animal food is discussed in sections
XIII and XXII.
(Comment 35) Some comments ask us
to clarify that mixing or blending intact
RACs is considered ‘‘holding’’
regardless of whether the RACs are the
same or different.
(Response 35) We use the term
‘‘blending’’ when referring to RACs such
as grain and when the RACs are the
same. For example, we consider the
activity of ‘‘blending’’ different lots of
the same grain to meet a customer’s
quality specifications to be a practical
necessity for product distribution and,
thus, to be within the definition of
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‘‘holding’’ (see 79 FR 58476 at 58483).
However, we use the term ‘‘mixing’’
when the RACs are different. For
example, we consider the activity of
‘‘mixing’’ corn and oats in the
production of animal food to be
manufacturing/processing, because
mixing two different foods is ‘‘making
food from one or more ingredients’’
(which is our definition of
‘‘manufacturing/processing’’) and the
animal food produced by mixing corn
and oats is a processed food.
We classify ‘‘mixing’’ intact RACs that
does not create a processed animal food
as incidental to, and therefore part of,
‘‘packing’’ or ‘‘holding’’ as applicable.
For example, mixing heads or bunches
of lettuce does not create a processed
food, because the mixing has not created
a distinct commodity, but only a set of
mixed RACs. On the other hand, mixing
that creates a processed animal food is
not ‘‘packing’’ or ‘‘holding.’’ The
definitions of both ‘‘packing’’ and
‘‘holding’’ are limited so that they do
not include activities that transform a
RAC into processed animal food. Some
kinds of mixing of RACs does create a
distinct commodity (for example,
mixing corn and oats to make animal
food). In such cases, the mixing is
manufacturing/processing and is not
within the farm definition.
(Comment 36) Some comments ask us
to clarify whether the expanded
definition of holding that we proposed
in the 2014 supplemental human
preventive controls notice would mean
that a warehouse that both stores and
fumigates a RAC to prevent pest
infestation would be exempt from the
requirements for hazard analysis and
risk-based preventive controls for a
facility solely engaged in the storage of
RACs (other than fruits and vegetables)
for further distribution or processing
(§ 507.5).
(Response 36) Fumigating RACs to
prevent pest infestation would be
within the definition of ‘‘holding’’ and
therefore would not prevent a facility
that stores RACs (other than fruits and
vegetables) from being eligible for the
exemption in § 507.5(g), provided that
the facility does not conduct other
activities not classified as ‘‘holding.’’
However, a threshold question for any
facility solely engaged in the storage of
RACs is whether the stored RACs are
fruits or vegetables.
(Comment 37) Some comments ask us
to clarify whether there is a timeframe
associated with holding and to better
distinguish between ‘‘holding’’ and
‘‘storage.’’
(Response 37) There is no timeframe
(maximum or minimum) associated
with holding. The definition of holding
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states ‘‘Holding means storage of food’’
and, thus, there is no distinction
between ‘‘holding’’ and ‘‘storing.’’
(Comment 38) Some comments ask us
to clarify how the definition of holding
relates to practices, such as fumigation,
on almond hull stockpiles held on a
farm, a farm mixed-type facility or offfarm.
(Response 38) Practices that are
incidental to storage of food, such as
fumigation of almond hull stockpiles,
are holding, regardless of whether they
are conducted on-farm, on a farm
mixed-type facility, or off-farm.
(Comment 39) Some comments ask us
to clarify that value added activities
(such as repacking and blast freezing)
conducted in facilities such as
warehouses would be considered
holding when product is not exposed to
the environment.
(Response 39) We consider the
activities described in these comments
to be activities performed as a practical
necessity for the distribution of the food
and, thus, to be within the definition of
holding.
(Comment 40) Several comments do
not support the proposed definition of
‘‘holding’’ stating that the definition
would exempt grain receiving and
storage facilities that are the primary
suppliers of the main ingredient in
many animal foods including distiller’s
products. Some comments ask us to
clarify what is a practical necessity.
(Response 40) Section 418(m) of the
FD&C Act provides us with the
authority to exempt certain facilities
from the requirements of section 418, or
to modify those requirements. We
proposed to use this authority to exempt
facilities that solely engage in the
storage (holding) of RACs (other than
fruits and vegetables) intended for
further distribution or processing. We
tentatively concluded that there would
not be significant public (human and
animal) health benefit to be gained by
having these facilities subject to the
requirements of subpart C. Outbreaks of
illness associated with feeding RACs to
animals have not been traced back to
storage facilities solely engaged in the
storage of RACs, therefore we think it is
appropriate to exempt them from the
requirements of subparts C and E of the
final rule. Such facilities remain subject
to the requirements of section 402 of the
FD&C Act that the animal food being
held is not adulterated.
The revised definition of ‘‘holding’’
encompasses activities performed as a
practical necessity for the distribution of
RACs, such as blending of the same
RAC and breaking down pallets.
Sampling for grading or quality control
purposes, repacking, and drying grains
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and oilseeds would also be considered
performed as a practical necessity for
the distribution of animal food within
the definition of ‘‘holding.’’
13. Known or Reasonably Foreseeable
Hazard
We proposed to define the term
‘‘known or reasonably foreseeable
hazard’’ to mean a biological, chemical
(including radiological), or physical
hazard that has the potential to be
associated with the facility or the food.
(Comment 41) Some comments
support the definition as proposed,
noting that it implies that the
implementation of a preventive control
be based both on the severity and
likelihood of the hazard, can help to
distinguish between the requirements of
this rule and HACCP requirements, and
provides for the proper consideration of
both the food and the facility when
determining whether a hazard is
‘‘known or reasonably foreseeable.’’
Other comments ask us to modify the
definition to specify that the term means
a hazard ‘‘that is known to be, or has the
potential to be, associated with the
facility or the food’’ to better align with
the term as FDA proposed to define it
in the proposed FSVP rule. (See 79 FR
58574 at 58595.)
(Response 41) We have revised the
definition as requested by the comments
to better align with the proposed FSVP
rule.
(Comment 42) Some comments ask us
to revise the definition so that it
addresses a hazard that is known to be,
or has the potential to be, associated
with a food, the facility in which it is
manufactured/processed, or the location
or type of farm on which it is grown or
raised. These comments assert that the
type of farm may affect those hazards
that are known or reasonably
foreseeable.
(Response 42) We decline this
request, which appears related to
another difference between the
definition proposed in this rule and the
definition of this term in the proposed
FSVP rule. The proposed FSVP rule
would define ‘‘known or reasonably
foreseeable hazard’’ as a hazard that is
known to be, or has the potential to be,
associated with a food or the facility ‘‘in
which it is manufactured/processed.’’
(See 79 FR 58574 at 58595.) In this rule,
we do not need to specify that the
applicable facility is the one ‘‘in which
the food is manufactured/processed’’
because this rule applies to the owner,
operator, or agent in charge of the
facility in which the food is
manufactured, processed, packed, or
held, and that applicability does not
need to be repeated in each provision.
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To the extent that this comment is
expressing concern about raw materials
or other ingredients that a facility would
receive from a farm, those concerns
would be considered in the facility’s
hazard analysis, which would include a
hazard evaluation that considers factors
such as those related to the source of
raw materials and other ingredients (see
§ 507.33(d)(3)).
14. Lot
We proposed to define ‘‘lot’’ to mean
the food produced during a period of
time indicated by a specific code.
(Comment 43) Some comments state
that many animal food processors
operate on a batch-production basis
rather than a continuous-production
basis and request that we take this into
account with respect to the definition of
‘‘lot.’’ Other comments suggest replacing
‘‘lot’’ with ‘‘lot identifier’’ where ‘‘lot
identifier’’ means a unique identifier for
each lot, batch or production run that
enables the manufacturer to trace
accurately the complete manufacturing
and distribution history of the product.
Other comments ask us to modify the
proposed definition so that it is not
limited by a period of time and suggest
using an approach that would allow for
a lot to be defined by either time or by
a specific identifier. Other comments
express the view that the individual
operators should be able to define their
lot designations and make these
definitions available to FDA upon
request.
(Response 43) Although the term
‘‘lot’’ is associated with a period of time,
an establishment has flexibility to
determine the code, with or without any
indication of time in the code. For
example, a code could be based on a
date, time of day, production
characteristic (such as origin, variety,
and type of packing), combination of
date/time/production characteristic, or
any other method that works best for the
establishment. To clarify that the rule
does not require that time be
‘‘indicated’’ by the code, and emphasize
the establishment’s flexibility to
determine the code, we have revised
‘‘period of time indicated by a specific
code’’ to ‘‘period of time and identified
by an establishment’s specific code.’’
15. Manufacturing/Processing
We proposed to define
‘‘manufacturing/processing’’ to mean
making food from one or more
ingredients, or synthesizing, preparing,
treating, modifying, or manipulating
food, including food crops or
ingredients. We proposed that examples
of manufacturing/processing activities
would be cutting, peeling, trimming,
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washing, waxing, eviscerating,
rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing,
mixing, formulating, bottling, milling,
grinding, extracting juice, distilling,
labeling, or packaging. For farms and
farm mixed-type facilities,
manufacturing/processing would not
include activities that are part of
harvesting, packing, or holding. In this
rule, we add more examples to include,
‘‘artificial ripening,’’ ‘‘boiling,’’
‘‘canning,’’ ‘‘drying/dehydrating raw
agricultural commodities to create a
distinct commodity (such as drying/
dehydrating grapes to produce raisins),’’
‘‘evaporating,’’ ‘‘extruding,’’ and
‘‘pelleting.’’ We also alphabetize the list
of examples.
(Comment 44) Some comments
express concern that some activities
included in the definition of
‘‘manufacturing/processing’’ overlap
with activities (such as trimming,
washing, and cooling) included in the
definition of ‘‘harvesting.’’
(Response 44) We acknowledge that
there is some overlap in the activities
that the regulatory text lists as examples
of both ‘‘manufacturing/processing’’ and
‘‘harvesting,’’ because some activities
can occur during more than one
operation (see table 1 in the Appendix
to the 2014 supplemental notice (79 FR
58476 at 58520 through 58521)). For
example, ‘‘cutting’’ lettuce from the crop
plant occurs on-farm in the field where
the lettuce is harvested, and ‘‘cutting’’
the core of the lettuce from the rest of
the harvested lettuce occurs in a freshcut processing facility. An important
consequence of the multiple revisions
we have made to the ‘‘farm’’ definition
in this rulemaking is that there are fewer
situations in which classification of a
particular activity is the only trigger for
an operation to be subject to the section
415 registration requirements. For
example, the revised ‘‘farm’’ definition
no longer classifies the packing and
holding of others’ RACs to be a
manufacturing/processing activity that
triggers the registration requirement. As
another example, the revised ‘‘farm’’
definition specifies three
manufacturing/processing activities that
are within the ‘‘farm’’ definition. We
conclude that the overlap in the
examples of activities listed in the
definitions of ‘‘harvesting’’ and
‘‘manufacturing/processing’’ does not
create problems with determining the
status of an operation as a ‘‘farm’’ or a
‘‘facility’’ and we are retaining examples
in both definitions because doing so
reflects current practices on farms and
in manufacturing/processing facilities.
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16. Microorganisms
We proposed to define the term
‘‘microorganisms’’ to mean yeasts,
molds, bacteria, viruses, protozoa, and
microscopic parasites, including species
having animal or human health
significance. We also proposed that the
term ‘‘undesirable microorganisms’’
includes those microorganisms that are
of animal or human health significance,
that subject food to decomposition, that
indicate that food is contaminated with
filth, or that otherwise may cause food
to be adulterated. We have revised the
definition to replace ‘‘includes species
having animal or human health
significance’’ with ‘‘and includes
species that are pathogens,’’ and
replacing ‘‘’undesirable
microorganisms’’’ includes those
microorganisms that are of animal or
human health significance’’ with
‘‘’undesirable microorganisms’’’
includes those microorganisms that are
pathogens.’’
(Comment 45) Some comments
express concern that the term
‘‘undesirable microorganisms’’ includes
microorganisms that subject food to
decomposition. These comments assert
that the definition would expand
regulation beyond food safety and ask
us to clarify that decomposition means
a degradation of product that is only
relevant when it affects the safety of the
product, rather than simple spoilage.
(Response 45) We have not modified
the regulatory text of this longstanding
definition of the term ‘‘undesirable
microorganisms’’ regarding
microorganisms that subject food to
decomposition. The regulations
established by this rule are designed to
prevent the growth of undesirable
microorganisms. The scope of the
definition of ‘‘undesirable
microorganisms’’ is not limited to
microorganisms of public health
significance because these regulations
are also concerned with sanitation,
decomposition, and filth (51 FR 22458
at 22460, June 19, 1986).
17. Mixed-Type Facility
We proposed to define ‘‘mixed-type
facility’’ to mean an establishment that
engages in both activities that are
exempt from registration under section
415 of the FD&C Act and activities that
require the establishment to be
registered. We proposed that an
example of such a facility is a ‘‘farm
mixed-type facility,’’ which is an
establishment that grows and harvests
crops or raises animals and may
conduct other activities within the farm
definition, but also conducts activities
that require the establishment to be
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registered. As a conforming change
associated with the revisions to the
‘‘farm’’ definition, we have revised the
example of a ‘‘farm mixed-type facility’’
to specify that it is an establishment that
is a farm, but also conducts activities
outside the farm definition that require
the establishment to be registered. (See
section IV of the final rule for
preventive controls for human food
published elsewhere in this addition of
the Federal Register.)
(Comment 46) Some comments ask us
to revise the definition to exclude those
establishments that only conduct lowrisk activities specified in the
exemptions for on-farm, low-risk
activity/animal food combinations
(§ 507.5(e) and (f)).
(Response 46) We decline this
request. Whether a particular
establishment that falls within the
definition of ‘‘mixed-type facility’’ is
subject to the requirements for hazard
analysis and risk based preventive
controls is governed by the exemptions
established in this rule.
18. Monitor
We proposed to define the term
‘‘monitor’’ to mean to conduct a
planned sequence of observations or
measurements to assess whether a
process, point, or procedure is under
control and to produce an accurate
record for use in verification.
(Comment 47) Some comments assert
that our proposed definition of monitor
is directed to the narrow circumstance
of monitoring that would be applied to
a CCP under the National Advisory
Committee on Microbiological Criteria
for Foods (advisory committee chartered
under the USDA) (NACMCF) HACCP
guidelines and the Codex HACCP
Annex. These comments also assert that,
using such definitions, monitoring
would not apply to control measures for
which parameters cannot be established
and that are not amenable to
documentation. These comments
suggest that we use a definition of
monitoring consistent with that
provided in ISO 22000:2005
(conducting a planned sequence of
observations or measurements to assess
whether control measures are operating
as intended) to clarify that monitoring
may be conducted where appropriate for
preventive controls that are not CCPs.
(ISO is an abbreviation for
‘‘International Organization for
Standardization.’’ ISO develops and
publishes International Standards.)
According to these comments, an
advantage of this definition is that it
also would clarify the difference
between monitoring activities
(observations conducted during the
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operation of a control measure to ensure
that it is under control) and verification
activities (to evaluate performance of a
control measure).
(Response 47) We have revised the
definition of monitor to mean to
conduct a planned sequence of
observations or measurements to assess
whether control measures are operating
as intended. We agree that the revised
definition, which reflects an
international standard, more effectively
communicates that monitoring also
applies to controls that are not at CCPs
and may apply to control measures for
which parameters cannot be established.
However, we disagree that this
definition signals that it is not possible
to obtain documentation when
monitoring preventive controls that are
not at CCPs, such as for controls that are
not process controls and do not involve
parameters and maximum or minimum
values, or combinations of values, to
which a parameter must be controlled to
significantly minimize or prevent a
hazard requiring a preventive control.
For example, it is possible to monitor
that a specific sanitation control activity
has taken place, such as the cleaning of
a piece of equipment to prevent crosscontact.
The requirement for documenting
monitoring in records is established by
the requirements for monitoring, not by
the definition of monitor. As discussed
in section XXX.C, we have made several
revisions to the regulatory text, with
associated editorial changes, to clarify
that monitoring records may not always
be necessary.
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19. Packaging (When Used as a Verb)
We proposed to define ‘‘packaging
(when used as a verb)’’ as placing food
into a container that directly contacts
the food and that the consumer receives.
Based on comments received to the
proposed rule for preventive controls for
human food, we have decided not to
establish the definition ‘‘packaging
(when used as a verb)’’ in part 507. For
a discussion of those comments
received to the human food preventive
controls rule, see section IX.C.20 in the
final rule for preventive controls for
human food published elsewhere in this
issue of the Federal Register.
20. Packing
We proposed to define ‘‘packing’’ as
placing food into a container other than
packaging the food, including activities
performed incidental to packing a food
(e.g., activities performed for the safe or
effective packing of that food (such as
sorting, culling and grading)), but not
including activities that transform a raw
agricultural commodity, as defined in
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section 201(r) of the FD&C Act, into a
processed food as defined in section
201(gg). We have revised the definition
to clarify that packing includes ‘‘repacking.’’
For comments on the definition of
‘‘packing,’’ see section IV.G of the final
rule for preventive controls for human
food, published elsewhere in this
addition of the Federal Register.
We are finalizing the definition as
proposed, with the addition of another
example of an activity performed for the
safe or effective packing of the food, i.e.,
weighing or conveying incidental to
packing or repacking, and the addition
of ‘‘animal’’ in front of food.
21. Pathogen
We proposed to define the term
‘‘pathogen’’ to mean a microorganism of
public (human or animal) health
significance.
(Comment 48) Some comments ask us
to revise the definition to mean a
‘‘microorganism of such severity and
exposure that it would be deemed of
public health significance’’ because the
significance of pathogens to public
health depends on the organism’s
severity and the nature of exposure.
(Response 48) We decline this
request. Our purpose in defining the
term pathogen was to simplify the
regulations, including our longstanding
CGMP regulations for human food, by
substituting a single term (i.e.,
‘‘pathogen’’) for a more complex term
(i.e., ‘‘microorganism of public health
(human and animal) significance’’)
throughout the regulations. These
comments fail to explain how we have
interpreted the current term
‘‘microorganism of public health
significance’’ in a way that does not take
into account factors such as the severity
of illness and the route of exposure.
22. Plant
We proposed to define the term
‘‘plant’’ to mean the building or
establishment or parts thereof, used for
or in connection with the
manufacturing, processing, packing, or
holding of animal food.
(Comment 49) Some comments state
that it would not be helpful to use
‘‘plant’’ interchangeably with
‘‘establishment’’ when referring to a
business that is not required to register.
These comments ask us to consistently
use one of these terms and to define a
term that would mean ‘‘a business that
is not required to register’’ to help
distinguish such businesses from
‘‘facilities.’’
(Response 49) We agree that it is
appropriate to consistently use one term
when referring to a business entity.
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However, we disagree that it is
necessary to establish a definition for a
business entity that is not required to
register. A business that meets the
definition of ‘‘facility’’ is required to
register; a business that is not required
to register is simply a business that does
not meet the definition of ‘‘facility.’’
To address these comments, we have
revised provisions of the rule in three
ways. First, we have revised the
definition of ‘‘plant’’ to focus it on the
building, structure, or parts thereof,
used for or in connection with the
manufacturing, processing, packing, or
holding of animal food, rather than on
the ‘‘building or establishment.’’
Second, we have revised applicable
provisions of part 507 to use
‘‘establishment’’ rather than ‘‘plant’’
when focusing on a business entity
rather than on buildings or other
structures. Third, we have revised
provisions that use the terms ‘‘plant,’’
‘‘establishment,’’ or both to conform to
the definition of ‘‘plant’’ and the
described usage of ‘‘establishment.’’ For
example, § 507.14 establishes
requirements for ‘‘the management of
the establishment’’ rather than ‘‘plant
management,’’ because ‘‘establishment’’
is the term focusing on the business
entity. As another example,
§ 507.17(a)(1) establishes requirements
for properly storing equipment,
removing litter and waste, and cutting
weeds or grass within the immediate
vicinity of the ‘‘plant’’ rather than
within the immediate vicinity of the
‘‘plant buildings or structures,’’ because
the defined term ‘‘plant’’ focuses on the
buildings and structures, and it is not
necessary to repeat ‘‘buildings and
structures’’ when the term ‘‘plant’’ is
used.
23. Preventive Controls
We proposed to define the term
‘‘preventive controls’’ to mean those
risk-based, reasonably appropriate
procedures, practices, and processes
that a person knowledgeable about the
safe manufacturing, processing, packing,
or holding of food would employ to
significantly minimize or prevent the
hazards identified under the hazard
analysis that are consistent with the
current scientific understanding of safe
food manufacturing, processing,
packing, or holding at the time of the
analysis.
(Comment 50) Some comments ask us
to clarify the meaning of ‘‘current
scientific understanding’’ because
scientific understanding can vary
depending on the risk profile of a
commodity.
(Response 50) By ‘‘current scientific
understanding,’’ we mean to emphasize
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that scientific information changes over
time and a facility needs to keep current
regarding safe handling and production
practices such that the facility has the
information necessary to apply
appropriate handling and production
practices.
24. Preventive Controls Qualified
Individual
We proposed to define the term
‘‘qualified individual’’ to mean a person
who has successfully completed
training in the development and
application of risk-based preventive
controls at least equivalent to that
received under a standardized
curriculum recognized as adequate by
FDA, or is otherwise qualified through
job experience to develop and apply a
food safety system. We have changed
the proposed term ‘‘qualified
individual’’ to ‘‘preventive controls
qualified individual’’ because we are
establishing a new definition for
‘‘qualified individual,’’ with a meaning
distinct from ‘‘preventive controls
qualified individual.’’ To minimize the
potential for confusion, for when the
term ‘‘qualified individual’’ refers to the
proposed meaning of the term and when
the term ‘‘qualified individual’’ refers to
the meaning of that term as finalized in
this rule, in the remainder of this
document we use the new term
‘‘preventive controls qualified
individual’’ whenever we mean ‘‘a
person who has successfully completed
training in the development and
application of risk-based preventive
controls at least equivalent to that
received under a standardized
curriculum recognized as adequate by
FDA or is otherwise qualified through
job experience to develop and apply a
food safety system,’’ even though the
proposed rule used the term ‘‘qualified
individual.’’ Likewise, we use the new
term ‘‘preventive controls qualified
individual’’ for the proposed term
‘‘qualified individual’’ when describing
the comments to the proposed rule,
even though those comments use the
term ‘‘qualified individual.’’
In the following paragraphs, we
discuss comments on this proposed
definition. (See also our discussion in
section XXXVII.B of the requirements
applicable to the preventive controls
qualified individual (§ 507.53(c)).)
(Comment 51) Some comments assert
that the proposed definition of
preventive controls qualified individual
is ambiguous.
(Response 51) The comments provide
no basis for asserting that this definition
is ambiguous. The proposed definition
includes a performance standard
(qualified to develop and apply a food
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safety system), two criteria for how a
person can become qualified
(specialized training or job experience),
and a description of the type of
applicable training (development and
application of risk-based preventive
controls at least equivalent to that
received under a standardized
curriculum). The proposed definition
provides flexibility for how an
individual can become qualified, but
this flexibility does not make the
definition ambiguous.
(Comment 52) Some comments ask us
to expand the definition so that it
includes a team of preventive controls
qualified individuals, not just a single
person.
(Response 52) We decline this
request. The definition applies to each
preventive controls qualified individual
that a facility relies on to satisfy the
requirements of the rule without
limiting the number of such preventive
controls qualified individuals. The
requirements of the rule make clear that
a facility may rely on more than one
preventive controls qualified individual
(see, e.g., § 507.53(a)).
(Comment 53) Several comments state
that there is a lack of specificity about
what constitutes appropriate training
and experience to qualify as a
‘‘preventive controls qualified
individual.’’ Another comment asks us
to clarify how the qualification of the
‘‘preventive controls qualified
individual’’ will be assessed. One
comment asks how the resume and
experience of preventive controls
qualified individuals in other countries
will be evaluated by FDA to determine
that they meet the required
qualifications.
(Response 53) As discussed further in
Response 395, we do not expect to
directly assess the qualifications
(whether obtained by training or by job
experience) of persons who function as
preventive controls qualified
individuals. Instead, we intend to focus
our inspections of both domestic and
foreign facilities on the adequacy of the
food safety plan prepared by the
preventive controls qualified individual
(or under their oversight). As necessary
and appropriate, we will consider
whether deficiencies we identify in the
food safety plan suggest that the
preventive controls qualified individual
may not have adequate training or
experience to carry out the required
functions. If the food safety plan
suggests the preventive controls
qualified individual does not have
adequate training or experience, we will
perform a more in-depth review of the
preventive controls qualified
individual’s training or experience,
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including any associated
documentation.
See also our discussion in section
XXXVII.B about the requirements
applicable to the preventive controls
qualified individual (§ 507.53(c)).
25. Qualified Auditor
We proposed to define the term
‘‘qualified auditor’’ to mean a person
who is a preventive controls qualified
individual as defined in this part and
has technical expertise obtained by a
combination of training and experience
appropriate to perform the auditing
function as required by § 507.53(c)(2).
As discussed in Response 399, we have
revised the definition to specify that
‘‘qualified auditor’’ means a person who
is a ‘‘qualified individual’’ as that term
is defined in this final rule, rather than
a ‘‘preventive controls qualified
individual,’’ because some auditors may
be auditing businesses (such as produce
farms) that are not subject to the
requirements for hazard analysis and
risk-based preventive controls, and it
would not be necessary for such an
auditor to be a ‘‘preventive controls
qualified individual.’’ We also have
clarified that the technical expertise is
obtained through education, training, or
experience (or a combination thereof)
necessary to perform the auditing
function to align the description of
applicable education, training, and
experience with the description of
applicable education, training, and
experience in the definition of
‘‘qualified individual’’ (see § 507.3).
(Comment 54) Some comments ask us
to revise the definition of qualified
auditor to include persons who have
technical expertise obtained by a
combination of training, experience, or
education appropriate to perform audits.
Some comments ask us to recognize that
training and/or experience can make a
person a qualified auditor; the
comments state that people with
experience performing audits likely
have applicable training but might not
have completed a specific regimen of
courses. Some comments maintain that
we should recognize the role of the
education of a potential qualified
auditor, as well as training and
experience to meet the criteria.
(Response 54) We agree that a
qualified auditor might obtain the
necessary auditing expertise in part
through education, as well as through
training and experience, and we have
revised the definition of qualified
auditor accordingly. The revised
definition states that a qualified auditor
has technical expertise obtained through
education, training, or experience (or
the combination thereof).
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(Comment 55) Some comments that
support the proposed definition ask us
to revise the definition to specify certain
individuals who would be considered
qualified auditors, such as FDA
inspectors, properly trained Federal
auditors, and State and private auditors
operating under a contract with the
Federal Government.
(Response 55) We have revised the
regulatory text to specify that examples
of potential qualified auditors include:
(1) A government employee, including a
foreign government employee and (2) an
audit agent of a certification body that
is accredited in accordance with
regulations in part 1, subpart M (i.e.,
regulations in our forthcoming thirdparty certification rule implementing
section 808 of the FD&C Act (21 U.S.C.
348d)). Although we agree that it is
useful to include examples of
individuals who would have the
appropriate qualifications, the example
of an audit agent of a certification body
that has been accredited in accordance
with our regulations in our forthcoming
third-party certification rule adds
context about the standard for such
individuals. Because paragraph (2) of
the new provision refers to provisions in
a future third-party certification rule, we
will publish a document in the Federal
Register announcing the effective date
of paragraph (2) when we finalize the
third-party certification rule.
26. Qualified End-User
We proposed to define the term
‘‘qualified end-user’’ to mean, with
respect to an animal food, the consumer
of the food (where the term consumer
does not include a business); or a
restaurant or retail food establishment
(as those terms are defined in § 1.227(b))
that: (1) Is located (a) in the same State
as the qualified facility that sold the
food to such restaurant or
establishment; or (b) is not more than
275 miles from such facility; and (2) is
purchasing the food for sale directly to
consumers at such restaurant or retail
food establishment. We have revised the
definition of ‘‘qualified end-user’’ to add
‘‘or the same Indian reservation’’ to
clarify for purposes of this rule that ‘‘in
the same State’’ under section
418(l)(4)(B)(ii)(I) of the FD&C Act
includes both within a State and within
the reservation of a FederallyRecognized Tribe.
(Comment 56) One comment requests
the term ‘‘restaurant’’ be removed from
the proposed definition of ‘‘qualified
end-user’’ and replaced with the
appropriate definitional terms for
‘‘restaurant’’ provided in § 1.227: Pet
shelters, kennels, and veterinary
facilities in which animal food is
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provided to animals. The comment also
suggests we modify the definition of
‘‘qualified end-user’’ to be reflective of
the customer who is the purchaser of
the animal food.
(Response 56) We decline these
requests. The definition of ‘‘qualified
end-user’’ is consistent with the
definition in section 418(l)(4)(B) of the
FD&C Act. As discussed in Response 81,
we decline to define consumer.
27. Qualified Facility
We proposed to define ‘‘qualified
facility’’ by incorporating the
description of ‘‘qualified facility’’ in
section 418(l)(1) of the FD&C Act with
editorial changes to improve clarity.
That definition includes two types of
facilities: (1) A facility that is a very
small business as defined in this rule
and (2) a facility to which certain
statutory criteria apply regarding the
average monetary value of animal food
sold by the facility and the entities to
which the animal food was sold.
For the second type of facility, to
represent accurately the language of
section 418(l) of the FD&C Act, we have
changed ‘‘animal food’’ to ‘‘food.’’
Some comments discuss issues
related to the definition of very small
business. See section VIII.A.36 for the
discussion of the definition of very
small business.
(Comment 57) Some comments assert
that the definitions of ‘‘affiliate’’ and
‘‘subsidiary’’ in the definition of
‘‘qualified facility’’ fail to account for
the legal differences between a piece of
property (i.e., a facility) and a business
entity or person. These comments ask us
to consider revising the proposed
definition of ‘‘qualified facility’’ to
clarify what sales to include in
determining whether a facility so
qualifies.
(Response 57) We have not revised
the proposed definition of ‘‘qualified
facility’’ as requested by these
comments. The sales to be included
when a facility determines whether it
meets the definition of a qualified
facility are the sales of animal food by
a business entity meeting the ‘‘very
small business’’ definition or food by a
business entity meeting the other
qualified facility definition, each of
which includes the parent company and
all its subsidiaries and affiliates. The
total sales are applicable to each entity,
whether it is the parent, the subsidiary
or the affiliate. We intend to address
issues such as these in guidance as
directed by section 418(l)(2)(B)(ii) of the
FD&C Act.
(Comment 58) Some comments ask us
to clarify who will determine whether a
particular facility is a qualified facility.
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(Response 58) Any facility that
determines that it satisfies the criteria
for a ‘‘qualified facility’’ must notify
FDA of that determination (see § 507.7)
and, thus, the first determination will be
made by the facility itself. During
inspection, the investigator could ask to
see the records that support the facility’s
determination to verify the facility’s
determination.
In this rule, we remove the term
‘‘quality control operation’’ because the
term is very broad within the animal
food industry and may not be specific
to animal food safety.
28. Receiving Facility
We proposed to define the term
‘‘receiving facility’’ to mean a facility
that is subject to subpart C of this part
and that manufactures/processes a raw
material or ingredient that it receives
from a supplier.
(Comment 59) Some comments ask us
to modify the definition to specify that
the receiving facility could receive the
raw material or ingredient directly from
a supplier or by means of an
intermediary entity. These comments
assert that without this added regulatory
text the proposed definition implies that
the material or ingredient must be
received directly from the supplier.
(Response 59) We decline this
request. As discussed in section XLII.B
and C, the two parties that are critical
to the supplier verification program are
the receiving facility and the supplier,
even if there are entities in the supply
chain between the two. The definition
of receiving facility does not preclude
the participation of intermediary
entities in the supply chain, and the
rule does provide for such participation
(see § 507.115). However, the definition
of receiving facility does highlight the
fact that a receiving facility must have
a link to a supplier.
29. Rework
We proposed to define ‘‘rework’’ to
mean clean, unadulterated food that has
been removed from processing for
reasons other than insanitary conditions
or that has been successfully
reconditioned by reprocessing and that
is suitable for use as food. In this rule,
we add ‘‘animal’’ before food for clarity.
(Comment 60) Several comments
request that we replace ‘‘insanitary’’
with ‘‘unclean’’ as the former term is not
utilized in the animal food industry.
Other comments state that the proposed
definition for ‘‘rework’’ is too narrow
and does not represent its use in animal
food production.
(Response 60) We decline this
request. The word ‘‘insanitary’’ is used
in the FD&C Act and human food
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regulations, including the Current Good
Manufacturing Practice in
Manufacturing, Packing, or Holding
Human Food (currently 21 CFR part 110
and updated and included in the final
rule for preventive controls for human
food (21 CFR part 117) published
elsewhere in this Federal Register).
Because of the use of the term in the
FD&C Act and various FDA regulations,
we think industry is familiar with the
word ‘‘insanitary’’ and it is an
appropriate word to use in this final
rule.
We disagree that the definition of the
term ‘‘rework’’ is too narrow. The
definition allows the flexibility for an
establishment to consider clean,
unadulterated animal food that was
never adulterated or was successfully
reconditioned to be rework.
30. Sanitize
We proposed to define ‘‘sanitize’’ to
mean to adequately treat cleaned foodcontact surfaces by a process that is
effective in destroying vegetative cells of
microorganisms of animal or human
health significance, and in substantially
reducing numbers of other undesirable
microorganisms, but without adversely
affecting the product or its safety for
animals or humans.
(Comment 61) Several comments
request that we replace the term
‘‘sanitize’’ with ‘‘clean,’’ as the former
term is not utilized in the animal food
industry. Other comments ask us to
modify the definition because the
destruction of all microorganisms of
animal or human health concern is not
always practical, and because the
terminology ‘‘adversely affecting the
product or its safety for animal or
humans’’ is ambiguous. Others ask us to
revise the definition to state that
‘‘adequate’’ or ‘‘adequately’’ means to
reduce the presence of organisms of
concern sufficient to help prevent
illness through cleaning and sanitizing
using EPA registered/FDA regulated
food use antimicrobials and other means
such as heat, ozone, etc. Some
comments ask us to clarify that the
‘‘cleaning’’ should be appropriate to the
specific food system and method used
for sanitizing, and that cleaning should
only be required when the sanitizing
process alone would not be effective
without a prior cleaning step.
Some comments express concern
about whether the proposed definition
of ‘‘sanitize’’ would preclude the
continued, routine use of dry cleaning
methods with no sanitizing step. These
comments note that adding routine
aqueous-based cleaning and sanitizing
procedures could create a public health
risk in certain operations such as low
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moisture food production. These
comments also note that dry cleaning
procedures can result in equipment that,
while sanitary, is neither visibly clean
nor suitable for aqueous chemical
sanitizers.
(Response 61) When the destruction
of microorganisms is required, we use
the terms ‘‘sanitize’’ or ‘‘sanitizing,’’ to
differentiate from ‘‘cleaning’’ or
‘‘sanitation,’’ which is consistent with
how these terms are used throughout
our current regulations for human food.
Therefore, we believe that ‘‘sanitize’’ is
a word that is commonly understood by
industry and is used in this final rule in
a way that is consistent with how it is
used in our other regulations relating to
food.
We consider that systems such as
steam systems clean the surfaces, as
well as sanitize them and, thus, satisfy
the definition of ‘‘sanitize.’’ The
definition of ‘‘sanitize’’ does not
preclude the continued use of dry
cleaning methods with no sanitizing
step because the definition describes the
meaning of the term ‘‘sanitize’’ without
establishing any requirement for when
equipment must be sanitized.
We have revised the definition so that
it means adequately treating ‘‘surfaces’’
rather than ‘‘food-contact surfaces.’’ As
a technical matter, adequately treating
any surface—regardless of whether it is
a food-contact surface—by a process
that is effective in destroying vegetative
cells of pathogens, and in substantially
reducing numbers of other undesirable
microorganisms, but without adversely
affecting the product or its safety for
animals or humans, is ‘‘sanitizing’’ the
surface. Clarifying this technical
meaning of the term ‘‘sanitize’’ imposes
no requirements to sanitize surfaces
other than animal food-contact surfaces;
the requirements for sanitizing surfaces
are established by provisions such as
§ 507.19(b)(2), not by the definition of
the term ‘‘sanitize.’’
31. Significant Hazard (Hazard
Requiring a Preventive Control)
We proposed to define the term
‘‘significant hazard’’ to mean a known
or reasonably foreseeable hazard for
which a person knowledgeable about
the safe manufacturing, processing,
packing, or holding of animal food
would, based on the outcome of a
hazard analysis, establish controls to
significantly minimize or prevent the
hazard in an animal food. The rule
would use the term ‘‘significant hazard’’
rather than ‘‘hazard reasonably likely to
occur’’ to reduce the potential for a
misinterpretation that all necessary
preventive controls must be established
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at CCPs (79 FR 58476 at 58477 through
58478).
(Comment 62) Comments support
using a term other than ‘‘hazard
reasonably likely to occur’’ and agree
that using a term other than ‘‘hazard
reasonably likely to occur’’ throughout
the rule will reduce the potential for a
misinterpretation that all necessary
preventive controls must be established
at CCPs.
Some comments support the
regulatory text of the proposed
definition of the term ‘‘significant
hazard.’’ These comments state that the
proposed regulatory text more closely
aligns with the principles in FSMA
(‘‘reasonably foreseeable’’ and
‘‘significantly minimize or prevent’’)
and provides operators the flexibility to
implement a range of preventive
controls that are commensurate with the
risk and probability posed by a specific
hazard. Some comments agree that the
proposed regulatory text can clarify the
difference between HACCP rules and
the animal preventive controls rule.
Some comments state that the proposed
regulatory text plainly reflects the
concept that significant hazards are
those hazards to be addressed through
the very broad category of preventive
controls, and the rule is explicit that
preventive controls may be controls
other than CCPs. Some comments state
that the definition reflects the risk-based
nature (i.e., both the severity of a
potential hazard and the probability that
the hazard will occur) of the
requirements and provides additional
flexibility so that facilities can take into
account the nature of the preventive
control in determining when and how to
establish and implement appropriate
preventive control management
components. Some comments support
including the phrase ‘‘based on the
outcome of a hazard analysis’’ in the
definition because it ensures that
identification of significant hazards will
be risk based. Some comments ask us to
be clear about FDA’s expectations
concerning a hazard analysis conducted
by those involved in animal food
production. Some comments ask us to
preserve in the final definition two key
aspects that grant the animal food
industry the flexibility that it needs: (1)
The logical conclusion that not all
hazards will have the same impact or
will even constitute ‘‘significant
hazards’’ at all, depending on the
facility’s products and position in the
supply chain and (2) the fact that a
‘‘person knowledgeable about the safe
manufacturing, processing, packing, or
holding of food’’ must be knowledgeable
about the specific food produced at that
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facility and in that specific sector of the
food industry.
Some of the comments that support
the regulatory text of the proposed
definition nonetheless express concern
about the term ‘‘significant hazard.’’
Some of these comments express
concern that a facility may not recognize
hazards that need to be controlled
because they do not rise to the
commonly understood meaning of
‘‘significant.’’ Other comments express
concern that the adjective ‘‘significant’’
is subject to many interpretations and
suggest that the term ‘‘hazard requiring
control’’ would be more straightforward,
accurate, and suitable.
Other comments express concern that
the term ‘‘significant hazard’’ could
cause confusion because it has
implications in HACCP systems. For
example, ‘‘significant hazard’’ is often
used in the context of CCPs and
preventive controls are not necessarily
established at CCPs. Some of these
comments suggest that we eliminate the
term and instead use the full regulatory
text of the proposed definition in place
of ‘‘significant hazard’’ throughout the
regulations. Other comments suggest
using a term such as ‘‘food safety
hazard’’ or ‘‘actionable hazard’’ instead
of ‘‘significant hazard to avoid a term
that has HACCP implications. Other
comments state that the term
‘‘significant hazard’’ has implications
for facilities that follow the Codex
HACCP Annex and express concern that
foreign facilities would be especially
likely to be confused by the term
‘‘significant hazard.’’
Some comments ask us to ensure that
the term ‘‘significant hazard’’ is used
consistently and express the view that
some regulatory text refers to a ‘‘hazard’’
or ‘‘known and reasonably foreseeable
hazard’’ where ‘‘significant hazard’’
should instead be used. As discussed in
Comment 31, some comments express
concern that the rule would refer to
multiple levels of hazard and ask us to
provide sufficient clarity to be able to
distinguish between these types of
hazards.
(Response 62) We have changed the
term ‘‘significant hazard’’ to ‘‘hazard
requiring a preventive control.’’ The
new term uses the explicit language of
FSMA (i.e., ‘‘preventive control’’), is
consistent with the specific suggestion
of one comment (i.e., hazard requiring a
control’’), and is not commonly
associated with HACCP systems. We
decline the request to use the term
‘‘food safety hazard’’ because that term
already is established in Federal HACCP
regulations for seafood and meat/
poultry, and the comments are
particularly concerned about using a
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term that has implications for HACCP
systems. We also decline the request to
use the term ‘‘actionable hazard,’’
because the term ‘‘actionable’’ is
associated with violations at a food
processing plant.
We reviewed the full regulatory text
of proposed subpart C and replaced
‘‘significant hazard’’ with ‘‘hazard
requiring a preventive control’’ in most
cases. See table 31.
We also reviewed the full regulatory
text of proposed subpart C to evaluate
whether there were any circumstances
where the regulatory text should more
appropriately refer to ‘‘hazard requiring
a preventive control’’ rather than
‘‘hazard’’ or ‘‘known or reasonably
foreseeable hazard.’’ The term ‘‘known
or reasonably foreseeable hazard’’
appears only once, in the requirement
for a facility to conduct a hazard
analysis (§ 507.33(a)). We are retaining
‘‘known or reasonably foreseeable
hazard’’ in that requirement because it
is necessary to implement the tiered
approach to the requirements for hazard
analysis and risk-based preventive
controls (see Response 31). To reinforce
this tiered approach, and emphasize
that the facility only conducts a hazard
analysis for known or reasonably
foreseeable hazards, we revised
‘‘hazard’’ to ‘‘known or reasonably
foreseeable hazard’’ in two additional
provisions in the requirements for
hazard identification (see the
introductory regulatory text for
§ 507.33(b)(1) and (2)).
In our review of the full regulatory
text of proposed subpart C, we did not
identify any circumstances where we
believe it is appropriate and necessary
to specify ‘‘hazard requiring a
preventive control’’ in place of
‘‘hazard.’’ It is not necessary for the
regulatory text of requirements for
preventive controls, the supply-chain
program, the recall plan, corrective
actions, and verification to specify
‘‘hazard requiring a preventive control’’
every time that the requirements use the
term ‘‘hazard’’ because the context of
the requirement establishes the
applicability to ‘‘hazards requiring a
preventive control.’’ Although we
acknowledge that using ‘‘hazard
requiring a preventive control’’ in place
of ‘‘hazard’’ throughout applicable
provisions of proposed subpart C would
emphasize the tiered approach to the
requirements for hazard analysis and
risk-based preventive controls, doing so
would make the regulatory text
unnecessarily bulky and awkward and
would be inconsistent with comments
that ask us to make the regulatory text
understandable (see Comment 13 in
section III of the final rule for preventive
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controls for human food, published
elsewhere in this issue of the Federal
Register).
(Comment 63) Some comments ask us
to allow facilities to continue to
implement existing controls outside the
framework of this rule (i.e., outside the
framework that requires preventive
control management components as
appropriate to ensure the effectiveness
of the preventive controls, taking into
account the nature of the preventive
control and its role in the food safety
system) when a hazard addressed by the
existing controls does not rise to the
level of ‘‘significant hazard.’’
Other comments express concern that
the term ‘‘significant hazard’’ may create
a disincentive for facilities to
voluntarily implement preventive
controls for hazards that only pose a
remote risk or are very rarely
encountered, because implementing
preventive controls for hazards of very
low probability and severity may be
misinterpreted as requiring preventive
controls applicable to a ‘‘significant
hazard’’ even if the hazard does not
meet the definition of ‘‘significant
hazard’’ established in the rule. Some
comments ask us to revise the definition
to provide facilities with the flexibility
and discretion to establish appropriate
preventive controls for hazards that do
not rise to the criteria of a ‘‘significant
hazard,’’ as well as ensuring that
preventive controls that address remote
or very unlikely hazards not be subject
to the preventive control management
requirements for a ‘‘significant hazard.’’
(Response 63) We have revised the
definition to specify that the term
‘‘hazard requiring a preventive control’’
applies when a knowledgeable person
would, based on the outcome of a
hazard analysis, ‘‘establish one or more
preventive controls’’ rather than
‘‘establish controls.’’ By narrowing
‘‘controls’’ to ‘‘one or more preventive
controls,’’ we mean to signify that the
proposed term ‘‘significant hazard’’
(which we now refer to as ‘‘hazard
requiring a preventive control’’) only
applies to those controls that the facility
establishes to comply with the
requirements of subparts C and E for
hazard analysis and risk-based
preventive controls. A facility that
establishes other controls (such as those
that the comments describe as
‘‘prerequisite programs,’’ or controls
directed to hazards of very low
probability and severity) for hazards
that are not, based on the outcome of the
facility’s hazard analysis, ‘‘hazards
requiring a preventive control’’ would
not need to establish preventive control
management components for such
controls. However, some controls
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previously established in ‘‘prerequisite
programs’’ would be considered
‘‘preventive controls.’’ We provide some
flexibility for facilities with respect to
how they manage preventive controls,
and the preventive control management
components may be different for
hazards that have been managed as
‘‘prerequisite programs’’ compared to
those managed with CCPs. A facility
that is concerned about the potential for
an investigator to disagree during
inspection that certain controls are not
directed to ‘‘hazards requiring a
preventive control’’ could, for example,
include information relevant to its
classification of those other controls in
its hazard analysis, whether by merely
listing the ‘‘other controls’’ or by
providing a brief explanation why such
controls are not ‘‘preventive controls’’ as
that term is defined in this rule.
(Comment 64) Some comments assert
that the proposed definition of
‘‘significant hazard’’ is tautological
because it essentially establishes a
‘‘significant hazard’’ to be a known or
reasonably foreseeable hazard (i.e., the
type of hazards identified in the first
step of the analysis) for which
preventive controls should be
implemented. These comments assert
that the proposed definition of
‘‘significant hazard’’ would collapse the
second step of hazard analysis into the
first, which in turn would lead to the
unintended consequence of facilities
identifying the same hazards in the
second step as in the first. Some
comments ask us to revise the definition
to include evaluation of severity and
probability, because these concepts are
integral for making a proper
determination of whether a hazard is
significant. Other comments ask us to
revise the definition to better reflect the
risk-based approach that preventive
controls be implemented to control
hazards that have a higher probability of
resulting in public health consequence
in the absence of control.
(Response 64) We have revised the
definition of ‘‘significant hazard’’
(which we now refer to as ‘‘hazard
requiring a preventive control’’) to
specify that the hazard analysis includes
an assessment of the severity of the
illness or injury if the hazard were to
occur and the probability that the
hazard will occur in the absence of
preventive controls. By specifying that
the determination of a ‘‘significant
hazard’’ is based on the outcome of a
hazard analysis, the proposed definition
did, as requested by the comments,
include the risk-based nature of the
determination. However, explicitly
adding that the hazard analysis is based
on probability and severity (i.e., risk)
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makes the risk-based nature of the
determination clearer.
We disagree that the proposed
definition was tautological and would
collapse the second step of hazard
analysis into the first. A facility begins
its hazard analysis by narrowing down
the universe of all potential hazards to
those that are ‘‘known or reasonably
foreseeable’’ for each type of animal
food manufactured, processed, packed,
or held at its facility. The outcome of
the facility’s hazard analysis is a
determination of a subset of those
known or reasonably foreseeable
hazards, i.e., those hazards requiring a
preventive control. To the extent that
these comments are asserting that the
tautology was created by the phrase ‘‘in
the absence of its control’’ in the
proposed definition of ‘‘hazard,’’ we
have deleted that phrase from the final
definition of ‘‘hazard.’’
We decline the request to repeat in
the definition of ‘‘hazard requiring a
preventive control’’ the requirement for
the types of information that a facility
would consider in conducting its hazard
analysis. The requirements for hazard
analysis clearly specify that a facility
must conduct its hazard analysis based
on experience, illness data, scientific
reports, and other information (see
§ 507.33(a)).
(Comment 65) Some comments that
broadly address the overall framework
for the new requirements for hazard
analysis and risk-based preventive
controls ask us to consistently refer to
‘‘the nature of the preventive control’’
(rather than simply to ‘‘the preventive
control’’) when communicating the
flexibility that a facility has in
identifying preventive controls and
associated preventive control
management components. Other
comments that broadly address the
overall framework for the new
requirements for hazard analysis and
risk-based preventive controls ask us to
emphasize that the requirements for
preventive control management
components convey not only that the
application of a particular element is
appropriate (i.e., capable of being
applied), but also necessary for food
safety. Some comments recommend that
we do so by specifying that preventive
control management components take
into account the role of the preventive
control in the food safety system.
(Response 65) We agree with these
comments and have revised the
definition of ‘‘hazard requiring a
preventive control’’ to specify that
preventive control management
components are established as
appropriate to ‘‘the nature of the
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preventive control and its role in the
facility’s food safety system.’’
(Comment 66) Some comments assert
that the problem is how to separate the
hazards addressed by ‘‘HACCP’’ from
those addressed by CGMPs. These
comments suggest that control measures
that are implemented for hazards from
ingredients and food-contact packaging
material, and from production and
process, be called CCPs and that control
measures that are implemented for
hazards from personnel, equipment, and
the plant be called preventive controls.
(Response 66) The facility must
control hazards through the application
of CGMPs and preventive controls as
appropriate to the hazard. Although
some preventive controls will be
established at CCPs, and ‘‘CCP’’ is a
term commonly used in HACCP
systems, this rule establishes
requirements for hazard analysis and
risk-based preventive controls, not
‘‘HACCP,’’ and this rule provides that
preventive controls include controls at
CCPs, if there are any CCPs, as well as
controls, other than those at CCPs, that
are also appropriate for animal food
safety (see § 507.34(a)(2)).
Under the rule, some hazards may be
addressed by CGMPs and others by
preventive controls. For example, a
facility could control a physical hazard
such as metal by using screens and
magnets under CGMPs and then use a
metal detector as a preventive control.
(Comment 67) Some comments
express concern that the term
‘‘significant hazard’’ may lead to
misunderstanding by medium and
smaller processors and ask how
businesses with limited food safety
experience will understand the
difference between a food safety hazard
that is ‘‘reasonably likely to occur’’ (and,
thus, must be controlled by a full
HACCP Plan) and a ‘‘significant hazard’’
that can be controlled by a preventive
control plan.
(Response 67) It will not be necessary
for an animal food processor to
understand the difference between a
hazard that is ‘‘reasonably likely to
occur’’ in the concept of HACCP
requirements and a ‘‘hazard requiring a
preventive control’’ in the context of
this rule. FDA does not have any
HACCP regulations that apply to animal
food.
(Comment 68) Some comments ask us
to concur that ‘‘temporal hazards’’ in
some food products (specifically,
aflatoxin, pesticides, and radiological
contamination) do not represent
‘‘significant hazards’’ that require
monitoring and verification activities on
an ongoing basis. These comments also
ask us to acknowledge that in many
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cases the testing done by FDA and
others is sufficient for protecting public
health and that it is not necessary to
require ongoing monitoring by
individual facilities in order to comply
with the rule.
(Response 68) We decline these
requests because such a determination
should be facility specific. However, we
have revised the considerations for the
hazard evaluation to clarify that in
making the determination as to what
hazards require preventive controls, the
facility can consider factors such as the
temporal nature of the hazard (see
§ 507.33 and section XXV). In
determining the appropriate preventive
control management components, the
facility can take into account the nature
of the preventive control and its role in
the facility’s food safety system (see
§ 507.39(a)).
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32. Significantly Minimize
We proposed to define the term
‘‘significantly minimize’’ to mean to
reduce to an acceptable level, including
to eliminate. We did not receive
comment and are finalizing it as
proposed.
33. Small Business
We proposed to define the term
‘‘small business’’ to mean, for the
purposes of part 507, a business
employing fewer than 500 persons. We
conducted a Food Processing Sector
Study as required by section 418(l)(5) of
the FD&C Act (Ref. 12) and used the
results of the study in defining the term
‘‘small business.’’ (78 FR 64736 at 64758
through 64759.) We made the results of
the Food Processing Sector Study
available in Docket No. FDA–2011–N–
0922 and requested public comment on
that study.
(Comment 69) Some comments
express concern that the Food
Processing Sector Study is not
comprehensive. Some comments assert
that FDA did not sufficiently collaborate
with USDA, and that FDA significantly
underestimated the number of mixeduse facilities, particularly by neglecting
to count farms that perform the
processing steps on RACs to become a
processed food. Other comments assert
that the Food Processing Sector Study is
woefully inadequate and must be
undertaken again to comply with the
law.
(Response 692) We previously
acknowledged the limitations of the
Food Processing Sector Study (78 FR
64736 at 64758 through 64759). We
have revised and extended the results of
our earlier study by expanding our data
sources and by including
representatives from USDA’s Economic
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Research Service, USDA’s Agricultural
Marketing Service and the American
Farm Bureau to help oversee the revised
study. The revised Food Processing
Sector Study is available in the docket
of this rule (Ref. 21).
Our original analysis was based on
the merger of Dun & Bradstreet data and
FDA’s Food Facility Registration data to
help us estimate the number of
manufacturing facilities that are also
classified as farms. We have updated
that data source and added data sources.
To better account for farms that perform
processing activities, we included
Census of Agriculture (Ag Census) data
both to provide a count of total U.S.
farms and to estimate the number of
farms conducting food processing
activities, to the extent that the data
identifies processing activities. We also
included the Agricultural Resource
Management Survey (ARMS) data
because it included questions about
some processing activities for select
commodities.
Both the Ag Census and ARMS are
silent about many processing activities.
Therefore, we also obtained estimates
from commodity specialists at trade
associations, USDA, and universities
with in-depth knowledge of the
processing activities for specific
agricultural commodities.
(Comment 70) Some comments ask us
to explain how to calculate the number
of full-time equivalent employees, e.g.,
with respect to temporary workers,
seasonal workers, and part-time
workers. Other comments say it is
unclear whether fewer than 500 fulltime equivalent employees means those
involved in the entire business or those
involved only in the animal food-related
portions of the business, noting that the
term ‘‘business’’ is unclear (i.e., whether
business means a corporation and all its
subsidiaries or only the portion of the
business related to animal food be it
animal feed, pet food and/or
ingredients).
(Response 70) As previously
discussed, we proposed to establish the
same definition for small business as
that which has been established by the
U.S. Small Business Administration
under 13 CFR part 121 for most food
manufacturers, and the limit of 500
employees would include all employees
of the business rather than be limited to
the employees at a particular facility (78
FR 64736 at 64759). We will base the
calculation on ‘‘full-time equivalent
employees’’ and use the same approach
to calculating full-time equivalent
employees for the purpose of this rule
as we used to calculate full-time
equivalent employees in the section 414
recordkeeping regulations (see § 1.328).
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This approach is similar to the approach
the Agency used to calculate the small
business exemption for nutrition
labeling of food (§ 101.9(j)(18)(iv)(D)).
Under this approach, the number of fulltime equivalent employees is
determined by dividing the total
number of hours of salary or wages paid
directly to employees of the business
entity claiming the exemption and of all
of its subsidiaries and affiliates by the
number of hours of work in 1 year,
2,080 hours (i.e., 40 hours × 52 weeks).
The calculation for the number of
employees affects exemptions (i.e., the
exemptions for on-farm, low-risk
activity/animal food combinations in
§ 507.5(e) and (f), which apply only to
small and very small businesses), not
just compliance dates. Therefore, we are
establishing the definition of ‘‘full-time
equivalent employee’’ in the definitions
for this rule (§ 507.3) and modifying the
definition of ‘‘small business’’ to use the
term ‘‘500 full-time equivalent
employees’’ rather than ‘‘500 persons.’’
(Comment 71) Some comments assert
that there should be no exemption from
compliance with this rule based on total
annual sales or number of employees,
noting that all companies regardless of
size should have food safety programs
in place.
(Response 71) The definition of
‘‘small business’’ is relevant to the
exemptions for on-farm, low-risk
activity/animal food combinations for
manufacturing/processing, packing, and
holding animal food by mixed-type
facilities. This exemption is a risk-based
exemption, because it only applies to
activity/animal food combinations that
are low-risk and, thus, should not affect
animal food safety.
34. Supplier
We proposed to define the term
‘‘supplier’’ to mean the establishment
that manufactures/processes the food,
raises the animal, or harvests the food
that is provided to a receiving facility
without further manufacturing/
processing by another establishment,
except for further manufacturing/
processing that consists solely of the
addition of labeling or similar activity of
a de minimis nature.
As discussed in section IV.B of the
final rule for preventive controls for
human food, published elsewhere in
this issue of the Federal Register, we
have revised the ‘‘farm’’ definition to
explicitly include business models in
which one operation grows crops but
does not harvest them, and another
operation, not under the same
management, harvests crops but does
not grow them. This revision represents
a change from the existing and proposed
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‘‘farm’’ definitions, which describe a
‘‘farm’’ as an entity ‘‘devoted to the
growing and harvesting of crops’’
(emphasis added). We proposed the
‘‘supplier’’ definition in the context of a
single business entity ‘‘devoted to the
growing and harvesting of crops’’
(emphasis added). We used the term
‘‘harvesting,’’ rather than ‘‘growing,’’ to
reflect the last stage of production on a
farm, except for packing.
Because the proposed ‘‘supplier’’
definition contemplated that the same
business entity that grows crops also
harvests them, we have revised the
‘‘supplier’’ definition so that the grower
remains the supplier when the harvester
is under separate management.
Specifically, ‘‘supplier’’ is now defined
to include an establishment that
‘‘grows’’ food rather than an
establishment that ‘‘harvests’’ food.
Doing so focuses the requirements for
the supply-chain program (see subpart
E) on the entity that produces the food,
rather than on the entity that removes
the food from the growing area, when
the grower and the harvester are not
under the same management. Doing so
also simplifies the determination of who
the supplier is in complex business
models, such as when a ‘‘handler’’
arranges for harvest by another business
entity.
(Comment 72) Some comments assert
that the definition of supplier is not
workable because the status of
warehouses and brokers is unclear in
the definition. Other comments ask us
to modify the definition to specify, in
addition to the proposed definition, that
the supplier could be an intermediary
entity that takes responsibility on behalf
of the receiving facility to ensure that
the food meets the requirements of this
part.
(Response 72) As discussed in section
XL, we agree that the role of
intermediaries in the supply chain is
critical and we have added options for
entities other than the receiving facility
to perform certain supplier verification
activities, provided that the receiving
facility reviews and assesses the
documentation produced by the other
entity and documents that review and
assessment. However, this does not
mean that these entities take on the role
of the supplier. As discussed in
Response 59 and in section XL, we
believe it is important to supplier
verification to retain the identities of
two parties involved—the receiving
facility and the supplier. Therefore, we
are retaining our definition of supplier,
with the minor change previously
discussed.
(Comment 73) Some comments
regarding RACs ask us to modify the
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definition of supplier in the case of
comingled RACs, such that the supplier
would be the person immediately back
from the receiving facility in the supply
chain provided that this entity
(presumably a warehouse or aggregator)
voluntarily complies with the
requirements of subpart C of this part.
One comment asks us to clarify in our
definition that the supplier must be the
establishment that controls the hazard
in question.
(Response 73) We decline this
request. As discussed in section XL, we
recognize that doing supplier
verification with comingled products
will be a challenge. However, we
believe it is important that there be a
link between the receiving facility
(which is manufacturing/processing the
animal food) and the supplier (who
controlled the hazard(s) in the animal
food). We are allowing an entity such as
an aggregator or distributor to perform
some verification activities, so the
outcome requested by these comments
will be achieved while maintaining the
identities of the two primary parties in
the supplier verification relationship
(see Response 492).
(Comment 74) One comment asks us
to clarify that the proposed definition of
supplier does not include sources of
processing aids or chemicals required
for post-harvest treatments and packing
processes (including waxes, fungicides,
detergents and sanitizers).
(Response 74) As defined, the
supplier is the establishment growing
the food, not those establishments
providing inputs (such as waxes,
fungicides, detergents and sanitizers) to
that entity.
35. Validation and Verification
We proposed to define the term
‘‘validation’’ to mean that element of
verification focused on collecting and
evaluating scientific and technical
information to determine whether the
food safety plan, when properly
implemented, will effectively control
the identified hazards. We proposed to
define the term ‘‘verification’’ to mean
those activities, other than monitoring,
that establish the validity of the food
safety plan and that the system is
operating according to the plan.
(Comment 75) Some comments ask us
to revise the definitions of ‘‘validation’’
and ‘‘verification’’ to be consistent with
the Codex definitions. Codex defines
‘‘validation’’ to mean obtaining
evidence that a control measure or
combination of control measures, if
properly implemented, is capable of
controlling the hazard to a specified
outcome. Codex defines ‘‘verification’’
to mean the application of methods,
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procedures, tests and other evaluations,
in addition to monitoring, to determine
whether a control measure is or has
been operating as intended (Ref. 22).
Some comments ask us to more
clearly distinguish between
‘‘validation’’ and ‘‘verification.’’ Some
comments assert that validation is not
an element of verification as stated in
our proposed definition and suggest that
we clearly separate requirements for
validation from requirements for
verification, e.g., by moving the
proposed requirements for verification
to a distinct section in the regulatory
text.
(Response 75) We have explained
how our proposed definitions for
‘‘validation’’ and ‘‘verification’’ align
with a variety of widely recognized
definitions, including definitions
established by Codex, the NACMCF
HACCP guidelines, and Federal HACCP
(78 FR 64736 at 64758). We disagree
that validation is not an element of
verification, but acknowledge it is not
necessary to say so within the definition
of ‘‘validation.’’ Although we have
moved the details of the requirements
for validation from its proposed location
within the requirements for verification
(i.e., proposed § 507.45(a)) to a separate
section (§ 507.47), we did so as an
editorial change to improve clarity and
readability rather than as a substantive
change to signal that validation is not an
element of verification (see table 8, 79
FR 58476 at 58504).
We agree that validation can apply to
a specific control measure as specified
in the Codex definition. We also agree
that validation can apply to a
combination of control measures as
specified in the Codex definition. The
food safety plan is one example of a
combination of control measures.
Although we likewise agree that
verification can apply to a specific
control measure as specified in the
Codex definition, we disagree that to be
consistent with the Codex definition we
should adopt a definition that excludes
the application of verification to the
food safety plan. It is well established
that some verification measures, such as
testing for a pathogen, verify that
multiple control measures operated as
intended.
To more clearly distinguish between
‘‘validation’’ and ‘‘verification,’’ the
definition of ‘‘validation’’ we are
establishing in this rule specifies that
validation means obtaining and
evaluating scientific and technical
evidence that a control measure,
combination of control measures, or the
food safety plan as a whole, when
properly implemented, is capable of
effectively controlling the identified
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hazards (emphasis added). We also
made conforming changes associated
with the revised definition of
‘‘validation’’ in the requirements for
validation (see § 507.47(b)(2)). The
definition of ‘‘verification’’ we are
establishing in this rule specifies that
verification means the application of
methods, procedures, tests and other
evaluations, in addition to monitoring,
to determine whether a control measure
or combination of control measures is or
has been operating as intended and to
establish the validity of the food safety
plan as a whole (emphasis added).
Consistent with the request of the
comments, the definition of
‘‘verification’’ uses the Codex
description of verification as the
application of methods, procedures,
tests and other evaluations, in addition
to monitoring.
36. Very Small Business
We proposed to define the term ‘‘very
small business’’ to mean, for the
purposes of proposed part 507, a
business that has less than $2,500,000 in
total annual sales of food for animals,
adjusted for inflation. As discussed in
the proposed rule, we conducted a Food
Processing Sector Study as required by
section 418(l)(5) of the FD&C Act (Ref.
12) and used the results of the study in
defining the term ‘‘very small business’’
(78 FR 64736 at 64758 through 64760).
We made the results of the Food
Processing Sector Study available in
Docket No. FDA–2011–N–0922. Some
comments support defining ‘‘very small
business’’ as a business that has less
than $2,500,000 in total annual sales of
animal food, adjusted for inflation.
Other comments disagree or offer
alternative recommendations.
(Comment 76) Some comments ask us
to clarify how to classify the size of a
business that does not take ownership
or directly sell food (e.g., warehouses
and contract manufacturers) to
determine status as a qualified facility.
Some comments recommend
modifications to the proposed very
small business definition based on a
discussion of certain farming models in
the 2014 supplemental notice for animal
food (79 FR 58476 at 58482). These
comments express concern that the
proposed definition of very small
business would not account for animal
food that is not ‘‘sold,’’ but is
manufactured and then distributed to
another entity without a sale, such as in
the contract farming model discussed in
the 2014 supplemental notice.
Other comments recommend
modifications to the definition to use
the value or volume of animal food
manufactured and distributed in
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establishing whether a facility is a very
small business. The comments state that
this would account for the animal food
manufactured by feed mills servicing
contract farms. Some of these comments
state that the value of food produced by
feed mills operating under this contract
model often exceeds the $2,500,000
threshold of the proposed very small
business definition. They state that
because this proposed definition only
includes sales, it would allow large
facilities to be considered very small
businesses (as they would have no or a
very small amount of actual sales).
Other comments request that we
modify the proposed definition to
specify that animal food produced for
contract farms is not included in ‘‘sales’’
in the definition for very small business;
thereby allowing these feed mills to be
very small businesses, which would
result in qualified facility status.
Some comments ask us to specify that
the monetary threshold for the
definition be based on average sales
during a 3-year period on a rolling basis
because otherwise firms may be subject
to significant changes in status from
year to year. These comments also ask
us to clarify that the sales are to be
evaluated retrospectively, not
prospectively.
(Response 76) We have revised the
definition of very small business to
specify that it is based on an average
during the 3-year period preceding the
applicable calendar year in sales of
animal food plus the market value of
animal human food manufactured,
processed, packed, or held without sale
(e.g., held for a fee or supplied to a farm
without sale). The applicable calendar
year is the year after the 3 calendar
years used to determine whether a
facility is a very small business. The
most recent applicable calendar year is
the current year. For example, on June
3, 2024, 2024 is the most recent
applicable calendar year and is the
applicable calendar year when the 3
calendar years used to determine
whether a facility is a very small
business are 2021 to 2023. The
exception is when 3 calendar years of
records are not available, such as when
a facility begins business after the
compliance date for very small
businesses. In such situations the
applicable calendar year refers to the
year during which the calculation is
made but is not preceded by 3 calendar
years used to determine whether a
facility is a very small business.
As a companion change, we are
explicitly requiring that a facility
determine and document its status as a
qualified facility on an annual basis by
no later than July 1 of each calendar
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year (see § 507.7(c)(1)). Although this
requirement was implicit in the
proposed requirement that a facility
must resubmit a notification to FDA if
its status changes as a qualified facility
(proposed § 507.7(c)(2), which we are
finalizing as § 507.7(c)(3)), we are
making this requirement explicit to
clarify the responsibility of the facility
to affirmatively determine its status
when the calendar years that apply to
the 3-year average change. The July 1
deadline for a facility to determine its
status provides facilities with 6 months
to make the determination after the end
of the previous 3 calendar years.
We also are establishing an earlier
compliance date for the financial
records that a facility maintains to
support its status as a very small
business. Specifically, the compliance
date for a facility to retain records to
support its status as a qualified facility
is January 1, 2017. Even with this earlier
compliance date for these records, we
realize that although the calculation for
‘‘very small business’’ in the regulatory
text is based on 3 calendar years, a
facility will only be required to have 2
calendar years of records as of the
general compliance date for very small
businesses. Specifically, by December
16, 2019 a facility that begins retaining
applicable financial records on January
1, 2017, would only have such records
for 2 previous calendar years. Therefore,
it would be reasonable for a facility to
make the calculation based on the 2
previous calendar years. If a facility has
records for 3 previous calendar years,
the facility could make the calculation
based on the longer time period. During
inspection in 2019, when a facility has
records for the preceding 2 calendar
years, but not for the preceding 3
previous calendar years, we will accept
records for the preceding 2 calendar
years as adequate to support status as a
qualified facility based on calculating an
average for those two years. We note
that in some situations, a shorter time
period is sufficient to determine that a
facility is not a very small business. For
example, a facility with sales exceeding
$7,500,000 for the preceding calendar
year cannot qualify as a very small
business because no amount of sales
from other years will reduce average
sales below the threshold of $2,500,000.
The available financial records for a
facility that begins operations between
January 1, 2018 and September 17, 2019
would not cover even 2 complete
calendar years by September 17, 2019.
During the first 3 calendar years of such
a facility’s operation, it would be
reasonable for a facility to make the
calculation based on records it has (i.e.,
for 1 or 2 preceding calendar years), and
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we will accept records for the preceding
1 or 2 years as adequate to support
status as a qualified facility in these
circumstances.
When a facility does not begin
operations until after January 1, 2019, it
would be reasonable for the facility to
rely on a projected estimate of revenue
(or market value) when it begins
operations. We would evaluate the
credibility of the projection considering
factors such as the facility’s number of
full-time equivalent employees. After
the facility has records for 1 or 2
preceding calendar years, it would be
reasonable for the facility to make the
calculation based on records it has (i.e.,
for 1 or 2 preceding calendar years) and
we will accept records for the preceding
1 or 2 years as adequate to support
status as a qualified facility in these
circumstances.
We agree with the comments that
state the animal food distributed, but
not ‘‘sold,’’ by feed mills operating
under contract farming agreements (and
required to register as a food facility
under section 415 of the FD&C Act)
should be included in determining
whether a facility is a very small
business. In addition to annual sales of
animal food, the market value of the
animal food supplied to a farm(s)
without sale must be included when
determining if a business is a very small
business for purposes of this rule.
The qualified facility exemption of
§ 507.7 applicable to very small
businesses is intended to enable these
businesses to comply with modified
requirements because they have fewer
resources to direct to full compliance
with subpart Cs and E of the rule and
they provide a small volume of animal
food for consumption. Many of the
businesses that have feed mills that
provide animal food under contract
farming agreements are extensive and
sophisticated businesses, such as some
large-scale meat and poultry operations.
Such businesses are not the intended
beneficiaries of the qualified facility
exemption because they should have
adequate resources, such as personnel,
equipment, and expertise, to implement
the requirements of subparts C and E at
their feed mills. In addition, many of
these feed mills manufacture and
distribute a large volume of animal food
yearly. These were some of the factors
we considered when we revised the
proposed definition of a very small
business to include the market value of
the animal food that is manufactured,
processed, packed, or held without sales
or supplied to a farm without sales.
(Comment 77) Some comments
support the proposed dollar threshold of
$2,500,000, noting that it would provide
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sufficient flexibility to companies that
receive the exemption to allow them to
continue to operate. Some comments
say there should be no exemption from
compliance with this rule based on total
annual sales or number of employees
and that all companies regardless of size
should have food safety programs in
place. Several comments request
different dollar amounts for determining
the threshold.
Some comments propose that the
threshold should be $1,000,000, a figure
that would provide greater coverage
than the $2,500,000 proposed threshold
and also would simplify compliance
with all FSMA rules for animal food
facilities. Other comments suggest the
definition for a very small business
should mean, for purposes of part 507,
a business that has less than $1,000,000
in total annual sales of animal food,
adjusted for inflation, and distributes
less than 5,000 tons of animal food
annually. Several comments urge us to
consider applying a $500,000 threshold
to the value of animal feed produced by
a facility, not just the value of animal
food that is sold. The comments state
that the vertically integrated structure of
some livestock and poultry operations
means that some animal feed produced
at large operations may never be sold
because the company supplies feed to
contract operations raising animals
owned by the company.
Other comments suggest ensuring
sufficient flexibility for a diverse array
of animal food businesses and that we
should establish an outright exemption
from the rule for businesses with, at the
very most, $100,000 or less in annual
average monetary value of animal food
sold over the previous 3-year period,
adjusted for inflation. Another comment
suggests a threshold of $250,000. Other
comments recommend defining a very
small business as one with less than
$10,000 in annual sales believing that a
rule encompassing virtually all
ingredient and feed manufacturing and
distribution facilities will encourage
large firms to continue to do business
with very small firms. One comment
suggested excluding the value of
donated by-product in the calculation of
total annual sales of animal food.
(Response 77) We are establishing a
$2,500,000 threshold for the definition
of ‘‘very small business.’’ Under section
418(l)(1)(A) and (B) of the FD&C Act, a
very small business is a qualified
facility; under the exemption authorized
in section 418(l)(2) of the FD&C Act, a
qualified facility is subject to modified
requirements rather than the
requirements for hazard analysis and
risk-based preventive controls. We have
acknowledged that a $2,500,000
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threshold exempts a greater portion of
the animal food supply than thresholds
of either $500,000 or $1,000,000 (79 FR
58476 at 58502), but reaffirm that under
the $2,500,000 threshold the businesses
that would be exempt from the
requirements for hazard analysis and
risk-based preventive controls would
represent a small portion of the
potential risk of foodborne illness;
businesses that fall within this
definition of ‘‘very small business,’’
collectively, produce less than 0.6
percent of the animal food supply (Ref.
3). In addition, most of these facilities
will be subject to the CGMP
requirements in subpart B; the only
exemptions from those CGMP
requirements are the exemptions in
§ 507.5(a) (which applies to farms and
activities of ‘‘farm mixed-type facilities’’
that fall within the definition of
‘‘farm’’), and in § 507.5(h) (which
applies to: (1) The holding or
transportation of one or more RACs; (2)
hulling, shelling, and drying nuts and
hulls (without manufacturing/
processing); and (3) the ginning of
cotton (without manufacturing/
processing)). Facilities subject to and in
compliance with human food CGMPs
and applicable FDA human food safety
requirements that process human food
and ‘‘donate’’ or sell the human food byproducts without further processing for
use as animal food are only subject to
certain provisions in subpart B for those
by-products. This applies whether they
are a qualified facility or not. They are
not subject to the requirements of
subparts C and E for the human food byproducts used for animal food.
(Comment 78) Some comments ask us
to only include the total annual sales of
food in the United States, adjusted for
inflation, for foreign facilities that
export food to the United States.
(Response 78) We decline this
request. The purpose of the definition of
‘‘very small business’’ is principally to
enable such businesses to comply with
modified requirements, because they
have fewer resources to direct to full
compliance with the rule. A foreign
business that sells more than the
threshold dollar amount of animal food
has more resources than the businesses
being excluded, even if less than that
threshold dollar amount reflects sales to
the United States. Likewise, a domestic
business that sells more than the
threshold dollar amount of food has
more resources than the businesses
being excluded, even if that domestic
business exports some of its food and,
as a result, less than that threshold
dollar amount reflects sales within the
United States.
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(Comment 79) Some comments ask us
to base the threshold on the total
‘‘volume of product’’ or ‘‘amount of
product’’ handled or sold. These
comments assert that an approach using
product volume or amount would be
more risk based because it would
correlate more closely to consumer
exposures than dollar amounts, which
can be skewed by product values.
(Response 79) We acknowledge that
dollar amounts can be skewed by
product values but nonetheless disagree
that we should base the threshold on the
total ‘‘volume of product’’ or ‘‘amount of
product’’ handled or sold. We see no
practical way to identify a threshold
based on volume or amount of product
that could be applied across all product
sectors, and the comments provide no
suggestions for how their
recommendation could be carried out.
(Comment 80) Some comments
express concern that establishing a
threshold based on U.S. dollars would
place domestic firms at a disadvantage
relative to foreign firms whose sales are
often denominated in currencies valued
lower than the dollar and often reflect
much lower costs for factors such as
land, labor, and environmental
compliance. These comments ask us to
base the threshold on an alternate
measure, such as number of employees,
or to calculate the sales of foreign very
small businesses using an appropriate
measure of purchasing power parity, if
there is a straightforward way to do so.
(Response 80) We decline these
requests. As previously discussed, we
use dollar estimates to evaluate the
percent of all food produced in the
United States that would not be covered
by the rule (79 FR 58476 at 58502). We
acknowledge that the definition of
‘‘small business’’ is based on number of
employees, and that two exemptions
(i.e., the exemptions in § 507.5(e) and (f)
for on-farm, low-risk activity animal
food combinations) apply to small
businesses. However, the exemptions
for on-farm, low-risk activity animal
food combinations are limited to a
narrow sector of the animal food
industry, whereas the exemption
applicable to a very small business will
apply to all sectors of the animal food
industry.
We do not know of a straightforward
way to calculate the sales of foreign very
small businesses using an appropriate
measure of purchasing power parity
and, thus, are basing the threshold only
on U.S. dollars.
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B. Comments Asking FDA To Establish
Additional Definitions or Otherwise
Clarify Terms Not Defined in the Rule
Some comments ask us to define
certain terms such as ‘‘associated,’’
‘‘contaminate,’’ ‘‘directly linked,’’
‘‘integrated operator,’’ ‘‘material to the
safety of food,’’ ‘‘written,’’ and
‘‘necessary.’’ We believe that it is not
necessary to define these and certain
other new terms proposed by the
comments. We discuss in this section of
this document comments that ask us to
establish other new terms or clarify
terms in the rule not defined.
1. Consumer/Final Consumer/Customer
(Comment 81) A few comments
request that we define consumer as the
animal consuming the food. Some
comments ask us to define ‘‘customer’’
as the purchaser of the animal food.
Other comments ask us to define ‘‘final
consumer’’ to mean a person that feeds
animals under the control or ownership
of that person. The comments suggest
‘‘final consumer’’ could be used in the
animal food rule to help clarify the
meaning of qualified end user.
(Response 81) We decline these
requests. We stated that for purposes of
the proposed rule, the term consumer
refers to the person purchasing the
animal food to feed to an animal(s), as
well as the animal(s) consuming the
food (78 FR 64736 at 64756 through
64757). To limit the definition of
consumer to the animal consuming the
food would be inconsistent with how
that term is used throughout FSMA and
would create confusion. Therefore,
‘‘consumer’’ also includes the person
purchasing the animal food.
2. Corrections
(Comment 82) Some comments assert
that clearly distinguishing between the
terms ‘‘corrective actions’’ and
‘‘corrections’’ will be imperative for
industry to comply with the rule and for
regulators to enforce the rule. Some
comments ask us to use the ISO
definitions of ‘‘corrective actions’’ and
‘‘corrections.’’ (According to ISO
22000:2005 definition 3.13, a
‘‘correction’’ is action to eliminate a
detected non conformity; according to
ISO 22000:2005 definition 3.14,
corrective action is action to eliminate
the cause of a detected non conformity
or other undesirable situation.) Other
comments ask us to eliminate the term
‘‘correction’’ and instead revise the rule
to clarify the type of situation in which
‘‘corrective actions’’ are neither
necessary nor appropriate. As an
example, these comments suggest that
the proposed provisions for corrections
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could refer to ‘‘prompt actions taken in
response to minor and isolated
deviations that do not directly impact
product safety.’’
Other comments agree with the
concept of simple ‘‘corrections’’ but
assert that the term ‘‘corrections’’ is
unnecessary and could be confusing
because different facilities may use the
term differently. These comments
explain that sometimes ‘‘correction’’ is
used to refer to the action taken to fix
a deviation, and may or may not be part
of an overall corrective action taken to
identify the root cause of the deviation
and to prevent a similar occurrence.
These comments suggest that the
provisions explain that prompt actions
taken to address minor and isolated
deviations are not subject to the same
requirements as corrective actions to
address potentially systemic concerns,
without defining the term ‘‘corrections.’’
(Response 82) We are defining the
term ‘‘correction’’ to mean an action to
identify and correct a problem that
occurred during the production of
animal food, without other actions
associated with a corrective action
procedure (such as actions to reduce the
likelihood that the problem will recur,
evaluate all affected animal food for
safety, and prevent affected animal food
from entering commerce). We agree that
clearly distinguishing between the terms
‘‘corrective actions’’ and ‘‘corrections’’
will be important for both industry and
regulators. We acknowledge that one
way to distinguish between ‘‘corrective
actions’’ and actions that we would
consider ‘‘corrections’’ could be to avoid
the term ‘‘corrections’’ and instead say
what we mean each time the rule uses
the term ‘‘corrections.’’ However, after
reviewing the full regulatory text of
proposed subpart C, we concluded that
it was not practical to do so, because the
term ‘‘corrections’’ was used more often
in a title or a cross-reference than in a
provision where the full text of what we
mean by the term ‘‘corrections’’ is
necessary to communicate a
requirement. Our definition of
‘‘corrections’’ focuses on the first step in
a ‘‘corrective action procedure’’ (i.e.,
identify and correct the problem) and
also specifies those aspects of a
corrective action procedure that do not
apply to a correction (i.e., actions to
reduce the likelihood that the problem
will recur, evaluate all affected animal
food for safety, and prevent affected
animal food from entering commerce).
(A note to the ISO 22000:2005 definition
of corrective action indicates that it
includes cause analysis and is taken to
prevent recurrence.) We believe that this
definition will be adequate to
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distinguish ‘‘corrective actions’’ from
‘‘corrections.’’
As an example, if a facility applies
sanitation controls for an environmental
pathogen such as Salmonella spp. and
animal food residue is observed on
‘‘clean’’ equipment prior to production,
corrections would involve re-cleaning
and sanitizing the equipment before it is
used. Because the observation of animal
food residue was made prior to
production of animal food, no animal
food is affected, and no actions are
needed with respect to animal food.
Although there are actions that can be
taken to prevent reoccurrence, such as
retraining sanitation personnel, these
types of situations may reoccur from
time to time.
3. Crop
(Comment 83) Some comments
request we define a new term ‘‘crop’’ to
mean the edible or inedible cultivated
or harvested plants.
(Response 83) We decline this
request. The term ‘‘crop’’ has a common
meaning, and it is not necessary to
establish a meaning for this term in this
rule.
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4. Establishment
(Comment 84) Several comments
request we establish a definition for
establishment as it is used in the
supplier definition. Also, the comments
suggest that we replace in the definition
of farm the term ‘‘establishment’’ with
‘‘operation.’’
(Response 84) Comments concerning
the meaning of the term
‘‘establishment’’ as it relates to the
‘‘supplier’’ definition are addressed in
section XL pertaining to subpart E, the
supply-chain program. Comments
directed to the meaning of the term
‘‘establishment’’ as it relates to the farm
definition are addressed in section IV.A
and B of the final rule for preventive
controls for human food, published
elsewhere in this issue of the Federal
Register.
5. Parameter and Value as Used in the
Requirements for Process Controls
(Comment 85) Some comments ask us
to define the terms ‘‘parameter’’ and
‘‘value’’ used in the requirements for
preventive controls (§ 507.34). These
comments ask us to define ‘‘parameter’’
as a measurable attribute and ‘‘value’’ as
a specific measurement.
(Response 85) We decline this
request. Both of these terms are used in
the context of process controls and both
have common meanings when
associated with process controls.
Therefore, it is not necessary for the rule
to define them.
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6. Prerequisite Program
(Comment 86) Some comments ask
that we adapt the definition of
prerequisite program from the ISO’s
food safety standard, ISO 22000:2005,
noting that the ISO definition is: Basic
practices and procedures in animal food
production that are necessary for the
manufacture, handling and provision of
safe end products and safe food for
animal consumption.
(Response 86) We do not use the term
‘‘prerequisite program’’ in the
regulations established by this
rulemaking and do not find it necessary
to define it. We understand that some
facilities may refer to practices and
procedures such as CGMPs, training, or
certain controls for hazards as a
‘‘prerequisite program.’’
7. Qualified Facility Exemption
(Comment 873) Some comments note
that some of the terminology associated
with the exemption for qualified
facilities in the preventive controls rule
is different from terminology associated
with an exemption in the proposed
produce safety rule. These comments
point out that the exemption in the
proposed produce safety rule refers to
‘‘qualified exemptions’’ (§ 112.5),
whereas the exemption in the proposed
animal preventive controls rule refers to
‘‘exemptions’’ and ‘‘qualified facilities’’
(§ 507.5(d)).
(Response 873) We have added a
definition for the term ‘‘qualified facility
exemption,’’ to mean an exemption
applicable to a qualified facility under
§ 507.5(d) (see the regulatory text in
§ 507.3). We also have made conforming
changes throughout the rule to use the
term ‘‘qualified facility exemption’’
when it applies. (See table 31).
8. Qualified Investigator
(Comment 88) Once comment
proposes a new term ‘‘qualified
investigator’’ where the term ‘‘qualified
investigator’’ means an FDA or state
commissioned investigator that has
successfully completed a formal training
course on inspections; CGMPs; hazard
analysis and preventive controls for
animal food facilities, both animal feed
and pet food, and has demonstrated an
understanding of the differences
between pet food and animal feed
manufacturing facilities.
(Response 88) We decline this
request. Our inspectors will be trained
on the requirements of this part.
9. Reanalysis
(Comment 89) Some comments
request we define the term reanalysis to
mean a reassessment of the validity of
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a preventive control or food safety plan
to control a hazard.
(Response 89) We decline this
request. Section 418(i) of the FD&C Act
sets the requirement for conducting a
reanalysis, which is in the regulatory
text in § 507.50, including how often
and under what circumstances a
reanalysis of the food safety plan must
be performed, and how to handle the
results. Therefore, we have determined
that a definition of ‘‘reanalysis’’ is not
necessary. For a discussion of the
reanalysis requirement, see section
XXXV.
10. Risk Assessment
(Comment 90) Some comments
request that we add a new term ‘‘risk
assessment’’ and define this term as a
scientifically based process consisting of
hazard identification, hazard
characterization, exposure assessment,
and risk characterization.
(Response 90) We do not use the term
‘‘risk assessment’’ in the regulations
established by this rulemaking and do
not find it necessary to define it. As
directed by section 103(c) of FSMA, we
issued for public comment a draft risk
assessment, as described in section I.D
and are including the final risk
assessment in the docket established for
this rule.
The definition proposed by the
comment is similar to the requirements
for the hazard analysis of § 507.33. The
term ‘‘hazard analysis’’ comes from
section 418 of the FD&C Act. For
discussion of hazard analysis, see
section XXV.
11. Undesirable Microorganisms
(Comment 91) Some comments
request we define a new term
‘‘undesirable microorganisms’’ as those
microorganisms that are of animal or
human health significance, thereby
rendering the animal food unfit for
consumption or distribution.
(Response 91) We decline this
request. See Response 45.
12. Unexposed Packaged Animal Food
As discussed in section XXXVI, some
comments ask us to clarify that
modified requirements for packaged
animal food that is not exposed to the
environment only apply to such animal
food that requires time/temperature
controls for safety (TCS animal food). To
do so, we are defining the term
‘‘unexposed packaged animal food’’ to
mean packaged animal food that is not
exposed to the environment and using
this term throughout the rule. Doing so
simplifies the regulatory text and makes
it clearer.
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C. Additional Definitions To Clarify
Terms Not Defined in the Proposed Rule
1. Audit
As already noted, some comments ask
us to make the various rules we are
establishing to implement FSMA
consistent with each other, and we have
worked to align the provisions of this
rule with the provisions of the FSVP
rule to the extent practicable. (See
Comment 4 and Response 4.) To align
these provisions, we are establishing in
this final rule a definition of ‘‘audit’’
analogous to the definition of ‘‘audit’’
we proposed for the FSVP rule. For the
purposes of this rule, ‘‘audit’’ means the
systematic, independent, and
documented examination (through
observation, investigation, records
review, discussions with employees of
the audited entity, and, as appropriate,
sampling and laboratory analysis) to
assess a supplier’s food safety processes
and procedures.
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2. Full-Time Equivalent Employee
As discussed in Response 70, we have
established a definition for ‘‘full-time
equivalent employee’’ as a term used to
represent the number of employees of a
business entity for the purpose of
determining whether the business
qualifies for the small business
exemption. The number of full-time
equivalent employees is determined by
dividing the total number of hours of
salary or wages paid directly to
employees of the business entity and of
all of its subsidiaries and affiliates by
the number of hours of work in 1 year,
2,080 hours (i.e., 40 hours × 52 weeks).
If the result is not a whole number,
round down to the next lowest whole
number.
3. Qualified Individual
As discussed in section IX.A, we are
clarifying in new § 507.4(b)(1) that each
individual engaged in manufacturing,
processing, packing, or holding animal
food (including temporary and seasonal
personnel) or in the supervision thereof
must have the education, training, or
experience (or combination thereof)
necessary to manufacture, process, pack,
or hold safe animal food as appropriate
to the individual’s assigned duties. To
better align with the FSVP rule, we use
the term ‘‘qualified individual’’ in new
§ 507.4 and are defining the term
‘‘qualified individual’’ to mean a person
who has the education, training, or
experience (or a combination thereof)
necessary to manufacture, process, pack,
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or hold safe animal food as appropriate
to the individuals assigned duties. A
qualified individual may be, but is not
required to be, an employee of the
establishment.
4. Raw Agricultural Commodity
We have added a definition of the
term ‘‘raw agricultural commodity’’ to
have the meaning given in section 201(r)
of the FD&C Act. We decided to define
this term in the rule to simplify the
provisions in part 507 that refer to raw
agricultural commodities.
5. Supply-Chain-Applied Control
We have added a definition of the
term ‘‘supply-chain-applied control’’ to
mean a preventive control for a hazard
in a raw material or other ingredient
when the hazard in the raw material or
other ingredient is controlled before its
receipt. We decided to define this term
in the rule to simplify the provisions in
part 507, and in this document, that
refer to preventive controls applied by
a supplier before receipt by a receiving
facility.
6. Written Procedures for Receiving Raw
Materials and Other Ingredients
We have added a definition of the
term ‘‘written procedures for receiving
raw materials and other ingredients’’ to
mean written procedures to ensure that
raw materials and other ingredients are
received only from suppliers approved
by the receiving facility (or, when
necessary and appropriate, on a
temporary basis from unapproved
suppliers whose raw materials or other
ingredients are subjected to adequate
verification activities before acceptance
for use). We decided to define this term
in the rule to simplify the provisions in
part 507, and in this document, that
refer to these procedures.
IX. Subpart A: Comments on
Qualifications of Individuals Who
Manufacture, Process, Pack, or Hold
Animal Food
In the 2013 proposed preventive
controls rule for animal food we
proposed that personnel responsible for
identifying sanitation failures or animal
food contamination should have a
background of education or experience,
or a combination thereof, to provide a
level of competency necessary for
production of clean and safe animal
food. Animal food handlers and
supervisors should receive appropriate
training in proper food handling
techniques and food-protection
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principles and should be informed of
the danger of poor personal hygiene and
insanitary practices. We asked if the
recommendations should be
requirements for employee education
and training (78 FR 64736 at 64778). In
addition, we requested comment on
how best to implement section 418(o)(3)
of the FD&C Act and the
recommendations of the CGMP Working
Group for human food with respect to
training (78 FR 64736 at 64778). We
requested comment on whether the rule
should specify that each person engaged
in animal food manufacturing,
processing, packing, or holding
(including temporary and seasonal
personnel and supervisors) must receive
training as appropriate to the person’s
duties; specifying the frequency of
training (e.g., upon hiring and
periodically thereafter); specify that
training include the principles of animal
food hygiene and animal food safety,
including the importance of employee
health and personal hygiene, as applied
at the facility; and specify that records
document required training of personnel
and, if so, specify minimum
requirements for the documentation
(e.g., the date of the training, the type of
training, and the person(s) trained). We
also requested comment on whether to
establish some or all of the potential
requirements for education and training
in subpart B, subpart C, or both.
In the following paragraphs, we
discuss comments that respond to our
requests for comment on potential
requirements for education and training
and whether to establish any
requirements in subpart B, subpart C, or
both. After considering these comments,
we are establishing requirements for the
qualifications of individuals engaged in
manufacturing, processing, packing, or
holding animal food, as well as the
associated recordkeeping requirements
in new § 507.4 in subpart A. The
regulatory text makes clear that these
requirements, established in subpart A,
apply to individuals engaged in
manufacturing, processing, packing, or
holding animal food regardless of
whether the individuals conduct these
activities under the framework of the
CGMPs established in subpart B or the
framework for hazard analysis and riskbased preventive controls established in
subparts C, D, and E. The regulatory text
also makes clear that the qualification
requirements apply to the recordkeeping
requirements of subpart F. See table 5
for a description of these provisions.
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56207
TABLE 5—PROVISIONS FOR QUALIFICATIONS OF INDIVIDUALS WHO MANUFACTURE, PROCESS, PACK OR HOLD ANIMAL
FOOD
Final section designation
Proposed
section
designation
Description
N/A
507.4(a)(2) ................................................
N/A
507.4(b)(1) ................................................
507.14(b)
507.4(b)(2) ................................................
507.14(b)
507.4(c) .....................................................
507.4(d) .....................................................
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507.4(a)(1) ................................................
507.14(c)
507.4(d)
A. Applicability and Qualifications of
All Individuals Engaged in
Manufacturing, Processing, Packing, or
Holding Animal Food (Final § 507.4(a),
(b), and (d))
(Comment 92) Some comments prefer
that we continue to only provide
recommendations for education and
training and allow the animal food
industry to determine the appropriate
level of specific employee training that
may be needed. Some comments say
that we should allow facilities to
conduct employee training in a flexible
manner, with the facility determining
the training content and frequency that
is appropriate for the duties of a given
employee as they relate to ensuring the
safe production and distribution of
animal food.
Some comments recommend that
employees be trained ‘‘initially’’ and
‘‘periodically thereafter’’ but ask that we
recognize the seasonal nature of a
facility’s workforce. Some comments
ask that the training include the
principles of animal food hygiene and
animal food safety, including the
importance of employee health and
personal hygiene as applied at the
facility.
Some comments ask that training
requirements be established in subpart
B so that the requirements would also
apply to establishments that
manufacture, process, pack, or hold
animal food, including establishments
that are not subject to FSMA’s
requirements for hazard analysis and
risk-based preventive controls. Some
comments that recommend establishing
the training requirement in subpart B
assert that training is more
appropriately considered a prerequisite
program than a preventive control that
would belong in subpart C.
Other comments ask that the training
and related recordkeeping requirements
for the facility’s preventive controls
qualified individuals be established
under subpart C because this is directly
related to the facility’s food safety plan.
Other comments ask that training
requirements be established in both
subpart B and subpart C. Other
comments say that including
requirements for education and training
in both subparts B and C would be
confusing.
(Response 92) We are establishing a
series of requirements for the
qualifications of individuals engaged in
manufacturing, processing, packing, or
holding animal food in new § 507.4.
First, to clarify how these qualification
requirements apply to establishments
subject to subparts B and F, we are
requiring that the management of an
establishment ensure that all
individuals who manufacture, process,
pack, or hold animal food subject to
subparts B and F are qualified to
perform their assigned duties
(§ 507.4(a)(1)). To clarify how these
qualification requirements apply to
facilities, we are requiring that the
owner, operator, or agent in charge of a
facility must ensure that all individuals
who manufacture, process, pack, or hold
animal food subject to subparts C, D, E,
or F are qualified to perform their
assigned duties (§ 507.4(a)(2)).
We are not requiring training specific
to the person’s assigned duties. Each
establishment engaged in the
manufacturing, processing, packing and
holding of food for animal consumption
would already have procedures in place
to ensure that all individuals who
manufacture, process, pack, or hold
animal food know how to do their jobs.
However, to emphasize that we expect
all individuals who conduct such
activities to know how to do their jobs,
we are specifying that each individual
engaged in manufacturing, processing,
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Applicability to individuals who manufacture, process, pack, or hold animal food
subject to subparts B and F.
Applicability to individuals who manufacture, process, pack, or hold animal food
subject to subparts C, D, E, or F.
Each individual engaged in manufacturing, processing, packing, or holding animal
food must have the education, training, or experience (or combination thereof)
necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties.
Required training in the principles of animal food hygiene and animal food safety,
including the importance of employee health and personal hygiene.
Additional qualifications of supervisory personnel.
Records of required training. The required records are subject to the recordkeeping
requirements of subpart F.
Frm 00039
Fmt 4701
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packing, or holding animal food
(including temporary and seasonal
personnel) or in the supervision thereof
must have the education, training, or
experience (or combination thereof)
necessary to manufacture, process, pack,
or hold safe animal food as appropriate
to the individual’s assigned duties
(§ 507.4(b)(1)). To better align with the
forthcoming FSVP rule, we are using the
term ‘‘qualified individual’’ in new
§ 507.4(b)(1) and are defining the term
‘‘qualified individual’’ to mean a person
who has the education, training, or
experience (or combination thereof)
necessary to manufacture, process, pack,
or hold safe animal food as appropriate
to the individual’s assigned duties. A
qualified individual may be, but is not
required to be, an employee of the
establishment. See the discussion of the
term ‘‘preventive controls qualified
individual’’ in section VIII.A.10,
including a discussion of how we have
changed the proposed term ‘‘qualified
individual’’ to ‘‘preventive controls
qualified individual’’ because we are
establishing a new definition for
‘‘qualified individual,’’ with a meaning
distinct from ‘‘preventive controls
qualified individual.’’
We also are requiring that each
individual engaged in manufacturing,
processing, packing, or holding animal
food (including temporary and seasonal
personnel) or in the supervision thereof,
receive training in the principles of
animal food hygiene and animal food
safety, including the importance of
employee health and personal hygiene,
as appropriate to the animal food, the
facility and the person’s assigned duties
(see § 507.4(b)(2)). Records that
document this required training must be
established and maintained and are
subject to the recordkeeping
requirements of subpart F (§ 507.4(d)).
The rule does not specify the frequency
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of the required training. We expect that
production employees will receive
training before working in production
operations. We expect that most
facilities will also provide some form of
refresher training.
We disagree that we should continue
to only provide recommendations for
education and training. Although the
comments express concern about overly
prescriptive requirements that may not
consider variables that would affect an
establishment’s training program (such
as training course content, training
provider, effectiveness of the course and
instructor and frequency of training per
topic, an employee’s type and length of
experience, nature of formal education,
and the animal food product type and
point in the animal food supply chain
at which the employee works with the
animal food product), the training
requirement we are establishing in the
rule provides flexibility for each
establishment to provide training, and
determine the scope and frequency of
the training, in a way that works best for
the establishment.
We agree that it is appropriate to
establish training requirements so that
the requirements apply to all
establishments that manufacture,
process, pack, or hold animal food,
including establishments that are not
subject to FSMA’s requirements for
hazard analysis and risk-based
preventive controls, and we are
establishing the qualification and
training requirements in subpart A to
clarify the applicability of these
requirements to all establishments and
facilities subject to part 507. Although
we agree that employees in facilities
that are subject to the requirements for
hazard analysis and risk-based
preventive controls need to understand
their responsibilities under the facility’s
food safety plan, we are setting forth a
training requirement focused on the
principles of animal food hygiene and
animal food safety. We consider training
in the principles of animal food hygiene
and animal food safety, including the
importance of employee health and
personal hygiene, to be fundamental to
the concept of CGMPs. We agree that
establishing a training requirement in
both subpart B and subpart C could be
confusing.
(Comment 93) Some comments agree
that training should be documented and
assert that those records should show
the date of training, a description of the
training, and the name of the person
trained. However, comments ask that we
allow flexibility in the way these
records are kept. Other comments assert
that requiring that records document
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required training of personnel is
burdensome, arbitrary, and capricious.
(Response 93) The rule requires that
records that document training required
by § 507.4(b)(2) be established and
maintained without prescribing any
content of those records. Although one
approach to documenting training
would be to provide the date of training,
a description of the training, and the
name of the person trained, the rule
provides flexibility for each
establishment to document its training
in a way that works best for that
establishment. We disagree that
requiring records to document required
training is burdensome, arbitrary, and
capricious in light of the flexibility
provided by the rule for the content of
training records.
(Comment 94) Some comments agree
that any requirements should include
training appropriate to the person’s
duties but emphasize that the decision
as to what is appropriate to the person’s
assigned duties should be determined
by the establishment.
(Response 94) The requirement for
employees to receive training in the
principles of animal food hygiene and
animal food safety, including the
importance of employee health and
personal hygiene, as appropriate to the
person’s assigned duties, provides
flexibility for the establishment to
provide training that is appropriate for
its employees in light of each person’s
assigned duties. However, the rule does
not require training specific to the
person’s assigned duties.
(Comment 95) Some comments assert
that the training requirement would be
an unreasonable burden for small
businesses and that companies may
incur substantial cost for the time that
workers would be in training rather than
in production. Some comments ask us
to provide non-specific training
recommendations for smaller processors
that need flexibility to control the cost
of training. Some comments assert that
the training and education requirements
must be accessible and flexible enough
to allow employers to bring in
temporary help when demand is high
without causing a delay in hiring.
(Response 95) All employees will
need enough training to do their job and
understand the importance of hygiene
for animal food safety. The training
offered does not need to be expensive
(e.g., offsite training or off-the-shelf
purchased training) and we expect that
much of the training will be provided
in-house by knowledgeable employees.
As discussed in Response 1, the FSPCA
is developing a preventive controls
training curriculum. These training
materials will be available online, and
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we expect these training materials to be
useful to small businesses to use for inhouse training.
B. Additional Requirements Applicable
to Supervisory Personnel (Final
§ 507.4(c))
We proposed that responsibility for
ensuring compliance by all personnel
with all requirements of this subpart
must be clearly assigned to competent
supervisory personnel in § 507.14(c).
We are finalizing this provision in
§ 507.4(c). We are correcting ‘‘all
requirements of this subpart’’ to ‘‘all
requirements of this part.’’ As a
conforming change for consistency with
the provisions of § 507.4(b), we are
replacing the phrase ‘‘competent
supervisory personnel’’ with the phrase
‘‘supervisory personnel who have the
education, training, or experience (or a
combination thereof) necessary to
supervise the production safe animal
food.’’
X. Subpart A: Comments on Proposed
§ 507.5—Exemptions
We proposed to establish a series of
exemptions from the requirements for
hazard analysis and preventive controls
that would be established in subpart C,
with modified requirements in some
cases.
Some comments support one or more
of the proposed exemptions without
change. For example, some comments
note that the exemptions are specified
in FSMA and, thus, reflect the intent of
Congress. Some comments state that
some exemptions (i.e., those for
products already subject to our
regulations for the control of
microbiological hazards for low-acid
canned foods (LACF)) make sense
because they are risk-based. Other
comments that support one or more of
the proposed exemptions ask us to
clarify particulars associated with these
exemptions or expand the scope of some
of these exemptions. Other comments
ask us to include additional exemptions
in the rule.
In the remainder of this section, we
discuss comments that ask us to clarify
the proposed exemptions or that
disagree with, or suggest one or more
changes to, the proposed exemptions.
We also discuss comments that ask us
to include additional exemptions in the
rule. After considering these comments,
we have revised the proposed
exemptions as shown in table 6 with
editorial and conforming changes as
shown in table 31. A key conforming
change that affects all proposed
exemptions from the requirements of
subpart C is that the final exemptions
are from the requirements of subpart E,
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as well as subpart C. As discussed in
section XL, the final rule establishes the
requirements for a supply-chain
56209
program in subpart E, rather than within
subpart C as proposed.
TABLE 6—REVISIONS TO THE PROPOSED EXEMPTIONS
Section
Exemption
Modification
507.5(e) ................
From the requirements of subpart C for on-farm
packing or holding of food by a small or very
small business if the only packing and holding
activities subject to section 418 of the FD&C Act
that the business conducts are the specified lowrisk packing or holding activity/animal food combinations.
507.5(f) .................
From the requirements of subpart C for on-farm
manufacturing/processing activities conducted by
a small or very small business for distribution into
commerce if the only manufacturing/processing
activities subject to section 418 of the FD&C Act
that the business conducts are the specified lowrisk manufacturing/processing activity/animal food
combinations.
507.5(h) ................
From the requirements of subpart B for the holding
and transportation of RACs.
• Changes consequential to the revised ‘‘farm’’ definition—i.e., no
longer identifying any packing or holding activities for any RACs.
• Clarification that the modified requirements do not apply to onfarm packing or holding of food by a very small business if the
only packing and holding activities subject to section 418 of the
FD&C Act that the business conducts are the listed low-risk packing or holding activity/animal food combinations.
• Updated animal food categories consistent with the animal food
categories included in table 1 in the section 103(c)(1)(C) RA.
• Additions of low-risk packing or holding activity/animal food combinations as a result of an updated risk assessment.
• Changes consequential to the revised ‘‘farm’’ definition—i.e.:
• No longer distinguishing between manufacturing/processing activities conducted on a farm mixed-type facility’s own RACs and
manufacturing/processing activities conducted on food other than the
farm mixed-type facility’s own RACs; and
• Eliminating activities, conducted on others’ RACs, that would no
longer be classified as manufacturing/processing and instead would
be classified as harvesting, packing, or holding.
• Clarification that the modified requirements do not apply to onfarm manufacturing/processing activities conducted by a very small
business for distribution into commerce, if the only manufacturing/
processing activities subject to section 418 of the FD&C Act that
the business conducts are the listed low-risk manufacturing/processing activity/animal food combinations.
• Updated animal food categories consistent with the animal food
categories included in table 1 in the section 103(c)(1)(C) RA.
• Additions of low-risk manufacturing/processing activity/animal food
combinations as a result of an updated risk assessment.
Change from an exemption for specific activities (i.e., holding and
transportation of RACs) to facilities solely engaged in those activities.
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A. General Comments on the Proposed
Exemptions
(Comment 96) Some comments ask us
to provide the same flexibility for
foreign small businesses as for domestic
small businesses.
(Response 96) The exemptions apply
to both foreign small businesses and
domestic small businesses.
(Comment 97) Some comments ask us
to clarify whether an establishment that
is exempt from the requirements for
hazard analysis and risk-based
preventive controls in subpart C
remains subject to the CGMP
requirments in subpart B.
(Response 97) An establishment that
is exempt from the requirements for
hazard analysis and risk-based
preventive controls in subparts C and E
remains subject to the CGMP
requirements in subpart B, unless that
establishment is specifically exempt
from subpart B under § 507.5(a) (which
applies to farms and activities of ‘‘farm
mixed-type facilities’’ that fall within
the definition of ‘‘farm’’); or § 507.5(h)
(which applies to: (1) Establishments
solely engaged in the holding or
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transportation of one or more RACs; (2)
hulling, shelling, and drying nuts and
hulls (without manufacturing/
processing, such as grinding shells or
roasting nuts); and (3) ginning of cotton
(without manufacturing/processing,
such as extracting oil from cottonseed)).
(Comment 98) Some comments
request that we clearly articulate what
activities are not covered and why; as
well as what activities we are
specifically exempting and why. This
comment requests clarification about
the differences between the categories of
‘‘not covered’’ and ‘‘exempt.’’
(Response 98) We use the terms ‘‘not
covered’’ and ‘‘exempt’’ interchangeably
to describe what animal food operations
or activities within an operation are not
required to comply with all or parts of
this rule. Farms, for example, are ‘‘not
covered’’ by this rule, as established in
§ 507.5, which lists certain exemptions.
As another example, a business meeting
the very small business criteria is a
qualified facility subject to the
requirements of § 507.7, but ‘‘exempt’’
from the requirements of subparts C and
E (see § 507.5(d)). Whether a particular
exemption applies to an animal food
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operation depends on the type of
operation and the activities it is
conducting. We believe the exemptions
as codified provide enough specificity
for a facility to determine whether it
must comply with or is exempt from
this final regulation, or certain
provisions of the final regulation.
(Comment 99) One comment
expressed the opinion that exemptions
should be driven by risk of activities
rather than by whether they are
conducted on or off a farm.
(Response 99) Consistent with the
statutory direction in section 103(c) of
FSMA, including conducting a
qualitative risk assessment, we have
finalized exemptions for on-farm
activity/animal food combinations
conducted by farm-mixed-type facilities
that are small or very small businesses
as discussed further in sections VI and
X.
B. Proposed § 507.5(a)—Exemption for
Facilities Not Required To Register
Under Section 415 Regulations
We proposed that this part does not
apply to establishments, including
‘‘farms’’ (as defined in § 1.227 of this
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chapter), that are not required to register
under section 415 of the FD&C Act.
However, we proposed that subpart B
would apply to the packaging, packing,
and holding of dried commodities if a
‘‘farm’’ or ‘‘farm mixed-type facility’’
dries/dehydrates raw agricultural
commodities that are produce to create
a distinct commodity.
After reviewing all of the comments
concerning raw agricultural
commodities as discussed elsewhere in
this final rule, we have removed the
requirement that subpart B would apply
to the packaging, packing, and holding
of dried commodities from a ‘‘farm’’ or
‘‘farm mixed-type facility’’ that dries/
dehydrates RACs that are produce to
create a distinct commodity. We have
made this change because produce
RACs are not typically dried or
dehydrated to create distinct animal
food commodities, as they are to create
human food commodities (e.g., drying/
dehydrating grapes to make raisins).
(Comment 100) One comment
requests that we provide clarity and
examples for animal food facilities that
are exempt from facility registration and
therefore exempt from compliance with
part 507 because they are considered
restaurants or retail food establishments.
(Response 100) Our food facility
registration requirements are found in
21 CFR part 1, subpart H. Specifically,
‘‘restaurant’’ and ‘‘retail food
establishment’’ are defined in 1.227(b).
Additional information may be found in
our ‘‘Guidance for Industry: Questions
and Answers Regarding Food Facility
Registration (Sixth Edition)’’ (Ref. 23).
As discussed in section I.E. of the final
rule for preventive controls for human
food published elsewhere in this issue
of the Federal Register, we are
addressing the requirements of section
102(c) of FSMA in a separate
rulemaking and issued a separate
proposed rule to amend the definition of
‘‘retail food establishment’’ in the
section 415 registration regulations and
the section 414 recordkeeping
regulations (80 FR 19160, April 9, 2015).
C. Proposed § 507.5(b)—Exemption
Applicable to Food Subject to 21 CFR
Part 113—Thermally Processed LowAcid Foods Packaged in Hermetically
Sealed Containers
We proposed that activities in animal
food facilities that are regulated under
and are in compliance with § 500.23 and
part 113 would be exempt from subpart
C only with respect to microbiological
hazards regulated under part 113. We
further proposed that the facilities must
comply with subparts C and F with
regard to all other potential hazards and
must comply with subparts A and B. We
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requested comment on the criteria that
should be used to determine whether a
facility is in compliance with § 500.23
and part 113 (78 FR 64736 at 64762).
(Comment 101) Some comments
express concern that the partial
exemption for products subject to part
113 could generate confusion for both
regulators and regulated facilities. These
comments also assert that the partial
exemption for products subject to part
113 would generate duplicative
recordkeeping requirements under the
two rules.
(Response 101) We acknowledge the
potential for confusion and expect any
confusion to decrease over time as both
regulators and facilities gain experience
with the new requirements. We also
expect that in most instances a facility
that is subject to § 500.23 and part 113,
and that evaluates potential
microbiological hazards as part of its
hazard analysis, would conclude that
the potential hazards are controlled by
the targeted requirements of part 113
and conclude there are no significant
microbiological hazards that require
preventive controls to significantly
minimize or prevent the hazards.
We disagree that the partial
exemption for products subject to part
113 would generate duplicative
recordkeeping requirements. The
requirements of part 113 to control
biological hazards are different from the
requirements of subparts C and E to
conduct a hazard evaluation for
chemical and physical hazards, and
implement preventive controls and
associated preventive control
management components to address
significant chemical and physical
hazards. Likewise, the records
associated with the control of biological
hazards under part 113 are not the same
as the records associated with a hazard
analysis, preventive controls, and
associated preventive control
management components for control of
chemical and physical hazards.
However, to the extent that a facility
determines that existing records
required by part 113 can be used to
comply with the requirements of
subparts C and E, a facility may rely on
those records (see § 507.212).
(Comment 102) Some comments ask
us to provide guidance to industry and
the regulatory community regarding the
criteria that will be used to determine
when a facility is ‘‘in compliance with’’
part 113.
(Response 102) As an example, an
LACF manufacturing facility that has
ongoing problems controlling biological
hazards may be better able to address
biological hazards by preparing and
implementing a written food safety
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plan. As with facilities subject to our
HACCP regulations, we expect that
situations in which enforcement actions
to ensure compliance with part 113 are
insufficient to correct problems, and
lead to a facility losing its exemption
from the requirements of subparts C and
E, will be rare and will depend on very
specific circumstances. Therefore, at
this time we do not anticipate issuing
guidance on when violations of part 113
could lead to this outcome.
D. Proposed § 507.5(c)—Exemption
Applicable to Activities Subject to
Standards for Produce Safety in Section
419 of the FD&C Act
We proposed that subpart C would
not apply to activities of a facility that
are subject to section 419 of the FD&C
Act (Standards for Produce Safety) of
the FD&C Act (21 U.S.C. 350h).
(Comment 103) Some comments
request that we broaden the exemption
to operations that handle culls of raw,
intact, fresh produce. One comment
requested that fresh citrus be considered
a low risk product or excluded from the
rule entirely. This comment requested
that culls should not be considered a byproduct of fresh citrus production.
(Response 103) We decline these
requests. We have included a provision
under § 507.12 that exempts byproducts of off-farm packing and
holding of RACs for animal food use
from most of part 507 if ‘‘the human
food facility is subject to and in
compliance with § 117.8 of part 117,
and in compliance with all applicable
human food safety requirements of the
Federal Food, Drug, and Cosmetic Act
and implementing regulations.’’ The
human food facility also must not
further manufacture or process the byproducts intended for use as animal
food. The resulting animal food must be
held and distributed in accordance with
the CGMPs for the holding and
distribution of human food by-products
for use as animal food in § 507.28 and
§ 117.95. Thus, facilities subject to and
in compliance with § 117.8 and
applicable safety requirements of the
FD&C Act and its implementing
regulations, that pack or hold produce
culls off-farm for use as animal food
(without manufacturing or processing
the culls) would be exempt from part
507, except for the limited holding and
distribution CGMPs in § 507.28.
Facilities that manufacture or process
culls of raw, intact, fresh produce for
use as animal food would be subject to
part 507. Activities, such as packing
fresh citrus, of a facility that is subject
to section 419 of the FD&C Act are
exempt from subparts C.
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E. Proposed § 507.5(d)—Exemption
Applicable to a Qualified Facility
We proposed that subpart C would
not apply to a qualified facility, except
as provided by subpart D (Withdrawal
of an Exemption Applicable to a
Qualified Facility), and that qualified
facilities would be subject to the
requirements in § 507.7.
(Comment 104) Some comments
support the proposed exemption for a
qualified facility. Other comments
oppose this proposed exemption,
asserting that it is not risk based and
expressing concern that qualified
facilities would cause significant food
safety problems. Some comments ask us
to strictly construct and narrowly apply
the exemptions to as few businesses as
possible.
Some comments do not agree that
qualified facilities should be subject to
modified requirements because even the
modified requirements are burdensome.
Some comments assert that qualified
facilities having an average annual value
of animal food sold during the previous
3-year period of $10,000 or less should
be exempt from all requirements related
to hazard analysis and risk-based
preventive controls, including modified
requirements. One comment does not
specify an amount of annual sales of
animal food, but states that whether a
facility is a qualified facility should be
based on whether the facility has caused
any reported injury or illness to humans
or animals.
(Response 104) The exemption for
qualified facilities, including the criteria
for being a qualified facility and the
applicability of modified requirements,
is expressly directed by section 418(l) of
the FD&C Act. In defining ‘‘very small
business’’ to mean a business (including
any subsidiaries or affiliates) averaging
less than $2,500,000, adjusted for
inflation, per year, during the 3-year
period preceding the applicable
calendar year in sales of animal food
plus the market value of animal food
manufactured, processed, packed, or
held without sale (e.g., held for a fee or
supplied to a farm without sale), we
constructed this exemption to apply to
businesses that, collectively, produce
less than 2 percent of the dollar value
of animal food produced in the United
States. This is comparable to the
percentage of the human food supply
that is exempt under the definition of
very small business for human food (see
section XI.B of the final rule for
preventive controls for human food
published elsewhere in this issue of the
Federal Register). As previously
discussed in section VIII.A.36, the
businesses that will be exempt from the
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requirements for hazard analysis and
risk-based preventive controls, and will
instead be subject to other requirements,
will produce a small portion of the
animal food at potential risk of causing
foodborne illness (see the discussion at
79 FR 58476 at 58502).
(Comment 105) Some comments
assert that a qualified facility should be
exempt from the CGMP requirements of
subpart B, as well as the requirements
for hazard analysis and risk-based
preventive controls in subpart C.
(Response 105) The exemption for
qualified facilities is expressly directed
by section 418(l) of the FD&C Act and
is limited to an exemption from the
requirements for hazard analysis and
risk-based preventive controls in
subparts C and E. The comments
provide no basis for why new statutory
requirements for hazard analysis and
risk-based preventive controls should in
any way impact CGMP requirements
that apply to the manufacturing,
processing, packing, and holding of
animal food. CGMPs provide the basic
requirements for ensuring production of
safe animal food. Following the CGMPs
is essential to properly address public
(human and animal) health risks from
very small facilities that are provided an
exemption from subparts C and E in
order to minimize the burden on such
facilities.
(Comment 106) Some comments ask
us to provide that a qualified facility
may voluntarily choose to comply with
the requirements for hazard analysis
and preventive controls.
(Response 106) A qualified facility
may voluntarily choose to comply with
the requirements for hazard analysis
and risk-based preventive controls
without a specific provision authorizing
it to do so. One way that a qualified
facility could comply voluntarily would
be to simply not submit the attestation
that it is a qualified facility (see
§ 507.7(b) for the requirement for a
qualified facility to submit an attestation
regarding its status as a qualified
facility). When we inspect the facility,
we would inspect the facility for
compliance with the requirements for
hazard analysis and risk-based
preventive controls. Another way for a
facility to voluntarily comply would be
to submit the attestation, and specify
that it will satisfy the statutory
documentation requirement through
documentation of its food safety
practices rather than documentation
that it is in compliance with nonFederal food safety law.
(Comment 107) Some comments ask
us to specify in guidance that a qualified
facility is not required to prepare and
implement a food safety plan.
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(Response 107) We intend to
recommend in guidance how a qualified
facility could comply with the
requirements in § 507.7 without
satisfying all of the requirements in
subparts C and E.
F. Proposed § 507.5(e) and (f)—
Exemptions Applicable to On-Farm
Low-Risk Activity/Animal Food
Combinations Conducted by a Small or
Very Small Business
As discussed in section VI.A,
consistent with the statutory direction
in section 103(c) of FSMA, including
conducting a qualitative risk
assessment, we proposed three
exemptions for on-farm activity/food
combinations conducted by farm-mixedtype facilities that are small or very
small businesses (proposed §§ 507.5(e),
(f)(1), and (f)(2)).
1. General Comments on the Proposed
Exemptions Applicable to On-Farm
Low-Risk Activity/Animal Food
Combinations Conducted by a Small or
Very Small Business
(Comment 108) Some comments
assert that conducting a low-risk
activity/food combination should be
sufficient to qualify any facility for
exemption from subpart C, regardless of
whether the activity is conducted onfarm or off-farm, or meets the economic
threshold for a small or very small
business.
(Response 108) The statute provides
specific direction for those facilities that
can qualify for this exemption. (See
sections 418(l) and 418(o)(2) of the
FD&C Act.) See also Response 104 in
this final rule, and Responses 220 and
222 in the final rule for preventive
controls for human food published
elsewhere in this issue of the Federal
Register.
(Comment 109) Some comments state
that the exemptions for farming
activities are confusing.
(Response 109) The activity/animal
food combinations listed in § 507.5(e)
are directed to an exemption for packing
and holding activities, whereas the
activity/animal food combinations listed
in § 507.5(f) are directed to an
exemption for manufacturing/
processing activities. Although these
exemptions are more complex than
other exemptions (e.g., because they are
directed to specific activities conducted
on specific animal foods), the final
‘‘farm’’ definition has simplified them to
the extent practicable. For example,
under the ‘‘farm’’ definition in the 2013
proposed human preventive controls
rule, whether an activity was packing or
manufacturing/processing depended, in
part, on whether the RACs being packed
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were the farm’s own RACs or others’
RACs. In contrast, under the ‘‘farm’’
definition established in the final rule
for preventive controls for human food
published elsewhere in this Federal
Register, packing RACs is a ‘‘packing’’
activity, regardless of ownership of the
RACs being packed.
(Comment 110) Some comments note
a distinction between the exemptions
for on-farm low-risk activity/animal
food combinations conducted by small
and very small businesses and the
exemption for qualified facilities.
Specifically, the comments state that a
farm mixed-type facility that only
conducts low-risk activity/animal food
combinations (such as grinding grains)
would be exempt from the requirements
of subpart C, whereas an off-farm
qualified facility grinding grains, while
exempt from the requirements of
subpart C, would nonetheless be subject
to the requirements for a qualified
facility in § 507.7. These comments ask
whether it would be better for a farm or
farm mixed-type facility that satisfies
criteria for a small or very small
business, and also satisfies criteria for a
qualified facility, to classify itself as a
small or very small business or to
classify itself as a qualified facility.
(Response 110) In light of the final
‘‘farm’’ definition, these comments no
longer apply with respect to activities
within the farm definition.
For activities conducted by a farm
mixed-type facility, we acknowledge
that the exemptions provided by
§ 507.5(e) and (f) for on-farm low-risk
activity/animal food combinations are
different from the exemption provided
by § 507.5(a) for a qualified facility. A
farm mixed-type facility that only
conducts low-risk activity/animal food
combinations listed in § 507.5(e) and (f)
is fully exempt from the requirements of
subparts C and E, and is not subject to
the requirements for a qualified facility
in § 507.7, even if that farm mixed-type
facility is also a very small business
(and, thus, also is a qualified facility).
To make this clear, we have revised
proposed § 507.5(e) to specify that
§ 507.7 does not apply to on-farm
packing or holding of animal food by a
very small business if the only packing
and holding activities subject to section
418 of the FD&C Act that the business
conducts are the listed low-risk packing
or holding activity/animal food
combinations. Likewise, we have
revised proposed § 507.5(f) to specify
that § 507.7 does not apply to on-farm
manufacturing/processing activities
conducted by a very small business for
distribution into commerce, if the only
manufacturing/processing activities
subject to section 418 of the FD&C Act
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that the business conducts are the listed
low-risk manufacturing/processing
activity/animal food combinations.
With these changes, a farm mixedtype facility that is a very small business
and that only conducts the low-risk
activity/animal food combinations listed
in § 507.5(e) and/or (f) may find it
advantageous to classify itself as a very
small business eligible for the
exemption in § 507.5(e) and/or (f) rather
than as a qualified facility, which would
be subject to the requirements in
§ 507.7.
(Comment 111) Some comments ask
for a process to keep the list of low-risk
activity/food combinations up to date,
such as through guidance.
(Response 111) We decline this
request. The exemptions established in
this rule are binding, whereas any list of
additional activity/animal food
combinations established in a guidance
document would not be binding. We
established the list of activity/animal
food combinations included in these
exemptions through an extensive public
process, including a request for
comments on the section 103(c)(1)(C)
draft RA. From this time forward, the
process available to a person who
wishes us to consider an additional
activity/animal food combination is to
submit a citizen petition in accordance
with 21 CFR 10.30.
2. Proposed § 507.5(e)—Exemption
Applicable to On-Farm Low-Risk
Packing or Holding Activity/Animal
Food Combinations Conducted by a
Small or Very Small Business
We proposed that subpart C would
not apply to on-farm packing or holding
of animal food by a small or very small
business if the only packing and holding
activities subject to section 418 of the
FD&C Act that the business conducts are
low-risk packing or holding activity/
animal food combinations on animal
food not grown, raised, or consumed on
that farm mixed-type facility or another
farm or farm mixed-type facility under
the same ownership.
(Comment 112) Many comments state
that it is common practice among farms
to hold RACs from farms under different
ownership and that classifying
establishments as being within the
‘‘farm’’ definition, or outside the ‘‘farm’’
definition, based on who owns the
RACs being packed is not a risk-based
classification.
(Response 112) We proposed a revised
definition of ‘‘farm’’ in the 2014
preventive controls supplemental notice
for human food to include packing and
holding of RACs grown on another farm
not under the same ownership (79 FR
58524 at 58531 through 58532). As a
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consequential change in light of the
final ‘‘farm’’ definition established in
the final rule for preventive controls for
human food published elsewhere in this
Federal Register, the exemption no
longer identifies any packing or holding
activities for any RACs (whether the
farm’s own RACs or others’ RACs),
because an on-farm establishment
would no longer be subject to the
requirements for hazard analysis and
risk-based preventive controls (subpart
C) when it packs or holds RACs,
regardless of whether it is packing and
holding its own RACs or others’ RACs.
In light of the change in the ‘‘farm’’
definition, we have revised the section
103(c)(1)(C) RA, starting with the list of
on-farm activity/animal food
combinations outside the farm
definition in table 1, to exclude packing
and holding of RACs.
3. Proposed § 507.5(f)—Exemption
Applicable to On-Farm Low-Risk
Manufacturing/Processing Activity/
Animal Food Combinations Conducted
by a Small or Very Small Business
We proposed that subpart C would
not apply to on-farm low-risk
manufacturing/processing activities
conducted by a small or very small
business if the only manufacturing/
processing activities subject to section
418 of the FD&C Act that the business
conducts are those listed in the
proposed exemption. The proposed
exemption specified those activity/
animal food combinations that would be
exempt when conducted on a farm
mixed-type facility’s own RACs and
those activity/animal food combinations
that would be exempt when conducted
on animal food other than the farm
mixed-type facility’s own RACs for
distribution into commerce.
As a consequential change in light of
the final ‘‘farm’’ definition, the final
exemption no longer distinguishes
between manufacturing/processing
activities conducted on a farm mixedtype facility’s own RACs and
manufacturing/processing activities
conducted on animal food other than
the farm mixed-type facility’s own
RACs. As another consequential change,
the exemption has been revised to
eliminate activities, conducted on
others’ RACs, which no longer are
classified as manufacturing/processing
and instead are classified as harvesting,
packing, or holding. In addition, we
have revised the final exemption to list
animal food categories consistent with
the animal food categories included in
table 1 in the section 103(c)(1)(C) RA
(Ref. 3), modified in response to
revisions of the ‘‘farm’’ definition. (See
Response 112.) In constructing
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categories of animal food based upon
the new ‘‘farm’’ definition, we grouped
together processed grain products (e.g.,
flour, grits, etc.) and grain by-products
(e.g., brewers’ grain, distillers’ grain,
and corn gluten meal). The category
does not include culled products from
processing grain for human food such as
misshapen pasta. Pasta used in animal
food falls under a new category (any
other animal food that does not require
time/temperature control for safety) that
was added to include the wide range of
possibilities for animal food that was
originally processed to be human food,
as well as other types of animal food not
listed separately.
(Comment 113) Some comments ask
us to include in the exemption a single
list of low-risk manufacturing/
processing activity/food combinations
applicable to farm mixed-type facilities
conducting activities on their own RACs
and farm mixed-type facilities
conducting activities on other’s RACs.
(Response 113) These comments no
longer apply. As a consequence of the
‘‘farm’’ definition established by the
final rule for preventive controls for
human food published elsewhere in this
Federal Register, the exemption no
longer distinguishes between
manufacturing/processing activities
conducted on a farm mixed-type
facility’s own RACs and manufacturing/
processing activities conducted on
animal food other than the farm mixedtype facility’s own RACs.
(Comment 114) Some comments ask
us to include manufacturing of animal
food from low risk ingredients as
additional activity/animal food
combinations in the exemption. Other
comments support our conclusion that
manufacturing animal food ready for
consumption is not a low risk activity.
(Response 114) We evaluated
manufacturing of animal food as one of
the activity/animal food combinations
within the qualitative risk assessment
(Ref. 3). The 103(c)(1)(C) RA explains
why we determined that manufacturing
animal food ready for consumption is
not a low-risk activity/animal food
combination.
G. Proposed § 507.5(g)—Exemption
Applicable to Facilities Solely Engaged
in Storage of Raw Agricultural
Commodities Other Than Fruits and
Vegetables Intended for Further
Distribution or Processing
We proposed that subpart C would
not apply to facilities that are solely
engaged in the storage of RACs (other
than fruits and vegetables) intended for
further distribution or processing. In the
following paragraphs, we discuss
comments that ask us to clarify how the
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proposed exemption would apply to
specific circumstances.
(Comment 115) Some comments ask
whether this proposed exemption
(proposed § 507.5(g)) would apply to
facilities such as peanut buying points
or bean elevators and assert that such
commodities are analogous to grains
and the activities conducted at such
facilities are analogous to those
performed by grain elevators.
(Response 115) We classify peanuts
and beans (such as kidney beans, lima
beans, and pinto beans) within the
category of ‘‘fruits and vegetables’’; we
classify soybeans as grain (see the
discussion of grains at 78 FR 64736 at
64764 and 79 FR 58476 at 5848, and
fruits and vegetables at 78 FR 3646 at
3690 and proposed §§ 112.1 and 112.2
in the proposed produce safety rule).
The exemption for facilities solely
engaged in storage of RACs intended for
further distribution or processing does
not apply to facilities that store fruit and
vegetable RACs and, thus, does not
apply to facilities such as peanut buying
points and bean elevators. As discussed
in section IV.B, we have revised the
‘‘farm’’ definition to provide that an
operation devoted only to the harvesting
(such as hulling or shelling), packing,
and/or holding of RACs is within the
‘‘farm’’ definition, provided that the
farms that grow or raise the majority of
the RACs harvested, packed, and/or
held by the operation own, or jointly
own, a majority interest in the
operation. With this revision, some
operations dedicated to holding RACs,
including fruit and vegetable RACs, will
be within the ‘‘farm’’ definition.
Peanut buying points and bean
elevators that do not meet the revised
farm definition are storing RACs that are
‘‘fruits and vegetables’’ and do not meet
the criteria for exemption under
§ 507.5(g). However, we would not
expect such facilities to need an
extensive food safety plan. A facility
that appropriately determines through
its hazard analysis that there are no
hazards requiring preventive controls
would document that determination in
its written hazard analysis but would
not need to establish preventive controls
and associated management
components.
(Comment 116) One comment states
that genetically modified food should be
added to the list of hazards that are seen
as potential risks for animals.
(Response 116) We decline this
request. We have not seen evidence that
foods derived from genetically
engineered plants differ from other
foods in any meaningful or uniform
way, or that, as a class, such foods
present different or greater safety
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concerns than their non-genetically
engineered counterparts. We have a
voluntary consultation process for foods
derived from genetically engineered
plants through which we engage with
the developers of genetically engineered
plants to help ensure the safety of the
derived foods. Foods that have
undergone this consultation process are
as safe as foods from conventionally
bred plants. Foods derived from
genetically engineered plants,
irrespective of the method of
development, are subject to the same
food safety and other regulatory
requirements as foods derived from
conventionally-bred plants. Therefore
genetically engineered foods do not
need to be singled out as a hazard.
(Comment 117) Some comments
assert that the exemption for storage of
raw agricultural commodities (other
than fruits and vegetables) should
extend to those distinct and physically
separate portions of oilseed processing
facilities that are devoted solely to RAC
storage. According to these comments,
in the overwhelming majority of cases
the inclusion of a separate RAC storage
area in the same building as the oilseed
processing area will not introduce
additional risk either to the processing
area or to the operations that take place
there and that storage areas, whether
standing alone as a separate facility or
incorporated into a larger processing
facility, store RACs safely. These
comments ask us to recognize that
storage activities may include grain
drying to standardize moisture levels
and preserve product quality.
(Response 117) The activities
included within the definition of
holding include activities that are
performed as a practical necessity for
the distribution of RACs. In the 2014
supplemental notice, we explained that
facilities that conduct operations similar
to those conducted at grain elevators
and silos, such as some facilities that
hold oilseeds, may satisfy the criteria for
exemption if activities other than
storage are performed as a practical
necessity for the distribution of RACs
(see 79 FR 58476 at 58483 and the
definition of ‘‘holding’’ in § 507.3).
Examples of holding activities include
drying/dehydrating RACs when the
drying/dehydrating does not create a
distinct commodity (see § 507.3). Thus,
the specific example of drying grains to
standardize moisture levels and
preserve product quality would fall
within the definition of holding as a
practical necessity for the distribution of
RACs. A facility that stores oilseeds, and
dries them as a practical necessity for
the distribution of RACs, would be
covered by the exemption in § 507.5(g).
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However, we decline the request to
modify the exemption in § 507.5(g) to
also apply to distinct and physically
separate storage areas that are used
solely for storage of RACs (other than
fruits and vegetables) intended for
further distribution or processing. To
the extent that the comments are asking
us to do so to provide for facilities that
conduct activities as a practical
necessity for the distribution of RACs to
be eligible for the exemption, doing so
is not necessary in light of the definition
of holding. To the extent that the
comments are asking us to do so to
provide for facilities that conduct
manufacturing/processing activities in
addition to holding activities, we
disagree that doing so would be
consistent with the statutory direction
in FSMA. As previously discussed,
section 418(m) of the FD&C Act
provides in relevant part that we may by
regulation exempt or modify the
requirements for compliance under
section 418 of the FD&C Act with
respect to facilities that are solely
engaged in the storage of RACs (other
than fruits and vegetables) intended for
further distribution or processing (78 FR
64736 at 64764). The plain meaning of
‘‘solely’’ is only, completely, entirely;
without another or others; singly; alone
(Ref. 24). Facilities that conduct
manufacturing/processing activities in
addition to holding activities are not
‘‘solely’’ engaged in the storage of RACs
(other than fruits and vegetables)
intended for further distribution and
processing.
(Comment 118) Some comments
request that the language of § 507.5(g)
explicitly state that the exemption from
subpart C would apply to facilities that
are solely engaged in the packing and
holding of raw agricultural commodities
(other than fruits and vegetables)
intended for further distribution or
processing. These comments indicate
that packing is frequently involved
when a facility distributes raw
agricultural commodities that they have
been holding. They cite the § 110.19(a)
exemption from the human food CGMP
regulation for establishments ‘‘engaged
solely in the harvesting, storage, or
distribution of one or more ‘raw
agricultural commodities’ ’’ and remark
that in application of the regulation, the
activity of packing has been
encompassed within the term
‘‘distribution.’’ In addition, some
comments ask that the exemption
proposed in § 507.5(g) be extended to an
exemption from subpart B, as well as
from subpart C.
(Response 118) We decline the
request to add the term ‘‘packing’’ to
§ 507.5(g). As discussed in Response
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117, the activities included within the
definition of holding include activities
that are performed as a practical
necessity for the distribution of RACs.
Under § 507.5(h), subpart B does not
apply to the holding or transportation of
one or more RACs. (See section X.H.)
H. Proposed § 507.5(h)—Exemption
Applicable to the Holding or
Transportation of One or More Raw
Agricultural Commodities
We proposed to provide that subpart
B would not apply to the holding or
transportation of one or more RACs as
defined in section 201(r) of the FD&C
Act.
(Comment 119) Some comments ask
us to include the term ‘‘packing’’ in
§ 507.5(h) to say ‘‘Subpart B of this part
does not apply to the packing and
holding or transportation of one or more
raw agricultural commodities as defined
in section 201(r) of the Federal Food,
Drug, and Cosmetic Act.’’
(Response 119) We decline the
request to add the term ‘‘packing’’ to
§ 507.5(h). As discussed in Response
117, the activities included within the
definition of holding include activities
that are performed as a practical
necessity for the distribution of RACs.
(Comment 120) Some comments ask
us to clarify that CGMP requirements
(such as using protective coverings
where necessary and appropriate
(§ 507.17(c)) do not apply to the bulk
outdoor storage of RACs for further
processing.
(Response 120) We are returning to
the longstanding approach that the
exemption applies to establishments
‘‘solely engaged’’ in specific activities.
Under the exemption we are
establishing in § 507.5(h)(1), those
activities are holding and transportation
of RACs. We explain why in the
following paragraphs.
These comments appear to interpret
the proposed exemption in a way that
goes beyond the longstanding ‘‘RAC
exemption’’ in the human food CGMPs
in § 110.19 and is inconsistent with the
intent in updating § 110.19 to adjust and
clarify what activities fall within this
exemption based on experience and
changes in related areas of the law since
issuance of this exemption from the
CGMPs (78 FR 64736 at 64764 and 78
FR 3646 at 3710). The suggestion of
these comments, i.e., that CGMPs
should not apply to the holding of
RACS in a facility that manufactures,
processes, or packs RACs—would not
make sense in some circumstances and
would create complex situations for
establishments (in determining how to
comply with the CGMP requirements)
and for regulators (in determining how
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to enforce the CGMP requirements). For
example, it does not make sense for the
part of a facility that holds RACs prior
to processing to be exempt and the parts
of the facility that are processing the
RACs and storing them after processing
to be covered. Likewise, it does not
make sense for part of a transportation
vehicle to be covered and part to be
exempt.
By revising the proposed ‘‘RAC
exemption’’ so that it applies only to
establishments ‘‘solely engaged’’ in the
storage or transportation of RACs, we
are providing for a predictable
framework for interpreting exemptions
for facilities ‘‘solely engaged’’ in other
activities. For example, as discussed in
Comment 117, comments ask us to
expand the exemption (in § 507.5(g))
from the requirements for hazard
analysis and risk-based preventive
controls for facilities that are ‘‘solely
engaged’’ in the storage of RACs (other
than fruits and vegetables) intended for
further distribution or processing to also
apply to distinct and physically separate
storage areas that are used solely for
storage of such RACs. In our response,
we noted that facilities that conduct
manufacturing/processing activities in
addition to holding activities are not
‘‘solely engaged’’ in the storage of such
RACs (see Response 117). In addition, as
discussed in Comment 146, comments
ask us to apply the exemption (in
§ 507.10) from the requirements for
hazard analysis and risk-based
preventive controls for facilities that are
‘‘solely engaged’’ in the storage of
unexposed packaged food to storage
areas of facilities that also engage in
food processing activities, e.g., for
distributors that are engaged in limited
food processing, such as blending seeds
to make bird food. In our response, we
noted that such distributors are not
‘‘solely’’ engaged in the storage of
unexposed packaged animal food (see
Response 146).
The exemption we are establishing in
this rule for establishments solely
engaged in the storage or transportation
of RACs remains consistent with our
announced intent to adjust and clarify
what activities fall within this
exemption based, in part, on changes in
related areas of the law since this
exemption from the CGMP requirements
was first issued. As discussed in section
IV of the final rule for preventive
controls for human food, published
elsewhere in this issue of the Federal
Register, we have made a number of
changes to the ‘‘farm’’ definition,
including changes that provide for an
operation devoted to harvesting,
packing, and/or holding of RACs to be
a ‘‘farm’’ (i.e., a ‘‘secondary activities
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farm’’) (and, thus, be exempt from the
CGMP requirements under § 507.5(a))
even though the operation does not
grow RACs (see § 507.3). With this
revised ‘‘farm’’ definition, some
establishments solely engaged in the
‘‘storage’’ of RACs will be exempt from
the CGMP requirements because they
are a ‘‘farm.’’ For further discussion on
this provision, see section XI.J in the
final rule for preventive controls for
human food.
I. Comments Requesting Additional
Exemptions
(Comment 121) Some comments
request additional exemptions from the
requirements for hazard analysis and
risk-based preventive controls in
subpart C, the CGMP requirements of
subpart B, or both.
(Response 121) We believe that our
CGMP regulations, coupled with
implementation of FSMA’s directives to
focus more on preventing food safety
problems than on reacting to problems
after they occur, will play an important
role in increasing animal food safety.
We did not propose any exemptions or
exceptions from the requirements of
subpart C other than those authorized
by section 103 of FSMA (78 FR 64736
at 64743 through 64744). We drew on
our experience with the CGMP
regulation for human food and changes
in related areas of the FD&C Act since
issuance of the CGMP regulation (78 FR
3646 at 3709 through 3711) to adjust
and clarify what activities fall within a
longstanding exclusion related to raw
agricultural commodities (see § 110.19)
and to modify the CGMPs for human
food by-products for use as food for
animals.
(Comment 122) Some comments state
that facilities that hull, shell, and dry
tree nuts without further processing
could be characterized as
establishments engaged solely engaged
in the harvesting, storage, or
distribution of one or more raw
agricultural commodities. These
comments express an expectation that
since hulled or shelled dried nuts retain
their raw agricultural commodity status,
that facilities hulling, shelling and
drying tree nuts without further
processing would qualify for exemption
under both proposed §§ 507.5(g) and
507.5(h).
(Response 122) Hulling and shelling
of tree nuts (such as walnuts, almonds,
and pistachios) are harvesting activities
that are within the ‘‘farm’’ definition
when conducted on a farm or farm
mixed-type facility. Drying/dehydrating
RACs without creating a distinct
commodity (such as drying walnuts and
hulls) is a holding activity that also is
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within the ‘‘farm’’ definition when
conducted on a farm or farm mixed-type
facility. As discussed in section IV.B of
the final rule for preventive controls for
human food (published elsewhere in
this issue of the Federal Register) we
have revised the ‘‘farm’’ definition to
provide that an operation, not
conducted on a Primary Production
Farm, devoted to the harvesting (such as
hulling or shelling), packing, and/or
holding of RACs is within the ‘‘farm’’
definition (as a ‘‘secondary activities
farm’’), provided that the primary
production farm(s) that grow or raise the
majority of the RACs harvested, packed,
and/or held by the secondary activities
farm own, or jointly own, a majority
interest in the operation. Non-farm
facilities dedicated to the hulling,
shelling, and drying of nuts and hulls
perform the same activities as those
performed by farms. When done on a
primary production farm or by a
secondary activities farm, those
activities would not be subject to
CGMPs. Furthermore, these activities do
not transform the RAC into a processed
food. Therefore, we have added
regulatory text in § 507.5(h) to provide
an exemption from subpart B for
hulling, shelling, and drying nuts and
hulls (without further manufacturing/
processing) by a non-farm hulling/
shelling/drying facility because of the
similarity in the activities of a farmowned operation and a non-farm owned
facility. However, non-farm facilities are
not exempt from subparts C and E under
§ 507.5(g) as they are not solely engaged
in the storage of raw agricultural
commodities. A facility that
appropriately determines through its
hazard analysis that there are no
hazards requiring preventive controls
would document that determination in
its written hazard analysis but would
not need to establish preventive controls
and associated management
components.
(Comment 123) Some comments state
that ginning cotton to separate cotton
fiber from cotton seed is a low-risk
harvesting activity. Comments further
note that since cotton seed used as
animal food is a by-product from the
production of cotton lint, the cotton
seed coming from a ginning facility
would not qualify as a human food byproduct. The comments request that
facilities whose entire operation
consists of receiving and ginning cotton
without further processing the cotton
seeds be exempt from both subpart C
under § 507.5(g) and subpart B under
§ 507.5(h).
(Response 123) Ginning cotton is a
harvesting activity that is within the
‘‘farm’’ definition when conducted on a
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farm or farm mixed-type facility.
Drying/dehydrating the cottonseed
without further processing is a holding
activity that also is within the ‘‘farm’’
definition when conducted on a farm or
farm mixed-type facility. (See Response
122 for a discussion on modification to
the farm definition). When done on a
primary production farm or by a
secondary activities farm, these
activities (ginning, drying, dehydrating)
would not be subject to CGMPs, and
these activities do not transform the
RAC into a processed food. Therefore,
we have added regulatory text in
§ 507.5(h)(2) to provide an exemption
from subpart B for the ginning of cotton
(without further manufacturing/
processing) by a non-farm cotton
ginning facility because of the similarity
between a farm-owned operation and a
non-farm owned facility (See Response
122). However, non-farm facilities are
not exempt from subparts C and E under
§ 507.5(g) as they are not solely engaged
in the storage of raw agricultural
commodities. A facility that
appropriately determines through its
hazard analysis that there are no
hazards requiring preventive controls
would document that determination in
its written hazard analysis but would
not need to establish preventive controls
and associated management
components.
XI. Subpart A: Comments on Proposed
§ 507.7—Requirements That Apply to a
Qualified Facility
As previously discussed (78 FR 64736
at 64765), sections 418(l)(2)(A) and (B)
of the FD&C Act provide that a qualified
facility must submit two types of
documentation to us. The first type of
required documentation relates to food
safety practices at the facility, with two
options for satisfying this
documentation requirement. Under the
first option, the qualified facility may
choose to submit documentation that
demonstrates that it has identified
potential hazards associated with the
animal food being produced, is
implementing preventive controls to
address the hazards, and is monitoring
the preventive controls to ensure that
such controls are effective.
Alternatively, under the second option,
the qualified facility may choose to
submit documentation (which may
include licenses, inspection reports,
certificates, permits, credentials,
certification by an appropriate agency
(such as a State department of
agriculture), or other evidence of
oversight), that the facility is in
compliance with State, local, county, or
other applicable non-Federal food safety
law. The second type of required
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documentation relates to whether the
facility satisfies the definition of a
qualified facility.
If a qualified facility does not prepare
documentation demonstrating that it has
identified potential hazards associated
with the animal food being produced, is
implementing preventive controls to
address the hazards, and is monitoring
the preventive controls to ensure that
such controls are effective, it must
provide notification to consumers of
certain facility information by one of
two procedures, depending on whether
an animal food packaging label is
required on the animal food.
Consistent with the statutory
direction of section 418(l) of the FD&C
Act, we proposed the following
requirements for qualified facilities: (1)
Submission of certain documentation
(proposed § 507.7(a)); (2) procedures for
submission of the documentation
(proposed § 507.7(b)); (3) the frequency
of the submissions (proposed
§ 507.7(c)); (4) notification to consumers
in certain circumstances (proposed
§ 507.7(d)); and (5) applicable records
that a qualified facility must maintain
(proposed § 507.7(e)).
In the 2013 proposed preventive
controls rule for animal food, we
tentatively concluded that a certified
statement would be acceptable for the
purposes of satisfying the submission
requirements of proposed § 507.7(a). We
also requested comment on the
efficiency and practicality of submitting
the required documentation using the
existing mechanism for registration of
food facilities, with added features to
enable a facility to identify whether or
not the facility is a qualified facility.
Some comments support one or more
of the proposed requirements without
change. For example, some comments
state that our proposed interpretation of
the statutory term ‘‘business address’’ is
consistent with our use of the term
‘‘business address’’ in our regulations
regarding information that must be
included in a prior notice for imported
food (§ 1.281). Some comments that
support the proposed provisions suggest
alternative or additional regulatory text
or ask us to clarify how we will
interpret the provision.
In this section, we discuss comments
that ask us to clarify the proposed
requirements or that disagree with, or
suggest one or more changes to, the
proposed requirements. We also address
comments discussing our tentative
conclusion regarding the submission of
certified statements to FDA, including
submitting certified statements using
the existing mechanism for registration
of food facilities. After considering these
comments, we have revised the
proposed requirements as shown in
table 7 with editorial and conforming
changes as shown in table 31.
As discussed in Response 76, we have
revised the definition of very small
business to specify that it is based on an
average (of sales plus market value of
animal food held without sale) during
the 3-year period preceding the
applicable calendar year and, as a
companion change, we are explicitly
requiring that a facility determine and
document its status as a qualified
facility on an annual basis (see
§ 507.7(c)(1)).
TABLE 7—REVISIONS TO THE PROPOSED REQUIREMENTS FOR QUALIFIED FACILITIES
Section
Description
Revision
507.7(a) .........................
Documentation to be
submitted.
Procedure for submission.
Frequency of determination and submission.
• Specify that the submitted documentation is an ‘‘attestation.‘‘
• Add ‘‘tribal’’ as an example of applicable non-Federal food safety law.
Update details regarding the electronic and paper submission of a form specific to the attestation requirement.
• New requirement to determine and document status as a qualified facility on an annual
basis no later than July 1 of each calendar year.
• Specify that a facility that begins manufacturing, processing, packing, or holding animal
food after September 17, 2019 must submit the attestation before beginning such operations.
• Specify that a facility must notify FDA of a change in status from ‘‘not a qualified facility’’
to ‘‘qualified facility’’ by July 31 of the applicable calendar year.
• Specify that when the status of a facility changes from ‘‘qualified facility’’ to ‘‘not a qualified facility’’ based on the annual determination, the facility must notify FDA of that change
in status using Form FDA 3942b by July 31 of the applicable calendar year.
• Specify that the required biennial submissions of the attestations must be made during a
timeframe that will coincide with the required biennial updates to facility registration.
When the status of a facility changes from ‘‘qualified facility’’ to ‘‘not a qualified facility,’’ the
facility must comply with subparts C and E no later than December 31 of the applicable
calendar year unless otherwise agreed to by FDA and the facility.
507.7(b) .........................
507.7(c) .........................
507.7(d) .........................
507.7(e) .........................
507.7(f) ..........................
Timeframe for compliance with the requirements of subparts C and E.
Notification to consumers.
Records ......................
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A. Comments on Submission of a
Certification Statement
(Comment 124) Some comments ask
us to clarify the distinction between the
documentation that would be submitted
to FDA and the records that a qualified
facility relies on to support the
submitted documentation.
Some comments agree with our
tentative conclusion to use certified
statements to satisfy the proposed
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Conforming changes associated with the term ‘‘attestation.‘‘
Conforming changes associated with the term ‘‘attestation.‘‘
submission requirements, noting that it
would save time and money and reduce
the paperwork burden on qualified
facilities. Some comments ask us to
revise the proposed requirements to
make this use of certified statements
explicit in the regulatory text.
Other comments disagree with our
tentative conclusion to use certified
statements to satisfy the submission
requirements. These comments focus on
the importance of actual copies of
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documents in determining compliance
with the documentation requirements
and assert that proof of qualification
requires more than a checked box in an
online registration database. Some
comments ask us to require that a
qualified facility affirm that it has the
original documents on file and available
for FDA inspection. Other comments
assert that requiring qualified facilities
to submit copies of the actual
documentation would enable us to
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easily review food safety plans or
inspection reports and to target our
compliance and enforcement activities
to those qualified facilities that pose a
greater risk because of inadequate
prevention measures or deficient
inspections.
(Response 124) We are affirming our
tentative decision that we will not
require a qualified facility to submit to
FDA as part of its attestation the
underlying documentation that
establishes its compliance. We agree
that the underlying records are needed
to determine compliance with the
documentation requirements and that a
qualified facility must retain the
documents it is relying on to support its
attestation and make them available to
us during inspection. We also agree that
the regulatory text needs to be explicit
regarding the required documentation
and that we need to clearly distinguish
between the documentation that would
be submitted to FDA and the records
that a qualified facility relies on to
support the submitted documentation.
Therefore, we have made the following
three revisions to the proposed
regulatory text.
First, we have revised proposed
§ 507.7(a) to specify that the submitted
documentation is an ‘‘attestation.’’
Second, we have revised proposed
§ 507.7(b) to update details regarding
the electronic and paper submission of
a form specific to this attestation
requirement. Third, we have revised
proposed § 507.7(e) (final § 507.7(f)) to
specify that you must maintain those
records relied upon to support the
‘‘attestations’’ that are required by
§ 507.7(a).
We acknowledge that requiring
submission of the actual documentation
would enable us to easily review food
safety plans or inspection reports and to
target our compliance activities based
on information that we see in those food
safety plans or inspection reports.
However, as discussed in Response 245,
we are not requiring that other facilities
submit a ‘‘facility profile’’ that would
allow us to more broadly review food
safety plans and target our compliance
activities based on information that we
see in those food safety plans and will
instead explore other mechanisms to
achieve the goals we described in the
2013 proposed preventive controls rule
for animal food for a facility profile.
B. General Comments on Requirements
That Apply to a Qualified Facility
(Comment 125) Some comments
assert that the proposed requirements
would create a costly burden for
qualified facilities (e.g., registering and
making submissions to FDA) that would
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not be imposed on other types of
exempted facilities. Some of these
comments question whether the
exemption for qualified facilities is
meaningful in light of the significant
burden imposed by the proposed
requirements. Some comments contrast
the proposed requirement for qualified
facilities to submit documentation to
FDA with proposed requirements for all
other facilities to simply establish and
maintain applicable records.
(Response 125) The submission
requirements that we are establishing in
this rule for qualified facilities reflect
the statutory framework for qualified
facilities (section 418(l)(2)(B) of the
FD&C Act). Although the submission
requirements only apply to qualified
facilities, the reporting burden
associated with submission of an
attestation is much lower than the
recordkeeping burden for facilities that
are subject to the requirements for
hazard analysis and risk-based
preventive controls (see section LVIII).
(Comment 126) Some comments ask
us to minimize setting different
standards even though the requirements
reflect express statutory provisions.
(Response 126) These comments
appear to be referring to the statutory
provisions of section 418(n)(3)(C) of the
FD&C Act, which specify that the
regulations we establish to implement
section 418 of the FD&C Act
acknowledge differences in risk and
minimize, as appropriate, the number of
separate standards that apply to separate
foods. We disagree that the statutory
provisions of section 418(n)(3)(C) are
directly relevant to the submission
requirements of this rule for qualified
facilities. The requirements for qualified
facilities, but not other facilities, to
submit documentation to FDA reflect
different regulatory requirements. The
different regulatory requirements are
directed at different facilities, and do
not set separate standards for particular
animal foods. Regardless, even if the
statutory provisions of section
418(n)(3)(C) were relevant to the
submission requirements of qualified
facilities, provisions of this rule that
reflect express statutory provisions
would not conflict with the statutory
direction in section 418(n)(3)(C).
(Comment 127) Some comments
emphasize that the requirements need to
ensure adequate protection of public
health and state that we should
maintain and exercise oversight of
qualified facilities. Some comments ask
that we provide enough specificity so
that qualified facilities know and
understand their food safety
responsibilities towards consumers.
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(Response 127) A facility that satisfies
criteria to be a qualified facility
continues to be responsible to produce
animal food that will not be adulterated
under section 402 of the FD&C Act.
Such a facility is also subject to the
requirements of section 421 of the FD&C
Act regarding frequency of inspection of
all facilities and to the new
administrative tools provided by FSMA,
such as for suspension of registration
(section 415 of the FD&C Act) and for
mandatory recall (section 423 of the
FD&C Act). As discussed in Response
77, we expect that most qualified
facilities will be subject to the CGMP
requirements of subpart B. When they
are inspected, we will be ensuring they
are in compliance with the CGMP
requirements once the applicable
compliance date is reached.
(Comment 128) Some comments ask
which exemption a farm mixed-type
facility should follow if it satisfies
criteria for a qualified facility
(§ 507.5(d)), as well as criteria for a very
small business that only conducts onfarm low-risk activity/animal food
combinations (specified in § 507.5(e)
and (f)) and one comment suggests that
FDA should allow such a facility to
choose which exemption to follow.
(Response 128) We describe these
comments in more detail in Comment
110. A farm mixed-type facility that is
a very small business and that only
conducts the low-risk activity/animal
food combinations listed in § 507.5(e)
and (f) may find it advantageous to
classify itself as a very small business
eligible for the exemption in § 507.5(e)
and (f) (which is not subject to the
requirements in § 507.7) rather than as
a qualified facility (which is subject to
the requirements in § 507.7).
(Comment 129) Some comments
express concern about State access to
the records that a qualified facility
maintains to support its attestations,
particularly when a State would
conduct an inspection for compliance
with part 507 under contract to FDA.
These comments express concern about
the time and resources necessary to
verify the status of a facility as a
qualified facility and note that previous
mechanisms whereby we provide
information to States in advance of
inspection have been slow. These
comments also express concern that if
the state must verify the ‘‘qualified
facility’’ status of all firms, including
those that are not FDA contracts, this
could delay their ability to conduct
timely inspections and increase
inspection time, reducing the number of
inspections conducted.
(Response 129) We are sensitive to the
time required for various inspection
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activities and intend to communicate
with States regarding our expectations
for how to verify whether a facility is a
qualified facility.
(Comment 130) Some comments point
out that the proposed procedures for
submission are silent on the process and
timeframe for our review and approval
of the submitted documentation and ask
us to clarify this process and timeframe.
Other comments ask us to clarify the
consequences to a facility if its
submission is found to be insufficient.
(Response 130) We will not be
approving the submitted attestations.
Instead, we intend to use the
information to determine whether the
facility should be inspected for
compliance with the requirements for
hazard analysis and risk-based
preventive controls, or for compliance
with the requirements for a qualified
facility. During the inspection, we
would ask to see the records that the
facility maintains to support any
submitted attestations.
(Comment 131) Some comments ask
us to clarify whether a foreign facility
would need to submit documentation of
its status as qualified facility. These
comments note that a foreign facility
also would be required to provide
information to an importer and assert
that submitting information to both FDA
and an importer would be a duplication
of effort. These comments ask us to
allow a foreign facility that is a qualified
facility to submit information to either
FDA or the importer, rather than to both
FDA and the importer.
(Response 131) We decline this
request. Documentation submitted to an
importer would not reach FDA and,
thus, could not satisfy the requirements
of this rule. We are requiring
submission of an attestation, on a form
that can be submitted either
electronically or on paper, rather than
submission of the underlying
information.
C. Proposed § 507.7(a)—Documentation
To Be Submitted
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1. Section 507.7(b)(1)—Documentation
That the Facility Is a Qualified Facility
We proposed that a qualified facility
must submit documentation that the
facility is a qualified facility. We also
proposed that for the purpose of
determining whether a facility satisfies
the definition of a qualified facility, the
baseline year for calculating the
adjustment for inflation is 2011. As
discussed in Response 124, we have
revised the provision to specify that the
documentation that must be submitted
is an attestation.
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(Comment 132) Some comments ask
us to clarify the documentation required
to certify that an operation is a qualified
facility. Some comments ask us to
explicitly state that the documentation
must include financial and sales records
of the business and its subsidiaries or
affiliates. Some comments ask us to
clarify the types of records that would
be required to be submitted by foreign
establishments to support the
classification of a foreign establishment
as a ‘‘qualified facility.’’
(Response 132) The submission to
FDA will be an attestation rather than
the records that the qualified facility
relies on to support the attestation;
however, you must maintain those
records relied upon to support the
‘‘attestations’’ (see § 507.7(f)). As
previously discussed, consistent with
section 418(l)(2)(B)(ii) of the FD&C Act,
we intend to issue guidance on the
records that a facility could retain to
demonstrate that it is a qualified facility
(78 FR 64736 at 64767). As discussed in
Response 124, we have revised the
regulatory text to provide for qualified
facilities to submit an attestation that
the facility is in compliance with State,
local, county, tribal, or other applicable
non-Federal food safety law. We intend
to focus on records demonstrating that
a facility is a very small business (i.e.,
financial records demonstrating that a
business averages less than $2,500,000
adjusted for inflation, per year, during
the 3-year period preceding the
applicable calendar year in sales of
animal food plus the market value of
animal food manufactured, processed,
packed, or held without sale (e.g., held
for a fee or supplied to a farm without
sale)) rather than records demonstrating
that the average annual monetary value
of the food manufactured, processed,
packed or held at such facility that is
sold directly to qualified end-users
during a 3-year period exceeded the
average annual monetary value of the
food sold by the facility to all other
purchasers. We expect that financial
records demonstrating that a business is
a very small business will be less
burdensome for a qualified facility to
maintain and require fewer resources for
FDA to review.
During an inspection, we expect the
facility to be able to show us how the
facility is complying with the applicable
food safety regulation (including
relevant licenses, inspection reports,
certificates, permits, credentials, or
certifications), and producing safe
animal food.
(Comment 133) Some comments ask
how the adjustment for inflation will be
calculated and how regulators such as
the states will get this information.
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(Response 133) We intend to use the
Federal calculation for the Gross
Domestic Product price deflator, as
provided by the Bureau of Economic
Analysis, to adjust for inflation. We will
make the inflation-adjusted dollar value
to the baseline very small business
cutoffs (e.g. $2,500,000 in 2011)
available on our Internet site. We will
update the values for the very small
business exemptions and qualifications
annually using this calculation.
2. Proposed § 507.7(a)(2)(i)—First
Option for Documentation: Food Safety
Practices.
We proposed two options for
satisfying the statutory documentation
requirement in section 418(l)(2)(B)(i) of
the FD&C Act. Under the first option
(the food safety practices option), a
qualified facility could submit
documentation demonstrating that it has
identified the potential hazards
associated with the animal food being
produced, is implementing preventive
controls to address the hazards, and is
monitoring the performance of the
preventive controls to ensure that such
controls are effective. As discussed in
Response 124, we have revised the
provision to specify that the submission
is an attestation.
(Comment 134) Some comments
assert that the rule is vague about what
the applicable documentation should
include and how exhaustive it should
be. Some comments ask whether
documentation (such as a food safety
plan) must address all operations at the
establishment or only those that trigger
the registration of the establishment as
a facility. Some comments ask us to
clarify the difference between having
documentation to support food safety
practices and attesting that the facility
has such documentation. Other
comments ask whether a qualified
facility would need to have records
documenting a risk analysis and
monitoring.
(Response 134) If a qualified facility
submits an attestation regarding its food
safety practices, the documentation that
the facility maintains for review during
inspection must specify that the facility
has identified the potential hazards
associated with the animal food being
produced, is implementing preventive
controls to address the hazards, and is
monitoring the performance of the
preventive controls to ensure that such
controls are effective (see
§ 507.7(a)(2)(i)). For example, a qualified
facility that produces raw dog food
might have documentation specifying
that it has determined that Salmonella
is a hazard requiring a preventive
control, describing the process that will
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control Salmonella, describing
sanitation controls to prevent
contamination of raw dog food with
Salmonella, and describing an
environmental monitoring program to
verify that its sanitation controls are
effective. Likewise, a qualified facility
that makes a custom cattle food might
have documentation specifying that it
has determined that metal objects are a
hazard requiring a preventive control
and supporting the use of a magnet to
remove metal objects from the cattle
food, with procedures for monitoring
the magnet’s use if applicable.
As discussed in Response 124, a
qualified facility that chooses the food
safety practices option for complying
with the submission requirements of
this rule will attest to that by checking
a statement on a form. In contrast, a
food safety plan (or other
documentation) that the qualified
facility relies on to support the
attestation will be a record subject to the
recordkeeping requirements of
subpart F.
3. Proposed § 507.7(a)(2)(ii)—Second
Option for Documentation: Compliance
With Other Applicable Non-Federal
Food Safety Law
Under the second option for satisfying
the statutory documentation
requirement, a qualified facility could
submit documentation that it is in
compliance with State, local, county, or
other applicable non-Federal food safety
law, including relevant laws and
regulations of foreign countries. As
discussed in Response 124, we have
revised the provision to specify that the
submission is an attestation. We also
have revised the provision to add
‘‘tribal’’ as an example of applicable
non-Federal food safety law to clarify
for purposes of this rule that a qualified
facility could submit an attestation that
it is in compliance with tribal food
safety law.
(Comment 135) Some comments
object to the proposed provision. These
comments point out that State and local
requirements are inconsistent and assert
that such requirements are not
sufficiently rigorous to substitute for the
FSMA requirement to conduct a hazard
analysis and establish and execute a
documented food safety plan. One
comment asserts that the state laws may
not provide the same level of protection
to consumers.
(Response 135) The provision reflects
the express statutory direction of section
418(l)(2)(B)(i)(II) of the FD&C Act. Most
of these qualified facilities are subject to
the CGMP requirements of subpart B
and a facility that satisfies criteria to be
a qualified facility continues to be
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responsible to produce animal food that
will not be adulterated under section
402 of the FD&C Act.
(Comment 136) Some comments ask
us to specify that a qualified facility
must document compliance with all
applicable non-Federal food safety laws.
One comment asks what evaluation
FDA will conduct of any non-Federal
food safety law before determining that
compliance with such law constitutes
compliance under FSMA for a qualified
facility.
(Response 136) We decline this
request. Section 418(l)(2)(B)(i)(II) of the
FD&C Act refers to apply to compliance
with ‘‘State, local, county, or other
applicable non-Federal food safety law’’
(emphasis added). As discussed in
Response 132, we have revised the
regulatory text to provide for qualified
facilities to submit an attestation that
the facility is in compliance with State,
local, county, or other applicable nonFederal food safety law During an
inspection, we expect the facility to be
able to show us how the facility is
complying with the applicable food
safety regulation (including relevant
licenses, inspection reports, certificates,
permits, credentials, or certifications),
and producing safe animal food.
(Comment 137) Some comments ask
us to provide resources to the States to
implement the proposed provision.
These comments also ask us to develop
and implement a strategic plan to
provide resources (e.g. training,
guidance) to State and local inspection
agencies in advance of the anticipated
increased burden on State and local
inspection programs that will be created
by the provision.
(Response 137) We do not believe that
specific training for State or other
government counterparts is necessary
for the purposes of inspecting a
qualified facility that attested to having
documentation from a non-Federal
regulatory authority. The State or other
government counterpart would merely
examine applicable documentation
(such as a license, inspection report,
certificate, permit, credentials, or
certification by an appropriate agency
(such as a State department of
agriculture)), which is specified in the
provision. After inspecting such
documentation, the State or other
government counterpart would focus on
inspection for compliance with CGMPs.
D. Proposed § 507.7(b)—Procedure for
Submission
We proposed that the documentation
must be submitted to FDA either
electronically or by mail. As discussed
in Response 124, we have revised the
regulatory text to update details
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regarding the electronic and paper
submission of a specific form. We are
developing paper and electronic
versions of Form FDA 3942b, which is
an information collection provision that
is subject to review by OMB under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 to 3520). We intend to make
the paper Form FDA 3942b available in
the near future and invite comments
consistent with procedures for approval
of the form by OMB.
(Comment 138) Some comments
recommend that any interface for
electronic submission of certification
statements post adequate notice of
requirements the facility must meet and
warnings detailing potential penalties
(e.g., for fraudulent submission).
(Response 138) We intend that the
electronic submission system will
operate in a manner similar to the
existing electronic submission system
for registration of food facilities,
including a certification statement
advising the person signing the form
that, under 18 U.S.C. 1001, anyone who
makes a materially false, fictitious, or
fraudulent statement to the U.S.
Government is subject to criminal
penalties. We intend to include a
similar certification statement on paper
forms that will be available for qualified
facilities that choose to submit by paper
rather than through the electronic
system. The electronic and paper
submission forms will focus on the
attestation statements rather than on
other requirements to which the facility
is subject. The Small Entity Compliance
Guide that we will issue in accordance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121) will be better suited
to helping qualified facilities
understand the requirements of the rule
than information presented on a
submission form.
E. Proposed § 507.7(c)—Frequency of
Determination and Submission
We proposed that the documentation
must be: (1) Submitted to FDA initially
within 90 days of the applicable
compliance date and (2) resubmitted at
least every 2 years, or whenever there is
a material change to the information
applicable to determining the status of
a facility.
(Comment 139) Some comments
assert that the proposed timeframe of 90
days to submit the required
documentation would not provide
sufficient time to gather and submit the
required documentation and ask us to
extend the timeframe, e.g., to 120 or 180
days.
(Response 139) We are retaining the
proposed timeframe for the initial
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submission (within 90 days of the
applicable compliance date). The only
documentation that the qualified facility
will need to submit is an attestation,
which does not need to be gathered.
Importantly, however, documentation
supporting the attestation must be
available for inspection by September
17, 2019. As discussed in Response 76,
the compliance date for a facility to
retain records to support its status as a
qualified facility is January 1, 2017. As
a companion change, we are explicitly
requiring that a facility determine and
document its status as a qualified
facility on an annual basis by no later
than July 1of each calendar year (see
§ 507.7(c)(1)).
In addition, we have revised proposed
§ 507.7(c)(1) (which we are finalizing as
§ 507.7(c)(2)(i)(A), (B), and (C)) to
specify the timeframe for the initial
submission for three distinct
circumstances: (A) By December 16,
2019 for a facility that begins
manufacturing, processing, packing, or
holding animal food before September
17, 2019; (B) Before beginning
operations, for a facility that begins
manufacturing, processing, packing or
holding animal food after September 17,
2019; or (C) By July 31 of the applicable
calendar year, when the status of a
facility changes from ‘‘not a qualified
facility’’ to ‘‘qualified facility’’ based on
the annual determination required by
paragraph (c)(1) of this section. See the
discussion in Response 76 regarding the
approach we intend to take in a number
of circumstances that could lead to a
facility having records to support its
status as a qualified facility for fewer
than 3 preceding calendar years.
We have revised the provision to
specify that the required biennial
submissions of the attestations must be
made during a timeframe that will
coincide with the required biennial
updates to facility registration (see
section 102 of FSMA), i.e., during the
period beginning on October 1 and
ending on December 31, beginning in
2020. In determining that 2020 would
be the first year for the required biennial
submissions of the attestations, we first
considered that the first submission of
an attestation would be approximately
December 2019 for qualified facilities
that are operating as of the date of this
final rule (i.e., approximately 90 days
after the date of publication of this rule).
For qualified facilities that do not begin
operations until after December 2019,
the first biennial submission will be
required in a timeframe less than 2
years, but once the qualified facility has
made its first submission the subsequent
biennial submissions will all be at 2year intervals. Coordinating the biennial
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submissions of the required attestations
with the biennial registration will
reduce the cumulative economic impact
on the animal food industry of
complying with two separate
requirements because qualified facilities
that choose to submit electronically will
be able to submit electronically while
accessing the same electronic portal
used for facility registration.
(Comment 140) Some comments ask
us to include an option within the
system to notify us when a facility’s
status as a ‘‘qualified facility’’ changes,
e.g., because its business expands or
changes.
(Response 140) Notifying us when
there is a material change in the
facility’s status from ‘‘qualified facility’’
to ‘‘not a qualified facility’’ is a
requirement rather than an option. We
included this requirement in the
proposed rule, and are establishing it in
this final rule. We made editorial
changes to the provision to make this
clearer.
We also established a series of dates
associated with the facility’s change in
status from ‘‘qualified facility’’ to ‘‘not
a qualified facility.’’ First, we are
specifying that when the status of a
facility changes from ‘‘qualified facility’’
to ‘‘not a qualified facility’’ based on the
required annual determination, the
facility must notify FDA of that change
in status using Form FDA 3942b by July
31 of the applicable calendar year (see
§ 507.7(c)(3)). We have provided the
facility with flexibility to wait until July
1 of a given calendar year to determine
whether its status changes (see
§ 507.7(c)(1)); 30 days is an adequate
timeframe to submit the form notifying
us of the change in status.
Second, we are specifying that when
the status of a facility changes from
‘‘qualified facility’’ to ‘‘not a qualified
facility,’’ the facility must comply with
subparts C and E no later than December
31 of the applicable calendar year
unless otherwise agreed to by FDA and
the facility (see § 507.7(d)). In essence,
this provision can provide a facility
with up to a full year to comply with the
full requirements for hazard analysis
and risk-based preventive controls when
the facility determines its change in
status early in the calendar year. A
facility that does not determine that
change in status until the required date
of July 1 would still have 6 months to
comply with the full requirements for
hazard analysis and risk-based
preventive controls. As we have done in
the case of a qualified exemption being
withdrawn (see § 507.65(d)(1)), we are
providing flexibility for a facility to
comply in an alternative timeframe if
agreed to by FDA and the facility.
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(Comment 141) One comment asks us
to specify that the required attestations
be submitted every 5 years rather than
every 2 years. This comment asserts that
doing so would be consistent with the
statutory direction of section 201 of
FSMA (Targeting of Inspection
Resources) for non-high risk food
facilities. This comment also asserts that
we did not provide specific reasons for
the proposed 2-year timeframe and that
resubmitting the attestations every 2
years will increase cost in time and
labor.
(Response 141) We decline the
request. The rule requires resubmission
whenever there is a material change to
the information that changes the status
of a facility as a qualified facility.
Therefore, if the facility’s sales change
its status, so that it is no longer a
qualified facility, the rule requires that
facility to notify us when its status
changes. (Note that the definition of
very small business established in this
rule bases the threshold dollar amount
for a very small business on an average
(of sales plus the market value of animal
food held without sale) during the 3year period preceding the applicable
calendar year, rather than on annual
sales plus market value. A biennial
submission is adequate to otherwise
require a qualified facility to
affirmatively attest that it continues to
satisfy the criteria for being a qualified
facility. A biennial submission is not
overly burdensome, because a facility
can coordinate its biennial submission
with its biennial update to its facility
registration. The suggested 5-year
submission based on the targeted
inspection frequency for non-high risk
animal food facilities implies that all
qualified facilities produce such animal
foods, which is not the case.
F. Proposed § 507.7(d)—Notification to
Consumers (Final § 507.7(e))
We proposed that a qualified facility
that does not submit documentation of
its food safety practices must provide
notification to consumers as to the name
and complete business address of the
facility where the animal food was
manufactured or processed (including
the street address, or P.O. Box, city,
state, and zip code for domestic
facilities, and comparable full address
information for foreign facilities).
(Comment 142) One comment
recommends that information giving the
location of the manufacturing site, and
not just the corporation contact
information, be provided on the animal
food labels. Other comments state that
specifically for pet food and pet treats,
the manufacturer should be required to
include the co-packer information on
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the product labels to include the copacker’s name, private label contact
information, address, and co-packer’s
contact information (phone and/or
email).
(Response 142) Section 418(l)(7) of
the FD&C Act specifically mandates for
a qualified facility that ‘‘the name and
business address of the facility where
the food was manufactured or
processed,’’ not the corporate contact
information, be included on a label for
a food for which a food packaging label
is required. It does not require co-packer
information. The statute makes no
requirements for non-qualified facilities.
G. Proposed § 507.7(e)—Records (Final
§ 507.7(f))
We proposed that a qualified facility
must maintain those records relied upon
to support the required documentation.
We also proposed that the records that
a qualified facility must maintain would
be subject to the requirements that
would be established in subpart F of
this rule. As discussed in Response 124,
after considering comments we have
revised the rule to specify that a
qualified facility must maintain those
records relied upon to support the
required attestations (rather than the
required documentation).
(Comment 143) Some comments ask
us to explicitly specify that we have
access to documents that establish a
facility as a qualified facility. Some
comments assert that a facility may
reasonably assume that records such as
financial records would not be available
to us because such records are excluded
from the records that we have access to
under the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and as provided by § 1.362.
(Response 143) The rule explicitly
specifies that we have access to records
that are required by the rule (see
§ 507.200). If a facility relies on
financial records to demonstrate its
status as a qualified facility, we will
have access to those financial records.
The exemption referred to by the
comments for financial records (§ 1.362)
is narrowly targeted to records required
by the section 414 recordkeeping
regulations and does not apply to
records required by this preventive
controls rule for animal food.
XII. Subpart A: Comments on Proposed
§ 507.10—Applicability of Part 507 to a
Facility Solely Engaged in the Storage
of Unexposed Packaged Animal Food
We proposed that subpart C would
not apply to a facility solely engaged in
the storage of packaged animal food that
is not exposed to the environment and
does not require time/temperature
control to ensure the safety of the
animal food (proposed § 507.10(a)). We
also proposed that a facility solely
engaged in the storage of packaged
animal food that is not exposed to the
environment but requires time/
temperature control for safety would be
subject to the modified requirements
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that would be established in proposed
§ 507.48 of subpart C (proposed
§ 507.10(b)).
Some comments support these
proposed provisions without change.
For example, one comment expresses
the view that a facility solely engaged in
the storage of packaged animal food that
does not require time/temperature
control for safety does not need to
conduct its own hazard analysis, nor
establish and implement preventive
controls because there would be no
hazards to trigger such activities. Other
comments that support the proposed
provisions ask us to clarify some aspects
of the provisions or to clarify how the
provisions will apply in particular
circumstances. Other comments that
support the proposed provisions ask us
to broaden them.
In the following paragraphs, we
discuss comments that disagree with, or
suggest one or more changes to, the
proposed provisions. After considering
these comments, we have revised the
proposed requirements as shown in
table 8 with editorial and conforming
changes as shown in table 31. A key
conforming change that affects § 507.10
is that it includes an exemption from
the requirements of subpart E, as well as
subpart C. As discussed in section XL,
the final rule establishes the
requirements for a supply-chain
program in subpart E, rather than within
subpart C as proposed.
TABLE 8—REVISIONS TO THE PROPOSED APPLICABILITY OF SUBPART C TO A FACILITY SOLELY ENGAGED IN THE
STORAGE OF UNEXPOSED PACKAGED ANIMAL FOOD
Description
Revision
507.10(b) .........................................
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Section
Applicability of modified requirements in § 507.51 of subpart C.
Clarification that § 507.51 of subpart C only applies to those unexposed packaged animal foods that require time/temperature control
to significantly minimize or prevent the growth of, or toxin production by, pathogens.
(Comment 144) Some comments ask
us to clarify that temperature controls
should be implemented when
determined to be necessary by the
facility or preventive controls qualified
individual. Some comments ask us to
clarify that if a facility stores both TCS
food and non-TCS food (i.e., unexposed
packaged animal food that does not
require time/temperature control for
safety), then the modified requirements
only apply for the portion of the facility
that holds the TCS foods.
(Response 144) We have revised
§ 507.10(b) to clarify that a facility
solely engaged in the storage of
unexposed packaged animal food,
including unexposed packaged animal
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food that requires time/temperature
control to significantly minimize or
prevent the growth of, or toxin
production by, pathogens is subject to
the modified requirements in § 507.51 of
subpart C of this part for any unexposed
packaged food that requires time/
temperature control to significantly
minimize or prevent the growth of, or
toxin production by, pathogens.
(Comment 145) Some comments ask
us to revise the regulatory text to be
explicit that frozen unexposed packaged
food is not a TCS food subject to
modified requirements.
(Response 145) We decline this
request. In the 2013 proposed animal
food preventive controls rule, we
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tentatively concluded that it would be
rare for a frozen animal food to be a TCS
food (78 FR 64736 at 64802), and we
affirm that conclusion in this document.
However, specifying in the regulatory
text that a frozen animal food is not a
TCS food would require us to conclude
that a frozen animal food would ‘‘never’’
(rather than ‘‘rarely’’) be a TCS food,
and we lack information to support
‘‘never.’’
(Comment 146) Some comments ask
us to apply the exemption to storage
areas of facilities that also engage in
food processing activities, e.g., for
distributors that are engaged in limited
food processing, such as blending seeds
to make bird food. These comments
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assert that the intent of the term
‘‘solely’’ is to make clear that a facility
that conducts an activity subject to the
exemption does not escape
responsibility for complying with the
requirements for hazard analysis and
risk-based preventive controls when
conducting activities that are not
exempt.
(Response 146) We disagree with the
comment’s interpretation of the term
‘‘solely.’’ The plain meaning of ‘‘solely’’
is only, completely, entirely; without
another or others; singly; alone (Ref. 24).
The facility described in the comment is
not ‘‘solely’’ engaged in the storage of
unexposed packaged animal food.
Such a facility must conduct a hazard
analysis that addresses all activities
conducted by the facility. The
preventive controls that the facility
would establish and implement would
depend on the facility, the animal food,
and the outcome of the facility’s hazard
analysis and any preventive control
management components associated
with a facility’s preventive controls
would be established as appropriate to
ensure the effectiveness of the
preventive controls, taking into account
the nature of the preventive control and
its role in the facility’s food safety
system. A facility that stores unexposed
packaged animal food that is not a TCS
animal food could, for example,
determine that no preventive controls
and associated management
components would be necessary. A
facility that stores unexposed
refrigerated packaged TCS animal food
could, for example, determine that
preventive controls and management
components patterned after the
modified requirements in § 507.51 are
adequate to address significant hazards
associated with that animal food.
(Comment 147) Some comments ask
us to allow a facility to designate a
storage area as a separate facility for
purposes of compliance with the
requirements for hazard analysis and
risk-based preventive controls. In the
comments’ view, an area solely engaged
in the storage of unexposed packaged
food could fall within the exemption in
§ 507.10 even though other areas would
be subject to the requirements for
hazard analysis and risk-based
preventive controls.
(Response 147) We disagree that a
designated storage area in an
establishment that conducts
manufacturing, processing, or packing
in addition to storage can fall within the
exemption for facilities ‘‘solely engaged
in . . . storage.’’ The statute provides
authority for us to exempt or modify the
requirements for compliance with
respect to ‘‘facilities’’ that are solely
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engaged in the storage of packaged foods
that are not exposed to the environment
(section 418(m) of the FD&C Act). The
statute defines ‘‘facility’’ as a domestic
facility or a foreign facility that is
required to register under section 415 of
the FD&C Act (section 418(o)(2) of the
FD&C Act). The section 415 registration
regulations define facility as ‘‘any
establishment, structure, or structures
under one ownership at one general
physical location . . .’’ The comment’s
interpretation that we could view
‘‘areas’’ of registered facilities to be
‘‘facilities that are solely engaged in the
storage of packaged foods that are not
exposed to the environment’’ is
inconsistent with the statutory and
regulatory framework under sections
415 and 418 of the FD&C Act.
(Comment 148) Some comments ask
us to consider an alternative to the
exemption for unexposed packaged
foods when a facility conducts
manufacturing, processing, packing, or
holding activities in addition to storing
unexposed packaged food. Specifically,
these comments ask us to recognize that
the minimal risks of storing unexposed
packaged foods can be addressed
through a combination of compliance
with the modified requirements for TCS
foods (if applicable) and the CGMPs in
subpart B and state that doing so would
be consistent with our discussion in the
2013 proposed animal food preventive
controls rule.
(Response 148) These comments
appear to suggest the outcome of a
facility’s hazard analysis and food safety
plan for storing unexposed packaged
animal food, i.e., that the only
significant hazards are the potential for
growth of pathogens in refrigerated
unexposed packaged animal foods and
that the preventive controls and
preventive control management
components specified in the modified
requirements for TCS animal food are
adequate to address such hazards. It is
the responsibility of the facility’s
preventive controls qualified individual
to identify the significant hazards
associated with the facility and the
animal food it stores, as well as the
appropriate preventive controls and
preventive control management
components. However, we agree that in
some cases the approach suggested in
these comments would be appropriate.
(Comment 149) Some comments
assert that it is difficult to identify TCS
foods. These comments ask us to work
with industry and professional
organizations to develop guidance on
when the modified requirements apply.
(Response 149) This document does
not include guidance on whether
specific animal foods are TCS foods. We
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will consider including guidance on
animal foods that are TCS foods in the
implementing guidances we are
developing (see Response 1). A facility
solely engaged in storage of unexposed
packaged animal food can work with the
manufacturer of the food to identify TCS
food. Alternatively, such a facility could
simply treat any refrigerated food as a
TCS food.
XIII. Subpart A: Comments on
Proposed § 507.12—Applicability of
Part 507 to the Holding and
Distribution of Human Food ByProducts for Use as Animal Food.
We proposed to add provisions for
human food by-products for use as
animal food. We proposed that the
requirements of this part would not
apply to by-products of human food
production that are packed or held by
that human food facility for distribution
as animal food if: the facility is subject
to and in compliance with subpart B of
part 117 (the CGMPs in the proposed
preventive controls rule for human
food) and in compliance with all other
applicable human food safety
requirements of the FD&C Act and
implementing regulations; and the
facility does not further manufacture or
process the by-products intended for
use as animal food. Proposed § 507.12(b)
would require that once the animal food
was separated from the human food, the
facility would need to comply with
proposed §§ 507.28 and 117.95 of part
117 for the holding and distribution of
that animal food. We also proposed
§ 117.95 be added to the proposed
preventive controls rule for human food
and asked for comment on whether the
requirements should be placed in both
§ 117.95 and § 507.28.
Section 507.12 does not apply to
human food by-products when
contamination or other adulteration has
occurred that is materially related to
food safety. We handle requests for
diversion of these products for animal
food use on a case-by-case basis.
Additional information on diversion of
contaminated or adulterated food for
animal food use is available in
compliance policy guidances (CPG) CPG
Sec. 675.100 ‘‘Diversion of
Contaminated Food for Animal Use’’
and CPG Sec. 675.200 ‘‘Diversion of
Adulterated Food to Acceptable Animal
Feed Use’’ (Refs. 25 and 26). We asked
for comment on whether we should
include regulations for these types of
requests.
Many comments generally support the
concept that certain human food byproducts intended for use as animal
food which do not undergo further
processing by the human food
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manufacturer only need to comply with
proposed § 507.28 for holding and
distribution of human food by-products
for use as animal food. Some of these
comments note that human food byproducts are an important source of
animal food. Other comments agree but
request changes and/or additional
exemptions.
We have modified § 507.12 to clarify
that the requirements of part 507 do not
apply to off-farm packing and holding of
RACs packed or held by a human food
facility for distribution as animal food
provided certain conditions are met. For
off-farm packing and holding of produce
(as defined in part 112 of this chapter),
if the human food facility is subject to
and in compliance with § 117.8 of part
117 of this chapter and in compliance
with all applicable human food safety
requirements of the FD&C Act and
implementing regulations, and the
human food facility does not further
manufacture or process the by-products
intended for use as animal food, then
the requirements of part 507 do not
apply to the by-products.
(Comment 150) Some comments
request that the proposed provisions be
included in both this rule and the final
rule for preventive controls for human
food so that it would be easier for
human food processors to understand
the requirements for human food byproducts intended for use as animal
food. One comment does not support
placing these provisions in both of the
final rules, preferring that all animal
food provisions be in part 507, and that
part 117 should pertain only to human
food.
(Response 150) Section 117.95—
‘‘Holding and distribution of human
food by-products for use as animal
food’’ is established in this rule. Section
117.95 will appear in 21 CFR part 117,
preventive controls for human food. The
by-products holding and distribution
provisions also will appear in § 507.28,
the animal food CGMPs. The
requirements of § 117.95 and § 507.28
are identical and appear in both places
for the convenience of the facilities to
which the provisions would apply.
(Comment 151) Two comments state
it must be clear in the rule that not only
by-products but also products which are
already authorized for food like gelatin
or collagen must be authorized for food
for animals, without further
requirements and additional CGMP
implementation.
(Response 151) We understand this
comment to be stating that a human
food product that also may be used as
an animal food should not be required
to comply with part 507 if it is in
compliance with human food
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requirements. We agree with this
comment. A facility that manufactures
and sells a food just for human
consumption is not subject to part 507,
even if the purchaser of that food may
use it for animal food.
If a facility manufactures, processes,
packs, or holds human food and animal
food, and is subject to subpart C of part
117, it can comply with subpart C of
part 117 for the animal food, but needs
to address any hazards unique to the
animal food that require a preventive
control, if applicable. Except as
provided by § 507.12 for human food
by-products, if a facility is required to
comply with subpart B of part 507 and
also subpart B of part 117 because the
facility manufactures, processes, packs,
or holds human food and animal food,
then the facility may comply with the
requirements in subpart B of part 117,
instead of subpart B of part 507, as to
the manufacturing, processing, packing,
and holding of animal food at that
facility (see the regulatory text for
§ 507.1(d)).
(Comment 152) Some comments
request that facilities regulated by the
United States Department of Agriculture
(USDA) Food Safety and Inspection
Service (FSIS) not be required to comply
with part 507 for animal-derived human
food by-products intended for use as
animal food. Some comments state the
requirements are duplicative and are
unnecessary because FSIS food safety
requirements are already in place, and
that oftentimes the FSIS establishment
is unaware of what purpose or animal
species the purchaser will use the byproduct for as animal food.
(Response 152) Only animal food
facilities that are required to register as
a food facility under section 415 of the
FD&C Act are required to comply with
this rule. Establishments regulated
exclusively throughout by FSIS under
the Federal Meat Inspection Act, the
Poultry Products Inspection Act, or the
Egg Products Inspection Act, i.e.,
establishments handling only meat,
poultry, or certain egg products, are
exempt from registration under section
415 of the FD&C Act (see § 1.226(g) (21
CFR 1.226(g))). Therefore, these
establishments are not subject to this
rule.
(Comment 153) Some comments state
we did not provide support for the
tentative conclusion that animal-derived
by-products carry different risks than
other by-products, and therefore did not
provide a basis for why animal-derived
by-products should be subject to all of
part 507 while other human food byproducts are subject to only § 507.28.
(Response 153) As explained in
Response 152, animal-derived by-
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products from establishments that are
not required to register as food facilities
would not be subject to part 507.
Facilities may be jointly regulated by
FDA and FSIS if they produce some
products that are under FDA
jurisdiction and some that are under
FSIS jurisdiction. Such facilities may be
required to register as a food facility
under section 415 of the FD&C Act.
Examples of facilities jointly regulated
by FDA and FSIS include FSIS
establishments that also process animal
food (such as certain pet food), and
facilities that process meat and nonmeat
products (such as frozen entrees, some
of which contain meat and are regulated
by FSIS, and some of which do not
contain meat but which contain seafood
or vegetables that are regulated by FDA).
FSIS establishments that are required
to register with FDA because they also
process FDA-regulated human food,
must follow §§ 507.28 and 117.95 for
the holding and distribution of their
FDA-regulated human food by-products
for use as animal food, if the
establishments meet the requirements of
§ 507.12(a). FSIS establishments that are
required to register with FDA because
they also process FDA-regulated animal
food must comply with the provisions
in the preventive controls rule for
animal food (part 507).
(Comment 154) Some comments
assert that requiring FSIS-regulated
establishments to comply with part 507
would result in more by-products being
diverted to other disposal methods
which might have an economic or
environmental impact.
(Response 154) We do not agree that
compliance with part 507 will likely
result in substantially less use of human
food by-products as animal food
because it applies only to those
establishments that are required to
register under section 415 of the FD&C
Act. Furthermore, other disposal
methods for these products may be more
cost prohibitive than compliance with
these regulations.
(Comment 155) One comment
requests the wording in proposed
§ 507.12 be revised to explicitly exclude
animal-derived human food by-products
for use as animal food because of
pathogen risk.
(Response 155) Animal-derived
human food by-products have a long
history of use in the animal food
industry. These human food byproducts typically are sold from the
human food facility to an animal food
manufacturer/processor, such as a pet
food manufacturer, that uses the byproducts as an ingredient in a finished
animal food. These manufacturers/
processors are required to comply with
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part 507 and must address any potential
pathogens. Furthermore, 21 CFR
589.2000 prohibits the use of
mammalian protein in the manufacture
of animal food given to ruminant
animals, such as cows, sheep, and goats,
and regulations issued under the Swine
Health Protection Act (7 U.S.C. 3801 et
seq.) are intended to ensure that food
waste containing meat does not contain
active disease organisms that pose a risk
to swine who eat it (see 9 CFR part 166).
(Comment 156) A few comments state
that USDA, not FDA, should issue any
regulations concerning the food safety of
animal-derived by-products intended
for use as animal food.
(Response 156) The FD&C Act gives
FDA certain authority to regulate food,
which includes food for animals. As
explained in section XV of the 2013
proposed preventive controls rule for
animal food, the FD&C Act authorizes
FDA to issue CGMP and preventive
controls regulations to enhance the
safety of animal food, including human
food by-products that are intended for
use as animal food. We decline to
address what USDA’s role in animal
food safety should be as is it out of the
scope of this rulemaking.
(Comment 157) One comment
suggests an alternative approach to
animal-derived human food byproducts. The comment suggests that we
consider a provision that would allow
the purchaser to take legal responsibility
for evaluating and mitigating risk
associated with by-products intended
for use as animal food if both parties
agree.
(Response 157) For facilities subject to
subpart C, the supply-chain program in
subpart E is required when the receiving
facility’s hazard analysis identifies a
hazard requiring a supply-chain-applied
control and the receiving facility’s
manufacturing/processing will not
control the hazard. However, when a
manufacturer/processor identifies a
hazard requiring a preventive control,
but can demonstrate and document that
the hazard will be controlled by an
entity in its distribution chain (e.g., its
customer), then the manufacturer/
processor is not required to implement
a preventive control (see §§ 507.36 and
507.37). For a discussion of these
provisions, see section XXVII. For
facilities exempt from the requirements
of subpart C, we are aware that parties
may enter into purchase contracts that
include specifications or information for
the animal food purchased.
(Comment 158) The comments
support seafood, dietary supplements,
and infant formula by-products
intended for use as animal food without
further processing be subject only to the
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holding and distribution provisions in
proposed § 507.28.
(Response 158) We agree with these
comments. We did not receive
comments indicating by-products from
these human foods have specific
problems if used as animal food.
Facilities that process seafood, dietary
supplements, and infant formula that
meet the requirements of § 507.12(a)
must follow the requirements of
§ 507.28 and § 117.95 for human food
by-products for use as animal food.
(Comment 159) Some comments state
that all human food by-products,
including those further processed,
should only have to comply with the
holding and distribution requirements
in proposed § 507.28. Other comments
support the requirement that human
food by-products which are further
processed should be required to comply
with all of proposed part 507. Some
comments request clarification about
what constitutes further processing.
(Response 159) We decline the
request to exempt human food byproducts that are further processed from
the requirements of part 507 because
following CGMPs for the processing will
help ensure the animal food’s safety and
because processing can introduce
hazards requiring preventive controls.
Further processing includes any
manufacturing/processing as defined in
§ 507.3 and includes activities such as
cooking, freezing, pelleting, and milling.
Some passive activities such as
dewatering by holding a by-product in
a container with a screened bottom
which allows water to escape, or
holding in a perforated container which
allows natural drying to occur are not
considered further processing. Holding
by-products at particular temperature to
facilitate easier transportation of the byproducts is not considered further
processing; however, cooking or
freezing a by-product to prevent
deterioration or adulteration is
considered further processing. Facilities
holding human food by-products for use
as animal food must follow the
requirements of § 507.28.
(Comment 160) Some comments state
we should not include diversion
requests for contaminated or adulterated
human food to animal food in the
regulations; that the information
contained in the guidance documents
should remain in guidance and be
handled on a case-by-case basis.
However, some comments request that
the existing compliance policy
guidances be reviewed and updated and
provide suggested changes.
(Response 160) We have not included
regulations for diversion of
contaminated or adulterated human
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food for animal food use in this final
rule. We will continue to handle
diversion requests on an individual
basis. We will consider reviewing and
revising the current compliance policy
guidances, CPG Sec. 675.100,
‘‘Diversion of Contaminated Food for
Animal Use’’ and CPG Sec. 675.200,
‘‘Diversion of Adulterated Food to
Acceptable Animal Feed Use’’ (Refs. 25
and 26).
(Comment 161) One comment
requests clarification on whether these
provisions would apply to retail outlets
such as grocery stores or bakeries. One
comment asserts that when a pig farmer
gets outdated milk from a dairy
processing bottling plant after the plant
takes it back from grocery stores that the
dairy processor (the human food
manufacturer) would be exempt from
the animal food preventive controls
final rule.
(Response 161) Retail food
establishments such as grocery stores
and bakeries are not required to register
as food facilities (see §§ 1.226(c) and
1.227(b)(11)) and as a result are not
required to comply with part 507.
However, the products they distribute
for animal food must not be adulterated.
If milk has been returned to a
processing plant because it is
contaminated or adulterated, the facility
must follow our compliance policy
guidances for requests to divert human
food for use as animal food (Refs. 25 and
26). If the returned milk is not
contaminated or adulterated, but is
returned for a quality reason, the facility
must follow the holding and
distribution requirements of § 507.28
and § 117.95, but would be exempt from
the other provisions in subpart B and
subpart C of part 507.
(Comment 162) One comment
requests clarification on whether a
facility that is producing human food
by-products intended for animal food
that fall under proposed § 507.12 has to
state in its food safety plan that § 507.12
applies.
(Response 162) If the human food
processor meets the requirements in
§ 507.12(a), the facility only needs to
comply with § 507.28 and § 117.95, for
the holding and distribution of the
human food by-products for use as
animal food. The facility does not need
to include this information in its food
safety plan for the human food, but may
choose to include it so that employees
and other individuals viewing the food
safety plan understand what regulatory
requirements the human food processor
is applying to those human food byproducts intended for animal food.
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XIV. Subpart B: General Comments on
Proposed Subpart B—Current Good
Manufacturing Practice
In the 2014 supplemental proposed
rule we revised the proposed CGMPs to
be more appropriate for the animal food
industry. Following are comments on
the proposed CGMP requirements.
(Comment 163) Some comments state
that the risks for pet food, especially
with respect to pathogens, are different
than the risks for livestock feed, and
therefore FDA should issue two sets of
CGMPs. Some comments say that
CGMPs for pet food should be modeled
after the human food CGMPs because of
the high level of care people provide
and demand for their pets, pets may eat
or sleep with humans, and pet owners
often store pet food close to human
food.
(Response 163) We believe the single
set of CGMPs can serve as baseline
standards for producing safe animal
food across all types of animal food
facilities and animal food. We
considered the diverse needs of industry
and the ultimate goal of animal food
safety as we finalized the CGMP
regulations. We believe the final
requirements are flexible enough to be
applied appropriately in various animal
food production settings. For example,
§ 507.19(b) contains requirements for
the cleaning of animal food-contact
surfaces of equipment and utensils to
protect against contamination of animal
food. We do not specify exactly how
this is to be done (except some
requirements for cleaning with wet
processing of animal food), knowing
that what constitutes adequate cleaning
will depend on the plant and the animal
food. (See Response 182).
As discussed in the 2013 proposed
rule for preventive controls for animal
food, in 2003 we introduced the concept
of the Animal Feed Safety System
(AFSS) which was intended to address
the safety of all animal food at all stages
of production and use. After obtaining
input from the general public, State
regulatory officials, industry,
veterinarians, and consumers, the AFSS
working group began developing a
proposed rule for process controls for
animal food, prior to FSMA, that was
intended to apply to all animal food
(including pet food, livestock feed, and
raw materials and other ingredients) (78
FR 64736 at 64740).
When we revised the proposed
CGMPs in the 2014 supplemental
notice, we not only consulted the
human food CGMPs and their
development history, but also reviewed
the draft AFSS process controls
proposed rule. We also reviewed
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CGMPs developed by organizations
such as the British Standards Institute’s
Publicly Available Specification (PAS)
222 and the Association of American
Feed Control Officials (AAFCO) model
GMPs for feed and feed ingredients
(which are adopted by many states for
regulation of animal food) (Refs. 27 and
28). Both PAS 222 and AAFCO GMPs
apply to pet food and other animal food
such as feed for livestock. Many of the
raw materials and other ingredients
used in making finished animal food are
used by multiple types of animal food
manufacturers producing a variety of
animal food products. It would not be
feasible to enforce different sets of
standards for pet food and livestock feed
in a plant supplying the same
ingredients to a pet food manufacturer
and a livestock feed manufacturer. We
expect our CGMP requirements to be
applied appropriately in all facilities
manufacturing and processing animal
food.
(Comment 164) Some comments say
that CGMP requirements for animal food
in general are not appropriate for some
products used in animal food.
Comments provide examples such as
rendered products, which are thermally
processed before being used as
ingredients in animal food; humic
products because raw mined materials
are low risk; and oilseed products
because they have not been associated
with any significant food safety risks
and are intermediate ingredients that
will undergo a subsequent kill step.
(Response 164) We understand that
some ingredients utilized in the
production of animal food may pose a
low risk. Nevertheless, facilities that are
required to register under section 415 of
the FD&C Act and are suppliers of
ingredients used in animal food will be
required to meet the CGMP
requirements being finalized in this
rule. We believe these CGMPs provide
a great deal of flexibility in establishing
baseline standards for safely
manufacturing, processing, packing, or
holding the wide diversity of
ingredients used in animal food.
(Comment 165) One comment
suggests that a new section be added at
the end of subpart B that would
eliminate the need to comply with the
CGMPs if a facility showed that the
hazard analysis and risk-based
preventive controls required by subpart
C had been properly conducted,
implemented and validated.
(Response 165) We decline this
request. The requested change is
counter to the intent of this regulation,
that the CGMPs in subpart B provide
baseline safety and sanitation standards,
while hazards specific to a facility and
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the animal food it produces are
identified and controlled under subpart
C. We consider CGMPs to be a
prerequisite program important for
effective preventive controls, and
believe that the CGMPs being finalized
in this rule provide enough flexibility
for a facility to use CGMPs to address
certain hazards so they do not become
hazards that would require a preventive
control.
(Comment 166) One comment from a
foreign government says that minimum
requirements for recordkeeping and
traceability, which are recommended in
the CODEX Code of Practice on Good
Animal Feeding, might be appropriate
in subpart B so that they would apply
to establishments exempt from subpart
C.
(Response 166) We agree that
traceability and associated
recordkeeping are important tools for a
facility to use for tracing animal food in
the event of a recall or foodborne illness
outbreak. Recordkeeping requirements
currently exist in the Bioterrorism Act,
and implementing regulations in part 1
subpart J for persons who manufacture,
process, pack, transport, distribute,
receive, hold, or import food in the
United States. In addition, the
responsible party at any food facility
required to register under section 415 of
the FD&C Act (domestic and foreign) is
subject to the RFR requirements under
section 417 of the FD&C Act. Section
417 requires under certain
circumstances that the responsible party
notify the previous source and
subsequent recipient of the article of
reportable food, providing traceability.
(Comment 167) Some comments
request that we use the term
‘‘adulteration’’ instead of
‘‘contamination’’ in subpart B of the
final rule because ‘‘adulteration’’ of food
is the regulatory standard for action,
whereas contamination is currently
undefined. These comments state that
the term contamination should carry a
different meaning than in part 117
because what is considered a
contaminant in human food may differ
from what is considered a contaminant
in animal food.
(Response 167) We decline this
request. Section 402(a)(3) and (4) of the
FD&C Act were added to expand our
bases for initiating enforcement
proceedings against adulterated food,
particularly to allow us to act where a
food has been prepared, packed, or held
under insanitary conditions, whereby it
may have become contaminated. In
other words, a food need not be shown
to contain contaminants to be
adulterated; a showing that the food was
prepared, packed, or held under
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conditions whereby it may become
contaminated is sufficient to prove
adulteration. Thus, the word
‘‘contamination’’ serves a necessary
purpose in the context of adulteration.
The CGMPs in this final rule are
intended to help protect against the
contamination of animal food, so that it
will not become adulterated.
The word ‘‘contamination’’ is used
widely in FDA regulations, including
our Current Good Manufacturing
Practice for Medicated Feeds (21 CFR
part 225), Thermally Processed LowAcid Foods Packaged in Hermetically
Sealed Containers (21 CFR part 113),
and the Current Good Manufacturing
Practice in Manufacturing, Packing, or
Holding Human Food (21 CFR part 110,
and updated and included in the final
rule for preventive controls for human
food, 21 CFR part 117, published
elsewhere in this Federal Register). In
addition, ‘‘contamination’’ is used in
Codex Good Practices for the Feed
Industry and PAS 222 (Ref. 27). Because
of the wide use of the term throughout
current FDA regulations and in
international standards, we conclude
that industry is familiar with the word
‘‘contamination’’ and it is an
appropriate word to use in this final
rule.
We recognize that it may not always
be possible to prevent contamination of
animal food. Therefore, we have
changed the regulatory text throughout
subpart B to stress that the goal of the
regulations is to ‘‘protect against’’ or
‘‘minimize’’ the contamination of
animal food. We recognize that what is
considered contamination of human
food may not be considered
contamination in animal food.
(Comment 168) Some comments
object to the use of the terms ‘‘sanitize’’
and ‘‘sanitation’’ in the CGMPs, saying
that the destruction of microorganisms
is not always necessary in animal food
facilities and therefore ‘‘cleaning’’ or
‘‘housekeeping’’ should be used instead
of ‘‘sanitizing.’’ Some of these
comments also ask that we change the
title of proposed § 507.19 from
‘‘Sanitation’’ to ‘‘Cleaning and
Housekeeping.’’
(Response 168) We decline this
request. We use the term ‘‘sanitation’’ in
a general way that we believe is well
understood by the animal food industry
and does not mean the destruction of
microorganisms. For example, the term
‘‘sanitation’’ is defined in PAS–222 (Ref.
27). When the destruction of vegetative
cells of pathogens and substantial
reduction of numbers of other
undesirable microorganisms is required,
we use the terms ‘‘sanitize’’ or
‘‘sanitizing,’’ not ‘‘sanitation,’’ which is
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consistent with how these terms are
used throughout our current regulations
for human and animal food. The only
requirement for sanitizing in subpart B
is in regards to wet processing (see
regulatory text for § 507.19(b)(2)).
Therefore, we believe that ‘‘sanitation’’
is a word that is commonly understood
by industry and is used in this final rule
in a way that is consistent with how it
is used in our other regulations relating
to human and animal food.
(Comment 169) Some comments
request that we use ‘‘tools’’ instead of
‘‘utensils’’ in the CGMPs to better fit the
terminology used in the animal food
industry.
(Response 169) We decline this
request. We recognize that ‘‘utensil’’ is
not commonly used in the animal food
industry; however, we believe it is well
understood. The term ‘‘utensil’’ is used
in PAS–222 and Codex Good Practices
for the Feed Industry, as well as in the
CGMPs for human food in part 110 and
in the revised CGMPs in the final rule
for preventive controls for human food,
part 117 (Refs. 27 and 29). Further,
because ‘‘tools’’ is broadly used to refer
to such things as construction
equipment, software, educational
material, and even laws and regulations,
we believe it is not a good substitute for
‘‘utensils.’’
(Comment 170) A number of
comments request that wherever we
require measures to protect against
contamination of animal food, animal
food-contact surfaces, and animal foodpackaging materials, that we delete
animal food-contact surfaces and animal
food-packaging materials because the
focus should be solely on the animal
food.
(Response 170) We decline this
request. While the ultimate goal of the
CGMP requirements is to protect against
contamination of animal food, we
believe that protecting animal foodcontact surfaces and animal foodpackaging material from contamination
is a necessary step to achieve this goal
because the surfaces and packaging can
be a source of contamination.
XV. Subpart B: Comments on Proposed
§ 507.14—Personnel
We proposed that plant management
must take all reasonable measures and
precautions to ensure that all persons
working in direct contact with animal
food, animal food-contact surfaces, and
animal food-packaging materials
conform to hygienic practices to the
extent necessary to protect against the
contamination of animal food. We are
finalizing this provision with the
discussed changes in § 507.14(a). We
have changed ‘‘plant’’ to
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‘‘establishment’’ for clarity. We are
finalizing the proposed list of methods
for maintaining cleanliness that were
proposed in § 507.14(a)(1) through (5) in
new § 507.14(b)(1) through (5). We have
added paragraph (b) to read: ‘‘the
methods for conforming to hygienic
practices and maintaining cleanliness
include.’’
(Comment 171) Some comments ask
us to remove ‘‘all’’ because it is too
extreme and prescriptive.
(Response 171) We have revised the
regulatory text to delete ‘‘all’’. We
disagree that the term ‘‘all’’ is too
extreme and prescriptive, but conclude
that the term ‘‘all’’ is not necessary to
communicate the intent of the
requirement.
A. Proposed § 507.14(a)(1)—Personal
Cleanliness (Final § 507.14(b)(1))
We proposed that the methods for
maintaining cleanliness include
maintaining adequate personal
cleanliness. We did not receive
comments specific to this provision and
are finalizing it as proposed.
B. Proposed § 507.14(a)(2)—Hand
Washing (Final § 507.14(b)(2))
We proposed that the methods for
maintaining cleanliness include
washing hands thoroughly in an
adequate hand-washing facility as
necessary and appropriate to prevent
contamination.
(Comment 172) One comment
disagrees with FDA’s decision to revise
the language from the 2013 proposed
rule by removing the parenthetic
statement about sanitizing hands if
necessary to protect against
contamination with undesirable
organisms. The comment recommends
that FDA add a qualifying statement that
if hand washing facilities are not readily
available, the use of hand sanitizers is
permitted.
(Response 172) We decline this
request. We deleted the parenthetic
statement because we did not intend to
require hand sanitizing after hand
washing. We are providing flexibility for
plant management to determine if hand
sanitizing after washing is necessary to
protect against contamination of animal
food with undesirable microorganisms.
We recognize that there may be some
situations where hand washing facilities
are not readily available. The use of
waterless hand cleaners (including hand
sanitizers) may be adequate under these
circumstances.
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C. Proposed § 507.14(a)(3)—Unsecured
Jewelry and Other Objects (Final
§ 507.14(b)(3))
We proposed that personnel be
required to remove or secure jewelry
and other objects that might fall into
animal food, equipment, or containers.
(Comment 173) One comment says
this requirement is unnecessary since
the proposed CGMPs contain numerous
other provisions that require facilities to
protect against the adulteration of
products. The focus placed on jewelry
and other items that may potentially fall
into products is unwarranted due to the
limited risk of such occurrences.
(Response 173) We believe that a
specific provision to protect against
jewelry and other personal items falling
into animal food is appropriate, and is
not redundant to other requirements in
the CGMPs that are intended to protect
against adulteration of animal food.
D. Proposed § 507.14(a)(4)—Storing
Clothing and Personal Belongings (Final
§ 507.14(b)(4))
We proposed requiring personnel to
store clothing and other personal
belongings in areas other than where
animal food is exposed or where
equipment or utensils are cleaned.
(Comment 174) One comment says
that the requirement is not practical or
necessary to ensure the safety of animal
food. The comment states that the
temperature in a facility can be highly
variable, so it would be unreasonable to
require an employee to store clothing
outside of areas where animal food is
exposed.
(Response 174) We understand that
personnel may need layers of clothing
in certain plants that are exposed to
varying temperatures. However, when
clothing is removed, it needs to be
stored away from exposed animal food
so it does not become a source of
contamination. We believe storing
clothing and other personal belongings
in areas other than where animal food
is exposed is a reasonable protection.
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E. Proposed § 507.14(a)(5)—Taking
Other Necessary Precautions (Final
§ 507.14(b)(5))
We proposed that personnel must take
any other necessary precautions to
protect against the contamination of
animal food, animal food-contact
surfaces, or animal food-packaging
materials.
(Comment 175) One comment
requests that we provide examples in a
guidance document for the requirement
to take ‘‘any other necessary precautions
to protect against contamination of
animal food, animal food contact
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surfaces, or animal food packaging
materials.’’
(Response 175) We believe this
provision indicates that the listed
requirements are not meant to be
exhaustive and provides needed
flexibility for the diverse animal food
industry to implement precautions
specific to their operations to protect
against the contamination of animal
food. We will consider providing
examples in any future guidance.
XVI. Subpart B: Comments on Proposed
§ 507.17—Plant and Grounds
A. Proposed § 507.17(a)—Grounds
Surrounding an Animal Food Plant
We proposed that the grounds
surrounding an animal food plant under
the control of the operator must be kept
in a condition that will protect against
the contamination of animal food,
including provisions to keep areas from
being a harborage for pests, maintaining
areas so they are not a source of
contamination, adequately draining
areas, and treating and disposing of
waste so it is not a source of
contamination.
(Comment 176) One comment says
that the term ‘‘surrounding’’ the plant is
too ambiguous, and that we should
specify the distance from a plant that
must be controlled to prevent animal
food contamination.
(Response 176) We decline to specify
a distance from the plant because the
area that could impact plant operations
is highly variable from plant to plant.
We have replaced the word
‘‘surrounding’’ with the word ‘‘around,’’
meaning the grounds of the plant under
control of the plant management that
could impact plant operations.
(Comment 177) Some comments say
that the requirements are highly
prescriptive and should be more
flexible. Other comments state that the
general language that requires the
grounds to be kept in a condition that
will protect against the contamination of
animal food is sufficient and that the
specific requirements should be
recommendations.
(Response 177) The specific
requirements provide the baseline
expectations we have for plants to
maintain their grounds in a way that
does not result in the contamination of
animal food. The specific requirements
are common to most plants and provide
necessary information to the plant
management about what it must do to
comply with this final rule. However,
the requirements do not preclude a
plant from addressing unique
circumstances that could lead to the
contamination of animal food.
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B. Proposed § 507.17(b)(1)—Adequate
Space Between Equipment, Walls, and
Stored Materials
We proposed that the buildings,
structures, fixtures, and other physical
facilities of the plant must be suitable in
size, construction, and design to
facilitate cleaning, maintenance, and
pest control to reduce the potential for
contamination of animal food, animal
food-contract surfaces, and animal foodpackaging materials. We also proposed
that the plant must provide adequate
space between equipment, walls, and
stored materials to permit employees to
perform their duties and to allow
cleaning and maintenance of
equipment.
(Comment 178) Two comments
disagree with this requirement. One
comment says that the focus is on
equipment design and not protecting
against animal food contamination. The
other comment suggests simplifying the
requirement to provide access between
equipment and walls.
(Response 178) We believe protecting
animal food from contamination
requires proper plant design. We
decline the request to change the
requirement by deleting the reference to
stored materials because we do not
agree that stored materials should be
allowed to prevent employees from
performing their duties or inhibit the
cleaning and maintenance of
equipment. We did modify the language
in paragraph (b) to replace ‘‘buildings,
structures, fixtures, and other physical
facilities of the plant’’ with ‘‘the plant’’
because the plant would include its
buildings, structures, fixtures, and
physical facilities.
C. Proposed § 507.17(b)(2)—Dripping
and Condensation
We proposed that the plant must be
constructed in a manner such that drip
or condensate from fixtures, ducts, and
pipes does not serve as a source of
contamination.
(Comment 179) One comment asks
that we allow for facilities to be
‘‘constructed or maintained,’’ rather
than ‘‘constructed’’ only, to ensure that
drip or condensate does not serve as a
source of animal food contamination.
Another comment asks that the
requirement be deleted, since it is
generally not relevant and is redundant
to the opening statement in proposed
paragraph (b). Other comments say that
requirements pertaining to the
construction of buildings and structures
are too prescriptive and should specify
only that the plant be constructed in
such a manner as to protect against
adulteration of animal food.
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(Response 179) We decline the
requests to revise or delete this
requirement. The requirements in (b)(1)
to (5) are some of the specific
requirements that we believe are needed
to meet the general requirement in
paragraph (b) that the plant be designed
and constructed to reduce the potential
for contamination. We believe it is
important to specify that fixtures, ducts,
and pipes be constructed so that they do
not serve as a source of contamination
because condensate and drip may serve
as a source of contamination. As
specified in § 507.20(b)(3), plumbing
must be maintained to avoid being a
source of contamination to animal food.
In addition, as specified in 507.19(a),
the fixtures and physical facilities of the
plant must be kept in good repair to
prevent animal food from becoming
adulterated. This would include
fixtures, ducts, and pipes. Thus, we
agree that one way to manage dripping
and condensation is through
maintenance or repair to the plumbing
or structure, and do not intend that
existing plants must be redesigned or
reconstructed.
D. Proposed § 507.17(b)(3)—Ventilation
We proposed that the plant must
provide adequate ventilation or control
equipment to minimize vapors (for
example, steam) and fumes in areas
where they may contaminate animal
food, and locate and operate fans and
other air-blowing equipment in a
manner that minimizes the potential for
contaminating animal food.
(Comment 180) One comment says
that while steam is a key manufacturing
component, it is unlikely to be a source
of potentially hazardous contaminants.
Several comments state that steam is not
commonly used in animal food
processing, and should not be specified
in the rule, or language stating ‘‘where
appropriate and necessary’’ should be
included in the regulatory text. Other
comments suggest additional alternative
language.
(Response 180) We agree that not all
plants use steam and the phrase ‘‘where
appropriate and necessary’’ provides
that distinction and have added it to the
regulatory text. We also recognize that
animal food facilities commonly rely on
natural ventilation. As a result, we have
added the parenthetical (mechanical or
natural) to the regulatory text to read:
‘‘Provide adequate ventilation
(mechanical or natural) . . .’’
E. Proposed § 507.17(b)(4)—Lighting
We proposed that the plant must
provide adequate lighting in handwashing areas, toilet rooms, areas where
animal food is received, manufactured,
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processed, packed, or held, and areas
where equipment or utensils are
cleaned. We received no comments on
this provision and are finalizing it as
proposed.
F. Proposed § 507.17(b)(5)—Glass
We proposed that the plant must
provide safety-type light bulbs, fixtures,
and skylights, or other glass items
suspended over exposed animal food in
any step of preparation, to protect
against the contamination of animal
food in case of glass breakage. We did
not receive specific comments on this
paragraph. However, for clarity, we have
replaced the term ‘‘safety-type’’ with
‘‘shatter-resistant.’’
G. Proposed § 507.17(b)(6)—Outdoor
Storage
We proposed that animal food stored
outdoors in bulk be protected by any
effective means, including using
protective coverings, controlling areas
over and around the bulk animal food
to eliminate harborages for pests, and
checking on a regular basis for pests and
pest infestation.
(Comment 181) Several comments say
that protecting animal food stored
outdoors is better addressed in proposed
§ 507.19 (Sanitation). One comment says
that at livestock facilities and farms
animal food such as hay, silage, grain,
human food by-products, and other
commodities are commonly stored
outside with no cover. Another
comment requests that the regulation be
revised to recommend rather than
require the provisions.
(Response 181) While we disagree
with the recommendation to move this
requirement to § 507.19 (Sanitation), we
moved it from proposed paragraph (b) to
new paragraph (c) in § 507.17 because
paragraph (b) pertains to buildings and
structures and this requirement is about
animal food stored outside of the
building or structure. We have revised
the regulatory text in paragraph (c)(1) to
read ‘‘Using protective coverings where
necessary and appropriate’’ to account
for the situations that may not require
protective coverings. In addition, we
have added checking for product
condition related to the safety of the
animal food in paragraph (c)(3) to
ensure that if the animal food is not
covered, animal food safety is
maintained. We decline to specify under
what circumstance protective coverage
is required (such as, to protect against
adverse weather conditions) since there
could be several reasons for needing
protective coverage to help protect
against contamination of the animal
food.
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XVII. Subpart B: Comments on
Proposed § 507.19—Sanitation
A. Proposed § 507.19(a)—Buildings
We proposed that buildings,
structures, fixtures, and other physical
facilities of the plant must be kept clean
and in good repair to prevent animal
food from becoming contaminated. We
received no comments on this
provision, however we are replacing
‘‘contaminated’’ with the broader
standard ‘‘adulterated’’ as proposed in
the 2013 proposed preventive controls
rule for animal food.
B. Proposed § 507.19(b)—Cleaning
We proposed that animal food-contact
and non-contact surfaces of utensils and
equipment must be cleaned and
maintained and utensils and equipment
stored as necessary and appropriate to
protect against the contamination of
animal food, animal food-contact
surfaces, or animal food-packaging
materials, and that when necessary,
equipment be disassembled for
thorough cleaning.
(Comment 182) Two comments state
that the proposed provision is too
prescriptive because of the requirement
to disassemble equipment for cleaning
when necessary.
(Response 182) We believe the
language provides flexibility for plants
to prevent contamination of animal food
contact and non-contact surfaces of
utensils and equipment. The language
‘‘when necessary’’ provides the plant
the option whether to disassemble the
equipment for cleaning based on the
manufacturer’s knowledge and
experience of when this cleaning
procedure is necessary to protect against
the contamination of animal food,
animal food-contact surfaces, or animal
food-packaging materials.
C. Proposed § 507.19(b)(1)—Wet
Cleaning
We proposed that when it is necessary
to wet-clean animal food-contact
surfaces used for manufacturing,
processing, packing, or holding lowmoisture animal food, the surfaces must
be thoroughly dried before subsequent
use.
(Comment 183) One comment states
that ‘‘low-moisture animal food’’ is not
defined, so for clarity we should either
define it or replace it with ‘‘safe
moisture level animal food’’ because
‘‘safe moisture level’’ is already defined
in the proposed rule.
(Response 183) We agree that the term
‘‘low-moisture’’ is not well known when
applied to the animal food industry as
a whole and we have removed the term.
We believe that in most cases, animal
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food contact surfaces must be
thoroughly dried after wet cleaning
because the moisture could provide an
environment for growth of undesirable
microorganisms. However, we also
understand that in some situations, for
example in wet processing areas, it
would not be necessary to dry surfaces
thoroughly before subsequent use in
order to protect against contamination.
Therefore, we have inserted ‘‘when
necessary,’’ so that the requirement is
appropriate for all types of animal food
facilities.
(Comment 184) Two comments note
that the proposed rule includes explicit
requirements for wet cleaning, but none
for dry cleaning. One comment suggests
adding language to paragraph (b) for dry
cleaning, including vacuuming or
sweeping. The second comment
suggests adding language for dry
cleaning when used solely for lowmoisture feed ingredients.
(Response 184) We decline these
requests. The regulatory text in
paragraph (b) requires that utensils and
equipment be cleaned and maintained,
but it does not specify the exact
procedures. Adequate cleanout of socalled dry feeds has been an important
CGMP requirement applicable to
medicated feed for more than 40 years
and, as such, some of the animal food
industry is well aware of this practice.
The dry cleaning procedures suggested
in the comments would be allowable
methods of cleaning and maintaining
where appropriate to protect against the
contamination of animal food. We do
not believe additional language is
necessary in the regulatory text for dry
cleaning. The provisions in paragraph
(b)(1) for wet cleaning are in addition to
the more general requirements in
paragraph (b) to help ensure that water
from the wet-cleaning process does not
result in subsequent contamination of
animal food.
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D. Proposed § 507.19(b)(2)—Wet
Processing
We proposed that in wet processing,
when cleaning and sanitizing is
necessary to protect against the
introduction of undesirable
microorganisms into animal food, all
animal food-contact surfaces must be
cleaned and sanitized before use and
after any interruption during which the
animal food-contact surfaces may have
become contaminated.
(Comment 185) One comment says
the proposed requirements for cleaning
in wet processing areas should be more
flexible and suggests the additional
wording ‘‘as necessary to protect against
adulteration of animal food.’’
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(Response 185) We believe this
requirement is sufficiently flexible
because it applies only when necessary
to protect against the introduction of
undesirable microorganisms into animal
food.
E. Proposed § 507.19(c)—Cleaning
Compounds and Sanitizing Agents
We proposed that cleaning
compounds and sanitizing agents must
be safe and adequate under the
conditions of use. We received no
comments on this provision and are
finalizing it as proposed.
F. Proposed § 507.19(d)(1)—Toxic
Materials
We proposed that only certain toxic
materials may be used or stored in a
plant where animal food is
manufactured, processed, or exposed,
i.e., those that are required to maintain
clean and sanitary conditions, those
necessary for use in laboratory testing
procedures, those necessary for plant
and equipment maintenance and
operation, and those necessary for use
in the plant’s operations.
(Comment 186) Some comments say
that the proposed regulation would
require an absolute prohibition of any
potentially toxic materials that are
stored but not used by an animal food
plant. The comments note that animal
food plants that hold and distribute
materials such as fertilizers and
pesticides would either need to
discontinue this practice or construct
new storage buildings, which may be
expensive. Several comments suggest
alternative language to allow toxic
materials to be held and distributed in
a way that would not require significant
physical improvements to the plant.
(Response 186) We agree that it might
be common for an animal food plant to
have toxic materials not identified in
paragraph (d)(1), such as fertilizers or
other non-plant chemicals, as part of its
business inventory. However, we
disagree with the comments that state
the provisions in the rule would require
new investments in storage buildings.
The intent of the provision is to keep
toxic chemical categories not listed in
paragraph (d)(1) out of the plant area so
animal food is not exposed. We revised
the regulatory text to add paragraph
(d)(3), which reads ‘‘Other toxic
materials (such as fertilizers and
pesticides not included in paragraph
(d)(1) of this section) must be stored in
an area of the plant where animal food
is not manufactured, processed, or
exposed.’’ We expect that this will
result in toxic materials not identified in
paragraph (d)(1) being separated from
animal food either by sufficient space or
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a sufficient physical barrier such that
they are not able to contaminate the
animal food. With this clarification, we
do not believe that establishments will
need to make significant investments to
their buildings and structures to comply
with these requirements.
G. Proposed § 507.19(d)(2)—
Identification, Use, and Storage of Toxic
Materials
We proposed that toxic materials
described in paragraph (d)(1) of this
section (for example, cleaning
compounds, sanitizing agents, and
pesticide chemicals) must be identified,
used, and stored in a manner that
protects against the contamination of
animal food, animal food-contact
surfaces, or animal food-packaging
materials.
(Comment 187) A number of
comments object to the use of ‘‘toxic’’ in
proposed paragraph (d)(2). Several
comments suggest that ‘‘cleaning
materials’’ rather than ‘‘toxic cleaning
compounds’’ be used in paragraph (d)(2)
because any substance may be
considered ‘‘toxic’’ if handled or used
inappropriately. One comment asks that
the term ‘‘toxic materials’’ be deleted
and requirements established instead for
the control of substances that are not
approved for use in animal food.
(Response 187) We decline the
request. The term ‘‘toxic’’ is important
to specify that this paragraph applies to
toxic cleaning compounds. The term
‘‘cleaning compounds’’ would be too
general and might include materials that
would not need to be handled as
specified in these requirements to
protect against the contamination of
animal food. For example, water could
be considered a cleaning compound, but
it is not considered toxic at regular use
levels and we would not expect a plant
to treat its use of cleaning water in a
manner consistent with this
requirement. We decline the request to
substitute ‘‘substances that are not
approved for use in animal food’’ for
‘‘toxic materials.’’ Not all animal food
ingredients have been or must be
preapproved by the Agency before being
used to produce animal food.
Additionally, ingredients that have not
been approved by the Agency would not
necessarily be toxic.
H. Proposed § 507.19(e)—Pest Control
We proposed that effective measures
must be taken to exclude pests from the
manufacturing, processing, packing, and
holding areas and to protect against the
contamination of animal food by pests.
The use of insecticides and rodenticides
in the plant is permitted only under
precautions and restrictions that will
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protect against the contamination of
animal food, animal food-contact
surfaces, and animal food-packaging
materials. We received no comments on
this provision. We have replaced the
words ‘‘insecticides and rodenticides’’
with ‘‘pesticides’’ for simplicity and
because we have defined pest as ‘‘any
objectionable animals or insects
including birds, rodents, flies, and
larvae.’’ Thus, pests are not limited to
insects and rodents.
I. Proposed § 507.19(f)—Trash and
Garbage
We proposed that trash and garbage
must be conveyed, stored, and disposed
of in a way that protects against the
contamination of animal food, animal
food-contact surfaces, animal foodpackaging materials, water supplies, and
ground surfaces, and minimizes the
potential for the trash and garbage to
become an attractant and harborage or
breeding place for pests. We received no
comments on this provision; however
we are removing the term ‘‘garbage.’’
(See Response 227).
XVIII. Subpart B: Comments on
Proposed § 507.20—Water Supply and
Plumbing
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A. Proposed § 507.20(a)—Water Supply
(Final § 507.20(a)(1)–(4))
We proposed that the water supply
must be adequate for the operations and
must be derived from a suitable source.
Running water at a suitable temperature,
and under suitable pressure as needed,
must be provided in all areas where
required for the manufacturing or
processing of animal food, for the
cleaning of equipment, utensils, and
animal food-packaging materials, or for
employee hand-washing facilities.
Water that contacts animal food, animal
food-contact surfaces, or animal foodpackaging materials must be safe for its
intended use. Water may be reused for
washing, rinsing, or conveying animal
food if it does not increase the level of
contamination of the animal food.
(Comment 188) One comment
suggests that we develop an
enforcement plan for water quality that
takes into account the intended use of
the animal food being manufactured.
Another comment says that many of the
details contained in this paragraph of
the proposed regulation should be
handled as guidance rather than
regulation.
(Response 188) We believe that the
details contained in this paragraph
should remain requirements because
they are important to helping ensure the
safety of animal food and to provide the
regulated facility with information
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about what is expected of the water
supply for the plant and the animal food
being manufactured, processed, packed
or held. We will consider including
water supply in any future guidance.
(Comment 189) Two comments say
that that the requirements pertaining to
the water supply are overly prescriptive
and we should require only that the
water supply be adequate for the
operations. Two comments suggest that
the requirement about the reuse of water
be reworded to provide more
clarification on the recycling of water
within the plant.
(Response 189) We believe the source
of the water is relevant to ensuring that
animal food is protected from
contamination. We also believe
specifying that water be safe for its
intended use, and that it be provided at
a suitable temperature and pressure
where it is needed for manufacturing,
processing, cleaning, and hand washing
helps protect against animal food
contamination. With respect to reuse of
water, we believe our statement that
water may be reused for washing,
rinsing, or conveying animal food if it
does not increase the level of
contamination of the animal food allows
flexibility for recycling water within the
plant. Additional clarification could
have the unintended effect of reducing
flexibility.
B. Proposed § 507.20(b)—Plumbing
We proposed that plumbing be
designed, installed, and maintained to
carry adequate quantities of water to
required locations throughout the plant;
properly convey sewage and liquid
disposable waste from the plant; avoid
being a source of contamination to
animal food, animal food-contact
surfaces, or animal food-packaging
materials, water supplies, equipment, or
utensils, or creating an unsanitary
condition; provide adequate floor
drainage in all areas where floors are
subject to flooding-type cleaning or
where normal operations release or
discharge water or other liquid waste on
the floor; and ensure there is no
backflow or cross-connections between
piping for water for processing and for
waste water.
(Comment 190) One comment says we
are proposing to establish specific
requirements for plumbing design,
installation, and maintenance that are
not necessary to prevent the
adulteration of animal food, and
suggests deleting the plumbing design
section entirely. Two comments say that
floor drains are not the only way to
remove water or other fluids from floors,
and suggest we allow other options such
as vacuuming, mopping, or fans.
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(Response 190) We decline these
requests. We believe these are basic and
necessary requirements for helping
ensure production of safe animal food.
The regulatory text requires adequate
floor drainage for areas where floors are
subject to flooding-type cleaning or
where normal operations release or
discharge water or other liquid waste on
the floor. Plants that do not perform
these activities as part of their normal
operations would not be expected to
have floor drainage and vacuuming or
mopping may be adequate.
C. Proposed § 507.20(c)—Sewage
We proposed that sewage must be
disposed of through an adequate
sewerage system or through other
adequate means.
(Comment 191) Some comments say
that the requirement to provide an
adequate sewer system is covered by the
requirement in proposed § 507.20(b)(2)
for plumbing and that one of the
requirements should be deleted to
eliminate this redundancy.
(Response 191) The requirement in
paragraph (b)(2) is intended to make
sure the plumbing in the plant is
sufficient to remove sewage and liquid
disposable waste from the points at
which it is generated within the plant,
while the requirement in paragraph (c)
is intended to make sure that the sewage
and liquid disposable waste created by
the plant is delivered to a wastewater
system, such as a sewer or septic
system, which has a capacity adequate
to ensure that this wastewater does not
contaminate the animal food.
D. Proposed § 507.20(d)—Toilet
Facilities
We proposed that each plant must
provide employees with adequate,
readily accessible toilet facilities, and
that the toilet facilities be kept clean
and not be a potential source of
contamination of animal food, animal
food-contact surfaces, or animal foodpackaging materials.
(Comment 192) Some comments
suggest adding ‘‘as appropriate’’ to the
requirement to provide adequate toilet
facilities for plant employees.
(Response 192) We decline this
request. We understand that there may
be an exception where toilet facilities
are not inside a plant, but we believe it
is important that toilet facilities are
available near the plant for employee
use, and the requirement as proposed
provides this flexibility.
E. Proposed § 507.20(e)—Hand-Washing
Facilities
We proposed that each plant must
provide hand-washing facilities
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designed to ensure that an employee’s
hands are not a source of contamination
of animal food, animal food-contact
surfaces, or animal food-packaging
materials.
(Comment 193) Some comments
suggest adding the words ‘‘as
appropriate’’ to the requirement to
provide flexibility for those plants that
may not need hand-washing facilities.
Another comment asks that we add an
option that allows for the use of hand
sanitizing in plants that may not need
hand-washing facilities.
(Response 193) We understand that
there may not be running water in every
plant, but we believe it is important that
hand-washing facilities be available to
employees. We understand that in some
cases hand-washing facilities might
consist of waterless hand cleaners
(including hand sanitizers).
XIX. Subpart B: Comments on Proposed
§ 507.22—Equipment and Utensils
A. Proposed § 507.22(a)(1)—Plant
Equipment and Utensils
We proposed that all plant equipment
and utensils must be designed and of
such material and workmanship to be
adequately cleanable, and must be
properly maintained.
(Comment 194) Some comments
suggest that this be a recommendation
rather than a requirement because it is
too prescriptive and applies to all
equipment in a plant, rather than only
to equipment used in the production of
animal food.
(Response 194) We decline this
request. We believe that all plant
equipment with the potential to
contaminate animal food must be
cleanable and maintained. To clarify
this requirement, we have added
language stating that this requirement
applies to equipment and utensils used
in manufacturing, processing, packing,
and holding animal food, as well as
equipment and utensils that do not
come in contact with animal food but
could still serve as a source of
contamination of animal food.
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B. Proposed § 507.22(a)(2)—Design of
Equipment and Utensils
We proposed that the design,
construction, and use of equipment and
utensils must preclude the
contamination of animal food with
lubricants, fuel, metal fragments,
contaminated water, or any other
contaminants.
(Comment 195) Some comments say
that this requirement is too prescriptive
because equipment and utensils are
designed and constructed by entities
independent of the animal food
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manufacturers/processers. Some
comments also say that we should
clarify that we are not requiring the use
of food-grade lubricants.
(Response 195) We understand that
plants do not normally design and
construct the equipment they use.
However, we believe it is the plant’s
responsibility to select equipment and
utensils that when used will not
adulterate animal food. We have revised
the text to clarify that the presence of
non-food grade lubricants, fuel, metal
fragments, contaminated water, or other
contaminants in animal food may
render it adulterated. We also have
revised the wording for easier reading.
We are not requiring that only food
grade lubricants be used in the plant,
but food grade lubricants must be used
on equipment that comes in contact
with animal food. When a non-food
grade lubricant is used on non-food
contact equipment, it must not
adulterate the animal food. We have
added the term ‘‘non-food grade’’ for
lubricants to clarify this.
C. Proposed § 507.22(a)(3)—Equipment
Installation
We proposed that equipment should
be installed and maintained in such a
way as to facilitate the cleaning of the
equipment and adjacent spaces. This
provision has been revised to be a
requirement, not a recommendation as it
is a requirement, not guidance.
(Comment 196) One comment
suggests that we combine proposed
§§ 507.22(a)(1) and 507.22(a)(3).
(Response 196) We decline this
request. The first provision requires that
equipment be properly designed and
constructed, and the second requires
that it be installed in a way that
facilitates cleaning and maintenance.
We have revised the wording in (a)(3)
for clarity.
D. Proposed § 507.22(a)(4)—Animal
Food Contact Surfaces
We proposed that animal food-contact
surfaces must be made of materials that
withstand the environment of their use
and the action of animal food, and, if
applicable, the action of cleaning
compounds, and sanitizing agents; be
made of nontoxic materials; and
maintained to protect animal food from
being contaminated.
(Comment 197) Some comments ask
us to specify that food-contact surfaces
must be designed to withstand cleaning
procedures.
(Response 197) We have revised the
regulatory text to include cleaning
procedures. For example animal foodcontact surfaces must be designed to
withstand the actions of scrubbing
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utensils that could damage the
equipment.
E. Proposed § 507.22(a)(5)—Non-Animal
Food Contact Equipment (Final
§ 507.22(a)(1))
We proposed that equipment in the
animal food in manufacturing/
processing area, that does not come into
contact with animal food must be
constructed in such a way that it can be
kept in a clean condition.
(Comment 198) One comment says
that this requirement should be deleted
because it is highly prescriptive,
redundant to proposed paragraph (a)(1),
and not performance based or necessary.
Further, the comment states FDA’s focus
should be on whether the area is
adequately cleaned, not on whether
equipment that does not come in
contact with animal food is properly
designed.
(Response 198) We disagree that the
requirement is too prescriptive.
However, we agree that there is some
redundancy between proposed
paragraphs (a)(1) and (a)(5). We have
removed proposed paragraph (a)(5) and
have modified the regulatory text in
paragraph (a)(1) as discussed in section
XIX.A.
F. Proposed § 507.22(b)—System Design
and Construction
We proposed that holding, conveying,
manufacturing, and processing systems,
including gravimetric, pneumatic,
closed, and automated systems, must be
designed, constructed, and maintained
in a way that does not contaminate
animal food.
(Comment 199) Several comments
suggest that this requirement be revised
or deleted to allow plants the flexibility
to maintain their equipment in a
manner that is appropriate for their
facility, and because it is redundant to
proposed § 507.22(a)(1) through (4).
(Response 199) We decline to revise
or eliminate this provision. The
requirements in § 507.22(a) are specific
to individual pieces of equipment. The
requirement in § 507.22(b) is meant to
address entire systems that may contain
multiple pieces of equipment. While an
individual piece of equipment may be
designed, constructed and maintained
so that it protects against the
contamination of animal food, when
that piece of equipment becomes part of
a system, its use in the system must be
in a manner that protects against the
contamination of animal food. (See
Response 167.)
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G. Proposed § 507.22(c)—Monitoring
Cold Storage Temperatures
We proposed that each freezer and
cold storage compartment used to hold
animal food must be fitted with an
accurate temperature-monitoring device.
(Comment 200) Some comments state
requiring monitoring devices for each
compartment goes too far. Facilities
should have flexibility in controlling
temperatures in freezers and cold
storage compartments. One comment
says this requirement should not require
the use of continuous temperaturemonitoring devices.
(Response 200) We believe that a
temperature-measuring device for each
compartment is necessary because the
temperature may be different in each
compartment. We have replaced the
term ‘‘temperature -monitoring device’’
with ‘‘temperature-measuring device’’ as
we do not intend the establishment to
use a continuous monitoring device or
temperature recording device.
H. Proposed § 507.22(d)—Instruments
We proposed that instruments and
controls used for measuring, regulating,
or recording temperatures, pH, aw, or
other conditions that control or prevent
the growth of undesirable
microorganisms in animal food must be
accurate, precise, adequately
maintained, and adequate in number for
their designated uses. We received no
comments on this provision and are
finalizing it as proposed.
I. Proposed § 507.22(e)—Compressed
Air
We proposed that compressed air or
other gases mechanically introduced
into animal food or used to clean animal
food-contact surfaces or equipment
must be used in such a way so animal
food is not contaminated. We received
no comments on this provision and are
finalizing it as proposed with the
revision ‘‘to protect against the
contamination of animal food.’’ (See
Response 167.)
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XX. Subpart B: Comments on Proposed
§ 507.25—Plant Operations
A. Proposed § 507.25(a)(1)—CGMPs
We proposed that plant management
must ensure that all operations in the
manufacturing, processing, packing, and
holding of animal food are conducted in
accordance with the CGMP
requirements of this subpart. We
received no comments on this
provision. We are revising paragraph (a)
to read ‘‘Management of the
establishment must ensure that:’’ based
on the definition of ‘‘plant’’ (see section
VIII.A.23).
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B. Proposed § 507.25(a)(2)—Identifying
Contents of Containers
We proposed that plant management
must ensure that containers holding
animal food, including raw materials,
other ingredients, or rework, accurately
identify the contents.
(Comment 201) Some comments
suggest that we revise the proposed
requirements by clarifying that the
contents of containers, not the
containers themselves, are accurately
identified, and that we clarify that bulk
silos and bins are not required to be
placarded, because this is impractical
and not industry practice.
(Response 201) We agree that the
animal food in the containers is what
must be identified and have clarified the
language in the regulatory text to require
management to ensure animal food,
including raw materials, other
ingredients, or rework is accurately
identified. We recognize that a variety of
systems are used by establishments to
identify animal food within the plant
including labeling, computer systems,
paper records, chalkboards, and other
methods. It is necessary that plant
personnel be able to accurately identify
animal food, including raw materials,
other ingredients, or rework within the
plant so that animal food is not
commingled, substituted, or incorrectly
formulated in a manner that results in
adulterated animal food.
C. Proposed § 507.25(a)(3)—Labeling of
Finished Product (Final § 507.27(b))
We proposed that plant management
must ensure that the labeling for
finished animal food product contains
information and instructions for safely
using the product for the intended
animal species.
(Comment 202) Many comments
suggest that instead of specifying that
labeling for the finished animal food
product contains information and
instructions for safely using the product
for the intended animal species we
specify only that labeling for finished
animal food products conforms to
requirements in existing FDA
regulations. One comment asks that we
clarify that finished product means the
product that the animal receives.
(Response 202) We decline the
request. We do not intend ‘‘finished
animal food product’’ to mean only
product that the animal receives. A
finished animal food product could be
ready-to-eat animal food or it could be
an ingredient or mixture of ingredients
that will be further processed, mixed, or
blended before it is suitable for feeding
to animals.
Labeling containing information and
instructions for safe use is important for
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both the person feeding the animal(s)
and the downstream facilities that may
use an ingredient or mixture of
ingredients to further process, mix, or
blend into an animal food product.
Some animal food products may pose a
food safety concern for some species for
which the food is not intended, or may
pose a food safety concern for an
intended species if not used properly.
For example, the manufacturer of a
copper product might include the use
levels for food for different species or a
labeling statement specifying the
maximum safe level of copper in an
animal food intended for sheep.
We have moved this requirement to
paragraph (b) in § 507.27 ‘‘Holding and
Distribution.’’ We believe that this move
helps to clarify that the labeling is
intended for finished animal food
leaving the plant. We have renumbered
the other requirements in this section
accordingly.
D. Proposed § 507.25(a)(4)—Animal
Food Packaging Material (Final
§ 507.25(a)(3))
We proposed that plant management
must ensure that animal food-packaging
materials are safe and suitable.
(Comment 203) One comment
suggests that instead of requiring that
animal food-packaging materials are safe
and suitable, we require that they are
safe and suitable for the intended use.
(Response 203) We disagree that this
clarification is needed because the
intended use is inherent in the current
wording of this regulation.
E. Proposed § 507.25(a)(5)—
Responsibility for Overall Plant
Cleanliness (Final § 507.25(a)(4))
We proposed that plant management
must ensure that overall cleanliness of
the plant is under the supervision of one
or more competent individuals assigned
responsibility for this function.
(Comment 204) One comment
suggests that we require that the
competent individuals responsible for
overall cleanliness of the plant be
‘‘qualified competent individuals.’’
(Response 204) As discussed in
Response 92, we expect all individuals
who perform activities required under
part 507 to know how to do their jobs;
thus, we are establishing new § 507.4(b),
which specifies that all individuals who
perform activities required under part
507 must be ‘‘qualified individuals’’ as
that term is defined in § 507.3 (i.e., a
person who has the necessary
education, training, and experience to
perform an activity required under part
507). A qualified individual may be, but
is not required to be, an employee of the
establishment.
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F. Proposed § 507.25(a)(6)—
Contamination Precautions (Final
§ 507.25(a)(5))
We proposed that plant management
must ensure that reasonable precautions
are taken so that plant operations do not
contribute to the contamination of
animal food, animal food-contact
surfaces, and animal food packaging
materials. We received no comments on
this provision. We did replace the term
‘‘reasonable’’ with the term ‘‘adequate’’
to be more consistent with the rest of
the regulatory text in subpart B.
G. Proposed § 507.25(a)(7)—Testing
Procedures (Final § 507.25(a)(6))
We proposed that plant management
must ensure that chemical, microbial, or
extraneous-material testing procedures
are used where necessary to identify
sanitation failures or possible animal
food contamination.
(Comment 205) Some comments say
that the need for chemical, microbial, or
extraneous-material testing should be
determined by a facility when
identifying hazards and controls under
subpart C, and therefore it should not be
required under CGMPs. One comment
says that it should be deleted because it
is already addressed under the testing
provisions in subpart C.
(Response 205) The CGMP regulations
in subpart B are intended to establish
baseline requirements that apply to all
plants that manufacture, process, pack,
or hold animal food (and thus are
required to register as food facilities in
accordance with § 415 of the FD&C Act).
Using testing procedures, where
necessary, to identify sanitation failures
or to identify contaminated animal food
may be an important component of
manufacturing, processing, packing, or
holding animal food. This type of
testing may be independent of the
requirements of subpart C, hazard
analysis and risk based preventive
controls, and therefore we have
included it in the CGMP regulations.
The provision provides flexibility for
management to determine when testing
is required by providing that testing be
used ‘‘where necessary.’’
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H. Proposed § 507.25(a)(8)—
Contaminated Product (Final
§ 507.25(a)(7))
We proposed that plant management
must ensure that animal food that has
become contaminated to the extent that
it is adulterated is rejected, disposed of,
or if permissible, treated or processed to
eliminate the adulteration. If disposed
of, it must be done in a manner that
protects against the contamination of
other animal food. Whatever methods
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are used to dispose of adulterated
animal food, the methods should
comply with state and local
requirements.
(Comment 206) One comment
requests that if we require
reconditioning of an animal found to be
adulterated, that we clarify that such a
requirement does not apply to grains
subject to the review inspection
provisions provided for by 7 CFR
800.125 and 800.135.
(Response 206) In most cases, grains
subject to the review inspection
provisions provided for by 7 CFR
800.125 and 800.135 are RACs that are
being held or transported and subpart B
(including § 507.25(a)(7)) would not
apply to the grains (see § 507.5(h)). In
addition this provision only applies to
animal food that has actually been
found to be adulterated. The provisions
provided for by 7 CFR 800.125 and
800.135 are administered by USDA’s
Federal Grain Inspection Service and
relate to their mission of facilitating the
marketing of grains and related
commodities.
I. Proposed § 507.25(a)(9)—Protecting
Against Contamination (Final
§ 507.25(a)(8))
We proposed that plant management
must ensure that all animal food
manufacturing, processing, packing, and
holding is conducted under such
conditions and controls as are necessary
to minimize the potential for the growth
of undesirable microorganisms or for the
contamination of animal food.
(Comment 207) Some comments
suggest that we remove the requirement
to minimize the potential for the growth
of undesirable microorganisms, so that
the requirement would be to minimize
contamination of animal food or
protecting against adulteration of animal
food.
(Response 207) We decline this
request. In addition to other
contaminants, we conclude that it is
important for an establishment to
address undesirable microorganisms
because they are a common source of
contamination (78 FR 64736 at 64747).
J. Proposed § 507.25(b)(1)—Raw
Materials and Ingredients
We proposed that raw materials and
ingredients must be inspected to ensure
that they are suitable for manufacturing/
processing into animal food and
handled under conditions that protect
against contamination and minimize
deterioration. We are revising the phrase
‘‘raw materials and ingredients’’ to read
‘‘raw materials and other ingredients’’ to
make it clear that raw materials are
ingredients.
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(Comment 208) Some comments ask
that we insert ‘‘as appropriate and
necessary’’ into the requirement to
inspect raw materials and ingredients to
ensure that they are suitable for
manufacturing/processing into animal
food. Another comment says that
‘‘minimize deterioration’’ and
‘‘deterioration’’ are highly subjective
and should be deleted.
(Response 208) We decline the
requests. However, we have revised the
regulatory text by replacing ‘‘inspected’’
with ‘‘examined.’’ We believe that the
use of the word ‘‘examined’’ provides
more clarity for the animal food
industry because the term ‘‘inspected’’
often implies a regulatory activity. We
believe such an examination is
necessary to protect against
contamination of animal food. An
examination of raw materials and other
ingredients may include basic activities
such as a simple visual examination of
the product (e.g., looking for broken
bags), or performing a chemical or
microbial analysis. Deterioration of
animal food includes the loss of
palatability or nutritive value typically
associated with the animal food and we
believe this could be a safety concern
because animals are often fed the same
food containing the same ingredients for
prolonged periods of time. As a result,
food refusal or consumption of animal
food containing fewer nutrients than the
animal food is expected to provide may
result in poor animal productivity or
health issues. Furthermore,
deterioration can indicate that the
animal food has been held under
conditions that would also support the
growth of undesirable microorganisms.
K. Proposed § 507.25(b)(1)(i)—Shipping
Containers
We proposed that shipping containers
(for example, totes, drums, and tubs)
and bulk vehicles holding raw materials
and other ingredients must be inspected
upon receipt to determine whether
contamination or deterioration of
animal food has occurred.
(Comment 209) Some comments say
that inspection of shipping containers
should be as appropriate and necessary,
or at a frequency appropriate and
necessary.
(Response 209) We decline this
request. We have revised the regulatory
text by replacing ‘‘inspected’’ with
‘‘examined.’’ We believe this change
better conveys our intent that incoming
containers consistently be checked to
make sure there is no gross visible
contamination or deterioration of
animal food.
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L. Proposed § 507.25(b)(1)(ii)—Raw
Materials
We proposed that raw materials must
be cleaned as necessary to minimize soil
or other contamination.
(Comment 210) Many comments say
that it is not always necessary to
minimize soil contamination of raw
materials because livestock routinely
ingest soil when consuming pasture
plants, hay, and other feeds without
adverse consequences.
Recommendations are to delete
reference to soil or else insert ‘‘as
appropriate.’’
(Response 210) We agree. We have
revised the regulatory text to remove the
words ‘‘soil or other’’ from the
requirement.
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M. Proposed § 507.25(b)(1)(iii)—Raw
Materials
We proposed that raw materials and
ingredients must be stored under
conditions that will protect against
contamination and deterioration.
(Comment 211) One comment
suggests that the requirement that raw
materials be stored under conditions
that will protect against contamination
and deterioration be qualified to say
‘‘unreasonable contamination’’ and
‘‘excessive deterioration’’ to be more
appropriate for raw materials that will
be rendered. One comment asks that we
delete ‘‘and deterioration.’’ Another
comment suggests that a new section be
added to require that air flow be
controlled so that contamination does
not spread from the raw material areas
into the finished product areas of the
plant.
(Response 211) We believe the rule as
proposed is clear, and that the qualifiers
suggested do not help reduce
subjectivity and may create confusion
about what is considered unreasonable
or excessive. We decline to add a
requirement that specifically addresses
air flow, because ventilation is
addressed in § 507.17(b)(3). Also, the
broad language requires that raw
materials and other ingredients must be
stored under conditions that will protect
against contamination, which would
include protection from airborne
contaminants. We have determined,
however, that it is logical from a food
safety standpoint to include rework in
this provision. Therefore, we have
incorporated proposed § 507.25(b)(3)
into this requirement.
N. Proposed § 507.25(b)(2)—Raw
Materials Susceptible to Mycotoxins
We proposed that raw materials and
ingredients susceptible to
contamination with mycotoxins or other
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natural toxins must be evaluated and
used in a manner that does not result in
animal food that can cause injury or
illness to animals or humans.
(Comment 212) Several comments
suggest that we eliminate this
requirement because this activity
belongs in subpart C, not subpart B.
Other comments say that the
requirement could be interpreted to
mean that every load of incoming cereal
grains must be evaluated for
mycotoxins, which would not always be
necessary. Other suggestions are to
remove ‘‘evaluated’’ from the
requirement, leaving only the
requirement that raw materials and
ingredients susceptible to mycotoxin
contamination be used in a manner that
does not result in harm to humans or
animals.
(Response 212) We are locating
requirements that are common to most
establishments and plants and serve as
a baseline for animal food safety in
subpart B, current good manufacturing
practice. Also, we do not intend that
every load of grain received must be
tested before it can be used. We intend
for ‘‘evaluation’’ to be broad and flexible
enough to consider any information that
allows the plant to use the raw materials
and other ingredients in a manner that
does not result in harm to humans or
animals. For example, an evaluation
could be based on a general review of
the weather conditions during the
growing season and whether it could
result in mycotoxins.
(Comment 213) One comment
disagrees with our decision in the 2014
supplemental proposed rule to remove a
requirement in § 507.25(b)(2) of the
2013 proposed rule for preventive
controls for animal food that raw
materials and ingredients not contain
microorganisms injurious to human or
animal health. This comment says that
we should have modified the regulatory
text to require that raw materials that
are expected to contain levels of
microorganisms that may be injurious to
animal or human health, such as
materials to be rendered, be stored and
handled in a way that prevents
contaminating the facility and finished
product, and that the materials be
treated (e.g., heat treated) during
manufacturing operations so that they
no longer contain levels that would
cause the product to be adulterated.
(Response 213) Incoming raw
materials and other ingredients may
contain microorganisms injurious to
human or animal health. As we stated
in the 2014 supplemental notice for
animal food, we proposed to remove
this requirement because we did not
intend that incoming raw materials and
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other ingredients must be tested for
pathogens. Instead, we have included
requirements that are meant to
minimize the growth of undesirable
microorganisms, and protect animal
food from the contamination with
undesirable microorganisms from raw
materials and other ingredients,
including those that may be injurious to
human or animal health. We believe
these requirements are sufficient to help
ensure the safety of animal food.
O. Proposed § 507.25(b)(3)—Raw
Materials and Rework (Final
§ 507.25(b)(1)(iii))
We proposed that raw materials and
ingredients and all rework must be held
in containers designed and constructed
in a way that protects against
contamination, and must be held under
conditions, e.g., appropriate
temperature and relative humidity, that
will minimize the potential for growth
of undesirable microorganisms and in a
manner that prevents the animal food
from becoming adulterated.
(Comment 214) Some comments say
that requiring that rework be held under
conditions that will minimize the
potential for growth of undesirable
microorganisms is too prescriptive, and
suggest that the requirement be
modified to require that all rework must
be held in a manner that prevents the
animal food from becoming adulterated.
Some comments say that this
requirement should be addressed in
subpart C rather than subpart B.
(Response 214).We disagree that the
requirement should be addressed in
subpart C instead of subpart B because
we consider this to be a baseline
requirement that should apply to all
establishments that manufacture,
process, pack, or hold animal food.
However, we have decided that
proposed paragraph (b)(3) contains
requirements that are similar to
proposed § 507.25(b)(1)(iii). We have
moved this provision and included it in
paragraph (b)(1)(iii) in the final rule.
P. Proposed § 507.25(b)(4)—Frozen Raw
Materials (Final § 507.25(b)(3))
We proposed that raw materials and
ingredients, if frozen, must be kept
frozen. If thawing is required prior to
use, it must be done in a manner that
minimizes the potential for the growth
of undesirable microorganisms.
(Comment 215) One comment says
that the requirement to keep frozen raw
materials frozen or thaw them in a
manner that minimizes the potential for
the growth of undesirable
microorganisms is redundant to other
requirements in § 507.25(b)(1) and
therefore should be deleted.
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(Response 215) We decline this
request. The requirements in
§ 507.25(b)(1) and 507.25(b)(1)(iii)
address raw material and other
ingredient inspection, storage and
handling in general. This requirement
speaks specifically to the storage and
handling of frozen raw materials. We
believe it is important for those
establishments that use frozen raw
material to thaw that material safely to
minimize the potential for the growth of
undesirable microorganisms during the
thawing process.
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Q. Proposed § 507.25(c)(1)—
Appropriate Conditions for Animal
Food
We proposed that animal food must
be maintained under conditions, e.g.,
appropriate temperature and relative
humidity, that will minimize the
potential for growth of undesirable
microorganisms and prevent the animal
food from becoming adulterated during
manufacturing, processing, packing, and
holding.
(Comment 216) Some comments say
that the requirement to hold and
manufacture products at a temperatures
and relative humidity that will
minimize the potential for growth of
undesirable microorganisms should be
deleted because it is not relevant to
most animal food facilities. With this
deletion, the requirement would be that
animal food be maintained under
conditions that would prevent the
animal food from becoming adulterated
during manufacturing, processing,
packing, and holding.
(Response 216) Temperature and
relative humidity are examples of
conditions and may not apply to all
plants and animal food. This
requirement is important for animal
food safety in plants that produce
animal food that must be handled under
specific processing, packing or holding
conditions to prevent the growth of
undesirable microorganisms and
adulteration.
R. Proposed § 507.25(c)(2)—Control of
Undesirable Microorganisms
We proposed that measures taken
during manufacturing, processing,
packing, and holding of animal food to
significantly minimize or prevent the
growth of undesirable microorganisms
(for example, heat treating, freezing,
refrigerating, irradiating, controlling pH,
or controlling aw) must be adequate to
prevent adulteration of animal food.
(Comment 217) Most of the comments
say that measures to significantly
minimize or prevent the growth of
undesirable microorganisms should be
addressed under subpart C, and that this
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requirement should be removed from
the CGMPs. One comment recommends
deleting only the examples of measures
that might be taken. Another comment
recommends deleting the term
‘‘significantly’’ as this term is not
defined and is difficult to quantify.
(Response 217) We disagree that the
requirement should be addressed in
subpart C instead of subpart B. We
consider controlling undesirable
microorganisms to be a baseline
requirement that should apply to all
establishments that manufacture,
process, pack, or hold animal food. We
also decline the request to remove the
examples of measures that can be used
to significantly minimize or prevent the
growth of undesirable microorganisms
because they are examples of practical
solutions already used by industry. We
decline to delete the term
‘‘significantly.’’ The term ‘‘significantly
minimize’’ is defined in § 507.3 and
means to reduce to an acceptable level,
including to eliminate.
S. Proposed § 507.25(c)(3)—Work-inProcess and Rework
We proposed that work-in-process
and rework must be handled in such a
way that it is protected against
contamination and the growth of
undesirable microorganisms.
(Comment 218) Some comments
request that we delete ‘‘and the growth
of undesirable microorganisms’’ and
require only that work-in-process and
rework be handled in such a way that
it is protected against adulteration.
(Response 218) We decline this
request. Because undesirable
microorganisms are a common source of
contamination of animal food, including
work-in-process and rework, we have
decided to specify that establishments
must protect against the growth of
undesirable microorganisms, as well as
other contamination.
T. Proposed § 507.25(c)(4)—Processing
Steps
We proposed that steps such as
cutting, drying, defatting, grinding,
mixing, extruding, pelleting, and
cooling, must be performed in a way
that protects against the contamination
of animal food.
(Comment 219) One comment
suggests that we revise the requirement
to say that steps be performed in a way
that protects against animal food
adulteration rather than protects against
animal food contamination. Another
comment suggests that the requirement
be deleted because it is redundant to
other requirements in the proposed rule.
(Response 219) As discussed in
Response 167, we believe contamination
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is the better word to use in this context.
These specific requirements provide a
level of detail that we believe is
important because these activities are
common in the animal food industry
and can contribute to the contamination
of animal food. We believe that this
requirement for these activities is not
redundant to other requirements in this
final rule.
U. Proposed § 507.25(c)(5)—Processing
Operations
We proposed that filling, assembling,
packaging, and other operations must be
performed in such a way that protects
against the contamination of animal
food and the growth of undesirable
microorganisms.
(Comment 220) One comment
requests that we delete ‘‘and the growth
of undesirable microorganisms’’ and
require only that operations be
performed in such a way that the animal
food is protected against adulteration.
Another comment suggests that the
requirement be deleted because it is
redundant, but does not identify the
redundant section.
(Response 220) As discussed in
Response 167, we believe contamination
is the better word to use in this context.
These specific requirements, including
the requirement for the protection
against the growth of undesirable
microorganisms, provide a level of
detail that we believe is important
because these activities are common in
the animal food industry and can
contribute to the contamination of
animal food. We believe that these
requirements for these activities are not
redundant with other requirements in
this final rule.
V. Proposed § 507.25(c)(6)—Controlling
Water Activity (aw)
We proposed that animal food that
relies on the control of water activity for
preventing the growth of undesirable
microorganisms must be processed to
and maintained at a safe moisture level.
(Comment 221) Some comments
request that we delete the requirement
because controlling water activity
belongs in subpart C, not in the CGMP
regulations. Another comment says that
controlling moisture level is not
sufficient and the requirement should
be revised to require that animal food
that relies on the control of water
activity for preventing the growth of
undesirable microorganisms be
processed to and maintained at a
suitable water activity, not a safe
moisture level. We also received
comments asserting that water activity
may not be the only factor responsible
for preventing the growth of undesirable
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microorganisms in dry products and
that we should modify the regulatory
text to take into account other
synergistic barriers for microbial growth
and toxin formation.
(Response 221) We disagree that
controlling water activity belongs in
subpart C. While not all animal food
establishments rely on the control of
water activity for preventing the growth
of undesirable microorganisms in their
animal food, we have determined it is
important to have this requirement in
CGMP regulations for those
establishments that do, considering the
potential public health significance of
undesirable microorganisms. We agree
that the term ‘‘safe water activity level’’
is more commonly understood by the
animal food industry than ‘‘safe
moisture level’’ and we have revised the
regulatory text accordingly. We agree
with the comment that water activity
may not be the only factor responsible
for preventing growth of undesirable
microorganisms in certain animal food
and have revised the regulatory text to
clarify that such products rely
‘‘principally’’ on the control of water
activity.
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W. Proposed § 507.25(c)(7)—Controlling
pH
We proposed that animal food that
relies principally on the control of pH
for preventing the growth of undesirable
microorganisms must be monitored and
maintained at the appropriate pH.
(Comment 222) Some comments
request that we delete this proposed
requirement because controlling pH
belongs in subpart C, not in subpart B.
One comment also says that it is too
prescriptive and duplicative of
protections against adulteration in other
proposed sections of subpart B.
(Response 222) We decline the
request. While not all animal food
establishments principally rely on the
control of pH for preventing the growth
of undesirable microorganisms in their
animal food, we have determined it is
important to have this requirement in
the CGMP regulations for those
establishments that do, considering the
potential public health significance of
undesirable microorganisms.
X. Proposed § 507.25(c)(8)—Ice
We proposed that when ice is used in
contact with animal food, it must be
made from water that is safe and must
be used only if it has been manufactured
in accordance with current good
manufacturing practice as outlined in
this subpart.
(Comment 223) One comment
suggests that this requirement be
deleted because ice is rarely used in the
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manufacturing/processing of animal
food.
(Response 223) We decline this
request. We have established this
requirement to help ensure that when
ice is used for the manufacture of
animal food, the ice is made from water
that is safe so that it does not
contaminate the animal food it contacts.
XXI. Subpart B: Comments on Proposed
§ 507.27—Holding and Distribution
A. Proposed § 507.27(a)—Holding and
Distribution
We proposed that animal food held
for distribution must be held under
conditions that will protect against
contamination and minimize
deterioration.
(Comment 224) A few comments
request that we remove ‘‘minimize
deterioration’’ from this requirement.
These comments say that although
deterioration may lead to animals
refusing food, an animal’s refusal of
food does not necessarily mean that the
food has deteriorated. The comments
suggest that we instead use the phrase
‘‘ensure product integrity throughout
the intended shelf life,’’ or that we
clarify the definition of deterioration if
we do not remove it.
(Response 224) We decline this
request. We believe it is important that
animal food be held and distributed in
manner that does not lead to
deterioration. Deterioration of animal
food includes the loss of palatability or
nutritive value typically associated with
the animal food and we believe this
could be a safety concern because
animals are often fed the same food
containing the same ingredients for
prolonged periods of time. As a result,
food refusal or consumption of animal
food containing fewer nutrients than the
animal food is expected to provide may
result in poor animal productivity or
health issues. Furthermore,
deterioration can indicate that the
animal food has been held under
conditions that would also support the
growth of undesirable microorganisms.
B. Proposed § 507.27(a)(1)—Containers
We proposed that containers used for
holding animal food for distribution
must be designed, constructed of
appropriate material, cleaned, and
maintained to prevent contamination of
animal food.
(Comment 225) A few comments
request that the terms ‘‘designed’’ and
‘‘constructed of appropriate material,’’
which may have different
interpretations, be replaced by ‘‘fit for
purpose’’ a term recognized by the
animal food industry.
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(Response 225) We decline the
request. We believe the terms
‘‘designed’’ and ‘‘constructed of
appropriate material’’ are well
understood by the animal food industry
and ‘‘fit for purpose’’ does not improve
clarity.
(Comment 226) A few comments note
containers used to hold animal food
may include bins, totes or other
intermediate storage containers, each of
which may require differing levels and
frequency of cleaning. Some of these
comments ask that we add the phrase
‘‘where necessary’’ when discussing
cleaning to provide flexibility.
(Response 226) We agree that
containers used to hold animal food will
require different cleaning methods and
frequency of cleaning. These differences
may result from the types of containers
used, the amount and type of animal
food held, the frequency at which
containers are reused, as well as other
factors. As a result, we agree that it is
appropriate to include language that
indicates that different methods and
frequencies of cleaning may be
appropriate to protect against
contamination of the animal food and
we have revised the regulatory text to
add ‘‘as necessary’’ after cleaned.
C. Proposed § 507.27(a)(2)—Protection
From Contamination
We proposed that animal food held
for distribution must be held in a way
that prevents contamination from
sources such as trash and garbage.
(Comment 227) A few comments
request that the phrase ‘‘from sources
such as trash and garbage’’ be deleted.
A few comments request that the term
‘‘garbage’’ not be used because some
products that may be considered
garbage may actually be suitable for use
as animal food. Some of these comments
suggested alternative language.
(Response 227) We agree in part with
this comment. The mistaken inclusion
of trash or garbage into animal food
could be a potential source of
contamination. The terms ‘‘trash’’ and
‘‘garbage’’ are intended in their general
sense and refer to items that are not
suitable for animal food, or are not
intended for animal food. However,
under the Swine Health Protection Act,
‘‘garbage’’ as defined by the act is
prohibited for use as food for swine,
unless it is treated to kill disease
organisms. For this reason, and because
the terms can be considered synonyms,
we are removing the term ‘‘garbage’’
throughout subpart B to avoid
confusion.
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D. Proposed § 507.27(a)(3)—Labeling of
Animal Food Held for Distribution
(Final § 507.27(b))
We proposed that labeling identifying
the product by the common or usual
name must be affixed to or accompany
the animal food.
(Comment 228) Some comments
support the labeling requirement
because accurate identification of
animal food throughout the distribution
chain is an important food safety step
and loss of identity can have serious
animal and human health implications.
One comment suggests that this
requirement be revised to specify that
the proposed labeling be required
during holding and distribution of both
packaged animal food and bulk animal
food. One comment says that FDA’s
primary interest should be
identification, not labeling, because
labeling for animal food being held for
distribution in bulk is impractical. The
comment also notes that plants may use
a central computer system or other
method to identify animal food location.
A few comments suggest that we should
require that animal food held for
distribution be labeled as required by
regulations for finished products.
(Response 228) We agree that animal
food may be identified in the plant
through methods other than labeling.
We expect that while animal food is
being processed in the plant that the
animal food is accurately identified as
required in § 507.25(a)(2) of this final
rule.
We have moved the requirement that
labeling must include information and
instructions for safely using the animal
food product for the intended animal
species from proposed § 507.25(a)(3)
‘‘Plant operations’’ in the 2014
supplemental proposed rule to
§ 507.27(b) of ‘‘Holding and
distribution’’ to clarify that this labeling
information must be included when the
product is ready for distribution. We
think that placing the labeling
requirements for animal food products
ready for distribution under ‘‘Holding
and distribution’’ will help reduce
confusion and make these requirements
for labeling for distribution easier to
find in the final rule. Labeling that
meets applicable FDA labeling
regulations must accompany or be
affixed to the animal food and that the
labeling must include, when applicable,
information and instructions for safely
using the product for the intended
animal species. We have added the
clarification that it is ‘‘when
applicable,’’ understanding that not all
animal food product will need
information on its safe use. We have
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deleted the requirement that labeling
that identifies the product by the
common or usual name must be affixed
to or accompany the animal food in this
section because it is already covered by
current FDA regulations.
E. Proposed § 507.27(b)—Shipping
Containers (Final § 507.27(c))
We proposed that shipping containers
(for example, totes, drums, and tubs)
and bulk vehicles used to distribute
animal food must be inspected prior to
use to ensure the container or vehicle
will not contaminate the animal food.
(Comment 229) Some comments state
that the requirement to inspect shipping
containers is not practical because
containers are frequently reused without
intervening cleaning or because the
animal food is distributed in dedicated
containers or vehicles. One comment
says that it is pointless to inspect the
containers when the product being
distributed may be decayed and may be
dumped on the ground for the animals
to eat. Other comments state that
sometimes nobody is available to
inspect the vehicle when third-party
transportation is used and that thirdparty transportation vehicles may
already contain animal food or byproducts because they are used to pick
up from several facilities. Some
comments say that contractual
provisions specify how third-party
shipping container may be used, and
therefore inspection prior to each load
would not be necessary to manage this
risk.
(Response 229) Though we disagree
with the comments, we are revising the
regulatory text in §§ 507.27 and 507.28
to replace the word ‘‘inspected’’ with
‘‘examined’’. We believe that the use of
the word ‘‘examined’’ provides more
clarity for the animal food industry
because the term ‘‘inspected’’ often
implies a regulatory activity. This does
not mean that the shipping container
must be cleaned prior to each use. The
plant or facility is responsible for
examining shipping containers and bulk
vehicles that it uses to transport the
animal food (e.g., the facility transports
the animal food, or arranges with a
third-party to distribute the animal food
to the facility’s customer). We expect
the plant or facility personnel involved
in the process of loading the product
into the shipping container or vehicle to
be aware of the condition of the
shipping container or vehicle, and
consider whether its condition would
contaminate the animal food. This
examination could include viewing the
shipping container or vehicle to observe
whether there are any unusual residues
in it that may contaminate the animal
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food, or it could be simply knowing
what the shipping container or vehicle
had previously been used for and
because of that, whether the container
needed to be cleaned prior to use. We
do not expect a plant or facility to
examine the shipping container or bulk
vehicle when a customer transports the
animal food or arranges for a third-party
to pick up the animal food. However, a
plant or facility may choose to examine
a customer’s shipping container or bulk
vehicle as a business decision to ensure
that shipping container or bulk vehicle
will not lead to the contamination or
adulteration of the animal food.
F. Proposed § 507.27(c)—Returned
Animal Food (Final § 507.27(d))
We proposed that animal food
returned from distribution must be
assessed for animal food safety to
determine the appropriate disposition.
Returned animal food must be identified
as such and segregated until assessed.
We received no comments on this
requirement and are finalizing it as
proposed.
G. Proposed § 507.27(d)—Unpackaged
Bulk Animal Food (Final § 507.27(e))
We proposed that unpackaged or bulk
animal food must be held in a manner
that does not result in cross
contamination with other animal food.
We received no comment on this
requirement and are finalizing it as
proposed with one wording change. We
have added the term ‘‘unsafe’’ to modify
cross contamination to make it clear that
this requirement applies to cross
contamination that would result in
unsafe animal food.
XXII. Subpart B: Comments on
Proposed § 507.28—Holding and
Distribution of Human Food ByProducts for Use as Animal Food
We proposed to add provisions for
human food by-products for use as
animal food. We proposed that the
requirements of this part (with the
exception of proposed § 507.28) would
not apply to by-products of human food
production that are packed and held by
that facility for distribution as animal
food if certain requirements were met
(see discussion in section XIII). The
facility would only need to comply with
proposed § 507.28 of this part and
proposed § 117.95 of part 117 (which
contains identical requirements).
A. Proposed § 507.28(a)—
Contamination
We proposed that human food byproducts held for distribution as animal
food must be held under conditions that
will protect against contamination.
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(Comment 230) Multiple comments
request that the term ‘‘human food byproducts,’’ not ‘‘animal food,’’ be used
throughout §§ 507.28 and 117.95 (of part
117). These comments note that it is
important to make clear that human
food by-products do not change from
human food to animal food until they
are transferred to someone with the
intent to use it as an animal food.
(Response 230) We disagree that
human food by-products are not animal
food until they have been transferred to
someone with the intent to use it as
animal food. Furthermore, we think that
the use of the term ‘‘human food byproducts’’ would be more confusing
here because not all human food byproducts are intended for use as animal
food. However, we have revised the
regulatory text to use the term ‘‘human
food by-products for use as animal
food’’ throughout this section to
differentiate it from other requirements
in parts 117 and 507. The purpose of
these provisions in §§ 507.28 and 117.95
is to ensure that when the processer is
holding and distributing human food
by-products for use as animal food, the
by-products are recognized as human
food by-products for use as animal food
by all employees and treated as such.
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B. Proposed § 507.28(a)(1)—Containers
We proposed that containers used to
hold animal food before distribution
must be designed, constructed of
appropriate material, cleaned, and
maintained to prevent the
contamination of animal food.
(Comment 231) Some comments state
that the provisions about containers are
too prescriptive because by-products
may be held and conveyed in ways that
do not use containers (such as using
storage silos, augers, pipes, chutes or
conveyor belts to convey product
directly to transportation vehicles).
Some comments request clarification on
cleaning the containers because they are
frequently reused for holding byproduct without intervening cleaning
procedures.
(Response 231) We agree that human
food by-products for use as animal food
may be held and conveyed using
equipment instead of containers. We
have revised the regulatory text to add
‘‘equipment’’ in addition to containers,
and have added the words ‘‘convey’’
and ‘‘cleaned as necessary’’ (see
regulatory text for §§ 507.28(a)(1) and
117.95(a)(1)). We expect containers and
equipment to be cleaned at a frequency
that protects against contamination of
human food by-products for use as
animal food by contaminants that could
be harmful to the public (human and
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animal) health. This may not require
cleaning after each use.
C. Proposed § 507.28(a)(2)—Protection
From Contamination
We proposed that animal food held
for distribution must be held in a way
to prevent contamination from sources
such as trash and garbage. As discussed
in Response 227, we have revised the
regulatory text to remove the term
garbage. We did not receive additional
comments related to this paragraph and
are finalizing the proposed language
with changes previously discussed. (See
Responses 227 and 230.)
D. Proposed § 507.28(a)(3)—Labeling
We proposed that labeling identifying
the product by the common or usual
name must be affixed to or accompany
animal food.
(Comment 232) Some comments state
that by-products only need to be
reasonably identified while they are
being held by the facility and state that
once they are ready for distribution,
they should be labeled in conformance
with applicable regulatory
requirements. One comment states that
what is considered the ‘‘common and
usual name’’ varies between the human
food industry, the animal food industry,
producers and regulators. This comment
suggests that FDA work with regulatory
partners to provide guidance on the
proper ‘‘common and usual name’’ of
by-products to promote consistency.
(Response 232) We agree in part with
these comments. As with animal food
subject to all of part 507, we expect that
while human food by-product for use as
animal food is being held in the human
food facility, it is accurately identified.
(See Response 201.) We have revised the
regulatory text to clarify that the human
food by-product for use as animal food
must be accurately identified while held
in the human food facility (see
§ 507.28(a)(3) of the final rule). We
retained the requirement that when the
human food by-product for use as
animal food is distributed, it must have
labeling that identifies the common or
usual name of the product affixed to or
accompanying it (see § 507.28(b) of the
final rule).
Our CPG Sec. 665.100 discusses
common or usual names for animal food
ingredients (Ref. 25). There are also
industry and other regulatory resources
that may assist facilities in determining
the common or usual name of the
animal food. For example, USDA
maintains the National Nutrient
Database for Standard Reference, a
database that includes a list of names for
human food items (Ref. 30). We will
take into consideration these comments
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when determining whether to issue
additional guidance about the common
or usual name of animal food.
(Comment 233) One comment
requests that FDA require human food
manufacturers to document the
recipient’s intended use of the byproducts so the by-products do not
become ingredients of human food. This
comment also requests that these byproducts be required to be labeled with
the statement ‘‘For Use as Animal Feed
Only.’’
(Response 233) We decline these
requests. Human food is produced
under human food regulations, such as
CGMPs, and HACCP regulations for
juice and seafood, and facilities must
meet the applicable requirements for
food that is manufactured, processed,
packed, or held to ensure the safety of
that human food. This requirement in
§ 507.28 is meant only for human food
by-products for use as animal food that
are only held and distributed (i.e. not
further processed). Human food byproducts may be used as human food
ingredients as long as they are in
compliance with the applicable human
food regulations. However, we would
not object if a facility labels the human
food by-products for use as animal food
‘‘For Use as Animal Food Only.’’
E. Proposed § 507.28(b)—Shipping
Containers
We proposed that shipping containers
(for example, totes, drums, and tubs)
and bulk vehicles used to distribute
animal food must be inspected prior to
use to ensure the container or vehicle
will not contaminate the animal food.
This provision is paragraph (c) of this
section in the final rule.
(Comment 234) We received the same
comments on § 507.28(c) as § 507.27(c).
(See Comment 229.)
(Response 234) We are revising the
regulatory text in §§ 507.28(c) and
117.95(c). (See Response 229.)
XXIII. Subpart C: Comments on Overall
Framework for Hazard Analysis and
Risk-Based Preventive Controls
In the 2014 supplemental notice for
preventive controls for animal food, we
proposed a series of changes to
proposed subpart C and reopened the
comment period specifically with
respect to these changes. The proposed
changes included: (1) Eliminating the
term ‘‘hazard reasonably likely to
occur’’ throughout proposed subpart C
(and, thus, deleting the definition we
had proposed for this term); (2) adding
a new defined term, ‘‘significant
hazard,’’ and, in general, using this new
term instead of ‘‘hazard reasonably
likely to occur’’ throughout the re-
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proposed regulations; (3) defining
‘‘known or reasonably foreseeable
hazard’’ in place of ‘‘reasonably
foreseeable hazard’’ and clarifying that
the new term means a hazard ‘‘that has
the potential to be associated with the
facility or the food’’ rather than ‘‘a
potential . . . hazard that may be
associated with the facility or the food’’;
and (4) providing additional flexibility
to address concerns about rewriting
existing plans or programs to conform
with the requirement of the preventive
controls rule.
We received many comments on the
overall framework for hazard analysis
56239
and risk-based preventive controls. We
discuss each of these comments in the
discussion of the specific regulatory text
applicable to each comment. We show
highlights of the changes we made after
considering these comments in table 9.
TABLE 9—REVISIONS TO THE OVERALL FRAMEWORK FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS
Section
Description
Revision
507.3 ...............................................
Definition of ‘‘significant hazard‘‘ ...
507.3 ...............................................
Definition of ‘‘corrections‘‘ ..............
507.34(c)(1), 507.39(a), 507.40,
507.45(a), 507.47(a), 507.49(a),
507.49(b).
Flexibility in preventive controls
and preventive control management components for monitoring, corrective actions and
corrections, and verification.
Hazard identification ......................
Revise the proposed term ‘‘significant hazard’’ to ‘‘hazard requiring a
preventive control’’ and revise the definition to emphasize the role
of risk in determining whether a hazard requires a preventive control.
Define the term ‘‘correction’’ to distinguish ‘‘corrections’’ from ‘‘corrective actions.’’
Clarify that preventive control management components depend on
the role of a preventive control in the facility’s food safety system,
as well as the nature of the preventive control.
507.33(b)(1) .....................................
507.33(b)(2) .....................................
507.40(c)(2) .....................................
Monitoring records .........................
507.42(a) .........................................
Corrective action procedures ........
507.42(c) .........................................
Corrections ....................................
507.47(c) .........................................
Preventive controls that do not require validation.
Activities to verify implementation
and effectiveness.
507.49(a)(5) .....................................
507.49(b) .........................................
Written procedures for verification
of implementation and effectiveness.
507.50(b) .........................................
Reanalysis .....................................
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XXIV. Subpart C: Comments on
Proposed § 507.31—Food Safety Plan
We proposed requirements for a food
safety plan. Some comments support the
proposed requirements without change.
Some comments that support the
proposed provisions suggest alternative
or additional regulatory text or ask us to
clarify how we will interpret the
provision.
In the following sections, we discuss
comments that ask us to clarify the
proposed requirements, or disagree
with, or suggest one or more changes to
the proposed requirements. After
considering these comments, we are
finalizing the provisions as proposed,
with editorial and conforming changes
as shown in table 31.
We proposed that the food safety plan
be under the oversight of one or more
‘‘qualified individuals.’’ As discussed in
section VIII.A.24, we have changed the
proposed term ‘‘qualified individual’’ to
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Emphasize that the hazard identification focuses on known or reasonably foreseeable hazards (rather than on all hazards).
Provide for the use of ‘‘exception records’’ for monitoring preventive
controls.
Clarify that corrective action procedures depend on the nature of the
hazard.
Provide for additional circumstances when corrections, rather than
corrective actions, are warranted.
Clarify that a list of preventive controls that do not require validation
is not an exhaustive list.
Clarify that there could be alternative verification activities of implementation and effectiveness other than those that we specify in the
rule.
Clarify that written procedures for verification of implementation and
effectiveness are established and implemented as appropriate to
the role of the preventive control in the facility’s food safety system,
as well as appropriate to the facility, the animal food, and the nature of the preventive control.
Provide for reanalysis of an applicable portion of the food safety plan
(rather than the complete food safety plan) in specified circumstances.
‘‘preventive controls qualified
individual’’ because we are establishing
a new definition for ‘‘qualified
individual,’’ with a meaning distinct
from ‘‘preventive controls qualified
individual.’’ To minimize the potential
for confusion for when the term
‘‘qualified individual’’ refers to the
proposed meaning of the term and when
the term ‘‘qualified individual’’ refers to
the meaning of that term as finalized in
this rule, in the remainder of this
document we substitute the new term
‘‘preventive controls qualified
individual’’ for the proposed term
‘‘qualified individual,’’ even though the
proposed rule used the term ‘‘qualified
individual.’’ Likewise, we substitute the
new term ‘‘preventive controls qualified
individual’’ for the proposed term
‘‘qualified individual’’ when describing
the comments to the proposed rule,
even though those comments use the
term ‘‘qualified individual.’’
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We proposed that several other
provisions of subpart C be under the
oversight of a ‘‘qualified individual’’
(now ‘‘preventive controls qualified
individual’’), and also proposed
requirements that would apply to the
‘‘qualified individual’’ (now ‘‘preventive
controls qualified individual’’). See, e.g.,
§§ 507.47, 507.49, 507.50, 507.51,
507.53, and 507.55). As discussed in the
preceding paragraph, in the remainder
of this document, we substitute the new
term ‘‘preventive controls qualified
individual’’ for the proposed term
‘‘qualified individual,’’ when describing
these proposed provisions and the
comments to these proposed provisions.
A. Proposed § 507.31(a)—Requirement
for a Food Safety Plan
We proposed that you must prepare,
or have prepared, and implement a
written food safety plan.
(Comment 235) Some comments ask
us to develop a final preventive controls
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rule with separate requirements for food
safety plans for manufacturers of
livestock food and for manufactures of
food for other animal species.
(Response 235) We decline this
request. The required elements of the
food safety plan listed in § 507.31(c)
apply to each type of animal food
manufactured at a facility. Animal food
types or production method types may
be grouped together if the hazards,
preventive controls, parameters, and
management components (monitoring,
corrective actions and corrections, and
verification) necessary to ensure the
effectiveness of the preventive controls
are essentially identical. We have
provided additional flexibility within
the required elements of the food safety
plan in the final rule. Therefore the
same requirements for a food safety plan
are applicable to a facility that makes
food for livestock and one that makes
food for other animal species.
(Comment 236) Some comments ask
us to add regulatory text to this section
stating that an existing written food
safety plan, including any plan intended
to satisfy the requirements of a foreign
jurisdiction or that complies with
existing standards developed by other
organizations (such as PAS 222 (Ref.
27)), satisfies the requirements of this
section if it contains the information
specified by § 507.31(c).
(Response 236) To the extent that an
existing food safety plan includes all
required information, a facility can use
such plans to meet the requirements of
this rule. We expect that many existing
plans will need only minor
supplementation to fully comply with
these requirements. Relying on existing
records, with supplementation as
necessary to satisfy the requirements of
the preventive controls rule, is
acceptable (see § 507.212).
(Comment 237) Some comments agree
with our previous statements that
facilities should be able to group animal
food types or production method types
if hazards, control measures,
parameters, and required procedures,
such as monitoring, are identical (78 FR
64736 at 64779). Some comments ask us
to emphasize that each facility needs
only one food safety plan, regardless of
how many animal species it makes food
for, or how many different types of food
it makes. These comments further state
that facilities are under the impression
that any given facility will need
multiple food safety plans if they make
many food types or make food for
multiple animal species.
(Response 237) We are requiring that
a facility have a written food safety plan
that covers all types of animal food it
manufactures, processes, packs, or holds
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and all of the animal species for which
the food is intended. We recognize that,
to the extent that the controls are the
same, there may be common controls
that broadly apply to some or all of a
facility’s animal food products.
However, any product-, process-, or
animal species-specific differences must
be carefully delineated and observed in
practice.
In some facilities with limited types
of animal food products or animal
species for which the food is intended,
the written food safety plan may contain
a single set of procedures that addresses
all of the products produced. For other
facilities, there may not be a practical
way to group the products and the
written food safety plan may need to
contain more than one set of procedures
to address all of its products.
(Comment 238) Some comments ask
us to emphasize that ‘‘written’’ means
‘‘any type of recordable and
reproducible format’’ (e.g., as paper or
electronic documents). Some comments
ask us to specify that the components of
the food safety plan need not be in a
single document or stored in one place.
(Response 238) A ‘‘written’’ food
safety plan can be either a paper
document or an electronic document, as
provided for by § 507.202(a). The final
rule specifies that required information
(which would include the food safety
plan) does not need to be kept in one
set of records (see § 507.212(b)), and a
food safety plan may be prepared as a
set of documents kept in different
locations within the facility (e.g., based
on where they will be used), provided
that each set of documents is onsite. As
provided in the recordkeeping
provisions, electronic records are
considered to be onsite if they are
accessible from an onsite location.
(Comment 239) Some comments ask
us to provide that the food safety plan
be handled at the corporate level rather
than the facility level if a corporation
owns many facilities.
(Response 239) A corporation may
designate an individual at the corporate
level as the owner, operator, or agent in
charge of a particular facility. In
addition, an employee of the
corporation, whether at headquarters or
at another facility owned by the
corporation, may provide input into a
particular facility’s food safety plan. As
previously discussed, the food safety
plan does need to be facility specific
(see the discussion of the facility-based
nature of the food safety plan in the
2013 proposed preventive controls rule
for animal food, 78 FR 64736 at 64780).
For example, even if a corporation
makes similar products at two separate
facilities, it is unlikely that the two
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facilities have exactly the same
equipment and layout. Procedural
instructions must be tailored to the
equipment being used, and the layout of
a facility may affect its approach to
preventive controls.
(Comment 240) Some comments
assert that a food safety plan should
only be required for high-risk processing
facilities because adhering to CGMPs is
sufficient for low-risk facilities. Some
comments assert that FSMA does not
authorize us to require farms to develop
food safety plans.
(Response 240) We decline the
request to establish additional
exemptions based on risk, other than the
exemptions for on-farm low-risk
activity/animal food combinations
provided by section 103(c)(1)(D) of
FSMA (§ 507.5(e) and (f)). The
applicability of the requirements of the
preventive controls rule to facilities that
are required to register is required by
the statute (see the definition of facility
in section 418(o)(2) of the FD&C Act).
Section 418(h) of the FD&C Act requires
that a facility prepare and implement a
food safety plan, unless an exemption
applies. Neither FSMA nor this rule
establishes an exemption for ‘‘low-risk’’
facilities, including ‘‘low-risk’’ facilities
that are regularly inspected by State,
local, or tribal government Agencies. A
farm is not subject to this rule for
activities within the ‘‘farm’’ definition.
A farm mixed-type facility that is a
small or very small business and only
conducts the low-risk activity/animal
food combinations specified in
§ 507.5(e) and (f) is exempt from the
requirements of subparts C and E,
including the requirement for a food
safety plan.
(Comment 241) Some comments ask
us to clarify that a food safety plan is
not required when a facility is exempt
as a qualified facility (§ 507.7(a)) or as
a facility solely engaged in the storage
of packaged food that is not exposed to
the environment (§ 507.10)
(Response 241) A qualified facility is
exempt from the requirements of
subparts C and E, including the
requirement to prepare and implement
a food safety plan, and is instead subject
to the requirements in § 507.7. Likewise,
a facility solely engaged in the storage
of packaged animal food that is not
exposed to the environment and does
not require time/temperature control to
significantly minimize or prevent the
growth of, or toxin production by,
pathogens is exempt from the
requirements of subparts C and E,
including the requirement to prepare
and implement a food safety plan. See
Response 242 for unexposed, packaged
TCS animal food.
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(Comment 242) Some comments ask
us to clarify that a food safety plan is
not required for facilities that store
unexposed, refrigerated, packaged TCS
animal foods.
(Response 242) We agree that a
facility ‘‘solely engaged’’ in the storage
of unexposed, refrigerated, packaged
TCS animal food is exempt from the
requirements of subparts C and E,
including the requirement to prepare
and implement a food safety plan, and
instead is subject to the modified
requirements in § 507.51 (see § 507.10).
However, if a facility engages in other
activities in addition to the storage of
unexposed, refrigerated, packaged TCS
animal food, the exemption does not
apply. In such a case, the facility must
prepare and implement a food safety
plan. However, the modified
requirements of § 507.51 can be
informative with respect to what the
food safety plan could include regarding
the storage of unexposed, refrigerated,
packaged TCS animal food.
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B. Proposed § 507.31(b)—Preparation of
the Food Safety Plan by a Preventive
Controls Qualified Individual
We proposed that the food safety plan
must be prepared, or its preparation
overseen, by one or more preventive
controls qualified individuals.
(Comment 243) Some comments ask
us to provide for a group of qualified
individuals to prepare, or oversee the
preparation of, a food safety plan.
(Response 243) The proposed
regulatory text included in the 2014
supplemental notice provides for the
food safety plan to be prepared, or its
preparation overseen, by one or more
preventive controls qualified
individuals, and we are finalizing it as
proposed.
C. Proposed § 507.31(c)—Contents of a
Food Safety Plan
We proposed that the written food
safety plan must include the written
hazard analysis, preventive controls
(including the supplier program and
recall plan), procedures for monitoring
the implementation of the preventive
controls, corrective action procedures,
and verification procedures. As
discussed in more detail in section XL,
we have revised the phrase ‘‘supplier
program’’ to ‘‘supply-chain program’’
throughout the regulatory text. In the
remainder of this document, we use the
phrase ‘‘supply-chain program’’ in
section headings and when referring to
the provisions of the final rule. We
continue to use the term ‘‘supplier
program’’ when describing the proposed
provisions and the comments regarding
the proposed provisions.
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(Comment 244) Some comments ask
us to specify that sanitation controls
must be in the food safety plan. Some
comments ask us to require that the food
safety plan include the qualifications of
the preventive controls qualified
individual.
(Response 244) Sanitation controls are
one type of preventive control. As
appropriate to the facility and the
animal food (e.g., to control hazards
such as environmental pathogens),
sanitation controls for cleanliness of
animal food-contact surfaces and
prevention of cross contamination are
required to be in the food safety plan
(§ 507.34(c)(2)).
We are requiring that you document
all applicable training taken by the
preventive controls qualified individual
(see § 507.53(d)). This documentation
must be established and maintained (see
§ 507.55(a)(6)).
D. Proposed § 507.31(d)—Records
We proposed that the food safety plan
is a record that is subject to the
recordkeeping requirements of subpart
F. We received no comments that
disagreed with this proposed
requirement and are finalizing it as
proposed.
E. Comments on Potential Requirements
for Submission of a Facility Profile to
FDA
We requested comment on whether to
require submission to FDA of a subset
of the information that would be in a
food safety plan (78 FR 64736 at 64809).
This information, which could be
referred to as a ‘‘facility profile,’’ could
be submitted through an electronic form
using a menu selection approach at the
same time as facility registration and
updated biennially simultaneously with
the required biennial update of the food
facility registration. We described
potential benefits to having a facility’s
food safety plan in advance of an
inspection, such as aiding in the
efficient oversight of preventive controls
by allowing us to better target
inspectional activities to facilities that
produce foods that have an increased
potential for contamination (particularly
with biological hazards). We noted that
facilities could benefit from our advance
preparation through interaction with
better-informed investigators and
potentially reduced inspection time. We
requested comment on the utility and
necessity of such an approach and on
the specific types of information that
would be useful in developing a facility
profile. We also requested comment on
any additional benefits that might be
obtained from using such an approach
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and any potential concerns with this
approach.
We noted that we had previously
announced an opportunity for public
comment on the proposed collection of
additional food facility profile
information on a voluntary basis from
firms that complete the FDA food
facility registration process (Federal
Register of May 11, 2012, 77 FR 27779).
In contrast to the voluntary submission
of food facility profile information
described in that document, in the 2013
proposed preventive controls rule for
animal food we requested comment on
whether the submission of such
information should be required.
(Comment 245) Some comments state
that submission of a facility profile
would be useful and support requiring
such a submission. However, most of
the comments that addressed our
request for comments on such a
submission express concern. Some
comments assert that requiring
submission of a facility profile is
outside of FDA’s statutory authority
under FSMA. Other comments assert
that submitting a facility profile would
not advance food safety goals or have a
commensurate benefit to food safety.
Some comments express concern about
protection of confidential information.
Other comments express concerns that
we would misinterpret the submitted
information in the absence of discussion
with the facility. Some comments assert
that receiving and evaluating the
submitted information would be too
time-consuming for FDA, whereas other
comments assert that submitting the
information would be too timeconsuming for the facility. Some
comments state that a subset of the
information that would be submitted
could be found in the Establishment
Inspection Reports. Some comments
assert that we could use information
already available through the RFR to
identify facilities that have needed to
address a serious food safety violation
and target our inspectional resources to
those facilities. Some comments state
that a facility profile is a not a static
document and would be very difficult to
keep up to date. Other comments state
that such a profile would be of limited
or no use to FDA because information
regarding hazards and preventive
controls is best assessed in the context
of a full food safety plan and related
documentation. These comments further
state that food safety plans will
constantly evolve as facilities undertake
new activities and refine their
processes; a profile would present only
a static picture of the food safety
measures in place at a given time; FDA
has already implemented changes to the
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registration process that require
facilities to provide more information
about the activities at the facility. One
comment asks us to refrain from
requiring written or electronic
submission of facility profiles.
(Response 245) We have decided that
we will not establish a requirement for
submission of a facility profile. We will
explore other mechanisms to achieve
the goals we described in the 2013
proposed preventive controls rule for
animal food.
XXV. Subpart C: Comments on
Proposed § 507.33—Hazard Analysis
We proposed requirements for hazard
analysis, including hazard identification
and hazard evaluation. Some comments
support the proposed requirements
without change. For example, some
comments support our proposal for the
hazard analysis to address ‘‘known or
reasonably foreseeable hazards’’ because
this is consistent with Codex. Other
comments agree that the hazard analysis
should address both the severity of the
potential hazard and the probability that
the hazard will be present in an animal
food product. Other comments state that
testing for environmental pathogens
may be impractical in certain situations
for facilities in chemical plants that also
produce food additives and that the
proposed requirements for hazard
evaluation make it clear that in such
facilities environmental monitoring
would not be required. Some comments
that support the proposed provisions
suggest alternative or additional
regulatory text or ask us to clarify how
we will interpret the provision.
In the following sections, we discuss
comments that ask us to clarify the
proposed requirements or that disagree
with, or suggest one or more changes to,
the proposed requirements. After
considering these comments, we have
revised the proposed requirements as
shown in table 10 with editorial and
conforming changes as shown in table
31.
TABLE 10—REVISIONS TO THE PROPOSED REQUIREMENTS FOR HAZARD ANALYSIS
Section
Description
Revision
507.33(a)(1) .....................................
Requirement for a hazard analysis
507.33(a)(2) .....................................
507.33(b)(1) and (b)(2) ...................
Requirement for the hazard analysis to be written.
Hazard identification ......................
507.33(b)(1)(ii) .................................
Hazard identification ......................
507.33(b)(1)(iii) ................................
507.33(c)(2) .....................................
Hazard identification ......................
Hazard evaluation ..........................
507.33(d)(10) ...................................
Hazard evaluation ..........................
Specify that a facility must ‘‘conduct a hazard analysis’’ to identify
and evaluate known or reasonably foreseeable hazards, rather
than merely specify that a facility must ‘‘identify and evaluate’’
known or reasonably foreseeable hazards.
Clarify that the hazard analysis must be written, regardless of its outcome.
Emphasize that the hazard identification focuses on known or reasonably foreseeable hazards (rather than on all hazards).
Replace ‘‘imbalances’’ with’’ deficiencies or toxicities’’ and provide examples of these hazards.
Add examples of physical hazards.
Provide that hazard evaluation does not need to include an evaluation of environmental pathogens whenever finished animal food is
exposed to the environment prior to packaging if the packaged
food includes a control measure (such as a formulation lethal to
the pathogen) that would significantly minimize the pathogen.
Provide an example of ‘‘other relevant factor’’ that the hazard evaluation must consider (the example is the temporal (e.g., weather-related) nature of some hazards (e.g., levels of some natural toxins)).
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A. Proposed § 507.33(a)—Requirement
for a Written Hazard Analysis
We proposed that you must identify
and evaluate, based on experience,
illness data, scientific reports, and other
information, known or reasonably
foreseeable hazards for each type of
animal food manufactured, processed,
packed, or held at your facility to
determine whether there are significant
hazards. We also proposed that the
hazard analysis must be written.
As discussed in Response 62, we have
revised the term ‘‘significant hazard’’ to
‘‘hazard requiring a preventive control.’’
In addition, we have revised the
regulatory text to specify that the
outcome of a hazard analysis is to
determine whether there are any
hazards requiring a preventive control.
(Comment 246) Some comments ask
us to specify that the rule requires a
written hazard analysis even if the
hazard analysis concludes that no
hazards exist.
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(Response 246) As proposed, the
regulatory text would require a written
hazard analysis even if the hazard
analysis concludes that no hazards
exist. To make this clearer, we have
made two revisions to the regulatory
text. First, we have revised the
regulatory text to specify that a facility
must ‘‘conduct a hazard analysis’’ to
identify and evaluate known or
reasonably foreseeable hazards, rather
than merely specify that a facility must
‘‘identify and evaluate’’ known or
reasonably foreseeable hazards. Second,
we have revised the regulatory text to
specify that the hazard analysis must be
written regardless of its outcome.
(Comment 247) Some comments
assert that a facility should not be able
to conclude that no hazard exists in its
production process and that any such
conclusion reached should be a ‘‘red
flag’’ to FDA investigators.
(Response 247) The purpose of a
hazard analysis is to identify and
evaluate known or reasonably
foreseeable hazards to determine
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whether there are any hazards requiring
a preventive control. If a facility
appropriately determines, under the
oversight of a preventive controls
qualified individual, that no such
hazards exist, then that is the outcome
of its hazard analysis, and the facility
must document that outcome in its
written hazard analysis.
We expect that there will be many
circumstances in which a facility
appropriately determines that certain
biological, chemical, or physical
hazards are not hazards requiring a
preventive control that must be
addressed in the food safety plan. The
provisions of the rule that allow a
facility to appropriately determine that
a particular hazard is not a hazard
requiring a preventive control in certain
animal food products are not equivalent
to an exemption from the rule. For
example, a facility that appropriately
determines that there are no hazards
requiring a preventive control
associated with its animal food products
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must document that determination in its
written hazard analysis (§ 507.33);
however, no preventive controls,
including supplier verification
activities, and associated management
components would be required in such
a situation. There are several types of
animal food products for which a
facility may determine that there are no
hazards requiring a preventive control.
Such products include, but are not
limited to: alfalfa cubes, vegetable oils,
and molasses.
However, we agree that our
investigators should take appropriate
steps to evaluate a facility’s hazard
analysis when the outcome is that there
are no hazards requiring a preventive
control. We expect that our investigators
would both review the facility’s written
hazard analysis and discuss the
outcome with the facility. During the
initial stages of implementation, we also
expect that our investigators will ask
subject matter experts in our Center for
Veterinary Medicine (CVM) to review
such a hazard analysis. Over time, as
our investigators gain experience with
appropriate determinations that there
are no hazards requiring a preventive
control, we expect that there will be
fewer circumstances in which our
investigators would consult CVM about
such an outcome.
(Comment 248) Some comments ask
us to require that the hazard analysis be
re-evaluated every 3 years and updated
as needed.
(Response 248) The written hazard
analysis is one component of the food
safety plan, and the food safety plan is
subject to reanalysis at least once every
3 years, and sooner under certain
circumstances (see § 507.50).
(Comment 249) Some comments ask
us to modify the provision to specify
that the hazard analysis identify and
evaluate known or reasonably
foreseeable hazards for each type of
animal food manufactured, processed,
packed, or held at the facility, including
hazards in the raw materials and
ingredients used in the animal food
(emphasis added).
(Response 249) We decline this
request. Other provisions in the
requirements for hazard analysis specify
that the hazard evaluation must
consider raw materials and ingredients
(see § 507.33(d)(3)). It is not necessary to
repeat the specific requirements
associated with the hazard evaluation in
the provision that directs each facility to
conduct a hazard analysis.
(Comment 250) Some comments state
that the standard for hazard analysis in
the preventive controls rule should both
align with the reproposed requirements
for hazard analysis set forth in the
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supplemental FSVP notice and be
consistent with the statutory standard
for hazard analysis in section 418(b)(1)
of the FD&C Act.
(Response 250) We have aligned the
requirements of the animal food
preventive controls rule and the
proposed FSVP rule to the extent
practicable, consistent with the
applicable statutory requirements.
B. Proposed § 507.33(b)—Hazard
Identification
We proposed that the hazard
identification must consider hazards
that include biological, chemical, and
physical hazards. We proposed
examples of biological hazards (e.g.,
microbiological hazards such as
parasites, environmental pathogens, and
other pathogens) and chemical hazards
(e.g., radiological hazards and
substances such as pesticide and drug
residues, natural toxins, decomposition,
unapproved food or color additives, and
nutrient imbalances).
In the preamble for the 2013 proposed
preventive controls rule for animal food,
we explained that nutrient imbalance
hazards can result from excessive levels
of a nutrient in animal food resulting in
toxicity to the animal, or a nutrient
deficiency in the animal food that can
compromise the health of an animal and
provided examples (78 FR 64736 at
64782). These nutrient imbalance
hazards are of particular concern for
animals that consume one animal food
type as their sole source of nutrition.
Because different species have different
nutritional needs, certain quantities of a
nutrient that are needed by one species
of animal could pose a health risk to
another species of animal.
In the preamble for the 2013 proposed
preventive controls rule for animal food
we also provided examples of physical
hazards (e.g., stones, glass, or metal
fragments that could inadvertently be
introduced into animal food) (78 FR
64736 at 64782) but did not include
these examples in the proposed
regulatory text.
We also proposed that the hazard
identification must consider hazards
that may be present in the animal food
if they occur naturally or may be
unintentionally introduced. In the 2014
preventive controls supplemental notice
for animal food we proposed to add that
the hazard analysis also must consider
hazards that may be intentionally
introduced for purposes of economic
gain (proposed § 507.33(b)(2)(iii)).
(Comment 251) As discussed in
Comment 62, some comments express
concern that the rule would refer to
multiple levels of hazards (i.e.,
‘‘hazard,’’ ‘‘known or reasonably
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foreseeable hazard,’’ and ‘‘significant
hazard’’ (which we now refer to as
‘‘hazard requiring a preventive control’’)
and ask us to provide sufficient clarity
to be able to distinguish between these
types of hazards.
(Response 251) As discussed in
Response 62, we have revised the
requirements for hazard identification to
emphasize that the hazard identification
focuses on known or reasonably
foreseeable hazards (rather than on all
hazards).
(Comment 252) Some comments ask
us to include examples of physical
hazards in the regulatory text.
(Response 252) We have added
stones, glass, and metal fragments as
examples of physical hazards in the
regulatory text. This is consistent with
the regulatory text for biological and
chemical hazards, even though the
hazards listed in section 418(b)(1) of the
FD&C Act include examples of chemical
and biological hazards but do not
include examples of physical hazards.
(Comment 253) Some comments ask
us to separately list some hazards (such
as parasites and drug residues) rather
than include them as examples of
biological hazards and chemical
hazards.
(Response 253) We decline this
request. Although section 418(b)(1)(A)
of the FD&C Act lists such items
separately, we believe it is clearer to
acknowledge that some of the hazards
listed in the statute are in fact a subset
of the broader categories of biological
and chemical hazards.
(Comment 254) Some comments ask
us to rephrase the requirement for
hazard identification to specify ‘‘The
hazard analysis must identify hazards’’
rather than ‘‘The hazard identification
must consider hazards.’’
(Response 254) We decline this
request. The provision is directed to the
first step of a hazard analysis, i.e.,
hazard identification, rather than to the
overall hazard analysis (which is
addressed in § 507.33(a)). The purpose
of the hazard identification is to
consider the types of hazards listed as
a step in determining whether there are
any hazards requiring a preventive
control; the suggestion of the comments
implies that such hazards will always be
identified. As discussed in Response
247, the outcome of a hazard analysis
for an animal food product could be that
there are no hazards requiring a
preventive control.
(Comment 255) Some comments ask
us to revise the chemical hazard
examples by replacing the term
‘‘nutrient imbalances’’ with ‘‘nutrient
deficiencies or toxicities.’’
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(Response 255) We agree that the
suggested revision adds clarity and have
modified the regulatory text to replace
‘‘nutrient imbalances’’ with ‘‘nutrient
deficiencies or toxicities,’’ and provide
examples, such as ‘‘inadequate thiamine
in cat food,’’ ‘‘excessive vitamin D in
dog food’’, and ‘‘excessive copper in
food for sheep.’’
(Comment 256) Some comments
assert that nutrient imbalances should
not be addressed in an animal food
safety plan because they pose no threat
to humans.
(Response 256) We disagree with
these comments. The preventive
controls rule for animal food is intended
to protect animal health, as well as
human health. Section 418 of the FD&C
Act, which authorizes the preventive
controls rules, applies to facilities
registered under section 415 of the
FD&C Act, which includes facilities that
manufacture, process, pack, and hold
animal food.
(Comment 257) Some comments
assert that while serious, ongoing
imbalances of nutrients such as copper
and selenium must be avoided with
checks and balances, and perhaps
product testing, there could be a
multitude of other incidents that could
occur without serious consequences and
to address every possible scenario, by
species, when the Agency is aware of a
limited number of rare cases, is
unreasonable. Some comments state that
the notion that nutrient deficiencies or
toxicities for animals are hazards likely
to occur in the manufacture of animal
food seems like a poor fit in this set of
food safety regulations.
(Response 257) The Agency has a
history of animal food incidents
resulting in recall of animal food and in
animal illnesses and deaths from
nutrient deficiencies or toxicities.
From 2012 to 2014, FDA received
multiple reports through its RFR that
were attributable to animal food
associated with nutrient deficiencies or
toxicities. For example, during the
2010/2011 reporting period, 3.57
percent of 224 primary (industry and
voluntary) RFR entries were associated
with nutrient deficiencies or toxicities
in animal food. During the 2012/2013
period, 2.97 percent of 202 entries were
attributable to nutrient imbalances or
toxicities in animal food (Refs. 14 and
16). Reports included low levels of
thiamine in cat food; high levels of
vitamin D in dog food; low levels of
vitamin D in food for swine; high levels
of vitamin D in food for guinea pigs,
fish, and other animal species; high
levels of calcium and phosphorus in
food for broiler chickens and turkeys
causing the death of several hundred
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young birds (Refs. 13 to 16); high levels
of salt in food for broilers; high levels
of protein/urea in food for cattle; and
high levels of copper in food for sheep.
Many of these animal foods with
nutrient imbalances (deficiencies or
toxicities) resulted in a recall of the
affected animal food (Refs. 31 to 39).
Moreover, an analysis of thiamin
levels in randomly selected commercial
canned cat foods was conducted during
a period from December 2012 through
January 2013 (Ref. 40). The study found
13.3 percent of the cat foods tested fell
below the minimum set for thiamine by
AAFCO and 15.6 percent were below
the recommended allowance of the
National Research Council.
We also disagree with the implication
that facilities must address every
possible hazard. Facilities must identify
and evaluate known or reasonably
foreseeable hazards for each type of
animal food manufactured, processed,
packed, or held at the facility to
determine whether there are any
hazards requiring a preventive control.
(Comment 258) Some comments
suggest that nutrient imbalances should
be addressed through CGMPs.
(Response 258) We disagree with
these comments. We consider nutrient
deficiencies and toxicities to be a type
of chemical hazard that are
appropriately addressed through
preventive controls. If a facility
identifies a nutrient deficiency or
toxicity as a hazard that is known or
reasonably foreseeable in an animal
food and is a hazard that requires a
preventive control, the facility must
implement preventive controls for that
hazard. The facility has flexibility in
determining what preventive controls it
needs to implement to control the
hazard. Preventive controls for
identified nutrient toxicity or deficiency
hazards can include CGMPs, but the
specific CGMP needs to be included in
the food safety plan (or for a qualified
facility, the documentation supporting
an attestation under § 507.7(a)(2)).
(Comment 259) Some comments ask
us to consider revising the proposed
rule to include food allergens in animal
food much in the same way that they
have been proposed in the human food
rule.
(Response 259) We decline this
request. We are not aware of evidence
indicating that foodborne allergens pose
a significant health risk to animals (78
FR 64736 at 64771). Animals with
actual food allergies typically have
digestive disorders or dermatologic
conditions, not the anaphylactic
reaction that humans have to the major
food allergens (defined in section
201(qq) of the FD&C Act).
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(Comment 260) Some comments
assert that physical hazards in animal
food are not likely to cause any serious
injuries to humans as the contaminant
is not assimilated into edible tissue.
(Response 260) We disagree with
these comments. The rule defines the
term hazard to include a physical agent
that has the potential to cause injury or
illness in animals, as well as humans.
Physical hazards in animal food can
cause illness or injury in animals.
(Comment 261) Some comments ask
us to delete ‘‘decomposition’’ from the
list of chemical hazards in this
provision.
(Response 261) We decline this
request. As discussed previously,
decomposition of animal food consists
of microbial breakdown of the normal
food product tissues and the subsequent
enzyme-induced chemical changes.
These changes are manifested by
abnormal odors, taste, texture, color,
etc., and can lead to reduced food intake
or rejection of the food by the intended
animal species, resulting in illness or
death (see 78 FR 64736 at 64782).
(Comment 262) Some comments
assert that we should not require all
food safety plans to specifically address
the likelihood of radiological hazards.
(Response 262) The rule only requires
that a facility consider whether
radiological hazards are known or
reasonably foreseeable, and we have
described situations where radiological
hazards could be considered to be
known or reasonably foreseeable. A
facility that appropriately determines
that no radiological hazards are known
or reasonably foreseeable would
document that determination in its
written hazard analysis but would not
need to establish preventive controls
and associated preventive control
management components to address
radiological hazards.
(Comment 263) Some comments
assert that predictable intentional
hazards should be in the food safety
plan but unexpected intentional hazards
should be part of a food defense plan.
(Response 263) This rule only
requires a facility to consider
intentionally introduced hazards when
such hazards are introduced for
purposes of economic gain. Hazards that
may be intentionally introduced by acts
of terrorism are the subject of the 2013
proposed intentional adulteration rule
(78 FR 78014, December 24, 2013),
which applies only to human foods.
(Comment 264) Some comments
disagree that the animal food preventive
controls rule should address hazards
that are intentionally introduced for
purposes of economic gain
(economically motivated adulteration).
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Some of these comments assert that
economically motivated adulteration is
not a good fit for the hazard analysis
and preventive controls framework
because it is, in all but the rarest of
circumstances, an issue of product
integrity and quality, whereas food
safety systems are designed and built to
prevent or mitigate food safety hazards.
Some comments state that traditional
food safety hazards are primarily both
identified and addressed at the facility
level, but economically motivated
adulteration is typically handled by the
corporate parent company, where
supply-chain management programs are
typically located. These comments also
assert that food safety-related
economically motivated adulteration is
extremely rare and that predicting
economically motivated adulteration to
prevent it is extremely difficult. Some
comments assert there will be no
measurable benefit to food safety by
imposing requirements to consider
economically motivated adulteration as
part of a food safety plan and that doing
so will consume limited resources
without a corresponding increase in
consumer protection. Other comments
assert that there is no need to require a
facility to identify hazards intentionally
introduced for purposes of economic
gain because the misbranding and
adulteration provisions of the FD&C Act
already sufficiently provide safeguards
against economic gain.
(Response 264) We agree with the
comments that state that the
requirement to consider hazards
intentionally introduced for purposes of
economic gain is narrow. Such hazards
will be identified in rare circumstances,
usually in cases where there has been a
pattern of economically motivated
adulteration in the past. In addition, we
define hazards to only include those
agents that have the potential to cause
illness or injury. Economically
motivated adulteration that affects
product integrity or quality, for
example, but not animal food safety, is
out of the scope of this rule. We
continue to believe that there is benefit
in taking this preventive approach to
economically motivated adulteration
and not relying solely on enforcing the
preexisting misbranding and
adulteration provisions of the FD&C Act
after a violation occurs.
As discussed in sections XL through
XLVII, we are finalizing supply-chain
program provisions. It is consistent with
the framework of this rule for a facility
to address hazards requiring a
preventive control that may be
intentionally introduced for purposes of
economic gain through the facility’s
supply-chain program.
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(Comment 265) Some comments
express concern about identifying
hazards that may be intentionally
introduced for purposes of economic
gain because there are potentially an
unlimited number of unknown or yet-tobe identified hazards that could be
intentionally introduced for purposes of
economic gain by an unscrupulous
supplier. These comments disagree with
our attempt to narrow the field of
potential scenarios for economically
motivated adulteration to circumstances
where there has been a pattern of such
adulteration in the past.
Some comments assert that our
attempt to narrow the field of potential
scenarios for economically motivated
adulteration is both too broad and too
narrow at the same time. These
comments assert that our attempt is too
broad, because we expect facilities to
consider patterns of adulteration from
the past ‘‘even though the past
occurrences may not be associated with
the specific supplier or the specific food
product’’ and a requirement to consider
every potential product and potential
supplier makes the task open ended.
These comments further assert that our
attempt is too narrow, because a focus
on patterns of adulteration in the past is
unlikely to reveal potential future
instances of economically motivated
adulteration and because those
intending to defraud purchasers for
economic gain are trying to avoid
detection. According to these
comments, once an animal food safety
related instance of economically
motivated adulteration is uncovered,
perpetrators quickly move to carry out
their fraudulent activities in a different
way. Some comments assert that there
are alternative ways to control hazards
that may be intentionally introduced for
purposes of economic gain without
specific regulatory requirements, such
as by having an effective supplier
approval program with appropriate
qualification and verification activities;
through business-to-business relations,
expectations, and contracts; and through
a vulnerability assessment and control
plan tailored specifically to
economically motivated adulteration.
(Response 265) We disagree that the
requirement is too broad. A facility must
conduct a hazard analysis for each type
of animal food manufactured,
processed, packed, or held at the
facility. There is no requirement to
consider every potential product or
potential supplier. We also disagree that
the requirement is too narrow. Some
individuals intending to defraud
purchasers for economic gain will
develop entirely novel ways of
adulterating food to suit their purposes.
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We agree that these circumstances may
not lend themselves to the preventive
approach required here. We encourage,
but do not mandate, that facilities adopt
other measures they deem appropriate
to mitigate the risks of economically
motivated adulteration that this
rulemaking does not address. Still, the
repeated use of melamine over the
years, in animal foods and in foods for
people, demonstrates that patterns of
economically motivated adulteration
can emerge and should be considered as
part of a hazard analysis.
(Comment 266) Some comments ask
us to limit the requirement to identify
hazards that may be introduced for
purposes of economic gain to only those
hazards that pose a risk to public health
for which there has been a pattern in the
past. Some comments assert that in
those few instances where a hazard was
intentionally introduced the underlying
intention was to defraud rather than to
cause harm, and the food safety hazard
was an unintended consequence. Some
comments ask us to focus the hazard
identification solely on inbound
products, because it is obvious that
hazards introduced by the facility itself
will not be prevented through a hazard
analysis. Some comments ask us to
narrow the scope of the requirement by
specifying that facilities focus on three
situations: (1) Situations in which there
has been a pattern of similar
adulteration in the past; (2) animal
foods or ingredients for which quality
assurance methods may not sufficiently
characterize the animal food or
ingredient to assure its identity, and; (3)
animal foods or ingredients for which
there are substitutes that are likely to be
harmful that would be considered
obvious to one skilled in food science.
(Response 266) We decline to make
the changes suggested in these
comments because they are
unnecessary. Because of our definition
of hazard, the requirement is already
limited to economically motivated
adulteration that is reasonably likely to
cause illness or injury. Under the final
rule, a facility does not need to identify
a hazard related to economically
motivated adulteration when there is no
risk to public health or when the
economically motivated adulteration is
not known or reasonably foreseeable.
We agree that the three circumstances
suggested by the comments are an
appropriate focus for facilities who seek
guidance on how to approach the
requirements, but decline the request to
specify these limitations of the scope in
the regulatory text. As already noted,
some comments assert that our attempt
to narrow the field of potential scenarios
for economically motivated adulteration
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is both too broad and too narrow at the
same time. (See Comment 265.)
Although we continue to believe that
the instances in which a facility will
identify a hazard intentionally
introduced for economic gain will be
rare, we also consider that limiting the
scope of the requirement in the
regulatory text would be both
prejudging the future and inconsistent
with the public health objectives of this
rule.
(Comment 267) Some comments ask
us to allow implementation of the major
provisions in FSMA before establishing
requirements to address economically
motivated adulteration. These
comments assert that economically
motivated adulteration requires a
completely different paradigm than
unintentional adulteration. In addition,
because economically motivated
adulteration is typically addressed
through product specifications, supplier
relationships, and good business
practices, implementation of these other
provisions of the animal food preventive
controls rule are likely to have a
positive effect on preventing
economically motivated adulteration.
(Response 267) We disagree that
economically motivated adulteration
requires a completely different
paradigm than unintentional
adulteration. Hazards intentionally
introduced for economic gain are
addressed here with the same
preventive framework as every other
hazard. As such, we do not see a
compelling reason to delay
implementation of the requirements to
address economically motivated
adulteration.
C. Proposed § 507.33(c) and (d)—
Evaluation of Whether a Hazard
Requires a Preventive Control
We proposed that the hazard analysis
must include an evaluation of the
identified hazards to assess the severity
of the illness or injury if the hazard
were to occur and the probability that
the hazard will occur in the absence of
preventive controls; and environmental
pathogens whenever an animal food is
exposed to the environment prior to
packaging and the packaged animal food
does not receive a treatment that would
significantly minimize the pathogen
(proposed § 507.33(c)(2)). We also
proposed that the hazard evaluation
must consider the effect of the following
on the safety of the finished animal food
for the intended consumer: (1) The
formulation of the animal food; (2) the
condition, function, and design of the
facility and equipment; (3) raw
materials and ingredients; (4)
transportation practices; (5)
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manufacturing/processing procedures;
(6) packaging activities and labeling
activities; (7) storage and distribution;
(8) intended or reasonably foreseeable
use; (9) sanitation, including employee
hygiene; and (10) any other relevant
factors (proposed § 507.33(d)(1) through
(10)).
(Comment 268) Some comments ask
us to revise the requirement to include
an evaluation of environmental
pathogens to avoid the implication that
an intervention is needed when there
may be other controls (such as pH or
formulation) that would significantly
minimize or prevent the pathogen.
These comments suggest that we revise
the provision to require that a hazard
evaluation include an evaluation of
environmental pathogens whenever a
food is exposed to the environment
prior to packaging and the packaged
food does not receive a treatment ‘‘or
otherwise include a control measure’’
that would significantly minimize the
pathogen.
(Response 268) We have revised the
provision on the hazard evaluation for
environmental pathogens to specify that
the packaged animal food does not
receive a treatment or otherwise include
a control measure (such as a formulation
lethal to the pathogen) that would
significantly minimize the pathogen. We
agree that controls such as formulation
can function as a ‘‘kill step’’ and that the
provision should make clear that such
controls can be used in lieu of
‘‘treatment.’’
(Comment 269) Some comments ask
us to clarify what we meant by ‘‘other
relevant factors’’ and note that natural
disasters (which we previously
discussed) (78 FR 64736 at 64785) are
‘‘usually exceptional events’’ that are
best managed in a facility crisis
management plan. Other comments ask
us to specify that the hazard evaluation
must consider any relevant geographic,
temporal, agricultural, or other factors
that may affect the severity or
probability of the hazard.
(Response 269) We included ‘‘other
relevant factors’’ to emphasize that the
list of factors in the provision is not an
exhaustive list and that a facility is
responsible for considering those factors
that play a role in its determination of
whether a potential hazard is a hazard
requiring a preventive control,
regardless of whether those factors are
listed in the provision. A facility that
already addresses circumstances such as
natural disasters in other plans may
consider the applicable part of those
plans to be part of its food safety plan
(see § 507.212).
We agree that geographic, temporal,
and agricultural factors are examples of
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‘‘other relevant factors.’’ For example,
hazards such as aflatoxin are subject to
a weather-dependent effect in that
aflatoxin levels in some RACs are more
of a problem in some years than in
others. We have added the temporal
nature of some hazards associated with
some RACs as an example of ‘‘other
relevant factors’’ to consider (see
§ 507.33(d)(10)).
(Comment 270) Some comments ask
us to specify that the hazard evaluation
be more specific about issues relevant to
raw materials and ingredients, including
how raw materials are selected and
shipped, how suppliers are evaluated,
and how shipments are inspected on
receipt.
(Response 270) We decline this
request. When a hazard requiring a
preventive control in a raw material or
other ingredient is controlled before
receipt, the receiving facility would
address such specifics in the supplychain program that would be required as
a preventive control (see subpart E).
(Comment 271) Some comments
assert that the proposed requirements
for hazard evaluation could be
interpreted in many ways. For example,
a facility could conclude that the
presence of a hand sink or boot dip
prior to entering the processing area will
reduce the likelihood of environmental
pathogens and that environmental
pathogens are not a significant hazard,
whereas a regulator could interpret this
provision to mean that a facility must
always consider an environmental
pathogen to be a significant hazard
when the criteria in the provision are
met, unless the facility can provide
evidence to the contrary.
(Response 271) We agree that the
requirements for hazard evaluation are
subject to alternative interpretations.
This is often the case, particularly when
a regulation is new. The provision
specifies that a facility must evaluate
whether an environmental pathogens is
a hazard requiring a preventive control
in particular circumstances, i.e.,
whenever a finished animal food (for
which an environmental pathogen is
identified as a hazard) is exposed to the
environment prior to packaging and the
packaged animal food does not receive
a treatment or otherwise include a
control measure (such as a formulation
lethal to the pathogen) that would
significantly minimize the pathogen.
The written hazard analysis must be
prepared (or its preparation overseen
by) a preventive controls qualified
individual (see § 507.31(b) and (c)(1)).
The preventive controls qualified
individual for a facility that determines
that an environmental pathogen is not a
hazard requiring a preventive control in
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such circumstances must document that
determination, and a regulator would
consider the adequacy of the
documented determination before
reaching a conclusion as to whether the
facility had failed to satisfy the
requirements. However, the use of a
hand sink or boot dip prior to entering
the processing areas to reduce the
likelihood of environmental pathogens
may also be considered to be part of the
sanitation controls for the
environmental pathogen.
(Comment 272) Some comments ask
us to focus on language that will clearly
differentiate between functions,
processes, and controls for facilities
with food safety plans that identify
microbial hazards and those that do not
identify microbial hazards, and other
known or reasonably foreseeable
hazards. These comments assert that
sanitation of objects and surfaces may
be appropriate for the former, but not
necessarily for the latter.
(Response 272) The facility is
responsible for conducting a hazard
analysis, and if hazards are identified
that require a preventive control, the
facility must consider the effect of
sanitation on the safety of the finished
animal food for the intended animal (see
§ 507.33(d)). Based on the outcome of its
hazard evaluation, the facility may
determine that sanitation is not an
appropriate preventive control for the
hazards it identified.
(Comment 273) Some comments
assert that a food safety plan and hazard
analysis should not include numerous
hazards and hazard analysis steps. Some
comments assert that hazard analysis
should not be as detailed (stringent) for
animal food as it is for human food.
These comments maintain that
prerequisite programs, which reduce the
likelihood of a potential hazard to the
point where the hazard is not
reasonably likely to occur, would satisfy
the requirement that the hazard be
adequately controlled, making it
unnecessary for a facility to include the
identified hazards in its hazard analysis
and preventive controls. Other
comments assert that many hazards can
be exclusively controlled through
prerequisite programs without a need
for CCPs.
(Response 273) While known and
reasonably foreseeable hazards and the
outcome of a hazard analysis for human
food and animal food may not be
identical, in each case the purpose of a
hazard analysis is to identify and
evaluate known or reasonably
foreseeable hazards for the type of food
manufactured, processed, packed, or
held to determine whether there are any
hazards requiring a preventive control.
As previously discussed in the 2013
animal food preventive control
proposed rule (78 FR 64736 at 64781),
the process of identifying and
evaluating the hazards that may occur
for specific types of animal food
handled in a facility provides an
efficient means for keeping track of
multiple hazards that may occur in a
facility that handles several types of
animal food. Such a process also
provides an efficient means for ensuring
that preventive controls are applied to
specific animal food products when
required. If a facility identifies a hazard
requiring a preventive control, the
facility must determine an appropriate
preventive control and include that
preventive control in its food safety
plan. A facility that establishes other
controls (such as those that the
comments describe as ‘‘prerequisite
programs’’) for hazards that are not,
based on the outcome of the facility’s
hazard analysis, ‘‘hazards requiring a
preventive control’’ would not need to
establish preventive control
management components for such
controls. However, some controls
previously established in ‘‘prerequisite
programs’’ would be considered
‘‘preventive controls.’’ We provide some
flexibility for facilities with respect to
how they manage preventive controls,
and the preventive control management
components may be different for
hazards that have been managed as
‘‘prerequisite programs’’ compared to
those managed with CCPs. The same
principles would apply for the hazards
a facility identifies as needing a
preventive control.
(Comment 274) Some comments
assert that the statutory language within
FSMA does not mandate that covered
animal food and pet food facilities
implement regulatory HACCP plans.
These comments further urge us to
remove reference to HACCP.
(Response 274) We agree that section
103 of FSMA does not mandate HACCP
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regulations; however, we have
concluded that HACCP is the
appropriate framework to reference in
interpreting and implementing section
103 of FSMA. For discussion, see
section II.C.2. of the 2013 proposed
preventive controls rule for human food
(78 FR 3646 at 3660).
(Comment 275) Some comments ask
us to allow consideration of both
severity and probability in the scientific
hazard analysis as this would be
consistent with international standards.
(Response 275) Section 507.33(c)(1)
requires that a hazard evaluation must
include an assessment of the severity of
the injury or illness if a hazard were to
occur and the probability that the
hazard will occur in the absence of
preventive controls.
For additional discussion of
comments on hazard analysis, see
section XXV in the final rule for
preventive controls for human food
published elsewhere in this issue of the
Federal Register.
XXVI. Subpart C: Comments on
Proposed § 507.36—Preventive Controls
(Final § 507.34)
We proposed requirements to identify
and implement preventive controls to
provide assurances that significant
hazards will be significantly minimized
or prevented and the animal food
manufactured, processed, packed, or
held by the facility will not be
adulterated under section 402 of the
FD&C Act. Some comments support the
proposed requirements without change.
For example, some comments agree that
preventive controls must be written and
include process controls, sanitation
controls, a recall plan, and other
controls as appropriate and necessary.
Some comments that support the
proposed provisions suggest alternative
or additional regulatory text or ask us to
clarify how we will interpret the
provision.
In the following sections, we discuss
comments that ask us to clarify the
proposed requirements or that disagree
with, or suggest one or more changes to,
the proposed requirements. After
considering these comments, we have
revised the proposed requirements as
shown in table 11, with editorial and
conforming changes as shown in table
31.
TABLE 11—REVISIONS TO THE PROPOSED REQUIREMENTS FOR PREVENTIVE CONTROLS
Section
Description
Revision
507.34(c)(1) .....................................
Process controls ............................
Clarify that the requirements for process controls depend on the role
of the process control in the food safety system.
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A. Proposed § 507.36(a)—Requirement
To Identify and Implement Preventive
Controls (Final § 507.34(a))
We proposed that you must identify
and implement preventive controls,
including at critical control points, if
any, to provide assurances that
significant hazards will be significantly
minimized or prevented and the animal
food manufactured, processed, packed,
or held by your facility will not be
adulterated under section 402 of the
FD&C Act. We also proposed that these
preventive controls include controls at
CCPs, if there are any CCPs, and
controls, other than those at CCPs, that
are also appropriate for animal food
safety.
Some comments support the
flexibility provided to facilities to
implement preventive controls that are
appropriate to the facility and the
animal food. Other comments support
the clarification, in the 2014
supplemental notice, that not all
preventive controls are established at
CCPs and that some food safety plans
will not have CCPs. We are finalizing
the provision as proposed with the
editorial and conforming changes in
table 31.
B. Proposed § 507.36(b)—Requirement
for Written Preventive Controls (Final
§ 507.34(b))
We proposed that preventive controls
must be written.
(Comment 276) Some comments ask
us to clarify whether documentation of
treatment by a ‘‘custom processor’’
would be accepted as a ‘‘written
preventive control’’ when the ‘‘custom
processor’’ controls the hazard.
(Response 276) The question posed by
these comments highlights the
difference between the records required
in the food safety plan and the records
documenting the implementation of the
food safety plan. The ‘‘written
preventive controls’’ are part of the food
safety plan, whereas the records
documenting treatment are
implementation records.
Implementation records documenting
treatment, whether by a facility or its
‘‘custom processor,’’ would not satisfy
the requirements for written preventive
controls. However, specifying that the
preventive control for a specific hazard
is a particular treatment by a ‘‘custom
processor,’’ along with information that
describes the treatment, would satisfy
the requirement for written preventive
controls.
C. Proposed § 507.36(c)(1)—Process
Controls (Final § 507.34(c)(1))
We proposed that preventive controls
include process controls as appropriate
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to the facility and the animal food.
Process controls include procedures,
practices, and processes to ensure the
control of parameters during operations
such as heat processing, irradiating, and
refrigerating animal foods. Process
controls must include, as appropriate to
the applicable control, parameters
associated with the control of the
hazard, and the maximum or minimum
value, or combination of values, to
which any biological, chemical, or
physical parameter must be controlled
to significantly minimize or prevent a
significant hazard.
(Comment 277) Some comments state
that assigning a parameter and
associated minimum and maximum
values for some process controls (such
as refrigeration (including freezing), or
water activity) may be possible, but not
be necessary for food safety. These
comments ask us to require minimum
and maximum values to be assessed
against the applicable food safety need,
or otherwise make clear that the
implications of not controlling
minimum and maximum values must be
assessed in light of the circumstances.
Other comments express concern that
‘‘as appropriate to the applicable
control’’ could be interpreted as
suggesting that if it is merely feasible to
establish parameters for a process
control, they must be established. Other
comments express concern that the
proposed requirement suggests that if a
parameter is not ‘‘controlled,’’ a
regulator could conclude that the
facility is not in compliance with the
rule because it necessarily has not
significantly minimized or prevented a
significant hazard.
Some comments recommend
incorporating recognition that the
degree of rigor in application of subpart
C parameters should be applied on a
sliding scale, commensurate with the
nature of the risk and the preventive
control used. The comments request
that the language in this section is
altered to indicate that the parameters
will not always be applicable.
(Response 277) See Response 293. We
have revised the regulatory text to
specify that process controls must
include parameters and minimum or
maximum values as appropriate to both
the nature of the applicable control and
its role in the facility’s food safety
system. We decline the request to
indicate that parameters of subpart C
will not always be applicable, as the
revised regulatory text provides
adequate flexibility for a facility to
determine what preventive controls,
including process controls, are
appropriate to the facility and its animal
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food, if a hazard requiring a preventive
control is identified.
(Comment 278) Some comments ask
us to delete the phrase ‘‘to significantly
minimize or prevent a significant
hazard.’’
(Response 278) We decline this
request. ‘‘Significantly minimize or
prevent a significant hazard’’ (which we
have revised to ‘‘significantly minimize
or prevent a hazard requiring a process
control’’) is the standard for controlling
the hazards. Although the phrase could
be viewed as redundant with the
standard in the requirement to identify
and implement preventive controls
(§ 507.34(a)(1)), repeating that standard
in the requirements for parameters and
the minimum or maximum values
associated with control of the hazard
emphasizes the standard, which is
appropriate for process controls.
D. Proposed § 507.36(c)(2)—Sanitation
Controls (Final § 507.34(c)(2))
We proposed that preventive controls
include, as appropriate to the facility
and the animal food, sanitation controls
that include procedures, practices, and
processes to ensure that the facility is
maintained in a sanitary condition
adequate to significantly minimize or
prevent hazards such as environmental
pathogens and biological hazards due to
employee handling. We also proposed
that sanitation controls must include
procedures, practices, and processes for
the cleanliness of animal food-contact
surfaces, including animal food-contact
surfaces of utensils and equipment, and
procedures for the prevention of crosscontamination from insanitary objects
and from personnel to animal food,
animal food packaging material, and
other animal food-contact surfaces and
from raw product to processed product.
(Comment 279) One comment states
that sanitation is not always a feasible
step for facilities handling animal food,
especially in dry blending facilities and
dry storage operations. The comment
asks us to remove the reference to
‘‘sanitary condition’’ and replace it with
language consistent with the GMP
section such as ‘‘to ensure the facility is
adequately cleaned and properly
maintained to significantly minimize or
prevent hazards.’’
(Response 279) We decline this
request. The sanitation controls are
flexible so that a facility can determine
what sanitation controls are necessary
for their facility and animal food if they
identify a hazard requiring sanitation
controls as a preventive control.
Replacing the term ‘‘sanitary condition’’
with the suggested language would not
improve the flexibility of the sanitation
control requirements.
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(Comment 280) Some comments
assert that sanitation controls are not
necessary to prevent any hazards in
distribution facilities where animal
food-contact surfaces are not present.
Other comments assert that sanitation
controls should be required in all cases
(rather than ‘‘as appropriate’’) given
their central importance.
(Response 280) Under the framework
established by FSMA, and implemented
in this rule, each facility determines
through its hazard analysis when
sanitation controls are necessary to
control a hazard requiring a preventive
control. The rule neither establishes
circumstances (such as in distribution
centers) where sanitation controls are
not necessary nor prejudges whether
sanitation controls are necessary in
specific circumstances. Although we do
not expect that facilities such as
distribution centers would determine
through their hazard analysis that
sanitation controls are required, we do
expect all animal food establishments
that are subject to the CGMP
requirements established in subpart B to
fully comply with the applicable
requirements for sanitation.
(Comment 281) One comment states
that sanitation is discussed in two
sections, as a CGMP and as a preventive
control, and asks that all of the
discussion related to sanitation is
moved to one section.
(Response 281) The two sections
discuss sanitation for different
purposes. The requirements for general
sanitation are located in the CGMP
regulations, which may be considered
prerequisites to the preventive controls.
The requirements for sanitation as a
preventive control are specific for
controlling an identified hazard.
Sanitation activities conducted at a
facility may be different depending on
whether the sanitation activity is used
as general facility sanitation or
specifically to control a hazard. Also,
sanitation as a preventive control is
subject to the management components
of § 507.39.
E. Proposed § 507.36(c)(3)—Supplier
Controls (Final § 507.34(c)(3))
We proposed that supplier controls
include the supplier program. See the
discussion of comments on the supplychain program, now in subpart E, in
sections XL through XLVII.
F. Proposed § 507.36(c)(4)—Recall Plan
(Final § 507.34(c)(4))
We proposed that preventive controls
include, as appropriate, a recall plan as
would be required by proposed
§ 507.38. See the discussion of
comments on the recall plan in section
XXVIII.
G. Proposed § 507.36(c)(5)—Other
Controls (Final § 507.34(c)(5))
We proposed that preventive controls
include any other procedures, practices,
and processes necessary to satisfy the
requirements of paragraph (a) of this
section. Examples of other controls
include hygiene training and other
current good manufacturing practices.
(Comment 282) Some comments ask
us to specify that preventive controls
include controls on raw materials and
other ingredients.
(Response 282) The final rule
specifies that preventive controls
include supply-chain controls as
appropriate to the facility and the
animal food. The request of these
comments is addressed by the
requirements for the supply-chain
program (see § 507.34(c)(3) and subpart
E).
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(Comment 283) One comment asks us
to require compliance with the good
manufacturing and feeding practices
that apply to GRAS substances, found in
§ 582.1(b), as a preventive control.
(Response 283) Facilities required to
register that manufacture, process, pack,
or hold GRAS substances are subject to
this final rule, including applicable
preventive controls requirements.
Preventive controls are intended to
address certain known or reasonably
foreseeable hazards, not an animal food
facility’s compliance with the good
manufacturing and feeding practices of
§ 582.1(b), although a facility may
determine that a good manufacturing
practice is a preventive control for a
particular hazard.
XXVII. Subpart C: Circumstances in
Which the Owner, Operator or Agent in
Charge of a Manufacturing/Processing
Facility Is Not Required To Implement
a Preventive Control (Final §§ 507.36
and 507.37)
In the 2014 supplemental notice, we
provided an opportunity for public
comment on potential requirements for
a supplier program as a preventive
control, including comments on when a
supplier program would not be
required. As discussed in more detail in
section XL, we have revised the phrase
‘‘supplier program’’ to ‘‘supply-chain
program’’ throughout the regulatory
text. As summarized in table 12 and
discussed more fully in the following
paragraphs, after considering comments
on when a supplier program would not
be required, we are establishing two
new provisions. Although both sets of
provisions have an effect on the
required supply-chain program, they
will be implemented outside the
framework of a supply-chain program.
TABLE 12—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF
A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL
Proposed section
designation
Description
507.36(a)(1) ............
N/A .....................................
507.36(a)(2) ............
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Final section
designation
507.37(a)(1)(ii)(C) ...............
A manufacturer/processor is not required to implement a
preventive control if it determines and documents that
the type of animal food could not be consumed without
application of an appropriate control.
A manufacturer/processor is not required to implement a
preventive control if it relies on its customer, who is subject to the requirements for hazard analysis and riskbased preventive controls in subpart C, to ensure that
the identified hazard will be significantly minimized or
prevented and both: (1) Discloses in documents accompanying the animal food that the animal food is ‘‘not
processed to control [identified hazard]’’ and (2) annually
obtains from its customer written assurance that the customer has established and is following procedures that
will significantly minimize or prevent the identified hazard.
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Includes a requirement for
documentation that the animal food is ‘‘not processed
to control [identified hazard].’’
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TABLE 12—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF
A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL—Continued
Proposed section
designation
Description
507.36(a)(3) ............
.............................................
507.36(a)(4) ............
507.37(a)(1)(ii)(C) ...............
507.36(a)(5) ............
N/A .....................................
507.36(b) ................
507.37(g)(3) ........................
A manufacturer/processor is not required to implement a
preventive control if it relies on its customer who is not
subject to the requirements for hazard analysis and riskbased preventive controls in subpart C to provide assurance it is manufacturing, processing, or preparing the
animal food in accordance with applicable animal food
safety requirements and it: (1) Discloses in documents
accompanying the animal food, in accordance with the
practice of the trade, that the animal food is ‘‘not processed to control [identified hazard]’’ and (2) annually obtains from its customer written assurance that it is manufacturing, processing, or preparing the animal food in accordance with applicable animal food safety requirements.
A manufacturer/processor is not required to implement a
preventive control if it relies on its customer to ensure
that the animal food will be processed to control the
identified hazard by an entity in the distribution chain
subsequent to the customer and both: (1) Discloses in
documents accompanying the animal food that the animal food is ‘‘not processed to control [identified hazard]’’
and (2) annually obtains from its customer written assurance that the customer will both disclose the information
that the animal food is ‘‘not processed to control [identified hazard]’’ and will only sell to another entity that
agrees, in writing, it will either follow procedures that will
significantly minimize or prevent the identified hazard (if
the entity is subject to subject to the requirements for
hazard analysis and risk-based preventive controls in
subpart C) or manufacture, process, or prepare the animal food in accordance with applicable animal food safety requirements (if the entity is not subject to the requirements for hazard analysis and risk-based preventive controls in subpart C) or obtain a similar written assurance
from the entity’s customer.
A manufacturer/processor is not required to implement a
preventive control if it has established, documented, and
implemented a system that ensures control, at a subsequent distribution step, of the hazards in the animal food
product it distributes and documents the implementation
of that system.
Records documenting the applicable circumstances in
§ 507.36(a).
507.36(c) .................
N/A .....................................
507.36(d) ................
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Final section
designation
N/A .....................................
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If a customer of the manufacturer/processer has determined that the identified hazard is not a hazard in the
animal food intended for use for a specific animal species, the customer may provide this determination (including animal species and why the identified hazard is
not a hazard) in its written assurance under
§ 507.36(a)(2)(ii) instead of providing assurance of procedures established and followed that will significantly minimize or prevent the identified hazard.
If a customer of the customer of the manufacturer/
processer (i.e., another entity in the distribution chain)
has determined that the identified hazard is not a hazard
in the animal food intended for use for a specific animal
species, the entity may provide this determination (including animal species and why the identified hazard is
not a hazard) in its written assurance under
§ 507.36(a)(4)(ii)(B instead of providing assurance of procedures established and followed that will significantly
minimize or prevent the identified hazard.
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• Addresses the circumstance where an entity
(other than the facility’s
customer) in the distribution chain controls the hazard
• Includes a requirement for
documentation that the animal food is ‘‘not processed
to control [identified hazard].’’
N/A.
Includes a requirement for
documentation of the additional circumstances in
which a manufacturer/processor is not required to implement a preventive control.
N/A.
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TABLE 12—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF
A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL—Continued
Proposed section
designation
507.37 .....................
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Final section
designation
N/A .....................................
The first provision allows a
manufacturer/processor to not
implement a preventive control if the
manufacturer/processor determines and
documents that the type of animal food
could not be consumed without
application of the appropriate control by
an entity in the supply or distribution
chain other than that manufacturer/
processor (see § 507.36(a)(1)). We
describe comments leading to this
provision, and our response to those
comments, in Comment 284 and
Response 284 respectively. Although we
are establishing these provisions outside
the framework of the supply-chain
program, these provisions continue to
play a role in the requirements for a
supply-chain program, because they
also provide an exception to the
requirements for a manufacturer/
processor to establish and implement a
supply-chain program.
The second provision relates to
comments we received on a proposed
exception to the requirement for a
manufacturer/processor to establish and
implement a supplier program
(proposed § 507.37(a)(1)(ii)(C)). (See
Comment 285). Under proposed
§ 507.37(a)(1)(ii)(C), a receiving facility
would not have been required to have
a supplier program if it relied on its
customer to control the hazard and
annually obtained from its customer
written assurance that the customer has
established and is following procedures
(identified in the written assurance) that
will significantly minimize or prevent
the hazard. As discussed in Response
285, we are replacing this provision
with several provisions that apply when
a manufacturer/processor identifies a
hazard requiring a preventive control
(‘‘identified hazard’’), does not control
the identified hazard, but can
demonstrate and document that the
identified hazard will be controlled by
an entity in its distribution chain. A
manufacturer/processor that satisfies the
criteria in these provisions will not be
required to implement a preventive
control for the identified hazard. Under
these provisions, the combination of
three requirements will provide
adequate assurance that the animal food
will be processed to control the
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Description
A
facility that provides a written assurance under
§ 507.36(a)(2), (3), or (4) must act consistently with the
assurance and document its actions taken to satisfy the
written assurance.
identified hazard before it reaches
consumers. These requirements are: (1)
Documentation provided by the
manufacturer/processor to its direct
customer that the animal food is ‘‘not
processed to control [identified
hazard]’’; (2) written assurances from
customers regarding appropriate
procedures to ensure that the animal
food will receive further processing to
control the identified hazards; and (3)
provisions relating to accountability for
written assurances. (In these provisions,
‘‘customer’’ means a commercial
customer, not a consumer.)
(Comment 284) Some comments
express concern about the ability for
distributors/cooperatives identify the
individual raw material or other
ingredient supplier when the supplier
that applied the control is more than
one step back in the food chain. Some
comments assert that receiving facilities
should not be required to verify
suppliers with which they do not have
a direct commercial relationship. For
example, in the case of the soybean
supply chain, the U.S. processing
facility likely has no direct relationship
with the many farms involved in the
growing and harvesting of the soybeans.
Some comments ask for an exemption
from supplier verification activities for
animal foods such as soybeans because
it is problematic to have a requirement
that potentially could necessitate trace
back to farms.
(Response 284) We are establishing a
provision, applicable to both the supply
chain and the distribution chain of a
manufacturer/processor, for a
circumstance when a manufacturer/
processor does not need to implement a
preventive control. We are providing
that a manufacturer/processor does not
need to implement a preventive control
if it determines and documents that the
type of animal food could not be
consumed without application of the
appropriate control (see § 507.36(a)(1)).
However, depending on the facility, the
raw material or other ingredient, and the
type of animal food produced by the
manufacturer/processor, there may be
some circumstances where a
manufacturer/processor could
determine that a particular animal food
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N/A.
that passes through its facility satisfies
the criterion ‘‘could not be consumed
without application of the appropriate
control.’’ In other cases, a facility may
have determined through its hazard
analysis that there are no hazards
requiring a preventive control, and will
not consider whether one of the
circumstances in new § 507.36 apply.
As a consequential addition, new
§ 507.36(b) specifies the records that a
manufacturer/processor would need to
satisfy the documentation requirements
established in new § 507.36(a)(1), and
we have added new § 507.36(b) to the
list of implementation records (§ 507.55)
that are subject to the recordkeeping
requirements of subpart F.
See also Comment 429, in which we
discuss comments asking us to add
flexibility to the requirements for a
supply-chain program such that any
entity other than the receiving facility
can perform supplier verification
activities. As discussed in Response
429, the rule provides additional
flexibility in the supply-chain program
with regard to who can perform certain
activities (see § 507.115).
(Comment 285) Some comments ask
us to delete the criterion for control of
the hazard by the receiving facility’s
customer, with annual written
assurance that the customer had
established and was following
procedures (identified in the written
assurance) that would significantly
minimize or prevent the hazard. The
stated reasons varied. For example,
some comments state that a receiving
facility may have so many customers
that it is not possible to obtain written
assurance annually from all customers.
Other comments express concern that a
customer may be unwilling to describe
confidential trade secrets in order to
identify in writing the procedures the
customer has established and is
following to control the hazard. Other
comments express concern about ‘‘legal
issues’’ when a receiving facility needs
to assess the adequacy of the customers’
procedures for controlling a hazard
because under current business
practices a vendor can provide
assurance to a buyer (its customer), but
buyers do not typically provide such
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assurance to vendors. Some comments
express concern that written assurance
does not guarantee that the customer is
actually doing anything to significantly
minimize or prevent the hazard.
Some comments ask us to provide an
alternative that would allow the
receiving facility to provide
documentation to its customer about a
hazard that needs a preventive control
at a processing facility later in the
distribution chain rather than obtain
written assurance that its customer will
control a hazard. If written assurance
must be required, these comments ask
us to allow the written assurance
provided by the customer to state that
the customer would evaluate the hazard
and if necessary establish and follow
procedures to significantly minimize or
prevent the hazard.
Some comments state the receiving
facility may not know the identity of all
its ultimate customers, particularly if
the receiving facility sells its products to
a distributor who then sells to other
entities. Some comments ask us to
provide flexibility for facilities to
determine whether annual updates of
written assurance are necessary. Other
comments ask us to specify that a
receiving facility need not establish and
implement a supplier program for raw
materials and ingredients intended for
further processing.
Some comments assert that the
presence of low levels of pathogens on
a raw product that will be subject to a
lethal process further downstream does
not pose a risk to the consumer, and
should not be considered a significant
hazard (i.e., a hazard requiring a
preventive control). These comments
also assert that if we maintain that
Salmonella contamination is a
significant hazard for each member of
the supply chain, then we should allow
the preventive control to be applied in
a subsequent step at another facility.
Other comments ask us to clarify that a
facility would not need to develop
preventive controls where it produces
raw materials or ingredients that are
subject to subsequent processing that
will address known or reasonably
foreseeable hazards.
(Response 285) We are establishing
several provisions, specifically
applicable to the distribution chain of a
manufacturer/processor, for
circumstances when a manufacturer/
processor does not need to implement a
preventive control (§§ 507.36(a)(2), (3),
(4), and (5); 507.36(b)(2), (3), (4) and (5);
507.36(c); 507.36(c) and (d), 507.37; and
507.215). See Response 284 for another
new provision that applies to the supply
chain in addition to the distribution
chain (§ 507.36(a)(1)).
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Under the first of these provisions
(§ 507.36(a)(2)), a manufacturer/
processor is not required to implement
a preventive control if it relies on its
customer (who is subject to the
requirements for hazard analysis and
risk-based preventive controls in
subpart C) to ensure that the identified
hazard will be significantly minimized
or prevented and: (1) Discloses in
documents accompanying the animal
food, in accordance with the practice of
the trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and (2) annually obtains from
its customer written assurance, subject
to the requirements of § 507.37, that the
customer has established and is
following procedures (identified in the
written assurance) that will significantly
minimize or prevent the hazard. The
manufacturer/processor would include
the specific hazard requiring a
preventive control (e.g., Salmonella)
where the statement says ‘‘[identified
hazard].’’ A facility that provides the
written assurance must act consistently
with the assurance and document its
actions taken to satisfy the written
assurance (see new § 507.37). The
documents could be bills of lading or
other papers that accompany the animal
food or labels on the containers of the
animal food.
Under the second of these provisions,
(§ 507.36(a)(3)), a manufacturer/
processor is not required to implement
a preventive control if it relies on its
customer (who is not subject to the
requirements for hazard analysis and
risk-based preventive controls in
subpart C), to provide assurance it is
manufacturing, processing, or preparing
the animal food in accordance with
applicable animal food safety
requirements and it: (1) Discloses in
documents accompanying the animal
food, in accordance with the practice of
the trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and (2) annually obtains from
its customer written assurance that it is
manufacturing, processing, or preparing
the animal food in accordance with
applicable animal food safety
requirements. By ‘‘customer who is not
required to implement preventive
controls under this part’’ we mean
entities such as qualified facilities and
retail food establishments.
Under the third of these provisions
(§ 507.36(a)(4)), a manufacturer/
processor is not required to implement
a preventive control if it relies on its
customer to provide assurance that the
animal food will be processed to control
the identified hazard by an entity in the
distribution chain subsequent to the
customer and: (1) Discloses in
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documents accompanying the animal
food, in accordance with the practice of
the trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and (2) annually obtains from
its customer written assurance, subject
to the requirements of § 507.37, that the
customer will disclose in documents
accompanying the animal food, in
accordance with the practice of the
trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’. The manufacturer/processor
also must obtain written assurance that
its customer will only sell to another
entity that agrees, in writing, it will
either: (1) Follow procedures (identified
in a written assurance) that will
significantly minimize or prevent the
hazard (if the entity is subject to the
requirements for hazard analysis and
risk-based preventive controls in
subpart C), or manufacture, process, or
prepare the animal food in accordance
with applicable animal food safety
requirements (if the entity is not subject
to the requirements for hazard analysis
and risk-based preventive controls in
subpart C) or (2) obtain a similar written
assurance from the entity’s customer.
Under the fourth of these provisions
(§ 507.36(a)(5)), a manufacturer/
processor is not required to implement
a preventive control if it has established,
documented, and implemented a system
that ensures control, at a subsequent
distribution step, of the hazards in the
animal food product it distributes and
documents the implementation of that
system. Comments did not provide
examples of such a system, but we do
not want to preclude the development
of such systems.
We have added several other
requirements related to the four new
provisions that we are specifically
establishing as circumstances in which
a manufacturer/processor need not
implement a preventive control. As
already noted in this response, new
§ 507.37 requires that a facility that
provides a written assurance must act
consistently with the assurance and
document its actions taken to satisfy the
written assurance. In addition, new
§ 507.36(b)(2), (3), (4), and (5) specify
the records that a manufacturer/
processor would need to satisfy the
documentation requirements
established in new § 507.36(a)(2), (3), (4)
and (5), and new § 507.215 establishes
requirements applicable to the written
assurance between a manufacturer/
processor and its customer. Taken
together, the provisions of §§ 507.37 and
507.215 establish legal responsibilities
for a facility that provides a written
assurance under § 507.36(a)(2), (3) or
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(4), even if that facility is not a
manufacturer/processor.
The point of these provisions is to
ensure that hazards that a manufacturer/
processor has determined, through its
hazard analysis, require a preventive
control, but are not controlled in the
supply chain before the manufacturer/
processor or by the manufacturer/
processor itself, are in fact controlled by
a subsequent entity in the distribution
chain. With the assurance from the
manufacturer/processor’s customer that
the hazards will be controlled after the
animal food product leaves the
manufacturer/processor it is not
necessary for the first manufacturer/
processor to implement the applicable
preventive control. We continue to
believe that annual written assurance
from a manufacturer/processor’s direct
customer is an appropriate mechanism
to ensure that its customer is aware of
the identified hazard and is taking steps
to ensure that the animal food is
processed to control the identified
hazard. We do not believe that a
manufacturers/processor will need all of
the details of its customer’s process to
satisfy the requirement to state in
writing the procedures the customer has
established and is following to control
the hazard. For example, the customer
could merely state that its
manufacturing processes include a
lethality step for microbial pathogens of
concern.
We agree that it is appropriate to
require that the manufacturer/processor
provide documentation to its customer
indicating that the animal food must be
processed to control an identified
hazard. Such documentation will be a
means of clear communication from the
manufacturer/processor to its customer.
When the hazard will not be controlled
by the customer, the customer will still
have documentation that can be passed
on to the entity that is expected to
process the animal food to control the
identified hazard, so that it will be very
clear to that entity that the identified
hazard still needs to be controlled.
We understand that not all identified
hazards in an animal food will be a
hazard to all species of animals. For
example, we consider all serotypes of
Salmonella to be a hazard for dog and
cat food. However, we would not
consider Salmonella Heidelberg a
hazard in food for cattle. Therefore, we
have added provisions to allow this
determination to be included in the
customer’s written assurance regarding
an identified hazard so that the
customer will not be required to assure
it is controlling a hazard that it has
determined does not need to be
controlled for a specific animal species.
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For the written assurance required by
§ 507.36(a)(2)(ii), new paragraph (c) of
this section provides that if the
customer has determined that the
identified hazard is not a hazard in the
animal food intended for use for a
specific animal species, the customer’s
written assurance may provide this
determination (including animal species
and why the identified hazard is not a
hazard) instead of providing assurance
of procedures established and followed
that will significantly minimize or
prevent the identified hazard.
For the written assurance required by
§ 507.36(a)(4)(ii)(B), new paragraph (d)
of this section provides that if the entity
in the distribution chain subsequent to
the customer is subject to subpart C and
has determined that the identified
hazard is not a hazard in the animal
food intended for use for a specific
animal species, that entity’s written
assurance may provide this
determination (including animal species
and why the identified hazard is not a
hazard) in its written assurance instead
of providing assurance that the
identified hazard will be significantly
minimized or prevented.
(Comment 286) Some comments that
ask us to delete the proposed
requirement to maintain the written
assurance as a record. Other comments
ask us to revise the regulatory text of the
documentation requirement to focus on
documentation that (1) the receiving
facility has notified its customers of the
existence of actual or potential hazards
in animal food provided to them by the
receiving facility; or (2) the receiving
facility has notified its customers of the
existence of actual or potential hazards
in animal food provided to them by the
receiving facility and has received a
written assurance that the customer will
evaluate the hazard and, if necessary,
will follow procedures to significantly
minimize or prevent the hazard.
(Response 286) We decline this
request. As already discussed in this
section, it is the combination of
requirements (i.e., for documentation
that the animal food is ‘‘not processed
to control [identified hazard]’’;
assurance from customers regarding
appropriate procedures to ensure that
the animal food will receive further
processing to control the identified
hazards; and provisions relating to
accountability for written assurances)
that will provide adequate assurance
that the animal food will be processed
to control the identified hazard before it
reaches consumers. Records
documenting the written assurances are
a key component of the provisions.
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XXVIII. Subpart C: Comments on
Proposed § 507.38—Recall Plan
We proposed that you must establish
a written recall plan for animal food
with a significant hazard and that the
recall plan must include certain
procedures. Some comments support
the proposed requirements without
change. For example, some comments
express the view that a written recall
plan is critical in the event of a system
breakdown where adulterated animal
foods have been distributed. Some
comments that support the proposed
requirements suggest alternative or
additional regulatory text or other
changes.
In the following paragraphs, we
discuss comments that ask us to clarify
the proposed requirements or that
disagree with, or suggest one or more
changes to, the proposed requirements.
After considering these comments, we
are finalizing the requirements as
proposed with the conforming revision
to use the term ‘‘hazard requiring a
preventive control’’ rather than
‘‘significant hazard.’’ See Response 62
and table 31. As discussed in section
XXVII, we are establishing a provision
applying to certain assurances in
§ 507.37.
A. Proposed § 507.38(a)—Requirement
for a Written Recall Plan
We proposed that you must establish
a written recall plan for animal food
with a significant hazard.
(Comment 287) Some comments ask
us to require a written recall plan for all
animal food (rather than just for animal
food with a significant hazard) and to
establish the requirements for a written
recall plan as CGMP requirements in
subpart B rather than as part of the
requirements for hazard analysis and
risk-based preventive controls in
subpart C. These comments assert that
all products can be subject to a recall.
These comments contrast recall plans
with other preventive controls in that
recall plans are often specific to a firm
or facility, but rarely are specific to
particular animal foods. In addition,
these comments note that a recall may
be administered and managed at the
corporate office rather than at the
specific manufacturing facility that
produced the animal food.
Some comments note the
requirements for a written recall plan
are sufficiently different from other
provisions in subpart C that we
proposed to specify that the recall plan
would not be subject to the preventive
control management requirements for
monitoring, corrective actions, and
verification (see § 507.39(c)). Other
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comments assert that a recall plan is not
a preventive control because it deals
with products after they have been
produced. Some comments note that
facilities that are exempt from the
requirements of subpart C, but remain
subject to the CGMP requirements,
would not be required to have a recall
plan unless we establish the
requirements in subpart B. Other
comments note that the requirement for
a recall plan is only if there is a hazard
that requires a preventive control, but
assert that a recall should only be
initiated if a hazard has actually been
identified to be present in the product.
Some comments note that our
authority to require recall plans is not
limited to section 418 of the FD&C Act
and that we can use other legal
authority to impose a requirement for
recall plans in subpart B. Some
comments note that FSMA specifically
amended the FD&C Act to provide us
with the authority to mandate a food
recall (section 423 of the FD&C Act).
These comments assert that it would be
reasonable for us to conclude that in
order to efficiently carry out section 423
of the FD&C Act we should issue
requirements governing the conduct of
recalls, because section 423 of the FD&C
Act requires that we provide a firm with
an opportunity to voluntarily recall a
product before issuing an order to the
firm to cease distribution and recall a
product.
(Response 287) We decline the
request to establish requirements for a
written recall plan as a CGMP
requirement in subpart B and are
establishing the requirements as a
preventive control in subpart C as
proposed. We acknowledge that a recall
plan would be useful to all animal food
establishments, and we encourage all
animal food establishments to have a
recall plan. However, the report issued
by the human food CGMP
Modernization Working Group did not
identify the lack of a written recall plan
as something that needed to be changed
(Ref. 41). (See 78 FR 3646 at 3651, the
proposed rule for preventive controls for
human food, for a discussion of the
CGMP Modernization Working Group
and the process leading to its report.)
However, going forward we intend to
monitor whether the lack of a broader
requirement for a recall plan leads to
problems when animal food
establishments that are not subject to
the requirements of subpart C are faced
with recall situations. As we gain
experience with the impact of the new
requirement for a recall plan on those
facilities subject to subpart C, we can
reassess at a later date whether to
conduct rulemaking to broaden the
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requirement to apply to all animal food
establishments subject to the CGMP
requirements in subpart B. For now,
animal food establishments that are not
subject to subpart C can continue to
follow our longstanding recall policy in
part 7 (21 CFR part 7).
Consistent with the overall framework
of FSMA, a recall plan (like other
preventive controls) is only required
when the facility has identified a hazard
requiring a preventive control. A facility
could establish a recall plan that applies
to other animal foods it manufactures.
We recognize that recalls may be
managed by the corporate office of a
firm rather than at the specific
manufacturing facility that produced the
animal food. Nothing in the rule
precludes this approach. In such cases
the corporate recall policy would be
reflected in a facility’s recall plan. (See
also Response 239.) In addition, a
facility that identifies one or more
hazards requiring a preventive control
in multiple animal food products could
use the same recall plan for all
applicable animal food products.
The rule specifies that the
requirements for preventive control
management components (i.e.,
monitoring, corrective actions and
corrections, and verification) apply as
appropriate to ensure the effectiveness
of the preventive control, taking into
account the nature of the preventive
control (§ 507.39(a)). As previously
discussed, the preventive control
management components are directed at
animal food that remains at the facility,
whereas the recall plan addresses
animal food that has left the facility (78
FR 64736 at 64788). Our determination
that the nature of the recall plan does
not require these preventive control
management components demonstrates
the flexibility provided by FSMA and
this rule, not that the recall plan must
be considered a CGMP rather than a
preventive control.
We have not yet made a
determination of whether we should
issue requirements governing the
conduct of recalls, rather than rely on
the guidelines in part 7, in order to fully
implement section 423 of the FD&C Act.
However, we have issued a draft
guidance entitled ‘‘Draft Guidance for
Industry: Questions and Answers
Regarding Mandatory Food Recalls’’
which, when finalized, would address
topics such as the criteria for a
mandatory recall and the process that
FDA must follow for a mandatory recall
(Ref. 42).
(Comment 288) Some comments ask
us to cross-reference the provisions of
part 7 (21 CFR part 7) rather than
establish requirements that these
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comments assert would be duplicative
with the provisions of part 7. These
comments ask us to address any more
substantive requirements than are
already in part 7 as part of a review of
part 7. These comments assert that part
507 should require a written recall plan,
but not require a written recall plan for
the animal food, to be consistent with
the approach of part 7.
(Response 288) We decline these
requests. Part 7 addresses enforcement
policy and the provisions for recalls in
subpart C of part 7 are ‘‘Guidance on
Policy, Procedures, and Industry
Responsibilities.’’ These recall
provisions do not establish
requirements and are not binding on
industry. They also are broadly directed
to recalls for all FDA-regulated
products, not just food. As already
discussed in Response 284, nothing in
this rule would prevent a facility that
establishes a recall plan for a particular
animal food from using that recall plan
for any animal food product that the
facility decides to recall.
(Comment 289) Some comments
request that we have separate recall
program requirements for human food
by-products so that by-products
produced during the manufacture of
food and sold, or otherwise provided,
for use in animal food would not be
recalled if the product for people is
recalled. Other comments assert we will
need to define the criteria for an animal
food recall in guidance.
(Response 289) We decline the
request to have separate recall program
requirements for human food byproducts for use as animal food.
Whether or not the by-product of a
human food that is recalled should itself
be recalled may depend on assessment
of several factors such as what the
hazard is, whether the hazard for which
the human food is recalled is also a
hazard for the animal(s) that consume
the by-product, and where the hazard
occurred in the manufacturing process.
We have previously addressed the
request for guidance. (See Response 1.)
B. Proposed § 507.38(b)—Procedures
That Describe the Steps To Be Taken,
and Assign Responsibility for Taking
Those Steps
We proposed that the recall plan must
include procedures that describe the
steps to be taken, and assign
responsibility for taking those steps, to
perform the following actions as
appropriate to the facility: (1) Directly
notify the direct consignees of the
animal food being recalled, including
how to return or dispose of the affected
animal food; (2) notify the public about
any hazard presented by the animal
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food when appropriate to protect human
or animal health; (3) conduct
effectiveness checks to verify that the
recall is carried out; and (4)
appropriately dispose of recalled animal
food (e.g., through reprocessing,
reworking, diverting to another use that
would not present a safety concern, or
destroying). We requested comment on
whether: (1) The proposed procedures
are appropriate for all types of facilities;
(2) we should require a recall plan to
include procedures and assignment of
responsibility for notifying FDA of
recalls subject to the plan; and (3) we
should include a requirement for a
mock recall as a verification activity.
(Comment 290) Some comments ask
us to delete the proposed requirement
that the recall plan include procedures
for a facility to notify the public about
any hazard presented by the animal
food when appropriate to protect public
health. These comments assert that such
a requirement would be highly
subjective and create a nebulous
regulatory burden that could subject
facilities to unnecessary regulatory
oversight and enforcement actions.
Other comments indicate that the
requirement for notifying the public
should specifically prevent silent recalls
when manufacturers pull products from
store shelves without consumer
notification.
(Response 290) We decline this
request. Our guidance for a recall
strategy has long recommended issuing
a public warning to alert the public that
a product being recalled presents a
serious hazard to health in urgent
situations where other means for
preventing use of the recalled product
appear inadequate (§ 7.42(b)(2)).
Operationally, such notification to the
public is so common that our current
home page on our Internet site (Ref. 43)
gives prominence to recall information
and we have established a free email
subscription service for updates on
recalls (Ref. 44). Consistent with the
longstanding recall policy in part 7,
subpart C, the proposed requirement
qualifies that the notification to the
public is ‘‘when appropriate to protect
public health.’’ A market withdrawal of
a product (see § 7.3(j)) is not a recall that
would be subject to public notification.
(Comment 291) Some comments ask
us to specify that the procedures require
facilities to notify us about a recall to
ensure that all suppliers, retailers, and
consumers will have adequate
notification of the recall action. Other
comments agree that it is important for
facilities to involve us in a recall
situation as soon as possible, but assert
that the best way to address such a
notification is through the existing RFR
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system. These comments assert that
additional procedures or means to
notify us would involve unnecessary
additional steps and be duplicative,
with no improvement to the public
health. Some comments assert that if the
recall is issued by a foreign facility, the
responsibility should be with the
importer of the product for notifying
FDA. Some comments ask us to specify
that the appropriate State regulatory
Agency with inspection jurisdiction be
notified in the event of a recall.
(Response 291) We agree with
comments that it is important to notify
us about a recall and that doing so can
help to ensure that suppliers, retailers,
and consumers will have adequate
notification of the recall action. We also
agree that the existing procedures to
notify us through the RFR system can
accomplish this goal when an animal
food presents a risk of serious adverse
health consequences or death and that
it therefore is not necessary to duplicate
the notification procedures already
established in the RFR system in part
507. However, we encourage facilities to
include in their recall plan any
procedures they have to comply with
the RFR or to include a cross-reference
to those procedures. Doing so may save
time, which is critical during a recall.
When the recalled animal food does not
present a risk of serious adverse health
consequences or death (and, thus, there
is not a report to the RFR), our guidance
entitled ‘‘Guidance for Industry: Product
Recalls, Including Removals and
Corrections’’ recommends that recalling
firms notify the local FDA District
Recall Coordinator as soon as a decision
is made that a recall is appropriate and
prior to the issuance of press or written
notification to customers (Ref. 45).
Including this guidance with the
facility’s recall procedures may also
save time.
We decline the request to designate
that it is solely the importer of a food
manufactured by a foreign facility who
must notify FDA if the food is recalled
by the foreign facility. We are not
requiring that a recall plan include
procedures and assignments of
responsibility for notifying FDA of
recalls subject to the recall plan.
Facilities should refer to our guidance
in part 7 entitled ‘‘Guidance for
Industry: Product Recalls, Including
Removals and Corrections’’ for
recommendations on conducting recalls
of food that does not present a risk of
serious adverse health consequences or
death, including notification to FDA
(Ref. 45). If the recalled food is a
reportable food (i.e., it does present a
reasonable probability that use will
cause serious adverse health
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56255
consequences or death to humans or
animals), then section 417 of the FD&C
Act requires that the responsible party,
as defined in section 417, submit a
report to FDA.
We agree with comments that it is
important to notify appropriate State
regulatory Agencies about a recall. We
generally request that FDA District
Offices notify State control officials of
recalls issued by animal food
manufacturers. Also, State officials with
responsibilities for regulating animal
food can access our Web site for
‘‘Animal and Veterinary Recalls and
Withdrawals’’ where we post the
current and most recent recalls of
animal products, including animal food
(Ref. 46). We note that whatever
methods are used to dispose of
adulterated animal food, the methods
should comply with State and local
requirements.
(Comment 292) Some comments ask
us to add a requirement for mock recalls
on a regular basis, such as biannually.
Some of these comments state that mock
recalls would familiarize the staff and
communications network(s) with the
recall process and would improve the
facility’s capacity to conduct effective
and efficient recalls in the event of a
contamination event. Other comments
assert that mock recalls would be the
only way to determine the effectiveness
of a recall program. Some comments
note that mock recalls would be
particularly critical for manufacturers
that have limited experience in actual
recalls.
Some comments acknowledge that a
mock recall could be an important
element of a recall plan but recommend
that mock recalls remain voluntary,
such as by including mock recalls as an
example of how verification may be
accomplished. Other comments note
that the current recall procedures in part
7 do not recommend mock recalls. Some
comments assert that a requirement to
include a mock recall as a verification
activity would be an excessive and
inappropriate burden; that any gain in
the protection of public health will not
offset the resource requirements to
accomplish a mock recall; that resources
are better dedicated to developing a
robust plan; and, use of a mock recall
should be addressed in FDA guidance.
Some comments ask us to clarify the
‘‘metrics’’ for a mock recall, particularly
with respect to the consequences of
failing to meet an appropriate metric if
a mock recall is conducted as a
verification activity.
(Response 292) We agree that a mock
recall would familiarize the facility with
the recall process, could improve the
facility’s capacity to conduct effective
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and efficient recalls during a
contamination event, may be
particularly helpful for manufacturers
that have limited experience in actual
recalls, and could support the
development of guidance on best
practices for recalls, and we encourage
facilities to conduct one or more mock
recalls to accomplish these goals.
However, as previously discussed, a
recall plan would address food that had
left the facility, whereas the proposed
requirements for monitoring, corrective
actions, and verification would all be
directed at food while it remains at the
facility. Comments are mixed regarding
whether the rule should require a mock
recall as a verification activity for the
recall plan, and we have decided to not
require a facility to conduct a mock
recall as a verification activity for its
recall plan so that the focus of the
monitoring, corrective actions, and
verification in the rule remains focused
on food being produced rather than on
food that is distributed in commerce.
We acknowledge that requiring mock
recalls would go beyond our
longstanding policies established in part
7. A facility that voluntarily conducts a
mock recall would establish metrics
appropriate to its plan and take action
(such as modifications to its procedures,
or additional training for its employees)
if it is not satisfied with the results of
the mock recall.
We note that retail companies are not
subject to this rule and, thus, are not
subject to the requirement to have a
written recall plan.
XXIX. Comments on Proposed
§ 507.39—Preventive Control
Management Components
We proposed preventive control
management components as appropriate
to ensure the effectiveness of the
preventive controls, taking into account
the nature of the preventive control.
Most of the comments that support the
proposed provisions suggest alternative
or additional regulatory text.
In the following sections, we discuss
comments that disagree with, or suggest
one or more changes to, the proposed
requirements. After considering these
comments, we have revised the
proposed requirements as shown in
table 13 with editorial and conforming
changes as shown in table 31.
TABLE 13—REVISIONS TO THE PROPOSED REQUIREMENTS FOR PREVENTIVE CONTROL MANAGEMENT COMPONENTS
Section
507.39 ...........................
Description
Flexible requirements
for preventive control management
components.
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A. Proposed § 507.39(a)—Flexible
Requirements for Monitoring, Corrective
Actions and Corrections, and
Verification
We proposed that, with some
exceptions, the preventive controls
would be subject to three preventive
control management components as
appropriate to ensure the effectiveness
of the preventive controls, taking into
account the nature of the preventive
control: Monitoring, corrective actions
and corrections, and verification.
(Comment 293) Some comments
support our proposal to provide
flexibility in the oversight and
management of preventive controls,
including the explicit provision that
preventive control management
components take into account the
nature of the preventive control. Some
of these comments state that the
provisions for the preventive control
management components will allow
facilities to tailor their food safety plans
to their specific facility, product, and
process and ensure that the regulatory
requirements are risk-based. Other
comments state that the proposed
approach acknowledges the safety
benefits derived from the use of
prerequisite programs, such as CGMPs,
and provides for a framework whereby
appropriate decisions may be reached
regarding hazards that require
management controls that may include
monitoring, corrections or corrective
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Provide that preventive control management components take into account both the nature
of the preventive control and its role in the facility’s food safety system.
actions, verification, and records. Other
comments state that the provisions will
allow businesses to allocate resources to
spend the most time and resources
controlling and monitoring those
hazards that pose the greatest risk to
public health.
However, many of these comments
also ask us to convey not only that the
application of a particular management
component be appropriate (i.e., capable
of being applied), but also that it be
necessary for food safety (i.e., to meet
the overall FSMA food safety goals or to
ensure a particular control is effective)
by specifying that the preventive control
management components take into
account both the nature of the
preventive control and its role within
the facility’s overall food safety system.
Some of these comments ask us to make
companion changes reflecting that the
preventive control management
components take into account both the
nature of the preventive control and its
role within the facility’s overall food
safety system throughout applicable
provisions of the rule, such as the
definition of ‘‘significant hazard’’
(which we now refer to as ‘‘hazard
requiring a preventive control’’) and in
the requirements for preventive
controls, monitoring, corrective actions
and corrections, and verification. Some
comments ask us to consistently refer to
‘‘the nature of the preventive control’’
(rather than simply to ‘‘the preventive
control’’) when communicating the
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flexibility that a facility has in
identifying preventive controls and
associated preventive control
management components.
(Response 293) We agree that
preventive control management
components should take into account
both the nature of the preventive control
and its role in the facility’s food safety
system and have modified the
regulatory text of § 507.39 to incorporate
this suggestion. We reviewed the full
regulatory text of proposed subpart C
and made similar modifications to the
regulatory text for the definition of
‘‘hazard requiring a preventive control’’
(§ 507.3); process controls
(§ 507.34(c)(1)); monitoring (§ 507.40);
verification (§ 507.45); validation
(§ 507.47); and verification of
implementation and effectiveness
(§ 507.49).
(Comment 294) Some comments
assert that the flexibility explicitly
provided in the regulatory text could
result in some facilities taking a broad
approach to significant hazards and
other facilities taking a more detailed
approach. These comments express
concern that inspectors will view the
detailed approach (e.g., with more
preventive controls), as the standard to
judge compliance with the rule. Other
comments express concern that
identifying a large number of preventive
controls could also undermine the value
of HACCP programs because treating too
many controls as CCPs will pull
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resources from those controls that are
truly critical.
(Response 294) We agree that facilities
are likely to take different approaches to
complying with the rule. A facilityspecific approach is consistent with
FSMA, which places responsibility for
hazard analysis and risk-based
preventive controls on the owner,
operator, or agent in charge of the
facility (section 418(a) of the FD&C Act).
We agree that having too many CCPs
could dilute their significance, but not
every hazard will require a CCP to be
controlled. See table 6 in the 2014
supplemental notice for examples of
preventive controls that would not be
CCPs (79 FR 58476 at 58493).
During the initial stages of
implementation, we expect that our
investigators will ask subject matter
experts in CVM to review the outcome
of the facility’s hazard analysis, the
preventive controls established by the
facility, and the associated preventive
control management components that
the facility has established and
implemented. Over time, as our
investigators gain experience, we expect
that there will be fewer circumstances
in which our investigators would
consult CVM about such an outcome.
(See also Response 2 and section LIV
regarding our approach to compliance.)
(Comment 295) Some comments state
that USDA’s regulations (in 7 CFR
205.201(a)(3)) for the National Organic
Program include regulatory text to
‘‘ensure the effectiveness’’ of measures
in that program and that this regulatory
text is similar to regulatory text in the
requirements for preventive control
management components. These
comments assert that this type of
regulatory text has created compliance
challenges and ask us to consult with
USDA about its experience with
implementing effectiveness language
associated with monitoring practices
and procedures and ensure that the final
rule uses regulatory text that will be
clearly understood and readily
implementable by those subject to its
provisions.
(Response 295) Under the USDA
regulation cited by these comments, an
organic production or handling system
plan must include a description of the
monitoring practices and procedures to
be performed and maintained, including
the frequency with which they will be
performed, to ‘‘verify that the plan is
effectively implemented.’’ We have not
consulted with USDA regarding its
experience in evaluating compliance
with this requirement because we
addressed the issue likely to cause these
compliance challenges for monitoring
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practices and procedures in an organic
production or handling system plan
when we established our requirements
for monitoring preventive controls.
Specifically, we require that a facility
monitor the preventive controls with
adequate frequency to ‘‘provide
assurance that they are consistently
performed,’’ not to ‘‘verify that the plan
is effectively implemented.’’ Our
requirements more clearly distinguish
the purpose of monitoring and
verification activities. See our previous
discussion of the relationship between
monitoring and verification, and our
tentative conclusion to require
monitoring of the performance of the
preventive controls (78 FR 64736 at
64790). We are affirming that
conclusion in this rule. (See Response
297.)
B. Proposed § 507.39(b)—Applicability
of Preventive Control Management
Components to the Supply-Chain
Program
We proposed that the supplier
program (which we now refer to as
‘‘supply-chain program’’) would be
subject to the following preventive
control management components as
appropriate to ensure the effectiveness
of the supplier program, taking into
account the nature of the hazard
controlled before receipt of the raw
material or ingredient: (1) Corrective
actions and corrections, taking into
account the nature of any supplier nonconformance; (2) review of records; and
(3) reanalysis. We address comments on
the supply-chain program in sections
XL through XLVII. We are finalizing the
applicability of preventive control
management components to the supplychain program as proposed.
C. Proposed § 507.39(c)—Recall Plan Is
Not Subject to Preventive Control
Management Components
We proposed that the recall plan that
would be established in § 507.38 would
not be subject to the preventive control
management components.
(Comment 296) As discussed in
Comment 287, some comments ask us to
establish requirements for a written
recall plan as a CGMP requirement in
subpart B rather than as a preventive
control in subpart C. As a companion
change, some of these comments ask us
to delete our proposed provision that
the recall plan would not be subject to
the preventive control management
components.
(Response 296) As discussed in
Response 287, we are establishing the
requirements as a preventive control in
subpart C as proposed. Therefore, we
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are finalizing the provision that the
recall plan not be subject to the
preventive control management
components.
For further discussion on comments
on preventive control management
components, see section XXIX in the
final rule for preventive controls for
human food, published elsewhere in
this issue of the Federal Register.
XXX. Subpart C: Comments on
Proposed § 507.40—Monitoring
We proposed to establish
requirements for monitoring the
preventive controls. We also discussed
our tentative conclusion that the
language of section 418 of the FD&C Act
regarding monitoring is ambiguous and
that it would be appropriate to require
monitoring of the ‘‘performance’’ of
preventive controls.
Some comments agree with our
tentative conclusion regarding the
ambiguous nature of section 418. For
example, some comments state that our
interpretation seems appropriate
because requiring monitoring of the
‘‘effectiveness’’ of the preventive
controls would be redundant with
required verification activities. In
addition, requiring monitoring of the
performance of preventive controls is
consistent with applicable domestic and
internationally recognized standards.
Some comments agree that facilities
must be required to maintain records;
but disagree regarding the scope of
monitoring. One comment agrees that
monitoring the performance of
preventive controls would provide
evidence that the preventive controls
established to control the identified
hazards are implemented appropriately.
Some comments support the proposed
provisions without change. Some
comments ask us to clarify how we will
interpret the provision.
In the following paragraphs, we
discuss comments that disagree with
our tentative conclusion or with the
proposed requirements, or ask us to
clarify the proposed requirements or
suggest one or more changes to the
proposed requirements. After
considering these comments, we are
affirming our tentative conclusion that
the language of section 418 of the FD&C
Act regarding monitoring is ambiguous
and that it would be appropriate to
require monitoring of the
‘‘performance’’ of preventive controls.
We also have revised the proposed
requirements as shown in table 14, with
editorial and conforming changes as
shown in table 31.
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TABLE 14—REVISIONS TO THE PROPOSED REQUIREMENTS FOR MONITORING
Description
Revision
507.40 .............................................
507.40(c)(2)(i) ..................................
Flexibility in requirements for monitoring.
Records of monitoring ...................
507.40(c)(2)(ii) .................................
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Section
Records of monitoring ...................
Provide that monitoring take into account both the nature of the preventive control and its role in the facility’s food safety system.
Provide that records of refrigeration temperature during storage of
animal food that requires time/temperature control to significantly
minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control.
Provide for exception records for monitoring of preventive controls
other than refrigeration.
A. Our Tentative Conclusion To Require
Monitoring of the Performance of
Preventive Controls
(Comment 297) Some comments
disagree with our tentative conclusion
that it would be appropriate to require
monitoring of the ‘‘performance’’ of
preventive controls and assert that the
concept of ‘‘performance evaluation’’ is
too complex to be included in the rule.
(Response 297) These comments may
have misinterpreted what we meant by
‘‘monitoring performance of preventive
controls.’’ We used the term
‘‘performance’’ to mean ‘‘the execution
or accomplishment of an action,
operation, or process undertaken or
ordered’’ (78 FR 64736 at 64790). We
acknowledge that the definition of
‘‘monitoring’’ that we are establishing in
this rule includes that the purpose of
observations or measurements
conducted as part of monitoring is to
‘‘assess’’ whether control measures are
operating as intended. However, we
provided examples showing that this
assessment is a straightforward
determination of whether a process is
operating as intended and is not a
complex evaluation as asserted by the
comments. (See, e.g., the discussion of
monitoring oven temperature to ensure
pathogen elimination during baking of a
pet treat 78 FR 64736 at 64789 through
64790.)
(Comment 298) Some comments that
support monitoring the performance of
preventive controls assert that our
proposed definition of ‘‘monitoring’’
(proposed § 507.3), and our preamble
discussions of ‘‘monitoring,’’ have the
potential to confuse ‘‘monitoring the
performance of preventive controls’’
with verification activities that address
ongoing implementation of control
measures.
(Response 298) See Response 47 in
which we discuss comments on the
definition of monitoring and describe
the changes we have made to that
definition to address concerns about the
potential to confuse ‘‘monitoring the
performance of preventive controls’’
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with verification activities that address
ongoing implementation of control
measures.
(Comment 299) Some comments
assert that authority should be explicitly
granted to the States to conduct food
safety monitoring and that we should
maintain our responsibilities for
product tracing.
(Response 299) These comments
misinterpret the provisions of section
418 of the FD&C Act and this rule.
Section 418 places the responsibility for
establishing and implementing a food
safety system (including hazard
analysis, risk-based preventive controls,
preventive control management
components (including monitoring,
corrective action procedures, and
verification), and recordkeeping) on the
owner, operator, or agent in charge of a
facility, not on FDA or any other
regulatory authority. This requirement
for monitoring within the framework of
hazard analysis and risk-based
preventive controls is distinct from
regulatory oversight of animal food
safety, such as during inspections and
investigations of outbreaks of foodborne
illness, which generally involve product
tracing. We agree that it is important to
coordinate regulatory oversight of
animal food safety with the States and
other food safety partners. As discussed
in Response 2, we are working through
the PFP to develop and implement a
national Integrated Food Safety System
consistent with FSMA’s emphasis on
establishing partnerships for achieving
compliance (see section 209(b) of
FSMA).
(Comment 300) One comment
requests that routine monitoring not be
required for feed mills unless they
manufacture pet food.
(Response 300) We decline this
request. We assume this comment is
based on a presumption that pet food is
a higher risk product than livestock or
poultry food. The exemptions from
preventive control requirements that we
are establishing are specifically
provided by section 103 of FSMA and
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we decline to apply the rule only to
animal foods deemed to be of higher
risk. Instead, several provisions of the
rule expressly qualify that the
requirements apply as appropriate to the
facility, the animal food, the nature of
the preventive control, and its role in
the facility’s food safety system, the
nature of the hazard, or a combination
of these factors (e.g., monitoring
procedures must be established as
appropriate to the nature of the
preventive control and its role in the
facility’s food safety system). For
example, the hazards in a facility and
historical information on the
consistency of the control measure can
be factors in determining the frequency
of monitoring.
B. Proposed § 507.40(a) and (b)—
Flexibility in Requirements for
Monitoring
We proposed that, as appropriate to
the preventive control, you must
establish and implement written
procedures, including the frequency
with which they are to be performed, for
monitoring the preventive controls, and
monitor the preventive controls with
adequate frequency to provide
assurance that they are consistently
performed.
(Comment 301) Some comments agree
that frequency and areas to be tested
and monitored need to be determined
based on each product and facility and
ask us to allow each individual facility
to determine the frequency and areas to
be monitored based on a completed risk
assessment. Some comments ask us to
specify that the frequency of monitoring
preventive controls must have a
scientific basis.
(Response 301) It is unclear whether
the comment agreeing that monitoring
frequency and areas to be tested need to
be determined based on each product
and facility was directed to the
monitoring provision or to
environmental monitoring. Regardless,
by requiring written procedures for
monitoring, and specifying that the
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procedures include the frequency with
which the procedures are to be
performed, the rule provides that each
facility must determine the frequency of
monitoring, as well as details such as
the areas to be monitored. However, we
decline the request to specify that these
procedures be based on a completed
‘‘risk assessment.’’ The rule requires the
facility to conduct a hazard analysis,
which determines whether there are any
hazards requiring a preventive control,
and the facility would establish
preventive controls for such hazards as
appropriate to the facility and the
animal food. The facility must consider
factors associated with risk (i.e., the
severity of the illness or injury if the
hazard were to occur and the probability
that the hazard will occur in the absence
of preventive controls) in evaluating
whether any potential hazard is a
hazard requiring a preventive control
(§ 507.33(c)). Risk could be relevant to a
facility’s identification of appropriate
preventive controls for a particular
hazard requiring a preventive control.
However, it is the nature of the
preventive control, rather than the risk
associated with the hazard, that is more
relevant to the frequency of monitoring
and the areas to be monitored.
Accordingly, the rule specifies that the
facility establish written procedures,
and conduct monitoring, as appropriate
to the preventive control rather than
based on risk associated with the
hazard. (See, e.g., the discussion of
monitoring oven temperature to ensure
pathogen elimination during baking of a
pet treat 78 FR 64736 at 64789 through
64790.)
We decline the request to specify that
the frequency of monitoring preventive
controls must have a scientific basis.
Monitoring should take place with
sufficient frequency to detect a problem
in the performance of a preventive
control. The importance of the
preventive control to the safety of the
animal food can be one factor in setting
a frequency. We acknowledge that
scientific information may be
appropriate in determining the
frequency of monitoring in some cases.
For example, the frequency may be
statistically based, such as with
statistical process control. However, in
some cases, factors other than scientific
information may be appropriate in
determining the frequency of
monitoring. For example, historical
information on the consistency of the
control measure can be a factor in
determining frequency. When
variability of the process is low, the
frequency may be less than with a
process that has more variability. As
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another example, a process that is
operated at a point close to a food safety
parameter limit may be monitored more
frequently than one where there is a
large safety margin built into the
process.
C. Proposed § 507.40(c)—Records
We proposed that all monitoring of
preventive controls must be
documented in records that are subject
to verification and records review.
(Comment 302) Some comments point
out that table 6 in the 2014
supplemental notice includes an
example of a monitoring activity that
generally would not require monitoring
records (i.e., monitoring for pieces of
ferrous material with magnets) (see 79
FR 585476 at 58493). These comments
assert that this example is in conflict
with the proposed regulatory text and
ask us to modify the regulatory text to
provide the flexibility we acknowledged
in the 2014 supplemental notice. One
comment states the examples provided
by FDA for monitoring performance of
preventive controls pertain to
preventive controls that have specific
parameters. The comment states in the
absence of specific parameters for a
preventive control, monitoring is
neither necessary nor appropriate. Other
comments ask us to specify that
monitoring must be documented as
appropriate to the nature of the
preventive control.
Some comments ask us to recognize
the acceptability of monitoring systems
that exclusively provide exception
reports. These comments describe
exception reporting as a structure where
automated systems are designed to alert
operators and management on an
exception basis, i.e., only when a
deviation from food safety parameter
limits are observed by the system. These
comments assert that, in many cases,
monitoring of preventive controls can be
done by automated systems that provide
exception reporting in a much more
efficient manner than if performed by
operators and that automated
monitoring allows for increased
sampling frequency (often continuous)
and reduction of human error. The
comments provide an example of a
refrigeration temperature control that
notifies on exception (e.g., high
temperature alarm) and may only record
temperatures that exceed the specified
temperature (without recording
temperatures that meet control
requirements). These comments
acknowledge that such systems must be
validated and periodically verified to
ensure they are working properly. These
comments ask us to clarify in the
preamble to the final rule that
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monitoring systems can work
affirmatively or by exception and that
both types of systems and their related
documentation are acceptable.
(Response 302) We have made several
revisions to the regulatory text, with
associated editorial changes, to clarify
that monitoring records may not always
be necessary. We agree that the
exception reporting described in these
comments, including validation and
periodic verification to ensure that the
system is working properly, would be
an acceptable monitoring system in the
circumstances provided in the
comments, i.e., for monitoring
refrigeration temperature. Therefore, we
have revised the regulatory text to
provide that records of refrigeration
temperature during storage of food that
requires time/temperature control to
significantly minimize or prevent the
growth of, or toxin production by,
pathogens may be affirmative records
demonstrating temperature is controlled
or exception records demonstrating loss
of temperature control. Although the
comments specifically requested that we
clarify our view on exception records in
the preamble, we believe that clarifying
the regulatory text will be more useful,
both to facilities and to regulatory
agencies that conduct inspections for
compliance with the rule. If a facility
uses ‘‘exception records,’’ the facility
must have evidence that the system is
working as intended, such as a record
that the system has been challenged by
increasing the temperature to a point at
which an ‘‘exception record’’ is
generated.
We also have revised the regulatory
text to provide that exception records
may be adequate in circumstances other
than monitoring of refrigeration
temperature. For example, in table 6 of
the 2014 supplemental notice the
example we provided of a monitoring
activity that generally would not require
monitoring records is monitoring for
pieces of ferrous material with magnets.
We believe that a magnet system that
monitors for ferrous material would
result in a record only when the system
detects ferrous material.
XXXI. Subpart C: Comments on
Proposed § 507.42—Corrective Actions
and Corrections
We proposed to establish
requirements for corrective actions and
corrections. Some comments support
the proposed requirements without
change. For example, some comments
assert that there is virtually no reason to
have a food safety plan unless there are
proper corrective actions in place so the
product can be properly disposed of.
Some comments agree that there should
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be written procedures for corrective
actions and note the importance of
identifying and evaluating the problem,
correcting it, and documenting the
corrective action. Some comments
express the view that the proposed
requirement for clear corrective action
in the event of an unanticipated
problem, and documenting all
corrective actions, contributes to a
comprehensive safety plan. Some
comments that support the proposed
provisions suggest alternative or
additional regulatory text.
In the following paragraphs, we
discuss comments that disagree with, or
suggest one or more changes to, the
proposed requirements. After
considering these comments, we have
revised the proposed requirements as
shown in table 15 with editorial and
conforming changes as shown in table
31.
TABLE 15—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CORRECTIVE ACTIONS AND CORRECTIONS
Section
Description
Revision
507.42(a) .........................................
Corrective action procedures ........
507.42(a)(1) .....................................
Corrective action procedures ........
507.42(b) .........................................
507.42(b)(1)(ii) .................................
Corrective action in
an unanticipated
problem.
Corrective action in
an unanticipated
problem.
507.42(c)(2) .....................................
Corrections ....................................
Clarify that corrective action procedures depend on the nature of the
hazard, as well as the nature of the preventive control.
Clarify that the specified list of corrective action procedures is not intended to be finite.
Specify that the requirement applies when ‘‘a corrective action procedure’’ (rather than ‘‘a specific corrective action procedure’’) has not
been established.
Specify that the requirement applies when a preventive control, combination of preventive controls, or the food safety plan as a whole
is found to be ineffective (rather than just when a single preventive
control has been found to be ineffective).
Provide for additional circumstances when corrections, rather than
corrective actions, are warranted.
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A. Proposed § 507.42(a)(1)—
Requirement To Establish and
Implement Corrective Action Procedures
We proposed that, with some
exceptions, as appropriate to the
preventive control you must establish
and implement written corrective action
procedures that must be taken if
preventive controls are not properly
implemented. The corrective action
procedures must include procedures to
address, as appropriate, the presence of
a pathogen or appropriate indicator
organism in animal food detected as a
result of product testing, as well as the
presence of an environmental pathogen
or appropriate indicator organism
detected through environmental
monitoring.
(Comment 303) Some comments note
that we proposed to list two
circumstances that require written
corrective active procedures (i.e.,
product testing and environmental
monitoring) and that it is not clear
whether this list is intended to be
exhaustive or not (i.e., whether written
corrective action procedures are
required in only these two
circumstances, or whether there may be
other circumstances that require written
corrective action procedures). These
comments ask us to insert ‘‘but are not
limited to’’ after ‘‘must include,’’ if we
intend that the list is not exhaustive.
Likewise, other comments state our
proposal to specifically require
corrective action procedures may result
in a misunderstanding by some facilities
about the need to take corrective actions
in circumstances other than in response
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the event of
food safety
the event of
food safety
to testing results, other nonconformances, or other types of
verification activities. These comments
assert that it would be better for food
safety if the regulatory requirements
took a more principled approach and
generally required corrective action
procedures, with the importance of
corrective action procedures for testing
programs addressed through guidance.
If, however, we conclude that specific
requirements for corrective action
procedures for testing programs are
necessary, these comments ask us to
clarify that the nature and extent of any
corrective actions should be
proportional to the nature of the test
findings.
(Response 303) We have revised the
regulatory text, with associated editorial
revisions and redesignations, to clarify
that the specified list of corrective
action procedures is not intended to be
exhaustive (i.e., not limited to the two
corrective action procedures that we
specified in the 2014 supplemental
notice). The approach we used in the
modified regulatory text (i.e., ‘‘You must
establish and implement written
corrective action procedures . . .,
including procedures to address, as
appropriate . . .’’) is similar to the
approach used in several other
provisions of the rule. (See, e.g.,
sanitation controls (§ 507.34(c)(2)); and
monitoring (§ 507.40(a)). We decline the
suggestion to modify the regulatory text
by adding ‘‘but is not limited to’’ after
‘‘includes’’. The word ‘‘includes’’ means
to have (someone or something) as part
of a group or total; to contain (someone
or something) in a group or as a part of
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something (Ref. 47). The word
‘‘includes’’ does not need to be followed
by ‘‘but is not limited to’’ to clearly
communicate that a following list is not
complete. We agree that the nature and
extent of any corrective actions in
response to the findings of testing
programs should be proportional to the
nature of the test findings. (See
Response 304.)
(Comment 304) Some comments state
that the nature and extent of the
corrective actions should be
proportional to the nature of the testing
results. These comments ask us to
require that a facility establish and
implement corrective action procedures
that must be taken if preventive controls
are not properly implemented as
appropriate to the nature of the hazard,
the nature of the control measure, and
the extent of the deviation.
(Response 304) We have revised the
regulatory text to specify that the
corrective action procedures are
established and implemented based on
the nature of the hazard in addition to
the nature of the preventive control. We
agree that the nature of the hazard plays
a key role in the corrective actions that
a facility would take. Although a
facility’s corrective action procedures
likely would specify actions to take
based on the extent of the deviation, we
consider this a detail that does not need
to be specified in the rule.
(Comment 305) Some comments ask
us to revise the provisions to clarify that
corrective action procedures are not
always necessary when testing detects
the presence of a pathogen or indicator
organism. These comments assert that
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the extent of the corrective actions
should be proportional to the nature of
the testing results themselves because
the level of contamination matters for
those microorganisms with thresholds
that need to be taken into account and
because the location of contamination in
the food processing environment
matters (e.g., the zone in the facility
where the contamination is detected).
(For information about zones associated
with environmental monitoring, see 78
FR 3646 at 3816.)
(Response 305) We decline this
request. These comments appear to be
confusing the requirement to establish
and implement corrective action
procedures with the content of the
corrective action procedures. These
comments also appear to assume that a
requirement to have corrective action
procedures (which describe the steps to
be taken to ensure that appropriate
action is taken to identify and correct a
problem and, when necessary, to reduce
the likelihood that the problem will
recur; that all affected animal food is
evaluated for safety; and that all affected
animal food is prevented from entering
into commerce when appropriate) predetermines the outcome of following the
corrective action procedures. This is not
the case. If, as the comments assert, a
facility concludes, for example, that the
nature of some test results do not
warrant steps to reduce the likelihood
that a problem will recur and that
affected animal food is safe and lawful
(or, in the case of finding a pathogen in
some zones in the facility, that no
animal food is affected), then that is
what its corrective action procedures
would say. The reason to have
corrective action procedures is to
consider the likely scenarios in advance,
with appropriate input from the
facility’s food safety team and
preventive controls qualified individual,
rather than react to these scenarios on
an ad hoc basis.
(Comment 306) Some comments ask
us to require that corrective actions
include an analysis to determine the
root cause of a problem, not only
identify it. These comments also ask us
to require follow-up actions to ensure
the corrective action was effective and
assert that although the requirements
address the need to reanalyze the food
safety plan they do not appear to
specifically address a review of the
corrective action.
(Response 306) The requests of these
comments do not require any revisions
to the regulatory text. The rule does not
use the term ‘‘root cause’’ but it does
require the facility to take appropriate
action, when necessary, to reduce the
likelihood that the problem will recur
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(see § 507.42(a)(2)(ii)). Root cause
analysis is simply part of a common
approach to complying with this
requirement. (Knowing the root cause is
key to reducing the likelihood that a
problem will happen again.) The rule
also requires a review of records of
corrective actions, but does so as a
verification activity rather than as part
of the corrective action procedures (see
§ 507.49(a)(4)).
(Comment 307) Some comments ask
us to revise the proposed rule to address
corrective actions in a more general way
and then outline areas where specific
corrective action procedures would be
helpful, such as for testing programs, in
guidance.
(Response 307) The proposed
provisions do not prescribe the outcome
of the corrective action procedures, but
merely direct the facility to the types of
actions that the procedures must
address. In essence, the proposed
provisions already do, as the comments
request, address corrective actions in a
general way.
(Comment 308) Some comments ask
us to specify that the requirements to
establish and implement written
corrective action procedures also apply
when a preventive control is found to be
ineffective.
(Response 308) We have not revised
the regulatory text as requested by these
comments. The appropriate action when
a preventive control is found to be
ineffective is to reanalyze the food
safety plan and to establish and
implement a preventive control that is
effective, not follow a corrective action
procedure. A corrective action
procedure is intended to address a
problem that happens when following
the procedures in a food safety plan that
previously was verified to be valid, not
to fix problems on an ongoing basis
when a preventive control is ineffective
(and, thus, the food safety plan is not
valid). We agree that some of the steps
that apply to corrective actions may
need to be taken, such as evaluating
affected animal food for safety and
ensuring that adulterated animal food
does not enter commerce. This is
addressed by the provisions for
corrective actions in the event of an
unanticipated problem (§ 507.42(b)(1)),
which require specific corrective actions
to be taken (§ 507.42(b)(2)).
(Comment 309) Some comments
requests flexibility as every facility is
different from the next so prescriptive
corrective actions required by rules may
not be applicable or possible in all
cases. Some commenters requested that
documentation be maintained for
corrective actions only if the corrective
action was made to address an animal
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food safety issue. Other comments say
that the animal food safety plan should
outline when a corrective action is
required, as well as the procedure to be
followed and the requirement should
only focus on animal food safety issues
and not quality issues.
(Response 309) As stated in Response
304, we have revised the regulatory text
to specify that the corrective action
procedures are established and
implemented based on the nature of the
hazard in addition to the nature of the
preventive control. We agree that the
nature of the hazard plays a key role in
the corrective actions that a facility
would take. The requirement is
intended to address hazards and
therefore would not address animal food
quality issues unless they would present
a hazard (e.g., if insufficient mixing
would present the potential for nutrient
deficiencies or toxicities). All corrective
actions must be documented in records
(see § 507.42(d)).
B. Proposed § 507.42(a)(2)—Content of
Corrective Action Procedures
We proposed that corrective action
procedures must describe the steps to be
taken to ensure that: (1) Appropriate
action is taken to identify and correct a
problem that has occurred with
implementation of a preventive control;
(2) appropriate action is taken to reduce
the likelihood that the problem will
recur; (3) all affected animal food is
evaluated for safety; and (4) all affected
animal food is prevented from entering
into commerce, if you cannot ensure
that the affected animal food is not
adulterated under section 402 of the
FD&C Act.
(Comment 310) Some comments
assert that the corrective action
procedures should not consider food to
be ‘‘affected’’ if it is immediately
subjected to an additional (or repeat)
preventive control after determining
that the initial preventive control was
not properly implemented. These
comments discuss an example in which
there is a temperature deviation below
accepted parameter limits for a given
process, and the incorrectly processed
product is re-processed correctly, and
assert that it would be illogical to
consider the food to be ‘‘affected’’ in the
circumstance. Other comments ask us to
modify the requirements to specify that
they apply to all affected food ‘‘if any.’’
One comment states the use of the term
‘‘all’’ with ‘‘affected’’ is redundant and
may contribute to unwarranted and
unnecessary regulatory emphasis and
requests that the word ‘‘all’’ be removed.
(Response 310) We decline the
requests to modify the regulatory text to
remove the word ‘‘all’’ or specify that
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the requirements apply to all affected
animal food ‘‘if any.’’ Animal food is
‘‘affected’’ if a preventive control is not
properly implemented during its
production. However, the rule does not
pre-determine the consequences when
animal food is ‘‘affected.’’ Instead, the
rule provides for the facility to evaluate
the affected animal food for safety. If, as
in the example described by the
comments, the facility reapplies the
preventive control such that the animal
food is safe and is not adulterated under
section 402 of the FD&C Act, there
would be no need to take steps to
prevent that animal food from entering
commerce.
(Comment 311) Some comments ask
us to provide that requirements for
corrective actions be principle-based
(e.g., affected product containment,
control restored to operation before
commencing production) rather than
prescriptive.
(Response 311) The requirements for
corrective actions established by this
rule are principle-based in that they
require the facility to describe the steps
it will take rather than prescribe the
steps it will take.
(Comment 312) Some comments ask
us to revise the provision to make
resampling and/or retesting one of the
first steps in a corrective action
procedure to take into account human
error. These comments assert that
mishandling during sampling, transport,
and testing can contribute to a false
positive result and that if the results of
a followup test are negative, then the
previous test could be considered an
anomaly that could be ignored.
(Response 312) We decline this
request. We disagree that an appropriate
approach to positive findings of a test
for contamination is to resample and
retest and to consider positive findings
to be an anomaly if subsequent test
results are negative. Many animal food
products are not homogeneous and
contamination is localized. Even for
homogeneous animal food products
(such as liquids), the problem could be
the sensitivity of the method if the level
of contamination is low. For further
discussion on our current thinking on
presumptive positive results and
additional testing, see our guidance
entitled ‘‘Guidance for Industry: Testing
for Salmonella Species in Human Foods
and Direct-Human-Contact Animal
Foods’’ (Ref. 48).
C. Proposed § 507.42(b)—Corrective
Action in the Event of an Unanticipated
Problem
With some exceptions, we proposed
that you must take corrective action to
identify and correct a problem, reduce
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the likelihood that the problem will
recur, evaluate all affected animal food
for safety, and, as necessary, prevent
affected animal food from entering
commerce as would be done following
a corrective action procedure if any of
the following circumstances apply: (1) A
preventive control is not properly
implemented and a specific corrective
action has not been established; (2) a
preventive control is found to be
ineffective; or (3) a review of records
finds that the records are not complete,
the activities conducted did not occur in
accordance with the food safety plan, or
appropriate decisions were not made
about corrective actions. We also
proposed that if any of these
circumstances apply, when appropriate
you must reanalyze the food safety plan
to determine whether modification of
the food safety plan is required.
(Comment 313) Some comments ask
us to delete the proposed requirement
that a facility must reanalyze the food
safety plan in the event of an
unanticipated problem. These
comments argue that FSMA does not
specify reanalysis in the event of an
unanticipated problem. In addition,
these comments assert that the proposed
requirement for reanalysis in the event
of an unanticipated problem would be
redundant with the proposed
requirements for reanalysis as a
verification activity (proposed § 507.50)
and would not add value for food safety.
These comments also assert that the
term ‘‘problem’’ is ambiguous and ask
us to replace ‘‘problem’’ with ‘‘food
safety issue’’ if we retain the provision
in the final rule.
(Response 313) We acknowledge that
section 418 of the FD&C Act does not
explicitly specify that a facility must
reanalyze its food safety plan in the
event of an unanticipated problem. In
the 2014 supplemental notice, we
clarified that reanalysis would be
conducted ‘‘when appropriate.’’ For
example, if a problem occurs because
personnel did not understand the
procedures or carry out the procedures
correctly, additional training for
applicable personnel may be warranted,
but there likely would be no need to
reanalyze the food safety plan.
We disagree that the term ‘‘problem’’
is ambiguous. The term ‘‘problem’’
signifies that something is wrong,
whereas the term suggested by the
comments (i.e., ‘‘issue’’) may or may not
signify that something is wrong. We
agree that the requirements are directed
to problems related to animal food
safety.
We agree that there is a relationship
between the requirements for corrective
actions in the event of an unanticipated
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food safety problem and the
requirements for reanalysis. To reduce
redundant regulatory text, in the 2014
supplemental notice we proposed to
modify the regulatory text of the
requirements for reanalysis to specify
that reanalysis is required when
appropriate after an unanticipated food
safety problem, and we are establishing
that modified provision in this final
rule. Importantly, the provisions for
reanalysis continue to require reanalysis
when a preventive control is found to be
ineffective. We are not aware of any
circumstances in which it would not be
appropriate to reanalyze the food safety
plan if a preventive control is found to
be ineffective.
(Comment 314) Some comments
assert that the word ‘‘specific’’ is not
appropriate as a modifier for ‘‘corrective
action procedure’’ because many
preventive controls will have corrective
action procedures that allow flexibility
based upon the nature of the hazard and
control. These comments also state that
the term ‘‘specific’’ in this context is
more appropriate for a CCP control in a
HACCP system.
(Response 314) We have revised the
regulatory text to delete the word
‘‘specific.’’
(Comment 315) Some comments ask
us to emphasize that reanalysis is
required only when a combination of
two events occurs (i.e., a preventive
control is not properly implemented
and the facility has not established a
corrective action procedure).
(Response 315) In the 2014
supplemental notice, we proposed
revisions to the regulatory text to clearly
specify the circumstances requiring
reanalysis. One such circumstance is
when a preventive control is not
properly implemented and a corrective
action procedure has not been
established, as stated in
§ 507.42(b)(1)(i)). The final provision
includes the revisions included in the
2014 supplemental notice and is
consistent with the request of these
comments.
(Comment 316) Some comments ask
us to add that corrective actions in the
event of an unanticipated problem also
apply when a preventive control is
‘‘missing.’’
(Response 316) We have revised the
regulatory text to require corrective
actions whenever a preventive control,
combination of preventive controls, or
the food safety plan as a whole, is
ineffective. (See § 507.42(b)(1)(ii).) In
assessing what the comment might
mean by a preventive control that is
‘‘missing,’’ we concluded that an
unanticipated problem could, in some
cases, mean that a combination of
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preventive controls, or the facility’s food
safety plan as a whole (rather than a
single preventive control), simply was
not effective. If this is the case,
reanalysis would be appropriate, and we
also have modified the requirements for
reanalysis to specify that a facility must
reanalyze its food safety plan whenever
it finds that a preventive control,
combination of preventive controls, or
the food safety plan as a whole is
ineffective.
(Comment 317) Some comments ask
us to replace the term ‘‘reanalyze’’ with
the term ‘‘reassess.’’
(Response 317) We decline this
request. Reanalysis goes beyond
assessing the validity of a preventive
control or food safety plan to control a
hazard. Reanalysis can also include
assessing whether all hazards have been
identified, whether established
procedures are practical and effective,
and other factors.
D. Proposed § 507.42(c)—Corrections
We proposed that you do not need to
comply with the requirements for
corrective actions and corrections for
conditions and practices that are not
consistent with specified sanitation if
you take action, in a timely manner, to
correct such conditions and practices.
(Comment 318) Some comments
support our proposal to provide for
corrections, rather than corrective
actions, for sanitation controls in some
circumstances. Other comments assert
that situations in which ‘‘corrections’’
can be applied are not limited to
sanitation controls and could include
actions to address other preventive
controls such as preventive
maintenance controls or CGMPs. As
discussed in Comment 82, some
comments emphasize the importance of
distinguishing between the terms
‘‘correction’’ and ‘‘corrective action.’’
(Response 318) We have revised the
regulatory text, with associated editorial
revisions and redesignations, to provide
for corrections, rather than corrective
actions and corrective action
procedures, for minor and isolated
problems that do not directly impact
product safety. As discussed in
Response 82, we also have defined the
term ‘‘correction’’ to mean an action to
identify and correct a problem that
occurred during the production of
animal food, without other actions
associated with a corrective action
procedure (such as actions to reduce the
likelihood that the problem will recur,
evaluate all affected animal food for
safety, and prevent affected animal food
from entering commerce).
E. Proposed § 507.42(d)—Records
We proposed that all corrective
actions (and, when appropriate,
corrections) must be documented in
records and that these records are
subject to the verification requirements
in §§ 507.45(a)(3) and 507.49(a)(4)(i).
We received no comments that
disagreed with this proposed
requirement and are finalizing it as
proposed.
XXXII. Subpart C: Comments on
Proposed § 507.45—Verification
In the 2013 proposed preventive
controls rule for animal food, we
proposed verification activities that
would include validation, verification of
monitoring, verification of corrective
actions, verification of implementation
and effectiveness, written procedures,
reanalysis, and documentation of all
verification activities. We also requested
comment on whether we should specify
the verification activities that must be
conducted for verification of monitoring
(78 FR 64736 at 64796) and for
verification of corrective actions (78 FR
64736 at 64796), and if so, what
verification activities should be
required.
To improve clarity and readability, in
the 2014 supplemental notice we
proposed to move the more extensive
verification requirements for validation,
implementation and effectiveness, and
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reanalysis from the single proposed
section (proposed § 507.45) to separate
sections (proposed §§ 507.47, 507.49,
and 507.50, respectively). In addition, to
address comments that asked us to
provide more flexibility to facilities,
including flexibility in determining
whether and how to conduct
verification activities, in the 2014
supplemental notice we proposed that
the verification activities be performed
‘‘as appropriate to the preventive
control.’’
In this section, we discuss the
proposed requirements for verification
of monitoring, verification of corrective
actions, and documentation of
verification activities. See sections
XXXIII through XXXV for comments on
the proposed requirements for
validation, verification of
implementation and effectiveness,
written procedures, and reanalysis. See
tables 17, 18, and 19 for a summary of
the revisions to those proposed
requirements.
Some comments support the proposed
requirements for verification of
monitoring, verification of corrective
actions, and documentation of
verification activities without change.
For example, comments support the
documentation of verification activities
(see section XXXI.C). In the following
paragraphs, we discuss comments on
the flexibility provided for a facility to
conduct verification activities as
appropriate to the nature of the
preventive control. We also discuss
comments that address our request for
comment on whether we should revise
the regulatory text to specify the
verification activities that must be
conducted for verification of monitoring
and for verification of corrective actions,
or express concern that the
requirements as proposed are too
prescriptive. After considering these
comments, we have revised the
verification requirements described in
§ 507.45 as shown in table 16.
TABLE 16—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VERIFICATION
Description
Revision
507.45(a) .........................................
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Section
Flexibility to conduct verification
activities.
Provide that verification activities take into account both the nature of
the preventive control and its role in the facility’s food safety system.
A. Flexibility in Requirements for
Verification
(Comment 319) Some comments
support the flexibility provided by use
of the phrase ‘‘as appropriate to the
preventive control’’ in the requirement
that verification activities must include,
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as appropriate to the preventive control,
specified verification activities (i.e.,
validation, verification that monitoring
is being conducted, verification that
appropriate decisions about corrective
actions are being made, verification of
implementation and effectiveness, and
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reanalysis). These comments emphasize
that verification activities must be
tailored to the preventive control and
assert that the use of the word ‘‘must’’
is potentially confusing in light of this
flexibility, e.g., because not all
preventive controls must be validated
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for food safety, and those preventive
controls that do not need monitoring
would not need verification of
monitoring. Other comments ask us to
allow facilities flexibility to verify that
preventive controls are effective in the
manner prescribed by FSMA, i.e., such
controls should be deemed to be
effective by an appropriate means as
determined and supported by the
facility within its food safety plan.
(Response 319) The provisions for
preventive control management
components make clear that all
preventive control management
components, including verification, are
required as appropriate to ensure the
effectiveness of the preventive control,
taking into account the nature of the
preventive control and its role in the
facility’s food safety system (see
§ 507.39). Likewise, the provisions for
each of the preventive control
management components (i.e.,
monitoring, corrective actions and
corrections, and verification)
individually provide flexibility, either
by specifying that the provisions apply
as appropriate to the nature of the
preventive control and its role in the
facility’s food safety system (i.e., for
monitoring and verification) or both the
nature of the preventive control and the
nature of the hazard (i.e., for corrective
actions and corrections). The word
‘‘must’’ specifies the type of activities
that a facility can use to satisfy the
requirements for a particular preventive
control management component.
We are retaining the term ‘‘must.’’
However, we agree that the rule should
provide flexibility for additional
verification of implementation and
effectiveness. To provide that additional
flexibility, we have revised the specific
requirements for verification of
implementation and effectiveness to
provide for other activities appropriate
for verification of implementation and
effectiveness (see § 507.49(a)(5)). As a
conforming revision, we have revised
the requirement for review of records to
include a review of records of other
verification activities within a
reasonable time after the records are
created (see § 507.49(a)(4)(ii)).
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B. Proposed § 507.45(a)—Verification
Activities
1. Proposed § 507.45(a)(1)—Validation
We proposed that verification
activities must include, as appropriate
to the preventive control, validation in
accordance with § 507.47. See section
XXXIII for comments on validation as a
verification activity.
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2. Proposed § 507.45(a)(2)—Verification
of Monitoring
We proposed that verification
activities must include, as appropriate
to the preventive control, verification
that monitoring is being conducted in
accordance with § 507.40. We requested
comment on whether we should specify
the verification activities that must be
conducted for monitoring, and if so,
what verification activities should be
required.
(Comment 320) Comments that
address our request for comment on
whether we should specify the
verification activities that must be
conducted for monitoring ask us to not
do so because this prescriptive approach
would be too limiting. These comments
ask us to instead provide flexibility for
the facility to determine the appropriate
verification activities.
(Response 320) We agree that we
should provide flexibility for the facility
to determine these verification
activities, and are not specifying the
verification activities that must be
conducted for monitoring.
3. Proposed § 507.45(a)(3)—Verification
of Corrective Actions
We proposed that verification
activities must include, as appropriate
to the preventive control, verification
that appropriate decisions about
corrective actions are being made in
accordance with § 507.42. We requested
comment on whether this section
should specify the verification activities
that must be conducted for corrective
actions, and if so, what verification
activities should be required.
(Comment 321) Some comments ask
us not to specify the verification
activities that must be conducted for
corrective actions because this approach
would be too limiting. These comments
ask us to instead provide flexibility for
the facility to determine the appropriate
verification activities.
(Response 321) We agree that we
should provide flexibility for the facility
to determine the appropriate
verification activities for corrective
actions, and are not specifying the
verification activities that must be
conducted for corrective actions.
4. Proposed § 507.45(a)(4)—Verification
of Implementation and Effectiveness
We proposed that verification
activities must include, as appropriate
to the preventive control, verification of
implementation and effectiveness in
accordance with § 507.49. See section
XXXIV for comments on verification of
implementation and effectiveness.
(Comment 322) One comment
contends that animal food facilities
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should not be required to conduct
product testing or environmental
monitoring to verify implementation
and effectiveness of preventive controls.
The comment states that product testing
and environmental monitoring at a
facility that is not using appropriate
controls will not normally discover
potential hazards. The comment also
states that all of the safety requirements
necessary to protect the health of
animals are already being met because
this is necessary as a good business
practice and is required by customers.
(Response 322) When a food safety
plan is completed by a preventive
controls qualified individual, they must
ensure that the preventive controls in
place are adequate to provide assurance
that any hazards requiring a preventive
control will be significantly minimized
or prevented. We have provided
adequate flexibility for a preventive
controls qualified individual in an
animal food facility to determine if
product testing or environmental
monitoring is necessary considering the
facility, the animal food, the nature of
the preventive control, and its role in
the facility’s food safety system (for
further discussion see section XXXIV.C
and XXXIV.E).
We disagree that all food safety
measures necessary to protect the health
of animals are always being followed.
Each year, animal food is recalled, often
due to a hazard that could cause serious
health consequences or death. Animal
food from a facility that is required to
register and for which there is a
reasonable probability that use of or
exposure to the food would cause
serious adverse health consequences or
death to humans or animals is subject to
reporting to FDA under section 417 of
the FD&C Act (Reportable Food
Registry).
5. Proposed § 507.45(a)(5)—Reanalysis
We proposed that verification
activities must include, as appropriate
to the preventive control, reanalysis in
accordance with § 507.50. See section
XXXV for comments on reanalysis as a
verification activity.
C. Proposed § 507.45(b)—
Documentation of Verification Activities
We proposed that all verification
activities must be documented in
records. We received no comments that
disagreed with this proposed
requirement and are finalizing it as
proposed.
D. Comments on Potential Requirements
Regarding Complaints
We requested comment on whether
and how a facility’s review of
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complaints, including complaints from
consumers, customers, or other parties,
should be required as a component of its
activities to verify that its preventive
controls are effectively minimizing the
occurrence of hazards (78 FR 64736 at
64809).
(Comment 323) Some comments ask
us to require review of consumer
complaints as a verification activity and
note that our HACCP regulations for
seafood and juice require that
verification activities include a review
of consumer complaints to determine
whether they relate to the performance
of the HACCP plan or reveal the
existence of unidentified CCPs. Some
comments note circumstances in which
consumer complaints have identified
food safety problems that resulted in a
company report to the RFR. Other
comments assert that review of
customer complaint data should not be
required in the rule to verify that a
facility’s preventive controls are
effectively minimizing the occurrence of
hazards.
Some comments state that the
frequency and type of complaints a
facility receives is a very good indicator
of the underlying issues associated with
food production, reviewing these
records would provide valuable insight
into the type of issues that should be
investigated, and this type of
verification activity could therefore be
extremely effective with little to no cost
because the facility would already be
performing this type of activity. Some
comments state that many foodborne
outbreaks have been identified through
complaints and a review of complaints
is a critical component of a food safety
system. One comment says that many
times customer complaints may be the
first and only clue that problems exist
in animal food because animal illnesses
are not subject to the same reporting
requirements as human illnesses,
resulting in a much weaker basis for
identifying, tracing, and correcting
foodborne problems.
Other comments state that a food
safety review of complaints is a prudent
part of a food safety program but that
the value of such a review is in
providing information and feedback for
continuous improvement of the food
safety management system rather than
as a verification of preventive controls.
These comments caution against use of
consumer complaints as a regulatory
requirement for verification of the food
safety plan because most complaints
relate to product quality. If such a
requirement is nonetheless established
in the final rule, these comments
recommend that the rule only require
followup and documentation for the
rare occurrences where consumer
complaints relate to food safety issues.
Other comments ask us not to require
review of complaints as a verification
activity. Some of these comments assert
that complaints rarely relate to food
safety or yield information that leads to
discovery of a food safety issue. Some
comments assert that requiring review
of consumer complaints could result in
unnecessary time and effort being spent
on an activity with a limited correlation
to food safety. Some comments assert
that the provision would provide FDA
access unnecessarily to all complaint
files and lead to unproductive and
subjective evaluations as to whether a
given complaint pertains to the
performance of the food safety plan.
Other comments assert that complaints
would be acted upon immediately for
business reasons, and that waiting to
react to complaints until conducting a
review of records as a verification
activity would be too late. Other
comments assert that complaints are
sensitive business information. Other
comments assert that some consumer
complaints are false or emotional (rather
than factual) and have no place in
development of preventive controls.
Some comments assert that FSMA does
not expressly direct us to require review
of complaints. Some comments assert
that review of complaints is not a
precise scientific process, and that
consumer comments are often open to
different interpretations.
Some comments discuss the
feasibility of consumer complaint
56265
review. Comments state that consumer
complaint records are often kept at a
corporate level rather than at the
individual facility. One comment
requests mandatory complaint
monitoring for animal food
manufacturers. One comment points out
FDA already has access to records,
including complaint files, associated
with animal food, which the Agency
reasonably believes to be adulterated
and presenting a threat of serious
adverse health consequences.
(Response 323) We are not
establishing a requirement for a review
of complaints as a verification activity.
We agree that review of complaints is
more likely to be useful in providing
information and feedback for
continuous improvement of the food
safety system rather than as a
verification of preventive controls.
However, we encourage facilities to do
such a review, as they occasionally do
uncover animal food safety issues.
XXXIII. Subpart C: Comments on
Proposed § 507.47—Validation
We proposed to establish
requirements for validation of
preventive controls. Some comments
support the proposed requirements
without change. For example, some
comments agree that validation must be
performed by (or overseen by) a
preventive controls qualified individual
and that some preventive controls (e.g.,
sanitation controls and recall plans) do
not require validation. Some comments
that support the proposed provisions
suggest alternative or additional
regulatory text or ask us to clarify how
we will interpret the provision.
In the following paragraphs, we
discuss comments that ask us to clarify
the proposed requirements or that
disagree with, or suggest one or more
changes to, the proposed requirements.
After considering these comments, we
have revised the proposed requirements
as shown in table 17, with editorial and
conforming changes as shown in table
31.
TABLE 17—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VALIDATION
Description
Revision
507.47(a) .........................................
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Section
Flexibility for validating preventive
controls.
507.47(b)(1) .....................................
Circumstances requiring validation
Provide that validation be conducted as appropriate to both the nature of the preventive control and its role in the facility’s food safety
system.
Provide that, when necessary to demonstrate the control measures
can be implemented as designed, validation may be performed (1)
Within 90 calendar days after production of the applicable animal
food first begins or (2) within a reasonable timeframe, provided that
the preventive controls qualified individual prepares (or oversees
the preparation of) a written justification.
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TABLE 17—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VALIDATION—Continued
Description
Revision
507.47(b)(1) .....................................
Circumstances requiring validation
507.47(c) .........................................
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Section
Preventive controls that do not require validation.
Add an additional circumstance requiring validation, i.e., whenever a
change to a control measure or combination of control measures
could impact whether the control measure or combination of control
measures, when properly implemented, will effectively control the
hazards requiring a preventive control.
Clarify that a list of preventive controls that do not require validation
is not an exhaustive list.
A. Flexibility in the Requirements To
Validate Preventive Controls
With some exceptions (see discussion
of proposed § 507.47(b)(3) in section
XXXIII.D), we proposed that you must
validate that the preventive controls
identified and implemented in
accordance with proposed § 507.36 to
control the significant hazards are
adequate to do (proposed § 507.47(a)).
(Comment 324) Some comments
assert that the regulatory text is in
conflict with the preamble discussion in
the 2014 supplemental notice because
the regulatory text (i.e., ‘‘(e)xcept as
provided by . . .’’) narrowly provides
exceptions only for validation of
sanitation controls, supplier controls,
and the recall plan, whereas the
preamble discussion provides other
examples of preventive controls that
would not require validation (i.e.,
zoning, training, preventive
maintenance, and refrigerated storage).
These comments also assert that
although the regulatory text specifies
that validation requirements apply ‘‘as
appropriate to the nature of the
preventive control,’’ that phrase could
be interpreted to mean that only the
validation act itself can be tailored and
that the facility does not have the
flexibility to conclude that validation
isn’t necessary.
Some comments assert that the
proposed regulatory text would prevent
us from requiring validation of specific
sanitation controls where it may be
prudent to do so, either now or in the
future as a result of a newly identified
hazard, or the development of a tool,
such as a test method, that would enable
validation of the control for the specific
hazard.
(Response 324) We have deleted
‘‘except as provided by paragraph (b)(3)
of this section’’ from proposed
§ 507.47(a) to remove the limitation seen
by the comments on the exceptions to
the requirement for validation of
preventive controls. We also have
revised the regulatory text of § 507.47(c)
to provide that a facility does not need
to validate other preventive controls, if
the preventive controls qualified
individual prepares (or oversees the
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preparation of) a written justification
that validation is not applicable based
on factors such as the nature of the
hazard, and the nature of the preventive
control and its role in the facility’s food
safety system. We specified that the
determination that validation is not
required must be made by the
preventive controls qualified individual
to emphasize that specialized
experience is necessary to evaluate
whether validation is required. We
made a conforming revision to the list
of responsibilities of the preventive
controls qualified individual (see
§ 507.53(a)).
(Comment 325) Some comments ask
us to separate requirements for
validation from requirements for
verification because verification and
validation are two different concepts
and combining them is confusing. One
comment said that we reversed the
definitions of validation and
verification, compared to the common
use of the terms in HACCP activities.
Some comments point out that while
section 418(f)(1) of the FD&C Act
explicitly requires verification, it does
not require validation. Some of these
comments assert that our proposed
requirements for validation exceed the
mandate of FSMA while others argue
that the lack of explicit language in
section 418 of the FD&C Act gives us
legal flexibility in determining whether
and how to require validation.
(Response 325) Our approach is
consistent with section 418 of the FD&C
Act. Section 418(f)(1) of the FD&C Act
requires verification of the preventive
controls, and validation is an element of
verification (see both the NACMCF
HACCP guidelines (Ref. 49) and our
HACCP regulation for juice (§ 120.3(p)).
We agree that the purpose of validation
is different from the purpose of other
verification activities, and we have
revised the definitions of both terms to
make this clearer. Although we are
establishing a separate regulatory
section for the validation requirements,
we did so to improve clarity and
readability rather than as a substantive
change relevant to the issues discussed
in these comments. (See Response 75.)
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(Comment 326) Some comments
assert that validation is more
appropriate for a HACCP regulation and
that requiring the validation of all
preventive controls does not reflect the
flexibility mandated by section
418(n)(3)(A) of FSMA. Other comments
assert that effective preventive measures
may be identified in the future that are
not amenable to validation and it would
be counterproductive for them not to be
employed in food safety plans because
they cannot meet the validation
requirements. These comments explain
that certain control measures are not
suitable for validation activities due to
the nature of the activity or previous
validation by another entity (e.g., a
supplier).
(Response 326) The 2013 proposed
preventive controls rule for animal food
would not have required the validation
of all preventive controls. For example,
we specifically proposed that the
validation of preventive controls need
not address sanitation controls and the
recall plan. To emphasize that a facility
has flexibility in determining which
other preventive controls require
validation, in the 2014 supplemental
notice we revised the proposed
regulatory text to require validation ‘‘as
appropriate to the nature of the
preventive control.’’ See Response 324
for additional revisions we have made
to the regulatory text to provide
flexibility for a facility to determine that
validation is not necessary.
(Comment 327) Some comments ask
us to allow validation of the whole
system instead of individual controls.
(Response 327) See the discussion of
the definition of validation in Response
75. Under the definition, validation can
be directed to a control measure,
combination of control measures, or the
food safety plan as a whole.
(Comment 328) Some comments ask
us to align validation requirements with
the relative risk of operations.
(Response 328) Validation
requirements apply only to preventive
controls that are established and
implemented based on the outcome of a
hazard analysis, which requires
consideration of risk. We also require
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validation as appropriate to the nature
of the preventive control and its role in
the facility’s food safety system. This
provides flexibility with respect to
validation and allows consideration of
risk.
(Comment 329) Some comments ask
us to provide guidance and clarification
on topics relevant to validation,
especially for small facilities that may
lack the resources needed to generate
studies and scientific data to validate
processes. Some comments ask us to
clarify our expectations for a validated
process and on conducting studies for
validation purposes. Some comments
ask us to provide resources for
validation, noting that some preventive
controls will be difficult to validate and
that no scientific research or data are
available for certain controls. Some
comments indicate that validation
information provided by FDA should be
in the form of non-binding guidance
documents. Some comments ask us to
delay enforcement for the validation
requirements until a readily accessible
repository of validated processes, and
scientific and technical information, can
be created to assist stakeholders in
complying with the validation
requirements.
(Response 329) We intend that the
guidance we are developing will
address topics such as those
recommended in the comments. (See
Response 1). In addition, the FSPCA is
developing information for training,
which may be useful to animal food
facilities. We are not requiring facilities
to comply with the requirements of
subparts C and E of this rule, including
the validation requirements, for 2, 3, or
4 years depending on the size of the
facility. We expect that segments of the
animal food industry will work together
and with the FSPCA to develop
scientific and technical information that
can be used as evidence to validate a
variety of preventive controls, and will
be helpful to facilities.
(Comment 330) Some comments
indicate that the rule lacked
specifications for, and was unclear on,
the process that FDA would utilize to
approve or accept validation data and/
or studies. Some comments ask us to
develop a mechanism for industry to
make sure their approach and studies
meet the requirements of the rule, such
as certification of process authorities or
the establishment of a liaison between
FDA and industry to ensure validation
protocols are in compliance.
(Response 330) As discussed in
Response 1, we are developing several
guidance documents within FDA,
including guidance on validation. In
addition, as part of a collaborative effort
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with the FSPCA we are obtaining
technical information useful for
developing guidelines for preventive
controls and outreach to industry, and
we intend that effort to include
guidance on approaches to satisfy the
validation requirements of the rule. We
do not intend to develop a mechanism
for certification of process authorities or
establish a liaison between FDA and
industry to ensure validation protocols
are in compliance. The guidance we are
developing on validation should help
industry determine whether their
validation approaches are likely to be
acceptable to us.
B. Proposed § 507.47(b)(1)—When
Validation Must Be Performed and Role
of Preventive Controls Qualified
Individual in Validation
We proposed that validation of the
preventive controls must be performed
by (or overseen by) a preventive controls
qualified individual prior to
implementation of the food safety plan
(or, when necessary, during the first 6
weeks of production) and whenever a
reanalysis of the food safety plan reveals
the need to do so.
(Comment 331) Some comments ask
us to clarify whether an individual
attending food safety training by an
entity such as a cooperative extension or
a State department of agriculture could
be a ‘‘preventive controls qualified
individual’’ for the purpose of
performing or overseeing the validation
of preventive controls.
(Response 331) See the discussion in
section XXXVII.B for additional
information about training applicable to
a preventive controls qualified
individual. We have not specified
additional requirements for a preventive
controls qualified individual with
respect to validation. A person may be
a preventive controls qualified
individual through job experience, as
well as training. Food safety training
provided by an entity such as a
cooperative extension specialist or a
State department of agriculture could be
appropriate training for many of the
functions of the preventive controls
qualified individual if the training is
consistent with the standardized
curriculum being developed by the
FSPCA.
(Comment 332) Some comments
question whether 6 weeks is enough
time to perform all applicable validation
studies that would address the
execution element of validation. Some
comments ask us to explain the basis for
the proposed 6-week timeframe. Some
comments ask us to align with the 90day timeframe in the FSIS Validation
Guidelines (Ref. 50). Some comments
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note that the seasonal nature of
production of some food products may
make it impractical to perform all
required validations within 6 weeks.
Some comments suggest that validation
be performed within a specified number
of production batches, such as 10
production batches. Some comments
emphasize the need for flexibility and
ask us to both adopt a 90-day timeframe
and provide for a longer timeframe with
a written justification, or provide for
ongoing evidence of process validation.
One comment recommends removing a
required timeframe for validation or
providing a compliance extension until
such time as we could better support the
requirements, such as in guidance. One
comment asserts that the timeframe
should be prior to implementation of
the food safety plan. Some comments
ask as us to specify that validation be
performed within a reasonable time as
justified by the preventive controls
qualified individual. Some comments
ask for more time for small businesses
to perform validation studies.
(Response 332) We note that the 90day timeframe for validation is
established in FSIS’ regulations at 9 CFR
304.3(b) and (c) and 9 CFR 381.22(b)
and (c) (Conditions for receiving
inspection for meat and meat products
and poultry and poultry products,
respectively). The FSIS Validation
Guidelines are a companion to those
regulations. We have revised the
regulatory text, with associated editorial
changes, to make two changes to the
proposed 6-week timeframe for
validation of preventive controls. First,
we have adopted the 90-day timeframe
already established in the FSIS’
regulations by specifying that when
necessary to demonstrate the control
measures can be implemented as
designed, validation may be performed
within 90 days after production of the
applicable animal food first begins.
Although we had proposed a 6-week
timeframe based on the 3 to 6 week
timeframe suggested in the Codex
Guidelines for the Validation of Food
Safety Control Measures (Ref. 22), we
agree that practical limitations
associated with the production of some
animal food products may make it
difficult to perform validation within 6
weeks. The 90-day timeframe in FSIS’
regulations, and incorporated into the
FSIS Validation Guidelines, reflects
more than 15 years of experience with
validating HACCP systems for meat and
poultry. Although we have provided for
validation to be performed within 90
days after production of the applicable
food first begins, we do not believe it
would take a full 90-days of production
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to determine whether the facility can
provide assurances that a control
measure is working as intended to
control the hazard.
Second, we have provided for
validation within a reasonable
timeframe, provided that the preventive
controls qualified individual prepares
(or oversees the preparation of) a written
justification for a timeframe that
exceeds 90 days after production of the
applicable animal food first begins. We
acknowledge that practical limitations
such as those described in the
comments could prevent a facility from
performing the validation within 90
days after production of the applicable
animal food first begins. A timeframe
that exceeds 90 days after production of
the applicable animal food first begins
will be the exception rather than the
norm and we are requiring that the
preventive controls qualified individual
provide (or oversee the preparation of)
a written justification for such a
timeframe. We made a conforming
revision to the list of responsibilities of
the preventive controls qualified
individual (see § 507.53(a)).
(Comment 333) Some comments ask
us to add another circumstance when
validation would be required, i.e.,
whenever a change is made to the
control being applied.
(Response 333) We have revised the
regulatory text to require validation
whenever a change to a control measure
or combination of control measures
could impact whether the control
measure or combination of control
measures, when properly implemented,
will effectively control the hazards
requiring a preventive control. Under
this provision, a facility would
revalidate a preventive control if, for
example, a different type of equipment
is used to deliver a heat process,
because it would be necessary to
determine that the new equipment can
consistently achieve the required
temperature and time of the process.
However, a facility would not need to
revalidate a preventive control if, for
example, a thermal process is changed
by increasing the time or temperature,
because a less stringent thermal process
would already have been validated.
(Comment 334) Some comments ask
us to require validation both before
production and 6 weeks after
production begins.
(Response 334) We decline this
request. A facility has flexibility to
perform validation as appropriate to the
nature of the preventive controls,
whether before production (e.g., by
obtaining and evaluating generally
available scientific and technical
information or by conducting studies),
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after production begins (to demonstrate
the control measures can be
implemented as designed during fullscale production), or both.
C. Proposed § 507.47(b)(2)—What
Validation Must Include
We proposed that the validation of
preventive controls must include
collecting and evaluating scientific and
technical information (or, when such
information is not available or is
inadequate, conducting studies) to
determine whether the preventive
controls, when properly implemented,
will effectively control the significant
hazards.
(Comment 335) Some comments
assert that our discussion of validation
refers to ‘‘scientific proof’’ for the
validation of a processing step and ask
us to define what is and is not
considered scientific proof for
validation.
(Response 335) We used terms such as
‘‘scientific and technical information’’
and ‘‘scientific and technical basis’’
rather than ‘‘scientific proof’’ when
discussing validation. For information
about what we mean by ‘‘scientific and
technical information,’’ (see 78 FR
64736 at 64794 through 64795).
(Comment 336) Some comments ask
us to clarify expectations of validations
for basic sanitary processes. Another
comment asks us to exempt the
validation of CGMPs.
(Response 336) The requirements for
validation only apply to preventive
controls. Any practice governed by
CGMPs only requires validation if a
facility identifies that practice as a
preventive control for a hazard. To the
extent that the comment is referring to
sanitary practices governed by CGMPs
(such as in § 507.19), the validation
requirements would not apply. To the
extent that the comment is referring to
sanitation controls established as a
preventive control, those sanitation
controls are excluded from the
validation requirements (see
§ 507.47(c)).
(Comment 337) Some comments ask
that we not require further validation of
well-accepted preventive controls, such
as refrigeration temperature.
(Response 337) A facility may rely on
generally available scientific and
technical information to demonstrate
the adequacy of controls such as
refrigeration but must obtain that
information and establish it as a record
(see § 507.45(b)).
(Comment 338) Some comments
express concern that specific methods
are not available to enable validation.
Some comments express concern that
the requirement to ‘‘conduct studies’’
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might be intended, or could be
interpreted, to mean that firms are
required to develop or validate
analytical methods (either in general or
for specific food matrices). These
comments assert that any such
requirement would incur extreme costs
and burdens without delivering
commensurate public health benefits.
(Response 338) We do not intend the
requirement to ‘‘conduct studies’’ to
mean that firms are required to develop
or validate analytical methods.
(Comment 339) Some comments
recommend validation via indirect
methods such as scientific publications,
government documents, predictive
modeling and other technical
information from equipment
manufacturers and other sources. Other
comments assert that there are a variety
of circumstances in which the collection
and evaluation of scientific and
technical information is not necessary
(e.g., the use of sieving or metal
detectors to control physical hazards).
(Response 339) See Responses 324
and 326. We agree that not all
preventive controls require validation,
and the facility has flexibility to take
into account the nature of the
preventive control when determining
whether to perform validation. The
regulatory text, which provides for
scientific and technical evidence that a
control measure is capable of effectively
controlling the identified hazards,
provides for the use of ‘‘indirect
methods’’ as recommended by the
comments. However, even when sources
such as scientific publications are the
basis for validation, studies may be
needed to demonstrate that the process
used can be implemented in the facility
to control the hazard.
D. Proposed § 507.47(c)(3)—Preventive
Controls for Which Validation Is Not
Required
We proposed that validation need not
address sanitation controls, the recall
plan, and the supplier program (which
we now refer to as the ‘‘supply-chain’’
program).
(Comment 340) Some comments ask
us to eliminate the specific list of
controls that are excluded from the
validation requirement and instead
revise the regulatory text to provide the
facility with flexibility to determine
when validation is appropriate.
(Response 340) As discussed in
Response 324, we have deleted ‘‘except
as provided by paragraph (b)(3) of this
section’’ from proposed § 507.47(a) to
remove the limitation seen by the
comments on the exceptions to the
requirement for validation of preventive
controls. We also have revised the
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regulatory text of § 507.47(c) to provide
that a facility does not need to validate
other preventive controls, if the
preventive controls qualified individual
prepares (or oversees the preparation of)
a written justification that validation is
not applicable based on factors such as
the nature of the hazard, and the nature
of the preventive control and its role in
the facility’s food safety system. We see
no reason to also eliminate the list of
those controls for which we have
already determined that validation is
not necessary, and require each facility
to develop its own rationale for
concluding that validation is not
necessary based on the nature of these
preventive controls. The rule would not
prevent a facility from validating one of
these preventive controls, such as a
sanitation control, if it chooses to do so.
XXXIV. Subpart C: Comments on
Proposed § 507.49—Verification of
Implementation and Effectiveness
We proposed that you must verify that
the preventive controls are consistently
implemented and are effectively and
significantly minimizing or preventing
the significant hazards. We proposed
that to do so you must conduct specified
activities (i.e., calibration, product
testing, environmental monitoring, and
review of records) as appropriate to the
facility, the animal food, and the nature
of the preventive control. We also
proposed that you must establish and
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implement written procedures for the
frequency of calibrating process
monitoring instruments and verification
instruments, product testing, and
environmental monitoring.
Some comments that support the
proposed provisions suggest alternative
or additional regulatory text or ask us to
clarify how we will interpret the
provision. In the following paragraphs,
we discuss comments that ask us to
clarify the proposed requirements or
that disagree with, or suggest one or
more changes to, the proposed
requirements. After considering these
comments, we have revised the
proposed requirements as shown in
table 18.
TABLE 18—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VERIFICATION OF IMPLEMENTATION AND EFFECTIVENESS
Section
Description
Revision
507.49(a) .........................................
Flexibility in the requirement to
conduct activities to verify implementation and effectiveness.
Verification of implementation and
effectiveness for process monitoring
instruments
and
verification instruments.
Timeframe for review of records of
monitoring and corrective action
records.
Provide that activities for verification of implementation and effectiveness take into account both the nature of the preventive control
and its role in the facility’s food safety system.
Provide for accuracy checks in addition to calibration.
507.49(a)(1) .....................................
507.49(a)(4)(i) .................................
507.49(a)(5) .....................................
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507.49(b)(1) .....................................
Other activities appropriate for
verification of implementation
and effectiveness.
Written procedures for verification
of implementation and effectiveness.
Written procedures for verification
of implementation and effectiveness for process monitoring instruments and verification instruments.
A. Flexibility in the Requirement To
Conduct Activities To Verify
Implementation and Effectiveness
We proposed that you must verify that
the preventive controls are consistently
implemented and are effectively and
significantly minimizing or preventing
the significant hazards by conducting
specified activities as appropriate to the
facility, the animal food, and the nature
of the preventive control. We proposed
to specify the following verification
activities: (1) Calibration; (2) product
testing; (3) environmental monitoring;
and (4) review of records.
In the following paragraphs, we
discuss comments generally directed to
the need for a facility to have flexibility
to apply these requirements
(particularly the requirements for
product testing and environmental
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Provide for records review within 7 working days after the records are
created, or within or within a reasonable timeframe, provided that
the preventive controls qualified individual prepares (or oversees
the preparation of) a written justification.
Clarify that there could be alternative verification activities of implementation and effectiveness other than those that we specify in the
rule.
Clarify that written procedures for verification of implementation and
effectiveness are established and implemented as appropriate to
the role of the preventive control in the facility’s food safety system,
as well as appropriate to the facility, the animal food, and the nature of the preventive control.
Require written procedures for accuracy checks in addition to calibration.
monitoring) in a manner that works best
for the facility in light of its animal food
products and the nature of the
preventive controls that would be
verified. In sections XXXIV.B through
XXXIV.F, we discuss the requirements
for calibration, product testing,
environmental monitoring, and review
of records more specifically.
(Comment 341) Some comments
express support for the flexibility
provided by specifying that verification
activities must be conducted ‘‘as
appropriate to the facility, the animal
food, and the nature of the preventive
control.’’ Some comments state that the
proposed provision means that, based
on risk, an animal food manufacturer
could decide whether or not to do
product testing and, when applicable,
the type of test and the testing
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frequency. One comment says the
provision will have limited value where
the presence of some levels of pathogens
is expected and is not necessarily an
animal food safety problem. Some
comments agree with the proposed
provisions because they address product
testing through flexible written
procedures that consider both testing
and corrective action plans rather than
through mandatory or prescribed
requirements. Other comments agree
with the proposed provisions because
they require facilities to develop and
use testing programs that are tailored to
their facility, equipment, processes,
products, and other specific
circumstances, and do not prescribe
specific requirements for testing, such
as finished product testing. Some
comments state that product testing may
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not be effective in identifying the
acceptability of a specific ingredient or
finished product lot on any given day,
but it can help assess and verify the
effectiveness of a food safety plan as a
whole and the facility’s capability to
consistently deliver against it.
Some comments assert that the
preamble discussion in the 2014
supplemental notice is in conflict with
the proposed regulatory text and ask us
to modify the regulatory text to provide
the flexibility we signaled in that
supplemental notice. These comments
express concern that the term ‘‘must’’
(i.e., ‘‘you must conduct activities that
include the following’’) could be
interpreted to mean that activities listed
in the regulatory text (in particular,
product testing and environmental
monitoring) are always required in some
form. Some comments ask us to clarify
whether product testing and
environmental monitoring are required
or optional. Other comments assert that
facilities should have the flexibility to
determine whether to conduct product
testing and environmental monitoring
based on a risk assessment. Some
comments assert that there are
circumstances (such as unpackaged
animal food; ingredients for animal food
stored in vented or open areas, in
oilseed production; and rendering)
where these tests would not be
necessary. Some comments assert that a
determination to conduct environmental
monitoring should be on a case-by-case
basis and that other verification
activities may be used (such as process
verifications or testing of intermediates)
to verify implementation and
effectiveness. Other comments ask us to
exempt operations when their hazard
analysis appropriately concludes that
there is no foreseeable risk. One
comment says FDA should not require
routine monitoring for feed mills unless
they manufacture pet food.
One comment says environmental
monitoring should not be required as a
verification activity for significant
hazards as other controls can be used
and environmental monitoring will
impose undue burdens and costs to
industry. Many comments state that
environmental monitoring requirements
should only be applied to ‘‘significant
hazards,’’ if any, that are present within
the firm’s operation, and as with
product testing, animal food facilities
must be provided the flexibility to tailor
their environmental monitoring
programs based on risk. Comments note
that in cases where the animal food is
likely to undergo further processing that
would minimize or eliminate any
microbiological hazards, environmental
pathogens would not be a significant
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hazard and such facilities could focus
their resources on other controls. One
comment says it does not agree that the
potential for later processing mitigates
the need for environmental monitoring
because processes such as pelleting
reduce but do not entirely eliminate
pathogens.
(Response 341) The provisions for
verification provide flexibility by
specifying that they apply as
appropriate to the nature of the
preventive control and its role in the
facility’s food safety system. As noted
by some comments, the provisions
address testing through flexible written
procedures that allow facilities to
develop and use testing programs that
are tailored to their facility, equipment,
processes, products, and other specific
circumstances. We agree that an
appropriate outcome of the hazard
analysis for some facilities will be that
product testing and environmental
monitoring are not required; it is not
necessary to grant an ‘‘exemption’’ to
allow a facility to achieve this outcome.
For example, environmental monitoring
would be required to verify
effectiveness of sanitation controls
when an animal food is exposed to the
environment prior to packaging and the
packaged food does not receive a
treatment or otherwise include a control
measure (such as a formulation lethal to
the pathogen) that would significantly
minimize the pathogen because such
environmental monitoring is
appropriate to the facility (one
manufacturing animal food), the food
(such as a dry (extruded) pet food
exposed to the environment), and the
nature of the preventive control
(sanitation controls). Animal food such
as dry and raw pet food and pet treats
are among the products for which
manufacturing operations might need to
have an environmental monitoring
program when such animal food is
exposed to the environment.
We discuss product testing for
microbial pathogens in another FDA
memorandum, including the use of
pathogens and indicator organisms and
microbial testing of foods for process
control and for problem solving (Ref.
52). The circumstances in which
product testing would be required are
dependent on a variety of factors as
described in the Appendix to the 2013
proposed preventive controls rule for
animal food (78 FR 64736 at 64836). As
with environmental monitoring, product
testing must be conducted as
appropriate to the facility, the animal
food, and the nature of the preventive
control and its role in the facility’s food
safety system. For example, a raw
material or other ingredient added to an
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animal food after a pathogen ‘‘kill step’’
must be tested before use when the raw
material or other ingredient has been
associated with a pathogen and has not
been treated to significantly minimize or
prevent that pathogen (e.g., poultry
based flavoring spray applied on dry pet
food). Product testing would be required
because it is appropriate to the facility
(one making an animal food), the food
(pet food), and the nature of the
preventive control (there is no control
applied to the poultry based flavoring
spray).
When process control testing for an
indicator organism, or environmental
monitoring for an indicator organism,
indicates an animal food (e.g., dry pet
food) is reasonably likely to be
contaminated with a pathogen, that
animal food must be tested for the
pathogen. For example, if
environmental monitoring reveals
animal food-contact surfaces
contaminated with Salmonella and
additional environmental monitoring
following corrective actions indicates
animal food-contact surfaces are still
contaminated with Salmonella, product
testing would be required because it is
appropriate to the facility (one making
that animal food), the animal food (pet
food, which supports the growth of
Salmonella), test results from
environmental monitoring (which show
the presence of an indicator organism
for Salmonella on animal food-contact
surfaces in the animal food processing
environment), and the nature of the
preventive control (sanitation controls
to prevent contamination by
environmental pathogens, which appear
to be inadequate).
The word ‘‘must’’ specifies the type of
activities that a facility can use to satisfy
the requirements for a particular
preventive control management
component, and we are retaining the
term ‘‘must.’’ However, we agree that
the rule should provide flexibility for
additional verification of
implementation and effectiveness. To
provide that additional flexibility, we
have revised the specific requirements
for verification of implementation and
effectiveness to provide for other
activities appropriate for verification of
implementation and effectiveness (see
§ 507.49(a)(5)).
We believe that the performance of
environmental monitoring, for an
appropriate microorganism of public
(human and animal) health significance
or for an appropriate indicator
organism, is particularly useful as a
verification measure for preventive
controls (i.e., sanitation controls) when
contamination of animal food with an
environmental pathogen is a hazard
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requiring a preventive control. We
anticipate that facilities producing
animal food that enters into the home
and is frequently handled in the home
will include biologic hazards of human
health concerns associated with that
animal food, as well as those of animal
health concerns in their hazards
requiring a preventive control. (See, for
example, our discussion of Salmonella
in pet food in the 2013 proposed
preventive controls rule for animal food
(78 FR 64736 at 64747).)
(Comment 342) Many comments ask
us to issue guidance, rather than
requirements, for product testing and
environmental monitoring based on
concerns such as the following: The
value of environmental monitoring will
be reduced if it becomes a minimum
regulatory requirement; there are wellknown limitations to product testing
and negative results from product
testing can create a false sense of
security; negative results are likely to
occur unless intensive sampling is
conducted dependent upon quality
sampling criteria; product testing is not
preventive, would put industry into a
reactive mode, and would pull valuable
resources from activities focused on
preventing contamination; there is
limited technology available to test
contaminants in some animal food
matrices and limited time available for
perishable commodities; any regulatory
requirement will soon be outdated as
products change and science improves;
and product testing would vastly
increase the cost of the rule and will
drive many businesses out of business
without necessarily improving animal
food safety; and requirements for
product testing would require the States
to direct resources to respond to noncompliant product testing results, and
such resources would be better directed
to environmental monitoring.
Some of these comments emphasize
the need for flexibility so that product
testing and environmental monitoring
are options that are available to the
facility rather than requirements for all
facilities. Other comments assert that
guidance provides greater opportunity
for industry innovation and stakeholder
participation to determine the
appropriate use of verification
measures, and avoids a ‘‘one-size-fitsall’’ approach to regulations. Some of
these comments state that we should
encourage environmental monitoring to
be conducted ‘‘through facility specific
food safety plans,’’ which would
provide the flexibility necessary to
monitor risks associated with exposures
of animal foods. Other comments state
that operators should be given the
necessary flexibility to implement any
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requirements in the most effective and
efficient manner using a risk-based
approach and taking into account the
specific conditions of their facilities and
operations. Some comments express
concern that including a requirement
makes it difficult for businesses to
justify a conclusion that testing is not
necessary.
Some comments ask us to solicit
drafts of proposed guidance documents
from the sustainable agriculture and
local/regional food system community;
publish a list of possible topics for
future guidance each year; seek input in
advance from the sustainable agriculture
and local/regional food system
community before preparing draft
guidance (including public meetings,
workshops, and formation of an
advisory committee); hold public
meetings on draft guidance after
publication; and present draft guidance
to an advisory committee including
representatives from the sustainable
agriculture and local/regional food
system community.
Some comments suggest that an
ingredient manufacturer may identify an
environmental pathogen but the facility
would not implement a preventive
control to significantly minimize or
prevent the environmental pathogen
because the ingredient would be
subsequently processed to control the
hazard by another facility.
(Response 342) We are retaining the
requirements for product testing and
environmental monitoring in the rule,
with the revisions, already discussed, to
provide that verification activities
depend on the role of the preventive
control in the facility’s food safety
system (see Response 293); corrective
action procedures depend on the nature
of the hazard (see Response 304); and
written procedures for product testing
and environmental monitoring are
established and implemented as
appropriate to the role of the preventive
control in the facility’s food safety
system. These revisions clarify in the
regulatory text the flexibility that we
discussed in the 2014 supplemental
notice (79 FR 58476 at 58493 through
58495). Some of the comments that ask
us to issue guidance rather than
requirements appear to believe that only
guidance can provide sufficient
flexibility for product testing and
environmental monitoring. This is not
the case. (See Response 341.)
We disagree that environmental
monitoring will become a minimum
regulatory requirement in all cases; the
decision to conduct environmental
monitoring is made by the facility and
some comments discuss specific
examples of when environmental
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monitoring or product testing would not
be warranted. If a facility relies on its
customer to control an environmental
pathogen then the facility must follow
the requirements in subpart E for
supply-chain program. Moreover, the
fact that further manufacturing might be
capable of eliminating an environmental
pathogen that has contaminated an
animal food is not a reason to not take
reasonable measures to prevent
contamination from the environment
and to verify that such measures are
effective through environmental
monitoring.
We have acknowledged limitations of
product testing (79 FR 58476 at 58493
through 58494) and agree that a facility
should consider such limitations when
determining whether to conduct
product testing and keep such
limitations in mind when obtaining
negative results from product testing.
We also agree that product testing is not
preventive. However, the mere facts that
there are limitations, and that product
testing is itself not a preventive
measure, do not eliminate all benefits of
product testing; we agree with
comments that although product testing
may not be effective in identifying the
acceptability of a specific ingredient or
finished product lot on any given day,
it can help assess and verify the
effectiveness of a food safety plan as a
whole and the facility’s capability to
consistently deliver against it. We agree
that there is limited technology
available to test for some hazards in
animal food but expect that testing of
animal food by a facility as the sole
verification of the effectiveness its food
safety plan as a whole would be the
exception rather than the norm.
We disagree that regulatory
requirements for product testing and
environmental monitoring will soon be
outdated as products change and
science improves; the rule requires
reanalysis of the food safety plan as a
whole at least every 3 years, and
requires reanalysis of the food safety
plan as a whole, or the applicable
preventive control, in light of new
information (see § 507.50(a) and (b)). We
agree that there are some costs to
product testing, but the rule provides
flexibility for the facility to determine
when product testing is appropriate. We
acknowledge that the States will be
required, in many cases, to follow up on
positive findings obtained during
product testing but disagree that this is
a reason to eliminate the proposed
requirements. The States would only be
directing resources when the findings
indicate contamination of animal food,
and doing so will protect public (human
and animal) health.
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We will follow the procedures in
§ 10.115 for issuing guidance
documents. Under § 10.115(f), members
of the public can suggest areas for
guidance document development and
submit drafts of proposed guidance
documents for FDA to consider. Under
§ 10.115(g), after we prepare a draft
guidance we may hold public meetings
or workshops, or present the draft
guidance document to an advisory
committee for review; doing so is not
common and is determined on a caseby-case basis.
(Comment 343) One comment
requests that we add the additional
factor of the ‘‘intended use of the animal
food’’ to help further clarify that these
activities should be conducted based
upon the appropriate end use of the
animal food as it was intended by the
manufacturer, and not upon any
potential use of the product not
originally intended.
(Response 343) We believe the
requirement as written allows the
manufacturer’s intended use to be taken
into consideration when conducting the
hazard analysis. However, to the extent
that these comments are asserting that a
facility can ignore consumer behavior
that the facility considers contrary to
principles of food safety, we disagree.
For example, a facility could not
conclude that it need not identify and
evaluate a known or reasonably
foreseeably hazard because the facility
intends to provide safe handling
instructions on the label of a packaged
pet food. We do recognize that if a
manufacturer/processor has adequately
controlled a hazard and has properly
packaged, held, and labeled their
product, they are not responsible for
unforeseeable misuse by a consumer,
such as a person who intentionally
feeds swine food to sheep even though
the product is accurately labeled as
containing copper which can be toxic
for sheep. For manufacturers/processors
that rely on their customer or another
entity in the distribution chain to the
control a hazard, they must follow the
requirements in § 507.36(a)(2), (3), (4) or
(5). (See Response 285 for additional
information.)
B. Proposed § 507.49(a)(1)—Calibration
We proposed to require calibration of
process monitoring instruments and
verification instruments.
(Comment 344) Some comments
distinguish ‘‘calibration’’ from an
accuracy check, which the comments
describe as a test to confirm that a
particular equipment or measurement
device is accurate. These comments
assert that calibration may not be
possible for certain equipment or
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measurement devices, and the
appropriate corrective action may be
replacement or application of corrective
values. These comments ask us to
specify that an accuracy check may be
used as a verification activity in lieu of
calibration.
(Response 344) We have revised the
proposed requirements to require
calibration of process monitoring
instruments and verification
instruments, or checking them for
accuracy. However, if the outcome of an
accuracy check is that a process
monitoring instrument or verification
instrument is not accurate, the facility
must follow up by calibrating the
device, rather than by applying
corrective values, when it is practical to
do so and replace the device when it is
not practical to calibrate it.
C. Comments Directed to Proposed
Requirements for Both Product Testing
(Proposed § 507.49(a)(2) and (b)(2)) and
Environmental Monitoring (Proposed
§ 507.49(a)(3) and (b)(3))
We proposed that to verify that the
preventive controls are consistently
implemented and are effectively and
significantly minimizing or preventing
the significant hazards you must
conduct activities that include product
testing and environmental monitoring,
as appropriate to the facility, the animal
food, and the nature of the preventive
control (§ 507.49(a)(2) and (a)(3)). We
also proposed that you must establish
and implement written procedures for
product testing and for environmental
monitoring (§ 507.49(b)(2) and (b)(3)).
(Comment 345) Some comments ask
us to revise the regulatory text to be
explicit that there are circumstances
when product testing and
environmental monitoring would not be
necessary. One comment supports a
requirement that incoming raw
materials and feed ingredients must be
tested for harmful pathogens. Another
comment opposes mandatory product
testing for every lot of raw material
received. Some comments discuss
topics for us to include in guidance on
procedures for product testing and
environmental monitoring, such as
which pathogens to test for; the range of
products that should be tested;
circumstances that warrant testing; what
a facility would document and what
factors the facility would consider
before determining that product testing
is not appropriate for its animal food
product; frequency of sampling and
number of samples to be collected;
actions to take after a positive result;
available test methods; reporting
requirements for results; compliance
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strategies; and criteria for laboratories
conducting the testing.
(Response 345) We decline to revise
the regulatory text. The decision as to
whether product testing and
environmental monitoring are
warranted depends on the facility and
its animal food product, as well as the
nature of the preventive control and its
role in the facility’s food safety system,
and a slight variation on circumstances
that would lead one facility to conclude
that such testing programs were not
required could lead a different facility to
the opposite conclusion. Memoranda
placed in the docket for the 2014
preventive controls supplemental notice
for human food provide additional
information on these topics requested in
the comment (Refs. 51 and 52).
Although directed to product testing
and environmental monitoring for
human food production, some of the
information is relevant to animal food,
as well.
(Comment 346) Some comments ask
us to clarify that tests can be performed
by third-party facilities or laboratories,
as well as by the facility itself. Some
comments ask us to clarify that we will
accept test results in the same format as
the format used for other purposes, such
as third-party certification services.
(Response 346) The rule places no
restrictions on who conducts testing.
However, facilities have a responsibility
to choose testing labs that will produce
reliable and accurate test results. (See
Response 348.) The rule does not
specify the format of test results,
provided that the record documenting
testing satisfies the recordkeeping
requirements of subpart F.
(Comment 347) Some comments
express concern about requirements for
product testing and environmental
monitoring in light of section 202 of
FSMA (section 422 of the FD&C Act (21
U.S.C. 350k)). (Section 422 of the FD&C
Act addresses laboratory accreditation
for the analyses of foods, including use
of accredited laboratories in certain
circumstances and including
requirements for accredited laboratories
to report the results of laboratory testing
to FDA in certain circumstances.) These
comments express concern that
requirements for facilities to submit
results of environmental monitoring to
us will create an additional disincentive
to looking for pathogens established in
the facility. These comments assert that
the results of environmental monitoring
tests should be available to us for
inspection but not submitted to us if
product has not been distributed and
that submitting the results of routine
tests would be burdensome without
benefit. These comments ask us to
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clarify whether facilities or laboratories
would be required to submit the results
of environmental monitoring tests to us.
Likewise, some comments ask us to
clarify whether product testing
(including testing of raw materials or
other ingredients as part of supplier
controls) is subject to the requirements
of section 422 of the FD&C Act for using
accredited laboratories and for reporting
test results to us. Other comments ask
us to establish standards and procedures
for certifying laboratories that would
perform the tests. These comments
assert that these standards and
procedures are needed to ensure the
credibility of the testing and to provide
direction for facilities that establish inhouse testing facilities. Other comments
urge us to establish regulations
implementing section 422 of the FD&C
Act because they would complement
the requirements of the animal food
preventive controls rule and because
model laboratory standards that address
quality controls, proficiency testing,
training and education of laboratory
personnel offer the protections
necessary for ensuring reliable, accurate
test results. Other comments assert that
if laboratories are not accredited or
samples are not collected in a sanitary
manner, there is no guarantee the results
will be scientifically valid.
(Response 347) Section 422 of the
FD&C Act would require, in relevant
part, that food testing be conducted by
an accredited laboratory (and the results
of such testing be sent directly to FDA)
whenever such testing is conducted in
response to a specific testing
requirement under the FD&C Act or its
implementing regulations when applied
to address an identified or suspected
animal food safety problem or to
support admission of an animal food
under an Import Alert that requires food
testing. Although another rulemaking
will address the requirements of section
422 of the FD&C Act, our current
thinking is that routine product testing
and environmental monitoring
conducted as a verification activity is
not being applied to address an
identified or suspected animal food
safety problem that requires food testing
and would not be subject to
requirements to use an accredited
laboratory that would submit the results
to FDA. We will review the results of
environmental monitoring and product
testing, if any, during inspections.
The primary concern expressed in
these comments was with respect to
laboratories reporting results to FDA
and not with use of accredited
laboratories. The rule requires a facility
to establish and implement written
procedures for product testing and
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environmental monitoring and that the
procedures for such testing be
scientifically valid. One way to comply
with the requirement that testing
procedures be scientifically valid is to
use an accredited laboratory.
(Comment 348) Some comments ask
us to expand the proposed requirement
to identify the laboratory conducting the
testing to also specify whether that
laboratory is accredited and uses the
appropriate standards (such as quality
control, proficiency testing, and trained
laboratory staff). These comments assert
that such information would be useful
to facilities.
(Response 348) We decline this
request. These comments appear to be
asking us to establish in the preventive
controls for animal food rule
requirements related to section 422 of
the FD&C Act. Doing so in advance of
regulations implementing section 422 of
the FD&C Act is premature. However,
facilities have a responsibility to choose
testing labs that will produce reliable
and accurate test results even if the rule
does not require the facility to specify
whether the laboratory is accredited.
(Comment 349) One comment
requested the FSMA regulations
regarding ISO methods for Listeria and
Salmonella be changed to using BAM
(Bacteriological Analytical Manual)
methodology.
(Response 349) While we require
scientifically valid procedures for
testing, the rule does not specify a
particular method be used. A laboratory
could use an FDA BAM method, an ISO
method, or another method that is
validated in the relevant animal food
matrix.
(Comment 350) Some comments say
that there is little scientific data to show
environmentally exposed animal food,
such as raw liquid ingredients and
finished liquid animal food products, as
well as food for livestock creates a
potential for harmful biological hazards
and an evaluation of environmental
pathogens should not be required as
part of the hazard analysis. Other
comments point out it is common
practice to store ingredients with some
exposure to the environment during a
portion of their storage, complete
outdoor storage is standard practice
both at the production facility, as well
as where it will be consumed without
resulting in harm. Some comments say
that mere exposure to the environment
does not inherently increase the risk of
contamination of animal food.
Some comments say environmental
testing should only be required for
packaged animal foods and recommend
that environmental testing be required
whenever animal food ingredients or
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finished animal foods are exposed to the
environment after undergoing a process
aimed at reducing pathogens (e.g., a heat
kill step such as rendering or the
extrusion process) or other hazards that
could be transmitted through the
environment. These comments say
processing aimed at reducing hazards
will be ineffective if pathogen loads or
hazard levels going into the processing
are too high and are concerned that the
proposed rule would not require
renderers, who often handle sick and
dead animals, to make sure that the
plant environment is not a pathway for
the recycling of pathogens into the
animal food system through
contaminated animal products. Many
comments state that all finished animal
food is ready to eat whether or not it is
packaged, so it is not reasonable to limit
environmental monitoring only to
animal foods that may be packaged.
(Response 350) We do not expect
either product testing or environmental
monitoring to be common in facilities
that process, pack, or hold RACs for
animal consumption. We agree that
there would be little or no benefit to
product testing or environmental
monitoring in facilities that pack or hold
RACs that are rarely consumed
unprocessed, such as soybeans, or for a
manufacturer/processor that will rely on
its customer or another entity in the
distribution chain to control a hazard as
specified in § 507.36(a)(2), (3), and (4).
We expect that many facilities that
conduct operations such as drying grain
are likely to conclude, as a result of
their hazard analysis, that neither
product testing nor environmental
monitoring are warranted and would
direct their resources to food safety
practices and verification measures
other than environmental monitoring or
product testing. While a hazard analysis
must include an evaluation of
environmental pathogens when animal
food is exposed to the environment
prior to packaging and the animal food
does not include a control measure that
would significantly minimize the
pathogens (see § 507.33(c)(2)), we agree
that holding animal food in areas
exposed to the environment in some
instances will present a low risk of
contamination from environmental
pathogens. Facilities in these instances
will likely conclude there is not a
hazard requiring a preventive control.
However, facilities that identify an
environmental pathogen requiring a
preventive control would conduct
environmental monitoring as
appropriate to the facility, the animal
food, and the nature of the preventive
control.
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(Comment 351) Some comments
express concern about the cost of testing
and suggest creation of a one-time grant
program for very small businesses that
would assist them in developing their
initial food safety plans and testing
programs. One comment says that
segments of the animal food production
industry currently not performing these
types of activities will be challenged to
interpret the requirements and develop
effective programs. The comment states
that inconsistent interpretations of these
requirements by an industry fearful of
being found in violation of the rule may
lead to unnecessary testing and supplier
activities and needlessly drive up the
cost of compliance.
(Response 351) Very small businesses
are qualified facilities that are subject to
modified requirements, which do not
require testing or development of a food
safety plan. We intend that the guidance
we are developing will be helpful to all
sizes of businesses, and particularly
those not currently conducting these
activities, that are subject to the
requirements for product testing and
environmental monitoring. (See
Response 1.)
D. Proposed § 507.49(a)(2)—Product
Testing
(Comment 352) Some comments ask
us to require finished product testing for
food products designated as high-risk,
particularly when the product supports
pathogen growth during its shelf life.
Other comments suggest that finished
product or ingredient testing should be
implemented as appropriate in
situations where a risk has been
identified and an effective preventive
control cannot be implemented. Other
comments ask us to require product
testing if an environmental pathogen is
identified as a significant hazard.
(Response 352) We decline these
requests. A facility’s decision to conduct
product testing, and to establish the
frequency of such testing, will reflect a
risk-based approach consistent with its
hazard analysis. Consequently, we
expect that facilities that produce
animal foods that have frequently been
associated with outbreaks of foodborne
illness (in humans or animals), or
produce animal food for which an
effective preventive control cannot be
implemented, would establish product
testing programs more often than
facilities that do not produce such
animal foods.
A facility that identifies an
environmental pathogen as a hazard
requiring a preventive control such as
sanitation controls would conduct
environmental monitoring. Such a
facility would decide what, if any, role
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product testing would play as a
verification activity, or as part of a
corrective action as a result of positive
findings from environmental
monitoring, based on the facility, the
animal food, the nature of the
preventive control, and the role of the
preventive control in the facility’s food
safety system.
(Comment 353) Some comments ask
us to clarify (or specify) when product
testing would be directed at raw
materials and other ingredients and
when product testing would be directed
at finished product. Some comments
favor testing raw materials and other
ingredients as part of ‘‘product testing,’’
whereas other comments state that
testing raw materials and other
ingredients should be considered part of
a supplier program rather than
verification of implementation and
effectiveness. Other comments state that
it is unclear what preventive control
step would be verified by product
testing and what types of facilities
would be required to perform product
testing. One comment states product
testing for animal food should solely
focus on finished products that are
consumed by animals in accordance
with their intended use as described in
the facility’s animal food safety plan.
(Response 353) We use the term
‘‘product testing’’ to mean testing any
animal food product, whether raw
materials or other ingredients, inprocess animal foods, or finished
products and, thus, product testing can
be directed to any of these animal food
products. For example, testing raw
materials and other ingredients could be
verification of a supplier; testing inprocess material after a kill step could
be verification of process control; testing
finished product could be verification of
the food safety plan as a whole, and
capture a problem introduced during
manufacture, including from
contaminated raw materials and other
ingredients, if raw materials and other
ingredients had been tested before use.
Product testing generally is not the most
effective means of measuring the
adequacy of cleaning and sanitation
programs, but such testing is common to
track a facility’s overall hygienic
production measures.
(Comment 354) Some comments
assert that a facility that implements
supplier verification and environmental
monitoring (or other measures) should
not be required to perform product
testing in addition to the other controls
and verification measures.
(Response 354) The facility
determines whether product testing is
necessary as appropriate to the facility,
the animal food, and the nature of the
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preventive control and its role in the
facility’s food safety system. The factors
mentioned by the comment are
examples of factors that a facility would
consider in making its determination.
(Comment 355) Some comments ask
us to revise the requirement for product
testing to clarify that product testing
applies to significant hazards.
(Response 355) We decline this
request. Product testing is a verification
activity for a preventive control, and a
preventive control is established for a
‘‘significant hazard’’ (which we now
refer to as ‘‘hazard requiring a
preventive control’’). It is not necessary
to repeat, for each type of verification
activity, that the activity applies to
hazards requiring a preventive control.
(Comment 356) Some comments
assert that the real point of product
testing is to test all lots or batches.
These comments explain that they
would be required to retest every lot of
product in order to pass an analysis of
the product on to its customers, even if
testing had already been performed by
their vendors (i.e., suppliers), because
each of their customers receives a
proprietary blend. These comments
further explain that it is not
economically or physically possible to
retest small lots of product already
tested by their vendors, and that the risk
has already been mitigated by its
vendors.
(Response 356) The situation
described by these comments appears to
be a supplier-customer relationship in
that the customer. not this rule, has
established a requirement for a
certificate of analysis for every lot of
received product. The product testing
that this rule requires as a verification
activity is to help assess and verify the
effectiveness of a food safety plan and
the facility’s capability to consistently
deliver against it, not to establish the
acceptability of every lot or batch.
(Comment 357) Some comments
assert product testing should primarily
be used as a measure of process control,
not for acceptance testing; that product
testing should normally be viewed as a
monitoring and review tool, not as a
product conformance verification tool.
The comment states testing programs for
product conformance verification
should be the exception rather than the
rule.
(Response 357) These comments
appear to have misunderstood the
proposed requirements for product
testing. Consistent with the views
expressed by these comments, we
proposed requirements for product
testing as a verification measure of the
food safety plan as a whole, not for
product conformance.
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(Comment 358) One comment says
test results, whether via voluntary
company programs to verify process
controls or mandated by regulation,
should not be required to be submitted
to FDA unless they indicate serious
human or animal health consequences
(i.e., necessitate a Class I recall) as is
required under the existing
requirements for the RFR. Comments
state that FDA inspectors should not
penalize facilities for finding potential
problems through verification if
appropriate corrective actions are taken.
(Response 358) This comment appears
to have misunderstood the requirements
for product testing, which do not
include reporting product testing results
to FDA. However, during an inspection,
if product testing was used as a
verification measure, the inspector may
review the documentation for that
testing and the records documenting
any corrective action procedures taken
as a result of that testing.
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E. Proposed § 507.49(a)(3)—
Environmental Monitoring
We proposed to require
environmental monitoring, for an
environmental pathogen or for an
appropriate indicator organism, if
contamination of an animal food with
an environmental pathogen is a
significant hazard, by collecting and
testing environmental samples.
(Comment 359) Some comments ask
us to specify that environmental
monitoring of pathogens be executed
according to a risk analysis. Many
comments say environmental
monitoring should be a verification tool
based on a risk assessment as different
animals show different susceptibility to
pathogens, pathogen growth is
dependent upon the animal food, and
pathogens grow differently in different
environments and seasons. Some
comments state that the corrective
actions for environmental monitoring
should be risk based and take into
account information such as organism
threshold, sampling, and analytical
methodology. One comment says the
requirement should be applied only to
‘‘significant hazards’’ if any, that are
present within the operation. One
comment states that it is not clear who
would be responsible for environmental
monitoring at various points in the
supply chain. The comment requests
more clarification on the ‘‘boundaries’’
of responsibility for proposed measures
like environmental monitoring. One
comment says prior to including
environmental monitoring in the
regulation, methodologies and
minimum standards that establish the
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threshold industry must meet should be
developed and vetted.
(Response 359) We decline these
requests. See the discussion in Response
301, which explains how risk applies to
the facility’s hazard analysis and the
determination by the facility to establish
preventive controls for hazards
requiring a preventive control as
appropriate to the facility and the
animal food. In contrast, the
requirements for environmental
monitoring are a verification activity
that a facility would conduct to verify
that one or more preventive controls are
consistently implemented and are
effectively and significantly minimizing
or preventing the hazards requiring a
preventive control and would be
established as appropriate to the facility,
the animal food, and the nature of the
preventive control rather than according
to a risk analysis. The rule provides
flexibility for the facility to determine
appropriate test methodologies and the
threshold appropriate for the
environmental pathogen being
monitored to verify the effectiveness of
the facility’s preventive control. For
requirements that apply to hazards that
a customer of the facility, ‘‘or another
entity in the distribution chain,’’ will
control. See the requirements in
§ 507.36 and the discussion in section
XXVII.
(Comment 360) Numerous comments
request that we distinguish between
production of pet food and other animal
food. Many comments state that FDA
has publically stated that it intends
environmental monitoring to apply
mainly to facilities that manufacture pet
food and pet treats; however, the
language extends the requirement to any
facility that packages animal food that
does not receive a treatment to
minimize pathogens. Comments say it
must be made clear, through outreach,
education, and compliance policy
guides, that the requirement to conduct
environmental monitoring is intended
for a limited range of facilities, products
and processes, and does not apply to
livestock feed or animal food for which
environmental pathogens do not pose a
significant hazard in the finished animal
food. Another comment expressed
concern because Salmonella has been
found in finished poultry feed. One
comment says we should require
Salmonella testing as part of an
environmental program. One comment
asks us to explicitly recognize in the
preamble to the final rule that
contamination of animal food with an
environmental pathogen may be a
significant hazard in many dry pet food
manufacturing facilities.
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(Response 360) We agree that
environmental monitoring may be
particularly relevant to pet food
manufacturing and the majority of
environmental monitoring may occur in
dry or raw pet food manufacturing
facilities. However, its usefulness is not
limited exclusively to pet food
production. Therefore, the requirement
for environmental monitoring is flexible
to allow a facility to determine whether
environmental monitoring is needed
based on the facility, the type of animal
food produced, the nature of the
preventive control for the
environmental hazard and its role in a
facility’s food safety system.
We decline the request to require
Salmonella testing as part of
environmental monitoring. We believe
that most facilities producing pet foods
(other than those subject to part 113 that
are exempt from subpart C with respect
to microbiological hazards regulated
under part 113) will identify Salmonella
spp. as a known or reasonably
foreseeable hazard that requires a
preventive control verified by
environmental monitoring. We decline
the request to exempt livestock food or
animal food other than pet food from
the provisions for environmental
monitoring. However, we believe use of
environmental monitoring by a livestock
or poultry food facility as a verification
of a preventive control would be the
exception rather than the norm.
F. Proposed § 507.49(a)(4)—Review of
Records
We proposed to require review of
specified records by (or under the
oversight of) a preventive controls
qualified individual, to ensure that the
records are complete, the activities
reflected in the records occurred in
accordance with the food safety plan,
the preventive controls are effective,
and appropriate decisions were made
about corrective actions. We proposed
to require review of records of
monitoring and corrective action
records within a week after the records
are made, and review of records of
calibration, product testing,
environmental monitoring, and supplier
verification activities within a
reasonable time after the records are
made.
(Comment 361) Some comments
assert that it is not necessary for a
preventive controls qualified individual
to conduct or oversee review of records
as a verification activity, noting that
review of records in another food safety
regulation (i.e., the LACF requirements
in part 113) can be done by persons
adequately trained in recordkeeping and
review of records.
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(Response 361) The rule does not
preclude review of records by persons
other than the preventive controls
qualified individual, provided that the
preventive controls qualified individual
provides oversight for that review.
Oversight by a preventive controls
qualified individual is necessary
because the review of records is critical
to assessing the facility’s application of
the preventive controls system and,
thus, is fundamental to ensuring its
successful operation (78 FR 64736 at
64796 through 64797). Oversight by a
preventive controls qualified individual
is consistent with requirements of
Federal HACCP regulations for seafood,
juice, and meat and poultry (Ref. 49) (78
FR 64736 at 64796 through 64797).
(Comment 362) Some comments ask
us to provide for a timeframe longer
than 1 week (such as 7 working days)
for review of records of monitoring and
corrective actions. Some comments ask
us to provide the same flexibility for
review of records of monitoring and
corrective actions as we proposed for
review of records of calibration, product
testing, environmental monitoring, and
supplier verification activities (‘‘within
a reasonable time’’ after the records are
made), e.g., because some preventive
controls may be monitored less
frequently than is typical in a traditional
HACCP plan dominated with CCPs.
Some comments note that corrective
actions may not be fully implemented
within 7 days and ask us to provide for
review of these records within a week
or other timeframe determined to be
appropriate to ensure that potentially
hazardous goods do not enter
commerce. Some comments ask us to
retain the 1 week timeframe for review
of records associated with perishable
foods, but to extend the timeframe to 1
month for nonperishable foods.
Some comments state that some food
processors that operate on a batch
production basis (rather than a
continuous production basis) review all
records related to a particular batch all
at once just before release of the batch
for distribution. These comments assert
that it would be inefficient,
unnecessary, and needlessly
complicated to require management to
review a few production records in
advance of the normal complete records
review, particularly when laboratory
testing conducted on the batch by an
outside laboratory takes several weeks
to complete.
(Response 362) We have revised the
proposed requirement to require review
of records of monitoring and corrective
actions within 7 working days after the
records are made or within a reasonable
timeframe, provided that the preventive
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controls qualified individual prepares
(or oversees the preparation of) a written
justification for a timeframe that
exceeds 7 working days. A timeframe
that exceeds 7 working days will be the
exception rather than the norm. For
example, reviewing records before
release of product may be considered
adequate by a facility, although this may
be later than one week after the records
were created. A facility may determine
that all records for a lot of product will
be reviewed after product testing or
environmental monitoring records
relevant to that lot of product are
available, which may be more than a
week after monitoring records were
created. We made a conforming change
to the list of responsibilities of the
preventive controls qualified individual
to address the requirement for the
preventive controls qualified individual
to provide (or oversee the preparation
of) a written justification for such a
timeframe (see § 507.53(a)).
We are not requiring that a facility
review records of monitoring and
corrective actions before release of
product or that the timeframe for the
review depends on the shelf life of the
animal food. The purpose of reviewing
records is not to determine whether to
release product. Instead, the purpose of
reviewing records is to ensure that the
records are complete, the activities
reflected in the records occurred in
accordance with the food safety plan,
the preventive controls are effective,
and appropriate decisions were made
about corrective actions. However, a
facility will have flexibility to review
records of monitoring and corrective
actions within a timeframe that exceeds
7 working days, such as before product
release, provided that the facility
provides a written justification for doing
so. Depending on the nature of the
record, a facility that reviews these
types of records in a timeframe that
exceeds 7 working days, and finds a
problem, may be faced with recall
decisions for a relatively large number
of affected lots of product.
(Comment 363) Some comments ask
us to revise the provisions for review of
records by more generally referring to
records of ‘‘verification testing (e.g.,
product testing and/or environmental
monitoring as applicable).’’
(Response 363) We have revised the
regulatory text to refer to records of
‘‘testing (e.g., product testing,
environmental monitoring).’’
(Comment 364) Some comments refer
to our request for comment on whether
the regulatory text should specify the
verification activities that must be
conducted for corrective actions. These
comments assert that if we do not
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further specify verification activities for
corrective actions then we should
eliminate the proposed requirement to
review records of corrective actions.
(Response 364) Records are necessary
to document all verification activities
(see § 507.45(b)). The fact that the rule
provides flexibility for the facility to
determine the verification activities for
corrective actions, rather than prescribes
these verification activities, has no
bearing on the requirement to document
the verification activities.
(Comment 365) Some comments
emphasize the importance of calibrating
those instruments and monitoring
devices that are critical to the
preventive control, and reviewing the
associated records, before validation of
a lethality step and as frequently as
necessary thereafter. These comments
question whether requiring review of
calibration records ‘‘within a reasonable
time’’ will be adequate.
(Response 365) We agree that
instruments and monitoring devices that
are critical to a preventive control
should be calibrated, and calibration
records should be reviewed, before
conducting studies to validate a
lethality step. However, the provision is
directed at verification of
implementation and effectiveness of
preventive controls on an ongoing basis.
This rule does not prescribe specific
steps that a facility must take before
conducting validation studies.
A facility has flexibility to
appropriately determine the frequency
of reviewing calibration records based
on the facility, the animal food, and the
nature of the preventive control. We
agree that it would be prudent to review
calibration records of those instruments
and monitoring devices that are critical
to the preventive control more
frequently than of those instruments
and monitoring devices that are not
critical to the preventive control.
Depending on the nature of the control
being calibrated, a facility that reviews
calibration records infrequently, and
finds a problem with calibration of
process monitoring instruments and
verification instruments, may be faced
with recall decisions for a relatively
large number of affected lots of product.
G. Proposed § 507.49(b)—Written
Procedures
1. Proposed § 507.49(b)(1)—Frequency
of Calibration
We proposed that you must establish
and implement written procedures for
the frequency of calibrating process
monitoring instruments and verification
instruments.
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(Comment 366) Some comments ask
us to specify that an accuracy check
may be used as a verification activity in
lieu of calibration. These comments also
ask us to specify that written procedures
address the frequency of accuracy
checks, as well as calibration.
(Response 366) We have revised the
proposed requirement to specify that
written procedures address the
frequency of accuracy checks, as well as
calibration.
2. Proposed § 507.49(b)(2) and (b)(3)—
Product Testing and Environmental
Monitoring
We proposed that you must establish
and implement written procedures for
product testing. We proposed that
procedures for product testing must: (1)
Be scientifically valid; (2) identify the
test microorganism(s); (3) specify the
procedures for identifying samples,
including their relationship to specific
lots of product; (4) include the
procedures for sampling, including the
number of samples and the sampling
frequency; (5) identify the test(s)
conducted, including the analytical
method(s) used; (6) identify the
laboratory conducting the testing; and
(7) include the corrective action
procedures required by § 507.42(a)(1).
Likewise, we proposed that you must
establish and implement written
procedures for environmental
monitoring. Procedures for
environmental monitoring must: (1) Be
scientifically valid; (2) identify the test
microorganism(s); (3) identify the
locations from which the samples will
be collected and the number of sites to
be tested during routine environmental
monitoring; (4) identify the timing and
frequency for collecting and testing
samples; (5) identify the test(s)
conducted, including the analytical
method(s) used; (6) identify the
laboratory conducting the testing; and
(7) include the corrective action
procedures required by
§ 507.42(a)(1)(ii).
(Comment 367) Some comments
express concern that the word ‘‘valid’’
in the phrase ‘‘scientifically valid’’
could be construed to mean ‘‘validated’’
because not all testing protocols can be
validated within the traditional meaning
of the term. These comments state their
belief that what we intend is for these
testing programs to be ‘‘technically
sound.’’ Other comments express
concern that ‘‘scientifically valid’’ may
be interpreted to mean that firms are
required to develop or validate
analytical methods (either in general or
for specific food matrices).
(Response 367) We are retaining the
term ‘‘scientifically valid’’ in these
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provisions. We disagree that we would
interpret ‘‘scientifically valid’’ to mean
that facilities are required to develop or
validate analytical methods. We
discussed our interpretation of the term
‘‘scientifically valid’’ in the Appendix to
the 2013 proposed preventive controls
rule (78 FR 64736 at 64834 through
64835), and noted that this
interpretation was consistent with our
previous discussion of the term
‘‘scientifically valid’’ (in place of
‘‘validated’’) in the rulemaking to
establish CGMP requirements for dietary
supplements (68 FR 12158 at 12198,
March 13, 2003). While validated
methods are considered ‘‘scientifically
valid,’’ methods that have not gone
through formal validation processes but
have been published in scientific
journals, for example, may also be
‘‘scientifically valid.’’ We do expect
methods used for testing to be adequate
for their intended use.
Although we agree that methods that
are ‘‘scientifically valid’’ would also be
‘‘technically sound,’’ we disagree that
the hypothetical concern that we would
construe ‘‘scientifically valid’’ to mean
‘‘validated’’ warrants changing
‘‘scientifically valid’’ to a new term
(such as ‘‘technically sound’’) in light of
our previous statements regarding this
term and experience in the context of
CGMP requirements. See the final rule
establishing the dietary supplement
CGMPs for additional discussion on the
terms ‘‘validated’’ and ‘‘scientifically
valid’’ (72 FR 34752 at 34853).
(Comment 368) Some comments
support the proposed requirements for
written procedures for environmental
monitoring, including providing
flexibility to use indicator organisms
and to design the timing, location, and
frequency of environmental monitoring
programs in a risk-based manner, and in
not prescribing specific locations (e.g.,
food-contact surfaces or ‘‘zone 1’’) or
sample quantities for testing. Other
comments ask us to add details to the
written procedures for product testing
and environmental monitoring
regarding when and where sampling is
required and the number of samples to
take. Some comments ask us to make
sure the most current ‘‘sampling
planning science’’ is used for
environmental monitoring by specifying
that procedures for environmental
monitoring must employ sample quality
criteria objectives. Other comments
assert that the product testing procedure
requirements are inadequate and ask us
to require that procedures for product
testing specify the procedures for
identifying samples (including their
relationship to specific lots of product);
describe how sampling was conducted
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(to establish that the sample obtained
adequately represents the lot of product
the sample is intended to represent);
and include the procedures for sample
quality control from field to lab.
(Response 368) We decline the
request to prescribe additional details,
such as those described in these
comments, in the requirements for
written procedures for product testing
and environmental monitoring. As with
other procedures required by the rule,
those relating to environmental
monitoring and product testing must be
adequate for their intended purpose.
Further, procedures will not be identical
in all circumstances. For example, a
facility that produces products with a
short shelf life may choose a different
frequency of swabbing and testing than
a facility that produces products with a
long shelf life.
(Comment 369) Some comments ask
us to provide more flexibility in product
testing by not requiring establishments
to provide written procedures for
product testing and corrective action
procedures.
(Response 369) These comments are
unclear. By requiring that a facility
establish its own procedures, the rule
provides facilities with flexibility to
develop a product testing program that
works best for its facility and its
products. We are retaining the
requirements for written procedures for
product testing, as well as for corrective
action procedures.
(Comment 370) Some comments ask
us to add a provision requiring that all
positive results must result in corrective
action being taken.
(Response 370) We decline this
request. The rule requires that a facility
must establish and implement written
corrective action procedures that must
be taken if preventive controls are not
properly implemented, including
procedures to address, as appropriate,
the presence of a pathogen or
appropriate indicator organism in an
animal food product detected as a result
of product testing and the presence of
an environmental pathogen or
appropriate indicator organism detected
through environmental monitoring (see
§ 507.42(a)(1)). However, the rule does
not predetermine what corrective
actions a facility must take when
presented with positive results from
product testing or environmental
monitoring. The corrective action
procedures that a facility would
develop, and the actual corrective
actions that the facility would take, will
depend on the nature of the hazard and
the nature of the preventive control, as
well as information relevant to the
positive result (e.g., pathogen or
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indicator organism, product or
environment, animal food-contact
surface or non-animal food-contact
surface).
For additional discussion of
comments on verification of
implementation and effectiveness, see
section XXXIV of the final rule for
preventive controls for human food
published elsewhere in this issue of the
Federal Register.
XXXV. Subpart C: Comments on
Proposed § 507.50—Reanalysis
We proposed to establish
requirements for reanalysis of the food
safety plan. Some comments support the
proposed requirements without change.
For example, comments agree that a
preventive controls qualified individual
must perform (or oversee) the reanalysis
(see section XXXV.D). Some comments
that support the proposed provisions
suggest alternative or additional
regulatory text.
In the following paragraphs, we
discuss comments that disagree with, or
suggest one or more changes to, the
proposed requirements. After
considering these comments, we have
revised the proposed requirements as
shown in table 19, with editorial and
conforming changes as shown in table
31.
TABLE 19—REVISIONS TO THE PROPOSED REQUIREMENTS FOR REANALYSIS
Description
Revision
507.50(b) ..............................
Circumstances that require reanalysis .....
507.50(b)(4) .........................
Circumstances that require reanalysis .....
507.507(c) ............................
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Section
Timeframe to complete the reanalysis .....
Provide for reanalysis of an applicable portion of the food safety plan
(rather than the complete food safety plan) in specified circumstances.
Require reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever a preventive control,
combination of preventive controls, or the food safety plan as a
whole is found to be ineffective.
Clarify that the requirement applies to completing the reanalysis and
validating any additional preventive controls (as appropriate to the
nature of the preventive control and its role in the facility’s food
safety system), rather than to completing the reanalysis and implementing any additional preventive controls (emphasis added).
A. Proposed § 507.50(a)—Circumstances
Requiring Reanalysis
We proposed that you must conduct
a reanalysis of the food safety plan: (1)
At least once every 3 years; (2)
whenever a significant change in the
activities conducted at your facility
creates a reasonable potential for a new
hazard or creates a significant increase
in a previously identified hazard; (3)
whenever you become aware of new
information about potential hazards
associated with the animal food; (4)
whenever appropriate after an
unanticipated animal food safety
problem; and (5) whenever you find that
a preventive control is ineffective.
(Comment 371) Some comments
assert that the need to reanalyze the
food safety plan will depend on the
nature of the preventive control and its
role in the food safety system. These
comments also assert that if a specific
preventive control is found to be
ineffective, only the applicable portion
of the food safety plan would need to be
reanalyzed.
(Response 371) We agree and have
revised the regulatory text, with
associated editorial changes and
redesignation, to separate the
requirement to reanalyze the food safety
plan as a whole every 3 years from all
other circumstances when reanalysis is
required ‘‘for cause.’’ When reanalysis is
‘‘for cause,’’ the regulatory text provides
that reanalysis is of the food safety plan
as a whole, or the applicable portion of
the food safety plan.
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(Comment 372) Some comments ask
us to define ‘‘reanalysis’’ to mean ‘‘a
reassessment of the validity of a
preventive control or food safety plan to
control a hazard. Reanalysis may
include a system review and, where
necessary, activities to revalidate a
control measure or combination of
control measures.’’
(Response 372) We decline this
request. Reanalysis goes beyond
assessing the validity of a preventive
control or food safety plan to control a
hazard. Reanalysis can also include
assessing whether all hazards have been
identified, whether established
procedures are practical and effective,
and other factors.
(Comment 373) Some comments ask
us to require reanalysis on an annual
basis, noting that annual reanalysis is
required by Federal HACCP regulations
for seafood, juice, and meat and poultry.
(Response 373) We decline this
request. We proposed to require
reanalysis at least once every 3 years as
a minimum requirement in the event
that there is no other circumstance
warranting reanalysis (see § 507.50(b)(2)
through (4)). That 3-year minimum is
consistent with the statute (see section
418(i) of the FD&C Act). As a practical
matter, we expect that reanalysis will
occur more frequently as a result of
changes in the activities conducted at a
facility (§ 507.50(b)(1) through (4)).
(Comment 374) Some comments
suggest editorial changes to improve the
readability of the requirement to
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conduct reanalysis when there is a
change in a preventive control.
(Response 374) We are including
these editorial changes in the regulatory
text, which now reads whenever ‘‘a
significant change in the activities
conducted at your facility creates a
reasonable potential . . .’’
(Comment 375) Some comments
assert that the proposed requirement to
conduct reanalysis whenever you
become aware of new information about
potential hazards associated with the
food does not align with FSMA
statutory language, is ambiguous, and
would establish vague compliance
obligations.
(Response 375) We disagree that the
proposed requirement is ambiguous and
would establish vague compliance
obligations. See our previous discussion
regarding the emergence of the first
outbreak of foodborne illness in the
United States, in 2006–2007, caused by
consumption of peanut butter
contaminated with Salmonella (78 FR
64736 at 64798). Although we
acknowledge that the proposed
requirement is not explicit in section
418(i) of the FD&C Act, we disagree it
is not in alignment with FSMA as a
whole. FSMA directs the owner,
operator, or agent in charge of a facility
to evaluate the hazards that could affect
food manufactured, processed, packed,
or held by such facility and identify and
implement preventive controls to
significantly minimize or prevent the
occurrence of those hazards (see section
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418(a) of the FD&C Act). In other words,
FSMA focuses on a system to prevent
food safety problems rather than a
system to react to problems after they
occur. Requiring that a facility reanalyze
its food safety plan, or the applicable
portion of the food safety plan, in
response to information such as the
emergence of a new foodborne
pathogen, or an outbreak of foodborne
illness from consumption of an animal
food product (or handling by consumers
of a pet food product) not previously
associated with foodborne illness from a
well-known pathogen, aligns very well
with the statutory direction in FSMA.
(Comment 376) Some comments ask
us to add a requirement to conduct
reanalysis whenever a preventive
control is found to be ‘‘missing’’ in
addition to whenever a preventive
control is found to be ‘‘ineffective.’’
(Response 376) We have revised the
regulatory text to require reanalysis
whenever a preventive control, a
combination of preventive controls, or
the food safety plan as a whole, is
ineffective. (See § 507.50(b)(4).) A
‘‘missing’’ preventive control could be
discovered during verification to
establish the validity of the food safety
plan as a whole or as a result of an
unanticipated problem. If circumstances
lead a facility to conclude that an
additional (or different) preventive
control is necessary, the facility would
include that preventive control in its
food safety plan along with associated
preventive control management
components, including verification to
establish the validity of the food safety
plan.
B. Proposed § 507.50(b)—Timeframe To
Complete Reanalysis
We proposed that you must complete
the reanalysis and implement any
additional preventive controls needed to
address the hazard identified, if any,
before the change in activities at the
facility is operative or, when necessary,
during the first 6 weeks of production.
We have clarified that the requirement
is to complete the reanalysis and
validate (rather than implement) any
additional preventive controls as
appropriate to the nature of the
preventive control and its role in the
facility’s food safety system.
(Comment 377) As discussed in
Comment 332, some comments question
whether 6 weeks is enough time to
perform all applicable validation studies
that would address the execution
element of validation. Likewise, some
comments question whether 6 weeks is
enough time to complete reanalysis.
(Response 377) Consistent with
revisions we have made to the
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timeframe to complete validation (see
Response 332), we have revised the
timeframe to complete the reanalysis
and validate, as appropriate to the
nature of the preventive control and its
role in the facility’s food safety system,
any additional preventive controls to be
within 90 days after production of the
applicable animal food first begins or
within a reasonable timeframe, provided
that the preventive controls qualified
individual provides (or oversees the
preparation of) a written justification for
a timeframe that exceeds 90 days after
production of the applicable animal
food first begins. We made a conforming
change to the list of responsibilities of
the preventive controls qualified
individual (see § 507.53(a)).
(Comment 378) Some comments state
that the phrase ‘‘before the change in
activities at the facility is operative’’ is
ambiguous in that it is unclear if the
phrase is referencing the initial change
in activities that triggered the reanalysis
or a change in activities subsequent to
the reanalysis. These comments ask us
to clarify the requirement by
substituting the phrase ‘‘before the
relevant process is operative.’’
(Response 378) We agree that there
was ambiguity in this phrase, because
changes in activities could result in the
need for reanalysis and reanalysis could
result in the need for changes in
activities, both of which can result in a
new preventive control. We have made
several revisions to the regulatory text,
with associated editorial changes, to
clarify the requirements for reanalysis.
First, we have clarified that reanalysis
can be routine (at least every 3 years) or
‘‘for cause’’ (i.e., a significant change
that creates the potential for a new
hazard or an increase in a previously
identified hazard; when you become
aware of new information about
potential hazards associated with the
animal food; when there is an
unanticipated animal food safety
problem; or whenever a preventive
control, combination of preventive
controls or the food safety plan as a
whole is ineffective). Second, we have
specified that the reanalysis ‘‘for cause’’
may be for the entire food safety plan or
only for an applicable portion.
In addition, we have clarified that the
reanalysis and the validation, as
appropriate to the nature of the
preventive control and its role in the
facility’s food safety system, of any
additional preventive controls needed to
address an identified hazard, would
need to be completed before any change
in activities (including any change in
preventive controls) is operative. When
additional time is necessary, we have
provided for a timeframe within 90 days
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after production of the applicable
animal food first begins or within a
reasonable timeframe, provided that the
preventive controls qualified individual
provides (or oversees the preparation of)
a written justification for a timeframe
that exceeds 90 days after production of
the applicable animal food first begins.
In other words, if you decide to make
a change, you should conduct a
reanalysis before you make that change
if there is potential for that change to
create or increase a hazard; a reanalysis
that results in changes to preventive
controls should be completed and the
preventive controls validated, as
appropriate to the nature of the
preventive control and its role in the
facility’s food safety system, before
changes in activities to produce animal
food using a new preventive control are
put into operation. However, we
acknowledge that it may be necessary to
produce product to demonstrate a
revised preventive control can be
implemented appropriately, and
provide for an extended timeframe to
make this assessment.
C. Proposed § 507.50(c)—Requirement
To Revise the Written Food Safety Plan
or Document Why Revisions Are Not
Needed
We proposed that you must revise the
written food safety plan if a significant
change is made or document the basis
for the conclusion that no revisions are
needed. We received no comments that
disagreed with this proposed
requirement and are finalizing it as
proposed.
D. Proposed § 507.50(d)—Requirement
for Oversight of Reanalysis by a
Preventive Controls Qualified Individual
We proposed that a preventive
controls qualified individual must
perform (or oversee) the reanalysis. We
received no comments that disagreed
with this proposed requirement and are
finalizing it as proposed. See section
XXXVII.B for comments on the
qualifications for a preventive controls
qualified individual who would perform
or oversee the reanalysis.
E. Proposed § 507.50(e)—Reanalysis on
the Initiative of FDA
We proposed that you must conduct
a reanalysis of the food safety plan
when FDA determines it is necessary to
respond to new hazards and
developments in scientific
understanding.
(Comment 379) Some comments ask
us to issue formal, written
communications about new hazards and
developments in scientific
understanding. These comments express
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concern that communications of this
type could be inconsistent if they are
communicated by individual
investigators. Other comments ask us to
specify in the regulatory text that it is
the Commissioner of Food and Drugs
who makes the determination that it is
necessary to conduct a reanalysis of the
food safety plan.
(Response 379) We agree that a
communication from FDA about the
need to reanalyze the food safety plan
should be issued in a formal written
manner but disagree that it is necessary
to specify that it is the Commissioner of
Food and Drugs who makes the
determination that it is necessary to
conduct a reanalysis of the food safety
plan. The comment provides no basis
for precluding such a determination by
an organizational component (such as
CVM or a component of FDA’s Office of
Regulatory Affairs) that has operational
responsibility for animal food safety and
subject matter experts to advise the
managers in those organizational
components.
XXXVI. Subpart C: Comments on
Proposed § 507.51—Modified
Requirements That Apply to a Facility
Solely Engaged in the Storage of
Unexposed Packaged Animal Food
We proposed that if your facility is
solely engaged in the storage of
packaged animal food that is not
exposed to the environment, you must
conduct certain activities for any such
refrigerated packaged animal food that
requires time/temperature controls for
safety (TCS animal food) to significantly
minimize or prevent the growth of, or
toxin production by, microorganisms of
animal or human health significance.
We requested comment on the proposed
list of modified requirements. Some
comments that support the proposed
provisions suggest alternative or
additional regulatory text or ask us to
clarify how we will interpret the
provision.
In this section, we discuss comments
that ask us to clarify the proposed
requirements or that disagree with, or
suggest one or more changes to, the
proposed requirements. After
considering these comments, we have
revised the proposed requirements as
shown in table 20.
TABLE 20—REVISIONS TO THE PROPOSED MODIFIED REQUIREMENTS FOR UNEXPOSED, REFRIGERATED, PACKAGED
ANIMAL FOOD
Section
Description
Revision
507.51(a) .........................................
Circumstances that make a facility
subject to the modified requirements for unexposed, refrigerated packaged animal food.
Modified requirements for monitoring the temperature controls.
Modified requirements for corrective actions.
Modified
requirements
for
verification of temperature controls.
Modified
requirements
for
verification of temperature controls.
Records documenting the monitoring of temperature controls.
Clarify that the requirements apply to a temperature control area in a
facility that holds TCS animal food rather than to each product in
the holding facility.
507.51(a)(2) .....................................
507.51(a)(3) .....................................
507.51(a)(4)(i) .................................
507.51(a)(4)(iii) ................................
507.51(a)(5)(i) .................................
507.51(a)(5)(ii) .................................
Records documenting corrective
actions.
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A. Proposed § 507.51(a)—Modified
Requirements for Unexposed
Refrigerated Packaged Animal Food
That Requires Time/Temperature
Controls
1. Proposed § 507.51(a)(1)—Establish
and Implement Temperature Controls
We proposed that if your facility is
subject to the modified requirements,
you must establish and implement
temperature controls adequate to
significantly minimize or prevent the
growth of, or toxin production by,
microorganisms of animal or human
health significance.
We also tentatively concluded that it
would be rare for a facility solely
engaged in the storage of unexposed
packaged animal food to not have
information regarding whether a
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Specify that it is the temperature controls that are consistently performed.
Clarify that corrective actions need only be taken when a loss of temperature control may impact the safety of the TCS animal food.
Provide additional flexibility for accuracy checks, in addition to calibration, to verify that temperature controls are consistently implemented.
Provide additional flexibility for reviewing records of monitoring and
corrective actions either within 7-working days after the records are
made or within a reasonable timeframe.
Provide additional flexibility for records documenting the monitoring of
temperature controls to be kept either as affirmative records demonstrating temperature is controlled or as exception records demonstrating loss of temperature control.
Conforming change associated with the modified requirements for
corrective actions to clarify that records of corrective actions are required when there is a loss of temperature control that may impact
the safety of the TCS animal food.
refrigerated packaged animal food is a
TCS animal food and, if so, what
specific temperature controls are
necessary for safe storage of the food.
We requested comment on this tentative
conclusion.
(Comment 380) Some comments ask
us to clarify that the requirement to
establish and implement temperature
controls applies to temperature control
areas in a facility rather than to each
product in a facility.
(Response 380) We agree that the
requirement to establish and implement
temperature controls applies to
temperature control areas in a facility
rather than to each product in a facility.
To make this clearer, we have revised
the proposed requirement to clarify that
the facility must conduct activities as
appropriate to ensure the effectiveness
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of the temperature controls rather than
conduct activities ‘‘for any such
refrigerated packaged animal food.’’
(Comment 381) Some comments
disagree with our tentative conclusion
that it would be rare for a facility solely
engaged in the storage of unexposed
packaged animal food to not have
information regarding whether a
refrigerated packaged food is a TCS
animal food and, if so, what specific
temperature controls are necessary for
safe storage of the animal food. These
comments ask us to specify that the
responsibility for determining whether
an animal food is a TCS animal food
falls to the manufacturer of the animal
food rather than the warehouse storing
the animal food, because the warehouse
merely provides a service. Other
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comments note that the animal food
product owners determine the optimal
conditions for storage of their products
based on their own hazard analysis and
preventive controls, and that the animal
food product owners can simply
communicate those requirements to the
warehouses that will store the products.
(Response 381) In this type of
circumstance, it is appropriate for the
manufacturer of the animal food to
share the responsibility with the
warehouse for proper storage of the
animal food. The various provisions of
section 418 of the FD&C Act explicitly
place the responsibility for complying
with the requirements for hazard
analysis and risk-based preventive
controls, including modified
requirements, on the owner, operator, or
agent in charge of a facility and, thus,
a facility that is a warehouse is
responsible for its own food safety plan.
Regardless, the manufacturer also has
responsibilities under section 418 of the
FD&C Act to determine the storage
conditions necessary for animal food
safety and to take steps to ensure that
the animal food is stored under
conditions that will ensure its safety.
It is not necessary to specify this joint
responsibility for determining storage
conditions in the rule, because the rule
already clearly specifies that its
provisions apply to persons who
manufacture/process animal food, as
well as to persons who hold animal
food. Both the warehouse and the
manufacturer have flexibility in
determining how to comply with the
rule, including the specific mechanism
whereby the warehouse would receive
information about storage of an animal
food product from the manufacturer or
owner of the product. Moreover, a
citizen petition submitted to FDA
(Docket No. FDA–2011–P–056), in
requesting an exemption or modified
requirements for facilities solely
engaged in the storage of packaged foods
not exposed to the environment, asserts
that such facilities work closely with
food manufacturers to understand the
conditions and controls needed to
ensure the quality of the foods they
store and distribute and that
manufacturers appropriately instruct the
warehouses to ensure packaged
products are being properly stored (78
FR 64736 at 64768).
(Comment 382) Some comments ask
us to clarify which facility, the shipping
facility or the receiving facility, will be
responsible for ensuring that
temperature control is maintained
during transportation of TCS animal
foods.
(Response 382) We address specifics
about the responsibilities of shipping
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facilities and receiving facilities in the
2014 proposed sanitary transportation
rule (79 FR 7006). We will address
comments regarding the responsibilities
of shippers and receivers in the final
sanitary transportation rule.
2. Proposed § 507.51(a)(2)—Monitor the
Temperature Controls
We proposed that if your facility is
subject to the modified requirements,
you must monitor the temperature
controls with sufficient frequency to
provide assurance they are consistently
performed. We requested comment on
whether there would be a benefit to
requiring a facility to develop written
procedures for monitoring temperature.
(Comment 383) Some comments ask
us to explain in the preamble of the
final rule that we will accept monitoring
systems that provide exception reports
to satisfy the modified requirements.
The comments describe exception
reporting as a structure where
automated systems are designed to alert
operators and management when the
monitoring system observes a deviation
from an established limit. These
comments assert that monitoring of
preventive controls by automated
systems can be more efficient than
monitoring by personnel, and can
eliminate human error.
(Response 383) We have revised the
recordkeeping provisions of these
modified requirements to provide that
the temperature monitoring records for
the modified requirements may be kept
either as affirmative records
demonstrating temperature is controlled
or as exception records demonstrating
loss of temperature control. Although
the comments explicitly asked us to
provide a clarification in the preamble
of this rule, we decided the clarification
within the regulatory text would be
clearer to facilities that are subject to the
requirements, as well as to investigators
who will be inspecting facilities for
compliance with the rule.
(Comment 384) Some comments state
that written procedures for monitoring
temperature are not necessary. One
reason provided by the comments is that
the required records (specified in
proposed § 507.51(a)(5)) would provide
sufficient information on the type and
frequency of monitoring. Another
reason is that the specific activities we
proposed to ensure the effectiveness of
the temperature controls already
address activities that a facility would
include in a written procedure.
(Response 384) We agree with the
comments that we need not require that
a facility develop written procedures for
monitoring temperature.
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3. Proposed § 507.51(a)(3)—
Requirement To Take Corrective
Actions
We proposed that if your facility is
subject to the modified requirements,
you must take appropriate corrective
actions if there is a problem with the
temperature controls for a TCS animal
food.
(Comment 385) Some comments ask
us to narrow the term ‘‘temperature
control’’ to more specifically focus it on
temperature controls that are relevant to
food safety because some problems with
the controls may not impact the product
temperature (and, thus, would not
impact food safety).
(Response 385) We have revised the
proposed requirement (and the
applicable recordkeeping requirement)
to specify that corrective actions are
necessary only when there is a loss of
temperature control that may impact the
safety of a TCS animal food.
(Comment 386) Some comments
assert that the responsibility for
determining any corrective actions for a
TCS animal food when there is a loss of
temperature control falls to the
manufacturer of the food rather than to
the warehouse. These comments also
assert that a warehouse is a third party
who is not legally empowered to make
independent decisions about when and
where to ship the product, or not to ship
it at all. These comments ask us to
clarify that the responsibility of a
warehouse for ‘‘preventing’’ affected
food entering commerce ends when the
product is returned to the manufacturer
or processor.
(Response 386) Returning affected
animal food to the manufacturer/
processor or owner of the animal food
is one way to satisfy the requirement to
prevent animal food from entering
commerce if the owner, operator, or
agent in charge of a warehouse cannot
ensure the affected animal food is not
adulterated under section 402 of the
FD&C Act, either on its own or after
consultation with the manufacturer or
processor of the animal food. It is not
necessary to specify this specific action
on the part of a warehouse in the
regulatory text.
4. Proposed § 507.51(a)(4)—
Requirement To Verify Consistent
Implementation of Temperature
Controls
We proposed that if your facility is
subject to the modified requirements,
you must verify that temperature
controls are consistently implemented
by: (1) Calibrating temperature
monitoring and recording devices; (2)
reviewing records of calibration within
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a reasonable time after the records are
made; and (3) reviewing records of
monitoring and corrective actions taken
to correct a problem with the control of
temperature within a week after the
records are made.
(Comment 387) Some comments
assert that the proposed requirement to
‘‘calibrate’’ devices that monitor and
record temperature is inconsistent with
the requirement to test such devices for
accuracy in the LACF regulations in part
113. These comments assert that
‘‘accuracy check’’ is a more appropriate
term to use in the modified
requirements because many instruments
that monitor or record temperature have
very low drift values and may seldom
require calibration.
(Response 387) We have revised the
proposed requirements to require
verification that temperature controls
are consistently implemented by
calibrating temperature monitoring and
recording devices or checking them for
accuracy. However, if the outcome of an
accuracy check is that a temperature
monitoring or recording device is not
accurate, the facility must follow up by
calibrating or replacing the device. See
also Comment 344 and Response 344.
(Comment 4388) Some comments
assert that reviewing records of
calibration or accuracy checks is only
needed if a designated tolerance is
exceeded.
(Response 4388) Although we
recognize that in most instances an outof-calibration device will be identified
and corrected at the time a calibration
or accuracy check is performed, this is
not always the case. The purpose of
reviewing records of calibration or
accuracy checks is to identify a problem
that may have been missed or may not
have been corrected rather than to react
to a problem after the problem is
identified. The records review is also a
verification that the temperature
controls were consistently implemented
and that corrective actions were taken if
needed.
(Comment 389) Some comments ask
us to modify the frequency of checking
monitoring records to specify that it be
done with a frequency to demonstrate
control rather than within a week after
the records are made.
(Response 389) We have revised the
proposed requirement to require review
of records of monitoring (as well as
records of corrective actions taken to
correct a problem with the control of
temperature) within 7-working days
after the records are created or within a
reasonable timeframe, provided that the
preventive controls qualified individual
prepares (or oversees the preparation of)
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a written justification for a timeframe
that exceeds 7 working days.
(Comment 390) Some comments
assert that the proposed verification and
review activities are too prescriptive
because they require reviews that are
not necessary. However, these
comments also assert that the proposed
verification activities are too vague
because they do not specify the reasons
for reviewing the records. These
comments ask us to focus the regulatory
text on achieving the overall objective of
the review (i.e., ensuring the adequacy
of the control) and to provide examples
of meaningful review activities in
guidance.
(Response 390) We disagree that the
proposed verification activities would
require reviews that are not necessary.
The purpose of the records review is
both to identify a problem with a
temperature monitoring device that may
not have been detected or corrected, and
to verify that the temperature controls
were consistently implemented and that
corrective actions were taken if needed.
The requirement is consistent with
requirement for records review in
subpart C (§ 507.49(a)(4)), which
specifies records review as a verification
activity to ensure that the records are
complete, the activities reflected in the
records occurred in accordance with the
food safety plan, the preventive controls
are effective, and appropriate decisions
were made about corrective actions.
5. Proposed § 507.51(a)(5)—Establish
and Maintain Records
We proposed that if your facility is
subject to the modified requirements,
you must establish and maintain records
that document monitoring, corrective
actions, and verification activities.
(Comment 391) Some comments state
that temperature controls in refrigerated
warehouses are extremely reliable and
therefore extensive record keeping and
record review are not value-added.
These comments ask us to revise the
proposed provision to require a record
only if a deviation in the environmental
temperature from the prescribed limits
was noted.
(Response 391) We have revised the
regulatory text to provide that
temperature monitoring records may be
kept either as affirmative records
demonstrating temperature is controlled
or as exception records demonstrating
loss of temperature control. The revised
provision is consistent with the more
general requirement for monitoring
records of refrigeration temperature
during storage of TCS animal food (see
§ 507.40(c)(2)).
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B. Proposed § 507.51(b)—Records
We proposed that the records that a
facility must establish and maintain for
the proposed modified requirements are
subject to the requirements that would
be established in proposed subpart F.
We received no comments that
disagreed with our proposal, and are
finalizing proposed § 507.51(b) without
change.
XXXVII. Subpart C: Comments on
Proposed § 507.53—Requirements
Applicable to a Preventive Controls
Qualified Individual and a Qualified
Auditor
We proposed to establish
requirements for the qualifications of a
preventive controls qualified individual
and a qualified auditor. Some comments
support the proposed requirements
without change. Some comments that
support the proposed provisions suggest
alternative or additional regulatory text.
In the following paragraphs, we
discuss comments that ask us to clarify
the proposed requirements or that
disagree with, or suggest one or more
changes to, the proposed requirements.
After considering these comments, we
are finalizing the provisions as proposed
with conforming changes as shown in
table 31.
A. Proposed § 507.53(a) and (b)—What
a Preventive Controls Qualified
Individual or Qualified Auditor Must Do
or Oversee
We proposed to list the functions that
must be performed by one or more
preventive controls qualified
individuals (i.e., preparation of the food
safety plan; validation of the preventive
controls; review of records for
implementation and effectiveness of
preventive controls and appropriateness
of corrective actions; and reanalysis of
the food safety plan) or by a qualified
auditor (i.e., conduct an onsite audit).
We proposed to list these functions for
simplicity (i.e., to make it easy to see all
of the requirements in a single place).
We specified that this list of functions
already proposed to be established in
applicable sections of the rule did not
in itself impose any additional
requirements.
(Comment 392) Some comments ask
us to clarify whether the preventive
controls qualified individual must be on
the premises during operating hours.
Other comments ask us to clarify that
the preventive controls qualified
individual is not responsible for
performing laboratory testing, because
the preventive controls qualified
individual may not be appropriately
educated and trained for laboratory
testing.
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(Response 392) The rule does not
require that the preventive controls
qualified individual be onsite during
operating hours. The rule also does not
require that the preventive controls
qualified individual be responsible for
performing laboratory testing, although
review of testing records (e.g., records of
product testing or environmental
testing) must be conducted or overseen
by a preventive controls qualified
individual.
(Comment 393) Some comments ask
us to consider the implication of having
the preventive controls qualified
individual serve as the process
authority, serve as the auditor, and offer
final sign off on a validation and
corrective actions, and suggest that a
third party may be necessary to ensure
that uniform standards are applied.
(Response 393) To the extent that the
comment suggests that the functions of
the preventive controls qualified
individual create a conflict of interest,
we disagree. The rule focuses on the
need for applicable training and
experience to perform certain functions.
The preventive controls qualified
individual must develop (or oversee the
development of) the food safety plan
that controls the identified hazards and
then ensures through review of records
that the plan is being implemented as
designed. The rule does not require that
a facility engage a third party to provide
oversight of any individual, including a
preventive controls qualified individual,
but does not preclude a facility from
doing so if it chooses.
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B. Proposed § 507.53(c)—Qualification
Requirements
1. Proposed § 507.53(c)(1)—Preventive
Controls Qualified Individual
We proposed that to be a preventive
controls qualified individual, the
individual must have successfully
completed training in the development
and application of risk-based preventive
controls at least equivalent to that
received under a standardized
curriculum recognized as adequate by
FDA or be otherwise qualified through
job experience to develop and apply a
food safety system. We also proposed
that this individual may be, but is not
required to be, an employee of the
facility.
(Comment 394) Some comments
express concern that there is lack of
specificity on what constitutes
appropriate training and experience for
a preventive controls qualified
individual and ask us to clarify what
FDA’s standardized curriculum for
preventive controls qualified
individuals will consist of, what
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experience will be recognized as
meeting the requirement, how FDA will
recognize the experience and whether
and how FDA will recognize industry
providers of training programs. Some
comments state that currently industry
members may choose from many private
organizations and academia to obtain
training under established HACCP
based training programs and audit
training programs. Some comments ask
us to allow flexibility for industry to
continue current training programs
without receiving express approval from
the FSPCA.
(Response 394) As discussed in
Response 1, the FSPCA is establishing a
standardized curriculum. The
curriculum will focus on the specific
requirements of the preventive controls
rule. Training providers do not need
approval from the FSPCA to use the
curriculum.
(Comment 395) Some comments ask
who will assess the qualifications of a
particular preventive controls qualified
individual or determine whether
particular individuals are in fact
‘‘qualified.’’ Some comments ask us to
use an outcome-based demonstration of
competency. Some comments ask us to
specify that all work experience must be
comparable or that a preventive controls
qualified individual must pass a
proficiency test. Some comments ask us
to establish minimum standards for
competency. Some comments ask us to
clarify what job experiences would be
sufficient. Some comments ask how we
will verify that reported training and
experience are true.
(Response 395) We are not
establishing minimum standards for
competency and do not intend routinely
to directly assess the qualifications of
persons who function as the preventive
controls qualified individual, whether
by their training or by their job
experience. Instead, we intend to focus
our inspections on the adequacy of the
food safety plan. As necessary and
appropriate, we will consider whether
deficiencies we identify in the food
safety plan suggest that the preventive
controls qualified individual may not
have adequate training or experience to
carry out the assigned functions,
including whether reported training and
experience is accurately represented.
(Comment 396) Some comments ask
us to provide for competency
requirements to be met through on-thejob experience in lieu of traditional
classroom training. Some comments ask
us to clarify what we mean by training
that is ‘‘at least equivalent’’ to that
received under a standardized
curriculum recognized as adequate by
FDA. Some comments ask us to clarify
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whether individuals who have
successfully completed training in the
development and application of riskbased preventive controls through
programs delivered and recognized
under the International HACCP Alliance
would be considered to have completed
training ‘‘equivalent’’ to that recognized
by FDA for the development and
application of risk-based preventive
controls.
(Response 396) The requirements do
provide for qualification through
appropriate job experience, such as
experience with successfully
implementing HACCP systems or other
preventive-based food safety systems. It
is the responsibility of the owner,
operator, or agent in charge of the
facility to determine whether any
individual who prepares (or oversees
the preparation of) the food safety plan
has appropriate qualifications to do so,
whether by on-the-job experience or by
training.
There are some differences in the
requirements of the animal food
preventive controls rule compared to
the requirements of HACCP regulations
for seafood, juice, and meat and poultry
such that training provided by the
International HACCP Alliance may not
be equivalent. To avoid unnecessary
duplication of training, such an
individual may only need to attend
partial, supplemental courses in order to
meet the training requirements.
Alternatively, a person who has
received the International HACCP
Alliance training and has implemented
a HACCP plan may be qualified through
job experience.
(Comment 397) Some comments ask
us to emphasize that a standardized
curriculum in the development and
application of risk-based preventive
controls may not provide a preventive
controls qualified individual with
sufficient expertise to design and
conduct robust, scientific validation
studies to support the adequacy of
control measures.
(Response 397) We acknowledge that
a single training course may not provide
adequate training for every function of
the preventive controls qualified
individual for the animal foods
produced by a facility. In some cases an
individual may gain the full
complement of knowledge and
experience through multiple, specific
training courses; in other cases an
individual may gain the full
complement of knowledge and
experience through job experience or
through a combination of training and
job experience.
(Comment 398) Some comments ask
us not to establish requirements that are
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overly strict because there is a finite
supply of food safety experts in the
country and many facilities will need
multiple preventive controls qualified
individuals.
(Response 398) We disagree that the
requirements applicable to the
preventive controls qualified individual
should be designed to match any
current limitations in the number of
individuals who have the knowledge
and skill to prepare (or oversee the
preparation of) a food safety plan. We
expect that market forces will act to
increase the number of preventive
controls qualified individuals to match
the demand generated by this rule. In
addition, as discussed in section LIII.A,
we are further staggering the compliance
dates for subparts C and E of the rule,
so that those businesses that are not
small will need to comply with subparts
C and E of the rule within 2 years, and
small businesses will need to comply
with subparts C and E of the rule within
3 years. Very small businesses are not
required to develop a food safety plan
or conduct other activities that require
oversight by a preventive controls
qualified individual.
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2. Proposed § 507.53(c)(2)—Qualified
Auditor
We proposed that to be a qualified
auditor, a preventive controls qualified
individual must have technical
expertise obtained by a combination of
training and experience appropriate to
perform the auditing function.
(Comment 399) Some comments
object to the proposed requirement that
a qualified auditor must be a preventive
controls qualified individual with
certain technical auditing expertise. One
comment asserts that a qualified auditor
should not be required to have the
broader skills of a preventive controls
qualified individual.
(Response 399) We have revised the
definition of ‘‘qualified auditor,’’ and
the requirements applicable to a
‘‘qualified auditor,’’ such that a
‘‘qualified auditor’’ means a person who
is a ‘‘qualified individual’’ as that term
is defined in this final rule, rather than
a ‘‘preventive controls qualified
individual,’’ because some auditors may
be auditing businesses (such as produce
farms) that are not subject to the
requirements for hazard analysis and
risk-based preventive controls, and it
would not be necessary for such an
auditor to be a ‘‘preventive controls
qualified individual.’’
(Comment 400) Some comments ask
us to consider specifying training for
qualified auditors. These comments also
ask us to consider certain industry
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documents in any guidance we may
issue regarding qualified auditors.
(Response 400) At this time, we are
not planning to specify a training
curriculum for qualified auditors. If we
develop guidance related to qualified
auditors, we will consider industry
documents that are already available.
C. Proposed § 507.53(d)—Records
We proposed that all applicable
training must be documented in records,
including the date of the training, the
type of training, and the person(s)
trained. For clarity, we have revised the
requirement to specify the type of
training that must be documented, i.e.,
applicable training in the development
and application of risk-based preventive
controls (see 78 FR 64736 at 64804).
(Comment 401) Some comments ask
us to explain how job experience should
be documented in records to prove
qualifications.
(Response 401) The rule does not
require documentation of job
experience. A facility has flexibility to
determine whether and how to
document a preventive controls
qualified individual’s job experience.
For example, a facility could ask a
preventive controls qualified individual
to provide a resume documenting
applicable experience. As discussed in
Response 395, we intend to focus our
inspections on the adequacy of the food
safety plan. As necessary and
appropriate, we will consider whether
deficiencies we identify in the food
safety plan suggest that the preventive
controls qualified individual may not
have adequate experience to carry out
the assigned functions.
For further discussion on comments
received to the proposed rule for
preventive controls rule for human food,
see the final rule of the human food
preventive controls rule published
elsewhere in this issue of the Federal
Register.
XXXVIII. Subpart C: Comments on
Proposed § 507.55—Implementation
Records
We proposed to list all records
documenting implementation of the
food safety plan in § 507.55(a). We
noted that proposed § 507.55(a) would
not establish any new requirements but
merely make it obvious at a glance what
implementation records are required
under proposed part 507, subpart C. We
received no comments that disagreed
with this proposed provision and are
finalizing it as proposed.
We proposed that the records that you
must establish and maintain are subject
to the requirements of proposed subpart
F (‘‘Requirements Applying to Records
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that Must be Established and
Maintained’’). (Proposed subpart F
would establish requirements that
would apply to all records that would
be required by the various proposed
provisions of proposed part 507.) We
received no comments that disagreed
with this proposed provision and are
finalizing it as proposed.
XXXIX. Subpart D: Comments on
Proposed New Provisions for
Withdrawal of a Qualified Facility
Exemption
In the 2013 proposed animal food
preventive controls rule, we proposed to
establish procedural requirements that
would govern our withdrawal of an
exemption for a qualified facility
(proposed subpart D; the withdrawal
provisions). In the 2014 supplemental
notice, we discussed several comments
we received on these withdrawal
provisions and proposed modifications
and additions to them. Some of the
reproposed provisions would modify
the provisions that we included in the
2013 proposed preventive controls rule
(such as the timeframe for compliance
with an order withdrawing an
exemption), whereas others would be
new provisions (such as a procedure to
reinstate an exemption that had been
withdrawn). In this section of this
document we discuss comments that we
received on the withdrawal provisions
in the 2013 proposed preventive
controls rule, but did not address in the
2014 supplemental notice. We also
discuss comments that we received on
the re-proposed withdrawal provisions
in the 2014 supplemental notice.
Most of the comments support the
proposed provisions, suggest alternative
or additional regulatory text, or ask us
to clarify how we will interpret the
provision.
For several provisions, we received no
comments that disagreed with our
proposal, and are finalizing the
provisions without change. These
provisions are § 507.75 (Presiding
officer for an appeal and for an informal
hearing); § 507.77 (Timeframe for
issuing a decision on an appeal);
§ 507.80 (Revocation of an order to
withdraw a qualified facility
exemption); and § 507.83 (Final agency
action).
In the following paragraphs, we
discuss comments that ask us to clarify
the proposed requirements or that
disagree with or suggest one or more
changes to the proposed requirements.
After considering these comments, we
have revised the proposed requirements
as shown in table 21 with editorial and
conforming changes as shown in table
31.
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TABLE 21—REVISIONS TO THE PROPOSED PROVISIONS FOR WITHDRAWAL OF A QUALIFIED FACILITY EXEMPTION
Section
Description
Revision
507.60(b)(2) ............
Timeframe for a qualified facility to respond to a notification from FDA
about circumstances that may lead
FDA to withdraw the facility’s exemption.
Contents of an order to withdraw a
qualified facility exemption.
Allow 15 calendar days, rather than 10 calendar days, for the facility to respond.
507.65(c) .................
507.65(d)(1) ............
Contents of an order to withdraw a
qualified facility exemption.
507.65(d)(2) ............
Timeframe for a qualified facility to appeal an order withdrawing the facility’s exemption.
Contents of an order to withdraw a
qualified facility exemption.
Compliance with, or appeal of, an order
to withdraw a qualified facility exemption.
Compliance with, or appeal of, an order
to withdraw a qualified facility exemption.
507.65(e) .................
507.67 .....................
507.67(a)(1) and
(c)(1).
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A. Proposed § 507.60—Circumstances
That May Lead FDA To Withdraw a
Qualified Facility Exemption
We proposed that we may withdraw
the exemption that would apply to a
qualified facility in the event of an
active investigation of a foodborne
illness outbreak that is directly linked to
the qualified facility, or if we determine
that it is necessary to protect the public
(human or animal) health and prevent
or mitigate a foodborne illness outbreak
based on conditions or conduct
associated with a qualified facility that
are material to the safety of the animal
food manufactured, processed, packed,
or held at such facility. We also
proposed that before we issue an order
to withdraw an exemption, we: (1) May
consider one or more other actions to
protect the public health or mitigate a
foodborne illness outbreak; (2) must
notify you, in writing, of circumstances
that may lead us to withdraw the
exemption, and provide an opportunity
for you to respond in writing, within 10
calendar days of the date of receipt of
the notification, to our notification; and
(3) must consider your actions to
address the circumstances that may lead
us to withdraw the exemption.
(Comment 402) Some comments agree
with the proposed provisions regarding
certain actions we may take, and other
actions we must take, before issuing an
order to withdraw a qualified facility
exemption. For example, some
comments agree that other regulatory
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Editorial changes to clarify that the order will specify which of two circumstances that may lead FDA to withdraw a qualified facility exemption
apply, or whether both of these two circumstances apply.
Specify that the timeframe for the qualified facility to comply with the order is
120 calendar days after the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted
to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order.
Allow 15 calendar days, rather than 10 calendar days, for the facility to appeal
the order.
Include a statement informing the facility that it may ask us to reinstate an exemption that was withdrawn by following the procedures in § 507.85.
Specifies that a qualified facility that loses its exemption would no longer need
to comply with the modified requirements that apply to qualified facilities that
have an active exemption.
Specify that the timeframe for the qualified facility to comply with the order is
120 calendar days after the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted
to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order.
actions should be considered before
withdrawing a qualified facility
exemption, and some comments agree
that it is appropriate to assess corrective
actions taken by a qualified facility in
response to an animal food safety
problem when considering whether to
withdraw its exemption. Other
comments agree that these provisions
are reasonable and will provide
qualified facilities due process and
greater clarity on the withdrawal
process, but suggest that we could issue
guidance rather than include these
provisions in the rule to allow us greater
flexibility should we have to act quickly
to protect the public (human or animal)
health.
Other comments disagree with these
proposed provisions and ask us to
delete them from the final rule. These
comments assert that FSMA does not
require us to describe the actions that
we may take prior to withdrawing a
qualified facility exemption and that it
is not necessary to do so because it is
customary for us to work with an animal
food facility to address problems before
taking enforcement actions. These
comments also express concern that
listing possible regulatory actions before
we would issue an order to withdraw a
qualified facility exemption could create
an expectation that we will always
exercise such regulatory actions before
issuing the order. These comments also
express concern that being bound by
these provisions could prevent us from
acting quickly to protect public health.
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(Response 402) We are retaining the
provisions regarding certain actions we
may take, and other actions we must
take, before issuing an order to
withdraw a qualified facility exemption.
We agree that it is customary for us to
work with an animal food facility to
address problems before taking
enforcement actions, but disagree that
specifying this customary practice in the
rule would prevent us from acting
quickly to protect public (human or
animal) health. As previously discussed,
we consider that issuing an order to
withdraw an exemption would be a rare
event, in part because alternative
actions such as those described in these
provisions may provide a more
expeditious approach to correcting a
problem than withdrawing an
exemption (79 FR 58524 at 58553). We
also disagree that the rule binds us to
take alternative regulatory action before
issuing an order to withdraw a qualified
facility exemption, other than to notify
the facility in writing of circumstances
that may lead us to withdraw the
exemption, provide an opportunity for
the facility to respond in writing, and
consider the actions taken by the facility
to address the circumstances we
describe. The rule clearly specifies that
regulatory actions such as a warning
letter, recall, administrative detention,
suspension of registration, refusal of
animal food offered for import, seizure,
and injunction are actions that we
‘‘may’’ (not ‘‘must’’) take before issuing
an order to withdraw a qualified facility
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exemption. Providing the facility with
an opportunity to correct the problems
before we take steps to withdraw an
exemption has the potential to save
Agency resources associated with
preparing an order, responding to an
appeal of the order and request for a
hearing, and administering a hearing.
Directing resources to help a facility
correct problems, rather than to
administer a withdrawal process that
could be resolved by the time of a
hearing, is appropriate public health
policy.
(Comment 403) Some comments ask
us to specify that the notification of
circumstances that may lead FDA to
withdraw the exemption must include
facts specific to the situation and
information about how the facility can
remedy the situation.
(Response 403) By specifying that we
must notify the facility of circumstances
that may lead us to withdraw an
exemption, we mean that we would
include facts specific to the situation. It
is the responsibility of the facility, not
FDA, to remedy the situation.
(Comment 404) Some comments ask
us to state affirmatively that we must
not withdraw the exemption if the
facility has satisfactorily addressed the
problematic conditions or conduct at
the facility. These comments assert that,
without this affirmative statement, the
requirement that we ‘‘consider the
actions taken by the facility’’ remains
unclear.
(Response 404) We decline this
request. If the facility has satisfactorily
addressed the problematic conditions or
conduct, there would be no problematic
circumstances for us to describe in the
order withdrawing the qualified facility
exemption.
(Comment 405) Some comments ask
us to provide additional time for a
qualified facility to respond, in writing,
to a notification of circumstances that
may lead us to withdraw its exemption.
Comments suggest timeframes of 60, 90,
and 120 days as a reasonable or
appropriate period of time for a
qualified facility to compile information
and documentation of facts and to
respond to a notification of
circumstances that may cause us to
withdraw its exemption. Some of these
comments express concern that the
proposed deadline is too short, and that
the short timeframe violates the intent
of the exemption. Some comments ask
us to establish graduated response
times, with less response time allowed
for more serious animal food safety
concerns.
(Response 405) We have revised the
provision to provide for 15 calendar
days, rather than 10 calendar days, for
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a facility to respond in writing to our
notification. The 15-day timeframe is
the same as the timeframe for
responding to a warning letter.
Circumstances that could lead us to
withdraw a qualified facility exemption
require prompt action on the part of a
facility, just as circumstances that lead
us to issue a warning letter require
prompt action.
(Comment 406) Some comments ask
us to clarify how an exemption can be
revoked (and restored) on diversified
farms that produce both exempt and
non-exempt products.
(Response 406) We assume that this
comment is referring to a farm mixedtype facility that produces some
products (such as forage products or
plant protein meals) that are exempt
from the requirements for hazard
analysis and risk-based preventive
controls, as well as some products that
are not exempt from these requirements.
Neither withdrawing nor reinstating a
qualified facility exemption would have
any impact on products that are not
subject to the requirements for hazard
analysis and risk-based preventive
controls. In contrast, administrative
procedures such as injunction and
suspension of registration likely would
apply to all animal food production by
the facility.
(Comment 407) Some comments ask
us to consistently use either ‘‘calendar
days’’ or ‘‘working days’’ throughout the
provisions directed to withdrawal of an
exemption. Some comments ask us to
use ‘‘business days’’ rather than
‘‘calendar days’’ or ‘‘working days.’’
(Response 407) We have expressed
the timeframes for all of the withdrawal
provisions in calendar days.
(Comment 408) Some comments ask
us to clarify that the decision to
withdraw a qualified facility exemption
is an individualized determination and
will not be applied to a class of farmers
by stating this clearly in the preamble.
(Response 408) The decision to
withdraw a qualified facility exemption
is an individualized determination and
will not be applied to a class of facilities
or farmers.
(Comment 409) Some comments
assert that the timeframes for
responding to a notification that an
exemption may be withdrawn should be
the same regardless of whether the
notification is sent to a qualified facility
subject to the human or animal food
preventive controls rule or a farm
subject to the produce safety rule. These
comments state that many small farms
do value-added processing and will be
subject to both rules.
(Response 409) Although the produce
safety rule is not yet final, we intend to
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make the administrative procedures
associated with withdrawal of an
exemption consistent to the extent
practicable, including the timeframe for
responding to a notification.
(Comment 410) Some comments ask
us to expand the scope of the
withdrawal provisions to include
facilities that would satisfy criteria for
an exemption from the requirements for
hazard analysis and risk-based
preventive controls for low-risk activity/
food combinations (i.e., the exemptions
in proposed §§ 507.5(e) and (f)).
(Response 410) We decline this
request. Section 418 of the FD&C Act
does not provide for withdrawal of the
exemptions established in § 507.5(e) and
(f). The withdrawal provision in section
418(l)(3) of the FD&C Act is limited to
qualified facilities.
B. Proposed § 507.62—Issuance of an
Order To Withdraw a Qualified Facility
Exemption
We proposed procedures for the steps
we would take to issue an order to
withdraw an exemption applicable to a
qualified facility, including procedures
that would: (1) Emphasize that a senior
FDA official (such as an FDA District
Director, the Director of the Division of
Compliance in CVM, or a more senior
FDA official) must approve an order to
withdraw the exemption before the
order is issued; (2) provide that any
officer or qualified employee of FDA
may issue the order after it has been
approved; (3) specify that we would
issue the order to the owner, operator,
or agent in charge of the facility; and (4)
require that the order be in writing and
be signed and dated by the officer or
qualified employee of FDA who is
issuing the order.
(Comment 411) Some comments ask
us to include in the procedures
timeframes for: (1) Submitting an order
after an initial determination that
criteria for withdrawing an exemption
are met; (2) approval or denial by the
FDA District Director; (3) issuing the
withdrawal (with automatic revocation
of order if FDA does not issue the order
within the specified timeframe); and (4)
delivery of the order to the owner,
operator, or agent in charge of the
facility. Other comments recommend
that the procedures for issuing an order
specify that we send the order in a way
that ensures its receipt, such as through
certified mail with confirmation of
delivery to ensure the facility operator
receives the order.
(Response 411) We are not
establishing timeframes for the steps we
take before a facility receives an order
for withdrawal of an exemption. The
timeframes surrounding our internal
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process for developing an order have no
bearing on the time that a facility will
need to respond to the order or on the
information it will need to do so. We
agree that it is appropriate to specify
timeframes for the procedural steps that
follow a facility’s receipt of an order,
and the withdrawal procedures include
such timeframes.
We are not specifying that we send an
order in a way that ensures its receipt.
Although certified mail with
confirmation of delivery is one way to
ensure receipt, other methods are
available, including delivery through
private carriers that provide
mechanisms to document receipt. In
light of the provision (which we
included in the 2014 supplemental
notice) linking the timeframes for a
facility to comply with, or appeal, an
order to the date of receipt of the order
(rather than to the date of the order), it
will be up to us to deliver the order in
a way that provides us with evidence of
receipt.
C. Proposed § 507.65—Contents of an
Order To Withdraw a Qualified Facility
Exemption
We proposed specific information that
would be included in an order to
withdraw an exemption, including (1)
The date of the order and the name,
address, and location of the qualified
facility; (2) a brief, general statement of
the reasons for the order, including
information relevant to the
circumstances that led us to issue the
order; (3) a statement that the facility
must either comply with subpart C
within 120 calendar days of receipt, or
appeal the order within 10 calendar
days of receipt; (4) the text of section
418(l) of the FD&C Act and of the
withdrawal provisions in part 507,
subpart D; (5) information about an
informal hearing on an appeal of the
order; and (6) contact information for
appropriate senior FDA officials, as well
as the name and the title of the FDA
representative who approved the order.
(Comment 412) Some comments
recommend that the order specify which
of the two circumstances that could lead
us to issue the order apply.
(Response 412) We have made
editorial changes to the regulatory text
to make it more clear that the provision
requires us to specify which
circumstance applies. (i.e., an active
investigation of foodborne illness, or
conduct or conditions associated with
the qualified facility), or whether both
of these two circumstances apply. See
the revised regulatory text for
§ 507.65(c).
(Comment 413) Some comments ask
us to add more specific requirements for
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the content of an order to withdraw an
exemption, including specific evidence
about the circumstances leading to the
order. The comments maintain that
doing so would help the facility respond
with particularity to the facts and issues
contained in the order if the facility
appeals the order. The comments also
recommend that the order include the
evidence on which the order is based
including, as applicable, evidence
linking the active investigation of a
foodborne illness outbreak directly to
the facility or measurable evidence
(collected using generally accepted
scientific standards) indicating the
presence in the facility of pathogens that
pose an imminent threat to public
(human or animal) health, or conduct or
conditions that are material to the safety
of animal food. The comments also
recommend that the order include,
when applicable, a statement explaining
how altering the conduct or conditions
would prevent or mitigate a foodborne
illness outbreak.
(Response 413) We agree that the
order must provide sufficient
information to enable a facility to
respond with particularity to specific
evidence about the circumstances
leading to the order. However, we
disagree that the order must do so by
including the specific information
recommended by the comments, and we
have not revised the proposed
withdrawal provisions to incorporate
the suggestions of these comments. The
comments appear to be more focused on
whether the circumstances that lead us
to issue an order meet an evidentiary
standard than on explaining the
problem so that a facility can both
understand the problem and respond
with particularity to the facts and issues
contained in the order. The withdrawal
provisions that we are establishing in
this provision require the order to
include a brief, general statement of the
reasons for the order, including
information relevant to: (1) An active
investigation of a foodborne illness
outbreak that is directly linked to the
facility; or (2) conditions or conduct
associated with a qualified facility that
are material to the safety of the animal
food manufactured, processed, packed,
or held at the facility. The requirements
that we are establishing in this
provision would enable a qualified
facility to both understand the problem
and respond to it. In addition, because
other requirements in these withdrawal
provisions specify that we must notify
a qualified facility of circumstances that
may lead us to withdraw its exemption
before we issue the actual order, the
order withdrawing the exemption
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would be the second time that the
facility hears about the problems (see
§ 507.60(b)(2)). We intend that the
process of responding to the notification
that we must send before issuing an
order to withdraw an exemption,
including discussing the problems with
FDA as warranted, would provide
additional information to the facility to
enable the facility to both understand
the problem and respond to it.
(Comment 414) Some comments ask
us to provide 15 ‘‘business days’’ from
date of receipt of the order, rather than
the proposed 10 calendar days from date
of receipt of the order, for the facility to
appeal the order.
(Response 414) We have revised the
provision to provide for 15 calendar
days, rather than 15 business days, for
a facility to appeal the order. We also
have made conforming changes to
establish the same 15 calendar day
timeframe in all provisions that specify
the timeframe to appeal the order (i.e.,
§§ 507.67(a)(2), 507.69(a)(1), and
507.71(a)(2)). We also extended the
timeframe for the hearing to be held to
be within 15 calendar days, rather than
the proposed 10 calendar days, after the
date the appeal is filed to provide more
time for the facility to prepare for the
hearing (see § 507.73(a)). The timeframe
for the hearing to be held continues to
provide for an alternative timeframe
agreed upon in writing by both the
facility and FDA; a facility that would
have preferred the proposed timeframe
of 10 calendar days could request that
the hearing be held more quickly than
15 calendar days.
The 15-day timeframe is the same as
the timeframe for responding to a
warning letter. Circumstances that could
lead us to withdraw a qualified facility
exemption require prompt action on the
part of a facility, just as circumstances
that lead us to issue a warning letter
require prompt action.
(Comment 415) Some comments
support the proposed timeframe of 120
calendar days for a qualified facility
whose exemption has been withdrawn
to comply with the animal food
preventive controls rule, but ask us to
make the timeframe for complying with
a FSMA rule the same regardless of
whether the exemption is withdrawn
from a qualified facility subject to the
animal food preventive controls rule or
from a farm subject to the produce
safety rule. Other comments ask us to
extend the timeframe to come into
compliance, e.g., to 1 or 2 years. Some
of these comments suggest that qualified
facilities should have 120 days to
develop a plan of action, but 2 years to
fully comply. Some of the comments
argue that large farms and
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manufacturers are given a year to come
into compliance, and that requiring
small and very small businesses to
comply in a shorter time period would
effectively drive them out of business.
Other comments ask us to consider
provisions that would require
compliance with only those portions of
the rule that formed the basis for the
revocation.
(Response 415) We continue to
believe that the 120-day timeframe is
adequate, but we have added flexibility
such that a facility may request, with a
justification in writing to FDA, a
reasonable timeframe for compliance
that exceeds 120 calendar days from the
receipt of the order. FDA must grant the
request for the facility to receive the
extended timeframe. We are not
generally extending the timeframe
because circumstances that could lead
us to withdraw a qualified facility
exemption require prompt action on the
part of a facility. A qualified facility that
receives an order to withdraw its
exemption would have received
advance notification of the
circumstances leading to the order and
would have had an opportunity to
correct the problems rather than have us
proceed to issue the order (see
§ 570.60(b)). If the facility requests a
hearing, more than 40 days could elapse
between the date that the facility
receives the order and the date that the
presiding officer for the hearing
confirms the order to withdraw the
exemption. Given that the
circumstances that would lead us to
issue the order involve either: (1) An
active investigation of a foodborne
illness outbreak that is directly linked to
the qualified facility or (2) a
determination that withdrawal of the
exemption is necessary to protect the
public (human or animal) health and
prevent or mitigate a foodborne illness
outbreak based on conditions or
conduct associated with the qualified
facility that are material to the safety of
the animal food manufactured,
processed, packed, or held at the
facility, a delay of 1 to 2 years to comply
with the rule is not warranted. We also
do not believe that it would be
appropriate to require a facility to come
into compliance with only those
provisions that formed the basis of the
revocation. The provisions of subparts C
and E are interrelated and operate as a
system and therefore are not optimized
through piecemeal implementation.
However, FDA may consider staggered
implementation as an option in granting
a request for an extension of the
timeframe to comply with an order to
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withdraw the exemption for a qualified
facility.
As already discussed, the new
requirements for hazard analysis and
risk-based preventive controls are not
‘‘one-size-fits-all.’’ Although each
facility subject to the rule must prepare
and implement a food safety plan, the
preventive controls that the facility
would establish and implement would
depend on the facility, the animal food,
and the outcome of the facility’s hazard
analysis. In addition, the preventive
control management components that a
facility would establish and implement
for its preventive controls would be
established as appropriate to ensure the
effectiveness of the preventive controls,
taking into account the nature of the
preventive control and its role in the
facility’s animal food safety system.
Although the produce safety rule is
not yet final, we intend to make the
administrative procedures associated
with withdrawal of an exemption
consistent to the extent practicable,
including the timeframe to comply with
the applicable rule if an exemption is
withdrawn.
(Comment 416) Some comments ask
us to include in the order a statement
that a facility may request that FDA
reinstate an exemption that was
withdrawn by following the procedures
in § 507.85.
(Response 416) We have revised the
requirements for the contents of an
order as requested by these comments.
D. Proposed § 507.67—Compliance
With, or Appeal of, an Order To
Withdraw a Qualified Facility
Exemption
We proposed that: (1) You must either
comply with applicable requirements of
part 507 within 120 calendar days of
receipt, or appeal the order within 10
calendar days of receipt; (2) submission
of an appeal, including submission of a
request for an informal hearing, will not
operate to delay or stay any
administrative action unless the
Commissioner of FDA, as a matter of
discretion, determines that delay or a
stay is in the public interest; and (3) if
you appeal the order, and we confirm
the order, you must comply with
applicable requirements of part 507
within 120 calendar days of
confirmation of receipt of the order.
(Comment 417) Some comments ask
us to specify that a qualified facility that
loses its exemption from the
requirements for hazard analysis and
risk-based preventive controls would no
longer need to comply with the
modified requirements that apply to
qualified facilities that have an active
exemption.
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(Response 417) A qualified facility
that loses its exemption from the
requirements for hazard analysis and
risk-based preventive controls would no
longer need to comply with the
modified requirements that apply to
qualified facilities that have an active
exemption. To make this clearer, the
final withdrawal procedures now
include this information (see the
regulatory text for § 507.67(c)).
E. Proposed § 507.69—Procedure for
Submitting an Appeal
We proposed that (1) To appeal an
order, you must submit a written appeal
to FDA within 15 calendar days of
receipt and respond with particularity
to the facts and issues contained in the
order, including any supporting
documentation upon which you rely;
and (2) In your written appeal, you may
include a written request for an informal
hearing.
(Comment 418) Some comments ask
us to rely on records kept in the normal
course of business for documentation
that will be sufficient to respond to an
order to withdraw a qualified facility’s
exemption, rather than requiring a
facility to ‘‘respond with particularity to
the facts and issues contained in the
order, including any supporting
documentation upon which the owner,
operator or agent in charge of the facility
relies.’’ These comments assert that we
should not require a facility that
submits a written appeal to provide
documents and records that they are not
required to keep.
(Response 418) We decline this
request. In a withdrawal action, FDA is
providing a qualified facility multiple
opportunities to persuade FDA that
withdrawal is not appropriate. If the
facility relies on documentation as part
of its response, it is reasonable to
require that this documentation be
provided to FDA.
F. Proposed § 507.71—Procedure for
Requesting an Informal Hearing
We proposed that if you appeal the
order: (1) You may request an informal
hearing, and must do so together with
your written appeal (within 15 calendar
days of the date of receipt of the order
and (2) a request for an informal hearing
may be denied, in whole or in part, if
the presiding officer determines that no
genuine and substantial issue of
material fact has been raised by the
material submitted; you would receive
written notice of the presiding officer’s
determination, explaining the reason for
the denial.
(Comment 419) Some comments ask
us to guarantee a hearing so that a
qualified facility can present its case in
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person before having its exemption
revoked.
(Response 419) We decline this
request. We agree that a qualified
facility has a right to appeal an order to
withdraw an exemption, and we have
provided for a right to appeal.
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G. Proposed § 507.73—Requirements
Applicable to an Informal Hearing
We proposed that if you request an
informal hearing, and we grant the
request: (1) The hearing will be held
within 10 calendar days after the date
the appeal is filed or, if applicable,
within a timeframe agreed upon in
writing by you and by us; (2) the
presiding officer may require that the
hearing be completed within 1 calendar
day; and (3) we must conduct the
hearing in accordance with part 16 (21
CFR part 16), with some specified
modifications, including that no party
shall have the right, under § 16.119, to
petition FDA for reconsideration or a
stay of the presiding officer’s final
decision.
(Comment 420) Some comments
object to our proposal that no party shall
have the right, under § 16.119 to
petition FDA for reconsideration or a
stay of the presiding officer’s final
decision. These comments assert that
our justification (i.e., that the
circumstances that would lead to a
withdrawal merit prompt action and
that a facility has the opportunity for
judicial review in accordance with 21
CFR 10.45) is not a sufficient argument
for justifying the removal of the option
to file a motion for reconsideration or
stay. These comments ask us to revise
proposed § 507.73(c)(6) to specify that
the qualified facility shall have the right
to file a motion for reconsideration or
stay.
(Response 420) We decline this
request. In the 2014 supplemental
controls notice, we proposed an
additional mechanism for a qualified
facility to present its view that its
exemption should not be withdrawn,
i.e., by providing advance written
notification to a qualified facility if we
are considering withdrawing an
exemption and providing an
opportunity for the facility to respond
before we issue an order to withdraw an
exemption. We also proposed to provide
an opportunity for reinstatement of an
exemption that had been withdrawn.
We believe the multiple opportunities
now available to a facility provide
adequate opportunities for a facility’s
views to be considered, and further
mechanisms are not warranted.
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H. Proposed § 507.85—Reinstatement of
a Qualified Facility Exemption That
Was Withdrawn
We proposed four provisions for
reinstating a withdrawn qualified
facility exemption. First, we proposed
that if the FDA District Director in
whose district your facility is located
(or, in the case of a foreign facility, the
Director of the Division of Compliance
in CVM) determines that a facility has
adequately resolved problems with the
conditions and conduct that are material
to the safety of the animal food
manufactured, processed, packed, or
held at the facility and that continued
withdrawal of the exemption is not
necessary to protect public health and
prevent or mitigate a foodborne illness
outbreak, the FDA District Director in
whose district your facility is located (or
in the case of a foreign facility, the
Director of the Division of Compliance
in CVM) will, on his own initiative or
on the request of a facility, reinstate the
exemption (proposed § 507.85(a)).
Second, we proposed that you may
ask FDA to reinstate an exemption that
has been withdrawn by following
specific steps (§ 507.85(b)(1) and (2)).
Third, we proposed that if your
exemption was withdrawn in the event
of an active investigation of a foodborne
illness outbreak that is directly linked to
your facility and FDA later determines,
after finishing the active investigation of
a foodborne illness outbreak, that the
outbreak is not directly linked to your
facility, FDA will reinstate your
qualified facility exemption and will
notify you in writing that your exempt
status has been reinstated.
We proposed that if your exemption
was withdrawn both in the event of an
active investigation of a foodborne
illness outbreak that is directly linked to
your facility and because FDA had
determined that it is necessary to
protect the public (human or animal)
health and prevent or mitigate a
foodborne illness outbreak based on
conditions or conduct associated with
your facility that are material to the
safety of the animal food manufactured,
processed, packed, or held at such
facility, and FDA later determines, after
finishing the active investigation of a
foodborne illness outbreak, that the
outbreak is not directly linked to your
facility, FDA will inform you of this
finding, and you may ask FDA to
reinstate your qualified facility
exemption.
(Comment 421) Some comments agree
with our tentative conclusion that the
absence of a specific provision in
section 418 of the FD&C Act for the
reinstatement of an exemption that is
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56289
withdrawn does not preclude us from
providing for such a process (79 FR
58524 at 58553). Other comments
disagree with that tentative conclusion
and assert that Congress crafted the
withdrawal provision as a ‘‘one strike,
you’re out’’ provision. These comments
also assert that including the
withdrawal provision as a ‘‘one strike,
you’re out’’ provision was an essential
part of the legislative agreement that
allowed for adoption of the qualified
facility exemption. These comments
also assert that reinstatement would
undermine the intent of the withdrawal
provision because it would reduce the
incentive for small animal food
processors to ensure that the products
they sell are as safe as possible. These
comments also assert that a recognized
principle of statutory interpretation
provides that exemptions to statutes
should be strictly construed,
particularly when the statute addresses
public health and safety, and that we are
giving the exemption an impermissibly
broad construction.
Some comments ask why we believe
that a business deserves a ‘‘second bite
of the apple’’ in light of the
understanding (under proposed
§ 507.60(b) and (c)) that we will first
seek to correct problems before
considering withdrawal. These
comments also question at what point a
facility would apply for reinstatement,
and ask why we would allow a facility
that has already come into compliance
with FSMA’s requirement to implement
preventive controls to abandon those
controls in favor of reinstating its
exempt status. These comments ask us
to eliminate the proposed provisions
allowing for reinstatement.
Some comments do not support the
proposed reinstatement provisions
when an animal food facility has been
directly linked to a foodborne illness
outbreak. Some comments support the
proposed reinstatement provisions only
when we determine, after finishing an
active investigation of a foodborne
illness outbreak, that the outbreak is not
directly linked to the facility that had its
exemption withdrawn.
(Response 421) We disagree that the
proposed reinstatement provisions
would give the exemption an
impermissibly broad construction. The
express statutory language of section
418(l) of the FD&C Act does not support
the comments’ assertion that the
withdrawal provision is a ‘‘one strike,
you’re out’’ provision. We also disagree
that reinstatement would undermine the
intent of the withdrawal provision
because it would reduce the incentive
for small animal food processors to
ensure that the products they sell are as
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safe as possible. We expect that the
withdrawal provision itself provides a
big incentive for small animal food
processors to ensure that the products
they sell are as safe as possible because
of the business disruption that would
occur if they are subject to withdrawal
of the exemption. We proposed that a
facility would need to present data and
information to demonstrate that it has
adequately resolved the problems with
the conditions or conduct that are
material to the safety of the animal food
manufactured, processed, packed, or
held at the facility, such that continued
withdrawal of the exemption is not
necessary to protect public (human or
animal) health and prevent or mitigate
a foodborne illness outbreak.
We disagree that we should
categorically refuse to consider
reinstating a qualified facility
exemption if we had withdrawn the
exemption because an animal food
facility had been directly linked to a
foodborne illness outbreak. First, if
information later comes to light to raise
considerable doubt that a qualified
facility had, indeed, been directly
linked to a foodborne illness outbreak,
and conditions and conduct at the
facility do not otherwise warrant
withdrawing the facility’s exemption, it
would be appropriate for us to reinstate
the facility’s exemption. Second, we
would only reinstate the exemption if
we determined that a facility has
adequately resolved any problems with
the conditions and conduct that are
material to the safety of the animal food
manufactured, processed, packed, or
held at the facility and that continued
withdrawal of the exemption is not
necessary to protect public (human or
animal) health and prevent or mitigate
a foodborne illness outbreak.
(Comment 422) Some comments that
support the reinstatement of a
withdrawn exemption ask us to
establish a timeframe within which FDA
will reinstate an exemption. Some
comments ask us to specify in the
regulatory text that the reinstatement
would occur in a reasonable period of
time, both in circumstances where FDA
has decided on its own initiative to
reinstate the exemption and in
circumstances where a facility submits
a request for reinstatement. Some
comments suggest 10 days is a
reasonable period of time within which
FDA should reinstate an exemption.
(Response 422) We decline the
requests to establish a timeframe for
reinstatement in the regulatory text. If
we determine on our own initiative to
reinstate an exemption (e.g., because we
later determine, after finishing the
active investigation of a foodborne
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illness outbreak, that the outbreak is not
directly linked to the facility), our
determination would be effective
immediately. If we receive a request to
reinstate a withdrawn exemption, we
intend to respond in a reasonable
timeframe consistent with available
resources. In some cases, we may
respond that we need more information
in order to evaluate your request.
(Comment 423) Some comments ask
that the process for reinstatement
include at least one level of
administrative appeal if we deny a
facility’s request for reinstatement.
(Response 423) We have not revised
the regulatory text to provide for an
administrative appeal if we deny a
facility’s request for reinstatement.
Existing procedures allow a facility to
ask for a meeting with applicable FDA
officials (see § 10.65(c)) and appeal our
decision if we deny the request (see
§ 10.75).
(Comment 424) Some comments ask
us to establish a 1-year probationary
period before the withdrawn qualified
facility exemption could be fully
reinstated.
(Response 424) We decline this
request. We intend to act on a request
for reinstatement based on the merits of
the data and information presented in
the request, not after a pre-determined
timeframe.
I. Conforming Amendment to 21 CFR
Part 16
We proposed to amend § 16.1(b)(2) to
include part 507, subpart D, relating to
the withdrawal of an exemption
applicable to a qualified facility, to the
list of regulatory provisions under
which regulatory hearings are available.
We received no comments that
disagreed with this proposed provision,
and are finalizing it as proposed.
J. Other Comments on the Withdrawal
Provisions
(Comment 425) Several comments ask
us to provide clarification through
guidance, issued for public comment,
on a variety of topics associated with
the withdrawal provisions.
(Response 425) We will consider the
need for guidance in the future. At this
time, we consider that withdrawing an
exemption would be both rare and
dependent upon the circumstances. We
need to direct our resources to
developing guidance on issues that
would apply more broadly, and more
generally, than the withdrawal
provisions.
(Comment 426) Some comments ask
detailed questions about how we would
coordinate the withdrawal process with
the States.
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(Response 426) In general, we work
with our State partners and other
government counterparts in dealing
with enforcement actions, including
coordinating actions or deferring to each
other when one department has
authority to swiftly act to protect the
consumer. In the specific case of this
rule, we are working through the PFP to
develop and implement a national
Integrated Food Safety System
consistent with FSMA’s emphasis on
establishing partnerships for achieving
compliance (see Response 2 and section
209(b) of FSMA).
(Comment 427) Some comments ask
us to add provisions regarding
notification of the appropriate State
regulatory agency when a qualified
facility exemption is withdrawn and
reinstated.
(Response 427) We decline this
request. As previously noted, we are
sensitive to the time required for various
inspection activities and intend to
communicate with States regarding our
expectations for how to verify whether
a facility is a qualified facility. The
status of a facility as a qualified facility
principally affects the requirements that
it is subject to, and will be most useful
to FDA and our food safety partners
when preparing for inspection. At this
time we do not intend to establish a
system notifying the applicable State
authorities at a point in time when the
status of a facility as a qualified facility
changes, whether as a result of
withdrawal or reinstatement of a
qualified facility exemption or because
the facility’s business has grown to the
point where it exceeds the financial for
very small business.
XL. Subpart E: General Comments on
Proposed Requirements for a SupplyChain Program
In the 2014 supplemental notice, we
provided an opportunity for public
comment on potential requirements for
a supplier program as a preventive
control. The supplier program for a
receiving facility would be limited to
those raw materials and other
ingredients for which the receiving
facility has identified a significant
hazard (which we now refer to as a
‘‘hazard requiring a preventive
control’’). Under the definitions
established in this rule, ‘‘supplier’’
means the establishment that
manufactures/processes the food, raises
the animal, or grows the food that is
provided to a receiving facility without
further manufacturing/processing by
another establishment, except for
further manufacturing/processing that
consists solely of the addition of
labeling or similar activity of a de
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minimis nature; ‘‘receiving facility’’
means a facility that is subject to
subparts C and E and that manufactures/
processes a raw material or other
ingredient that it receives from a
supplier (see § 507.3).
We previously explained our
understanding that, particularly for
RACs, there may be multiple
establishments, including cooperatives,
packing houses, and distributors,
between a receiving facility and the
establishment that would be considered
the supplier, which would make
supplier verification very challenging
under certain circumstances (79 FR
58476 at 58497). We requested comment
on what verification activities would be
appropriate for receiving facilities to
conduct when a raw material or
ingredient passes through more than
one facility that would not be required
to verify control of hazards if supplier
programs are limited to manufacturers/
processors. We discussed an example in
which a receiving facility is a feed mill
that receives oats from a distributor,
who receives grains from a cooperative,
and neither the distributor nor the
cooperative is required to establish
supplier controls for the farms, where
the hazards are being controlled, and
asked what supplier controls should be
applied for the grains coming from the
farms. We requested comment on
whether and how the requirements for
supplier verification should address
such situations. We also requested
comment regarding whether (and, if so,
how) the final preventive controls rule
for animal food should address the
potential for gaps in supplier controls
when a hazard is controlled at Point A
in the supply chain, and Point B in the
supply chain is a facility that only packs
or holds animal food, but does not
manufacture/process animal food (and
therefore would not be required to have
a supplier program) before passing it on
to Point C in the supply chain.
In the remainder of this section, we
discuss comments that address our
request for comment on complex
supply-chain scenarios such as those
described in the 2014 supplemental
notice. We also describe our reasons for
revising the proposed requirements for
a supplier program to provide
additional flexibility for an entity other
than the receiving facility to determine,
conduct, and document the appropriate
supplier verification activities. When an
entity other than the receiving facility
determines, conducts, or both
determines and conducts the
appropriate supplier verification
activities, the receiving facility must
review and assess that entity’s
applicable documentation, and
document the receiving facility’s review
and assessment. Providing this
additional flexibility required a series of
changes to multiple proposed
provisions. To improve clarity and
readability, we redesignated proposed
§ 507.36 into eight distinct sections of
regulatory text in a newly established
subpart E (Supply-Chain Program), with
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editorial changes associated with the
new structure of the redesignated
regulations. See table 22 for the section
numbers and titles in subpart E. See
table 23 for an overview of the major
revisions to the proposed requirements
for a supply-chain program. See sections
XLI through XLVII for a discussion of
the specific provisions of the final
requirements for a supply-chain
program, and tables 24 to 29 for more
detailed summaries of revisions to these
specific provisions. Because table 23 is
an overview, the changes identified in
table 23 appear again in, tables 24 to 29.
Because the editorial changes associated
with the redesignation are extensive, we
do not list them in table 31.
The title of subpart E is ‘‘SupplyChain Program’’ rather than ‘‘Supplier
Program.’’ As shown in table 23 and
discussed in more detail in section
XLI.D, we have added one requirement
applicable to non-suppliers. ‘‘Supplychain program’’ is a more appropriate
term to reflect a subpart that includes a
requirement applicable to nonsuppliers
in addition to the requirements
applicable to suppliers. In the
remainder of this document, we use the
phrase ‘‘supply-chain program’’ in
section headings and when referring to
the provisions of the final rule. We
continue to use the term ‘‘supplier
program’’ when describing the proposed
provisions and the comments regarding
the proposed provisions.
TABLE 22.4—REDESIGNATION OF THE REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM IN SUBPART E
[Supply-chain program]
Section
507.105
507.110
507.115
507.120
507.125
Description
....................................................
....................................................
....................................................
....................................................
....................................................
507.130 ....................................................
507.135 ....................................................
507.175 ....................................................
Requirement to establish and implement a supply-chain program.
General requirements applicable to a supply-chain program.
Responsibilities of the receiving facility.
Using approved suppliers.
Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
Conducting supplier verification activities for raw materials and other ingredients.
Onsite audit.
Records documenting the supply-chain program.
TABLE 23.5—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM
Proposed section
designation
Description
Revision
Throughout ..................
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Final section
designation
Throughout .................
The type of preventive control applicable to
the supply-chain program.
507.36(a)(2) (in subpart
C).
507.37(a)(1)(ii) ............
A supply-chain program is not required when
the hazard will be controlled by the receiving facility’s customer in the distribution
chain.
Refer to ‘‘supply-chain-applied control’’ rather
than ‘‘preventive control’’ or variations such
as ‘‘hazard requiring a preventive control
when the hazard is controlled before receipt of the raw material or other ingredient.’’
Shifted to be in provisions outside the framework of the supply-chain program in subpart E.
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TABLE 23.5—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM—Continued
Proposed section
designation
Description
Revision
507.105(a)(2) ...............
N/A .............................
Circumstances that do not require a supplychain program.
507.105(a)(3) ...............
N/A .............................
507.105(c) ...................
N/A .............................
Exemption from the requirements for a supply-chain program.
Requirements applicable to non-suppliers .....
507.110(c) ...................
507.37(a)(3)(ii) ............
Purpose of the supply-chain program ............
507.110(d) ...................
507.37(b) ....................
Factors that must be considered in determining appropriate supplier verification activities.
507.115(a) ...................
N/A .............................
Responsibilities of the receiving facility ..........
507.115(b) ...................
N/A .............................
Responsibilities of the receiving facility ..........
507.120(a) ...................
507.37(a)(3)(i) ............
Approval of suppliers ......................................
507.120(b) ...................
507.37(a)(3)(i) ............
Approval of suppliers ......................................
507.130(e) ...................
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Final section
designation
N/A .............................
Alternative supplier verification activity ...........
507.130(f) ....................
N/A .............................
Independence of the supplier .........................
The receiving facility does not need a supplychain program when the receiving facility is
an importer, is in compliance with the forthcoming FSVP requirements, and has documentation of verification activities conducted under the forthcoming FSVP program.
Exemption for animal food supplied for research or evaluation.
When a supply-chain-applied control is applied by an entity other than the receiving
facility’s supplier (e.g., when a nonsupplier
applies controls to certain produce (i.e.,
produce that will be subject to the forthcoming produce safety rule), because
growing, harvesting, and packing activities
are under different management), the receiving facility must (1) verify the supplychain-applied control; or (2) obtain documentation of an appropriate verification activity from another entity in the supply
chain, review and assess the entity’s applicable documentation, and document that
review and assessment.
Specify only that the supply-chain program
must provide assurance that a hazard requiring a supply-chain-applied control has
been significantly minimized or prevented.
• Clarification that these factors must be
considered in approving suppliers, as well
as in determining appropriate supplier
verification activities.
• Flexibility in the factors that must be considered if a supplier is a qualified facility, a
produce farm that will not be subject to the
forthcoming produce safety rule on the
basis of size and/or direct farm marketing,
or a shell egg producer that is not subject
to the requirements of 21 CFR part 118
(production, storage, and transportation of
shell eggs) because it has less than 3,000
laying hens.
Provide flexibility for an entity other than the
receiving facility to determine, conduct, and
document supplier verification activities,
provided that the receiving facility reviews
and assesses applicable documentation
from that entity and documents the receiving facility’s review and assessment.
Specify documentation that a receiving facility
may not accept from a supplier to satisfy
the receiving facility’s responsibilities for its
supply-chain program.
Explicit requirement for a receiving facility to
approve its suppliers.
Explicit requirement for a receiving facility to
establish and follow written procedures for
receiving raw materials and other ingredients.
Provide for an alternative supplier verification
activity when the supplier is a shell egg
producer with less than 3,000 laying hens.
Specify that there must not be any financial
conflicts of interests that influence the results of the verification activities listed in
§ 507.110(b) and payment must not be related to the results of the activity.
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TABLE 23.5—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM—Continued
Proposed section
designation
Description
Revision
507.135(c)(1) ...............
507.37(e) ....................
Substitution of an inspection for an audit .......
507.175 ........................
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Final section
designation
507.37(g) ....................
Records documenting the supply-chain program.
Provide additional flexibility for domestic inspection by representatives of other Federal Agencies (such as USDA), or by representatives of State, local, tribal, or territorial agencies.
List additional records associated with the revised provisions.
(Comment 428) Several comments ask
us to issue guidance rather than
establish requirements for a supplier
program in the rule. Some comments
assert that the benefits of a supplier
verification program do not outweigh
the costs; that we did not consider the
effects of such a requirement on farms
and small businesses; and that FSMA
does not actually contain a requirement
for a supplier verification program.
Conversely, other comments support
including a mandatory supplier program
in the rule for hazards that are
controlled in raw materials and other
ingredients before receipt by the
receiving facility, although many
comments assert that a supplier
verification program should be viewed
as a verification activity rather than a
preventive control. Some comments
assert that a mandatory domestic
supplier program is necessary to
provide parity with the requirements of
the FSVP rule authorized by FSMA,
while other comments assert that
FSMA’s authorization of foreign
supplier verification should not be used
to justify a domestic supplier program.
Some of these comments single out our
request for comment, in the proposed
FSVP rule, on whether to allow an
entity that would be both an importer
(under the FSVP rule) and a receiving
facility (under the animal food
preventive controls rule) to be deemed
in compliance with the FSVP rule if it
was in compliance with the supplier
verification provisions of the animal
food preventive controls rule, and agree
with such an approach (78 FR 45730 at
45748).
(Response 428) We agree that it is
necessary to include a mandatory
supply-chain program in the rule to
ensure the safety of animal food where
hazards are controlled in raw materials
and other ingredients before receipt by
a receiving facility, and we are
finalizing such a requirement in this
rule. The statute specifically identifies
supplier verification activities as a
preventive control (see section 418(o)(3)
of the FD&C Act). Further, we believe a
supply-chain program is a measure that
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a person knowledgeable about food
safety would establish and implement
in order to significantly minimize or
prevent hazards requiring a preventive
control in an incoming raw material or
other ingredient.
Supplier verification is sufficiently
important for the control of hazards in
both domestic and imported animal
foods that FSMA contains provisions for
both domestic and foreign supplier
verification (sections 418(o)(3) and 805
of the FD&C Act). Because we have
aligned the provisions for supplier
verification in the FSVP rule with the
provisions for a supply-chain program
in this rule, we are allowing importers
and receiving facilities to take advantage
of that fact in considering compliance
with both part 507 and our forthcoming
FSVP regulations that we proposed to
establish in part 1, subpart L, so that
they do not have to duplicate
verification activities (see
§ 507.105(a)(2)).
(Comment 429) Some comments that
addressed questions we asked in the
2013 proposed preventive controls rule
for animal food and the 2014
supplemental notice recommend that
we add flexibility to the requirements
for a supplier program such that any
entity in the supply chain between the
supplier and the receiving facility can
perform supplier verification activities.
Some comments ask us to allow a
receiving facility to have a supplier
program established for it by another
entity. Other comments assert that it
would be too burdensome for a
receiving facility to consider any
information related to the supplier’s
supplier or to go further back in the
supply chain beyond the entity that is
one back from the receiving facility.
Other comments assert that we should
eliminate any requirements for a
supplier program from the rule because
a supplier program involving more
entities than just the receiving facility
and the supplier would become too
complex. Some comments express
concern that we would be creating ‘‘an
environment where our supply chain is
required to be disclosed to our
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customers via product testing, audits
and supplier verification,’’ asserting that
this would discourage customers from
buying from entities such as repackers
when they could go to the source. Some
comments state that we have not taken
into account the low-risk nature of some
industries. Other comments ask us to
confirm that distributors and
warehouses are not included in the
requirements for a supplier program
because they would not likely meet the
definition of a receiving facility or a
supplier.
(Response 429) We agree with
comments recommending additional
flexibility in the supply-chain program
with regard to who can perform certain
activities and have added this flexibility
to the final rule (see § 507.115). Because
the receiving facility and the supplier
may be separated by several entities in
a supply chain, we are allowing such
entities (e.g., distributors, brokers,
aggregators) to determine, conduct, and
document supplier verification
activities as a service to the receiving
facility, provided that the receiving
facility reviews and assesses applicable
documentation provided by the other
entity and documents that review and
assessment. However, because the
approval of suppliers is ultimately the
responsibility of the receiving facility,
the rule specifies that only a receiving
facility can approve suppliers (see
§§ 507.115(a)(1) and 507.120(a) and
Response 430).
We disagree that complex supply
chains make a supply-chain program too
difficult and that a receiving facility
cannot be expected to reach further back
in a supply chain than the entity
immediately before it in the supply
chain. Supply-chain programs are
currently used by facilities as a standard
business practice and we understand
that some of those supply chains are
complex, with entities between the
receiving facility and the supplier. We
acknowledge that complex supply
chains present a challenge because
information will need to flow through
several entities to allow the link
between the receiving facility and the
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supplier. However, we believe a supplychain program is a critical preventive
control for receiving facilities that will
rely on suppliers to control hazards in
raw materials and other ingredients.
Although distributors, brokers, and
other entities in the supply chain
between a receiving facility and its
supplier are not required to have a role
in supplier verification, they have the
option to determine, conduct, and
document supplier verification
activities as a service to the receiving
facility if they so choose. If these
entities choose not to participate in
supplier verification, the receiving
facility will need to reach back in the
supply chain past them. In such
situations, it may be necessary for the
entities between the receiving facility
and the supplier to provide the identity
of the supplier to the receiving facility,
if that identity is not available on the
raw material or other ingredient or
otherwise apparent. In such cases, the
role that distributors, brokers,
aggregators and similar entities would
play in supplier verification would be
minimal. We cannot determine whether
having to provide the identity of the
supplier to the receiving facility would
change buying practices. However, we
believe that manufacturers consider a
number of factors in determining who
they will purchase from, including the
services provided, and that there will
continue to be a role for aggregators,
repackers, brokers and others. We have
provided flexibility for these entities to
play a role in supplier verification if the
receiving facility and the business entity
determine there is a benefit to do so.
See also the discussion in section
XLIII regarding the specific provisions
of § 507.115. Although comments focus
on flexibility for an entity in the supply
chain between the supplier and the
receiving facility to perform supplier
verification activities, and such entities
are the most likely to be determining,
conducting, and documenting supplier
verification activities, the flexibility
provided by the rule is not limited to
such entities.
(Comment 430) Some comments ask
us to establish a general requirement for
a supplier program without specifying
roles and responsibilities for the various
entities involved. Other comments ask
us to define ‘‘supplier’’ as the entity
with which the receiving facility has a
commercial relationship.
(Response 430) We disagree that we
should establish a general requirement
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for a supply-chain program without
specifying roles and responsibilities for
the various entities involved. Although
we have added flexibility to provide
that an entity other than the receiving
facility may determine, conduct, and
document supplier verification
activities (see § 507.115), we continue to
believe it is important to clearly define
two roles in the supply chain that share
the primary responsibility in the
supplier verification process—i.e., the
receiving facility and the supplier. In all
cases where we have added flexibility
for participation by an entity other than
the receiving facility, the responsibility
for the supply-chain program is clearly
lodged with the receiving facility, and
linked to the supplier (see § 507.115).
To emphasize the responsibility of the
receiving facility and its link to the
supplier, the final rule clearly states that
the receiving facility must approve its
suppliers before receiving raw materials
and other ingredients (see § 507.120(a)).
For the supply-chain program to be
meaningful and robust, there must be an
exchange of information between these
two entities—the entity receiving the
animal food and the entity that
controlled the hazard—even when an
entity other than the receiving facility
participates by determining, conducting,
and documenting some supplier
verification activities. The ultimate
responsibility for supplier verification
rests with the receiving facility through
its determination in approving suppliers
and in reviewing and assessing
applicable documentation provided by
another entity. Therefore, we also
disagree that the definition of
‘‘supplier’’ should be revised to be the
next entity back in a supply chain (e.g.,
the entity with which a receiving
facility has a commercial relationship).
The entity with which a receiving
facility has a commercial relationship
might be a distributor, broker or
aggregator. A distributor, broker or
aggregator does not control an identified
hazard and, therefore, cannot assume
the same role as an establishment that
manufactures/processes the animal
food, raises the animal, or grows the
food.
(Comment 431) Some comments ask
us to provide flexibility in the content
of the supplier program. Some
comments assert that specifying the
content of the supplier program would
result in duplicative requirements on
suppliers, who must first comply with
certain regulations and then
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demonstrate that compliance in order to
comply with a different regulation.
(Response 431) We disagree that a
requirement for a supply-chain program
in which compliance with an
underlying regulation is demonstrated is
duplicative with the need to comply
with the underlying regulation. The
requirement for a supply-chain program
is not mandating that the facility or farm
comply twice with the animal food
preventive controls rule or the produce
safety rule; it is merely requiring that
the compliance by the facility or the
farm with the applicable regulation be
verified to ensure that hazards requiring
a preventive control are being
controlled.
We are continuing to specify the basic
content of a supply-chain program, i.e.,
using approved suppliers; determining
appropriate supplier verification
activities; conducting supplier
verification activities; and establishing
records documenting these activities
(see § 507.110(a)). However, the rule
provides flexibility in the choice of
supplier verification activities and how
often such activities must be performed.
(See §§ 507.110(b)(4) and 507.130(b)(2),
(c), (d), and (e)). In addition, the rule
provides for an alternative supplier
verification activity for certain entities
(see § 507.130(c), (d), and (e) regarding
alternative supplier verification
activities for qualified facilities, certain
produce farms, and certain shell egg
producers, respectively).
XLI. Subpart E: Comments on
Requirement To Establish and
Implement a Supply-Chain Program
We proposed that the receiving
facility must establish and implement a
risk-based supplier program for those
raw materials and ingredients for which
the receiving facility has identified a
significant hazard when the hazard is
controlled before receipt of the raw
material or ingredient (proposed
§ 507.37(a)). We also proposed
circumstances when a receiving facility
would not be required to have a
supplier program.
In the following sections, we discuss
comments that ask us to clarify the
proposed requirement to establish and
implement a written supplier program
or that disagree with, or suggest one or
more changes to, the proposed
requirements. After considering these
comments, we have revised the
regulatory text as shown in table 24.
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TABLE 24—REVISIONS TO THE PROPOSED REQUIREMENTS TO ESTABLISH AND IMPLEMENT A SUPPLY-CHAIN PROGRAM
Final section
designation
Proposed section
designation
Description
N/A ...............................
507.37(a)(1)(ii) ............
N/A ...............................
507.37(a)(1)(ii) ............
507.36(a)(2) .................
507.37(a)(1)(ii) ............
507.105(a)(2) ...............
N/A .............................
507.105(a)(3) ...............
N/A .............................
507.105(c) ...................
N/A .............................
A supplier program is not required when
there are no hazards requiring a preventive
control.
A supplier program is not required when the
preventive controls at the receiving facility
are adequate to significantly minimize or
prevent each of the hazards requiring a
preventive control.
A supplier program is not required when the
hazard will be controlled by the receiving
facility’s customer in the distribution chain.
Circumstances that do not require a supplychain program even though the receiving
facility’s hazard analysis determines that a
hazard requires a supply-chain-applied
control.
Exemption from the requirements for a supply-chain program.
Requirements applicable to non-suppliers .....
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A. Requirement for a Written SupplyChain Program (Final § 507.105(a)(1)
and (b))
We proposed that the receiving
facility must establish and implement a
risk-based supplier program for those
raw materials and ingredients for which
the receiving facility has identified a
significant hazard when the hazard is
controlled before receipt of the raw
material or ingredient. We also
proposed that the supplier program
must be written. (See proposed
§ 507.37(a)(1)(i) and (2).) To improve
clarity, we have revised the provision to
substitute the phrase ‘‘hazard requiring
a supply-chain-applied control’’ for the
phrase ‘‘significant hazard when the
hazard is controlled before receipt of the
raw material or ingredient.’’ We have
added a definition for the term ‘‘supplychain-applied control’’ to mean a
preventive control for a hazard in a raw
material or other ingredient when the
hazard in the raw material or other
ingredient is controlled before its
receipt (see § 507.3) and use the more
specific term ’’ supply-chain-applied
control,’’ rather than the broader term
‘‘preventive control,’’ throughout the
provisions for a supply-chain program.
(Comment 432) As discussed in
Comment 428, several comments ask us
to issue guidance rather than establish
requirements for a supplier program in
the rule.
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(Response 432) See Response 428 for
a discussion of our reasons for declining
this request and establishing
requirements for a supply-chain
program in the rule.
(Comment 433) Some comments ask
us to revise the regulatory text to
remove the condition that all hazards be
foreseeable so that the supplier program
can address economically motivated
adulteration.
(Response 433) This comment is
unclear. The requirement for a supplychain program applies when the
outcome of a hazard analysis is that a
known or reasonably foreseeable hazard
requires a preventive control, and the
hazard would be controlled by the
receiving facility’s supplier. The
requirement applies regardless of
whether the hazard requiring a
preventive control is, or is not, a hazard
that would be introduced into a food for
the purposes of economic gain.
(Comment 434) Some comments ask
us to specify that a Certificate of
Analysis or other documentation of the
existence and/or level of a hazard could
be provided to the receiving facility to
indicate the potential for an actual
existence of a hazard so that the
receiving facility could evaluate
whether the hazard requires a
preventive control. Some comments
state that chemical hazards such as
nutrient imbalances are not controlled
through easily described ‘‘procedures’’
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Deleted as unnecessary.
Deleted as unnecessary.
Shifted to be in provisions outside the framework of the supply-chain program in subpart E.
A receiving facility is an importer, is in compliance with the FSVP requirements, and
has documentation of verification activities
conducted under the FSVP program.
Exemption for animal food supplied for research or evaluation.
When a supply-chain-applied control is applied by an entity other than the receiving
facility’s supplier, the receiving facility must
(1) verify the supply-chain-applied control;
or (2) obtain documentation of an appropriate verification activity from another entity in the supply chain, review and assess
the entity’s applicable documentation, and
document that review and assessment.
but are instead controlled through
factors such as product formulation
(e.g., controlling the levels of required
or contaminating chemicals in each
ingredient depending on the proportion
of the ingredient in the finished animal
food) and the amount fed. For example,
some comments explain that mineral
content of certain raw materials or
ingredients may require control in some
situations (e.g., copper content in food
for sheep) but not in other situations
(e.g., copper content in swine food). One
comment expresses concern about
whether customers would be willing to
provide the receiving facility with
confidential information about the
customer’s own hazard analysis with
respect to sensitive topics. Furthermore,
in such cases the receiving facility will
not even know whether the chemical
contaminant constitutes an actual
‘‘hazard’’ for the purposes of the
customer’s finished food. This comment
also asserts that a Certificate of Analysis
provided to a receiving facility
constitutes ‘‘control before receipt of the
raw material or ingredient.’’
(Response 434) We do not understand
the concern of this comment. A
receiving facility and a supplier do not
need to share all of the details of
product formulation for a receiving
facility to communicate its requirements
to a supplier. In the example provided
by the comment, the receiving facility
could provide the supplier with a
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written specification for a contaminant
such as lead, and the supplier could
demonstrate that it satisfied the
receiving facility’s specification by
providing a Certificate of Analysis
showing the results of laboratory testing
for lead. Neither the written
specification provided by the receiving
facility, nor the Certificate of Analysis
provided by the supplier, would
disclose confidential information about
the formulations or procedures of either
entity.
This comment also appears to
misunderstand the applicability of the
supply-chain program. The rule requires
a supply-chain program when the
receiving facility has identified, through
its hazard analysis, that there is a hazard
requiring a supplier-applied control. In
the circumstances described by the
comment, a Certificate of Analysis or
other documentation of test results from
the supplier to the receiving facility
could demonstrate that the supplier has
controlled the hazard to the receiving
facility’s specifications, but would not
overturn the outcome of the receiving
facility’s hazard analysis that there is a
hazard requiring a preventive control,
and that the appropriate control is
applied by the supplier. On the
contrary, the Certificate of Analysis
simply demonstrates that the supplychain-applied control functioned as
intended.
(Comment 435) One comment asks us
to specify in the regulatory text that the
supplier program must be written ‘‘if
required’’ because there are specified
circumstances when a supplier program
is not required.
(Response 435) We decline this
request. Although the rule provides
circumstances when a supply-chain
program is not required (see
§ 507.105(a)(2)), it is not necessary to
specify, for all other provisions of the
supply-chain program, that the
provision only applies ‘‘if required.’’
B. Circumstances That Do Not Require
a Written Supply-Chain Program (Final
§ 507.105(a)(2))
We proposed that the receiving
facility is not required to establish and
implement a supplier program for raw
materials and ingredients for which
there are no significant hazards; the
preventive controls at the receiving
facility are adequate to significantly
minimize or prevent each of the
significant hazards; or the receiving
facility relies on its customer to control
the hazard and annually obtains from its
customer written assurance that the
customer has established and is
following procedures (identified in the
written assurance) that will significantly
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minimize or prevent the hazard. (See
proposed § 507.37(a)(1)(ii)(A), (B), and
(C).)
We are deleting the proposed
provision that a supplier program is not
required for raw materials and
ingredients for which there are no
‘‘significant hazards’’ (which we now
refer to as ‘‘hazards requiring a
preventive control’’) because it is
unnecessary. The supply-chain program
is required when a hazard identified in
the receiving facility’s hazard analysis
identifies a hazard requiring a supplychain-applied control; it is not
necessary to also state the converse.
Likewise, we are deleting the proposed
provision that a supplier program is not
required if the preventive controls at the
receiving facility are adequate to
significantly minimize or prevent each
of the significant hazards. In such a
case, the outcome of the hazard analysis
would not be that the hazard requires a
supply-chain-applied control.
As discussed in section XXVII, after
considering comments, we are shifting
the provision in which the receiving
facility relies on its customer to control
the hazard from the requirements for a
supply-chain program to a series of
provisions that apply when a
manufacturer/processor identifies a
hazard requiring a preventive control,
but can demonstrate and document that
the hazard will be controlled by an
entity in its distribution chain (see
§§ 507.36 and 507.37). However, as
discussed in Response 428 and section
XLI.C, we also are establishing two
additional circumstances when a
supply-chain program is not required
(see § 507.105(a)(2) and (3)).
(Comment 436) As noted in Comment
428, some comments single out our
request for comment, in the proposed
FSVP rule, on whether to allow an
entity that would be both an importer
(under the FSVP rule) and a receiving
facility (under animal food the
preventive controls rule) to be deemed
in compliance with the FSVP rule if it
was in compliance with the supplier
verification provisions of the animal
food preventive controls rule, and agree
with such an approach (78 FR 45730 at
45748).
(Response 436) As noted in Response
428, we have aligned the provisions for
supplier verification in the FSVP rule
with the provisions for a supply-chain
program in this rule, and we are
allowing importers and receiving
facilities to take advantage of that fact in
considering compliance with our
forthcoming FSVP regulations that we
proposed to establish in in part 1,
subpart L, so that they do not have to
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duplicate verification activities (see
§ 507.105(a)(2)).
(Comment 437) Some comments
support the specified criteria for when
a receiving facility would not be
required to establish and implement a
supplier program. Other comments
express concern that these criteria
suggest no supplier verification is
needed at all in some circumstances
despite supplier verification activities
being potentially informative about a
particular supplier. These comments ask
us to establish some general
requirement to perform verification
activities for all suppliers.
(Response 437) We decline this
request because it is neither risk-based
nor consistent with the nature and
purpose of the supply-chain program,
which is to provide assurance that a
hazard requiring a supply-chain-applied
control has been significantly
minimized or prevented (see the
regulatory text of § 507.110(c)). We agree
that some degree of verification of all
suppliers may prove useful to a
receiving facility for various purposes,
and the rule would not prevent a
receiving facility from establishing a
supply-chain program for all of its
suppliers regardless of risk and
regardless of whether the applicable
hazard in a raw material or other
ingredient is controlled before its
receipt.
(Comment 438) Some comments ask
us to specify that a ‘‘kill step’’ would be
an adequate indicator to significantly
minimize or prevent significant hazards
identified by the receiving facility when
the receiving facility controls the
hazard.
(Response 438) These comments
appear to misunderstand the
applicability of the supply-chain
program. The rule requires a supplychain program when the receiving
facility has identified, through its
hazard analysis, that there is a hazard
requiring a preventive control and the
receiving facility’s manufacturing/
processing will not control the hazard.
In the circumstances described by the
comment, the receiving facility is
controlling the hazard and a supplychain program for the raw material or
other ingredient is not required. It is not
necessary to specify the types of
controls that the receiving facility may
use to control the hazard.
(Comment 439) Some comments ask
us to specify that a receiving facility
need not establish and implement a
supplier program for raw materials and
ingredients if those raw materials or
ingredients were received from an
affiliated party within the same
corporate or controlling entity.
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(Response 439) We decline this
request. With the revisions we have
made to the proposed requirements for
a supplier program, the supply-chain
program that we are establishing in this
rule provides ample opportunities for an
affiliated party within the same
corporate or controlling entity to
establish and implement a supply-chain
program that is suited to its relationship
to these entities. For example, as
discussed in Response 458, a receiving
facility might be able to determine and
document a justification for a supplier
verification activity other than an
annual audit when a supplier is an
affiliated party based on the receiving
facility’s knowledge of the corporate
policies regarding animal food safety
practices (see § 507.130(b)(2)). In
addition, as discussed in Response 461,
we have agreed that the corporate parent
of a facility can be active in developing
and implementing the facility’s food
safety plan (see section XXIV.A). If, for
example, a corporate headquarters
establishes and implements a supplychain program for use company-wide, a
receiving facility could rely on supplier
verification activities conducted by its
corporate headquarters, with applicable
documentation available during
inspection.
C. Exemption for Animal Food Supplied
for Research or Evaluation (Final
§ 507.105(a)(3))
We are establishing an exemption
from the requirement for a receiving
facility to establish and implement a
supply-chain program when it receives
animal food for the purposes of research
or evaluation, provided that certain
conditions are met (see § 507.105(a)(3)).
Those conditions are that the animal
food: (1) Is not intended for retail sale
and is not sold or distributed to the
public; (2) is labeled with the statement
‘‘Animal food for research or evaluation
use’’; (3) is supplied in a small quantity
that is consistent with a research,
analysis, or quality assurance purpose,
the animal food is used only for this
purpose, and any unused quantity is
properly disposed of; and (4) is
accompanied with documents, in
accordance with the practice of the
trade, stating that the animal food will
be used for research or evaluation
purposes and cannot be sold or
distributed to the public. The exemption
is analogous to an exemption we
proposed for the FSVP rule under
section 805(f) of the FD&C Act. (See
proposed § 1.501(c), 78 FR 45730 at
45745.) We believe it is not necessary to
conduct supplier verification activities
when animal food is obtained in this
limited circumstance.
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D. Additional Requirements for NonSuppliers (Final § 507.105(c))
As discussed in section IV.B of this
rule and in section IV.B of the final rule
for preventive controls for human food
as published elsewhere in this addition
of the Federal Register, the final rule for
preventive controls for human food
includes several revisions to the ‘‘farm’’
definition in response to comments.
One change includes adding a new
definition for a ‘‘secondary activities
farm,’’ which provides for practices
such as packing by cooperatives and
packing houses under the ownership of
multiple growers to remain within the
‘‘farm’’ definition (see Response 25 in
the final rule for preventive controls for
human food). Another change to the
‘‘farm’’ definition accommodates
business models in which one operation
grows crops but does not harvest them,
and another operation, not under the
same management, harvests crops but
does not grow them (see Response 32 in
the final rule for preventive controls for
human food). This revision is a change
from the ‘‘farm’’ definition established
in the section 415 registration
regulations in 2003, and the proposed
revisions to the ‘‘farm’’ definition in the
2013 proposed human food preventive
controls rule and the 2014 supplemental
human food preventive controls notice,
which all describe a ‘‘farm’’ as an entity
‘‘devoted to the growing and harvesting
of crops’’ (emphasis added).
We proposed the requirements for a
supplier program in the context of a
single business entity ‘‘devoted to the
growing and harvesting of crops’’
(emphasis added) in which packing
operations were often done by that same
business entity. The final ‘‘farm’’
definition accommodates business
models where growing, harvesting, and
packing operations will be done by
different business entities. Harvesting
and packing operations include some
supply-chain-applied controls, such as
controls on worker hygiene, quality of
water used during harvesting and
packing operations, and establishing
and following water-change schedules
for recirculated water, even though the
harvesting and packing operations do
not fall within the definition of
‘‘supplier.’’
A receiving facility has an obligation
to identify and implement preventive
controls to provide assurances that any
hazards requiring a preventive control
will be significantly minimized or
prevented and the animal food
manufactured, processed, packed, or
held by the facility will not be
adulterated under section 402 of the
FD&C Act (see section 418(c) of the
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FD&C Act and § 507.34(a)). That
obligation includes responsibilities for
raw materials and other ingredients
when a supply-chain-applied control is
applied by an entity other than the
receiving facility’s supplier. To clarify
the receiving facility’s responsibilities
when a supply-chain-applied control is
applied by a non-supplier, we are
establishing a requirement specifying
that when a supply-chain-applied
control is applied by an entity other
than the receiving facility’s supplier, the
receiving facility must: (1) Verify the
supply-chain-applied control or (2)
obtain documentation of an appropriate
verification activity from another entity
in the supply chain, review and assess
the entity’s applicable documentation,
and document that review and
assessment. See § 507.105(c). Because
§ 507.105(c) refers to provisions in a
future produce safety rule, we will
publish a document in the Federal
Register announcing the effective date
of that provision when we finalize the
produce safety rule.
We do not expect the receiving
facility to follow all of the requirements
of subpart E applicable to ‘‘suppliers’’
when verifying a control by a ‘‘nonsupplier,’’ as required by § 507.105(c).
Instead, we expect the receiving facility
to take steps such as a review of the
non-supplier’s applicable food safety
records. For example, if a receiving
facility receives produce from a supply
chain that includes a separate grower,
harvester, and packer, the grower is the
supplier and the requirements of
subpart E applicable to ‘‘suppliers’’
apply to the grower. To verify controls
applied by the harvester, the receiving
facility could review the harvester’s
records, such as records of training for
harvest workers and records of
agricultural water quality used in
harvest operations. To verify controls
applied by the packer, the receiving
facility could review the packer’s
records, such as records of agricultural
water quality used in packing
operations. As discussed in Response
429, we are allowing entities such as
distributors, brokers, and aggregators to
determine, conduct, and document
verification activities that apply to
suppliers as a service to the receiving
facility, provided that the receiving
facility reviews and assesses applicable
documentation provided by the other
entity and documents that review and
assessment. Likewise, under
§ 507.105(c)(2) a receiving facility could
obtain documentation of review of
applicable records maintained by the
harvester or packer from another entity,
review and assess the entity’s applicable
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documentation, and document that
review and assessment.
We recognize that 507.105(c) may
have limited applicability to raw
material and other ingredients used in
animal food. At this time, we do not
have an example of when we would
expect an animal food manufacturer to
verify non-supplier controls for its raw
materials or other ingredients. Although
we do not have examples and expect
limited applicability of § 507.105(c)(2),
we have included these provisions to
provide for instances when an animal
food facility identifies situations in
which controls applied by a ‘‘nonsupplier’’ need to be verified as part of
the facility’s supply-chain program.
E. Proposed General Requirements for
the Supply-Chain Program That We Are
Not Including in the Final Rule
(Proposed § 507.37(a)(4) and (5))
We proposed that when supplier
verification activities are required for
more than one type of hazard in a food,
the receiving facility must conduct the
verification activity or activities
appropriate for each of those hazards.
We also proposed that for some hazards,
in some situations it will be necessary
to conduct more than one verification
activity and/or to increase the frequency
of one or more verification activities to
provide adequate assurances that the
hazard is significantly minimized or
prevented. We have concluded that
these provisions are largely self-evident
and need not be included in the
regulatory text. Therefore, we are not
finalizing these proposed provisions.
We will consider whether it will add
value to discuss the principles in these
proposed provisions in guidance that
we intend to develop for the supplychain program.
XLII. Subpart E: Comments on General
Requirements for the Supply-Chain
Program
We proposed several requirements
generally applicable to the supplier
program (such as factors to consider in
determining appropriate supplier
verification activities (proposed
§ 507.37(b)), as well as several
requirements more narrowly targeted to
specific aspects of the supplier program
(such as requirements applicable to
onsite audits). As part of the
redesignation of proposed § 507.37 into
subpart E, with eight distinct sections,
we are establishing the more general
requirements in § 507.110 (see table 25).
Most comments that support the
proposed provisions suggest alternative
or additional regulatory text. In the
following sections, we discuss
comments that ask us to clarify the
proposed requirements or that disagree
with, or suggest one or more changes to,
the proposed requirements. After
considering these comments, we have
revised the regulatory text as shown in
table 25.
TABLE 25—REVISIONS TO THE PROPOSED GENERAL REQUIREMENTS APPLICABLE TO A SUPPLY-CHAIN PROGRAM
Proposed section
designation
Description
Revision
507.110(a) ...........................
507.37(a)(3) .......................
What the supply-chain program must include.
507.110(b) ...........................
507.37(c)(1) .......................
507.37(a)(3)(ii) ...................
507.110(d) ...........................
507.37(b) ...........................
507.110(d) ...........................
507.37(b) ...........................
Appropriate supplier
verification activities.
Purpose of supplier
verification activities for
raw materials and other
ingredients.
Factors that must be considered when approving
suppliers and determining appropriate supplier verification activities
for raw materials and
other ingredients.
Factors that must be considered when approving
suppliers and determining appropriate supplier verification activities
for raw materials and
other ingredients; Supplier performance..
Add that the supply-chain program includes, when applicable, verifying a supply-chain-applied control applied by an entity other than the receiving facility’s
supplier and documenting that verification, or obtaining documentation of an appropriate verification activity from another entity, reviewing and assessing
that documentation, and documenting the review
and assessment.
N/A.
507.110(c) ............................
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Final section
designation
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Specify only that the supply-chain program must provide assurance that a hazard requiring a supplychain-applied control has been significantly minimized or prevented.
Clarify that the factors apply in approving suppliers, as
well as in determining appropriate supplier
verification activities.
• Specify that three of the factors relate to ‘‘supplier
performance’’
• Specify ‘‘The entity or entities that will be applying
controls for the hazards requiring a supply-chain-applied control’’ rather than ‘‘Where the preventive
controls for those hazards are applied for the raw
material and ingredients—such as at the supplier or
the supplier’s supplier’’.
• Add ‘‘other FDA compliance actions related to food
safety’’ as an example of information relevant to the
supplier’s compliance with applicable FDA food
safety regulations.
• Clarify that consideration of supplier performance includes, when applicable, relevant laws and regulations of a country whose food safety system FDA
has officially recognized as comparable or has determined to be equivalent to that of the United
States and information relevant to the supplier’s
compliance with those laws and regulations.
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Continued
Final section
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507.110(e) ...........................
Proposed section
designation
507.37(f) ............................
A. Description of What the SupplyChain Program Must Include (Final
§ 507.110(a))
We proposed to require that a
supplier program include verification
activities, as appropriate to the hazard,
and documentation of these activities, to
ensure raw materials and ingredients are
received only from suppliers approved
for control of the hazard(s) in that raw
material or ingredient (or, when
necessary and appropriate, on a
temporary basis from unapproved
suppliers) (proposed § 507.37(a)(3)(i)).
We also proposed to require that a
supplier program include verification
activities, as appropriate to the hazard,
and documentation of these activities.
We also proposed requirements
applicable to the determination and
documentation of appropriate supplier
verification activities (proposed
§ 507.37(b)). We also proposed specific
documentation requirements for records
associated with the supplier program
(proposed § 507.37(g)).
The final rule specifies that the
supply-chain program must include: (1)
Using approved suppliers; (2)
determining appropriate supplier
verification activities (including
determining the frequency of
conducting the activity); (3) conducting
supplier verification activities; and (4)
documenting supplier verification
activities. For clarity, § 507.110(a) states
this general requirement for the supplychain program and §§ 507.120, 507.125,
507.130, 507.135, and 507.175 provide
the specific requirements for using
approved suppliers, determining
appropriate supplier verification
activities, conducting verification
activities, specific requirements for
onsite audits, and records, respectively.
See the discussion of the specific
requirements of §§ 507.120, 507.125,
507.130, 507.135, and 507.175 in
sections XLIV, XLV, XLVI, and XLVII,
respectively.
As discussed in section XLI.D, the
final rule establishes a verification
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Supplier non-conformance
• Provide flexibility in the factors that must be considered if a supplier is a qualified facility, a produce
farm that will not be subject to the forthcoming
produce safety rule on the basis of size and/or direct farm marketing, or a shell egg producer that is
not subject to the requirements of 21 CFR part 118
(production, storage, and transportation of shell
eggs) because it has less than 3,000 laying hens.
N/A.
requirement when a supply-chainapplied control is applied by an entity
other than the receiving facility’s
supplier (see § 507.105(c)). For clarity,
§ 507.110(a) states this general
requirement for the supply-chain
program in § 507.105(a)(5), and
§ 507.105(c) provides the specific
requirements that apply when a supplychain-applied control is applied by an
entity other than the receiving facility’s
supplier.
B. Appropriate Supplier Verification
Activities ((Final § 507.110(b))
We proposed to require that
appropriate supplier verification
activities include: (1) Onsite audits; (2)
sampling and testing of the raw material
or ingredient, which may be conducted
by either the supplier or receiving
facility; (3) review by the receiving
facility of the supplier’s relevant food
safety records; or (4) other appropriate
supplier verification activities based on
the risk associated with the ingredient
and the supplier (proposed
§ 507.37(c)(1)).
(Comment 440) Some comments
support the inclusion of onsite audits as
an appropriate supplier verification
activity. However, other comments
oppose it, and ask us to remove the
onsite audit requirement from the
supplier verification program, stating
that Congress prohibited FDA from
requiring third parties to verify or audit
compliance with the rules. These
comments express concern that the
supplier verification program effectively
imposes an ‘‘entire second layer of
regulation’’ on farms that are supplying
ingredients to processors, and claim this
is an unnecessary burden that is not
authorized by FSMA.
(Response 440) We are retaining
onsite audits as an appropriate supplier
verification activity. Onsite audits may
be less commonly used by the animal
food industry than the human food
industry. However, onsite audits
provide the opportunity to review the
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food safety plan and written procedures
and to observe the implementation of
animal food safety procedures, as well
as to review the records related to the
past application of control measures,
including laboratory test results. Audits
also provide the opportunity to
interview employees to assess their
understanding of the animal food safety
measures for which they are
responsible. Thus, an audit can provide
for a more comprehensive assessment of
animal food safety implementation by a
facility. Comments that oppose
including onsite audits as a verification
activity are concerned that farms will be
required to have audits to verify that
they are in compliance with produce
safety standards or facilities will be
required to have audits to verify
preventive controls. These comments
apparently refer to the provision in
section 419(c)(1)(E) of the FD&C Act that
the regulation issuing standards for the
safety of produce ‘‘not require a
business to hire a consultant or other
third party to identify, implement,
certify compliance with these
procedures, processes and practices,’’ or
the provision in section 418(n)(3)(D) of
the FD&C Act that the preventive
controls regulation ‘‘not require a
facility to hire a consultant or other
third party to identify, implement,
certify or audit preventative controls.’’
The regulations proposed under section
419 of the FD&C Act would not impose
such requirements. The requirements
for supplier verification in this rule
(under section 418 of the FD&C Act)
provide for audits as one supplier
verification activity. Although the rule
does specify an annual onsite audit as
the appropriate supplier verification
activity when a hazard in a raw material
or other ingredient will be controlled by
the supplier and is one for which there
is a reasonable probability that exposure
to the hazard will result in serious
adverse health consequences or death to
humans or animals, the receiving
facility is not required to hire a third
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party to conduct the audit. Any
qualified auditor, other than the
supplier, may conduct the audit,
including an employee of the receiving
facility or another entity, such as an
entity in the supply chain between the
supplier and the receiving facility. The
rule also provides that a receiving
facility may determine and document
that other verification activities and/or
less frequent onsite auditing of the
supplier provide adequate assurance
that the hazards are controlled (see
§ 507.130(b)(1) and (2)). Audits already
conducted on a supplier’s facility or
operation for other business purposes
may meet the requirement for supplier
verification. In addition, the rule
provides alternative requirements for
verification of suppliers that are farms
that grow produce and are not a covered
farm under part 112 in accordance with
§ 112.4(a), or in accordance with
§§ 112.4(b) and 112.5 (see § 507.130(d)).
Finally, we have also provided that
inspections may substitute for an audit
under specified circumstances (see
§ 507.135(c)).
While we realize that some farms may
receive audits under the supplier
verification provisions of part 507, we
anticipate that onsite audits will be used
as a verification activity more frequently
for non-farm facilities because hazards
associated with commercial animal food
production are not typically controlled
by the farm, but rather during
manufacture or processing of the animal
food.
(Comment 441) Some comments
support the inclusion of sampling and
testing of the raw material or other
ingredient as an appropriate supplier
verification activity, and note that
verification testing is more effective
when conducted by the supplier than
the receiving facility because the
supplier can control the lot of product
tested. However, other comments
oppose it, stating that sampling and
testing is not useful for products for
various reasons such as the nonhomogeneous distribution of some
hazards, or statistical limitations
because of practical limits on number of
samples or limited shelf life of some
products.
(Response 441) We are retaining
sampling and testing as an appropriate
supplier verification activity. As noted
in the FDA memorandum on supplier
programs, sampling and testing are
commonly used by industry in the
verification of supplier performance
(Ref. 53). We have previously discussed
factors that impact the utility and
frequency of raw material/ingredient
testing (see the Appendix published in
the 2013 proposed preventive controls
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rule for animal food (78 FR 64736 at
64836)). We agree that there are benefits
in having sampling and testing
conducted by the supplier, because the
supplier can then take appropriate
action with respect to the findings,
including not shipping contaminated
product. However, because
contamination with some hazards is
likely to be non-homogeneous and for
microbial pathogens or microbial toxins
the numbers are likely to be low, a
negative test result does not guarantee
the absence of contamination. This
should be taken into account when
deciding which verification activity (or
activities) is appropriate. Because of the
limitations of sampling and testing, the
controls the supplier has in place to
minimize contamination, and the
management of those controls, are key
in determining when sampling and
testing is appropriate as a verification
activity. For short shelf life products,
where holding product pending test
results can negatively impact product
quality and usefulness, an onsite audit
to verify control of hazards may be more
appropriate than sampling and testing.
(Comment 442) Some comments ask
us to specify in the regulatory text that
sampling and testing can be conducted
by or on behalf of the supplier or the
receiving facility.
(Response 442) The provisions of
§ 507.115 specify the responsibilities of
the receiving facility, and allow a
receiving facility to conduct all supplier
verification activities, including
sampling and testing. These provisions
also provide that a supplier, or an entity
other than the receiving facility (such as
an entity in the supply chain between
the supplier and the receiving facility),
can conduct sampling and testing,
provided that the receiving facility
reviews and assesses the documentation
provided by the supplier. The rule
places no restrictions on when a
receiving facility, a supplier, or an
entity other than the receiving facility
could have a business relationship with
a third party (such as a contract
laboratory) to conduct sampling and
testing.
(Comment 443) Some comments
suggest that, for a facility regularly
undergoing audits, reviewing a
‘‘supplier’s relevant food safety records’’
should allow for the receiving facility to
review documentation related to preexisting audits. These comments ask us
to revise the provision to add
‘‘including, but not limited to, records
related to audits previously performed
on the supplier’s facility.’’
(Response 443) We decline this
request. The comment misinterprets
what we mean by a ‘‘supplier’s relevant
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food safety records.’’ The rule provides
for onsite audits as a verification
activity, as well as reviewing a
‘‘supplier’s relevant food safety
records.’’ When an annual audit is
determined to be an appropriate
verification activity (see
§ 507.130(b)(1)), the audit would be
reviewed by the receiving facility, but a
review of this audit is not what we
meant by a ‘‘supplier’s relevant food
safety records.’’ As described in an FDA
memorandum on supplier programs,
food safety records are records
documenting that the food safety
procedures that have been established to
control hazards are being followed and
are adequately controlling such hazards
(Ref. 53). Thus, a receiving facility may
obtain documentation of a supplier’s
control measures for a particular lot of
a raw material or other ingredient
provided to the receiving facility, such
as the records created when a process
control measure was applied. The food
safety records may also include supplier
records that show that the supplier’s
supplier has controlled a hazard. Such
records may include audits, for
example, when the supplier’s supplier
controls the hazard and the supplier’s
records include records of an audit
conducted with respect to the hazard
control activities of the supplier’s
supplier. To emphasize that the review
of a supplier’s relevant food safety
records can include records other than
records of audits, we have revised the
documentation requirements applicable
to review of a supplier’s food safety
records to specify that the
documentation must include the general
nature of the records reviewed (see
§ 507.175(c)(9)). By ‘‘general nature of
the records reviewed’’, we mean
information such as ‘‘records of process
controls.’’
(Comment 444) Some comments
support the inclusion of other
appropriate supplier verification
activities based on the risks associated
with the ingredient and the supplier,
because it provides flexibility for
facilities to design risk-based programs
that are appropriate for their operations.
Comments suggest other verification
activities may include receiving raw
materials and other ingredients from a
supplier without a full audit report if
the supplier maintains certification to a
standard recognized by the Global Food
Safety Initiative (GFSI); providing for
documentary verification (such as factspecific questionnaires and
representations exchanged between the
supplier and the receiving facility); and
confirming that a facility, especially a
small manufacturing facility, is licensed
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by the appropriate State or local
regulatory authority.
(Response 444) We are retaining this
provision to allow other appropriate
supplier verification activities based on
supplier performance and the risk
associated with the raw material or
other ingredient (§ 507.110(b)(4)). We
have revised the regulatory text to refer
to ‘‘supplier performance and the risk
associated with the raw material or
other ingredient’’ because ‘‘supplier
performance’’ is more appropriate than
‘‘risk associated with the supplier.’’ We
use the term ‘‘risk’’ as defined by the
Codex Alimentarius Commission to be
‘‘a function of the probability of an
adverse health effect and the severity of
that effect, consequential to a hazard(s)
in food’’ (Ref. 54). As discussed in
section XLII.D, the considerations for
supplier performance, which can be
related to the probability of a hazard in
the raw material or ingredient and the
severity of adverse health effects that
can result, are broader than this.
We do not believe that a supplier
maintaining certification to an industry
standard would, by itself, serve as
verification that a supplier is controlling
the hazard; however we agree that this
can be a consideration in the
determination of the type and frequency
of the verification activity conducted.
Similarly, fact-specific questionnaires
and representations exchanged between
the supplier and the receiving facility
can be a consideration in the
determination of the type and frequency
of the verification activity conducted.
Confirming that a facility is licensed by
the appropriate State or local regulatory
authority should not serve as the only
verification that a supplier is controlling
the hazard, because the requirements for
a license and the degree of inspectional
oversight could vary greatly. We do
provide for modified supplier
verification activities for qualified
facilities, which are very small
businesses (§ 507.130(c)).
C. Purpose of Supplier Verification
Activities for Raw Materials and Other
Ingredients (Final § 507.110(c))
We proposed to require that a
supplier program include verification
activities, as appropriate to the hazard,
and documentation of these activities, to
verify that: (1) The hazard is
significantly minimized or prevented;
(2) the incoming raw material or
ingredient is not adulterated under
section 402 of the FD&C Act of the
FD&C Act; and (3) the incoming raw
material or ingredient is produced in
compliance with the requirements of
applicable FDA food safety regulations
(proposed § 507.37(a)(3)(ii)). We have
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revised the provision to specify that the
supply-chain program must provide
assurance that a hazard requiring a
supply-chain-applied control has been
significantly minimized or prevented. If
the supply-chain program provides
assurance that a hazard requiring a
supply-chain-applied control has been
significantly minimized or prevented, it
is not necessary to also specify that the
incoming raw material or ingredient is
not adulterated under section 402 of the
FD&C Act. We also have deleted the
requirement that the verification
activities must verify that the incoming
raw material or ingredient is produced
in compliance with the requirements of
applicable FDA food safety regulations
and instead focused that requirement as
a factor that must be considered in
approving suppliers and determining
the appropriate supplier verification
activities and the frequency with which
they are conducted rather than as one of
the stated purposes of the supply-chain
program. See the regulatory text of
§ 507.110(d)(i)(iii)(B).
(Comment 445) Some comments ask
us to revise this provision to state that
the receiving facility’s use of the
incoming raw material or ingredient
will not cause the finished food to be
adulterated under section 402 of the
FD&C Act. These comments assert that
FSMA does not mandate, nor is it
reasonable to expect, that incoming raw
materials and ingredients will not be
adulterated under section 402, and that
it is acceptable for a receiving facility to
control the ‘‘adulterating hazard,’’ even
if it relies on the supplier to control
other hazards.
(Response 445) We decline this
request. We acknowledge that in some
circumstances a receiving facility may
rely on the supplier to control certain
hazards, while controlling other hazards
itself. For example, a receiving facility
that produces dry dog food that contains
corn could rely on its supplier for the
control of the chemical hazard aflatoxin,
but control the biological hazard
Salmonella through its own heattreatment process. However, the supplychain program applies to hazards
requiring a supply-chain-applied
control, and the purpose relates to those
hazards. In the example where the
receiving facility is relying on the
supplier to control aflatoxin, the
provision would require the receiving
facility to verify that the hazard
(aflatoxin) has been significantly
minimized or prevented by the supplier
and that the level of aflatoxin in the
corn does not render it adulterated
under the FD&C Act.
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D. Factors That Must Be Considered
When Approving Suppliers and
Determining Appropriate Supplier
Verification Activities for Raw Materials
and Other Ingredients (Final
§ 507.110(d))
We proposed that in determining and
documenting the appropriate
verification activities, the receiving
facility must consider the following: (1)
The hazard analysis, including the
nature of the hazard, applicable to the
raw material and ingredients; (2) where
the preventive controls for those
hazards are applied for the raw material
and ingredients, such as at the supplier
or the supplier’s supplier; (3) the
supplier’s procedures, processes, and
practices related to the safety of the raw
material and ingredients; (4) applicable
FDA food safety regulations and
information relevant to the supplier’s
compliance with those regulations,
including an FDA warning letter or
import alert relating to the safety of the
animal food; (5) the supplier’s food
safety performance history relevant to
the raw materials or ingredients that the
receiving facility receives from the
supplier, including available
information about results from testing
raw materials or ingredients for hazards,
audit results relating to the safety of the
food, and responsiveness of the supplier
in correcting problems; and (6) any
other factors as appropriate and
necessary, such as storage and
transportation practices (proposed
§ 507.37(b)).
As discussed in Responses 429 and
430 and section XLIV.A, we have
revised the regulatory text regarding use
of approved suppliers to more explicitly
state that the receiving facility must
approve suppliers. The factors that must
be considered in determining the
appropriate supplier verification
activities are equally relevant to
approving suppliers, and the final rule
requires that these factors must be
considered in approving suppliers, as
well as in determining appropriate
supplier verification activities. For
clarity and consistency with terms used
throughout the final provisions for a
supply-chain program, the final rule
specifies ‘‘the entity or entities that will
be applying controls for the hazards
requiring a supply-chain-applied
control’’ rather than ‘‘Where the
preventive controls for those hazards are
applied for the raw material and
ingredients—such as at the supplier or
the supplier’s supplier.’’
As discussed in Response 444, we are
using the term ‘‘supplier performance,’’
rather than ‘‘risk of supplier,’’ when
discussing factors associated with
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suppliers. The final rule groups three of
the proposed factors as ‘‘supplier
performance.’’ As a companion change
to emphasize that ‘‘supplier
performance’’ applies to all three of
these factors, we refer to the supplier’s
‘‘food safety history’’ rather than ‘‘food
safety performance history.’’
We also have revised the regulatory
text to clarify that consideration of
supplier performance includes, when
applicable, relevant laws and
regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States and information
relevant to the supplier’s compliance
with those laws and regulations. We
made this change because the final rule
includes several provisions that
acknowledge that some animal food
establishments, including animal food
establishments that are ‘‘suppliers’’ as
that term is defined in this rule, operate
in a foreign country. (See, e.g., the
definition of ‘‘qualified auditor’’ in
§ 507.3 and §§ 507.7(a)(2)(ii), 507.7(e),
507.105(a)(2), 507.130(c),
507.135(c)(1)(ii), 507.135(c)(2), and
507.175(c)(15)). Some of these
provisions (e.g., §§ 507.105(a)(2),
507.130(c), 507.135(c)(1)(ii),
507.135(c)(2), and 507.175(c)(15)) are in
the requirements for a supply-chain
program. When the supplier is in a
foreign country whose food safety
system FDA has officially recognized as
comparable or determined to be
equivalent to that of the United States,
a receiving facility may substitute the
written results of an inspection by the
applicable food safety authority for an
audit, provided that certain conditions
are met (see § 507.135(c)(1)(ii) and (2)).
However, as of August 30, 2015, FDA
has not developed a systems recognition
program for animal food; therefore, we
have no signed systems recognition
agreements with any foreign food safety
authority relating to animal food. The
currently existing systems recognition
agreement relates solely to human food
and does not apply to animal food. The
final rule provides flexibility for
alternative verification requirements for
certain entities (see § 507.130(c), (d),
and (e)). We have revised the factors
that must be considered regarding
supplier performance to reflect the
flexibility the rule provides for
conducting supplier verification
activities for these entities (see
§ 507.110(d)(2)).
(Comment 446) Some comments
support the flexibility for receiving
facilities to determine the appropriate
supplier verification activities and
frequency with which to conduct these
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activities. Some comments state that not
all of the factors that we proposed a
receiving facility consider are relevant
for the process of selecting the
verification activity. These comments
suggest changing the regulatory text to
require a receiving facility to consider
‘‘both food and supplier related risks,
including the following, as appropriate’’
and then listing the factors as proposed.
Other comments suggested similar
changes to the regulatory text.
(Response 446) We disagree that not
all of the factors that we proposed a
receiving facility to consider are
relevant to determining the appropriate
verification activity. Every factor might
not be determinative in all cases, and
our requirement merely to consider each
factor does not assume so. However, any
one of these factors could be crucial
depending on the animal food, the
hazard, and the nature of the preventive
control. We continue to consider it
appropriate to require receiving
facilities to consider each of these
factors in making their determinations
about the appropriate verification
activities.
(Comment 447) Some comments ask
us to clarify that the phrase ‘‘the nature
of the hazard’’ means the nature of the
hazard requiring control.
(Response 447) We have revised the
regulatory text to specify ‘‘the nature of
the hazard controlled before receipt of
the raw material or other ingredient.’’
The revised regulatory text is consistent
with regulatory text in the provisions for
the preventive control management
components (see § 507.39(b), which
specifies ‘‘taking into account the nature
of the hazard controlled before receipt
of the raw material or other
ingredient’’).
(Comment 448) Some comments agree
that a receiving facility must consider
where the preventive controls for
hazards are applied for the raw
materials and ingredients, such as at the
supplier or the supplier’s supplier.
Other comments assert that this
consideration should not be used to
determine if supplier oversight is
needed. Other comments state that it
may be hard to review the procedures
used by a supplier’s supplier and
beyond and ask us to provide clear
flexibility regarding requirements for
the content and performance of a
receiving facility’s supplier program.
(Response 448) The purpose of the
requirement to consider where the
hazard is controlled is to assist a
receiving facility in determining what
supplier verification activities are
appropriate, not to determine whether
supplier oversight is needed. Once a
receiving facility has determined that a
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hazard requiring a preventive control is
controlled before receipt of a raw
material or other ingredient, supplier
oversight is needed.
We recognize that there is need for
additional flexibility regarding
conducting supplier verification
activities. As discussed in Response
429, we are providing significant
additional flexibility to address this
situation in the final rule.
(Comment 449) Some comments
object to the proposed requirement to
consider applicable FDA food safety
regulations and information relevant to
the supplier’s compliance with those
regulations, including an FDA warning
letter or import alert relating to the
safety of the food. These comments
assert that it is difficult for a receiving
facility to know a supplier’s compliance
status, because it is not easy to obtain
this kind of information in a timely
fashion. Some comments ask us to
develop an online database to house this
information to help make it easier to
find. Some comments ask us to replace
the broad requirement to consider
applicable FDA food safety regulations
and information relevant to the
supplier’s compliance with those
regulations with a narrower requirement
to only consider any FDA warning letter
or import alert relating to the safety of
the food.
(Response 449) We are retaining the
broad requirement to consider
applicable FDA food safety regulations
and information relevant to the
supplier’s compliance with those
regulations. Such information is
relevant to supplier performance
regardless of whether there is an
applicable warning letter or import
alert.
We currently have a searchable online
database for warning letters (Ref. 55)
and another searchable online database
for import alerts (Ref. 56). Both of these
databases are available to the public
from our homepage at https://
www.fda.gov. We also publicize actions
to suspend a facility’s registration, such
as in our 2012 suspension of registration
due to Salmonella contamination of nut
butter and nut products (including
ingredients used in animal foods)
manufactured, processed, packed, and
held by the facility (Ref. 57). Under the
requirement to consider supplier
performance with respect to applicable
food safety regulations, a receiving
facility cannot ignore published
information relating to a supplier’s
compliance with applicable FDA food
safety regulations in determining the
appropriate verification activities, such
as publicized information regarding
suspension of registration. To
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emphasize this point, we have revised
the regulatory text to specify that the
applicable information includes ‘‘other
FDA compliance actions related to
animal food safety.’’ We also have
revised the regulatory text to specify
that the compliance relates to an FDA
warning letter or import alert relating to
the ‘‘safety of animal food,’’ rather than
the ‘‘safety of the animal food,’’ to
provide flexibility for a receiving facility
to identify information that may raise a
question about a supplier’s compliance
history in a more general way, rather
than only with respect to a particular
animal food.
(Comment 450) Some comments state
we should only require consideration of
the supplier’s food safety performance
history relevant to the hazards requiring
control in the raw materials or
ingredients that the receiving facility
receives from the supplier.
(Response 450) Consideration of the
supplier’s animal food safety history
relevant to the raw materials or other
ingredients that the receiving facility
receives from the supplier will be
focused on the hazard that the supplier
is controlling because that is the food
safety information the receiving facility
will consider to be relevant and for
which the receiving facility would
develop a history. The information
could indicate that certain verification
activities may be more appropriate than
others for verifying the control of the
hazard at that particular supplier or
provide information useful in
determining a frequency for the
verification activity. However, we
decline to revise the provision to specify
that consideration should be limited to
the hazards requiring control. Even
though this is the most relevant
information, a facility may become
aware of information with respect to a
raw material or other ingredient
provided to another customer of the
supplier that may suggest the need to
conduct a different verification activity.
For example, if the receiving facility is
obtaining mineral premix from a
supplier that is controlling for a nutrient
imbalance of copper and molybdenum
and becomes aware that mineral
premixes from this supplier have been
associated with a recall due to
contamination with a physical hazard,
the receiving facility would determine
that it should implement verification
activities related to controlling for
physical hazards.
(Comment 451) Some comments ask
us to replace the phrase ‘‘examples of
factors that a receiving facility may
determine are appropriate and necessary
are storage and transportation’’ with
‘‘such as storage and transportation.’’
(Response 451) We have made this
editorial change.
E. Supplier Non-Conformance (Final
§ 507.110(e))
We proposed that if the owner,
operator, or agent in charge of a
receiving facility determines through
auditing, verification testing, relevant
consumer, customer or other
complaints, or otherwise that the
supplier is not controlling hazards that
the receiving facility has identified as
significant, the receiving facility must
take and document prompt action in
accordance with § 507.42 to ensure that
raw materials or ingredients from the
supplier do not cause food that is
manufactured or processed by the
receiving facility to be adulterated
under section 402 of the FD&C Act
(proposed § 507.37(f)).
(Comment 452) Some comments
object to the use of the word
‘‘significant’’ in this proposed provision,
recommending that we replace it with
‘‘requiring control by the supplier.’’
These comments reason that these
activities are only necessary if the
receiving facility is relying on the
supplier to control the specific hazards.
(Response 452) We have revised the
regulatory text to state ‘‘a hazard
requiring a supply-chain-applied
control’’ rather than ‘‘significant.’’
XLIII. Subpart E: New Requirement
Specifying the Responsibilities of the
Receiving Facility (Final § 507.115)
As discussed in Response 429, after
considering comments we are providing
flexibility for an entity other than the
receiving facility to determine, conduct,
and document the appropriate supplier
verification activities, provided that the
receiving facility reviews and assesses
the entity’s applicable documentation,
and documents the receiving facility’s
review and assessment. We are
specifying that flexibility in § 507.115.
We have titled this section
56303
‘‘Responsibilities of the receiving
facility’’ to emphasize the responsibility
of the receiving facility for its supplychain program. (See Responses 429 and
430.) Although comments focus on
flexibility for an entity in the supply
chain between the supplier and the
receiving facility to perform supplier
verification activities, and such entities
are the most likely entities to be the
entities determining, conducting, and
documenting supplier verification
activities, the flexibility provided by the
rule is not limited to such entities.
The rule does, however, set some
bounds on the flexibility for
determining, conducting, and
documenting appropriate supplier
verification activities. For example, as
discussed in Responses 429 and 430,
only the receiving facility can approve
its suppliers. As another example,
although it would not be appropriate for
a supplier to determine the appropriate
supplier verification activities for itself,
we had proposed that it would be
appropriate for a supplier to conduct
sampling and testing of raw materials
and ingredients as a supplier
verification activity (proposed
§ 507.37(c)(1)(ii)), and we are retaining
that provision in the final rule (see
§ 507.115(a)(4)). Likewise, it is common
industry practice for a supplier to
arrange for an audit by a third party
(Ref. 53), and the new flexibility
provision does not prohibit a receiving
facility from relying on an audit
provided by its supplier when the audit
of the supplier was conducted by a
third-party qualified auditor in
accordance with the requirements of the
rule applicable to audits (§ 507.135). See
§ 507.115 for the full text of this new
flexibility provision.
XLIV. Subpart E: Comments on Using
Approved Suppliers and Determining
Appropriate Supplier Verification
Activities
We proposed requirements for the use
of approved suppliers (proposed
§ 507.37(a)(3)(i)) and for determining
and documenting appropriate supplier
verification activities (proposed
§ 507.37(b)). See table 26 for a
description of the final provisions and
the changes we have made to clarify the
requirements.
TABLE 26—REVISIONS TO THE PROPOSED REQUIREMENTS FOR APPROVING SUPPLIERS AND FOR DETERMINING AND
DOCUMENTING APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES
Final section
designation
Proposed section
designation
Description
507.120(a) ...................
507.37(a)(3)(i) ............
The receiving facility must approve suppliers
and document that approval.
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Revision
Explicit statement of this requirement.
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TABLE 26—REVISIONS TO THE PROPOSED REQUIREMENTS FOR APPROVING SUPPLIERS AND FOR DETERMINING AND
DOCUMENTING APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES—Continued
Proposed section
designation
Description
507.120(b)(1) ...............
507.37(a)(3)(i) ............
507.120(b)(2) ...............
.....................................
507.120(b)(3) ...............
507.37(a)(3)(i) ............
507.125 ........................
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Final section
designation
507.37(b) ....................
Written procedures for receiving raw materials and other ingredients must be established and followed.
The purpose of the written procedures is to
ensure that raw materials and other ingredients are received only from approved
suppliers (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or
other ingredients the receiving facility subjects to adequate verification activities before acceptance for use).
Use of the written procedures for receiving
raw materials and other ingredients must
be documented.
Requirement to determine and document appropriate supplier verification activities.
A. Using Approved Suppliers (Final
§§ 507.120)
We proposed to require that a
supplier program include verification
activities, as appropriate to the hazard,
and documentation of these activities, to
ensure raw materials and ingredients are
received only from suppliers approved
for control of the hazard(s) in that raw
material or ingredient (or, when
necessary and appropriate, on a
temporary basis from unapproved
suppliers whose raw materials or
ingredients the receiving facility
subjects to adequate verification
activities before acceptance for use)
(proposed § 507.37(a)(i)).
This proposed requirement included
an implicit requirement that a facility
must approve suppliers. For clarity, we
make that requirement, and
documentation of that approval, explicit
in the final rule. (See § 507.120(a)).
The rule continues to require that a
receiving facility ensure raw materials
and other ingredients are received only
from suppliers approved for control of
the hazard(s) in that raw material or
other ingredient (or, when necessary
and appropriate, on a temporary basis
from unapproved suppliers whose raw
materials or other ingredients are
subject to adequate verification
activities before acceptance for use), but
we revised the provision to specify that
the receiving facility must do so by
establishing and following written
procedures, and require documentation
that these procedures were followed. To
simplify the provisions, we also
established a definition for the term
‘‘written procedures for receiving raw
materials and other ingredients’’ to
mean written procedures to ensure that
raw materials and other ingredients are
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Revision
received only from suppliers approved
by the receiving facility (or, when
necessary and appropriate, on a
temporary basis from unapproved
suppliers whose raw materials or other
ingredients are subjected to adequate
verification activities before acceptance
for use), and use that term throughout
subpart E. For example, a facility could
design a checklist for employees to use
when raw materials and other
ingredients are delivered to the facility.
We decided to specify use of written
procedures for receiving raw materials
and other ingredients in light of the
flexibility the final rule provides for an
entity other than the receiving facility
(such as an entity in the supply chain
between the supplier) to conduct this
activity (see § 507.115(a)(2)). Although
we agree that such an entity can do this
as a service to the receiving facility, a
written procedure is appropriate to
ensure a robust and meaningful
verification. As a companion change, we
revised the associated documentation
requirement to specify documentation
of use of the written procedures.
(Comment 453) Some comments
support the requirement to approve
suppliers. Other comments ask us to
provide guidance for use of unapproved
suppliers on a temporary basis, because
the use of unapproved suppliers could
be a high risk situation. Other comments
emphasize that if the final supplier
approval process is significantly
changed compared to the proposed
supplier approval process, industry
must have enough time to plan and
develop supplier verification plans and
a process for unapproved sources.
(Response 453) We will consider
including guidance for use of
unapproved suppliers on a temporary
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Explicit requirement for written procedures.
N/A.
Conforming change associated with the explicit requirement to establish and follow
written procedures.
N/A.
basis in guidance that we intend to issue
regarding the supply-chain program. We
do not believe that the final
requirements regarding the use of
approved suppliers will require
increased implementation time. The
principal change is to allow flexibility
for entities in the supply chain other
than the receiving facility to establish
written procedures for receiving raw
materials and other ingredients and
document that written procedures for
receiving raw materials and other
ingredients are being followed.
B. Determining Appropriate Verification
Activities (Final § 507.125)
The rule requires that a supply-chain
program include determining
appropriate supplier verification
activities (including determining the
frequency of conducting the activity)
(see § 507.110(a)(2)). Comments that
addressed the proposed provision for
determining appropriate verification
activities (which provides flexibility to
the facility to determine the appropriate
verification activities) did not disagree
with it. The rule also requires that
certain factors must be considered in
determining appropriate verification
activities (§ 507.110(d)). We discuss
those factors, and comments that
addressed those factors, in section
XLII.D. Both of these provisions (i.e.,
§ 507.110(a)(2) and § 507.110(d)) derive
from the proposed requirement
regarding factors that must be
considered in determining appropriate
supplier verification activities
(proposed § 507.37(b)). To give
prominence to both the responsibility
and the flexibility to determine
appropriate supplier verification
activities, and emphasize the factors
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that must be considered in addressing
this responsibility, new § 507.125
specifies that appropriate supplier
verification activities (including the
frequency of conducting the activity)
must be determined in accordance with
the requirements of § 507.110(d).
XLV. Subpart E: Comments on
Conducting Supplier Verification
Activities for Raw Materials and Other
Ingredients
We proposed requirements applicable
to conducting supplier verification
activities (proposed § 507.37(c)). Most
comments that support the proposed
provisions suggest alternative or
56305
additional regulatory text or ask us to
clarify how we will interpret the
provision. In the following sections, we
discuss comments that ask us to clarify
the proposed requirements or that
disagree with, or suggest one or more
changes to, the proposed requirements.
After considering these comments, we
have revised the proposed requirements
as shown in table 27.
TABLE 27—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR
RAW MATERIALS AND OTHER INGREDIENTS
Proposed section
designation
Description
Revision
507.130(a) ...................
507.37(c)(1) ................
Requirement to conduct one or more appropriate supplier verification activities.
507.130(b)(1) ...............
507.37(c)(2)(i) .............
507.37(c)(2)(ii) ............
507.130(c) ...................
507.37(c)(3) ................
Requirement to conduct an onsite audit as
the supplier verification activity when the
hazard being controlled by the supplier is
one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.
Exception to the requirement to conduct an
annual onsite audit with a written determination.
Alternative supplier verification activity when
the supplier is a qualified facility.
Add reference to an additional provision that
provides for alternative supplier verification
activities for shell egg producers that have
less than 3,000 laying hens.
N/A.
507.130(b)(2) ...............
507.130(d) ...................
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Final section
designation
507.37(c)(4) ................
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Alternative supplier verification activity when
the supplier is a farm that is not a ‘‘covered
farm’’ under part 112 in accordance with
§ 112.4(a)
or
in
accordance
with
§§ 112.4(b) and 112.5.
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N/A.
• Modify the regulatory text to better align
with the responsibilities of a qualified facility to submit an attestation to FDA about its
food safety practices or its compliance with
State, local, county, tribal, or other applicable non-Federal food safety law, including
relevant laws and regulations of foreign
countries.
• Clarify that the date for a receiving facility
to obtain written assurance that a supplier
is a qualified facility is before first approving the supplier for an applicable calendar
year, and on an annual basis thereafter, by
December 31 of each calendar year for the
following calendar year.
• Provide for written assurance that, when
applicable, the supplier is producing the
raw material or other ingredient in compliance with relevant laws and regulations of
a country whose food safety system FDA
has officially recognized as comparable or
has determined to be equivalent to that of
the United States.
• Clarify that the applicable farms are ‘‘not
covered farms’’ rather than ‘‘not subject to
part 112’’ because some of these farms
are subject to modified requirements in
§ 112.6.
• Clarify that the date for a receiving facility
to obtain written assurance from the farm
about its status is before first approving the
supplier for an applicable calendar year,
and on an annual basis thereafter, by December 31 of each calendar year for the
following calendar year.
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TABLE 27—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR
RAW MATERIALS AND OTHER INGREDIENTS—Continued
Final section
designation
507.130(e) ...................
Proposed section
designation
N/A .............................
A. Requirement To Conduct One or
More Supplier Verification Activities
(Final § 507.130(a))
With two exceptions, we proposed
that the receiving facility must conduct
and document one or more specified
supplier verification activities for each
supplier before using the raw material
or ingredient and periodically thereafter
(proposed § 507.37(c)(1)). See section
XLII.B for a discussion of comments
regarding the appropriate verification
activities (i.e., onsite audits, sampling
and testing, records review, and other
appropriate supplier verification
activities based on supplier performance
and the risk associated with the raw
material or other ingredient). See
sections XLV.C and XLV.D for a
discussion of the proposed exceptions
to this requirement to conduct and
document verification activities. As
discussed in section XLV.E, the final
rule provides for an additional
circumstance in which an alternative
supplier verification activity may be
conducted, i.e., when the supplier is a
shell egg producer that has fewer than
3,000 laying hens.
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B. Requirement for an Onsite Audit as
a Verification Activity When a Hazard
Has a Reasonable Probability of
Resulting in Serious Adverse Health
Consequences or Death to Humans or
Animals (Final § 507.130(b))
We proposed that when a hazard in a
raw material or ingredient will be
controlled by the supplier and is one for
which there is a reasonable probability
that exposure to the hazard will result
in serious adverse health consequences
or death to humans or animals, the
receiving facility must have
documentation of an onsite audit of the
supplier before using the raw material
or ingredient from the supplier and at
least annually thereafter. We also
proposed that this requirement does not
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Description
Revision
Alternative supplier verification activity when
the supplier is a shell egg producer that
has fewer than 3,000 laying hens.
• Clarify that the written assurance from the
farm is an acknowledgement that its food is
subject to section 402 of the Federal Food,
Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws
and regulations of a country whose food
safety system FDA has officially recognized
as comparable or has determined to be
equivalent to that of the United States).
Specify an additional situation where the receiving facility can consider an alternative
supplier verification activity.
apply if the receiving facility documents
its determination that other verification
activities and/or less frequent onsite
auditing of the supplier provide
adequate assurance that the hazards are
controlled. (Proposed § 507.37(c)(2)).
(Comment 454) Some comments
support the provision for audits when
there is a reasonable probability that
exposure to the hazard will result in
serious adverse health consequences or
death to humans or animals. Some of
these comments state that audits should
be the default verification activity in
order to eliminate facilities choosing the
lowest cost option regardless of whether
it was best for food safety. Other
comments state that audits would be the
best option for facilities that cannot visit
each supplier annually and that onsite
inspection can identify problems in
ways that paperwork reviews cannot.
However, other comments oppose this
requirement. Some of these comments
state that facilities should have
flexibility in choosing verification
activities, regardless of whether or not
the hazards could result in serious
adverse health consequences or death to
humans or animals and express concern
that this requirement does not allow the
necessary flexibility for a facility to
tailor an effective supplier program
based upon risk. Other comments
express concern that the provision sets
a precedent that annual audits are the
preferred or most effective verification
measure and that other verification
activities often can help paint a more
accurate picture of a supplier over time.
Other comments express concern that
audits only give a ‘‘snapshot’’ of a
supplier’s performance at a given time
and ask that we not overemphasize
audits.
(Response 454) We are retaining this
provision as proposed. As we indicated
in the Appendix of our 2013 proposed
preventive controls rule, an increasing
number of establishments are requiring,
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as a condition of doing business, that
their suppliers become certified to food
safety management schemes that
involve third-party audits (78 FR 64736
at 64836 through 64837). We agree that
onsite audits can identify problems in
ways that paperwork reviews cannot.
Because an audit involves more than
simply observing the facility producing
an animal food product, we believe it is
more than just a ‘‘snapshot’’ of the
supplier’s programs. As discussed in
Response 440, onsite audits can include
observations, records review and
employee interviews.
The requirement to conduct an annual
audit in specified circumstances is riskbased because the specified
circumstances are limited to situations
where there is a reasonable probability
that exposure to the hazard in the raw
material or other ingredient will result
in serious adverse health consequences
or death to humans or animals. The food
safety controls applied by suppliers of
such raw materials or other ingredients
are more important than for other types
of hazards because of the serious
adverse health consequences that can
occur if the hazards are not controlled.
Annual audits are required of
certification schemes that are
benchmarked to the Global Food Safety
Initiative Guidance Document for GFSI
recognition (Ref. 58). We disagree that
this requirement does not provide
flexibility in choosing verification
activities; in recognition that other
verification activities can help paint a
more accurate picture of a supplier over
time, we have provided for alternative
verification activities or audit
frequencies if the receiving facility
documents its determination that other
verification activities and/or less
frequent onsite auditing of the supplier
provide adequate assurance that the
hazards are controlled (see
§ 507.130(b)(2)).
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(Comment 455) Some comments ask
us to define those products that may
trigger the requirement for an audit,
especially with respect to farms. These
comments question how to assess
whether a hazard could result in serious
adverse health consequences or death to
humans or animals.
(Response 455) We decline this
request. Any list of such products
would be extensive and it is unlikely we
could capture all the circumstances in
which this could apply. Hazards for
which there is a reasonable probability
that exposure to the hazard will result
in serious adverse health consequences
or death are those for which a recall of
a violative product posing such a hazard
is designated as ‘‘Class 1’’ under 21 CFR
7.3(m)(1). Examples of such hazards
that, in some circumstances, have
resulted in serious adverse health
consequences or death to humans or
animals include pathogens or their
toxins in animal food. Animal food
containing a hazard for which there is
a reasonable probability that exposure to
the hazard will result in serious adverse
health consequences or death to humans
or animals are considered reportable
foods; examples of foods FDA has
considered to present a reasonable
probability of serious adverse health
consequences or death can be found in
our Guidance for Industry: Questions
and Answers Regarding the Reportable
Food Registry as Established by the
Food and Drug Administration
Amendments Act of 2007 (Refs. 19 and
20).
(Comment 456) Some comments ask
us to clarify the role of third-party
audits and the Good Agricultural
Practice (GAP) program and ask us to
allow GAPs to be a voluntary
mechanism to satisfy buyer demands for
food safety certification.
(Response 456) Although the rule
would not require a receiving facility to
hire a third party to conduct an audit,
onsite audits can include third-party
audits. There are likely to be benefits for
suppliers having a third-party audit,
because the same audit may be
acceptable to multiple receiving
facilities as an appropriate supplier
verification activity. For farms, GAPs
audits may be viewed as an appropriate
supplier verification activity. GAPs
audits and other third-party audits
would need to comply with the
requirements of this rule applicable to
onsite audits (see § 507.135).
(Comment 457) Some comments
assert that we should delete this
provision entirely, stating that this
requirement for an audit is ‘‘outside the
scope of FSMA.’’
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(Response 457) We disagree that a
requirement for an audit is ‘‘outside the
scope of FSMA.’’ See the discussion in
Response 440 regarding the provision in
section 419(c)(1)(E) of the FD&C Act that
the regulation issuing standards for the
safety of produce ‘‘not require a
business to hire a consultant or other
third party to identify, implement,
certify compliance with the procedures,
processes and practices’’ and the
provision in section 418(n)(3)(D) of the
FD&C Act that the preventive controls
regulation ‘‘not require a facility to hire
a consultant or other third party to
identify, implement, certify or audit
preventive controls.’’ As noted in that
response, a facility is not required to
hire a third party to conduct an audit.
(Comment 458) Some comments
support the flexibility to not conduct an
annual onsite audit if the receiving
facility documents its determination
that other verification activities and/or
less frequent onsite auditing of the
supplier provide adequate assurance
that the hazards are controlled. Other
comments question how a facility
would prove that alternative measures
are equally effective as an annual audit,
when it is not known how effective an
annual audit is. Other comments assert
that the provision is meaningless
because a farm or facility would not take
the legal risk of verifying it has received
‘‘adequate assurance,’’ because this
would be subject to an FDA inspector’s
interpretation.
(Response 458) This provision
requires a facility to use a verification
activity that provides adequate
assurance that a hazard is controlled,
not to determine how effective an audit
is and assess whether alternative
measures are equally effective.
As an example of using an alternative
approach to an annual onsite audit,
consider the situation in which a
receiving facility is part of a large
corporation, is making a pet food, and
obtains meat and bone meal from a
supplier that is a subsidiary of the
corporation and is operating under the
same food safety system as the receiving
facility. The receiving facility could
determine that the food safety
requirements established by the parent
company and applied at the subsidiary
provide the needed assurance that
Salmonella in meat and bone meal is
adequately controlled. The facility
could support its decision by
documenting this determination,
including the procedures in effect at the
supplier and the activities used by the
corporation to verify that the subsidiary
operates in accordance with corporate
food safety policies and practices to
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56307
ensure that hazards are adequately
controlled.
We disagree that the provision is
meaningless because a farm or facility
would see a legal risk in using an
alternative to annual onsite audits as a
supplier verification activity. First, a
farm would be a supplier and would not
be the entity that would determine
whether an onsite audit or some other
supplier verification activity is
appropriate. As established in § 507.115,
determining the appropriate supplier
verification activity would be the
responsibility of a receiving facility, and
although appropriate supplier
verification activities could be
determined by another entity in the
receiving facility’s supply chain as a
service, the supplier verification
activities could not be determined by
the supplier itself. Second, although
there is always a potential for
differences in interpretation between an
FDA inspector and an inspected firm,
we are establishing a new inspection
paradigm focused on whether firms are
implementing systems that effectively
prevent food contamination, requiring
fundamentally different approaches to
food safety inspection and compliance.
For example, FDA intends to deploy
specialized investigators, backed up by
technical experts, to assess the
soundness and performance of a
facility’s food safety system (Ref. 10). In
addition, a central element of FDA’s
strategy to gain industry compliance is
to help make available to farmers, food
processors, and importers, especially
small businesses, the education and
technical assistance they need to
understand and implement FSMA’s new
prevention-oriented standards (Ref. 5).
The new inspection paradigm and the
assistance and training for industry
should help minimize different
interpretations between industry and
regulators.
(Comment 459) Some comments ask
us to require facilities to notify us when
they determine that an alternative to an
audit is an appropriate supplier
verification activity and be able to
justify and document how an alternative
verification activity provides the same
level of assurance as an onsite audit.
(Response 459) We decline this
request. We will assess a facility’s
supplier verification activities during a
facility inspection, including the
documentation that an alternative
verification activity provides the same
level of assurance as an onsite audit.
(Comment 460) Some comments ask
us to specify the type of documentation
required for our investigators to
determine when the activities are ‘‘in
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compliance with the law and sufficient
to protect public health.’’
(Response 460) We decline this
request. The facility’s approach to the
determination, and the applicable
documentation required to support that
determination, would depend on the
circumstances. For example, in
Response 458, we discuss a possible
approach in a situation in which a
receiving facility is part of a corporation
and obtains an ingredient from a
supplier that is a subsidiary of the
corporation and is operating under the
same food safety system as the receiving
facility. Another situation could be
when a receiving facility has many years
of experience with the same supplier,
but the approach and documentation in
that situation likely would be different
from an approach and documentation
used when the supplier and the
receiving facility are part of the same
corporation.
(Comment 461) Some comments ask
that we not limit the determination for
a supplier verification activity other
than an onsite audit to a determination
by the receiving facility. These
comments explain that the corporate
parent of a facility can be the entity that
makes this determination. These
comments suggest that we can account
for the role of the corporation by
specifying that a facility documents ‘‘the
determination’’ (rather than ‘‘its’’
determination).
(Response 461) We have agreed that
the corporate parent of a facility can be
active in developing and implementing
the facility’s food safety plan (see
section XXIV.A). However, the specific
suggestion of these comments is not
necessary to achieve the outcome
requested by the comments because of
editorial changes we made to provide
for entities other than the receiving
facility to determine and conduct the
appropriate supplier verification
activities.
C. Alternative Verification Activity
When the Supplier Is a Qualified
Facility (Final § 507.130(c))
We proposed that if a supplier is a
qualified facility the receiving facility
need not comply with the specified
verification requirements if the
receiving facility: (1) Documents, at the
end of each calendar year, that the
supplier is a qualified facility and (2)
obtains written assurance, at least every
2 years, that the supplier is producing
the raw material or ingredient in
compliance with applicable FDA food
safety regulations and that the raw
material or ingredient is not adulterated
under section 402 of the FD&C Act. The
written assurance must include a brief
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description of the processes and
procedures that the supplier is
following to ensure the safety of the
animal food.
This rule has several provisions that
require written assurances. We have
established specific elements that each
of these written assurances must
include, i.e., the effective date; printed
names and signatures of authorized
officials; and the applicable assurance
(see § 507.215).
We have revised the provision to
clarify that the receiving facility must
have written assurance that a facility is
a qualified facility: (1) Before first
approving the supplier for an applicable
calendar year and (2) by December 31 of
each calendar year (rather than ‘‘at the
end of the calendar year’’) and that the
written assurance is regarding the status
of the qualified facility for the following
calendar year. By specifying ‘‘by
December 31,’’ a receiving facility can
work with each applicable supplier to
determine the specific date within a
calendar year for that supplier to
annually notify the receiving facility
about its status. See also Responses 76,
139, 140, the requirements in § 507.7(a)
for an annual determination of the
status of a facility as a qualified facility,
and the requirements in § 507.7(d) that
apply when the status of a facility
changes from ‘‘qualified facility’’ to ‘‘not
a qualified facility.’’ A receiving facility
and its suppliers have flexibility to
approach the potential for the status of
a facility to shift between ‘‘qualified
facility’’ and ‘‘not a qualified facility’’
(or vice versa) in a way that works best
for their specific business relationship.
As discussed in section XLII.D, we
have revised the requirements for
considering supplier performance to
provide that the receiving facility may,
when applicable, consider relevant laws
and regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States, and information
relevant to the supplier’s compliance
with those laws and regulations, rather
than consider applicable FDA food
safety regulations and information
relevant to the supplier’s compliance
with applicable FDA food safety
regulations. We have made a
conforming change to the alternative
verification activities for a qualified
facility (see the regulatory text of
§ 507.130(c)(2)).
(Comment 462) Some comments
support this alternative supplier
verification activity because it provides
flexibility. Other comments ask us to
revise the provision so that it only
requires that the supplier document its
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status as a qualified facility. Still other
comments ask us to remove all
provisions on qualified facilities
because they view these provisions as
effectively adding a second layer of
regulations on produce farms, and claim
this is not authorized by FSMA. Other
comments ask us to delete the
requirement that the written assurance
include a brief description of the
processes and procedures that the
supplier is following to ensure the
safety of the food.
(Response 462) We have revised the
provisions for an alternative verification
activity for a qualified facility to better
align with the responsibilities of a
qualified facility to submit an attestation
to FDA about its food safety practices
(§ 507.7(a)(2)(i)) or its compliance with
State, local, county, tribal, or other
applicable non-Federal food safety law,
including relevant laws and regulations
of foreign countries (§ 507.7(a)(2)(ii))
(see the regulatory text of § 507.130(c)).
Importantly, a qualified facility is still
subject to CGMPs and the FD&C Act,
and, if the qualified facility is a supplier
controlling a hazard, it is reasonable for
a receiving facility to expect the
qualified facility to provide to the
receiving facility, an assurance that
reflects an attestation the facility has
made to FDA. As modified, one
possibility is for a qualified facility to
provide a receiving facility with a brief
description of the preventive controls it
is implementing to control the
applicable hazard, consistent with an
attestation of its food safety practices in
accordance with § 507.7(a)(2)(i). For
example, the qualified facility could
state that its manufacturing processes
include a lethality step for microbial
pathogens of concern. As required by
§ 507.7(f), a qualified facility that
submits an attestation to FDA about its
animal food safety practices would have
documentation of those practices to
support its attestation to FDA and, thus,
would have documentation to support
its written assurance to the receiving
facility. Although a qualified facility
that submits an attestation to FDA about
its food safety practices also would have
documentation of monitoring the
performance of the preventive controls
to ensure that such controls are effective
as required by § 507.7(a)(2)(i), we are
not requiring the qualified facility to
describe its monitoring of the
performance of preventive controls to
ensure that they are effective.
Alternatively, a qualified facility could
provide a receiving facility with a
statement that the facility is in
compliance with State, local, county,
tribal, or other applicable non-Federal
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food safety law, including relevant laws
and regulations of foreign countries.
We disagree that the alternative
verification activity for produce farms
would add a second layer of regulations
on produce farms and are retaining this
provision.
(Comment 463) Some comments ask
us to remove the requirement that the
written assurance be obtained at least
every 2 years. Other comments ask us to
revise the purpose of the written
assurance from ‘‘the raw material or
ingredient is not adulterated’’ to ‘‘the
receiving facility’s use of the raw
material or ingredient will not cause the
finished food to be adulterated.’’
(Response 463) We decline these
requests. A supplier verification activity
needs to consider supplier performance
on an ongoing basis. Procedures and
practices evolve over time, and it is
appropriate for a receiving facility that
is obtaining written assurance from a
supplier as an alternative verification
activity to be aware of both procedures
and practices that have changed, as well
as procedures and practices that have
stayed the same. The specified
timeframe for updating the written
assurance, i.e., at least every two years,
is reasonable.
A supplier can only provide
assurance about raw materials and other
ingredients that it supplies to the
receiving facility, not about the animal
food product that the receiving facility
will produce using the supplier’s raw
material or other ingredients.
D. Alternative Verification Activity
When the Supplier Is a Produce Farm
That Is Not a ‘‘Covered Farm’’ for the
Purposes of the Future Produce Safety
Rule (Final § 507.130(d))
We proposed that if a supplier is a
farm that is not subject to the
requirements that we have proposed to
be established in the produce safety rule
in accordance with proposed § 112.4
regarding the raw material or ingredient
that the receiving facility receives from
the farm, the receiving facility does not
need to comply with the verification
requirements if the receiving facility: (1)
Documents, at the end of each calendar
year, that the raw material or ingredient
provided by the supplier is not subject
to the produce safety rule and (2)
obtains written assurance, at least every
2 years, that the supplier is producing
the raw material or ingredient in
compliance with applicable FDA food
safety regulations and that the raw
material or ingredient is not adulterated
under section 402 of the FD&C Act. See
also § 507.215, which establishes
specific elements that this written
assurance must include, i.e., the
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effective date; printed names and
signatures of authorized officials; and
the applicable assurance.
Produce farms that are not ‘‘covered
farms’’ under § 112.4 of the forthcoming
produce safety rule have less than
$25,000 in annual sales averaged over
the previous 3-year period, or satisfy the
requirements for a qualified exemption
in § 112.5 and associated modified
requirements in § 112.6 based on
average monetary value of all food sold
(less than $500,000) and direct farm
marketing (during the previous 3-year
period, the average annual monetary
value of food sold directly to qualified
end users exceeded the average annual
monetary value of the food sold to all
other buyers). In the 2014 supplemental
notice, we erroneously referred to these
farms as farms ‘‘not subject to the
requirements established in part 112.’’
While produce farms that make less
than $25,000 are not subject to the
requirements in part 112, produce farms
that satisfy the requirements for a
qualified exemption are not subject to
the full requirements of part 112, but
they do have certain modified
requirements that they must meet, as
described in § 112.6. We have corrected
the description of these farms in
§ 507.130(d).
We have revised the provision to
clarify that the receiving facility must
have documentation that the raw
material or other ingredient provided by
the supplier is not subject to part 112 in
accordance with § 112.4(a), or in
accordance with §§ 112.4(b) and 112.5:
(1) Before first approving the supplier
for an applicable calendar year and (2)
by December 31 of each calendar year
(rather than ‘‘at the end of the calendar
year’’) and that the documentation is
regarding the status of supplier for the
following calendar year. By specifying
‘‘by December 31,’’ a receiving facility
can work with each applicable supplier
to determine the specific date within a
calendar year for that supplier to
annually notify the receiving facility
about its status. See also the discussion
in section XLV.C regarding a similar
revision we made when the supplier is
a qualified facility.
(Comment 464) Some comments
support the proposed alternative
supplier verification activity. Other
comments support applying the
proposed alternative supplier
verification activity more broadly, i.e.,
to any farm that will not be subject to
part 112 (e.g., a farm that grows wheat),
stating that both small and large nonproduce farms should have the same
option as farms that are exempted under
§ 112.4. Some comments ask us to revise
the alternative verification requirements
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to apply to raw materials from farms
that do not grow and harvest ‘‘produce’’
as we proposed to define it in § 112.3(c)
so that the alternative verification
requirements would apply to grain.
Some comments assert that it is not
possible to receive ‘‘written assurances’’
of compliance from growers of grain
because there is no safety standard for
grain growers, and that any such
documents would be essentially
meaningless.
Some comments ask us to revise the
requirement to obtain written assurance
so that it does not apply to ‘‘food not
subject to the requirements of part 112
of this chapter pursuant to part 112.2.’’
Other comments assert that a
documentation requirement for
commodities that will be exempt from
the produce safety rule would increase
recordkeeping burdens without added
benefit because produce that will be
exempt from the produce safety rule is
low risk.
Some comments assert that farms
should not have to provide written
assurances because the requirement is
ambiguous. These comments assert that
exempt farmers are small-scale
producers who are subject primarily to
state and local laws and this provision
would require them to provide written
assurances that they are complying with
unspecified Federal regulations. The
comments claim that, without seeking
legal counsel, many exempt farmers
would be unable to provide such
assurances, limiting the ability of these
farmers to market their products to nonexempt facilities (the overwhelming
majority of the food market).
(Response 464) We have revised the to
specify that the written assurance from
the farm must state that the farm
acknowledges that its food is subject to
section 402 of the FD&C Act (or, when
applicable, that its food is subject to
relevant laws and regulations of a
country whose food safety system FDA
has officially recognized as comparable
or has determined to be equivalent to
that of the United States). Any business
that introduces food into interstate
commerce is subject the prohibited acts
provisions in section 301 of the FD&C
Act, and is accountable if it produces
food that is adulterated.
As discussed in Response 284, new
§ 507.36(a) allows a manufacturer/
processor to not implement a preventive
control if it determines and documents
that the type of animal food (e.g.,
soybeans) could not be consumed
without application of the appropriate
control. We believe most receiving
facilities will take advantage of this
provision, and not establish supplychain controls under the supply-chain
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program in subpart E for some specific
RACs.
This alternative supplier verification
activity is intended to minimize the
burden on suppliers that are small
farms. The amount of food produced by
such farms is small, and the exposure to
food from such farms therefore is low.
We disagree that a written assurance
from such a farm would be meaningless.
Any business that distributes food in
interstate commerce is subject to the
FD&C Act, and must produce food that
is in compliance with the FD&C Act,
regardless of whether FDA has
established a specific regulation
governing the production of the food.
(Comment 465) Some comments ask
us to delete this alternative supplier
verification activity because they see it
as a contradiction to the traceability
provisions of the Bioterrorism Act and
FSMA, because ‘‘trace back’’ is only
required for ‘‘one step back’’ or for a
single supplier for a particular shipment
of food.
(Response 465) The supply-chain
program that is being established in this
rule is a preventive control for the
ongoing production of safe animal food,
not a ‘‘trace back’’ provision, established
under the Bioterrorism Act, to help
address credible threats relating to food
that is reasonably believed to be
adulterated and to present a threat of
serious adverse health consequences or
death to humans or animals.
(Comment 466) Some comments ask
us to specify 3 options for verification
if a supplier is a farm subject to the
requirements of part 112: (1)
Documentation at the end of each
calendar year that the raw material or
ingredient provided by the supplier is
subject to part 112; (2) written
assurance, at least every 2 years, that the
supplier is producing the raw material
or ingredient in compliance with
applicable FDA food safety regulations
and that the raw material or ingredient
is not adulterated under the FD&C Act;
or (3) evidence that the supplier is
certified to a recognized third-party
GAP/GHP/GMP/HACCP audit scheme.
(We note that we are assuming that
‘‘GHP’’ is an abbreviation for ‘‘Good
Hygienic Practice.’’)
(Response 466) We decline this
request. Documenting that a raw
material or other ingredient is subject to
the produce safety rule has no bearing
on whether the farm is complying with
that rule to control the hazards. With
respect to all farms subject to the
requirements of part 112 providing a
written assurance, as discussed in
Response 464, the amount of food
produced by the small farms that could
provide written assurance to a receiving
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facility is small, and the exposure to
food from such farms therefore is low.
We disagree that it is appropriate to
extend this alternative supplier
verification activity to larger farms
because such farms provide a larger
volume of produce.
A farm that has been subject to an
audit that complies with the
requirements of this rule can provide
the results of the audit; a mere statement
that the farm has been certified based on
an audit is insufficient.
E. Alternative Verification Activity
When the Supplier Is a Shell Egg
Producer That Has Less Than 3,000
Laying Hens (Final § 507.130(e))
We are establishing an additional
alternative supplier verification activity
when a supplier is a shell egg producer
that is not subject to the requirements of
21 CFR part 118 because it has less than
3,000 laying hens. See the regulatory
text of § 507.130(e). The provision is
analogous to the alternative supplier
verification activity when a supplier is
a farm that meets the criteria in
§ 507.130(d) and would account for a
very small amount of eggs in the food
supply. See also § 507.215, which
establishes specific elements that the
required written assurance must
include, i.e., the effective date; printed
names and signatures of authorized
officials; and the applicable assurance.
F. Independence of Persons Who
Conduct Supplier Verification Activities
(Final § 507.130(f))
In the 2014 supplemental notice, we
requested comment on whether we
should include in the final preventive
controls rule requirements to address
conflicts of interest for individuals
conducting verification activities and, if
so, the scope of such requirements.
(Comment 467) Some comments
request that requirements to address
conflicts of interest should not be
implemented or ask that conflict of
interest provisions not be written too
broadly, and be limited to
circumstances where the individual
employee carrying out the verification
activities has a direct personal financial
interest in or financial ties to the
supplier (e.g., owns a substantial
amount of stock in the supplier or is
personally paid directly by the
supplier). Comments state that it would
not be uncommon for a receiving facility
to have a shared financial interest in the
supplier (e.g., partial ownership of one
by the other or both being owned by the
same parent company). Thus,
employees that have an indirect
financial interest (e.g., owning stock in
a supplier because they own stock in
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their own company, which in turn owns
an interest in the supplier) should not
be disqualified from performing
verification activities. Comments also
indicate that a laboratory analyst
performing ingredient testing should not
be precluded from testing ingredients
from a supplier in which the analyst has
a potential conflict of interest, as long as
the analyst is not aware of the identity
of the supplier at the time the test is
performed.
(Response 467) We are establishing a
requirement that there must not be any
financial conflicts of interests that
influence the results of the verification
activities listed in § 507.110(b) and
payment must not be related to the
results of the activity. This does not
prohibit employees of a supplier from
performing the functions specified in
§ 507.115 in accordance with § 507.115.
For example, this provision would not
prohibit an employee of a supplier from
conducting sampling and testing so that
the supplier could provide the results in
documentation provided to the
receiving facility. The provisions would
not prevent a person who is employed
by a receiving facility from having an
indirect financial interest in a supplier
(e.g., if a company in which the
employee owns stock owns an interest
in the supplier).
(Comment 468) Comments ask that we
not preclude a supplier from hiring an
outside party to perform onsite audits,
food certifications, or sampling and
testing.
(Response 468) We have specified that
the requirements do not prohibit a
receiving facility from relying on an
audit provided by its supplier when the
audit of the supplier was conducted by
a third-party qualified auditor (see
§ 507.115(c)). We also have specified
that a supplier may conduct and
document sampling and testing of raw
materials and other ingredients, for the
hazard controlled by the supplier, as a
supplier verification activity for a
particular lot of product and provide the
documentation to the receiving facility
(see § 507.115(a)(4)). This acknowledges
that it is common for suppliers to
include Certificates of Analysis for tests
conducted on specific lots of product
along with the shipment to the receiving
facility.
XLVI. Subpart E: Comments on Onsite
Audit
We proposed requirements that would
apply to an onsite audit. Most
comments that support the proposed
provisions suggest alternative or
additional regulatory text or ask us to
clarify how we will interpret the
provision. In the following sections, we
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discuss comments that ask us to clarify
the proposed requirements or that
disagree with, or suggest one or more
changes to, the proposed requirements.
After considering these comments, we
56311
have revised the proposed requirements
as shown in table 28.
TABLE 28—REVISIONS TO THE PROPOSED REQUIREMENTS FOR ONSITE AUDITS
Proposed section
designation
Description
507.135(a) .........................................
507.37(d)(1) ........................
507.135(b) .........................................
507.37(d)(2) ........................
An onsite audit of a
supplier must be performed by a qualified
auditor.
An onsite audit must
consider applicable
FDA regulations.
507.135(c)(1)(i) ..................................
507.37(e)(1) ........................
Substitution of inspection for domestic suppliers.
507.135(c)(1)(ii) and 507.135(c)(2) ...
507.37(e)(2) ........................
507.135(d) .........................................
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Final section designation
N/A .....................................
Substitution of inspection for foreign suppliers.
Use of a third-party
auditor that has been
accredited in accordance with regulations
that will be established in the forthcoming third-party
certification rule.
A. Requirements Applicable to an
Onsite Audit (Final § 507.135(a) and (b))
We proposed that an onsite audit of
a supplier must be performed by a
qualified auditor. If the raw material or
ingredient at the supplier is subject to
one or more FDA food safety
regulations, an onsite audit would need
to consider such regulations and
include a review of the supplier’s
written plan (e.g., HACCP plan or other
food safety plan), if any, including its
implementation, for the hazard being
audited (proposed § 507.37(d)). We have
revised ‘‘including its implementation’’
to ‘‘and its implementation’’ to
emphasize that implementation of the
plan is distinct from the plan itself (e.g.,
§ 507.31(c) establishes the
recordkeeping requirement for the food
safety ‘‘plan,’’ and § 507.55 lists
implementation records.)
As discussed in section XLII.D, we
have revised the requirements for
considering supplier performance to
provide that the receiving facility may,
when applicable, consider relevant laws
and regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States, and information
relevant to the supplier’s compliance
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with those laws and regulations, rather
than consider applicable FDA food
safety regulations and information
relevant to the supplier’s compliance
with applicable FDA food safety
regulations. We have made a
conforming change to the requirements
for an onsite audit to clarify that an
onsite audit may consider relevant laws
and regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States. However, as of
August 30, 2015, FDA has not
developed a systems recognition
program for animal food; therefore, we
have no signed systems recognition
agreements with any foreign food safety
authority relating to animal food. The
currently existing systems recognition
agreement relates solely to human food
and does not apply to animal food.
(Comment 469) Comments support a
requirement that an onsite audit be
performed by a qualified auditor,
provided that we finalize provisions (in
proposed § 507.37(e)) whereby an
inspection by certain authorities could
substitute for an audit. Some comments
ask us to specify that the rule permits
the use of audits conducted by private
third-party food safety auditing firms.
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Revision
N/A.
Clarify that, when applicable, an onsite audit
may consider relevant laws and regulations of
a country whose food safety system FDA has
officially recognized as comparable or has determined to be equivalent to that of the United
States.
Broaden the list of applicable inspections to include inspections by representatives of other
Federal Agencies (such as the United States
Department of Agriculture), or by representatives of State, local, tribal, or territorial agencies.
N/A.
If the onsite audit is solely conducted to meet
the requirements of the animal food preventive controls rule by an audit agent of a certification body that is accredited in accordance
with regulations that will be established in part
1, subpart M, the audit is not subject to the
requirements in those regulations.
Other comments ask us to provide a list
of recognized private third-party food
safety schemes and consider making
third-party food safety certification to a
recognized audit scheme mandatory for
all food operations that grow, pack, hold
and manufacture/process food for
wholesale markets. Other comments ask
us to further specify that FDA will audit
all food facilities no less than once
every 5 years to verify that private thirdparty audits are consistent with FDA
audits and findings.
(Response 469) See our discussion in
section XLVI.B of the final provisions
governing substitution of inspection for
an audit. We agree that onsite audits
may be conducted by third parties, but
disagree that it is necessary to specify
this in the rule. Nothing in this rule
prevents a facility from hiring a third
party to conduct audits.
We decline the requests to provide a
list of recognized private third-party
food safety schemes or to make thirdparty food safety certification to a
recognized audit scheme mandatory for
all food operations that grow, pack, hold
and manufacture/process animal food
for wholesale markets. The rule
provides flexibility regarding use of
third-party auditors and the information
is easily obtained from other sources.
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Private third-party food safety audit
schemes are a function of the private
sector, not a function of the Federal
government. Likewise, we decline the
request to specify that FDA will ‘‘audit’’
all food facilities no less than once
every 5 years to verify that private thirdparty audits are consistent with FDA
audits and findings. We will inspect
food facilities for compliance with this
rule, not to verify the findings of a thirdparty audit, with a frequency consistent
with our responsibilities under the
FD&C Act.
(Comment 470) Some comments
express concern about the multiple
audits that facilities are subject to each
year and ask us to encourage those
subject to the rule to accept an audit
performed by any of the ‘‘bona fide
authorities’’ where it is warranted.
Other comments note that food
manufacturers conduct their own audits
and have developed extensive expertise
in doing so, and oppose any supplier
verification requirement that would
affect those audits. Other comments ask
us to allow audits to industry standards
(such as GFSI or ISO) to satisfy supplier
verification requirements to avoid
adding a new audit to audits currently
being conducted. Some comments assert
that audits to industry standards (such
as GFSI or ISO) and other similarly
accredited audits should be considered
equivalent to onsite audits. Some
comments express concern that
requiring a new audit in addition to
audits already being conducted could
lead to auditor shortages and
unnecessary additional costs.
(Response 470) We expect that a
facility will adopt an approach to audits
that works best for the facility and
minimizes the number of audits
conducted for the same facility. An
employee of a receiving facility may
perform an audit, provided that the
employee satisfies the criteria
established in the rule for qualified
auditors. Under § 507.3 and § 507.53, a
qualified auditor is a qualified
individual (as defined in § 507.3) and
has technical expertise obtained through
education, training, or experience (or a
combination thereof) necessary to
perform the auditing function. For
additional information, see Response
700 in the final rule for preventive
controls for human food published
elsewhere in this issue of the Federal
Register, in which we discuss auditor
qualifications with respect to the GFSI’s
auditor competency model.
(Comment 471) Some comments ask
us to delete the proposed requirement
for a review of the supplier’s written
plan as part of an audit because review
of the supplier’s food safety plan should
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be part of an overall supplier
verification program when the supplier
is controlling a hazard that could cause
serious adverse health consequences or
death, but should not be tied to an
audit. These comments state that
receiving facilities may choose to use an
unannounced audit program where the
auditor spends time focusing on the
actual conditions on the production
floor, with a review of the supplier’s
food safety plan being done as a
separate verification activity.
(Response 471) We decline this
request. We agree that review of an
applicable food safety plan should be
part of an overall supplier verification
program and that the review of the food
safety plan may be conducted separately
from the observation of actual
conditions on the production floor,
provided that both are conducted within
the annual timeframe. However, we
believe it important that the audit
address whether the food safety plan is
being implemented as designed and
other comments to this rule support that
view. For example, as discussed in
Comment 493 regarding our inspection
of a food facility, some comments assert
that our access to company records must
be conducted onsite in the course of an
authorized inspection so that we may
understand the full context of what the
records show. Thus, the onsite
observations and the food safety plan
review cannot be entirely separated, as
the comment seems to suggest.
We note that the requirement to
include a review of the supplier’s food
safety plan only applies when the
supplier has a food safety plan. For
example, we did not propose a
requirement for a farm that would be
subject to the forthcoming produce
safety rule to have a food safety plan.
B. Substitution of Inspection by FDA or
an Officially Recognized or Equivalent
Food Safety Authority
We proposed that instead of an onsite
audit, a receiving facility may rely on
the results of an inspection of the
supplier by FDA or, for a foreign
supplier, by FDA or the food safety
authority of a country whose food safety
system FDA has officially recognized as
comparable or has determined to be
equivalent to that of the United States,
provided that the inspection was
conducted within 1 year of the date that
the onsite audit would have been
required to be conducted. For
inspections conducted by the food
safety authority of a country whose food
safety system FDA has officially
recognized as comparable or determined
to be equivalent to that of the United
States, the food that is the subject of the
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onsite audit would need to be within
the scope of the official recognition or
equivalence determination, and the
foreign supplier would need to be in,
and under the regulatory oversight of,
such country (proposed § 507.37(e)).
As of August 30 2015, FDA has not
developed a systems recognition
program for animal food; therefore, we
have no signed systems recognition
agreements with any foreign food safety
authority for animal food. A signed
systems recognition agreement for
human food does not apply to animal
food.
(Comment 472) Some comments ask
us to allow State or local inspection
reports, as well as FDA inspection
reports, to substitute for an onsite audit
for small and very small facilities. Other
comments ask us to create a ‘‘safe
harbor’’ provision in which a supplier
providing a copy of permits obtained
from the most recent inspection done by
Federal, State, or local health authorities
satisfies the supplier verification
requirement; if there are no permits,
review of relevant records and/or
sampling of raw material based on scale
of production should be adequate.
(Response 472) We have revised the
regulatory text to provide for an
appropriate inspection of the supplier
for compliance with applicable FDA
food safety regulations by FDA, by
representatives of other Federal
Agencies (such as USDA), or by
representatives of State, local, tribal, or
territorial agencies. We are specifying
that the inspection must be
‘‘appropriate’’ and be conducted for
compliance ‘‘with applicable FDA food
safety regulations’’ to make clear that
the inspection must be sufficiently
relevant to an onsite audit to credibly
substitute for an onsite audit. For
example, inspection by USDA to
determine whether a farm satisfies the
requirements of the produce safety rule
could constitute an appropriate
inspection that could substitute for an
audit, but an inspection by USDA to
determine whether a farm satisfies the
requirements of the National Organic
Program could not.
We have not provided for substitution
of a ‘‘permit obtained from the most
recent inspection’’ for an onsite audit.
We do not see how a ‘‘permit’’ could
shed light on whether a business is
complying with specific applicable FDA
regulations. We have provided for an
alternative verification activity to the
annual onsite audit (such as a review of
relevant records and/or sampling of raw
material) with a written justification
(see § 507.130(b)). The rule would not
preclude an appropriate review of
records, or sampling and testing of raw
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materials, by other Federal Agencies, or
by representatives of State, local, tribal,
or territorial agencies, provided that the
receiving facility satisfies the
requirements for an adequate written
justification.
(Comment 473) Some comments ask
us to clarify what we mean by ‘‘food
safety authority of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States.’’ These comments
also ask whether a specific country
qualifies and whether HACCP
certificates issued by a specific foreign
government agency would replace an
onsite audit.
(Response 473) A country whose food
safety system FDA has officially
recognized as ‘‘comparable’’ to that of
the United States would be one for
which there is a signed systems
recognition arrangement or other
agreement between FDA and the
country establishing official recognition
of the foreign food safety system.
Information on FDA systems recognition
can be found on the FDA Web site (Ref.
59). As of August 30 2015, FDA has not
developed a systems recognition
program for animal food; therefore, we
have no signed systems recognition
agreements with any foreign food safety
authority relating to animal food. The
currently existing systems recognition
agreement relates solely to human food
and does not apply to animal food. We
would not accept a HACCP certificate
issued by a foreign government as a
substitute for an onsite audit, but a
receiving facility could consider
whether such a certificate could be part
of its justification for conducting
another supplier verification activity in
lieu of an annual onsite audit, or for
conducting an audit on a less frequent
basis than annually.
(Comment 474) Some comments ask
us to clarify that the applicable
standards will be those applied by the
food safety authority of a country with
a food safety system recognized as
comparable or equivalent rather than
having to achieve compliance with the
applicable U.S. FDA food safety
regulations.
(Response 474) The applicable
standards will be those applied by the
food safety authority of a country with
a food safety system recognized as
comparable or equivalent to that of the
United States. As of August 30, 2015,
FDA has not developed a systems
recognition program for animal food;
therefore, we have no signed systems
recognition agreements with any foreign
food safety authority relating to animal
food. The currently existing systems
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recognition agreement relates solely to
human food and does not apply to
animal food.
C. Onsite Audit by a Third-Party
Auditor Accredited for the Purposes of
Section 808 of the FD&C Act
We have proposed to establish
regulations (in part 1, subpart M) to
provide for accreditation of third-party
auditors/certification bodies to conduct
food safety audits of foreign food
entities, including registered foreign
food facilities, and to issue food and
facility certifications (78 FR 45782, July
29, 2013). The purpose of the proposed
third-party certification rule is to help
us ensure the competence and
independence of third-party auditors/
certification bodies who conduct foreign
food safety audits and to help ensure the
reliability of food and facility
certifications issued by third-party
auditors/certification bodies that we
will use in making certain decisions
relating to imported animal food, such
as animal food certifications required by
FDA as a condition of granting
admission to an animal food determined
to pose a safety risk.
(Comment 475) Comments support
use of third-party auditors, but
emphasize that such auditors need not
be accredited under the requirements to
be established under our forthcoming
third-party certification rule.
(Response 475) We agree that a thirdparty auditor who conducts an audit as
a supplier verification activity to satisfy
the requirements of this rule need not be
accredited under our forthcoming thirdparty certification rule. In addition, we
see no reason that any requirements of
our forthcoming third-party certification
rule should apply to an audit merely
because it was conducted by a person
who had been accredited under that
rule. To make this clear, we have added
a provision to specify that if an onsite
audit is solely conducted to meet the
requirements of this rule by an audit
agent of a certification body that is
accredited in accordance with
regulations in part 1, subpart M, the
audit is not subject to the requirements
in those regulations. See § 507.135(d).
Because § 507.135(d) refers to
provisions in a future third-party
certification rule, we will publish a
document in the Federal Register
announcing the effective date of
§ 507.135(d) when we finalize the thirdparty certification rule.
XLVII. Subpart E: Comments on
Records Documenting the Supply-Chain
Program (Final § 507.175)
We proposed to require
documentation of verification activities
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in records, including minimum
requirements for records documenting
an audit, records of sampling and
testing, and records documenting a
review by the receiving facility of the
supplier’s relevant food safety records.
We also proposed that the receiving
facility must review such records in
accordance with the requirements
applicable to review of records as a
verification activity (i.e., in accordance
with § 507.49(a)(4)).
We did not receive comments on the
documentation requirements associated
with a written supplier program,
determination of appropriate supplier
verification activities, review of records,
supplier verification activities other
than an annual onsite audit when the
hazard being controlled by the supplier
is one for which there is a reasonable
probability that exposure to the hazard
will result in serious adverse health
consequences or death to humans or
animals, alternative supplier
verification activity when the supplier
is a qualified facility, substitution of
inspection for an audit, or supplier
nonconformance (proposed
§ 507.37(g)(1), (2), (7), (9), (10), (12), and
(13), respectively). We are finalizing
these documentation requirements with
editorial and conforming changes
associated with the final requirements
of the supply-chain program.
The supply-chain program includes
two provisions that are explicit
requirements of the final animal food
preventive controls rule, but had been
implicit requirements of the 2014
supplemental notice. The first of these
provisions is the explicit requirement
that the receiving facility must approve
suppliers in accordance with the
requirements of § 507.110(d), and
document that approval, before
receiving raw materials and other
ingredients from those suppliers (see
§ 507.120(a)). The second of these
requirements is that written procedures
for receiving raw materials and other
ingredients must be established and
followed (see § 507.120(b)(1)). We are
including in § 507.175 the
documentation associated with these
requirements (see § 507.175(c)(3) and
(4)).
The supply-chain program includes
four provisions that were not in the
2014 supplemental notice: (1) A
receiving facility that is an importer can
comply with the foreign supplier
verification requirements in the FSVP
rule rather than conduct supplier
verification activities for that raw
material or other ingredient under this
rule (§ 507.105(a)(2)); (2) a receiving
facility may use an alternative
verification activity for a supplier that is
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a shell egg producer that is not subject
to the requirements established in part
118 because it has less than 3,000 laying
hens (§ 507.130(e)); (3) when applicable,
a receiving facility must verify a supplychain-applied control applied by an
entity other than the receiving facility’s
supplier (§ 507.105(c)); and (4) entities
other than the receiving facility may
determine, conduct, and document
certain specified supplier verification
activities, provided that the receiving
facility reviews and assesses the other
entity’s applicable documentation, and
documents its review and assessment
(§ 507.115). We are establishing the
associated documentation requirements
in § 507.175(c)(2), (14), (17), and (18),
respectively.
In the following sections, we discuss
comments on the proposed records for
the supplier program. After considering
these comments, we have revised the
proposed requirements as shown in
table 29.
TABLE 29—REVISIONS TO THE PROPOSED REQUIREMENTS FOR RECORDS FOR THE SUPPLY-CHAIN PROGRAM
Did we receive
comments
regarding
the proposed
requirement?
Did we revise the documentation
requirement other than editorial and
conforming changes associated with
the final requirements for the
supply-chain program?
The records documenting the supply-chain
program are subject to the requirements
of subpart F.
N/A ...................
The receiving facility must review the
records
in
accordance
with
§ 507.49(a)(4).
The written supply-chain program ...............
Annual written assurance from a receiving
facility’s customer.
Yes ...................
Consequential change associated
with establishing the requirements
for a supplier in subpart E rather
than subpart C.
No.
Final section
designation
Proposed section
designation
Description
507.175(a) .............
N/A ........................
507.175(b) .............
507.37(g) ..............
507.175(c)(1) .........
507.36(b)(2) ...........
507.37(g)(1) ..........
507.37(g)(3) ..........
507.175(c)(2) .........
507.175(c)(3) .........
N/A ........................
507.37(g)(1) ..........
507.175(c)(4) .........
507.37(g)(1) ..........
507.175(c)(5) .........
507.37(g)(4) ..........
507.175(c)(6) .........
507.37(g)(2) ..........
507.175(c)(7) .........
507.37(g)(5) ..........
507.175(c)(8) .........
N/A ...................
No .....................
No .....................
No.
Yes ...................
Yes.
No .....................
No.
Yes ...................
507.37(g)(6) ..........
Documentation of sampling and testing
conducted as a supplier verification activity.
Yes ...................
507.175(c)(9) .........
507.37(g)(7) ..........
Documentation of the review of the supplier’s relevant food safety records.
No .....................
507.175(c)(10) .......
507.37(g)(8) ..........
Documentation of other appropriate supplier verification activities.
Yes ...................
507.175(c)(11) .......
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Documentation obtained from an importer
Documentation of the approval of a supplier.
Written procedures for receiving raw materials and other ingredients.
Documentation demonstrating use of the
written procedures for receiving raw materials and other ingredients.
Documentation of the determination of the
appropriate supplier verification activities
for raw materials and other ingredients.
Documentation of the conduct of an onsite
audit.
N/A.
Shifted to be in provisions outside
the framework of the supply-chain
program in subpart E.
N/A.
No.
507.37(g)(9) ..........
Documentation of any determination that
verification activities other than an onsite
audit, and/or less frequent onsite auditing
of a supplier, provide adequate assurance that the hazards are controlled
when a hazard in a raw material or other
ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the
hazard will result in serious adverse
health consequences or death to humans or animals.
No .....................
Added a requirement for the documentation to include the name of
the supplier subject to the onsite
audit.
Specify that the documentation include the date(s) on which the
test(s) were conducted and the
date of the report.
Specify that the documentation
must include the general nature
of the records reviewed and conclusions of the review.
Specify that the other appropriate
supplier verification activities are
based on supplier performance
and the risk associated with the
raw material or other ingredient.
No.
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No .....................
Yes ...................
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TABLE 29—REVISIONS TO THE PROPOSED REQUIREMENTS FOR RECORDS FOR THE SUPPLY-CHAIN PROGRAM—Continued
Did we receive
comments
regarding
the proposed
requirement?
Did we revise the documentation
requirement other than editorial and
conforming changes associated with
the final requirements for the
supply-chain program?
Documentation of an alternative verification
activity for a supplier that is a qualified
facility.
No .....................
Documentation of an alternative verification
activity for a supplier that is a farm that
supplies a raw material or other ingredient that would not be a covered farm
subject to the forthcoming produce safety
rule.
Documentation of an alternative verification
activity for a supplier that is a shell egg
producer that is not subject to the requirements established in part 118 because it has less than 3,000 laying hens.
The written results of an appropriate inspection of the supplier by FDA, by representatives of other Federal Agencies
(such as USDA), or by representatives
from State, local, tribal, or territorial
Agencies, or the food safety authority of
another country when the results of such
an inspection is substituted for an onsite
audit.
Documentation of actions taken with respect to supplier non-conformance.
Documentation of verification of a supplychain-applied control applied by an entity
other than the receiving facility’s supplier.
When applicable, documentation of the receiving facility’s review and assessment
of
documentation
of
a
supplier
verification activity provided by a supplier
or by an entity other than the receiving
facility.
Yes ...................
Provide for documentation, when
applicable, of a written assurance
that the supplier is producing the
raw material or other ingredient in
compliance with relevant laws
and regulations of a country
whose food safety system FDA
has officially recognized as comparable or has determined to be
equivalent to that of the United
States.
No.
N/A ...................
N/A.
No .....................
No.
No .....................
No.
N/A ...................
N/A.
N/A ...................
N/A.
Final section
designation
Proposed section
designation
Description
507.175(c)(12) .......
507.37(g)(10) ........
507.175(c)(13) .......
507.37(g)(11) ........
507.175(c)(14) .......
N/A ........................
507.175(c)(15) .......
507.37(g)(12) ........
507.175(c)(16) .......
507.37(g)(13) ........
507.175(c)(17) .......
N/A ........................
507.175(c)(18) .......
N/A ........................
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A. Applicability of the Recordkeeping
Requirements of Subpart F
We have added new § 507.175(a) to
specify that the records documenting
the supply-chain program in subpart E
are subject to the requirements of
subpart F. Under the 2014 supplemental
notice, the documentation requirements
would have been in subpart C, and the
applicability of subpart F was specified
in § 507.55 in subpart C. The new
provision specifying the applicability of
subpart F to the records associated with
the supply-chain program is a
consequential change associated with
establishing the requirements for a
supply-chain program in subpart E,
rather than in subpart C.
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B. Requirement To Review Records of
the Supply-Chain Program (Final
§ 507.175(b))
We proposed that a receiving facility
must review records documenting the
supplier program in accordance with
the requirements applicable to review of
records as a verification activity (i.e., in
accordance with § 507.49(a)(4)).
(Proposed § 507.37(g).)
(Comment 476) Some comments ask
us to provide consideration for records
associated with the supplier program to
be administered and maintained at
corporate headquarters rather than at
individual facilities, because this is
common industry practice.
(Response 476) We are aware that
certain programs are administered, and
records are maintained, at corporate
headquarters rather than at individual
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facilities. The rule provides that offsite
storage of records is permitted if such
records can be retrieved and provided
onsite within 24 hours of request for
official review and electronic records
are considered to be onsite if they are
accessible from an onsite location (see
§ 507.208(c)). We expect that the facility
would be able to access information and
records relevant to the supply-chain
program within 24 hours (e.g.,
electronically) when the records are
maintained at corporate headquarters.
As necessary and appropriate, we
intend to work with facilities on a caseby-case basis to determine the best way
to review records associated with the
supply-chain program when the supplychain program is administered at the
corporate level.
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(Comment 477) Some comments ask
us to clarify in the regulatory text that
the required records are ‘‘as appropriate
to the supplier program.’’
(Response 477) We have revised the
regulatory text to specify that the
required records are ‘‘as applicable to its
supply-chain program’’ (see
§ 507.175(c)).
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C. Documentation Demonstrating Use of
the Written Procedures for Receiving
Raw Materials and Other Ingredients
(Final § 507.175(c)(5))
We proposed to require
documentation demonstrating that
products are received only from
approved suppliers (proposed
§ 507.37(g)(4)).
(Comment 478) Some comments
support the proposed requirement with
no changes. Other comments ask us to
specify ‘‘raw materials and ingredients’’
rather than ‘‘products’’ in the regulatory
text.
(Response 478) We have revised the
regulatory text to specify ‘‘raw materials
and other ingredients’’ with associated
conforming changes.
D. Documentation of the Conduct of an
Onsite Audit (Final § 507.175(c)(7))
We proposed to require
documentation of an onsite audit. This
documentation must include: (1)
Documentation of audit procedures; (2)
the dates the audit was conducted; (3)
the conclusions of the audit; (4)
corrective actions taken in response to
significant deficiencies identified
during the audit; and (5) documentation
that the audit was conducted by a
qualified auditor. For clarity, we have
revised the regulatory text to specify
documentation of the ‘‘conduct’’ of an
audit and added a requirement for the
documentation to include the name of
the supplier subject to the onsite audit.
(Comment 479) Some comments ask
that we add ‘‘if applicable’’ to the
requirement to maintain documentation
of an audit because an audit may not be
necessary if a receiving facility has
documented that other verification
activities are appropriate.
(Response 479) We decline this
request. The documentation is always
necessary if an audit is used as a
verification activity. The provision is
about maintaining documentation when
an audit is conducted, not about when
an audit needs to be conducted.
(Comment 480) Some comments ask
us to maintain the confidentiality of
audit reports and exempt such audit
reports from disclosure under the
Freedom of Information Act (FOIA).
(Response 480) These comments are
similar to comments we received related
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to disclosure of other records required
by this part (see Comments 490 and
491). We would establish the status of
supply-chain program records, such as
audit reports, as available for, or
protected from, public disclosure on a
case-by-case basis. As discussed in
Response 491, we primarily intend to
copy such records when we conduct an
inspection for cause or if the
preliminary assessment by our
investigator during a routine inspection
is that regulatory followup may be
appropriate (e.g., if the report indicates
that a significant food safety problem
was noted). See Response 491 for a
discussion of situations in which
records would, or would not, be
protected from disclosure.
(Comment 481) Some comments
express concern about maintaining
documentation of the conclusions of an
audit and documentation of corrective
actions taken in response to significant
deficiencies identified during the audit.
These comments explain that FDA’s
access to such documentation during
inspection might discourage suppliers
from allowing unannounced audits.
These comments ask us to delete these
proposed requirements. If the
requirement regarding documentation of
corrective actions remains in the final
rule, these comments ask us to limit
such documentation to situations in
which the identified deficiencies posed
a risk to public health.
(Response 481) We are retaining these
documentation requirements as
proposed. These comments appear to be
suggesting that documentation
requirements be established based on
whether a business entity would want
us to see information during inspection
rather than on the utility and value of
the documentation. We expect that
receiving facilities, in general, maintain
documentation of the conclusions of
audits that they have conducted or
arranged to have conducted. A receiving
facility must approve all of its suppliers,
and documentation of corrective actions
taken in response to significant
deficiencies identified during an audit
has value to a receiving facility in
determining whether to approve a
supplier before first receiving any raw
materials or other ingredients and then
on an ongoing basis.
The rule does not require that onsite
audits be unannounced, although we
acknowledge that some receiving
facilities may see value in unannounced
audits. We decline the request to require
a receiving facility to maintain
documentation of corrective actions
only if the identified deficiencies posed
a risk to public (human and animal)
health. The purpose of an audit, like the
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purpose of all the supplier verification
activities, is broader than identifying
deficiencies that pose a risk to public
(human and animal) health and
includes verifying whether a raw
material or other ingredient is
adulterated under section 402 of the
FD&C Act and is produced in
compliance with applicable FDA food
safety regulations (see § 507.110(c)). If,
for example, a supplier’s facility has
filthy conditions or the raw materials
and other ingredients it supplies are
contaminated with filth, a receiving
facility may find it inappropriate to
approve that supplier. Even though filth
often does not pose a risk to public
(human and animal) health, a food may
be deemed to be adulterated under
section 402(a)(4) of the FD&C Act if it
has been prepared, packed, or held
under insanitary conditions whereby it
may have become contaminated with
filth.
E. Documentation of Sampling and
Testing (Final § 507.175(c)(8))
We proposed to require records of
sampling and testing. These records
must include: (1) Identification of the
raw material or ingredient tested
(including lot number, as appropriate)
and the number of samples tested; (2)
identification of the test(s) conducted,
including the analytical method(s) used;
(3) the date(s) on which the test(s) were
conducted and the date of the report; (4)
the results of the testing; (5) corrective
actions taken in response to detection of
hazards; and (6) information identifying
the laboratory conducting the testing.
(Comment 482) Some comments ask
us to not apply the requirement to
maintain records related to sampling
and testing to the receipt of RACs
because sampling and testing of RACs is
neither common nor effective for
detecting biological or chemical
hazards, especially in raw, intact
produce.
(Response 482) We decline this
request. These comments appear to
suggest that documentation
requirements be established based on
the frequency and utility of sampling
and testing a particular commodity
rather than on a determination by a
receiving facility that sampling and
testing is an appropriate supplier
verification activity for a particular
supplier. We disagree with such a
suggestion. A receiving facility that has
determined that sampling and testing is
an appropriate supplier verification
activity needs to maintain records of
those results as it would for any other
supplier verification activity. To the
extent that these comments are
concerned that the supply-chain
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program requires sampling and testing
of RACs, we emphasize that this is not
the case. See also Response 350 for a
discussion of the usefulness of sampling
and testing as a verification measure for
RACs.
(Comment 483) Some comments ask
us to allow documentation of testing to
include the date the test results were
reported as an alternative to the date(s)
on which the test(s) were conducted.
(Response 483) We have revised the
provision to require ‘‘The date(s) on
which the test(s) were conducted and
the date of the report.’’ We agree that the
date on which the test results are
reported can be important, but it should
not be a replacement for the date of the
test.
(Comment 484) Some comments ask
us to add ‘‘if necessary’’ to the end of
the proposed requirement for
documentation of corrective actions
taken in response to detection of
hazards.
(Response 484) We decline this
request. The documentation is always
necessary if corrective actions are taken.
The provision is about maintaining
documentation when corrective actions
are taken, not about the fact that
corrective actions may not always be
needed.
F. Documentation of Other Appropriate
Supplier Verification Activity (Final
§ 507.175(c)(10))
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We proposed to require records of
other appropriate verification activities
based on the risk associated with the
ingredient. For clarity and consistency,
we have revised the proposed
requirement to specify ‘‘documentation’’
of the other appropriate supplier
verification activity rather than
‘‘records’’ of the activity. As a
conforming change associated with
using the term ‘‘supplier performance,’’
rather than ‘‘risk of supplier,’’ when
discussing factors associated with
suppliers, the final requirement
specifies that the other appropriate
supplier verification activities are based
on the supplier performance and the
risk associated with the raw material or
other ingredient.
(Comment 485) Some comments ask
us to also specify that an ‘‘other’’
appropriate supplier verification
activity be based on the risk associated
with raw materials and suppliers.
(Response 485) We have revised the
regulatory text to specify
‘‘Documentation of other appropriate
supplier verification activities based on
the supplier performance and the risk
associated with the raw material or
other ingredient.’’ The revised
regulatory text of the documentation
tracks the regulatory text of this ‘‘other’’
appropriate supplier verification
activity (see § 507.110(b)(4)). As
discussed in Response 444, ‘‘supplier
performance’’ is more appropriate than
‘‘risk associated with the supplier.’’
G. Documentation of an Alternative
Verification Activity for a Supplier That
Is a Farm That Is Not a ‘‘Covered Farm’’
for the Purposes of the Future Produce
Safety Rule (Final § 507.175(c)(13))
We proposed to require
documentation of an alternative
verification activity for a supplier that is
a farm that is not a ‘‘covered farm’’ for
the purposes of the future produce
safety rule, including: (1) The
documentation that the raw material or
ingredient provided by the supplier is
not subject to the produce safety rule
and (2) the written assurance that the
supplier is producing the raw material
or ingredient in compliance with
applicable FDA food safety regulations
and that the raw material or ingredient
is not adulterated under section 402 of
the FD&C Act. We have revised the
documentation to reflect the final
requirements of § 507.130(d)—i.e., to
require: (1) Written assurance that the
supplier is not a covered farm under
part 112 in accordance with § 112.4(a),
or in accordance with §§ 112.4(b) and
112.5, before approving the supplier and
on an annual basis thereafter and (2) the
written assurance that the farm
acknowledges that its food is subject to
section 402 of the FD&C Act (or, when
applicable, that its food is subject to
relevant laws and regulations of a
country whose food safety system FDA
has officially recognized as comparable
or has determined to be equivalent to
that of the United States). However as of
August 30, 2015, FDA has not
developed a systems recognition
program for animal food; therefore, we
have no signed systems recognition
agreements with any foreign food safety
56317
authority relating to animal food. The
currently existing systems recognition
agreement relates solely to human food
and does not apply to animal food.
(Comment 486) Some comments ask
us to delete this documentation
requirement because RACs except fruits
and vegetables should be exempt from
supplier verification.
(Response 486) See Response 464.
This alternative supplier verification
activity is intended to minimize the
burden on suppliers that are small
farms.
(Comment 487) Some comments ask
us to include a cross-reference to the
applicable requirement.
(Response 487) We have not added
this cross-reference. We agree that
adding the cross-reference has the
potential to be helpful, but it also has
the potential to clutter the regulatory
text. We considered it would be more
useful to specify what the
documentation needs to be rather than
to specify the cross-reference to the
applicable alternative supplier
verification activity.
XLVIII. Subpart F: Comments on
Proposed New Recordkeeping
Requirements
We proposed to establish in subpart F
requirements that would apply to all
records that would be required by the
various provisions of proposed part 507,
including general requirements related
to the content and form of records;
additional requirements specific to the
food safety plan; requirements for
record retention; requirements for
official review of records by FDA; and
public disclosure.
Some comments support the proposed
requirements without change. Some
comments that support the proposed
provisions suggest alternative or
additional regulatory text or ask us to
clarify how we will interpret the
provision.
In the following paragraphs, we
discuss comments that disagree with or
suggest one or more changes to the
proposed requirements. After
considering these comments, we have
revised the proposed requirements as
shown in table 30 with editorial and
conforming changes as shown in table
31.
TABLE 30—REVISIONS TO THE PROPOSED RECORDKEEPING REQUIREMENTS
Section
Description
Revision
507.200(b) ....................................
507.200(c) ....................................
Requirements for public disclosure ..
Requirements for official review .......
Specify that the requirement applies to records ‘‘obtained by FDA.’’
Clarify that FDA may copy records upon oral or written request by a
duly authorized representative of the Secretary of Health and
Human Services.
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TABLE 30—REVISIONS TO THE PROPOSED RECORDKEEPING REQUIREMENTS—Continued
Section
Description
Revision
507.202(b) ....................................
507.208(a)(2) ...............................
General requirements applying to
records.
General requirements applying to
records.
Requirements for record retention ....
507.208(c) ....................................
Requirements for record retention ....
507.208(d) ....................................
Requirements for record retention ....
507.215 ........................................
Special requirements applicable to a
written assurance.
Provide that the time of an activity being documented only include
the time of the activity when appropriate.
Specify that electronic records are exempt from the requirements of
21 CFR part 11.
Specify that records that a facility relies on during the 3-year period
preceding the applicable calendar year to support its status as a
qualified facility must be retained at the facility for as long as necessary to support the status of a facility as a qualified facility during
the applicable calendar year.
Provide for offsite storage of all records other than the food safety
plan, provided that the offsite records can be retrieved and provided onsite within 24 hours of request for official review.
Provide that the food safety plan may be transferred to some other
reasonably accessible location if the plant or facility is closed for a
prolonged period, provided that it is returned to the plant or facility
within 24 hours of request for official review.
• Establish requirements applicable to all written assurances required
by the rule.
• Establish additional requirements applicable to written assurances
that are required when a food product distributed by manufacturer/
processor requires further processing for food safety by a subsequent manufacturer.
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507.202(c) ....................................
A. Proposed § 507.200—Records Subject
to the Requirements of Subpart F and
Requirements for Official Review
We proposed that all records required
by part 507 would be subject to all
requirements of subpart F, except that
certain specific requirements (proposed
§ 507.206) would apply only to the
written food safety plan. We also
proposed that certain proposed
requirements (e.g., for records to contain
the actual values and observations
obtained during monitoring and, as
appropriate, during verification
activities) would not apply to the
records that would be kept by qualified
facilities. We proposed that records
required by proposed part 507 are
subject to the disclosure requirements
under part 20 (21 CFR part 20). We
proposed that all records required by
proposed part 507 be made promptly
available to a duly authorized
representative of the Secretary of HHS
upon oral or written request. We also
asked for comment on whether we
should require a facility to send records
to us rather than make the records
available for review at a facility’s place
of business and, if so, whether we
should require that the records be
submitted electronically.
(Comment 488) Some comments
disagree with the proposal to exempt
the records that would be kept by
qualified facilities from requirements to
keep accurate, detailed records. The
comments note that the proposed
exemption would apply to qualified
facilities regardless of whether they
operate under the first option for
documentation (i.e., food safety
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practices) plans or under the second
option for documentation (i.e.
compliance with non-Federal food
safety laws). These comments assert that
the proposed detailed record keeping
requirements should apply to records
relating to monitoring food safety
practices and ask us to revise the
proposed requirements so that this
exemption would apply only to those
qualified facilities that operate under
non-Federal food safety laws.
(Response 488) We decline this
request. We based the proposed
exemption on a statutory provision that
a qualified facility is not subject to
certain requirements, including the
statutory recordkeeping requirements
(see section 418(l)(2) of the FD&C Act).
Although the requirements that apply to
a qualified facility require submission of
certain attestations to FDA (see
§ 507.7(a) and (b)), and these attestations
must be supported by documentation
(see § 507.7(f)), the rule does not require
that records kept by a qualified facility
to support its attestations be the same
type of records that would be kept by a
facility subject to subparts C and E. For
example, if the facility attests that it has
identified the potential hazards
associated with the animal food being
produced, implemented preventive
controls to address the hazards, and is
monitoring the performance of the
preventive controls, the qualified
facility might support its attestation by
having a standard operating procedure
for monitoring preventive controls
rather than detailed records of actual
monitoring.
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(Comment 489) Some comments
assert that the proposed requirements
governing public disclosure are not
aligned with other risk-based preventive
controls programs, such as HACCP
programs. These comments argue that
these proposed requirements should be
realigned with other risk-based
preventive controls programs to
preserve the privacy of information
maintained in required records unless
that information has been otherwise
made publicly available. Some
comments suggest that we revise the
proposed requirements to be analogous
to the public disclosure requirements in
our HACCP regulations for seafood and
juice (see §§ 123.9(d) and 120.12(f),
respectively).
(Response 489) We disagree that the
proposed provisions governing public
disclosure are not aligned with the
public disclosure provisions of our
HACCP regulations for seafood and
juice. Our regulations in part 20
regarding public information apply to
all Agency records, regardless of
whether a particular recordkeeping
requirement says so. In the case of the
recordkeeping requirements for our
HACCP regulations for seafood and
juice, we framed the provisions
regarding public disclosure by
providing specific details about how
particular provisions in part 20 (i.e.,
§ 20.61 (Trade secrets and commercial
or financial information which is
privileged or confidential) and § 20.81
(Data and information previously
disclosed to the public)) would apply to
the applicable records. In the case of the
recordkeeping requirements for this
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rule, we framed the provisions regarding
public disclosure by more broadly
referring to all the requirements of part
20, consistent with our more recent
approach for framing the provisions
regarding public disclosure in the rule
‘‘Prevention of Salmonella Enteritidis in
Shell Eggs During Production, Storage,
and Transportation’’ (part 118; see
§ 118.10(f)). Provisions such as § 20.20
(Policy on disclosure of Food and Drug
Administration records) apply to all
records that we have in our system,
including HACCP records, even though
the HACCP regulations do not specify
that this is the case.
(Comment 490) Some comments ask
us to clarify that the disclosure
requirements of part 20 include
protections for trade secrets and
privileged or confidential commercial
information and financial information.
Other comments ask us to clarify that
written food safety plans and associated
records are not subject to public
disclosure because they represent trade
secret or confidential commercial
information. Other comments ask us to
clarify how the disclosure requirements
of part 20 would apply to verification
records (such as testing records).
(Response 490) The questions raised
in these comments are similar to some
of the questions raised during the
rulemaking to establish FDA’s HACCP
regulation for seafood (see the
discussion at 60 FR 65096 at 65137
through 65140, December 18, 1995).
FDA’s experience in conducting CGMP
inspections in processing plants, our
experience with enforcing the HACCP
regulations for seafood and juice, and
our understanding from the Final
Regulatory Impact Analysis (FRIA) for
this rule (Ref. 60) make it clear that food
safety plans will take each facility some
time and money to develop. Thus, we
conclude that food safety plans
generally will meet the definition of
trade secret, including the court’s
definition in Public Citizen Health
Research Group v. FDA, 704 F.2d 1280
(D.C. Cir. 1983). Plans that incorporate
unique regimens or parameters to
achieve product safety, which are the
result of considerable research and
effort, will surely meet this definition.
We would establish the status of
verification records, such as the results
of product testing and environmental
monitoring, as available for, or protected
from, public disclosure on a case by
case basis. As discussed in Response
491, we primarily intend to copy such
records when we conduct an inspection
for cause. We also intend to copy such
records if the preliminary assessment by
our investigator during a routine
inspection is that regulatory followup
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may be appropriate (e.g., if these records
demonstrate that an environmental
pathogen has become established in a
niche environment in an animal food
processing plant).
(Comment 491) Some comments
assert that we should not copy
documents as part of routine
investigations so as to prevent critical
documents from release under the
FOIA. These comments are particularly
concerned that our ability to copy
verification records (such as testing
records) and potentially release these
records under the FOIA would
discourage facilities from testing as a
verification activity. These comments
also express concern that some facilities
would include in their food safety plans
elements, not required by the proposed
rule, that address food defense, as well
as food safety, and that disclosure of
such a food safety plan without proper
redaction could provide useful
information to persons seeking to defeat
the facility’s food defense strategies. In
addition, these comments express
concern that the task of reviewing all of
these records and redacting trade secrets
and confidential information would
further set back FDA’s already
overburdened FOIA offices and create
even longer delays in responding to
FOIA requests.
(Response 491) We have revised the
proposed requirement to specify that all
required records must be made
promptly available ‘‘for official review
and copying’’ to increase the alignment
of the recordkeeping requirements of
this rule with those of our HACCP
regulations for seafood and juice. The
issues raised by these comments are
similar to some of the issues raised by
comments during the rulemaking to
establish our HACCP regulations for
seafood (see the discussion at 60 FR
65096 at 65137 through 65140) and our
regulations in part 118 for the
prevention of Salmonella Enteritidis in
shell eggs. We intend to copy records on
a case-by-case basis as necessary and
appropriate. We may consider it
necessary to copy records when, for
example, our investigators may need
assistance in reviewing a certain record
from relevant experts in headquarters. If
we are unable to copy the records, we
would have to rely solely on our
investigators’ notes and reports when
drawing conclusions. In addition,
copying records will facilitate followup
regulatory actions.
We primarily intend to copy records
such as the results of product testing or
environmental monitoring when we
conduct an inspection for cause, e.g., as
a result of an outbreak investigation,
violative sample results, or followup to
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a consumer complaint. See Response
490 for a discussion of how the FOIA
would apply to records, such as records
of testing as a verification activity, that
we copy during an inspection and
maintain in our system.
(Comment 492) Some comments ask
us to modify the proposed requirement
to clarify that it is ‘‘records required by
this part and provided to the Agency,’’
rather than ‘‘records obtained by the
Agency’’ that are subject to public
disclosure.
(Response 492) We agree that it is
appropriate to specify that the
disclosure requirements of this rule
apply to information that we maintain
as a record (see the description of
‘‘record’’ in § 20.20(e)). (See also the
discussion (in the proposed rule to
establish our seafood HACCP regulation,
59 FR 4142 at 4160, January 28, 1994)
that there are significant legal and
practical questions as to whether FDA
has the authority to require disclosure of
industry records that are not in FDA’s
possession.) However, we see no
meaningful distinction between records
‘‘provided to FDA’’ and records
‘‘obtained by FDA,’’ and have revised
the provision to specify that records
obtained by FDA in accordance with
this part are subject to the disclosure
requirements under part 20. The revised
regulatory text makes clear that the
requirements of part 20 attach to those
documents obtained by FDA. To the
extent that these comments are
addressing the difference between
records provided during inspection and
records submitted to us, as already
discussed we have decided not to
require submission of certain records to
us (see Response 493).
(Comment 493) Some comments
strongly oppose any requirement for
submission of records to FDA remotely
and assert that there is no basis in
FSMA for such a requirement. Some
comments express concern about our
ability to protect confidential
information (such as supplier and
customer records received by a facility
under the protection of confidentiality
agreements) that is transmitted
electronically (e.g., the information that
might be released through computer
hacking or leaks). Some comments note
that inadvertent disclosure of
information related to specific products,
hazards, and preventive controls
implemented at food facilities could
both prove harmful from a commercial
or competitive standpoint and expose
existing vulnerabilities in the U.S. food
supply, thus potentially rendering food
facilities susceptible to malicious attack.
Some comments express concern over
any potential requirements to submit
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reports from third-party audits to FDA.
The comments state that a requirement
to submit audit reports, which may be
included as voluntary or required
components of a facility’s food safety
plan, would not be of public health
benefit and could potentially impact a
facility’s willingness to use audits in
their food safety program.
Some comments offered that instead
of submission of the food safety plan, a
facility should submit a ‘‘certification’’
that the facility has a food safety plan
during the course of the facility
registration process.
Some comments oppose the concept
of a ‘‘desk audit’’ whereby our
investigators conduct their inspections
from a remote office without actually
visiting the facility and assert that our
access to company records must be
conducted on-site in the course of an
authorized inspection so that we may
understand the full context of what the
records show. Some comments point
out that there would be challenges
associated with credential validation
when we asked for records to be sent
remotely, such as in an email request.
Some comments ask that we modify the
proposed requirement to specify that
records would only be made available to
us during a facility inspection.
(Response 493) We have decided not
to establish any requirements for a
facility to send records to us. We will
review records when we are onsite in
the course of an authorized inspection,
and copy records as necessary and
appropriate.
We are not modifying the proposed
requirement to specify that records
would only be made available to us
during a facility inspection because it is
not necessary to do so. The regulatory
text specifying that the records be made
available to a duly authorized
representative of the Secretary of HHS
provides the context that the records
would be made available during
inspection.
B. Proposed § 507.202—General
Requirements Applying to Records
We proposed that the records must:
(1) Be kept as original records, true
copies, or electronic records (and that
electronic records must be kept in
accordance with part 11 (21 CFR part
11)); (2) contain the actual values and
observations obtained during
monitoring and, as appropriate, during
verification activities; (3) be accurate,
indelible, and legible; (4) be created
concurrently with performance of the
activity documented; (5) be as detailed
as necessary to provide history of work
performed; and (6) include the name
and location of the plant or facility, the
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date and time of the activity
documented, the signature or initials of
the person performing the activity, and,
where appropriate, the identity of the
product and the production code, if any.
We have revised the provision to
require information adequate to identify
the plant or facility (e.g., the name, and
when necessary, the location of the
plant or facility) rather than to always
require both the name and location of
the plant or facility (see § 507.202(b)(1)).
In some cases, the name of the plant or
facility will be adequate to identify it,
e.g., when a plant or facility is not part
of a larger corporation that has facilities
at more than one location. In other
cases, the name of the plant or facility
may not, by itself, be adequate to
identify the plant or facility, e.g., when
a plant or facility is part of a larger
corporation with more than one location
and the ‘‘name’’ of each plant or facility
is the same.
(Comment 494) Some comments
express concern about ‘‘apparent
mandates’’ that we will require records
to be kept as paper copies, even if the
records were generated electronically,
for 2 years.
(Response 494) We did not propose to
require that all records must be kept as
paper copies. A facility has the choice
to keep records as original records, true
copies, or electronic records.
(Comment 495) Some comments
assert that compliance with part 11 for
the secure operation of many systems
currently in use is unnecessary and
would create the need to redesign and
recreate existing systems, thus leading
to considerable cost and complexity.
These comments identify the
requirement for hardware and software
to be validated as a key cost concern
and assert that validation activities
would be difficult to maintain and
would not deliver added value. As an
example, these comments explain that
an expectation for validation of
electronic recordkeeping software and
hardware would be particularly
problematic because software patches
and security updates are distributed on
a nearly weekly basis, and express the
view that validation procedures are
most appropriately applied before use of
a new system and after major software
changes or updates. These comments
also assert that it would be costly,
burdensome, and require specialized
resources to modify or replace existing
electronic systems to comply with part
11. These comments provide an
example in which a facility needed
more than 9 months to upgrade one
system alone to comply with part 11,
and note that it would not be unusual
for companies to employ multiple
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systems, so the burden and cost would
exponentially increase. These comments
ask us to instead require facilities that
use electronic records to a use secure
system that ensures records are
trustworthy, reliable, and generally
equivalent to paper records and
handwritten signatures executed on
paper.
Other comments express concern
about the financial burden for small
facilities such as farm mixed-type
facilities and ask us to either modify
requirements for farm mixed-type
facilities, very small businesses, and
small businesses or provide that such
facilities be fully exempt from part 11
requirements for electronic records.
Other comments state that, as with the
recordkeeping requirements under the
Bioterrorism Act, such requirements are
disproportionate to the regulatory need.
Some comments state that major
advances in software technology have
been made since part 11 published in
1997, and such advances must be
carefully considered in evaluating any
potential expansion or new applications
of part 11. These comments also state
that we already are in the process of
reevaluating part 11 for the regulations
for which it currently applies, citing
industry guidance issued more than 10
years ago in which we acknowledged
that part 11 is unworkable in many
respects and decided to exercise
enforcement discretion for part of the
regulations and announced plans to
reexamine part 11 as a whole.
Some comments recommend that we
develop guidance, with input from key
stakeholders, to describe the kinds of
systems and steps that can be used to
assure records meet the required
standard. This guidance should clearly
establish that specific security needs
will depend on the circumstances,
including the system at issue, its
intended use, the criticality of the
preventive control or other food safety
measure it is used to manage, and other
relevant factors. For example, these
comments explain that a quality system
used to manage CCP documentation
would have greater security needs than
a review of a Certificate of Analysis for
a non-sensitive ingredient.
(Response 495) In light of the
substantial burden that could be created
by the need to redesign large numbers
of already existing electronic records
and recordkeeping, we are providing in
new § 507.202(c) that records that are
established or maintained to satisfy the
requirements of part 507 and that meet
the definition of electronic records in
§ 11.3(b)(6) are exempt from the
requirements of part 11. As we did in
the section 414 recordkeeping
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regulations, we also are specifying that
records that satisfy the requirements of
part 507, but that also are required
under other applicable statutory
provisions or regulations, remain
subject to part 11. The rule provides that
a facility may rely on existing records to
satisfy the requirements of this rule, and
this rule does not change the status
under part 11 of any such records if
those records are currently subject to
part 11. As we did in the rulemaking to
establish the section 414 recordkeeping
regulations, we are establishing a
conforming change in part 11 to specify
in new § 11.1(j) that part 11 does not
apply to records required to be
established or maintained under part
507, and that records that satisfy the
requirements of part 507, but that also
are required under other applicable
statutory provisions or regulations,
remain subject to part 11.
Although we are not specifying that
part 11 applies, facilities should take
appropriate measures to ensure that
records are trustworthy, reliable, and
generally equivalent to paper records
and handwritten signatures executed on
paper.
(Comment 496) Some comments
assert that certain production and
associated activities are not timesensitive and would not require
documentation of the time the activity
is performed. These comments ask us to
modify the proposed requirements so
that the records would only require the
time of the activity documented where
appropriate for food safety.
(Response 496) We agree that certain
activities (e.g., record review and
verification activities) are not timesensitive and, thus, would not need to
include the time that the activity was
performed. The final rule provides
flexibility for the facility to determine
when to document the time by
specifying that the time be documented
‘‘when appropriate’’ (see
§ 507.202(b)(2)).
(Comment 497) Some comments
assert that concurrent record creation
will prove difficult in many animal
food-processing environments. These
comments ask us to modify the
proposed requirement that records be
created concurrently with the
performance of the activity documented
to qualify that the requirement only
applies where feasible, and that the
records could be created as soon as
possible thereafter under circumstances
where concurrent record creation is not
feasible.
(Response 497) We decline this
request. The comments did not provide
any examples of activities where
concurrent record creation in animal
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food manufacturing/processing,
packing, or holding environments
would prove difficult, and we are not
aware of any such example. For
example, we are not aware of any
difficulty complying with longstanding
similar requirements associated with
our HACCP regulations for seafood and
juice (see §§ 123.9(a)(4) and
120.12(b)(4), respectively).
C. Proposed § 507.206—Additional
Requirements Applying to the Food
Safety Plan
We proposed that the food safety plan
must be signed and dated by the owner,
operator, or agent in charge of the
facility upon initial completion and
upon any modification.
(Comment 498) Some comments ask
for clarification on who can sign and
date the food safety plan. Some
comments state that the proposed rule
would exclude the preventive controls
qualified individual from signing and
dating the food safety plan unless the
preventive controls qualified individual
is the owner, operator, or agent in
charge of the facility. These comments
ask us to revise the rule to allow the
preventive controls qualified individual
to sign and date the food safety plan
(e.g., because it is the preventive
controls qualified individual who
prepares (or oversees the preparation of)
the food safety plan). One comment
suggests that ‘‘agent in charge’’ be
defined to include all preventive
controls qualified individuals. Some
comments ask us to require that any
preventive controls qualified
individuals who prepare (or oversee the
preparation of) specific sections of the
food safety plan sign and date
applicable sections.
(Response 498) We decline these
requests. The statute expressly directs
the owner, operator, or agent in charge
of a facility to prepare the food safety
plan (see section 418(h) of the FD&C
Act). As previously discussed, such a
signature would provide direct evidence
of the owner, operator or agent’s
acceptance of the plan and commitment
to implementation of the plan (78 FR
64736 at 64816). A facility has
flexibility to require the signature of one
or more preventive controls qualified
individuals who prepared, or oversaw
the preparation of, its food safety plan
in addition to the minimum signature
requirement specified in the rule.
Likewise, a facility also has flexibility to
require the signature of one or more
members of its food safety team who
contributed to the preparation of the
food safety plan, even if those
individuals are not serving as the
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preventive controls qualified individual
for the facility.
D. Proposed § 507.208—Requirements
for Record Retention
We proposed that: (1) All required
records must be retained at the plant or
facility for at least 2 years after the date
they were prepared; (2) records relating
to the general adequacy of equipment or
processes being used by a facility,
including the results of scientific
studies and evaluations, must be
retained at the facility for at least 2 years
after their use is discontinued; (3)
except for the food safety plan, offsite
storage of records is permitted after 6
months following the date that the
records were made if such records can
be retrieved and provided onsite within
24 hours of request for official review;
and (4) if the plant or facility is closed
for a prolonged period, the records may
be transferred to some other reasonably
accessible location but must be returned
to the plant or facility within 24 hours
for official review upon request.
(Comment 499) Some comments ask
us to clarify that the 2-year record
retention requirement only applies to
records created after the compliance
date for the final rule.
(Response 499) The retention
requirements only apply to records
created after the applicable compliance
date for the final rule. See Response 76
and section LIII.A, which explain that
the compliance date for a facility to
retain records to support its status as a
qualified facility is January 1, 2017. See
also Response 502, which explains that
we have revised the record retention
provisions to specify that records that a
facility relies on during the 3-year
period preceding the applicable
calendar year to support its status as a
qualified facility must be retained at the
facility for as long as necessary to
support the status of facility as a
qualified facility during the applicable
calendar year.
(Comment 500) Some comments ask
us to delete the proposed requirement to
keep records on site for 6 months or 2
years (depending on the record) and
assert that it should suffice to require
that records be available within 24
hours of request or within a reasonable
period of time. Some comments assert
that records should be able to be kept
in the location where they are created,
which may be at corporate headquarters.
Other comments state that it may be
difficult to obtain records within 24
hours and requested additional time.
Comments also assert that specifying the
location for record storage will increase
costs but will not contribute to
improvements in public health. Some
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comments ask us to permit offsite
storage for all records over 6 months
old, in contrast to the 2-year retention
period we proposed for records relating
to the general adequacy of equipment or
processes being used by a facility,
including the results of scientific
studies and evaluations.
(Response 500) We have revised the
provisions to provide for offsite storage
of all records (except the food safety
plan), provided that the records can be
retrieved and made available to us
within 24 hours of request for official
review. We have determined that in
order to maintain inspectional
efficiency, 24 hours is a reasonable
period to allow for retrieval of any
offsite records. We expect that many
records will be electronic records that
are accessible from an onsite location
and, thus, would be classified as being
onsite (see § 507.208(c)). As a
companion change, we have revised the
proposed provision directed to the
special circumstance of storing records
when a facility is closed for prolonged
periods of time so that it only relates to
the offsite storage of the food safety plan
in such circumstances (see
§ 507.208(d)).
(Comment 501) Some comments
assert that a 2-year retention period for
records is much longer than needed for
animal food products, as animal food is
often consumed within a short time
after manufacture. These comments ask
us to establish a 1-year period for record
retention, which would be similar to
record retention periods required in
other FDA regulations. Some comments
assert that records should be required to
be kept for the shelf life of the product
plus an additional 6 months, for certain
animal foods such as pet foods.
(Response 501) We decline these
requests. The proposed 2-year retention
period is authorized by the statute (see
section 418(g) of the FD&C Act).
Moreover, the reasons discussed by the
comments for linking the retention
period to shelf life are more relevant to
the record retention requirements for
the purpose of tracking potentially
contaminated food (part 1, subpart J; see
§ 1.360) than to the record retention
requirements for the purpose of
evaluating compliance with this rule.
(Comment 502) Some comments ask
us to require that qualified facilities
keep financial and sales records for 3 or
4 years, because a qualified facility must
document that the average value of food
it sold over the prior 3 years did not
exceed $500,000 annually.
(Response 502) We have revised the
record retention provisions to specify
that records that a facility relies on
during the 3-year period preceding the
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applicable calendar year to support its
status as a qualified facility must be
retained at the facility as long as
necessary to support the status of a
facility as a qualified facility during the
applicable calendar year. As discussed
in section VIII.A, the definition of very
small business established in this rule is
based on an average (of sales plus
market value of animal food held
without sale) during the 3-year period
preceding the applicable calendar year.
Thus, both of the criteria for the
qualified facility exemption are based
on financial records associated with the
preceding 3-year period. The actual
retention time necessary to support the
status of a qualified facility during the
applicable calendar year could be as
long as 4 years. For example, if we
inspect a facility on May 1, 2024, the
facility would have retained the records
from 2021 to 2023 for 3 years and 4
months. If we inspect the facility on
December 28, 2024, the facility would
have retained the records from 2021 to
2023 for nearly 4 years.
E. Proposed § 507.212—Use of Existing
Records
We proposed that existing records
(e.g., records that are kept to comply
with other Federal, State, or local
regulations, or for any other reason) do
not need to be duplicated if they contain
all of the required information and
satisfy the requirements of subpart F.
Existing records may be supplemented
as necessary to include all of the
required information and satisfy the
requirements of subpart F. We also
proposed that the information required
by part 507 does not need to be kept in
one set of records. If existing records
contain some of the required
information, any new information
required by part 507 may be kept either
separately or combined with the
existing records.
Comments that address this proposed
requirement support it. For example,
some comments state that this provision
would provide flexibility to facilities to
comply with the record requirements in
an efficient manner. Other comments
state that this provision would prevent
companies from having to duplicate
records or create new records solely to
satisfy recordkeeping requirements.
(Comment 503) Some comments state
that food safety plan records are a ‘‘web
of related documents’’ that may be used
in other programs and cannot be
collected or reduced to a ‘‘binder.’’
(Response 503) We agree that food
safety plan records could be considered
a ‘‘web of related documents,’’ i.e., a set
of records that could include documents
used in other programs. We also agree
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that the food safety plan records need
not be collected in a single location or
‘‘reduced to a binder.’’ Likewise, the
records documenting implementation of
the plan could be a ‘‘web of related
documents.’’ For example, a facility that
collects samples of product and sends
them to a laboratory for testing would
have records documenting its collection
of samples, as well as records
documenting the laboratory’s test
results. Consistent with the
requirements of the rule for written
procedures for product testing
(§ 507.49(b)(2)) and the general
recordkeeping requirements of subpart F
(§ 507.202), the sampling records would
contain information such as the name
and location of the facility, the date
when the samples were collected, the
signature or initials of the person
collecting the samples, and the identity
and lot code of the sampled product.
Likewise, the laboratory report would
contain information identifying the
laboratory, the product tested (and
associated lot code), the test analyte, the
test(s) conducted (including the
analytical method(s) used), the date of
the test(s), the test results, and the
signature or initials of the person who
conducted the test. Alternatively, it
would be acceptable to have the
signature or initials of the person who
approved the release of the test results
from the laboratory. Together, these
records contain all the required
information to associate them with a
facility, a specific lot of product, and the
results of laboratory testing on that
product.
Although the provisions for use of
existing records provide flexibility,
there are some limitations. For example,
monitoring records must be created
concurrently with the monitoring
activity and contain the signature or
initials of the person conducting the
monitoring. If the facility has an existing
form that it uses to document the
monitoring activity, and that form does
not provide (or have space to add)
information adequate to identify the
plant or facility (e.g., the name and,
when necessary, the location of the
facility), and does have (or have space
to add) a place for the signature of the
person performing the activity, we
expect the facility to modify the form
rather than use the existing form. The
provisions for ‘‘supplementing’’ existing
records do not extend to providing
information identifying the facility, or
signatures, on separate pages.
(Comment 504) Some comments state
that our review of records should be
limited to issues under our jurisdiction,
regardless of the other information that
may be contained in the record. Other
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comments ask us to ensure that
inspectors are adequately trained on
how to review facility records for the
requisite information across multiple
sets of documents, as needed.
(Response 504) Section 418(h) of the
FD&C Act requires that the written plan
that documents and describes the
procedures used by the facility to
comply with the requirements of section
418, together with the documentation of
monitoring of preventive controls,
instances of nonconformance material to
food safety, the results of testing and
other means of verification, instances
when corrective actions were
implemented and the efficacy of
preventive controls and corrective
actions, be made available to FDA. Our
inspectors will be trained to focus on
the written food safety plan and the
records documenting implementation of
the plan during inspections. Our
inspectors have experience in the
review of records that an animal food
business establishes and maintains for
more than one purpose—e.g., during the
review of records kept under the section
414 recordkeeping regulations during
the investigation of an outbreak of
foodborne illness.
For further discussion of comments
received on recordkeeping
requirements, see section XLI in the
final rulemaking for preventive controls
for human food published elsewhere in
this issue of the Federal Register.
F. Final § 507.215—Special
Requirements Applicable to a Written
Assurance
As discussed in section XXVII, new
§ 507.215 establishes requirements
applicable to the written assurance a
manufacturer/processor obtains from its
customer. New § 507.215(a) applies to
all written assurances required by the
rule, i.e., the assurance must contain the
effective date; printed names and
signatures of authorized officials; and
the applicable assurance.
The provisions of § 507.215(b),
together with another new provision
(§ 507.37), establish legal
responsibilities under the rule for a
facility that provides a written
assurance regarding a food product that
a manufacturer/processor distributes
without application of a preventive
control that is needed to control a
hazard. This responsibility exists even
for a facility that is not itself a
manufacturer/processor, such as for a
facility that is a distributor. We are
establishing legal responsibilities for the
facilities that provide these written
assurances because following these
assurances is critical to ensuring that
required preventive controls are applied
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to the food by an entity in the
distribution chain before the food
reaches consumers.
XLIX. Comments by Foreign
Governments and Foreign Businesses
We received several comments from
foreign governments and foreign
businesses covering a wide range of
issues. Many of those comments were
similar to comments made on certain
topics by domestic stakeholders, so we
are addressing those comments in other
sections throughout this preamble. In
this section, we are responding to
comments that are primarily focused on
international issues, such as the
obligations of the United States under
the World Trade Organization
Agreement (WTO).
(Comment 505) Some comments by
foreign government representatives ask
us to provide extended periods of time
for the implementation of the rule for
facilities in foreign countries.
(Response 505) The concept of special
and differential treatment is
incorporated in the WTO Agreements.
Article 10.2 of the WTO Sanitary and
Phytosanitary (SPS) Agreement states:
‘‘Where the appropriate level of sanitary
or phytosanitary protection allows
scope for the phased introduction . . .
longer timeframes for compliance
should be accorded on products of
interest to developing country Members
so as to maintain opportunities for their
exports.’’
In 2001, at the WTO Ministerial
Conference in Doha, WTO Members
issued a Ministerial Decision that
interpreted the special and differential
obligations of the SPS Agreement (Ref.
61). The Ministerial Decision defined
‘‘longer timeframe for compliance’’ to
normally mean a period of not less than
6 months.
We recognize that businesses of all
sizes may need more time to comply
with the new requirements established
under this rule. As discussed in section
LIII, the compliance date for
implementation of subpart C, Hazard
Analysis and Preventive Controls is
extended one year beyond the
compliance date for the implementation
of subpart B, Current Good
Manufacturing Practice. Businesses
other than small and very small
businesses will have 1 year after the
date of publication to comply with the
CGMP requirements and 2 years after
publication to comply with preventive
controls requirements. Small businesses
will have 2 years after publication to
comply with the CGMP requirements
and 3 years after publication to comply
with preventive controls requirements.
Very small businesses will have 3 years
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after publication to comply with the
CGMP requirements and 4 years after
publication to comply with preventive
controls requirements. We anticipate
that these extended implementation
periods for small businesses and very
small businesses will apply to a number
of businesses in developing countries.
Because all of these time periods are
longer than the 6 month minimum
defined in the WTO Ministerial
Decision, we believe these
implementation periods are sufficient to
address the needs of businesses in
developing countries, particularly for
small and very small businesses in such
countries.
In addition to the extended time
periods for compliance for small and
very small businesses, we have also
established modified requirements for
very small businesses, which we define
as a business (including any
subsidiaries; and affiliates) averaging
less than $2,500,000, adjusted for
inflation, per year, during the 3-year
period preceding the applicable
calendar year, in sales of animal food
plus the market value of animal food
manufactured, processed, packed, or
held without sale (e.g., held for a fee or
supplied to a farm without sale). These
modified requirements for very small
businesses are less burdensome and are
described in § 507.7 of this regulation.
In addition to the extended and
staggered time periods for compliance
for all firms, and modified requirements
for very small businesses, we intend to
work with the animal food industry,
education organizations, USDA, the
United States Agency for International
Development, and foreign governments
to develop tools and training programs
to facilitate implementation of this rule.
(Comment 506) Some comments
assert that the food safety systems of the
European Union and other countries
afford a similar level of food safety
protection and must therefore be
recognized by FDA as equivalent under
the WTO SPS Agreement. These
comments urge FDA to accept the
HACCP plans and other steps taken to
comply with European food safety laws
as being sufficient to comply with this
rule.
(Response 506) The concept of
‘‘equivalence’’ for food safety regulatory
measures is contained in Article 4 of the
World Trade Organization Agreement
on the Application of Sanitary and
Phytosanitary Measures (the ‘‘SPS
Agreement’’) (Ref. 62). That article
provides that WTO Member countries
‘‘shall accept the sanitary or
phytosanitary measures of other
Members as equivalent, even if these
measures differ from their own or from
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those used by other Members trading in
the same product, if the exporting
Member objectively demonstrates to the
importing Member that its measures
achieve the importing Member’s
appropriate level of sanitary or
phytosanitary protection.’’ This
provision of the SPS Agreement
envisions a process in which the
exporting country provides evidence to
the food safety regulator in the
importing country in order to
‘‘objectively demonstrate’’ that the food
safety system in the exporting member
meets the level of food safety protection
established by the importing country.
To date, FDA has considered
equivalence as most appropriately
applied to the assessment of a foreign
government’s specific programs for
specific types of foods, such as shellfish
and dairy products. In that context, the
equivalence assessment provides a very
detailed comparison of each measure
that a country applies in controlling
risks associated with the particular
commodity under review. FDA
continues to have latitude to engage in
equivalence determinations for market
access and as required by our
regulations for certain commodities.
In contrast to the assessment of
equivalence for the regulation of
specific foods based upon a detailed
review of an individual food safety
measure or group of measures applied to
a specific food, FDA has established a
process of assessing foreign food safety
systems to identify systems that offer a
comparable level of public health
protection as the U.S. food safety system
for FDA regulated foods. We refer to that
process as ‘‘systems recognition,’’ which
we discuss in Response 507.
(Comment 507) Some comments urge
FDA to include a provision in this rule
that would reflect a determination made
by FDA in the ‘‘systems recognition’’
process so that FDA’s compliance
framework, including audit and
inspection activities, takes into account
the effectiveness of the regulatory or
administrative control of food safety
systems. These comments ask us to
include a provision in this rule
establishing that an affirmative systems
recognition determination by FDA for
an exporting country would be a
sufficient basis to exempt exporting
businesses from that country from their
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obligation to comply with the
requirements of this rule. Another
comment urges FDA to utilize the
systems recognition process to recognize
the effectiveness of the European Union
(EU) system in order to avoid
unnecessary or duplicative
requirements and controls on food
imports from the EU. Another comment
requests that FDA coordinate inspection
and audits with the relevant competent
authority.
(Response 507) We agree, in part, with
this comment. We agree that the systems
recognition program can allow FDA to
take into account the effectiveness of a
foreign food safety regulatory system as
we develop a compliance framework for
imported foods from a country for
which we have made an affirmative
determination of comparability via the
systems recognition program. While we
decline to add an exemption for food
imported from a country with
affirmative systems recognition
determination by FDA, we note that the
systems recognition program is based
upon the concept that foreign food
businesses can meet U.S. food safety
requirements by providing assurances
that these foods are produced according
to the food safety standards of a country
that FDA has found to be comparable or
equivalent to that of the United States.
Several provisions of the supply-chain
program specifically provide for
consideration of relevant laws and
regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States (see
§§ 507.110(d)(1)(iii)(B); 507.130(c)(2),
(d)(2), and (e)(2); and 507.135(b) and
(c)(1)(ii)). However, as of August 30,
2015, FDA has not developed a systems
recognition program for animal food;
therefore, we have no signed systems
recognition agreements with any foreign
food safety authority relating to animal
food. The currently existing systems
recognition agreement relates solely to
human food and does not apply to
animal food. For further discussion of
the systems recognition program, see
Response 718 of the final rule for
preventive controls for human food,
published elsewhere in this issue of the
Federal Register.
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We also note that we intend to
publish a final FSVP rule in the near
future. There, we intend to establish
modified requirements for food
imported from a foreign supplier in, and
under the regulatory oversight of, a
country whose food safety system FDA
has officially recognized as
‘‘comparable’’ to that of the United
States.
Section 507.105(a)(2) of this rule
provides the option for a receiving
facility that is an importer to comply
with the supplier verification
requirements in this rule or with the
foreign supplier verification program
requirements that we will establish in
part 1, subpart L for a raw material or
other ingredient. We intend that the
final FSVP rule will contain a similar
provision (derived from proposed
§ 1.502), so that only one supplier
verification procedure needs to be
undertaken in order to comply with
both rules when the specified
conditions are met.
(Comment 508) Some comments
assert that a proper harmonization is
needed with international standards and
ask us to harmonize the FSMA
requirements for the food safety plan
with international and domestic HACCP
programs. These comments also ask us
to explain any differences between the
FSMA food safety plan and the existing
HACCP programs and ask us to provide
exporters with background information
and specific examples of differences,
including how firms are directed to set
their CCPs and critical limits.
(Response 508) We currently have no
HACCP requirements applicable to
animal food. For discussion of this
comment, see Response 725 in the final
rule for preventive controls for human
food, published elsewhere in this issue
of the Federal Register.
L. Editorial and Conforming Changes
The revised regulatory text includes
several changes that we have made to
make the requirements more clear and
improve readability. The revised
regulatory text also includes several
conforming changes that we have made
when a change to one provision affects
other provisions. We summarize the
principal editorial and conforming
changes in table 31.
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TABLE 31—PRINCIPAL EDITORIAL AND CONFORMING CHANGES
Designation in the revised
regulatory text (§ )
Revision
Explanation
• 11.1(j) ................................................
Specify that part 11 does not
apply to records required to be
established or maintained under
part 507, and that records that
satisfy the requirements of part
507, but that also are required
under other applicable statutory
provisions or regulations, remain
subject to part 11.
• Substitute the term ‘‘adequate’’
for the term ‘‘sufficient’’.
• Substitute the term ‘‘inadequate’’
for the term ‘‘insufficient’’.
Substitute the term ‘‘pathogen’’ for
the term ‘‘microorganism of public health significance’’.
Substitute the term ‘‘preventive
controls qualified individual’’ for
the term ‘‘qualified individual’’.
Substitute the term ‘‘unexposed
packaged animal food’’ for the
phrase ‘‘packaged animal food
that is not exposed to the environment’’.
Substitute the phrase ‘‘chemical
(including radiological) hazards’’
for phrases such as ‘‘chemical
and radiological hazards’’.
Substitute the term ‘‘hazard requiring a preventive control’’ for the
term ‘‘significant hazard’’.
Shorten ‘‘raw agricultural commodity as defined in section
201(r) of the Federal Food,
Drug, and Cosmetic Act’’ to
‘‘raw agricultural commodity’’.
Redesignate subparagraphs to
distinguish between applying the
provisions in determining whether animal food is adulterated
and applying the provisions in
determining whether there is a
violation of the PHS Act.
Substitute ‘‘apply’’ for ‘‘are applicable’’ in the introductory paragraph.
Alphabetize the examples of harvesting activities in the definition
of ‘‘harvesting’’.
Alphabetize the examples of manufacturing/processing activities
in the definition of ‘‘manufacturing/processing’’.
Specify that the definition of ‘‘very
small business’’ includes any
subsidiaries and affiliates.
Conforming change associated with the recordkeeping requirements in § 507.202, which provide that part 11 does not apply
to records required to be established or maintained under part
507.
Throughout part 507 .............................
Throughout part 507 .............................
Throughout part 507 .............................
Throughout part 507 .............................
Throughout part 507 .............................
Throughout part 507 .............................
Throughout part 507 .............................
507.1(a) .................................................
507.3 .....................................................
507.3 .....................................................
507.3 .....................................................
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507.3 .....................................................
•
•
•
•
•
507.3 .................................................
507.5 .................................................
507.7(d) .............................................
507.10(a) ...........................................
507.65(d)(1) .......................................
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Substitute ‘‘subparts C and E’’ for
‘‘subpart C’’.
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Conforming change associated with our proposal, in the 2014
supplemental animal preventive controls notice, to make this
substitution so that the rule consistently uses the term ‘‘adequate.’’
Conforming change associated with the definition of ‘‘pathogen.’’
Conforming change associated with adding the term ‘‘preventive
controls qualified individual’’.
Conforming change associated with the definition of ‘‘unexposed
packaged animal food’’.
Conforming change associated with the definition of ‘‘hazard’’.
Conforming change associated with the proposed definition of
‘‘significant hazard’’ (which we now refer to as ‘‘hazard requiring
a preventive control’’).
Conforming change associated with the new definition of ‘‘raw agricultural commodity’’.
Improve clarity.
Improve clarity.
Improve clarity.
Improve clarity.
Give prominence to this aspect of the definition of ‘‘very small
business.’’ The relevance of subsidiaries and affiliates to the
definition of ‘‘very small business’’ is established in the definition of ‘‘qualified facility,’’ but including it again in the definition
of ‘‘very small business’’ will help to ensure that it is considered
when determining whether the business is within the dollar
threshold established in the definition of ‘‘very small business’’.
Conforming change associated with the redesignation of the requirements for a supply-chain program in new subpart E.
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TABLE 31—PRINCIPAL EDITORIAL AND CONFORMING CHANGES—Continued
Designation in the revised
regulatory text (§ )
Revision
507.7(a)(2)(ii) ........................................
Editorial change to place the
clause ‘‘including an attestation
based on licenses, inspection
reports, certificates, permits,
credentials, certification by an
appropriate agency (such as a
State department of agriculture),
or other evidence of oversight’’
at the end of the provision, rather than in a parenthetical at the
beginning of the provision.
Conforming changes associated
with the definition of ‘‘plant’’.
•
•
•
•
507.14 ...............................................
507.17(a) ...........................................
507.20(d) ...........................................
507.202(b) .........................................
507.20(d) ...............................................
• 507.25(a)(2) through(b)(1) ................
• 507.33(d)(3) .......................................
• 507.105(a)(1) .....................................
• 507.110(b) through (e) ......................
• 507.115(a) .........................................
• 507.120(a) and (b) ............................
• 507.130 .............................................
• 507.175(c) .........................................
507.31(b)(3), 507.34(c)(3), 507.39(b),
507.47(c)(3), 507.55(a)(5).
• 507.47(b)(2) .......................................
• 507.50(b)(4) .......................................
507.49(a)(4)(ii) ......................................
507.49(b)(1) ..........................................
507.50(c)(2) ..........................................
507.50(d) ...............................................
507.51(a)(2) ..........................................
• 507.51(a)(4)(ii) ...................................
• 507.51(a)(4)(iii) ..................................
507.51(a)(4)(iii) .....................................
507.53(a)(3) ..........................................
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507.53(a)(4) ..........................................
507.53(a)(6) ..........................................
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Explanation
Refer to ‘‘employees’’ rather than
‘‘its employees’’.
Changes to consistently refer to
raw materials and ‘‘other ingredients’’.
Refer to ‘‘supply-chain program’’
rather than ‘‘supplier program’’.
Conforming changes associated
with the definition of ‘‘validation’’.
Refer to ‘‘supply-chain verification
activities,’’ as well as ‘‘supplier
verification activities’’.
Changes to require written procedures for method and frequency
of accuracy checks for process
monitoring
instruments
and
verification instruments.
Conforming changes associated
with the timeframe for validating
preventive controls.
Editorial changes to the requirement to revise the written food
safety plan or document why revisions are not needed.
Editorial change to specify ‘‘provide assurance that the temperature controls are consistently performed’’ rather than
‘‘provide assurance that they are
consistently performed’’.
Substitute the phrase ‘‘records are
created’’ for the phrase ‘‘records
are made’’.
Change ‘‘within a week’’ to ‘‘within
7 working days’’.
Change to specify the role of the
preventive controls qualified individual in determining an alternative timeframe for validation.
Change to specify the role of the
preventive controls qualified individual in determining that validation is not required.
Change to specify the role of the
preventive controls qualified individual in determining an alternative timeframe for review of
records of monitoring and corrective actions.
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Improve clarity.
The definition of ‘‘plant’’ focuses on the building, structure, or
parts thereof, used for or in connection with the manufacturing,
processing, packing, or holding of animal food. The term ‘‘establishment’’ focuses on a business entity rather than on buildings or other structures.
Editorial change.
Conforming change with preventive controls rule for human food.
Conforming change associated with the title of final subpart E
(proposed § 507.37).
Improve clarity; consistency with the requirements for validation.
Consequential change as a result of the requirement in
§ 507.105(c) for verification of an entity that is in the supplychain but is not a supplier.
Conforming change associated with the requirements to calibrate
process monitoring instruments and verification instruments (or
check them for accuracy).
Consistency with the requirements for validating preventive controls.
Improve clarity.
Improve clarity.
Consistency with other recordkeeping requirements of the rule.
Conforming change associated with review of records of monitoring and corrective action records.
Conforming change associated with flexibility to determine the
timeframe for validation of a preventive control.
Conforming change associated with flexibility to determine that
validation of a preventive control is not required.
Conforming change associated with flexibility to determine the
timeframe for review of records of monitoring and corrective actions.
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TABLE 31—PRINCIPAL EDITORIAL AND CONFORMING CHANGES—Continued
Designation in the revised
regulatory text (§ )
Revision
Explanation
507.53(a)(8) ..........................................
Change to specify the role of the
preventive controls qualified individual in determining an alternative timeframe for completing
reanalysis.
Substitute the term ‘‘qualified facility exemption’’ for the phrase
‘‘exemption applicable to a
qualified facility’’ or the phrase
‘‘exemption applicable to a
qualified
facility
under
§ 507.5(d)’’.
Change ‘‘import alert’’ to ‘‘refusal
of animal food offered for import’’.
Change ‘‘FDA official senior to
such Director’’ to ‘‘FDA official
senior to either such Director’’.
Refer to ‘‘conditions or conduct’’
rather than ‘‘conduct or conditions’’.
Change ‘‘within 10 calendar days’’
to ‘‘within 15 calendar days’’.
Conforming change associated with flexibility to determine the
timeframe for completing reanalysis.
Subpart D (title) ....................................
507.60 ............................................
507.62 ............................................
507.65 ............................................
507.67 ............................................
507.80 ............................................
507.85 ............................................
507.60(b)(1) ..........................................
507.62(a) ...............................................
507.65(c)(2) ..........................................
•
•
•
•
•
•
507.67(a)(2) .......................................
507.69(a)(1) .......................................
507.71(a)(2), ......................................
507.73(a) ...........................................
507.85(a) ...........................................
507.85(b)(2) .......................................
507.202 .................................................
507.206 .................................................
Specify ‘‘any problems with the
conditions and conduct’’ rather
than ‘‘problems with the conditions and conduct’’ or ‘‘problems
with the conditions or conduct’’.
Refer to ‘‘lot code’’ rather than
‘‘production code’’.
Editorial changes to present the
requirement in active voice.
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LI. Comments on FSMA’s Rulemaking
Provisions
A. Comments on Section 418(m) of the
FDA&C Act Regarding Modified
Requirements for Facilities Solely
Engaged in the Production of Food for
Animals Other Than Man
Section 418(m) of the FD&C Act
authorizes the Secretary, by regulation,
to modify the requirements for
compliance under the section with
respect to facilities that are solely
engaged in the production of food for
animals other than man. We tentatively
concluded that the requirements of
section 418 of the FD&C Act are needed
to ensure the safety of animal food and
in turn the health of animals, the health
of humans who are exposed to animal
food, and the safety of animal derived
products for human consumption. We
proposed certain limited exemptions,
described elsewhere in this rule, as
provided by section 103 of FSMA. We
sought comment on whether the
requirements in section 418 of the FD&C
Act should be modified further for
facilities that are solely engaged in the
production of food for animals other
than man, based on scientific and public
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Conforming change associated with the definition of ‘‘qualified facility exemption’’.
Align with statutory language regarding imports rather than with
specific procedures that FDA uses for refusing admission to
animal foods offered for import.
The provision refers to two ‘‘Directors’’ and the clause applies to
either Director.
Consistency with regulatory text in § 507.60(a)(2).
Conforming change to reflect a timeframe of 15 calendar days,
rather than 10 calendar days, in the order withdrawing a qualified facility exemption.
Clarify that reinstatement of a qualified exemption that was withdrawn requires resolution of any problems, regardless of whether the problems related to conditions, conduct, or both conditions and conduct.
Consistency with the definition of ‘‘lot’’.
Improve clarity.
health principles (78 FR 64736 at
64745).
(Comment 509) Some comments agree
with our proposal to establish only
minor modifications to the requirements
of section 418 of the FD&C Act for
facilities solely engaged in the
production of food for animals other
than man. Other comments ask that we
consider proposing more extensive
modified requirements for animal food,
or exempting feed mills, using the
authority under section 418(m).
(Response 509) We did not receive
comments that provided sufficient data
and rationale to support changing our
proposed modifications to the
requirements in section 418 of the FD&C
Act. However, the final rule provides
risk-based flexibility in the preventive
controls requirements and their
management components by
recognizing the importance of the
facility, the food, the nature of the
preventive control, and its role in the
facility’s food safety system. For our
approach to feed mills, see our
discussion in section IV.
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B. Comments on Requirements in
Section 418(n)(3) of the FD&C Act
Regarding Content
FSMA specifies that this rule
acknowledge differences in risk and
minimize, as appropriate, the number of
separate standards that apply to separate
foods (section 418(n)(3)(C) of the FD&C
Act).
(Comment 510) Some comments agree
that the proposed preventive controls
requirements reflect a risk-based
approach and recognition that a ‘‘onesize-fits-all’’ approach is not appropriate
in the application of hazard analysis
and risk-based preventive controls
across the entire domestic and
international food industry. These
comments ask us to retain this
flexibility in the final rule by describing
the required and expected results of the
program, but not going as far as
prescribing the process and
methodology taken to get there. Other
comments emphasize that the final rule
must provide sufficient flexibility to
allow facilities to adopt practices that
are practical and effective for their
specific, individual operations. One
comment expressed the opinion that
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different manufacturing and distribution
practices are necessary to ensure the
safety of human food, pet food, and
livestock food.
(Response 510) The final rule directs
the owner, operator, or agent in charge
of a facility to establish and implement
a food safety plan that includes a
written hazard analysis, preventive
controls that the facility identifies to
control hazards requiring a preventive
control, and establish and implement
appropriate preventive control
management components to ensure the
effectiveness of the preventive controls,
taking into account the facility, the food,
the nature of the hazard, the nature of
the preventive control and its role in the
facility’s food safety system. As
requested by the comments, the rule
does not prescribe the process and
methodology to ‘‘get there.’’
(Comment 511) Some comments
interpret the statutory direction in
section 418(n)(3)(C) of the FD&C Act to
mean that Congress granted us authority
to provide flexibility for businesses of
all sizes and types (i.e., not just small
businesses), as well as to acknowledge
differences in risk. These comments
assert that section 418(n)(3)(C) grants us
authority to exempt distribution centers
from the requirements for hazard
analysis and risk-based preventive
controls because: (1) Distribution
centers are very low-risk facilities and
(2) requiring distribution centers to
comply with those requirements would
not be practicable.
(Response 511) We disagree with
these comments. A pet food distribution
center must register as a food facility
because it holds food for animal
consumption and does not satisfy any of
the criteria for entities that are not
required to register (see § 1.226). The
preventive controls that such a facility
would establish and implement would
depend on the facility, the animal food,
and the outcome of the facility’s hazard
analysis, and any preventive control
management components associated
with a facility’s preventive controls
would be established as appropriate to
ensure the effectiveness of the
preventive controls, taking into account
the nature of the preventive control and
its role in the facility’s food safety
system. In the case of a facility that is
a pet food distribution center, the
facility would, as part of its evaluation,
determine whether any preventive
controls are necessary for unexposed,
non-refrigerated packaged animal foods.
The facility might determine that the
modified requirements in § 507.51 for
unexposed, refrigerated, packaged TCS
animal foods are appropriate to apply to
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the following paragraphs, we discuss
comments that disagree with, or suggest
one or more changes to, these proposed
compliance dates. After considering
these comments, we have concluded
LII. Comments on Proposed Conforming
that additional time is needed for the
Amendments
animal food industry to comply with
We proposed a series of conforming
this final rule. Therefore, the
amendments to current regulations to
compliance date for implementation of
add a reference to part 507. The affected subpart C, Hazard Analysis and
sections in Title 21 CFR Chapter 1 are:
Preventive Controls and subpart E,
• § 11.1 Scope;
Supply-Chain Program, is extended one
• § 16.1 Scope;
year beyond the compliance date for the
• § 117.95 Holding and distribution of
implementation of subpart B, Current
human food by-products for use as
Good Manufacturing Practice.
animal food;
Businesses other than small and very
• § 225.1 Current good manufacturing
small businesses will have 1 year after
practice;
the date of publication to comply with
• § 500.23 Thermally processed lowthe CGMP requirements and 2 years
acid foods packaged in hermetically
after publication to comply with
sealed containers; and
preventive controls and supply-chain
• § 579.12 Incorporation of
requirements. Small businesses will
regulations in part 179.
have 2 years after publication to comply
We received no comments that
with the CGMP requirements and 3
disagree with the proposed conforming
years after publication to comply with
changes. Therefore, at this time we are
preventive controls and supply-chain
amending each of these current
regulations so that they refer to part 507 requirements. Very small businesses
will have 3 years after publication to
except for the amendment to part 225.
We proposed to add a new paragraph (d) comply with the CGMP requirements
and 4 years after publication to comply
in § 225.1 stating that ‘‘In addition,
nonmedicated feed is subject to part 507 with preventive controls requirements.
In addition, we are establishing an
of this chapter.’’ All animal food
earlier compliance date for the financial
facilities that are required to register as
records that a facility maintains to
a food facility under section 415 of the
support its status as a very small
FD&C Act are subject to the
business that is eligible for the qualified
requirements of part 507. This would
include those facilities that manufacture facility exemption in § 507.5(d).
Specifically, the compliance date for a
medicated animal feed, nonmedicated
animal feed, or both. Because of this, we facility to retain records to support its
status as a qualified facility is January
do not think the conforming change to
1, 2017. (See Response 76.)
part 225 is necessary and we are not
finalizing this conforming change.
We are also establishing separate
compliance dates for the supply-chain
LIII. Effective and Compliance Dates
program provisions. As discussed in
A. Effective and Compliance Dates for
Response 515, a receiving facility’s
Part 507
compliance date for the supply-chain
We proposed that the final rule based program provisions of this rule is the
later of: (1) The receiving facility’s
on proposed part 507 would become
compliance date for the other preventive
effective 60 days after its date of
controls requirements under this
publication in the Federal Register,
with staggered compliance dates (78 FR rulemaking; (2) for a raw material or
other ingredient from a supplier subject
64736 at 64751). We tentatively
to the preventive controls requirements
concluded that it was reasonable to
of this rule, six months after the
allow for 1 year after the date of
receiving facility’s supplier of that raw
publication of the final rule for
material or ingredient is required to
businesses other than small and very
comply with the preventive controls
small businesses to comply with the
rule. We also tentatively concluded that requirements of this rule; or (3) for a raw
material or other ingredient that from a
it was reasonable to allow for 2 years
supplier subject to CGMPs, but not the
after the date of publication of the final
rule for small businesses to comply with preventive controls requirements of this
rule, 6 months after the receiving
the rule, and 3 years after the date of
facility’s supplier of that animal food is
publication of the final rule for very
required to comply with the CGMP
small businesses to comply with the
requirements of this rule. See tables 32
rule.
and 33 for a summary of these
We received one comment agreeing
with our proposed compliance dates. In compliance dates.
such foods that it holds. If so, the
facility could establish its food safety
plan by building on the provisions
established in § 507.51.
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56329
TABLE 32—COMPLIANCE DATES FOR THE REQUIREMENTS OF PART 507 OTHER THAN THE REQUIREMENTS FOR A
SUPPLY-CHAIN PROGRAM (SUBPART E)
Size of business
Compliance date for subpart B
and related
requirements
Qualified facility (including very small
business) as defined in § 507.3.
September 17, 2018 ...........
Small business as defined in § 507.3 .....
All other businesses ................................
September 18, 2017 ...........
September 19, 2016 ...........
Compliance date for subpart C and § 507.7
September 17, 2019, except that the compliance date for a facility to
retain records to support its status as a qualified facility is January 1,
2017.
September 17, 2018.
September 18, 2017.
TABLE 33—COMPLIANCE DATES FOR THE REQUIREMENTS OF THE SUPPLY-CHAIN PROGRAM (SUBPART E)
Situation
Compliance date:
A receiving facility is a small business and its supplier will be subject to
the CGMPs, but not the preventive control requirements, of the animal food preventive controls rule.
A receiving facility is a small business and its supplier is subject to the
animal food preventive controls rule.
6 months after the receiving facility’s supplier of that raw material or
other ingredient is required to comply with the CGMP requirements
of this rule.
The later of: September 17, 2018 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to
comply with this rule.
6 months after the receiving facility’s supplier of that raw material or
other ingredient is required to comply with the CGMP requirements
of this rule.
The later of: September 18, 2017 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to
comply with the applicable rule.
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A receiving facility is not a small business or a very small business and
its supplier will be subject to CGMPs, but not the preventive control
requirements, of the animal food preventive controls rule.
A receiving facility is not a small business or a very small business and
its supplier will be subject to the animal food preventive controls rule.
We also are establishing two
additional compliance dates applicable
to qualified facilities. We are
establishing December 16, 2019 first as
the compliance date for the initial
submission of the attestation by a
facility that it is a qualified facility (see
§ 507.7(a)(1)) and the attestation by a
qualified facility about its food safety
practices (see § 507.7(a)(2)(i)), or that it
is in compliance with non-Federal food
safety law (see § 507.7(a)(2)(ii)), and
second as the compliance date for the
notification requirement of § 507.7(e)(1).
A qualified facility that submits an
attestation that it is in compliance with
applicable non-Federal food safety law
must notify consumers as to the name
and complete business address of the
facility where the animal food was
manufactured or processed (see
§ 507.7(e)). If an animal food packaging
label is required, the required
notification must appear prominently
and conspicuously on the label of the
animal food (see § 507.7(e)(1)). This
notification requirement may require
some qualified facilities to update the
labels of their packaged animal food
products.
(Comment 512) Some comments
disagree with the proposed compliance
dates and our tentative conclusion that
concepts in the CGMP regulations
would not be new to the animal food
industry. Comments state that both large
and small facilities would need to
expend considerable resources to
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implement the practices and procedures
to comply with the new requirements. A
few comments note that the complexity
of the proposed regulation presents a
challenge for compliance within the
proposed timeframes. Because both
CGMPs and preventive controls are new
for the animal food industry, comments
request additional time to comply with
the regulations. Some comments also
note that manufacturers of human food
have had many years to comply with
CGMPs, and the expectation that the
animal food industry will comply with
both CGMP and preventive controls
requirements in a narrow timeframe is
not reasonable. The majority of
comments agree that the
implementation dates for the CGMP
regulations should come before the
implementation date of the preventive
controls regulations.
(Response 512) We agree with the
comments and are extending the
compliance date for implementation of
the preventive controls regulations 1
year beyond the compliance date for the
implementation of CGMP requirements.
Because both the CGMP and preventive
controls regulations are new to the
animal food industry, we understand
that these facilities would have been
learning and implementing many new
requirements during the proposed
timeframe. With an extra year before
they must implement preventive
controls requirements, animal food
facilities will be able to focus on
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developing and implementing the
applicable CGMPs for their facilities.
Many of these CGMPs are considered
prerequisites for a preventive controls
program. Having CGMPs well in place
before having to implement the
preventive controls requirements will
provide the facility with a better
understanding of the additional controls
that might be needed to significantly
minimize or prevent any significant
hazards associated with the animal food
that the facility has identified. In
addition, facilities will have more time
to educate and train their employees on
the preventive controls requirements the
facility will need to implement. FDA
intends to work closely with the animal
food industry, extension and education
organizations, and state partners to
develop the tools and training programs
needed to facilitate implementation of
the final rule.
(Comment 513) Some comments
recommend that compliance dates for
the preventive controls rule for animal
food be set for 3 years after the 60-day
effective date of the rule, regardless of
firm size.
(Response 513) We disagree with this
comment. Although the requirements in
this final regulation are new for the
animal food industry, some individual
animal food facilities, either
individually or through feed industry
associations, have implemented some
procedures that are consistent with the
proposed requirements. Not all concepts
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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations
and processes are new to the entire
animal food industry, especially the
larger facilities. Therefore, we conclude
that these larger facilities should not
need 3 years to comply with the
requirements of this final regulation, in
contrast to some of the very small
businesses.
(Comment 514) Some comments ask
us to clarify when a very small business
would need to comply with the rule if
the business starts up after the rule goes
into effect.
(Response 514) A very small business
that is operating as of the date of
publication of the final rule, or begins
operating any time before the
compliance date for very small
businesses, must comply with the rule
by the compliance date for very small
businesses. A very small business that
begins operation any time after the
compliance date for very small
businesses must comply with the rule
when it begins operation, and should
plan accordingly.
(Comment 515) Some comments
request that compliance dates for the
proposed preventive controls rule
coincide with the requirements of the
proposed foreign supplier verification
program rule.
(Response 515) We are finalizing
separate compliance dates for the
supply-chain program provisions of this
rule. While this adds complexity, we are
doing this for two main reasons. First,
we are aligning, to the extent feasible,
the compliance dates of the supplychain program provisions of this rule
with the compliance dates of the
forthcoming FSVP rule, which we
intend to publish in the coming months.
This will provide greater coordination
across the programs, particularly with
respect to the verification of domestic
and imported raw materials and other
ingredients. Second, we want to
minimize the likelihood that a receiving
facility will be required to comply with
the supply-chain program provisions of
this rulemaking before its supplier is
required to comply with applicable new
food safety regulations implementing
FSMA. Our goal is to avoid a situation
in which a receiving facility would be
required to develop a supply-chain
program for an animal food from a
particular supplier and then be required
to revise this supply-chain program
shortly thereafter once the supplier is
subject to an applicable new food safety
regulation—specifically, the preventive
controls rule for animal food. Therefore,
the compliance dates for the supplychain program have been revised. A
receiving facility’s compliance date for
the supply-chain program provisions of
this rule is the later of: (1) The receiving
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facility’s compliance date for the other
preventive controls requirements under
this rulemaking; (2) for a raw material
or other ingredient from a supplier
subject to the preventive controls
requirements of this rule, 6 months after
the receiving facility’s supplier of that
raw material or ingredient is required to
comply with the preventive controls
requirements of this rule; or (3) for a raw
material or other ingredient that from a
supplier subject to CGMPs, but not the
preventive controls requirements of this
rule, 6 months after the receiving
facility’s supplier of that animal food is
required to comply with the CGMP
requirements of this rule.
B. Effective Dates for Conforming
Amendments
The conforming amendments to
regulations in parts 500 and 579 are
technical amendments that add a crossreference to part 507. The conforming
amendment to part 11 adds a reference
to the scope of part 11 that the records
required under part 507 are not subject
to part 11. The conforming amendment
to part 16 adds a reference to the scope
of part 16 for new procedures in part
507, subpart D that provide a person
with an opportunity for a hearing under
part 16. These conforming amendments
are effective on November 16, 2015, the
same date as the effective date of part
507. We are not establishing compliance
dates for these conforming amendments.
As a practical matter, compliance dates
will be determined by the dates for
compliance with part 507.
C. Delayed Effective Dates for Provisions
That Refer to the Forthcoming Rules for
Produce Safety and Third-Party
Certification
The following provisions refer to
provisions we intend to establish in the
near future in part 112 (Standards for
the Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption): §§ 507.12(a)(1)(ii),
507.105(c), 507.110(d)(2)(ii), 507.130(d),
and 507.175(c)(13). In addition,
paragraph (2) of the definition of
‘‘qualified auditor’’ in § 507.3 and
§ 507.135(d) refers to provisions we
intend to establish in the near future in
part 1, subpart M (Accredited ThirdParty Food Safety Audits and Food or
Facility Certification). In addition,
§§ 507.105(a)(2) and 507.175(c)(2) refer
to provisions we intend to establish in
the near future in part 1, subpart L
(Foreign Supplier Verification Programs
for Food Importers). We will publish a
document in the Federal Register
announcing the effective dates of
paragraph (2) of the definition of
‘‘qualified auditor’’ in § 507.3, and
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§§ 507.12(a)(1)(ii), 507.105(a)(2),
507.105(c), 507.110(d)(2)(ii), 507.130(d),
507.135(d), 507.175(c)(2) and
507.175(c)(13).
LIV. Compliance and Enforcement
Gaining industry compliance with the
provisions of this rule is as important as
establishing the provisions. A central
element of our strategy to gain industry
compliance is to help make available to
facilities subject to this rule the
education and technical assistance they
need to understand and implement the
requirements (Ref. 5). Within the
Agency we are establishing a Food
Safety Technical Assistance Network
and seeking funding to increase FDA
staffing to provide a central source of
information to support industry
understanding and implementation of
FSMA standards (Ref. 5). This will
allow us to respond in a timely and
consistent way to industry questions on
preventive controls technical and
compliance issues (Ref. 5).
We also are working in collaboration
with the FSPCA to develop training
materials and establish training and
technical assistance programs (Ref. 4)
and (Ref. 6). The FSPCA includes
members from FDA, State food
protection agencies, the animal food
industry, and academia. It is funded by
a grant to the Illinois Institute of
Technology’s Institute for Food Safety
and Health, a nationally-recognized
leader in food safety. In addition to
developing a standardized preventive
controls training curriculum, the FSPCA
is developing selected sections of model
food safety plans for several animal food
types that will provide needed
instructional examples. Although we
have provided funding to the FSPCA to
develop a standardized preventive
controls training curriculum, we are
unable to fund training for individual
groups who might need particular
training materials.
We also are partnering with the NIFA
of USDA to administer the FSMAmandated National Food Safety
Training, Education, Extension,
Outreach, and Technical Assistance
Program, a grant program to provide
technical assistance for FSMA
compliance to owners and operators of
small and medium-size farms and small
food processors (Ref. 7). Such efforts
will help ensure widespread voluntary
compliance by encouraging greater
understanding and adoption of
established food safety standards,
guidance, and protocols.
With regard to inspections, we will
conduct regular inspections of domestic
facilities to ensure that facilities subject
to this rule are adequately implementing
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the required preventive controls and
supply-chain program, pursuant to our
inspection authority under section 704
of the FD&C Act. Our inspections will
verify that such facilities are
implementing systems that effectively
protect against animal food
contamination, and in particular, that
they comply with the rule by
implementing preventive controls,
including supply-chain programs, to
provide assurances that any hazard
requiring a preventive control or
supply-chain applied control has been
significantly minimized or prevented.
In order to effectively carry out this
new paradigm of animal food safety, we
will need to reorient and retrain our
staff. To this end, we are seeking
additional funding, including for the
training of more than 2,000 FDA
inspectors, compliance officers, and
other staff involved in food safety
activities (Ref. 10).
We also plan to leverage the resources
of State, local, tribal, and territorial
governments to conduct domestic
verification activities. We are working
with officials from these governments
through the PFP to develop and
implement a national Integrated Food
Safety System, which will focus on
establishing partnerships for achieving
compliance (see section 209(b) of
FSMA), and which will allow us to
utilize the thousands of State, local, and
tribal inspectors available to help with
the domestic verification process.
Section 201 of FSMA mandates that
FDA inspect domestic high-risk
facilities no less than once every 3
years. Consistent with FSMA, FDA will
use its current resources, new resources
that it obtains, and its partnerships to
conduct regular inspections of covered
facilities, focusing on those facilities
that pose the highest risk to animal food
safety.
LV. Executive Order 13175
In accordance with Executive Order
13175, FDA has consulted with tribal
government officials. A tribal summary
impact statement has been prepared that
includes a summary of tribal officials’
concerns and how FDA has addressed
them (Ref. 63). Persons with access to
the Internet may obtain the tribal
consultation report at https://
www.fda.gov/pcafrule or at https://
www.regulations.gov. Copies of the
tribal summary impact statement also
may be obtained by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT.
LVI. Economic Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
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Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct Agencies to
assess all costs and benefits of available
regulatory alternatives and, when
regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity).
Executive Order 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. FDA has developed an FRIA
that presents the benefits and costs of
this final rule (Ref. 60). The Office of
Management and Budget (OMB) has
determined that this final rule is an
economically significant regulatory
action as defined by Executive Order
12866.
The summary analysis of benefits and
costs included in this document is
drawn from the detailed FRIA (Ref. 60)
which is available at https://
www.regulations.gov (enter Docket No.
FDA–2011–N–0922), and is also
available on FDA’s Web site at https://
www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on a
substantial number of small entities.
Because the final rule would impose
annualized costs that range from
$25,000 to $34,000 on many small
entities, the Agency determined that the
final rule will have a significant
economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that Agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before finalizing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $144
million, using the most current (2014)
Implicit Price Deflator for the Gross
Domestic Product. FDA expects this
final rule will likely result in a 1-year
expenditure that will meet or exceed
this amount.
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56331
LVII. Analysis of Environmental Impact
FDA has determined under 21 CFR
25.30(j) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment (Ref. 64). Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
LVIII. Paperwork Reduction Act of
1995
This final rule contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The title, description, and
respondent description of the
information collection provisions are
shown in this section with an estimate
of the annual reporting, recordkeeping,
and third-party disclosure burden.
Included in the estimate is the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing each
collection of information.
Title: Current Good Manufacturing
Practice, Hazard Analysis and RiskBased Preventive Controls for Food for
Animals.
Description: Regulations issued in the
final rule entitled, ‘‘Current Good
Manufacturing Practice, Hazard
Analysis and Risk-Based Preventive
Controls for Food for Animals,’’
implement section 418 of the FD&C Act,
as amended by the FDA Food Safety
Modernization Act (FSMA). The
regulations establish science-based
minimum standards for conducting a
hazard analysis, documenting hazards
requiring preventive controls,
implementing preventive controls, and
documenting the implementation of the
preventive controls by domestic and
foreign animal food facilities registered
with FDA under section 415 of the
FD&C Act. The regulations also
establish current good manufacturing
practice for the manufacturing,
processing, packing, and holding of
animal food.
The preventive controls regulations
require animal food facilities to have a
written food safety plan that includes a
hazard analysis; a description of
preventive controls (including recall
procedures); a supply-chain program, a
description of procedures for
monitoring the preventive controls;
corrective action if preventive controls
are not properly implemented; and a
description of procedures for verifying
implementation and effectiveness of the
preventive controls.
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The regulations further require
facilities to establish and implement
verification procedures for product
testing and environmental monitoring,
and require that the hazard analysis and
risk-based preventive controls for
animal food take into account the
possibility of economically motivated
adulteration of animal food. Facilities
that manufacture, process, pack, or hold
food for animals and foods for human
consumption and are subject to part 117
(as finalized elsewhere in this issue of
the Federal Register) may choose to
comply with part 117 with respect to
the animal food, provided the food
safety plan addresses the hazards
specific to animal food where
applicable.
The final rule also establishes certain
exemptions, under applicable
regulations. The rule imposes specific
reporting requirements on facilities
claiming the very small business
qualified facility exemption.
Description of Respondents: Facilities
that manufacture, process, pack, or hold
food for animals. Generally, a facility is
required to register if it manufactures,
processes, packs, or holds animal food
for consumption in the United States. At
the time of this analysis, the number of
animal food facilities registered with the
Agency was 7,469.
In the Federal Register of October 29,
2013 (78 FR 64736), FDA published a
proposed rule including a Paperwork
Reduction Act (PRA) analysis of the
information collection provisions found
in the regulations. In the Federal
Register of September 29, 2014 (79 FR
58476), FDA published a supplemental
notice of proposed rulemaking also
including a PRA analysis. Although
FDA did not receive comments
specifically addressing the four
information collection topics solicited
in both the 2013 proposed preventive
controls rule for animal food and the
2014 supplemental notice, we have
revised our burden estimate consistent
with finalization of the rule’s
requirements.
FDA estimates the burden for this
information collection as follows:
Reporting Burden
Table 34 shows the total estimated
annual reporting burden associated with
this final rule. This estimate is a
revision from reporting estimates found
in our proposed rulemaking, reflecting
an updated count of the number of
facilities registered with the Agency as
animal food facilities, and resulting in
an overall decrease from our previous
estimate.
TABLE 34—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section; activity
Average
burden per
response
(in hours)
Total annual
responses
Total hours
507.7 exemption: submit attestation that facility is a qualified facility and attestation of preventive controls or
compliance with non-Federal food safety laws ................
507.67, 507.69, and 507.71; submission of an appeal, including submission of a request for an informal hearing
507.85(b); requests for reinstatement of exemption ...........
1,120
.5
560
*.5
280
1
1
1
1
1
1
4
2
4
2
Total ..............................................................................
........................
........................
........................
........................
286
1 Capital
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and other costs of implementation and compliance for this final rule are discussed in the FRIA (Ref. 60).
* (30 minutes).
Out of 7,469 animal food facilities
registered with FDA, we estimate
approximately 15% (1,120) could be
‘‘qualified’’ facilities under the ‘‘very
small business’’ definition as discussed
in the FRIA (Ref. 60), and thus eligible
for certain limited exemptions under the
applicable regulations. Section 507.5
exempts qualified facilities from subpart
C and E of the regulations, which
includes all of the hazard analysis and
preventive controls requirements,
including supply-chain program
requirements. The number of
respondents in table 34, row 1 is
derived from Agency estimates of the
number of qualified animal food
facilities that must report their status as
such a facility every 2 years. The
number of total annual responses is
calculated by multiplying the number of
respondents by the number of responses
submitted annually. The average hourly
time burden per response found in table
34, column 5 is based on FDA’s
assumption that a facility will report its
status electronically through a Web
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portal maintained by FDA, and that this
will take approximately 0.5 hours (30
minutes).
The estimated burden associated with
the requirements under §§ 507.67,
507.69, and 507.71 of the regulations is
reflected in table 34, row 2. Based on
the limited data on foodborne illness
outbreaks originating at very small
animal food facilities, FDA does not
expect to withdraw many qualified
facility exemptions and expects the
number of appeals to be even fewer. The
estimated number of respondents is
based on the Agency’s expectation that
the number of appeals will be very few.
The number of responses per
respondent reflects that the rule only
requires one submission per appeal.
Given that facilities must respond with
particularity to the facts and issues
contained in the withdrawal order, the
Agency estimates an average burden of
4 hours per response.
The estimated burden associated with
the requirements under § 507.85(b) is
reflected in table 34, row 3. The Agency
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expects few, if any, requests for
reinstatement of an exemption that has
been withdrawn under the regulations
and thus is providing an estimate of
only 1 per year at this time. We estimate
the time necessary for making such a
request to be no more than 2 hours,
which includes submitting the written
request and presenting information that
the animal food safety problems were
adequately resolved and continued
withdrawal of the exemption is not
necessary to protect public (human and
animal) health.
Recordkeeping Burden
Table 35 shows the total estimated
annual recordkeeping burden associated
with this final rule. This estimate is a
revision from the recordkeeping
estimates found in our proposed
rulemaking, reflecting an updated count
of the number of registered animal food
facilities, as well as additional
recordkeeping requirements associated
with the various preventive control
provisions and recordkeeping
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requirements associated with the
supply-chain program implemented at
Subpart E.
TABLE 35—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR part 507; activity
Average
burden per
recordkeeping
(in hours)
Total annual
records
Total hours
Subpart A—General Provisions
507.7(e); records attesting that the facility is a
‘‘qualified’’ facility.
507.4(d); documentation of animal food safety and
hygiene training.
1,120
.5
560
.1 (6 minutes) ......
56
7,469
0.75
5,579
0.04 (2 minutes) ..
279
3,876,411
.10 (6 minutes) ....
387,641
3,876,411
.10 (6 minutes) ....
387,641
Subpart C—Hazard Analysis and Risk-Based Preventive Controls
507.31–507.55; food safety plan, including hazard
analysis, preventive controls, and procedures for
monitoring, corrective actions, and verification;
recall plan; validation; reanalysis; modifications;
and implementation records.
7,469
519
Subpart E—Supply-Chain Program
507.105–507.175; written supply-chain program, including records documenting program.
7,469
519
Subpart F—Requirements Applying to Records
507.200–507.215; general requirements, additional
requirements applying to food safety plan, requirements for record retention, use of existing
records, and special requirements applicable to
written assurance.
7,469
519
3,876,411
.10 (6 minutes) ....
387,641
Total ..................................................................
..........................
..........................
11,629,793
.............................
1,163,258
1 Capital
and other costs of implementation and compliance with this final rule are discussed in the FRIA (Ref. 60).
Under the final rule, we estimate a
total of 7,469 respondents (the number
of registered animal food facilities) are
subject to recordkeeping requirements
found in the applicable regulations.
Although FDA believes that, in some
cases, all respondents will incur new
recordkeeping activities as a result of
the final rule (e.g., documentation of
training in the principles of animal food
hygiene and safety), we believe other
provisions may apply only to certain
respondents (e.g., documentation of a
supply-chain program), depending upon
the applicable regulation. With regard to
the hazard-analysis and risk-based
preventive controls, the supply-chain
program, and the requirements applying
to records under part 507 subparts C, E,
and F, respectively, we have provided a
cumulative burden and averaged burden
per recordkeeping that we believe will
be incurred by the respondents under
this final rule based on information
available to us at this time. After
allowing for implementation of the final
rule and upon seeking reauthorization
for its information collection provisions,
FDA will reassess its burden estimate
accordingly.
Third-Party Disclosure Burden
Table 36 shows the total estimated
third-party disclosure burden associated
with the final rule. This figure has been
revised from the third-party disclosure
estimates found in our proposed
rulemaking. This revision reflects fewer
than anticipated third-party disclosure
requirements under the final rule and
results in an overall decrease to our total
estimated annual third-party disclosure
burden by 36,315 hours.
TABLE 36—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
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21 CFR Section; activity
507.27(b); labeling for the animal food product contains
the specific information and instructions needed so
the food can be safely used for the intended animal
species.
507.7(e)(1); change labels on products with labels .......
507.7(e)(2); change address on labeling (sales documents) for qualified facilities.
507.25(a)(2); animal food, including raw materials,
other ingredients, and rework, is accurately identified.
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19:06 Sep 16, 2015
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PO 00000
Frm 00165
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
(in hours)
Total hours
330
10
3,300
0.25 (15 minutes).
1,526
1,329
4
1
6,104
1,329
1 ....................
1 ....................
6,104
1,329
330
312
102,960
.01 (1 minute)
1,030
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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations
TABLE 36—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
21 CFR Section; activity
Number of
disclosures per
respondent
Total annual
disclosures
507.28(b); holding and distribution of human food byproducts for use as animal food.
40,798
2
81,596
Total .........................................................................
..........................
..........................
..........................
mstockstill on DSK4VPTVN1PROD with RULES3
1
Average
burden per
disclosure
(in hours)
Total hours
0.25 (15 minutes).
20,399
.......................
29,687
Capital and other costs of implementation and compliance for this final rule are discussed in the FRIAs (Ref. 60).
Under the final rule, we estimate all
(7,469) respondents are subject to thirdparty disclosure requirements found in
the applicable regulations. The number
in column 2 represents an estimated
annual number of those respondents we
believe will incur third-party disclosure
burdens under the respective regulation
shown in column 1. This figure is
derived from our familiarity with thirdparty burden associated with similar
FDA regulations. Upon implementation
of the final rule, the Agency will
reevaluate its estimate accordingly.
To calculate the number of annual
disclosures, we multiplied the number
of respondents in column 2 by an
estimated number of disclosures in
column 3. This figure represents the
estimated annual number of disclosures
per respondent we attribute for the
respective requirement. To calculate the
annual hourly burden, we multiplied
the number of annual disclosures by an
estimated hourly burden in column 5.
This figure represents the amount of
time we attribute to conducting the
respective disclosure activities
identified in column 1.
Section 507.7(a)(2) provides that
qualified facilities must either submit to
FDA attestation of hazard identification,
preventive controls implementation,
and monitoring, or attestation that the
facility is in compliance with applicable
non-Federal food safety law.
Section 507.7(e) requires a qualified
facility that chose the latter to notify
consumers of the name and business
address of the facility where the animal
food was manufactured or processed: (1)
On the label if a package label is
required by other provisions of the
FD&C Act or (2) on labeling at the point
of purchase if no label is required.
Section 507.25(a)(2) provides that the
management of the plant must ensure
that animal food, including raw
materials, other ingredients, or rework,
is accurately identified as part of plant
operations. (See §§ 7.49 and 7.42(b)(1)
and (2) (21 CFR 7.49 and 7.42(b)(1) and
(2)).)
Section 507.38(b)(1) and (2) does not
add to the estimated hourly burden
because facilities initiating recalls may
VerDate Sep<11>2014
19:06 Sep 16, 2015
Jkt 235001
notify consignees and the public. (See
§§ 7.49 and 7.42(b)(1) and (2)).)
Under section 507.28(b), labeling that
identifies the product by the common or
usual name must be affixed to or
accompany the human food by-product
for use as animal food when distributed.
The estimated number of disclosures
per respondent and average burden per
disclosure assumes that 60 percent of
the 67,996 domestic human food
manufacturing facilities (Ref. 65) or
40,798 facilities are affected, and that
two sets of labeling per facility per year
will be required. We estimate 0.25 hours
per disclosure to prepare labeling, and
affix to the containers, for a total of
20,399 burden hours.
The information collection provisions
of this final rule have been submitted to
OMB for review. Prior to the effective
date of this final rule, FDA will publish
a notice in the Federal Register
announcing OMB’s decision to approve,
modify, or disapprove the information
collection provisions in this final rule.
An Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number.
LIX. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
Agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
LX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
PO 00000
Frm 00166
Fmt 4701
Sfmt 4700
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses in this section,
but FDA is not responsible for any
subsequent changes to the Web sites
after this document publishes in the
Federal Register.)
1. FDA, ‘‘Record of Outreach for Proposed
Rule for PC Animal Food,’’ 2014.
2. FDA, ‘‘ Record of Outreach for
Supplemental Rule for PC Animal
Food,’’ 2015.
3. FDA, ‘‘ Qualitative Risk Assessment: Risk
of Activity/Animal Food Combinations
for Activities (Outside the Farm
Definition) Conducted in a Facility CoLocated on a Farm,’’ 2015.
4. FDA, ‘‘Technical Staffing and Guidance
Development at FDA,’’ (https://
www.fda.gov/Food/GuidanceRegulation/
FSMA/UCM436592.pdf), 2015 Accessed
on June 19, 2015.
5. FDA, ‘‘Education and Technical Assistance
for Industry,’’ (https://www.fda.gov/
downloads/Food/GuidanceRegulation/
FSMA/UCM436593.pdf), March 5, 2015.
Accessed on June 19, 2015.
6. FDA, ‘‘Food Safety Preventive Controls
Alliance,’’ (https://www.fda.gov/food/
guidanceregulation/fsma/
ucm284406.htm), November 12, 2013.
Accessed on June 19, 2015.
7. FDA, ‘‘FDA Announces Competitive Grant
Program with NIFA to Fund Food Safety
Training, Education and Technical
Assistance,’’ (https://www.fda.gov/food/
newsevents/constituentupdates/
ucm430492.htm), January 15, 2015.
Accessed on June 19, 2015.
8. Partnership for Food Protection National
Workplan Workgroup, ‘‘Model for Local
Federal/State Planning and Coordination
of Field Operations and Training: A
Partnership for Food Protection ‘‘Best
Practice’’,’’ (https://www.fda.gov/
downloads/
ForFederalStateandLocalOfficials/
FoodSafetySystem/UCM373333.pdf)
October, 2013. Accessed on August 10,
2015.
9. FDA, ‘‘Operational Strategy for
Implementing the FDA Food Safety
Modernization Act (FSMA),’’ (https://
www.fda.gov/Food/GuidanceRegulation/
FSMA/ucm395105.htm), May 2, 2014.
Accessed on June 25, 2015.
10. FDA, ‘‘Inspection Modernization and
Training: Key Investments for
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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations
Implementing the FDA Food Safety
Modernization Act (FSMA),’’ (https://
www.fda.gov/food/guidanceregulation/
fsma/ucm432576.htm), 2015. Accessed
on June 25, 2015.
11. FDA, ‘‘Draft Qualitative Risk Assessment
Risk of Activity/Animal Food
Combinations for Activities (Outside the
Farm Definition) Conducted in a Facility
Co-Located on a Farm,’’ 2012. See
Reference 33 to the 2013 proposed rule
for preventive controls for animal food.
12. Muth, M. K., C. Zhen, M. Coglaiti, S.
Karns, and C. Viator, ‘‘Food Processing
Sector Study,’’ 2011. See Reference 21 to
the 2014 supplemental notice.
13. FDA, ‘‘The Reportable Food Registry: A
New Approach to Targeting Inspection
Resources and Identifying Patterns of
Adulteration—First Annual Report:
September 8, 2009–September 7, 2010,’’
(https://www.fda.gov/downloads/Food/
ComplianceEnforcement/UCM291297
.pdf), January, 2011. Accessed on June
29, 2015. See Reference 48 to the 2013
proposed rule for preventive controls for
animal food.
14. FDA, ‘‘The Reportable Food Registry:
Targeting Inspection Resources and
Identifying Patterns of Adulteration—
Second Annual Report: September 8,
2010–September 7, 2011,’’ (https://
www.fda.gov/downloads/Food/
ComplianceEnforcement/UCM301013
.pdf), April 19, 2012. Accessed on June
29, 2015.
15. FDA, ‘‘The Reportable Food Registry:
Targeting Inspection Resources and
Identifying Patterns of Adulteration—
Third Annual Report: September 8,
2011–September 7, 2012,’’ (https://
www.fda.gov/downloads/Food/
ComplianceEnforcement/RFR/
UCM349856.pdf), May 1, 2013. Accessed
on June 29, 2015.
16. FDA, ‘‘The Reportable Food Registry:
Targeting Inspection Resources and
Identifying Patterns of Adulteration—
Fourth Annual Report: September 8,
2012–September 7, 2013,’’ (https://
www.fda.gov/downloads/Food/
ComplianceEnforcement/RFR/
UCM395684.pdf), May 5, 2014. Accessed
on June 29, 2015.
17. FDA, ‘‘Bravo Issues Nationwide Recall of
Pet Food for Dogs and Cats,’’ (https://
www.fda.gov/Safety/Recalls/ucm397362
.htm), May 14, 2014. Accessed on June
26, 2015.
18. FDA, ‘‘J.J. Fuds, Inc. Issues Recall of Pet
Food,’’ (https://www.fda.gov/Safety/
Recalls/ucm431432.htm), January 20,
2015. Accessed on July 1, 2015.
19. FDA, ‘‘Draft Guidance for Industry:
Questions and Answers Regarding the
Reportable Food Registry as Established
by the Food and Drug Administration
Amendments Act of 2007 (Edition 2),’’
(https://www.fda.gov/downloads/Food/
GuidanceRegulation/UCM213214.pdf),
May, 2010. Accessed on June 29, 2015.
20. FDA, ‘‘Guidance for Industry: Questions
and Answers Regarding the Reportable
Food Registry as Established by the Food
and Drug Administration Amendments
Act of 2007,’’ (https://www.fda.gov/Food/
VerDate Sep<11>2014
19:06 Sep 16, 2015
Jkt 235001
GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/RFR/
ucm180761.htm), September, 2009.
Accessed on June 29, 2015.
21. Capogrossi, K., L. Calvin, M. Coglaiti, D.
Hinman, S. Karns, A. Lasher, T. Minor,
M.K. Muth, V. Nigh, P. Vardon, C. Viator
and C. Zhen, ‘‘Food Processing Sector
Study, (Contract HHSF–223–2011–
10005B, Task Order 20), Final Report,’’
2015.
22. Codex Alimentarius Commission,
‘‘Guidelines for the Validation of Food
Safety Control Measures, CAC/GL 69–
2008,’’ (https://www.codexalimentarius.
org/input/download/standards/11022/
CXG_069e.pdf), 2008. Accessed on June
29, 2015. See Reference 79 to the 2013
proposed rule for preventive controls for
animal food.
23. FDA, ‘‘Guidance for Industry: Questions
and Answers Regarding Food Facility
Registration (Sixth Edition),’’ (https://
www.fda.gov/downloads/Food/Guidance
Regulation/UCM332460.pdf), 2014.
Accessed and printed on June 29, 2015.
24. Dictionary.com, ‘‘Definition of ‘‘Solely’’,’’
(https://dictionary.reference.com/browse/
solely), 2015. Accessed on June 11, 2015.
25. FDA, ‘‘Compliance Policy Guide
Sec.675.100 Diversion of Contaminated
Food for Animal Use,’’ (https://
www.fda.gov/iceci/compliancemanuals/
compliancepolicyguidancemanual/
ucm074693.htm) Revised: March 1995,
Page Last Updated: December 15, 2009.
Accessed on September 5, 2014. See
Reference 11 to the 2014 supplemental
notice.
26. FDA, ‘‘Compliance Policy Guide
Sec.675.200 Diversion of Adulterated
Food to Acceptable Animal Feed Use.’’
(https://www.fda.gov/iceci/compliance
manuals/compliancepolicyguidance
manual/ucm074694.htm) Revised:
March 1995. Page Last Updated:
December 15, 2009. Accessed on
September 5, 2014). See Reference 12 to
the 2014 supplemental notice.
27. British Standards Institute (BSI),
‘‘Publicly Available Specification
(PAS)222:2011 Prerequisite Programmes
for Food Safety in the Manufacture of
Food and Feed for Animals,’’ 2011. See
Reference 44 to the 2013 proposed rule
for preventive controls for animal food.
28. Association of American Feed Control
Officials (AAFCO), ‘‘Model Good
Manufacturing Practice Regulations for
Feed and Feed Ingredients’’, In: AAFCO
Official Publication, 210–215, 2010. See
Reference 42 to the 2013 proposed rule
for preventive controls for animal food.
29. Food and Agriculture Organization of the
United Nations (FAO) and World Health
Organization (WHO), ‘‘Good Practices for
the Feed Industry—Implementing the
Codex Alimentarius Code of Practice on
Good Animal Feeding—Section 3 Good
Production Practices,’’ (https://
www.fao.org/docrep/012/i1379e/
i1379e00.htm), 2010. Accessed on June
29, 2015. See Reference 14 in the 2014
supplemental notice.
30. USDA National Nutrient Database for
Standard Reference, (https://
PO 00000
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Fmt 4701
Sfmt 4700
56335
ndb.nal.usda.gov/), 2011. Accessed on
June 29, 2015.
31. FDA, ‘‘P&G Recalls Specific Canned Cat
Foods Due to Low Levels of Thiamine
(Vitamin B1),’’ (https://www.fda.gov/
Safety/Recalls/ArchiveRecalls/2010/
ucm214996.htm), June 9, 2010. Accessed
on June 30, 2015.
32. FDA, ‘‘Ridley Block Operations
Announces Voluntary Recall in
Oklahoma and Texas,’’ (https://
www.fda.gov/Safety/Recalls/
ucm266082.htm), July 29, 2011.
Accessed on June 30, 2015.
33. FDA, ‘‘Expanded Voluntary Recall of
Mazuri and LabDiet Feed Products Due
to Potential Elevated Vitamin D Level,’’
(https://www.fda.gov/safety/recalls/
ucm312988.htm), July 20, 2012.
Accessed on June 30, 2015.
34. FDA, ‘‘ADM Alliance Nutrition Recalling
MoorMan’s ShowTec 18 Elite Lamb
Feed,’’ (https://www.fda.gov/Safety/
Recalls/ucm333676.htm), December 28,
2012. Accessed on June 30, 2015.
35. FDA, ‘‘PGG/HSC Feed Company LLC
Issues Voluntary Recall of Champion
Lamb Texturized Feed B30, Lot–
88022114M908840,’’ (https://
www.fda.gov/Safety/Recalls/
ucm399978.htm), June 4, 2014. Accessed
on June 30, 2015.
36. FDA, ‘‘Cargill Conducts Voluntary Recall
of Select Nutrena® NatureWise Meatbird
Feed Due to Possible Animal Health
Risk,’’ (https://www.fda.gov/Safety/
Recalls/ucm403829.htm), July 1, 2014.
Accessed on June 30, 2015.
37. FDA, ‘‘Natura Pet Recalls 5 Lots of Dry
Cat and Dry Ferret Food due to Vitamin
Insufficiency,’’ (https://www.fda.gov/
Safety/Recalls/ucm424607.htm),
November 24, 2014. Accessed on June
30, 2015.
38. FDA, ‘‘Primal Pet Foods Voluntarily
Recalls A Single Lot of Raw Frozen Cat
Food,’’ (https://www.fda.gov/Safety/
Recalls/ucm438183.htm), March 13,
2015. Accessed on June 30, 2015.
39. FDA, ‘‘Ainsworth Pet Nutrition
Voluntarily Recalls Five Nutrish Wet Cat
Food Varieties for Potentially Elevated
Vitamin D Levels,’’ (https://www.fda.gov/
Safety/Recalls/ucm449841.htm), June 4,
2015. Accessed on June 30, 2015.
40. Markovich, J.E., Freeman, L.M., and
Heinze, C.R., ‘‘Analysis of thiamine
concentrations in commercial canned
foods formulated for cats,’’ Journal of the
American Veterinary Medical
Association, Vol. 244, No. 2, January 15,
2014.
41. FDA, ‘‘Food CGMP Modernization—A
Focus on Food Safety,’’ (https://
www.fda.gov/Food/
GuidanceComplianceRegulatory
Information/CurrentGoodManufacturing
PracticesCGMPs/ucm207458.htm),
November 2, 2005. Accessed on June 29,
2015. See Reference 49 to the 2013
proposed rule for preventive controls for
animal food.
42. FDA, ‘‘Draft Guidance for Industry:
Questions and Answers Regarding
Mandatory Food Recalls,’’ (https://
www.fda.gov/Food/GuidanceRegulation/
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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations
GuidanceDocumentsRegulatory
Information/ucm445428.htm), May,
2015. Accessed on June 30, 2015.
43. FDA, ‘‘FDA Homepage,’’ (https://
www.fda.gov/), March 25, 2015.
Accessed and printed on June 30, 2015.
44. FDA, ‘‘Recalls, Market Withdrawals, &
Safety Alerts (FDA Email Sign-up Web
page),’’ (https://service.govdelivery.com/
accounts/USFDA/subscriber/new?topic_
id=USFDA_48), 2015. Accessed on June
30, 2015.
45. FDA, ‘‘Guidance for Industry: Product
Recalls, Including Removals and
Corrections,’’ (https://www.fda.gov/
Safety/Recalls/IndustryGuidance/
ucm129259.htm), November 3, 2003.
Accessed on June 30, 2015.
46. FDA, ‘‘Animal and Veterinary Recalls and
Withdrawals Web page,’’ (https://
www.fda.gov/AnimalVeterinary/
SafetyHealth/RecallsWithdrawals/
default.htm2015), 2015. Accessed on
June 30, 2015.
47. Merriam-Webster.com, ‘‘Definition of
‘‘Include’’,’’ (https://www.merriamwebster.com/dictionary/include), 2015.
Accessed on June 30, 2015.
48. FDA, ‘‘Guidance for Industry: Testing for
Salmonella in Human Foods and DirectHuman-Contact Animal Foods,’’ (https://
www.fda.gov/food/guidanceregulation/
guidancedocumentsregulatory
information/salmonella/
ucm295271.htm), March, 2012. Accessed
on June 30, 2015.
49. National Advisory Committee on
Microbiological Criteria for Foods,
‘‘Hazard Analysis and Critical Control
Point Principles and Application
Guidelines,’’ Journal of Food Protection,
61:1246–1259, 1998. See Reference 29 to
the 2013 proposed preventive controls
rule for animal food.
50. USDA Food Safety and Inspection
Service, ‘‘Compliance Guideline HACCP
Systems Validation,’’ (https://
www.fsis.usda.gov/shared/PDF/HACCP_
Systems_Validation.pdf), May 2013.
Accessed on June 30, 2015.
51. FDA, ‘‘Memorandum on Environmental
Monitoring,’’ 2014. See Reference 23 to
the 2014 supplemental human
preventive controls notice, Docket No.
FDA–2011–N–0920.
52. FDA, ‘‘Memorandum on Product
Testing,’’ 2014. See Reference 18 to the
2014 supplemental human preventive
controls notice, Docket No. FDA–2011–
N–0920.
53. FDA, ‘‘Memorandum on Supplier
Programs,’’ 2014. See Reference 24 to the
2014 supplemental human preventive
controls notice, Docket No. FDA–2011–
N–0920.
54. Codex Alimentarius Commission, ‘‘Codex
Alimentarius Commission Procedural
Manual, 23rd Edition,’’ (ftp://ftp.fao.org/
codex/Publications/ProcManuals/
Manual_23e.pdf), 2015. Accessed on
June 30, 2015.
55. FDA, ‘‘Inspections, Compliance,
Enforcement, and Criminal
Investigations: Warning Letters,’’ (https://
www.fda.gov/ICECI/
EnforcementActions/WarningLetters/
VerDate Sep<11>2014
19:06 Sep 16, 2015
Jkt 235001
default.htm), March 26, 2015. Accessed
on June 30, 2015.
56. FDA, ‘‘Import Alerts,’’ (https://
www.fda.gov/ForIndustry/
ImportProgram/ImportAlerts/
default.htm), 2015. Accessed on June 30,
2015.
57. FDA, ‘‘Letter to Sunland Inc. Concerning
Suspension of Food Facility Registration;
Notice of Opportunity for Hearing,’’
(https://www.fda.gov/aboutfda/
centersoffices/officeoffoods/cfsan/
cfsanfoiaelectronicreadingroom/
ucm329370.htm), November 26, 2012.
Accessed June 30, 2015.
58. Global Food Safety Initiative, ‘‘GFSI
Guidance Document, Version 6.3,’’
(https://www.mygfsi.com/images/mygfsi/
gfsifiles/gfsi_guidance/GFSI_Guidance_
Document_Over.pdf), 2013. Accessed on
June 30, 2015.
59. FDA, ‘‘Information for Foreign
Governments: Frequently Asked
Questions on Systems Recognition,’’
(https://www.fda.gov/Food/International
InteragencyCoordination/
ucm367400.htm), September 5, 2013.
Accessed on July 1, 2015.
60. FDA, ‘‘FSMA Final Rulemaking for
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals
Final Regulatory Impact Analysis,’’ 2015.
61. World Trade Organization, ‘‘WTO
Ministerial Conference: ImplementationRelated Issues and Concerns,’’ (https://
www.wto.org/english/thewto_e/minist_e/
min01_e/mindecl_implementation_
e.pdf), November 20, 2001. Accessed on
July 1, 2015.
62. World Trade Organization, ‘‘The WTO
Agreement on the Application of
Sanitary and Phytosanitary Measures
(SPS Agreement),’’ (https://www.wto.org/
english/tratop_e/sps_e/spsagr_e.htm),
April 15, 1994. Accessed on July 1, 2015.
63. FDA, ‘‘Tribal Summary Impact
Statement,’’ 2015.
64. Environmental Review of Final Rule:
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for
Animals, August 28, 2015.
65. FDA, ‘‘Current Good Manufacturing
Practice and Hazard Analysis and Riskbased Preventive Controls for Human
Food—Preliminary Regulatory Impact
Analysis,’’ 2013. See Reference 23 in the
2014 supplemental notice.
List of Subjects
Administrative practice and
procedure, Computer technology,
Reporting and recordkeeping
requirements.
21 CFR Part 16
Administrative practice and
procedure.
21 CFR Part 117
Food packaging, Foods.
Frm 00168
Fmt 4701
Animal drugs, Animal feeds, Cancer,
Labeling, Packaging and containers,
Polychlorinated biphenyls (PCB’s).
21 CFR Part 507
Animal foods, Labeling, Packaging
and containers, Reporting and
recordkeeping requirements.
21 CFR Part 579
Animal feeds, Animal foods,
Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR chapter I is
amended as follows:
PART 11—ELECTRONIC RECORDS;
ELECTRONIC SIGNATURES
1. The authority citation for 21 CFR
part 11 continues to read as follows:
■
Authority: 21 U.S.C. 321–393; 42 U.S.C.
262.
2. In § 11.1, add paragraph (j) to read
as follows:
■
§ 11.1
Scope.
*
*
*
*
*
(j) This part does not apply to records
required to be established or maintained
by part 507 of this chapter. Records that
satisfy the requirements of part 507 of
this chapter, but that also are required
under other applicable statutory
provisions or regulations, remain
subject to this part.
PART 16—REGULATORY HEARING
BEFORE THE FOOD AND DRUG
ADMINISTRATION
3. The authority citation for 21 CFR
part 16 continues to read as follows:
■
Authority: 15 U.S.C. 1451–1461; 21 U.S.C.
141–149, 321–394, 467f, 679, 821, 1034; 28
U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.
4. In § 16.1(b)(2), add the following
entry in numerical order to read as
follows:
■
21 CFR Part 11
PO 00000
21 CFR Part 500
Sfmt 4700
§ 16.1
Scope.
*
*
*
*
*
(b) * * *
(2) * * *
§§ 507.60 through 507.85 (part 507,
subpart D of this chapter) relating to
withdrawal of a qualified facility
exemption.
*
*
*
*
*
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PART 117—CURRENT GOOD
MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISK–
BASED PREVENTIVE CONTROLS FOR
HUMAN FOOD
5. The authority citation for 21 CFR
part 117 continues to read as follows:
■
Authority: 21 U.S.C. 331, 342, 343, 350d
note, 350g, 350g note, 371, 374; 42 U.S.C.
243, 264, 271.
§ 500.23 Thermally processed low-acid
foods packaged in hermetically sealed
containers.
Except as provided in § 507.5(b) of
this chapter, the provisions of parts 507
and 113 of this chapter apply to the
manufacturing, processing, or packing
of low-acid foods in hermetically sealed
containers, and intended for use as food
for animals.
■
6. Add § 117.95 to subpart B to read
as follows:
■
§ 117.95 Holding and distribution of
human food by-products for use as animal
food.
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(a) Human food by-products held for
distribution as animal food without
additional manufacturing or processing
by the human food processor, as
identified in § 507.12 of this chapter,
must be held under conditions that will
protect against contamination, including
the following:
(1) Containers and equipment used to
convey or hold human food by-products
for use as animal food before
distribution must be designed,
constructed of appropriate material,
cleaned as necessary, and maintained to
protect against the contamination of
human food by-products for use as
animal food;
(2) Human food by-products for use as
animal food held for distribution must
be held in a way to protect against
contamination from sources such as
trash; and
(3) During holding, human food byproducts for use as animal food must be
accurately identified.
(b) Labeling that identifies the byproduct by the common or usual name
must be affixed to or accompany human
food by-products for use as animal food
when distributed.
(c) Shipping containers (e.g., totes,
drums, and tubs) and bulk vehicles used
to distribute human food by-products
for use as animal food must be
examined prior to use to protect against
contamination of the human food byproducts for use as animal food from the
container or vehicle when the facility is
responsible for transporting the human
food by-products for use as animal food
itself or arranges with a third party to
transport the human food by-products
for use as animal food.
PART 500—GENERAL
7. The authority citation for 21 CFR
part 500 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 342, 343,
348, 351, 352, 353, 360b, 371, 379e.
■
8. Revise § 500.23 to read as follows:
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9. Add part 507 to read as follows:
PART 507—CURRENT GOOD
MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISK–
BASED PREVENTIVE CONTROLS FOR
FOOD FOR ANIMALS
Subpart A—General Provisions
Sec.
507.1 Applicability and status.
507.3 Definitions.
507.4 Qualifications of individuals who
manufacture, process, pack, or hold
animal food.
507.5 Exemptions.
507.7 Requirements that apply to a
qualified facility.
507.10 Applicability of subparts C and E of
this part to a facility solely engaged in
the storage of unexposed packaged
animal food.
507.12 Applicability of this part to the
holding and distribution of human food
by-products for use as animal food.
Subpart B—Current Good Manufacturing
Practice
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitation.
507.20 Water supply and plumbing.
507.22 Equipment and utensils.
507.25 Plant operations.
507.27 Holding and distribution.
507.28 Holding and distribution of human
food by-products for use as animal food.
Subpart C—Hazard Analysis and RiskBased Preventive Controls
507.31 Food safety plan.
507.33 Hazard analysis.
507.34 Preventive controls.
507.36 Circumstances in which the owner,
operator, or agent in charge of a
manufacturing/processing facility is not
required to implement a preventive
control.
507.37 Provision of assurances required
under § 507.36(a)(2), (3), and (4).
507.38 Recall plan.
507.39 Preventive control management
components.
507.40 Monitoring.
507.42 Corrective actions and corrections.
507.45 Verification.
507.47 Validation.
507.49 Verification of implementation and
effectiveness.
507.50 Reanalysis.
507.51 Modified requirements that apply to
a facility solely engaged in the storage of
unexposed packaged animal food.
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507.53 Requirements applicable to a
preventive controls qualified individual
and a qualified auditor.
507.55 Implementation records required
for this subpart.
Subpart D—Withdrawal of a Qualified
Facility Exemption
507.60 Circumstances that may lead FDA
to withdraw a qualified facility
exemption.
507.62 Issuance of an order to withdraw a
qualified facility exemption.
507.65 Contents of an order to withdraw a
qualified facility exemption.
507.67 Compliance with, or appeal of, an
order to withdraw a qualified facility
exemption.
507.69 Procedure for submitting an appeal.
507.71 Procedure for requesting an
informal hearing.
507.73 Requirements applicable to an
informal hearing.
507.75 Presiding officer for an appeal and
for an informal hearing.
507.77 Timeframe for issuing a decision on
an appeal.
507.80 Revocation of an order to withdraw
a qualified facility exemption.
507.83 Final agency action.
507.85 Reinstatement of a qualified facility
exemption that was withdrawn.
Subpart E—Supply-Chain Program
507.105 Requirement to establish and
implement a supply-chain program.
507.110 General requirements applicable to
a supply-chain program.
507.115 Responsibilities of the receiving
facility.
507.120 Using approved suppliers.
507.125 Determining appropriate supplier
verification activities (including
determining the frequency of conducting
the activity).
507.130 Conducting supplier verification
activities for raw materials and other
ingredients.
507.135 Onsite audit.
507.175 Records documenting the supplychain program.
Subpart F—Requirements Applying to
Records That Must Be Established and
Maintained
507.200 Records subject to the
requirements of this subpart.
507.202 General requirements applying to
records.
507.206 Additional requirements applying
to the food safety plan.
507.208 Requirements for record retention.
507.212 Use of existing records.
507.215 Special requirements applicable to
a written assurance.
Authority: 21 U.S.C. 331, 342, 343, 350d
note, 350g, 350g note, 371, 374; 42 U.S.C.
243, 264, 271.
Subpart A—General Provisions
§ 507.1
Applicability and status.
(a) The criteria and definitions in this
part apply in determining whether an
animal food is:
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(1) Adulterated within the meaning
of:
(i) Section 402(a)(3) of the Federal
Food, Drug, and Cosmetic Act in that
the food has been manufactured under
such conditions that it is unfit for food;
or
(ii) Section 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act in that
the food has been prepared, packed, or
held under insanitary conditions
whereby it may have become
contaminated with filth, or whereby it
may have been rendered injurious to
health; and
(2) In violation of section 361 of the
Public Health Service Act (42 U.S.C.
264).
(b) The operation of a facility that
manufactures, processes, packs, or holds
animal food for sale in the United States
if the owner, operator, or agent in charge
of such facility is required to comply
with, and is not in compliance with,
section 418 of the Federal Food, Drug,
and Cosmetic Act or subparts C, D, E,
or F of this part and § 507.7 is a
prohibited act under section 301(uu) of
the Federal Food, Drug, and Cosmetic
Act.
(c) Animal food covered by specific
current good manufacturing practice
regulations also is subject to the
requirements of those regulations.
(d) Except as provided by § 507.12, if
a facility is required to comply with
subpart B of part 507 and is also
required to comply with subpart B of
part 117 of this chapter because the
facility manufactures, processes, packs,
or holds human food and animal food,
then the facility may choose to comply
with the requirements in subpart B of
part 117, instead of subpart B of part
507, as to the manufacturing,
processing, packing, and holding of
animal food at that facility. If a facility
is required to comply with subpart C of
part 507 and is also required to comply
with subpart C of part 117 of this
chapter, then the facility may choose to
comply with the requirements in
subpart C of part 117 as to the
manufacturing, processing, packing, and
holding of animal food at the facility,
instead of subpart C of part 507,
provided the food safety plan also
addresses hazards for the animal food,
if applicable, that require a preventive
control. When applying the
requirements of part 117 of this chapter
to animal food, the term ‘‘food’’ in part
117 includes animal food.
§ 507.3
Definitions.
The definitions and interpretations
contained in section 201 of the Federal
Food, Drug, and Cosmetic Act apply to
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such terms when used in this part. The
following definitions also apply:
Adequate means that which is needed
to accomplish the intended purpose in
keeping with good public (human and
animal) health practice.
Affiliate means any facility that
controls, is controlled by, or is under
common control with another facility.
Animal food means food for animals
other than man and includes pet food,
animal feed, and raw materials and
ingredients.
Audit means the systematic,
independent, and documented
examination (through observation,
investigation, records review,
discussions with employees of the
audited entity, and, as appropriate,
sampling and laboratory analysis) to
assess a supplier’s food safety processes
and procedures.
Calendar day means every day shown
on the calendar.
Correction means an action to identify
and correct a problem that occurred
during the production of animal food,
without other actions associated with a
corrective action procedure (such as
actions to reduce the likelihood that the
problem will recur, evaluate all affected
animal food for safety, and prevent
affected animal food from entering
commerce).
Critical control point means a point,
step, or procedure in a food process at
which control can be applied and is
essential to prevent or eliminate a food
safety hazard or reduce such hazard to
an acceptable level.
Environmental pathogen means a
pathogen capable of surviving and
persisting within the manufacturing,
processing, packing, or holding
environment such that food for animals
may be contaminated and may result in
foodborne illness if that animal food is
not treated to significantly minimize or
prevent the environmental pathogen.
Examples of environmental pathogens
for the purposes of this part include
Listeria monocytogenes and Salmonella
spp. but do not include the spores of
pathogenic sporeforming bacteria.
Facility means a domestic facility or
a foreign facility that is required to
register under section 415 of the Federal
Food, Drug, and Cosmetic Act, in
accordance with the requirements of
part 1, subpart H of this chapter.
Farm means farm as defined in
§ 1.227 of this chapter.
FDA means the Food and Drug
Administration.
Food means food as defined in section
201(f) of the Federal Food, Drug, and
Cosmetic Act and includes raw
materials and ingredients.
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Food-contact surfaces are those
surfaces that contact animal food and
those surfaces from which drainage, or
other transfer, onto the animal food or
onto surfaces that contact the animal
food ordinarily occurs during the
normal course of operations. ‘‘Foodcontact surfaces’’ includes utensils and
animal food-contact surfaces of
equipment.
Full-time equivalent employee is a
term used to represent the number of
employees of a business entity for the
purpose of determining whether the
business qualifies for the small business
exemption. The number of full-time
equivalent employees is determined by
dividing the total number of hours of
salary or wages paid directly to
employees of the business entity and of
all of its affiliates and subsidiaries by
the number of hours of work in 1 year,
2,080 hours (i.e., 40 hours × 52 weeks).
If the result is not a whole number,
round down to the next lowest whole
number.
Harvesting applies to farms and farm
mixed-type facilities and means
activities that are traditionally
performed on farms for the purpose of
removing raw agricultural commodities
from the place they were grown or
raised and preparing them for use as
animal food. Harvesting is limited to
activities performed on raw agricultural
commodities, or on processed foods
created by drying/dehydrating a raw
agricultural commodity without
additional manufacturing/processing,
on a farm. Harvesting does not include
activities that transform a raw
agricultural commodity into a processed
food as defined in section 201(gg) of the
Federal Food, Drug, and Cosmetic Act.
Examples of harvesting include cutting
(or otherwise separating) the edible
portion of the raw agricultural
commodity from the crop plant and
removing or trimming part of the raw
agricultural commodity (e.g., foliage,
husks, roots or stems). Examples of
harvesting also include cooling, field
coring, filtering, gathering, hulling,
removing stems and husks from,
shelling, sifting, threshing, trimming of
outer leaves of, and washing raw
agricultural commodities grown on a
farm.
Hazard means any biological,
chemical (including radiological), or
physical agent that has the potential to
cause illness or injury in humans or
animals.
Hazard requiring a preventive control
means a known or reasonably
foreseeable hazard for which a person
knowledgeable about the safe
manufacturing, processing, packing, or
holding of animal food would, based on
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the outcome of a hazard analysis (which
includes an assessment of the severity of
the illness or injury if the hazard were
to occur and the probability that the
hazard will occur in the absence of
preventive controls), establish one or
more preventive controls to significantly
minimize or prevent the hazard in an
animal food and components to manage
those controls (such as monitoring,
corrections or corrective actions,
verification, and records) as appropriate
to the animal food, the facility, and the
nature of the preventive control and its
role in the facility’s food safety system.
Holding means storage of animal food
and also includes activities performed
incidental to storage of an animal food
(e.g., activities performed for the safe or
effective storage of that animal food,
such as fumigating animal food during
storage, and drying/dehydrating raw
agricultural commodities when the
drying/dehydrating does not create a
distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding
also includes activities performed as a
practical necessity for the distribution of
that animal food (such as blending of
the same raw agricultural commodity
and breaking down pallets), but does
not include activities that transform a
raw agricultural commodity into a
processed food as defined in section
201(gg) of the Federal Food, Drug, and
Cosmetic Act. Holding facilities could
include warehouses, cold storage
facilities, storage silos, grain elevators,
and liquid-storage tanks.
Known or reasonably foreseeable
hazard means a biological, chemical
(including radiological), or physical
hazard that is known to be, or has the
potential to be, associated with the
facility or the animal food.
Lot means the animal food produced
during a period of time and identified
by an establishment’s specific code.
Manufacturing/processing means
making animal food from one or more
ingredients, or synthesizing, preparing,
treating, modifying, or manipulating
animal food, including food crops or
ingredients. Examples of
manufacturing/processing activities
include: Baking, boiling, bottling,
canning, cooking, cooling, cutting,
distilling, drying/dehydrating raw
agricultural commodities to create a
distinct commodity (such as drying/
dehydrating grapes to produce raisins),
evaporating, eviscerating, extracting
juice, extruding, formulating, freezing,
grinding, homogenizing, irradiating,
labeling, milling, mixing, packaging
(including modified atmosphere
packaging), pasteurizing, peeling,
pelleting, rendering, treating to
manipulate ripening, trimming,
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washing, or waxing. For farms and farm
mixed-type facilities, manufacturing/
processing does not include activities
that are part of harvesting, packing, or
holding.
Microorganisms means yeasts, molds,
bacteria, viruses, protozoa, and
microscopic parasites and includes
species that are pathogens. The term
‘‘undesirable microorganisms’’ includes
those microorganisms that are
pathogens, that subject animal food to
decomposition, that indicate that animal
food is contaminated with filth, or that
otherwise may cause animal food to be
adulterated.
Mixed-type facility means an
establishment that engages in both
activities that are exempt from
registration under section 415 of the
Federal Food, Drug, and Cosmetic Act
and activities that require the
establishment to be registered. An
example of such a facility is a ‘‘farm
mixed-type facility,’’ which is an
establishment that is a farm, but also
conducts activities outside the farm
definition that require the establishment
to be registered.
Monitor means to conduct a planned
sequence of observations or
measurements to assess whether control
measures are operating as intended.
Packing means placing animal food
into a container other than packaging
the animal food and also includes
repacking and activities performed
incidental to packing or repacking an
animal food (e.g., activities performed
for the safe or effective packing or
repacking of that animal food (such as
sorting, culling, grading, and weighing
or conveying incidental to packing or
repacking)), but does not include
activities that transform a raw
agricultural commodity into a processed
food as defined in section 201(gg) of the
Federal Food, Drug, and Cosmetic Act.
Pathogen means a microorganism of
public (human or animal) health
significance.
Pest refers to any objectionable
animals or insects including birds,
rodents, flies, and larvae.
Plant means the building or structure,
or parts thereof, used for or in
connection with the manufacturing,
processing, packing, or holding of
animal food.
Preventive controls means those riskbased, reasonably appropriate
procedures, practices, and processes
that a person knowledgeable about the
safe manufacturing, processing, packing,
or holding of animal food would employ
to significantly minimize or prevent the
hazards identified under the hazard
analysis that are consistent with the
current scientific understanding of safe
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food manufacturing, processing,
packing, or holding at the time of the
analysis.
Preventive controls qualified
individual means a qualified individual
who has successfully completed
training in the development and
application of risk-based preventive
controls at least equivalent to that
received under a standardized
curriculum recognized as adequate by
FDA, or is otherwise qualified through
job experience to develop and apply a
food safety system.
Qualified auditor means a person who
is a qualified individual as defined in
this part and has technical expertise
obtained through education, training, or
experience (or the combination thereof)
necessary to perform the auditing
function. Examples of potential
qualified auditors include:
(1) A government employee,
including a foreign government
employee; and
(2) An audit agent of a certification
body that is accredited in accordance
with regulations in part 1, subpart M of
this chapter.
Qualified end-user, with respect to
food, means the consumer of the food
(where the term consumer does not
include a business); or a restaurant or
retail food establishment (as those terms
are defined in § 1.227 of this chapter)
that:
(1) Is located:
(i) In the same State or the same
Indian reservation as the qualified
facility that sold the food to such
restaurant or retail food establishment;
or
(ii) Not more than 275 miles from
such facility; and
(2) Is purchasing the food for sale
directly to consumers at such restaurant
or retail food establishment.
Qualified facility means (when
including the sales by any subsidiary;
affiliate; or subsidiaries or affiliates,
collectively, of any entity of which the
facility is a subsidiary or affiliate) a
facility that is a very small business as
defined in this part, or a facility to
which both of the following apply:
(1) During the 3-year period preceding
the applicable calendar year, the average
annual monetary value of the food
manufactured, processed, packed, or
held at such facility that is sold directly
to qualified end-users (as defined in this
part) during such period exceeded the
average annual monetary value of the
food sold by such facility to all other
purchasers; and
(2) The average annual monetary
value of all food sold during the 3-year
period preceding the applicable
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calendar year was less than $500,000,
adjusted for inflation.
Qualified facility exemption means an
exemption applicable to a qualified
facility under § 507.5(d).
Qualified individual means a person
who has the education, training, or
experience (or a combination thereof)
necessary to manufacture, process, pack,
or hold safe animal food as appropriate
to the individual’s assigned duties. A
qualified individual may be, but is not
required to be, an employee of the
establishment.
Raw agricultural commodity has the
meaning given in section 201(r) of the
Federal Food, Drug, and Cosmetic Act.
Receiving facility means a facility that
is subject to subparts C and E of this part
and that manufactures/processes a raw
material or other ingredient that it
receives from a supplier.
Rework means clean, unadulterated
animal food that has been removed from
processing for reasons other than
insanitary conditions or that has been
successfully reconditioned by
reprocessing and that is suitable for use
as animal food.
Sanitize means to adequately treat
cleaned surfaces by a process that is
effective in destroying vegetative cells of
pathogens, and in substantially reducing
numbers of other undesirable
microorganisms, but without adversely
affecting the product or its safety for
animals or humans.
Significantly minimize means to
reduce to an acceptable level, including
to eliminate.
Small business means, for purposes of
this part, a business employing fewer
than 500 full-time equivalent
employees.
Subsidiary means any company
which is owned or controlled directly or
indirectly by another company.
Supplier means the establishment that
manufactures/processes the animal
food, raises the animal, or grows the
food that is provided to a receiving
facility without further manufacturing/
processing by another establishment,
except for further manufacturing/
processing that consists solely of the
addition of labeling or similar activity of
a de minimis nature.
Supply-chain-applied control means a
preventive control for a hazard in a raw
material or other ingredient when the
hazard in the raw material or other
ingredient is controlled before its
receipt.
Unexposed packaged animal food
means packaged animal food that is not
exposed to the environment.
Validation means obtaining and
evaluating scientific and technical
evidence that a control measure,
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combination of control measures, or the
food safety plan as a whole, when
properly implemented, is capable of
effectively controlling the identified
hazards.
Verification means the application of
methods, procedures, tests and other
evaluations, in addition to monitoring,
to determine whether a control measure
or combination of control measures is or
has been operating as intended and to
establish the validity of the food safety
plan.
Very small business means, for
purposes of this part, a business
(including any subsidiaries and
affiliates) averaging less than
$2,500,000, adjusted for inflation, per
year, during the 3-year period preceding
the applicable calendar year in sales of
animal food plus the market value of
animal food manufactured, processed,
packed, or held without sale (e.g., held
for a fee or supplied to a farm without
sale).
Water activity (aw) means a measure of
the free moisture in an animal food and
is the quotient of the water vapor
pressure of the substance divided by the
vapor pressure of pure water at the same
temperature.
Written procedures for receiving raw
materials and other ingredients means
written procedures to ensure that raw
materials and other ingredients are
received only from suppliers approved
by the receiving facility (or, when
necessary and appropriate, on a
temporary basis from unapproved
suppliers whose raw materials or other
ingredients are subjected to adequate
verification activities before acceptance
for use).
You means, for purposes of this part,
the owner, operator, or agent in charge
of a facility.
§ 507.4 Qualifications of individuals who
manufacture, process, pack, or hold animal
food.
(a)(1) The management of an
establishment must ensure that all
individuals who manufacture, process,
pack, or hold animal food subject to
subparts B and F of this part are
qualified to perform their assigned
duties; and
(2) The owner, operator, or agent in
charge of a facility must ensure that all
individuals who manufacture, process,
pack, or hold animal food subject to
subparts C, D, E, or F of this part are
qualified to perform their assigned
duties.
(b) Each individual engaged in
manufacturing, processing, packing, or
holding animal food (including
temporary and seasonal personnel) or in
the supervision thereof must:
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(1) Be a qualified individual as that
term is defined in § 507.3, i.e., have the
education, training, or experience (or a
combination thereof) necessary to
manufacture, process, pack, or hold safe
animal food as appropriate to the
individual’s assigned duties; and
(2) Receive training in the principles
of animal food hygiene and animal food
safety, including the importance of
employee health and personal hygiene,
as appropriate to the animal food, the
facility and the individual’s assigned
duties.
(c) Responsibility for ensuring
compliance by individuals with the
requirements of this part must be clearly
assigned to supervisory personnel who
have the education, training, or
experience (or a combination thereof)
necessary to supervise the production of
safe animal food.
(d) Records that document training
required by paragraph (b)(2) of this
section must be established and
maintained and are subject to the
recordkeeping requirements in subpart
F of this part.
§ 507.5
Exemptions.
(a) This part does not apply to
establishments, including ‘‘farms’’ (as
defined in § 1.227 of this chapter), that
are not required to register under
section 415 of the Federal Food, Drug,
and Cosmetic Act.
(b)(1) Subparts C and E of this part do
not apply with respect to activities that
are subject to § 500.23 and part 113 of
this chapter (Thermally Processed LowAcid Foods Packaged in Hermetically
Sealed Containers) at an animal food
facility if you are required to comply
with, and are in compliance with, part
113 of this chapter with respect to those
activities.
(2) The exemption in paragraph (b)(1)
of this section is applicable only with
respect to those microbiological hazards
regulated under part 113 of this chapter.
(c) Subparts C and E of this part do
not apply to activities of a facility that
are subject to section 419 of the Federal
Food, Drug, and Cosmetic Act
(Standards for Produce Safety).
(d) Except as provided in subpart D of
this part, subparts C and E of this part
do not apply to a qualified facility.
Qualified facilities are subject to the
requirements in § 507.7.
(e) For a farm mixed-type facility that
is a small or very small business,
subparts C and E of this part do not
apply to on-farm packing or holding of
processed animal food, and § 507.7 does
not apply to on-farm packing or holding
of processed animal food by a very
small business, if the only packing or
holding activities subject to section 418
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of the Federal Food, Drug, and Cosmetic
Act that the business conducts are the
following low-risk packing or holding
activity/animal food combinations—i.e.,
packing (or repacking) (including
weighing or conveying incidental to
packing or repacking); sorting, culling,
or grading incidental to packing or
storing; and storing (ambient, cold and
controlled atmosphere) of:
(1) Roughage products (e.g., alfalfa
meal, entire plant meal, stem meal,
pomace, and pulp);
(2) Plant protein meals (e.g., algae,
coconut (copra), guar, and peanut);
(3) Grain by-products and processed
grain products (e.g., bran, flour, germ
meal, grits, groats, hominy feed, malt
sprouts, middlings, pearled grain,
polished grain, brewers grain, distillers
grain, and gluten meal);
(4) Oilseed products (e.g., oil and
meal of safflower, soybean, or
sunflower);
(5) Molasses (e.g., processed sugar
cane, sugar beets, and citrus).;
(6) Animal protein meals (e.g., blood,
feather, meat, meat and bone, and
marine (e.g., crab, fish, shrimp));
(7) Milk products (e.g., casein, cheese
rind, and lactalbumin);
(8) Animal tissue-derived products
(e.g., fat);
(9) Vitamins, minerals, and
concentrates;
(10) Processing aids (e.g., enzymes,
preservatives, and stabilizers); and
(11) Any other processed animal food
that does not require time/temperature
control for safety.
(f) For a farm mixed-type facility that
is a small or very small business,
subparts C and E of this part do not
apply to on-farm manufacturing/
processing activities conducted by a
small or very small business for
distribution into commerce, and § 507.7
does not apply to on-farm
manufacturing/processing activities
conducted by a very small business for
distribution into commerce, if the only
manufacturing/processing activities
subject to section 418 of the Federal
Food, Drug, and Cosmetic Act that the
business conducts consists of the
following low-risk manufacturing/
processing activity/animal food
combinations:
(1) Chopping or shredding hay;
(2) Cracking, crimping, flaking,
pearling, peeling, shelling, or
wafering—grain (e.g., barley, sorghum,
corn, oats, rice, rye, and wheat) or
oilseed (e.g., beans, canola, cottonseed,
linseed, soybeans, and sunflowers);
(3) Crushing, dry rolling, grinding,
milling, pulverizing—grain, oilseed,
grain by-products and processed grain
products, oilseed products, hay, ensiled
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material, culled fruits and vegetables,
roughage (e.g., cobs, hulls, husks, and
straws), or roughage products;
(4) Ensiling (including chopping,
shredding, mixing, storing, or
fermenting), that is, making silage or
haylage from forage (e.g., sorghum
(milo), corn (maize), alfalfa, and grass),
grain, culled fruits and vegetables, or
roughage;
(5) Extracting (mechanical) or wet
rolling grain, oilseed, brewers grain byproducts, or distillers grain by-products;
(6) Labeling roughage products, plant
protein meals, grain by-products and
processed grain products, oilseed
products, molasses, animal protein
meals, milk products, animal tissuederived products, vitamins, minerals,
concentrates, processing aids, finished
animal food, including animal food
ready for consumption, or any other
processed animal food that does not
require time/temperature control for
safety; and
(7) Packaging roughage products,
plant protein meals, grain by-products
and processed grain products, oilseed
products, molasses, animal protein
meals, milk products, animal tissuederived products, vitamins, minerals,
concentrates, processing aids, finished
animal food, including animal food
ready for consumption, or any other
processed animal food that does not
require time/temperature control for
safety.
(g) Subparts C and E of this part do
not apply to facilities that are solely
engaged in the storage of raw
agricultural commodities (other than
fruits and vegetables) intended for
further distribution or processing.
(h) Subpart B of this part does not
apply to any of the following:
(1) Establishments solely engaged in
the holding and/or transportation of one
or more raw agricultural commodities;
(2) Establishments solely engaged in
hulling, shelling, drying, packing, and/
or holding nuts and hulls (without
manufacturing/processing, such as
grinding shells or roasting nuts); and
(3) Establishments solely engaged in
ginning of cotton (without
manufacturing/processing, such as
extracting oil from cottonseed).
§ 507.7 Requirements that apply to a
qualified facility.
(a) A qualified facility must submit
the following attestations to FDA:
(1) An attestation that the facility is a
qualified facility as defined in § 507.3.
For the purpose of determining whether
a facility satisfies the definition of
qualified facility, the baseline year for
calculating the adjustment for inflation
is 2011; and
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(2)(i) An attestation that you have
identified the potential hazards
associated with the animal food being
produced, are implementing preventive
controls to address the hazards, and are
monitoring the performance of the
preventive controls to ensure that such
controls are effective; or
(ii) An attestation that the facility is
in compliance with State, local, county,
tribal, or other applicable non-Federal
food safety law, including relevant laws
and regulations of foreign countries,
including an attestation based on
licenses, inspection reports, certificates,
permits, credentials, certification by an
appropriate agency (such as a State
department of agriculture), or other
evidence of oversight.
(b) The attestations required by
paragraph (a) of this section must be
submitted to FDA by any one of the
following means:
(1) Electronic submission. To submit
electronically, go to https://www.fda.gov/
furls and follow the instructions. This
Web site is available from wherever the
Internet is accessible, including
libraries, copy centers, schools, and
Internet cafes. FDA encourages
electronic submission.
(2) Submission by mail. (i) You must
use Form FDA 3942b. You may obtain
a copy of this form by any of the
following mechanisms:
(A) Download it from https://
www.fda.gov/pcafrule;
(B) Write to the U.S. Food and Drug
Administration (HFS–681), 5100 Paint
Branch Parkway, College Park, MD
20550; or
(C) Request a copy of this form by
phone at 1–800–216–7331 or 301–575–
0156.
(ii) Send a paper Form FDA 3942b to
the U.S. Food and Drug Administration
(HFS–681), 5100 Paint Branch Parkway,
College Park, MD 20550. We
recommend that you submit a paper
copy only if your facility does not have
reasonable access to the Internet.
(c)(1) A facility must determine and
document its status as a qualified
facility on an annual basis no later than
July 1 of each calendar year.
(2) The attestations required by
paragraph (a) of this section must be:
(i) Submitted to FDA initially:
(A) By December 16, 2019 for a
facility that begins manufacturing,
processing, packing, or holding animal
food before September 17, 2019;
(B) Before beginning operations, for a
facility that begins manufacturing,
processing, packing, or holding animal
food after September 17, 2019; or
(C) By July 31 of the applicable
calendar year, when the status of a
facility changes from ‘‘not a qualified
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facility’’ to ‘‘qualified facility’’ based on
the annual determination required by
paragraph (c)(1) of this section; and
(ii) Beginning in 2020, submitted to
FDA every 2 years during the period
beginning on October 1 and ending on
December 31.
(3) When the status of a facility
changes from ‘‘qualified facility’’ to ‘‘not
a qualified facility’’ based on the annual
determination required by paragraph
(c)(1) of this section, the facility must
notify FDA of that change in status
using Form FDA 3942b by July 31 of the
applicable calendar year.
(d) When the status of a facility
changes from ‘‘qualified facility’’ to ‘‘not
a qualified facility,’’ the facility must
comply with subparts C and E of this
part no later than December 31 of the
applicable calendar year unless
otherwise agreed to by FDA and the
facility.
(e) A qualified facility that does not
submit attestations under paragraph
(a)(2)(i) of this section must provide
notification to consumers as to the name
and complete business address of the
facility where the animal food was
manufactured or processed (including
the street address or P.O. Box, city,
state, and zip code for domestic
facilities, and comparable full address
information for foreign facilities) as
follows:
(1) If an animal food packaging label
is required, the notification required by
paragraph (e) of this section must
appear prominently and conspicuously
on the label of the animal food.
(2) If an animal food packaging label
is not required, the notification required
by paragraph (e) of this section must
appear prominently and conspicuously,
at the point of purchase, on a label,
poster, sign, placard, or documents
delivered contemporaneously with the
animal food in the normal course of
business, or in an electronic notice, in
the case of Internet sales.
(f)(1) A qualified facility must
maintain those records relied upon to
support the attestations that are required
by paragraph (a) of this section.
(2) The records that a qualified facility
must maintain are subject to the
requirements of subpart F of this part.
§ 507.10 Applicability of subparts C and E
of this part to a facility solely engaged in
the storage of unexposed packaged animal
food.
(a) Subparts C and E of this part do
not apply to a facility solely engaged in
the storage of unexposed packaged
animal food that does not require time/
temperature control to significantly
minimize or prevent the growth of, or
toxin production by, pathogens.
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(b) A facility solely engaged in the
storage of unexposed packaged animal
food, including unexposed packaged
animal food that requires time/
temperature control to significantly
minimize or prevent the growth of, or
toxin production by, pathogens is
subject to the modified requirements in
§ 507.51 for any unexposed packaged
animal food that requires time/
temperature control to significantly
minimize or prevent the growth of, or
toxin production by, pathogens.
§ 507.12 Applicability of this part to the
holding and distribution of human food byproducts for use as animal food.
(a) Except as provided by paragraph
(b) of this section, the requirements of
this part do not apply to by-products of
human food production, or the off-farm
packing and holding of raw agricultural
commodities, that are packed or held by
that human food facility for distribution
as animal food if:
(1)(i) The human food facility is
subject to and in compliance with
subpart B of part 117 of this chapter and
in compliance with all applicable
human food safety requirements of the
Federal Food, Drug, and Cosmetic Act
and implementing regulations; or
(ii) For the off-farm packing and
holding of produce (as defined in part
112 of this chapter), the human food
facility is subject to and in compliance
with § 117.8 of this chapter and in
compliance with all applicable human
food safety requirements of the Federal
Food, Drug, and Cosmetic Act and
implementing regulations; and
(2) The human food facility does not
further manufacture or process the byproducts intended for use as animal
food.
(b) The human food by-products for
use as animal food identified in
paragraph (a) of this section must be
held and distributed by that facility in
accordance with § 507.28 and § 117.95
of this chapter.
Subpart B—Current Good
Manufacturing Practice
§ 507.14
Personnel.
(a) The management of the
establishment must take reasonable
measures and precautions to ensure that
all persons working in direct contact
with animal food, animal food-contact
surfaces, and animal food-packaging
materials conform to hygienic practices
to the extent necessary to protect against
the contamination of animal food.
(b) The methods for conforming to
hygienic practices and maintaining
cleanliness include:
(1) Maintaining adequate personal
cleanliness;
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(2) Washing hands thoroughly in an
adequate hand-washing facility as
necessary and appropriate to protect
against contamination;
(3) Removing or securing jewelry and
other objects that might fall into animal
food, equipment, or containers;
(4) Storing clothing or other personal
belongings in areas other than where
animal food is exposed or where
equipment or utensils are cleaned; and
(5) Taking any other necessary
precautions to protect against the
contamination of animal food, animal
food-contact surfaces, or animal foodpackaging materials.
§ 507.17
Plant and grounds.
(a) The grounds around an animal
food plant under the control of the
management of the establishment must
be kept in a condition that will protect
against the contamination of animal
food. Maintenance of grounds must
include:
(1) Properly storing equipment,
removing litter and waste, and cutting
weeds or grass within the immediate
vicinity of the plant that may constitute
an attractant, breeding place, or
harborage for pests;
(2) Maintaining driveways, yards, and
parking areas so that they do not
constitute a source of contamination in
areas where animal food is exposed;
(3) Adequately draining areas that
may contribute to contamination of
animal food; and
(4) Treating and disposing of waste so
that it does not constitute a source of
contamination in areas where animal
food is exposed.
(b) The plant must be suitable in size,
construction, and design to facilitate
cleaning, maintenance, and pest control
to reduce the potential for
contamination of animal food, animal
food-contact surfaces, and animal foodpackaging materials, including that the
plant must:
(1) Provide adequate space between
equipment, walls, and stored materials
to permit employees to perform their
duties and to allow cleaning and
maintenance of equipment;
(2) Be constructed in a manner such
that drip or condensate from fixtures,
ducts, and pipes does not serve as a
source of contamination;
(3) Provide adequate ventilation
(mechanical or natural) where necessary
and appropriate to minimize vapors
(e.g., steam) and fumes in areas where
they may contaminate animal food and
in a manner that minimizes the
potential for contaminating animal food;
(4) Provide adequate lighting in handwashing areas, toilet rooms, areas where
animal food is received, manufactured,
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processed, packed, or held, and areas
where equipment or utensils are
cleaned; and
(5) Provide shatter-resistant light
bulbs, fixtures, and skylights, or other
glass items suspended over exposed
animal food in any step of preparation,
to protect against the contamination of
animal food in case of glass breakage.
(c) The plant must protect animal
food stored outdoors in bulk from
contamination by any effective means,
including:
(1) Using protective coverings where
necessary and appropriate;
(2) Controlling areas over and around
the bulk animal food to eliminate
harborages for pests; and
(3) Checking on a regular basis for
pests, pest infestation, and product
condition related to safety of the animal
food.
mstockstill on DSK4VPTVN1PROD with RULES3
§ 507.19
Sanitation.
(a) Buildings, structures, fixtures, and
other physical facilities of the plant
must be kept clean and in good repair
to prevent animal food from becoming
adulterated.
(b) Animal food-contact and noncontact surfaces of utensils and
equipment must be cleaned and
maintained and utensils and equipment
stored as necessary to protect against the
contamination of animal food, animal
food-contact surfaces, or animal foodpackaging materials. When necessary,
equipment must be disassembled for
thorough cleaning. In addition:
(1) When animal food-contact surfaces
used for manufacturing, processing,
packing, or holding animal food are wetcleaned, the surfaces must, when
necessary, be thoroughly dried before
subsequent use; and
(2) In wet processing of animal food,
when cleaning and sanitizing is
necessary to protect against the
introduction of undesirable
microorganisms into animal food, all
animal food-contact surfaces must be
cleaned and sanitized before use and
after any interruption during which the
animal food-contact surfaces may have
become contaminated.
(c) Cleaning compounds and
sanitizing agents must be safe and
adequate under the conditions of use.
(d) The following applies to toxic
materials:
(1) Only the following toxic materials
may be used or stored in the plant area
where animal food is manufactured,
processed, or exposed:
(i) Those required to maintain clean
and sanitary conditions;
(ii) Those necessary for use in
laboratory testing procedures;
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(iii) Those necessary for plant and
equipment maintenance and operation;
and
(iv) Those necessary for use in the
plant’s operations.
(2) Toxic materials described in
paragraph (d)(1) of this section (e.g.,
cleaning compounds, sanitizing agents,
and pesticide chemicals) must be
identified, used, and stored in a manner
that protects against the contamination
of animal food, animal food-contact
surfaces, or animal food-packaging
materials; and
(3) Other toxic materials (such as
fertilizers and pesticides not included in
paragraph (d)(1) of this section) must be
stored in an area of the plant where
animal food is not manufactured,
processed, or exposed.
(e) Effective measures must be taken
to exclude pests from the
manufacturing, processing, packing, and
holding areas and to protect against the
contamination of animal food by pests.
The use of pesticides in the plant is
permitted only under precautions and
restrictions that will protect against the
contamination of animal food, animal
food-contact surfaces, and animal foodpackaging materials.
(f) Trash must be conveyed, stored,
and disposed of in a way that protects
against the contamination of animal
food, animal food-contact surfaces,
animal food-packaging materials, water
supplies, and ground surfaces, and
minimizes the potential for the trash to
become an attractant and harborage or
breeding place for pests.
§ 507.20
Water supply and plumbing.
(a) The following apply to the water
supply:
(1) Water must be adequate for the
operations and must be derived from an
adequate source;
(2) Running water at a suitable
temperature, and under suitable
pressure as needed, must be provided in
all areas where required for the
manufacturing, processing, packing, or
holding of animal food, for the cleaning
of equipment, utensils, and animal foodpackaging materials, or for employee
hand-washing facilities;
(3) Water that contacts animal food,
animal food-contact surfaces, or animal
food-packaging materials must be safe
for its intended use; and
(4) Water may be reused for washing,
rinsing, or conveying animal food if it
does not increase the level of
contamination of the animal food.
(b) Plumbing must be designed,
installed, and maintained to:
(1) Carry adequate quantities of water
to required locations throughout the
plant;
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(2) Properly convey sewage and liquid
disposable waste from the plant;
(3) Avoid being a source of
contamination to animal food, water
supplies, equipment, or utensils, or
creating an unsanitary condition;
(4) Provide adequate floor drainage in
all areas where floors are subject to
flooding-type cleaning or where normal
operations release or discharge water or
other liquid waste on the floor; and
(5) Ensure that there is no backflow
from, or cross-connection between,
piping systems that discharge waste
water or sewage and piping systems that
carry water for animal food or animal
food manufacturing.
(c) Sewage and liquid disposal waste
must be disposed of through an
adequate sewerage system or through
other adequate means.
(d) Each plant must provide
employees with adequate, readily
accessible toilet facilities. Toilet
facilities must be kept clean and must
not be a potential source of
contamination of animal food, animal
food-contact surfaces, or animal foodpackaging materials.
(e) Each plant must provide handwashing facilities designed to ensure
that an employee’s hands are not a
potential source of contamination of
animal food, animal food-contact
surfaces, or animal food-packaging
materials.
§ 507.22
Equipment and utensils.
(a) The following apply to plant
equipment and utensils used in
manufacturing, processing, packing, and
holding animal food:
(1) All plant equipment and utensils,
including equipment and utensils that
do not come in contact with animal
food, must be designed and constructed
of such material and workmanship to be
adequately cleanable, and must be
properly maintained;
(2) Equipment and utensils must be
designed, constructed, and used
appropriately to avoid the adulteration
of animal food with non-food grade
lubricants, fuel, metal fragments,
contaminated water, or any other
contaminants;
(3) Equipment must be installed so as
to facilitate the cleaning and
maintenance of the equipment and
adjacent spaces;
(4) Animal food-contact surfaces must
be:
(i) Made of materials that withstand
the environment of their use and the
action of animal food, and, if applicable,
the action of cleaning compounds,
cleaning procedures, and sanitizing
agents;
(ii) Made of nontoxic materials; and
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(iii) Maintained to protect animal food
from being contaminated.
(b) Holding, conveying,
manufacturing, and processing systems,
including gravimetric, pneumatic,
closed, and automated systems, must be
designed, constructed, and maintained
in a way to protect against the
contamination of animal food.
(c) Each freezer and cold storage
compartment used to hold animal food
must be fitted with an accurate
temperature-measuring device.
(d) Instruments and controls used for
measuring, regulating, or recording
temperatures, pH, aw, or other
conditions that control or prevent the
growth of undesirable microorganisms
in animal food must be accurate,
precise, adequately maintained, and
adequate in number for their designated
uses.
(e) Compressed air or other gases
mechanically introduced into animal
food or used to clean animal foodcontact surfaces or equipment must be
used in such a way to protect against the
contamination of animal food.
mstockstill on DSK4VPTVN1PROD with RULES3
§ 507.25
Plant operations.
(a) Management of the establishment
must ensure that:
(1) All operations in the
manufacturing, processing, packing, and
holding of animal food (including
operations directed to receiving,
inspecting, transporting, and
segregating) are conducted in
accordance with the current good
manufacturing practice requirements of
this subpart;
(2) Animal food, including raw
materials, other ingredients, or rework is
accurately identified;
(3) Animal food-packaging materials
are safe and suitable;
(4) The overall cleanliness of the plant
is under the supervision of one or more
competent individuals assigned
responsibility for this function;
(5) Adequate precautions are taken so
that plant operations do not contribute
to contamination of animal food, animal
food-contact surfaces, and animal foodpackaging materials;
(6) Chemical, microbial, or
extraneous-material testing procedures
are used where necessary to identify
sanitation failures or possible animal
food contamination;
(7) Animal food that has become
adulterated is rejected, disposed of, or if
appropriate, treated or processed to
eliminate the adulteration. If disposed
of, it must be done in a manner that
protects against the contamination of
other animal food; and
(8) All animal food manufacturing,
processing, packing, and holding is
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conducted under such conditions and
controls as are necessary to minimize
the potential for the growth of
undesirable microorganisms to protect
against the contamination of animal
food.
(b) Raw materials and other
ingredients:
(1) Must be examined to ensure that
they are suitable for manufacturing and
processing into animal food and must be
handled under conditions that will
protect against contamination and
minimize deterioration. In addition:
(i) Shipping containers (e.g., totes,
drums, and tubs) and bulk vehicles
holding raw materials and other
ingredients must be examined upon
receipt to determine whether
contamination or deterioration of
animal food has occurred;
(ii) Raw materials must be cleaned as
necessary to minimize contamination;
and
(iii) Raw materials and other
ingredients, including rework, must be
stored in containers designed and
constructed in a way that protects
against contamination and deterioration,
and held under conditions, e.g.,
appropriate temperature and relative
humidity, that will minimize the
potential for growth of undesirable
microorganisms and prevent the animal
food from becoming adulterated;
(2) Susceptible to contamination with
mycotoxins or other natural toxins must
be evaluated and used in a manner that
does not result in animal food that can
cause injury or illness to animals or
humans; and
(3) If frozen, must be kept frozen. If
thawing is required prior to use, it must
be done in a manner that minimizes the
potential for the growth of undesirable
microorganisms.
(c) For the purposes of manufacturing,
processing, packing, and holding
operations, the following apply:
(1) Animal food must be maintained
under conditions, e.g., appropriate
temperature and relative humidity, that
will minimize the potential for growth
of undesirable microorganisms and
prevent the animal food from becoming
adulterated during manufacturing,
processing, packing, and holding;
(2) Measures taken during
manufacturing, processing, packing, and
holding of animal food to significantly
minimize or prevent the growth of
undesirable microorganisms (e.g., heat
treating, freezing, refrigerating,
irradiating, controlling pH, or
controlling aw) must be adequate to
prevent adulteration of animal food;
(3) Work-in-process and rework must
be handled in such a way that it is
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protected against contamination and the
growth of undesirable microorganisms;
(4) Steps such as cutting, drying,
defatting, grinding, mixing, extruding,
pelleting, and cooling, must be
performed in a way that protects against
the contamination of animal food;
(5) Filling, assembling, packaging, and
other operations must be performed in
such a way that protects against the
contamination of animal food and the
growth of undesirable microorganisms;
(6) Animal food that relies principally
on the control of water activity (aw) for
preventing the growth of undesirable
microorganisms must be processed to
and maintained at a safe aw level;
(7) Animal food that relies principally
on the control of pH for preventing the
growth of undesirable microorganisms
must be monitored and maintained at
the appropriate pH; and
(8) When ice is used in contact with
animal food, it must be made from water
that is safe and must be used only if it
has been manufactured in accordance
with current good manufacturing
practice as outlined in this subpart.
§ 507.27
Holding and distribution.
(a) Animal food held for distribution
must be held under conditions that will
protect against contamination and
minimize deterioration, including the
following:
(1) Containers used to hold animal
food before distribution must be
designed, constructed of appropriate
material, cleaned as necessary, and
maintained to protect against the
contamination of animal food; and
(2) Animal food held for distribution
must be held in a way that protects
against contamination from sources
such as trash.
(b) The labeling for the animal food
product ready for distribution must
contain, when applicable, information
and instructions for safely using the
animal food product for the intended
animal species.
(c) Shipping containers (e.g., totes,
drums, and tubs) and bulk vehicles used
to distribute animal food must be
examined prior to use to protect against
the contamination of animal food from
the container or vehicle when the
facility is responsible for transporting
the animal food itself or arranges with
a third party to transport the animal
food.
(d) Animal food returned from
distribution must be assessed for animal
food safety to determine the appropriate
disposition. Returned animal food must
be identified as such and segregated
until assessed.
(e) Unpackaged or bulk animal food
must be held in a manner that does not
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result in unsafe cross contamination
with other animal food.
§ 507.28 Holding and distribution of
human food by-products for use as animal
food.
(a) Human food by-products held for
distribution as animal food must be held
under conditions that will protect
against contamination, including the
following:
(1) Containers and equipment used to
convey or hold human food by-products
for use as animal food before
distribution must be designed,
constructed of appropriate material,
cleaned as necessary, and maintained to
protect against the contamination of
human food by-products for use as
animal food;
(2) Human food by-products for use as
animal food held for distribution must
be held in a way to protect against
contamination from sources such as
trash; and
(3) During holding, human food byproducts for use as animal food must be
accurately identified.
(b) Labeling that identifies the
product by the common or usual name
must be affixed to or accompany the
human food by-products for use as
animal food when distributed.
(c) Shipping containers (e.g., totes,
drums, and tubs) and bulk vehicles used
to distribute human food by-products
for use as animal food must be
examined prior to use to protect against
the contamination of animal food from
the container or vehicle when the
facility is responsible for transporting
the human food by-products for use as
animal food itself or arranges with a
third party to transport the human food
by-products for use as animal food.
Subpart C—Hazard Analysis and RiskBased Preventive Controls
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§ 507.31
Food safety plan.
(a) You must prepare, or have
prepared, and implement a written food
safety plan.
(b) One or more preventive controls
qualified individuals must prepare, or
oversee the preparation of, the food
safety plan.
(c) The written food safety plan must
include:
(1) The written hazard analysis as
required by § 507.33(a)(2);
(2) The written preventive controls as
required by § 507.34(b);
(3) The written supply-chain program
as required by subpart E of this part;
(4) The written recall plan as required
by § 507.38(a)(1);
(5) The written procedures for
monitoring the implementation of the
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preventive controls as required by
§ 507.40(a)(1);
(6) The written corrective action
procedures as required by § 507.42(a)(1);
and
(7) The written verification
procedures as required by § 507.49(b).
(d) The food safety plan required by
this section is a record that is subject to
the requirements of subpart F of this
part.
§ 507.33
Hazard analysis.
(a)(1) You must conduct a hazard
analysis to identify and evaluate, based
on experience, illness data, scientific
reports, and other information, known
or reasonably foreseeable hazards for
each type of animal food manufactured,
processed, packed, or held at your
facility to determine whether there are
any hazards requiring a preventive
control; and
(2) The hazard analysis must be
written regardless of its outcome.
(b) The hazard identification must
consider:
(1) Known or reasonably foreseeable
hazards that include:
(i) Biological hazards, including
microbiological hazards such as
parasites, environmental pathogens, and
other pathogens;
(ii) Chemical hazards, including
radiological hazards, substances such as
pesticide and drug residues, natural
toxins, decomposition, unapproved food
or color additives, and nutrient
deficiencies or toxicities (such as
inadequate thiamine in cat food,
excessive vitamin D in dog food, and
excessive copper in food for sheep); and
(iii) Physical hazards (such as stones,
glass, and metal fragments); and
(2) Known or reasonably foreseeable
hazards that may be present in the
animal food for any of the following
reasons:
(i) The hazard occurs naturally;
(ii) The hazard may be
unintentionally introduced; or
(iii) The hazard may be intentionally
introduced for purposes of economic
gain.
(c)(1) The hazard analysis must
include an evaluation of the hazards
identified in paragraph (b) of this
section to assess the severity of the
illness or injury if the hazard were to
occur and the probability that the
hazard will occur in the absence of
preventive controls.
(2) The hazard evaluation required by
paragraph (c)(1) of this section must
include an evaluation of environmental
pathogens whenever an animal food is
exposed to the environment prior to
packaging and the packaged animal food
does not receive a treatment or
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otherwise include a control measure
(such as a formulation lethal to the
pathogen) that would significantly
minimize the pathogen.
(d) The hazard evaluation must
consider the effect of the following on
the safety of the finished animal food for
the intended animal:
(1) The formulation of the animal
food;
(2) The condition, function, and
design of the facility and equipment;
(3) Raw materials and other
ingredients;
(4) Transportation practices;
(5) Manufacturing/processing
procedures;
(6) Packaging activities and labeling
activities;
(7) Storage and distribution;
(8) Intended or reasonably foreseeable
use;
(9) Sanitation, including employee
hygiene; and
(10) Any other relevant factors such as
the temporal (e.g., weather-related)
nature of some hazards (e.g., levels of
some natural toxins).
§ 507.34
Preventive controls.
(a)(1) You must identify and
implement preventive controls to
provide assurances that any hazards
requiring a preventive control will be
significantly minimized or prevented
and the animal food manufactured,
processed, packed, or held by your
facility will not be adulterated under
section 402 of the Federal Food, Drug,
and Cosmetic Act; and
(2) Preventive controls required by
paragraph (a)(1) of this section include:
(i) Controls at critical control points
(CCPs), if there are any CCPs; and
(ii) Controls, other than those at CCPs,
that are also appropriate for animal food
safety.
(b) Preventive controls must be
written.
(c) Preventive controls include, as
appropriate to the facility and animal
food:
(1) Process controls. Process controls
include procedures, practices, and
processes to ensure the control of
parameters during operations such as
heat processing, irradiating, and
refrigerating animal food. Process
controls must include, as appropriate to
the nature of the applicable control and
its role in the facility’s food safety
system:
(i) Parameters associated with the
control of the hazard; and
(ii) The maximum or minimum value,
or combination of values, to which any
biological, chemical, or physical
parameter must be controlled to
significantly minimize or prevent a
hazard requiring a process control.
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(2) Sanitation controls. Sanitation
controls include procedures, practices,
and processes to ensure that the facility
is maintained in a sanitary condition
adequate to significantly minimize or
prevent hazards such as environmental
pathogens and biological hazards due to
employee handling. Sanitation controls
must include, as appropriate to the
facility and the animal food, procedures,
practices, and processes for the:
(i) Cleanliness of animal food-contact
surfaces, including animal food-contact
surfaces of utensils and equipment; and
(ii) Prevention of cross-contamination
from insanitary objects and from
personnel to animal food, animal foodpackaging material, and other animal
food-contact surfaces and from raw
product to processed product.
(3) Supply-chain controls. Supplychain controls include the supply-chain
program as required by subpart E of this
part;
(4) A recall plan as required by
§ 507.38; and
(5) Other preventive controls. These
include any other procedures, practices,
and processes necessary to satisfy the
requirements of paragraph (a) of this
section. Examples of other controls
include hygiene training and other
current good manufacturing practices.
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§ 507.36 Circumstances in which the
owner, operator, or agent in charge of a
manufacturing/processing facility is not
required to implement a preventive control.
(a) If you are a manufacturer/
processor, you are not required to
implement a preventive control when
you identify a hazard requiring a
preventive control (identified hazard)
and any of the following circumstances
apply:
(1) You determine and document that
the type of animal food could not be
consumed without application of an
appropriate control;
(2) You rely on your customer who is
subject to the requirements for hazard
analysis and risk-based preventive
controls in subpart C of this part to
ensure that the identified hazard will be
significantly minimized or prevented;
and you:
(i) Disclose in documents
accompanying the animal food, in
accordance with the practice of the
trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and
(ii) Annually obtain from your
customer written assurance, subject to
the requirements of § 507.37, that the
customer has established and is
following procedures (identified in the
written assurance) that will significantly
minimize or prevent the identified
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hazard (except as provided in paragraph
(c) of this section);
(3) You rely on your customer who is
not subject to the requirements for
hazard analysis and risk-based
preventive controls in subpart C of this
part to provide assurance it is
manufacturing, processing, or preparing
the animal food in accordance with
applicable animal food safety
requirements and you:
(i) Disclose in documents
accompanying the animal food, in
accordance with the practice of the
trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and
(ii) Annually obtain from your
customer written assurance that it is
manufacturing, processing, or preparing
the animal food in accordance with
applicable animal food safety
requirements;
(4) You rely on your customer to
provide assurance that the animal food
will be processed to control the
identified hazard by an entity in the
distribution chain subsequent to the
customer and you:
(i) Disclose in documents
accompanying the animal food, in
accordance with the practice of the
trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and
(ii) Annually obtain from your
customer written assurance, subject to
the requirements of § 507.37, that your
customer:
(A) Will disclose in documents
accompanying the animal food, in
accordance with the practice of the
trade, that the animal food is ‘‘not
processed to control [identified
hazard]’’; and
(B) Will only sell to another entity
that agrees, in writing, it will:
(1) Follow procedures (identified in a
written assurance) that will significantly
minimize or prevent the identified
hazard (if the entity is subject to the
requirements for hazard analysis and
risk-based preventive controls in
subpart C of this part), except as
provided in paragraph (d) of this
section, or manufacture, process, or
prepare the animal food in accordance
with applicable animal food safety
requirements (if the entity is not subject
to the requirements for hazard analysis
and risk-based preventive controls in
subpart C of this part); or
(2) Obtain a similar written assurance
from the entity’s customer, subject to
the requirements of § 507.37, as in
paragraphs (a)(4)(ii)(A) and (B) of this
section, as appropriate; or
(5)You have established, documented,
and implemented a system that ensures
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control, at a subsequent distribution
step, of the hazards in the animal food
product you distribute and you
document the implementation of that
system.
(b) You must document any
circumstance specified in paragraph (a)
of this section that applies to you,
including:
(1) A determination in accordance
with paragraph (a) of this section that
the type of animal food could not be
consumed without application of an
appropriate control;
(2) The annual written assurance from
your customer in accordance with
paragraph (a)(2) of this section;
(3) The annual written assurance from
your customer in accordance with
paragraph (a)(3) of this section;
(4) The annual written assurance from
your customer in accordance with
paragraph (a)(4) of this section; and
(5) Your system, in accordance with
paragraph (a)(5) of this section, that
ensures control, at a subsequent
distribution step, of the hazards in the
animal food product you distribute.
(c) For the written assurance required
by paragraph (a)(2)(ii) of this section, if
your customer has determined that the
identified hazard in paragraph (a) of this
section is not a hazard in the animal
food intended for use for a specific
animal species, your customer’s written
assurance may provide this
determination (including animal species
and why the identified hazard is not a
hazard) instead of providing assurance
of procedures established and followed
that will significantly minimize or
prevent the identified hazard.
(d) For the written assurance required
by paragraph (a)(4)(ii)(B) of this section,
if the entity in the distribution chain
subsequent to your customer is subject
to subpart C of this part and has
determined that the identified hazard in
paragraph (a) of this section is not a
hazard in the animal food intended for
use for a specific animal species, that
entity’s written assurance may provide
this determination (including animal
species and why the identified hazard is
not a hazard) instead of providing
assurance that the identified hazard will
be significantly minimized or
prevented.
§ 507.37 Provision of assurances required
under § 507.36(a)(2), (3), and (4).
A facility that provides a written
assurance under § 507.36(a)(2), (3), or
(4) must act consistently with the
assurance and document its actions
taken to satisfy the written assurance.
§ 507.38
Recall plan.
(a) For animal food with a hazard
requiring a preventive control you must:
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(1) Establish a written recall plan for
the animal food; and
(2) Assign responsibility for
performing all procedures in the recall
plan.
(b) The written recall plan must
include procedures that describe the
steps to perform the following actions as
appropriate to the facility:
(1) Directly notify direct consignees
about the animal food being recalled,
including how to return or dispose of
the affected animal food;
(2) Notify the public about any hazard
presented by the animal food when
appropriate to protect human and
animal health;
(3) Conduct effectiveness checks to
verify the recall has been carried out;
and
(4) Appropriately dispose of recalled
animal food, e.g., through reprocessing,
reworking, diverting to another use that
would not present a safety concern, or
destroying the animal food.
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§ 507.39 Preventive control management
components.
(a) Except as provided by paragraphs
(b) and (c) of this section, the preventive
controls required under § 507.34 are
subject to the following preventive
control management components as
appropriate to ensure the effectiveness
of the preventive controls, taking into
account the nature of the preventive
control and its role in the facility’s food
safety system:
(1) Monitoring in accordance with
§ 507.40;
(2) Corrective actions and corrections
in accordance with § 507.42; and
(3) Verification in accordance with
§ 507.45.
(b) The supply-chain program
established in subpart E of this part is
subject to the following preventive
control management components as
appropriate to ensure the effectiveness
of the supply-chain program, taking into
account the nature of the hazard
controlled before receipt of the raw
material or other ingredient:
(1) Corrective actions and corrections
in accordance with § 507.42, taking into
account the nature of any supplier nonconformance;
(2) Review of records in accordance
with § 507.49(a)(4)(ii); and
(3) Reanalysis in accordance with
§ 507.50.
(c) The recall plan established in
§ 507.38 is not subject to the
requirements of paragraph (a) of this
section.
§ 507.40
Monitoring.
As appropriate to the nature of the
preventive control and its role in the
facility’s food safety system you must:
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(a) Establish and implement written
procedures, including the frequency
with which they are to be performed, for
monitoring the preventive controls; and
(b) Monitor the preventive controls
with adequate frequency to provide
assurance that they are consistently
performed.
(c)(1) You must document the
monitoring of preventive controls in
accordance with this section in records
that are subject to verification in
accordance with § 507.45(a)(2) and
records review in accordance with
§ 507.49(a)(4)(i);
(2)(i) Records of refrigeration
temperature during storage of animal
food that requires time/temperature
control to significantly minimize or
prevent the growth of, or toxin
production by, pathogens may be
affirmative records demonstrating
temperature is controlled or exception
records demonstrating loss of
temperature control; and
(ii) Exception records may be
adequate in circumstances other than
monitoring of refrigeration temperature.
§ 507.42 Corrective actions and
corrections.
(a) As appropriate to the nature of the
hazard and the nature of the preventive
control, except as provided by
paragraph (c) of this section:
(1) You must establish and implement
written corrective action procedures
that must be taken if preventive controls
are not properly implemented,
including procedures to address, as
appropriate:
(i) The presence of a pathogen or
appropriate indicator organism in
animal food detected as a result of
product testing conducted in
accordance with § 507.49(a)(2); and
(ii) The presence of an environmental
pathogen or appropriate indicator
organism detected through the
environmental monitoring conducted in
accordance with § 507.49(a)(3).
(2) The corrective action procedures
must describe the steps to be taken to
ensure that:
(i) Appropriate action is taken to
identify and correct a problem that has
occurred with implementation of a
preventive control;
(ii) Appropriate action is taken when
necessary, to reduce the likelihood that
the problem will recur;
(iii) All affected animal food is
evaluated for safety; and
(iv) All affected animal food is
prevented from entering into commerce
if you cannot ensure the affected animal
food is not adulterated under section
402 of the Federal Food, Drug, and
Cosmetic Act.
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(b)(1) Except as provided by
paragraph (c) of this section, you are
subject to the requirements of paragraph
(b)(2) of this section if any of the
following circumstances apply:
(i) A preventive control is not
properly implemented and a corrective
action procedure has not been
established;
(ii) A preventive control, combination
of preventive controls, or the food safety
plan as a whole is found to be
ineffective; or
(iii) A review of records in accordance
with § 507.49(a)(4) finds that the records
are not complete, the activities
conducted did not occur in accordance
with the food safety plan, or appropriate
decisions were not made about
corrective actions.
(2) If any of the circumstances listed
in paragraph (b)(1) of this section apply,
you must:
(i) Take corrective action to identify
and correct the problem;
(ii) Reduce the likelihood that the
problem will recur;
(iii) Evaluate all affected animal food
for safety;
(iv) As necessary, prevent affected
animal food from entering commerce as
would be done following the corrective
action procedure under paragraph (a)(2)
of this section; and
(v) When appropriate, reanalyze the
food safety plan in accordance with
§ 507.50 to determine whether
modification of the food safety plan is
required.
(c) You do not need to comply with
the requirements of paragraphs (a) and
(b) of this section if:
(1) You take action, in a timely
manner, to identify and correct
conditions and practices that are not
consistent with the sanitation controls
in § 507.34(c)(2)(i) or (ii); or
(2) You take action, in a timely
manner, to identify and correct a minor
and isolated problem that does not
directly impact product safety.
(d) All corrective actions (and, when
appropriate, corrections) taken in
accordance with this section must be
documented in records. These records
are subject to verification in accordance
with § 507.45(a)(3) and records review
in accordance with § 507.49(a)(4)(i).
§ 507.45
Verification.
(a) Verification activities must
include, as appropriate to the nature of
the preventive control and its role in the
facility’s food safety system:
(1) Validation in accordance with
§ 507.47;
(2) Verification that monitoring is
being conducted as required by § 507.39
(and in accordance with § 507.40);
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(3) Verification that appropriate
decisions about corrective actions are
being made as required by § 507.39 (and
in accordance with § 507.42);
(4) Verification of implementation
and effectiveness in accordance with
§ 507.49; and
(5) Reanalysis in accordance with
§ 507.50.
(b) All verification activities
conducted in accordance with this
section must be documented in records.
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§ 507.47
Validation.
(a) You must validate that the
preventive controls identified and
implemented in accordance with
§ 507.34 are adequate to control the
hazard as appropriate to the nature of
the preventive control and its role in the
facility’s food safety system.
(b) The validation of the preventive
controls:
(1) Must be performed (or overseen)
by a preventive controls qualified
individual:
(i)(A) Prior to implementation of the
food safety plan or;
(B) When necessary to demonstrate
the control measures can be
implemented as designed:
(1) Within 90 calendar days after
production of the applicable animal
food first begins;
(2) Within a reasonable timeframe,
provided that the preventive controls
qualified individual prepares (or
oversees the preparation of) a written
justification for a timeframe that
exceeds 90 calendar days after
production of the applicable animal
food first begins;
(ii) Whenever a change to a control
measure or combination of control
measures could impact whether the
control measure or combination of
control measures, when properly
implemented, will effectively control
the hazards; and
(iii) Whenever a reanalysis of the food
safety plan reveals the need to do so.
(2) Must include obtaining and
evaluating scientific and technical
evidence (or, when such evidence is not
available or is inadequate, conducting
studies) to determine whether the
preventive controls, when properly
implemented, will effectively control
the hazards.
(c) You do not need to validate:
(1) The sanitation controls in
§ 507.34(c)(2);
(2) The recall plan in § 507.38;
(3) The supply-chain program in
subpart E of this part; and
(4) Other preventive controls, if the
preventive controls qualified individual
prepares (or oversees the preparation of)
a written justification that validation is
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not applicable based on factors such as
the nature of the hazard, and the nature
of the preventive control and its role in
the facility’s food safety system.
§ 507.49 Verification of implementation
and effectiveness.
(a) You must verify that the
preventive controls are consistently
implemented and are effectively and
significantly minimizing or preventing
the hazards. To do so, you must conduct
activities that include the following, as
appropriate to the facility, the animal
food, and the nature of the preventive
control and its role in the facility’s food
safety system:
(1) Calibration of process monitoring
and verification instruments (or
checking them for accuracy);
(2) Product testing for a pathogen (or
appropriate indicator organism) or other
hazard;
(3) Environmental monitoring, for an
environmental pathogen or for an
appropriate indicator organism, if
contamination of an animal food with
an environmental pathogen is a hazard
requiring a preventive control, by
collecting and testing environmental
samples; and
(4) Review of the following records
within the specified timeframes, by (or
under the oversight of) a preventive
controls qualified individual, to ensure
the records are complete, the activities
reflected in the records occurred in
accordance with the food safety plan,
the preventive controls are effective,
and appropriate decisions were made
about corrective actions:
(i) Monitoring and corrective action
records within 7-working days after the
records are created or within a
reasonable timeframe, provided that the
preventive controls qualified individual
prepares (or oversees the preparation of)
a written justification for a timeframe
that exceeds 7-working days; and
(ii) Records of calibration, testing
(e.g., product testing, environmental
monitoring), and supplier and supplychain verification activities, and other
verification activities within a
reasonable time after the records are
created; and
(5) Other activities appropriate for
verification of implementation and
effectiveness.
(b) As appropriate to the facility, the
food, the nature of the preventive
control, and the role of the preventive
control in the facility’s food safety
system, you must establish and
implement written procedures for the
following activities:
(1) The method and frequency of
calibrating process monitoring
instruments and verification
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instruments (or checking them for
accuracy) as required by paragraph
(a)(1) of this section;
(2) Product testing as required by
paragraph (a)(2) of this section.
Procedures for product testing must:
(i) Be scientifically valid;
(ii) Identify the test microorganism(s)
or other analyte(s);
(iii) Specify the procedures for
identifying samples, including their
relationship to specific lots of product;
(iv) Include the procedures for
sampling, including the number of
samples and the sampling frequency;
(v) Identify the test(s) conducted,
including the analytical method(s) used;
(vi) Identify the laboratory conducting
the testing; and
(vii) Include the corrective action
procedures required by § 507.42(a)(1).
(3) Environmental monitoring as
required by paragraph (a)(3) of this
section. Procedures for environmental
monitoring must:
(i) Be scientifically valid;
(ii) Identify the test microorganism(s);
(iii) Identify the locations from which
samples will be collected and the
number of sites to be tested during
routine environmental monitoring. The
number and location of sampling sites
must be adequate to determine whether
preventive controls are effective;
(iv) Identify the timing and frequency
for collecting and testing samples. The
timing and frequency for collecting and
testing samples must be adequate to
determine whether preventive controls
are effective;
(v) Identify the test(s) conducted,
including the analytical method(s) used;
(vi) Identify the laboratory conducting
the testing; and
(vii) Include the corrective action
procedures required by
§ 507.42(a)(1)(ii).
§ 507.50
Reanalysis.
(a) You must conduct a reanalysis of
the food safety plan as a whole at least
once every 3 years.
(b) You must conduct a reanalysis of
the food safety plan as a whole, or the
applicable portion of the food safety
plan:
(1) Whenever a significant change in
the activities conducted at your facility
creates a reasonable potential for a new
hazard or creates a significant increase
in a previously identified hazard;
(2) Whenever you become aware of
new information about potential
hazards associated with the animal
food;
(3) Whenever appropriate after an
unanticipated animal food safety
problem in accordance with § 507.42(b);
and
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(4) Whenever you find that a
preventive control, combination of
preventive controls, or the food safety
plan as a whole is ineffective.
(c) You must complete the reanalysis
required by paragraphs (a) and (b) of
this section and validate, as appropriate
to the nature of the preventive control
and its role in the facility’s food safety
system, any additional preventive
controls needed to address the hazard
identified:
(1) Before any change in activities
(including any change in preventive
control) at the facility is operative; or,
(2) When necessary to demonstrate
the control measures can be
implemented as designed:
(i) Within 90 calendar days after
production of the applicable animal
food first begins; or
(ii) Within a reasonable timeframe,
provided that the preventive controls
qualified individual prepares (or
oversees the preparation of) a written
justification for a timeframe that
exceeds 90 calendar days after
production of the applicable animal
food first begins.
(d) You must revise the written food
safety plan if a significant change in the
activities conducted at your facility
creates a reasonable potential for a new
hazard or a significant increase in a
previously identified hazard, or
document the basis for the conclusion
that no revisions are needed.
(e) A preventive controls qualified
individual must perform (or oversee) the
reanalysis.
(f) You must conduct a reanalysis of
the food safety plan when FDA
determines it is necessary to respond to
new hazards and developments in
scientific understanding.
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§ 507.51 Modified requirements that apply
to a facility solely engaged in the storage
of unexposed packaged animal food.
(a) If a facility that is solely engaged
in the storage of unexposed packaged
animal food stores any such refrigerated
packaged animal food that requires
time/temperature control to
significantly minimize or prevent the
growth of, or toxin formation by
pathogens, the facility must conduct the
following activities as appropriate to
ensure the effectiveness of the
temperature controls:
(1) Establish and implement
temperature controls adequate to
significantly minimize or prevent the
growth of, or toxin formation by,
pathogens;
(2) Monitor the temperature controls
with adequate frequency to provide
assurance that the temperature controls
are consistently performed;
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(3) If there is a loss of temperature
control that may impact the safety of
such refrigerated packaged animal food,
take appropriate corrective actions to:
(i) Correct the problem and reduce the
likelihood that the problem will recur;
(ii) Evaluate all affected animal food
for safety; and
(iii) Prevent the animal food from
entering commerce, if you cannot
ensure the affected animal food is not
adulterated under section 402 of the
Federal Food, Drug, and Cosmetic Act;
(4) Verify that temperature controls
are consistently implemented by:
(i) Calibrating temperature monitoring
and recording devices (or checking them
for accuracy);
(ii) Reviewing records of calibration
within a reasonable time after the
records are created; and
(iii) Reviewing records of monitoring
and corrective actions taken to correct a
problem with the control of temperature
within 7-working days after the records
are created or within a reasonable
timeframe, provided that the preventive
controls qualified individual prepares
(or oversees the preparation of) a written
justification for a timeframe that
exceeds 7-working days;
(5) Establish and maintain the
following records:
(i) Records (whether affirmative
records demonstrating temperature is
controlled or exception records
demonstrating loss of temperature
control) documenting the monitoring of
temperature controls for any such
refrigerated packaged animal food;
(ii) Records of corrective actions taken
when there is a loss of temperature
control that may impact the safety of
any such refrigerated packaged animal
food; and
(iii) Records documenting the
verification activities.
(b) The records that a facility must
establish and maintain under paragraph
(a)(5) of this section are subject to the
requirements of subpart F of this part.
§ 507.53 Requirements applicable to a
preventive controls qualified individual and
a qualified auditor.
(a) One or more preventive controls
qualified individuals must do or oversee
the following:
(1) Preparation of the food safety plan
(§ 507.31(b));
(2) Validation of the preventive
controls (§ 507.47(b)(1));
(3) Written justification for validation
to be performed in a timeframe that
exceeds the first 90 calendar days of
production of the applicable animal
food;
(4) Determination that validation is
not required (§ 507.47(c)(4));
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56349
(5) Review of records (§ 507.49(a)(4));
(6) Written justification for review of
records of monitoring and corrective
actions within a timeframe that exceeds
7-working days;
(7) Reanalysis of the food safety plan
(§ 507.50(d)); and
(8) Determination that reanalysis can
be completed, and additional preventive
controls validated, as appropriate to the
nature of the preventive control and its
role in the facility’s food safety system,
in a timeframe that exceeds the first 90
calendar days of production of the
applicable animal food.
(b) A qualified auditor must conduct
an onsite audit (§ 507.135(a)).
(c)(1) To be a preventive controls
qualified individual, the individual
must have successfully completed
training in the development and
application of risk-based preventive
controls at least equivalent to that
received under a standardized
curriculum recognized as adequate by
FDA or be otherwise qualified through
job experience to develop and apply a
food safety system. Job experience may
qualify an individual to perform these
functions if such experience has
provided an individual with knowledge
at least equivalent to that provided
through the standardized curriculum.
This individual may be, but is not
required to be, an employee of the
facility; and
(2) To be a qualified auditor, a
qualified individual must have
technical expertise obtained through
education, training, or experience (or a
combination thereof) necessary to
perform the auditing function.
(d) All applicable training in the
development and application of riskbased preventive controls must be
documented in records, including the
date of the training, the type of training,
and the person(s) trained.
§ 507.55 Implementation records required
for this subpart.
(a) You must establish and maintain
the following records documenting
implementation of the food safety plan:
(1) Documentation, as required by
§ 507.36(b), of the basis for not
establishing a preventive control in
accordance with § 507.36(a);
(2) Records that document the
monitoring of preventive controls;
(3) Records that document corrective
actions;
(4) Records that document
verification, including, as applicable,
those related to:
(i) Validation;
(ii) Verification of monitoring;
(iii) Verification of corrective actions;
(iv) Calibration of process monitoring
and verification instruments;
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(v) Product testing;
(vi) Environmental monitoring;
(vii) Records review; and
(viii) Reanalysis;
(5) Records that document the supplychain program; and
(6) Records that document applicable
training for the preventive controls
qualified individual and the qualified
auditor.
(b) The records that you must
establish and maintain are subject to the
requirements of subpart F of this part.
Subpart D—Withdrawal of a Qualified
Facility Exemption
§ 507.60 Circumstances that may lead FDA
to withdraw a qualified facility exemption.
(a) FDA may withdraw a qualified
facility exemption under § 507.5(d):
(1) In the event of an active
investigation of a foodborne illness
outbreak that is directly linked to the
qualified facility; or
(2) If FDA determines that it is
necessary to protect the public (human
or animal) health and prevent or
mitigate a foodborne illness outbreak
based on conditions or conduct
associated with the qualified facility
that are material to the safety of the
animal food manufactured, processed,
packed, or held at such facility.
(b) Before FDA issues an order to
withdraw a qualified facility exemption,
FDA:
(1) May consider one or more other
actions to protect the public (human or
animal) health or mitigate a foodborne
illness outbreak, including, a warning
letter, recall, administrative detention,
suspension of registration, refusal of
animal food offered for import, seizure,
and injunction;
(2) Must notify the owner, operator, or
agent in charge of the facility, in writing
of circumstances that may lead FDA to
withdraw the exemption, and provide
an opportunity for the owner, operator,
or agent in charge of the facility to
respond in writing, within 15 calendar
days of the date of receipt of the
notification, to FDA’s notification; and
(3) Must consider the actions taken by
the facility to address the circumstances
that may lead FDA to withdraw the
exemption.
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§ 507.62 Issuance of an order to withdraw
a qualified facility exemption.
(a) An FDA District Director in whose
district the qualified facility is located
(or, in the case of a foreign facility, the
Director of the Division of Compliance
in the Center for Veterinary Medicine),
or an FDA official senior to either such
Director, must approve an order to
withdraw the exemption before the
order is issued.
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(b) Any officer or qualified employee
of FDA may issue an order to withdraw
the exemption after it has been
approved in accordance with paragraph
(a) of this section.
(c) FDA must issue an order to
withdraw the exemption to the owner,
operator, or agent in charge of the
facility.
(d) FDA must issue an order to
withdraw the exemption in writing,
signed and dated by the officer or
qualified employee of FDA who is
issuing the order.
§ 507.65 Contents of an order to withdraw
a qualified facility exemption.
An order to withdraw a qualified
facility exemption under § 507.5(d)
must include the following information:
(a) The date of the order;
(b) The name, address, and location of
the qualified facility;
(c) A brief, general statement of the
reasons for the order, including
information relevant to one or both of
the following circumstances that leads
FDA to issue the order:
(1) An active investigation of a
foodborne illness outbreak that is
directly linked to the facility; or
(2) Conditions or conduct associated
with a qualified facility that are material
to the safety of the animal food
manufactured, processed, packed, or
held at such facility.
(d) A statement that the facility must
either:
(1) Comply with subparts C and E of
this part on the date that is 120 calendar
days after the date of receipt of the order
or within a reasonable timeframe,
agreed to by FDA, based on a written
justification, submitted to FDA, for a
timeframe that exceeds 120 calendar
days from the date of receipt of the
order; or
(2) Appeal the order within 15
calendar days of the date of receipt of
the order in accordance with the
requirements of § 507.69.
(e) A statement that a facility may
request that FDA reinstate an exemption
that was withdrawn by following the
procedures in § 507.85.
(f) The text of section 418(l) of the
Federal Food, Drug, and Cosmetic Act
and of this subpart;
(g) A statement that any informal
hearing on an appeal of the order must
be conducted as a regulatory hearing
under part 16 of this chapter, with
certain exceptions described in § 507.73;
(h) The mailing address, telephone
number, email address, and facsimile
number of the FDA district office and
the name of the FDA District Director in
whose district the facility is located (or,
in the case of a foreign facility, the same
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information for the Director of the
Division of Compliance in the Center for
Veterinary Medicine); and
(i) The name and the title of the FDA
representative who approved the order.
§ 507.67 Compliance with, or appeal of, an
order to withdraw a qualified facility
exemption.
(a) If you receive an order under
§ 507.65 to withdraw a qualified facility
exemption, you must either:
(1) Comply with applicable
requirements of this part within 120
calendar days of the date of receipt of
the order, or within a reasonable
timeframe, agreed to by FDA, based on
a written justification, submitted to
FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of
the order; or
(2) Appeal the order within 15
calendar days of the date of receipt of
the order in accordance with the
requirements of § 507.69.
(b) Submission of an appeal,
including submission of a request for an
informal hearing, will not operate to
delay or stay any administrative action,
including enforcement action by FDA,
unless the Commissioner of Food and
Drugs, as a matter of discretion,
determines that delay or a stay is in the
public interest.
(c) If you appeal the order, and FDA
confirms the order:
(1) You must comply with applicable
requirements of this part within 120
calendar days of the date of receipt of
the order, or within a reasonable
timeframe, agreed to by FDA, based on
a written justification, submitted to
FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of
the order; and
(2) You are no longer subject to the
requirements in § 507.7.
§ 507.69
appeal.
Procedure for submitting an
(a) To appeal an order to withdraw a
qualified facility exemption, you must:
(1) Submit the appeal in writing to the
FDA District Director in whose district
the facility is located (or, in the case of
a foreign facility, the Director of the
Division of Compliance in the Center for
Veterinary Medicine), at the mailing
address, email address, or facsimile
number identified in the order within
15 calendar days of the date of receipt
of confirmation of the order;
(2) Respond with particularity to the
facts and issues contained in the order,
including any supporting
documentation upon which you rely.
(b) In a written appeal of the order
withdrawing an exemption provided
under § 507.5(d), you may include a
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written request for an informal hearing
as provided in § 507.71.
§ 507.71 Procedure for requesting an
informal hearing.
(a) If you appeal the order, you:
(1) May request an informal hearing;
and
(2) Must submit any request for an
informal hearing together with your
written appeal submitted in accordance
with § 507.69 within 15 calendar days of
the date of receipt of the order.
(b) A request for an informal hearing
may be denied, in whole or in part, if
the presiding officer determines that no
genuine and substantial issue of
material fact has been raised by the
material submitted. If the presiding
officer determines that a hearing is not
justified, written notice of the
determination will be given to you
explaining the reason for the denial.
mstockstill on DSK4VPTVN1PROD with RULES3
§ 507.73 Requirements applicable to an
informal hearing.
If you request an informal hearing,
and FDA grants the request:
(a) The hearing will be held within 15
calendar days after the date the appeal
is filed or, if applicable, within a
timeframe agreed upon in writing by
you and FDA.
(b) The presiding officer may require
that a hearing conducted under this
subpart be completed within 1 calendar
day, as appropriate.
(c) FDA must conduct the hearing in
accordance with part 16 of this chapter,
except that:
(1) The order withdrawing an
exemption under §§ 507.62 and 507.65,
rather than the notice under § 16.22(a)
of this chapter, provides notice of
opportunity for a hearing under this
section and is part of the administrative
record of the regulatory hearing under
§ 16.80(a) of this chapter.
(2) A request for a hearing under this
subpart must be addressed to the FDA
District Director (or, in the case of a
foreign facility, the Director of the
Division of Compliance in the Center for
Veterinary Medicine) as provided in the
order withdrawing an exemption.
(3) Section 507.75, rather than
§ 16.42(a) of this chapter, describes the
FDA employees who preside at hearings
under this subpart.
(4) Section 16.60(e) and (f) of this
chapter does not apply to a hearing
under this subpart. The presiding officer
must prepare a written report of the
hearing. All written material presented
at the hearing will be attached to the
report. The presiding officer must
include as part of the report of the
hearing a finding on the credibility of
witnesses (other than expert witnesses)
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whenever credibility is a material issue,
and must include a proposed decision,
with a statement of reasons. The hearing
participant may review and comment on
the presiding officer’s report within 2
calendar days of issuance of the report.
The presiding officer will then issue the
final decision.
(5) Section 16.80(a)(4) of this chapter
does not apply to a regulatory hearing
under this subpart. The presiding
officer’s report of the hearing and any
comments on the report by the hearing
participant under paragraph (c)(4) of
this section are part of the
administrative record.
(6) No party shall have the right,
under § 16.119 of this chapter to
petition the Commissioner of Food and
Drugs for reconsideration or a stay of the
presiding officer’s final decision.
(7) If FDA grants a request for an
informal hearing on an appeal of an
order withdrawing an exemption, the
hearing must be conducted as a
regulatory hearing under a regulation in
accordance with part 16 of this chapter,
except that § 16.95(b) does not apply to
a hearing under this subpart. With
respect to a regulatory hearing under
this subpart, the administrative record
of the hearing specified in §§ 16.80(a)(1)
through (3), and (a)(5), of this chapter,
and 507.73(c)(5) constitutes the
exclusive record for the presiding
officer’s final decision. For purposes of
judicial review under § 10.45 of this
chapter, the record of the administrative
proceeding consists of the record of the
hearing and the presiding officer’s final
decision.
§ 507.75 Presiding officer for an appeal
and for an informal hearing.
The presiding officer for an appeal,
and for an informal hearing, must be an
FDA Regional Food and Drug Director
or another FDA official senior to an FDA
District Director.
§ 507.77 Timeframe for issuing a decision
on an appeal.
(a) If you appeal the order without
requesting a hearing, the presiding
officer must issue a written report that
includes a final decision confirming or
revoking the withdrawal by the 10th
calendar day after the appeal is filed.
(b) If you appeal the order and request
an informal hearing:
(1) If FDA grants the request for a
hearing and the hearing is held, the
presiding officer must provide a 2
calendar day opportunity for the hearing
participants to review and submit
comments on the report of the hearing
under § 507.73(c)(4), and must issue a
final decision within 10 calendar days
after the hearing is held; or
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(2) If FDA denies the request for a
hearing, the presiding officer must issue
a final decision on the appeal
confirming or revoking the withdrawal
within 10 calendar days after the date
the appeal is filed.
§ 507.80 Revocation of an order to
withdraw a qualified facility exemption.
An order to withdraw a qualified
facility exemption is revoked if:
(a) You appeal the order and request
an informal hearing, FDA grants the
request for an informal hearing, and the
presiding officer does not confirm the
order within the 10 calendar days after
the hearing, or issues a decision
revoking the order within that time; or
(b) You appeal the order and request
an informal hearing, FDA denies the
request for an informal hearing, and
FDA does not confirm the order within
the 10 calendar days after the appeal is
filed, or issues a decision revoking the
order within that time; or
(c) You appeal the order without
requesting an informal hearing, and
FDA does not confirm the order within
the 10 calendar days after the appeal is
filed, or issues a decision revoking the
order within that time.
§ 507.83
Final agency action.
Confirmation of a withdrawal order
by the presiding officer is considered a
final agency action for purposes of 5
U.S.C. 702.
§ 507.85 Reinstatement of a qualified
facility exemption that was withdrawn.
(a) If the FDA District Director in
whose district your facility is located
(or, in the case of a foreign facility, the
Director of the Division of Compliance
in the Center for Veterinary Medicine)
determines that a facility has adequately
resolved any problems with the
conditions and conduct that are material
to the safety of the animal food
manufactured, processed, packed, or
held at the facility and that continued
withdrawal of the exemption is not
necessary to protect public (human and
animal) health and prevent or mitigate
a foodborne illness outbreak, the FDA
District Director in whose district your
facility is located (or, in the case of a
foreign facility, the Director of the
Division of Compliance in the Center for
Veterinary Medicine) will, on his own
initiative or on the request of a facility,
reinstate the exemption.
(b) You may ask FDA to reinstate an
exemption that has been withdrawn
under the procedures of this subpart as
follows:
(1) Submit a request, in writing, to the
FDA District Director in whose district
your facility is located (or, in the case
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of a foreign facility, the Director of the
Division of Compliance in the Center for
Veterinary Medicine); and
(2) Present data and information to
demonstrate that you have adequately
resolved any problems with the
conditions and conduct that are material
to the safety of the animal food
manufactured, processed, packed, or
held at your facility, such that
continued withdrawal of the exemption
is not necessary to protect public
(human and animal) health and prevent
or mitigate a foodborne illness outbreak.
(c) If your exemption was withdrawn
under § 507.60(a)(1) and FDA later
determines, after finishing the active
investigation of a foodborne illness
outbreak, that the outbreak is not
directly linked to your facility, FDA will
reinstate your exemption under
§ 507.5(d), and FDA will notify you in
writing that your exempt status has been
reinstated.
(d) If your exemption was withdrawn
under both § 507.60(a)(1) and (2) and
FDA later determines, after finishing the
active investigation of a foodborne
illness outbreak, that the outbreak is not
directly linked to your facility, FDA will
inform you of this finding and you may
ask FDA to reinstate your exemption
under § 507.5(d) in accordance with the
requirements of paragraph (b) of this
section.
Subpart E—Supply-Chain Program
mstockstill on DSK4VPTVN1PROD with RULES3
§ 507.105 Requirement to establish and
implement a supply-chain program.
(a)(1) Except as provided by
paragraphs (a)(2) and (3) of this section,
the receiving facility must establish and
implement a risk-based supply-chain
program for those raw materials and
other ingredients for which the
receiving facility has identified a hazard
requiring a supply-chain-applied
control.
(2) A receiving facility that is an
importer, is in compliance with the
foreign supplier verification
requirements under part 1, subpart L of
this chapter, and has documentation of
verification activities conducted under
§ 1.506(e) of this chapter (which
provides assurance that the hazards
requiring a supply-chain-applied
control for the raw material or other
ingredient have been significantly
minimized or prevented) need not
conduct supplier verification activities
for that raw material or other ingredient.
(3) The requirements in this subpart
do not apply to animal food that is
supplied for research or evaluation use,
provided that such animal food:
(i) Is not intended for retail sale and
is not sold or distributed to the public;
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(ii) Is labeled with the statement
‘‘Animal food for research or evaluation
use’’;
(iii) Is supplied in a small quantity
that is consistent with a research,
analysis, or quality assurance purpose,
the animal food is used only for this
purpose, and any unused quantity is
properly disposed of; and
(iv) Is accompanied with documents,
in accordance with the practice of the
trade, stating that the animal food will
be used for research or evaluation
purposes and cannot be sold or
distributed to the public.
(b) The supply-chain program must be
written.
(c) When a supply-chain-applied
control is applied by an entity other
than the receiving facility’s supplier
(e.g., when a non-supplier applies
controls to certain produce (i.e.,
produce covered by part 112 of this
chapter), because growing, harvesting,
and packing activities are under
different management), the receiving
facility must:
(1) Verify the supply-chain-applied
control; or
(2) Obtain documentation of an
appropriate verification activity from
another entity, review and assess the
entity’s applicable documentation, and
document that review and assessment.
§ 507.110 General requirements applicable
to a supply-chain program.
(a) The supply-chain program must
include:
(1) Using approved suppliers as
required by § 507.120;
(2) Determining appropriate supplier
verification activities (including
determining the frequency of
conducting the activity) as required by
§ 507.125;
(3) Conducting supplier verification
activities as required by §§ 507.130 and
507.135;
(4) Documenting supplier verification
activities as required by § 507.175; and
(5) When applicable, verifying a
supply-chain-applied control applied by
an entity other than the receiving
facility’s supplier and documenting that
verification as required by § 507.175, or
obtaining documentation of an
appropriate verification activity from
another entity, reviewing and assessing
that documentation, and documenting
the review and assessment as required
by § 507.175.
(b) The following are appropriate
supplier verification activities for raw
materials and other ingredients:
(1) Onsite audits;
(2) Sampling and testing of the raw
material or other ingredient;
(3) Review of the supplier’s relevant
food safety records; and
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(4) Other appropriate supplier
verification activities based on supplier
performance and the risk associated
with the raw material or other
ingredient.
(c) The supply-chain program must
provide assurance that a hazard
requiring a supply-chain-applied
control has been significantly
minimized or prevented.
(d)(1) Except as provided by
paragraph (d)(2) of this section, in
approving suppliers and determining
the appropriate supplier verification
activities and the frequency with which
they are conducted, the following must
be considered:
(i) The hazard analysis of the animal
food, including the nature of the hazard
controlled before receipt of the raw
material or other ingredient, applicable
to the raw material and other
ingredients;
(ii) The entity or entities that will be
applying controls for the hazards
requiring a supply-chain-applied
control;
(iii) Supplier performance, including:
(A) The supplier’s procedures,
processes, and practices related to the
safety of the raw material and other
ingredients;
(B) Applicable FDA food safety
regulations and information relevant to
the supplier’s compliance with those
regulations, including an FDA warning
letter or import alert relating to the
safety of animal food and other FDA
compliance actions related to animal
food safety (or, when applicable,
relevant laws and regulations of a
country whose food safety system FDA
has officially recognized as comparable
or has determined to be equivalent to
that of the United States, and
information relevant to the supplier’s
compliance with those laws and
regulations); and
(C) The supplier’s food safety history
relevant to the raw materials or other
ingredients that the receiving facility
receives from the supplier, including
available information about results from
testing raw materials or other
ingredients for hazards, audit results
relating to the safety of the animal food,
and responsiveness of the supplier in
correcting problems; and
(iv) Any other factors as appropriate
and necessary, such as storage and
transportation practices.
(2) Considering supplier performance
can be limited to the supplier’s
compliance history as required by
paragraph (d)(1)(iii)(B) of this section, if
the supplier is:
(i) A qualified facility as defined by
§ 507.3;
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(ii) A farm that grows produce and is
not a covered farm under part 112 of
this chapter in accordance with
§ 112.4(a), or in accordance with
§§ 112.4(b) and 112.5; or
(iii) A shell egg producer that is not
subject to the requirements of part 118
of this chapter because it has less than
3,000 laying hens.
(e) If the owner, operator, or agent in
charge of a receiving facility determines
through auditing, verification testing,
document review, relevant consumer,
customer, or other complaints, or
otherwise that the supplier is not
controlling hazards that the receiving
facility has identified as requiring a
supply-chain-applied control, the
receiving facility must take and
document prompt action in accordance
with § 507.42 to ensure that raw
materials or other ingredients from the
supplier do not cause animal food that
is manufactured or processed by the
receiving facility to be adulterated
under section 402 of the Federal Food,
Drug, and Cosmetic Act.
mstockstill on DSK4VPTVN1PROD with RULES3
§ 507.115
facility.
Responsibilities of the receiving
(a)(1) The receiving facility must
approve suppliers.
(2) Except as provided by paragraphs
(a)(3) and (4) of this section, the
receiving facility must determine and
conduct appropriate supplier
verification activities, and satisfy all
documentation requirements of this
subpart.
(3) An entity other than the receiving
facility may do any of the following,
provided that the receiving facility
reviews and assesses the entity’s
applicable documentation, and
documents that review and assessment:
(i) Establish written procedures for
receiving raw materials and other
ingredients by the entity;
(ii) Document that written procedures
for receiving raw materials and other
ingredients are being followed by the
entity; and
(iii) Determine, conduct, or both
determine and conduct, the appropriate
supplier verification activities, with
appropriate documentation.
(4) The supplier may conduct and
document sampling and testing of raw
materials and other ingredients, for the
hazard controlled by the supplier, as a
supplier verification activity for a
particular lot of product and provide
such documentation to the receiving
facility, provided that the receiving
facility reviews and assesses that
documentation, and documents that
review and assessment.
(b) For the purposes of this subpart,
a receiving facility may not accept any
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of the following as a supplier
verification activity:
(1) A determination by its supplier of
the appropriate supplier verification
activities for that supplier;
(2) An audit conducted by its
supplier;
(3) A review by its supplier of that
supplier’s own relevant food safety
records; or
(4) The conduct by its supplier of
other appropriate supplier verification
activities for that supplier within the
meaning of § 507.110(b)(4).
(c) The requirements of this section
do not prohibit a receiving facility from
relying on an audit provided by its
supplier when the audit of the supplier
was conducted by a third-party
qualified auditor in accordance with
§§ 507.130(f) and 507.135.
§ 507.120
Using approved suppliers.
(a) The receiving facility must
approve suppliers in accordance with
the requirements of § 507.110(d), and
document that approval, before
receiving raw materials and other
ingredients received from those
suppliers;
(b)(1) Written procedures for receiving
raw materials and other ingredients
must be established and followed;
(2) The written procedures for
receiving raw materials and other
ingredients must ensure that raw
materials and other ingredients are
received only from approved suppliers
(or, when necessary and appropriate, on
a temporary basis from unapproved
suppliers whose raw materials or other
ingredients are subjected to adequate
verification activities before acceptance
for use); and
(3) Use of the written procedures for
receiving raw materials and other
ingredients must be documented.
§ 507.125 Determining appropriate
supplier verification activities (including
determining the frequency of conducting
the activity).
Appropriate supplier verification
activities (including the frequency of
conducting the activity) must be
determined in accordance with the
requirements of § 507.110(d).
§ 507.130 Conducting supplier verification
activities for raw materials and other
ingredients.
(a) Except as provided by paragraphs
(c), (d), or (e) of this section, one or
more of the supplier verification
activities specified in § 507.110(b), as
determined under § 507.110(d), must be
conducted for each supplier before
using the raw material or other
ingredient from that supplier and
periodically thereafter.
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56353
(b)(1) Except as provided by
paragraph (b)(2) of this section, when a
hazard in a raw material or other
ingredient will be controlled by the
supplier and is one for which there is
a reasonable probability that exposure to
the hazard will result in serious adverse
health consequences or death to humans
or animals:
(i) The appropriate supplier
verification activity is an onsite audit of
the supplier; and
(ii) The audit must be conducted
before using the raw material or other
ingredient from the supplier and at least
annually thereafter.
(2) The requirements of paragraph
(b)(1) of this section do not apply if
there is a written determination that
other verification activities and/or less
frequent onsite auditing of the supplier
provide adequate assurance that the
hazards are controlled.
(c) If a supplier is a qualified facility
as defined by § 507.3, the receiving
facility does not need to comply with
paragraphs (a) and (b) of this section if
the receiving facility:
(1) Obtains written assurance that the
supplier is a qualified facility as defined
by § 507.3:
(i) Before first approving the supplier
for an applicable calendar year; and
(ii) On an annual basis thereafter, by
December 31 of each calendar year, for
the following calendar year; and
(2) Obtains written assurance, at least
every 2 years, that the supplier is
producing the raw material or other
ingredient in compliance with
applicable FDA food safety regulations
(or, when applicable, relevant laws and
regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States). The written
assurance must include either:
(i) A brief description of the
preventive controls that the supplier is
implementing to control the applicable
hazard in the animal food; or
(ii) A statement that the facility is in
compliance with State, local, county,
tribal or other applicable non-Federal
food safety laws, including relevant
laws and regulations of foreign counties.
(d) If a supplier is a farm that grows
produce and is not a covered farm under
part 112 of this chapter in accordance
with § 112.4(a), or in accordance with
§§ 112.4(b) and 112.5, the receiving
facility does not need to comply with
paragraphs (a) and (b) of this section for
produce that the receiving facility
receives from the farm as a raw material
or other ingredient if the receiving
facility:
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(1) Obtains written assurance that the
raw material or other ingredient
provided by the supplier is not subject
to part 112 of this chapter in accordance
with § 112.4(a), or in accordance with
§§ 112.4(b) and 112.5:
(i) Before first approving the supplier
for an applicable calendar year; and
(ii) On an annual basis thereafter, by
December 31 of each calendar year, for
the following calendar year; and
(2) Obtains written assurance, at least
every 2 years, that the farm
acknowledges that its food is subject to
section 402 of the Federal Food, Drug,
and Cosmetic Act (or, when applicable,
that its food is subject to relevant laws
and regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States).
(e) If a supplier is a shell egg producer
that is not subject to the requirements of
part 118 of this chapter because it has
less than 3,000 laying hens, the
receiving facility does not need to
comply with paragraphs (a) and (b) of
this section if the receiving facility:
(1) Obtains written assurance that the
shell eggs produced by the supplier are
not subject to part 118 because the shell
egg producer has less than 3,000 laying
hens:
(i) Before first approving the supplier
for an applicable calendar year; and
(ii) On an annual basis thereafter, by
December 31 of each calendar year, for
the following calendar year; and
(2) Obtains written assurance, at least
every 2 years, that the shell egg
producer acknowledges that its food is
subject to section 402 of the Federal
Food, Drug, and Cosmetic Act (or, when
applicable, that its food is subject to
relevant laws and regulations of a
country whose food safety system FDA
has officially recognized as comparable
or has determined to be equivalent to
that of the United States).
(f) There must not be any financial
conflicts of interest that influence the
results of the verification activities
listed in § 507.110(b) and payment must
not be related to the results of the
activity.
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§ 507.135
Onsite audit.
(a) An onsite audit of a supplier must
be performed by a qualified auditor.
(b) If the raw material or other
ingredient at the supplier is subject to
one or more FDA food safety
regulations, an onsite audit must
consider such regulations and include a
review of the supplier’s written plan
(e.g., Hazard Analysis and Critical
Control Point (HACCP) plan or other
food safety plan), if any, and its
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implementation, for the hazard being
controlled (or, when applicable, an
onsite audit may consider relevant laws
and regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States).
(c)(1) The following may be
substituted for an onsite audit, provided
that the inspection was conducted
within 1 year of the date that the onsite
audit would have been required to be
conducted:
(i) The written results of an
appropriate inspection of the supplier
for compliance with applicable FDA
food safety regulations by FDA, by
representatives of other Federal
Agencies (such as the United States
Department of Agriculture), or by
representatives of State, local, tribal, or
territorial agencies; or
(ii) For a foreign supplier, the written
results of an inspection by FDA or the
food safety authority of a country whose
food safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States.
(2) For inspections conducted by the
food safety authority of a country whose
food safety system FDA has officially
recognized as comparable or determined
to be equivalent, the animal food that is
the subject of the onsite audit must be
within the scope of the official
recognition or equivalence
determination, and the foreign supplier
must be in, and under the regulatory
oversight of, such country.
(d) If the onsite audit is solely
conducted to meet the requirements of
this subpart by an audit agent of a
certification body that is accredited in
accordance with regulations in part 1,
subpart M of this chapter, the audit is
not subject to the requirements in those
regulations.
§ 507.175 Records documenting the
supply-chain program.
(a) The records documenting the
supply-chain program are subject to the
requirements of subpart F of this part.
(b) The receiving facility must review
the records listed in paragraph (c) of this
section in accordance with
§ 507.49(a)(4).
(c) The receiving facility must
document the following in records as
applicable to its supply-chain program:
(1) The written supply-chain program;
(2) Documentation that a receiving
facility that is an importer is in
compliance with the foreign supplier
verification program requirements
under part 1, subpart L of this chapter,
including documentation of verification
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activities conducted under § 1.506(e) of
this chapter;
(3) Documentation of the approval of
a supplier;
(4) Written procedures for receiving
raw materials and other ingredients;
(5) Documentation demonstrating use
of the written procedures for receiving
raw materials and other ingredients;
(6) Documentation of the
determination of the appropriate
supplier verification activities for raw
materials and other ingredients;
(7) Documentation of the conduct of
an onsite audit. This documentation
must include:
(i) The name of the supplier subject to
the onsite audit;
(ii) Documentation of audit
procedures;
(iii) The dates the audit was
conducted;
(iv) The conclusions of the audit;
(v) Corrective actions taken in
response to significant deficiencies
identified during the audit; and
(vi) Documentation that the audit was
conducted by a qualified auditor;
(8) Documentation of sampling and
testing conducted as a supplier
verification activity. This
documentation must include:
(i) Identification of the raw material or
other ingredient tested (including lot
number, as appropriate) and the number
of samples tested;
(ii) Identification of the test(s)
conducted, including the analytical
method(s) used;
(iii) The date(s) on which the test(s)
were conducted and the date of the
report;
(iv) The results of the testing;
(v) Corrective actions taken in
response to detection of hazards; and
(vi) Information identifying the
laboratory conducting the testing;
(9) Documentation of the review of
the supplier’s relevant food safety
records. This documentation must
include:
(i) The name of the supplier whose
records were reviewed;
(ii) The date(s) of review;
(iii) The general nature of the records
reviewed;
(iv) The conclusions of the review;
and
(v) Corrective actions taken in
response to significant deficiencies
identified during the review;
(10) Documentation of other
appropriate supplier verification
activities based on the supplier
performance and the risk associated
with the raw material or other
ingredient;
(11) Documentation of any
determination that verification activities
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other than an onsite audit, and/or less
frequent onsite auditing of a supplier,
provide adequate assurance that the
hazards are controlled when a hazard in
a raw material or other ingredient will
be controlled by the supplier and is one
for which there is a reasonable
probability that exposure to the hazard
will result in serious adverse health
consequences or death to humans or
animals;
(12) The following documentation of
an alternative verification activity for a
supplier that is a qualified facility:
(i) The written assurance that the
supplier is a qualified facility as defined
by § 507.3; and
(ii) The written assurance that the
supplier is producing the raw material
or other ingredient in compliance with
applicable FDA food safety regulations
(or, when applicable, relevant laws and
regulations of a country whose food
safety system FDA has officially
recognized as comparable or has
determined to be equivalent to that of
the United States);
(13) The following documentation of
an alternative verification activity for a
supplier that is a farm that supplies a
raw material or other ingredient and is
not a covered farm under part 112 of
this chapter:
(i) The written assurance that supplier
is not a covered farm under part 112 of
this chapter in accordance with
§ 112.4(a), or in accordance with
§§ 112.4(b) and 112.5; and
(ii) The written assurance that the
farm acknowledges that its food is
subject to section 402 of the Federal
Food, Drug, and Cosmetic Act (or, when
applicable, that its food is subject to
relevant laws and regulations of a
country whose food safety system FDA
has officially recognized as comparable
or has determined to be equivalent to
that of the United States);
(14) The following documentation of
an alternative verification activity for a
supplier that is a shell egg producer that
is not subject to the requirements
established in part 118 of this chapter
because it has less than 3,000 laying
hens:
(i) The written assurance that the
shell eggs provided by the supplier are
not subject to part 118 of this chapter
because the supplier has less than 3,000
laying hens; and
(ii) The written assurance that the
shell egg producer acknowledges that its
food is subject to section 402 of the
Federal Food, Drug, and Cosmetic Act
(or, when applicable, that its food is
subject to relevant laws and regulations
of a country whose safety system FDA
has officially recognized as comparable
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or has determined to be equivalent to
that of the United States);
(15) The written results of an
appropriate inspection of the supplier
for compliance with applicable FDA
food safety regulations by FDA, by
representatives of other Federal
Agencies (such as the United States
Department of Agriculture), or by
representatives from State, local, tribal,
or territorial agencies, or the food safety
authority of another country when the
results of such an inspection is
substituted for an onsite audit;
(16) Documentation of actions taken
with respect to supplier nonconformance;
(17) Documentation of verification of
a supply-chain-applied control applied
by an entity other than the receiving
facility’s supplier; and
(18) When applicable, documentation
of the receiving facility’s review and
assessment of:
(i) Applicable documentation from an
entity other than the receiving facility
that written procedures for receiving
raw materials and other ingredients are
being followed;
(ii) Applicable documentation, from
an entity other than the receiving
facility, of the determination of the
appropriate supplier verification
activities for raw materials and other
ingredients;
(iii) Applicable documentation, from
an entity other than the receiving
facility, of conducting the appropriate
supplier verification activities for raw
materials and other ingredients;
(iv) Applicable documentation, from
its supplier, of:
(A) The results of sampling and
testing conducted by the supplier; or
(B) The results of an audit conducted
by a third-party qualified auditor in
accordance with §§ 507.130(f) and
507.135; and
(v) Applicable documentation, from
an entity other than the receiving
facility, of verification activities when a
supply-chain-applied control is applied
by an entity other than the receiving
facility’s supplier.
Subpart F—Requirements Applying to
Records That Must Be Established and
Maintained
§ 507.200 Records subject to the
requirements of this subpart.
(a) Except as provided by paragraphs
(d) and (e) of this section, all records
required by this part are subject to all
requirements of this subpart.
(b) Records obtained by FDA in
accordance with this part are subject to
the disclosure requirements under part
20 of this chapter.
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56355
(c) All records required by this part
must be made promptly available to a
duly authorized representative of the
Secretary of Health and Human Services
for official review and copying upon
oral or written request.
(d) The requirements of § 507.206
apply only to the written food safety
plan.
(e) The requirements of
§ 507.202(a)(2), (4), and (5) and (b) do
not apply to the records required by
§ 507.7.
§ 507.202 General requirements applying
to records.
(a) Records must:
(1) Be kept as original records, true
copies (such as photocopies, pictures,
scanned copies, microfilm, microfiche,
or other accurate reproductions of the
original records), or electronic records;
(2) Contain the actual values and
observations obtained during
monitoring and as appropriate, during
verification activities;
(3) Be accurate, indelible, and legible;
(4) Be created concurrently with
performance of the activity documented;
and
(5) Be as detailed as necessary to
provide history of work performed.
(b) All records must include:
(1) Information adequate to identify
the plant or facility (e.g., the name, and
when necessary, the location of the
plant or facility);
(2) The date and, when appropriate,
the time of the activity documented;
(3) The signature or initials of the
person performing the activity; and
(4) Where appropriate, the identity of
the product and the lot code, if any.
(c) Records that are established or
maintained to satisfy the requirements
of this part and that meet the definition
of electronic records in § 11.3(b)(6) of
this chapter are exempt from the
requirements of part 11 of this chapter.
Records that satisfy the requirements of
this part, but that also are required
under other applicable statutory
provisions or regulations, remain
subject to part 11 of this chapter.
§ 507.206 Additional requirements
applying to the food safety plan.
The owner, operator, or agent in
charge of the facility must sign and date
the food safety plan upon initial
completion and upon any modification.
§ 507.208 Requirements for record
retention.
(a)(1) All records required by this part
must be retained at the plant or facility
for at least 2 years after the date they
were prepared.
(2) Records that a facility relies on
during the 3-year period preceding the
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applicable calendar year to support its
status as a qualified facility must be
retained at the facility as long as
necessary to support the status of a
facility as a qualified facility during the
applicable calendar year.
(b) Records that relate to the general
adequacy of the equipment or processes
being used by a facility, including the
results of scientific studies and
evaluations, must be retained by the
facility for at least 2 years after their use
is discontinued (e.g., because the facility
has updated the written food safety plan
(§ 507.31) or records that document
validation of the written food safety
plan (§ 507.45(b))).
(c) Except for the food safety plan,
offsite storage of records is permitted if
such records can be retrieved and
provided onsite within 24 hours of
request for official review. The food
safety plan must remain onsite.
Electronic records are considered to be
onsite if they are accessible from an
onsite location.
(d) If the plant or facility is closed for
a prolonged period, the food safety plan
may be transferred to some other
reasonably accessible location but must
be returned to the plant or facility
within 24 hours for official review upon
request.
§ 507.212
Use of existing records.
mstockstill on DSK4VPTVN1PROD with RULES3
(a) Existing records (e.g., records that
are kept to comply with other Federal,
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State, or local regulations, or for any
other reason) do not need to be
duplicated if they contain all of the
required information and satisfy the
requirements of this subpart. Existing
records may be supplemented as
necessary to include all of the required
information and satisfy the
requirements of this subpart.
(b) The information required by this
part does not need to be kept in one set
of records. If existing records contain
some of the required information, any
new information required by this part
may be kept either separately or
combined with the existing records.
§ 507.215 Special requirements applicable
to a written assurance.
(a) Any written assurance required by
this part must contain the following
elements:
(1) Effective date;
(2) Printed names and signatures of
authorized officials;
(3) The applicable assurance under:
(i) § 507.36(a)(2);
(ii) § 507.36(a)(3);
(iii) § 507.36(a)(4);
(iv) § 507.130(c)(2);
(v) § 507.130(d)(2); or
(vi) § 507.130(e)(2).
(b) A written assurance required
under § 507.36(a)(2), (3) or (4) must
include:
(1) Acknowledgement that the facility
that provides the written assurance
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assumes legal responsibility to act
consistently with the assurance and
document its actions taken to satisfy the
written assurance; and
(2) Provision that if the assurance is
terminated in writing by either entity,
responsibility for compliance with the
applicable provisions of this part reverts
to the manufacturer/processor as of the
date of termination.
PART 579—IRRADIATION IN THE
PRODUCTION, PROCESSING, AND
HANDLING OF ANIMAL FEED AND
PET FOOD
10. The authority citation for 21 CFR
part 579 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 343, 348,
371.
11. In § 579.12, add the following
sentence to the end of the paragraph to
read as follows:
■
§ 579.12 Incorporation of regulations in
part 179.
* * * Any facility that treats animal
feed and pet food with ionizing
radiation must comply with the
requirements of part 507 of this chapter
and other applicable regulations.
Dated:August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–21921 Filed 9–10–15; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 56169-56356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21921]
[[Page 56169]]
Vol. 80
Thursday,
No. 180
September 17, 2015
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
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21 CFR Parts 11, 16, 117, et al.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals; Final Rule
Federal Register / Vol. 80 , No. 180 / Thursday, September 17, 2015 /
Rules and Regulations
[[Page 56170]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11, 16, 117, 500, 507, and 579
[Docket No. FDA-2011-N-0922]
RIN 0910-AG10
Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is adding
regulations for the Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals.
These regulations will, for the first time, establish requirements for
the current good manufacturing practice (CGMP) for food for animals. In
addition, we are adding requirements for certain domestic and foreign
animal food facilities to establish and implement hazard analysis and
risk-based preventive controls for food for animals. We are taking this
action to provide greater assurance that animal food is safe and will
not cause illness or injury to humans and animals and to implement new
statutory provisions in the FDA Food Safety Modernization Act (FSMA).
The rule is intended to build an animal food safety system for the
future that makes modern science- and risk-based preventive controls
the norm across all sectors of the animal food system.
DATES: This rule is effective November 16, 2015, except for paragraph
(2) of the definition of ``qualified auditor'' in Sec. 507.3, and
Sec. Sec. 507.12(a)(1)(ii), 507.105(a)(2), 507.105(c),
507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and
507.175(c)(13). FDA will publish a document in the Federal Register
announcing the effective dates of paragraph (2) of the definition of
``qualified auditor'' in Sec. 507.3, Sec. Sec. 507.12(a)(1)(ii),
507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d),
507.175(c)(2), and 507.175(c)(13). Certain provisions have later
compliance dates as discussed in section LIII ``Effective and
Compliance Dates.''
FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-6246, email: jenny.murphy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
Executive Summary
Purpose and Coverage of the Rule
Summary of the Major Provisions of the Rule
Costs and Benefits
I. Background
A. FDA Food Safety Modernization Act
B. Stages in the Rulemaking for the Animal Food Preventive
Controls Rule
C. Summary of the Major Provisions of Proposed Rule for
Preventive Controls for Food for Animals
D. Draft Risk Assessment
E. Public Comments
II. Legal Authority
A. Current Good Manufacturing Practice Regulations
B. Hazard Analysis and Risk-Based Preventive Controls
III. General Comments on the Proposed Rule
IV. Definitions in the Section 415 Registration Regulations (21 CFR
Part 1, Subpart H)
A. Definitions That Impact a Determination of Whether an
Establishment Is a ``Farm''
B. Proposed Revisions to the Definition of Farm
C. Proposed Revisions to Definitions of Harvesting, Holding,
Manufacturing/Processing, Mixed-Type Facility, and Packing
D. Comments on Feed Mills Associated With Fully Vertically
Integrated Farming Operations
V. Comments on the Organizing Principles for How the Status of a
Food as a Raw Agricultural Commodity or as a Processed Food Affects
the Requirements Applicable to a Farm Under Sections 415 and 418 of
the FD&C Act
VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm
Activities
A. Section 103(c)(1)(C) of FSMA
B. Comments on Qualitative Risk Assessment of On-Farm Activities
Outside of the Farm Definition
C. Comments Regarding an Exemption for Small and Very Small Farm
Mixed-Type Facilities Under Section 421 of the FD&C Act
VII. Subpart A: Comments on Proposed Sec. 507.1--Applicability and
Status
A. Comments on Proposed Sec. 507.1(a)--Applicability
B. Comments on Proposed Sec. 507.1(b)--Prohibited Act
C. Comments on Proposed Sec. 507.1(c)--Specific CGMP
Requirements
D. Comments on Proposed Sec. 507.1(d)--Human Food Facilities
That Manufacture Animal Food
VIII. Subpart A: Comments on Proposed Sec. 507.3--Definitions
A. Definitions We Proposed To Establish in Part 507
B. Comments Asking FDA To Establish Additional Definitions or
Otherwise Clarify Terms Not Defined in the Rule
C. Additional Definitions To Clarify Terms Not Defined in the
Proposed Rule
IX. Subpart A: Comments on Qualifications of Individuals Who
Manufacture, Process, Pack, or Hold Animal Food
A. Applicability and Qualifications of All Individuals Engaged
in Manufacturing, Processing, Packing, or Holding Animal Food (Final
Sec. 507.4(a), (b), and (d))
B. Additional Requirements Applicable to Supervisory Personnel
(Final Sec. 507.4(c))
X. Subpart A: Comments on Proposed Sec. 507.5--Exemptions
A. General Comments on the Proposed Exemptions
B. Proposed Sec. 507.5(a)--Exemption for Facilities Not
Required To Register Under Section 415 Regulations
C. Proposed Sec. 507.5(b)--Exemption Applicable to Food Subject
to 21 CFR part 113--Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers
D. Proposed Sec. 507.5(c)--Exemption Applicable to Activities
Subject to Standards for Produce Safety in Section 419 of the FD&C
Act
E. Proposed Sec. 507.5(d)--Exemption Applicable to a Qualified
Facility
F. Proposed Sec. 507.5(e) and (f)--Exemptions Applicable to On-
Farm Low-Risk Activity/Animal Food Combinations Conducted by a Small
or Very Small Business
G. Proposed Sec. 507.5(g)--Exemption Applicable to Facilities
Solely Engaged in Storage of Raw Agricultural Commodities Other Than
Fruits and Vegetables Intended for Further Distribution or
Processing
H. Proposed Sec. 507.5(h)--Exemption Applicable to the Holding
or Transportation of One or More Raw Agricultural Commodities
I. Comments Requesting Additional Exemptions
XI. Subpart A: Comments on Proposed Sec. 507.7--Requirements That
Apply to a Qualified Facility
A. Comments on Submission of a Certification Statement
B. General Comments on Requirements That Apply to a Qualified
Facility
C. Proposed Sec. 507.7(a)--Documentation To Be Submitted
D. Proposed Sec. 507.7(b)--Procedure for Submission
E. Proposed Sec. 507.7(c)--Frequency of Determination and
Submission
F. Proposed Sec. 507.7(d)--Notification to Consumers (Final
Sec. 507.7(e))
G. Proposed Sec. 507.7(e)--Records (Final Sec. 507.7(f))
XII. Subpart A: Comments on Proposed Sec. 507.10--Applicability of
Part 507 to a Facility Solely Engaged in the Storage of Unexposed
Packaged Animal Food
XIII. Subpart A: Comments on Proposed Sec. 507.12--Applicability of
Part 507 to the Holding and Distribution of Human Food By-Products
for Use as Animal Food
XIV. Subpart B: General Comments on Proposed Subpart B--Current Good
Manufacturing Practice
XV. Subpart B: Comments on Proposed Sec. 507.14--Personnel
A. Proposed Sec. 507.14(a)(1)--Personal Cleanliness (Final
Sec. 507.14(b)(1))
[[Page 56171]]
B. Proposed Sec. 507.14(a)(2)--Hand Washing (Final Sec.
507.14(b)(2))
C. Proposed Sec. 507.14(a)(3)--Unsecured Jewelry and Other
Objects (Final Sec. 507.14(b)(3))
D. Proposed Sec. 507.14(a)(4)--Storing Clothing and Personal
Belongings (Final Sec. 507.14(b)(4))
E. Proposed Sec. 507.14(a)(5)--Taking Other Necessary
Precautions (Final Sec. 507.14(b)(5))
XVI. Subpart B: Comments on Proposed Sec. 507.17--Plant and Grounds
A. Proposed Sec. 507.17(a)--Grounds Surrounding an Animal Food
Plant
B. Proposed Sec. 507.17(b)(1)--Adequate Space Between
Equipment, Walls, and Stored Materials
C. Proposed Sec. 507.17(b)(2)--Dripping and Condensation
D. Proposed Sec. 507.17(b)(3)--Ventilation
E. Proposed Sec. 507.17(b)(4)--Lighting
F. Proposed Sec. 507.17(b)(5)--Glass
G. Proposed Sec. 507.17(b)(6)--Outdoor Storage
XVII. Subpart B: Comments on Proposed Sec. 507.19--Sanitation
A. Proposed Sec. 507.19(a)--Buildings
B. Proposed Sec. 507.19(b)--Cleaning
C. Proposed Sec. 507.19(b)(1)--Wet Cleaning
D. Proposed Sec. 507.19(b)(2)--Wet Processing
E. Proposed Sec. 507.19(c)--Cleaning Compounds and Sanitizing
Agents
F. Proposed Sec. 507.19(d)(1)--Toxic Materials
G. Proposed Sec. 507.19(d)(2)--Identification, Use, and Storage
of Toxic Materials
H. Proposed Sec. 507.19(e)--Pest Control
I. Proposed Sec. 507.19(f)--Trash and Garbage
XVIII. Subpart B: Comments on Proposed Sec. 507.20--Water Supply
and Plumbing
A. Proposed Sec. 507.20(a)--Water Supply
B. Proposed Sec. 507.20(b)--Plumbing
C. Proposed Sec. 507.20(c)--Sewage
D. Proposed Sec. 507.20(d)--Toilet Facilities
E. Proposed Sec. 507.20(e)--Hand-Washing Facilities
XIX. Subpart B: Comments on Proposed Sec. 507.22--Equipment and
Utensils
A. Proposed Sec. 507.22(a)(1)--Plant Equipment and Utensils
B. Proposed Sec. 507.22(a)(2)--Design of Equipment and Utensils
C. Proposed Sec. 507.22(a)(3)--Equipment Installation
D. Proposed Sec. 507.22(a)(4)--Animal Food Contact Surfaces
E. Proposed Sec. 507.22(a)(5)--Non-Animal Food Contact
Equipment (Final Sec. 507.22(a)(1))
F. Proposed Sec. 507.22(b)--System Design and Construction
G. Proposed Sec. 507.22(c)--Monitoring Cold Storage
Temperatures
H. Proposed Sec. 507.22(d)--Instruments
I. Proposed Sec. 507.22(e)--Compressed Air
XX. Subpart B: Comments on Proposed Sec. 507.25--Plant Operations
A. Proposed Sec. 507.25(a)(1)--CGMPs
B. Proposed Sec. 507.25(a)(2)--Identifying Contents of
Containers
C. Proposed Sec. 507.25(a)(3)--Labeling of Finished Product
(Final Sec. 507.27(b))
D. Proposed Sec. 507.25(a)(4)--Animal Food Packaging Material
(Final Sec. 507.25(a)(3))
E. Proposed Sec. 507.25(a)(5)--Responsibility for Overall Plant
Cleanliness (Final Sec. 507.25(a)(4))
F. Proposed Sec. 507.25(a)(6)--Contamination Precautions (Final
Sec. 507.25(a)(5))
G. Proposed Sec. 507.25(a)(7)--Testing Procedures (Final Sec.
507.25(a)(6))
H. Proposed Sec. 507.25(a)(8)--Contaminated Product (Final
Sec. 507.25(a)(7))
I. Proposed Sec. 507.25(a)(9)--Protecting Against Contamination
(Final Sec. 507.25(a)(8))
J. Proposed Sec. 507.25(b)(1)--Raw Materials and Ingredients
K. Proposed Sec. 507.25(b)(1)(i)--Shipping Containers
L. Proposed Sec. 507.25(b)(1)(ii)--Raw Materials
M. Proposed Sec. 507.25(b)(1)(iii)--Raw Materials
N. Proposed Sec. 507.25(b)(2)--Raw Materials Susceptible to
Mycotoxins
O. Proposed Sec. 507.25(b)(3)--Raw Materials and Rework (Final
Sec. 507.25(b)(1)(iii))
P. Proposed Sec. 507.25(b)(4)--Frozen Raw Materials (Final
Sec. 507.25(b)(3))
Q. Proposed Sec. 507.25(c)(1)--Appropriate Conditions for
Animal Food
R. Proposed Sec. 507.25(c)(2)--Control of Undesirable
Microorganisms
S. Proposed Sec. 507.25(c)(3)--Work-in-Process and Rework
T. Proposed Sec. 507.25(c)(4)--Processing Steps
U. Proposed Sec. 507.25(c)(5)--Processing Operations
V. Proposed Sec. 507.25(c)(6)--Controlling Water Activity (aw)
W. Proposed Sec. 507.25(c)(7)--Controlling pH
X. Proposed Sec. 507.25(c)(8)--Ice
XXI. Subpart B: Comments on Proposed Sec. 507.27--Holding and
Distribution
A. Proposed Sec. 507.27(a)--Holding and Distribution
B. Proposed Sec. 507.27(a)(1)--Containers
C. Proposed Sec. 507.27(a)(2)--Protection From Contamination
D. Proposed Sec. 507.27(a)(3)--Labeling of Animal Food Held for
Distribution (Final Sec. 507.27(b))
E. Proposed Sec. 507.27(b)--Shipping Containers (Final Sec.
507.27(c))
F. Proposed Sec. 507.27(c)--Returned Animal Food (Final Sec.
507.27(d))
G. Proposed Sec. 507.27(d)--Unpackaged Bulk Animal Food (Final
Sec. 507.27(e))
XXII. Subpart B: Comments on Proposed Sec. 507.28--Holding and
Distribution of Human Food By-Products for Use as Animal Food
A. Proposed Sec. 507.28(a)--Contamination
B. Proposed Sec. 507.28(a)(1)--Containers
C. Proposed Sec. 507.28(a)(2)--Protection From Contamination
D. Proposed Sec. 507.28(a)(3)--Labeling
E. Proposed Sec. 507.28(b)--Shipping Containers
XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis
and Risk-Based Preventive Controls
XXIV. Subpart C: Comments on Proposed Sec. 507.31--Food Safety Plan
A. Proposed Sec. 507.31(a)--Requirement for a Food Safety Plan
B. Proposed Sec. 507.31(b)--Preparation of the Food Safety Plan
by a Preventive Controls Qualified Individual
C. Proposed Sec. 507.31(c)--Contents of a Food Safety Plan
D. Proposed Sec. 507.31(d)--Records
E. Comments on Potential Requirements for Submission of a
Facility Profile to FDA
XXV. Subpart C: Comments on Proposed Sec. 507.33--Hazard Analysis
A. Proposed Sec. 507.33(a)--Requirement for a Written Hazard
Analysis
B. Proposed Sec. 507.33(b)--Hazard Identification
C. Proposed Sec. 507.33(c) and (d)--Evaluation of Whether a
Hazard Requires a Preventive Control
XXVI. Subpart C: Comments on Proposed Sec. 507.36--Preventive
Controls (Final Sec. 507.34)
A. Proposed Sec. 507.36(a)--Requirement To Identify and
Implement Preventive Controls (Final Sec. 507.34(a))
B. Proposed Sec. 507.36(b)--Requirement for Written Preventive
Controls (Final Sec. 507.34(b))
C. Proposed Sec. 507.36(c)(1)--Process Controls (Final Sec.
507.34(c)(1))
D. Proposed Sec. 507.36(c)(2)--Sanitation Controls (Final Sec.
507.34(c)(2))
E. Proposed Sec. 507.36(c)(3)--Supply-Chain Controls (Final
Sec. 507.34(c)(3))
F. Proposed Sec. 507.36(c)(4)--Recall Plan (Final Sec.
507.34(c)(4))
G. Proposed Sec. 507.36(c)(5)--Other Controls (Final Sec.
507.34(c)(5))
XXVII. Subpart C: Circumstances in Which the Owner, Operator, or
Agent in Charge of a Manufacturing/Processing Facility Is Not
Required To Implement a Preventive Control (Final Sec. Sec. 507.36
and 507.37)
XXVIII. Subpart C: Comments on Proposed Sec. 507.38--Recall Plan
A. Proposed Sec. 507.38(a)--Requirement for a Written Recall
Plan
B. Proposed Sec. 507.38(b)--Procedures That Describe the Steps
To Be Taken, and Assign Responsibility for Taking Those Steps
XXIX. Comments on Proposed Sec. 507.39--Preventive Control
Management Components
A. Proposed Sec. 507.39(a)--Flexible Requirements for
Monitoring, Corrective Actions and Corrections, and Verification
B. Proposed Sec. 507.39(b)--Applicability of Preventive Control
Management Components to Supply-Chain Program
C. Proposed Sec. 507.39(c)--Recall Plan is Not Subject to
Preventive Control Management Components
XXX. Subpart C: Comments on Proposed Sec. 507.40--Monitoring
A. Our Tentative Conclusion To Require Monitoring of the
Performance of Preventive Controls
B. Proposed Sec. 507.40(a) and (b)--Flexibility in Requirements
for Monitoring
C. Proposed Sec. 507.40(c)--Records
XXXI. Subpart C: Comments on Proposed Sec. 507.42--Corrective
Actions and Corrections
A. Proposed Sec. 507.42(a)(1)(i)--Requirement To Establish and
Implement Corrective Action Procedures
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B. Proposed Sec. 507.42(a)(2)--Content of Corrective Action
Procedures
C. Proposed Sec. 507.42(b)--Corrective Action in the Event of
an Unanticipated Problem
D. Proposed Sec. 507.42(c)--Corrections
E. Proposed Sec. 507.42(d)--Records
XXXII. Subpart C: Comments on Proposed Sec. 507.45--Verification
A. Flexibility in Requirements for Verification
B. Proposed Sec. 507.45(a)--Verification Activities
C. Proposed Sec. 507.45(b)--Documentation of Verification
Activities
D. Comments on Potential Requirements Regarding Complaints
XXXIII. Subpart C: Comments on Proposed Sec. 507.47--Validation
A. Flexibility in the Requirements To Validate Preventive
Controls
B. Proposed Sec. 507.47(b)(1)--When Validation Must Be
Performed and Role of Preventive Controls Qualified Individual in
Validation
C. Proposed Sec. 507.47(b)(2)--What Validation Must Include
D. Proposed Sec. 507.47(b)(3)--Preventive Controls for Which
Validation Is Not Required
XXXIV. Subpart C: Comments on Proposed Sec. 507.49--Verification of
Implementation and Effectiveness
A. Flexibility in the Requirements To Conduct Activities To
Verify Implementation and Effectiveness
B. Proposed Sec. 507.49(a)(1)--Calibration
C. Comments Directed to Proposed Requirements for Both Product
Testing (Proposed Sec. 507.49(a)(2) and (b)(2)) and Environmental
Monitoring (Proposed Sec. 507.49(a)(3) and (b)(3))
D. Proposed Sec. 507.49(a)(2)--Product Testing
E. Proposed Sec. 507.49(a)(3)--Environmental Monitoring
F. Proposed Sec. 507.49(a)(4)--Review of Records
G. Proposed Sec. 507.49(b)--Written Procedures
XXXV. Subpart C: Comments on Proposed Sec. 507.50--Reanalysis
A. Proposed Sec. 507.50(a)--Circumstances Requiring Reanalysis
B. Proposed Sec. 507.50(b)--Timeframe To Complete Reanalysis
C. Proposed Sec. 507.50(c)--Requirement To Revise the Written
Food Safety Plan or Document Why Revisions Are Not Needed
D. Proposed Sec. 507.50(d) --Requirement for Oversight of
Reanalysis by a Preventive Controls Qualified Individual
E. Proposed Sec. 507.50(e)--Reanalysis on the Initiative of FDA
XXXVI. Subpart C: Comments on Proposed Sec. 507.51--Modified
Requirements That Apply to a Facility Solely Engaged in the Storage
of Unexposed Packaged Animal Food
A. Proposed Sec. 507.51(a)--Modified Requirements for Unexposed
Refrigerated Packaged Animal Food That Requires Time/Temperature
Controls
B. Proposed Sec. 507.51(b)--Records
XXXVII. Subpart C: Comments on Proposed Sec. 507.53--Requirements
Applicable to a Preventive Controls Qualified Individual and a
Qualified Auditor
A. Proposed Sec. 507.53(a) and (b)--What a Preventive Controls
Qualified Individual or Qualified Auditor Must Do or Oversee
B. Proposed Sec. 507.53(c)--Qualification Requirements
C. Proposed Sec. 507.53(d)--Records
XXXVIII. Subpart C: Comments on Proposed Sec. 507.55--
Implementation Records
XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal
of a Qualified Facility Exemption
A. Proposed Sec. 507.60--Circumstances That May Lead FDA To
Withdraw a Qualified Facility Exemption
B. Proposed Sec. 507.62--Issuance of an Order To Withdraw a
Qualified Facility Exemption
C. Proposed Sec. 507.65--Contents of an Order To Withdraw a
Qualified Facility Exemption
D. Proposed Sec. 507.67--Compliance With, or Appeal of, an
Order To Withdraw a Qualified Facility Exemption
E. Proposed Sec. 507.69--Procedure for Submitting an Appeal
F. Proposed Sec. 507.71--Procedure for Requesting an Informal
Hearing
G. Proposed Sec. 507.73--Requirements Applicable to an Informal
Hearing
H. Proposed Sec. 507.85--Reinstatement of a Qualified Facility
Exemption That Was Withdrawn
I. Conforming Amendment to 21 CFR Part 16
J. Other Comments on the Withdrawal Provisions
XL. Subpart E: General Comments on Proposed Requirements Applicable
to a Supply-Chain Program
XLI. Subpart E: Comments on Requirement To Establish and Implement a
Supply-Chain Program
A. Requirement for a Written Supply-Chain Program (Final Sec.
507.105(a)(1) and (b))
B. Circumstances That Do Not Require a Written Supply-Chain
Program (Final Sec. 507.105(a)(2))
C. Exemption for Animal Food Supplied for Research or Evaluation
(Final Sec. 507.105(a)(3))
D. Additional Requirements for Non-Suppliers (Final Sec.
507.105(c))
E. Proposed General Requirements for the Supply-Chain Program
That We Are Not Including in the Final Rule (Proposed Sec.
507.37(a)(4) and (5))
XLII. Subpart E: Comments on General Requirements for the Supply-
Chain Program
A. Description of What the Supply-Chain Program Must Include
(Final Sec. 507.110(a))
B. Appropriate Supplier Verification Activities ((Final Sec.
507.110(b))
C. Purpose of Supplier Verification Activities for Raw Materials
and Other Ingredients (Final Sec. 507.110(c))
D. Factors That Must Be Considered When Approving Suppliers and
Determining Appropriate Supplier Verification Activities for Raw
Materials and Other Ingredients (Final Sec. 507.110(d))
E. Supplier Non-Conformance (Final Sec. 507.110(e))
XLIII. Subpart E: New Requirement Specifying the Responsibilities of
the Receiving Facility (Final Sec. 507.115)
XLIV. Subpart E: Comments on Using Approved Suppliers and
Determining Appropriate Supplier Verification Activities
A. Using Approved Suppliers (Final Sec. 507.120)
B. Determining Appropriate Verification Activities (Final Sec.
507.125)
XLV. Subpart E: Comments on Conducting Supplier Verification
Activities for Raw Materials and Other Ingredients
A. Requirement To Conduct One or More Supplier Verification
Activities (Final Sec. 507.130(a))
B. Requirement for an Onsite Audit as a Verification Activity
When a Hazard Has a Reasonable Probability of Resulting in Serious
Adverse Health Consequences or Death to Humans or Animals (Final
Sec. 507.130(b))
C. Alternative Verification Activity When the Supplier Is a
Qualified Facility (Final Sec. 507.130(c))
D. Alternative Verification Activity When the Supplier Is a
Produce Farm That Is Not a ``Covered Farm'' for the Purposes of the
Future Produce Safety Rule (Final Sec. 507.130(d))
E. Alternative Verification Activity When the Supplier Is a
Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final Sec.
507.130(e))
F. Independence of Persons Who Conduct Supplier Verification
Activities (Final Sec. 507.130(f))
XLVI. Subpart E: Comments on Onsite Audit
A. Requirements Applicable to an Onsite Audit (Final Sec.
507.135(a) and (b))
B. Substitution of Inspection by FDA or an Officially Recognized
or Equivalent Food Safety Authority
C. Onsite Audit by a Third-Party Auditor Accredited for the
Purposes of Section 808 of the FD&C Act
XLVII. Subpart E: Comments on Records Documenting the Supply-Chain
Program
A. Applicability of the Recordkeeping Requirements of Subpart F
(Final Sec. 507.175(a))
B. Requirement To Review Records of the Supply-Chain Program
(Final Sec. 507.175(b))
C. Documentation Demonstrating Use of the Written Procedures for
Receiving Raw Materials and Other Ingredients (Final Sec.
507.175(c)(5))
D. Documentation of the Conduct of an Onsite Audit (Final Sec.
507.175(c)(7))
E. Documentation of Sampling and Testing (Final Sec.
507.175(c)(8))
F. Documentation of Other Appropriate Supplier Verification
Activity (Final Sec. 507.175(c)(10))
G. Documentation of an Alternative Verification Activity for a
Supplier That Is a Farm That Is Not a ``Covered Farm'' for the
Purposes of the Future Produce Safety Rule (Final Sec.
507.175(c)(13))
XLVIII. Subpart F: Comments on Proposed New Recordkeeping
Requirements
A. Proposed Sec. 507.200--Records Subject to the Requirements
of Subpart F and Requirements for Official Review
[[Page 56173]]
B. Proposed Sec. 507.202--General Requirements Applying to
Records
C. Proposed Sec. 507.206--Additional Requirements Applying to
the Food Safety Plan
D. Proposed Sec. 507.208--Requirements for Record Retention
E. Proposed Sec. 507.212--Use of Existing Records
F. Final Sec. 507.215--Special Requirements Applicable to a
Written Assurance
XLIX. Comments by Foreign Governments and Foreign Businesses
L. Editorial and Conforming Changes
LI. Comments on FSMA's Rulemaking Provisions
A. Comments on Section 418(m) of the FDA&C Act Regarding
Modified Requirements for Facilities Solely Engaged in the
Production of Food for Animals Other Than Man
B. Comments on Requirements in Section 418(n)(3) of the FD&C Act
Regarding Content
LII. Comments on Proposed Conforming Amendments
LIII. Effective and Compliance Dates
A. Effective and Compliance Dates for Part 507
B. Effective Dates for Conforming Amendments
C. Delayed Effective Dates for Provisions That Refer to the
Forthcoming Rules for Produce Safety and Third-Party Certification
LIV. Compliance and Enforcement
LV. Executive Order 13175
LVI. Economic Analysis of Impacts
LVII. Analysis of Environmental Impact
LVIII. Paperwork Reduction Act of 1995
LIX. Federalism
LX. References
Executive Summary
Purpose and Coverage of the Rule
This rule is part of FDA's implementation of FSMA, which intends to
better protect public (human and animal) health by, among other things,
adopting a modern, preventive, and risk-based approach to food safety
regulation. This rule establishes new requirements for the production
of animal food by registered food facilities in two ways.
First, this rule creates new CGMP regulations that specifically
address the manufacturing, processing, packing, and holding of food for
animals. These requirements apply to establishments that are required
to register with FDA as a food ``facility.'' Second, this rule creates
new requirements for certain domestic and foreign facilities to
establish and implement hazard analysis and risk-based preventive
controls for food for animals. As with the CGMPs, these requirements
apply to establishments that are required to register with FDA as a
food facility. This portion of the rule requires registered animal food
facilities to maintain a food safety plan, perform a hazard analysis,
and institute preventive controls for the mitigation of those hazards,
unless an exemption applies. Facilities must also monitor their
controls, conduct verification activities to ensure the controls are
effective, take appropriate corrective actions, and maintain records
documenting these actions.
This final rule is the result of significant stakeholder
engagement, beginning before the proposed rule. In response to
extensive stakeholder input on the proposed rule, we revised key
provisions in a supplemental notice of proposed rulemaking. After the
supplemental notice of proposed rulemaking, we conducted even more
outreach to the stakeholder community to ensure that the risk-based,
preventive requirements in this final rule are practical and protective
of public (human and animal) health.
Summary of the Major Provisions of the Rule
The final rule establishes CGMP provisions to ensure the safety and
suitability of animal food. Specifically, the rule establishes
requirements in the following areas:
Personnel;
Plant and grounds;
Sanitation;
Water supply and plumbing;
Equipment and utensils;
Plant operations;
Holding and distribution; and
Holding and distribution of human food by-products for use
as animal food.
We have added flexibility and clarity to the CGMPs in response to
comments. These CGMPs establish baseline standards for producing safe
animal food that take into consideration the unique aspects of the
animal food industry and provide flexibility for the wide diversity in
types of animal food facilities. In addition, the CGMPs in this final
regulation allow human food facilities subject to and in compliance
with CGMPs for human food and in compliance with all applicable FDA
human food safety requirements to only follow the specific CGMPs for
the holding and distribution of human food by-products for use as
animal food, as long as they do not further process the by-product.
Under this final rule, all other requirements of part 507, including
the hazard analysis, preventive controls and supply-chain program
provisions, would not apply to these by-products of human food
production.
The final rule implements the requirements of FSMA for covered
facilities to establish and implement a food safety system that
includes a hazard analysis and risk-based preventive controls.
Specifically, the rule establishes requirements for:
A written food safety plan;
Hazard analysis;
Preventive controls;
Monitoring;
Corrective actions and corrections;
Verification;
Supply-chain program;
Recall plan; and
Associated records.
We have added flexibility and clarity to these provisions in
response to comments. Although there are similarities between these
requirements of FSMA and the requirements of food safety systems known
as Hazard Analysis and Critical Control Point (HACCP) systems, not
every provision in FSMA is identical to the provisions of HACCP
systems, and we have revised much of our terminology to distinguish
FSMA's requirements for hazard analysis and risk-based preventive
controls from HACCP requirements. A facility subject to the rule must
conduct a hazard analysis to identify and evaluate known or reasonably
foreseeable hazards for each type of animal food manufactured,
processed, packed, or held at the facility to determine whether there
are any hazards requiring preventive controls. The first step of a
hazard analysis is hazard identification, which must consider known or
reasonably foreseeable hazards, including biological, chemical, and
physical hazards. The hazard analysis must consider hazards that may be
present in the animal food because they occur naturally, are
unintentionally introduced, or are intentionally introduced for
purposes of economic gain. We continue to believe that hazards that may
be intentionally introduced for economic gain will need preventive
controls in rare circumstances, usually in cases where there has been a
pattern of economically motivated adulteration in the past.
Economically motivated adulteration that affects product integrity or
quality, for example, but not animal food safety, is out of the scope
of this rule.
A facility subject to the rule must identify and implement
preventive controls to provide assurances that any hazards requiring a
preventive control will be significantly minimized or prevented and the
animal food manufactured, processed, packed, or held by the facility
will not be adulterated. The rule establishes preventive control
management components (monitoring, corrective actions and corrections,
and verification) as appropriate to ensure the
[[Page 56174]]
effectiveness of the preventive controls. One way we have clarified the
risk-based flexibility of these requirements is by clearly stating in
the final rule that a facility must take into account the nature of the
preventive control and the facility's food safety system when
considering which activities are appropriate for that facility.
We have also added flexibility and made risk-based modifications
for specific preventive control management components. For example, the
final rule allows flexibility for the specific records required to
document monitoring of refrigeration controls during storage of an
animal food that requires time/temperature control for safety. These
records can be either affirmative records demonstrating temperature is
controlled or ``exception records'' demonstrating loss of temperature
control. As another example, the rule includes tailored, less
burdensome requirements for corrections. A correction is defined in
this rule as an action to identify and correct a problem that occurred
during the production of animal food, without other actions associated
with a corrective action procedure (such as actions to reduce the
likelihood that the problem will recur, evaluate all affected food for
safety, and prevent affected animal food from entering commerce). The
final rule clarifies that corrections must be taken in a timely manner
and must be recorded when appropriate, but they do not, for example,
need to be included in a written plan or accompanied by a reanalysis of
the written food safety plan.
As a third example, the final rule provides flexibility for which
verification activities must occur. In general, a facility is required
to conduct verification activities, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
including validation, verification of monitoring, verification of
corrective actions, verification of implementation and effectiveness,
and reanalysis. Validation is not required for all controls. For
example, the rule specifies that validation is not required for certain
types of preventive controls (i.e., sanitation controls, supply-chain
controls, and the recall plan) and provides flexibility for the
facility to not validate other preventive controls with a written
justification based on factors such as the nature of the hazard, and
the nature of the preventive control and its role in the facility's
food safety system. Product testing and environmental monitoring are
listed as possible verification activities, but, like other preventive
control management components in general, they are only required as
appropriate to the animal food, facility, the nature of the preventive
control, and the preventive control's role in the facility's food
safety system. In many cases, neither product testing nor environmental
monitoring will be appropriate. For example, there would be little or
no benefit to product testing or environmental monitoring in facilities
that pack or hold raw agricultural commodities that are rarely consumed
unprocessed, such as soybeans.
A facility must reanalyze the food safety plan as a whole at least
once every 3 years. The final rule provides the flexibility for a
facility to only reanalyze the applicable portion of the food safety
plan under certain other circumstances, such as when a facility becomes
aware of new information about potential hazards associated with an
animal food.
The final rule also adds flexibility to the preventive controls
requirements and recognizes the reality of modern distribution chains
by not requiring a manufacturing/processing facility to implement a
preventive control in certain circumstances when the hazard requiring a
preventive control will be controlled by another entity in the
distribution chain. For example, if a facility's customer (or another
entity in the distribution chain) will control the hazard, then that
facility can rely on its customer to provide written assurance that the
identified hazard will be controlled by an entity in the distribution
chain, with flexibility for how the customer provides that written
assurance depending on whether the customer, or an entity subsequent to
the customer, will control the hazard. We have identified four specific
circumstances in which a manufacturing/processing facility can rely on
another entity in the distribution chain to control a hazard, with
practical solutions explained further in section XXVII. We also have
provided flexibility for a facility to establish, document, and
implement an alternative system that ensures adequate control, at a
later distribution step, of the hazards in the food product distributed
by a manufacturing/processing facility such that the facility would not
need to implement a preventive control.
We revised the proposed provisions for a supplier program to add
flexibility, recognizing that the receiving facility and the supplier
may be separated by several entities in a supply chain. We are allowing
entities such as distributors, brokers, and aggregators to determine,
conduct, and document appropriate supplier verification activities as a
service to the receiving facility, provided that the receiving facility
reviews and assesses applicable documentation provided by the other
entity and documents that review and assessment. However, because the
approval of suppliers is ultimately the responsibility of the receiving
facility, the rule specifies that only a receiving facility can approve
suppliers. To improve clarity and readability we redesignated the
proposed provisions into eight distinct sections of regulatory text in
a newly established subpart E (Supply-Chain Program).
Each facility subject to the rule must have a recall plan for an
animal food with a hazard requiring a preventive control.
Many activities required by the final rule must be conducted (or
overseen) by a preventive controls qualified individual, a new term we
are coining here. A preventive controls qualified individual is a
qualified individual who has successfully completed certain training in
the development and application of risk-based preventive controls or is
otherwise qualified through job experience to develop and apply a food
safety system.
The rule establishes several exemptions (including modified
requirements in some cases) from the requirements for hazard analysis
and risk-based preventive controls. All of these exemptions are
expressly authorized by FSMA. A facility that manufactures, processes,
packs, or holds food and that is required to register with FDA would be
required to comply with the requirements for hazard analysis and risk-
based preventive controls unless it is covered by an exemption, as
shown in the following table.
[[Page 56175]]
Proposed Exemptions From the New Requirements for Hazard Analysis and
Risk-Based Preventive Controls
------------------------------------------------------------------------
Who or what is exempt from the
requirements for hazard analysis and Notes
risk-based preventive controls
------------------------------------------------------------------------
``Qualified Facility'' as defined by Modified requirements apply--
FSMA: i.e., a qualified facility is
Business with average annual sales of required to:
<$500,000 and at least half the sales Notify FDA about its
to consumers or local retailers or status and either:
restaurants (within the same state or [cir] Notify FDA that it is
within 275 miles); or addressing hazards through
Very small business, which the preventive controls and
rule defines as a business (including monitoring; or
any subsidiaries or affiliates) [cir] Notify FDA that it
averaging less than $2,500,000, complies with applicable non-
adjusted for inflation, per year, Federal food safety
during the 3-year period preceding the regulations, and notify
applicable calendar year in sales of consumers of the name and
animal food plus the market value of complete business address of
animal food manufactured, processed, the facility where the animal
packed, or held without sale (e.g., food was manufactured or
held for a fee or supplied to a farm processed.
without sale) The notification is in
the form of an attestation,
and must be submitted every 2
years, during the same
timeframe as the facility is
required to update its
facility registration.
Low-risk, on-farm activities Small and very small on-farm
performed by small business (<500 full- businesses conducting only the
time equivalent employees). specified low-risk activities
are exempt from the
requirements for hazard
analysis and risk-based
preventive controls.
-or-
Low-risk, on-farm activities We define the low-risk, on-farm
performed by a very small business activities that qualify for
(dollar threshold of $2,500,000, as the exemption, including the
described previously). specific animal foods to which
they relate (such as re-
packing roughage products, or
cracking grains).
Activities that are subject to the The exemption applies
``low-acid canned food'' requirements only with respect to
of part 113 (21 CFR part 113). microbiological hazards
regulated under part 113.
The facility must be
in compliance with part 113.
Activities of a facility that are These activities will be
subject to section 419 of the Federal established in FDA's
Food, Drug, and Cosmetic Act forthcoming rule for produce
(Standards for Produce Safety) (21 safety.
U.S.C. 350h).
Facilities that are solely engaged in A facility that stores raw
the storage of raw agricultural agricultural commodities that
commodities (other than fruits and are fruits and vegetables is
vegetables) intended for further not exempt.
distribution or processing.
A facility solely engaged in the Modified requirements apply for
storage of unexposed packaged animal the storage of unexposed
food that does not require time/ packaged animal food that
temperature control to significantly requires time/temperature
minimize or prevent the growth of, or control to significantly
toxin production by, pathogens. minimize or prevent the growth
of, or toxin production by,
pathogens.
------------------------------------------------------------------------
The rule includes procedures for withdrawing a qualified facility
exemption, in the event of an active investigation of a foodborne
illness outbreak that is directly linked to the facility, or if FDA
determines that it is necessary to protect the public (human and
animal) health and prevent or mitigate a foodborne illness outbreak
based on relevant conditions or conduct associated with the qualified
facility. The final rule provides procedures for a facility to appeal
an order to withdraw a qualified facility exemption, for a facility to
request an informal hearing, for the conduct of an informal hearing,
for an appeal, for revoking an order to withdraw a qualified facility
exemption, and for reinstating an exemption that was withdrawn.
The rule finalizes recordkeeping provisions associated with the new
provisions for hazard analysis and risk-based preventive controls.
These records allow facilities to show, and FDA to determine,
compliance with the new requirements. To meet these requirements, a
facility may use existing records as appropriate.
Costs and Benefits
This final regulation requires domestic and foreign facilities to
adopt a food safety plan, perform a hazard analysis, and to institute
preventive controls for the mitigation of those hazards identified as
requiring a preventive control. It also includes requirements for
facilities to institute risk-based environmental monitoring, product
testing, and a supply-chain program as appropriate to the animal food,
the facility and the nature of the preventive controls, as well as a
requirement to institute controls to help prevent hazards associated
with economically motivated adulteration. The total annualized costs
are estimated at $139.0 to $170.7 million per year (over 10 years at a
7 percent discount rate), and $135.6 to $166.7 million per year (over
10 years at a 3 percent discount rate). The total annualized benefits
to pets are estimated at $10.1-$138.0 million.
Estimated Total Costs and Benefits
[Millions]
----------------------------------------------------------------------------------------------------------------
Total annualized Total annualized
One-time Annual cost at 7% \1\ cost at 3% \1\
----------------------------------------------------------------------------------------------------------------
Total Costs..................... $135.6 to $160.1 $119.7 to $147.9 $139.0 to $170.7 $135.6 to $166.7
Total Benefits to Pets.......... \2\ N/A $10.1 to $138.0 $10.1 to $138.0 $10.1 to $138.0
----------------------------------------------------------------------------------------------------------------
\1\ Total annualized cost equal to annualized one-time cost plus annual cost.
\2\ N/A = Not applicable
[[Page 56176]]
Table of Abbreviations and Acronyms
------------------------------------------------------------------------
Abbreviation/Acronym What it means
------------------------------------------------------------------------
AAFCO........................ Association of American Feed Control
Officials.
AFSS......................... Animal Feed Safety System.
BAM.......................... Bacteriological Analytical Method.
Bioterrorism Act............. Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
(Pub. L. 107-188).
CCP.......................... Critical Control Point.
CFR.......................... Code of Federal Regulations.
CGMP......................... Current Good Manufacturing Practice.
Codex........................ Codex Alimentarius Commission.
CPG.......................... Compliance Policy Guide.
CVM.......................... Center for Veterinary Medicine.
EPA.......................... U.S. Environmental Protection Agency.
EU........................... European Union.
FDA.......................... U.S. Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FOIA......................... Freedom of Information Act.
FSIS......................... Food Safety and Inspection Service of the
U.S. Department of Agriculture.
FSIS Validation Guidelines... FSIS' Compliance Guidelines on HACCP
Systems Validation.
FSMA......................... FDA Food Safety Modernization Act.
FSPCA........................ Food Safety Preventive Controls Alliance.
FSVP......................... Foreign Supplier Verification Programs.
GAP.......................... Good Agricultural Practices.
GFSI......................... Global Food Safety Initiative.
GRAS......................... Generally Recognized as Safe.
HACCP........................ Hazard Analysis and Critical Control
Point.
HHS.......................... U.S. Department of Health and Human
Services.
ISO.......................... International Organization for
Standardization.
LACF......................... Thermally processed low-acid foods
packaged in hermetically sealed contain
(commonly called ``low-acid canned
foods'').
N/A.......................... Not Applicable.
NACMCF....................... The National Advisory Committee on
Microbiological Criteria for Foods
(advisory committee chartered under the
USDA).
NIFA......................... National Institute of Food and
Agriculture of the U.S. Department of
Agriculture.
OMB.......................... Office of Management and Budget.
PAS.......................... British Standards Institute ``Publically
Available Specification 222:2011''.
PFP.......................... Partnership for Food Protection.
PHS.......................... Public Health Service Act.
PRA.......................... Paperwork Reduction Act.
PSA.......................... Protein Surveillance Assignment.
RA........................... Risk Assessment.
RAC.......................... Raw Agricultural Commodity.
RFR.......................... Reportable Food Registry.
Section 103(c)(1)(C) draft RA Draft Qualitative Risk Assessment of Risk
of Activity/Food Combinations for
Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a
Farm.
Section 103(c)(1)(C) RA...... Qualitative Risk Assessment of Risk of
Activity/Food Combinations for
Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a
Farm (Final).
TCS.......................... Time/Temperature Control for Safe Animal
Food.
USDA......................... U.S. Department of Agriculture.
------------------------------------------------------------------------
I. Background
A. FDA Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
signed into law by President Obama on January 4, 2011, is intended to
allow FDA to better protect public (human and animal) health by helping
to ensure the safety and security of the food supply. FSMA enables us
to focus more on preventing food safety problems rather than relying
primarily on reacting to problems after they occur. The law also
provides new enforcement authorities to help achieve higher rates of
compliance with risk-based, prevention-oriented safety standards and to
better respond to and contain problems when they do occur. In addition,
the law contains important new tools to better ensure the safety of
imported foods and encourages partnerships with State, local, tribal,
and territorial authorities. A top priority for FDA are those FSMA-
required regulations that provide the framework for industry's
implementation of preventive controls and enhance our ability to
oversee their implementation for both domestic and imported animal
food. To that end, we proposed the seven foundational rules listed in
table 1 and requested comments on all aspects of these proposed rules.
Table 1--Published Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
Title Abbreviation Publication
------------------------------------------------------------------------
Current Good Manufacturing 2013 proposed rule 78 FR 64736,
Practice and Hazard Analysis for preventive October 29, 2013.
and Risk-Based Preventive controls for
Controls for Food for Animals. animal food.
[[Page 56177]]
Current Good Manufacturing 2013 proposed rule 78 FR 3646,
Practice and Hazard Analysis for preventive January 16, 2013.
and Risk-Based Preventive controls for
Controls for Human Food. human food.
Standards for the Growing, 2013 proposed 78 FR 3504,
Harvesting, Packing, and produce safety January 16, 2013.
Holding of Produce for Human rule.
Consumption.
Foreign Supplier Verification 2013 proposed FSVP 78 FR 45730, July
Programs (FSVP) for Importers rule. 29, 2013.
of Food for Humans and Animals.
Accreditation of Third-Party 2013 proposed 78 FR 45782, July
Auditors/Certification Bodies third-party 29, 2013.
to Conduct Food Safety Audits certification
and to Issue Certifications. rule.
Focused Mitigation Strategies To 2013 proposed 78 FR 78014,
Protect Food Against intentional December 24,
Intentional Adulteration. adulteration rule 2013.
(human food only).
Sanitary Transportation of Human 2014 proposed 79 FR 7006,
and Animal Food. sanitary February 5, 2014.
transportation
rule.
------------------------------------------------------------------------
We also issued a supplemental notice of proposed rulemaking for the
rules listed in table 2 and requested comments on specific issues
identified in each supplemental notice of proposed rulemaking.
Table 2--Published Supplemental Notices of Proposed Rulemaking for the
Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
Title Abbreviation Publication
------------------------------------------------------------------------
Current Good Manufacturing 2014 supplemental 79 FR 58476,
Practice and Hazard Analysis notice. September 29,
and Risk-Based Preventive 2014.
Controls for Food for Animals.
Current Good Manufacturing 2014 supplemental 79 FR 58524,
Practice and Hazard Analysis human preventive September 29,
and Risk-Based Preventive controls notice. 2014.
Controls for Human Food.
Standards for the Growing, 2014 supplemental 79 FR 58434,
Harvesting, Packing, and produce safety September 29,
Holding of Produce for Human notice. 2014.
Consumption.
Foreign Supplier Verification 2014 supplemental 79 FR 58574,
Programs (FSVP) for Importers FSVP notice. September 29,
of Food for Humans and Animals. 2014.
------------------------------------------------------------------------
As FDA finalizes these seven foundational rulemakings, we are
putting in place a framework for food safety that is modern and brings
to bear the most recent science on provisions to enhance food safety,
that is risk-based and focuses effort where the hazards are reasonably
likely to occur, and that is flexible and practical given our current
knowledge of food safety practices. To achieve this, FDA has engaged in
a great deal of outreach to the stakeholder community to find the right
balance in these regulations of flexibility and accountability.
Since FSMA was enacted in 2011, we have been involved in
approximately 600 engagements on FSMA and the proposed rules, including
public meetings, Webinars, listening sessions, farm tours, and
extensive presentations and meetings with various stakeholder groups
(Refs. 1 and 2). As a result of this stakeholder dialogue, FDA decided
to issue the four supplemental notices of proposed rulemaking to share
our thinking on key issues and get additional stakeholder input on
those issues. As we move forward into the next phase of FSMA
implementation, we intend to continue this dialogue and collaboration
with our stakeholders, through guidance, education, training, and
assistance, to ensure that everyone understands and engages in their
role in food safety. FDA believes these seven foundational final rules,
when implemented, will fulfill the paradigm shift toward prevention
that was envisioned in FSMA and be a major step forward for food safety
that will protect consumers into the future.
B. Stages in the Rulemaking for the Animal Food Preventive Controls
Rule
With regard to this rulemaking, we published proposed provisions in
the 2013 proposed animal food preventive controls rule and we published
new and re-proposed provisions in the 2014 supplemental notice. In the
2014 supplemental notice, we reopened the comment period only with
respect to specific proposed provisions. In addition, we emphasized
that the re-proposed provisions we included in the regulatory text were
based on a preliminary review of the comments.
In this document, we use the broad term ``proposed animal food
preventive controls rule'' to refer to the complete proposed regulatory
text, including both the proposed provisions we published in the 2013
proposed animal food preventive controls rule and the new and re-
proposed provisions we published in the 2014 supplemental notice. We
use the narrow terms ``2013 proposed preventive controls rule for
animal food'' and ``2014 supplemental notice'' to refer to specific
text published in the Federal Register of October 29, 2013 (78 FR
64736) and September 29, 2014 (79 FR 58476), respectively. We use the
terms ``final preventive controls rule for animal food'' and ``this
rule'' to refer to the regulations we are establishing as a result of
this rulemaking.
C. Summary of the Major Provisions of Proposed Rule for Preventive
Controls for Food for Animals
As part of our implementation of new statutory provisions in FSMA,
we proposed to add, in newly established part 507, regulations for
CGMPs. In addition, we proposed to add requirements for certain
domestic and foreign facilities to establish and implement hazard
analysis and risk-based preventive controls for food for animals. As
directed by FSMA (see section 418 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 350g)), these new provisions would
apply to domestic and foreign facilities that are required to register
under section 415 of the FD&C Act (21 U.S.C. 350d) and our regulation
for Registration of Food Facilities (21 CFR part 1, subpart H; the
section 415 registration regulations). As directed by FSMA (see section
418(l) and (m) of the FD&C Act), we proposed to establish
[[Page 56178]]
modified requirements for certain facilities. We requested comment on
all aspects of the proposed requirements, including an opportunity for
public comment on potential requirements for product testing,
environmental monitoring, a supplier program, and hazards that may be
intentionally introduced for purposes of economic gain.
We proposed to establish the requirements for CGMPs, for hazard
analysis and risk-based preventive controls, and related requirements
in new 21 CFR 507 as shown in table 3:
Table 3--Proposed Subparts in New Part 507
------------------------------------------------------------------------
Subpart Title
------------------------------------------------------------------------
A................................. General Provisions.
B................................. Current Good Manufacturing Practice.
C................................. Hazard Analysis and Risk-Based
Preventive Controls.
D................................. Withdrawal of an Exemption
Applicable to a Qualified Facility.
E................................. Reserved.
F................................. Requirements Applying to Records
That Must be Established and
Maintained.
------------------------------------------------------------------------
D. Draft Risk Assessment
We issued for public comment a ``Draft Qualitative Risk Assessment
of Risk of Activity/Animal Food Combinations for Activities (Outside
the Farm Definition) Conducted in a Facility Co-Located on a Farm''
(the section 103(c)(1)(C) draft risk assessment (RA)) (78 FR 64428,
October 29, 2013). The purpose of the section 103(c)(1)(C) draft RA was
to provide a science-based risk analysis of those activity/animal food
combinations that would be considered low risk when conducted in a
facility co-located on a farm. We used the tentative conclusions of the
section 103(c)(1)(C) draft RA to propose to exempt food facilities that
are small or very small businesses that are engaged only in specific
types of on-farm manufacturing, processing, packing, or holding
activities from the requirements for hazard analysis and risk-based
preventive controls. We are including the final risk assessment (the
section 103(c)(1)(C) RA) in the docket established for this document
(Ref. 3).
E. Public Comments
We received more than 2400 public submissions on the 2013 proposed
preventive controls rule for animal food, and more than 140 public
submissions on the 2014 preventive controls supplement notice, each
containing one or more comments. We received submissions from diverse
members of the public, including animal food facilities (including
facilities co-located on a farm); farms; cooperatives; coalitions;
trade organizations; consulting firms; law firms; academia; public
health organizations; public advocacy groups; consumers; pet owners,
consumer groups; Congress, Federal, State, local, and foreign
Government Agencies; and other organizations. Some submissions included
signatures and statements from multiple individuals. Comments address
virtually every provision of the proposed animal preventive controls
rule. In the remainder of this document, we describe these comments,
respond to them, and explain any revisions we made to the proposed
preventive controls rule for animal food.
Some comments address issues that are outside the scope of this
rule. For example, some comments ask for more inspections of pet food
facilities. Other comments express concern about the use of
bioengineered animal food ingredients, and ask that animal foods
containing such ingredients not be used in pet food. Other comments
have concerns with FDA's general obligations for the outcome of
regulations it issues and implements, general concerns with FDA's
regulation and oversight of industry, concerns about banning specific
products or imports from specific countries, testing procedures at the
borders, and concerns about animal food marketing. We do not discuss
such comments in this document.
II. Legal Authority
The proposed rule contained an explanation of its legal basis under
authorities in FSMA, the FD&C Act, and the Public Health Service Act
(the PHS Act). After considering comments received in response to the
2013 proposed rule and the 2014 supplemental notice, we made changes in
the final rule. The legal authorities relied on for the final rule are
generally the same as in the proposed rule unless otherwise described.
A. Current Good Manufacturing Practice Regulations
The CGMP regulations finalized in this document establish current
good manufacturing practice requirements for the manufacturing,
processing, packing and holding of animal food. FDA's legal authority
to require current good manufacturing practice derives from sections
402(a)(3) and (4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3) and
(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a
food is adulterated if it consists in whole or in part of any filthy,
putrid, or decomposed substance, or if it is otherwise unfit for food.
Section 402(a)(4) of the FD&C Act provides that a food is adulterated
if it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may
have been rendered injurious to health. Under section 701(a) of the
FD&C Act, FDA is authorized to issue regulations for the efficient
enforcement of the FD&C Act. The CGMP regulations we are establishing
are necessary to prevent animal food from containing filthy, putrid, or
decomposed substances, being otherwise unfit for food, or being
prepared, packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby it may have been
rendered injurious to health.
In addition to the FD&C Act, FDA's legal authority for establishing
CGMP requirements derives from the PHS Act to the extent such measures
are related to communicable disease. Authority under the PHS Act is
derived from the provisions of sections 311, 361, and 368 (42 U.S.C.
243, 264, and 271) that relate to communicable disease. The PHS Act
authorizes the Secretary to make and enforce such regulations as ``are
necessary to prevent the introduction, transmission, or spread of
communicable diseases from foreign countries into the States * * * or
from one State * * * into any other State'' (section 361(a) of the PHS
Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for
transfer of authority from the Surgeon General to the Secretary.) The
CGMP regulations are necessary to prevent the spread of communicable
disease.
The CGMP regulations finalized in this document include limited
labeling requirements. These requirements are partly to help prevent
accidental co-mingling or mix-ups of products at the facility, which
could result in contaminated animal food. Thus, FDA's legal authority
for these requirements derives from its authority to require current
good manufacturing practice. The labeling requirements also are
intended to enable animal producers and owners, and facilities
receiving the animal food for further manufacture, to use the animal
food appropriately. Accordingly, the requirements are supported by
section 403(a)(1) of the FD&C Act, which states that a food is
misbranded if its labeling is false or misleading in any particular,
and by section 403(i) of the FD&C Act, which states that a food is
misbranded unless
[[Page 56179]]
its label bears the common or usual name of the food or its
ingredients.
B. Hazard Analysis and Risk-Based Preventive Controls
Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive
Controls, amends the FD&C Act to create a new section 418, which
mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that
the Secretary issue regulations ``to establish science-based minimum
standards for conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the implementation of
the preventive controls. . . .'' Section 418(n)(1)(B) of the FD&C Act
requires that the regulations define the terms ``small business'' and
``very small business,'' taking into consideration the study of the
food processing sector required by section 418(l)(5) of the FD&C Act.
Further, section 103(e) of FSMA creates a new section 301(uu) in the
FD&C Act (21 U.S.C. 331(uu)) to prohibit ``(t)he operation of a
facility that manufactures, processes, packs, or holds food for sale in
the United States if the owner, operator, or agent in charge of such
facility is not in compliance with section 418 (of the FD&C Act).''
In addition to rulemaking requirements, section 418 contains
requirements applicable to the owner, operator, or agent in charge of a
facility required to register under section 415. Section 418(a) is a
general provision that requires the owner, operator, or agent in charge
of a facility to evaluate the hazards that could affect food
manufactured, processed, packed, or held by the facility, identify and
implement preventive controls, monitor the performance of those
controls, and maintain records of the monitoring. Section 418(a)
specifies that the purpose of the preventive controls is to ``prevent
the occurrence of such hazards and provide assurances that such food is
not adulterated under section 402 (of the FD&C Act). . . .'' In
addition to the general requirements in section 418(a) of the FD&C Act,
sections 418(b) to (i) contain more specific requirements applicable to
facilities. These include hazard analysis (section 418(b)), preventive
controls (section 418(c)), monitoring (section 418(d)), corrective
actions (section 418(e)), verification (section 418(f)), recordkeeping
(section 418(g)), a written plan and documentation (section 418(h)),
and reanalysis of hazards (section 418(i)).
Section 103(c)(2)(C) of FSMA requires that the Secretary adopt a
final rule with respect to the requirements under sections 418 and 421
of the FD&C Act from which the Secretary may issue exemptions or
modifications of the requirements for certain types of facilities.
Sections 418(j) to (m) of the FD&C Act and sections 103(c)(1)(D) and
(g) of FSMA provide authority for certain exemptions and modifications
to the requirements of section 418 of the FD&C Act. These include
provisions related to low-acid canned food (section 418(j)); activities
of facilities subject to section 419 of the FD&C Act (Standards for
Produce Safety) (section 418(k)); qualified facilities (section
418(l)); facilities that are solely engaged in the production of food
for animals other than man, the storage of raw agricultural commodities
(other than fruits and vegetables) intended for further distribution or
processing, or the storage of packaged foods that are not exposed to
the environment (section 418(m)); and facilities engaged only in
certain low-risk on-farm activities on certain foods conducted by small
or very small businesses (section 103(c)(1)(D) of FSMA). In sections X,
XI, XII, and XXXVI we discuss provisions that implement these
exemptions and modified requirements.
In the supplemental notice, we included potential requirements for
a supplier program, environmental monitoring, and product testing. We
are including provisions for such activities in the final rule. Section
418(o)(3) of the FD&C Act provides supplier verification activities and
an environmental monitoring program as examples of preventive controls.
Section 418(f)(4) of the FD&C Act provides for the use of environmental
and product testing programs as part of required verification that the
preventive controls are effectively and significantly minimizing or
preventing the occurrence of identified hazards.
In certain circumstances, the final rule does not require a
manufacturing/processing facility to implement a preventive control for
a hazard requiring a preventive control. Instead, the facility is
permitted to rely on a subsequent entity in the distribution chain to
significantly minimize or prevent the hazard. In such a circumstance, a
facility must disclose in documents accompanying the animal food, that
the food is ``not processed to control [identified hazard].'' This
requirement is supported by sections 418 and 701(a) of the FD&C Act (21
U.S.C. 350g and 371(a)). The requirement that facilities apply
preventive controls to significantly minimize or prevent hazards is
fundamental to the public health benefits of the rule. To accommodate
the realities of modern food production, the rule allows a facility to
rely on a subsequent entity in the distribution chain rather than
requiring that facility to apply the control. An animal food may pass
through multiple entities in the distribution chain before it reaches
consumers. Further, ordinarily it is not apparent from visual
examination of the animal food whether a hazard requiring a preventive
control has been addressed. Consequently, without labeling, a facility
might not know that a facility upstream in the supply chain has not
applied a preventive control and is relying on a downstream entity to
do so. Therefore, the agency concludes that information that animal
food has not been processed to control an identified hazard is
necessary for a facility to fulfil its obligation under section 418
when a facility is relying on a subsequent entity to control the
hazard. The agency also concludes that such labeling is necessary for
the efficient enforcement of the FD&C Act because the labelling is
critical for FDA to hold facilities responsible for their obligations
under this regulatory scheme. Further, when the hazard can cause a
communicable disease, FDA concludes that the requirement is necessary
to prevent the spread of communicable disease from one state into
another state and relies on sections 311, 361, and 368 of the PHS Act.
FDA concludes that the provisions in subpart C and related
requirements in subparts A, E and F should be applicable to activities
that are intrastate in character. Facilities are required to register
under section 415 of the FD&C Act regardless of whether the food from
the facility enters interstate commerce (Sec. 1.225(b) (21 CFR
1.225(b))). The plain language of section 418 of the FD&C Act applies
to facilities that are required to register under section 415 (section
418(o)(2) of the FD&C Act) and does not exclude a facility from the
requirements because food from such a facility is not in interstate
commerce. Further, the prohibited act provision associated with section
418 (section 301(uu) of the FD&C Act) does not require interstate
commerce for a violation.
FDA also is issuing the provisions in subpart C and related
requirements in subparts A, E and F, under sections 402(a)(3) and (4),
and 701(a) of the FD&C Act to the extent such requirements are
necessary to prevent animal food from being held under insanitary
conditions whereby it may become contaminated with filth or rendered
injurious to health, or being unfit for food. FDA also is finalizing
those provisions under sections 311, 361, and 368 of the PHS Act
relating to communicable disease to the extent
[[Page 56180]]
those provisions are necessary to prevent the interstate spread of
communicable disease.
III. General Comments on the Proposed Rule
(Comment 1) Several comments ask us to develop guidance to
accompany the rule, particularly with respect to the new requirements
for hazard analysis and risk-based preventive controls. For example,
comments ask us to provide guidance on topics such as hazard analysis,
environmental monitoring, and validation. Some of these comments ask
that drafts of the guidance first be made available for public comment.
Some of these comments request that the guidance be available as soon
as possible and before the rule becomes effective. Some comments
request guidance specific to small businesses. Several comments suggest
FDA revisit some current compliance policy guidances in light of FSMA
and the proposed rules.
Other comments emphasize the importance of education and outreach
and ask us to provide support for ongoing education and outreach,
including an active role in providing needed instructional examples and
lessons learned from current investigations and foodborne outbreaks.
Some comments ask us to convene a scientific workgroup that includes
experts in food and laboratory science, public health, proficiency
testing, quality control, and other areas on at least an annual basis
to assess what hazards should be addressed in food safety plan. Other
comments ask us to engage universities and extension in education and
training efforts.
Some comments ask that funding and information on funding for
training be provided. Other comments assert that we must make available
adequate resources to support outreach and technical assistance
delivered by State regulatory Agencies, as well as Cooperative
Extension programs and non-governmental organizations that work
directly with farmers and facilities.
(Response 1) We are developing several guidance documents,
including general guidance on hazard analysis and preventive controls,
as well as guidance for complying with the CGMP requirements of subpart
B (Ref. 4). We will develop and issue this guidance in accordance with
our good guidance practices regulation, which establishes criteria for
when we issue a guidance document as an initial draft, invite public
comment, and prepare a final version of the guidance document that
incorporates suggested changes, when appropriate (Sec. 10.115(g)) (21
CFR 10.115(g)). The public may submit comments on any guidance document
at any time (Sec. 10.115(g)(5)). In addition, we intend to review
current guidance documents and make a determination whether they need
to be withdrawn or revised based on this final rule.
We agree with comments that stress the importance of education and
outreach. A central element of our strategy to gain industry compliance
is to help make available to facilities subject to this rule the
education and technical assistance they need to understand and
implement the requirements (Ref. 5). Within the Agency we are
establishing a Food Safety Technical Assistance Network and seeking
funding to increase FDA staffing to provide a central source of
information to support industry understanding and implementation of
FSMA standards (Ref. 5). This will allow us to respond in a timely and
consistent way to industry questions on preventive controls technical
and compliance issues (Ref. 5).
We also are working in collaboration with the Food Safety
Preventive Controls Alliance (FSPCA) to develop training materials and
establish training and technical assistance programs (Refs. 5 and 6).
The Alliance includes members from FDA, State food protection Agencies,
the food (human and animal) industry, and academia. It is funded by a
grant to the Illinois Institute of Technology's Institute for Food
Safety and Health, a nationally recognized leader in food safety. In
addition to developing a standardized preventive controls training
curriculum, the FSPCA is developing selected sections of model food
safety plans for several food types that will provide needed
instructional examples. Although we have provided funding to the FSPCA
to develop a standardized preventive controls training curriculum, we
are unable to fund training for individual groups who might need
particular training materials.
We also are partnering with the National Institute of Food and
Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) to
administer the FSMA-mandated National Food Safety Training, Education,
Extension, Outreach, and Technical Assistance Program, a grant program
to provide technical assistance for FSMA compliance to owners and
operators of small and medium-size farms and small food processors
(Ref. 7). Such efforts will help ensure widespread voluntary compliance
by encouraging greater understanding and adoption of established food
safety standards, guidance, and protocols.
(Comment 2) Some comments ask us to explain how we will enforce the
rule, particularly with respect to coordination with State and local
authorities and with other Federal Agencies. For example, some comments
ask whether FDA or the States will pay for inspections, whereas other
comments ask us to coordinate inspection of imports with USDA's Food
Safety and Inspection Service (FSIS) or ask us to combine our
inspections with those of USDA where possible. Some comments express
concern about the time gap between the effective date of this rule and
the time it will take to incorporate applicable provisions into State
law.
(Response 2) We are working through the Partnership for Food
Protection (PFP) (a group of dedicated professionals from Federal,
State, local, tribal, and territorial governments with roles in
protecting the food supply and public health) to develop and implement
a national Integrated Food Safety System consistent with FSMA's
emphasis on establishing partnerships for achieving compliance (see
section 209(b) of FSMA). For an example of our current thinking on
establishing partnerships for achieving compliance, see the ``best
practices'' document made available by PFP (Ref. 8). This ``best
practices'' document provides information to FDA field and State
programs on a variety of issues, including how to coordinate compliance
activities. Our document entitled ``Operational Strategy for
Implementing FSMA'' also recognizes the importance of developing
operational partnerships with States and other government counterparts
to optimize the effectiveness, efficiency, and consistency of FSMA
implementation domestically (Ref. 9).
We are implementing a new inspection paradigm focused on whether
firms are implementing systems that effectively prevent food
contamination, requiring fundamentally different approaches to food
safety inspection and compliance (Ref. 10). This new paradigm involves
a major reorientation and retraining, for which we are seeking funding,
of more than 2,000 FDA inspectors, compliance officers, and other staff
involved in food safety activities, as well as thousands of State,
local, and tribal inspectors (Ref. 10).
(Comment 3) Some comments ask us to reevaluate the proposed animal
food preventive controls rule, compare it with existing programs, and
identify a mechanism for integrating compliance verification with
existing industry and
[[Page 56181]]
governmental programs. These comments note that many handlers/
processors use and understand voluntary food safety management systems
such as HACCP and HACCP-based certification programs and ask us why we
proposed to create a separate inspection framework for FSMA, without
integrating that inspection framework with existing programs.
(Response 3) We decline this request. As previously discussed, we
are establishing this rule as required by section 103 of FSMA (78 FR
64736 at 64743 through 64745 and 64817 through 64818). However, where
compliance with this rule mirrors compliance with existing regulatory
requirements, there is no need to duplicate existing records, which may
be supplemented as necessary to include all of the required
information. (See also Response 2 regarding implementation of a
national Integrated Food Safety System.)
(Comment 4) Some comments ask us to make the various rules we are
establishing to implement FSMA consistent with each other. One comment
specifically asks us to harmonize the human and animal food preventive
controls final rules to avoid confusion by firms that produce both
human and animal food.
(Response 4) We have aligned the provisions of the various rules to
the extent practicable. For example, we use the same definitions of
``farm'' and the same terms used in the definition of ``farm'' (i.e.,
packing, holding, and manufacturing/processing) in this rule, the human
food preventive controls rule, and the proposed produce safety rule.
However, the statutory direction is not the same for all the rules, and
this difference in statutory direction does lead to some differences
between the rules. For example, section 418(l) of the FD&C Act (which
relates to this rule) provides for modified requirements for facilities
that are very small businesses in addition to facilities that satisfy
criteria for sales to qualified end-users, but section 419(f) of the
FD&C Act (which relates to the proposed produce safety rule) only
provides for modified requirements for direct farm marketing.
Likewise, we have worked to align the provisions of this rule with
the provisions of the Foreign Supplier Verification Program (FSVP)
rule. Again, however, there are statutory differences that lead to some
differences between the rules. For example, section 805 of the FD&C Act
(21 U.S.C. 348a), applies to an importer, whereas section 418 of the
FD&C Act applies to a facility that is required to register under
section 415 of the FD&C Act. Except in the circumstance where an
importer is also a manufacturer/processor, an importer must conduct a
hazard analysis as part of the foreign supplier verification
requirements, whereas a facility that is a manufacturer/processor must
conduct a hazard analysis to determine whether the requirements of the
animal food preventive controls rule apply to it. As another example,
section 805 of the FD&C Act does not provide an exemption for small or
very small entities, whereas section 418 of the FD&C Act provides an
exemption for ``qualified facilities,'' which include very small
businesses.
To the extent possible, we have attempted to harmonize the animal
food preventive controls final rule with the human food preventive
controls final rule. The CGMP (subpart B) requirements address the
manufacturing, processing, packing, and holding practices at animal
food plants, but are similar to those for human food, where
appropriate. Furthermore, Sec. 507.1(d) contains provisions for a
human food facility that also manufactures, processes, packs, or holds
animal food. This is intended to reduce confusion and increase
flexibility for facilities that produce both human and animal food.
(Comment 5) Some comments express concern that we will enforce the
rule more strictly for domestic facilities than for foreign facilities,
e.g., because we lack the funds and manpower to enforce the rule for
foreign facilities. Other comments assert that it is unprecedented for
importing countries to regulate the production processes in exporting
countries and that no scientific evidence supports such regulation.
These comments express concern that this regulatory requirement will
greatly increase trading costs and might constitute a barrier to trade
for exporting countries.
(Response 5) We intend to enforce this rule in a consistent manner
to ensure that imported and domestically produced animal foods are in
full compliance with the requirements of this rule. We note that the
forthcoming FSVP rule will require importers to help ensure that animal
food imported into the United States is produced in compliance with
processes and procedures, including reasonably appropriate risk-based
preventive controls, that provide the same level of public (human and
animal) health protection as those required under this rule. The
implementation of these supplier verification programs by U.S.
importers will thus provide assurances that imported animal food is in
compliance with this regulation.
We disagree that we are seeking to ``regulate the production
processes in exporting countries'' inappropriately. This rule provides
for a flexible set of principles and a framework for hazard analysis
and risk-based preventive controls to be applied to a given production
process in order to ensure the production of safe animal food destined
for the United States. Mandating that a finished animal food is
manufactured under general methods applicable to all animal foods
(e.g., good manufacturing practices) is a widely accepted regulatory
practice and fundamentally different than mandating that animal food be
produced in a certain way. We note that other countries have adopted
animal food safety regulations that mandate certain principles and
conditions be applied to animal food manufacturing. Because the
requirements being implemented by FDA under this regulation are
flexible and not prescriptive, we do not agree that this regulation
will significantly increase costs or impede trade.
We also disagree that there is no scientific evidence supporting
this rule. In the 2013 proposed preventive controls rule for human and
animal food, we provided an extensive background discussing the
scientific evidence upon which this rule is based (78 FR 3646 at 3659
through 3667, January 16, 2013 and 78 FR 64736 at 64745, October 29,
2013). In addition, the Appendix to the 2013 proposed preventive
controls rule provided additional scientific information on activities
such as product testing and environmental monitoring to support their
role in ensuring safe food and how these align with international
standards such as those of Codex Alimentarius (78 FR 64736 at 64834
through 64836).
(Comment 6) Many comments from pet owners are generally supportive
of the rule; however, some request additional regulations and oversight
for pet food. Many comments state that pet food should meet the same
standards as human food. Some comments request that pet food be
required to be tested for safety.
(Response 6) The CGMP requirements in subpart B are intended to
serve as baseline standards for producing safe animal food across all
types of animal food facilities, including pet food facilities. For
discussion of the relevance of the CGMP requirements to pet food, see
Response 163. Many pet food facilities (as well as facilities producing
other animal food) will be subject to the preventive controls
requirements of subpart C. These provisions require the pet food
manufacturer to identify and evaluate
[[Page 56182]]
potential hazards for the pet food to determine whether a preventive
control is required (see Sec. 507.33). These could be hazards to the
pet consuming the pet food or the person handling the pet food (e.g.,
Salmonella). The preventive controls provisions also include
requirements for product testing for pathogens or other hazards and
environmental monitoring for pathogens under certain circumstances (see
Sec. 507.49), in order to help ensure the safety of the pet (animal)
food. Currently, low-acid canned animal food in a hermetically sealed
container (such as canned pet food) is subject to the requirements of
Sec. 500.23 (21 CFR 500.23) and part 113 to control microbiological
hazards.
(Comment 7) Some comments request communication and coordination
with state regulators throughout the FSMA implementation phase. Some
comments specifically request training of FDA staff and regulatory
partners to inspect animal food facilities because there are
differences between animal food and human food facilities. Some
comments request that inspectors receive training on the broad range of
animal food manufacturing. At least one comment requests we establish a
national advisory committee to provide ongoing input throughout FSMA
implementation and enforcement. Some comments request that we provide
methods for communication with State and other regulatory partners,
including possibly a call center or other direct-contact resource for
regulators and industry to obtain information on FSMA.
(Response 7) As discussed in Response 1, we are working in
collaboration with the FSPCA to develop training materials and programs
to be used by industry and regulators. The training will be specific to
human or animal food and will include information on developing a food
safety plan tailored to each facility's unique hazards. We will
consider these and other recommendations for the content of such
training as part of that collaborative effort.
As discussed in Responses 1 and 2, we are working through two
working groups (FSCPA and PFP) that involve State and local regulators
in order to implement this final rule. We will continue to work through
these groups, as well as use other methods of communication and
coordination (e.g., arranged teleconference meetings with the States
(i.e., 50-State calls) to collaborate with State and local regulatory
officials to implement this final rule. We will consider these
recommendations as we communicate with State and local regulatory
partners during the implementation of this final rule.
(Comment 8) Some comments request that this final rule have a
provision similar to the proposed produce safety rule that allows a
state or foreign country to request a variance from the rule's
requirements due to procedures, processes, and practices that ensure a
product is not adulterated.
(Response 8) We are implementing these regulations according to the
statutory direction of FSMA. A variance request and review process is
specified for produce in section 419(c)(2) of the FD&C Act; however,
there are no similar provisions in FSMA directing FDA to create a
variance process for facilities subject to the preventive controls
regulations and we therefore are declining to do so.
(Comment 9) Some comments ask us to take a ``BASE'' approach to
implementing FSMA. These comments describe this approach as follows: B
stands for borders, a critical area where FDA should be focusing its
attention and resources; A stands for audits, recognizing that FDA will
need to actively audit states and foreign suppliers; S stands for
standard, representing the standards FDA will set by which firms will
be audited; and E stands for education, ensuring that all stakeholders
know their roles and responsibilities required by the rules.
(Response 9) While we do not intend to follow the BASE approach
described in the comment, we expect that some of our implementation
efforts will be similar to the approach described. For discussion of
our implementation planning, see Responses 1 and 2. To the extent this
comment is referring to animal food from foreign suppliers presented
for import, this is a subject of the forthcoming FSVP rule.
(Comment 10) Some comments requested exceptions or reduced
requirements that were not previously proposed. One comment requests a
narrower scope of requirements for facilities involved in the
production of chemicals used as food additives or in accordance with
generally recognized as safe (GRAS) standards.
(Response 10) We decline these requests. The CGMPs in subpart B and
preventive controls in subpart C are written to serve as baseline
standards for producing safe animal food across all types of animal
food facilities, including those producing food additives or other
ingredients.
IV. Definitions in the Section 415 Registration Regulations (21 CFR
Part 1, Subpart H)
A. Definitions That Impact a Determination of Whether an Establishment
Is a ``Farm''
The 2013 proposed rule for human food preventive controls contained
a description (78 FR 3646 at 3675 through 3676) of the current legal
and regulatory framework that governs the determination of when an
establishment is required to register as a food facility in accordance
with the section 415 registration regulations. That description focused
on the framework that governs whether an establishment that grows and
harvests crops or raises animals satisfies the definition of ``farm,''
because the facility registration requirements of section 415 of the
FD&C Act do not apply to ``farms.'' Under that framework, a key factor
in whether an establishment falls within the definition of ``farm,''
even with respect to crops it grows and harvests itself, is whether the
activities conducted by the establishment fall within definitions of
``harvesting,'' ``packing,'' or ``holding'' (which are within the
``farm'' definition). Another key factor is whether activities
conducted by the establishment fall within the definition of
manufacturing/processing (which have been outside the ``farm''
definition).
In the 2014 supplemental human preventive controls notice, comments
were described regarding proposed revisions to the definitions of
``farm,'' ``harvesting,'' ``packing'' and ``holding,'' as well as
comments regarding the triggers for an activity to be considered
manufacturing/processing (79 FR 58524 at 58530 through 58538).
Additional revisions were proposed to the definitions of ``farm,''
``harvesting,'' ``packing'' and ``holding'' to address these comments.
Even after the revisions we proposed in the 2014 supplemental human
preventive controls notice, some comments assert that the overall
``farm'' definition still presents an unrealistic and incomplete
understanding of how most farms in America are structured with regard
to their physical location(s) and business models. See table 4 for
revised definitions that are being finalized in the human food
preventive controls for the section 415 registration regulations and
the section 414 recordkeeping regulations.
In section IV of the final rule for preventive controls for human
food, published elsewhere in this issue of the Federal Register,
comments on the proposed changes to the section 415
[[Page 56183]]
registration regulations and to the section 414 recordkeeping
regulations are discussed.
Table 4--Revisions to the Proposed Definitions in the Section 415
Registration Regulations and the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
Definition Revision
------------------------------------------------------------------------
Farm......................................... A farm is an
``operation'' rather
than an
``establishment.``
There are two
types of farms: (1)
Primary production farm;
and (2) secondary
activities farm.
Primary production farm...................... A primary
production farm is
``under one management''
rather than ``under one
ownership.''
Although a
primary production farm
continues to be ``in one
general physical
location,'' we have
clarified that ``one
general physical
location is ``not
necessarily
contiguous.''
A primary
production farm is an
operation devoted to the
growing of crops, the
harvesting of crops, the
raising of animals
(including seafood), or
any combination of these
activities. Although
some primary production
farms both grow and
harvest crops, other
primary production farms
grow crops but do not
harvest them, and other
primary production farms
harvest crops but do not
grow them.
Treatment to
manipulate the ripening
of raw agricultural
commodities (RACs), and
packaging and labeling
the treated RACs,
without additional
manufacturing/
processing, is within
the ``farm'' definition.
We added an
example of drying/
dehydrating RACs to
create a distinct
commodity that would
fall within the ``farm''
definition (i.e., drying/
dehydrating grapes to
produce raisins), as
well as an example of
additional manufacturing/
processing that would
cause an operation that
dries/dehydrates RACs to
create a distinct
commodity to fall
outside the ``farm''
definition (i.e.,
slicing).
We added an
example of additional
manufacturing/processing
that can cause an
operation that packages
and labels RACs to fall
outside the ``farm''
definition (i.e.,
irradiation).
Secondary activities farm.................... A ``secondary
activities farm'' is an
operation, not located
on a primary production
farm, devoted to
harvesting (such as
hulling or shelling),
packing, and/or holding
of RACs, provided that
the primary production
farm(s) that grows,
harvests, and/or raises
the majority of the RACs
harvested, packed, and/
or held by the secondary
activities farm owns, or
jointly owns, a majority
interest in the
secondary activities
farm.
A secondary
activities farm may also
conduct those additional
activities allowed on a
primary production farm.
Harvesting................................... We added
additional examples of
harvesting activities.
Holding...................................... We added
additional examples of
holding activities.
Manufacturing/Processing..................... We added
additional examples of
manufacturing/processing
activities.
------------------------------------------------------------------------
B. Proposed Revisions to the Definition of Farm
In the human food proposed preventive controls rule, we proposed to
revise the ``farm'' definition to (1) Provide for on-farm packing and
holding of RACs to remain within the farm definition regardless of
ownership of the RACs; (2) include, within the ``farm'' definition, a
description of packing activities that include packaging RACs grown or
raised on a farm without additional manufacturing/processing; and (3)
provide for drying/dehydrating RACs to create a distinct commodity
(such as the on-farm drying of grapes to produce raisins), and
packaging and labeling such commodities, without additional
manufacturing/processing, to remain within the farm definition. See
section IV.B of the final rule for preventive controls for human food,
published elsewhere in this issue of the Federal Register, for a full
discussion of comments and responses on the proposed revisions to the
farm definition.
In the final rule for preventive controls for human food, published
elsewhere in this issue of the Federal Register, we have revised the
definition of farm to replace the term ``under one ownership'' with the
term ``under one management.'' As discussed in section IV.B of the
final rule for preventive controls for human food, although the
original phrase ``under one ownership'' was not referring to a single
owner, the ``farm'' definition should reflect modern business models
(such as cooperatives, on-farm packinghouses under ownership by
multiple growers, food aggregators, and food hubs) and use language
that the modern farming community understands. The term ``under one
management'' refers to the control structure of the business, that is,
the management of the business entity that is the farm operation. Thus,
for example, a primary production farm that hires another company as a
contract harvester to perform harvesting services on the primary
production farm's behalf is not ``under one management'' with the
primary production farm just because the primary production farm is
directing the contractor's activities performed on the primary
production farm's behalf. The primary production farm and the contract
harvester have separate and independent management structures because
they are separate and independent businesses. (See Response 25 in the
final rule for preventive controls for human food). As another example,
if a poultry processing company contracts with a primary production
farm to raise chickens on the poultry processor's behalf, the poultry
processor and the primary production farm are not ``under one
management,'' even if their contract strictly controls almost all
aspects of the raising of the poultry. The poultry processor and the
primary production farm have separate and independent management
structures because they are separate and independent businesses.
In the final rule for preventive controls for human food, we also
revised the farm definition to add a new category: A ``secondary
activities farm.'' (See Response 25 in the final rule for preventive
controls for human food). An important limitation on the types of
operations that fit within this category is that they must be majority
owned (or majority jointly owned) by the primary production farm(s)
that grows, harvests, and/or raises the majority of the RACs the
secondary activities farm harvests, packs, and/or holds. Thus, both
product and majority ownership must link a secondary activities farm to
a primary production farm(s).
For example, a primary production farm may own a majority interest
in a separate business that holds RACs and processes them into animal
food (e.g., a feed mill). If the majority of the RACs held by the feed
mill come from the primary production farm that owns the feed mill's
majority interest, the feed
[[Page 56184]]
mill is a secondary activities farm and may manufacture/process animal
food within the farm definition, but only to the extent that the animal
food manufactured is consumed at the feed mill or on another farm whose
``one management'' is the same management as the feed mill. However, if
the feed mill in this example manufactures/processes animal food that
is consumed on farms that are not under the same management as the feed
mill, that manufacturing/processing is outside the farm definition, the
feed mill is subject to registration under section 415 of the FD&C Act,
and its manufacturing/processing of animal food for consumption on
farms not under the same management is subject to the requirements of
this rule.
To further clarify, a feed mill that is not majority owned by a
primary production farm(s) cannot be a secondary activities farm. Also,
a feed mill that does not receive more than half of the RACs it holds
from primary production farm(s) that own a majority interest in the
feed mill cannot be a secondary activities farm. For example, a feed
mill owned by a poultry processing company will be required to register
as a food facility, unless the feed mill otherwise meets the definition
of ``farm.'' When a feed mill is owned by a company such as a poultry
processor, it is not majority owned by the primary production farm(s)
that supply the majority of the RACs it holds, and therefore the feed
mill cannot be a secondary activities farm.
C. Proposed Revisions to Definitions of Harvesting, Holding,
Manufacturing/Processing, Mixed-Type Facility, and Packing
See section VIII. for a discussion of comments and responses and
revisions to the definitions in part 507 of harvesting, holding,
manufacturing/processing, mixed-type facility, and packing. For a
discussion of comments and responses to these definitions in the
section 415 registration regulations and the section 414 recordkeeping
regulations, see section IV.C through IV.G of the final rule for
preventive controls for human food, published elsewhere in this issue
of the Federal Register.
D. Comments on Feed Mills Associated With Fully Vertically Integrated
Farming Operations
In the 2014 supplemental notice for animal food, we requested
comment on whether feed mills that are part of fully vertically
integrated farming operations, including cooperatives that fit this
model, that meet the farm definition should be required to register
under section 415 of the FD&C Act (and thus would be subject to the
rule). For comments that supported applying the final preventive
controls rule to feed mills that are part of fully vertically
integrated farming operations, we requested input on how the farm
definition should be modified. If they were required to register, we
also requested comment on whether there should be exemptions from
registration under section 415 based on size, such as number of animals
being fed or the amount of animal food being fed (based on tonnage,
monetary value, or some other factor). Lastly, since there would be no
total annual sales figure for the animal food produced by these feed
mills, we requested comment on how to value the animal food being fed
to animals for purposes of determining whether the feed mill would be a
qualified facility (proposed Sec. 507.7) and in particular a very
small business.
(Comment 11) Some comments generally agree with our recognition
that there are different types of farm models for raising animals but
request additional clarification on what we mean by a fully vertically
integrated farming operation and the depth of integration within an
operation.
(Response 11) Feed mills that are part of fully vertically
integrated farming operations, or certain cooperative farming
operations that meet the definition of a farm (see Sec. 1.227, as
revised by the final rule for preventive controls for human food
published elsewhere in this Federal Register), are not subject to this
final rule because they are not required to register under section 415
of the FD&C Act (see Sec. 507.5(a)). Because expanding on the
characteristics of a fully integrated farming operation is beyond the
scope of this rule, we decline to further clarify the fully vertically
integrated farming operation farming model discussed in the 2014
supplemental notice.
(Comment 12) Some comments do not support modifying the farm
definition to subject feed mills that are part of fully vertically
integrated farming operations to the requirements of this final rule.
These comments state that these feed mills are currently making safe
animal food and that some are following industry best practices that
would meet or exceed the requirements of our proposed CGMPs. Some
comments also state that these feed mills are producing a narrower
range of animal food when compared to independent feed mills because
these integrated feed mills typically provide animal food to a single
species and therefore utilize fewer ingredients, resulting in less
chance of harmful error. Some comments note that for large farming
operations, feeding of the animals is overseen by dedicated
individuals, such as a nutritionist, which ensures an extra layer of
oversight for the safety of animal food.
Some comments express concern that feed mills associated with
contract farming operations (contract feed mills) will be treated
differently because, as proposed in the 2013 proposed rule, they would
need to comply with the rule unlike the feed mills that are part of
fully vertically integrated farming operations. These comments
recommend modifications to the farm definition to incorporate the
contract feed mills into the farm definition, resulting in the contract
feed mills no longer being required to register under section 415 and
therefore no longer being subject to the requirements of this rule.
Some comments (including ones that support and ones that oppose
modifying the farm definition) generally agree there is no evidence
that the safety of animal food varies depending on whether a feed mill
is associated with vertically integrated or contract farming. These
comments also state that the farm definition as proposed has the
potential to create disparity in regulatory requirements that feed
mills must follow based solely on the type of farming model with which
they are associated (i.e., some will be subject to CGMP and preventive
controls requirements, while some will be subject to neither).
Some comments support modifying the farm definition to subject feed
mills that are part of fully vertically integrated farming operations
to the requirements of this final rule, and some of those comments also
support providing an exclusion if it is limited to small on-farm animal
food mixers. Other comments contend that some of the feed mills that
are part of fully vertically integrated farming operations produce
large volumes of animal food that feed a substantial portion of the
U.S. food-producing animal population and that these feed mills should
be subject to the final rule to ensure continual production of safe
animal food. Some comments state concern that the feed mills that are
part of fully vertically integrated farming operations could introduce
food safety hazards into the human food supply because they are not
being adequately controlled due to the feed mills' exemption from this
rule.
Comments that support modifying the farm definition to subject feed
mills that are part of fully vertically integrated farming operations
to the requirements of this final rule recommend that any exemption
from this final rule
[[Page 56185]]
applicable to farms be limited based on the volume of the animal feed
produced or animal equivalency units.
(Response 12) The farm definition in 21 CFR part 1 has been
modified based on other comments received to both the 2014 supplemental
notice for human food preventive controls and to the 2014 supplemental
notice for animal food preventive controls (see section IV.B of the
final rule for preventive controls for human food published elsewhere
in this issue of the Federal Register). However, feed mills that are
part of fully vertically integrated farming operations still meet the
definition of farm. As a result, they are not required to register as a
food facility under section 415 and are not subject to the requirements
of this rule including CGMPs (subpart B) and Hazard Analysis and Risk-
Based Preventive Controls (subpart C), and supply-chain program
(subpart E). We remain concerned that this leaves a gap in the
protection of public (human and animal) health because these feed mill
operations manufacture significant amounts of animal food. While some
of these feed mills may be voluntarily implementing some type of animal
food safety measures, not all feed mills that are part of vertically
integrated farming operations do. In addition, the voluntary measures
adopted by some feed mills may not meet the standards of the food
safety requirements in this rule. Moreover, we do not and cannot
enforce compliance with purely voluntary practices. Finally, we
recognize that other feed mills not part of a ``farm'' as defined in
part 1 will have to comply with the requirements of this rule (unless
they qualify for an exemption). As we have previously stated, we do not
have evidence that the safety of animal food varies depending on
whether a feed mill is part of vertically integrated or contract
farming. Therefore, we intend to publish a proposed rule that would
require some feed mill operations that currently are part of a farm to
comply with the CGMPs (subpart B) of this rule.
The animal food CGMP requirements help ensure that animal food is
protected from contamination during manufacturing, processing, packing,
and holding (see sections XIV to XXII for further discussion of the
animal food CGMP). By implementing these CGMPs, we believe that feed
mills not currently covered by this rule would be able to provide a
baseline level of animal food safety, thus further protecting the
public (human and animal) health. We will continue to review the
comments received from the 2014 supplemental proposed rule and other
available data in considering a proposed rule for feed mills that are
part of fully vertically integrated farming operations that are not
required to register under section 415, but produce a large volume of
animal food. One reason we are not finalizing new food safety
requirements for feed mills that are part of fully integrated farming
operations in this rulemaking is that we need more information to help
guide the scope of the requirements. As part of the future rulemaking
process we will seek input on the best way to subject vertically
integrated feed mills that produce large volumes of animal food to food
safety requirements while avoiding overburdening on-farm feed mixers
that produce a small amount of food for a small number of animals. The
proposed rulemaking would not change the applicability of subpart C,
``Hazard Analysis and Risk-Based Preventive Controls,'' for feed mills
that are part of a farm. Because farms meeting the definition of Sec.
1.227 are not required to register under section 415 of the FD&C Act,
Sec. 507.5(a) exempts them from compliance with subpart C, as required
by FSMA.
V. Comments on the Organizing Principles for How the Status of a Food
as a Raw Agricultural Commodity or as a Processed Food Affects the
Requirements Applicable to a Farm Under Sections 415 and 418 of the
FD&C Act
In the 2014 supplemental notice (79 FR 58476 at 58482), we referred
to the 2014 supplemental human preventive controls notice that
discussed comments on the organizing principles that formed the basis
for proposed revisions to section 415 registration regulations and the
section 414 recordkeeping regulations (79 FR 58524 at 58538). We also
explained how its proposed revisions to the ``farm'' definition would
require FDA to reconsider those organizing principles (79 FR 58524 at
58538).
For discussion of comments, see section V of the final rule for
preventive controls for human food, published elsewhere in this issue
of the Federal Register.
VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities
A. Section 103(c)(1)(C) of FSMA
We previously described provisions of FSMA that direct us to
conduct a science-based risk analysis to cover specific types of on-
farm packing, holding, and manufacturing/processing activities that
would be outside the ``farm'' definition and, thus, subject to the
requirements for hazard analysis and risk-based preventive controls
(see section 103(c)(1)(C)) of FSMA and 78 FR 64736 at 64751 and 64752
through 64754). Consistent with this statutory direction, we developed
the section 103(c)(1)(C) draft RA and made it available for public
comment (Ref. 11 and 78 FR 64428). We are including the final risk
assessment (the section 103(c)(1)(C) RA) in the docket established for
this document (Ref. 3).
We previously described provisions of FSMA that direct us to
consider the results of the science-based risk analysis and exempt
facilities that are small or very small businesses from the
requirements for hazard analysis and risk-based preventive controls (or
modify these requirements, as we determine appropriate), if such
facilities are engaged only in specific types of on-farm activities
that we determine to be low risk involving specific animal foods that
we determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR
64736 at 64751, 64753 through 64754, and 64763 through 64764). In
section X.F, we discuss the provisions we are establishing in Sec.
507.5(e) and (f), based on the results of the section 103(c)(1)(C) RA,
to exempt farm mixed-type facilities that are small or very small
businesses from requirements for hazard analysis and risk-based
preventive controls if the only activities that the business conducts
that are subject to those requirements are low-risk activity/animal
food combinations.
We also previously described provisions of FSMA that direct us to:
(1) Identify high risk-facilities and allocate resources to inspect
facilities according to the known safety risks of the facilities (as
determined by several factors) and immediately increase the frequency
of inspection of all facilities (see the discussion of section 421 of
the FD&C Act at 78 FR 64736 at 64754) and (2) consider a possible
exemption from or modification of requirements of section 421 of the
FD&C Act as we deem appropriate (see the discussion of section
103(c)(1)(D) of FSMA at 78 FR 64736 at 64744). We tentatively concluded
that we should not exempt or modify the frequency requirements under
section 421 based solely upon whether a facility only engages in low-
risk activity/animal food combinations and is a small or very small
business and requested comment on this tentative conclusion.
B. Comments on Qualitative Risk Assessment of On-Farm Activities
Outside of the Farm Definition
(Comment 13) Some comments address the qualitative nature of the
section 103(c)(1)(C) draft RA and assert
[[Page 56186]]
that it is based on professional judgment rather than data. These
comments ask us to update the section 103(c)(1)(C) draft RA when more
data become available. Some comments assert that we should not rely on
data from the Food Processing Sector Study (Ref. 12), but instead
collect data from large-scale surveys of actual farm mixed-type
facilities and their activities. Other comments ask us to collect,
analyze, and interpret data about the levels of hazards from animal
food samples taken from small and very small mixed-type facilities and
use consumption to estimate the likelihood of exposure to hazards in
animal food from such facilities. Some comments ask us to consult with
subject matter experts to ensure that the final risk assessment
reflects sufficient geographic diversity.
(Response 13) We have acknowledged the limitations of the section
103(c)(1)(C) draft RA (Ref. 11 and 78 FR 64428; see section I.F in that
document). Rather than limit public input to subject matter experts, we
requested comment from all interested persons, and received a number of
comments about activity/animal food combinations conducted on farms and
farm mixed-type facilities, including comments from diverse geographic
areas comprising both areas where farms and farm mixed-type facilities
tend to be small and where they tend to be large. We disagree that we
need to conduct large scale surveys, or enter into agreements with
agencies/organizations, to collect additional information in light of
the previous opportunity for broad public input regarding the activity/
animal food combinations conducted on farms and farm mixed-type
facilities.
(Comment 14) Some comments assert that we should revise the section
103(c)(1)(C) draft RA and then make it available for additional public
comment before finalizing the rule.
(Response 14) We subjected the section 103(c)(1)(C) draft RA to
peer review in accordance with the requirements of the Final
Information Quality Bulletin for Peer Review (issued by the Office of
Management and Budget to implement the Information Quality Act (Pub. L.
106-554)) before we made it available for broader public comment during
a time period that exceeded 10 months. The additional iterative process
recommended by these comments is not necessary and would go beyond the
processes we routinely apply for public input on a risk assessment.
C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-
Type Facilities Under Section 421 of the FD&C Act
1. Request for Comment on Data Submission Requirements
We requested comment on whether we should establish data submission
requirements that would allow us to identify types of facilities in
order to exempt them from the inspection frequencies, or modify the
inspection frequencies that apply to them, under section 421 of the
FD&C Act. We provided examples of such data elements, including
identification of a facility as a farm mixed-type facility, annual
monetary value of sales, number of employees, and animal food category/
activity type. We also requested comment on any other criteria that may
be appropriate for the purposes of allocating inspection resources to
these facilities.
Comments did not support these data submission requirements. We are
not establishing any data submission requirements that would allow us
to identify types of facilities in order to exempt them from the
inspection frequencies, or modify the inspection frequencies that apply
to them, under section 421 of the FD&C Act.
2. Request for Comment on an Exemption From the Requirements of Section
421 of the FD&C Act
We received no comments that disagreed with our tentative
conclusion that we should not exempt or modify the frequency
requirements under section 421 based solely upon whether a facility
only engages in low-risk activity/animal food combinations and is a
small or very small business. We are not establishing any exemption
from, or modification to, the frequency requirements under section 421
for facilities that only engage in low-risk activity/animal food
combinations and are a small or very small business.
VII. Subpart A: Comments on Proposed Sec. 507.1--Applicability and
Status
We proposed in Sec. 507.1 to establish the significance of this
part in determinations of whether animal food is adulterated. We also
proposed a provision relevant to FSMA's statutory provisions for a
prohibited act under section 301(uu) of the FD&C Act. We proposed that
animal food covered by specific CGMPs would also be subject to those
requirements. For facilities required to comply with CGMPs and
preventive controls for both the proposed preventive controls rule for
animal food and the proposed preventive controls rule for human food,
we proposed that the facility must comply with either rule for the
animal food, as long as the food safety plan addresses hazards unique
to animal food. Some comments support the proposed provisions without
change. Some comments that support the proposed provisions ask us to
clarify how we will interpret the provisions.
In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements, disagree with, or suggest one or
more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements along with
editorial and conforming changes as shown in table 31.
A. Comments on Proposed Sec. 507.1(a)--Applicability
We proposed that the criteria and definitions in part 507 apply in
determining whether a food is adulterated: (1) Within the meaning of
section 402(a)(3) of the FD&C Act in that the food has been
manufactured under such conditions that it is unfit for food; or (2)
Within the meaning of section 402(a)(4) of the FD&C Act in that the
food has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may
have been rendered injurious to health. We also proposed that the
criteria and definitions in part 507 also apply in determining whether
an animal food is in violation of section 361 of the PHS Act.
(Comment 15) Some comments note that FSMA granted FDA mandatory
recall authority for adulterated food. These comments express concern
that theoretically we could use a violation of the requirements for
hazard analysis and risk-based preventive controls to determine that
food is adulterated, thereby providing the basis for a mandatory recall
of that food. These comments raise three issues relevant to how we will
apply Sec. 507.1(a), with consequences for a potential mandatory
recall of food.
First, these comments note that the regulatory text stating that
the ``criteria and definitions'' apply in making a determination of
adulteration appears to encompass the entirety of the rule. As a
result, farms or facilities that violate any of the requirements in the
proposed rules, including components not directly related to the safety
of the food (such as recordkeeping requirements), could face a risk
that we would deem their food adulterated.
Second, these comments assert that the regulatory text suggests
that we
[[Page 56187]]
would not automatically consider a food adulterated as a result of a
violation of the proposed rule, because it states that the criteria and
definitions ``apply in determining'' whether a food will be considered
adulterated, rather than that the food ``is'' adulterated.
Third, these comments state that it is not clear how the exemption
applicable to qualified facilities is included in the ``criteria and
definitions'' used in making a determination of adulteration. These
comments ask us to clarify that we will not just automatically assume
that qualified facilities are selling adulterated food because they are
by definition exempt from the requirements for hazard analysis and
risk-based preventive controls.
(Response 15) The comments are correct that the criteria and
definitions ``apply in determining'' whether an animal food will be
considered adulterated, rather than that the animal food ``is''
adulterated. In determining whether an animal food that is
manufactured, processed, packed, or held in violation of part 507
(including a violation of the recordkeeping requirement) is
adulterated, we would consider the totality of the available data and
information about the violation and the animal food before reaching a
conclusion that the animal food is adulterated.
Although this rule does not address the mandatory recall provisions
of FSMA, the statutory provisions establish two basic criteria. (See
section 423(a) of the FD&C Act (21 U.S.C. 3501).) First, we must
determine that there is a ``reasonable probability'' that the animal
food is adulterated under section 402 of the FD&C Act. A violation of
part 507 would be relevant to determining whether an animal food is
adulterated under section 402 of the FD&C Act. Second, we must
determine that there is a reasonable possibility that the use of, or
exposure to, that animal food will cause serious adverse health
consequences or death to humans or animals. Not all animal food that is
adulterated has a reasonable probability of causing serious adverse
health consequences or death to humans or animals. For examples of
animal food contamination with a reasonable probability of causing
serious adverse health consequences or death to humans or animals, see
the annual reports of the Reportable Food Registry (RFR) (Refs. 13, 14,
15, and 16).
A facility that is exempt from any requirement of part 507,
including the requirements for hazard analysis and risk-based
preventive controls, would not be in violation of part 507 if it did
not comply with provisions that it is not subject to.
B. Comments on Proposed Sec. 507.1(b)--Prohibited Act
We proposed that the operation of a facility that manufactures,
processes, packs, or holds animal food for sale in the United States is
a prohibited act under section 301(uu) of the FD&C Act if the owner,
operator, or agent in charge of such facility is required to comply
with, and is not in compliance with, section 418 of the FD&C Act or
subparts C, D, or F of part 507 and Sec. 507.7 (proposed Sec.
507.1(b)).
(Comment 16) Some comments from State regulatory Agencies note that
this new provision is not covered under the applicable state statute
and that making any changes to the state statute can be a lengthy
process that takes up to 3 years to complete.
(Response 16) See Response 2 for a discussion of our approach to
working with our food safety partners in the States.
C. Comments on Proposed Sec. 507.1(c)--Specific CGMP Requirements
We proposed Sec. 507.1(c) would establish that animal food covered
by specific current good manufacturing practice regulations also be
subject to the requirement of those regulations. We received no
comments that disagreed with our proposal, and are finalizing the
proposed provision without change.
D. Comments on Proposed Sec. 507.1(d)--Human Food Facilities That
Manufacture Animal Food
We proposed in Sec. 507.1(d) that a facility that would be
required to comply with subpart B of part 507 and would be required to
comply with subpart B of proposed part 117 for human food, may choose
to comply with part 117 for the animal food. We also proposed that a
facility that would be required to comply with subpart C of part 507
and would be required to comply with subpart C of proposed part 117 for
human food, may choose to comply with part 117 for the animal food as
long as the food safety plan also addressed hazards that are reasonably
likely to occur in the animal food. We also proposed that when applying
the requirements of part 117 to animal food, the term ``food'' in part
117 would include animal food.
Based on comments received in the 2014 supplemental notice, we
proposed in Sec. 507.12 that human food by-products held by the human
food processor for distribution for use as animal food without
additional manufacturing/processing by the human food processor would
only need to comply with proposed Sec. 507.28 in part 507 and proposed
Sec. 117.95 in part 117 (79 58476 at 58487 to 58489). (See section
XIII for a discussion of comments received on proposed Sec. 507.12.)
We are finalizing the proposed provisions in 507.1(d) with the
exceptions in Sec. 507.12.
For further discussion of comments on applicability and status, see
section VIII in the final rule for preventive controls for human food
published elsewhere in this issue of the Federal Register.
VIII. Subpart A: Comments on Proposed Sec. 507.3--Definitions
We proposed definitions in the preventive controls rule for animal
food to be consistent with the proposed preventive controls rule for
human food with some minor differences and clarifications applicable to
animal food (e.g., adding ``animal'' before ``food''). Some comments
support one or more of these proposed definitions without change. For
example, some comments state that they support the proposed definitions
for ``microorganism'' and ``subsidiary'' with no suggested revisions.
Some comments support our proposal in the 2014 supplemental notice to
use the phrase ``chemical (including radiological)'' in the definition
of ``hazard,'' noting that doing so is consistent with FSMA, current
industry practice, and Codex and global HACCP standards. Some comments
that support a proposed definition suggest alternative or additional
regulatory text, such as adding examples to make the definition
clearer. Some comments that support a proposed definition ask us to
clarify how we will interpret the definition. Comments generally ask
that we maintain consistency of terms among the FSMA rules to avoid
confusion and ensure regulatory compliance.
We did not receive comment on the following terms and therefore,
are finalizing them as proposed: ``calendar day,'' ``FDA,'' ``pest,''
``water activity,'' and ``you.''
We removed some proposed definitions because the final rule does
not use them. The proposed definitions that are removed in this final
rule are ``batter,'' ``blanching,'' ``packaging,'' ``quality control
operation,'' ``safe moisture level,'' ``should,'' and ``significant
hazard.''
In the following sections, we discuss comments that ask us to
clarify proposed definitions or that disagree with, or suggest one or
more changes to, a proposed definition. After considering these
comments, we have revised the proposed requirements with editorial
[[Page 56188]]
and conforming changes as shown in table 31.
We also discuss definitions for additional terms (i.e., ``audit,''
``correction,'' ``full-time equivalent employee,'' ``hazard requiring a
preventive control,'' ``qualified facility exemption,'' ``raw
agricultural commodity,'' ``supply-chain-applied control,'' ``unexposed
packaged animal food,'' and ``written procedures for receiving raw
materials and other ingredients'') that we are establishing in the
final rule to simplify the regulatory text throughout the regulations
and improve clarity. We also discuss a new name (i.e., ``preventive
controls qualified individual'') for the definition of a term that we
had proposed to name ``qualified individual,'' and are establishing a
new definition for the term ``qualified individual.'' Finally, we also
discuss definitions that comments ask us to add, but that we did not
add, to the final rule.
A. Definitions We Proposed To Establish in Part 507
1. Adequate
We proposed to define the term ``adequate'' to mean that which is
needed to accomplish the intended purpose in keeping with good public
health practice.
(Comment 17) Some comments express concern that there is no
standard or definition for ``good public health practice'' and, for
animal food establishments, the term ``good public health practice''
creates more uncertainty than it removes. The comments request that we
remove from the definition the term ``good public health practice.''
Other comments ask us to develop guidance on thresholds and processes
that qualify as ``adequate.'' Other comments assert that the word
``adequate'' must be used in combination with the word ``reasonable''
to properly describe the intended measures and precautions.
(Response 17) We disagree that there is no standard for ``good
public health practice.'' However, we have revised the definition to
add after public ``(human and animal)'' to clarify it includes both.
Our intent in using the term ``adequate'' is to provide flexibility for
an animal food establishment to comply with the requirement in a way
that is most suitable for its establishment. We decline the request to
develop guidance to explicitly address ``thresholds'' or to describe
processes that qualify as adequate. The CGMPs and preventive controls
requirements established in this rule are broadly applicable procedures
and practices rather than very specific procedures and practices where
additional interpretation from FDA might be appropriate.
2. Affiliate and Subsidiary
We proposed to define the term ``affiliate'' to mean any facility
that controls, is controlled by, or is under common control with
another facility. We proposed to define the term ``subsidiary'' to mean
any company which is owned or controlled directly or indirectly by
another company. These proposed definitions would incorporate the
definition in section 418(l)(4)(A) and (D) of the FD&C Act and would
make the meanings of these terms clear when used in the proposed
definition of ``qualified facility.''
(Comment 18) Some comments ask us to clarify that a facility that
has no material connection with another food processing operation would
not be considered as an ``affiliate'' of that operation.
(Response 18) It is not clear what the comments mean by ``no
material connection with another food processing operation.'' To the
extent that a facility does not control, is not controlled by, or is
not under common control with another facility, we agree that the
facility would not be considered an affiliate of that food processing
operation.
(Comment 19) Some comments assert that the definitions of
``affiliate'' and ``subsidiary'' fail to account for the legal
differences between a piece of property (i.e., a facility) and a
business entity or person. These comments ask us to consider amending
the proposed definition of ``qualified facility'' to clarify what sales
to include in determining whether a facility so qualifies.
(Response 19) See Response 57.
3. Animal Food
We proposed to define the term ``animal food'' to mean food for
animals other than man that includes pet food, animal feed, and raw
materials and ingredients.
(Comment 20) Several comments voice concerns about including within
the definition of animal food the term ``raw materials.'' The main
concern is whether firms producing raw materials for animal food must
register and create animal food safety plans. The comments fear firms
would dispose of the raw material products due to the high cost of
developing and maintaining safety plans, and disposal of those raw
material products would have a significant economic impact due to a
considerable increase in the cost of animal food in the United States.
(Response 20) We decline to change the definition. We do not expect
that the inclusion of the term ``raw materials'' in the definition for
animal food will change current practices, noting that a facility
producing raw materials for animal food is already required to
register. The definition of ``animal food'' is intended to clarify that
the rule refers to ``food for animals'' and not ``food derived from
animals.''
4. Critical Control Point
We proposed to define the term ``critical control point'' (CCP) to
mean a point, step, or procedure in a food process at which control can
be applied and is essential to prevent or eliminate a food safety
hazard or reduce such hazard to an acceptable level.
(Comment 21) Some comments oppose the use of ``critical control
point'' in the rule because the term is confusing and not understood by
the relevant industry in the context of FSMA and the required
preventive controls. The comments suggest critical control point is a
HACCP term and not appropriate for use in this rule where the scope is
defined differently by the statute.
(Response 21) We decline to modify or remove the definition as
these comments request because we believe the term is helpful to
industry. The proposed definition matches the statutory definition in
section 418(o)(1) of the FD&C Act and is consistent with definitions in
the Federal HACCP regulations for seafood, juice, and meat and poultry
(parts 123 and 120 (21 CFR part 123 and 120) and 9 CFR part 417
respectively). By specifying that a point, step, or procedure in an
animal food safety process would reduce a hazard to an ``acceptable
level,'' the definition provides flexibility for a facility to
determine an appropriate level in a particular circumstance.
(Comment 22) Some comments request that we define the term
``control point.'' The comments suggest defining this term as a point,
step, or procedure in the production of an animal food at which a
control may be applied.
(Response 22) We decline this request. We define ``critical control
point'' as a point, step, or procedure in a food process at which
control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce such hazard to an acceptable level. Also,
``control point'' is not a term used in the regulatory text of the rule
and therefore does not need to be defined.
5. Environmental Pathogen
We proposed to define the term ``environmental pathogen'' to mean a
[[Page 56189]]
pathogen capable of surviving and persisting within the manufacturing,
processing, packing, or holding environment such that food for animals
may be contaminated and may result in foodborne illness if that animal
food is not treated to significantly minimize or prevent the
environmental pathogen. We also proposed to specify that environmental
pathogen does not include the spores of pathogenic sporeformers. By
``pathogenic sporeformers,'' we mean ``pathogenic sporeforming
bacteria,'' and we are substituting the term ``pathogenic sporeforming
bacteria'' for ``pathogenic sporeformers'' in the definition of
``environmental pathogen'' to make that clearer.
(Comment 23) Some comments ask us to include Salmonella spp. and
Listeria monocytogenes in the regulatory text as examples of
environmental pathogens. Other comments believe the definition is too
broad because it would include any pathogen that is capable of
surviving or persisting in the environment, and the definition should
be limited to the pathogenic bacteria that are more appropriate for
protecting animal food safety.
(Response 23) We agree that Salmonella spp. and L. monocytogenes
are useful examples of environmental pathogens and have added these two
examples to the proposed definition, which had not included examples.
Adding these two examples to the definition does not mean that these
two pathogens are the only environmental pathogens that a facility must
consider in its hazard analysis. New environmental pathogens can emerge
at any time, and other pathogens can also be environmental pathogens.
Salmonella spp in pet food have been involved in foodborne illness
outbreaks in humans (78 FR 64736 at 64747). In addition, there have
been recalls of pet food found to contain L. monocytogenes, though no
human or animal illnesses were associated with these recalls to date
(Refs. 17 and 18).
(Comment 24) Some comments ask us to clarify the meaning of the
term ``persisting'' as used in the definition, such as whether it means
that a sanitation process will not remove the microorganism.
(Response 24) We use the term ``persisting'' to mean that a
pathogen can get established if cleaning is not adequate. Once a
pathogen gets established, appropriate sanitation measures can remove
the pathogen. However, sanitation procedures necessary to eliminate an
environmental pathogen that has become established generally are more
aggressive than routine sanitation procedures.
6. Facility
We proposed to define the term ``facility'' to mean a domestic
facility or a foreign facility that is required to register under
section 415 of the FD&C Act in accordance with the requirements of part
1, subpart H. Comments directed to the meaning of the term ``facility''
address its meaning as established in the section 415 registration
regulations, rather than this definition established in part 507.
For a discussion of comments on definitions in part 1, see section
IV of the final rule for preventive controls for human food published
elsewhere in this issue of the Federal Register.
7. Farm
We proposed to define the term ``farm'' by reference to the
definition of that term in Sec. 1.227(b) rather than by repeating the
full text of the ``farm'' definition in part 507. For a discussion of
comments to the farm definition and of the ``farm'' definition that we
are establishing in Sec. 1.227, see section IV of the final rule for
preventive controls for human food published elsewhere in this issue of
the Federal Register.
8. Food
We proposed to define the term ``food'' to mean food as defined in
section 201(f) of the FD&C Act and to include raw materials and
ingredients. Under section 201(f), the term ``food'' means: (1)
Articles used for food or drink for man or other animals, (2) chewing
gum, and (3) articles used for components of any such article.
(Comment 25) Some comments ask us to include examples in the
definition. These comments also ask us to clarify whether the
definition applies to food for human consumption, animal consumption,
or both.
(Response 25) We decline the request to include examples in the
definition. There are many examples of food and adding a limited list
of examples could be confusing rather than helpful. Although the
definition of food includes food for both human consumption and animal
consumption, the provisions of the rule are clearly directed to food
for animal consumption.
(Comment 26) Some comments ask us to consider fundamental and
important differences between food additives and GRAS substances and
finished food. These comments explain that food additives and GRAS
substances may be synthesized using various chemical and biochemical
processes, or may be extracted, hydrolyzed or otherwise modified from
their natural sources, and result in food safety hazards that are quite
different from finished food preparations. These comments also explain
that food additives and GRAS substances are often produced using
processes that minimize microbial contamination hazards and are almost
always used in food products that undergo further downstream
processing. These comments assert that food additives and GRAS
substances generally present a significantly lower public health hazard
compared to finished food and should be regulated accordingly.
(Response 26) Substances such as food additives and GRAS substances
are food and are subject to the requirements of this rule. Both the
CGMP requirements in subpart B and the requirements for hazard analysis
and risk-based preventive controls in subparts C and E provide
flexibility to address all types of food. (As discussed in section XL,
the final rule establishes the requirements for a supply-chain program
in subpart E, rather than within subpart C as proposed. As a result,
this document refers to subparts C and E when broadly referring to the
requirements for preventive controls.) A manufacturer of a food
additive or GRAS substance has flexibility to comply with the
requirements of the rule based on the nature of the production
processes and the outcome of the hazard analysis for that animal food
substance.
9. Food-Contact Surfaces
We proposed to define ``food-contact surfaces'' to mean those
surfaces that contact animal food and those surfaces from which
drainage, or other transfer, onto the food or onto surfaces that
contact the food ordinarily occurs during the normal course of
operations. ``Food-contact surfaces'' include food-contact surfaces of
utensils and equipment.
(Comment 27) Several comments state that the terms ``drainage'' and
``utensils'' are not widely used or understood within animal feed and
pet food industry and that the definition for ``food-contact surfaces''
should be revised by deleting ``drainage, or other,'' and by replacing
``utensils'' with ``tools.''
(Response 27) We decline these requests. See our discussion of the
term ``utensils'' in Response 169. We believe the term ``drainage'' is
commonly understood.
10. Harvesting
We proposed to define the term ``harvesting'' to apply to farms and
farm
[[Page 56190]]
mixed-type facilities and to mean activities that are traditionally
performed by farms for the purpose of removing RACs from the place they
were grown or raised and preparing them for use as food. We proposed
that harvesting be limited to activities performed on RACs on a farm,
and that harvesting does not include activities that transform a RAC
into a processed food. The proposed definition included examples of
activities that would be harvesting.
In this final rule, we added or modified several examples of
harvesting (see Response 28). As noted in table 31, we have reorganized
the listed examples of harvesting to present them in alphabetical
order.
We are defining the term ``harvesting'' to apply to farms and farm
mixed-type facilities and to mean activities that are traditionally
performed on farms for the purpose of removing RACs from the place they
were grown or raised and preparing them for use as animal food. The
definition includes examples of activities that are harvesting, as
described in this section. Harvesting is also limited to activities
performed on RACs, or on processed foods created by drying/dehydrating
a RAC without additional manufacturing/processing, on a farm.
(Comment 28) Some comments ask us to provide more examples of
harvesting activities, in the regulatory text and in guidance. Examples
of the requested activities include braiding; bunching; cutting the
edible portion of the crop from the plant; hydro-cooling; maintaining
hydration of product; refrigerating; removing foliage; removing free
water from (e.g. spinning); removing or trimming roots; trimming the
tops of bunches of allium crops such as leeks, chives, or garlic and
root crops such as carrots, beets, turnips, parsnips, etc. to prepare
them for sale; and trimming the lower stems of harvested herb crops
such as parsley, basil, or cilantro, or the lower stems of leafy
greens. Other comments ask us to specify that harvesting also
encompasses seed conditioning (i.e., cleaning the seed, including
removal of leaves, stems, and husks to prepare for marketing), ripening
(artificial or natural) of fruit, and waxing or coating of RACs.
(Response 28) We have added or modified several examples of
harvesting in the regulatory text (i.e., cutting (or otherwise
separating) the edible portion of the RAC from the crop plant, removing
or trimming part of the RAC (e.g., foliage, husks, roots or stems) and
field coring and hulling). In table 1 in the Appendix to the 2014
supplemental notice (79 FR 58476 at 58520 through 58521), we provided a
more extensive list of examples of harvesting activities, including
examples that are not in the regulatory text. We have classified some
of these activities in more than one way (see 79 FR 58476 at 58520
through 58521). For example, trimming of outer leaves from RACs can be
a harvesting activity, as well as a manufacturing/processing activity.
Artificial ripening of fruit is manufacturing/processing (not
harvesting), but is now within the ``farm'' definition.
(Comment 29) Some comments ask us to periodically review the list
of harvesting activities to ensure that it reflects current practices.
(Response 29) If particular activities present questions in the
future about whether the activity is a harvesting activity within the
``farm'' definition, or a manufacturing/processing activity that is
outside the ``farm'' definition, we will consider issuing guidance or
updating any existing guidance to clarify our recommended
classification of the activity.
(Comment 30) Some comments note that the proposed definition for
``harvesting'' seems to be much more inclusive than FDA's original
proposed regulation, but is significantly more restrictive than the
current regulation in part 1 because it excludes future technological
developments. The comment further notes as technology and harvesting
techniques advance, the risk of tying the definition to traditional
activities will have a negative effect on agriculture's ability to
adapt. Furthermore, harvesting is merely the first step in transforming
a RAC into processed food.
(Response 30) The comment did not make a specific request or
provide any suggestions as to how future technological developments
should be handled; therefore, we are finalizing the definition with the
changes previously described.
11. Hazard
We proposed to define the term ``hazard'' to mean any biological,
chemical (including radiological), or physical agent that is reasonably
likely to cause illness or injury in humans or animals in the absence
of its control.
(Comment 31) Some comments express concern that the rule would
refer to four levels of ``hazard,'' i.e., ``hazard,'' ``known or
reasonably foreseeable hazard,'' ``significant hazard,'' and ``serious
adverse health consequences or death to humans or animals'' hazard.
These comments ask us to provide sufficient clarity to be able to
distinguish between these types of hazards and to provide examples in
guidance as to how these terms will be applied in determining
compliance with the rule. Other comments express concern that the
definitions do not establish a meaningful distinction between
``hazard'' and ``significant hazards'' and do not sufficiently
distinguish between the hazards identified in the first and second
steps of the hazard analysis (first narrowing hazards to ``known or
reasonably foreseeable hazards'' and then narrowing the ``known or
reasonably foreseeable hazards'' to ``significant hazards'').
(Response 31) The rule uses three of these terms (i.e., ``hazard,''
``known or reasonably foreseeable hazard,'' and the proposed term
``significant hazard'') to establish a tiered approach to the
requirements for hazard analysis and risk-based preventive controls.
The term ``hazard'' is the broadest of these three terms--any
biological, chemical (including radiological), or physical agent has
the potential to cause illness or injury. To conduct its hazard
analysis, a facility starts by first narrowing down the universe of all
potential hazards to those that are ``known or reasonably foreseeable''
for each type of food for animals manufactured, processed, packed, or
held at its facility. The outcome of the facility's hazard analysis is
a determination of ``significant hazards,'' i.e., the subset of those
known or reasonably foreseeable hazards that require a preventive
control.
To make this clearer, we have: (1) Revised the proposed definitions
of ``hazard'' and (2) changed the term ``significant hazard'' to
``hazard requiring a preventive control'' (formerly ``significant
hazard''). See Responses 32 and 62.
The rule does not define the term ``serious adverse health
consequences or death to humans or animals'' hazard. However, the
requirements for a supply-chain program refer to a hazard for which
there is a reasonable probability that exposure to the hazard will
result in serious adverse health consequences or death to humans or
animals (see Sec. 507.130(b)). For additional information on how we
interpret ``serious adverse health consequences or death to humans or
animals,'' see our guidance regarding the RFR (Refs. 19 and 20), which
addresses statutory requirements regarding ``reportable foods.'' As
explained in that guidance, a ``reportable food'' is an article of food
for which there is a reasonable probability that the use of, or
exposure to, such article of food will cause serious adverse health
consequences or
[[Page 56191]]
death to humans or animals. The guidance includes examples of
circumstances under which food might be reportable.
(Comment 32) Some comments assert that the distinction between the
definitions of ``hazard'' and ``significant hazard'' is not discernable
because the proposed definition of ``hazard'' currently takes into
account whether or not a ``hazard'' is or is not controlled. These
comments ask us to delete the phrase ``in the absence of its control''
from the definition of ``hazard'' to clarify that hazards are simply
the agents that are reasonably likely to cause illness or injury.
Likewise, other comments assert that any hazard that is ``reasonably
likely to cause illness or injury in the absence of its control'' will,
if known or reasonably foreseeable, likely be controlled by any
knowledgeable person.
(Response 32) We have deleted the phrase ``in the absence of its
control'' from the definition of ``hazard.'' We agree that deleting
this phrase from the definition of ``hazard'' will more clearly
distinguish between the terms ``hazard'' and ``hazard requiring a
preventive control'' that we are establishing in this rule.
We also replaced the phrase ``that is reasonably likely to cause
illness or injury'' with ``that has the potential to cause illness or
injury'' to more clearly distinguish ``hazard'' from ``known or
reasonably foreseeable hazard.'' This increases the alignment of the
definition of ``hazard'' in this rule with the Codex definition of
``hazard.''
(Comment 33) Some comments ask us to include ``in the intended
species'' in the definition of ``hazard.''
(Response 33) We decline this request. During the hazard analysis
the facility must identify and evaluate, based on experience, illness
data, scientific reports, and other information, known or reasonably
foreseeable hazards for each type of animal food manufactured,
processed, packed, or held at the facility to determine whether there
are hazards requiring a preventive control (Sec. 507.33(a)). During
the hazard evaluation, the facility must consider the effect of the
intended or reasonably foreseeable use on the safety of the finished
animal food for the intended animal (Sec. 507.33(d)(8)).
12. Holding
We proposed to define ``holding'' to mean storage of food,
including activities performed incidental to storage of a food (e.g.,
activities performed for the safe or effective storage of that food and
activities performed as a practical necessity for the distribution of
that food (such as blending of the same RAC and breaking down
pallets)), but not including activities that transform a RAC into a
processed food. We proposed that holding facilities could include
warehouses, cold-storage facilities, storage silos, grain elevators,
and liquid-storage tanks.
(Comment 34) Some comments ask us to provide more examples of
holding activities, in the regulatory text and in guidance. Examples of
the requested activities include fumigating RACs; application of
chemicals (including fungicides, sanitizers, and anti-oxidants); and
``coating'' grain RACs with diatomaceous earth to control insects.
According to these comments, these activities are incidental to storage
and do not transform RACs into processed food. Other comments wanted
examples of holding of human-food by-products destined for animal food
(for example wet pasta that dries naturally while being held).
(Response 34) We have added or modified several examples of holding
in the regulatory text (i.e., fumigating animal food during storage,
and drying/dehydrating RACs when the drying/dehydrating does not create
a distinct commodity (such as drying/dehydrating hay or alfalfa)). In
table 1 in the Appendix to the 2014 supplemental notice (79 FR 58476 at
58520 through 58521), we provided a more extensive list of examples of
holding activities, including examples that are not in the regulatory
text. We have previously classified some of these activities in more
than one way (see 79 FR 58476 at 58520 through 58521) depending on when
the activity occurs. For example, sorting, culling, and grading RACs
can be either a holding activity or a packing activity. Drying/
dehydrating RACs is holding when the drying/dehydrating does not create
a distinct commodity, but is manufacturing/processing when the drying/
dehydrating creates a distinct commodity (see section IV). Holding of
certain human food by-products for use as animal food is discussed in
sections XIII and XXII.
(Comment 35) Some comments ask us to clarify that mixing or
blending intact RACs is considered ``holding'' regardless of whether
the RACs are the same or different.
(Response 35) We use the term ``blending'' when referring to RACs
such as grain and when the RACs are the same. For example, we consider
the activity of ``blending'' different lots of the same grain to meet a
customer's quality specifications to be a practical necessity for
product distribution and, thus, to be within the definition of
``holding'' (see 79 FR 58476 at 58483). However, we use the term
``mixing'' when the RACs are different. For example, we consider the
activity of ``mixing'' corn and oats in the production of animal food
to be manufacturing/processing, because mixing two different foods is
``making food from one or more ingredients'' (which is our definition
of ``manufacturing/processing'') and the animal food produced by mixing
corn and oats is a processed food.
We classify ``mixing'' intact RACs that does not create a processed
animal food as incidental to, and therefore part of, ``packing'' or
``holding'' as applicable. For example, mixing heads or bunches of
lettuce does not create a processed food, because the mixing has not
created a distinct commodity, but only a set of mixed RACs. On the
other hand, mixing that creates a processed animal food is not
``packing'' or ``holding.'' The definitions of both ``packing'' and
``holding'' are limited so that they do not include activities that
transform a RAC into processed animal food. Some kinds of mixing of
RACs does create a distinct commodity (for example, mixing corn and
oats to make animal food). In such cases, the mixing is manufacturing/
processing and is not within the farm definition.
(Comment 36) Some comments ask us to clarify whether the expanded
definition of holding that we proposed in the 2014 supplemental human
preventive controls notice would mean that a warehouse that both stores
and fumigates a RAC to prevent pest infestation would be exempt from
the requirements for hazard analysis and risk-based preventive controls
for a facility solely engaged in the storage of RACs (other than fruits
and vegetables) for further distribution or processing (Sec. 507.5).
(Response 36) Fumigating RACs to prevent pest infestation would be
within the definition of ``holding'' and therefore would not prevent a
facility that stores RACs (other than fruits and vegetables) from being
eligible for the exemption in Sec. 507.5(g), provided that the
facility does not conduct other activities not classified as
``holding.'' However, a threshold question for any facility solely
engaged in the storage of RACs is whether the stored RACs are fruits or
vegetables.
(Comment 37) Some comments ask us to clarify whether there is a
timeframe associated with holding and to better distinguish between
``holding'' and ``storage.''
(Response 37) There is no timeframe (maximum or minimum) associated
with holding. The definition of holding
[[Page 56192]]
states ``Holding means storage of food'' and, thus, there is no
distinction between ``holding'' and ``storing.''
(Comment 38) Some comments ask us to clarify how the definition of
holding relates to practices, such as fumigation, on almond hull
stockpiles held on a farm, a farm mixed-type facility or off-farm.
(Response 38) Practices that are incidental to storage of food,
such as fumigation of almond hull stockpiles, are holding, regardless
of whether they are conducted on-farm, on a farm mixed-type facility,
or off-farm.
(Comment 39) Some comments ask us to clarify that value added
activities (such as repacking and blast freezing) conducted in
facilities such as warehouses would be considered holding when product
is not exposed to the environment.
(Response 39) We consider the activities described in these
comments to be activities performed as a practical necessity for the
distribution of the food and, thus, to be within the definition of
holding.
(Comment 40) Several comments do not support the proposed
definition of ``holding'' stating that the definition would exempt
grain receiving and storage facilities that are the primary suppliers
of the main ingredient in many animal foods including distiller's
products. Some comments ask us to clarify what is a practical
necessity.
(Response 40) Section 418(m) of the FD&C Act provides us with the
authority to exempt certain facilities from the requirements of section
418, or to modify those requirements. We proposed to use this authority
to exempt facilities that solely engage in the storage (holding) of
RACs (other than fruits and vegetables) intended for further
distribution or processing. We tentatively concluded that there would
not be significant public (human and animal) health benefit to be
gained by having these facilities subject to the requirements of
subpart C. Outbreaks of illness associated with feeding RACs to animals
have not been traced back to storage facilities solely engaged in the
storage of RACs, therefore we think it is appropriate to exempt them
from the requirements of subparts C and E of the final rule. Such
facilities remain subject to the requirements of section 402 of the
FD&C Act that the animal food being held is not adulterated.
The revised definition of ``holding'' encompasses activities
performed as a practical necessity for the distribution of RACs, such
as blending of the same RAC and breaking down pallets. Sampling for
grading or quality control purposes, repacking, and drying grains and
oilseeds would also be considered performed as a practical necessity
for the distribution of animal food within the definition of
``holding.''
13. Known or Reasonably Foreseeable Hazard
We proposed to define the term ``known or reasonably foreseeable
hazard'' to mean a biological, chemical (including radiological), or
physical hazard that has the potential to be associated with the
facility or the food.
(Comment 41) Some comments support the definition as proposed,
noting that it implies that the implementation of a preventive control
be based both on the severity and likelihood of the hazard, can help to
distinguish between the requirements of this rule and HACCP
requirements, and provides for the proper consideration of both the
food and the facility when determining whether a hazard is ``known or
reasonably foreseeable.'' Other comments ask us to modify the
definition to specify that the term means a hazard ``that is known to
be, or has the potential to be, associated with the facility or the
food'' to better align with the term as FDA proposed to define it in
the proposed FSVP rule. (See 79 FR 58574 at 58595.)
(Response 41) We have revised the definition as requested by the
comments to better align with the proposed FSVP rule.
(Comment 42) Some comments ask us to revise the definition so that
it addresses a hazard that is known to be, or has the potential to be,
associated with a food, the facility in which it is manufactured/
processed, or the location or type of farm on which it is grown or
raised. These comments assert that the type of farm may affect those
hazards that are known or reasonably foreseeable.
(Response 42) We decline this request, which appears related to
another difference between the definition proposed in this rule and the
definition of this term in the proposed FSVP rule. The proposed FSVP
rule would define ``known or reasonably foreseeable hazard'' as a
hazard that is known to be, or has the potential to be, associated with
a food or the facility ``in which it is manufactured/processed.'' (See
79 FR 58574 at 58595.) In this rule, we do not need to specify that the
applicable facility is the one ``in which the food is manufactured/
processed'' because this rule applies to the owner, operator, or agent
in charge of the facility in which the food is manufactured, processed,
packed, or held, and that applicability does not need to be repeated in
each provision. To the extent that this comment is expressing concern
about raw materials or other ingredients that a facility would receive
from a farm, those concerns would be considered in the facility's
hazard analysis, which would include a hazard evaluation that considers
factors such as those related to the source of raw materials and other
ingredients (see Sec. 507.33(d)(3)).
14. Lot
We proposed to define ``lot'' to mean the food produced during a
period of time indicated by a specific code.
(Comment 43) Some comments state that many animal food processors
operate on a batch-production basis rather than a continuous-production
basis and request that we take this into account with respect to the
definition of ``lot.'' Other comments suggest replacing ``lot'' with
``lot identifier'' where ``lot identifier'' means a unique identifier
for each lot, batch or production run that enables the manufacturer to
trace accurately the complete manufacturing and distribution history of
the product. Other comments ask us to modify the proposed definition so
that it is not limited by a period of time and suggest using an
approach that would allow for a lot to be defined by either time or by
a specific identifier. Other comments express the view that the
individual operators should be able to define their lot designations
and make these definitions available to FDA upon request.
(Response 43) Although the term ``lot'' is associated with a period
of time, an establishment has flexibility to determine the code, with
or without any indication of time in the code. For example, a code
could be based on a date, time of day, production characteristic (such
as origin, variety, and type of packing), combination of date/time/
production characteristic, or any other method that works best for the
establishment. To clarify that the rule does not require that time be
``indicated'' by the code, and emphasize the establishment's
flexibility to determine the code, we have revised ``period of time
indicated by a specific code'' to ``period of time and identified by an
establishment's specific code.''
15. Manufacturing/Processing
We proposed to define ``manufacturing/processing'' to mean making
food from one or more ingredients, or synthesizing, preparing,
treating, modifying, or manipulating food, including food crops or
ingredients. We proposed that examples of manufacturing/processing
activities would be cutting, peeling, trimming,
[[Page 56193]]
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging. For farms and farm mixed-type facilities, manufacturing/
processing would not include activities that are part of harvesting,
packing, or holding. In this rule, we add more examples to include,
``artificial ripening,'' ``boiling,'' ``canning,'' ``drying/dehydrating
raw agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins),'' ``evaporating,''
``extruding,'' and ``pelleting.'' We also alphabetize the list of
examples.
(Comment 44) Some comments express concern that some activities
included in the definition of ``manufacturing/processing'' overlap with
activities (such as trimming, washing, and cooling) included in the
definition of ``harvesting.''
(Response 44) We acknowledge that there is some overlap in the
activities that the regulatory text lists as examples of both
``manufacturing/processing'' and ``harvesting,'' because some
activities can occur during more than one operation (see table 1 in the
Appendix to the 2014 supplemental notice (79 FR 58476 at 58520 through
58521)). For example, ``cutting'' lettuce from the crop plant occurs
on-farm in the field where the lettuce is harvested, and ``cutting''
the core of the lettuce from the rest of the harvested lettuce occurs
in a fresh-cut processing facility. An important consequence of the
multiple revisions we have made to the ``farm'' definition in this
rulemaking is that there are fewer situations in which classification
of a particular activity is the only trigger for an operation to be
subject to the section 415 registration requirements. For example, the
revised ``farm'' definition no longer classifies the packing and
holding of others' RACs to be a manufacturing/processing activity that
triggers the registration requirement. As another example, the revised
``farm'' definition specifies three manufacturing/processing activities
that are within the ``farm'' definition. We conclude that the overlap
in the examples of activities listed in the definitions of
``harvesting'' and ``manufacturing/processing'' does not create
problems with determining the status of an operation as a ``farm'' or a
``facility'' and we are retaining examples in both definitions because
doing so reflects current practices on farms and in manufacturing/
processing facilities.
16. Microorganisms
We proposed to define the term ``microorganisms'' to mean yeasts,
molds, bacteria, viruses, protozoa, and microscopic parasites,
including species having animal or human health significance. We also
proposed that the term ``undesirable microorganisms'' includes those
microorganisms that are of animal or human health significance, that
subject food to decomposition, that indicate that food is contaminated
with filth, or that otherwise may cause food to be adulterated. We have
revised the definition to replace ``includes species having animal or
human health significance'' with ``and includes species that are
pathogens,'' and replacing ``'undesirable microorganisms''' includes
those microorganisms that are of animal or human health significance''
with ``'undesirable microorganisms''' includes those microorganisms
that are pathogens.''
(Comment 45) Some comments express concern that the term
``undesirable microorganisms'' includes microorganisms that subject
food to decomposition. These comments assert that the definition would
expand regulation beyond food safety and ask us to clarify that
decomposition means a degradation of product that is only relevant when
it affects the safety of the product, rather than simple spoilage.
(Response 45) We have not modified the regulatory text of this
longstanding definition of the term ``undesirable microorganisms''
regarding microorganisms that subject food to decomposition. The
regulations established by this rule are designed to prevent the growth
of undesirable microorganisms. The scope of the definition of
``undesirable microorganisms'' is not limited to microorganisms of
public health significance because these regulations are also concerned
with sanitation, decomposition, and filth (51 FR 22458 at 22460, June
19, 1986).
17. Mixed-Type Facility
We proposed to define ``mixed-type facility'' to mean an
establishment that engages in both activities that are exempt from
registration under section 415 of the FD&C Act and activities that
require the establishment to be registered. We proposed that an example
of such a facility is a ``farm mixed-type facility,'' which is an
establishment that grows and harvests crops or raises animals and may
conduct other activities within the farm definition, but also conducts
activities that require the establishment to be registered. As a
conforming change associated with the revisions to the ``farm''
definition, we have revised the example of a ``farm mixed-type
facility'' to specify that it is an establishment that is a farm, but
also conducts activities outside the farm definition that require the
establishment to be registered. (See section IV of the final rule for
preventive controls for human food published elsewhere in this addition
of the Federal Register.)
(Comment 46) Some comments ask us to revise the definition to
exclude those establishments that only conduct low-risk activities
specified in the exemptions for on-farm, low-risk activity/animal food
combinations (Sec. 507.5(e) and (f)).
(Response 46) We decline this request. Whether a particular
establishment that falls within the definition of ``mixed-type
facility'' is subject to the requirements for hazard analysis and risk
based preventive controls is governed by the exemptions established in
this rule.
18. Monitor
We proposed to define the term ``monitor'' to mean to conduct a
planned sequence of observations or measurements to assess whether a
process, point, or procedure is under control and to produce an
accurate record for use in verification.
(Comment 47) Some comments assert that our proposed definition of
monitor is directed to the narrow circumstance of monitoring that would
be applied to a CCP under the National Advisory Committee on
Microbiological Criteria for Foods (advisory committee chartered under
the USDA) (NACMCF) HACCP guidelines and the Codex HACCP Annex. These
comments also assert that, using such definitions, monitoring would not
apply to control measures for which parameters cannot be established
and that are not amenable to documentation. These comments suggest that
we use a definition of monitoring consistent with that provided in ISO
22000:2005 (conducting a planned sequence of observations or
measurements to assess whether control measures are operating as
intended) to clarify that monitoring may be conducted where appropriate
for preventive controls that are not CCPs. (ISO is an abbreviation for
``International Organization for Standardization.'' ISO develops and
publishes International Standards.) According to these comments, an
advantage of this definition is that it also would clarify the
difference between monitoring activities (observations conducted during
the
[[Page 56194]]
operation of a control measure to ensure that it is under control) and
verification activities (to evaluate performance of a control measure).
(Response 47) We have revised the definition of monitor to mean to
conduct a planned sequence of observations or measurements to assess
whether control measures are operating as intended. We agree that the
revised definition, which reflects an international standard, more
effectively communicates that monitoring also applies to controls that
are not at CCPs and may apply to control measures for which parameters
cannot be established. However, we disagree that this definition
signals that it is not possible to obtain documentation when monitoring
preventive controls that are not at CCPs, such as for controls that are
not process controls and do not involve parameters and maximum or
minimum values, or combinations of values, to which a parameter must be
controlled to significantly minimize or prevent a hazard requiring a
preventive control. For example, it is possible to monitor that a
specific sanitation control activity has taken place, such as the
cleaning of a piece of equipment to prevent cross-contact.
The requirement for documenting monitoring in records is
established by the requirements for monitoring, not by the definition
of monitor. As discussed in section XXX.C, we have made several
revisions to the regulatory text, with associated editorial changes, to
clarify that monitoring records may not always be necessary.
19. Packaging (When Used as a Verb)
We proposed to define ``packaging (when used as a verb)'' as
placing food into a container that directly contacts the food and that
the consumer receives.
Based on comments received to the proposed rule for preventive
controls for human food, we have decided not to establish the
definition ``packaging (when used as a verb)'' in part 507. For a
discussion of those comments received to the human food preventive
controls rule, see section IX.C.20 in the final rule for preventive
controls for human food published elsewhere in this issue of the
Federal Register.
20. Packing
We proposed to define ``packing'' as placing food into a container
other than packaging the food, including activities performed
incidental to packing a food (e.g., activities performed for the safe
or effective packing of that food (such as sorting, culling and
grading)), but not including activities that transform a raw
agricultural commodity, as defined in section 201(r) of the FD&C Act,
into a processed food as defined in section 201(gg). We have revised
the definition to clarify that packing includes ``re-packing.''
For comments on the definition of ``packing,'' see section IV.G of
the final rule for preventive controls for human food, published
elsewhere in this addition of the Federal Register.
We are finalizing the definition as proposed, with the addition of
another example of an activity performed for the safe or effective
packing of the food, i.e., weighing or conveying incidental to packing
or repacking, and the addition of ``animal'' in front of food.
21. Pathogen
We proposed to define the term ``pathogen'' to mean a microorganism
of public (human or animal) health significance.
(Comment 48) Some comments ask us to revise the definition to mean
a ``microorganism of such severity and exposure that it would be deemed
of public health significance'' because the significance of pathogens
to public health depends on the organism's severity and the nature of
exposure.
(Response 48) We decline this request. Our purpose in defining the
term pathogen was to simplify the regulations, including our
longstanding CGMP regulations for human food, by substituting a single
term (i.e., ``pathogen'') for a more complex term (i.e.,
``microorganism of public health (human and animal) significance'')
throughout the regulations. These comments fail to explain how we have
interpreted the current term ``microorganism of public health
significance'' in a way that does not take into account factors such as
the severity of illness and the route of exposure.
22. Plant
We proposed to define the term ``plant'' to mean the building or
establishment or parts thereof, used for or in connection with the
manufacturing, processing, packing, or holding of animal food.
(Comment 49) Some comments state that it would not be helpful to
use ``plant'' interchangeably with ``establishment'' when referring to
a business that is not required to register. These comments ask us to
consistently use one of these terms and to define a term that would
mean ``a business that is not required to register'' to help
distinguish such businesses from ``facilities.''
(Response 49) We agree that it is appropriate to consistently use
one term when referring to a business entity. However, we disagree that
it is necessary to establish a definition for a business entity that is
not required to register. A business that meets the definition of
``facility'' is required to register; a business that is not required
to register is simply a business that does not meet the definition of
``facility.''
To address these comments, we have revised provisions of the rule
in three ways. First, we have revised the definition of ``plant'' to
focus it on the building, structure, or parts thereof, used for or in
connection with the manufacturing, processing, packing, or holding of
animal food, rather than on the ``building or establishment.'' Second,
we have revised applicable provisions of part 507 to use
``establishment'' rather than ``plant'' when focusing on a business
entity rather than on buildings or other structures. Third, we have
revised provisions that use the terms ``plant,'' ``establishment,'' or
both to conform to the definition of ``plant'' and the described usage
of ``establishment.'' For example, Sec. 507.14 establishes
requirements for ``the management of the establishment'' rather than
``plant management,'' because ``establishment'' is the term focusing on
the business entity. As another example, Sec. 507.17(a)(1) establishes
requirements for properly storing equipment, removing litter and waste,
and cutting weeds or grass within the immediate vicinity of the
``plant'' rather than within the immediate vicinity of the ``plant
buildings or structures,'' because the defined term ``plant'' focuses
on the buildings and structures, and it is not necessary to repeat
``buildings and structures'' when the term ``plant'' is used.
23. Preventive Controls
We proposed to define the term ``preventive controls'' to mean
those risk-based, reasonably appropriate procedures, practices, and
processes that a person knowledgeable about the safe manufacturing,
processing, packing, or holding of food would employ to significantly
minimize or prevent the hazards identified under the hazard analysis
that are consistent with the current scientific understanding of safe
food manufacturing, processing, packing, or holding at the time of the
analysis.
(Comment 50) Some comments ask us to clarify the meaning of
``current scientific understanding'' because scientific understanding
can vary depending on the risk profile of a commodity.
(Response 50) By ``current scientific understanding,'' we mean to
emphasize
[[Page 56195]]
that scientific information changes over time and a facility needs to
keep current regarding safe handling and production practices such that
the facility has the information necessary to apply appropriate
handling and production practices.
24. Preventive Controls Qualified Individual
We proposed to define the term ``qualified individual'' to mean a
person who has successfully completed training in the development and
application of risk-based preventive controls at least equivalent to
that received under a standardized curriculum recognized as adequate by
FDA, or is otherwise qualified through job experience to develop and
apply a food safety system. We have changed the proposed term
``qualified individual'' to ``preventive controls qualified
individual'' because we are establishing a new definition for
``qualified individual,'' with a meaning distinct from ``preventive
controls qualified individual.'' To minimize the potential for
confusion, for when the term ``qualified individual'' refers to the
proposed meaning of the term and when the term ``qualified individual''
refers to the meaning of that term as finalized in this rule, in the
remainder of this document we use the new term ``preventive controls
qualified individual'' whenever we mean ``a person who has successfully
completed training in the development and application of risk-based
preventive controls at least equivalent to that received under a
standardized curriculum recognized as adequate by FDA or is otherwise
qualified through job experience to develop and apply a food safety
system,'' even though the proposed rule used the term ``qualified
individual.'' Likewise, we use the new term ``preventive controls
qualified individual'' for the proposed term ``qualified individual''
when describing the comments to the proposed rule, even though those
comments use the term ``qualified individual.''
In the following paragraphs, we discuss comments on this proposed
definition. (See also our discussion in section XXXVII.B of the
requirements applicable to the preventive controls qualified individual
(Sec. 507.53(c)).)
(Comment 51) Some comments assert that the proposed definition of
preventive controls qualified individual is ambiguous.
(Response 51) The comments provide no basis for asserting that this
definition is ambiguous. The proposed definition includes a performance
standard (qualified to develop and apply a food safety system), two
criteria for how a person can become qualified (specialized training or
job experience), and a description of the type of applicable training
(development and application of risk-based preventive controls at least
equivalent to that received under a standardized curriculum). The
proposed definition provides flexibility for how an individual can
become qualified, but this flexibility does not make the definition
ambiguous.
(Comment 52) Some comments ask us to expand the definition so that
it includes a team of preventive controls qualified individuals, not
just a single person.
(Response 52) We decline this request. The definition applies to
each preventive controls qualified individual that a facility relies on
to satisfy the requirements of the rule without limiting the number of
such preventive controls qualified individuals. The requirements of the
rule make clear that a facility may rely on more than one preventive
controls qualified individual (see, e.g., Sec. 507.53(a)).
(Comment 53) Several comments state that there is a lack of
specificity about what constitutes appropriate training and experience
to qualify as a ``preventive controls qualified individual.'' Another
comment asks us to clarify how the qualification of the ``preventive
controls qualified individual'' will be assessed. One comment asks how
the resume and experience of preventive controls qualified individuals
in other countries will be evaluated by FDA to determine that they meet
the required qualifications.
(Response 53) As discussed further in Response 395, we do not
expect to directly assess the qualifications (whether obtained by
training or by job experience) of persons who function as preventive
controls qualified individuals. Instead, we intend to focus our
inspections of both domestic and foreign facilities on the adequacy of
the food safety plan prepared by the preventive controls qualified
individual (or under their oversight). As necessary and appropriate, we
will consider whether deficiencies we identify in the food safety plan
suggest that the preventive controls qualified individual may not have
adequate training or experience to carry out the required functions. If
the food safety plan suggests the preventive controls qualified
individual does not have adequate training or experience, we will
perform a more in-depth review of the preventive controls qualified
individual's training or experience, including any associated
documentation.
See also our discussion in section XXXVII.B about the requirements
applicable to the preventive controls qualified individual (Sec.
507.53(c)).
25. Qualified Auditor
We proposed to define the term ``qualified auditor'' to mean a
person who is a preventive controls qualified individual as defined in
this part and has technical expertise obtained by a combination of
training and experience appropriate to perform the auditing function as
required by Sec. 507.53(c)(2). As discussed in Response 399, we have
revised the definition to specify that ``qualified auditor'' means a
person who is a ``qualified individual'' as that term is defined in
this final rule, rather than a ``preventive controls qualified
individual,'' because some auditors may be auditing businesses (such as
produce farms) that are not subject to the requirements for hazard
analysis and risk-based preventive controls, and it would not be
necessary for such an auditor to be a ``preventive controls qualified
individual.'' We also have clarified that the technical expertise is
obtained through education, training, or experience (or a combination
thereof) necessary to perform the auditing function to align the
description of applicable education, training, and experience with the
description of applicable education, training, and experience in the
definition of ``qualified individual'' (see Sec. 507.3).
(Comment 54) Some comments ask us to revise the definition of
qualified auditor to include persons who have technical expertise
obtained by a combination of training, experience, or education
appropriate to perform audits. Some comments ask us to recognize that
training and/or experience can make a person a qualified auditor; the
comments state that people with experience performing audits likely
have applicable training but might not have completed a specific
regimen of courses. Some comments maintain that we should recognize the
role of the education of a potential qualified auditor, as well as
training and experience to meet the criteria.
(Response 54) We agree that a qualified auditor might obtain the
necessary auditing expertise in part through education, as well as
through training and experience, and we have revised the definition of
qualified auditor accordingly. The revised definition states that a
qualified auditor has technical expertise obtained through education,
training, or experience (or the combination thereof).
[[Page 56196]]
(Comment 55) Some comments that support the proposed definition ask
us to revise the definition to specify certain individuals who would be
considered qualified auditors, such as FDA inspectors, properly trained
Federal auditors, and State and private auditors operating under a
contract with the Federal Government.
(Response 55) We have revised the regulatory text to specify that
examples of potential qualified auditors include: (1) A government
employee, including a foreign government employee and (2) an audit
agent of a certification body that is accredited in accordance with
regulations in part 1, subpart M (i.e., regulations in our forthcoming
third-party certification rule implementing section 808 of the FD&C Act
(21 U.S.C. 348d)). Although we agree that it is useful to include
examples of individuals who would have the appropriate qualifications,
the example of an audit agent of a certification body that has been
accredited in accordance with our regulations in our forthcoming third-
party certification rule adds context about the standard for such
individuals. Because paragraph (2) of the new provision refers to
provisions in a future third-party certification rule, we will publish
a document in the Federal Register announcing the effective date of
paragraph (2) when we finalize the third-party certification rule.
26. Qualified End-User
We proposed to define the term ``qualified end-user'' to mean, with
respect to an animal food, the consumer of the food (where the term
consumer does not include a business); or a restaurant or retail food
establishment (as those terms are defined in Sec. 1.227(b)) that: (1)
Is located (a) in the same State as the qualified facility that sold
the food to such restaurant or establishment; or (b) is not more than
275 miles from such facility; and (2) is purchasing the food for sale
directly to consumers at such restaurant or retail food establishment.
We have revised the definition of ``qualified end-user'' to add ``or
the same Indian reservation'' to clarify for purposes of this rule that
``in the same State'' under section 418(l)(4)(B)(ii)(I) of the FD&C Act
includes both within a State and within the reservation of a Federally-
Recognized Tribe.
(Comment 56) One comment requests the term ``restaurant'' be
removed from the proposed definition of ``qualified end-user'' and
replaced with the appropriate definitional terms for ``restaurant''
provided in Sec. 1.227: Pet shelters, kennels, and veterinary
facilities in which animal food is provided to animals. The comment
also suggests we modify the definition of ``qualified end-user'' to be
reflective of the customer who is the purchaser of the animal food.
(Response 56) We decline these requests. The definition of
``qualified end-user'' is consistent with the definition in section
418(l)(4)(B) of the FD&C Act. As discussed in Response 81, we decline
to define consumer.
27. Qualified Facility
We proposed to define ``qualified facility'' by incorporating the
description of ``qualified facility'' in section 418(l)(1) of the FD&C
Act with editorial changes to improve clarity. That definition includes
two types of facilities: (1) A facility that is a very small business
as defined in this rule and (2) a facility to which certain statutory
criteria apply regarding the average monetary value of animal food sold
by the facility and the entities to which the animal food was sold.
For the second type of facility, to represent accurately the
language of section 418(l) of the FD&C Act, we have changed ``animal
food'' to ``food.''
Some comments discuss issues related to the definition of very
small business. See section VIII.A.36 for the discussion of the
definition of very small business.
(Comment 57) Some comments assert that the definitions of
``affiliate'' and ``subsidiary'' in the definition of ``qualified
facility'' fail to account for the legal differences between a piece of
property (i.e., a facility) and a business entity or person. These
comments ask us to consider revising the proposed definition of
``qualified facility'' to clarify what sales to include in determining
whether a facility so qualifies.
(Response 57) We have not revised the proposed definition of
``qualified facility'' as requested by these comments. The sales to be
included when a facility determines whether it meets the definition of
a qualified facility are the sales of animal food by a business entity
meeting the ``very small business'' definition or food by a business
entity meeting the other qualified facility definition, each of which
includes the parent company and all its subsidiaries and affiliates.
The total sales are applicable to each entity, whether it is the
parent, the subsidiary or the affiliate. We intend to address issues
such as these in guidance as directed by section 418(l)(2)(B)(ii) of
the FD&C Act.
(Comment 58) Some comments ask us to clarify who will determine
whether a particular facility is a qualified facility.
(Response 58) Any facility that determines that it satisfies the
criteria for a ``qualified facility'' must notify FDA of that
determination (see Sec. 507.7) and, thus, the first determination will
be made by the facility itself. During inspection, the investigator
could ask to see the records that support the facility's determination
to verify the facility's determination.
In this rule, we remove the term ``quality control operation''
because the term is very broad within the animal food industry and may
not be specific to animal food safety.
28. Receiving Facility
We proposed to define the term ``receiving facility'' to mean a
facility that is subject to subpart C of this part and that
manufactures/processes a raw material or ingredient that it receives
from a supplier.
(Comment 59) Some comments ask us to modify the definition to
specify that the receiving facility could receive the raw material or
ingredient directly from a supplier or by means of an intermediary
entity. These comments assert that without this added regulatory text
the proposed definition implies that the material or ingredient must be
received directly from the supplier.
(Response 59) We decline this request. As discussed in section
XLII.B and C, the two parties that are critical to the supplier
verification program are the receiving facility and the supplier, even
if there are entities in the supply chain between the two. The
definition of receiving facility does not preclude the participation of
intermediary entities in the supply chain, and the rule does provide
for such participation (see Sec. 507.115). However, the definition of
receiving facility does highlight the fact that a receiving facility
must have a link to a supplier.
29. Rework
We proposed to define ``rework'' to mean clean, unadulterated food
that has been removed from processing for reasons other than insanitary
conditions or that has been successfully reconditioned by reprocessing
and that is suitable for use as food. In this rule, we add ``animal''
before food for clarity.
(Comment 60) Several comments request that we replace
``insanitary'' with ``unclean'' as the former term is not utilized in
the animal food industry. Other comments state that the proposed
definition for ``rework'' is too narrow and does not represent its use
in animal food production.
(Response 60) We decline this request. The word ``insanitary'' is
used in the FD&C Act and human food
[[Page 56197]]
regulations, including the Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Human Food (currently 21 CFR part
110 and updated and included in the final rule for preventive controls
for human food (21 CFR part 117) published elsewhere in this Federal
Register). Because of the use of the term in the FD&C Act and various
FDA regulations, we think industry is familiar with the word
``insanitary'' and it is an appropriate word to use in this final rule.
We disagree that the definition of the term ``rework'' is too
narrow. The definition allows the flexibility for an establishment to
consider clean, unadulterated animal food that was never adulterated or
was successfully reconditioned to be rework.
30. Sanitize
We proposed to define ``sanitize'' to mean to adequately treat
cleaned food-contact surfaces by a process that is effective in
destroying vegetative cells of microorganisms of animal or human health
significance, and in substantially reducing numbers of other
undesirable microorganisms, but without adversely affecting the product
or its safety for animals or humans.
(Comment 61) Several comments request that we replace the term
``sanitize'' with ``clean,'' as the former term is not utilized in the
animal food industry. Other comments ask us to modify the definition
because the destruction of all microorganisms of animal or human health
concern is not always practical, and because the terminology
``adversely affecting the product or its safety for animal or humans''
is ambiguous. Others ask us to revise the definition to state that
``adequate'' or ``adequately'' means to reduce the presence of
organisms of concern sufficient to help prevent illness through
cleaning and sanitizing using EPA registered/FDA regulated food use
antimicrobials and other means such as heat, ozone, etc. Some comments
ask us to clarify that the ``cleaning'' should be appropriate to the
specific food system and method used for sanitizing, and that cleaning
should only be required when the sanitizing process alone would not be
effective without a prior cleaning step.
Some comments express concern about whether the proposed definition
of ``sanitize'' would preclude the continued, routine use of dry
cleaning methods with no sanitizing step. These comments note that
adding routine aqueous-based cleaning and sanitizing procedures could
create a public health risk in certain operations such as low moisture
food production. These comments also note that dry cleaning procedures
can result in equipment that, while sanitary, is neither visibly clean
nor suitable for aqueous chemical sanitizers.
(Response 61) When the destruction of microorganisms is required,
we use the terms ``sanitize'' or ``sanitizing,'' to differentiate from
``cleaning'' or ``sanitation,'' which is consistent with how these
terms are used throughout our current regulations for human food.
Therefore, we believe that ``sanitize'' is a word that is commonly
understood by industry and is used in this final rule in a way that is
consistent with how it is used in our other regulations relating to
food.
We consider that systems such as steam systems clean the surfaces,
as well as sanitize them and, thus, satisfy the definition of
``sanitize.'' The definition of ``sanitize'' does not preclude the
continued use of dry cleaning methods with no sanitizing step because
the definition describes the meaning of the term ``sanitize'' without
establishing any requirement for when equipment must be sanitized.
We have revised the definition so that it means adequately treating
``surfaces'' rather than ``food-contact surfaces.'' As a technical
matter, adequately treating any surface--regardless of whether it is a
food-contact surface--by a process that is effective in destroying
vegetative cells of pathogens, and in substantially reducing numbers of
other undesirable microorganisms, but without adversely affecting the
product or its safety for animals or humans, is ``sanitizing'' the
surface. Clarifying this technical meaning of the term ``sanitize''
imposes no requirements to sanitize surfaces other than animal food-
contact surfaces; the requirements for sanitizing surfaces are
established by provisions such as Sec. 507.19(b)(2), not by the
definition of the term ``sanitize.''
31. Significant Hazard (Hazard Requiring a Preventive Control)
We proposed to define the term ``significant hazard'' to mean a
known or reasonably foreseeable hazard for which a person knowledgeable
about the safe manufacturing, processing, packing, or holding of animal
food would, based on the outcome of a hazard analysis, establish
controls to significantly minimize or prevent the hazard in an animal
food. The rule would use the term ``significant hazard'' rather than
``hazard reasonably likely to occur'' to reduce the potential for a
misinterpretation that all necessary preventive controls must be
established at CCPs (79 FR 58476 at 58477 through 58478).
(Comment 62) Comments support using a term other than ``hazard
reasonably likely to occur'' and agree that using a term other than
``hazard reasonably likely to occur'' throughout the rule will reduce
the potential for a misinterpretation that all necessary preventive
controls must be established at CCPs.
Some comments support the regulatory text of the proposed
definition of the term ``significant hazard.'' These comments state
that the proposed regulatory text more closely aligns with the
principles in FSMA (``reasonably foreseeable'' and ``significantly
minimize or prevent'') and provides operators the flexibility to
implement a range of preventive controls that are commensurate with the
risk and probability posed by a specific hazard. Some comments agree
that the proposed regulatory text can clarify the difference between
HACCP rules and the animal preventive controls rule. Some comments
state that the proposed regulatory text plainly reflects the concept
that significant hazards are those hazards to be addressed through the
very broad category of preventive controls, and the rule is explicit
that preventive controls may be controls other than CCPs. Some comments
state that the definition reflects the risk-based nature (i.e., both
the severity of a potential hazard and the probability that the hazard
will occur) of the requirements and provides additional flexibility so
that facilities can take into account the nature of the preventive
control in determining when and how to establish and implement
appropriate preventive control management components. Some comments
support including the phrase ``based on the outcome of a hazard
analysis'' in the definition because it ensures that identification of
significant hazards will be risk based. Some comments ask us to be
clear about FDA's expectations concerning a hazard analysis conducted
by those involved in animal food production. Some comments ask us to
preserve in the final definition two key aspects that grant the animal
food industry the flexibility that it needs: (1) The logical conclusion
that not all hazards will have the same impact or will even constitute
``significant hazards'' at all, depending on the facility's products
and position in the supply chain and (2) the fact that a ``person
knowledgeable about the safe manufacturing, processing, packing, or
holding of food'' must be knowledgeable about the specific food
produced at that
[[Page 56198]]
facility and in that specific sector of the food industry.
Some of the comments that support the regulatory text of the
proposed definition nonetheless express concern about the term
``significant hazard.'' Some of these comments express concern that a
facility may not recognize hazards that need to be controlled because
they do not rise to the commonly understood meaning of ``significant.''
Other comments express concern that the adjective ``significant'' is
subject to many interpretations and suggest that the term ``hazard
requiring control'' would be more straightforward, accurate, and
suitable.
Other comments express concern that the term ``significant hazard''
could cause confusion because it has implications in HACCP systems. For
example, ``significant hazard'' is often used in the context of CCPs
and preventive controls are not necessarily established at CCPs. Some
of these comments suggest that we eliminate the term and instead use
the full regulatory text of the proposed definition in place of
``significant hazard'' throughout the regulations. Other comments
suggest using a term such as ``food safety hazard'' or ``actionable
hazard'' instead of ``significant hazard to avoid a term that has HACCP
implications. Other comments state that the term ``significant hazard''
has implications for facilities that follow the Codex HACCP Annex and
express concern that foreign facilities would be especially likely to
be confused by the term ``significant hazard.''
Some comments ask us to ensure that the term ``significant hazard''
is used consistently and express the view that some regulatory text
refers to a ``hazard'' or ``known and reasonably foreseeable hazard''
where ``significant hazard'' should instead be used. As discussed in
Comment 31, some comments express concern that the rule would refer to
multiple levels of hazard and ask us to provide sufficient clarity to
be able to distinguish between these types of hazards.
(Response 62) We have changed the term ``significant hazard'' to
``hazard requiring a preventive control.'' The new term uses the
explicit language of FSMA (i.e., ``preventive control''), is consistent
with the specific suggestion of one comment (i.e., hazard requiring a
control''), and is not commonly associated with HACCP systems. We
decline the request to use the term ``food safety hazard'' because that
term already is established in Federal HACCP regulations for seafood
and meat/poultry, and the comments are particularly concerned about
using a term that has implications for HACCP systems. We also decline
the request to use the term ``actionable hazard,'' because the term
``actionable'' is associated with violations at a food processing
plant.
We reviewed the full regulatory text of proposed subpart C and
replaced ``significant hazard'' with ``hazard requiring a preventive
control'' in most cases. See table 31.
We also reviewed the full regulatory text of proposed subpart C to
evaluate whether there were any circumstances where the regulatory text
should more appropriately refer to ``hazard requiring a preventive
control'' rather than ``hazard'' or ``known or reasonably foreseeable
hazard.'' The term ``known or reasonably foreseeable hazard'' appears
only once, in the requirement for a facility to conduct a hazard
analysis (Sec. 507.33(a)). We are retaining ``known or reasonably
foreseeable hazard'' in that requirement because it is necessary to
implement the tiered approach to the requirements for hazard analysis
and risk-based preventive controls (see Response 31). To reinforce this
tiered approach, and emphasize that the facility only conducts a hazard
analysis for known or reasonably foreseeable hazards, we revised
``hazard'' to ``known or reasonably foreseeable hazard'' in two
additional provisions in the requirements for hazard identification
(see the introductory regulatory text for Sec. 507.33(b)(1) and (2)).
In our review of the full regulatory text of proposed subpart C, we
did not identify any circumstances where we believe it is appropriate
and necessary to specify ``hazard requiring a preventive control'' in
place of ``hazard.'' It is not necessary for the regulatory text of
requirements for preventive controls, the supply-chain program, the
recall plan, corrective actions, and verification to specify ``hazard
requiring a preventive control'' every time that the requirements use
the term ``hazard'' because the context of the requirement establishes
the applicability to ``hazards requiring a preventive control.''
Although we acknowledge that using ``hazard requiring a preventive
control'' in place of ``hazard'' throughout applicable provisions of
proposed subpart C would emphasize the tiered approach to the
requirements for hazard analysis and risk-based preventive controls,
doing so would make the regulatory text unnecessarily bulky and awkward
and would be inconsistent with comments that ask us to make the
regulatory text understandable (see Comment 13 in section III of the
final rule for preventive controls for human food, published elsewhere
in this issue of the Federal Register).
(Comment 63) Some comments ask us to allow facilities to continue
to implement existing controls outside the framework of this rule
(i.e., outside the framework that requires preventive control
management components as appropriate to ensure the effectiveness of the
preventive controls, taking into account the nature of the preventive
control and its role in the food safety system) when a hazard addressed
by the existing controls does not rise to the level of ``significant
hazard.''
Other comments express concern that the term ``significant hazard''
may create a disincentive for facilities to voluntarily implement
preventive controls for hazards that only pose a remote risk or are
very rarely encountered, because implementing preventive controls for
hazards of very low probability and severity may be misinterpreted as
requiring preventive controls applicable to a ``significant hazard''
even if the hazard does not meet the definition of ``significant
hazard'' established in the rule. Some comments ask us to revise the
definition to provide facilities with the flexibility and discretion to
establish appropriate preventive controls for hazards that do not rise
to the criteria of a ``significant hazard,'' as well as ensuring that
preventive controls that address remote or very unlikely hazards not be
subject to the preventive control management requirements for a
``significant hazard.''
(Response 63) We have revised the definition to specify that the
term ``hazard requiring a preventive control'' applies when a
knowledgeable person would, based on the outcome of a hazard analysis,
``establish one or more preventive controls'' rather than ``establish
controls.'' By narrowing ``controls'' to ``one or more preventive
controls,'' we mean to signify that the proposed term ``significant
hazard'' (which we now refer to as ``hazard requiring a preventive
control'') only applies to those controls that the facility establishes
to comply with the requirements of subparts C and E for hazard analysis
and risk-based preventive controls. A facility that establishes other
controls (such as those that the comments describe as ``prerequisite
programs,'' or controls directed to hazards of very low probability and
severity) for hazards that are not, based on the outcome of the
facility's hazard analysis, ``hazards requiring a preventive control''
would not need to establish preventive control management components
for such controls. However, some controls
[[Page 56199]]
previously established in ``prerequisite programs'' would be considered
``preventive controls.'' We provide some flexibility for facilities
with respect to how they manage preventive controls, and the preventive
control management components may be different for hazards that have
been managed as ``prerequisite programs'' compared to those managed
with CCPs. A facility that is concerned about the potential for an
investigator to disagree during inspection that certain controls are
not directed to ``hazards requiring a preventive control'' could, for
example, include information relevant to its classification of those
other controls in its hazard analysis, whether by merely listing the
``other controls'' or by providing a brief explanation why such
controls are not ``preventive controls'' as that term is defined in
this rule.
(Comment 64) Some comments assert that the proposed definition of
``significant hazard'' is tautological because it essentially
establishes a ``significant hazard'' to be a known or reasonably
foreseeable hazard (i.e., the type of hazards identified in the first
step of the analysis) for which preventive controls should be
implemented. These comments assert that the proposed definition of
``significant hazard'' would collapse the second step of hazard
analysis into the first, which in turn would lead to the unintended
consequence of facilities identifying the same hazards in the second
step as in the first. Some comments ask us to revise the definition to
include evaluation of severity and probability, because these concepts
are integral for making a proper determination of whether a hazard is
significant. Other comments ask us to revise the definition to better
reflect the risk-based approach that preventive controls be implemented
to control hazards that have a higher probability of resulting in
public health consequence in the absence of control.
(Response 64) We have revised the definition of ``significant
hazard'' (which we now refer to as ``hazard requiring a preventive
control'') to specify that the hazard analysis includes an assessment
of the severity of the illness or injury if the hazard were to occur
and the probability that the hazard will occur in the absence of
preventive controls. By specifying that the determination of a
``significant hazard'' is based on the outcome of a hazard analysis,
the proposed definition did, as requested by the comments, include the
risk-based nature of the determination. However, explicitly adding that
the hazard analysis is based on probability and severity (i.e., risk)
makes the risk-based nature of the determination clearer.
We disagree that the proposed definition was tautological and would
collapse the second step of hazard analysis into the first. A facility
begins its hazard analysis by narrowing down the universe of all
potential hazards to those that are ``known or reasonably foreseeable''
for each type of animal food manufactured, processed, packed, or held
at its facility. The outcome of the facility's hazard analysis is a
determination of a subset of those known or reasonably foreseeable
hazards, i.e., those hazards requiring a preventive control. To the
extent that these comments are asserting that the tautology was created
by the phrase ``in the absence of its control'' in the proposed
definition of ``hazard,'' we have deleted that phrase from the final
definition of ``hazard.''
We decline the request to repeat in the definition of ``hazard
requiring a preventive control'' the requirement for the types of
information that a facility would consider in conducting its hazard
analysis. The requirements for hazard analysis clearly specify that a
facility must conduct its hazard analysis based on experience, illness
data, scientific reports, and other information (see Sec. 507.33(a)).
(Comment 65) Some comments that broadly address the overall
framework for the new requirements for hazard analysis and risk-based
preventive controls ask us to consistently refer to ``the nature of the
preventive control'' (rather than simply to ``the preventive control'')
when communicating the flexibility that a facility has in identifying
preventive controls and associated preventive control management
components. Other comments that broadly address the overall framework
for the new requirements for hazard analysis and risk-based preventive
controls ask us to emphasize that the requirements for preventive
control management components convey not only that the application of a
particular element is appropriate (i.e., capable of being applied), but
also necessary for food safety. Some comments recommend that we do so
by specifying that preventive control management components take into
account the role of the preventive control in the food safety system.
(Response 65) We agree with these comments and have revised the
definition of ``hazard requiring a preventive control'' to specify that
preventive control management components are established as appropriate
to ``the nature of the preventive control and its role in the
facility's food safety system.''
(Comment 66) Some comments assert that the problem is how to
separate the hazards addressed by ``HACCP'' from those addressed by
CGMPs. These comments suggest that control measures that are
implemented for hazards from ingredients and food-contact packaging
material, and from production and process, be called CCPs and that
control measures that are implemented for hazards from personnel,
equipment, and the plant be called preventive controls.
(Response 66) The facility must control hazards through the
application of CGMPs and preventive controls as appropriate to the
hazard. Although some preventive controls will be established at CCPs,
and ``CCP'' is a term commonly used in HACCP systems, this rule
establishes requirements for hazard analysis and risk-based preventive
controls, not ``HACCP,'' and this rule provides that preventive
controls include controls at CCPs, if there are any CCPs, as well as
controls, other than those at CCPs, that are also appropriate for
animal food safety (see Sec. 507.34(a)(2)).
Under the rule, some hazards may be addressed by CGMPs and others
by preventive controls. For example, a facility could control a
physical hazard such as metal by using screens and magnets under CGMPs
and then use a metal detector as a preventive control.
(Comment 67) Some comments express concern that the term
``significant hazard'' may lead to misunderstanding by medium and
smaller processors and ask how businesses with limited food safety
experience will understand the difference between a food safety hazard
that is ``reasonably likely to occur'' (and, thus, must be controlled
by a full HACCP Plan) and a ``significant hazard'' that can be
controlled by a preventive control plan.
(Response 67) It will not be necessary for an animal food processor
to understand the difference between a hazard that is ``reasonably
likely to occur'' in the concept of HACCP requirements and a ``hazard
requiring a preventive control'' in the context of this rule. FDA does
not have any HACCP regulations that apply to animal food.
(Comment 68) Some comments ask us to concur that ``temporal
hazards'' in some food products (specifically, aflatoxin, pesticides,
and radiological contamination) do not represent ``significant
hazards'' that require monitoring and verification activities on an
ongoing basis. These comments also ask us to acknowledge that in many
[[Page 56200]]
cases the testing done by FDA and others is sufficient for protecting
public health and that it is not necessary to require ongoing
monitoring by individual facilities in order to comply with the rule.
(Response 68) We decline these requests because such a
determination should be facility specific. However, we have revised the
considerations for the hazard evaluation to clarify that in making the
determination as to what hazards require preventive controls, the
facility can consider factors such as the temporal nature of the hazard
(see Sec. 507.33 and section XXV). In determining the appropriate
preventive control management components, the facility can take into
account the nature of the preventive control and its role in the
facility's food safety system (see Sec. 507.39(a)).
32. Significantly Minimize
We proposed to define the term ``significantly minimize'' to mean
to reduce to an acceptable level, including to eliminate. We did not
receive comment and are finalizing it as proposed.
33. Small Business
We proposed to define the term ``small business'' to mean, for the
purposes of part 507, a business employing fewer than 500 persons. We
conducted a Food Processing Sector Study as required by section
418(l)(5) of the FD&C Act (Ref. 12) and used the results of the study
in defining the term ``small business.'' (78 FR 64736 at 64758 through
64759.) We made the results of the Food Processing Sector Study
available in Docket No. FDA-2011-N-0922 and requested public comment on
that study.
(Comment 69) Some comments express concern that the Food Processing
Sector Study is not comprehensive. Some comments assert that FDA did
not sufficiently collaborate with USDA, and that FDA significantly
underestimated the number of mixed-use facilities, particularly by
neglecting to count farms that perform the processing steps on RACs to
become a processed food. Other comments assert that the Food Processing
Sector Study is woefully inadequate and must be undertaken again to
comply with the law.
(Response 692) We previously acknowledged the limitations of the
Food Processing Sector Study (78 FR 64736 at 64758 through 64759). We
have revised and extended the results of our earlier study by expanding
our data sources and by including representatives from USDA's Economic
Research Service, USDA's Agricultural Marketing Service and the
American Farm Bureau to help oversee the revised study. The revised
Food Processing Sector Study is available in the docket of this rule
(Ref. 21).
Our original analysis was based on the merger of Dun & Bradstreet
data and FDA's Food Facility Registration data to help us estimate the
number of manufacturing facilities that are also classified as farms.
We have updated that data source and added data sources. To better
account for farms that perform processing activities, we included
Census of Agriculture (Ag Census) data both to provide a count of total
U.S. farms and to estimate the number of farms conducting food
processing activities, to the extent that the data identifies
processing activities. We also included the Agricultural Resource
Management Survey (ARMS) data because it included questions about some
processing activities for select commodities.
Both the Ag Census and ARMS are silent about many processing
activities. Therefore, we also obtained estimates from commodity
specialists at trade associations, USDA, and universities with in-depth
knowledge of the processing activities for specific agricultural
commodities.
(Comment 70) Some comments ask us to explain how to calculate the
number of full-time equivalent employees, e.g., with respect to
temporary workers, seasonal workers, and part-time workers. Other
comments say it is unclear whether fewer than 500 full-time equivalent
employees means those involved in the entire business or those involved
only in the animal food-related portions of the business, noting that
the term ``business'' is unclear (i.e., whether business means a
corporation and all its subsidiaries or only the portion of the
business related to animal food be it animal feed, pet food and/or
ingredients).
(Response 70) As previously discussed, we proposed to establish the
same definition for small business as that which has been established
by the U.S. Small Business Administration under 13 CFR part 121 for
most food manufacturers, and the limit of 500 employees would include
all employees of the business rather than be limited to the employees
at a particular facility (78 FR 64736 at 64759). We will base the
calculation on ``full-time equivalent employees'' and use the same
approach to calculating full-time equivalent employees for the purpose
of this rule as we used to calculate full-time equivalent employees in
the section 414 recordkeeping regulations (see Sec. 1.328). This
approach is similar to the approach the Agency used to calculate the
small business exemption for nutrition labeling of food (Sec.
101.9(j)(18)(iv)(D)). Under this approach, the number of full-time
equivalent employees is determined by dividing the total number of
hours of salary or wages paid directly to employees of the business
entity claiming the exemption and of all of its subsidiaries and
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e.,
40 hours x 52 weeks).
The calculation for the number of employees affects exemptions
(i.e., the exemptions for on-farm, low-risk activity/animal food
combinations in Sec. 507.5(e) and (f), which apply only to small and
very small businesses), not just compliance dates. Therefore, we are
establishing the definition of ``full-time equivalent employee'' in the
definitions for this rule (Sec. 507.3) and modifying the definition of
``small business'' to use the term ``500 full-time equivalent
employees'' rather than ``500 persons.''
(Comment 71) Some comments assert that there should be no exemption
from compliance with this rule based on total annual sales or number of
employees, noting that all companies regardless of size should have
food safety programs in place.
(Response 71) The definition of ``small business'' is relevant to
the exemptions for on-farm, low-risk activity/animal food combinations
for manufacturing/processing, packing, and holding animal food by
mixed-type facilities. This exemption is a risk-based exemption,
because it only applies to activity/animal food combinations that are
low-risk and, thus, should not affect animal food safety.
34. Supplier
We proposed to define the term ``supplier'' to mean the
establishment that manufactures/processes the food, raises the animal,
or harvests the food that is provided to a receiving facility without
further manufacturing/processing by another establishment, except for
further manufacturing/processing that consists solely of the addition
of labeling or similar activity of a de minimis nature.
As discussed in section IV.B of the final rule for preventive
controls for human food, published elsewhere in this issue of the
Federal Register, we have revised the ``farm'' definition to explicitly
include business models in which one operation grows crops but does not
harvest them, and another operation, not under the same management,
harvests crops but does not grow them. This revision represents a
change from the existing and proposed
[[Page 56201]]
``farm'' definitions, which describe a ``farm'' as an entity ``devoted
to the growing and harvesting of crops'' (emphasis added). We proposed
the ``supplier'' definition in the context of a single business entity
``devoted to the growing and harvesting of crops'' (emphasis added). We
used the term ``harvesting,'' rather than ``growing,'' to reflect the
last stage of production on a farm, except for packing.
Because the proposed ``supplier'' definition contemplated that the
same business entity that grows crops also harvests them, we have
revised the ``supplier'' definition so that the grower remains the
supplier when the harvester is under separate management. Specifically,
``supplier'' is now defined to include an establishment that ``grows''
food rather than an establishment that ``harvests'' food. Doing so
focuses the requirements for the supply-chain program (see subpart E)
on the entity that produces the food, rather than on the entity that
removes the food from the growing area, when the grower and the
harvester are not under the same management. Doing so also simplifies
the determination of who the supplier is in complex business models,
such as when a ``handler'' arranges for harvest by another business
entity.
(Comment 72) Some comments assert that the definition of supplier
is not workable because the status of warehouses and brokers is unclear
in the definition. Other comments ask us to modify the definition to
specify, in addition to the proposed definition, that the supplier
could be an intermediary entity that takes responsibility on behalf of
the receiving facility to ensure that the food meets the requirements
of this part.
(Response 72) As discussed in section XL, we agree that the role of
intermediaries in the supply chain is critical and we have added
options for entities other than the receiving facility to perform
certain supplier verification activities, provided that the receiving
facility reviews and assesses the documentation produced by the other
entity and documents that review and assessment. However, this does not
mean that these entities take on the role of the supplier. As discussed
in Response 59 and in section XL, we believe it is important to
supplier verification to retain the identities of two parties
involved--the receiving facility and the supplier. Therefore, we are
retaining our definition of supplier, with the minor change previously
discussed.
(Comment 73) Some comments regarding RACs ask us to modify the
definition of supplier in the case of comingled RACs, such that the
supplier would be the person immediately back from the receiving
facility in the supply chain provided that this entity (presumably a
warehouse or aggregator) voluntarily complies with the requirements of
subpart C of this part. One comment asks us to clarify in our
definition that the supplier must be the establishment that controls
the hazard in question.
(Response 73) We decline this request. As discussed in section XL,
we recognize that doing supplier verification with comingled products
will be a challenge. However, we believe it is important that there be
a link between the receiving facility (which is manufacturing/
processing the animal food) and the supplier (who controlled the
hazard(s) in the animal food). We are allowing an entity such as an
aggregator or distributor to perform some verification activities, so
the outcome requested by these comments will be achieved while
maintaining the identities of the two primary parties in the supplier
verification relationship (see Response 492).
(Comment 74) One comment asks us to clarify that the proposed
definition of supplier does not include sources of processing aids or
chemicals required for post-harvest treatments and packing processes
(including waxes, fungicides, detergents and sanitizers).
(Response 74) As defined, the supplier is the establishment growing
the food, not those establishments providing inputs (such as waxes,
fungicides, detergents and sanitizers) to that entity.
35. Validation and Verification
We proposed to define the term ``validation'' to mean that element
of verification focused on collecting and evaluating scientific and
technical information to determine whether the food safety plan, when
properly implemented, will effectively control the identified hazards.
We proposed to define the term ``verification'' to mean those
activities, other than monitoring, that establish the validity of the
food safety plan and that the system is operating according to the
plan.
(Comment 75) Some comments ask us to revise the definitions of
``validation'' and ``verification'' to be consistent with the Codex
definitions. Codex defines ``validation'' to mean obtaining evidence
that a control measure or combination of control measures, if properly
implemented, is capable of controlling the hazard to a specified
outcome. Codex defines ``verification'' to mean the application of
methods, procedures, tests and other evaluations, in addition to
monitoring, to determine whether a control measure is or has been
operating as intended (Ref. 22).
Some comments ask us to more clearly distinguish between
``validation'' and ``verification.'' Some comments assert that
validation is not an element of verification as stated in our proposed
definition and suggest that we clearly separate requirements for
validation from requirements for verification, e.g., by moving the
proposed requirements for verification to a distinct section in the
regulatory text.
(Response 75) We have explained how our proposed definitions for
``validation'' and ``verification'' align with a variety of widely
recognized definitions, including definitions established by Codex, the
NACMCF HACCP guidelines, and Federal HACCP (78 FR 64736 at 64758). We
disagree that validation is not an element of verification, but
acknowledge it is not necessary to say so within the definition of
``validation.'' Although we have moved the details of the requirements
for validation from its proposed location within the requirements for
verification (i.e., proposed Sec. 507.45(a)) to a separate section
(Sec. 507.47), we did so as an editorial change to improve clarity and
readability rather than as a substantive change to signal that
validation is not an element of verification (see table 8, 79 FR 58476
at 58504).
We agree that validation can apply to a specific control measure as
specified in the Codex definition. We also agree that validation can
apply to a combination of control measures as specified in the Codex
definition. The food safety plan is one example of a combination of
control measures.
Although we likewise agree that verification can apply to a
specific control measure as specified in the Codex definition, we
disagree that to be consistent with the Codex definition we should
adopt a definition that excludes the application of verification to the
food safety plan. It is well established that some verification
measures, such as testing for a pathogen, verify that multiple control
measures operated as intended.
To more clearly distinguish between ``validation'' and
``verification,'' the definition of ``validation'' we are establishing
in this rule specifies that validation means obtaining and evaluating
scientific and technical evidence that a control measure, combination
of control measures, or the food safety plan as a whole, when properly
implemented, is capable of effectively controlling the identified
[[Page 56202]]
hazards (emphasis added). We also made conforming changes associated
with the revised definition of ``validation'' in the requirements for
validation (see Sec. 507.47(b)(2)). The definition of ``verification''
we are establishing in this rule specifies that verification means the
application of methods, procedures, tests and other evaluations, in
addition to monitoring, to determine whether a control measure or
combination of control measures is or has been operating as intended
and to establish the validity of the food safety plan as a whole
(emphasis added). Consistent with the request of the comments, the
definition of ``verification'' uses the Codex description of
verification as the application of methods, procedures, tests and other
evaluations, in addition to monitoring.
36. Very Small Business
We proposed to define the term ``very small business'' to mean, for
the purposes of proposed part 507, a business that has less than
$2,500,000 in total annual sales of food for animals, adjusted for
inflation. As discussed in the proposed rule, we conducted a Food
Processing Sector Study as required by section 418(l)(5) of the FD&C
Act (Ref. 12) and used the results of the study in defining the term
``very small business'' (78 FR 64736 at 64758 through 64760). We made
the results of the Food Processing Sector Study available in Docket No.
FDA-2011-N-0922. Some comments support defining ``very small business''
as a business that has less than $2,500,000 in total annual sales of
animal food, adjusted for inflation. Other comments disagree or offer
alternative recommendations.
(Comment 76) Some comments ask us to clarify how to classify the
size of a business that does not take ownership or directly sell food
(e.g., warehouses and contract manufacturers) to determine status as a
qualified facility. Some comments recommend modifications to the
proposed very small business definition based on a discussion of
certain farming models in the 2014 supplemental notice for animal food
(79 FR 58476 at 58482). These comments express concern that the
proposed definition of very small business would not account for animal
food that is not ``sold,'' but is manufactured and then distributed to
another entity without a sale, such as in the contract farming model
discussed in the 2014 supplemental notice.
Other comments recommend modifications to the definition to use the
value or volume of animal food manufactured and distributed in
establishing whether a facility is a very small business. The comments
state that this would account for the animal food manufactured by feed
mills servicing contract farms. Some of these comments state that the
value of food produced by feed mills operating under this contract
model often exceeds the $2,500,000 threshold of the proposed very small
business definition. They state that because this proposed definition
only includes sales, it would allow large facilities to be considered
very small businesses (as they would have no or a very small amount of
actual sales).
Other comments request that we modify the proposed definition to
specify that animal food produced for contract farms is not included in
``sales'' in the definition for very small business; thereby allowing
these feed mills to be very small businesses, which would result in
qualified facility status.
Some comments ask us to specify that the monetary threshold for the
definition be based on average sales during a 3-year period on a
rolling basis because otherwise firms may be subject to significant
changes in status from year to year. These comments also ask us to
clarify that the sales are to be evaluated retrospectively, not
prospectively.
(Response 76) We have revised the definition of very small business
to specify that it is based on an average during the 3-year period
preceding the applicable calendar year in sales of animal food plus the
market value of animal human food manufactured, processed, packed, or
held without sale (e.g., held for a fee or supplied to a farm without
sale). The applicable calendar year is the year after the 3 calendar
years used to determine whether a facility is a very small business.
The most recent applicable calendar year is the current year. For
example, on June 3, 2024, 2024 is the most recent applicable calendar
year and is the applicable calendar year when the 3 calendar years used
to determine whether a facility is a very small business are 2021 to
2023. The exception is when 3 calendar years of records are not
available, such as when a facility begins business after the compliance
date for very small businesses. In such situations the applicable
calendar year refers to the year during which the calculation is made
but is not preceded by 3 calendar years used to determine whether a
facility is a very small business.
As a companion change, we are explicitly requiring that a facility
determine and document its status as a qualified facility on an annual
basis by no later than July 1 of each calendar year (see Sec.
507.7(c)(1)). Although this requirement was implicit in the proposed
requirement that a facility must resubmit a notification to FDA if its
status changes as a qualified facility (proposed Sec. 507.7(c)(2),
which we are finalizing as Sec. 507.7(c)(3)), we are making this
requirement explicit to clarify the responsibility of the facility to
affirmatively determine its status when the calendar years that apply
to the 3-year average change. The July 1 deadline for a facility to
determine its status provides facilities with 6 months to make the
determination after the end of the previous 3 calendar years.
We also are establishing an earlier compliance date for the
financial records that a facility maintains to support its status as a
very small business. Specifically, the compliance date for a facility
to retain records to support its status as a qualified facility is
January 1, 2017. Even with this earlier compliance date for these
records, we realize that although the calculation for ``very small
business'' in the regulatory text is based on 3 calendar years, a
facility will only be required to have 2 calendar years of records as
of the general compliance date for very small businesses. Specifically,
by December 16, 2019 a facility that begins retaining applicable
financial records on January 1, 2017, would only have such records for
2 previous calendar years. Therefore, it would be reasonable for a
facility to make the calculation based on the 2 previous calendar
years. If a facility has records for 3 previous calendar years, the
facility could make the calculation based on the longer time period.
During inspection in 2019, when a facility has records for the
preceding 2 calendar years, but not for the preceding 3 previous
calendar years, we will accept records for the preceding 2 calendar
years as adequate to support status as a qualified facility based on
calculating an average for those two years. We note that in some
situations, a shorter time period is sufficient to determine that a
facility is not a very small business. For example, a facility with
sales exceeding $7,500,000 for the preceding calendar year cannot
qualify as a very small business because no amount of sales from other
years will reduce average sales below the threshold of $2,500,000.
The available financial records for a facility that begins
operations between January 1, 2018 and September 17, 2019 would not
cover even 2 complete calendar years by September 17, 2019. During the
first 3 calendar years of such a facility's operation, it would be
reasonable for a facility to make the calculation based on records it
has (i.e., for 1 or 2 preceding calendar years), and
[[Page 56203]]
we will accept records for the preceding 1 or 2 years as adequate to
support status as a qualified facility in these circumstances.
When a facility does not begin operations until after January 1,
2019, it would be reasonable for the facility to rely on a projected
estimate of revenue (or market value) when it begins operations. We
would evaluate the credibility of the projection considering factors
such as the facility's number of full-time equivalent employees. After
the facility has records for 1 or 2 preceding calendar years, it would
be reasonable for the facility to make the calculation based on records
it has (i.e., for 1 or 2 preceding calendar years) and we will accept
records for the preceding 1 or 2 years as adequate to support status as
a qualified facility in these circumstances.
We agree with the comments that state the animal food distributed,
but not ``sold,'' by feed mills operating under contract farming
agreements (and required to register as a food facility under section
415 of the FD&C Act) should be included in determining whether a
facility is a very small business. In addition to annual sales of
animal food, the market value of the animal food supplied to a farm(s)
without sale must be included when determining if a business is a very
small business for purposes of this rule.
The qualified facility exemption of Sec. 507.7 applicable to very
small businesses is intended to enable these businesses to comply with
modified requirements because they have fewer resources to direct to
full compliance with subpart Cs and E of the rule and they provide a
small volume of animal food for consumption. Many of the businesses
that have feed mills that provide animal food under contract farming
agreements are extensive and sophisticated businesses, such as some
large-scale meat and poultry operations. Such businesses are not the
intended beneficiaries of the qualified facility exemption because they
should have adequate resources, such as personnel, equipment, and
expertise, to implement the requirements of subparts C and E at their
feed mills. In addition, many of these feed mills manufacture and
distribute a large volume of animal food yearly. These were some of the
factors we considered when we revised the proposed definition of a very
small business to include the market value of the animal food that is
manufactured, processed, packed, or held without sales or supplied to a
farm without sales.
(Comment 77) Some comments support the proposed dollar threshold of
$2,500,000, noting that it would provide sufficient flexibility to
companies that receive the exemption to allow them to continue to
operate. Some comments say there should be no exemption from compliance
with this rule based on total annual sales or number of employees and
that all companies regardless of size should have food safety programs
in place. Several comments request different dollar amounts for
determining the threshold.
Some comments propose that the threshold should be $1,000,000, a
figure that would provide greater coverage than the $2,500,000 proposed
threshold and also would simplify compliance with all FSMA rules for
animal food facilities. Other comments suggest the definition for a
very small business should mean, for purposes of part 507, a business
that has less than $1,000,000 in total annual sales of animal food,
adjusted for inflation, and distributes less than 5,000 tons of animal
food annually. Several comments urge us to consider applying a $500,000
threshold to the value of animal feed produced by a facility, not just
the value of animal food that is sold. The comments state that the
vertically integrated structure of some livestock and poultry
operations means that some animal feed produced at large operations may
never be sold because the company supplies feed to contract operations
raising animals owned by the company.
Other comments suggest ensuring sufficient flexibility for a
diverse array of animal food businesses and that we should establish an
outright exemption from the rule for businesses with, at the very most,
$100,000 or less in annual average monetary value of animal food sold
over the previous 3-year period, adjusted for inflation. Another
comment suggests a threshold of $250,000. Other comments recommend
defining a very small business as one with less than $10,000 in annual
sales believing that a rule encompassing virtually all ingredient and
feed manufacturing and distribution facilities will encourage large
firms to continue to do business with very small firms. One comment
suggested excluding the value of donated by-product in the calculation
of total annual sales of animal food.
(Response 77) We are establishing a $2,500,000 threshold for the
definition of ``very small business.'' Under section 418(l)(1)(A) and
(B) of the FD&C Act, a very small business is a qualified facility;
under the exemption authorized in section 418(l)(2) of the FD&C Act, a
qualified facility is subject to modified requirements rather than the
requirements for hazard analysis and risk-based preventive controls. We
have acknowledged that a $2,500,000 threshold exempts a greater portion
of the animal food supply than thresholds of either $500,000 or
$1,000,000 (79 FR 58476 at 58502), but reaffirm that under the
$2,500,000 threshold the businesses that would be exempt from the
requirements for hazard analysis and risk-based preventive controls
would represent a small portion of the potential risk of foodborne
illness; businesses that fall within this definition of ``very small
business,'' collectively, produce less than 0.6 percent of the animal
food supply (Ref. 3). In addition, most of these facilities will be
subject to the CGMP requirements in subpart B; the only exemptions from
those CGMP requirements are the exemptions in Sec. 507.5(a) (which
applies to farms and activities of ``farm mixed-type facilities'' that
fall within the definition of ``farm''), and in Sec. 507.5(h) (which
applies to: (1) The holding or transportation of one or more RACs; (2)
hulling, shelling, and drying nuts and hulls (without manufacturing/
processing); and (3) the ginning of cotton (without manufacturing/
processing)). Facilities subject to and in compliance with human food
CGMPs and applicable FDA human food safety requirements that process
human food and ``donate'' or sell the human food by-products without
further processing for use as animal food are only subject to certain
provisions in subpart B for those by-products. This applies whether
they are a qualified facility or not. They are not subject to the
requirements of subparts C and E for the human food by-products used
for animal food.
(Comment 78) Some comments ask us to only include the total annual
sales of food in the United States, adjusted for inflation, for foreign
facilities that export food to the United States.
(Response 78) We decline this request. The purpose of the
definition of ``very small business'' is principally to enable such
businesses to comply with modified requirements, because they have
fewer resources to direct to full compliance with the rule. A foreign
business that sells more than the threshold dollar amount of animal
food has more resources than the businesses being excluded, even if
less than that threshold dollar amount reflects sales to the United
States. Likewise, a domestic business that sells more than the
threshold dollar amount of food has more resources than the businesses
being excluded, even if that domestic business exports some of its food
and, as a result, less than that threshold dollar amount reflects sales
within the United States.
[[Page 56204]]
(Comment 79) Some comments ask us to base the threshold on the
total ``volume of product'' or ``amount of product'' handled or sold.
These comments assert that an approach using product volume or amount
would be more risk based because it would correlate more closely to
consumer exposures than dollar amounts, which can be skewed by product
values.
(Response 79) We acknowledge that dollar amounts can be skewed by
product values but nonetheless disagree that we should base the
threshold on the total ``volume of product'' or ``amount of product''
handled or sold. We see no practical way to identify a threshold based
on volume or amount of product that could be applied across all product
sectors, and the comments provide no suggestions for how their
recommendation could be carried out.
(Comment 80) Some comments express concern that establishing a
threshold based on U.S. dollars would place domestic firms at a
disadvantage relative to foreign firms whose sales are often
denominated in currencies valued lower than the dollar and often
reflect much lower costs for factors such as land, labor, and
environmental compliance. These comments ask us to base the threshold
on an alternate measure, such as number of employees, or to calculate
the sales of foreign very small businesses using an appropriate measure
of purchasing power parity, if there is a straightforward way to do so.
(Response 80) We decline these requests. As previously discussed,
we use dollar estimates to evaluate the percent of all food produced in
the United States that would not be covered by the rule (79 FR 58476 at
58502). We acknowledge that the definition of ``small business'' is
based on number of employees, and that two exemptions (i.e., the
exemptions in Sec. 507.5(e) and (f) for on-farm, low-risk activity
animal food combinations) apply to small businesses. However, the
exemptions for on-farm, low-risk activity animal food combinations are
limited to a narrow sector of the animal food industry, whereas the
exemption applicable to a very small business will apply to all sectors
of the animal food industry.
We do not know of a straightforward way to calculate the sales of
foreign very small businesses using an appropriate measure of
purchasing power parity and, thus, are basing the threshold only on
U.S. dollars.
B. Comments Asking FDA To Establish Additional Definitions or Otherwise
Clarify Terms Not Defined in the Rule
Some comments ask us to define certain terms such as
``associated,'' ``contaminate,'' ``directly linked,'' ``integrated
operator,'' ``material to the safety of food,'' ``written,'' and
``necessary.'' We believe that it is not necessary to define these and
certain other new terms proposed by the comments. We discuss in this
section of this document comments that ask us to establish other new
terms or clarify terms in the rule not defined.
1. Consumer/Final Consumer/Customer
(Comment 81) A few comments request that we define consumer as the
animal consuming the food. Some comments ask us to define ``customer''
as the purchaser of the animal food. Other comments ask us to define
``final consumer'' to mean a person that feeds animals under the
control or ownership of that person. The comments suggest ``final
consumer'' could be used in the animal food rule to help clarify the
meaning of qualified end user.
(Response 81) We decline these requests. We stated that for
purposes of the proposed rule, the term consumer refers to the person
purchasing the animal food to feed to an animal(s), as well as the
animal(s) consuming the food (78 FR 64736 at 64756 through 64757). To
limit the definition of consumer to the animal consuming the food would
be inconsistent with how that term is used throughout FSMA and would
create confusion. Therefore, ``consumer'' also includes the person
purchasing the animal food.
2. Corrections
(Comment 82) Some comments assert that clearly distinguishing
between the terms ``corrective actions'' and ``corrections'' will be
imperative for industry to comply with the rule and for regulators to
enforce the rule. Some comments ask us to use the ISO definitions of
``corrective actions'' and ``corrections.'' (According to ISO
22000:2005 definition 3.13, a ``correction'' is action to eliminate a
detected non conformity; according to ISO 22000:2005 definition 3.14,
corrective action is action to eliminate the cause of a detected non
conformity or other undesirable situation.) Other comments ask us to
eliminate the term ``correction'' and instead revise the rule to
clarify the type of situation in which ``corrective actions'' are
neither necessary nor appropriate. As an example, these comments
suggest that the proposed provisions for corrections could refer to
``prompt actions taken in response to minor and isolated deviations
that do not directly impact product safety.''
Other comments agree with the concept of simple ``corrections'' but
assert that the term ``corrections'' is unnecessary and could be
confusing because different facilities may use the term differently.
These comments explain that sometimes ``correction'' is used to refer
to the action taken to fix a deviation, and may or may not be part of
an overall corrective action taken to identify the root cause of the
deviation and to prevent a similar occurrence. These comments suggest
that the provisions explain that prompt actions taken to address minor
and isolated deviations are not subject to the same requirements as
corrective actions to address potentially systemic concerns, without
defining the term ``corrections.''
(Response 82) We are defining the term ``correction'' to mean an
action to identify and correct a problem that occurred during the
production of animal food, without other actions associated with a
corrective action procedure (such as actions to reduce the likelihood
that the problem will recur, evaluate all affected animal food for
safety, and prevent affected animal food from entering commerce). We
agree that clearly distinguishing between the terms ``corrective
actions'' and ``corrections'' will be important for both industry and
regulators. We acknowledge that one way to distinguish between
``corrective actions'' and actions that we would consider
``corrections'' could be to avoid the term ``corrections'' and instead
say what we mean each time the rule uses the term ``corrections.''
However, after reviewing the full regulatory text of proposed subpart
C, we concluded that it was not practical to do so, because the term
``corrections'' was used more often in a title or a cross-reference
than in a provision where the full text of what we mean by the term
``corrections'' is necessary to communicate a requirement. Our
definition of ``corrections'' focuses on the first step in a
``corrective action procedure'' (i.e., identify and correct the
problem) and also specifies those aspects of a corrective action
procedure that do not apply to a correction (i.e., actions to reduce
the likelihood that the problem will recur, evaluate all affected
animal food for safety, and prevent affected animal food from entering
commerce). (A note to the ISO 22000:2005 definition of corrective
action indicates that it includes cause analysis and is taken to
prevent recurrence.) We believe that this definition will be adequate
to
[[Page 56205]]
distinguish ``corrective actions'' from ``corrections.''
As an example, if a facility applies sanitation controls for an
environmental pathogen such as Salmonella spp. and animal food residue
is observed on ``clean'' equipment prior to production, corrections
would involve re-cleaning and sanitizing the equipment before it is
used. Because the observation of animal food residue was made prior to
production of animal food, no animal food is affected, and no actions
are needed with respect to animal food. Although there are actions that
can be taken to prevent reoccurrence, such as retraining sanitation
personnel, these types of situations may reoccur from time to time.
3. Crop
(Comment 83) Some comments request we define a new term ``crop'' to
mean the edible or inedible cultivated or harvested plants.
(Response 83) We decline this request. The term ``crop'' has a
common meaning, and it is not necessary to establish a meaning for this
term in this rule.
4. Establishment
(Comment 84) Several comments request we establish a definition for
establishment as it is used in the supplier definition. Also, the
comments suggest that we replace in the definition of farm the term
``establishment'' with ``operation.''
(Response 84) Comments concerning the meaning of the term
``establishment'' as it relates to the ``supplier'' definition are
addressed in section XL pertaining to subpart E, the supply-chain
program. Comments directed to the meaning of the term ``establishment''
as it relates to the farm definition are addressed in section IV.A and
B of the final rule for preventive controls for human food, published
elsewhere in this issue of the Federal Register.
5. Parameter and Value as Used in the Requirements for Process Controls
(Comment 85) Some comments ask us to define the terms ``parameter''
and ``value'' used in the requirements for preventive controls (Sec.
507.34). These comments ask us to define ``parameter'' as a measurable
attribute and ``value'' as a specific measurement.
(Response 85) We decline this request. Both of these terms are used
in the context of process controls and both have common meanings when
associated with process controls. Therefore, it is not necessary for
the rule to define them.
6. Prerequisite Program
(Comment 86) Some comments ask that we adapt the definition of
prerequisite program from the ISO's food safety standard, ISO
22000:2005, noting that the ISO definition is: Basic practices and
procedures in animal food production that are necessary for the
manufacture, handling and provision of safe end products and safe food
for animal consumption.
(Response 86) We do not use the term ``prerequisite program'' in
the regulations established by this rulemaking and do not find it
necessary to define it. We understand that some facilities may refer to
practices and procedures such as CGMPs, training, or certain controls
for hazards as a ``prerequisite program.''
7. Qualified Facility Exemption
(Comment 873) Some comments note that some of the terminology
associated with the exemption for qualified facilities in the
preventive controls rule is different from terminology associated with
an exemption in the proposed produce safety rule. These comments point
out that the exemption in the proposed produce safety rule refers to
``qualified exemptions'' (Sec. 112.5), whereas the exemption in the
proposed animal preventive controls rule refers to ``exemptions'' and
``qualified facilities'' (Sec. 507.5(d)).
(Response 873) We have added a definition for the term ``qualified
facility exemption,'' to mean an exemption applicable to a qualified
facility under Sec. 507.5(d) (see the regulatory text in Sec. 507.3).
We also have made conforming changes throughout the rule to use the
term ``qualified facility exemption'' when it applies. (See table 31).
8. Qualified Investigator
(Comment 88) Once comment proposes a new term ``qualified
investigator'' where the term ``qualified investigator'' means an FDA
or state commissioned investigator that has successfully completed a
formal training course on inspections; CGMPs; hazard analysis and
preventive controls for animal food facilities, both animal feed and
pet food, and has demonstrated an understanding of the differences
between pet food and animal feed manufacturing facilities.
(Response 88) We decline this request. Our inspectors will be
trained on the requirements of this part.
9. Reanalysis
(Comment 89) Some comments request we define the term reanalysis to
mean a reassessment of the validity of a preventive control or food
safety plan to control a hazard.
(Response 89) We decline this request. Section 418(i) of the FD&C
Act sets the requirement for conducting a reanalysis, which is in the
regulatory text in Sec. 507.50, including how often and under what
circumstances a reanalysis of the food safety plan must be performed,
and how to handle the results. Therefore, we have determined that a
definition of ``reanalysis'' is not necessary. For a discussion of the
reanalysis requirement, see section XXXV.
10. Risk Assessment
(Comment 90) Some comments request that we add a new term ``risk
assessment'' and define this term as a scientifically based process
consisting of hazard identification, hazard characterization, exposure
assessment, and risk characterization.
(Response 90) We do not use the term ``risk assessment'' in the
regulations established by this rulemaking and do not find it necessary
to define it. As directed by section 103(c) of FSMA, we issued for
public comment a draft risk assessment, as described in section I.D and
are including the final risk assessment in the docket established for
this rule.
The definition proposed by the comment is similar to the
requirements for the hazard analysis of Sec. 507.33. The term ``hazard
analysis'' comes from section 418 of the FD&C Act. For discussion of
hazard analysis, see section XXV.
11. Undesirable Microorganisms
(Comment 91) Some comments request we define a new term
``undesirable microorganisms'' as those microorganisms that are of
animal or human health significance, thereby rendering the animal food
unfit for consumption or distribution.
(Response 91) We decline this request. See Response 45.
12. Unexposed Packaged Animal Food
As discussed in section XXXVI, some comments ask us to clarify that
modified requirements for packaged animal food that is not exposed to
the environment only apply to such animal food that requires time/
temperature controls for safety (TCS animal food). To do so, we are
defining the term ``unexposed packaged animal food'' to mean packaged
animal food that is not exposed to the environment and using this term
throughout the rule. Doing so simplifies the regulatory text and makes
it clearer.
[[Page 56206]]
C. Additional Definitions To Clarify Terms Not Defined in the Proposed
Rule
1. Audit
As already noted, some comments ask us to make the various rules we
are establishing to implement FSMA consistent with each other, and we
have worked to align the provisions of this rule with the provisions of
the FSVP rule to the extent practicable. (See Comment 4 and Response
4.) To align these provisions, we are establishing in this final rule a
definition of ``audit'' analogous to the definition of ``audit'' we
proposed for the FSVP rule. For the purposes of this rule, ``audit''
means the systematic, independent, and documented examination (through
observation, investigation, records review, discussions with employees
of the audited entity, and, as appropriate, sampling and laboratory
analysis) to assess a supplier's food safety processes and procedures.
2. Full-Time Equivalent Employee
As discussed in Response 70, we have established a definition for
``full-time equivalent employee'' as a term used to represent the
number of employees of a business entity for the purpose of determining
whether the business qualifies for the small business exemption. The
number of full-time equivalent employees is determined by dividing the
total number of hours of salary or wages paid directly to employees of
the business entity and of all of its subsidiaries and affiliates by
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52
weeks). If the result is not a whole number, round down to the next
lowest whole number.
3. Qualified Individual
As discussed in section IX.A, we are clarifying in new Sec.
507.4(b)(1) that each individual engaged in manufacturing, processing,
packing, or holding animal food (including temporary and seasonal
personnel) or in the supervision thereof must have the education,
training, or experience (or combination thereof) necessary to
manufacture, process, pack, or hold safe animal food as appropriate to
the individual's assigned duties. To better align with the FSVP rule,
we use the term ``qualified individual'' in new Sec. 507.4 and are
defining the term ``qualified individual'' to mean a person who has the
education, training, or experience (or a combination thereof) necessary
to manufacture, process, pack, or hold safe animal food as appropriate
to the individuals assigned duties. A qualified individual may be, but
is not required to be, an employee of the establishment.
4. Raw Agricultural Commodity
We have added a definition of the term ``raw agricultural
commodity'' to have the meaning given in section 201(r) of the FD&C
Act. We decided to define this term in the rule to simplify the
provisions in part 507 that refer to raw agricultural commodities.
5. Supply-Chain-Applied Control
We have added a definition of the term ``supply-chain-applied
control'' to mean a preventive control for a hazard in a raw material
or other ingredient when the hazard in the raw material or other
ingredient is controlled before its receipt. We decided to define this
term in the rule to simplify the provisions in part 507, and in this
document, that refer to preventive controls applied by a supplier
before receipt by a receiving facility.
6. Written Procedures for Receiving Raw Materials and Other Ingredients
We have added a definition of the term ``written procedures for
receiving raw materials and other ingredients'' to mean written
procedures to ensure that raw materials and other ingredients are
received only from suppliers approved by the receiving facility (or,
when necessary and appropriate, on a temporary basis from unapproved
suppliers whose raw materials or other ingredients are subjected to
adequate verification activities before acceptance for use). We decided
to define this term in the rule to simplify the provisions in part 507,
and in this document, that refer to these procedures.
IX. Subpart A: Comments on Qualifications of Individuals Who
Manufacture, Process, Pack, or Hold Animal Food
In the 2013 proposed preventive controls rule for animal food we
proposed that personnel responsible for identifying sanitation failures
or animal food contamination should have a background of education or
experience, or a combination thereof, to provide a level of competency
necessary for production of clean and safe animal food. Animal food
handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary
practices. We asked if the recommendations should be requirements for
employee education and training (78 FR 64736 at 64778). In addition, we
requested comment on how best to implement section 418(o)(3) of the
FD&C Act and the recommendations of the CGMP Working Group for human
food with respect to training (78 FR 64736 at 64778). We requested
comment on whether the rule should specify that each person engaged in
animal food manufacturing, processing, packing, or holding (including
temporary and seasonal personnel and supervisors) must receive training
as appropriate to the person's duties; specifying the frequency of
training (e.g., upon hiring and periodically thereafter); specify that
training include the principles of animal food hygiene and animal food
safety, including the importance of employee health and personal
hygiene, as applied at the facility; and specify that records document
required training of personnel and, if so, specify minimum requirements
for the documentation (e.g., the date of the training, the type of
training, and the person(s) trained). We also requested comment on
whether to establish some or all of the potential requirements for
education and training in subpart B, subpart C, or both.
In the following paragraphs, we discuss comments that respond to
our requests for comment on potential requirements for education and
training and whether to establish any requirements in subpart B,
subpart C, or both. After considering these comments, we are
establishing requirements for the qualifications of individuals engaged
in manufacturing, processing, packing, or holding animal food, as well
as the associated recordkeeping requirements in new Sec. 507.4 in
subpart A. The regulatory text makes clear that these requirements,
established in subpart A, apply to individuals engaged in
manufacturing, processing, packing, or holding animal food regardless
of whether the individuals conduct these activities under the framework
of the CGMPs established in subpart B or the framework for hazard
analysis and risk-based preventive controls established in subparts C,
D, and E. The regulatory text also makes clear that the qualification
requirements apply to the recordkeeping requirements of subpart F. See
table 5 for a description of these provisions.
[[Page 56207]]
Table 5--Provisions for Qualifications of Individuals Who Manufacture,
Process, Pack or Hold Animal Food
------------------------------------------------------------------------
Proposed
Final section designation section Description
designation
------------------------------------------------------------------------
507.4(a)(1).................... N/A Applicability to
individuals who
manufacture, process,
pack, or hold animal
food subject to
subparts B and F.
507.4(a)(2).................... N/A Applicability to
individuals who
manufacture, process,
pack, or hold animal
food subject to
subparts C, D, E, or
F.
507.4(b)(1).................... 507.14(b) Each individual engaged
in manufacturing,
processing, packing,
or holding animal food
must have the
education, training,
or experience (or
combination thereof)
necessary to
manufacture, process,
pack, or hold safe
animal food as
appropriate to the
individual's assigned
duties.
507.4(b)(2).................... 507.14(b) Required training in
the principles of
animal food hygiene
and animal food
safety, including the
importance of employee
health and personal
hygiene.
507.4(c)....................... 507.14(c) Additional
qualifications of
supervisory personnel.
507.4(d)....................... 507.4(d) Records of required
training. The required
records are subject to
the recordkeeping
requirements of
subpart F.
------------------------------------------------------------------------
A. Applicability and Qualifications of All Individuals Engaged in
Manufacturing, Processing, Packing, or Holding Animal Food (Final Sec.
507.4(a), (b), and (d))
(Comment 92) Some comments prefer that we continue to only provide
recommendations for education and training and allow the animal food
industry to determine the appropriate level of specific employee
training that may be needed. Some comments say that we should allow
facilities to conduct employee training in a flexible manner, with the
facility determining the training content and frequency that is
appropriate for the duties of a given employee as they relate to
ensuring the safe production and distribution of animal food.
Some comments recommend that employees be trained ``initially'' and
``periodically thereafter'' but ask that we recognize the seasonal
nature of a facility's workforce. Some comments ask that the training
include the principles of animal food hygiene and animal food safety,
including the importance of employee health and personal hygiene as
applied at the facility.
Some comments ask that training requirements be established in
subpart B so that the requirements would also apply to establishments
that manufacture, process, pack, or hold animal food, including
establishments that are not subject to FSMA's requirements for hazard
analysis and risk-based preventive controls. Some comments that
recommend establishing the training requirement in subpart B assert
that training is more appropriately considered a prerequisite program
than a preventive control that would belong in subpart C.
Other comments ask that the training and related recordkeeping
requirements for the facility's preventive controls qualified
individuals be established under subpart C because this is directly
related to the facility's food safety plan. Other comments ask that
training requirements be established in both subpart B and subpart C.
Other comments say that including requirements for education and
training in both subparts B and C would be confusing.
(Response 92) We are establishing a series of requirements for the
qualifications of individuals engaged in manufacturing, processing,
packing, or holding animal food in new Sec. 507.4. First, to clarify
how these qualification requirements apply to establishments subject to
subparts B and F, we are requiring that the management of an
establishment ensure that all individuals who manufacture, process,
pack, or hold animal food subject to subparts B and F are qualified to
perform their assigned duties (Sec. 507.4(a)(1)). To clarify how these
qualification requirements apply to facilities, we are requiring that
the owner, operator, or agent in charge of a facility must ensure that
all individuals who manufacture, process, pack, or hold animal food
subject to subparts C, D, E, or F are qualified to perform their
assigned duties (Sec. 507.4(a)(2)).
We are not requiring training specific to the person's assigned
duties. Each establishment engaged in the manufacturing, processing,
packing and holding of food for animal consumption would already have
procedures in place to ensure that all individuals who manufacture,
process, pack, or hold animal food know how to do their jobs. However,
to emphasize that we expect all individuals who conduct such activities
to know how to do their jobs, we are specifying that each individual
engaged in manufacturing, processing, packing, or holding animal food
(including temporary and seasonal personnel) or in the supervision
thereof must have the education, training, or experience (or
combination thereof) necessary to manufacture, process, pack, or hold
safe animal food as appropriate to the individual's assigned duties
(Sec. 507.4(b)(1)). To better align with the forthcoming FSVP rule, we
are using the term ``qualified individual'' in new Sec. 507.4(b)(1)
and are defining the term ``qualified individual'' to mean a person who
has the education, training, or experience (or combination thereof)
necessary to manufacture, process, pack, or hold safe animal food as
appropriate to the individual's assigned duties. A qualified individual
may be, but is not required to be, an employee of the establishment.
See the discussion of the term ``preventive controls qualified
individual'' in section VIII.A.10, including a discussion of how we
have changed the proposed term ``qualified individual'' to ``preventive
controls qualified individual'' because we are establishing a new
definition for ``qualified individual,'' with a meaning distinct from
``preventive controls qualified individual.''
We also are requiring that each individual engaged in
manufacturing, processing, packing, or holding animal food (including
temporary and seasonal personnel) or in the supervision thereof,
receive training in the principles of animal food hygiene and animal
food safety, including the importance of employee health and personal
hygiene, as appropriate to the animal food, the facility and the
person's assigned duties (see Sec. 507.4(b)(2)). Records that document
this required training must be established and maintained and are
subject to the recordkeeping requirements of subpart F (Sec.
507.4(d)). The rule does not specify the frequency
[[Page 56208]]
of the required training. We expect that production employees will
receive training before working in production operations. We expect
that most facilities will also provide some form of refresher training.
We disagree that we should continue to only provide recommendations
for education and training. Although the comments express concern about
overly prescriptive requirements that may not consider variables that
would affect an establishment's training program (such as training
course content, training provider, effectiveness of the course and
instructor and frequency of training per topic, an employee's type and
length of experience, nature of formal education, and the animal food
product type and point in the animal food supply chain at which the
employee works with the animal food product), the training requirement
we are establishing in the rule provides flexibility for each
establishment to provide training, and determine the scope and
frequency of the training, in a way that works best for the
establishment.
We agree that it is appropriate to establish training requirements
so that the requirements apply to all establishments that manufacture,
process, pack, or hold animal food, including establishments that are
not subject to FSMA's requirements for hazard analysis and risk-based
preventive controls, and we are establishing the qualification and
training requirements in subpart A to clarify the applicability of
these requirements to all establishments and facilities subject to part
507. Although we agree that employees in facilities that are subject to
the requirements for hazard analysis and risk-based preventive controls
need to understand their responsibilities under the facility's food
safety plan, we are setting forth a training requirement focused on the
principles of animal food hygiene and animal food safety. We consider
training in the principles of animal food hygiene and animal food
safety, including the importance of employee health and personal
hygiene, to be fundamental to the concept of CGMPs. We agree that
establishing a training requirement in both subpart B and subpart C
could be confusing.
(Comment 93) Some comments agree that training should be documented
and assert that those records should show the date of training, a
description of the training, and the name of the person trained.
However, comments ask that we allow flexibility in the way these
records are kept. Other comments assert that requiring that records
document required training of personnel is burdensome, arbitrary, and
capricious.
(Response 93) The rule requires that records that document training
required by Sec. 507.4(b)(2) be established and maintained without
prescribing any content of those records. Although one approach to
documenting training would be to provide the date of training, a
description of the training, and the name of the person trained, the
rule provides flexibility for each establishment to document its
training in a way that works best for that establishment. We disagree
that requiring records to document required training is burdensome,
arbitrary, and capricious in light of the flexibility provided by the
rule for the content of training records.
(Comment 94) Some comments agree that any requirements should
include training appropriate to the person's duties but emphasize that
the decision as to what is appropriate to the person's assigned duties
should be determined by the establishment.
(Response 94) The requirement for employees to receive training in
the principles of animal food hygiene and animal food safety, including
the importance of employee health and personal hygiene, as appropriate
to the person's assigned duties, provides flexibility for the
establishment to provide training that is appropriate for its employees
in light of each person's assigned duties. However, the rule does not
require training specific to the person's assigned duties.
(Comment 95) Some comments assert that the training requirement
would be an unreasonable burden for small businesses and that companies
may incur substantial cost for the time that workers would be in
training rather than in production. Some comments ask us to provide
non-specific training recommendations for smaller processors that need
flexibility to control the cost of training. Some comments assert that
the training and education requirements must be accessible and flexible
enough to allow employers to bring in temporary help when demand is
high without causing a delay in hiring.
(Response 95) All employees will need enough training to do their
job and understand the importance of hygiene for animal food safety.
The training offered does not need to be expensive (e.g., offsite
training or off-the-shelf purchased training) and we expect that much
of the training will be provided in-house by knowledgeable employees.
As discussed in Response 1, the FSPCA is developing a preventive
controls training curriculum. These training materials will be
available online, and we expect these training materials to be useful
to small businesses to use for in-house training.
B. Additional Requirements Applicable to Supervisory Personnel (Final
Sec. 507.4(c))
We proposed that responsibility for ensuring compliance by all
personnel with all requirements of this subpart must be clearly
assigned to competent supervisory personnel in Sec. 507.14(c). We are
finalizing this provision in Sec. 507.4(c). We are correcting ``all
requirements of this subpart'' to ``all requirements of this part.'' As
a conforming change for consistency with the provisions of Sec.
507.4(b), we are replacing the phrase ``competent supervisory
personnel'' with the phrase ``supervisory personnel who have the
education, training, or experience (or a combination thereof) necessary
to supervise the production safe animal food.''
X. Subpart A: Comments on Proposed Sec. 507.5--Exemptions
We proposed to establish a series of exemptions from the
requirements for hazard analysis and preventive controls that would be
established in subpart C, with modified requirements in some cases.
Some comments support one or more of the proposed exemptions
without change. For example, some comments note that the exemptions are
specified in FSMA and, thus, reflect the intent of Congress. Some
comments state that some exemptions (i.e., those for products already
subject to our regulations for the control of microbiological hazards
for low-acid canned foods (LACF)) make sense because they are risk-
based. Other comments that support one or more of the proposed
exemptions ask us to clarify particulars associated with these
exemptions or expand the scope of some of these exemptions. Other
comments ask us to include additional exemptions in the rule.
In the remainder of this section, we discuss comments that ask us
to clarify the proposed exemptions or that disagree with, or suggest
one or more changes to, the proposed exemptions. We also discuss
comments that ask us to include additional exemptions in the rule.
After considering these comments, we have revised the proposed
exemptions as shown in table 6 with editorial and conforming changes as
shown in table 31. A key conforming change that affects all proposed
exemptions from the requirements of subpart C is that the final
exemptions are from the requirements of subpart E,
[[Page 56209]]
as well as subpart C. As discussed in section XL, the final rule
establishes the requirements for a supply-chain program in subpart E,
rather than within subpart C as proposed.
Table 6--Revisions to the Proposed Exemptions
----------------------------------------------------------------------------------------------------------------
Section Exemption Modification
----------------------------------------------------------------------------------------------------------------
507.5(e)........................ From the requirements of subpart Changes consequential to the
C for on-farm packing or holding revised ``farm'' definition--i.e., no
of food by a small or very small longer identifying any packing or holding
business if the only packing and activities for any RACs.
holding activities subject to Clarification that the modified
section 418 of the FD&C Act that requirements do not apply to on-farm
the business conducts are the packing or holding of food by a very small
specified low-risk packing or business if the only packing and holding
holding activity/animal food activities subject to section 418 of the
combinations. FD&C Act that the business conducts are
the listed low-risk packing or holding
activity/animal food combinations.
Updated animal food categories
consistent with the animal food categories
included in table 1 in the section
103(c)(1)(C) RA.
Additions of low-risk packing or
holding activity/animal food combinations
as a result of an updated risk assessment.
507.5(f)........................ From the requirements of subpart Changes consequential to the
C for on-farm manufacturing/ revised ``farm'' definition--i.e.:
processing activities conducted No longer distinguishing between
by a small or very small manufacturing/processing activities
business for distribution into conducted on a farm mixed-type facility's
commerce if the only own RACs and manufacturing/processing
manufacturing/processing activities conducted on food other than
activities subject to section the farm mixed-type facility's own RACs;
418 of the FD&C Act that the and
business conducts are the Eliminating activities, conducted
specified low-risk manufacturing/ on others' RACs, that would no longer be
processing activity/animal food classified as manufacturing/processing and
combinations. instead would be classified as harvesting,
packing, or holding.
Clarification that the modified
requirements do not apply to on-farm
manufacturing/processing activities
conducted by a very small business for
distribution into commerce, if the only
manufacturing/processing activities
subject to section 418 of the FD&C Act
that the business conducts are the listed
low-risk manufacturing/processing activity/
animal food combinations.
Updated animal food categories
consistent with the animal food categories
included in table 1 in the section
103(c)(1)(C) RA.
Additions of low-risk
manufacturing/processing activity/animal
food combinations as a result of an
updated risk assessment.
507.5(h)........................ From the requirements of subpart Change from an exemption for specific
B for the holding and activities (i.e., holding and
transportation of RACs. transportation of RACs) to facilities
solely engaged in those activities.
----------------------------------------------------------------------------------------------------------------
A. General Comments on the Proposed Exemptions
(Comment 96) Some comments ask us to provide the same flexibility
for foreign small businesses as for domestic small businesses.
(Response 96) The exemptions apply to both foreign small businesses
and domestic small businesses.
(Comment 97) Some comments ask us to clarify whether an
establishment that is exempt from the requirements for hazard analysis
and risk-based preventive controls in subpart C remains subject to the
CGMP requirments in subpart B.
(Response 97) An establishment that is exempt from the requirements
for hazard analysis and risk-based preventive controls in subparts C
and E remains subject to the CGMP requirements in subpart B, unless
that establishment is specifically exempt from subpart B under Sec.
507.5(a) (which applies to farms and activities of ``farm mixed-type
facilities'' that fall within the definition of ``farm''); or Sec.
507.5(h) (which applies to: (1) Establishments solely engaged in the
holding or transportation of one or more RACs; (2) hulling, shelling,
and drying nuts and hulls (without manufacturing/processing, such as
grinding shells or roasting nuts); and (3) ginning of cotton (without
manufacturing/processing, such as extracting oil from cottonseed)).
(Comment 98) Some comments request that we clearly articulate what
activities are not covered and why; as well as what activities we are
specifically exempting and why. This comment requests clarification
about the differences between the categories of ``not covered'' and
``exempt.''
(Response 98) We use the terms ``not covered'' and ``exempt''
interchangeably to describe what animal food operations or activities
within an operation are not required to comply with all or parts of
this rule. Farms, for example, are ``not covered'' by this rule, as
established in Sec. 507.5, which lists certain exemptions. As another
example, a business meeting the very small business criteria is a
qualified facility subject to the requirements of Sec. 507.7, but
``exempt'' from the requirements of subparts C and E (see Sec.
507.5(d)). Whether a particular exemption applies to an animal food
operation depends on the type of operation and the activities it is
conducting. We believe the exemptions as codified provide enough
specificity for a facility to determine whether it must comply with or
is exempt from this final regulation, or certain provisions of the
final regulation.
(Comment 99) One comment expressed the opinion that exemptions
should be driven by risk of activities rather than by whether they are
conducted on or off a farm.
(Response 99) Consistent with the statutory direction in section
103(c) of FSMA, including conducting a qualitative risk assessment, we
have finalized exemptions for on-farm activity/animal food combinations
conducted by farm-mixed-type facilities that are small or very small
businesses as discussed further in sections VI and X.
B. Proposed Sec. 507.5(a)--Exemption for Facilities Not Required To
Register Under Section 415 Regulations
We proposed that this part does not apply to establishments,
including ``farms'' (as defined in Sec. 1.227 of this
[[Page 56210]]
chapter), that are not required to register under section 415 of the
FD&C Act. However, we proposed that subpart B would apply to the
packaging, packing, and holding of dried commodities if a ``farm'' or
``farm mixed-type facility'' dries/dehydrates raw agricultural
commodities that are produce to create a distinct commodity.
After reviewing all of the comments concerning raw agricultural
commodities as discussed elsewhere in this final rule, we have removed
the requirement that subpart B would apply to the packaging, packing,
and holding of dried commodities from a ``farm'' or ``farm mixed-type
facility'' that dries/dehydrates RACs that are produce to create a
distinct commodity. We have made this change because produce RACs are
not typically dried or dehydrated to create distinct animal food
commodities, as they are to create human food commodities (e.g.,
drying/dehydrating grapes to make raisins).
(Comment 100) One comment requests that we provide clarity and
examples for animal food facilities that are exempt from facility
registration and therefore exempt from compliance with part 507 because
they are considered restaurants or retail food establishments.
(Response 100) Our food facility registration requirements are
found in 21 CFR part 1, subpart H. Specifically, ``restaurant'' and
``retail food establishment'' are defined in 1.227(b). Additional
information may be found in our ``Guidance for Industry: Questions and
Answers Regarding Food Facility Registration (Sixth Edition)'' (Ref.
23). As discussed in section I.E. of the final rule for preventive
controls for human food published elsewhere in this issue of the
Federal Register, we are addressing the requirements of section 102(c)
of FSMA in a separate rulemaking and issued a separate proposed rule to
amend the definition of ``retail food establishment'' in the section
415 registration regulations and the section 414 recordkeeping
regulations (80 FR 19160, April 9, 2015).
C. Proposed Sec. 507.5(b)--Exemption Applicable to Food Subject to 21
CFR Part 113--Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers
We proposed that activities in animal food facilities that are
regulated under and are in compliance with Sec. 500.23 and part 113
would be exempt from subpart C only with respect to microbiological
hazards regulated under part 113. We further proposed that the
facilities must comply with subparts C and F with regard to all other
potential hazards and must comply with subparts A and B. We requested
comment on the criteria that should be used to determine whether a
facility is in compliance with Sec. 500.23 and part 113 (78 FR 64736
at 64762).
(Comment 101) Some comments express concern that the partial
exemption for products subject to part 113 could generate confusion for
both regulators and regulated facilities. These comments also assert
that the partial exemption for products subject to part 113 would
generate duplicative recordkeeping requirements under the two rules.
(Response 101) We acknowledge the potential for confusion and
expect any confusion to decrease over time as both regulators and
facilities gain experience with the new requirements. We also expect
that in most instances a facility that is subject to Sec. 500.23 and
part 113, and that evaluates potential microbiological hazards as part
of its hazard analysis, would conclude that the potential hazards are
controlled by the targeted requirements of part 113 and conclude there
are no significant microbiological hazards that require preventive
controls to significantly minimize or prevent the hazards.
We disagree that the partial exemption for products subject to part
113 would generate duplicative recordkeeping requirements. The
requirements of part 113 to control biological hazards are different
from the requirements of subparts C and E to conduct a hazard
evaluation for chemical and physical hazards, and implement preventive
controls and associated preventive control management components to
address significant chemical and physical hazards. Likewise, the
records associated with the control of biological hazards under part
113 are not the same as the records associated with a hazard analysis,
preventive controls, and associated preventive control management
components for control of chemical and physical hazards. However, to
the extent that a facility determines that existing records required by
part 113 can be used to comply with the requirements of subparts C and
E, a facility may rely on those records (see Sec. 507.212).
(Comment 102) Some comments ask us to provide guidance to industry
and the regulatory community regarding the criteria that will be used
to determine when a facility is ``in compliance with'' part 113.
(Response 102) As an example, an LACF manufacturing facility that
has ongoing problems controlling biological hazards may be better able
to address biological hazards by preparing and implementing a written
food safety plan. As with facilities subject to our HACCP regulations,
we expect that situations in which enforcement actions to ensure
compliance with part 113 are insufficient to correct problems, and lead
to a facility losing its exemption from the requirements of subparts C
and E, will be rare and will depend on very specific circumstances.
Therefore, at this time we do not anticipate issuing guidance on when
violations of part 113 could lead to this outcome.
D. Proposed Sec. 507.5(c)--Exemption Applicable to Activities Subject
to Standards for Produce Safety in Section 419 of the FD&C Act
We proposed that subpart C would not apply to activities of a
facility that are subject to section 419 of the FD&C Act (Standards for
Produce Safety) of the FD&C Act (21 U.S.C. 350h).
(Comment 103) Some comments request that we broaden the exemption
to operations that handle culls of raw, intact, fresh produce. One
comment requested that fresh citrus be considered a low risk product or
excluded from the rule entirely. This comment requested that culls
should not be considered a by-product of fresh citrus production.
(Response 103) We decline these requests. We have included a
provision under Sec. 507.12 that exempts by-products of off-farm
packing and holding of RACs for animal food use from most of part 507
if ``the human food facility is subject to and in compliance with Sec.
117.8 of part 117, and in compliance with all applicable human food
safety requirements of the Federal Food, Drug, and Cosmetic Act and
implementing regulations.'' The human food facility also must not
further manufacture or process the by-products intended for use as
animal food. The resulting animal food must be held and distributed in
accordance with the CGMPs for the holding and distribution of human
food by-products for use as animal food in Sec. 507.28 and Sec.
117.95. Thus, facilities subject to and in compliance with Sec. 117.8
and applicable safety requirements of the FD&C Act and its implementing
regulations, that pack or hold produce culls off-farm for use as animal
food (without manufacturing or processing the culls) would be exempt
from part 507, except for the limited holding and distribution CGMPs in
Sec. 507.28. Facilities that manufacture or process culls of raw,
intact, fresh produce for use as animal food would be subject to part
507. Activities, such as packing fresh citrus, of a facility that is
subject to section 419 of the FD&C Act are exempt from subparts C.
[[Page 56211]]
E. Proposed Sec. 507.5(d)--Exemption Applicable to a Qualified
Facility
We proposed that subpart C would not apply to a qualified facility,
except as provided by subpart D (Withdrawal of an Exemption Applicable
to a Qualified Facility), and that qualified facilities would be
subject to the requirements in Sec. 507.7.
(Comment 104) Some comments support the proposed exemption for a
qualified facility. Other comments oppose this proposed exemption,
asserting that it is not risk based and expressing concern that
qualified facilities would cause significant food safety problems. Some
comments ask us to strictly construct and narrowly apply the exemptions
to as few businesses as possible.
Some comments do not agree that qualified facilities should be
subject to modified requirements because even the modified requirements
are burdensome. Some comments assert that qualified facilities having
an average annual value of animal food sold during the previous 3-year
period of $10,000 or less should be exempt from all requirements
related to hazard analysis and risk-based preventive controls,
including modified requirements. One comment does not specify an amount
of annual sales of animal food, but states that whether a facility is a
qualified facility should be based on whether the facility has caused
any reported injury or illness to humans or animals.
(Response 104) The exemption for qualified facilities, including
the criteria for being a qualified facility and the applicability of
modified requirements, is expressly directed by section 418(l) of the
FD&C Act. In defining ``very small business'' to mean a business
(including any subsidiaries or affiliates) averaging less than
$2,500,000, adjusted for inflation, per year, during the 3-year period
preceding the applicable calendar year in sales of animal food plus the
market value of animal food manufactured, processed, packed, or held
without sale (e.g., held for a fee or supplied to a farm without sale),
we constructed this exemption to apply to businesses that,
collectively, produce less than 2 percent of the dollar value of animal
food produced in the United States. This is comparable to the
percentage of the human food supply that is exempt under the definition
of very small business for human food (see section XI.B of the final
rule for preventive controls for human food published elsewhere in this
issue of the Federal Register). As previously discussed in section
VIII.A.36, the businesses that will be exempt from the requirements for
hazard analysis and risk-based preventive controls, and will instead be
subject to other requirements, will produce a small portion of the
animal food at potential risk of causing foodborne illness (see the
discussion at 79 FR 58476 at 58502).
(Comment 105) Some comments assert that a qualified facility should
be exempt from the CGMP requirements of subpart B, as well as the
requirements for hazard analysis and risk-based preventive controls in
subpart C.
(Response 105) The exemption for qualified facilities is expressly
directed by section 418(l) of the FD&C Act and is limited to an
exemption from the requirements for hazard analysis and risk-based
preventive controls in subparts C and E. The comments provide no basis
for why new statutory requirements for hazard analysis and risk-based
preventive controls should in any way impact CGMP requirements that
apply to the manufacturing, processing, packing, and holding of animal
food. CGMPs provide the basic requirements for ensuring production of
safe animal food. Following the CGMPs is essential to properly address
public (human and animal) health risks from very small facilities that
are provided an exemption from subparts C and E in order to minimize
the burden on such facilities.
(Comment 106) Some comments ask us to provide that a qualified
facility may voluntarily choose to comply with the requirements for
hazard analysis and preventive controls.
(Response 106) A qualified facility may voluntarily choose to
comply with the requirements for hazard analysis and risk-based
preventive controls without a specific provision authorizing it to do
so. One way that a qualified facility could comply voluntarily would be
to simply not submit the attestation that it is a qualified facility
(see Sec. 507.7(b) for the requirement for a qualified facility to
submit an attestation regarding its status as a qualified facility).
When we inspect the facility, we would inspect the facility for
compliance with the requirements for hazard analysis and risk-based
preventive controls. Another way for a facility to voluntarily comply
would be to submit the attestation, and specify that it will satisfy
the statutory documentation requirement through documentation of its
food safety practices rather than documentation that it is in
compliance with non-Federal food safety law.
(Comment 107) Some comments ask us to specify in guidance that a
qualified facility is not required to prepare and implement a food
safety plan.
(Response 107) We intend to recommend in guidance how a qualified
facility could comply with the requirements in Sec. 507.7 without
satisfying all of the requirements in subparts C and E.
F. Proposed Sec. 507.5(e) and (f)--Exemptions Applicable to On-Farm
Low-Risk Activity/Animal Food Combinations Conducted by a Small or Very
Small Business
As discussed in section VI.A, consistent with the statutory
direction in section 103(c) of FSMA, including conducting a qualitative
risk assessment, we proposed three exemptions for on-farm activity/food
combinations conducted by farm-mixed-type facilities that are small or
very small businesses (proposed Sec. Sec. 507.5(e), (f)(1), and
(f)(2)).
1. General Comments on the Proposed Exemptions Applicable to On-Farm
Low-Risk Activity/Animal Food Combinations Conducted by a Small or Very
Small Business
(Comment 108) Some comments assert that conducting a low-risk
activity/food combination should be sufficient to qualify any facility
for exemption from subpart C, regardless of whether the activity is
conducted on-farm or off-farm, or meets the economic threshold for a
small or very small business.
(Response 108) The statute provides specific direction for those
facilities that can qualify for this exemption. (See sections 418(l)
and 418(o)(2) of the FD&C Act.) See also Response 104 in this final
rule, and Responses 220 and 222 in the final rule for preventive
controls for human food published elsewhere in this issue of the
Federal Register.
(Comment 109) Some comments state that the exemptions for farming
activities are confusing.
(Response 109) The activity/animal food combinations listed in
Sec. 507.5(e) are directed to an exemption for packing and holding
activities, whereas the activity/animal food combinations listed in
Sec. 507.5(f) are directed to an exemption for manufacturing/
processing activities. Although these exemptions are more complex than
other exemptions (e.g., because they are directed to specific
activities conducted on specific animal foods), the final ``farm''
definition has simplified them to the extent practicable. For example,
under the ``farm'' definition in the 2013 proposed human preventive
controls rule, whether an activity was packing or manufacturing/
processing depended, in part, on whether the RACs being packed
[[Page 56212]]
were the farm's own RACs or others' RACs. In contrast, under the
``farm'' definition established in the final rule for preventive
controls for human food published elsewhere in this Federal Register,
packing RACs is a ``packing'' activity, regardless of ownership of the
RACs being packed.
(Comment 110) Some comments note a distinction between the
exemptions for on-farm low-risk activity/animal food combinations
conducted by small and very small businesses and the exemption for
qualified facilities. Specifically, the comments state that a farm
mixed-type facility that only conducts low-risk activity/animal food
combinations (such as grinding grains) would be exempt from the
requirements of subpart C, whereas an off-farm qualified facility
grinding grains, while exempt from the requirements of subpart C, would
nonetheless be subject to the requirements for a qualified facility in
Sec. 507.7. These comments ask whether it would be better for a farm
or farm mixed-type facility that satisfies criteria for a small or very
small business, and also satisfies criteria for a qualified facility,
to classify itself as a small or very small business or to classify
itself as a qualified facility.
(Response 110) In light of the final ``farm'' definition, these
comments no longer apply with respect to activities within the farm
definition.
For activities conducted by a farm mixed-type facility, we
acknowledge that the exemptions provided by Sec. 507.5(e) and (f) for
on-farm low-risk activity/animal food combinations are different from
the exemption provided by Sec. 507.5(a) for a qualified facility. A
farm mixed-type facility that only conducts low-risk activity/animal
food combinations listed in Sec. 507.5(e) and (f) is fully exempt from
the requirements of subparts C and E, and is not subject to the
requirements for a qualified facility in Sec. 507.7, even if that farm
mixed-type facility is also a very small business (and, thus, also is a
qualified facility). To make this clear, we have revised proposed Sec.
507.5(e) to specify that Sec. 507.7 does not apply to on-farm packing
or holding of animal food by a very small business if the only packing
and holding activities subject to section 418 of the FD&C Act that the
business conducts are the listed low-risk packing or holding activity/
animal food combinations. Likewise, we have revised proposed Sec.
507.5(f) to specify that Sec. 507.7 does not apply to on-farm
manufacturing/processing activities conducted by a very small business
for distribution into commerce, if the only manufacturing/processing
activities subject to section 418 of the FD&C Act that the business
conducts are the listed low-risk manufacturing/processing activity/
animal food combinations.
With these changes, a farm mixed-type facility that is a very small
business and that only conducts the low-risk activity/animal food
combinations listed in Sec. 507.5(e) and/or (f) may find it
advantageous to classify itself as a very small business eligible for
the exemption in Sec. 507.5(e) and/or (f) rather than as a qualified
facility, which would be subject to the requirements in Sec. 507.7.
(Comment 111) Some comments ask for a process to keep the list of
low-risk activity/food combinations up to date, such as through
guidance.
(Response 111) We decline this request. The exemptions established
in this rule are binding, whereas any list of additional activity/
animal food combinations established in a guidance document would not
be binding. We established the list of activity/animal food
combinations included in these exemptions through an extensive public
process, including a request for comments on the section 103(c)(1)(C)
draft RA. From this time forward, the process available to a person who
wishes us to consider an additional activity/animal food combination is
to submit a citizen petition in accordance with 21 CFR 10.30.
2. Proposed Sec. 507.5(e)--Exemption Applicable to On-Farm Low-Risk
Packing or Holding Activity/Animal Food Combinations Conducted by a
Small or Very Small Business
We proposed that subpart C would not apply to on-farm packing or
holding of animal food by a small or very small business if the only
packing and holding activities subject to section 418 of the FD&C Act
that the business conducts are low-risk packing or holding activity/
animal food combinations on animal food not grown, raised, or consumed
on that farm mixed-type facility or another farm or farm mixed-type
facility under the same ownership.
(Comment 112) Many comments state that it is common practice among
farms to hold RACs from farms under different ownership and that
classifying establishments as being within the ``farm'' definition, or
outside the ``farm'' definition, based on who owns the RACs being
packed is not a risk-based classification.
(Response 112) We proposed a revised definition of ``farm'' in the
2014 preventive controls supplemental notice for human food to include
packing and holding of RACs grown on another farm not under the same
ownership (79 FR 58524 at 58531 through 58532). As a consequential
change in light of the final ``farm'' definition established in the
final rule for preventive controls for human food published elsewhere
in this Federal Register, the exemption no longer identifies any
packing or holding activities for any RACs (whether the farm's own RACs
or others' RACs), because an on-farm establishment would no longer be
subject to the requirements for hazard analysis and risk-based
preventive controls (subpart C) when it packs or holds RACs, regardless
of whether it is packing and holding its own RACs or others' RACs. In
light of the change in the ``farm'' definition, we have revised the
section 103(c)(1)(C) RA, starting with the list of on-farm activity/
animal food combinations outside the farm definition in table 1, to
exclude packing and holding of RACs.
3. Proposed Sec. 507.5(f)--Exemption Applicable to On-Farm Low-Risk
Manufacturing/Processing Activity/Animal Food Combinations Conducted by
a Small or Very Small Business
We proposed that subpart C would not apply to on-farm low-risk
manufacturing/processing activities conducted by a small or very small
business if the only manufacturing/processing activities subject to
section 418 of the FD&C Act that the business conducts are those listed
in the proposed exemption. The proposed exemption specified those
activity/animal food combinations that would be exempt when conducted
on a farm mixed-type facility's own RACs and those activity/animal food
combinations that would be exempt when conducted on animal food other
than the farm mixed-type facility's own RACs for distribution into
commerce.
As a consequential change in light of the final ``farm''
definition, the final exemption no longer distinguishes between
manufacturing/processing activities conducted on a farm mixed-type
facility's own RACs and manufacturing/processing activities conducted
on animal food other than the farm mixed-type facility's own RACs. As
another consequential change, the exemption has been revised to
eliminate activities, conducted on others' RACs, which no longer are
classified as manufacturing/processing and instead are classified as
harvesting, packing, or holding. In addition, we have revised the final
exemption to list animal food categories consistent with the animal
food categories included in table 1 in the section 103(c)(1)(C) RA
(Ref. 3), modified in response to revisions of the ``farm'' definition.
(See Response 112.) In constructing
[[Page 56213]]
categories of animal food based upon the new ``farm'' definition, we
grouped together processed grain products (e.g., flour, grits, etc.)
and grain by-products (e.g., brewers' grain, distillers' grain, and
corn gluten meal). The category does not include culled products from
processing grain for human food such as misshapen pasta. Pasta used in
animal food falls under a new category (any other animal food that does
not require time/temperature control for safety) that was added to
include the wide range of possibilities for animal food that was
originally processed to be human food, as well as other types of animal
food not listed separately.
(Comment 113) Some comments ask us to include in the exemption a
single list of low-risk manufacturing/processing activity/food
combinations applicable to farm mixed-type facilities conducting
activities on their own RACs and farm mixed-type facilities conducting
activities on other's RACs.
(Response 113) These comments no longer apply. As a consequence of
the ``farm'' definition established by the final rule for preventive
controls for human food published elsewhere in this Federal Register,
the exemption no longer distinguishes between manufacturing/processing
activities conducted on a farm mixed-type facility's own RACs and
manufacturing/processing activities conducted on animal food other than
the farm mixed-type facility's own RACs.
(Comment 114) Some comments ask us to include manufacturing of
animal food from low risk ingredients as additional activity/animal
food combinations in the exemption. Other comments support our
conclusion that manufacturing animal food ready for consumption is not
a low risk activity.
(Response 114) We evaluated manufacturing of animal food as one of
the activity/animal food combinations within the qualitative risk
assessment (Ref. 3). The 103(c)(1)(C) RA explains why we determined
that manufacturing animal food ready for consumption is not a low-risk
activity/animal food combination.
G. Proposed Sec. 507.5(g)--Exemption Applicable to Facilities Solely
Engaged in Storage of Raw Agricultural Commodities Other Than Fruits
and Vegetables Intended for Further Distribution or Processing
We proposed that subpart C would not apply to facilities that are
solely engaged in the storage of RACs (other than fruits and
vegetables) intended for further distribution or processing. In the
following paragraphs, we discuss comments that ask us to clarify how
the proposed exemption would apply to specific circumstances.
(Comment 115) Some comments ask whether this proposed exemption
(proposed Sec. 507.5(g)) would apply to facilities such as peanut
buying points or bean elevators and assert that such commodities are
analogous to grains and the activities conducted at such facilities are
analogous to those performed by grain elevators.
(Response 115) We classify peanuts and beans (such as kidney beans,
lima beans, and pinto beans) within the category of ``fruits and
vegetables''; we classify soybeans as grain (see the discussion of
grains at 78 FR 64736 at 64764 and 79 FR 58476 at 5848, and fruits and
vegetables at 78 FR 3646 at 3690 and proposed Sec. Sec. 112.1 and
112.2 in the proposed produce safety rule). The exemption for
facilities solely engaged in storage of RACs intended for further
distribution or processing does not apply to facilities that store
fruit and vegetable RACs and, thus, does not apply to facilities such
as peanut buying points and bean elevators. As discussed in section
IV.B, we have revised the ``farm'' definition to provide that an
operation devoted only to the harvesting (such as hulling or shelling),
packing, and/or holding of RACs is within the ``farm'' definition,
provided that the farms that grow or raise the majority of the RACs
harvested, packed, and/or held by the operation own, or jointly own, a
majority interest in the operation. With this revision, some operations
dedicated to holding RACs, including fruit and vegetable RACs, will be
within the ``farm'' definition.
Peanut buying points and bean elevators that do not meet the
revised farm definition are storing RACs that are ``fruits and
vegetables'' and do not meet the criteria for exemption under Sec.
507.5(g). However, we would not expect such facilities to need an
extensive food safety plan. A facility that appropriately determines
through its hazard analysis that there are no hazards requiring
preventive controls would document that determination in its written
hazard analysis but would not need to establish preventive controls and
associated management components.
(Comment 116) One comment states that genetically modified food
should be added to the list of hazards that are seen as potential risks
for animals.
(Response 116) We decline this request. We have not seen evidence
that foods derived from genetically engineered plants differ from other
foods in any meaningful or uniform way, or that, as a class, such foods
present different or greater safety concerns than their non-genetically
engineered counterparts. We have a voluntary consultation process for
foods derived from genetically engineered plants through which we
engage with the developers of genetically engineered plants to help
ensure the safety of the derived foods. Foods that have undergone this
consultation process are as safe as foods from conventionally bred
plants. Foods derived from genetically engineered plants, irrespective
of the method of development, are subject to the same food safety and
other regulatory requirements as foods derived from conventionally-bred
plants. Therefore genetically engineered foods do not need to be
singled out as a hazard.
(Comment 117) Some comments assert that the exemption for storage
of raw agricultural commodities (other than fruits and vegetables)
should extend to those distinct and physically separate portions of
oilseed processing facilities that are devoted solely to RAC storage.
According to these comments, in the overwhelming majority of cases the
inclusion of a separate RAC storage area in the same building as the
oilseed processing area will not introduce additional risk either to
the processing area or to the operations that take place there and that
storage areas, whether standing alone as a separate facility or
incorporated into a larger processing facility, store RACs safely.
These comments ask us to recognize that storage activities may include
grain drying to standardize moisture levels and preserve product
quality.
(Response 117) The activities included within the definition of
holding include activities that are performed as a practical necessity
for the distribution of RACs. In the 2014 supplemental notice, we
explained that facilities that conduct operations similar to those
conducted at grain elevators and silos, such as some facilities that
hold oilseeds, may satisfy the criteria for exemption if activities
other than storage are performed as a practical necessity for the
distribution of RACs (see 79 FR 58476 at 58483 and the definition of
``holding'' in Sec. 507.3). Examples of holding activities include
drying/dehydrating RACs when the drying/dehydrating does not create a
distinct commodity (see Sec. 507.3). Thus, the specific example of
drying grains to standardize moisture levels and preserve product
quality would fall within the definition of holding as a practical
necessity for the distribution of RACs. A facility that stores
oilseeds, and dries them as a practical necessity for the distribution
of RACs, would be covered by the exemption in Sec. 507.5(g).
[[Page 56214]]
However, we decline the request to modify the exemption in Sec.
507.5(g) to also apply to distinct and physically separate storage
areas that are used solely for storage of RACs (other than fruits and
vegetables) intended for further distribution or processing. To the
extent that the comments are asking us to do so to provide for
facilities that conduct activities as a practical necessity for the
distribution of RACs to be eligible for the exemption, doing so is not
necessary in light of the definition of holding. To the extent that the
comments are asking us to do so to provide for facilities that conduct
manufacturing/processing activities in addition to holding activities,
we disagree that doing so would be consistent with the statutory
direction in FSMA. As previously discussed, section 418(m) of the FD&C
Act provides in relevant part that we may by regulation exempt or
modify the requirements for compliance under section 418 of the FD&C
Act with respect to facilities that are solely engaged in the storage
of RACs (other than fruits and vegetables) intended for further
distribution or processing (78 FR 64736 at 64764). The plain meaning of
``solely'' is only, completely, entirely; without another or others;
singly; alone (Ref. 24). Facilities that conduct manufacturing/
processing activities in addition to holding activities are not
``solely'' engaged in the storage of RACs (other than fruits and
vegetables) intended for further distribution and processing.
(Comment 118) Some comments request that the language of Sec.
507.5(g) explicitly state that the exemption from subpart C would apply
to facilities that are solely engaged in the packing and holding of raw
agricultural commodities (other than fruits and vegetables) intended
for further distribution or processing. These comments indicate that
packing is frequently involved when a facility distributes raw
agricultural commodities that they have been holding. They cite the
Sec. 110.19(a) exemption from the human food CGMP regulation for
establishments ``engaged solely in the harvesting, storage, or
distribution of one or more `raw agricultural commodities' '' and
remark that in application of the regulation, the activity of packing
has been encompassed within the term ``distribution.'' In addition,
some comments ask that the exemption proposed in Sec. 507.5(g) be
extended to an exemption from subpart B, as well as from subpart C.
(Response 118) We decline the request to add the term ``packing''
to Sec. 507.5(g). As discussed in Response 117, the activities
included within the definition of holding include activities that are
performed as a practical necessity for the distribution of RACs. Under
Sec. 507.5(h), subpart B does not apply to the holding or
transportation of one or more RACs. (See section X.H.)
H. Proposed Sec. 507.5(h)--Exemption Applicable to the Holding or
Transportation of One or More Raw Agricultural Commodities
We proposed to provide that subpart B would not apply to the
holding or transportation of one or more RACs as defined in section
201(r) of the FD&C Act.
(Comment 119) Some comments ask us to include the term ``packing''
in Sec. 507.5(h) to say ``Subpart B of this part does not apply to the
packing and holding or transportation of one or more raw agricultural
commodities as defined in section 201(r) of the Federal Food, Drug, and
Cosmetic Act.''
(Response 119) We decline the request to add the term ``packing''
to Sec. 507.5(h). As discussed in Response 117, the activities
included within the definition of holding include activities that are
performed as a practical necessity for the distribution of RACs.
(Comment 120) Some comments ask us to clarify that CGMP
requirements (such as using protective coverings where necessary and
appropriate (Sec. 507.17(c)) do not apply to the bulk outdoor storage
of RACs for further processing.
(Response 120) We are returning to the longstanding approach that
the exemption applies to establishments ``solely engaged'' in specific
activities. Under the exemption we are establishing in Sec.
507.5(h)(1), those activities are holding and transportation of RACs.
We explain why in the following paragraphs.
These comments appear to interpret the proposed exemption in a way
that goes beyond the longstanding ``RAC exemption'' in the human food
CGMPs in Sec. 110.19 and is inconsistent with the intent in updating
Sec. 110.19 to adjust and clarify what activities fall within this
exemption based on experience and changes in related areas of the law
since issuance of this exemption from the CGMPs (78 FR 64736 at 64764
and 78 FR 3646 at 3710). The suggestion of these comments, i.e., that
CGMPs should not apply to the holding of RACS in a facility that
manufactures, processes, or packs RACs--would not make sense in some
circumstances and would create complex situations for establishments
(in determining how to comply with the CGMP requirements) and for
regulators (in determining how to enforce the CGMP requirements). For
example, it does not make sense for the part of a facility that holds
RACs prior to processing to be exempt and the parts of the facility
that are processing the RACs and storing them after processing to be
covered. Likewise, it does not make sense for part of a transportation
vehicle to be covered and part to be exempt.
By revising the proposed ``RAC exemption'' so that it applies only
to establishments ``solely engaged'' in the storage or transportation
of RACs, we are providing for a predictable framework for interpreting
exemptions for facilities ``solely engaged'' in other activities. For
example, as discussed in Comment 117, comments ask us to expand the
exemption (in Sec. 507.5(g)) from the requirements for hazard analysis
and risk-based preventive controls for facilities that are ``solely
engaged'' in the storage of RACs (other than fruits and vegetables)
intended for further distribution or processing to also apply to
distinct and physically separate storage areas that are used solely for
storage of such RACs. In our response, we noted that facilities that
conduct manufacturing/processing activities in addition to holding
activities are not ``solely engaged'' in the storage of such RACs (see
Response 117). In addition, as discussed in Comment 146, comments ask
us to apply the exemption (in Sec. 507.10) from the requirements for
hazard analysis and risk-based preventive controls for facilities that
are ``solely engaged'' in the storage of unexposed packaged food to
storage areas of facilities that also engage in food processing
activities, e.g., for distributors that are engaged in limited food
processing, such as blending seeds to make bird food. In our response,
we noted that such distributors are not ``solely'' engaged in the
storage of unexposed packaged animal food (see Response 146).
The exemption we are establishing in this rule for establishments
solely engaged in the storage or transportation of RACs remains
consistent with our announced intent to adjust and clarify what
activities fall within this exemption based, in part, on changes in
related areas of the law since this exemption from the CGMP
requirements was first issued. As discussed in section IV of the final
rule for preventive controls for human food, published elsewhere in
this issue of the Federal Register, we have made a number of changes to
the ``farm'' definition, including changes that provide for an
operation devoted to harvesting, packing, and/or holding of RACs to be
a ``farm'' (i.e., a ``secondary activities
[[Page 56215]]
farm'') (and, thus, be exempt from the CGMP requirements under Sec.
507.5(a)) even though the operation does not grow RACs (see Sec.
507.3). With this revised ``farm'' definition, some establishments
solely engaged in the ``storage'' of RACs will be exempt from the CGMP
requirements because they are a ``farm.'' For further discussion on
this provision, see section XI.J in the final rule for preventive
controls for human food.
I. Comments Requesting Additional Exemptions
(Comment 121) Some comments request additional exemptions from the
requirements for hazard analysis and risk-based preventive controls in
subpart C, the CGMP requirements of subpart B, or both.
(Response 121) We believe that our CGMP regulations, coupled with
implementation of FSMA's directives to focus more on preventing food
safety problems than on reacting to problems after they occur, will
play an important role in increasing animal food safety. We did not
propose any exemptions or exceptions from the requirements of subpart C
other than those authorized by section 103 of FSMA (78 FR 64736 at
64743 through 64744). We drew on our experience with the CGMP
regulation for human food and changes in related areas of the FD&C Act
since issuance of the CGMP regulation (78 FR 3646 at 3709 through 3711)
to adjust and clarify what activities fall within a longstanding
exclusion related to raw agricultural commodities (see Sec. 110.19)
and to modify the CGMPs for human food by-products for use as food for
animals.
(Comment 122) Some comments state that facilities that hull, shell,
and dry tree nuts without further processing could be characterized as
establishments engaged solely engaged in the harvesting, storage, or
distribution of one or more raw agricultural commodities. These
comments express an expectation that since hulled or shelled dried nuts
retain their raw agricultural commodity status, that facilities
hulling, shelling and drying tree nuts without further processing would
qualify for exemption under both proposed Sec. Sec. 507.5(g) and
507.5(h).
(Response 122) Hulling and shelling of tree nuts (such as walnuts,
almonds, and pistachios) are harvesting activities that are within the
``farm'' definition when conducted on a farm or farm mixed-type
facility. Drying/dehydrating RACs without creating a distinct commodity
(such as drying walnuts and hulls) is a holding activity that also is
within the ``farm'' definition when conducted on a farm or farm mixed-
type facility. As discussed in section IV.B of the final rule for
preventive controls for human food (published elsewhere in this issue
of the Federal Register) we have revised the ``farm'' definition to
provide that an operation, not conducted on a Primary Production Farm,
devoted to the harvesting (such as hulling or shelling), packing, and/
or holding of RACs is within the ``farm'' definition (as a ``secondary
activities farm''), provided that the primary production farm(s) that
grow or raise the majority of the RACs harvested, packed, and/or held
by the secondary activities farm own, or jointly own, a majority
interest in the operation. Non-farm facilities dedicated to the
hulling, shelling, and drying of nuts and hulls perform the same
activities as those performed by farms. When done on a primary
production farm or by a secondary activities farm, those activities
would not be subject to CGMPs. Furthermore, these activities do not
transform the RAC into a processed food. Therefore, we have added
regulatory text in Sec. 507.5(h) to provide an exemption from subpart
B for hulling, shelling, and drying nuts and hulls (without further
manufacturing/processing) by a non-farm hulling/shelling/drying
facility because of the similarity in the activities of a farm-owned
operation and a non-farm owned facility. However, non-farm facilities
are not exempt from subparts C and E under Sec. 507.5(g) as they are
not solely engaged in the storage of raw agricultural commodities. A
facility that appropriately determines through its hazard analysis that
there are no hazards requiring preventive controls would document that
determination in its written hazard analysis but would not need to
establish preventive controls and associated management components.
(Comment 123) Some comments state that ginning cotton to separate
cotton fiber from cotton seed is a low-risk harvesting activity.
Comments further note that since cotton seed used as animal food is a
by-product from the production of cotton lint, the cotton seed coming
from a ginning facility would not qualify as a human food by-product.
The comments request that facilities whose entire operation consists of
receiving and ginning cotton without further processing the cotton
seeds be exempt from both subpart C under Sec. 507.5(g) and subpart B
under Sec. 507.5(h).
(Response 123) Ginning cotton is a harvesting activity that is
within the ``farm'' definition when conducted on a farm or farm mixed-
type facility. Drying/dehydrating the cottonseed without further
processing is a holding activity that also is within the ``farm''
definition when conducted on a farm or farm mixed-type facility. (See
Response 122 for a discussion on modification to the farm definition).
When done on a primary production farm or by a secondary activities
farm, these activities (ginning, drying, dehydrating) would not be
subject to CGMPs, and these activities do not transform the RAC into a
processed food. Therefore, we have added regulatory text in Sec.
507.5(h)(2) to provide an exemption from subpart B for the ginning of
cotton (without further manufacturing/processing) by a non-farm cotton
ginning facility because of the similarity between a farm-owned
operation and a non-farm owned facility (See Response 122). However,
non-farm facilities are not exempt from subparts C and E under Sec.
507.5(g) as they are not solely engaged in the storage of raw
agricultural commodities. A facility that appropriately determines
through its hazard analysis that there are no hazards requiring
preventive controls would document that determination in its written
hazard analysis but would not need to establish preventive controls and
associated management components.
XI. Subpart A: Comments on Proposed Sec. 507.7--Requirements That
Apply to a Qualified Facility
As previously discussed (78 FR 64736 at 64765), sections
418(l)(2)(A) and (B) of the FD&C Act provide that a qualified facility
must submit two types of documentation to us. The first type of
required documentation relates to food safety practices at the
facility, with two options for satisfying this documentation
requirement. Under the first option, the qualified facility may choose
to submit documentation that demonstrates that it has identified
potential hazards associated with the animal food being produced, is
implementing preventive controls to address the hazards, and is
monitoring the preventive controls to ensure that such controls are
effective. Alternatively, under the second option, the qualified
facility may choose to submit documentation (which may include
licenses, inspection reports, certificates, permits, credentials,
certification by an appropriate agency (such as a State department of
agriculture), or other evidence of oversight), that the facility is in
compliance with State, local, county, or other applicable non-Federal
food safety law. The second type of required
[[Page 56216]]
documentation relates to whether the facility satisfies the definition
of a qualified facility.
If a qualified facility does not prepare documentation
demonstrating that it has identified potential hazards associated with
the animal food being produced, is implementing preventive controls to
address the hazards, and is monitoring the preventive controls to
ensure that such controls are effective, it must provide notification
to consumers of certain facility information by one of two procedures,
depending on whether an animal food packaging label is required on the
animal food.
Consistent with the statutory direction of section 418(l) of the
FD&C Act, we proposed the following requirements for qualified
facilities: (1) Submission of certain documentation (proposed Sec.
507.7(a)); (2) procedures for submission of the documentation (proposed
Sec. 507.7(b)); (3) the frequency of the submissions (proposed Sec.
507.7(c)); (4) notification to consumers in certain circumstances
(proposed Sec. 507.7(d)); and (5) applicable records that a qualified
facility must maintain (proposed Sec. 507.7(e)).
In the 2013 proposed preventive controls rule for animal food, we
tentatively concluded that a certified statement would be acceptable
for the purposes of satisfying the submission requirements of proposed
Sec. 507.7(a). We also requested comment on the efficiency and
practicality of submitting the required documentation using the
existing mechanism for registration of food facilities, with added
features to enable a facility to identify whether or not the facility
is a qualified facility.
Some comments support one or more of the proposed requirements
without change. For example, some comments state that our proposed
interpretation of the statutory term ``business address'' is consistent
with our use of the term ``business address'' in our regulations
regarding information that must be included in a prior notice for
imported food (Sec. 1.281). Some comments that support the proposed
provisions suggest alternative or additional regulatory text or ask us
to clarify how we will interpret the provision.
In this section, we discuss comments that ask us to clarify the
proposed requirements or that disagree with, or suggest one or more
changes to, the proposed requirements. We also address comments
discussing our tentative conclusion regarding the submission of
certified statements to FDA, including submitting certified statements
using the existing mechanism for registration of food facilities. After
considering these comments, we have revised the proposed requirements
as shown in table 7 with editorial and conforming changes as shown in
table 31.
As discussed in Response 76, we have revised the definition of very
small business to specify that it is based on an average (of sales plus
market value of animal food held without sale) during the 3-year period
preceding the applicable calendar year and, as a companion change, we
are explicitly requiring that a facility determine and document its
status as a qualified facility on an annual basis (see Sec.
507.7(c)(1)).
Table 7--Revisions to the Proposed Requirements for Qualified Facilities
----------------------------------------------------------------------------------------------------------------
Section Description Revision
----------------------------------------------------------------------------------------------------------------
507.7(a)............................. Documentation to be Specify that the submitted
submitted. documentation is an ``attestation.``
Add ``tribal'' as an example of
applicable non-Federal food safety law.
507.7(b)............................. Procedure for Update details regarding the electronic and
submission. paper submission of a form specific to the
attestation requirement.
507.7(c)............................. Frequency of New requirement to determine and
determination and document status as a qualified facility on an
submission. annual basis no later than July 1 of each
calendar year.
Specify that a facility that begins
manufacturing, processing, packing, or holding
animal food after September 17, 2019 must
submit the attestation before beginning such
operations.
Specify that a facility must notify FDA
of a change in status from ``not a qualified
facility'' to ``qualified facility'' by July 31
of the applicable calendar year.
Specify that when the status of a
facility changes from ``qualified facility'' to
``not a qualified facility'' based on the
annual determination, the facility must notify
FDA of that change in status using Form FDA
3942b by July 31 of the applicable calendar
year.
Specify that the required biennial
submissions of the attestations must be made
during a timeframe that will coincide with the
required biennial updates to facility
registration.
507.7(d)............................. Timeframe for When the status of a facility changes from
compliance with the ``qualified facility'' to ``not a qualified
requirements of facility,'' the facility must comply with
subparts C and E. subparts C and E no later than December 31 of
the applicable calendar year unless otherwise
agreed to by FDA and the facility.
507.7(e)............................. Notification to Conforming changes associated with the term
consumers. ``attestation.``
507.7(f)............................. Records................ Conforming changes associated with the term
``attestation.``
----------------------------------------------------------------------------------------------------------------
A. Comments on Submission of a Certification Statement
(Comment 124) Some comments ask us to clarify the distinction
between the documentation that would be submitted to FDA and the
records that a qualified facility relies on to support the submitted
documentation.
Some comments agree with our tentative conclusion to use certified
statements to satisfy the proposed submission requirements, noting that
it would save time and money and reduce the paperwork burden on
qualified facilities. Some comments ask us to revise the proposed
requirements to make this use of certified statements explicit in the
regulatory text.
Other comments disagree with our tentative conclusion to use
certified statements to satisfy the submission requirements. These
comments focus on the importance of actual copies of documents in
determining compliance with the documentation requirements and assert
that proof of qualification requires more than a checked box in an
online registration database. Some comments ask us to require that a
qualified facility affirm that it has the original documents on file
and available for FDA inspection. Other comments assert that requiring
qualified facilities to submit copies of the actual documentation would
enable us to
[[Page 56217]]
easily review food safety plans or inspection reports and to target our
compliance and enforcement activities to those qualified facilities
that pose a greater risk because of inadequate prevention measures or
deficient inspections.
(Response 124) We are affirming our tentative decision that we will
not require a qualified facility to submit to FDA as part of its
attestation the underlying documentation that establishes its
compliance. We agree that the underlying records are needed to
determine compliance with the documentation requirements and that a
qualified facility must retain the documents it is relying on to
support its attestation and make them available to us during
inspection. We also agree that the regulatory text needs to be explicit
regarding the required documentation and that we need to clearly
distinguish between the documentation that would be submitted to FDA
and the records that a qualified facility relies on to support the
submitted documentation. Therefore, we have made the following three
revisions to the proposed regulatory text.
First, we have revised proposed Sec. 507.7(a) to specify that the
submitted documentation is an ``attestation.'' Second, we have revised
proposed Sec. 507.7(b) to update details regarding the electronic and
paper submission of a form specific to this attestation requirement.
Third, we have revised proposed Sec. 507.7(e) (final Sec. 507.7(f))
to specify that you must maintain those records relied upon to support
the ``attestations'' that are required by Sec. 507.7(a).
We acknowledge that requiring submission of the actual
documentation would enable us to easily review food safety plans or
inspection reports and to target our compliance activities based on
information that we see in those food safety plans or inspection
reports. However, as discussed in Response 245, we are not requiring
that other facilities submit a ``facility profile'' that would allow us
to more broadly review food safety plans and target our compliance
activities based on information that we see in those food safety plans
and will instead explore other mechanisms to achieve the goals we
described in the 2013 proposed preventive controls rule for animal food
for a facility profile.
B. General Comments on Requirements That Apply to a Qualified Facility
(Comment 125) Some comments assert that the proposed requirements
would create a costly burden for qualified facilities (e.g.,
registering and making submissions to FDA) that would not be imposed on
other types of exempted facilities. Some of these comments question
whether the exemption for qualified facilities is meaningful in light
of the significant burden imposed by the proposed requirements. Some
comments contrast the proposed requirement for qualified facilities to
submit documentation to FDA with proposed requirements for all other
facilities to simply establish and maintain applicable records.
(Response 125) The submission requirements that we are establishing
in this rule for qualified facilities reflect the statutory framework
for qualified facilities (section 418(l)(2)(B) of the FD&C Act).
Although the submission requirements only apply to qualified
facilities, the reporting burden associated with submission of an
attestation is much lower than the recordkeeping burden for facilities
that are subject to the requirements for hazard analysis and risk-based
preventive controls (see section LVIII).
(Comment 126) Some comments ask us to minimize setting different
standards even though the requirements reflect express statutory
provisions.
(Response 126) These comments appear to be referring to the
statutory provisions of section 418(n)(3)(C) of the FD&C Act, which
specify that the regulations we establish to implement section 418 of
the FD&C Act acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to separate
foods. We disagree that the statutory provisions of section
418(n)(3)(C) are directly relevant to the submission requirements of
this rule for qualified facilities. The requirements for qualified
facilities, but not other facilities, to submit documentation to FDA
reflect different regulatory requirements. The different regulatory
requirements are directed at different facilities, and do not set
separate standards for particular animal foods. Regardless, even if the
statutory provisions of section 418(n)(3)(C) were relevant to the
submission requirements of qualified facilities, provisions of this
rule that reflect express statutory provisions would not conflict with
the statutory direction in section 418(n)(3)(C).
(Comment 127) Some comments emphasize that the requirements need to
ensure adequate protection of public health and state that we should
maintain and exercise oversight of qualified facilities. Some comments
ask that we provide enough specificity so that qualified facilities
know and understand their food safety responsibilities towards
consumers.
(Response 127) A facility that satisfies criteria to be a qualified
facility continues to be responsible to produce animal food that will
not be adulterated under section 402 of the FD&C Act. Such a facility
is also subject to the requirements of section 421 of the FD&C Act
regarding frequency of inspection of all facilities and to the new
administrative tools provided by FSMA, such as for suspension of
registration (section 415 of the FD&C Act) and for mandatory recall
(section 423 of the FD&C Act). As discussed in Response 77, we expect
that most qualified facilities will be subject to the CGMP requirements
of subpart B. When they are inspected, we will be ensuring they are in
compliance with the CGMP requirements once the applicable compliance
date is reached.
(Comment 128) Some comments ask which exemption a farm mixed-type
facility should follow if it satisfies criteria for a qualified
facility (Sec. 507.5(d)), as well as criteria for a very small
business that only conducts on-farm low-risk activity/animal food
combinations (specified in Sec. 507.5(e) and (f)) and one comment
suggests that FDA should allow such a facility to choose which
exemption to follow.
(Response 128) We describe these comments in more detail in Comment
110. A farm mixed-type facility that is a very small business and that
only conducts the low-risk activity/animal food combinations listed in
Sec. 507.5(e) and (f) may find it advantageous to classify itself as a
very small business eligible for the exemption in Sec. 507.5(e) and
(f) (which is not subject to the requirements in Sec. 507.7) rather
than as a qualified facility (which is subject to the requirements in
Sec. 507.7).
(Comment 129) Some comments express concern about State access to
the records that a qualified facility maintains to support its
attestations, particularly when a State would conduct an inspection for
compliance with part 507 under contract to FDA. These comments express
concern about the time and resources necessary to verify the status of
a facility as a qualified facility and note that previous mechanisms
whereby we provide information to States in advance of inspection have
been slow. These comments also express concern that if the state must
verify the ``qualified facility'' status of all firms, including those
that are not FDA contracts, this could delay their ability to conduct
timely inspections and increase inspection time, reducing the number of
inspections conducted.
(Response 129) We are sensitive to the time required for various
inspection
[[Page 56218]]
activities and intend to communicate with States regarding our
expectations for how to verify whether a facility is a qualified
facility.
(Comment 130) Some comments point out that the proposed procedures
for submission are silent on the process and timeframe for our review
and approval of the submitted documentation and ask us to clarify this
process and timeframe. Other comments ask us to clarify the
consequences to a facility if its submission is found to be
insufficient.
(Response 130) We will not be approving the submitted attestations.
Instead, we intend to use the information to determine whether the
facility should be inspected for compliance with the requirements for
hazard analysis and risk-based preventive controls, or for compliance
with the requirements for a qualified facility. During the inspection,
we would ask to see the records that the facility maintains to support
any submitted attestations.
(Comment 131) Some comments ask us to clarify whether a foreign
facility would need to submit documentation of its status as qualified
facility. These comments note that a foreign facility also would be
required to provide information to an importer and assert that
submitting information to both FDA and an importer would be a
duplication of effort. These comments ask us to allow a foreign
facility that is a qualified facility to submit information to either
FDA or the importer, rather than to both FDA and the importer.
(Response 131) We decline this request. Documentation submitted to
an importer would not reach FDA and, thus, could not satisfy the
requirements of this rule. We are requiring submission of an
attestation, on a form that can be submitted either electronically or
on paper, rather than submission of the underlying information.
C. Proposed Sec. 507.7(a)--Documentation To Be Submitted
1. Section 507.7(b)(1)--Documentation That the Facility Is a Qualified
Facility
We proposed that a qualified facility must submit documentation
that the facility is a qualified facility. We also proposed that for
the purpose of determining whether a facility satisfies the definition
of a qualified facility, the baseline year for calculating the
adjustment for inflation is 2011. As discussed in Response 124, we have
revised the provision to specify that the documentation that must be
submitted is an attestation.
(Comment 132) Some comments ask us to clarify the documentation
required to certify that an operation is a qualified facility. Some
comments ask us to explicitly state that the documentation must include
financial and sales records of the business and its subsidiaries or
affiliates. Some comments ask us to clarify the types of records that
would be required to be submitted by foreign establishments to support
the classification of a foreign establishment as a ``qualified
facility.''
(Response 132) The submission to FDA will be an attestation rather
than the records that the qualified facility relies on to support the
attestation; however, you must maintain those records relied upon to
support the ``attestations'' (see Sec. 507.7(f)). As previously
discussed, consistent with section 418(l)(2)(B)(ii) of the FD&C Act, we
intend to issue guidance on the records that a facility could retain to
demonstrate that it is a qualified facility (78 FR 64736 at 64767). As
discussed in Response 124, we have revised the regulatory text to
provide for qualified facilities to submit an attestation that the
facility is in compliance with State, local, county, tribal, or other
applicable non-Federal food safety law. We intend to focus on records
demonstrating that a facility is a very small business (i.e., financial
records demonstrating that a business averages less than $2,500,000
adjusted for inflation, per year, during the 3-year period preceding
the applicable calendar year in sales of animal food plus the market
value of animal food manufactured, processed, packed, or held without
sale (e.g., held for a fee or supplied to a farm without sale)) rather
than records demonstrating that the average annual monetary value of
the food manufactured, processed, packed or held at such facility that
is sold directly to qualified end-users during a 3-year period exceeded
the average annual monetary value of the food sold by the facility to
all other purchasers. We expect that financial records demonstrating
that a business is a very small business will be less burdensome for a
qualified facility to maintain and require fewer resources for FDA to
review.
During an inspection, we expect the facility to be able to show us
how the facility is complying with the applicable food safety
regulation (including relevant licenses, inspection reports,
certificates, permits, credentials, or certifications), and producing
safe animal food.
(Comment 133) Some comments ask how the adjustment for inflation
will be calculated and how regulators such as the states will get this
information.
(Response 133) We intend to use the Federal calculation for the
Gross Domestic Product price deflator, as provided by the Bureau of
Economic Analysis, to adjust for inflation. We will make the inflation-
adjusted dollar value to the baseline very small business cutoffs (e.g.
$2,500,000 in 2011) available on our Internet site. We will update the
values for the very small business exemptions and qualifications
annually using this calculation.
2. Proposed Sec. 507.7(a)(2)(i)--First Option for Documentation: Food
Safety Practices.
We proposed two options for satisfying the statutory documentation
requirement in section 418(l)(2)(B)(i) of the FD&C Act. Under the first
option (the food safety practices option), a qualified facility could
submit documentation demonstrating that it has identified the potential
hazards associated with the animal food being produced, is implementing
preventive controls to address the hazards, and is monitoring the
performance of the preventive controls to ensure that such controls are
effective. As discussed in Response 124, we have revised the provision
to specify that the submission is an attestation.
(Comment 134) Some comments assert that the rule is vague about
what the applicable documentation should include and how exhaustive it
should be. Some comments ask whether documentation (such as a food
safety plan) must address all operations at the establishment or only
those that trigger the registration of the establishment as a facility.
Some comments ask us to clarify the difference between having
documentation to support food safety practices and attesting that the
facility has such documentation. Other comments ask whether a qualified
facility would need to have records documenting a risk analysis and
monitoring.
(Response 134) If a qualified facility submits an attestation
regarding its food safety practices, the documentation that the
facility maintains for review during inspection must specify that the
facility has identified the potential hazards associated with the
animal food being produced, is implementing preventive controls to
address the hazards, and is monitoring the performance of the
preventive controls to ensure that such controls are effective (see
Sec. 507.7(a)(2)(i)). For example, a qualified facility that produces
raw dog food might have documentation specifying that it has determined
that Salmonella is a hazard requiring a preventive control, describing
the process that will
[[Page 56219]]
control Salmonella, describing sanitation controls to prevent
contamination of raw dog food with Salmonella, and describing an
environmental monitoring program to verify that its sanitation controls
are effective. Likewise, a qualified facility that makes a custom
cattle food might have documentation specifying that it has determined
that metal objects are a hazard requiring a preventive control and
supporting the use of a magnet to remove metal objects from the cattle
food, with procedures for monitoring the magnet's use if applicable.
As discussed in Response 124, a qualified facility that chooses the
food safety practices option for complying with the submission
requirements of this rule will attest to that by checking a statement
on a form. In contrast, a food safety plan (or other documentation)
that the qualified facility relies on to support the attestation will
be a record subject to the recordkeeping requirements of subpart F.
3. Proposed Sec. 507.7(a)(2)(ii)--Second Option for Documentation:
Compliance With Other Applicable Non-Federal Food Safety Law
Under the second option for satisfying the statutory documentation
requirement, a qualified facility could submit documentation that it is
in compliance with State, local, county, or other applicable non-
Federal food safety law, including relevant laws and regulations of
foreign countries. As discussed in Response 124, we have revised the
provision to specify that the submission is an attestation. We also
have revised the provision to add ``tribal'' as an example of
applicable non-Federal food safety law to clarify for purposes of this
rule that a qualified facility could submit an attestation that it is
in compliance with tribal food safety law.
(Comment 135) Some comments object to the proposed provision. These
comments point out that State and local requirements are inconsistent
and assert that such requirements are not sufficiently rigorous to
substitute for the FSMA requirement to conduct a hazard analysis and
establish and execute a documented food safety plan. One comment
asserts that the state laws may not provide the same level of
protection to consumers.
(Response 135) The provision reflects the express statutory
direction of section 418(l)(2)(B)(i)(II) of the FD&C Act. Most of these
qualified facilities are subject to the CGMP requirements of subpart B
and a facility that satisfies criteria to be a qualified facility
continues to be responsible to produce animal food that will not be
adulterated under section 402 of the FD&C Act.
(Comment 136) Some comments ask us to specify that a qualified
facility must document compliance with all applicable non-Federal food
safety laws. One comment asks what evaluation FDA will conduct of any
non-Federal food safety law before determining that compliance with
such law constitutes compliance under FSMA for a qualified facility.
(Response 136) We decline this request. Section 418(l)(2)(B)(i)(II)
of the FD&C Act refers to apply to compliance with ``State, local,
county, or other applicable non-Federal food safety law'' (emphasis
added). As discussed in Response 132, we have revised the regulatory
text to provide for qualified facilities to submit an attestation that
the facility is in compliance with State, local, county, or other
applicable non-Federal food safety law During an inspection, we expect
the facility to be able to show us how the facility is complying with
the applicable food safety regulation (including relevant licenses,
inspection reports, certificates, permits, credentials, or
certifications), and producing safe animal food.
(Comment 137) Some comments ask us to provide resources to the
States to implement the proposed provision. These comments also ask us
to develop and implement a strategic plan to provide resources (e.g.
training, guidance) to State and local inspection agencies in advance
of the anticipated increased burden on State and local inspection
programs that will be created by the provision.
(Response 137) We do not believe that specific training for State
or other government counterparts is necessary for the purposes of
inspecting a qualified facility that attested to having documentation
from a non-Federal regulatory authority. The State or other government
counterpart would merely examine applicable documentation (such as a
license, inspection report, certificate, permit, credentials, or
certification by an appropriate agency (such as a State department of
agriculture)), which is specified in the provision. After inspecting
such documentation, the State or other government counterpart would
focus on inspection for compliance with CGMPs.
D. Proposed Sec. 507.7(b)--Procedure for Submission
We proposed that the documentation must be submitted to FDA either
electronically or by mail. As discussed in Response 124, we have
revised the regulatory text to update details regarding the electronic
and paper submission of a specific form. We are developing paper and
electronic versions of Form FDA 3942b, which is an information
collection provision that is subject to review by OMB under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 to 3520). We intend to
make the paper Form FDA 3942b available in the near future and invite
comments consistent with procedures for approval of the form by OMB.
(Comment 138) Some comments recommend that any interface for
electronic submission of certification statements post adequate notice
of requirements the facility must meet and warnings detailing potential
penalties (e.g., for fraudulent submission).
(Response 138) We intend that the electronic submission system will
operate in a manner similar to the existing electronic submission
system for registration of food facilities, including a certification
statement advising the person signing the form that, under 18 U.S.C.
1001, anyone who makes a materially false, fictitious, or fraudulent
statement to the U.S. Government is subject to criminal penalties. We
intend to include a similar certification statement on paper forms that
will be available for qualified facilities that choose to submit by
paper rather than through the electronic system. The electronic and
paper submission forms will focus on the attestation statements rather
than on other requirements to which the facility is subject. The Small
Entity Compliance Guide that we will issue in accordance with section
212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L.
104-121) will be better suited to helping qualified facilities
understand the requirements of the rule than information presented on a
submission form.
E. Proposed Sec. 507.7(c)--Frequency of Determination and Submission
We proposed that the documentation must be: (1) Submitted to FDA
initially within 90 days of the applicable compliance date and (2)
resubmitted at least every 2 years, or whenever there is a material
change to the information applicable to determining the status of a
facility.
(Comment 139) Some comments assert that the proposed timeframe of
90 days to submit the required documentation would not provide
sufficient time to gather and submit the required documentation and ask
us to extend the timeframe, e.g., to 120 or 180 days.
(Response 139) We are retaining the proposed timeframe for the
initial
[[Page 56220]]
submission (within 90 days of the applicable compliance date). The only
documentation that the qualified facility will need to submit is an
attestation, which does not need to be gathered. Importantly, however,
documentation supporting the attestation must be available for
inspection by September 17, 2019. As discussed in Response 76, the
compliance date for a facility to retain records to support its status
as a qualified facility is January 1, 2017. As a companion change, we
are explicitly requiring that a facility determine and document its
status as a qualified facility on an annual basis by no later than July
1of each calendar year (see Sec. 507.7(c)(1)).
In addition, we have revised proposed Sec. 507.7(c)(1) (which we
are finalizing as Sec. 507.7(c)(2)(i)(A), (B), and (C)) to specify the
timeframe for the initial submission for three distinct circumstances:
(A) By December 16, 2019 for a facility that begins manufacturing,
processing, packing, or holding animal food before September 17, 2019;
(B) Before beginning operations, for a facility that begins
manufacturing, processing, packing or holding animal food after
September 17, 2019; or (C) By July 31 of the applicable calendar year,
when the status of a facility changes from ``not a qualified facility''
to ``qualified facility'' based on the annual determination required by
paragraph (c)(1) of this section. See the discussion in Response 76
regarding the approach we intend to take in a number of circumstances
that could lead to a facility having records to support its status as a
qualified facility for fewer than 3 preceding calendar years.
We have revised the provision to specify that the required biennial
submissions of the attestations must be made during a timeframe that
will coincide with the required biennial updates to facility
registration (see section 102 of FSMA), i.e., during the period
beginning on October 1 and ending on December 31, beginning in 2020. In
determining that 2020 would be the first year for the required biennial
submissions of the attestations, we first considered that the first
submission of an attestation would be approximately December 2019 for
qualified facilities that are operating as of the date of this final
rule (i.e., approximately 90 days after the date of publication of this
rule). For qualified facilities that do not begin operations until
after December 2019, the first biennial submission will be required in
a timeframe less than 2 years, but once the qualified facility has made
its first submission the subsequent biennial submissions will all be at
2-year intervals. Coordinating the biennial submissions of the required
attestations with the biennial registration will reduce the cumulative
economic impact on the animal food industry of complying with two
separate requirements because qualified facilities that choose to
submit electronically will be able to submit electronically while
accessing the same electronic portal used for facility registration.
(Comment 140) Some comments ask us to include an option within the
system to notify us when a facility's status as a ``qualified
facility'' changes, e.g., because its business expands or changes.
(Response 140) Notifying us when there is a material change in the
facility's status from ``qualified facility'' to ``not a qualified
facility'' is a requirement rather than an option. We included this
requirement in the proposed rule, and are establishing it in this final
rule. We made editorial changes to the provision to make this clearer.
We also established a series of dates associated with the
facility's change in status from ``qualified facility'' to ``not a
qualified facility.'' First, we are specifying that when the status of
a facility changes from ``qualified facility'' to ``not a qualified
facility'' based on the required annual determination, the facility
must notify FDA of that change in status using Form FDA 3942b by July
31 of the applicable calendar year (see Sec. 507.7(c)(3)). We have
provided the facility with flexibility to wait until July 1 of a given
calendar year to determine whether its status changes (see Sec.
507.7(c)(1)); 30 days is an adequate timeframe to submit the form
notifying us of the change in status.
Second, we are specifying that when the status of a facility
changes from ``qualified facility'' to ``not a qualified facility,''
the facility must comply with subparts C and E no later than December
31 of the applicable calendar year unless otherwise agreed to by FDA
and the facility (see Sec. 507.7(d)). In essence, this provision can
provide a facility with up to a full year to comply with the full
requirements for hazard analysis and risk-based preventive controls
when the facility determines its change in status early in the calendar
year. A facility that does not determine that change in status until
the required date of July 1 would still have 6 months to comply with
the full requirements for hazard analysis and risk-based preventive
controls. As we have done in the case of a qualified exemption being
withdrawn (see Sec. 507.65(d)(1)), we are providing flexibility for a
facility to comply in an alternative timeframe if agreed to by FDA and
the facility.
(Comment 141) One comment asks us to specify that the required
attestations be submitted every 5 years rather than every 2 years. This
comment asserts that doing so would be consistent with the statutory
direction of section 201 of FSMA (Targeting of Inspection Resources)
for non-high risk food facilities. This comment also asserts that we
did not provide specific reasons for the proposed 2-year timeframe and
that resubmitting the attestations every 2 years will increase cost in
time and labor.
(Response 141) We decline the request. The rule requires
resubmission whenever there is a material change to the information
that changes the status of a facility as a qualified facility.
Therefore, if the facility's sales change its status, so that it is no
longer a qualified facility, the rule requires that facility to notify
us when its status changes. (Note that the definition of very small
business established in this rule bases the threshold dollar amount for
a very small business on an average (of sales plus the market value of
animal food held without sale) during the 3-year period preceding the
applicable calendar year, rather than on annual sales plus market
value. A biennial submission is adequate to otherwise require a
qualified facility to affirmatively attest that it continues to satisfy
the criteria for being a qualified facility. A biennial submission is
not overly burdensome, because a facility can coordinate its biennial
submission with its biennial update to its facility registration. The
suggested 5-year submission based on the targeted inspection frequency
for non-high risk animal food facilities implies that all qualified
facilities produce such animal foods, which is not the case.
F. Proposed Sec. 507.7(d)--Notification to Consumers (Final Sec.
507.7(e))
We proposed that a qualified facility that does not submit
documentation of its food safety practices must provide notification to
consumers as to the name and complete business address of the facility
where the animal food was manufactured or processed (including the
street address, or P.O. Box, city, state, and zip code for domestic
facilities, and comparable full address information for foreign
facilities).
(Comment 142) One comment recommends that information giving the
location of the manufacturing site, and not just the corporation
contact information, be provided on the animal food labels. Other
comments state that specifically for pet food and pet treats, the
manufacturer should be required to include the co-packer information on
[[Page 56221]]
the product labels to include the co-packer's name, private label
contact information, address, and co-packer's contact information
(phone and/or email).
(Response 142) Section 418(l)(7) of the FD&C Act specifically
mandates for a qualified facility that ``the name and business address
of the facility where the food was manufactured or processed,'' not the
corporate contact information, be included on a label for a food for
which a food packaging label is required. It does not require co-packer
information. The statute makes no requirements for non-qualified
facilities.
G. Proposed Sec. 507.7(e)--Records (Final Sec. 507.7(f))
We proposed that a qualified facility must maintain those records
relied upon to support the required documentation. We also proposed
that the records that a qualified facility must maintain would be
subject to the requirements that would be established in subpart F of
this rule. As discussed in Response 124, after considering comments we
have revised the rule to specify that a qualified facility must
maintain those records relied upon to support the required attestations
(rather than the required documentation).
(Comment 143) Some comments ask us to explicitly specify that we
have access to documents that establish a facility as a qualified
facility. Some comments assert that a facility may reasonably assume
that records such as financial records would not be available to us
because such records are excluded from the records that we have access
to under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act), and as provided by Sec.
1.362.
(Response 143) The rule explicitly specifies that we have access to
records that are required by the rule (see Sec. 507.200). If a
facility relies on financial records to demonstrate its status as a
qualified facility, we will have access to those financial records. The
exemption referred to by the comments for financial records (Sec.
1.362) is narrowly targeted to records required by the section 414
recordkeeping regulations and does not apply to records required by
this preventive controls rule for animal food.
XII. Subpart A: Comments on Proposed Sec. 507.10--Applicability of
Part 507 to a Facility Solely Engaged in the Storage of Unexposed
Packaged Animal Food
We proposed that subpart C would not apply to a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment and does not require time/temperature control to ensure
the safety of the animal food (proposed Sec. 507.10(a)). We also
proposed that a facility solely engaged in the storage of packaged
animal food that is not exposed to the environment but requires time/
temperature control for safety would be subject to the modified
requirements that would be established in proposed Sec. 507.48 of
subpart C (proposed Sec. 507.10(b)).
Some comments support these proposed provisions without change. For
example, one comment expresses the view that a facility solely engaged
in the storage of packaged animal food that does not require time/
temperature control for safety does not need to conduct its own hazard
analysis, nor establish and implement preventive controls because there
would be no hazards to trigger such activities. Other comments that
support the proposed provisions ask us to clarify some aspects of the
provisions or to clarify how the provisions will apply in particular
circumstances. Other comments that support the proposed provisions ask
us to broaden them.
In the following paragraphs, we discuss comments that disagree
with, or suggest one or more changes to, the proposed provisions. After
considering these comments, we have revised the proposed requirements
as shown in table 8 with editorial and conforming changes as shown in
table 31. A key conforming change that affects Sec. 507.10 is that it
includes an exemption from the requirements of subpart E, as well as
subpart C. As discussed in section XL, the final rule establishes the
requirements for a supply-chain program in subpart E, rather than
within subpart C as proposed.
Table 8--Revisions to the Proposed Applicability of Subpart C to a
Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.10(b)..................... Applicability of Clarification that
modified Sec. 507.51 of
requirements in subpart C only
Sec. 507.51 of applies to those
subpart C. unexposed packaged
animal foods that
require time/
temperature control
to significantly
minimize or prevent
the growth of, or
toxin production by,
pathogens.
------------------------------------------------------------------------
(Comment 144) Some comments ask us to clarify that temperature
controls should be implemented when determined to be necessary by the
facility or preventive controls qualified individual. Some comments ask
us to clarify that if a facility stores both TCS food and non-TCS food
(i.e., unexposed packaged animal food that does not require time/
temperature control for safety), then the modified requirements only
apply for the portion of the facility that holds the TCS foods.
(Response 144) We have revised Sec. 507.10(b) to clarify that a
facility solely engaged in the storage of unexposed packaged animal
food, including unexposed packaged animal food that requires time/
temperature control to significantly minimize or prevent the growth of,
or toxin production by, pathogens is subject to the modified
requirements in Sec. 507.51 of subpart C of this part for any
unexposed packaged food that requires time/temperature control to
significantly minimize or prevent the growth of, or toxin production
by, pathogens.
(Comment 145) Some comments ask us to revise the regulatory text to
be explicit that frozen unexposed packaged food is not a TCS food
subject to modified requirements.
(Response 145) We decline this request. In the 2013 proposed animal
food preventive controls rule, we tentatively concluded that it would
be rare for a frozen animal food to be a TCS food (78 FR 64736 at
64802), and we affirm that conclusion in this document. However,
specifying in the regulatory text that a frozen animal food is not a
TCS food would require us to conclude that a frozen animal food would
``never'' (rather than ``rarely'') be a TCS food, and we lack
information to support ``never.''
(Comment 146) Some comments ask us to apply the exemption to
storage areas of facilities that also engage in food processing
activities, e.g., for distributors that are engaged in limited food
processing, such as blending seeds to make bird food. These comments
[[Page 56222]]
assert that the intent of the term ``solely'' is to make clear that a
facility that conducts an activity subject to the exemption does not
escape responsibility for complying with the requirements for hazard
analysis and risk-based preventive controls when conducting activities
that are not exempt.
(Response 146) We disagree with the comment's interpretation of the
term ``solely.'' The plain meaning of ``solely'' is only, completely,
entirely; without another or others; singly; alone (Ref. 24). The
facility described in the comment is not ``solely'' engaged in the
storage of unexposed packaged animal food.
Such a facility must conduct a hazard analysis that addresses all
activities conducted by the facility. The preventive controls that the
facility would establish and implement would depend on the facility,
the animal food, and the outcome of the facility's hazard analysis and
any preventive control management components associated with a
facility's preventive controls would be established as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control and its role in the
facility's food safety system. A facility that stores unexposed
packaged animal food that is not a TCS animal food could, for example,
determine that no preventive controls and associated management
components would be necessary. A facility that stores unexposed
refrigerated packaged TCS animal food could, for example, determine
that preventive controls and management components patterned after the
modified requirements in Sec. 507.51 are adequate to address
significant hazards associated with that animal food.
(Comment 147) Some comments ask us to allow a facility to designate
a storage area as a separate facility for purposes of compliance with
the requirements for hazard analysis and risk-based preventive
controls. In the comments' view, an area solely engaged in the storage
of unexposed packaged food could fall within the exemption in Sec.
507.10 even though other areas would be subject to the requirements for
hazard analysis and risk-based preventive controls.
(Response 147) We disagree that a designated storage area in an
establishment that conducts manufacturing, processing, or packing in
addition to storage can fall within the exemption for facilities
``solely engaged in . . . storage.'' The statute provides authority for
us to exempt or modify the requirements for compliance with respect to
``facilities'' that are solely engaged in the storage of packaged foods
that are not exposed to the environment (section 418(m) of the FD&C
Act). The statute defines ``facility'' as a domestic facility or a
foreign facility that is required to register under section 415 of the
FD&C Act (section 418(o)(2) of the FD&C Act). The section 415
registration regulations define facility as ``any establishment,
structure, or structures under one ownership at one general physical
location . . .'' The comment's interpretation that we could view
``areas'' of registered facilities to be ``facilities that are solely
engaged in the storage of packaged foods that are not exposed to the
environment'' is inconsistent with the statutory and regulatory
framework under sections 415 and 418 of the FD&C Act.
(Comment 148) Some comments ask us to consider an alternative to
the exemption for unexposed packaged foods when a facility conducts
manufacturing, processing, packing, or holding activities in addition
to storing unexposed packaged food. Specifically, these comments ask us
to recognize that the minimal risks of storing unexposed packaged foods
can be addressed through a combination of compliance with the modified
requirements for TCS foods (if applicable) and the CGMPs in subpart B
and state that doing so would be consistent with our discussion in the
2013 proposed animal food preventive controls rule.
(Response 148) These comments appear to suggest the outcome of a
facility's hazard analysis and food safety plan for storing unexposed
packaged animal food, i.e., that the only significant hazards are the
potential for growth of pathogens in refrigerated unexposed packaged
animal foods and that the preventive controls and preventive control
management components specified in the modified requirements for TCS
animal food are adequate to address such hazards. It is the
responsibility of the facility's preventive controls qualified
individual to identify the significant hazards associated with the
facility and the animal food it stores, as well as the appropriate
preventive controls and preventive control management components.
However, we agree that in some cases the approach suggested in these
comments would be appropriate.
(Comment 149) Some comments assert that it is difficult to identify
TCS foods. These comments ask us to work with industry and professional
organizations to develop guidance on when the modified requirements
apply.
(Response 149) This document does not include guidance on whether
specific animal foods are TCS foods. We will consider including
guidance on animal foods that are TCS foods in the implementing
guidances we are developing (see Response 1). A facility solely engaged
in storage of unexposed packaged animal food can work with the
manufacturer of the food to identify TCS food. Alternatively, such a
facility could simply treat any refrigerated food as a TCS food.
XIII. Subpart A: Comments on Proposed Sec. 507.12--Applicability of
Part 507 to the Holding and Distribution of Human Food By-Products for
Use as Animal Food.
We proposed to add provisions for human food by-products for use as
animal food. We proposed that the requirements of this part would not
apply to by-products of human food production that are packed or held
by that human food facility for distribution as animal food if: the
facility is subject to and in compliance with subpart B of part 117
(the CGMPs in the proposed preventive controls rule for human food) and
in compliance with all other applicable human food safety requirements
of the FD&C Act and implementing regulations; and the facility does not
further manufacture or process the by-products intended for use as
animal food. Proposed Sec. 507.12(b) would require that once the
animal food was separated from the human food, the facility would need
to comply with proposed Sec. Sec. 507.28 and 117.95 of part 117 for
the holding and distribution of that animal food. We also proposed
Sec. 117.95 be added to the proposed preventive controls rule for
human food and asked for comment on whether the requirements should be
placed in both Sec. 117.95 and Sec. 507.28.
Section 507.12 does not apply to human food by-products when
contamination or other adulteration has occurred that is materially
related to food safety. We handle requests for diversion of these
products for animal food use on a case-by-case basis. Additional
information on diversion of contaminated or adulterated food for animal
food use is available in compliance policy guidances (CPG) CPG Sec.
675.100 ``Diversion of Contaminated Food for Animal Use'' and CPG Sec.
675.200 ``Diversion of Adulterated Food to Acceptable Animal Feed Use''
(Refs. 25 and 26). We asked for comment on whether we should include
regulations for these types of requests.
Many comments generally support the concept that certain human food
by-products intended for use as animal food which do not undergo
further processing by the human food
[[Page 56223]]
manufacturer only need to comply with proposed Sec. 507.28 for holding
and distribution of human food by-products for use as animal food. Some
of these comments note that human food by-products are an important
source of animal food. Other comments agree but request changes and/or
additional exemptions.
We have modified Sec. 507.12 to clarify that the requirements of
part 507 do not apply to off-farm packing and holding of RACs packed or
held by a human food facility for distribution as animal food provided
certain conditions are met. For off-farm packing and holding of produce
(as defined in part 112 of this chapter), if the human food facility is
subject to and in compliance with Sec. 117.8 of part 117 of this
chapter and in compliance with all applicable human food safety
requirements of the FD&C Act and implementing regulations, and the
human food facility does not further manufacture or process the by-
products intended for use as animal food, then the requirements of part
507 do not apply to the by-products.
(Comment 150) Some comments request that the proposed provisions be
included in both this rule and the final rule for preventive controls
for human food so that it would be easier for human food processors to
understand the requirements for human food by-products intended for use
as animal food. One comment does not support placing these provisions
in both of the final rules, preferring that all animal food provisions
be in part 507, and that part 117 should pertain only to human food.
(Response 150) Section 117.95--``Holding and distribution of human
food by-products for use as animal food'' is established in this rule.
Section 117.95 will appear in 21 CFR part 117, preventive controls for
human food. The by-products holding and distribution provisions also
will appear in Sec. 507.28, the animal food CGMPs. The requirements of
Sec. 117.95 and Sec. 507.28 are identical and appear in both places
for the convenience of the facilities to which the provisions would
apply.
(Comment 151) Two comments state it must be clear in the rule that
not only by-products but also products which are already authorized for
food like gelatin or collagen must be authorized for food for animals,
without further requirements and additional CGMP implementation.
(Response 151) We understand this comment to be stating that a
human food product that also may be used as an animal food should not
be required to comply with part 507 if it is in compliance with human
food requirements. We agree with this comment. A facility that
manufactures and sells a food just for human consumption is not subject
to part 507, even if the purchaser of that food may use it for animal
food.
If a facility manufactures, processes, packs, or holds human food
and animal food, and is subject to subpart C of part 117, it can comply
with subpart C of part 117 for the animal food, but needs to address
any hazards unique to the animal food that require a preventive
control, if applicable. Except as provided by Sec. 507.12 for human
food by-products, if a facility is required to comply with subpart B of
part 507 and also subpart B of part 117 because the facility
manufactures, processes, packs, or holds human food and animal food,
then the facility may comply with the requirements in subpart B of part
117, instead of subpart B of part 507, as to the manufacturing,
processing, packing, and holding of animal food at that facility (see
the regulatory text for Sec. 507.1(d)).
(Comment 152) Some comments request that facilities regulated by
the United States Department of Agriculture (USDA) Food Safety and
Inspection Service (FSIS) not be required to comply with part 507 for
animal-derived human food by-products intended for use as animal food.
Some comments state the requirements are duplicative and are
unnecessary because FSIS food safety requirements are already in place,
and that oftentimes the FSIS establishment is unaware of what purpose
or animal species the purchaser will use the by-product for as animal
food.
(Response 152) Only animal food facilities that are required to
register as a food facility under section 415 of the FD&C Act are
required to comply with this rule. Establishments regulated exclusively
throughout by FSIS under the Federal Meat Inspection Act, the Poultry
Products Inspection Act, or the Egg Products Inspection Act, i.e.,
establishments handling only meat, poultry, or certain egg products,
are exempt from registration under section 415 of the FD&C Act (see
Sec. 1.226(g) (21 CFR 1.226(g))). Therefore, these establishments are
not subject to this rule.
(Comment 153) Some comments state we did not provide support for
the tentative conclusion that animal-derived by-products carry
different risks than other by-products, and therefore did not provide a
basis for why animal-derived by-products should be subject to all of
part 507 while other human food by-products are subject to only Sec.
507.28.
(Response 153) As explained in Response 152, animal-derived by-
products from establishments that are not required to register as food
facilities would not be subject to part 507.
Facilities may be jointly regulated by FDA and FSIS if they produce
some products that are under FDA jurisdiction and some that are under
FSIS jurisdiction. Such facilities may be required to register as a
food facility under section 415 of the FD&C Act. Examples of facilities
jointly regulated by FDA and FSIS include FSIS establishments that also
process animal food (such as certain pet food), and facilities that
process meat and nonmeat products (such as frozen entrees, some of
which contain meat and are regulated by FSIS, and some of which do not
contain meat but which contain seafood or vegetables that are regulated
by FDA).
FSIS establishments that are required to register with FDA because
they also process FDA-regulated human food, must follow Sec. Sec.
507.28 and 117.95 for the holding and distribution of their FDA-
regulated human food by-products for use as animal food, if the
establishments meet the requirements of Sec. 507.12(a). FSIS
establishments that are required to register with FDA because they also
process FDA-regulated animal food must comply with the provisions in
the preventive controls rule for animal food (part 507).
(Comment 154) Some comments assert that requiring FSIS-regulated
establishments to comply with part 507 would result in more by-products
being diverted to other disposal methods which might have an economic
or environmental impact.
(Response 154) We do not agree that compliance with part 507 will
likely result in substantially less use of human food by-products as
animal food because it applies only to those establishments that are
required to register under section 415 of the FD&C Act. Furthermore,
other disposal methods for these products may be more cost prohibitive
than compliance with these regulations.
(Comment 155) One comment requests the wording in proposed Sec.
507.12 be revised to explicitly exclude animal-derived human food by-
products for use as animal food because of pathogen risk.
(Response 155) Animal-derived human food by-products have a long
history of use in the animal food industry. These human food by-
products typically are sold from the human food facility to an animal
food manufacturer/processor, such as a pet food manufacturer, that uses
the by-products as an ingredient in a finished animal food. These
manufacturers/processors are required to comply with
[[Page 56224]]
part 507 and must address any potential pathogens. Furthermore, 21 CFR
589.2000 prohibits the use of mammalian protein in the manufacture of
animal food given to ruminant animals, such as cows, sheep, and goats,
and regulations issued under the Swine Health Protection Act (7 U.S.C.
3801 et seq.) are intended to ensure that food waste containing meat
does not contain active disease organisms that pose a risk to swine who
eat it (see 9 CFR part 166).
(Comment 156) A few comments state that USDA, not FDA, should issue
any regulations concerning the food safety of animal-derived by-
products intended for use as animal food.
(Response 156) The FD&C Act gives FDA certain authority to regulate
food, which includes food for animals. As explained in section XV of
the 2013 proposed preventive controls rule for animal food, the FD&C
Act authorizes FDA to issue CGMP and preventive controls regulations to
enhance the safety of animal food, including human food by-products
that are intended for use as animal food. We decline to address what
USDA's role in animal food safety should be as is it out of the scope
of this rulemaking.
(Comment 157) One comment suggests an alternative approach to
animal-derived human food by-products. The comment suggests that we
consider a provision that would allow the purchaser to take legal
responsibility for evaluating and mitigating risk associated with by-
products intended for use as animal food if both parties agree.
(Response 157) For facilities subject to subpart C, the supply-
chain program in subpart E is required when the receiving facility's
hazard analysis identifies a hazard requiring a supply-chain-applied
control and the receiving facility's manufacturing/processing will not
control the hazard. However, when a manufacturer/processor identifies a
hazard requiring a preventive control, but can demonstrate and document
that the hazard will be controlled by an entity in its distribution
chain (e.g., its customer), then the manufacturer/processor is not
required to implement a preventive control (see Sec. Sec. 507.36 and
507.37). For a discussion of these provisions, see section XXVII. For
facilities exempt from the requirements of subpart C, we are aware that
parties may enter into purchase contracts that include specifications
or information for the animal food purchased.
(Comment 158) The comments support seafood, dietary supplements,
and infant formula by-products intended for use as animal food without
further processing be subject only to the holding and distribution
provisions in proposed Sec. 507.28.
(Response 158) We agree with these comments. We did not receive
comments indicating by-products from these human foods have specific
problems if used as animal food. Facilities that process seafood,
dietary supplements, and infant formula that meet the requirements of
Sec. 507.12(a) must follow the requirements of Sec. 507.28 and Sec.
117.95 for human food by-products for use as animal food.
(Comment 159) Some comments state that all human food by-products,
including those further processed, should only have to comply with the
holding and distribution requirements in proposed Sec. 507.28. Other
comments support the requirement that human food by-products which are
further processed should be required to comply with all of proposed
part 507. Some comments request clarification about what constitutes
further processing.
(Response 159) We decline the request to exempt human food by-
products that are further processed from the requirements of part 507
because following CGMPs for the processing will help ensure the animal
food's safety and because processing can introduce hazards requiring
preventive controls. Further processing includes any manufacturing/
processing as defined in Sec. 507.3 and includes activities such as
cooking, freezing, pelleting, and milling. Some passive activities such
as dewatering by holding a by-product in a container with a screened
bottom which allows water to escape, or holding in a perforated
container which allows natural drying to occur are not considered
further processing. Holding by-products at particular temperature to
facilitate easier transportation of the by-products is not considered
further processing; however, cooking or freezing a by-product to
prevent deterioration or adulteration is considered further processing.
Facilities holding human food by-products for use as animal food must
follow the requirements of Sec. 507.28.
(Comment 160) Some comments state we should not include diversion
requests for contaminated or adulterated human food to animal food in
the regulations; that the information contained in the guidance
documents should remain in guidance and be handled on a case-by-case
basis. However, some comments request that the existing compliance
policy guidances be reviewed and updated and provide suggested changes.
(Response 160) We have not included regulations for diversion of
contaminated or adulterated human food for animal food use in this
final rule. We will continue to handle diversion requests on an
individual basis. We will consider reviewing and revising the current
compliance policy guidances, CPG Sec. 675.100, ``Diversion of
Contaminated Food for Animal Use'' and CPG Sec. 675.200, ``Diversion of
Adulterated Food to Acceptable Animal Feed Use'' (Refs. 25 and 26).
(Comment 161) One comment requests clarification on whether these
provisions would apply to retail outlets such as grocery stores or
bakeries. One comment asserts that when a pig farmer gets outdated milk
from a dairy processing bottling plant after the plant takes it back
from grocery stores that the dairy processor (the human food
manufacturer) would be exempt from the animal food preventive controls
final rule.
(Response 161) Retail food establishments such as grocery stores
and bakeries are not required to register as food facilities (see
Sec. Sec. 1.226(c) and 1.227(b)(11)) and as a result are not required
to comply with part 507. However, the products they distribute for
animal food must not be adulterated.
If milk has been returned to a processing plant because it is
contaminated or adulterated, the facility must follow our compliance
policy guidances for requests to divert human food for use as animal
food (Refs. 25 and 26). If the returned milk is not contaminated or
adulterated, but is returned for a quality reason, the facility must
follow the holding and distribution requirements of Sec. 507.28 and
Sec. 117.95, but would be exempt from the other provisions in subpart
B and subpart C of part 507.
(Comment 162) One comment requests clarification on whether a
facility that is producing human food by-products intended for animal
food that fall under proposed Sec. 507.12 has to state in its food
safety plan that Sec. 507.12 applies.
(Response 162) If the human food processor meets the requirements
in Sec. 507.12(a), the facility only needs to comply with Sec. 507.28
and Sec. 117.95, for the holding and distribution of the human food
by-products for use as animal food. The facility does not need to
include this information in its food safety plan for the human food,
but may choose to include it so that employees and other individuals
viewing the food safety plan understand what regulatory requirements
the human food processor is applying to those human food by-products
intended for animal food.
[[Page 56225]]
XIV. Subpart B: General Comments on Proposed Subpart B--Current Good
Manufacturing Practice
In the 2014 supplemental proposed rule we revised the proposed
CGMPs to be more appropriate for the animal food industry. Following
are comments on the proposed CGMP requirements.
(Comment 163) Some comments state that the risks for pet food,
especially with respect to pathogens, are different than the risks for
livestock feed, and therefore FDA should issue two sets of CGMPs. Some
comments say that CGMPs for pet food should be modeled after the human
food CGMPs because of the high level of care people provide and demand
for their pets, pets may eat or sleep with humans, and pet owners often
store pet food close to human food.
(Response 163) We believe the single set of CGMPs can serve as
baseline standards for producing safe animal food across all types of
animal food facilities and animal food. We considered the diverse needs
of industry and the ultimate goal of animal food safety as we finalized
the CGMP regulations. We believe the final requirements are flexible
enough to be applied appropriately in various animal food production
settings. For example, Sec. 507.19(b) contains requirements for the
cleaning of animal food-contact surfaces of equipment and utensils to
protect against contamination of animal food. We do not specify exactly
how this is to be done (except some requirements for cleaning with wet
processing of animal food), knowing that what constitutes adequate
cleaning will depend on the plant and the animal food. (See Response
182).
As discussed in the 2013 proposed rule for preventive controls for
animal food, in 2003 we introduced the concept of the Animal Feed
Safety System (AFSS) which was intended to address the safety of all
animal food at all stages of production and use. After obtaining input
from the general public, State regulatory officials, industry,
veterinarians, and consumers, the AFSS working group began developing a
proposed rule for process controls for animal food, prior to FSMA, that
was intended to apply to all animal food (including pet food, livestock
feed, and raw materials and other ingredients) (78 FR 64736 at 64740).
When we revised the proposed CGMPs in the 2014 supplemental notice,
we not only consulted the human food CGMPs and their development
history, but also reviewed the draft AFSS process controls proposed
rule. We also reviewed CGMPs developed by organizations such as the
British Standards Institute's Publicly Available Specification (PAS)
222 and the Association of American Feed Control Officials (AAFCO)
model GMPs for feed and feed ingredients (which are adopted by many
states for regulation of animal food) (Refs. 27 and 28). Both PAS 222
and AAFCO GMPs apply to pet food and other animal food such as feed for
livestock. Many of the raw materials and other ingredients used in
making finished animal food are used by multiple types of animal food
manufacturers producing a variety of animal food products. It would not
be feasible to enforce different sets of standards for pet food and
livestock feed in a plant supplying the same ingredients to a pet food
manufacturer and a livestock feed manufacturer. We expect our CGMP
requirements to be applied appropriately in all facilities
manufacturing and processing animal food.
(Comment 164) Some comments say that CGMP requirements for animal
food in general are not appropriate for some products used in animal
food. Comments provide examples such as rendered products, which are
thermally processed before being used as ingredients in animal food;
humic products because raw mined materials are low risk; and oilseed
products because they have not been associated with any significant
food safety risks and are intermediate ingredients that will undergo a
subsequent kill step.
(Response 164) We understand that some ingredients utilized in the
production of animal food may pose a low risk. Nevertheless, facilities
that are required to register under section 415 of the FD&C Act and are
suppliers of ingredients used in animal food will be required to meet
the CGMP requirements being finalized in this rule. We believe these
CGMPs provide a great deal of flexibility in establishing baseline
standards for safely manufacturing, processing, packing, or holding the
wide diversity of ingredients used in animal food.
(Comment 165) One comment suggests that a new section be added at
the end of subpart B that would eliminate the need to comply with the
CGMPs if a facility showed that the hazard analysis and risk-based
preventive controls required by subpart C had been properly conducted,
implemented and validated.
(Response 165) We decline this request. The requested change is
counter to the intent of this regulation, that the CGMPs in subpart B
provide baseline safety and sanitation standards, while hazards
specific to a facility and the animal food it produces are identified
and controlled under subpart C. We consider CGMPs to be a prerequisite
program important for effective preventive controls, and believe that
the CGMPs being finalized in this rule provide enough flexibility for a
facility to use CGMPs to address certain hazards so they do not become
hazards that would require a preventive control.
(Comment 166) One comment from a foreign government says that
minimum requirements for recordkeeping and traceability, which are
recommended in the CODEX Code of Practice on Good Animal Feeding, might
be appropriate in subpart B so that they would apply to establishments
exempt from subpart C.
(Response 166) We agree that traceability and associated
recordkeeping are important tools for a facility to use for tracing
animal food in the event of a recall or foodborne illness outbreak.
Recordkeeping requirements currently exist in the Bioterrorism Act, and
implementing regulations in part 1 subpart J for persons who
manufacture, process, pack, transport, distribute, receive, hold, or
import food in the United States. In addition, the responsible party at
any food facility required to register under section 415 of the FD&C
Act (domestic and foreign) is subject to the RFR requirements under
section 417 of the FD&C Act. Section 417 requires under certain
circumstances that the responsible party notify the previous source and
subsequent recipient of the article of reportable food, providing
traceability.
(Comment 167) Some comments request that we use the term
``adulteration'' instead of ``contamination'' in subpart B of the final
rule because ``adulteration'' of food is the regulatory standard for
action, whereas contamination is currently undefined. These comments
state that the term contamination should carry a different meaning than
in part 117 because what is considered a contaminant in human food may
differ from what is considered a contaminant in animal food.
(Response 167) We decline this request. Section 402(a)(3) and (4)
of the FD&C Act were added to expand our bases for initiating
enforcement proceedings against adulterated food, particularly to allow
us to act where a food has been prepared, packed, or held under
insanitary conditions, whereby it may have become contaminated. In
other words, a food need not be shown to contain contaminants to be
adulterated; a showing that the food was prepared, packed, or held
under
[[Page 56226]]
conditions whereby it may become contaminated is sufficient to prove
adulteration. Thus, the word ``contamination'' serves a necessary
purpose in the context of adulteration. The CGMPs in this final rule
are intended to help protect against the contamination of animal food,
so that it will not become adulterated.
The word ``contamination'' is used widely in FDA regulations,
including our Current Good Manufacturing Practice for Medicated Feeds
(21 CFR part 225), Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers (21 CFR part 113), and the Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
(21 CFR part 110, and updated and included in the final rule for
preventive controls for human food, 21 CFR part 117, published
elsewhere in this Federal Register). In addition, ``contamination'' is
used in Codex Good Practices for the Feed Industry and PAS 222 (Ref.
27). Because of the wide use of the term throughout current FDA
regulations and in international standards, we conclude that industry
is familiar with the word ``contamination'' and it is an appropriate
word to use in this final rule.
We recognize that it may not always be possible to prevent
contamination of animal food. Therefore, we have changed the regulatory
text throughout subpart B to stress that the goal of the regulations is
to ``protect against'' or ``minimize'' the contamination of animal
food. We recognize that what is considered contamination of human food
may not be considered contamination in animal food.
(Comment 168) Some comments object to the use of the terms
``sanitize'' and ``sanitation'' in the CGMPs, saying that the
destruction of microorganisms is not always necessary in animal food
facilities and therefore ``cleaning'' or ``housekeeping'' should be
used instead of ``sanitizing.'' Some of these comments also ask that we
change the title of proposed Sec. 507.19 from ``Sanitation'' to
``Cleaning and Housekeeping.''
(Response 168) We decline this request. We use the term
``sanitation'' in a general way that we believe is well understood by
the animal food industry and does not mean the destruction of
microorganisms. For example, the term ``sanitation'' is defined in PAS-
222 (Ref. 27). When the destruction of vegetative cells of pathogens
and substantial reduction of numbers of other undesirable
microorganisms is required, we use the terms ``sanitize'' or
``sanitizing,'' not ``sanitation,'' which is consistent with how these
terms are used throughout our current regulations for human and animal
food. The only requirement for sanitizing in subpart B is in regards to
wet processing (see regulatory text for Sec. 507.19(b)(2)). Therefore,
we believe that ``sanitation'' is a word that is commonly understood by
industry and is used in this final rule in a way that is consistent
with how it is used in our other regulations relating to human and
animal food.
(Comment 169) Some comments request that we use ``tools'' instead
of ``utensils'' in the CGMPs to better fit the terminology used in the
animal food industry.
(Response 169) We decline this request. We recognize that
``utensil'' is not commonly used in the animal food industry; however,
we believe it is well understood. The term ``utensil'' is used in PAS-
222 and Codex Good Practices for the Feed Industry, as well as in the
CGMPs for human food in part 110 and in the revised CGMPs in the final
rule for preventive controls for human food, part 117 (Refs. 27 and
29). Further, because ``tools'' is broadly used to refer to such things
as construction equipment, software, educational material, and even
laws and regulations, we believe it is not a good substitute for
``utensils.''
(Comment 170) A number of comments request that wherever we require
measures to protect against contamination of animal food, animal food-
contact surfaces, and animal food-packaging materials, that we delete
animal food-contact surfaces and animal food-packaging materials
because the focus should be solely on the animal food.
(Response 170) We decline this request. While the ultimate goal of
the CGMP requirements is to protect against contamination of animal
food, we believe that protecting animal food-contact surfaces and
animal food-packaging material from contamination is a necessary step
to achieve this goal because the surfaces and packaging can be a source
of contamination.
XV. Subpart B: Comments on Proposed Sec. 507.14--Personnel
We proposed that plant management must take all reasonable measures
and precautions to ensure that all persons working in direct contact
with animal food, animal food-contact surfaces, and animal food-
packaging materials conform to hygienic practices to the extent
necessary to protect against the contamination of animal food. We are
finalizing this provision with the discussed changes in Sec.
507.14(a). We have changed ``plant'' to ``establishment'' for clarity.
We are finalizing the proposed list of methods for maintaining
cleanliness that were proposed in Sec. 507.14(a)(1) through (5) in new
Sec. 507.14(b)(1) through (5). We have added paragraph (b) to read:
``the methods for conforming to hygienic practices and maintaining
cleanliness include.''
(Comment 171) Some comments ask us to remove ``all'' because it is
too extreme and prescriptive.
(Response 171) We have revised the regulatory text to delete
``all''. We disagree that the term ``all'' is too extreme and
prescriptive, but conclude that the term ``all'' is not necessary to
communicate the intent of the requirement.
A. Proposed Sec. 507.14(a)(1)--Personal Cleanliness (Final Sec.
507.14(b)(1))
We proposed that the methods for maintaining cleanliness include
maintaining adequate personal cleanliness. We did not receive comments
specific to this provision and are finalizing it as proposed.
B. Proposed Sec. 507.14(a)(2)--Hand Washing (Final Sec. 507.14(b)(2))
We proposed that the methods for maintaining cleanliness include
washing hands thoroughly in an adequate hand-washing facility as
necessary and appropriate to prevent contamination.
(Comment 172) One comment disagrees with FDA's decision to revise
the language from the 2013 proposed rule by removing the parenthetic
statement about sanitizing hands if necessary to protect against
contamination with undesirable organisms. The comment recommends that
FDA add a qualifying statement that if hand washing facilities are not
readily available, the use of hand sanitizers is permitted.
(Response 172) We decline this request. We deleted the parenthetic
statement because we did not intend to require hand sanitizing after
hand washing. We are providing flexibility for plant management to
determine if hand sanitizing after washing is necessary to protect
against contamination of animal food with undesirable microorganisms.
We recognize that there may be some situations where hand washing
facilities are not readily available. The use of waterless hand
cleaners (including hand sanitizers) may be adequate under these
circumstances.
[[Page 56227]]
C. Proposed Sec. 507.14(a)(3)--Unsecured Jewelry and Other Objects
(Final Sec. 507.14(b)(3))
We proposed that personnel be required to remove or secure jewelry
and other objects that might fall into animal food, equipment, or
containers.
(Comment 173) One comment says this requirement is unnecessary
since the proposed CGMPs contain numerous other provisions that require
facilities to protect against the adulteration of products. The focus
placed on jewelry and other items that may potentially fall into
products is unwarranted due to the limited risk of such occurrences.
(Response 173) We believe that a specific provision to protect
against jewelry and other personal items falling into animal food is
appropriate, and is not redundant to other requirements in the CGMPs
that are intended to protect against adulteration of animal food.
D. Proposed Sec. 507.14(a)(4)--Storing Clothing and Personal
Belongings (Final Sec. 507.14(b)(4))
We proposed requiring personnel to store clothing and other
personal belongings in areas other than where animal food is exposed or
where equipment or utensils are cleaned.
(Comment 174) One comment says that the requirement is not
practical or necessary to ensure the safety of animal food. The comment
states that the temperature in a facility can be highly variable, so it
would be unreasonable to require an employee to store clothing outside
of areas where animal food is exposed.
(Response 174) We understand that personnel may need layers of
clothing in certain plants that are exposed to varying temperatures.
However, when clothing is removed, it needs to be stored away from
exposed animal food so it does not become a source of contamination. We
believe storing clothing and other personal belongings in areas other
than where animal food is exposed is a reasonable protection.
E. Proposed Sec. 507.14(a)(5)--Taking Other Necessary Precautions
(Final Sec. 507.14(b)(5))
We proposed that personnel must take any other necessary
precautions to protect against the contamination of animal food, animal
food-contact surfaces, or animal food-packaging materials.
(Comment 175) One comment requests that we provide examples in a
guidance document for the requirement to take ``any other necessary
precautions to protect against contamination of animal food, animal
food contact surfaces, or animal food packaging materials.''
(Response 175) We believe this provision indicates that the listed
requirements are not meant to be exhaustive and provides needed
flexibility for the diverse animal food industry to implement
precautions specific to their operations to protect against the
contamination of animal food. We will consider providing examples in
any future guidance.
XVI. Subpart B: Comments on Proposed Sec. 507.17--Plant and Grounds
A. Proposed Sec. 507.17(a)--Grounds Surrounding an Animal Food Plant
We proposed that the grounds surrounding an animal food plant under
the control of the operator must be kept in a condition that will
protect against the contamination of animal food, including provisions
to keep areas from being a harborage for pests, maintaining areas so
they are not a source of contamination, adequately draining areas, and
treating and disposing of waste so it is not a source of contamination.
(Comment 176) One comment says that the term ``surrounding'' the
plant is too ambiguous, and that we should specify the distance from a
plant that must be controlled to prevent animal food contamination.
(Response 176) We decline to specify a distance from the plant
because the area that could impact plant operations is highly variable
from plant to plant. We have replaced the word ``surrounding'' with the
word ``around,'' meaning the grounds of the plant under control of the
plant management that could impact plant operations.
(Comment 177) Some comments say that the requirements are highly
prescriptive and should be more flexible. Other comments state that the
general language that requires the grounds to be kept in a condition
that will protect against the contamination of animal food is
sufficient and that the specific requirements should be
recommendations.
(Response 177) The specific requirements provide the baseline
expectations we have for plants to maintain their grounds in a way that
does not result in the contamination of animal food. The specific
requirements are common to most plants and provide necessary
information to the plant management about what it must do to comply
with this final rule. However, the requirements do not preclude a plant
from addressing unique circumstances that could lead to the
contamination of animal food.
B. Proposed Sec. 507.17(b)(1)--Adequate Space Between Equipment,
Walls, and Stored Materials
We proposed that the buildings, structures, fixtures, and other
physical facilities of the plant must be suitable in size,
construction, and design to facilitate cleaning, maintenance, and pest
control to reduce the potential for contamination of animal food,
animal food-contract surfaces, and animal food-packaging materials. We
also proposed that the plant must provide adequate space between
equipment, walls, and stored materials to permit employees to perform
their duties and to allow cleaning and maintenance of equipment.
(Comment 178) Two comments disagree with this requirement. One
comment says that the focus is on equipment design and not protecting
against animal food contamination. The other comment suggests
simplifying the requirement to provide access between equipment and
walls.
(Response 178) We believe protecting animal food from contamination
requires proper plant design. We decline the request to change the
requirement by deleting the reference to stored materials because we do
not agree that stored materials should be allowed to prevent employees
from performing their duties or inhibit the cleaning and maintenance of
equipment. We did modify the language in paragraph (b) to replace
``buildings, structures, fixtures, and other physical facilities of the
plant'' with ``the plant'' because the plant would include its
buildings, structures, fixtures, and physical facilities.
C. Proposed Sec. 507.17(b)(2)--Dripping and Condensation
We proposed that the plant must be constructed in a manner such
that drip or condensate from fixtures, ducts, and pipes does not serve
as a source of contamination.
(Comment 179) One comment asks that we allow for facilities to be
``constructed or maintained,'' rather than ``constructed'' only, to
ensure that drip or condensate does not serve as a source of animal
food contamination. Another comment asks that the requirement be
deleted, since it is generally not relevant and is redundant to the
opening statement in proposed paragraph (b). Other comments say that
requirements pertaining to the construction of buildings and structures
are too prescriptive and should specify only that the plant be
constructed in such a manner as to protect against adulteration of
animal food.
[[Page 56228]]
(Response 179) We decline the requests to revise or delete this
requirement. The requirements in (b)(1) to (5) are some of the specific
requirements that we believe are needed to meet the general requirement
in paragraph (b) that the plant be designed and constructed to reduce
the potential for contamination. We believe it is important to specify
that fixtures, ducts, and pipes be constructed so that they do not
serve as a source of contamination because condensate and drip may
serve as a source of contamination. As specified in Sec. 507.20(b)(3),
plumbing must be maintained to avoid being a source of contamination to
animal food. In addition, as specified in 507.19(a), the fixtures and
physical facilities of the plant must be kept in good repair to prevent
animal food from becoming adulterated. This would include fixtures,
ducts, and pipes. Thus, we agree that one way to manage dripping and
condensation is through maintenance or repair to the plumbing or
structure, and do not intend that existing plants must be redesigned or
reconstructed.
D. Proposed Sec. 507.17(b)(3)--Ventilation
We proposed that the plant must provide adequate ventilation or
control equipment to minimize vapors (for example, steam) and fumes in
areas where they may contaminate animal food, and locate and operate
fans and other air-blowing equipment in a manner that minimizes the
potential for contaminating animal food.
(Comment 180) One comment says that while steam is a key
manufacturing component, it is unlikely to be a source of potentially
hazardous contaminants. Several comments state that steam is not
commonly used in animal food processing, and should not be specified in
the rule, or language stating ``where appropriate and necessary''
should be included in the regulatory text. Other comments suggest
additional alternative language.
(Response 180) We agree that not all plants use steam and the
phrase ``where appropriate and necessary'' provides that distinction
and have added it to the regulatory text. We also recognize that animal
food facilities commonly rely on natural ventilation. As a result, we
have added the parenthetical (mechanical or natural) to the regulatory
text to read: ``Provide adequate ventilation (mechanical or natural) .
. .''
E. Proposed Sec. 507.17(b)(4)--Lighting
We proposed that the plant must provide adequate lighting in hand-
washing areas, toilet rooms, areas where animal food is received,
manufactured, processed, packed, or held, and areas where equipment or
utensils are cleaned. We received no comments on this provision and are
finalizing it as proposed.
F. Proposed Sec. 507.17(b)(5)--Glass
We proposed that the plant must provide safety-type light bulbs,
fixtures, and skylights, or other glass items suspended over exposed
animal food in any step of preparation, to protect against the
contamination of animal food in case of glass breakage. We did not
receive specific comments on this paragraph. However, for clarity, we
have replaced the term ``safety-type'' with ``shatter-resistant.''
G. Proposed Sec. 507.17(b)(6)--Outdoor Storage
We proposed that animal food stored outdoors in bulk be protected
by any effective means, including using protective coverings,
controlling areas over and around the bulk animal food to eliminate
harborages for pests, and checking on a regular basis for pests and
pest infestation.
(Comment 181) Several comments say that protecting animal food
stored outdoors is better addressed in proposed Sec. 507.19
(Sanitation). One comment says that at livestock facilities and farms
animal food such as hay, silage, grain, human food by-products, and
other commodities are commonly stored outside with no cover. Another
comment requests that the regulation be revised to recommend rather
than require the provisions.
(Response 181) While we disagree with the recommendation to move
this requirement to Sec. 507.19 (Sanitation), we moved it from
proposed paragraph (b) to new paragraph (c) in Sec. 507.17 because
paragraph (b) pertains to buildings and structures and this requirement
is about animal food stored outside of the building or structure. We
have revised the regulatory text in paragraph (c)(1) to read ``Using
protective coverings where necessary and appropriate'' to account for
the situations that may not require protective coverings. In addition,
we have added checking for product condition related to the safety of
the animal food in paragraph (c)(3) to ensure that if the animal food
is not covered, animal food safety is maintained. We decline to specify
under what circumstance protective coverage is required (such as, to
protect against adverse weather conditions) since there could be
several reasons for needing protective coverage to help protect against
contamination of the animal food.
XVII. Subpart B: Comments on Proposed Sec. 507.19--Sanitation
A. Proposed Sec. 507.19(a)--Buildings
We proposed that buildings, structures, fixtures, and other
physical facilities of the plant must be kept clean and in good repair
to prevent animal food from becoming contaminated. We received no
comments on this provision, however we are replacing ``contaminated''
with the broader standard ``adulterated'' as proposed in the 2013
proposed preventive controls rule for animal food.
B. Proposed Sec. 507.19(b)--Cleaning
We proposed that animal food-contact and non-contact surfaces of
utensils and equipment must be cleaned and maintained and utensils and
equipment stored as necessary and appropriate to protect against the
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials, and that when necessary, equipment be
disassembled for thorough cleaning.
(Comment 182) Two comments state that the proposed provision is too
prescriptive because of the requirement to disassemble equipment for
cleaning when necessary.
(Response 182) We believe the language provides flexibility for
plants to prevent contamination of animal food contact and non-contact
surfaces of utensils and equipment. The language ``when necessary''
provides the plant the option whether to disassemble the equipment for
cleaning based on the manufacturer's knowledge and experience of when
this cleaning procedure is necessary to protect against the
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials.
C. Proposed Sec. 507.19(b)(1)--Wet Cleaning
We proposed that when it is necessary to wet-clean animal food-
contact surfaces used for manufacturing, processing, packing, or
holding low-moisture animal food, the surfaces must be thoroughly dried
before subsequent use.
(Comment 183) One comment states that ``low-moisture animal food''
is not defined, so for clarity we should either define it or replace it
with ``safe moisture level animal food'' because ``safe moisture
level'' is already defined in the proposed rule.
(Response 183) We agree that the term ``low-moisture'' is not well
known when applied to the animal food industry as a whole and we have
removed the term. We believe that in most cases, animal
[[Page 56229]]
food contact surfaces must be thoroughly dried after wet cleaning
because the moisture could provide an environment for growth of
undesirable microorganisms. However, we also understand that in some
situations, for example in wet processing areas, it would not be
necessary to dry surfaces thoroughly before subsequent use in order to
protect against contamination. Therefore, we have inserted ``when
necessary,'' so that the requirement is appropriate for all types of
animal food facilities.
(Comment 184) Two comments note that the proposed rule includes
explicit requirements for wet cleaning, but none for dry cleaning. One
comment suggests adding language to paragraph (b) for dry cleaning,
including vacuuming or sweeping. The second comment suggests adding
language for dry cleaning when used solely for low-moisture feed
ingredients.
(Response 184) We decline these requests. The regulatory text in
paragraph (b) requires that utensils and equipment be cleaned and
maintained, but it does not specify the exact procedures. Adequate
cleanout of so-called dry feeds has been an important CGMP requirement
applicable to medicated feed for more than 40 years and, as such, some
of the animal food industry is well aware of this practice. The dry
cleaning procedures suggested in the comments would be allowable
methods of cleaning and maintaining where appropriate to protect
against the contamination of animal food. We do not believe additional
language is necessary in the regulatory text for dry cleaning. The
provisions in paragraph (b)(1) for wet cleaning are in addition to the
more general requirements in paragraph (b) to help ensure that water
from the wet-cleaning process does not result in subsequent
contamination of animal food.
D. Proposed Sec. 507.19(b)(2)--Wet Processing
We proposed that in wet processing, when cleaning and sanitizing is
necessary to protect against the introduction of undesirable
microorganisms into animal food, all animal food-contact surfaces must
be cleaned and sanitized before use and after any interruption during
which the animal food-contact surfaces may have become contaminated.
(Comment 185) One comment says the proposed requirements for
cleaning in wet processing areas should be more flexible and suggests
the additional wording ``as necessary to protect against adulteration
of animal food.''
(Response 185) We believe this requirement is sufficiently flexible
because it applies only when necessary to protect against the
introduction of undesirable microorganisms into animal food.
E. Proposed Sec. 507.19(c)--Cleaning Compounds and Sanitizing Agents
We proposed that cleaning compounds and sanitizing agents must be
safe and adequate under the conditions of use. We received no comments
on this provision and are finalizing it as proposed.
F. Proposed Sec. 507.19(d)(1)--Toxic Materials
We proposed that only certain toxic materials may be used or stored
in a plant where animal food is manufactured, processed, or exposed,
i.e., those that are required to maintain clean and sanitary
conditions, those necessary for use in laboratory testing procedures,
those necessary for plant and equipment maintenance and operation, and
those necessary for use in the plant's operations.
(Comment 186) Some comments say that the proposed regulation would
require an absolute prohibition of any potentially toxic materials that
are stored but not used by an animal food plant. The comments note that
animal food plants that hold and distribute materials such as
fertilizers and pesticides would either need to discontinue this
practice or construct new storage buildings, which may be expensive.
Several comments suggest alternative language to allow toxic materials
to be held and distributed in a way that would not require significant
physical improvements to the plant.
(Response 186) We agree that it might be common for an animal food
plant to have toxic materials not identified in paragraph (d)(1), such
as fertilizers or other non-plant chemicals, as part of its business
inventory. However, we disagree with the comments that state the
provisions in the rule would require new investments in storage
buildings. The intent of the provision is to keep toxic chemical
categories not listed in paragraph (d)(1) out of the plant area so
animal food is not exposed. We revised the regulatory text to add
paragraph (d)(3), which reads ``Other toxic materials (such as
fertilizers and pesticides not included in paragraph (d)(1) of this
section) must be stored in an area of the plant where animal food is
not manufactured, processed, or exposed.'' We expect that this will
result in toxic materials not identified in paragraph (d)(1) being
separated from animal food either by sufficient space or a sufficient
physical barrier such that they are not able to contaminate the animal
food. With this clarification, we do not believe that establishments
will need to make significant investments to their buildings and
structures to comply with these requirements.
G. Proposed Sec. 507.19(d)(2)--Identification, Use, and Storage of
Toxic Materials
We proposed that toxic materials described in paragraph (d)(1) of
this section (for example, cleaning compounds, sanitizing agents, and
pesticide chemicals) must be identified, used, and stored in a manner
that protects against the contamination of animal food, animal food-
contact surfaces, or animal food-packaging materials.
(Comment 187) A number of comments object to the use of ``toxic''
in proposed paragraph (d)(2). Several comments suggest that ``cleaning
materials'' rather than ``toxic cleaning compounds'' be used in
paragraph (d)(2) because any substance may be considered ``toxic'' if
handled or used inappropriately. One comment asks that the term ``toxic
materials'' be deleted and requirements established instead for the
control of substances that are not approved for use in animal food.
(Response 187) We decline the request. The term ``toxic'' is
important to specify that this paragraph applies to toxic cleaning
compounds. The term ``cleaning compounds'' would be too general and
might include materials that would not need to be handled as specified
in these requirements to protect against the contamination of animal
food. For example, water could be considered a cleaning compound, but
it is not considered toxic at regular use levels and we would not
expect a plant to treat its use of cleaning water in a manner
consistent with this requirement. We decline the request to substitute
``substances that are not approved for use in animal food'' for ``toxic
materials.'' Not all animal food ingredients have been or must be
preapproved by the Agency before being used to produce animal food.
Additionally, ingredients that have not been approved by the Agency
would not necessarily be toxic.
H. Proposed Sec. 507.19(e)--Pest Control
We proposed that effective measures must be taken to exclude pests
from the manufacturing, processing, packing, and holding areas and to
protect against the contamination of animal food by pests. The use of
insecticides and rodenticides in the plant is permitted only under
precautions and restrictions that will
[[Page 56230]]
protect against the contamination of animal food, animal food-contact
surfaces, and animal food-packaging materials. We received no comments
on this provision. We have replaced the words ``insecticides and
rodenticides'' with ``pesticides'' for simplicity and because we have
defined pest as ``any objectionable animals or insects including birds,
rodents, flies, and larvae.'' Thus, pests are not limited to insects
and rodents.
I. Proposed Sec. 507.19(f)--Trash and Garbage
We proposed that trash and garbage must be conveyed, stored, and
disposed of in a way that protects against the contamination of animal
food, animal food-contact surfaces, animal food-packaging materials,
water supplies, and ground surfaces, and minimizes the potential for
the trash and garbage to become an attractant and harborage or breeding
place for pests. We received no comments on this provision; however we
are removing the term ``garbage.'' (See Response 227).
XVIII. Subpart B: Comments on Proposed Sec. 507.20--Water Supply and
Plumbing
A. Proposed Sec. 507.20(a)--Water Supply (Final Sec. 507.20(a)(1)-
(4))
We proposed that the water supply must be adequate for the
operations and must be derived from a suitable source. Running water at
a suitable temperature, and under suitable pressure as needed, must be
provided in all areas where required for the manufacturing or
processing of animal food, for the cleaning of equipment, utensils, and
animal food-packaging materials, or for employee hand-washing
facilities. Water that contacts animal food, animal food-contact
surfaces, or animal food-packaging materials must be safe for its
intended use. Water may be reused for washing, rinsing, or conveying
animal food if it does not increase the level of contamination of the
animal food.
(Comment 188) One comment suggests that we develop an enforcement
plan for water quality that takes into account the intended use of the
animal food being manufactured. Another comment says that many of the
details contained in this paragraph of the proposed regulation should
be handled as guidance rather than regulation.
(Response 188) We believe that the details contained in this
paragraph should remain requirements because they are important to
helping ensure the safety of animal food and to provide the regulated
facility with information about what is expected of the water supply
for the plant and the animal food being manufactured, processed, packed
or held. We will consider including water supply in any future
guidance.
(Comment 189) Two comments say that that the requirements
pertaining to the water supply are overly prescriptive and we should
require only that the water supply be adequate for the operations. Two
comments suggest that the requirement about the reuse of water be
reworded to provide more clarification on the recycling of water within
the plant.
(Response 189) We believe the source of the water is relevant to
ensuring that animal food is protected from contamination. We also
believe specifying that water be safe for its intended use, and that it
be provided at a suitable temperature and pressure where it is needed
for manufacturing, processing, cleaning, and hand washing helps protect
against animal food contamination. With respect to reuse of water, we
believe our statement that water may be reused for washing, rinsing, or
conveying animal food if it does not increase the level of
contamination of the animal food allows flexibility for recycling water
within the plant. Additional clarification could have the unintended
effect of reducing flexibility.
B. Proposed Sec. 507.20(b)--Plumbing
We proposed that plumbing be designed, installed, and maintained to
carry adequate quantities of water to required locations throughout the
plant; properly convey sewage and liquid disposable waste from the
plant; avoid being a source of contamination to animal food, animal
food-contact surfaces, or animal food-packaging materials, water
supplies, equipment, or utensils, or creating an unsanitary condition;
provide adequate floor drainage in all areas where floors are subject
to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and ensure there is
no backflow or cross-connections between piping for water for
processing and for waste water.
(Comment 190) One comment says we are proposing to establish
specific requirements for plumbing design, installation, and
maintenance that are not necessary to prevent the adulteration of
animal food, and suggests deleting the plumbing design section
entirely. Two comments say that floor drains are not the only way to
remove water or other fluids from floors, and suggest we allow other
options such as vacuuming, mopping, or fans.
(Response 190) We decline these requests. We believe these are
basic and necessary requirements for helping ensure production of safe
animal food. The regulatory text requires adequate floor drainage for
areas where floors are subject to flooding-type cleaning or where
normal operations release or discharge water or other liquid waste on
the floor. Plants that do not perform these activities as part of their
normal operations would not be expected to have floor drainage and
vacuuming or mopping may be adequate.
C. Proposed Sec. 507.20(c)--Sewage
We proposed that sewage must be disposed of through an adequate
sewerage system or through other adequate means.
(Comment 191) Some comments say that the requirement to provide an
adequate sewer system is covered by the requirement in proposed Sec.
507.20(b)(2) for plumbing and that one of the requirements should be
deleted to eliminate this redundancy.
(Response 191) The requirement in paragraph (b)(2) is intended to
make sure the plumbing in the plant is sufficient to remove sewage and
liquid disposable waste from the points at which it is generated within
the plant, while the requirement in paragraph (c) is intended to make
sure that the sewage and liquid disposable waste created by the plant
is delivered to a wastewater system, such as a sewer or septic system,
which has a capacity adequate to ensure that this wastewater does not
contaminate the animal food.
D. Proposed Sec. 507.20(d)--Toilet Facilities
We proposed that each plant must provide employees with adequate,
readily accessible toilet facilities, and that the toilet facilities be
kept clean and not be a potential source of contamination of animal
food, animal food-contact surfaces, or animal food-packaging materials.
(Comment 192) Some comments suggest adding ``as appropriate'' to
the requirement to provide adequate toilet facilities for plant
employees.
(Response 192) We decline this request. We understand that there
may be an exception where toilet facilities are not inside a plant, but
we believe it is important that toilet facilities are available near
the plant for employee use, and the requirement as proposed provides
this flexibility.
E. Proposed Sec. 507.20(e)--Hand-Washing Facilities
We proposed that each plant must provide hand-washing facilities
[[Page 56231]]
designed to ensure that an employee's hands are not a source of
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials.
(Comment 193) Some comments suggest adding the words ``as
appropriate'' to the requirement to provide flexibility for those
plants that may not need hand-washing facilities. Another comment asks
that we add an option that allows for the use of hand sanitizing in
plants that may not need hand-washing facilities.
(Response 193) We understand that there may not be running water in
every plant, but we believe it is important that hand-washing
facilities be available to employees. We understand that in some cases
hand-washing facilities might consist of waterless hand cleaners
(including hand sanitizers).
XIX. Subpart B: Comments on Proposed Sec. 507.22--Equipment and
Utensils
A. Proposed Sec. 507.22(a)(1)--Plant Equipment and Utensils
We proposed that all plant equipment and utensils must be designed
and of such material and workmanship to be adequately cleanable, and
must be properly maintained.
(Comment 194) Some comments suggest that this be a recommendation
rather than a requirement because it is too prescriptive and applies to
all equipment in a plant, rather than only to equipment used in the
production of animal food.
(Response 194) We decline this request. We believe that all plant
equipment with the potential to contaminate animal food must be
cleanable and maintained. To clarify this requirement, we have added
language stating that this requirement applies to equipment and
utensils used in manufacturing, processing, packing, and holding animal
food, as well as equipment and utensils that do not come in contact
with animal food but could still serve as a source of contamination of
animal food.
B. Proposed Sec. 507.22(a)(2)--Design of Equipment and Utensils
We proposed that the design, construction, and use of equipment and
utensils must preclude the contamination of animal food with
lubricants, fuel, metal fragments, contaminated water, or any other
contaminants.
(Comment 195) Some comments say that this requirement is too
prescriptive because equipment and utensils are designed and
constructed by entities independent of the animal food manufacturers/
processers. Some comments also say that we should clarify that we are
not requiring the use of food-grade lubricants.
(Response 195) We understand that plants do not normally design and
construct the equipment they use. However, we believe it is the plant's
responsibility to select equipment and utensils that when used will not
adulterate animal food. We have revised the text to clarify that the
presence of non-food grade lubricants, fuel, metal fragments,
contaminated water, or other contaminants in animal food may render it
adulterated. We also have revised the wording for easier reading. We
are not requiring that only food grade lubricants be used in the plant,
but food grade lubricants must be used on equipment that comes in
contact with animal food. When a non-food grade lubricant is used on
non-food contact equipment, it must not adulterate the animal food. We
have added the term ``non-food grade'' for lubricants to clarify this.
C. Proposed Sec. 507.22(a)(3)--Equipment Installation
We proposed that equipment should be installed and maintained in
such a way as to facilitate the cleaning of the equipment and adjacent
spaces. This provision has been revised to be a requirement, not a
recommendation as it is a requirement, not guidance.
(Comment 196) One comment suggests that we combine proposed
Sec. Sec. 507.22(a)(1) and 507.22(a)(3).
(Response 196) We decline this request. The first provision
requires that equipment be properly designed and constructed, and the
second requires that it be installed in a way that facilitates cleaning
and maintenance. We have revised the wording in (a)(3) for clarity.
D. Proposed Sec. 507.22(a)(4)--Animal Food Contact Surfaces
We proposed that animal food-contact surfaces must be made of
materials that withstand the environment of their use and the action of
animal food, and, if applicable, the action of cleaning compounds, and
sanitizing agents; be made of nontoxic materials; and maintained to
protect animal food from being contaminated.
(Comment 197) Some comments ask us to specify that food-contact
surfaces must be designed to withstand cleaning procedures.
(Response 197) We have revised the regulatory text to include
cleaning procedures. For example animal food-contact surfaces must be
designed to withstand the actions of scrubbing utensils that could
damage the equipment.
E. Proposed Sec. 507.22(a)(5)--Non-Animal Food Contact Equipment
(Final Sec. 507.22(a)(1))
We proposed that equipment in the animal food in manufacturing/
processing area, that does not come into contact with animal food must
be constructed in such a way that it can be kept in a clean condition.
(Comment 198) One comment says that this requirement should be
deleted because it is highly prescriptive, redundant to proposed
paragraph (a)(1), and not performance based or necessary. Further, the
comment states FDA's focus should be on whether the area is adequately
cleaned, not on whether equipment that does not come in contact with
animal food is properly designed.
(Response 198) We disagree that the requirement is too
prescriptive. However, we agree that there is some redundancy between
proposed paragraphs (a)(1) and (a)(5). We have removed proposed
paragraph (a)(5) and have modified the regulatory text in paragraph
(a)(1) as discussed in section XIX.A.
F. Proposed Sec. 507.22(b)--System Design and Construction
We proposed that holding, conveying, manufacturing, and processing
systems, including gravimetric, pneumatic, closed, and automated
systems, must be designed, constructed, and maintained in a way that
does not contaminate animal food.
(Comment 199) Several comments suggest that this requirement be
revised or deleted to allow plants the flexibility to maintain their
equipment in a manner that is appropriate for their facility, and
because it is redundant to proposed Sec. 507.22(a)(1) through (4).
(Response 199) We decline to revise or eliminate this provision.
The requirements in Sec. 507.22(a) are specific to individual pieces
of equipment. The requirement in Sec. 507.22(b) is meant to address
entire systems that may contain multiple pieces of equipment. While an
individual piece of equipment may be designed, constructed and
maintained so that it protects against the contamination of animal
food, when that piece of equipment becomes part of a system, its use in
the system must be in a manner that protects against the contamination
of animal food. (See Response 167.)
[[Page 56232]]
G. Proposed Sec. 507.22(c)--Monitoring Cold Storage Temperatures
We proposed that each freezer and cold storage compartment used to
hold animal food must be fitted with an accurate temperature-monitoring
device.
(Comment 200) Some comments state requiring monitoring devices for
each compartment goes too far. Facilities should have flexibility in
controlling temperatures in freezers and cold storage compartments. One
comment says this requirement should not require the use of continuous
temperature-monitoring devices.
(Response 200) We believe that a temperature-measuring device for
each compartment is necessary because the temperature may be different
in each compartment. We have replaced the term ``temperature -
monitoring device'' with ``temperature-measuring device'' as we do not
intend the establishment to use a continuous monitoring device or
temperature recording device.
H. Proposed Sec. 507.22(d)--Instruments
We proposed that instruments and controls used for measuring,
regulating, or recording temperatures, pH, aw, or other
conditions that control or prevent the growth of undesirable
microorganisms in animal food must be accurate, precise, adequately
maintained, and adequate in number for their designated uses. We
received no comments on this provision and are finalizing it as
proposed.
I. Proposed Sec. 507.22(e)--Compressed Air
We proposed that compressed air or other gases mechanically
introduced into animal food or used to clean animal food-contact
surfaces or equipment must be used in such a way so animal food is not
contaminated. We received no comments on this provision and are
finalizing it as proposed with the revision ``to protect against the
contamination of animal food.'' (See Response 167.)
XX. Subpart B: Comments on Proposed Sec. 507.25--Plant Operations
A. Proposed Sec. 507.25(a)(1)--CGMPs
We proposed that plant management must ensure that all operations
in the manufacturing, processing, packing, and holding of animal food
are conducted in accordance with the CGMP requirements of this subpart.
We received no comments on this provision. We are revising paragraph
(a) to read ``Management of the establishment must ensure that:'' based
on the definition of ``plant'' (see section VIII.A.23).
B. Proposed Sec. 507.25(a)(2)--Identifying Contents of Containers
We proposed that plant management must ensure that containers
holding animal food, including raw materials, other ingredients, or
rework, accurately identify the contents.
(Comment 201) Some comments suggest that we revise the proposed
requirements by clarifying that the contents of containers, not the
containers themselves, are accurately identified, and that we clarify
that bulk silos and bins are not required to be placarded, because this
is impractical and not industry practice.
(Response 201) We agree that the animal food in the containers is
what must be identified and have clarified the language in the
regulatory text to require management to ensure animal food, including
raw materials, other ingredients, or rework is accurately identified.
We recognize that a variety of systems are used by establishments to
identify animal food within the plant including labeling, computer
systems, paper records, chalkboards, and other methods. It is necessary
that plant personnel be able to accurately identify animal food,
including raw materials, other ingredients, or rework within the plant
so that animal food is not commingled, substituted, or incorrectly
formulated in a manner that results in adulterated animal food.
C. Proposed Sec. 507.25(a)(3)--Labeling of Finished Product (Final
Sec. 507.27(b))
We proposed that plant management must ensure that the labeling for
finished animal food product contains information and instructions for
safely using the product for the intended animal species.
(Comment 202) Many comments suggest that instead of specifying that
labeling for the finished animal food product contains information and
instructions for safely using the product for the intended animal
species we specify only that labeling for finished animal food products
conforms to requirements in existing FDA regulations. One comment asks
that we clarify that finished product means the product that the animal
receives.
(Response 202) We decline the request. We do not intend ``finished
animal food product'' to mean only product that the animal receives. A
finished animal food product could be ready-to-eat animal food or it
could be an ingredient or mixture of ingredients that will be further
processed, mixed, or blended before it is suitable for feeding to
animals.
Labeling containing information and instructions for safe use is
important for both the person feeding the animal(s) and the downstream
facilities that may use an ingredient or mixture of ingredients to
further process, mix, or blend into an animal food product. Some animal
food products may pose a food safety concern for some species for which
the food is not intended, or may pose a food safety concern for an
intended species if not used properly. For example, the manufacturer of
a copper product might include the use levels for food for different
species or a labeling statement specifying the maximum safe level of
copper in an animal food intended for sheep.
We have moved this requirement to paragraph (b) in Sec. 507.27
``Holding and Distribution.'' We believe that this move helps to
clarify that the labeling is intended for finished animal food leaving
the plant. We have renumbered the other requirements in this section
accordingly.
D. Proposed Sec. 507.25(a)(4)--Animal Food Packaging Material (Final
Sec. 507.25(a)(3))
We proposed that plant management must ensure that animal food-
packaging materials are safe and suitable.
(Comment 203) One comment suggests that instead of requiring that
animal food-packaging materials are safe and suitable, we require that
they are safe and suitable for the intended use.
(Response 203) We disagree that this clarification is needed
because the intended use is inherent in the current wording of this
regulation.
E. Proposed Sec. 507.25(a)(5)--Responsibility for Overall Plant
Cleanliness (Final Sec. 507.25(a)(4))
We proposed that plant management must ensure that overall
cleanliness of the plant is under the supervision of one or more
competent individuals assigned responsibility for this function.
(Comment 204) One comment suggests that we require that the
competent individuals responsible for overall cleanliness of the plant
be ``qualified competent individuals.''
(Response 204) As discussed in Response 92, we expect all
individuals who perform activities required under part 507 to know how
to do their jobs; thus, we are establishing new Sec. 507.4(b), which
specifies that all individuals who perform activities required under
part 507 must be ``qualified individuals'' as that term is defined in
Sec. 507.3 (i.e., a person who has the necessary education, training,
and experience to perform an activity required under part 507). A
qualified individual may be, but is not required to be, an employee of
the establishment.
[[Page 56233]]
F. Proposed Sec. 507.25(a)(6)--Contamination Precautions (Final Sec.
507.25(a)(5))
We proposed that plant management must ensure that reasonable
precautions are taken so that plant operations do not contribute to the
contamination of animal food, animal food-contact surfaces, and animal
food packaging materials. We received no comments on this provision. We
did replace the term ``reasonable'' with the term ``adequate'' to be
more consistent with the rest of the regulatory text in subpart B.
G. Proposed Sec. 507.25(a)(7)--Testing Procedures (Final Sec.
507.25(a)(6))
We proposed that plant management must ensure that chemical,
microbial, or extraneous-material testing procedures are used where
necessary to identify sanitation failures or possible animal food
contamination.
(Comment 205) Some comments say that the need for chemical,
microbial, or extraneous-material testing should be determined by a
facility when identifying hazards and controls under subpart C, and
therefore it should not be required under CGMPs. One comment says that
it should be deleted because it is already addressed under the testing
provisions in subpart C.
(Response 205) The CGMP regulations in subpart B are intended to
establish baseline requirements that apply to all plants that
manufacture, process, pack, or hold animal food (and thus are required
to register as food facilities in accordance with Sec. 415 of the FD&C
Act). Using testing procedures, where necessary, to identify sanitation
failures or to identify contaminated animal food may be an important
component of manufacturing, processing, packing, or holding animal
food. This type of testing may be independent of the requirements of
subpart C, hazard analysis and risk based preventive controls, and
therefore we have included it in the CGMP regulations. The provision
provides flexibility for management to determine when testing is
required by providing that testing be used ``where necessary.''
H. Proposed Sec. 507.25(a)(8)--Contaminated Product (Final Sec.
507.25(a)(7))
We proposed that plant management must ensure that animal food that
has become contaminated to the extent that it is adulterated is
rejected, disposed of, or if permissible, treated or processed to
eliminate the adulteration. If disposed of, it must be done in a manner
that protects against the contamination of other animal food. Whatever
methods are used to dispose of adulterated animal food, the methods
should comply with state and local requirements.
(Comment 206) One comment requests that if we require
reconditioning of an animal found to be adulterated, that we clarify
that such a requirement does not apply to grains subject to the review
inspection provisions provided for by 7 CFR 800.125 and 800.135.
(Response 206) In most cases, grains subject to the review
inspection provisions provided for by 7 CFR 800.125 and 800.135 are
RACs that are being held or transported and subpart B (including Sec.
507.25(a)(7)) would not apply to the grains (see Sec. 507.5(h)). In
addition this provision only applies to animal food that has actually
been found to be adulterated. The provisions provided for by 7 CFR
800.125 and 800.135 are administered by USDA's Federal Grain Inspection
Service and relate to their mission of facilitating the marketing of
grains and related commodities.
I. Proposed Sec. 507.25(a)(9)--Protecting Against Contamination (Final
Sec. 507.25(a)(8))
We proposed that plant management must ensure that all animal food
manufacturing, processing, packing, and holding is conducted under such
conditions and controls as are necessary to minimize the potential for
the growth of undesirable microorganisms or for the contamination of
animal food.
(Comment 207) Some comments suggest that we remove the requirement
to minimize the potential for the growth of undesirable microorganisms,
so that the requirement would be to minimize contamination of animal
food or protecting against adulteration of animal food.
(Response 207) We decline this request. In addition to other
contaminants, we conclude that it is important for an establishment to
address undesirable microorganisms because they are a common source of
contamination (78 FR 64736 at 64747).
J. Proposed Sec. 507.25(b)(1)--Raw Materials and Ingredients
We proposed that raw materials and ingredients must be inspected to
ensure that they are suitable for manufacturing/processing into animal
food and handled under conditions that protect against contamination
and minimize deterioration. We are revising the phrase ``raw materials
and ingredients'' to read ``raw materials and other ingredients'' to
make it clear that raw materials are ingredients.
(Comment 208) Some comments ask that we insert ``as appropriate and
necessary'' into the requirement to inspect raw materials and
ingredients to ensure that they are suitable for manufacturing/
processing into animal food. Another comment says that ``minimize
deterioration'' and ``deterioration'' are highly subjective and should
be deleted.
(Response 208) We decline the requests. However, we have revised
the regulatory text by replacing ``inspected'' with ``examined.'' We
believe that the use of the word ``examined'' provides more clarity for
the animal food industry because the term ``inspected'' often implies a
regulatory activity. We believe such an examination is necessary to
protect against contamination of animal food. An examination of raw
materials and other ingredients may include basic activities such as a
simple visual examination of the product (e.g., looking for broken
bags), or performing a chemical or microbial analysis. Deterioration of
animal food includes the loss of palatability or nutritive value
typically associated with the animal food and we believe this could be
a safety concern because animals are often fed the same food containing
the same ingredients for prolonged periods of time. As a result, food
refusal or consumption of animal food containing fewer nutrients than
the animal food is expected to provide may result in poor animal
productivity or health issues. Furthermore, deterioration can indicate
that the animal food has been held under conditions that would also
support the growth of undesirable microorganisms.
K. Proposed Sec. 507.25(b)(1)(i)--Shipping Containers
We proposed that shipping containers (for example, totes, drums,
and tubs) and bulk vehicles holding raw materials and other ingredients
must be inspected upon receipt to determine whether contamination or
deterioration of animal food has occurred.
(Comment 209) Some comments say that inspection of shipping
containers should be as appropriate and necessary, or at a frequency
appropriate and necessary.
(Response 209) We decline this request. We have revised the
regulatory text by replacing ``inspected'' with ``examined.'' We
believe this change better conveys our intent that incoming containers
consistently be checked to make sure there is no gross visible
contamination or deterioration of animal food.
[[Page 56234]]
L. Proposed Sec. 507.25(b)(1)(ii)--Raw Materials
We proposed that raw materials must be cleaned as necessary to
minimize soil or other contamination.
(Comment 210) Many comments say that it is not always necessary to
minimize soil contamination of raw materials because livestock
routinely ingest soil when consuming pasture plants, hay, and other
feeds without adverse consequences. Recommendations are to delete
reference to soil or else insert ``as appropriate.''
(Response 210) We agree. We have revised the regulatory text to
remove the words ``soil or other'' from the requirement.
M. Proposed Sec. 507.25(b)(1)(iii)--Raw Materials
We proposed that raw materials and ingredients must be stored under
conditions that will protect against contamination and deterioration.
(Comment 211) One comment suggests that the requirement that raw
materials be stored under conditions that will protect against
contamination and deterioration be qualified to say ``unreasonable
contamination'' and ``excessive deterioration'' to be more appropriate
for raw materials that will be rendered. One comment asks that we
delete ``and deterioration.'' Another comment suggests that a new
section be added to require that air flow be controlled so that
contamination does not spread from the raw material areas into the
finished product areas of the plant.
(Response 211) We believe the rule as proposed is clear, and that
the qualifiers suggested do not help reduce subjectivity and may create
confusion about what is considered unreasonable or excessive. We
decline to add a requirement that specifically addresses air flow,
because ventilation is addressed in Sec. 507.17(b)(3). Also, the broad
language requires that raw materials and other ingredients must be
stored under conditions that will protect against contamination, which
would include protection from airborne contaminants. We have
determined, however, that it is logical from a food safety standpoint
to include rework in this provision. Therefore, we have incorporated
proposed Sec. 507.25(b)(3) into this requirement.
N. Proposed Sec. 507.25(b)(2)--Raw Materials Susceptible to Mycotoxins
We proposed that raw materials and ingredients susceptible to
contamination with mycotoxins or other natural toxins must be evaluated
and used in a manner that does not result in animal food that can cause
injury or illness to animals or humans.
(Comment 212) Several comments suggest that we eliminate this
requirement because this activity belongs in subpart C, not subpart B.
Other comments say that the requirement could be interpreted to mean
that every load of incoming cereal grains must be evaluated for
mycotoxins, which would not always be necessary. Other suggestions are
to remove ``evaluated'' from the requirement, leaving only the
requirement that raw materials and ingredients susceptible to mycotoxin
contamination be used in a manner that does not result in harm to
humans or animals.
(Response 212) We are locating requirements that are common to most
establishments and plants and serve as a baseline for animal food
safety in subpart B, current good manufacturing practice. Also, we do
not intend that every load of grain received must be tested before it
can be used. We intend for ``evaluation'' to be broad and flexible
enough to consider any information that allows the plant to use the raw
materials and other ingredients in a manner that does not result in
harm to humans or animals. For example, an evaluation could be based on
a general review of the weather conditions during the growing season
and whether it could result in mycotoxins.
(Comment 213) One comment disagrees with our decision in the 2014
supplemental proposed rule to remove a requirement in Sec.
507.25(b)(2) of the 2013 proposed rule for preventive controls for
animal food that raw materials and ingredients not contain
microorganisms injurious to human or animal health. This comment says
that we should have modified the regulatory text to require that raw
materials that are expected to contain levels of microorganisms that
may be injurious to animal or human health, such as materials to be
rendered, be stored and handled in a way that prevents contaminating
the facility and finished product, and that the materials be treated
(e.g., heat treated) during manufacturing operations so that they no
longer contain levels that would cause the product to be adulterated.
(Response 213) Incoming raw materials and other ingredients may
contain microorganisms injurious to human or animal health. As we
stated in the 2014 supplemental notice for animal food, we proposed to
remove this requirement because we did not intend that incoming raw
materials and other ingredients must be tested for pathogens. Instead,
we have included requirements that are meant to minimize the growth of
undesirable microorganisms, and protect animal food from the
contamination with undesirable microorganisms from raw materials and
other ingredients, including those that may be injurious to human or
animal health. We believe these requirements are sufficient to help
ensure the safety of animal food.
O. Proposed Sec. 507.25(b)(3)--Raw Materials and Rework (Final Sec.
507.25(b)(1)(iii))
We proposed that raw materials and ingredients and all rework must
be held in containers designed and constructed in a way that protects
against contamination, and must be held under conditions, e.g.,
appropriate temperature and relative humidity, that will minimize the
potential for growth of undesirable microorganisms and in a manner that
prevents the animal food from becoming adulterated.
(Comment 214) Some comments say that requiring that rework be held
under conditions that will minimize the potential for growth of
undesirable microorganisms is too prescriptive, and suggest that the
requirement be modified to require that all rework must be held in a
manner that prevents the animal food from becoming adulterated. Some
comments say that this requirement should be addressed in subpart C
rather than subpart B.
(Response 214).We disagree that the requirement should be addressed
in subpart C instead of subpart B because we consider this to be a
baseline requirement that should apply to all establishments that
manufacture, process, pack, or hold animal food. However, we have
decided that proposed paragraph (b)(3) contains requirements that are
similar to proposed Sec. 507.25(b)(1)(iii). We have moved this
provision and included it in paragraph (b)(1)(iii) in the final rule.
P. Proposed Sec. 507.25(b)(4)--Frozen Raw Materials (Final Sec.
507.25(b)(3))
We proposed that raw materials and ingredients, if frozen, must be
kept frozen. If thawing is required prior to use, it must be done in a
manner that minimizes the potential for the growth of undesirable
microorganisms.
(Comment 215) One comment says that the requirement to keep frozen
raw materials frozen or thaw them in a manner that minimizes the
potential for the growth of undesirable microorganisms is redundant to
other requirements in Sec. 507.25(b)(1) and therefore should be
deleted.
[[Page 56235]]
(Response 215) We decline this request. The requirements in Sec.
507.25(b)(1) and 507.25(b)(1)(iii) address raw material and other
ingredient inspection, storage and handling in general. This
requirement speaks specifically to the storage and handling of frozen
raw materials. We believe it is important for those establishments that
use frozen raw material to thaw that material safely to minimize the
potential for the growth of undesirable microorganisms during the
thawing process.
Q. Proposed Sec. 507.25(c)(1)--Appropriate Conditions for Animal Food
We proposed that animal food must be maintained under conditions,
e.g., appropriate temperature and relative humidity, that will minimize
the potential for growth of undesirable microorganisms and prevent the
animal food from becoming adulterated during manufacturing, processing,
packing, and holding.
(Comment 216) Some comments say that the requirement to hold and
manufacture products at a temperatures and relative humidity that will
minimize the potential for growth of undesirable microorganisms should
be deleted because it is not relevant to most animal food facilities.
With this deletion, the requirement would be that animal food be
maintained under conditions that would prevent the animal food from
becoming adulterated during manufacturing, processing, packing, and
holding.
(Response 216) Temperature and relative humidity are examples of
conditions and may not apply to all plants and animal food. This
requirement is important for animal food safety in plants that produce
animal food that must be handled under specific processing, packing or
holding conditions to prevent the growth of undesirable microorganisms
and adulteration.
R. Proposed Sec. 507.25(c)(2)--Control of Undesirable Microorganisms
We proposed that measures taken during manufacturing, processing,
packing, and holding of animal food to significantly minimize or
prevent the growth of undesirable microorganisms (for example, heat
treating, freezing, refrigerating, irradiating, controlling pH, or
controlling aw) must be adequate to prevent adulteration of
animal food.
(Comment 217) Most of the comments say that measures to
significantly minimize or prevent the growth of undesirable
microorganisms should be addressed under subpart C, and that this
requirement should be removed from the CGMPs. One comment recommends
deleting only the examples of measures that might be taken. Another
comment recommends deleting the term ``significantly'' as this term is
not defined and is difficult to quantify.
(Response 217) We disagree that the requirement should be addressed
in subpart C instead of subpart B. We consider controlling undesirable
microorganisms to be a baseline requirement that should apply to all
establishments that manufacture, process, pack, or hold animal food. We
also decline the request to remove the examples of measures that can be
used to significantly minimize or prevent the growth of undesirable
microorganisms because they are examples of practical solutions already
used by industry. We decline to delete the term ``significantly.'' The
term ``significantly minimize'' is defined in Sec. 507.3 and means to
reduce to an acceptable level, including to eliminate.
S. Proposed Sec. 507.25(c)(3)--Work-in-Process and Rework
We proposed that work-in-process and rework must be handled in such
a way that it is protected against contamination and the growth of
undesirable microorganisms.
(Comment 218) Some comments request that we delete ``and the growth
of undesirable microorganisms'' and require only that work-in-process
and rework be handled in such a way that it is protected against
adulteration.
(Response 218) We decline this request. Because undesirable
microorganisms are a common source of contamination of animal food,
including work-in-process and rework, we have decided to specify that
establishments must protect against the growth of undesirable
microorganisms, as well as other contamination.
T. Proposed Sec. 507.25(c)(4)--Processing Steps
We proposed that steps such as cutting, drying, defatting,
grinding, mixing, extruding, pelleting, and cooling, must be performed
in a way that protects against the contamination of animal food.
(Comment 219) One comment suggests that we revise the requirement
to say that steps be performed in a way that protects against animal
food adulteration rather than protects against animal food
contamination. Another comment suggests that the requirement be deleted
because it is redundant to other requirements in the proposed rule.
(Response 219) As discussed in Response 167, we believe
contamination is the better word to use in this context. These specific
requirements provide a level of detail that we believe is important
because these activities are common in the animal food industry and can
contribute to the contamination of animal food. We believe that this
requirement for these activities is not redundant to other requirements
in this final rule.
U. Proposed Sec. 507.25(c)(5)--Processing Operations
We proposed that filling, assembling, packaging, and other
operations must be performed in such a way that protects against the
contamination of animal food and the growth of undesirable
microorganisms.
(Comment 220) One comment requests that we delete ``and the growth
of undesirable microorganisms'' and require only that operations be
performed in such a way that the animal food is protected against
adulteration. Another comment suggests that the requirement be deleted
because it is redundant, but does not identify the redundant section.
(Response 220) As discussed in Response 167, we believe
contamination is the better word to use in this context. These specific
requirements, including the requirement for the protection against the
growth of undesirable microorganisms, provide a level of detail that we
believe is important because these activities are common in the animal
food industry and can contribute to the contamination of animal food.
We believe that these requirements for these activities are not
redundant with other requirements in this final rule.
V. Proposed Sec. 507.25(c)(6)--Controlling Water Activity
(aw)
We proposed that animal food that relies on the control of water
activity for preventing the growth of undesirable microorganisms must
be processed to and maintained at a safe moisture level.
(Comment 221) Some comments request that we delete the requirement
because controlling water activity belongs in subpart C, not in the
CGMP regulations. Another comment says that controlling moisture level
is not sufficient and the requirement should be revised to require that
animal food that relies on the control of water activity for preventing
the growth of undesirable microorganisms be processed to and maintained
at a suitable water activity, not a safe moisture level. We also
received comments asserting that water activity may not be the only
factor responsible for preventing the growth of undesirable
[[Page 56236]]
microorganisms in dry products and that we should modify the regulatory
text to take into account other synergistic barriers for microbial
growth and toxin formation.
(Response 221) We disagree that controlling water activity belongs
in subpart C. While not all animal food establishments rely on the
control of water activity for preventing the growth of undesirable
microorganisms in their animal food, we have determined it is important
to have this requirement in CGMP regulations for those establishments
that do, considering the potential public health significance of
undesirable microorganisms. We agree that the term ``safe water
activity level'' is more commonly understood by the animal food
industry than ``safe moisture level'' and we have revised the
regulatory text accordingly. We agree with the comment that water
activity may not be the only factor responsible for preventing growth
of undesirable microorganisms in certain animal food and have revised
the regulatory text to clarify that such products rely ``principally''
on the control of water activity.
W. Proposed Sec. 507.25(c)(7)--Controlling pH
We proposed that animal food that relies principally on the control
of pH for preventing the growth of undesirable microorganisms must be
monitored and maintained at the appropriate pH.
(Comment 222) Some comments request that we delete this proposed
requirement because controlling pH belongs in subpart C, not in subpart
B. One comment also says that it is too prescriptive and duplicative of
protections against adulteration in other proposed sections of subpart
B.
(Response 222) We decline the request. While not all animal food
establishments principally rely on the control of pH for preventing the
growth of undesirable microorganisms in their animal food, we have
determined it is important to have this requirement in the CGMP
regulations for those establishments that do, considering the potential
public health significance of undesirable microorganisms.
X. Proposed Sec. 507.25(c)(8)--Ice
We proposed that when ice is used in contact with animal food, it
must be made from water that is safe and must be used only if it has
been manufactured in accordance with current good manufacturing
practice as outlined in this subpart.
(Comment 223) One comment suggests that this requirement be deleted
because ice is rarely used in the manufacturing/processing of animal
food.
(Response 223) We decline this request. We have established this
requirement to help ensure that when ice is used for the manufacture of
animal food, the ice is made from water that is safe so that it does
not contaminate the animal food it contacts.
XXI. Subpart B: Comments on Proposed Sec. 507.27--Holding and
Distribution
A. Proposed Sec. 507.27(a)--Holding and Distribution
We proposed that animal food held for distribution must be held
under conditions that will protect against contamination and minimize
deterioration.
(Comment 224) A few comments request that we remove ``minimize
deterioration'' from this requirement. These comments say that although
deterioration may lead to animals refusing food, an animal's refusal of
food does not necessarily mean that the food has deteriorated. The
comments suggest that we instead use the phrase ``ensure product
integrity throughout the intended shelf life,'' or that we clarify the
definition of deterioration if we do not remove it.
(Response 224) We decline this request. We believe it is important
that animal food be held and distributed in manner that does not lead
to deterioration. Deterioration of animal food includes the loss of
palatability or nutritive value typically associated with the animal
food and we believe this could be a safety concern because animals are
often fed the same food containing the same ingredients for prolonged
periods of time. As a result, food refusal or consumption of animal
food containing fewer nutrients than the animal food is expected to
provide may result in poor animal productivity or health issues.
Furthermore, deterioration can indicate that the animal food has been
held under conditions that would also support the growth of undesirable
microorganisms.
B. Proposed Sec. 507.27(a)(1)--Containers
We proposed that containers used for holding animal food for
distribution must be designed, constructed of appropriate material,
cleaned, and maintained to prevent contamination of animal food.
(Comment 225) A few comments request that the terms ``designed''
and ``constructed of appropriate material,'' which may have different
interpretations, be replaced by ``fit for purpose'' a term recognized
by the animal food industry.
(Response 225) We decline the request. We believe the terms
``designed'' and ``constructed of appropriate material'' are well
understood by the animal food industry and ``fit for purpose'' does not
improve clarity.
(Comment 226) A few comments note containers used to hold animal
food may include bins, totes or other intermediate storage containers,
each of which may require differing levels and frequency of cleaning.
Some of these comments ask that we add the phrase ``where necessary''
when discussing cleaning to provide flexibility.
(Response 226) We agree that containers used to hold animal food
will require different cleaning methods and frequency of cleaning.
These differences may result from the types of containers used, the
amount and type of animal food held, the frequency at which containers
are reused, as well as other factors. As a result, we agree that it is
appropriate to include language that indicates that different methods
and frequencies of cleaning may be appropriate to protect against
contamination of the animal food and we have revised the regulatory
text to add ``as necessary'' after cleaned.
C. Proposed Sec. 507.27(a)(2)--Protection From Contamination
We proposed that animal food held for distribution must be held in
a way that prevents contamination from sources such as trash and
garbage.
(Comment 227) A few comments request that the phrase ``from sources
such as trash and garbage'' be deleted. A few comments request that the
term ``garbage'' not be used because some products that may be
considered garbage may actually be suitable for use as animal food.
Some of these comments suggested alternative language.
(Response 227) We agree in part with this comment. The mistaken
inclusion of trash or garbage into animal food could be a potential
source of contamination. The terms ``trash'' and ``garbage'' are
intended in their general sense and refer to items that are not
suitable for animal food, or are not intended for animal food. However,
under the Swine Health Protection Act, ``garbage'' as defined by the
act is prohibited for use as food for swine, unless it is treated to
kill disease organisms. For this reason, and because the terms can be
considered synonyms, we are removing the term ``garbage'' throughout
subpart B to avoid confusion.
[[Page 56237]]
D. Proposed Sec. 507.27(a)(3)--Labeling of Animal Food Held for
Distribution (Final Sec. 507.27(b))
We proposed that labeling identifying the product by the common or
usual name must be affixed to or accompany the animal food.
(Comment 228) Some comments support the labeling requirement
because accurate identification of animal food throughout the
distribution chain is an important food safety step and loss of
identity can have serious animal and human health implications. One
comment suggests that this requirement be revised to specify that the
proposed labeling be required during holding and distribution of both
packaged animal food and bulk animal food. One comment says that FDA's
primary interest should be identification, not labeling, because
labeling for animal food being held for distribution in bulk is
impractical. The comment also notes that plants may use a central
computer system or other method to identify animal food location. A few
comments suggest that we should require that animal food held for
distribution be labeled as required by regulations for finished
products.
(Response 228) We agree that animal food may be identified in the
plant through methods other than labeling. We expect that while animal
food is being processed in the plant that the animal food is accurately
identified as required in Sec. 507.25(a)(2) of this final rule.
We have moved the requirement that labeling must include
information and instructions for safely using the animal food product
for the intended animal species from proposed Sec. 507.25(a)(3)
``Plant operations'' in the 2014 supplemental proposed rule to Sec.
507.27(b) of ``Holding and distribution'' to clarify that this labeling
information must be included when the product is ready for
distribution. We think that placing the labeling requirements for
animal food products ready for distribution under ``Holding and
distribution'' will help reduce confusion and make these requirements
for labeling for distribution easier to find in the final rule.
Labeling that meets applicable FDA labeling regulations must accompany
or be affixed to the animal food and that the labeling must include,
when applicable, information and instructions for safely using the
product for the intended animal species. We have added the
clarification that it is ``when applicable,'' understanding that not
all animal food product will need information on its safe use. We have
deleted the requirement that labeling that identifies the product by
the common or usual name must be affixed to or accompany the animal
food in this section because it is already covered by current FDA
regulations.
E. Proposed Sec. 507.27(b)--Shipping Containers (Final Sec.
507.27(c))
We proposed that shipping containers (for example, totes, drums,
and tubs) and bulk vehicles used to distribute animal food must be
inspected prior to use to ensure the container or vehicle will not
contaminate the animal food.
(Comment 229) Some comments state that the requirement to inspect
shipping containers is not practical because containers are frequently
reused without intervening cleaning or because the animal food is
distributed in dedicated containers or vehicles. One comment says that
it is pointless to inspect the containers when the product being
distributed may be decayed and may be dumped on the ground for the
animals to eat. Other comments state that sometimes nobody is available
to inspect the vehicle when third-party transportation is used and that
third-party transportation vehicles may already contain animal food or
by-products because they are used to pick up from several facilities.
Some comments say that contractual provisions specify how third-party
shipping container may be used, and therefore inspection prior to each
load would not be necessary to manage this risk.
(Response 229) Though we disagree with the comments, we are
revising the regulatory text in Sec. Sec. 507.27 and 507.28 to replace
the word ``inspected'' with ``examined''. We believe that the use of
the word ``examined'' provides more clarity for the animal food
industry because the term ``inspected'' often implies a regulatory
activity. This does not mean that the shipping container must be
cleaned prior to each use. The plant or facility is responsible for
examining shipping containers and bulk vehicles that it uses to
transport the animal food (e.g., the facility transports the animal
food, or arranges with a third-party to distribute the animal food to
the facility's customer). We expect the plant or facility personnel
involved in the process of loading the product into the shipping
container or vehicle to be aware of the condition of the shipping
container or vehicle, and consider whether its condition would
contaminate the animal food. This examination could include viewing the
shipping container or vehicle to observe whether there are any unusual
residues in it that may contaminate the animal food, or it could be
simply knowing what the shipping container or vehicle had previously
been used for and because of that, whether the container needed to be
cleaned prior to use. We do not expect a plant or facility to examine
the shipping container or bulk vehicle when a customer transports the
animal food or arranges for a third-party to pick up the animal food.
However, a plant or facility may choose to examine a customer's
shipping container or bulk vehicle as a business decision to ensure
that shipping container or bulk vehicle will not lead to the
contamination or adulteration of the animal food.
F. Proposed Sec. 507.27(c)--Returned Animal Food (Final Sec.
507.27(d))
We proposed that animal food returned from distribution must be
assessed for animal food safety to determine the appropriate
disposition. Returned animal food must be identified as such and
segregated until assessed. We received no comments on this requirement
and are finalizing it as proposed.
G. Proposed Sec. 507.27(d)--Unpackaged Bulk Animal Food (Final Sec.
507.27(e))
We proposed that unpackaged or bulk animal food must be held in a
manner that does not result in cross contamination with other animal
food. We received no comment on this requirement and are finalizing it
as proposed with one wording change. We have added the term ``unsafe''
to modify cross contamination to make it clear that this requirement
applies to cross contamination that would result in unsafe animal food.
XXII. Subpart B: Comments on Proposed Sec. 507.28--Holding and
Distribution of Human Food By-Products for Use as Animal Food
We proposed to add provisions for human food by-products for use as
animal food. We proposed that the requirements of this part (with the
exception of proposed Sec. 507.28) would not apply to by-products of
human food production that are packed and held by that facility for
distribution as animal food if certain requirements were met (see
discussion in section XIII). The facility would only need to comply
with proposed Sec. 507.28 of this part and proposed Sec. 117.95 of
part 117 (which contains identical requirements).
A. Proposed Sec. 507.28(a)--Contamination
We proposed that human food by-products held for distribution as
animal food must be held under conditions that will protect against
contamination.
[[Page 56238]]
(Comment 230) Multiple comments request that the term ``human food
by-products,'' not ``animal food,'' be used throughout Sec. Sec.
507.28 and 117.95 (of part 117). These comments note that it is
important to make clear that human food by-products do not change from
human food to animal food until they are transferred to someone with
the intent to use it as an animal food.
(Response 230) We disagree that human food by-products are not
animal food until they have been transferred to someone with the intent
to use it as animal food. Furthermore, we think that the use of the
term ``human food by-products'' would be more confusing here because
not all human food by-products are intended for use as animal food.
However, we have revised the regulatory text to use the term ``human
food by-products for use as animal food'' throughout this section to
differentiate it from other requirements in parts 117 and 507. The
purpose of these provisions in Sec. Sec. 507.28 and 117.95 is to
ensure that when the processer is holding and distributing human food
by-products for use as animal food, the by-products are recognized as
human food by-products for use as animal food by all employees and
treated as such.
B. Proposed Sec. 507.28(a)(1)--Containers
We proposed that containers used to hold animal food before
distribution must be designed, constructed of appropriate material,
cleaned, and maintained to prevent the contamination of animal food.
(Comment 231) Some comments state that the provisions about
containers are too prescriptive because by-products may be held and
conveyed in ways that do not use containers (such as using storage
silos, augers, pipes, chutes or conveyor belts to convey product
directly to transportation vehicles). Some comments request
clarification on cleaning the containers because they are frequently
reused for holding by-product without intervening cleaning procedures.
(Response 231) We agree that human food by-products for use as
animal food may be held and conveyed using equipment instead of
containers. We have revised the regulatory text to add ``equipment'' in
addition to containers, and have added the words ``convey'' and
``cleaned as necessary'' (see regulatory text for Sec. Sec.
507.28(a)(1) and 117.95(a)(1)). We expect containers and equipment to
be cleaned at a frequency that protects against contamination of human
food by-products for use as animal food by contaminants that could be
harmful to the public (human and animal) health. This may not require
cleaning after each use.
C. Proposed Sec. 507.28(a)(2)--Protection From Contamination
We proposed that animal food held for distribution must be held in
a way to prevent contamination from sources such as trash and garbage.
As discussed in Response 227, we have revised the regulatory text to
remove the term garbage. We did not receive additional comments related
to this paragraph and are finalizing the proposed language with changes
previously discussed. (See Responses 227 and 230.)
D. Proposed Sec. 507.28(a)(3)--Labeling
We proposed that labeling identifying the product by the common or
usual name must be affixed to or accompany animal food.
(Comment 232) Some comments state that by-products only need to be
reasonably identified while they are being held by the facility and
state that once they are ready for distribution, they should be labeled
in conformance with applicable regulatory requirements. One comment
states that what is considered the ``common and usual name'' varies
between the human food industry, the animal food industry, producers
and regulators. This comment suggests that FDA work with regulatory
partners to provide guidance on the proper ``common and usual name'' of
by-products to promote consistency.
(Response 232) We agree in part with these comments. As with animal
food subject to all of part 507, we expect that while human food by-
product for use as animal food is being held in the human food
facility, it is accurately identified. (See Response 201.) We have
revised the regulatory text to clarify that the human food by-product
for use as animal food must be accurately identified while held in the
human food facility (see Sec. 507.28(a)(3) of the final rule). We
retained the requirement that when the human food by-product for use as
animal food is distributed, it must have labeling that identifies the
common or usual name of the product affixed to or accompanying it (see
Sec. 507.28(b) of the final rule).
Our CPG Sec. 665.100 discusses common or usual names for animal
food ingredients (Ref. 25). There are also industry and other
regulatory resources that may assist facilities in determining the
common or usual name of the animal food. For example, USDA maintains
the National Nutrient Database for Standard Reference, a database that
includes a list of names for human food items (Ref. 30). We will take
into consideration these comments when determining whether to issue
additional guidance about the common or usual name of animal food.
(Comment 233) One comment requests that FDA require human food
manufacturers to document the recipient's intended use of the by-
products so the by-products do not become ingredients of human food.
This comment also requests that these by-products be required to be
labeled with the statement ``For Use as Animal Feed Only.''
(Response 233) We decline these requests. Human food is produced
under human food regulations, such as CGMPs, and HACCP regulations for
juice and seafood, and facilities must meet the applicable requirements
for food that is manufactured, processed, packed, or held to ensure the
safety of that human food. This requirement in Sec. 507.28 is meant
only for human food by-products for use as animal food that are only
held and distributed (i.e. not further processed). Human food by-
products may be used as human food ingredients as long as they are in
compliance with the applicable human food regulations. However, we
would not object if a facility labels the human food by-products for
use as animal food ``For Use as Animal Food Only.''
E. Proposed Sec. 507.28(b)--Shipping Containers
We proposed that shipping containers (for example, totes, drums,
and tubs) and bulk vehicles used to distribute animal food must be
inspected prior to use to ensure the container or vehicle will not
contaminate the animal food. This provision is paragraph (c) of this
section in the final rule.
(Comment 234) We received the same comments on Sec. 507.28(c) as
Sec. 507.27(c). (See Comment 229.)
(Response 234) We are revising the regulatory text in Sec. Sec.
507.28(c) and 117.95(c). (See Response 229.)
XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and
Risk-Based Preventive Controls
In the 2014 supplemental notice for preventive controls for animal
food, we proposed a series of changes to proposed subpart C and
reopened the comment period specifically with respect to these changes.
The proposed changes included: (1) Eliminating the term ``hazard
reasonably likely to occur'' throughout proposed subpart C (and, thus,
deleting the definition we had proposed for this term); (2) adding a
new defined term, ``significant hazard,'' and, in general, using this
new term instead of ``hazard reasonably likely to occur'' throughout
the re-
[[Page 56239]]
proposed regulations; (3) defining ``known or reasonably foreseeable
hazard'' in place of ``reasonably foreseeable hazard'' and clarifying
that the new term means a hazard ``that has the potential to be
associated with the facility or the food'' rather than ``a potential .
. . hazard that may be associated with the facility or the food''; and
(4) providing additional flexibility to address concerns about
rewriting existing plans or programs to conform with the requirement of
the preventive controls rule.
We received many comments on the overall framework for hazard
analysis and risk-based preventive controls. We discuss each of these
comments in the discussion of the specific regulatory text applicable
to each comment. We show highlights of the changes we made after
considering these comments in table 9.
Table 9--Revisions to the Overall Framework for Hazard Analysis and Risk-
Based Preventive Controls
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.3......................... Definition of Revise the proposed
``significant term ``significant
hazard``. hazard'' to ``hazard
requiring a
preventive control''
and revise the
definition to
emphasize the role
of risk in
determining whether
a hazard requires a
preventive control.
507.3......................... Definition of Define the term
``corrections``. ``correction'' to
distinguish
``corrections'' from
``corrective
actions.''
507.34(c)(1), 507.39(a), Flexibility in Clarify that
507.40, 507.45(a), 507.47(a), preventive preventive control
507.49(a), 507.49(b). controls and management
preventive components depend on
control the role of a
management preventive control
components for in the facility's
monitoring, food safety system,
corrective as well as the
actions and nature of the
corrections, and preventive control.
verification.
507.33(b)(1).................. Hazard Emphasize that the
507.33(b)(2).................. identification. hazard
identification
focuses on known or
reasonably
foreseeable hazards
(rather than on all
hazards).
507.40(c)(2).................. Monitoring Provide for the use
records. of ``exception
records'' for
monitoring
preventive controls.
507.42(a)..................... Corrective action Clarify that
procedures. corrective action
procedures depend on
the nature of the
hazard.
507.42(c)..................... Corrections...... Provide for
additional
circumstances when
corrections, rather
than corrective
actions, are
warranted.
507.47(c)..................... Preventive Clarify that a list
controls that do of preventive
not require controls that do not
validation. require validation
is not an exhaustive
list.
507.49(a)(5).................. Activities to Clarify that there
verify could be alternative
implementation verification
and activities of
effectiveness. implementation and
effectiveness other
than those that we
specify in the rule.
507.49(b)..................... Written Clarify that written
procedures for procedures for
verification of verification of
implementation implementation and
and effectiveness are
effectiveness. established and
implemented as
appropriate to the
role of the
preventive control
in the facility's
food safety system,
as well as
appropriate to the
facility, the animal
food, and the nature
of the preventive
control.
507.50(b)..................... Reanalysis....... Provide for
reanalysis of an
applicable portion
of the food safety
plan (rather than
the complete food
safety plan) in
specified
circumstances.
------------------------------------------------------------------------
XXIV. Subpart C: Comments on Proposed Sec. 507.31--Food Safety Plan
We proposed requirements for a food safety plan. Some comments
support the proposed requirements without change. Some comments that
support the proposed provisions suggest alternative or additional
regulatory text or ask us to clarify how we will interpret the
provision.
In the following sections, we discuss comments that ask us to
clarify the proposed requirements, or disagree with, or suggest one or
more changes to the proposed requirements. After considering these
comments, we are finalizing the provisions as proposed, with editorial
and conforming changes as shown in table 31.
We proposed that the food safety plan be under the oversight of one
or more ``qualified individuals.'' As discussed in section VIII.A.24,
we have changed the proposed term ``qualified individual'' to
``preventive controls qualified individual'' because we are
establishing a new definition for ``qualified individual,'' with a
meaning distinct from ``preventive controls qualified individual.'' To
minimize the potential for confusion for when the term ``qualified
individual'' refers to the proposed meaning of the term and when the
term ``qualified individual'' refers to the meaning of that term as
finalized in this rule, in the remainder of this document we substitute
the new term ``preventive controls qualified individual'' for the
proposed term ``qualified individual,'' even though the proposed rule
used the term ``qualified individual.'' Likewise, we substitute the new
term ``preventive controls qualified individual'' for the proposed term
``qualified individual'' when describing the comments to the proposed
rule, even though those comments use the term ``qualified individual.''
We proposed that several other provisions of subpart C be under the
oversight of a ``qualified individual'' (now ``preventive controls
qualified individual''), and also proposed requirements that would
apply to the ``qualified individual'' (now ``preventive controls
qualified individual''). See, e.g., Sec. Sec. 507.47, 507.49, 507.50,
507.51, 507.53, and 507.55). As discussed in the preceding paragraph,
in the remainder of this document, we substitute the new term
``preventive controls qualified individual'' for the proposed term
``qualified individual,'' when describing these proposed provisions and
the comments to these proposed provisions.
A. Proposed Sec. 507.31(a)--Requirement for a Food Safety Plan
We proposed that you must prepare, or have prepared, and implement
a written food safety plan.
(Comment 235) Some comments ask us to develop a final preventive
controls
[[Page 56240]]
rule with separate requirements for food safety plans for manufacturers
of livestock food and for manufactures of food for other animal
species.
(Response 235) We decline this request. The required elements of
the food safety plan listed in Sec. 507.31(c) apply to each type of
animal food manufactured at a facility. Animal food types or production
method types may be grouped together if the hazards, preventive
controls, parameters, and management components (monitoring, corrective
actions and corrections, and verification) necessary to ensure the
effectiveness of the preventive controls are essentially identical. We
have provided additional flexibility within the required elements of
the food safety plan in the final rule. Therefore the same requirements
for a food safety plan are applicable to a facility that makes food for
livestock and one that makes food for other animal species.
(Comment 236) Some comments ask us to add regulatory text to this
section stating that an existing written food safety plan, including
any plan intended to satisfy the requirements of a foreign jurisdiction
or that complies with existing standards developed by other
organizations (such as PAS 222 (Ref. 27)), satisfies the requirements
of this section if it contains the information specified by Sec.
507.31(c).
(Response 236) To the extent that an existing food safety plan
includes all required information, a facility can use such plans to
meet the requirements of this rule. We expect that many existing plans
will need only minor supplementation to fully comply with these
requirements. Relying on existing records, with supplementation as
necessary to satisfy the requirements of the preventive controls rule,
is acceptable (see Sec. 507.212).
(Comment 237) Some comments agree with our previous statements that
facilities should be able to group animal food types or production
method types if hazards, control measures, parameters, and required
procedures, such as monitoring, are identical (78 FR 64736 at 64779).
Some comments ask us to emphasize that each facility needs only one
food safety plan, regardless of how many animal species it makes food
for, or how many different types of food it makes. These comments
further state that facilities are under the impression that any given
facility will need multiple food safety plans if they make many food
types or make food for multiple animal species.
(Response 237) We are requiring that a facility have a written food
safety plan that covers all types of animal food it manufactures,
processes, packs, or holds and all of the animal species for which the
food is intended. We recognize that, to the extent that the controls
are the same, there may be common controls that broadly apply to some
or all of a facility's animal food products. However, any product-,
process-, or animal species-specific differences must be carefully
delineated and observed in practice.
In some facilities with limited types of animal food products or
animal species for which the food is intended, the written food safety
plan may contain a single set of procedures that addresses all of the
products produced. For other facilities, there may not be a practical
way to group the products and the written food safety plan may need to
contain more than one set of procedures to address all of its products.
(Comment 238) Some comments ask us to emphasize that ``written''
means ``any type of recordable and reproducible format'' (e.g., as
paper or electronic documents). Some comments ask us to specify that
the components of the food safety plan need not be in a single document
or stored in one place.
(Response 238) A ``written'' food safety plan can be either a paper
document or an electronic document, as provided for by Sec.
507.202(a). The final rule specifies that required information (which
would include the food safety plan) does not need to be kept in one set
of records (see Sec. 507.212(b)), and a food safety plan may be
prepared as a set of documents kept in different locations within the
facility (e.g., based on where they will be used), provided that each
set of documents is onsite. As provided in the recordkeeping
provisions, electronic records are considered to be onsite if they are
accessible from an onsite location.
(Comment 239) Some comments ask us to provide that the food safety
plan be handled at the corporate level rather than the facility level
if a corporation owns many facilities.
(Response 239) A corporation may designate an individual at the
corporate level as the owner, operator, or agent in charge of a
particular facility. In addition, an employee of the corporation,
whether at headquarters or at another facility owned by the
corporation, may provide input into a particular facility's food safety
plan. As previously discussed, the food safety plan does need to be
facility specific (see the discussion of the facility-based nature of
the food safety plan in the 2013 proposed preventive controls rule for
animal food, 78 FR 64736 at 64780). For example, even if a corporation
makes similar products at two separate facilities, it is unlikely that
the two facilities have exactly the same equipment and layout.
Procedural instructions must be tailored to the equipment being used,
and the layout of a facility may affect its approach to preventive
controls.
(Comment 240) Some comments assert that a food safety plan should
only be required for high-risk processing facilities because adhering
to CGMPs is sufficient for low-risk facilities. Some comments assert
that FSMA does not authorize us to require farms to develop food safety
plans.
(Response 240) We decline the request to establish additional
exemptions based on risk, other than the exemptions for on-farm low-
risk activity/animal food combinations provided by section 103(c)(1)(D)
of FSMA (Sec. 507.5(e) and (f)). The applicability of the requirements
of the preventive controls rule to facilities that are required to
register is required by the statute (see the definition of facility in
section 418(o)(2) of the FD&C Act). Section 418(h) of the FD&C Act
requires that a facility prepare and implement a food safety plan,
unless an exemption applies. Neither FSMA nor this rule establishes an
exemption for ``low-risk'' facilities, including ``low-risk''
facilities that are regularly inspected by State, local, or tribal
government Agencies. A farm is not subject to this rule for activities
within the ``farm'' definition. A farm mixed-type facility that is a
small or very small business and only conducts the low-risk activity/
animal food combinations specified in Sec. 507.5(e) and (f) is exempt
from the requirements of subparts C and E, including the requirement
for a food safety plan.
(Comment 241) Some comments ask us to clarify that a food safety
plan is not required when a facility is exempt as a qualified facility
(Sec. 507.7(a)) or as a facility solely engaged in the storage of
packaged food that is not exposed to the environment (Sec. 507.10)
(Response 241) A qualified facility is exempt from the requirements
of subparts C and E, including the requirement to prepare and implement
a food safety plan, and is instead subject to the requirements in Sec.
507.7. Likewise, a facility solely engaged in the storage of packaged
animal food that is not exposed to the environment and does not require
time/temperature control to significantly minimize or prevent the
growth of, or toxin production by, pathogens is exempt from the
requirements of subparts C and E, including the requirement to prepare
and implement a food safety plan. See Response 242 for unexposed,
packaged TCS animal food.
[[Page 56241]]
(Comment 242) Some comments ask us to clarify that a food safety
plan is not required for facilities that store unexposed, refrigerated,
packaged TCS animal foods.
(Response 242) We agree that a facility ``solely engaged'' in the
storage of unexposed, refrigerated, packaged TCS animal food is exempt
from the requirements of subparts C and E, including the requirement to
prepare and implement a food safety plan, and instead is subject to the
modified requirements in Sec. 507.51 (see Sec. 507.10). However, if a
facility engages in other activities in addition to the storage of
unexposed, refrigerated, packaged TCS animal food, the exemption does
not apply. In such a case, the facility must prepare and implement a
food safety plan. However, the modified requirements of Sec. 507.51
can be informative with respect to what the food safety plan could
include regarding the storage of unexposed, refrigerated, packaged TCS
animal food.
B. Proposed Sec. 507.31(b)--Preparation of the Food Safety Plan by a
Preventive Controls Qualified Individual
We proposed that the food safety plan must be prepared, or its
preparation overseen, by one or more preventive controls qualified
individuals.
(Comment 243) Some comments ask us to provide for a group of
qualified individuals to prepare, or oversee the preparation of, a food
safety plan.
(Response 243) The proposed regulatory text included in the 2014
supplemental notice provides for the food safety plan to be prepared,
or its preparation overseen, by one or more preventive controls
qualified individuals, and we are finalizing it as proposed.
C. Proposed Sec. 507.31(c)--Contents of a Food Safety Plan
We proposed that the written food safety plan must include the
written hazard analysis, preventive controls (including the supplier
program and recall plan), procedures for monitoring the implementation
of the preventive controls, corrective action procedures, and
verification procedures. As discussed in more detail in section XL, we
have revised the phrase ``supplier program'' to ``supply-chain
program'' throughout the regulatory text. In the remainder of this
document, we use the phrase ``supply-chain program'' in section
headings and when referring to the provisions of the final rule. We
continue to use the term ``supplier program'' when describing the
proposed provisions and the comments regarding the proposed provisions.
(Comment 244) Some comments ask us to specify that sanitation
controls must be in the food safety plan. Some comments ask us to
require that the food safety plan include the qualifications of the
preventive controls qualified individual.
(Response 244) Sanitation controls are one type of preventive
control. As appropriate to the facility and the animal food (e.g., to
control hazards such as environmental pathogens), sanitation controls
for cleanliness of animal food-contact surfaces and prevention of cross
contamination are required to be in the food safety plan (Sec.
507.34(c)(2)).
We are requiring that you document all applicable training taken by
the preventive controls qualified individual (see Sec. 507.53(d)).
This documentation must be established and maintained (see Sec.
507.55(a)(6)).
D. Proposed Sec. 507.31(d)--Records
We proposed that the food safety plan is a record that is subject
to the recordkeeping requirements of subpart F. We received no comments
that disagreed with this proposed requirement and are finalizing it as
proposed.
E. Comments on Potential Requirements for Submission of a Facility
Profile to FDA
We requested comment on whether to require submission to FDA of a
subset of the information that would be in a food safety plan (78 FR
64736 at 64809). This information, which could be referred to as a
``facility profile,'' could be submitted through an electronic form
using a menu selection approach at the same time as facility
registration and updated biennially simultaneously with the required
biennial update of the food facility registration. We described
potential benefits to having a facility's food safety plan in advance
of an inspection, such as aiding in the efficient oversight of
preventive controls by allowing us to better target inspectional
activities to facilities that produce foods that have an increased
potential for contamination (particularly with biological hazards). We
noted that facilities could benefit from our advance preparation
through interaction with better-informed investigators and potentially
reduced inspection time. We requested comment on the utility and
necessity of such an approach and on the specific types of information
that would be useful in developing a facility profile. We also
requested comment on any additional benefits that might be obtained
from using such an approach and any potential concerns with this
approach.
We noted that we had previously announced an opportunity for public
comment on the proposed collection of additional food facility profile
information on a voluntary basis from firms that complete the FDA food
facility registration process (Federal Register of May 11, 2012, 77 FR
27779). In contrast to the voluntary submission of food facility
profile information described in that document, in the 2013 proposed
preventive controls rule for animal food we requested comment on
whether the submission of such information should be required.
(Comment 245) Some comments state that submission of a facility
profile would be useful and support requiring such a submission.
However, most of the comments that addressed our request for comments
on such a submission express concern. Some comments assert that
requiring submission of a facility profile is outside of FDA's
statutory authority under FSMA. Other comments assert that submitting a
facility profile would not advance food safety goals or have a
commensurate benefit to food safety. Some comments express concern
about protection of confidential information. Other comments express
concerns that we would misinterpret the submitted information in the
absence of discussion with the facility. Some comments assert that
receiving and evaluating the submitted information would be too time-
consuming for FDA, whereas other comments assert that submitting the
information would be too time-consuming for the facility. Some comments
state that a subset of the information that would be submitted could be
found in the Establishment Inspection Reports. Some comments assert
that we could use information already available through the RFR to
identify facilities that have needed to address a serious food safety
violation and target our inspectional resources to those facilities.
Some comments state that a facility profile is a not a static document
and would be very difficult to keep up to date. Other comments state
that such a profile would be of limited or no use to FDA because
information regarding hazards and preventive controls is best assessed
in the context of a full food safety plan and related documentation.
These comments further state that food safety plans will constantly
evolve as facilities undertake new activities and refine their
processes; a profile would present only a static picture of the food
safety measures in place at a given time; FDA has already implemented
changes to the
[[Page 56242]]
registration process that require facilities to provide more
information about the activities at the facility. One comment asks us
to refrain from requiring written or electronic submission of facility
profiles.
(Response 245) We have decided that we will not establish a
requirement for submission of a facility profile. We will explore other
mechanisms to achieve the goals we described in the 2013 proposed
preventive controls rule for animal food.
XXV. Subpart C: Comments on Proposed Sec. 507.33--Hazard Analysis
We proposed requirements for hazard analysis, including hazard
identification and hazard evaluation. Some comments support the
proposed requirements without change. For example, some comments
support our proposal for the hazard analysis to address ``known or
reasonably foreseeable hazards'' because this is consistent with Codex.
Other comments agree that the hazard analysis should address both the
severity of the potential hazard and the probability that the hazard
will be present in an animal food product. Other comments state that
testing for environmental pathogens may be impractical in certain
situations for facilities in chemical plants that also produce food
additives and that the proposed requirements for hazard evaluation make
it clear that in such facilities environmental monitoring would not be
required. Some comments that support the proposed provisions suggest
alternative or additional regulatory text or ask us to clarify how we
will interpret the provision.
In the following sections, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
10 with editorial and conforming changes as shown in table 31.
Table 10--Revisions to the Proposed Requirements for Hazard Analysis
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.33(a)(1).................. Requirement for a Specify that a
hazard analysis. facility must
``conduct a hazard
analysis'' to
identify and
evaluate known or
reasonably
foreseeable hazards,
rather than merely
specify that a
facility must
``identify and
evaluate'' known or
reasonably
foreseeable hazards.
507.33(a)(2).................. Requirement for Clarify that the
the hazard hazard analysis must
analysis to be be written,
written. regardless of its
outcome.
507.33(b)(1) and (b)(2)....... Hazard Emphasize that the
identification. hazard
identification
focuses on known or
reasonably
foreseeable hazards
(rather than on all
hazards).
507.33(b)(1)(ii).............. Hazard Replace
identification. ``imbalances''
with'' deficiencies
or toxicities'' and
provide examples of
these hazards.
507.33(b)(1)(iii)............. Hazard Add examples of
identification. physical hazards.
507.33(c)(2).................. Hazard evaluation Provide that hazard
evaluation does not
need to include an
evaluation of
environmental
pathogens whenever
finished animal food
is exposed to the
environment prior to
packaging if the
packaged food
includes a control
measure (such as a
formulation lethal
to the pathogen)
that would
significantly
minimize the
pathogen.
507.33(d)(10)................. Hazard evaluation Provide an example of
``other relevant
factor'' that the
hazard evaluation
must consider (the
example is the
temporal (e.g.,
weather-related)
nature of some
hazards (e.g.,
levels of some
natural toxins)).
------------------------------------------------------------------------
A. Proposed Sec. 507.33(a)--Requirement for a Written Hazard Analysis
We proposed that you must identify and evaluate, based on
experience, illness data, scientific reports, and other information,
known or reasonably foreseeable hazards for each type of animal food
manufactured, processed, packed, or held at your facility to determine
whether there are significant hazards. We also proposed that the hazard
analysis must be written.
As discussed in Response 62, we have revised the term ``significant
hazard'' to ``hazard requiring a preventive control.'' In addition, we
have revised the regulatory text to specify that the outcome of a
hazard analysis is to determine whether there are any hazards requiring
a preventive control.
(Comment 246) Some comments ask us to specify that the rule
requires a written hazard analysis even if the hazard analysis
concludes that no hazards exist.
(Response 246) As proposed, the regulatory text would require a
written hazard analysis even if the hazard analysis concludes that no
hazards exist. To make this clearer, we have made two revisions to the
regulatory text. First, we have revised the regulatory text to specify
that a facility must ``conduct a hazard analysis'' to identify and
evaluate known or reasonably foreseeable hazards, rather than merely
specify that a facility must ``identify and evaluate'' known or
reasonably foreseeable hazards. Second, we have revised the regulatory
text to specify that the hazard analysis must be written regardless of
its outcome.
(Comment 247) Some comments assert that a facility should not be
able to conclude that no hazard exists in its production process and
that any such conclusion reached should be a ``red flag'' to FDA
investigators.
(Response 247) The purpose of a hazard analysis is to identify and
evaluate known or reasonably foreseeable hazards to determine whether
there are any hazards requiring a preventive control. If a facility
appropriately determines, under the oversight of a preventive controls
qualified individual, that no such hazards exist, then that is the
outcome of its hazard analysis, and the facility must document that
outcome in its written hazard analysis.
We expect that there will be many circumstances in which a facility
appropriately determines that certain biological, chemical, or physical
hazards are not hazards requiring a preventive control that must be
addressed in the food safety plan. The provisions of the rule that
allow a facility to appropriately determine that a particular hazard is
not a hazard requiring a preventive control in certain animal food
products are not equivalent to an exemption from the rule. For example,
a facility that appropriately determines that there are no hazards
requiring a preventive control associated with its animal food products
[[Page 56243]]
must document that determination in its written hazard analysis (Sec.
507.33); however, no preventive controls, including supplier
verification activities, and associated management components would be
required in such a situation. There are several types of animal food
products for which a facility may determine that there are no hazards
requiring a preventive control. Such products include, but are not
limited to: alfalfa cubes, vegetable oils, and molasses.
However, we agree that our investigators should take appropriate
steps to evaluate a facility's hazard analysis when the outcome is that
there are no hazards requiring a preventive control. We expect that our
investigators would both review the facility's written hazard analysis
and discuss the outcome with the facility. During the initial stages of
implementation, we also expect that our investigators will ask subject
matter experts in our Center for Veterinary Medicine (CVM) to review
such a hazard analysis. Over time, as our investigators gain experience
with appropriate determinations that there are no hazards requiring a
preventive control, we expect that there will be fewer circumstances in
which our investigators would consult CVM about such an outcome.
(Comment 248) Some comments ask us to require that the hazard
analysis be re-evaluated every 3 years and updated as needed.
(Response 248) The written hazard analysis is one component of the
food safety plan, and the food safety plan is subject to reanalysis at
least once every 3 years, and sooner under certain circumstances (see
Sec. 507.50).
(Comment 249) Some comments ask us to modify the provision to
specify that the hazard analysis identify and evaluate known or
reasonably foreseeable hazards for each type of animal food
manufactured, processed, packed, or held at the facility, including
hazards in the raw materials and ingredients used in the animal food
(emphasis added).
(Response 249) We decline this request. Other provisions in the
requirements for hazard analysis specify that the hazard evaluation
must consider raw materials and ingredients (see Sec. 507.33(d)(3)).
It is not necessary to repeat the specific requirements associated with
the hazard evaluation in the provision that directs each facility to
conduct a hazard analysis.
(Comment 250) Some comments state that the standard for hazard
analysis in the preventive controls rule should both align with the
reproposed requirements for hazard analysis set forth in the
supplemental FSVP notice and be consistent with the statutory standard
for hazard analysis in section 418(b)(1) of the FD&C Act.
(Response 250) We have aligned the requirements of the animal food
preventive controls rule and the proposed FSVP rule to the extent
practicable, consistent with the applicable statutory requirements.
B. Proposed Sec. 507.33(b)--Hazard Identification
We proposed that the hazard identification must consider hazards
that include biological, chemical, and physical hazards. We proposed
examples of biological hazards (e.g., microbiological hazards such as
parasites, environmental pathogens, and other pathogens) and chemical
hazards (e.g., radiological hazards and substances such as pesticide
and drug residues, natural toxins, decomposition, unapproved food or
color additives, and nutrient imbalances).
In the preamble for the 2013 proposed preventive controls rule for
animal food, we explained that nutrient imbalance hazards can result
from excessive levels of a nutrient in animal food resulting in
toxicity to the animal, or a nutrient deficiency in the animal food
that can compromise the health of an animal and provided examples (78
FR 64736 at 64782). These nutrient imbalance hazards are of particular
concern for animals that consume one animal food type as their sole
source of nutrition. Because different species have different
nutritional needs, certain quantities of a nutrient that are needed by
one species of animal could pose a health risk to another species of
animal.
In the preamble for the 2013 proposed preventive controls rule for
animal food we also provided examples of physical hazards (e.g.,
stones, glass, or metal fragments that could inadvertently be
introduced into animal food) (78 FR 64736 at 64782) but did not include
these examples in the proposed regulatory text.
We also proposed that the hazard identification must consider
hazards that may be present in the animal food if they occur naturally
or may be unintentionally introduced. In the 2014 preventive controls
supplemental notice for animal food we proposed to add that the hazard
analysis also must consider hazards that may be intentionally
introduced for purposes of economic gain (proposed Sec.
507.33(b)(2)(iii)).
(Comment 251) As discussed in Comment 62, some comments express
concern that the rule would refer to multiple levels of hazards (i.e.,
``hazard,'' ``known or reasonably foreseeable hazard,'' and
``significant hazard'' (which we now refer to as ``hazard requiring a
preventive control'') and ask us to provide sufficient clarity to be
able to distinguish between these types of hazards.
(Response 251) As discussed in Response 62, we have revised the
requirements for hazard identification to emphasize that the hazard
identification focuses on known or reasonably foreseeable hazards
(rather than on all hazards).
(Comment 252) Some comments ask us to include examples of physical
hazards in the regulatory text.
(Response 252) We have added stones, glass, and metal fragments as
examples of physical hazards in the regulatory text. This is consistent
with the regulatory text for biological and chemical hazards, even
though the hazards listed in section 418(b)(1) of the FD&C Act include
examples of chemical and biological hazards but do not include examples
of physical hazards.
(Comment 253) Some comments ask us to separately list some hazards
(such as parasites and drug residues) rather than include them as
examples of biological hazards and chemical hazards.
(Response 253) We decline this request. Although section
418(b)(1)(A) of the FD&C Act lists such items separately, we believe it
is clearer to acknowledge that some of the hazards listed in the
statute are in fact a subset of the broader categories of biological
and chemical hazards.
(Comment 254) Some comments ask us to rephrase the requirement for
hazard identification to specify ``The hazard analysis must identify
hazards'' rather than ``The hazard identification must consider
hazards.''
(Response 254) We decline this request. The provision is directed
to the first step of a hazard analysis, i.e., hazard identification,
rather than to the overall hazard analysis (which is addressed in Sec.
507.33(a)). The purpose of the hazard identification is to consider the
types of hazards listed as a step in determining whether there are any
hazards requiring a preventive control; the suggestion of the comments
implies that such hazards will always be identified. As discussed in
Response 247, the outcome of a hazard analysis for an animal food
product could be that there are no hazards requiring a preventive
control.
(Comment 255) Some comments ask us to revise the chemical hazard
examples by replacing the term ``nutrient imbalances'' with ``nutrient
deficiencies or toxicities.''
[[Page 56244]]
(Response 255) We agree that the suggested revision adds clarity
and have modified the regulatory text to replace ``nutrient
imbalances'' with ``nutrient deficiencies or toxicities,'' and provide
examples, such as ``inadequate thiamine in cat food,'' ``excessive
vitamin D in dog food'', and ``excessive copper in food for sheep.''
(Comment 256) Some comments assert that nutrient imbalances should
not be addressed in an animal food safety plan because they pose no
threat to humans.
(Response 256) We disagree with these comments. The preventive
controls rule for animal food is intended to protect animal health, as
well as human health. Section 418 of the FD&C Act, which authorizes the
preventive controls rules, applies to facilities registered under
section 415 of the FD&C Act, which includes facilities that
manufacture, process, pack, and hold animal food.
(Comment 257) Some comments assert that while serious, ongoing
imbalances of nutrients such as copper and selenium must be avoided
with checks and balances, and perhaps product testing, there could be a
multitude of other incidents that could occur without serious
consequences and to address every possible scenario, by species, when
the Agency is aware of a limited number of rare cases, is unreasonable.
Some comments state that the notion that nutrient deficiencies or
toxicities for animals are hazards likely to occur in the manufacture
of animal food seems like a poor fit in this set of food safety
regulations.
(Response 257) The Agency has a history of animal food incidents
resulting in recall of animal food and in animal illnesses and deaths
from nutrient deficiencies or toxicities.
From 2012 to 2014, FDA received multiple reports through its RFR
that were attributable to animal food associated with nutrient
deficiencies or toxicities. For example, during the 2010/2011 reporting
period, 3.57 percent of 224 primary (industry and voluntary) RFR
entries were associated with nutrient deficiencies or toxicities in
animal food. During the 2012/2013 period, 2.97 percent of 202 entries
were attributable to nutrient imbalances or toxicities in animal food
(Refs. 14 and 16). Reports included low levels of thiamine in cat food;
high levels of vitamin D in dog food; low levels of vitamin D in food
for swine; high levels of vitamin D in food for guinea pigs, fish, and
other animal species; high levels of calcium and phosphorus in food for
broiler chickens and turkeys causing the death of several hundred young
birds (Refs. 13 to 16); high levels of salt in food for broilers; high
levels of protein/urea in food for cattle; and high levels of copper in
food for sheep. Many of these animal foods with nutrient imbalances
(deficiencies or toxicities) resulted in a recall of the affected
animal food (Refs. 31 to 39).
Moreover, an analysis of thiamin levels in randomly selected
commercial canned cat foods was conducted during a period from December
2012 through January 2013 (Ref. 40). The study found 13.3 percent of
the cat foods tested fell below the minimum set for thiamine by AAFCO
and 15.6 percent were below the recommended allowance of the National
Research Council.
We also disagree with the implication that facilities must address
every possible hazard. Facilities must identify and evaluate known or
reasonably foreseeable hazards for each type of animal food
manufactured, processed, packed, or held at the facility to determine
whether there are any hazards requiring a preventive control.
(Comment 258) Some comments suggest that nutrient imbalances should
be addressed through CGMPs.
(Response 258) We disagree with these comments. We consider
nutrient deficiencies and toxicities to be a type of chemical hazard
that are appropriately addressed through preventive controls. If a
facility identifies a nutrient deficiency or toxicity as a hazard that
is known or reasonably foreseeable in an animal food and is a hazard
that requires a preventive control, the facility must implement
preventive controls for that hazard. The facility has flexibility in
determining what preventive controls it needs to implement to control
the hazard. Preventive controls for identified nutrient toxicity or
deficiency hazards can include CGMPs, but the specific CGMP needs to be
included in the food safety plan (or for a qualified facility, the
documentation supporting an attestation under Sec. 507.7(a)(2)).
(Comment 259) Some comments ask us to consider revising the
proposed rule to include food allergens in animal food much in the same
way that they have been proposed in the human food rule.
(Response 259) We decline this request. We are not aware of
evidence indicating that foodborne allergens pose a significant health
risk to animals (78 FR 64736 at 64771). Animals with actual food
allergies typically have digestive disorders or dermatologic
conditions, not the anaphylactic reaction that humans have to the major
food allergens (defined in section 201(qq) of the FD&C Act).
(Comment 260) Some comments assert that physical hazards in animal
food are not likely to cause any serious injuries to humans as the
contaminant is not assimilated into edible tissue.
(Response 260) We disagree with these comments. The rule defines
the term hazard to include a physical agent that has the potential to
cause injury or illness in animals, as well as humans. Physical hazards
in animal food can cause illness or injury in animals.
(Comment 261) Some comments ask us to delete ``decomposition'' from
the list of chemical hazards in this provision.
(Response 261) We decline this request. As discussed previously,
decomposition of animal food consists of microbial breakdown of the
normal food product tissues and the subsequent enzyme-induced chemical
changes. These changes are manifested by abnormal odors, taste,
texture, color, etc., and can lead to reduced food intake or rejection
of the food by the intended animal species, resulting in illness or
death (see 78 FR 64736 at 64782).
(Comment 262) Some comments assert that we should not require all
food safety plans to specifically address the likelihood of
radiological hazards.
(Response 262) The rule only requires that a facility consider
whether radiological hazards are known or reasonably foreseeable, and
we have described situations where radiological hazards could be
considered to be known or reasonably foreseeable. A facility that
appropriately determines that no radiological hazards are known or
reasonably foreseeable would document that determination in its written
hazard analysis but would not need to establish preventive controls and
associated preventive control management components to address
radiological hazards.
(Comment 263) Some comments assert that predictable intentional
hazards should be in the food safety plan but unexpected intentional
hazards should be part of a food defense plan.
(Response 263) This rule only requires a facility to consider
intentionally introduced hazards when such hazards are introduced for
purposes of economic gain. Hazards that may be intentionally introduced
by acts of terrorism are the subject of the 2013 proposed intentional
adulteration rule (78 FR 78014, December 24, 2013), which applies only
to human foods.
(Comment 264) Some comments disagree that the animal food
preventive controls rule should address hazards that are intentionally
introduced for purposes of economic gain (economically motivated
adulteration).
[[Page 56245]]
Some of these comments assert that economically motivated adulteration
is not a good fit for the hazard analysis and preventive controls
framework because it is, in all but the rarest of circumstances, an
issue of product integrity and quality, whereas food safety systems are
designed and built to prevent or mitigate food safety hazards. Some
comments state that traditional food safety hazards are primarily both
identified and addressed at the facility level, but economically
motivated adulteration is typically handled by the corporate parent
company, where supply-chain management programs are typically located.
These comments also assert that food safety-related economically
motivated adulteration is extremely rare and that predicting
economically motivated adulteration to prevent it is extremely
difficult. Some comments assert there will be no measurable benefit to
food safety by imposing requirements to consider economically motivated
adulteration as part of a food safety plan and that doing so will
consume limited resources without a corresponding increase in consumer
protection. Other comments assert that there is no need to require a
facility to identify hazards intentionally introduced for purposes of
economic gain because the misbranding and adulteration provisions of
the FD&C Act already sufficiently provide safeguards against economic
gain.
(Response 264) We agree with the comments that state that the
requirement to consider hazards intentionally introduced for purposes
of economic gain is narrow. Such hazards will be identified in rare
circumstances, usually in cases where there has been a pattern of
economically motivated adulteration in the past. In addition, we define
hazards to only include those agents that have the potential to cause
illness or injury. Economically motivated adulteration that affects
product integrity or quality, for example, but not animal food safety,
is out of the scope of this rule. We continue to believe that there is
benefit in taking this preventive approach to economically motivated
adulteration and not relying solely on enforcing the preexisting
misbranding and adulteration provisions of the FD&C Act after a
violation occurs.
As discussed in sections XL through XLVII, we are finalizing
supply-chain program provisions. It is consistent with the framework of
this rule for a facility to address hazards requiring a preventive
control that may be intentionally introduced for purposes of economic
gain through the facility's supply-chain program.
(Comment 265) Some comments express concern about identifying
hazards that may be intentionally introduced for purposes of economic
gain because there are potentially an unlimited number of unknown or
yet-to-be identified hazards that could be intentionally introduced for
purposes of economic gain by an unscrupulous supplier. These comments
disagree with our attempt to narrow the field of potential scenarios
for economically motivated adulteration to circumstances where there
has been a pattern of such adulteration in the past.
Some comments assert that our attempt to narrow the field of
potential scenarios for economically motivated adulteration is both too
broad and too narrow at the same time. These comments assert that our
attempt is too broad, because we expect facilities to consider patterns
of adulteration from the past ``even though the past occurrences may
not be associated with the specific supplier or the specific food
product'' and a requirement to consider every potential product and
potential supplier makes the task open ended. These comments further
assert that our attempt is too narrow, because a focus on patterns of
adulteration in the past is unlikely to reveal potential future
instances of economically motivated adulteration and because those
intending to defraud purchasers for economic gain are trying to avoid
detection. According to these comments, once an animal food safety
related instance of economically motivated adulteration is uncovered,
perpetrators quickly move to carry out their fraudulent activities in a
different way. Some comments assert that there are alternative ways to
control hazards that may be intentionally introduced for purposes of
economic gain without specific regulatory requirements, such as by
having an effective supplier approval program with appropriate
qualification and verification activities; through business-to-business
relations, expectations, and contracts; and through a vulnerability
assessment and control plan tailored specifically to economically
motivated adulteration.
(Response 265) We disagree that the requirement is too broad. A
facility must conduct a hazard analysis for each type of animal food
manufactured, processed, packed, or held at the facility. There is no
requirement to consider every potential product or potential supplier.
We also disagree that the requirement is too narrow. Some individuals
intending to defraud purchasers for economic gain will develop entirely
novel ways of adulterating food to suit their purposes. We agree that
these circumstances may not lend themselves to the preventive approach
required here. We encourage, but do not mandate, that facilities adopt
other measures they deem appropriate to mitigate the risks of
economically motivated adulteration that this rulemaking does not
address. Still, the repeated use of melamine over the years, in animal
foods and in foods for people, demonstrates that patterns of
economically motivated adulteration can emerge and should be considered
as part of a hazard analysis.
(Comment 266) Some comments ask us to limit the requirement to
identify hazards that may be introduced for purposes of economic gain
to only those hazards that pose a risk to public health for which there
has been a pattern in the past. Some comments assert that in those few
instances where a hazard was intentionally introduced the underlying
intention was to defraud rather than to cause harm, and the food safety
hazard was an unintended consequence. Some comments ask us to focus the
hazard identification solely on inbound products, because it is obvious
that hazards introduced by the facility itself will not be prevented
through a hazard analysis. Some comments ask us to narrow the scope of
the requirement by specifying that facilities focus on three
situations: (1) Situations in which there has been a pattern of similar
adulteration in the past; (2) animal foods or ingredients for which
quality assurance methods may not sufficiently characterize the animal
food or ingredient to assure its identity, and; (3) animal foods or
ingredients for which there are substitutes that are likely to be
harmful that would be considered obvious to one skilled in food
science.
(Response 266) We decline to make the changes suggested in these
comments because they are unnecessary. Because of our definition of
hazard, the requirement is already limited to economically motivated
adulteration that is reasonably likely to cause illness or injury.
Under the final rule, a facility does not need to identify a hazard
related to economically motivated adulteration when there is no risk to
public health or when the economically motivated adulteration is not
known or reasonably foreseeable.
We agree that the three circumstances suggested by the comments are
an appropriate focus for facilities who seek guidance on how to
approach the requirements, but decline the request to specify these
limitations of the scope in the regulatory text. As already noted, some
comments assert that our attempt to narrow the field of potential
scenarios for economically motivated adulteration
[[Page 56246]]
is both too broad and too narrow at the same time. (See Comment 265.)
Although we continue to believe that the instances in which a facility
will identify a hazard intentionally introduced for economic gain will
be rare, we also consider that limiting the scope of the requirement in
the regulatory text would be both prejudging the future and
inconsistent with the public health objectives of this rule.
(Comment 267) Some comments ask us to allow implementation of the
major provisions in FSMA before establishing requirements to address
economically motivated adulteration. These comments assert that
economically motivated adulteration requires a completely different
paradigm than unintentional adulteration. In addition, because
economically motivated adulteration is typically addressed through
product specifications, supplier relationships, and good business
practices, implementation of these other provisions of the animal food
preventive controls rule are likely to have a positive effect on
preventing economically motivated adulteration.
(Response 267) We disagree that economically motivated adulteration
requires a completely different paradigm than unintentional
adulteration. Hazards intentionally introduced for economic gain are
addressed here with the same preventive framework as every other
hazard. As such, we do not see a compelling reason to delay
implementation of the requirements to address economically motivated
adulteration.
C. Proposed Sec. 507.33(c) and (d)--Evaluation of Whether a Hazard
Requires a Preventive Control
We proposed that the hazard analysis must include an evaluation of
the identified hazards to assess the severity of the illness or injury
if the hazard were to occur and the probability that the hazard will
occur in the absence of preventive controls; and environmental
pathogens whenever an animal food is exposed to the environment prior
to packaging and the packaged animal food does not receive a treatment
that would significantly minimize the pathogen (proposed Sec.
507.33(c)(2)). We also proposed that the hazard evaluation must
consider the effect of the following on the safety of the finished
animal food for the intended consumer: (1) The formulation of the
animal food; (2) the condition, function, and design of the facility
and equipment; (3) raw materials and ingredients; (4) transportation
practices; (5) manufacturing/processing procedures; (6) packaging
activities and labeling activities; (7) storage and distribution; (8)
intended or reasonably foreseeable use; (9) sanitation, including
employee hygiene; and (10) any other relevant factors (proposed Sec.
507.33(d)(1) through (10)).
(Comment 268) Some comments ask us to revise the requirement to
include an evaluation of environmental pathogens to avoid the
implication that an intervention is needed when there may be other
controls (such as pH or formulation) that would significantly minimize
or prevent the pathogen. These comments suggest that we revise the
provision to require that a hazard evaluation include an evaluation of
environmental pathogens whenever a food is exposed to the environment
prior to packaging and the packaged food does not receive a treatment
``or otherwise include a control measure'' that would significantly
minimize the pathogen.
(Response 268) We have revised the provision on the hazard
evaluation for environmental pathogens to specify that the packaged
animal food does not receive a treatment or otherwise include a control
measure (such as a formulation lethal to the pathogen) that would
significantly minimize the pathogen. We agree that controls such as
formulation can function as a ``kill step'' and that the provision
should make clear that such controls can be used in lieu of
``treatment.''
(Comment 269) Some comments ask us to clarify what we meant by
``other relevant factors'' and note that natural disasters (which we
previously discussed) (78 FR 64736 at 64785) are ``usually exceptional
events'' that are best managed in a facility crisis management plan.
Other comments ask us to specify that the hazard evaluation must
consider any relevant geographic, temporal, agricultural, or other
factors that may affect the severity or probability of the hazard.
(Response 269) We included ``other relevant factors'' to emphasize
that the list of factors in the provision is not an exhaustive list and
that a facility is responsible for considering those factors that play
a role in its determination of whether a potential hazard is a hazard
requiring a preventive control, regardless of whether those factors are
listed in the provision. A facility that already addresses
circumstances such as natural disasters in other plans may consider the
applicable part of those plans to be part of its food safety plan (see
Sec. 507.212).
We agree that geographic, temporal, and agricultural factors are
examples of ``other relevant factors.'' For example, hazards such as
aflatoxin are subject to a weather-dependent effect in that aflatoxin
levels in some RACs are more of a problem in some years than in others.
We have added the temporal nature of some hazards associated with some
RACs as an example of ``other relevant factors'' to consider (see Sec.
507.33(d)(10)).
(Comment 270) Some comments ask us to specify that the hazard
evaluation be more specific about issues relevant to raw materials and
ingredients, including how raw materials are selected and shipped, how
suppliers are evaluated, and how shipments are inspected on receipt.
(Response 270) We decline this request. When a hazard requiring a
preventive control in a raw material or other ingredient is controlled
before receipt, the receiving facility would address such specifics in
the supply-chain program that would be required as a preventive control
(see subpart E).
(Comment 271) Some comments assert that the proposed requirements
for hazard evaluation could be interpreted in many ways. For example, a
facility could conclude that the presence of a hand sink or boot dip
prior to entering the processing area will reduce the likelihood of
environmental pathogens and that environmental pathogens are not a
significant hazard, whereas a regulator could interpret this provision
to mean that a facility must always consider an environmental pathogen
to be a significant hazard when the criteria in the provision are met,
unless the facility can provide evidence to the contrary.
(Response 271) We agree that the requirements for hazard evaluation
are subject to alternative interpretations. This is often the case,
particularly when a regulation is new. The provision specifies that a
facility must evaluate whether an environmental pathogens is a hazard
requiring a preventive control in particular circumstances, i.e.,
whenever a finished animal food (for which an environmental pathogen is
identified as a hazard) is exposed to the environment prior to
packaging and the packaged animal food does not receive a treatment or
otherwise include a control measure (such as a formulation lethal to
the pathogen) that would significantly minimize the pathogen. The
written hazard analysis must be prepared (or its preparation overseen
by) a preventive controls qualified individual (see Sec. 507.31(b) and
(c)(1)). The preventive controls qualified individual for a facility
that determines that an environmental pathogen is not a hazard
requiring a preventive control in
[[Page 56247]]
such circumstances must document that determination, and a regulator
would consider the adequacy of the documented determination before
reaching a conclusion as to whether the facility had failed to satisfy
the requirements. However, the use of a hand sink or boot dip prior to
entering the processing areas to reduce the likelihood of environmental
pathogens may also be considered to be part of the sanitation controls
for the environmental pathogen.
(Comment 272) Some comments ask us to focus on language that will
clearly differentiate between functions, processes, and controls for
facilities with food safety plans that identify microbial hazards and
those that do not identify microbial hazards, and other known or
reasonably foreseeable hazards. These comments assert that sanitation
of objects and surfaces may be appropriate for the former, but not
necessarily for the latter.
(Response 272) The facility is responsible for conducting a hazard
analysis, and if hazards are identified that require a preventive
control, the facility must consider the effect of sanitation on the
safety of the finished animal food for the intended animal (see Sec.
507.33(d)). Based on the outcome of its hazard evaluation, the facility
may determine that sanitation is not an appropriate preventive control
for the hazards it identified.
(Comment 273) Some comments assert that a food safety plan and
hazard analysis should not include numerous hazards and hazard analysis
steps. Some comments assert that hazard analysis should not be as
detailed (stringent) for animal food as it is for human food. These
comments maintain that prerequisite programs, which reduce the
likelihood of a potential hazard to the point where the hazard is not
reasonably likely to occur, would satisfy the requirement that the
hazard be adequately controlled, making it unnecessary for a facility
to include the identified hazards in its hazard analysis and preventive
controls. Other comments assert that many hazards can be exclusively
controlled through prerequisite programs without a need for CCPs.
(Response 273) While known and reasonably foreseeable hazards and
the outcome of a hazard analysis for human food and animal food may not
be identical, in each case the purpose of a hazard analysis is to
identify and evaluate known or reasonably foreseeable hazards for the
type of food manufactured, processed, packed, or held to determine
whether there are any hazards requiring a preventive control. As
previously discussed in the 2013 animal food preventive control
proposed rule (78 FR 64736 at 64781), the process of identifying and
evaluating the hazards that may occur for specific types of animal food
handled in a facility provides an efficient means for keeping track of
multiple hazards that may occur in a facility that handles several
types of animal food. Such a process also provides an efficient means
for ensuring that preventive controls are applied to specific animal
food products when required. If a facility identifies a hazard
requiring a preventive control, the facility must determine an
appropriate preventive control and include that preventive control in
its food safety plan. A facility that establishes other controls (such
as those that the comments describe as ``prerequisite programs'') for
hazards that are not, based on the outcome of the facility's hazard
analysis, ``hazards requiring a preventive control'' would not need to
establish preventive control management components for such controls.
However, some controls previously established in ``prerequisite
programs'' would be considered ``preventive controls.'' We provide some
flexibility for facilities with respect to how they manage preventive
controls, and the preventive control management components may be
different for hazards that have been managed as ``prerequisite
programs'' compared to those managed with CCPs. The same principles
would apply for the hazards a facility identifies as needing a
preventive control.
(Comment 274) Some comments assert that the statutory language
within FSMA does not mandate that covered animal food and pet food
facilities implement regulatory HACCP plans. These comments further
urge us to remove reference to HACCP.
(Response 274) We agree that section 103 of FSMA does not mandate
HACCP regulations; however, we have concluded that HACCP is the
appropriate framework to reference in interpreting and implementing
section 103 of FSMA. For discussion, see section II.C.2. of the 2013
proposed preventive controls rule for human food (78 FR 3646 at 3660).
(Comment 275) Some comments ask us to allow consideration of both
severity and probability in the scientific hazard analysis as this
would be consistent with international standards.
(Response 275) Section 507.33(c)(1) requires that a hazard
evaluation must include an assessment of the severity of the injury or
illness if a hazard were to occur and the probability that the hazard
will occur in the absence of preventive controls.
For additional discussion of comments on hazard analysis, see
section XXV in the final rule for preventive controls for human food
published elsewhere in this issue of the Federal Register.
XXVI. Subpart C: Comments on Proposed Sec. 507.36--Preventive Controls
(Final Sec. 507.34)
We proposed requirements to identify and implement preventive
controls to provide assurances that significant hazards will be
significantly minimized or prevented and the animal food manufactured,
processed, packed, or held by the facility will not be adulterated
under section 402 of the FD&C Act. Some comments support the proposed
requirements without change. For example, some comments agree that
preventive controls must be written and include process controls,
sanitation controls, a recall plan, and other controls as appropriate
and necessary. Some comments that support the proposed provisions
suggest alternative or additional regulatory text or ask us to clarify
how we will interpret the provision.
In the following sections, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
11, with editorial and conforming changes as shown in table 31.
Table 11--Revisions to the Proposed Requirements for Preventive Controls
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.34(c)(1).................. Process controls. Clarify that the
requirements for
process controls
depend on the role
of the process
control in the food
safety system.
------------------------------------------------------------------------
[[Page 56248]]
A. Proposed Sec. 507.36(a)--Requirement To Identify and Implement
Preventive Controls (Final Sec. 507.34(a))
We proposed that you must identify and implement preventive
controls, including at critical control points, if any, to provide
assurances that significant hazards will be significantly minimized or
prevented and the animal food manufactured, processed, packed, or held
by your facility will not be adulterated under section 402 of the FD&C
Act. We also proposed that these preventive controls include controls
at CCPs, if there are any CCPs, and controls, other than those at CCPs,
that are also appropriate for animal food safety.
Some comments support the flexibility provided to facilities to
implement preventive controls that are appropriate to the facility and
the animal food. Other comments support the clarification, in the 2014
supplemental notice, that not all preventive controls are established
at CCPs and that some food safety plans will not have CCPs. We are
finalizing the provision as proposed with the editorial and conforming
changes in table 31.
B. Proposed Sec. 507.36(b)--Requirement for Written Preventive
Controls (Final Sec. 507.34(b))
We proposed that preventive controls must be written.
(Comment 276) Some comments ask us to clarify whether documentation
of treatment by a ``custom processor'' would be accepted as a ``written
preventive control'' when the ``custom processor'' controls the hazard.
(Response 276) The question posed by these comments highlights the
difference between the records required in the food safety plan and the
records documenting the implementation of the food safety plan. The
``written preventive controls'' are part of the food safety plan,
whereas the records documenting treatment are implementation records.
Implementation records documenting treatment, whether by a facility or
its ``custom processor,'' would not satisfy the requirements for
written preventive controls. However, specifying that the preventive
control for a specific hazard is a particular treatment by a ``custom
processor,'' along with information that describes the treatment, would
satisfy the requirement for written preventive controls.
C. Proposed Sec. 507.36(c)(1)--Process Controls (Final Sec.
507.34(c)(1))
We proposed that preventive controls include process controls as
appropriate to the facility and the animal food. Process controls
include procedures, practices, and processes to ensure the control of
parameters during operations such as heat processing, irradiating, and
refrigerating animal foods. Process controls must include, as
appropriate to the applicable control, parameters associated with the
control of the hazard, and the maximum or minimum value, or combination
of values, to which any biological, chemical, or physical parameter
must be controlled to significantly minimize or prevent a significant
hazard.
(Comment 277) Some comments state that assigning a parameter and
associated minimum and maximum values for some process controls (such
as refrigeration (including freezing), or water activity) may be
possible, but not be necessary for food safety. These comments ask us
to require minimum and maximum values to be assessed against the
applicable food safety need, or otherwise make clear that the
implications of not controlling minimum and maximum values must be
assessed in light of the circumstances. Other comments express concern
that ``as appropriate to the applicable control'' could be interpreted
as suggesting that if it is merely feasible to establish parameters for
a process control, they must be established. Other comments express
concern that the proposed requirement suggests that if a parameter is
not ``controlled,'' a regulator could conclude that the facility is not
in compliance with the rule because it necessarily has not
significantly minimized or prevented a significant hazard.
Some comments recommend incorporating recognition that the degree
of rigor in application of subpart C parameters should be applied on a
sliding scale, commensurate with the nature of the risk and the
preventive control used. The comments request that the language in this
section is altered to indicate that the parameters will not always be
applicable.
(Response 277) See Response 293. We have revised the regulatory
text to specify that process controls must include parameters and
minimum or maximum values as appropriate to both the nature of the
applicable control and its role in the facility's food safety system.
We decline the request to indicate that parameters of subpart C will
not always be applicable, as the revised regulatory text provides
adequate flexibility for a facility to determine what preventive
controls, including process controls, are appropriate to the facility
and its animal food, if a hazard requiring a preventive control is
identified.
(Comment 278) Some comments ask us to delete the phrase ``to
significantly minimize or prevent a significant hazard.''
(Response 278) We decline this request. ``Significantly minimize or
prevent a significant hazard'' (which we have revised to
``significantly minimize or prevent a hazard requiring a process
control'') is the standard for controlling the hazards. Although the
phrase could be viewed as redundant with the standard in the
requirement to identify and implement preventive controls (Sec.
507.34(a)(1)), repeating that standard in the requirements for
parameters and the minimum or maximum values associated with control of
the hazard emphasizes the standard, which is appropriate for process
controls.
D. Proposed Sec. 507.36(c)(2)--Sanitation Controls (Final Sec.
507.34(c)(2))
We proposed that preventive controls include, as appropriate to the
facility and the animal food, sanitation controls that include
procedures, practices, and processes to ensure that the facility is
maintained in a sanitary condition adequate to significantly minimize
or prevent hazards such as environmental pathogens and biological
hazards due to employee handling. We also proposed that sanitation
controls must include procedures, practices, and processes for the
cleanliness of animal food-contact surfaces, including animal food-
contact surfaces of utensils and equipment, and procedures for the
prevention of cross-contamination from insanitary objects and from
personnel to animal food, animal food packaging material, and other
animal food-contact surfaces and from raw product to processed product.
(Comment 279) One comment states that sanitation is not always a
feasible step for facilities handling animal food, especially in dry
blending facilities and dry storage operations. The comment asks us to
remove the reference to ``sanitary condition'' and replace it with
language consistent with the GMP section such as ``to ensure the
facility is adequately cleaned and properly maintained to significantly
minimize or prevent hazards.''
(Response 279) We decline this request. The sanitation controls are
flexible so that a facility can determine what sanitation controls are
necessary for their facility and animal food if they identify a hazard
requiring sanitation controls as a preventive control. Replacing the
term ``sanitary condition'' with the suggested language would not
improve the flexibility of the sanitation control requirements.
[[Page 56249]]
(Comment 280) Some comments assert that sanitation controls are not
necessary to prevent any hazards in distribution facilities where
animal food-contact surfaces are not present. Other comments assert
that sanitation controls should be required in all cases (rather than
``as appropriate'') given their central importance.
(Response 280) Under the framework established by FSMA, and
implemented in this rule, each facility determines through its hazard
analysis when sanitation controls are necessary to control a hazard
requiring a preventive control. The rule neither establishes
circumstances (such as in distribution centers) where sanitation
controls are not necessary nor prejudges whether sanitation controls
are necessary in specific circumstances. Although we do not expect that
facilities such as distribution centers would determine through their
hazard analysis that sanitation controls are required, we do expect all
animal food establishments that are subject to the CGMP requirements
established in subpart B to fully comply with the applicable
requirements for sanitation.
(Comment 281) One comment states that sanitation is discussed in
two sections, as a CGMP and as a preventive control, and asks that all
of the discussion related to sanitation is moved to one section.
(Response 281) The two sections discuss sanitation for different
purposes. The requirements for general sanitation are located in the
CGMP regulations, which may be considered prerequisites to the
preventive controls. The requirements for sanitation as a preventive
control are specific for controlling an identified hazard. Sanitation
activities conducted at a facility may be different depending on
whether the sanitation activity is used as general facility sanitation
or specifically to control a hazard. Also, sanitation as a preventive
control is subject to the management components of Sec. 507.39.
E. Proposed Sec. 507.36(c)(3)--Supplier Controls (Final Sec.
507.34(c)(3))
We proposed that supplier controls include the supplier program.
See the discussion of comments on the supply-chain program, now in
subpart E, in sections XL through XLVII.
F. Proposed Sec. 507.36(c)(4)--Recall Plan (Final Sec. 507.34(c)(4))
We proposed that preventive controls include, as appropriate, a
recall plan as would be required by proposed Sec. 507.38. See the
discussion of comments on the recall plan in section XXVIII.
G. Proposed Sec. 507.36(c)(5)--Other Controls (Final Sec.
507.34(c)(5))
We proposed that preventive controls include any other procedures,
practices, and processes necessary to satisfy the requirements of
paragraph (a) of this section. Examples of other controls include
hygiene training and other current good manufacturing practices.
(Comment 282) Some comments ask us to specify that preventive
controls include controls on raw materials and other ingredients.
(Response 282) The final rule specifies that preventive controls
include supply-chain controls as appropriate to the facility and the
animal food. The request of these comments is addressed by the
requirements for the supply-chain program (see Sec. 507.34(c)(3) and
subpart E).
(Comment 283) One comment asks us to require compliance with the
good manufacturing and feeding practices that apply to GRAS substances,
found in Sec. 582.1(b), as a preventive control.
(Response 283) Facilities required to register that manufacture,
process, pack, or hold GRAS substances are subject to this final rule,
including applicable preventive controls requirements. Preventive
controls are intended to address certain known or reasonably
foreseeable hazards, not an animal food facility's compliance with the
good manufacturing and feeding practices of Sec. 582.1(b), although a
facility may determine that a good manufacturing practice is a
preventive control for a particular hazard.
XXVII. Subpart C: Circumstances in Which the Owner, Operator or Agent
in Charge of a Manufacturing/Processing Facility Is Not Required To
Implement a Preventive Control (Final Sec. Sec. 507.36 and 507.37)
In the 2014 supplemental notice, we provided an opportunity for
public comment on potential requirements for a supplier program as a
preventive control, including comments on when a supplier program would
not be required. As discussed in more detail in section XL, we have
revised the phrase ``supplier program'' to ``supply-chain program''
throughout the regulatory text. As summarized in table 12 and discussed
more fully in the following paragraphs, after considering comments on
when a supplier program would not be required, we are establishing two
new provisions. Although both sets of provisions have an effect on the
required supply-chain program, they will be implemented outside the
framework of a supply-chain program.
Table 12--Summary of Applicable Provisions Regarding When the Owner, Operator, or Agent in Charge of a
Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control
----------------------------------------------------------------------------------------------------------------
Final section designation Proposed section designation Description Revision
----------------------------------------------------------------------------------------------------------------
507.36(a)(1)................ N/A.................................. A manufacturer/ N/A.
processor is not
required to implement
a preventive control
if it determines and
documents that the
type of animal food
could not be consumed
without application of
an appropriate control.
507.36(a)(2)................ 507.37(a)(1)(ii)(C).................. A manufacturer/ Includes a
processor is not requirement for
required to implement documentation
a preventive control that the animal
if it relies on its food is ``not
customer, who is processed to
subject to the control
requirements for [identified
hazard analysis and hazard].''
risk-based preventive
controls in subpart C,
to ensure that the
identified hazard will
be significantly
minimized or prevented
and both: (1)
Discloses in documents
accompanying the
animal food that the
animal food is ``not
processed to control
[identified hazard]''
and (2) annually
obtains from its
customer written
assurance that the
customer has
established and is
following procedures
that will
significantly minimize
or prevent the
identified hazard.
[[Page 56250]]
507.36(a)(3)................ ..................................... A manufacturer/ N/A.
processor is not
required to implement
a preventive control
if it relies on its
customer who is not
subject to the
requirements for
hazard analysis and
risk-based preventive
controls in subpart C
to provide assurance
it is manufacturing,
processing, or
preparing the animal
food in accordance
with applicable animal
food safety
requirements and it:
(1) Discloses in
documents accompanying
the animal food, in
accordance with the
practice of the trade,
that the animal food
is ``not processed to
control [identified
hazard]'' and (2)
annually obtains from
its customer written
assurance that it is
manufacturing,
processing, or
preparing the animal
food in accordance
with applicable animal
food safety
requirements.
507.36(a)(4)................ 507.37(a)(1)(ii)(C).................. A manufacturer/ Addresses
processor is not the circumstance
required to implement where an entity
a preventive control (other than the
if it relies on its facility's
customer to ensure customer) in the
that the animal food distribution
will be processed to chain controls
control the identified the hazard
hazard by an entity in Includes
the distribution chain a requirement for
subsequent to the documentation
customer and both: (1) that the animal
Discloses in documents food is ``not
accompanying the processed to
animal food that the control
animal food is ``not [identified
processed to control hazard].''
[identified hazard]''
and (2) annually
obtains from its
customer written
assurance that the
customer will both
disclose the
information that the
animal food is ``not
processed to control
[identified hazard]''
and will only sell to
another entity that
agrees, in writing, it
will either follow
procedures that will
significantly minimize
or prevent the
identified hazard (if
the entity is subject
to subject to the
requirements for
hazard analysis and
risk-based preventive
controls in subpart C)
or manufacture,
process, or prepare
the animal food in
accordance with
applicable animal food
safety requirements
(if the entity is not
subject to the
requirements for
hazard analysis and
risk-based preventive
controls in subpart C)
or obtain a similar
written assurance from
the entity's customer.
507.36(a)(5)................ N/A.................................. A manufacturer/ N/A.
processor is not
required to implement
a preventive control
if it has established,
documented, and
implemented a system
that ensures control,
at a subsequent
distribution step, of
the hazards in the
animal food product it
distributes and
documents the
implementation of that
system.
507.36(b)................... 507.37(g)(3)......................... Records documenting the Includes a
applicable requirement for
circumstances in Sec. documentation of
507.36(a). the additional
circumstances in
which a
manufacturer/
processor is not
required to
implement a
preventive
control.
507.36(c)................... N/A.................................. If a customer of the N/A.
manufacturer/processer
has determined that
the identified hazard
is not a hazard in the
animal food intended
for use for a specific
animal species, the
customer may provide
this determination
(including animal
species and why the
identified hazard is
not a hazard) in its
written assurance
under Sec.
507.36(a)(2)(ii)
instead of providing
assurance of
procedures established
and followed that will
significantly minimize
or prevent the
identified hazard.
507.36(d)................... N/A.................................. If a customer of the N/A.
customer of the
manufacturer/processer
(i.e., another entity
in the distribution
chain) has determined
that the identified
hazard is not a hazard
in the animal food
intended for use for a
specific animal
species, the entity
may provide this
determination
(including animal
species and why the
identified hazard is
not a hazard) in its
written assurance
under Sec.
507.36(a)(4)(ii)(B
instead of providing
assurance of
procedures established
and followed that will
significantly minimize
or prevent the
identified hazard.
[[Page 56251]]
507.37...................... N/A.................................. A facility that N/A.
provides a written
assurance under Sec.
507.36(a)(2), (3), or
(4) must act
consistently with the
assurance and document
its actions taken to
satisfy the written
assurance.
----------------------------------------------------------------------------------------------------------------
The first provision allows a manufacturer/processor to not
implement a preventive control if the manufacturer/processor determines
and documents that the type of animal food could not be consumed
without application of the appropriate control by an entity in the
supply or distribution chain other than that manufacturer/processor
(see Sec. 507.36(a)(1)). We describe comments leading to this
provision, and our response to those comments, in Comment 284 and
Response 284 respectively. Although we are establishing these
provisions outside the framework of the supply-chain program, these
provisions continue to play a role in the requirements for a supply-
chain program, because they also provide an exception to the
requirements for a manufacturer/processor to establish and implement a
supply-chain program.
The second provision relates to comments we received on a proposed
exception to the requirement for a manufacturer/processor to establish
and implement a supplier program (proposed Sec. 507.37(a)(1)(ii)(C)).
(See Comment 285). Under proposed Sec. 507.37(a)(1)(ii)(C), a
receiving facility would not have been required to have a supplier
program if it relied on its customer to control the hazard and annually
obtained from its customer written assurance that the customer has
established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the hazard. As
discussed in Response 285, we are replacing this provision with several
provisions that apply when a manufacturer/processor identifies a hazard
requiring a preventive control (``identified hazard''), does not
control the identified hazard, but can demonstrate and document that
the identified hazard will be controlled by an entity in its
distribution chain. A manufacturer/processor that satisfies the
criteria in these provisions will not be required to implement a
preventive control for the identified hazard. Under these provisions,
the combination of three requirements will provide adequate assurance
that the animal food will be processed to control the identified hazard
before it reaches consumers. These requirements are: (1) Documentation
provided by the manufacturer/processor to its direct customer that the
animal food is ``not processed to control [identified hazard]''; (2)
written assurances from customers regarding appropriate procedures to
ensure that the animal food will receive further processing to control
the identified hazards; and (3) provisions relating to accountability
for written assurances. (In these provisions, ``customer'' means a
commercial customer, not a consumer.)
(Comment 284) Some comments express concern about the ability for
distributors/cooperatives identify the individual raw material or other
ingredient supplier when the supplier that applied the control is more
than one step back in the food chain. Some comments assert that
receiving facilities should not be required to verify suppliers with
which they do not have a direct commercial relationship. For example,
in the case of the soybean supply chain, the U.S. processing facility
likely has no direct relationship with the many farms involved in the
growing and harvesting of the soybeans. Some comments ask for an
exemption from supplier verification activities for animal foods such
as soybeans because it is problematic to have a requirement that
potentially could necessitate trace back to farms.
(Response 284) We are establishing a provision, applicable to both
the supply chain and the distribution chain of a manufacturer/
processor, for a circumstance when a manufacturer/processor does not
need to implement a preventive control. We are providing that a
manufacturer/processor does not need to implement a preventive control
if it determines and documents that the type of animal food could not
be consumed without application of the appropriate control (see Sec.
507.36(a)(1)). However, depending on the facility, the raw material or
other ingredient, and the type of animal food produced by the
manufacturer/processor, there may be some circumstances where a
manufacturer/processor could determine that a particular animal food
that passes through its facility satisfies the criterion ``could not be
consumed without application of the appropriate control.'' In other
cases, a facility may have determined through its hazard analysis that
there are no hazards requiring a preventive control, and will not
consider whether one of the circumstances in new Sec. 507.36 apply.
As a consequential addition, new Sec. 507.36(b) specifies the
records that a manufacturer/processor would need to satisfy the
documentation requirements established in new Sec. 507.36(a)(1), and
we have added new Sec. 507.36(b) to the list of implementation records
(Sec. 507.55) that are subject to the recordkeeping requirements of
subpart F.
See also Comment 429, in which we discuss comments asking us to add
flexibility to the requirements for a supply-chain program such that
any entity other than the receiving facility can perform supplier
verification activities. As discussed in Response 429, the rule
provides additional flexibility in the supply-chain program with regard
to who can perform certain activities (see Sec. 507.115).
(Comment 285) Some comments ask us to delete the criterion for
control of the hazard by the receiving facility's customer, with annual
written assurance that the customer had established and was following
procedures (identified in the written assurance) that would
significantly minimize or prevent the hazard. The stated reasons
varied. For example, some comments state that a receiving facility may
have so many customers that it is not possible to obtain written
assurance annually from all customers. Other comments express concern
that a customer may be unwilling to describe confidential trade secrets
in order to identify in writing the procedures the customer has
established and is following to control the hazard. Other comments
express concern about ``legal issues'' when a receiving facility needs
to assess the adequacy of the customers' procedures for controlling a
hazard because under current business practices a vendor can provide
assurance to a buyer (its customer), but buyers do not typically
provide such
[[Page 56252]]
assurance to vendors. Some comments express concern that written
assurance does not guarantee that the customer is actually doing
anything to significantly minimize or prevent the hazard.
Some comments ask us to provide an alternative that would allow the
receiving facility to provide documentation to its customer about a
hazard that needs a preventive control at a processing facility later
in the distribution chain rather than obtain written assurance that its
customer will control a hazard. If written assurance must be required,
these comments ask us to allow the written assurance provided by the
customer to state that the customer would evaluate the hazard and if
necessary establish and follow procedures to significantly minimize or
prevent the hazard.
Some comments state the receiving facility may not know the
identity of all its ultimate customers, particularly if the receiving
facility sells its products to a distributor who then sells to other
entities. Some comments ask us to provide flexibility for facilities to
determine whether annual updates of written assurance are necessary.
Other comments ask us to specify that a receiving facility need not
establish and implement a supplier program for raw materials and
ingredients intended for further processing.
Some comments assert that the presence of low levels of pathogens
on a raw product that will be subject to a lethal process further
downstream does not pose a risk to the consumer, and should not be
considered a significant hazard (i.e., a hazard requiring a preventive
control). These comments also assert that if we maintain that
Salmonella contamination is a significant hazard for each member of the
supply chain, then we should allow the preventive control to be applied
in a subsequent step at another facility. Other comments ask us to
clarify that a facility would not need to develop preventive controls
where it produces raw materials or ingredients that are subject to
subsequent processing that will address known or reasonably foreseeable
hazards.
(Response 285) We are establishing several provisions, specifically
applicable to the distribution chain of a manufacturer/processor, for
circumstances when a manufacturer/processor does not need to implement
a preventive control (Sec. Sec. 507.36(a)(2), (3), (4), and (5);
507.36(b)(2), (3), (4) and (5); 507.36(c); 507.36(c) and (d), 507.37;
and 507.215). See Response 284 for another new provision that applies
to the supply chain in addition to the distribution chain (Sec.
507.36(a)(1)).
Under the first of these provisions (Sec. 507.36(a)(2)), a
manufacturer/processor is not required to implement a preventive
control if it relies on its customer (who is subject to the
requirements for hazard analysis and risk-based preventive controls in
subpart C) to ensure that the identified hazard will be significantly
minimized or prevented and: (1) Discloses in documents accompanying the
animal food, in accordance with the practice of the trade, that the
animal food is ``not processed to control [identified hazard]''; and
(2) annually obtains from its customer written assurance, subject to
the requirements of Sec. 507.37, that the customer has established and
is following procedures (identified in the written assurance) that will
significantly minimize or prevent the hazard. The manufacturer/
processor would include the specific hazard requiring a preventive
control (e.g., Salmonella) where the statement says ``[identified
hazard].'' A facility that provides the written assurance must act
consistently with the assurance and document its actions taken to
satisfy the written assurance (see new Sec. 507.37). The documents
could be bills of lading or other papers that accompany the animal food
or labels on the containers of the animal food.
Under the second of these provisions, (Sec. 507.36(a)(3)), a
manufacturer/processor is not required to implement a preventive
control if it relies on its customer (who is not subject to the
requirements for hazard analysis and risk-based preventive controls in
subpart C), to provide assurance it is manufacturing, processing, or
preparing the animal food in accordance with applicable animal food
safety requirements and it: (1) Discloses in documents accompanying the
animal food, in accordance with the practice of the trade, that the
animal food is ``not processed to control [identified hazard]''; and
(2) annually obtains from its customer written assurance that it is
manufacturing, processing, or preparing the animal food in accordance
with applicable animal food safety requirements. By ``customer who is
not required to implement preventive controls under this part'' we mean
entities such as qualified facilities and retail food establishments.
Under the third of these provisions (Sec. 507.36(a)(4)), a
manufacturer/processor is not required to implement a preventive
control if it relies on its customer to provide assurance that the
animal food will be processed to control the identified hazard by an
entity in the distribution chain subsequent to the customer and: (1)
Discloses in documents accompanying the animal food, in accordance with
the practice of the trade, that the animal food is ``not processed to
control [identified hazard]''; and (2) annually obtains from its
customer written assurance, subject to the requirements of Sec.
507.37, that the customer will disclose in documents accompanying the
animal food, in accordance with the practice of the trade, that the
animal food is ``not processed to control [identified hazard]''. The
manufacturer/processor also must obtain written assurance that its
customer will only sell to another entity that agrees, in writing, it
will either: (1) Follow procedures (identified in a written assurance)
that will significantly minimize or prevent the hazard (if the entity
is subject to the requirements for hazard analysis and risk-based
preventive controls in subpart C), or manufacture, process, or prepare
the animal food in accordance with applicable animal food safety
requirements (if the entity is not subject to the requirements for
hazard analysis and risk-based preventive controls in subpart C) or (2)
obtain a similar written assurance from the entity's customer.
Under the fourth of these provisions (Sec. 507.36(a)(5)), a
manufacturer/processor is not required to implement a preventive
control if it has established, documented, and implemented a system
that ensures control, at a subsequent distribution step, of the hazards
in the animal food product it distributes and documents the
implementation of that system. Comments did not provide examples of
such a system, but we do not want to preclude the development of such
systems.
We have added several other requirements related to the four new
provisions that we are specifically establishing as circumstances in
which a manufacturer/processor need not implement a preventive control.
As already noted in this response, new Sec. 507.37 requires that a
facility that provides a written assurance must act consistently with
the assurance and document its actions taken to satisfy the written
assurance. In addition, new Sec. 507.36(b)(2), (3), (4), and (5)
specify the records that a manufacturer/processor would need to satisfy
the documentation requirements established in new Sec. 507.36(a)(2),
(3), (4) and (5), and new Sec. 507.215 establishes requirements
applicable to the written assurance between a manufacturer/processor
and its customer. Taken together, the provisions of Sec. Sec. 507.37
and 507.215 establish legal responsibilities for a facility that
provides a written assurance under Sec. 507.36(a)(2), (3) or
[[Page 56253]]
(4), even if that facility is not a manufacturer/processor.
The point of these provisions is to ensure that hazards that a
manufacturer/processor has determined, through its hazard analysis,
require a preventive control, but are not controlled in the supply
chain before the manufacturer/processor or by the manufacturer/
processor itself, are in fact controlled by a subsequent entity in the
distribution chain. With the assurance from the manufacturer/
processor's customer that the hazards will be controlled after the
animal food product leaves the manufacturer/processor it is not
necessary for the first manufacturer/processor to implement the
applicable preventive control. We continue to believe that annual
written assurance from a manufacturer/processor's direct customer is an
appropriate mechanism to ensure that its customer is aware of the
identified hazard and is taking steps to ensure that the animal food is
processed to control the identified hazard. We do not believe that a
manufacturers/processor will need all of the details of its customer's
process to satisfy the requirement to state in writing the procedures
the customer has established and is following to control the hazard.
For example, the customer could merely state that its manufacturing
processes include a lethality step for microbial pathogens of concern.
We agree that it is appropriate to require that the manufacturer/
processor provide documentation to its customer indicating that the
animal food must be processed to control an identified hazard. Such
documentation will be a means of clear communication from the
manufacturer/processor to its customer. When the hazard will not be
controlled by the customer, the customer will still have documentation
that can be passed on to the entity that is expected to process the
animal food to control the identified hazard, so that it will be very
clear to that entity that the identified hazard still needs to be
controlled.
We understand that not all identified hazards in an animal food
will be a hazard to all species of animals. For example, we consider
all serotypes of Salmonella to be a hazard for dog and cat food.
However, we would not consider Salmonella Heidelberg a hazard in food
for cattle. Therefore, we have added provisions to allow this
determination to be included in the customer's written assurance
regarding an identified hazard so that the customer will not be
required to assure it is controlling a hazard that it has determined
does not need to be controlled for a specific animal species.
For the written assurance required by Sec. 507.36(a)(2)(ii), new
paragraph (c) of this section provides that if the customer has
determined that the identified hazard is not a hazard in the animal
food intended for use for a specific animal species, the customer's
written assurance may provide this determination (including animal
species and why the identified hazard is not a hazard) instead of
providing assurance of procedures established and followed that will
significantly minimize or prevent the identified hazard.
For the written assurance required by Sec. 507.36(a)(4)(ii)(B),
new paragraph (d) of this section provides that if the entity in the
distribution chain subsequent to the customer is subject to subpart C
and has determined that the identified hazard is not a hazard in the
animal food intended for use for a specific animal species, that
entity's written assurance may provide this determination (including
animal species and why the identified hazard is not a hazard) in its
written assurance instead of providing assurance that the identified
hazard will be significantly minimized or prevented.
(Comment 286) Some comments that ask us to delete the proposed
requirement to maintain the written assurance as a record. Other
comments ask us to revise the regulatory text of the documentation
requirement to focus on documentation that (1) the receiving facility
has notified its customers of the existence of actual or potential
hazards in animal food provided to them by the receiving facility; or
(2) the receiving facility has notified its customers of the existence
of actual or potential hazards in animal food provided to them by the
receiving facility and has received a written assurance that the
customer will evaluate the hazard and, if necessary, will follow
procedures to significantly minimize or prevent the hazard.
(Response 286) We decline this request. As already discussed in
this section, it is the combination of requirements (i.e., for
documentation that the animal food is ``not processed to control
[identified hazard]''; assurance from customers regarding appropriate
procedures to ensure that the animal food will receive further
processing to control the identified hazards; and provisions relating
to accountability for written assurances) that will provide adequate
assurance that the animal food will be processed to control the
identified hazard before it reaches consumers. Records documenting the
written assurances are a key component of the provisions.
XXVIII. Subpart C: Comments on Proposed Sec. 507.38--Recall Plan
We proposed that you must establish a written recall plan for
animal food with a significant hazard and that the recall plan must
include certain procedures. Some comments support the proposed
requirements without change. For example, some comments express the
view that a written recall plan is critical in the event of a system
breakdown where adulterated animal foods have been distributed. Some
comments that support the proposed requirements suggest alternative or
additional regulatory text or other changes.
In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we are finalizing the requirements as proposed with the
conforming revision to use the term ``hazard requiring a preventive
control'' rather than ``significant hazard.'' See Response 62 and table
31. As discussed in section XXVII, we are establishing a provision
applying to certain assurances in Sec. 507.37.
A. Proposed Sec. 507.38(a)--Requirement for a Written Recall Plan
We proposed that you must establish a written recall plan for
animal food with a significant hazard.
(Comment 287) Some comments ask us to require a written recall plan
for all animal food (rather than just for animal food with a
significant hazard) and to establish the requirements for a written
recall plan as CGMP requirements in subpart B rather than as part of
the requirements for hazard analysis and risk-based preventive controls
in subpart C. These comments assert that all products can be subject to
a recall. These comments contrast recall plans with other preventive
controls in that recall plans are often specific to a firm or facility,
but rarely are specific to particular animal foods. In addition, these
comments note that a recall may be administered and managed at the
corporate office rather than at the specific manufacturing facility
that produced the animal food.
Some comments note the requirements for a written recall plan are
sufficiently different from other provisions in subpart C that we
proposed to specify that the recall plan would not be subject to the
preventive control management requirements for monitoring, corrective
actions, and verification (see Sec. 507.39(c)). Other
[[Page 56254]]
comments assert that a recall plan is not a preventive control because
it deals with products after they have been produced. Some comments
note that facilities that are exempt from the requirements of subpart
C, but remain subject to the CGMP requirements, would not be required
to have a recall plan unless we establish the requirements in subpart
B. Other comments note that the requirement for a recall plan is only
if there is a hazard that requires a preventive control, but assert
that a recall should only be initiated if a hazard has actually been
identified to be present in the product.
Some comments note that our authority to require recall plans is
not limited to section 418 of the FD&C Act and that we can use other
legal authority to impose a requirement for recall plans in subpart B.
Some comments note that FSMA specifically amended the FD&C Act to
provide us with the authority to mandate a food recall (section 423 of
the FD&C Act). These comments assert that it would be reasonable for us
to conclude that in order to efficiently carry out section 423 of the
FD&C Act we should issue requirements governing the conduct of recalls,
because section 423 of the FD&C Act requires that we provide a firm
with an opportunity to voluntarily recall a product before issuing an
order to the firm to cease distribution and recall a product.
(Response 287) We decline the request to establish requirements for
a written recall plan as a CGMP requirement in subpart B and are
establishing the requirements as a preventive control in subpart C as
proposed. We acknowledge that a recall plan would be useful to all
animal food establishments, and we encourage all animal food
establishments to have a recall plan. However, the report issued by the
human food CGMP Modernization Working Group did not identify the lack
of a written recall plan as something that needed to be changed (Ref.
41). (See 78 FR 3646 at 3651, the proposed rule for preventive controls
for human food, for a discussion of the CGMP Modernization Working
Group and the process leading to its report.) However, going forward we
intend to monitor whether the lack of a broader requirement for a
recall plan leads to problems when animal food establishments that are
not subject to the requirements of subpart C are faced with recall
situations. As we gain experience with the impact of the new
requirement for a recall plan on those facilities subject to subpart C,
we can reassess at a later date whether to conduct rulemaking to
broaden the requirement to apply to all animal food establishments
subject to the CGMP requirements in subpart B. For now, animal food
establishments that are not subject to subpart C can continue to follow
our longstanding recall policy in part 7 (21 CFR part 7).
Consistent with the overall framework of FSMA, a recall plan (like
other preventive controls) is only required when the facility has
identified a hazard requiring a preventive control. A facility could
establish a recall plan that applies to other animal foods it
manufactures. We recognize that recalls may be managed by the corporate
office of a firm rather than at the specific manufacturing facility
that produced the animal food. Nothing in the rule precludes this
approach. In such cases the corporate recall policy would be reflected
in a facility's recall plan. (See also Response 239.) In addition, a
facility that identifies one or more hazards requiring a preventive
control in multiple animal food products could use the same recall plan
for all applicable animal food products.
The rule specifies that the requirements for preventive control
management components (i.e., monitoring, corrective actions and
corrections, and verification) apply as appropriate to ensure the
effectiveness of the preventive control, taking into account the nature
of the preventive control (Sec. 507.39(a)). As previously discussed,
the preventive control management components are directed at animal
food that remains at the facility, whereas the recall plan addresses
animal food that has left the facility (78 FR 64736 at 64788). Our
determination that the nature of the recall plan does not require these
preventive control management components demonstrates the flexibility
provided by FSMA and this rule, not that the recall plan must be
considered a CGMP rather than a preventive control.
We have not yet made a determination of whether we should issue
requirements governing the conduct of recalls, rather than rely on the
guidelines in part 7, in order to fully implement section 423 of the
FD&C Act. However, we have issued a draft guidance entitled ``Draft
Guidance for Industry: Questions and Answers Regarding Mandatory Food
Recalls'' which, when finalized, would address topics such as the
criteria for a mandatory recall and the process that FDA must follow
for a mandatory recall (Ref. 42).
(Comment 288) Some comments ask us to cross-reference the
provisions of part 7 (21 CFR part 7) rather than establish requirements
that these comments assert would be duplicative with the provisions of
part 7. These comments ask us to address any more substantive
requirements than are already in part 7 as part of a review of part 7.
These comments assert that part 507 should require a written recall
plan, but not require a written recall plan for the animal food, to be
consistent with the approach of part 7.
(Response 288) We decline these requests. Part 7 addresses
enforcement policy and the provisions for recalls in subpart C of part
7 are ``Guidance on Policy, Procedures, and Industry
Responsibilities.'' These recall provisions do not establish
requirements and are not binding on industry. They also are broadly
directed to recalls for all FDA-regulated products, not just food. As
already discussed in Response 284, nothing in this rule would prevent a
facility that establishes a recall plan for a particular animal food
from using that recall plan for any animal food product that the
facility decides to recall.
(Comment 289) Some comments request that we have separate recall
program requirements for human food by-products so that by-products
produced during the manufacture of food and sold, or otherwise
provided, for use in animal food would not be recalled if the product
for people is recalled. Other comments assert we will need to define
the criteria for an animal food recall in guidance.
(Response 289) We decline the request to have separate recall
program requirements for human food by-products for use as animal food.
Whether or not the by-product of a human food that is recalled should
itself be recalled may depend on assessment of several factors such as
what the hazard is, whether the hazard for which the human food is
recalled is also a hazard for the animal(s) that consume the by-
product, and where the hazard occurred in the manufacturing process. We
have previously addressed the request for guidance. (See Response 1.)
B. Proposed Sec. 507.38(b)--Procedures That Describe the Steps To Be
Taken, and Assign Responsibility for Taking Those Steps
We proposed that the recall plan must include procedures that
describe the steps to be taken, and assign responsibility for taking
those steps, to perform the following actions as appropriate to the
facility: (1) Directly notify the direct consignees of the animal food
being recalled, including how to return or dispose of the affected
animal food; (2) notify the public about any hazard presented by the
animal
[[Page 56255]]
food when appropriate to protect human or animal health; (3) conduct
effectiveness checks to verify that the recall is carried out; and (4)
appropriately dispose of recalled animal food (e.g., through
reprocessing, reworking, diverting to another use that would not
present a safety concern, or destroying). We requested comment on
whether: (1) The proposed procedures are appropriate for all types of
facilities; (2) we should require a recall plan to include procedures
and assignment of responsibility for notifying FDA of recalls subject
to the plan; and (3) we should include a requirement for a mock recall
as a verification activity.
(Comment 290) Some comments ask us to delete the proposed
requirement that the recall plan include procedures for a facility to
notify the public about any hazard presented by the animal food when
appropriate to protect public health. These comments assert that such a
requirement would be highly subjective and create a nebulous regulatory
burden that could subject facilities to unnecessary regulatory
oversight and enforcement actions. Other comments indicate that the
requirement for notifying the public should specifically prevent silent
recalls when manufacturers pull products from store shelves without
consumer notification.
(Response 290) We decline this request. Our guidance for a recall
strategy has long recommended issuing a public warning to alert the
public that a product being recalled presents a serious hazard to
health in urgent situations where other means for preventing use of the
recalled product appear inadequate (Sec. 7.42(b)(2)). Operationally,
such notification to the public is so common that our current home page
on our Internet site (Ref. 43) gives prominence to recall information
and we have established a free email subscription service for updates
on recalls (Ref. 44). Consistent with the longstanding recall policy in
part 7, subpart C, the proposed requirement qualifies that the
notification to the public is ``when appropriate to protect public
health.'' A market withdrawal of a product (see Sec. 7.3(j)) is not a
recall that would be subject to public notification.
(Comment 291) Some comments ask us to specify that the procedures
require facilities to notify us about a recall to ensure that all
suppliers, retailers, and consumers will have adequate notification of
the recall action. Other comments agree that it is important for
facilities to involve us in a recall situation as soon as possible, but
assert that the best way to address such a notification is through the
existing RFR system. These comments assert that additional procedures
or means to notify us would involve unnecessary additional steps and be
duplicative, with no improvement to the public health. Some comments
assert that if the recall is issued by a foreign facility, the
responsibility should be with the importer of the product for notifying
FDA. Some comments ask us to specify that the appropriate State
regulatory Agency with inspection jurisdiction be notified in the event
of a recall.
(Response 291) We agree with comments that it is important to
notify us about a recall and that doing so can help to ensure that
suppliers, retailers, and consumers will have adequate notification of
the recall action. We also agree that the existing procedures to notify
us through the RFR system can accomplish this goal when an animal food
presents a risk of serious adverse health consequences or death and
that it therefore is not necessary to duplicate the notification
procedures already established in the RFR system in part 507. However,
we encourage facilities to include in their recall plan any procedures
they have to comply with the RFR or to include a cross-reference to
those procedures. Doing so may save time, which is critical during a
recall. When the recalled animal food does not present a risk of
serious adverse health consequences or death (and, thus, there is not a
report to the RFR), our guidance entitled ``Guidance for Industry:
Product Recalls, Including Removals and Corrections'' recommends that
recalling firms notify the local FDA District Recall Coordinator as
soon as a decision is made that a recall is appropriate and prior to
the issuance of press or written notification to customers (Ref. 45).
Including this guidance with the facility's recall procedures may also
save time.
We decline the request to designate that it is solely the importer
of a food manufactured by a foreign facility who must notify FDA if the
food is recalled by the foreign facility. We are not requiring that a
recall plan include procedures and assignments of responsibility for
notifying FDA of recalls subject to the recall plan. Facilities should
refer to our guidance in part 7 entitled ``Guidance for Industry:
Product Recalls, Including Removals and Corrections'' for
recommendations on conducting recalls of food that does not present a
risk of serious adverse health consequences or death, including
notification to FDA (Ref. 45). If the recalled food is a reportable
food (i.e., it does present a reasonable probability that use will
cause serious adverse health consequences or death to humans or
animals), then section 417 of the FD&C Act requires that the
responsible party, as defined in section 417, submit a report to FDA.
We agree with comments that it is important to notify appropriate
State regulatory Agencies about a recall. We generally request that FDA
District Offices notify State control officials of recalls issued by
animal food manufacturers. Also, State officials with responsibilities
for regulating animal food can access our Web site for ``Animal and
Veterinary Recalls and Withdrawals'' where we post the current and most
recent recalls of animal products, including animal food (Ref. 46). We
note that whatever methods are used to dispose of adulterated animal
food, the methods should comply with State and local requirements.
(Comment 292) Some comments ask us to add a requirement for mock
recalls on a regular basis, such as biannually. Some of these comments
state that mock recalls would familiarize the staff and communications
network(s) with the recall process and would improve the facility's
capacity to conduct effective and efficient recalls in the event of a
contamination event. Other comments assert that mock recalls would be
the only way to determine the effectiveness of a recall program. Some
comments note that mock recalls would be particularly critical for
manufacturers that have limited experience in actual recalls.
Some comments acknowledge that a mock recall could be an important
element of a recall plan but recommend that mock recalls remain
voluntary, such as by including mock recalls as an example of how
verification may be accomplished. Other comments note that the current
recall procedures in part 7 do not recommend mock recalls. Some
comments assert that a requirement to include a mock recall as a
verification activity would be an excessive and inappropriate burden;
that any gain in the protection of public health will not offset the
resource requirements to accomplish a mock recall; that resources are
better dedicated to developing a robust plan; and, use of a mock recall
should be addressed in FDA guidance.
Some comments ask us to clarify the ``metrics'' for a mock recall,
particularly with respect to the consequences of failing to meet an
appropriate metric if a mock recall is conducted as a verification
activity.
(Response 292) We agree that a mock recall would familiarize the
facility with the recall process, could improve the facility's capacity
to conduct effective
[[Page 56256]]
and efficient recalls during a contamination event, may be particularly
helpful for manufacturers that have limited experience in actual
recalls, and could support the development of guidance on best
practices for recalls, and we encourage facilities to conduct one or
more mock recalls to accomplish these goals. However, as previously
discussed, a recall plan would address food that had left the facility,
whereas the proposed requirements for monitoring, corrective actions,
and verification would all be directed at food while it remains at the
facility. Comments are mixed regarding whether the rule should require
a mock recall as a verification activity for the recall plan, and we
have decided to not require a facility to conduct a mock recall as a
verification activity for its recall plan so that the focus of the
monitoring, corrective actions, and verification in the rule remains
focused on food being produced rather than on food that is distributed
in commerce. We acknowledge that requiring mock recalls would go beyond
our longstanding policies established in part 7. A facility that
voluntarily conducts a mock recall would establish metrics appropriate
to its plan and take action (such as modifications to its procedures,
or additional training for its employees) if it is not satisfied with
the results of the mock recall.
We note that retail companies are not subject to this rule and,
thus, are not subject to the requirement to have a written recall plan.
XXIX. Comments on Proposed Sec. 507.39--Preventive Control Management
Components
We proposed preventive control management components as appropriate
to ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control. Most of the comments that
support the proposed provisions suggest alternative or additional
regulatory text.
In the following sections, we discuss comments that disagree with,
or suggest one or more changes to, the proposed requirements. After
considering these comments, we have revised the proposed requirements
as shown in table 13 with editorial and conforming changes as shown in
table 31.
Table 13--Revisions to the Proposed Requirements for Preventive Control Management Components
----------------------------------------------------------------------------------------------------------------
Section Description Revision
----------------------------------------------------------------------------------------------------------------
507.39............................... Flexible requirements Provide that preventive control management
for preventive control components take into account both the nature of
management components. the preventive control and its role in the
facility's food safety system.
----------------------------------------------------------------------------------------------------------------
A. Proposed Sec. 507.39(a)--Flexible Requirements for Monitoring,
Corrective Actions and Corrections, and Verification
We proposed that, with some exceptions, the preventive controls
would be subject to three preventive control management components as
appropriate to ensure the effectiveness of the preventive controls,
taking into account the nature of the preventive control: Monitoring,
corrective actions and corrections, and verification.
(Comment 293) Some comments support our proposal to provide
flexibility in the oversight and management of preventive controls,
including the explicit provision that preventive control management
components take into account the nature of the preventive control. Some
of these comments state that the provisions for the preventive control
management components will allow facilities to tailor their food safety
plans to their specific facility, product, and process and ensure that
the regulatory requirements are risk-based. Other comments state that
the proposed approach acknowledges the safety benefits derived from the
use of prerequisite programs, such as CGMPs, and provides for a
framework whereby appropriate decisions may be reached regarding
hazards that require management controls that may include monitoring,
corrections or corrective actions, verification, and records. Other
comments state that the provisions will allow businesses to allocate
resources to spend the most time and resources controlling and
monitoring those hazards that pose the greatest risk to public health.
However, many of these comments also ask us to convey not only that
the application of a particular management component be appropriate
(i.e., capable of being applied), but also that it be necessary for
food safety (i.e., to meet the overall FSMA food safety goals or to
ensure a particular control is effective) by specifying that the
preventive control management components take into account both the
nature of the preventive control and its role within the facility's
overall food safety system. Some of these comments ask us to make
companion changes reflecting that the preventive control management
components take into account both the nature of the preventive control
and its role within the facility's overall food safety system
throughout applicable provisions of the rule, such as the definition of
``significant hazard'' (which we now refer to as ``hazard requiring a
preventive control'') and in the requirements for preventive controls,
monitoring, corrective actions and corrections, and verification. Some
comments ask us to consistently refer to ``the nature of the preventive
control'' (rather than simply to ``the preventive control'') when
communicating the flexibility that a facility has in identifying
preventive controls and associated preventive control management
components.
(Response 293) We agree that preventive control management
components should take into account both the nature of the preventive
control and its role in the facility's food safety system and have
modified the regulatory text of Sec. 507.39 to incorporate this
suggestion. We reviewed the full regulatory text of proposed subpart C
and made similar modifications to the regulatory text for the
definition of ``hazard requiring a preventive control'' (Sec. 507.3);
process controls (Sec. 507.34(c)(1)); monitoring (Sec. 507.40);
verification (Sec. 507.45); validation (Sec. 507.47); and
verification of implementation and effectiveness (Sec. 507.49).
(Comment 294) Some comments assert that the flexibility explicitly
provided in the regulatory text could result in some facilities taking
a broad approach to significant hazards and other facilities taking a
more detailed approach. These comments express concern that inspectors
will view the detailed approach (e.g., with more preventive controls),
as the standard to judge compliance with the rule. Other comments
express concern that identifying a large number of preventive controls
could also undermine the value of HACCP programs because treating too
many controls as CCPs will pull
[[Page 56257]]
resources from those controls that are truly critical.
(Response 294) We agree that facilities are likely to take
different approaches to complying with the rule. A facility-specific
approach is consistent with FSMA, which places responsibility for
hazard analysis and risk-based preventive controls on the owner,
operator, or agent in charge of the facility (section 418(a) of the
FD&C Act). We agree that having too many CCPs could dilute their
significance, but not every hazard will require a CCP to be controlled.
See table 6 in the 2014 supplemental notice for examples of preventive
controls that would not be CCPs (79 FR 58476 at 58493).
During the initial stages of implementation, we expect that our
investigators will ask subject matter experts in CVM to review the
outcome of the facility's hazard analysis, the preventive controls
established by the facility, and the associated preventive control
management components that the facility has established and
implemented. Over time, as our investigators gain experience, we expect
that there will be fewer circumstances in which our investigators would
consult CVM about such an outcome. (See also Response 2 and section LIV
regarding our approach to compliance.)
(Comment 295) Some comments state that USDA's regulations (in 7 CFR
205.201(a)(3)) for the National Organic Program include regulatory text
to ``ensure the effectiveness'' of measures in that program and that
this regulatory text is similar to regulatory text in the requirements
for preventive control management components. These comments assert
that this type of regulatory text has created compliance challenges and
ask us to consult with USDA about its experience with implementing
effectiveness language associated with monitoring practices and
procedures and ensure that the final rule uses regulatory text that
will be clearly understood and readily implementable by those subject
to its provisions.
(Response 295) Under the USDA regulation cited by these comments,
an organic production or handling system plan must include a
description of the monitoring practices and procedures to be performed
and maintained, including the frequency with which they will be
performed, to ``verify that the plan is effectively implemented.'' We
have not consulted with USDA regarding its experience in evaluating
compliance with this requirement because we addressed the issue likely
to cause these compliance challenges for monitoring practices and
procedures in an organic production or handling system plan when we
established our requirements for monitoring preventive controls.
Specifically, we require that a facility monitor the preventive
controls with adequate frequency to ``provide assurance that they are
consistently performed,'' not to ``verify that the plan is effectively
implemented.'' Our requirements more clearly distinguish the purpose of
monitoring and verification activities. See our previous discussion of
the relationship between monitoring and verification, and our tentative
conclusion to require monitoring of the performance of the preventive
controls (78 FR 64736 at 64790). We are affirming that conclusion in
this rule. (See Response 297.)
B. Proposed Sec. 507.39(b)--Applicability of Preventive Control
Management Components to the Supply-Chain Program
We proposed that the supplier program (which we now refer to as
``supply-chain program'') would be subject to the following preventive
control management components as appropriate to ensure the
effectiveness of the supplier program, taking into account the nature
of the hazard controlled before receipt of the raw material or
ingredient: (1) Corrective actions and corrections, taking into account
the nature of any supplier non-conformance; (2) review of records; and
(3) reanalysis. We address comments on the supply-chain program in
sections XL through XLVII. We are finalizing the applicability of
preventive control management components to the supply-chain program as
proposed.
C. Proposed Sec. 507.39(c)--Recall Plan Is Not Subject to Preventive
Control Management Components
We proposed that the recall plan that would be established in Sec.
507.38 would not be subject to the preventive control management
components.
(Comment 296) As discussed in Comment 287, some comments ask us to
establish requirements for a written recall plan as a CGMP requirement
in subpart B rather than as a preventive control in subpart C. As a
companion change, some of these comments ask us to delete our proposed
provision that the recall plan would not be subject to the preventive
control management components.
(Response 296) As discussed in Response 287, we are establishing
the requirements as a preventive control in subpart C as proposed.
Therefore, we are finalizing the provision that the recall plan not be
subject to the preventive control management components.
For further discussion on comments on preventive control management
components, see section XXIX in the final rule for preventive controls
for human food, published elsewhere in this issue of the Federal
Register.
XXX. Subpart C: Comments on Proposed Sec. 507.40--Monitoring
We proposed to establish requirements for monitoring the preventive
controls. We also discussed our tentative conclusion that the language
of section 418 of the FD&C Act regarding monitoring is ambiguous and
that it would be appropriate to require monitoring of the
``performance'' of preventive controls.
Some comments agree with our tentative conclusion regarding the
ambiguous nature of section 418. For example, some comments state that
our interpretation seems appropriate because requiring monitoring of
the ``effectiveness'' of the preventive controls would be redundant
with required verification activities. In addition, requiring
monitoring of the performance of preventive controls is consistent with
applicable domestic and internationally recognized standards.
Some comments agree that facilities must be required to maintain
records; but disagree regarding the scope of monitoring. One comment
agrees that monitoring the performance of preventive controls would
provide evidence that the preventive controls established to control
the identified hazards are implemented appropriately. Some comments
support the proposed provisions without change. Some comments ask us to
clarify how we will interpret the provision.
In the following paragraphs, we discuss comments that disagree with
our tentative conclusion or with the proposed requirements, or ask us
to clarify the proposed requirements or suggest one or more changes to
the proposed requirements. After considering these comments, we are
affirming our tentative conclusion that the language of section 418 of
the FD&C Act regarding monitoring is ambiguous and that it would be
appropriate to require monitoring of the ``performance'' of preventive
controls. We also have revised the proposed requirements as shown in
table 14, with editorial and conforming changes as shown in table 31.
[[Page 56258]]
Table 14--Revisions to the Proposed Requirements for Monitoring
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.40........................ Flexibility in Provide that
requirements for monitoring take into
monitoring. account both the
nature of the
preventive control
and its role in the
facility's food
safety system.
507.40(c)(2)(i)............... Records of Provide that records
monitoring. of refrigeration
temperature during
storage of animal
food that requires
time/temperature
control to
significantly
minimize or prevent
the growth of, or
toxin production by,
pathogens may be
affirmative records
demonstrating
temperature is
controlled or
exception records
demonstrating loss
of temperature
control.
507.40(c)(2)(ii).............. Records of Provide for exception
monitoring. records for
monitoring of
preventive controls
other than
refrigeration.
------------------------------------------------------------------------
A. Our Tentative Conclusion To Require Monitoring of the Performance of
Preventive Controls
(Comment 297) Some comments disagree with our tentative conclusion
that it would be appropriate to require monitoring of the
``performance'' of preventive controls and assert that the concept of
``performance evaluation'' is too complex to be included in the rule.
(Response 297) These comments may have misinterpreted what we meant
by ``monitoring performance of preventive controls.'' We used the term
``performance'' to mean ``the execution or accomplishment of an action,
operation, or process undertaken or ordered'' (78 FR 64736 at 64790).
We acknowledge that the definition of ``monitoring'' that we are
establishing in this rule includes that the purpose of observations or
measurements conducted as part of monitoring is to ``assess'' whether
control measures are operating as intended. However, we provided
examples showing that this assessment is a straightforward
determination of whether a process is operating as intended and is not
a complex evaluation as asserted by the comments. (See, e.g., the
discussion of monitoring oven temperature to ensure pathogen
elimination during baking of a pet treat 78 FR 64736 at 64789 through
64790.)
(Comment 298) Some comments that support monitoring the performance
of preventive controls assert that our proposed definition of
``monitoring'' (proposed Sec. 507.3), and our preamble discussions of
``monitoring,'' have the potential to confuse ``monitoring the
performance of preventive controls'' with verification activities that
address ongoing implementation of control measures.
(Response 298) See Response 47 in which we discuss comments on the
definition of monitoring and describe the changes we have made to that
definition to address concerns about the potential to confuse
``monitoring the performance of preventive controls'' with verification
activities that address ongoing implementation of control measures.
(Comment 299) Some comments assert that authority should be
explicitly granted to the States to conduct food safety monitoring and
that we should maintain our responsibilities for product tracing.
(Response 299) These comments misinterpret the provisions of
section 418 of the FD&C Act and this rule. Section 418 places the
responsibility for establishing and implementing a food safety system
(including hazard analysis, risk-based preventive controls, preventive
control management components (including monitoring, corrective action
procedures, and verification), and recordkeeping) on the owner,
operator, or agent in charge of a facility, not on FDA or any other
regulatory authority. This requirement for monitoring within the
framework of hazard analysis and risk-based preventive controls is
distinct from regulatory oversight of animal food safety, such as
during inspections and investigations of outbreaks of foodborne
illness, which generally involve product tracing. We agree that it is
important to coordinate regulatory oversight of animal food safety with
the States and other food safety partners. As discussed in Response 2,
we are working through the PFP to develop and implement a national
Integrated Food Safety System consistent with FSMA's emphasis on
establishing partnerships for achieving compliance (see section 209(b)
of FSMA).
(Comment 300) One comment requests that routine monitoring not be
required for feed mills unless they manufacture pet food.
(Response 300) We decline this request. We assume this comment is
based on a presumption that pet food is a higher risk product than
livestock or poultry food. The exemptions from preventive control
requirements that we are establishing are specifically provided by
section 103 of FSMA and we decline to apply the rule only to animal
foods deemed to be of higher risk. Instead, several provisions of the
rule expressly qualify that the requirements apply as appropriate to
the facility, the animal food, the nature of the preventive control,
and its role in the facility's food safety system, the nature of the
hazard, or a combination of these factors (e.g., monitoring procedures
must be established as appropriate to the nature of the preventive
control and its role in the facility's food safety system). For
example, the hazards in a facility and historical information on the
consistency of the control measure can be factors in determining the
frequency of monitoring.
B. Proposed Sec. 507.40(a) and (b)--Flexibility in Requirements for
Monitoring
We proposed that, as appropriate to the preventive control, you
must establish and implement written procedures, including the
frequency with which they are to be performed, for monitoring the
preventive controls, and monitor the preventive controls with adequate
frequency to provide assurance that they are consistently performed.
(Comment 301) Some comments agree that frequency and areas to be
tested and monitored need to be determined based on each product and
facility and ask us to allow each individual facility to determine the
frequency and areas to be monitored based on a completed risk
assessment. Some comments ask us to specify that the frequency of
monitoring preventive controls must have a scientific basis.
(Response 301) It is unclear whether the comment agreeing that
monitoring frequency and areas to be tested need to be determined based
on each product and facility was directed to the monitoring provision
or to environmental monitoring. Regardless, by requiring written
procedures for monitoring, and specifying that the
[[Page 56259]]
procedures include the frequency with which the procedures are to be
performed, the rule provides that each facility must determine the
frequency of monitoring, as well as details such as the areas to be
monitored. However, we decline the request to specify that these
procedures be based on a completed ``risk assessment.'' The rule
requires the facility to conduct a hazard analysis, which determines
whether there are any hazards requiring a preventive control, and the
facility would establish preventive controls for such hazards as
appropriate to the facility and the animal food. The facility must
consider factors associated with risk (i.e., the severity of the
illness or injury if the hazard were to occur and the probability that
the hazard will occur in the absence of preventive controls) in
evaluating whether any potential hazard is a hazard requiring a
preventive control (Sec. 507.33(c)). Risk could be relevant to a
facility's identification of appropriate preventive controls for a
particular hazard requiring a preventive control. However, it is the
nature of the preventive control, rather than the risk associated with
the hazard, that is more relevant to the frequency of monitoring and
the areas to be monitored. Accordingly, the rule specifies that the
facility establish written procedures, and conduct monitoring, as
appropriate to the preventive control rather than based on risk
associated with the hazard. (See, e.g., the discussion of monitoring
oven temperature to ensure pathogen elimination during baking of a pet
treat 78 FR 64736 at 64789 through 64790.)
We decline the request to specify that the frequency of monitoring
preventive controls must have a scientific basis. Monitoring should
take place with sufficient frequency to detect a problem in the
performance of a preventive control. The importance of the preventive
control to the safety of the animal food can be one factor in setting a
frequency. We acknowledge that scientific information may be
appropriate in determining the frequency of monitoring in some cases.
For example, the frequency may be statistically based, such as with
statistical process control. However, in some cases, factors other than
scientific information may be appropriate in determining the frequency
of monitoring. For example, historical information on the consistency
of the control measure can be a factor in determining frequency. When
variability of the process is low, the frequency may be less than with
a process that has more variability. As another example, a process that
is operated at a point close to a food safety parameter limit may be
monitored more frequently than one where there is a large safety margin
built into the process.
C. Proposed Sec. 507.40(c)--Records
We proposed that all monitoring of preventive controls must be
documented in records that are subject to verification and records
review.
(Comment 302) Some comments point out that table 6 in the 2014
supplemental notice includes an example of a monitoring activity that
generally would not require monitoring records (i.e., monitoring for
pieces of ferrous material with magnets) (see 79 FR 585476 at 58493).
These comments assert that this example is in conflict with the
proposed regulatory text and ask us to modify the regulatory text to
provide the flexibility we acknowledged in the 2014 supplemental
notice. One comment states the examples provided by FDA for monitoring
performance of preventive controls pertain to preventive controls that
have specific parameters. The comment states in the absence of specific
parameters for a preventive control, monitoring is neither necessary
nor appropriate. Other comments ask us to specify that monitoring must
be documented as appropriate to the nature of the preventive control.
Some comments ask us to recognize the acceptability of monitoring
systems that exclusively provide exception reports. These comments
describe exception reporting as a structure where automated systems are
designed to alert operators and management on an exception basis, i.e.,
only when a deviation from food safety parameter limits are observed by
the system. These comments assert that, in many cases, monitoring of
preventive controls can be done by automated systems that provide
exception reporting in a much more efficient manner than if performed
by operators and that automated monitoring allows for increased
sampling frequency (often continuous) and reduction of human error. The
comments provide an example of a refrigeration temperature control that
notifies on exception (e.g., high temperature alarm) and may only
record temperatures that exceed the specified temperature (without
recording temperatures that meet control requirements). These comments
acknowledge that such systems must be validated and periodically
verified to ensure they are working properly. These comments ask us to
clarify in the preamble to the final rule that monitoring systems can
work affirmatively or by exception and that both types of systems and
their related documentation are acceptable.
(Response 302) We have made several revisions to the regulatory
text, with associated editorial changes, to clarify that monitoring
records may not always be necessary. We agree that the exception
reporting described in these comments, including validation and
periodic verification to ensure that the system is working properly,
would be an acceptable monitoring system in the circumstances provided
in the comments, i.e., for monitoring refrigeration temperature.
Therefore, we have revised the regulatory text to provide that records
of refrigeration temperature during storage of food that requires time/
temperature control to significantly minimize or prevent the growth of,
or toxin production by, pathogens may be affirmative records
demonstrating temperature is controlled or exception records
demonstrating loss of temperature control. Although the comments
specifically requested that we clarify our view on exception records in
the preamble, we believe that clarifying the regulatory text will be
more useful, both to facilities and to regulatory agencies that conduct
inspections for compliance with the rule. If a facility uses
``exception records,'' the facility must have evidence that the system
is working as intended, such as a record that the system has been
challenged by increasing the temperature to a point at which an
``exception record'' is generated.
We also have revised the regulatory text to provide that exception
records may be adequate in circumstances other than monitoring of
refrigeration temperature. For example, in table 6 of the 2014
supplemental notice the example we provided of a monitoring activity
that generally would not require monitoring records is monitoring for
pieces of ferrous material with magnets. We believe that a magnet
system that monitors for ferrous material would result in a record only
when the system detects ferrous material.
XXXI. Subpart C: Comments on Proposed Sec. 507.42--Corrective Actions
and Corrections
We proposed to establish requirements for corrective actions and
corrections. Some comments support the proposed requirements without
change. For example, some comments assert that there is virtually no
reason to have a food safety plan unless there are proper corrective
actions in place so the product can be properly disposed of. Some
comments agree that there should
[[Page 56260]]
be written procedures for corrective actions and note the importance of
identifying and evaluating the problem, correcting it, and documenting
the corrective action. Some comments express the view that the proposed
requirement for clear corrective action in the event of an
unanticipated problem, and documenting all corrective actions,
contributes to a comprehensive safety plan. Some comments that support
the proposed provisions suggest alternative or additional regulatory
text.
In the following paragraphs, we discuss comments that disagree
with, or suggest one or more changes to, the proposed requirements.
After considering these comments, we have revised the proposed
requirements as shown in table 15 with editorial and conforming changes
as shown in table 31.
Table 15--Revisions to the Proposed Requirements for Corrective Actions
and Corrections
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.42(a)..................... Corrective action Clarify that
procedures. corrective action
procedures depend on
the nature of the
hazard, as well as
the nature of the
preventive control.
507.42(a)(1).................. Corrective action Clarify that the
procedures. specified list of
corrective action
procedures is not
intended to be
finite.
507.42(b)..................... Corrective action Specify that the
in the event of requirement applies
an unanticipated when ``a corrective
food safety action procedure''
problem. (rather than ``a
specific corrective
action procedure'')
has not been
established.
507.42(b)(1)(ii).............. Corrective action Specify that the
in the event of requirement applies
an unanticipated when a preventive
food safety control, combination
problem. of preventive
controls, or the
food safety plan as
a whole is found to
be ineffective
(rather than just
when a single
preventive control
has been found to be
ineffective).
507.42(c)(2).................. Corrections...... Provide for
additional
circumstances when
corrections, rather
than corrective
actions, are
warranted.
------------------------------------------------------------------------
A. Proposed Sec. 507.42(a)(1)--Requirement To Establish and Implement
Corrective Action Procedures
We proposed that, with some exceptions, as appropriate to the
preventive control you must establish and implement written corrective
action procedures that must be taken if preventive controls are not
properly implemented. The corrective action procedures must include
procedures to address, as appropriate, the presence of a pathogen or
appropriate indicator organism in animal food detected as a result of
product testing, as well as the presence of an environmental pathogen
or appropriate indicator organism detected through environmental
monitoring.
(Comment 303) Some comments note that we proposed to list two
circumstances that require written corrective active procedures (i.e.,
product testing and environmental monitoring) and that it is not clear
whether this list is intended to be exhaustive or not (i.e., whether
written corrective action procedures are required in only these two
circumstances, or whether there may be other circumstances that require
written corrective action procedures). These comments ask us to insert
``but are not limited to'' after ``must include,'' if we intend that
the list is not exhaustive. Likewise, other comments state our proposal
to specifically require corrective action procedures may result in a
misunderstanding by some facilities about the need to take corrective
actions in circumstances other than in response to testing results,
other non-conformances, or other types of verification activities.
These comments assert that it would be better for food safety if the
regulatory requirements took a more principled approach and generally
required corrective action procedures, with the importance of
corrective action procedures for testing programs addressed through
guidance. If, however, we conclude that specific requirements for
corrective action procedures for testing programs are necessary, these
comments ask us to clarify that the nature and extent of any corrective
actions should be proportional to the nature of the test findings.
(Response 303) We have revised the regulatory text, with associated
editorial revisions and redesignations, to clarify that the specified
list of corrective action procedures is not intended to be exhaustive
(i.e., not limited to the two corrective action procedures that we
specified in the 2014 supplemental notice). The approach we used in the
modified regulatory text (i.e., ``You must establish and implement
written corrective action procedures . . ., including procedures to
address, as appropriate . . .'') is similar to the approach used in
several other provisions of the rule. (See, e.g., sanitation controls
(Sec. 507.34(c)(2)); and monitoring (Sec. 507.40(a)). We decline the
suggestion to modify the regulatory text by adding ``but is not limited
to'' after ``includes''. The word ``includes'' means to have (someone
or something) as part of a group or total; to contain (someone or
something) in a group or as a part of something (Ref. 47). The word
``includes'' does not need to be followed by ``but is not limited to''
to clearly communicate that a following list is not complete. We agree
that the nature and extent of any corrective actions in response to the
findings of testing programs should be proportional to the nature of
the test findings. (See Response 304.)
(Comment 304) Some comments state that the nature and extent of the
corrective actions should be proportional to the nature of the testing
results. These comments ask us to require that a facility establish and
implement corrective action procedures that must be taken if preventive
controls are not properly implemented as appropriate to the nature of
the hazard, the nature of the control measure, and the extent of the
deviation.
(Response 304) We have revised the regulatory text to specify that
the corrective action procedures are established and implemented based
on the nature of the hazard in addition to the nature of the preventive
control. We agree that the nature of the hazard plays a key role in the
corrective actions that a facility would take. Although a facility's
corrective action procedures likely would specify actions to take based
on the extent of the deviation, we consider this a detail that does not
need to be specified in the rule.
(Comment 305) Some comments ask us to revise the provisions to
clarify that corrective action procedures are not always necessary when
testing detects the presence of a pathogen or indicator organism. These
comments assert that
[[Page 56261]]
the extent of the corrective actions should be proportional to the
nature of the testing results themselves because the level of
contamination matters for those microorganisms with thresholds that
need to be taken into account and because the location of contamination
in the food processing environment matters (e.g., the zone in the
facility where the contamination is detected). (For information about
zones associated with environmental monitoring, see 78 FR 3646 at
3816.)
(Response 305) We decline this request. These comments appear to be
confusing the requirement to establish and implement corrective action
procedures with the content of the corrective action procedures. These
comments also appear to assume that a requirement to have corrective
action procedures (which describe the steps to be taken to ensure that
appropriate action is taken to identify and correct a problem and, when
necessary, to reduce the likelihood that the problem will recur; that
all affected animal food is evaluated for safety; and that all affected
animal food is prevented from entering into commerce when appropriate)
pre-determines the outcome of following the corrective action
procedures. This is not the case. If, as the comments assert, a
facility concludes, for example, that the nature of some test results
do not warrant steps to reduce the likelihood that a problem will recur
and that affected animal food is safe and lawful (or, in the case of
finding a pathogen in some zones in the facility, that no animal food
is affected), then that is what its corrective action procedures would
say. The reason to have corrective action procedures is to consider the
likely scenarios in advance, with appropriate input from the facility's
food safety team and preventive controls qualified individual, rather
than react to these scenarios on an ad hoc basis.
(Comment 306) Some comments ask us to require that corrective
actions include an analysis to determine the root cause of a problem,
not only identify it. These comments also ask us to require follow-up
actions to ensure the corrective action was effective and assert that
although the requirements address the need to reanalyze the food safety
plan they do not appear to specifically address a review of the
corrective action.
(Response 306) The requests of these comments do not require any
revisions to the regulatory text. The rule does not use the term ``root
cause'' but it does require the facility to take appropriate action,
when necessary, to reduce the likelihood that the problem will recur
(see Sec. 507.42(a)(2)(ii)). Root cause analysis is simply part of a
common approach to complying with this requirement. (Knowing the root
cause is key to reducing the likelihood that a problem will happen
again.) The rule also requires a review of records of corrective
actions, but does so as a verification activity rather than as part of
the corrective action procedures (see Sec. 507.49(a)(4)).
(Comment 307) Some comments ask us to revise the proposed rule to
address corrective actions in a more general way and then outline areas
where specific corrective action procedures would be helpful, such as
for testing programs, in guidance.
(Response 307) The proposed provisions do not prescribe the outcome
of the corrective action procedures, but merely direct the facility to
the types of actions that the procedures must address. In essence, the
proposed provisions already do, as the comments request, address
corrective actions in a general way.
(Comment 308) Some comments ask us to specify that the requirements
to establish and implement written corrective action procedures also
apply when a preventive control is found to be ineffective.
(Response 308) We have not revised the regulatory text as requested
by these comments. The appropriate action when a preventive control is
found to be ineffective is to reanalyze the food safety plan and to
establish and implement a preventive control that is effective, not
follow a corrective action procedure. A corrective action procedure is
intended to address a problem that happens when following the
procedures in a food safety plan that previously was verified to be
valid, not to fix problems on an ongoing basis when a preventive
control is ineffective (and, thus, the food safety plan is not valid).
We agree that some of the steps that apply to corrective actions may
need to be taken, such as evaluating affected animal food for safety
and ensuring that adulterated animal food does not enter commerce. This
is addressed by the provisions for corrective actions in the event of
an unanticipated problem (Sec. 507.42(b)(1)), which require specific
corrective actions to be taken (Sec. 507.42(b)(2)).
(Comment 309) Some comments requests flexibility as every facility
is different from the next so prescriptive corrective actions required
by rules may not be applicable or possible in all cases. Some
commenters requested that documentation be maintained for corrective
actions only if the corrective action was made to address an animal
food safety issue. Other comments say that the animal food safety plan
should outline when a corrective action is required, as well as the
procedure to be followed and the requirement should only focus on
animal food safety issues and not quality issues.
(Response 309) As stated in Response 304, we have revised the
regulatory text to specify that the corrective action procedures are
established and implemented based on the nature of the hazard in
addition to the nature of the preventive control. We agree that the
nature of the hazard plays a key role in the corrective actions that a
facility would take. The requirement is intended to address hazards and
therefore would not address animal food quality issues unless they
would present a hazard (e.g., if insufficient mixing would present the
potential for nutrient deficiencies or toxicities). All corrective
actions must be documented in records (see Sec. 507.42(d)).
B. Proposed Sec. 507.42(a)(2)--Content of Corrective Action Procedures
We proposed that corrective action procedures must describe the
steps to be taken to ensure that: (1) Appropriate action is taken to
identify and correct a problem that has occurred with implementation of
a preventive control; (2) appropriate action is taken to reduce the
likelihood that the problem will recur; (3) all affected animal food is
evaluated for safety; and (4) all affected animal food is prevented
from entering into commerce, if you cannot ensure that the affected
animal food is not adulterated under section 402 of the FD&C Act.
(Comment 310) Some comments assert that the corrective action
procedures should not consider food to be ``affected'' if it is
immediately subjected to an additional (or repeat) preventive control
after determining that the initial preventive control was not properly
implemented. These comments discuss an example in which there is a
temperature deviation below accepted parameter limits for a given
process, and the incorrectly processed product is re-processed
correctly, and assert that it would be illogical to consider the food
to be ``affected'' in the circumstance. Other comments ask us to modify
the requirements to specify that they apply to all affected food ``if
any.'' One comment states the use of the term ``all'' with ``affected''
is redundant and may contribute to unwarranted and unnecessary
regulatory emphasis and requests that the word ``all'' be removed.
(Response 310) We decline the requests to modify the regulatory
text to remove the word ``all'' or specify that
[[Page 56262]]
the requirements apply to all affected animal food ``if any.'' Animal
food is ``affected'' if a preventive control is not properly
implemented during its production. However, the rule does not pre-
determine the consequences when animal food is ``affected.'' Instead,
the rule provides for the facility to evaluate the affected animal food
for safety. If, as in the example described by the comments, the
facility reapplies the preventive control such that the animal food is
safe and is not adulterated under section 402 of the FD&C Act, there
would be no need to take steps to prevent that animal food from
entering commerce.
(Comment 311) Some comments ask us to provide that requirements for
corrective actions be principle-based (e.g., affected product
containment, control restored to operation before commencing
production) rather than prescriptive.
(Response 311) The requirements for corrective actions established
by this rule are principle-based in that they require the facility to
describe the steps it will take rather than prescribe the steps it will
take.
(Comment 312) Some comments ask us to revise the provision to make
resampling and/or retesting one of the first steps in a corrective
action procedure to take into account human error. These comments
assert that mishandling during sampling, transport, and testing can
contribute to a false positive result and that if the results of a
followup test are negative, then the previous test could be considered
an anomaly that could be ignored.
(Response 312) We decline this request. We disagree that an
appropriate approach to positive findings of a test for contamination
is to resample and retest and to consider positive findings to be an
anomaly if subsequent test results are negative. Many animal food
products are not homogeneous and contamination is localized. Even for
homogeneous animal food products (such as liquids), the problem could
be the sensitivity of the method if the level of contamination is low.
For further discussion on our current thinking on presumptive positive
results and additional testing, see our guidance entitled ``Guidance
for Industry: Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods'' (Ref. 48).
C. Proposed Sec. 507.42(b)--Corrective Action in the Event of an
Unanticipated Problem
With some exceptions, we proposed that you must take corrective
action to identify and correct a problem, reduce the likelihood that
the problem will recur, evaluate all affected animal food for safety,
and, as necessary, prevent affected animal food from entering commerce
as would be done following a corrective action procedure if any of the
following circumstances apply: (1) A preventive control is not properly
implemented and a specific corrective action has not been established;
(2) a preventive control is found to be ineffective; or (3) a review of
records finds that the records are not complete, the activities
conducted did not occur in accordance with the food safety plan, or
appropriate decisions were not made about corrective actions. We also
proposed that if any of these circumstances apply, when appropriate you
must reanalyze the food safety plan to determine whether modification
of the food safety plan is required.
(Comment 313) Some comments ask us to delete the proposed
requirement that a facility must reanalyze the food safety plan in the
event of an unanticipated problem. These comments argue that FSMA does
not specify reanalysis in the event of an unanticipated problem. In
addition, these comments assert that the proposed requirement for
reanalysis in the event of an unanticipated problem would be redundant
with the proposed requirements for reanalysis as a verification
activity (proposed Sec. 507.50) and would not add value for food
safety. These comments also assert that the term ``problem'' is
ambiguous and ask us to replace ``problem'' with ``food safety issue''
if we retain the provision in the final rule.
(Response 313) We acknowledge that section 418 of the FD&C Act does
not explicitly specify that a facility must reanalyze its food safety
plan in the event of an unanticipated problem. In the 2014 supplemental
notice, we clarified that reanalysis would be conducted ``when
appropriate.'' For example, if a problem occurs because personnel did
not understand the procedures or carry out the procedures correctly,
additional training for applicable personnel may be warranted, but
there likely would be no need to reanalyze the food safety plan.
We disagree that the term ``problem'' is ambiguous. The term
``problem'' signifies that something is wrong, whereas the term
suggested by the comments (i.e., ``issue'') may or may not signify that
something is wrong. We agree that the requirements are directed to
problems related to animal food safety.
We agree that there is a relationship between the requirements for
corrective actions in the event of an unanticipated food safety problem
and the requirements for reanalysis. To reduce redundant regulatory
text, in the 2014 supplemental notice we proposed to modify the
regulatory text of the requirements for reanalysis to specify that
reanalysis is required when appropriate after an unanticipated food
safety problem, and we are establishing that modified provision in this
final rule. Importantly, the provisions for reanalysis continue to
require reanalysis when a preventive control is found to be
ineffective. We are not aware of any circumstances in which it would
not be appropriate to reanalyze the food safety plan if a preventive
control is found to be ineffective.
(Comment 314) Some comments assert that the word ``specific'' is
not appropriate as a modifier for ``corrective action procedure''
because many preventive controls will have corrective action procedures
that allow flexibility based upon the nature of the hazard and control.
These comments also state that the term ``specific'' in this context is
more appropriate for a CCP control in a HACCP system.
(Response 314) We have revised the regulatory text to delete the
word ``specific.''
(Comment 315) Some comments ask us to emphasize that reanalysis is
required only when a combination of two events occurs (i.e., a
preventive control is not properly implemented and the facility has not
established a corrective action procedure).
(Response 315) In the 2014 supplemental notice, we proposed
revisions to the regulatory text to clearly specify the circumstances
requiring reanalysis. One such circumstance is when a preventive
control is not properly implemented and a corrective action procedure
has not been established, as stated in Sec. 507.42(b)(1)(i)). The
final provision includes the revisions included in the 2014
supplemental notice and is consistent with the request of these
comments.
(Comment 316) Some comments ask us to add that corrective actions
in the event of an unanticipated problem also apply when a preventive
control is ``missing.''
(Response 316) We have revised the regulatory text to require
corrective actions whenever a preventive control, combination of
preventive controls, or the food safety plan as a whole, is
ineffective. (See Sec. 507.42(b)(1)(ii).) In assessing what the
comment might mean by a preventive control that is ``missing,'' we
concluded that an unanticipated problem could, in some cases, mean that
a combination of
[[Page 56263]]
preventive controls, or the facility's food safety plan as a whole
(rather than a single preventive control), simply was not effective. If
this is the case, reanalysis would be appropriate, and we also have
modified the requirements for reanalysis to specify that a facility
must reanalyze its food safety plan whenever it finds that a preventive
control, combination of preventive controls, or the food safety plan as
a whole is ineffective.
(Comment 317) Some comments ask us to replace the term
``reanalyze'' with the term ``reassess.''
(Response 317) We decline this request. Reanalysis goes beyond
assessing the validity of a preventive control or food safety plan to
control a hazard. Reanalysis can also include assessing whether all
hazards have been identified, whether established procedures are
practical and effective, and other factors.
D. Proposed Sec. 507.42(c)--Corrections
We proposed that you do not need to comply with the requirements
for corrective actions and corrections for conditions and practices
that are not consistent with specified sanitation if you take action,
in a timely manner, to correct such conditions and practices.
(Comment 318) Some comments support our proposal to provide for
corrections, rather than corrective actions, for sanitation controls in
some circumstances. Other comments assert that situations in which
``corrections'' can be applied are not limited to sanitation controls
and could include actions to address other preventive controls such as
preventive maintenance controls or CGMPs. As discussed in Comment 82,
some comments emphasize the importance of distinguishing between the
terms ``correction'' and ``corrective action.''
(Response 318) We have revised the regulatory text, with associated
editorial revisions and redesignations, to provide for corrections,
rather than corrective actions and corrective action procedures, for
minor and isolated problems that do not directly impact product safety.
As discussed in Response 82, we also have defined the term
``correction'' to mean an action to identify and correct a problem that
occurred during the production of animal food, without other actions
associated with a corrective action procedure (such as actions to
reduce the likelihood that the problem will recur, evaluate all
affected animal food for safety, and prevent affected animal food from
entering commerce).
E. Proposed Sec. 507.42(d)--Records
We proposed that all corrective actions (and, when appropriate,
corrections) must be documented in records and that these records are
subject to the verification requirements in Sec. Sec. 507.45(a)(3) and
507.49(a)(4)(i). We received no comments that disagreed with this
proposed requirement and are finalizing it as proposed.
XXXII. Subpart C: Comments on Proposed Sec. 507.45--Verification
In the 2013 proposed preventive controls rule for animal food, we
proposed verification activities that would include validation,
verification of monitoring, verification of corrective actions,
verification of implementation and effectiveness, written procedures,
reanalysis, and documentation of all verification activities. We also
requested comment on whether we should specify the verification
activities that must be conducted for verification of monitoring (78 FR
64736 at 64796) and for verification of corrective actions (78 FR 64736
at 64796), and if so, what verification activities should be required.
To improve clarity and readability, in the 2014 supplemental notice
we proposed to move the more extensive verification requirements for
validation, implementation and effectiveness, and reanalysis from the
single proposed section (proposed Sec. 507.45) to separate sections
(proposed Sec. Sec. 507.47, 507.49, and 507.50, respectively). In
addition, to address comments that asked us to provide more flexibility
to facilities, including flexibility in determining whether and how to
conduct verification activities, in the 2014 supplemental notice we
proposed that the verification activities be performed ``as appropriate
to the preventive control.''
In this section, we discuss the proposed requirements for
verification of monitoring, verification of corrective actions, and
documentation of verification activities. See sections XXXIII through
XXXV for comments on the proposed requirements for validation,
verification of implementation and effectiveness, written procedures,
and reanalysis. See tables 17, 18, and 19 for a summary of the
revisions to those proposed requirements.
Some comments support the proposed requirements for verification of
monitoring, verification of corrective actions, and documentation of
verification activities without change. For example, comments support
the documentation of verification activities (see section XXXI.C). In
the following paragraphs, we discuss comments on the flexibility
provided for a facility to conduct verification activities as
appropriate to the nature of the preventive control. We also discuss
comments that address our request for comment on whether we should
revise the regulatory text to specify the verification activities that
must be conducted for verification of monitoring and for verification
of corrective actions, or express concern that the requirements as
proposed are too prescriptive. After considering these comments, we
have revised the verification requirements described in Sec. 507.45 as
shown in table 16.
Table 16--Revisions to the Proposed Requirements for Verification
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.45(a)..................... Flexibility to Provide that
conduct verification
verification activities take into
activities. account both the
nature of the
preventive control
and its role in the
facility's food
safety system.
------------------------------------------------------------------------
A. Flexibility in Requirements for Verification
(Comment 319) Some comments support the flexibility provided by use
of the phrase ``as appropriate to the preventive control'' in the
requirement that verification activities must include, as appropriate
to the preventive control, specified verification activities (i.e.,
validation, verification that monitoring is being conducted,
verification that appropriate decisions about corrective actions are
being made, verification of implementation and effectiveness, and
reanalysis). These comments emphasize that verification activities must
be tailored to the preventive control and assert that the use of the
word ``must'' is potentially confusing in light of this flexibility,
e.g., because not all preventive controls must be validated
[[Page 56264]]
for food safety, and those preventive controls that do not need
monitoring would not need verification of monitoring. Other comments
ask us to allow facilities flexibility to verify that preventive
controls are effective in the manner prescribed by FSMA, i.e., such
controls should be deemed to be effective by an appropriate means as
determined and supported by the facility within its food safety plan.
(Response 319) The provisions for preventive control management
components make clear that all preventive control management
components, including verification, are required as appropriate to
ensure the effectiveness of the preventive control, taking into account
the nature of the preventive control and its role in the facility's
food safety system (see Sec. 507.39). Likewise, the provisions for
each of the preventive control management components (i.e., monitoring,
corrective actions and corrections, and verification) individually
provide flexibility, either by specifying that the provisions apply as
appropriate to the nature of the preventive control and its role in the
facility's food safety system (i.e., for monitoring and verification)
or both the nature of the preventive control and the nature of the
hazard (i.e., for corrective actions and corrections). The word
``must'' specifies the type of activities that a facility can use to
satisfy the requirements for a particular preventive control management
component.
We are retaining the term ``must.'' However, we agree that the rule
should provide flexibility for additional verification of
implementation and effectiveness. To provide that additional
flexibility, we have revised the specific requirements for verification
of implementation and effectiveness to provide for other activities
appropriate for verification of implementation and effectiveness (see
Sec. 507.49(a)(5)). As a conforming revision, we have revised the
requirement for review of records to include a review of records of
other verification activities within a reasonable time after the
records are created (see Sec. 507.49(a)(4)(ii)).
B. Proposed Sec. 507.45(a)--Verification Activities
1. Proposed Sec. 507.45(a)(1)--Validation
We proposed that verification activities must include, as
appropriate to the preventive control, validation in accordance with
Sec. 507.47. See section XXXIII for comments on validation as a
verification activity.
2. Proposed Sec. 507.45(a)(2)--Verification of Monitoring
We proposed that verification activities must include, as
appropriate to the preventive control, verification that monitoring is
being conducted in accordance with Sec. 507.40. We requested comment
on whether we should specify the verification activities that must be
conducted for monitoring, and if so, what verification activities
should be required.
(Comment 320) Comments that address our request for comment on
whether we should specify the verification activities that must be
conducted for monitoring ask us to not do so because this prescriptive
approach would be too limiting. These comments ask us to instead
provide flexibility for the facility to determine the appropriate
verification activities.
(Response 320) We agree that we should provide flexibility for the
facility to determine these verification activities, and are not
specifying the verification activities that must be conducted for
monitoring.
3. Proposed Sec. 507.45(a)(3)--Verification of Corrective Actions
We proposed that verification activities must include, as
appropriate to the preventive control, verification that appropriate
decisions about corrective actions are being made in accordance with
Sec. 507.42. We requested comment on whether this section should
specify the verification activities that must be conducted for
corrective actions, and if so, what verification activities should be
required.
(Comment 321) Some comments ask us not to specify the verification
activities that must be conducted for corrective actions because this
approach would be too limiting. These comments ask us to instead
provide flexibility for the facility to determine the appropriate
verification activities.
(Response 321) We agree that we should provide flexibility for the
facility to determine the appropriate verification activities for
corrective actions, and are not specifying the verification activities
that must be conducted for corrective actions.
4. Proposed Sec. 507.45(a)(4)--Verification of Implementation and
Effectiveness
We proposed that verification activities must include, as
appropriate to the preventive control, verification of implementation
and effectiveness in accordance with Sec. 507.49. See section XXXIV
for comments on verification of implementation and effectiveness.
(Comment 322) One comment contends that animal food facilities
should not be required to conduct product testing or environmental
monitoring to verify implementation and effectiveness of preventive
controls. The comment states that product testing and environmental
monitoring at a facility that is not using appropriate controls will
not normally discover potential hazards. The comment also states that
all of the safety requirements necessary to protect the health of
animals are already being met because this is necessary as a good
business practice and is required by customers.
(Response 322) When a food safety plan is completed by a preventive
controls qualified individual, they must ensure that the preventive
controls in place are adequate to provide assurance that any hazards
requiring a preventive control will be significantly minimized or
prevented. We have provided adequate flexibility for a preventive
controls qualified individual in an animal food facility to determine
if product testing or environmental monitoring is necessary considering
the facility, the animal food, the nature of the preventive control,
and its role in the facility's food safety system (for further
discussion see section XXXIV.C and XXXIV.E).
We disagree that all food safety measures necessary to protect the
health of animals are always being followed. Each year, animal food is
recalled, often due to a hazard that could cause serious health
consequences or death. Animal food from a facility that is required to
register and for which there is a reasonable probability that use of or
exposure to the food would cause serious adverse health consequences or
death to humans or animals is subject to reporting to FDA under section
417 of the FD&C Act (Reportable Food Registry).
5. Proposed Sec. 507.45(a)(5)--Reanalysis
We proposed that verification activities must include, as
appropriate to the preventive control, reanalysis in accordance with
Sec. 507.50. See section XXXV for comments on reanalysis as a
verification activity.
C. Proposed Sec. 507.45(b)--Documentation of Verification Activities
We proposed that all verification activities must be documented in
records. We received no comments that disagreed with this proposed
requirement and are finalizing it as proposed.
D. Comments on Potential Requirements Regarding Complaints
We requested comment on whether and how a facility's review of
[[Page 56265]]
complaints, including complaints from consumers, customers, or other
parties, should be required as a component of its activities to verify
that its preventive controls are effectively minimizing the occurrence
of hazards (78 FR 64736 at 64809).
(Comment 323) Some comments ask us to require review of consumer
complaints as a verification activity and note that our HACCP
regulations for seafood and juice require that verification activities
include a review of consumer complaints to determine whether they
relate to the performance of the HACCP plan or reveal the existence of
unidentified CCPs. Some comments note circumstances in which consumer
complaints have identified food safety problems that resulted in a
company report to the RFR. Other comments assert that review of
customer complaint data should not be required in the rule to verify
that a facility's preventive controls are effectively minimizing the
occurrence of hazards.
Some comments state that the frequency and type of complaints a
facility receives is a very good indicator of the underlying issues
associated with food production, reviewing these records would provide
valuable insight into the type of issues that should be investigated,
and this type of verification activity could therefore be extremely
effective with little to no cost because the facility would already be
performing this type of activity. Some comments state that many
foodborne outbreaks have been identified through complaints and a
review of complaints is a critical component of a food safety system.
One comment says that many times customer complaints may be the first
and only clue that problems exist in animal food because animal
illnesses are not subject to the same reporting requirements as human
illnesses, resulting in a much weaker basis for identifying, tracing,
and correcting foodborne problems.
Other comments state that a food safety review of complaints is a
prudent part of a food safety program but that the value of such a
review is in providing information and feedback for continuous
improvement of the food safety management system rather than as a
verification of preventive controls. These comments caution against use
of consumer complaints as a regulatory requirement for verification of
the food safety plan because most complaints relate to product quality.
If such a requirement is nonetheless established in the final rule,
these comments recommend that the rule only require followup and
documentation for the rare occurrences where consumer complaints relate
to food safety issues.
Other comments ask us not to require review of complaints as a
verification activity. Some of these comments assert that complaints
rarely relate to food safety or yield information that leads to
discovery of a food safety issue. Some comments assert that requiring
review of consumer complaints could result in unnecessary time and
effort being spent on an activity with a limited correlation to food
safety. Some comments assert that the provision would provide FDA
access unnecessarily to all complaint files and lead to unproductive
and subjective evaluations as to whether a given complaint pertains to
the performance of the food safety plan. Other comments assert that
complaints would be acted upon immediately for business reasons, and
that waiting to react to complaints until conducting a review of
records as a verification activity would be too late. Other comments
assert that complaints are sensitive business information. Other
comments assert that some consumer complaints are false or emotional
(rather than factual) and have no place in development of preventive
controls. Some comments assert that FSMA does not expressly direct us
to require review of complaints. Some comments assert that review of
complaints is not a precise scientific process, and that consumer
comments are often open to different interpretations.
Some comments discuss the feasibility of consumer complaint review.
Comments state that consumer complaint records are often kept at a
corporate level rather than at the individual facility. One comment
requests mandatory complaint monitoring for animal food manufacturers.
One comment points out FDA already has access to records, including
complaint files, associated with animal food, which the Agency
reasonably believes to be adulterated and presenting a threat of
serious adverse health consequences.
(Response 323) We are not establishing a requirement for a review
of complaints as a verification activity. We agree that review of
complaints is more likely to be useful in providing information and
feedback for continuous improvement of the food safety system rather
than as a verification of preventive controls. However, we encourage
facilities to do such a review, as they occasionally do uncover animal
food safety issues.
XXXIII. Subpart C: Comments on Proposed Sec. 507.47--Validation
We proposed to establish requirements for validation of preventive
controls. Some comments support the proposed requirements without
change. For example, some comments agree that validation must be
performed by (or overseen by) a preventive controls qualified
individual and that some preventive controls (e.g., sanitation controls
and recall plans) do not require validation. Some comments that support
the proposed provisions suggest alternative or additional regulatory
text or ask us to clarify how we will interpret the provision.
In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
17, with editorial and conforming changes as shown in table 31.
Table 17--Revisions to the Proposed Requirements for Validation
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.47(a)..................... Flexibility for Provide that
validating validation be
preventive conducted as
controls. appropriate to both
the nature of the
preventive control
and its role in the
facility's food
safety system.
507.47(b)(1).................. Circumstances Provide that, when
requiring necessary to
validation. demonstrate the
control measures can
be implemented as
designed, validation
may be performed (1)
Within 90 calendar
days after
production of the
applicable animal
food first begins or
(2) within a
reasonable
timeframe, provided
that the preventive
controls qualified
individual prepares
(or oversees the
preparation of) a
written
justification.
[[Page 56266]]
507.47(b)(1).................. Circumstances Add an additional
requiring circumstance
validation. requiring
validation, i.e.,
whenever a change to
a control measure or
combination of
control measures
could impact whether
the control measure
or combination of
control measures,
when properly
implemented, will
effectively control
the hazards
requiring a
preventive control.
507.47(c)..................... Preventive Clarify that a list
controls that do of preventive
not require controls that do not
validation. require validation
is not an exhaustive
list.
------------------------------------------------------------------------
A. Flexibility in the Requirements To Validate Preventive Controls
With some exceptions (see discussion of proposed Sec. 507.47(b)(3)
in section XXXIII.D), we proposed that you must validate that the
preventive controls identified and implemented in accordance with
proposed Sec. 507.36 to control the significant hazards are adequate
to do (proposed Sec. 507.47(a)).
(Comment 324) Some comments assert that the regulatory text is in
conflict with the preamble discussion in the 2014 supplemental notice
because the regulatory text (i.e., ``(e)xcept as provided by . . .'')
narrowly provides exceptions only for validation of sanitation
controls, supplier controls, and the recall plan, whereas the preamble
discussion provides other examples of preventive controls that would
not require validation (i.e., zoning, training, preventive maintenance,
and refrigerated storage). These comments also assert that although the
regulatory text specifies that validation requirements apply ``as
appropriate to the nature of the preventive control,'' that phrase
could be interpreted to mean that only the validation act itself can be
tailored and that the facility does not have the flexibility to
conclude that validation isn't necessary.
Some comments assert that the proposed regulatory text would
prevent us from requiring validation of specific sanitation controls
where it may be prudent to do so, either now or in the future as a
result of a newly identified hazard, or the development of a tool, such
as a test method, that would enable validation of the control for the
specific hazard.
(Response 324) We have deleted ``except as provided by paragraph
(b)(3) of this section'' from proposed Sec. 507.47(a) to remove the
limitation seen by the comments on the exceptions to the requirement
for validation of preventive controls. We also have revised the
regulatory text of Sec. 507.47(c) to provide that a facility does not
need to validate other preventive controls, if the preventive controls
qualified individual prepares (or oversees the preparation of) a
written justification that validation is not applicable based on
factors such as the nature of the hazard, and the nature of the
preventive control and its role in the facility's food safety system.
We specified that the determination that validation is not required
must be made by the preventive controls qualified individual to
emphasize that specialized experience is necessary to evaluate whether
validation is required. We made a conforming revision to the list of
responsibilities of the preventive controls qualified individual (see
Sec. 507.53(a)).
(Comment 325) Some comments ask us to separate requirements for
validation from requirements for verification because verification and
validation are two different concepts and combining them is confusing.
One comment said that we reversed the definitions of validation and
verification, compared to the common use of the terms in HACCP
activities. Some comments point out that while section 418(f)(1) of the
FD&C Act explicitly requires verification, it does not require
validation. Some of these comments assert that our proposed
requirements for validation exceed the mandate of FSMA while others
argue that the lack of explicit language in section 418 of the FD&C Act
gives us legal flexibility in determining whether and how to require
validation.
(Response 325) Our approach is consistent with section 418 of the
FD&C Act. Section 418(f)(1) of the FD&C Act requires verification of
the preventive controls, and validation is an element of verification
(see both the NACMCF HACCP guidelines (Ref. 49) and our HACCP
regulation for juice (Sec. 120.3(p)). We agree that the purpose of
validation is different from the purpose of other verification
activities, and we have revised the definitions of both terms to make
this clearer. Although we are establishing a separate regulatory
section for the validation requirements, we did so to improve clarity
and readability rather than as a substantive change relevant to the
issues discussed in these comments. (See Response 75.)
(Comment 326) Some comments assert that validation is more
appropriate for a HACCP regulation and that requiring the validation of
all preventive controls does not reflect the flexibility mandated by
section 418(n)(3)(A) of FSMA. Other comments assert that effective
preventive measures may be identified in the future that are not
amenable to validation and it would be counterproductive for them not
to be employed in food safety plans because they cannot meet the
validation requirements. These comments explain that certain control
measures are not suitable for validation activities due to the nature
of the activity or previous validation by another entity (e.g., a
supplier).
(Response 326) The 2013 proposed preventive controls rule for
animal food would not have required the validation of all preventive
controls. For example, we specifically proposed that the validation of
preventive controls need not address sanitation controls and the recall
plan. To emphasize that a facility has flexibility in determining which
other preventive controls require validation, in the 2014 supplemental
notice we revised the proposed regulatory text to require validation
``as appropriate to the nature of the preventive control.'' See
Response 324 for additional revisions we have made to the regulatory
text to provide flexibility for a facility to determine that validation
is not necessary.
(Comment 327) Some comments ask us to allow validation of the whole
system instead of individual controls.
(Response 327) See the discussion of the definition of validation
in Response 75. Under the definition, validation can be directed to a
control measure, combination of control measures, or the food safety
plan as a whole.
(Comment 328) Some comments ask us to align validation requirements
with the relative risk of operations.
(Response 328) Validation requirements apply only to preventive
controls that are established and implemented based on the outcome of a
hazard analysis, which requires consideration of risk. We also require
[[Page 56267]]
validation as appropriate to the nature of the preventive control and
its role in the facility's food safety system. This provides
flexibility with respect to validation and allows consideration of
risk.
(Comment 329) Some comments ask us to provide guidance and
clarification on topics relevant to validation, especially for small
facilities that may lack the resources needed to generate studies and
scientific data to validate processes. Some comments ask us to clarify
our expectations for a validated process and on conducting studies for
validation purposes. Some comments ask us to provide resources for
validation, noting that some preventive controls will be difficult to
validate and that no scientific research or data are available for
certain controls. Some comments indicate that validation information
provided by FDA should be in the form of non-binding guidance
documents. Some comments ask us to delay enforcement for the validation
requirements until a readily accessible repository of validated
processes, and scientific and technical information, can be created to
assist stakeholders in complying with the validation requirements.
(Response 329) We intend that the guidance we are developing will
address topics such as those recommended in the comments. (See Response
1). In addition, the FSPCA is developing information for training,
which may be useful to animal food facilities. We are not requiring
facilities to comply with the requirements of subparts C and E of this
rule, including the validation requirements, for 2, 3, or 4 years
depending on the size of the facility. We expect that segments of the
animal food industry will work together and with the FSPCA to develop
scientific and technical information that can be used as evidence to
validate a variety of preventive controls, and will be helpful to
facilities.
(Comment 330) Some comments indicate that the rule lacked
specifications for, and was unclear on, the process that FDA would
utilize to approve or accept validation data and/or studies. Some
comments ask us to develop a mechanism for industry to make sure their
approach and studies meet the requirements of the rule, such as
certification of process authorities or the establishment of a liaison
between FDA and industry to ensure validation protocols are in
compliance.
(Response 330) As discussed in Response 1, we are developing
several guidance documents within FDA, including guidance on
validation. In addition, as part of a collaborative effort with the
FSPCA we are obtaining technical information useful for developing
guidelines for preventive controls and outreach to industry, and we
intend that effort to include guidance on approaches to satisfy the
validation requirements of the rule. We do not intend to develop a
mechanism for certification of process authorities or establish a
liaison between FDA and industry to ensure validation protocols are in
compliance. The guidance we are developing on validation should help
industry determine whether their validation approaches are likely to be
acceptable to us.
B. Proposed Sec. 507.47(b)(1)--When Validation Must Be Performed and
Role of Preventive Controls Qualified Individual in Validation
We proposed that validation of the preventive controls must be
performed by (or overseen by) a preventive controls qualified
individual prior to implementation of the food safety plan (or, when
necessary, during the first 6 weeks of production) and whenever a
reanalysis of the food safety plan reveals the need to do so.
(Comment 331) Some comments ask us to clarify whether an individual
attending food safety training by an entity such as a cooperative
extension or a State department of agriculture could be a ``preventive
controls qualified individual'' for the purpose of performing or
overseeing the validation of preventive controls.
(Response 331) See the discussion in section XXXVII.B for
additional information about training applicable to a preventive
controls qualified individual. We have not specified additional
requirements for a preventive controls qualified individual with
respect to validation. A person may be a preventive controls qualified
individual through job experience, as well as training. Food safety
training provided by an entity such as a cooperative extension
specialist or a State department of agriculture could be appropriate
training for many of the functions of the preventive controls qualified
individual if the training is consistent with the standardized
curriculum being developed by the FSPCA.
(Comment 332) Some comments question whether 6 weeks is enough time
to perform all applicable validation studies that would address the
execution element of validation. Some comments ask us to explain the
basis for the proposed 6-week timeframe. Some comments ask us to align
with the 90-day timeframe in the FSIS Validation Guidelines (Ref. 50).
Some comments note that the seasonal nature of production of some food
products may make it impractical to perform all required validations
within 6 weeks. Some comments suggest that validation be performed
within a specified number of production batches, such as 10 production
batches. Some comments emphasize the need for flexibility and ask us to
both adopt a 90-day timeframe and provide for a longer timeframe with a
written justification, or provide for ongoing evidence of process
validation. One comment recommends removing a required timeframe for
validation or providing a compliance extension until such time as we
could better support the requirements, such as in guidance. One comment
asserts that the timeframe should be prior to implementation of the
food safety plan. Some comments ask as us to specify that validation be
performed within a reasonable time as justified by the preventive
controls qualified individual. Some comments ask for more time for
small businesses to perform validation studies.
(Response 332) We note that the 90-day timeframe for validation is
established in FSIS' regulations at 9 CFR 304.3(b) and (c) and 9 CFR
381.22(b) and (c) (Conditions for receiving inspection for meat and
meat products and poultry and poultry products, respectively). The FSIS
Validation Guidelines are a companion to those regulations. We have
revised the regulatory text, with associated editorial changes, to make
two changes to the proposed 6-week timeframe for validation of
preventive controls. First, we have adopted the 90-day timeframe
already established in the FSIS' regulations by specifying that when
necessary to demonstrate the control measures can be implemented as
designed, validation may be performed within 90 days after production
of the applicable animal food first begins. Although we had proposed a
6-week timeframe based on the 3 to 6 week timeframe suggested in the
Codex Guidelines for the Validation of Food Safety Control Measures
(Ref. 22), we agree that practical limitations associated with the
production of some animal food products may make it difficult to
perform validation within 6 weeks. The 90-day timeframe in FSIS'
regulations, and incorporated into the FSIS Validation Guidelines,
reflects more than 15 years of experience with validating HACCP systems
for meat and poultry. Although we have provided for validation to be
performed within 90 days after production of the applicable food first
begins, we do not believe it would take a full 90-days of production
[[Page 56268]]
to determine whether the facility can provide assurances that a control
measure is working as intended to control the hazard.
Second, we have provided for validation within a reasonable
timeframe, provided that the preventive controls qualified individual
prepares (or oversees the preparation of) a written justification for a
timeframe that exceeds 90 days after production of the applicable
animal food first begins. We acknowledge that practical limitations
such as those described in the comments could prevent a facility from
performing the validation within 90 days after production of the
applicable animal food first begins. A timeframe that exceeds 90 days
after production of the applicable animal food first begins will be the
exception rather than the norm and we are requiring that the preventive
controls qualified individual provide (or oversee the preparation of) a
written justification for such a timeframe. We made a conforming
revision to the list of responsibilities of the preventive controls
qualified individual (see Sec. 507.53(a)).
(Comment 333) Some comments ask us to add another circumstance when
validation would be required, i.e., whenever a change is made to the
control being applied.
(Response 333) We have revised the regulatory text to require
validation whenever a change to a control measure or combination of
control measures could impact whether the control measure or
combination of control measures, when properly implemented, will
effectively control the hazards requiring a preventive control. Under
this provision, a facility would revalidate a preventive control if,
for example, a different type of equipment is used to deliver a heat
process, because it would be necessary to determine that the new
equipment can consistently achieve the required temperature and time of
the process. However, a facility would not need to revalidate a
preventive control if, for example, a thermal process is changed by
increasing the time or temperature, because a less stringent thermal
process would already have been validated.
(Comment 334) Some comments ask us to require validation both
before production and 6 weeks after production begins.
(Response 334) We decline this request. A facility has flexibility
to perform validation as appropriate to the nature of the preventive
controls, whether before production (e.g., by obtaining and evaluating
generally available scientific and technical information or by
conducting studies), after production begins (to demonstrate the
control measures can be implemented as designed during full-scale
production), or both.
C. Proposed Sec. 507.47(b)(2)--What Validation Must Include
We proposed that the validation of preventive controls must include
collecting and evaluating scientific and technical information (or,
when such information is not available or is inadequate, conducting
studies) to determine whether the preventive controls, when properly
implemented, will effectively control the significant hazards.
(Comment 335) Some comments assert that our discussion of
validation refers to ``scientific proof'' for the validation of a
processing step and ask us to define what is and is not considered
scientific proof for validation.
(Response 335) We used terms such as ``scientific and technical
information'' and ``scientific and technical basis'' rather than
``scientific proof'' when discussing validation. For information about
what we mean by ``scientific and technical information,'' (see 78 FR
64736 at 64794 through 64795).
(Comment 336) Some comments ask us to clarify expectations of
validations for basic sanitary processes. Another comment asks us to
exempt the validation of CGMPs.
(Response 336) The requirements for validation only apply to
preventive controls. Any practice governed by CGMPs only requires
validation if a facility identifies that practice as a preventive
control for a hazard. To the extent that the comment is referring to
sanitary practices governed by CGMPs (such as in Sec. 507.19), the
validation requirements would not apply. To the extent that the comment
is referring to sanitation controls established as a preventive
control, those sanitation controls are excluded from the validation
requirements (see Sec. 507.47(c)).
(Comment 337) Some comments ask that we not require further
validation of well-accepted preventive controls, such as refrigeration
temperature.
(Response 337) A facility may rely on generally available
scientific and technical information to demonstrate the adequacy of
controls such as refrigeration but must obtain that information and
establish it as a record (see Sec. 507.45(b)).
(Comment 338) Some comments express concern that specific methods
are not available to enable validation. Some comments express concern
that the requirement to ``conduct studies'' might be intended, or could
be interpreted, to mean that firms are required to develop or validate
analytical methods (either in general or for specific food matrices).
These comments assert that any such requirement would incur extreme
costs and burdens without delivering commensurate public health
benefits.
(Response 338) We do not intend the requirement to ``conduct
studies'' to mean that firms are required to develop or validate
analytical methods.
(Comment 339) Some comments recommend validation via indirect
methods such as scientific publications, government documents,
predictive modeling and other technical information from equipment
manufacturers and other sources. Other comments assert that there are a
variety of circumstances in which the collection and evaluation of
scientific and technical information is not necessary (e.g., the use of
sieving or metal detectors to control physical hazards).
(Response 339) See Responses 324 and 326. We agree that not all
preventive controls require validation, and the facility has
flexibility to take into account the nature of the preventive control
when determining whether to perform validation. The regulatory text,
which provides for scientific and technical evidence that a control
measure is capable of effectively controlling the identified hazards,
provides for the use of ``indirect methods'' as recommended by the
comments. However, even when sources such as scientific publications
are the basis for validation, studies may be needed to demonstrate that
the process used can be implemented in the facility to control the
hazard.
D. Proposed Sec. 507.47(c)(3)--Preventive Controls for Which
Validation Is Not Required
We proposed that validation need not address sanitation controls,
the recall plan, and the supplier program (which we now refer to as the
``supply-chain'' program).
(Comment 340) Some comments ask us to eliminate the specific list
of controls that are excluded from the validation requirement and
instead revise the regulatory text to provide the facility with
flexibility to determine when validation is appropriate.
(Response 340) As discussed in Response 324, we have deleted
``except as provided by paragraph (b)(3) of this section'' from
proposed Sec. 507.47(a) to remove the limitation seen by the comments
on the exceptions to the requirement for validation of preventive
controls. We also have revised the
[[Page 56269]]
regulatory text of Sec. 507.47(c) to provide that a facility does not
need to validate other preventive controls, if the preventive controls
qualified individual prepares (or oversees the preparation of) a
written justification that validation is not applicable based on
factors such as the nature of the hazard, and the nature of the
preventive control and its role in the facility's food safety system.
We see no reason to also eliminate the list of those controls for which
we have already determined that validation is not necessary, and
require each facility to develop its own rationale for concluding that
validation is not necessary based on the nature of these preventive
controls. The rule would not prevent a facility from validating one of
these preventive controls, such as a sanitation control, if it chooses
to do so.
XXXIV. Subpart C: Comments on Proposed Sec. 507.49--Verification of
Implementation and Effectiveness
We proposed that you must verify that the preventive controls are
consistently implemented and are effectively and significantly
minimizing or preventing the significant hazards. We proposed that to
do so you must conduct specified activities (i.e., calibration, product
testing, environmental monitoring, and review of records) as
appropriate to the facility, the animal food, and the nature of the
preventive control. We also proposed that you must establish and
implement written procedures for the frequency of calibrating process
monitoring instruments and verification instruments, product testing,
and environmental monitoring.
Some comments that support the proposed provisions suggest
alternative or additional regulatory text or ask us to clarify how we
will interpret the provision. In the following paragraphs, we discuss
comments that ask us to clarify the proposed requirements or that
disagree with, or suggest one or more changes to, the proposed
requirements. After considering these comments, we have revised the
proposed requirements as shown in table 18.
Table 18--Revisions to the Proposed Requirements for Verification of
Implementation and Effectiveness
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.49(a)..................... Flexibility in Provide that
the requirement activities for
to conduct verification of
activities to implementation and
verify effectiveness take
implementation into account both
and the nature of the
effectiveness. preventive control
and its role in the
facility's food
safety system.
507.49(a)(1).................. Verification of Provide for accuracy
implementation checks in addition
and to calibration.
effectiveness
for process
monitoring
instruments and
verification
instruments.
507.49(a)(4)(i)............... Timeframe for Provide for records
review of review within 7
records of working days after
monitoring and the records are
corrective created, or within
action records. or within a
reasonable
timeframe, provided
that the preventive
controls qualified
individual prepares
(or oversees the
preparation of) a
written
justification.
507.49(a)(5).................. Other activities Clarify that there
appropriate for could be alternative
verification of verification
implementation activities of
and implementation and
effectiveness. effectiveness other
than those that we
specify in the rule.
507.49(b)..................... Written Clarify that written
procedures for procedures for
verification of verification of
implementation implementation and
and effectiveness are
effectiveness. established and
implemented as
appropriate to the
role of the
preventive control
in the facility's
food safety system,
as well as
appropriate to the
facility, the animal
food, and the nature
of the preventive
control.
507.49(b)(1).................. Written Require written
procedures for procedures for
verification of accuracy checks in
implementation addition to
and calibration.
effectiveness
for process
monitoring
instruments and
verification
instruments.
------------------------------------------------------------------------
A. Flexibility in the Requirement To Conduct Activities To Verify
Implementation and Effectiveness
We proposed that you must verify that the preventive controls are
consistently implemented and are effectively and significantly
minimizing or preventing the significant hazards by conducting
specified activities as appropriate to the facility, the animal food,
and the nature of the preventive control. We proposed to specify the
following verification activities: (1) Calibration; (2) product
testing; (3) environmental monitoring; and (4) review of records.
In the following paragraphs, we discuss comments generally directed
to the need for a facility to have flexibility to apply these
requirements (particularly the requirements for product testing and
environmental monitoring) in a manner that works best for the facility
in light of its animal food products and the nature of the preventive
controls that would be verified. In sections XXXIV.B through XXXIV.F,
we discuss the requirements for calibration, product testing,
environmental monitoring, and review of records more specifically.
(Comment 341) Some comments express support for the flexibility
provided by specifying that verification activities must be conducted
``as appropriate to the facility, the animal food, and the nature of
the preventive control.'' Some comments state that the proposed
provision means that, based on risk, an animal food manufacturer could
decide whether or not to do product testing and, when applicable, the
type of test and the testing frequency. One comment says the provision
will have limited value where the presence of some levels of pathogens
is expected and is not necessarily an animal food safety problem. Some
comments agree with the proposed provisions because they address
product testing through flexible written procedures that consider both
testing and corrective action plans rather than through mandatory or
prescribed requirements. Other comments agree with the proposed
provisions because they require facilities to develop and use testing
programs that are tailored to their facility, equipment, processes,
products, and other specific circumstances, and do not prescribe
specific requirements for testing, such as finished product testing.
Some comments state that product testing may
[[Page 56270]]
not be effective in identifying the acceptability of a specific
ingredient or finished product lot on any given day, but it can help
assess and verify the effectiveness of a food safety plan as a whole
and the facility's capability to consistently deliver against it.
Some comments assert that the preamble discussion in the 2014
supplemental notice is in conflict with the proposed regulatory text
and ask us to modify the regulatory text to provide the flexibility we
signaled in that supplemental notice. These comments express concern
that the term ``must'' (i.e., ``you must conduct activities that
include the following'') could be interpreted to mean that activities
listed in the regulatory text (in particular, product testing and
environmental monitoring) are always required in some form. Some
comments ask us to clarify whether product testing and environmental
monitoring are required or optional. Other comments assert that
facilities should have the flexibility to determine whether to conduct
product testing and environmental monitoring based on a risk
assessment. Some comments assert that there are circumstances (such as
unpackaged animal food; ingredients for animal food stored in vented or
open areas, in oilseed production; and rendering) where these tests
would not be necessary. Some comments assert that a determination to
conduct environmental monitoring should be on a case-by-case basis and
that other verification activities may be used (such as process
verifications or testing of intermediates) to verify implementation and
effectiveness. Other comments ask us to exempt operations when their
hazard analysis appropriately concludes that there is no foreseeable
risk. One comment says FDA should not require routine monitoring for
feed mills unless they manufacture pet food.
One comment says environmental monitoring should not be required as
a verification activity for significant hazards as other controls can
be used and environmental monitoring will impose undue burdens and
costs to industry. Many comments state that environmental monitoring
requirements should only be applied to ``significant hazards,'' if any,
that are present within the firm's operation, and as with product
testing, animal food facilities must be provided the flexibility to
tailor their environmental monitoring programs based on risk. Comments
note that in cases where the animal food is likely to undergo further
processing that would minimize or eliminate any microbiological
hazards, environmental pathogens would not be a significant hazard and
such facilities could focus their resources on other controls. One
comment says it does not agree that the potential for later processing
mitigates the need for environmental monitoring because processes such
as pelleting reduce but do not entirely eliminate pathogens.
(Response 341) The provisions for verification provide flexibility
by specifying that they apply as appropriate to the nature of the
preventive control and its role in the facility's food safety system.
As noted by some comments, the provisions address testing through
flexible written procedures that allow facilities to develop and use
testing programs that are tailored to their facility, equipment,
processes, products, and other specific circumstances. We agree that an
appropriate outcome of the hazard analysis for some facilities will be
that product testing and environmental monitoring are not required; it
is not necessary to grant an ``exemption'' to allow a facility to
achieve this outcome. For example, environmental monitoring would be
required to verify effectiveness of sanitation controls when an animal
food is exposed to the environment prior to packaging and the packaged
food does not receive a treatment or otherwise include a control
measure (such as a formulation lethal to the pathogen) that would
significantly minimize the pathogen because such environmental
monitoring is appropriate to the facility (one manufacturing animal
food), the food (such as a dry (extruded) pet food exposed to the
environment), and the nature of the preventive control (sanitation
controls). Animal food such as dry and raw pet food and pet treats are
among the products for which manufacturing operations might need to
have an environmental monitoring program when such animal food is
exposed to the environment.
We discuss product testing for microbial pathogens in another FDA
memorandum, including the use of pathogens and indicator organisms and
microbial testing of foods for process control and for problem solving
(Ref. 52). The circumstances in which product testing would be required
are dependent on a variety of factors as described in the Appendix to
the 2013 proposed preventive controls rule for animal food (78 FR 64736
at 64836). As with environmental monitoring, product testing must be
conducted as appropriate to the facility, the animal food, and the
nature of the preventive control and its role in the facility's food
safety system. For example, a raw material or other ingredient added to
an animal food after a pathogen ``kill step'' must be tested before use
when the raw material or other ingredient has been associated with a
pathogen and has not been treated to significantly minimize or prevent
that pathogen (e.g., poultry based flavoring spray applied on dry pet
food). Product testing would be required because it is appropriate to
the facility (one making an animal food), the food (pet food), and the
nature of the preventive control (there is no control applied to the
poultry based flavoring spray).
When process control testing for an indicator organism, or
environmental monitoring for an indicator organism, indicates an animal
food (e.g., dry pet food) is reasonably likely to be contaminated with
a pathogen, that animal food must be tested for the pathogen. For
example, if environmental monitoring reveals animal food-contact
surfaces contaminated with Salmonella and additional environmental
monitoring following corrective actions indicates animal food-contact
surfaces are still contaminated with Salmonella, product testing would
be required because it is appropriate to the facility (one making that
animal food), the animal food (pet food, which supports the growth of
Salmonella), test results from environmental monitoring (which show the
presence of an indicator organism for Salmonella on animal food-contact
surfaces in the animal food processing environment), and the nature of
the preventive control (sanitation controls to prevent contamination by
environmental pathogens, which appear to be inadequate).
The word ``must'' specifies the type of activities that a facility
can use to satisfy the requirements for a particular preventive control
management component, and we are retaining the term ``must.'' However,
we agree that the rule should provide flexibility for additional
verification of implementation and effectiveness. To provide that
additional flexibility, we have revised the specific requirements for
verification of implementation and effectiveness to provide for other
activities appropriate for verification of implementation and
effectiveness (see Sec. 507.49(a)(5)).
We believe that the performance of environmental monitoring, for an
appropriate microorganism of public (human and animal) health
significance or for an appropriate indicator organism, is particularly
useful as a verification measure for preventive controls (i.e.,
sanitation controls) when contamination of animal food with an
environmental pathogen is a hazard
[[Page 56271]]
requiring a preventive control. We anticipate that facilities producing
animal food that enters into the home and is frequently handled in the
home will include biologic hazards of human health concerns associated
with that animal food, as well as those of animal health concerns in
their hazards requiring a preventive control. (See, for example, our
discussion of Salmonella in pet food in the 2013 proposed preventive
controls rule for animal food (78 FR 64736 at 64747).)
(Comment 342) Many comments ask us to issue guidance, rather than
requirements, for product testing and environmental monitoring based on
concerns such as the following: The value of environmental monitoring
will be reduced if it becomes a minimum regulatory requirement; there
are well-known limitations to product testing and negative results from
product testing can create a false sense of security; negative results
are likely to occur unless intensive sampling is conducted dependent
upon quality sampling criteria; product testing is not preventive,
would put industry into a reactive mode, and would pull valuable
resources from activities focused on preventing contamination; there is
limited technology available to test contaminants in some animal food
matrices and limited time available for perishable commodities; any
regulatory requirement will soon be outdated as products change and
science improves; and product testing would vastly increase the cost of
the rule and will drive many businesses out of business without
necessarily improving animal food safety; and requirements for product
testing would require the States to direct resources to respond to non-
compliant product testing results, and such resources would be better
directed to environmental monitoring.
Some of these comments emphasize the need for flexibility so that
product testing and environmental monitoring are options that are
available to the facility rather than requirements for all facilities.
Other comments assert that guidance provides greater opportunity for
industry innovation and stakeholder participation to determine the
appropriate use of verification measures, and avoids a ``one-size-fits-
all'' approach to regulations. Some of these comments state that we
should encourage environmental monitoring to be conducted ``through
facility specific food safety plans,'' which would provide the
flexibility necessary to monitor risks associated with exposures of
animal foods. Other comments state that operators should be given the
necessary flexibility to implement any requirements in the most
effective and efficient manner using a risk-based approach and taking
into account the specific conditions of their facilities and
operations. Some comments express concern that including a requirement
makes it difficult for businesses to justify a conclusion that testing
is not necessary.
Some comments ask us to solicit drafts of proposed guidance
documents from the sustainable agriculture and local/regional food
system community; publish a list of possible topics for future guidance
each year; seek input in advance from the sustainable agriculture and
local/regional food system community before preparing draft guidance
(including public meetings, workshops, and formation of an advisory
committee); hold public meetings on draft guidance after publication;
and present draft guidance to an advisory committee including
representatives from the sustainable agriculture and local/regional
food system community.
Some comments suggest that an ingredient manufacturer may identify
an environmental pathogen but the facility would not implement a
preventive control to significantly minimize or prevent the
environmental pathogen because the ingredient would be subsequently
processed to control the hazard by another facility.
(Response 342) We are retaining the requirements for product
testing and environmental monitoring in the rule, with the revisions,
already discussed, to provide that verification activities depend on
the role of the preventive control in the facility's food safety system
(see Response 293); corrective action procedures depend on the nature
of the hazard (see Response 304); and written procedures for product
testing and environmental monitoring are established and implemented as
appropriate to the role of the preventive control in the facility's
food safety system. These revisions clarify in the regulatory text the
flexibility that we discussed in the 2014 supplemental notice (79 FR
58476 at 58493 through 58495). Some of the comments that ask us to
issue guidance rather than requirements appear to believe that only
guidance can provide sufficient flexibility for product testing and
environmental monitoring. This is not the case. (See Response 341.)
We disagree that environmental monitoring will become a minimum
regulatory requirement in all cases; the decision to conduct
environmental monitoring is made by the facility and some comments
discuss specific examples of when environmental monitoring or product
testing would not be warranted. If a facility relies on its customer to
control an environmental pathogen then the facility must follow the
requirements in subpart E for supply-chain program. Moreover, the fact
that further manufacturing might be capable of eliminating an
environmental pathogen that has contaminated an animal food is not a
reason to not take reasonable measures to prevent contamination from
the environment and to verify that such measures are effective through
environmental monitoring.
We have acknowledged limitations of product testing (79 FR 58476 at
58493 through 58494) and agree that a facility should consider such
limitations when determining whether to conduct product testing and
keep such limitations in mind when obtaining negative results from
product testing. We also agree that product testing is not preventive.
However, the mere facts that there are limitations, and that product
testing is itself not a preventive measure, do not eliminate all
benefits of product testing; we agree with comments that although
product testing may not be effective in identifying the acceptability
of a specific ingredient or finished product lot on any given day, it
can help assess and verify the effectiveness of a food safety plan as a
whole and the facility's capability to consistently deliver against it.
We agree that there is limited technology available to test for some
hazards in animal food but expect that testing of animal food by a
facility as the sole verification of the effectiveness its food safety
plan as a whole would be the exception rather than the norm.
We disagree that regulatory requirements for product testing and
environmental monitoring will soon be outdated as products change and
science improves; the rule requires reanalysis of the food safety plan
as a whole at least every 3 years, and requires reanalysis of the food
safety plan as a whole, or the applicable preventive control, in light
of new information (see Sec. 507.50(a) and (b)). We agree that there
are some costs to product testing, but the rule provides flexibility
for the facility to determine when product testing is appropriate. We
acknowledge that the States will be required, in many cases, to follow
up on positive findings obtained during product testing but disagree
that this is a reason to eliminate the proposed requirements. The
States would only be directing resources when the findings indicate
contamination of animal food, and doing so will protect public (human
and animal) health.
[[Page 56272]]
We will follow the procedures in Sec. 10.115 for issuing guidance
documents. Under Sec. 10.115(f), members of the public can suggest
areas for guidance document development and submit drafts of proposed
guidance documents for FDA to consider. Under Sec. 10.115(g), after we
prepare a draft guidance we may hold public meetings or workshops, or
present the draft guidance document to an advisory committee for
review; doing so is not common and is determined on a case-by-case
basis.
(Comment 343) One comment requests that we add the additional
factor of the ``intended use of the animal food'' to help further
clarify that these activities should be conducted based upon the
appropriate end use of the animal food as it was intended by the
manufacturer, and not upon any potential use of the product not
originally intended.
(Response 343) We believe the requirement as written allows the
manufacturer's intended use to be taken into consideration when
conducting the hazard analysis. However, to the extent that these
comments are asserting that a facility can ignore consumer behavior
that the facility considers contrary to principles of food safety, we
disagree. For example, a facility could not conclude that it need not
identify and evaluate a known or reasonably foreseeably hazard because
the facility intends to provide safe handling instructions on the label
of a packaged pet food. We do recognize that if a manufacturer/
processor has adequately controlled a hazard and has properly packaged,
held, and labeled their product, they are not responsible for
unforeseeable misuse by a consumer, such as a person who intentionally
feeds swine food to sheep even though the product is accurately labeled
as containing copper which can be toxic for sheep. For manufacturers/
processors that rely on their customer or another entity in the
distribution chain to the control a hazard, they must follow the
requirements in Sec. 507.36(a)(2), (3), (4) or (5). (See Response 285
for additional information.)
B. Proposed Sec. 507.49(a)(1)--Calibration
We proposed to require calibration of process monitoring
instruments and verification instruments.
(Comment 344) Some comments distinguish ``calibration'' from an
accuracy check, which the comments describe as a test to confirm that a
particular equipment or measurement device is accurate. These comments
assert that calibration may not be possible for certain equipment or
measurement devices, and the appropriate corrective action may be
replacement or application of corrective values. These comments ask us
to specify that an accuracy check may be used as a verification
activity in lieu of calibration.
(Response 344) We have revised the proposed requirements to require
calibration of process monitoring instruments and verification
instruments, or checking them for accuracy. However, if the outcome of
an accuracy check is that a process monitoring instrument or
verification instrument is not accurate, the facility must follow up by
calibrating the device, rather than by applying corrective values, when
it is practical to do so and replace the device when it is not
practical to calibrate it.
C. Comments Directed to Proposed Requirements for Both Product Testing
(Proposed Sec. 507.49(a)(2) and (b)(2)) and Environmental Monitoring
(Proposed Sec. 507.49(a)(3) and (b)(3))
We proposed that to verify that the preventive controls are
consistently implemented and are effectively and significantly
minimizing or preventing the significant hazards you must conduct
activities that include product testing and environmental monitoring,
as appropriate to the facility, the animal food, and the nature of the
preventive control (Sec. 507.49(a)(2) and (a)(3)). We also proposed
that you must establish and implement written procedures for product
testing and for environmental monitoring (Sec. 507.49(b)(2) and
(b)(3)).
(Comment 345) Some comments ask us to revise the regulatory text to
be explicit that there are circumstances when product testing and
environmental monitoring would not be necessary. One comment supports a
requirement that incoming raw materials and feed ingredients must be
tested for harmful pathogens. Another comment opposes mandatory product
testing for every lot of raw material received. Some comments discuss
topics for us to include in guidance on procedures for product testing
and environmental monitoring, such as which pathogens to test for; the
range of products that should be tested; circumstances that warrant
testing; what a facility would document and what factors the facility
would consider before determining that product testing is not
appropriate for its animal food product; frequency of sampling and
number of samples to be collected; actions to take after a positive
result; available test methods; reporting requirements for results;
compliance strategies; and criteria for laboratories conducting the
testing.
(Response 345) We decline to revise the regulatory text. The
decision as to whether product testing and environmental monitoring are
warranted depends on the facility and its animal food product, as well
as the nature of the preventive control and its role in the facility's
food safety system, and a slight variation on circumstances that would
lead one facility to conclude that such testing programs were not
required could lead a different facility to the opposite conclusion.
Memoranda placed in the docket for the 2014 preventive controls
supplemental notice for human food provide additional information on
these topics requested in the comment (Refs. 51 and 52). Although
directed to product testing and environmental monitoring for human food
production, some of the information is relevant to animal food, as
well.
(Comment 346) Some comments ask us to clarify that tests can be
performed by third-party facilities or laboratories, as well as by the
facility itself. Some comments ask us to clarify that we will accept
test results in the same format as the format used for other purposes,
such as third-party certification services.
(Response 346) The rule places no restrictions on who conducts
testing. However, facilities have a responsibility to choose testing
labs that will produce reliable and accurate test results. (See
Response 348.) The rule does not specify the format of test results,
provided that the record documenting testing satisfies the
recordkeeping requirements of subpart F.
(Comment 347) Some comments express concern about requirements for
product testing and environmental monitoring in light of section 202 of
FSMA (section 422 of the FD&C Act (21 U.S.C. 350k)). (Section 422 of
the FD&C Act addresses laboratory accreditation for the analyses of
foods, including use of accredited laboratories in certain
circumstances and including requirements for accredited laboratories to
report the results of laboratory testing to FDA in certain
circumstances.) These comments express concern that requirements for
facilities to submit results of environmental monitoring to us will
create an additional disincentive to looking for pathogens established
in the facility. These comments assert that the results of
environmental monitoring tests should be available to us for inspection
but not submitted to us if product has not been distributed and that
submitting the results of routine tests would be burdensome without
benefit. These comments ask us to
[[Page 56273]]
clarify whether facilities or laboratories would be required to submit
the results of environmental monitoring tests to us. Likewise, some
comments ask us to clarify whether product testing (including testing
of raw materials or other ingredients as part of supplier controls) is
subject to the requirements of section 422 of the FD&C Act for using
accredited laboratories and for reporting test results to us. Other
comments ask us to establish standards and procedures for certifying
laboratories that would perform the tests. These comments assert that
these standards and procedures are needed to ensure the credibility of
the testing and to provide direction for facilities that establish in-
house testing facilities. Other comments urge us to establish
regulations implementing section 422 of the FD&C Act because they would
complement the requirements of the animal food preventive controls rule
and because model laboratory standards that address quality controls,
proficiency testing, training and education of laboratory personnel
offer the protections necessary for ensuring reliable, accurate test
results. Other comments assert that if laboratories are not accredited
or samples are not collected in a sanitary manner, there is no
guarantee the results will be scientifically valid.
(Response 347) Section 422 of the FD&C Act would require, in
relevant part, that food testing be conducted by an accredited
laboratory (and the results of such testing be sent directly to FDA)
whenever such testing is conducted in response to a specific testing
requirement under the FD&C Act or its implementing regulations when
applied to address an identified or suspected animal food safety
problem or to support admission of an animal food under an Import Alert
that requires food testing. Although another rulemaking will address
the requirements of section 422 of the FD&C Act, our current thinking
is that routine product testing and environmental monitoring conducted
as a verification activity is not being applied to address an
identified or suspected animal food safety problem that requires food
testing and would not be subject to requirements to use an accredited
laboratory that would submit the results to FDA. We will review the
results of environmental monitoring and product testing, if any, during
inspections.
The primary concern expressed in these comments was with respect to
laboratories reporting results to FDA and not with use of accredited
laboratories. The rule requires a facility to establish and implement
written procedures for product testing and environmental monitoring and
that the procedures for such testing be scientifically valid. One way
to comply with the requirement that testing procedures be
scientifically valid is to use an accredited laboratory.
(Comment 348) Some comments ask us to expand the proposed
requirement to identify the laboratory conducting the testing to also
specify whether that laboratory is accredited and uses the appropriate
standards (such as quality control, proficiency testing, and trained
laboratory staff). These comments assert that such information would be
useful to facilities.
(Response 348) We decline this request. These comments appear to be
asking us to establish in the preventive controls for animal food rule
requirements related to section 422 of the FD&C Act. Doing so in
advance of regulations implementing section 422 of the FD&C Act is
premature. However, facilities have a responsibility to choose testing
labs that will produce reliable and accurate test results even if the
rule does not require the facility to specify whether the laboratory is
accredited.
(Comment 349) One comment requested the FSMA regulations regarding
ISO methods for Listeria and Salmonella be changed to using BAM
(Bacteriological Analytical Manual) methodology.
(Response 349) While we require scientifically valid procedures for
testing, the rule does not specify a particular method be used. A
laboratory could use an FDA BAM method, an ISO method, or another
method that is validated in the relevant animal food matrix.
(Comment 350) Some comments say that there is little scientific
data to show environmentally exposed animal food, such as raw liquid
ingredients and finished liquid animal food products, as well as food
for livestock creates a potential for harmful biological hazards and an
evaluation of environmental pathogens should not be required as part of
the hazard analysis. Other comments point out it is common practice to
store ingredients with some exposure to the environment during a
portion of their storage, complete outdoor storage is standard practice
both at the production facility, as well as where it will be consumed
without resulting in harm. Some comments say that mere exposure to the
environment does not inherently increase the risk of contamination of
animal food.
Some comments say environmental testing should only be required for
packaged animal foods and recommend that environmental testing be
required whenever animal food ingredients or finished animal foods are
exposed to the environment after undergoing a process aimed at reducing
pathogens (e.g., a heat kill step such as rendering or the extrusion
process) or other hazards that could be transmitted through the
environment. These comments say processing aimed at reducing hazards
will be ineffective if pathogen loads or hazard levels going into the
processing are too high and are concerned that the proposed rule would
not require renderers, who often handle sick and dead animals, to make
sure that the plant environment is not a pathway for the recycling of
pathogens into the animal food system through contaminated animal
products. Many comments state that all finished animal food is ready to
eat whether or not it is packaged, so it is not reasonable to limit
environmental monitoring only to animal foods that may be packaged.
(Response 350) We do not expect either product testing or
environmental monitoring to be common in facilities that process, pack,
or hold RACs for animal consumption. We agree that there would be
little or no benefit to product testing or environmental monitoring in
facilities that pack or hold RACs that are rarely consumed unprocessed,
such as soybeans, or for a manufacturer/processor that will rely on its
customer or another entity in the distribution chain to control a
hazard as specified in Sec. 507.36(a)(2), (3), and (4). We expect that
many facilities that conduct operations such as drying grain are likely
to conclude, as a result of their hazard analysis, that neither product
testing nor environmental monitoring are warranted and would direct
their resources to food safety practices and verification measures
other than environmental monitoring or product testing. While a hazard
analysis must include an evaluation of environmental pathogens when
animal food is exposed to the environment prior to packaging and the
animal food does not include a control measure that would significantly
minimize the pathogens (see Sec. 507.33(c)(2)), we agree that holding
animal food in areas exposed to the environment in some instances will
present a low risk of contamination from environmental pathogens.
Facilities in these instances will likely conclude there is not a
hazard requiring a preventive control. However, facilities that
identify an environmental pathogen requiring a preventive control would
conduct environmental monitoring as appropriate to the facility, the
animal food, and the nature of the preventive control.
[[Page 56274]]
(Comment 351) Some comments express concern about the cost of
testing and suggest creation of a one-time grant program for very small
businesses that would assist them in developing their initial food
safety plans and testing programs. One comment says that segments of
the animal food production industry currently not performing these
types of activities will be challenged to interpret the requirements
and develop effective programs. The comment states that inconsistent
interpretations of these requirements by an industry fearful of being
found in violation of the rule may lead to unnecessary testing and
supplier activities and needlessly drive up the cost of compliance.
(Response 351) Very small businesses are qualified facilities that
are subject to modified requirements, which do not require testing or
development of a food safety plan. We intend that the guidance we are
developing will be helpful to all sizes of businesses, and particularly
those not currently conducting these activities, that are subject to
the requirements for product testing and environmental monitoring. (See
Response 1.)
D. Proposed Sec. 507.49(a)(2)--Product Testing
(Comment 352) Some comments ask us to require finished product
testing for food products designated as high-risk, particularly when
the product supports pathogen growth during its shelf life. Other
comments suggest that finished product or ingredient testing should be
implemented as appropriate in situations where a risk has been
identified and an effective preventive control cannot be implemented.
Other comments ask us to require product testing if an environmental
pathogen is identified as a significant hazard.
(Response 352) We decline these requests. A facility's decision to
conduct product testing, and to establish the frequency of such
testing, will reflect a risk-based approach consistent with its hazard
analysis. Consequently, we expect that facilities that produce animal
foods that have frequently been associated with outbreaks of foodborne
illness (in humans or animals), or produce animal food for which an
effective preventive control cannot be implemented, would establish
product testing programs more often than facilities that do not produce
such animal foods.
A facility that identifies an environmental pathogen as a hazard
requiring a preventive control such as sanitation controls would
conduct environmental monitoring. Such a facility would decide what, if
any, role product testing would play as a verification activity, or as
part of a corrective action as a result of positive findings from
environmental monitoring, based on the facility, the animal food, the
nature of the preventive control, and the role of the preventive
control in the facility's food safety system.
(Comment 353) Some comments ask us to clarify (or specify) when
product testing would be directed at raw materials and other
ingredients and when product testing would be directed at finished
product. Some comments favor testing raw materials and other
ingredients as part of ``product testing,'' whereas other comments
state that testing raw materials and other ingredients should be
considered part of a supplier program rather than verification of
implementation and effectiveness. Other comments state that it is
unclear what preventive control step would be verified by product
testing and what types of facilities would be required to perform
product testing. One comment states product testing for animal food
should solely focus on finished products that are consumed by animals
in accordance with their intended use as described in the facility's
animal food safety plan.
(Response 353) We use the term ``product testing'' to mean testing
any animal food product, whether raw materials or other ingredients,
in-process animal foods, or finished products and, thus, product
testing can be directed to any of these animal food products. For
example, testing raw materials and other ingredients could be
verification of a supplier; testing in-process material after a kill
step could be verification of process control; testing finished product
could be verification of the food safety plan as a whole, and capture a
problem introduced during manufacture, including from contaminated raw
materials and other ingredients, if raw materials and other ingredients
had been tested before use. Product testing generally is not the most
effective means of measuring the adequacy of cleaning and sanitation
programs, but such testing is common to track a facility's overall
hygienic production measures.
(Comment 354) Some comments assert that a facility that implements
supplier verification and environmental monitoring (or other measures)
should not be required to perform product testing in addition to the
other controls and verification measures.
(Response 354) The facility determines whether product testing is
necessary as appropriate to the facility, the animal food, and the
nature of the preventive control and its role in the facility's food
safety system. The factors mentioned by the comment are examples of
factors that a facility would consider in making its determination.
(Comment 355) Some comments ask us to revise the requirement for
product testing to clarify that product testing applies to significant
hazards.
(Response 355) We decline this request. Product testing is a
verification activity for a preventive control, and a preventive
control is established for a ``significant hazard'' (which we now refer
to as ``hazard requiring a preventive control''). It is not necessary
to repeat, for each type of verification activity, that the activity
applies to hazards requiring a preventive control.
(Comment 356) Some comments assert that the real point of product
testing is to test all lots or batches. These comments explain that
they would be required to retest every lot of product in order to pass
an analysis of the product on to its customers, even if testing had
already been performed by their vendors (i.e., suppliers), because each
of their customers receives a proprietary blend. These comments further
explain that it is not economically or physically possible to retest
small lots of product already tested by their vendors, and that the
risk has already been mitigated by its vendors.
(Response 356) The situation described by these comments appears to
be a supplier-customer relationship in that the customer. not this
rule, has established a requirement for a certificate of analysis for
every lot of received product. The product testing that this rule
requires as a verification activity is to help assess and verify the
effectiveness of a food safety plan and the facility's capability to
consistently deliver against it, not to establish the acceptability of
every lot or batch.
(Comment 357) Some comments assert product testing should primarily
be used as a measure of process control, not for acceptance testing;
that product testing should normally be viewed as a monitoring and
review tool, not as a product conformance verification tool. The
comment states testing programs for product conformance verification
should be the exception rather than the rule.
(Response 357) These comments appear to have misunderstood the
proposed requirements for product testing. Consistent with the views
expressed by these comments, we proposed requirements for product
testing as a verification measure of the food safety plan as a whole,
not for product conformance.
[[Page 56275]]
(Comment 358) One comment says test results, whether via voluntary
company programs to verify process controls or mandated by regulation,
should not be required to be submitted to FDA unless they indicate
serious human or animal health consequences (i.e., necessitate a Class
I recall) as is required under the existing requirements for the RFR.
Comments state that FDA inspectors should not penalize facilities for
finding potential problems through verification if appropriate
corrective actions are taken.
(Response 358) This comment appears to have misunderstood the
requirements for product testing, which do not include reporting
product testing results to FDA. However, during an inspection, if
product testing was used as a verification measure, the inspector may
review the documentation for that testing and the records documenting
any corrective action procedures taken as a result of that testing.
E. Proposed Sec. 507.49(a)(3)--Environmental Monitoring
We proposed to require environmental monitoring, for an
environmental pathogen or for an appropriate indicator organism, if
contamination of an animal food with an environmental pathogen is a
significant hazard, by collecting and testing environmental samples.
(Comment 359) Some comments ask us to specify that environmental
monitoring of pathogens be executed according to a risk analysis. Many
comments say environmental monitoring should be a verification tool
based on a risk assessment as different animals show different
susceptibility to pathogens, pathogen growth is dependent upon the
animal food, and pathogens grow differently in different environments
and seasons. Some comments state that the corrective actions for
environmental monitoring should be risk based and take into account
information such as organism threshold, sampling, and analytical
methodology. One comment says the requirement should be applied only to
``significant hazards'' if any, that are present within the operation.
One comment states that it is not clear who would be responsible for
environmental monitoring at various points in the supply chain. The
comment requests more clarification on the ``boundaries'' of
responsibility for proposed measures like environmental monitoring. One
comment says prior to including environmental monitoring in the
regulation, methodologies and minimum standards that establish the
threshold industry must meet should be developed and vetted.
(Response 359) We decline these requests. See the discussion in
Response 301, which explains how risk applies to the facility's hazard
analysis and the determination by the facility to establish preventive
controls for hazards requiring a preventive control as appropriate to
the facility and the animal food. In contrast, the requirements for
environmental monitoring are a verification activity that a facility
would conduct to verify that one or more preventive controls are
consistently implemented and are effectively and significantly
minimizing or preventing the hazards requiring a preventive control and
would be established as appropriate to the facility, the animal food,
and the nature of the preventive control rather than according to a
risk analysis. The rule provides flexibility for the facility to
determine appropriate test methodologies and the threshold appropriate
for the environmental pathogen being monitored to verify the
effectiveness of the facility's preventive control. For requirements
that apply to hazards that a customer of the facility, ``or another
entity in the distribution chain,'' will control. See the requirements
in Sec. 507.36 and the discussion in section XXVII.
(Comment 360) Numerous comments request that we distinguish between
production of pet food and other animal food. Many comments state that
FDA has publically stated that it intends environmental monitoring to
apply mainly to facilities that manufacture pet food and pet treats;
however, the language extends the requirement to any facility that
packages animal food that does not receive a treatment to minimize
pathogens. Comments say it must be made clear, through outreach,
education, and compliance policy guides, that the requirement to
conduct environmental monitoring is intended for a limited range of
facilities, products and processes, and does not apply to livestock
feed or animal food for which environmental pathogens do not pose a
significant hazard in the finished animal food. Another comment
expressed concern because Salmonella has been found in finished poultry
feed. One comment says we should require Salmonella testing as part of
an environmental program. One comment asks us to explicitly recognize
in the preamble to the final rule that contamination of animal food
with an environmental pathogen may be a significant hazard in many dry
pet food manufacturing facilities.
(Response 360) We agree that environmental monitoring may be
particularly relevant to pet food manufacturing and the majority of
environmental monitoring may occur in dry or raw pet food manufacturing
facilities. However, its usefulness is not limited exclusively to pet
food production. Therefore, the requirement for environmental
monitoring is flexible to allow a facility to determine whether
environmental monitoring is needed based on the facility, the type of
animal food produced, the nature of the preventive control for the
environmental hazard and its role in a facility's food safety system.
We decline the request to require Salmonella testing as part of
environmental monitoring. We believe that most facilities producing pet
foods (other than those subject to part 113 that are exempt from
subpart C with respect to microbiological hazards regulated under part
113) will identify Salmonella spp. as a known or reasonably foreseeable
hazard that requires a preventive control verified by environmental
monitoring. We decline the request to exempt livestock food or animal
food other than pet food from the provisions for environmental
monitoring. However, we believe use of environmental monitoring by a
livestock or poultry food facility as a verification of a preventive
control would be the exception rather than the norm.
F. Proposed Sec. 507.49(a)(4)--Review of Records
We proposed to require review of specified records by (or under the
oversight of) a preventive controls qualified individual, to ensure
that the records are complete, the activities reflected in the records
occurred in accordance with the food safety plan, the preventive
controls are effective, and appropriate decisions were made about
corrective actions. We proposed to require review of records of
monitoring and corrective action records within a week after the
records are made, and review of records of calibration, product
testing, environmental monitoring, and supplier verification activities
within a reasonable time after the records are made.
(Comment 361) Some comments assert that it is not necessary for a
preventive controls qualified individual to conduct or oversee review
of records as a verification activity, noting that review of records in
another food safety regulation (i.e., the LACF requirements in part
113) can be done by persons adequately trained in recordkeeping and
review of records.
[[Page 56276]]
(Response 361) The rule does not preclude review of records by
persons other than the preventive controls qualified individual,
provided that the preventive controls qualified individual provides
oversight for that review. Oversight by a preventive controls qualified
individual is necessary because the review of records is critical to
assessing the facility's application of the preventive controls system
and, thus, is fundamental to ensuring its successful operation (78 FR
64736 at 64796 through 64797). Oversight by a preventive controls
qualified individual is consistent with requirements of Federal HACCP
regulations for seafood, juice, and meat and poultry (Ref. 49) (78 FR
64736 at 64796 through 64797).
(Comment 362) Some comments ask us to provide for a timeframe
longer than 1 week (such as 7 working days) for review of records of
monitoring and corrective actions. Some comments ask us to provide the
same flexibility for review of records of monitoring and corrective
actions as we proposed for review of records of calibration, product
testing, environmental monitoring, and supplier verification activities
(``within a reasonable time'' after the records are made), e.g.,
because some preventive controls may be monitored less frequently than
is typical in a traditional HACCP plan dominated with CCPs. Some
comments note that corrective actions may not be fully implemented
within 7 days and ask us to provide for review of these records within
a week or other timeframe determined to be appropriate to ensure that
potentially hazardous goods do not enter commerce. Some comments ask us
to retain the 1 week timeframe for review of records associated with
perishable foods, but to extend the timeframe to 1 month for
nonperishable foods.
Some comments state that some food processors that operate on a
batch production basis (rather than a continuous production basis)
review all records related to a particular batch all at once just
before release of the batch for distribution. These comments assert
that it would be inefficient, unnecessary, and needlessly complicated
to require management to review a few production records in advance of
the normal complete records review, particularly when laboratory
testing conducted on the batch by an outside laboratory takes several
weeks to complete.
(Response 362) We have revised the proposed requirement to require
review of records of monitoring and corrective actions within 7 working
days after the records are made or within a reasonable timeframe,
provided that the preventive controls qualified individual prepares (or
oversees the preparation of) a written justification for a timeframe
that exceeds 7 working days. A timeframe that exceeds 7 working days
will be the exception rather than the norm. For example, reviewing
records before release of product may be considered adequate by a
facility, although this may be later than one week after the records
were created. A facility may determine that all records for a lot of
product will be reviewed after product testing or environmental
monitoring records relevant to that lot of product are available, which
may be more than a week after monitoring records were created. We made
a conforming change to the list of responsibilities of the preventive
controls qualified individual to address the requirement for the
preventive controls qualified individual to provide (or oversee the
preparation of) a written justification for such a timeframe (see Sec.
507.53(a)).
We are not requiring that a facility review records of monitoring
and corrective actions before release of product or that the timeframe
for the review depends on the shelf life of the animal food. The
purpose of reviewing records is not to determine whether to release
product. Instead, the purpose of reviewing records is to ensure that
the records are complete, the activities reflected in the records
occurred in accordance with the food safety plan, the preventive
controls are effective, and appropriate decisions were made about
corrective actions. However, a facility will have flexibility to review
records of monitoring and corrective actions within a timeframe that
exceeds 7 working days, such as before product release, provided that
the facility provides a written justification for doing so. Depending
on the nature of the record, a facility that reviews these types of
records in a timeframe that exceeds 7 working days, and finds a
problem, may be faced with recall decisions for a relatively large
number of affected lots of product.
(Comment 363) Some comments ask us to revise the provisions for
review of records by more generally referring to records of
``verification testing (e.g., product testing and/or environmental
monitoring as applicable).''
(Response 363) We have revised the regulatory text to refer to
records of ``testing (e.g., product testing, environmental
monitoring).''
(Comment 364) Some comments refer to our request for comment on
whether the regulatory text should specify the verification activities
that must be conducted for corrective actions. These comments assert
that if we do not further specify verification activities for
corrective actions then we should eliminate the proposed requirement to
review records of corrective actions.
(Response 364) Records are necessary to document all verification
activities (see Sec. 507.45(b)). The fact that the rule provides
flexibility for the facility to determine the verification activities
for corrective actions, rather than prescribes these verification
activities, has no bearing on the requirement to document the
verification activities.
(Comment 365) Some comments emphasize the importance of calibrating
those instruments and monitoring devices that are critical to the
preventive control, and reviewing the associated records, before
validation of a lethality step and as frequently as necessary
thereafter. These comments question whether requiring review of
calibration records ``within a reasonable time'' will be adequate.
(Response 365) We agree that instruments and monitoring devices
that are critical to a preventive control should be calibrated, and
calibration records should be reviewed, before conducting studies to
validate a lethality step. However, the provision is directed at
verification of implementation and effectiveness of preventive controls
on an ongoing basis. This rule does not prescribe specific steps that a
facility must take before conducting validation studies.
A facility has flexibility to appropriately determine the frequency
of reviewing calibration records based on the facility, the animal
food, and the nature of the preventive control. We agree that it would
be prudent to review calibration records of those instruments and
monitoring devices that are critical to the preventive control more
frequently than of those instruments and monitoring devices that are
not critical to the preventive control. Depending on the nature of the
control being calibrated, a facility that reviews calibration records
infrequently, and finds a problem with calibration of process
monitoring instruments and verification instruments, may be faced with
recall decisions for a relatively large number of affected lots of
product.
G. Proposed Sec. 507.49(b)--Written Procedures
1. Proposed Sec. 507.49(b)(1)--Frequency of Calibration
We proposed that you must establish and implement written
procedures for the frequency of calibrating process monitoring
instruments and verification instruments.
[[Page 56277]]
(Comment 366) Some comments ask us to specify that an accuracy
check may be used as a verification activity in lieu of calibration.
These comments also ask us to specify that written procedures address
the frequency of accuracy checks, as well as calibration.
(Response 366) We have revised the proposed requirement to specify
that written procedures address the frequency of accuracy checks, as
well as calibration.
2. Proposed Sec. 507.49(b)(2) and (b)(3)--Product Testing and
Environmental Monitoring
We proposed that you must establish and implement written
procedures for product testing. We proposed that procedures for product
testing must: (1) Be scientifically valid; (2) identify the test
microorganism(s); (3) specify the procedures for identifying samples,
including their relationship to specific lots of product; (4) include
the procedures for sampling, including the number of samples and the
sampling frequency; (5) identify the test(s) conducted, including the
analytical method(s) used; (6) identify the laboratory conducting the
testing; and (7) include the corrective action procedures required by
Sec. 507.42(a)(1).
Likewise, we proposed that you must establish and implement written
procedures for environmental monitoring. Procedures for environmental
monitoring must: (1) Be scientifically valid; (2) identify the test
microorganism(s); (3) identify the locations from which the samples
will be collected and the number of sites to be tested during routine
environmental monitoring; (4) identify the timing and frequency for
collecting and testing samples; (5) identify the test(s) conducted,
including the analytical method(s) used; (6) identify the laboratory
conducting the testing; and (7) include the corrective action
procedures required by Sec. 507.42(a)(1)(ii).
(Comment 367) Some comments express concern that the word ``valid''
in the phrase ``scientifically valid'' could be construed to mean
``validated'' because not all testing protocols can be validated within
the traditional meaning of the term. These comments state their belief
that what we intend is for these testing programs to be ``technically
sound.'' Other comments express concern that ``scientifically valid''
may be interpreted to mean that firms are required to develop or
validate analytical methods (either in general or for specific food
matrices).
(Response 367) We are retaining the term ``scientifically valid''
in these provisions. We disagree that we would interpret
``scientifically valid'' to mean that facilities are required to
develop or validate analytical methods. We discussed our interpretation
of the term ``scientifically valid'' in the Appendix to the 2013
proposed preventive controls rule (78 FR 64736 at 64834 through 64835),
and noted that this interpretation was consistent with our previous
discussion of the term ``scientifically valid'' (in place of
``validated'') in the rulemaking to establish CGMP requirements for
dietary supplements (68 FR 12158 at 12198, March 13, 2003). While
validated methods are considered ``scientifically valid,'' methods that
have not gone through formal validation processes but have been
published in scientific journals, for example, may also be
``scientifically valid.'' We do expect methods used for testing to be
adequate for their intended use.
Although we agree that methods that are ``scientifically valid''
would also be ``technically sound,'' we disagree that the hypothetical
concern that we would construe ``scientifically valid'' to mean
``validated'' warrants changing ``scientifically valid'' to a new term
(such as ``technically sound'') in light of our previous statements
regarding this term and experience in the context of CGMP requirements.
See the final rule establishing the dietary supplement CGMPs for
additional discussion on the terms ``validated'' and ``scientifically
valid'' (72 FR 34752 at 34853).
(Comment 368) Some comments support the proposed requirements for
written procedures for environmental monitoring, including providing
flexibility to use indicator organisms and to design the timing,
location, and frequency of environmental monitoring programs in a risk-
based manner, and in not prescribing specific locations (e.g., food-
contact surfaces or ``zone 1'') or sample quantities for testing. Other
comments ask us to add details to the written procedures for product
testing and environmental monitoring regarding when and where sampling
is required and the number of samples to take. Some comments ask us to
make sure the most current ``sampling planning science'' is used for
environmental monitoring by specifying that procedures for
environmental monitoring must employ sample quality criteria
objectives. Other comments assert that the product testing procedure
requirements are inadequate and ask us to require that procedures for
product testing specify the procedures for identifying samples
(including their relationship to specific lots of product); describe
how sampling was conducted (to establish that the sample obtained
adequately represents the lot of product the sample is intended to
represent); and include the procedures for sample quality control from
field to lab.
(Response 368) We decline the request to prescribe additional
details, such as those described in these comments, in the requirements
for written procedures for product testing and environmental
monitoring. As with other procedures required by the rule, those
relating to environmental monitoring and product testing must be
adequate for their intended purpose. Further, procedures will not be
identical in all circumstances. For example, a facility that produces
products with a short shelf life may choose a different frequency of
swabbing and testing than a facility that produces products with a long
shelf life.
(Comment 369) Some comments ask us to provide more flexibility in
product testing by not requiring establishments to provide written
procedures for product testing and corrective action procedures.
(Response 369) These comments are unclear. By requiring that a
facility establish its own procedures, the rule provides facilities
with flexibility to develop a product testing program that works best
for its facility and its products. We are retaining the requirements
for written procedures for product testing, as well as for corrective
action procedures.
(Comment 370) Some comments ask us to add a provision requiring
that all positive results must result in corrective action being taken.
(Response 370) We decline this request. The rule requires that a
facility must establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented, including procedures to address, as appropriate, the
presence of a pathogen or appropriate indicator organism in an animal
food product detected as a result of product testing and the presence
of an environmental pathogen or appropriate indicator organism detected
through environmental monitoring (see Sec. 507.42(a)(1)). However, the
rule does not predetermine what corrective actions a facility must take
when presented with positive results from product testing or
environmental monitoring. The corrective action procedures that a
facility would develop, and the actual corrective actions that the
facility would take, will depend on the nature of the hazard and the
nature of the preventive control, as well as information relevant to
the positive result (e.g., pathogen or
[[Page 56278]]
indicator organism, product or environment, animal food-contact surface
or non-animal food-contact surface).
For additional discussion of comments on verification of
implementation and effectiveness, see section XXXIV of the final rule
for preventive controls for human food published elsewhere in this
issue of the Federal Register.
XXXV. Subpart C: Comments on Proposed Sec. 507.50--Reanalysis
We proposed to establish requirements for reanalysis of the food
safety plan. Some comments support the proposed requirements without
change. For example, comments agree that a preventive controls
qualified individual must perform (or oversee) the reanalysis (see
section XXXV.D). Some comments that support the proposed provisions
suggest alternative or additional regulatory text.
In the following paragraphs, we discuss comments that disagree
with, or suggest one or more changes to, the proposed requirements.
After considering these comments, we have revised the proposed
requirements as shown in table 19, with editorial and conforming
changes as shown in table 31.
Table 19--Revisions to the Proposed Requirements for Reanalysis
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.50(b)..................... Circumstances Provide for
that require reanalysis of an
reanalysis. applicable portion
of the food safety
plan (rather than
the complete food
safety plan) in
specified
circumstances.
507.50(b)(4).................. Circumstances Require reanalysis of
that require the food safety plan
reanalysis. as a whole, or the
applicable portion
of the food safety
plan, whenever a
preventive control,
combination of
preventive controls,
or the food safety
plan as a whole is
found to be
ineffective.
507.507(c).................... Timeframe to Clarify that the
complete the requirement applies
reanalysis. to completing the
reanalysis and
validating any
additional
preventive controls
(as appropriate to
the nature of the
preventive control
and its role in the
facility's food
safety system),
rather than to
completing the
reanalysis and
implementing any
additional
preventive controls
(emphasis added).
------------------------------------------------------------------------
A. Proposed Sec. 507.50(a)--Circumstances Requiring Reanalysis
We proposed that you must conduct a reanalysis of the food safety
plan: (1) At least once every 3 years; (2) whenever a significant
change in the activities conducted at your facility creates a
reasonable potential for a new hazard or creates a significant increase
in a previously identified hazard; (3) whenever you become aware of new
information about potential hazards associated with the animal food;
(4) whenever appropriate after an unanticipated animal food safety
problem; and (5) whenever you find that a preventive control is
ineffective.
(Comment 371) Some comments assert that the need to reanalyze the
food safety plan will depend on the nature of the preventive control
and its role in the food safety system. These comments also assert that
if a specific preventive control is found to be ineffective, only the
applicable portion of the food safety plan would need to be reanalyzed.
(Response 371) We agree and have revised the regulatory text, with
associated editorial changes and redesignation, to separate the
requirement to reanalyze the food safety plan as a whole every 3 years
from all other circumstances when reanalysis is required ``for cause.''
When reanalysis is ``for cause,'' the regulatory text provides that
reanalysis is of the food safety plan as a whole, or the applicable
portion of the food safety plan.
(Comment 372) Some comments ask us to define ``reanalysis'' to mean
``a reassessment of the validity of a preventive control or food safety
plan to control a hazard. Reanalysis may include a system review and,
where necessary, activities to revalidate a control measure or
combination of control measures.''
(Response 372) We decline this request. Reanalysis goes beyond
assessing the validity of a preventive control or food safety plan to
control a hazard. Reanalysis can also include assessing whether all
hazards have been identified, whether established procedures are
practical and effective, and other factors.
(Comment 373) Some comments ask us to require reanalysis on an
annual basis, noting that annual reanalysis is required by Federal
HACCP regulations for seafood, juice, and meat and poultry.
(Response 373) We decline this request. We proposed to require
reanalysis at least once every 3 years as a minimum requirement in the
event that there is no other circumstance warranting reanalysis (see
Sec. 507.50(b)(2) through (4)). That 3-year minimum is consistent with
the statute (see section 418(i) of the FD&C Act). As a practical
matter, we expect that reanalysis will occur more frequently as a
result of changes in the activities conducted at a facility (Sec.
507.50(b)(1) through (4)).
(Comment 374) Some comments suggest editorial changes to improve
the readability of the requirement to conduct reanalysis when there is
a change in a preventive control.
(Response 374) We are including these editorial changes in the
regulatory text, which now reads whenever ``a significant change in the
activities conducted at your facility creates a reasonable potential .
. .''
(Comment 375) Some comments assert that the proposed requirement to
conduct reanalysis whenever you become aware of new information about
potential hazards associated with the food does not align with FSMA
statutory language, is ambiguous, and would establish vague compliance
obligations.
(Response 375) We disagree that the proposed requirement is
ambiguous and would establish vague compliance obligations. See our
previous discussion regarding the emergence of the first outbreak of
foodborne illness in the United States, in 2006-2007, caused by
consumption of peanut butter contaminated with Salmonella (78 FR 64736
at 64798). Although we acknowledge that the proposed requirement is not
explicit in section 418(i) of the FD&C Act, we disagree it is not in
alignment with FSMA as a whole. FSMA directs the owner, operator, or
agent in charge of a facility to evaluate the hazards that could affect
food manufactured, processed, packed, or held by such facility and
identify and implement preventive controls to significantly minimize or
prevent the occurrence of those hazards (see section
[[Page 56279]]
418(a) of the FD&C Act). In other words, FSMA focuses on a system to
prevent food safety problems rather than a system to react to problems
after they occur. Requiring that a facility reanalyze its food safety
plan, or the applicable portion of the food safety plan, in response to
information such as the emergence of a new foodborne pathogen, or an
outbreak of foodborne illness from consumption of an animal food
product (or handling by consumers of a pet food product) not previously
associated with foodborne illness from a well-known pathogen, aligns
very well with the statutory direction in FSMA.
(Comment 376) Some comments ask us to add a requirement to conduct
reanalysis whenever a preventive control is found to be ``missing'' in
addition to whenever a preventive control is found to be
``ineffective.''
(Response 376) We have revised the regulatory text to require
reanalysis whenever a preventive control, a combination of preventive
controls, or the food safety plan as a whole, is ineffective. (See
Sec. 507.50(b)(4).) A ``missing'' preventive control could be
discovered during verification to establish the validity of the food
safety plan as a whole or as a result of an unanticipated problem. If
circumstances lead a facility to conclude that an additional (or
different) preventive control is necessary, the facility would include
that preventive control in its food safety plan along with associated
preventive control management components, including verification to
establish the validity of the food safety plan.
B. Proposed Sec. 507.50(b)--Timeframe To Complete Reanalysis
We proposed that you must complete the reanalysis and implement any
additional preventive controls needed to address the hazard identified,
if any, before the change in activities at the facility is operative
or, when necessary, during the first 6 weeks of production. We have
clarified that the requirement is to complete the reanalysis and
validate (rather than implement) any additional preventive controls as
appropriate to the nature of the preventive control and its role in the
facility's food safety system.
(Comment 377) As discussed in Comment 332, some comments question
whether 6 weeks is enough time to perform all applicable validation
studies that would address the execution element of validation.
Likewise, some comments question whether 6 weeks is enough time to
complete reanalysis.
(Response 377) Consistent with revisions we have made to the
timeframe to complete validation (see Response 332), we have revised
the timeframe to complete the reanalysis and validate, as appropriate
to the nature of the preventive control and its role in the facility's
food safety system, any additional preventive controls to be within 90
days after production of the applicable animal food first begins or
within a reasonable timeframe, provided that the preventive controls
qualified individual provides (or oversees the preparation of) a
written justification for a timeframe that exceeds 90 days after
production of the applicable animal food first begins. We made a
conforming change to the list of responsibilities of the preventive
controls qualified individual (see Sec. 507.53(a)).
(Comment 378) Some comments state that the phrase ``before the
change in activities at the facility is operative'' is ambiguous in
that it is unclear if the phrase is referencing the initial change in
activities that triggered the reanalysis or a change in activities
subsequent to the reanalysis. These comments ask us to clarify the
requirement by substituting the phrase ``before the relevant process is
operative.''
(Response 378) We agree that there was ambiguity in this phrase,
because changes in activities could result in the need for reanalysis
and reanalysis could result in the need for changes in activities, both
of which can result in a new preventive control. We have made several
revisions to the regulatory text, with associated editorial changes, to
clarify the requirements for reanalysis. First, we have clarified that
reanalysis can be routine (at least every 3 years) or ``for cause''
(i.e., a significant change that creates the potential for a new hazard
or an increase in a previously identified hazard; when you become aware
of new information about potential hazards associated with the animal
food; when there is an unanticipated animal food safety problem; or
whenever a preventive control, combination of preventive controls or
the food safety plan as a whole is ineffective). Second, we have
specified that the reanalysis ``for cause'' may be for the entire food
safety plan or only for an applicable portion.
In addition, we have clarified that the reanalysis and the
validation, as appropriate to the nature of the preventive control and
its role in the facility's food safety system, of any additional
preventive controls needed to address an identified hazard, would need
to be completed before any change in activities (including any change
in preventive controls) is operative. When additional time is
necessary, we have provided for a timeframe within 90 days after
production of the applicable animal food first begins or within a
reasonable timeframe, provided that the preventive controls qualified
individual provides (or oversees the preparation of) a written
justification for a timeframe that exceeds 90 days after production of
the applicable animal food first begins. In other words, if you decide
to make a change, you should conduct a reanalysis before you make that
change if there is potential for that change to create or increase a
hazard; a reanalysis that results in changes to preventive controls
should be completed and the preventive controls validated, as
appropriate to the nature of the preventive control and its role in the
facility's food safety system, before changes in activities to produce
animal food using a new preventive control are put into operation.
However, we acknowledge that it may be necessary to produce product to
demonstrate a revised preventive control can be implemented
appropriately, and provide for an extended timeframe to make this
assessment.
C. Proposed Sec. 507.50(c)--Requirement To Revise the Written Food
Safety Plan or Document Why Revisions Are Not Needed
We proposed that you must revise the written food safety plan if a
significant change is made or document the basis for the conclusion
that no revisions are needed. We received no comments that disagreed
with this proposed requirement and are finalizing it as proposed.
D. Proposed Sec. 507.50(d)--Requirement for Oversight of Reanalysis by
a Preventive Controls Qualified Individual
We proposed that a preventive controls qualified individual must
perform (or oversee) the reanalysis. We received no comments that
disagreed with this proposed requirement and are finalizing it as
proposed. See section XXXVII.B for comments on the qualifications for a
preventive controls qualified individual who would perform or oversee
the reanalysis.
E. Proposed Sec. 507.50(e)--Reanalysis on the Initiative of FDA
We proposed that you must conduct a reanalysis of the food safety
plan when FDA determines it is necessary to respond to new hazards and
developments in scientific understanding.
(Comment 379) Some comments ask us to issue formal, written
communications about new hazards and developments in scientific
understanding. These comments express
[[Page 56280]]
concern that communications of this type could be inconsistent if they
are communicated by individual investigators. Other comments ask us to
specify in the regulatory text that it is the Commissioner of Food and
Drugs who makes the determination that it is necessary to conduct a
reanalysis of the food safety plan.
(Response 379) We agree that a communication from FDA about the
need to reanalyze the food safety plan should be issued in a formal
written manner but disagree that it is necessary to specify that it is
the Commissioner of Food and Drugs who makes the determination that it
is necessary to conduct a reanalysis of the food safety plan. The
comment provides no basis for precluding such a determination by an
organizational component (such as CVM or a component of FDA's Office of
Regulatory Affairs) that has operational responsibility for animal food
safety and subject matter experts to advise the managers in those
organizational components.
XXXVI. Subpart C: Comments on Proposed Sec. 507.51--Modified
Requirements That Apply to a Facility Solely Engaged in the Storage of
Unexposed Packaged Animal Food
We proposed that if your facility is solely engaged in the storage
of packaged animal food that is not exposed to the environment, you
must conduct certain activities for any such refrigerated packaged
animal food that requires time/temperature controls for safety (TCS
animal food) to significantly minimize or prevent the growth of, or
toxin production by, microorganisms of animal or human health
significance. We requested comment on the proposed list of modified
requirements. Some comments that support the proposed provisions
suggest alternative or additional regulatory text or ask us to clarify
how we will interpret the provision.
In this section, we discuss comments that ask us to clarify the
proposed requirements or that disagree with, or suggest one or more
changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
20.
Table 20--Revisions to the Proposed Modified Requirements for Unexposed,
Refrigerated, Packaged Animal Food
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.51(a)..................... Circumstances Clarify that the
that make a requirements apply
facility subject to a temperature
to the modified control area in a
requirements for facility that holds
unexposed, TCS animal food
refrigerated rather than to each
packaged animal product in the
food. holding facility.
507.51(a)(2).................. Modified Specify that it is
requirements for the temperature
monitoring the controls that are
temperature consistently
controls. performed.
507.51(a)(3).................. Modified Clarify that
requirements for corrective actions
corrective need only be taken
actions. when a loss of
temperature control
may impact the
safety of the TCS
animal food.
507.51(a)(4)(i)............... Modified Provide additional
requirements for flexibility for
verification of accuracy checks, in
temperature addition to
controls. calibration, to
verify that
temperature controls
are consistently
implemented.
507.51(a)(4)(iii)............. Modified Provide additional
requirements for flexibility for
verification of reviewing records of
temperature monitoring and
controls. corrective actions
either within 7-
working days after
the records are made
or within a
reasonable
timeframe.
507.51(a)(5)(i)............... Records Provide additional
documenting the flexibility for
monitoring of records documenting
temperature the monitoring of
controls. temperature controls
to be kept either as
affirmative records
demonstrating
temperature is
controlled or as
exception records
demonstrating loss
of temperature
control.
507.51(a)(5)(ii).............. Records Conforming change
documenting associated with the
corrective modified
actions. requirements for
corrective actions
to clarify that
records of
corrective actions
are required when
there is a loss of
temperature control
that may impact the
safety of the TCS
animal food.
------------------------------------------------------------------------
A. Proposed Sec. 507.51(a)--Modified Requirements for Unexposed
Refrigerated Packaged Animal Food That Requires Time/Temperature
Controls
1. Proposed Sec. 507.51(a)(1)--Establish and Implement Temperature
Controls
We proposed that if your facility is subject to the modified
requirements, you must establish and implement temperature controls
adequate to significantly minimize or prevent the growth of, or toxin
production by, microorganisms of animal or human health significance.
We also tentatively concluded that it would be rare for a facility
solely engaged in the storage of unexposed packaged animal food to not
have information regarding whether a refrigerated packaged animal food
is a TCS animal food and, if so, what specific temperature controls are
necessary for safe storage of the food. We requested comment on this
tentative conclusion.
(Comment 380) Some comments ask us to clarify that the requirement
to establish and implement temperature controls applies to temperature
control areas in a facility rather than to each product in a facility.
(Response 380) We agree that the requirement to establish and
implement temperature controls applies to temperature control areas in
a facility rather than to each product in a facility. To make this
clearer, we have revised the proposed requirement to clarify that the
facility must conduct activities as appropriate to ensure the
effectiveness of the temperature controls rather than conduct
activities ``for any such refrigerated packaged animal food.''
(Comment 381) Some comments disagree with our tentative conclusion
that it would be rare for a facility solely engaged in the storage of
unexposed packaged animal food to not have information regarding
whether a refrigerated packaged food is a TCS animal food and, if so,
what specific temperature controls are necessary for safe storage of
the animal food. These comments ask us to specify that the
responsibility for determining whether an animal food is a TCS animal
food falls to the manufacturer of the animal food rather than the
warehouse storing the animal food, because the warehouse merely
provides a service. Other
[[Page 56281]]
comments note that the animal food product owners determine the optimal
conditions for storage of their products based on their own hazard
analysis and preventive controls, and that the animal food product
owners can simply communicate those requirements to the warehouses that
will store the products.
(Response 381) In this type of circumstance, it is appropriate for
the manufacturer of the animal food to share the responsibility with
the warehouse for proper storage of the animal food. The various
provisions of section 418 of the FD&C Act explicitly place the
responsibility for complying with the requirements for hazard analysis
and risk-based preventive controls, including modified requirements, on
the owner, operator, or agent in charge of a facility and, thus, a
facility that is a warehouse is responsible for its own food safety
plan. Regardless, the manufacturer also has responsibilities under
section 418 of the FD&C Act to determine the storage conditions
necessary for animal food safety and to take steps to ensure that the
animal food is stored under conditions that will ensure its safety.
It is not necessary to specify this joint responsibility for
determining storage conditions in the rule, because the rule already
clearly specifies that its provisions apply to persons who manufacture/
process animal food, as well as to persons who hold animal food. Both
the warehouse and the manufacturer have flexibility in determining how
to comply with the rule, including the specific mechanism whereby the
warehouse would receive information about storage of an animal food
product from the manufacturer or owner of the product. Moreover, a
citizen petition submitted to FDA (Docket No. FDA-2011-P-056), in
requesting an exemption or modified requirements for facilities solely
engaged in the storage of packaged foods not exposed to the
environment, asserts that such facilities work closely with food
manufacturers to understand the conditions and controls needed to
ensure the quality of the foods they store and distribute and that
manufacturers appropriately instruct the warehouses to ensure packaged
products are being properly stored (78 FR 64736 at 64768).
(Comment 382) Some comments ask us to clarify which facility, the
shipping facility or the receiving facility, will be responsible for
ensuring that temperature control is maintained during transportation
of TCS animal foods.
(Response 382) We address specifics about the responsibilities of
shipping facilities and receiving facilities in the 2014 proposed
sanitary transportation rule (79 FR 7006). We will address comments
regarding the responsibilities of shippers and receivers in the final
sanitary transportation rule.
2. Proposed Sec. 507.51(a)(2)--Monitor the Temperature Controls
We proposed that if your facility is subject to the modified
requirements, you must monitor the temperature controls with sufficient
frequency to provide assurance they are consistently performed. We
requested comment on whether there would be a benefit to requiring a
facility to develop written procedures for monitoring temperature.
(Comment 383) Some comments ask us to explain in the preamble of
the final rule that we will accept monitoring systems that provide
exception reports to satisfy the modified requirements. The comments
describe exception reporting as a structure where automated systems are
designed to alert operators and management when the monitoring system
observes a deviation from an established limit. These comments assert
that monitoring of preventive controls by automated systems can be more
efficient than monitoring by personnel, and can eliminate human error.
(Response 383) We have revised the recordkeeping provisions of
these modified requirements to provide that the temperature monitoring
records for the modified requirements may be kept either as affirmative
records demonstrating temperature is controlled or as exception records
demonstrating loss of temperature control. Although the comments
explicitly asked us to provide a clarification in the preamble of this
rule, we decided the clarification within the regulatory text would be
clearer to facilities that are subject to the requirements, as well as
to investigators who will be inspecting facilities for compliance with
the rule.
(Comment 384) Some comments state that written procedures for
monitoring temperature are not necessary. One reason provided by the
comments is that the required records (specified in proposed Sec.
507.51(a)(5)) would provide sufficient information on the type and
frequency of monitoring. Another reason is that the specific activities
we proposed to ensure the effectiveness of the temperature controls
already address activities that a facility would include in a written
procedure.
(Response 384) We agree with the comments that we need not require
that a facility develop written procedures for monitoring temperature.
3. Proposed Sec. 507.51(a)(3)--Requirement To Take Corrective Actions
We proposed that if your facility is subject to the modified
requirements, you must take appropriate corrective actions if there is
a problem with the temperature controls for a TCS animal food.
(Comment 385) Some comments ask us to narrow the term ``temperature
control'' to more specifically focus it on temperature controls that
are relevant to food safety because some problems with the controls may
not impact the product temperature (and, thus, would not impact food
safety).
(Response 385) We have revised the proposed requirement (and the
applicable recordkeeping requirement) to specify that corrective
actions are necessary only when there is a loss of temperature control
that may impact the safety of a TCS animal food.
(Comment 386) Some comments assert that the responsibility for
determining any corrective actions for a TCS animal food when there is
a loss of temperature control falls to the manufacturer of the food
rather than to the warehouse. These comments also assert that a
warehouse is a third party who is not legally empowered to make
independent decisions about when and where to ship the product, or not
to ship it at all. These comments ask us to clarify that the
responsibility of a warehouse for ``preventing'' affected food entering
commerce ends when the product is returned to the manufacturer or
processor.
(Response 386) Returning affected animal food to the manufacturer/
processor or owner of the animal food is one way to satisfy the
requirement to prevent animal food from entering commerce if the owner,
operator, or agent in charge of a warehouse cannot ensure the affected
animal food is not adulterated under section 402 of the FD&C Act,
either on its own or after consultation with the manufacturer or
processor of the animal food. It is not necessary to specify this
specific action on the part of a warehouse in the regulatory text.
4. Proposed Sec. 507.51(a)(4)--Requirement To Verify Consistent
Implementation of Temperature Controls
We proposed that if your facility is subject to the modified
requirements, you must verify that temperature controls are
consistently implemented by: (1) Calibrating temperature monitoring and
recording devices; (2) reviewing records of calibration within
[[Page 56282]]
a reasonable time after the records are made; and (3) reviewing records
of monitoring and corrective actions taken to correct a problem with
the control of temperature within a week after the records are made.
(Comment 387) Some comments assert that the proposed requirement to
``calibrate'' devices that monitor and record temperature is
inconsistent with the requirement to test such devices for accuracy in
the LACF regulations in part 113. These comments assert that ``accuracy
check'' is a more appropriate term to use in the modified requirements
because many instruments that monitor or record temperature have very
low drift values and may seldom require calibration.
(Response 387) We have revised the proposed requirements to require
verification that temperature controls are consistently implemented by
calibrating temperature monitoring and recording devices or checking
them for accuracy. However, if the outcome of an accuracy check is that
a temperature monitoring or recording device is not accurate, the
facility must follow up by calibrating or replacing the device. See
also Comment 344 and Response 344.
(Comment 4388) Some comments assert that reviewing records of
calibration or accuracy checks is only needed if a designated tolerance
is exceeded.
(Response 4388) Although we recognize that in most instances an
out-of-calibration device will be identified and corrected at the time
a calibration or accuracy check is performed, this is not always the
case. The purpose of reviewing records of calibration or accuracy
checks is to identify a problem that may have been missed or may not
have been corrected rather than to react to a problem after the problem
is identified. The records review is also a verification that the
temperature controls were consistently implemented and that corrective
actions were taken if needed.
(Comment 389) Some comments ask us to modify the frequency of
checking monitoring records to specify that it be done with a frequency
to demonstrate control rather than within a week after the records are
made.
(Response 389) We have revised the proposed requirement to require
review of records of monitoring (as well as records of corrective
actions taken to correct a problem with the control of temperature)
within 7-working days after the records are created or within a
reasonable timeframe, provided that the preventive controls qualified
individual prepares (or oversees the preparation of) a written
justification for a timeframe that exceeds 7 working days.
(Comment 390) Some comments assert that the proposed verification
and review activities are too prescriptive because they require reviews
that are not necessary. However, these comments also assert that the
proposed verification activities are too vague because they do not
specify the reasons for reviewing the records. These comments ask us to
focus the regulatory text on achieving the overall objective of the
review (i.e., ensuring the adequacy of the control) and to provide
examples of meaningful review activities in guidance.
(Response 390) We disagree that the proposed verification
activities would require reviews that are not necessary. The purpose of
the records review is both to identify a problem with a temperature
monitoring device that may not have been detected or corrected, and to
verify that the temperature controls were consistently implemented and
that corrective actions were taken if needed. The requirement is
consistent with requirement for records review in subpart C (Sec.
507.49(a)(4)), which specifies records review as a verification
activity to ensure that the records are complete, the activities
reflected in the records occurred in accordance with the food safety
plan, the preventive controls are effective, and appropriate decisions
were made about corrective actions.
5. Proposed Sec. 507.51(a)(5)--Establish and Maintain Records
We proposed that if your facility is subject to the modified
requirements, you must establish and maintain records that document
monitoring, corrective actions, and verification activities.
(Comment 391) Some comments state that temperature controls in
refrigerated warehouses are extremely reliable and therefore extensive
record keeping and record review are not value-added. These comments
ask us to revise the proposed provision to require a record only if a
deviation in the environmental temperature from the prescribed limits
was noted.
(Response 391) We have revised the regulatory text to provide that
temperature monitoring records may be kept either as affirmative
records demonstrating temperature is controlled or as exception records
demonstrating loss of temperature control. The revised provision is
consistent with the more general requirement for monitoring records of
refrigeration temperature during storage of TCS animal food (see Sec.
507.40(c)(2)).
B. Proposed Sec. 507.51(b)--Records
We proposed that the records that a facility must establish and
maintain for the proposed modified requirements are subject to the
requirements that would be established in proposed subpart F. We
received no comments that disagreed with our proposal, and are
finalizing proposed Sec. 507.51(b) without change.
XXXVII. Subpart C: Comments on Proposed Sec. 507.53--Requirements
Applicable to a Preventive Controls Qualified Individual and a
Qualified Auditor
We proposed to establish requirements for the qualifications of a
preventive controls qualified individual and a qualified auditor. Some
comments support the proposed requirements without change. Some
comments that support the proposed provisions suggest alternative or
additional regulatory text.
In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we are finalizing the provisions as proposed with conforming
changes as shown in table 31.
A. Proposed Sec. 507.53(a) and (b)--What a Preventive Controls
Qualified Individual or Qualified Auditor Must Do or Oversee
We proposed to list the functions that must be performed by one or
more preventive controls qualified individuals (i.e., preparation of
the food safety plan; validation of the preventive controls; review of
records for implementation and effectiveness of preventive controls and
appropriateness of corrective actions; and reanalysis of the food
safety plan) or by a qualified auditor (i.e., conduct an onsite audit).
We proposed to list these functions for simplicity (i.e., to make it
easy to see all of the requirements in a single place). We specified
that this list of functions already proposed to be established in
applicable sections of the rule did not in itself impose any additional
requirements.
(Comment 392) Some comments ask us to clarify whether the
preventive controls qualified individual must be on the premises during
operating hours. Other comments ask us to clarify that the preventive
controls qualified individual is not responsible for performing
laboratory testing, because the preventive controls qualified
individual may not be appropriately educated and trained for laboratory
testing.
[[Page 56283]]
(Response 392) The rule does not require that the preventive
controls qualified individual be onsite during operating hours. The
rule also does not require that the preventive controls qualified
individual be responsible for performing laboratory testing, although
review of testing records (e.g., records of product testing or
environmental testing) must be conducted or overseen by a preventive
controls qualified individual.
(Comment 393) Some comments ask us to consider the implication of
having the preventive controls qualified individual serve as the
process authority, serve as the auditor, and offer final sign off on a
validation and corrective actions, and suggest that a third party may
be necessary to ensure that uniform standards are applied.
(Response 393) To the extent that the comment suggests that the
functions of the preventive controls qualified individual create a
conflict of interest, we disagree. The rule focuses on the need for
applicable training and experience to perform certain functions. The
preventive controls qualified individual must develop (or oversee the
development of) the food safety plan that controls the identified
hazards and then ensures through review of records that the plan is
being implemented as designed. The rule does not require that a
facility engage a third party to provide oversight of any individual,
including a preventive controls qualified individual, but does not
preclude a facility from doing so if it chooses.
B. Proposed Sec. 507.53(c)--Qualification Requirements
1. Proposed Sec. 507.53(c)(1)--Preventive Controls Qualified
Individual
We proposed that to be a preventive controls qualified individual,
the individual must have successfully completed training in the
development and application of risk-based preventive controls at least
equivalent to that received under a standardized curriculum recognized
as adequate by FDA or be otherwise qualified through job experience to
develop and apply a food safety system. We also proposed that this
individual may be, but is not required to be, an employee of the
facility.
(Comment 394) Some comments express concern that there is lack of
specificity on what constitutes appropriate training and experience for
a preventive controls qualified individual and ask us to clarify what
FDA's standardized curriculum for preventive controls qualified
individuals will consist of, what experience will be recognized as
meeting the requirement, how FDA will recognize the experience and
whether and how FDA will recognize industry providers of training
programs. Some comments state that currently industry members may
choose from many private organizations and academia to obtain training
under established HACCP based training programs and audit training
programs. Some comments ask us to allow flexibility for industry to
continue current training programs without receiving express approval
from the FSPCA.
(Response 394) As discussed in Response 1, the FSPCA is
establishing a standardized curriculum. The curriculum will focus on
the specific requirements of the preventive controls rule. Training
providers do not need approval from the FSPCA to use the curriculum.
(Comment 395) Some comments ask who will assess the qualifications
of a particular preventive controls qualified individual or determine
whether particular individuals are in fact ``qualified.'' Some comments
ask us to use an outcome-based demonstration of competency. Some
comments ask us to specify that all work experience must be comparable
or that a preventive controls qualified individual must pass a
proficiency test. Some comments ask us to establish minimum standards
for competency. Some comments ask us to clarify what job experiences
would be sufficient. Some comments ask how we will verify that reported
training and experience are true.
(Response 395) We are not establishing minimum standards for
competency and do not intend routinely to directly assess the
qualifications of persons who function as the preventive controls
qualified individual, whether by their training or by their job
experience. Instead, we intend to focus our inspections on the adequacy
of the food safety plan. As necessary and appropriate, we will consider
whether deficiencies we identify in the food safety plan suggest that
the preventive controls qualified individual may not have adequate
training or experience to carry out the assigned functions, including
whether reported training and experience is accurately represented.
(Comment 396) Some comments ask us to provide for competency
requirements to be met through on-the-job experience in lieu of
traditional classroom training. Some comments ask us to clarify what we
mean by training that is ``at least equivalent'' to that received under
a standardized curriculum recognized as adequate by FDA. Some comments
ask us to clarify whether individuals who have successfully completed
training in the development and application of risk-based preventive
controls through programs delivered and recognized under the
International HACCP Alliance would be considered to have completed
training ``equivalent'' to that recognized by FDA for the development
and application of risk-based preventive controls.
(Response 396) The requirements do provide for qualification
through appropriate job experience, such as experience with
successfully implementing HACCP systems or other preventive-based food
safety systems. It is the responsibility of the owner, operator, or
agent in charge of the facility to determine whether any individual who
prepares (or oversees the preparation of) the food safety plan has
appropriate qualifications to do so, whether by on-the-job experience
or by training.
There are some differences in the requirements of the animal food
preventive controls rule compared to the requirements of HACCP
regulations for seafood, juice, and meat and poultry such that training
provided by the International HACCP Alliance may not be equivalent. To
avoid unnecessary duplication of training, such an individual may only
need to attend partial, supplemental courses in order to meet the
training requirements. Alternatively, a person who has received the
International HACCP Alliance training and has implemented a HACCP plan
may be qualified through job experience.
(Comment 397) Some comments ask us to emphasize that a standardized
curriculum in the development and application of risk-based preventive
controls may not provide a preventive controls qualified individual
with sufficient expertise to design and conduct robust, scientific
validation studies to support the adequacy of control measures.
(Response 397) We acknowledge that a single training course may not
provide adequate training for every function of the preventive controls
qualified individual for the animal foods produced by a facility. In
some cases an individual may gain the full complement of knowledge and
experience through multiple, specific training courses; in other cases
an individual may gain the full complement of knowledge and experience
through job experience or through a combination of training and job
experience.
(Comment 398) Some comments ask us not to establish requirements
that are
[[Page 56284]]
overly strict because there is a finite supply of food safety experts
in the country and many facilities will need multiple preventive
controls qualified individuals.
(Response 398) We disagree that the requirements applicable to the
preventive controls qualified individual should be designed to match
any current limitations in the number of individuals who have the
knowledge and skill to prepare (or oversee the preparation of) a food
safety plan. We expect that market forces will act to increase the
number of preventive controls qualified individuals to match the demand
generated by this rule. In addition, as discussed in section LIII.A, we
are further staggering the compliance dates for subparts C and E of the
rule, so that those businesses that are not small will need to comply
with subparts C and E of the rule within 2 years, and small businesses
will need to comply with subparts C and E of the rule within 3 years.
Very small businesses are not required to develop a food safety plan or
conduct other activities that require oversight by a preventive
controls qualified individual.
2. Proposed Sec. 507.53(c)(2)--Qualified Auditor
We proposed that to be a qualified auditor, a preventive controls
qualified individual must have technical expertise obtained by a
combination of training and experience appropriate to perform the
auditing function.
(Comment 399) Some comments object to the proposed requirement that
a qualified auditor must be a preventive controls qualified individual
with certain technical auditing expertise. One comment asserts that a
qualified auditor should not be required to have the broader skills of
a preventive controls qualified individual.
(Response 399) We have revised the definition of ``qualified
auditor,'' and the requirements applicable to a ``qualified auditor,''
such that a ``qualified auditor'' means a person who is a ``qualified
individual'' as that term is defined in this final rule, rather than a
``preventive controls qualified individual,'' because some auditors may
be auditing businesses (such as produce farms) that are not subject to
the requirements for hazard analysis and risk-based preventive
controls, and it would not be necessary for such an auditor to be a
``preventive controls qualified individual.''
(Comment 400) Some comments ask us to consider specifying training
for qualified auditors. These comments also ask us to consider certain
industry documents in any guidance we may issue regarding qualified
auditors.
(Response 400) At this time, we are not planning to specify a
training curriculum for qualified auditors. If we develop guidance
related to qualified auditors, we will consider industry documents that
are already available.
C. Proposed Sec. 507.53(d)--Records
We proposed that all applicable training must be documented in
records, including the date of the training, the type of training, and
the person(s) trained. For clarity, we have revised the requirement to
specify the type of training that must be documented, i.e., applicable
training in the development and application of risk-based preventive
controls (see 78 FR 64736 at 64804).
(Comment 401) Some comments ask us to explain how job experience
should be documented in records to prove qualifications.
(Response 401) The rule does not require documentation of job
experience. A facility has flexibility to determine whether and how to
document a preventive controls qualified individual's job experience.
For example, a facility could ask a preventive controls qualified
individual to provide a resume documenting applicable experience. As
discussed in Response 395, we intend to focus our inspections on the
adequacy of the food safety plan. As necessary and appropriate, we will
consider whether deficiencies we identify in the food safety plan
suggest that the preventive controls qualified individual may not have
adequate experience to carry out the assigned functions.
For further discussion on comments received to the proposed rule
for preventive controls rule for human food, see the final rule of the
human food preventive controls rule published elsewhere in this issue
of the Federal Register.
XXXVIII. Subpart C: Comments on Proposed Sec. 507.55--Implementation
Records
We proposed to list all records documenting implementation of the
food safety plan in Sec. 507.55(a). We noted that proposed Sec.
507.55(a) would not establish any new requirements but merely make it
obvious at a glance what implementation records are required under
proposed part 507, subpart C. We received no comments that disagreed
with this proposed provision and are finalizing it as proposed.
We proposed that the records that you must establish and maintain
are subject to the requirements of proposed subpart F (``Requirements
Applying to Records that Must be Established and Maintained'').
(Proposed subpart F would establish requirements that would apply to
all records that would be required by the various proposed provisions
of proposed part 507.) We received no comments that disagreed with this
proposed provision and are finalizing it as proposed.
XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal of
a Qualified Facility Exemption
In the 2013 proposed animal food preventive controls rule, we
proposed to establish procedural requirements that would govern our
withdrawal of an exemption for a qualified facility (proposed subpart
D; the withdrawal provisions). In the 2014 supplemental notice, we
discussed several comments we received on these withdrawal provisions
and proposed modifications and additions to them. Some of the
reproposed provisions would modify the provisions that we included in
the 2013 proposed preventive controls rule (such as the timeframe for
compliance with an order withdrawing an exemption), whereas others
would be new provisions (such as a procedure to reinstate an exemption
that had been withdrawn). In this section of this document we discuss
comments that we received on the withdrawal provisions in the 2013
proposed preventive controls rule, but did not address in the 2014
supplemental notice. We also discuss comments that we received on the
re-proposed withdrawal provisions in the 2014 supplemental notice.
Most of the comments support the proposed provisions, suggest
alternative or additional regulatory text, or ask us to clarify how we
will interpret the provision.
For several provisions, we received no comments that disagreed with
our proposal, and are finalizing the provisions without change. These
provisions are Sec. 507.75 (Presiding officer for an appeal and for an
informal hearing); Sec. 507.77 (Timeframe for issuing a decision on an
appeal); Sec. 507.80 (Revocation of an order to withdraw a qualified
facility exemption); and Sec. 507.83 (Final agency action).
In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements or that disagree with or suggest one
or more changes to the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
21 with editorial and conforming changes as shown in table 31.
[[Page 56285]]
Table 21--Revisions to the Proposed Provisions for Withdrawal of a
Qualified Facility Exemption
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.60(b)(2).................. Timeframe for a Allow 15 calendar
qualified days, rather than 10
facility to calendar days, for
respond to a the facility to
notification respond.
from FDA about
circumstances
that may lead
FDA to withdraw
the facility's
exemption.
507.65(c)..................... Contents of an Editorial changes to
order to clarify that the
withdraw a order will specify
qualified which of two
facility circumstances that
exemption. may lead FDA to
withdraw a qualified
facility exemption
apply, or whether
both of these two
circumstances apply.
507.65(d)(1).................. Contents of an Specify that the
order to timeframe for the
withdraw a qualified facility
qualified to comply with the
facility order is 120
exemption. calendar days after
the date of receipt
of the order, or
within a reasonable
timeframe, agreed to
by FDA, based on a
written
justification,
submitted to FDA,
for a timeframe that
exceeds 120 calendar
days from the date
of receipt of the
order.
507.65(d)(2).................. Timeframe for a Allow 15 calendar
qualified days, rather than 10
facility to calendar days, for
appeal an order the facility to
withdrawing the appeal the order.
facility's
exemption.
507.65(e)..................... Contents of an Include a statement
order to informing the
withdraw a facility that it may
qualified ask us to reinstate
facility an exemption that
exemption. was withdrawn by
following the
procedures in Sec.
507.85.
507.67........................ Compliance with, Specifies that a
or appeal of, an qualified facility
order to that loses its
withdraw a exemption would no
qualified longer need to
facility comply with the
exemption. modified
requirements that
apply to qualified
facilities that have
an active exemption.
507.67(a)(1) and (c)(1)....... Compliance with, Specify that the
or appeal of, an timeframe for the
order to qualified facility
withdraw a to comply with the
qualified order is 120
facility calendar days after
exemption. the date of receipt
of the order, or
within a reasonable
timeframe, agreed to
by FDA, based on a
written
justification,
submitted to FDA,
for a timeframe that
exceeds 120 calendar
days from the date
of receipt of the
order.
------------------------------------------------------------------------
A. Proposed Sec. 507.60--Circumstances That May Lead FDA To Withdraw a
Qualified Facility Exemption
We proposed that we may withdraw the exemption that would apply to
a qualified facility in the event of an active investigation of a
foodborne illness outbreak that is directly linked to the qualified
facility, or if we determine that it is necessary to protect the public
(human or animal) health and prevent or mitigate a foodborne illness
outbreak based on conditions or conduct associated with a qualified
facility that are material to the safety of the animal food
manufactured, processed, packed, or held at such facility. We also
proposed that before we issue an order to withdraw an exemption, we:
(1) May consider one or more other actions to protect the public health
or mitigate a foodborne illness outbreak; (2) must notify you, in
writing, of circumstances that may lead us to withdraw the exemption,
and provide an opportunity for you to respond in writing, within 10
calendar days of the date of receipt of the notification, to our
notification; and (3) must consider your actions to address the
circumstances that may lead us to withdraw the exemption.
(Comment 402) Some comments agree with the proposed provisions
regarding certain actions we may take, and other actions we must take,
before issuing an order to withdraw a qualified facility exemption. For
example, some comments agree that other regulatory actions should be
considered before withdrawing a qualified facility exemption, and some
comments agree that it is appropriate to assess corrective actions
taken by a qualified facility in response to an animal food safety
problem when considering whether to withdraw its exemption. Other
comments agree that these provisions are reasonable and will provide
qualified facilities due process and greater clarity on the withdrawal
process, but suggest that we could issue guidance rather than include
these provisions in the rule to allow us greater flexibility should we
have to act quickly to protect the public (human or animal) health.
Other comments disagree with these proposed provisions and ask us
to delete them from the final rule. These comments assert that FSMA
does not require us to describe the actions that we may take prior to
withdrawing a qualified facility exemption and that it is not necessary
to do so because it is customary for us to work with an animal food
facility to address problems before taking enforcement actions. These
comments also express concern that listing possible regulatory actions
before we would issue an order to withdraw a qualified facility
exemption could create an expectation that we will always exercise such
regulatory actions before issuing the order. These comments also
express concern that being bound by these provisions could prevent us
from acting quickly to protect public health.
(Response 402) We are retaining the provisions regarding certain
actions we may take, and other actions we must take, before issuing an
order to withdraw a qualified facility exemption. We agree that it is
customary for us to work with an animal food facility to address
problems before taking enforcement actions, but disagree that
specifying this customary practice in the rule would prevent us from
acting quickly to protect public (human or animal) health. As
previously discussed, we consider that issuing an order to withdraw an
exemption would be a rare event, in part because alternative actions
such as those described in these provisions may provide a more
expeditious approach to correcting a problem than withdrawing an
exemption (79 FR 58524 at 58553). We also disagree that the rule binds
us to take alternative regulatory action before issuing an order to
withdraw a qualified facility exemption, other than to notify the
facility in writing of circumstances that may lead us to withdraw the
exemption, provide an opportunity for the facility to respond in
writing, and consider the actions taken by the facility to address the
circumstances we describe. The rule clearly specifies that regulatory
actions such as a warning letter, recall, administrative detention,
suspension of registration, refusal of animal food offered for import,
seizure, and injunction are actions that we ``may'' (not ``must'') take
before issuing an order to withdraw a qualified facility
[[Page 56286]]
exemption. Providing the facility with an opportunity to correct the
problems before we take steps to withdraw an exemption has the
potential to save Agency resources associated with preparing an order,
responding to an appeal of the order and request for a hearing, and
administering a hearing. Directing resources to help a facility correct
problems, rather than to administer a withdrawal process that could be
resolved by the time of a hearing, is appropriate public health policy.
(Comment 403) Some comments ask us to specify that the notification
of circumstances that may lead FDA to withdraw the exemption must
include facts specific to the situation and information about how the
facility can remedy the situation.
(Response 403) By specifying that we must notify the facility of
circumstances that may lead us to withdraw an exemption, we mean that
we would include facts specific to the situation. It is the
responsibility of the facility, not FDA, to remedy the situation.
(Comment 404) Some comments ask us to state affirmatively that we
must not withdraw the exemption if the facility has satisfactorily
addressed the problematic conditions or conduct at the facility. These
comments assert that, without this affirmative statement, the
requirement that we ``consider the actions taken by the facility''
remains unclear.
(Response 404) We decline this request. If the facility has
satisfactorily addressed the problematic conditions or conduct, there
would be no problematic circumstances for us to describe in the order
withdrawing the qualified facility exemption.
(Comment 405) Some comments ask us to provide additional time for a
qualified facility to respond, in writing, to a notification of
circumstances that may lead us to withdraw its exemption. Comments
suggest timeframes of 60, 90, and 120 days as a reasonable or
appropriate period of time for a qualified facility to compile
information and documentation of facts and to respond to a notification
of circumstances that may cause us to withdraw its exemption. Some of
these comments express concern that the proposed deadline is too short,
and that the short timeframe violates the intent of the exemption. Some
comments ask us to establish graduated response times, with less
response time allowed for more serious animal food safety concerns.
(Response 405) We have revised the provision to provide for 15
calendar days, rather than 10 calendar days, for a facility to respond
in writing to our notification. The 15-day timeframe is the same as the
timeframe for responding to a warning letter. Circumstances that could
lead us to withdraw a qualified facility exemption require prompt
action on the part of a facility, just as circumstances that lead us to
issue a warning letter require prompt action.
(Comment 406) Some comments ask us to clarify how an exemption can
be revoked (and restored) on diversified farms that produce both exempt
and non-exempt products.
(Response 406) We assume that this comment is referring to a farm
mixed-type facility that produces some products (such as forage
products or plant protein meals) that are exempt from the requirements
for hazard analysis and risk-based preventive controls, as well as some
products that are not exempt from these requirements. Neither
withdrawing nor reinstating a qualified facility exemption would have
any impact on products that are not subject to the requirements for
hazard analysis and risk-based preventive controls. In contrast,
administrative procedures such as injunction and suspension of
registration likely would apply to all animal food production by the
facility.
(Comment 407) Some comments ask us to consistently use either
``calendar days'' or ``working days'' throughout the provisions
directed to withdrawal of an exemption. Some comments ask us to use
``business days'' rather than ``calendar days'' or ``working days.''
(Response 407) We have expressed the timeframes for all of the
withdrawal provisions in calendar days.
(Comment 408) Some comments ask us to clarify that the decision to
withdraw a qualified facility exemption is an individualized
determination and will not be applied to a class of farmers by stating
this clearly in the preamble.
(Response 408) The decision to withdraw a qualified facility
exemption is an individualized determination and will not be applied to
a class of facilities or farmers.
(Comment 409) Some comments assert that the timeframes for
responding to a notification that an exemption may be withdrawn should
be the same regardless of whether the notification is sent to a
qualified facility subject to the human or animal food preventive
controls rule or a farm subject to the produce safety rule. These
comments state that many small farms do value-added processing and will
be subject to both rules.
(Response 409) Although the produce safety rule is not yet final,
we intend to make the administrative procedures associated with
withdrawal of an exemption consistent to the extent practicable,
including the timeframe for responding to a notification.
(Comment 410) Some comments ask us to expand the scope of the
withdrawal provisions to include facilities that would satisfy criteria
for an exemption from the requirements for hazard analysis and risk-
based preventive controls for low-risk activity/food combinations
(i.e., the exemptions in proposed Sec. Sec. 507.5(e) and (f)).
(Response 410) We decline this request. Section 418 of the FD&C Act
does not provide for withdrawal of the exemptions established in Sec.
507.5(e) and (f). The withdrawal provision in section 418(l)(3) of the
FD&C Act is limited to qualified facilities.
B. Proposed Sec. 507.62--Issuance of an Order To Withdraw a Qualified
Facility Exemption
We proposed procedures for the steps we would take to issue an
order to withdraw an exemption applicable to a qualified facility,
including procedures that would: (1) Emphasize that a senior FDA
official (such as an FDA District Director, the Director of the
Division of Compliance in CVM, or a more senior FDA official) must
approve an order to withdraw the exemption before the order is issued;
(2) provide that any officer or qualified employee of FDA may issue the
order after it has been approved; (3) specify that we would issue the
order to the owner, operator, or agent in charge of the facility; and
(4) require that the order be in writing and be signed and dated by the
officer or qualified employee of FDA who is issuing the order.
(Comment 411) Some comments ask us to include in the procedures
timeframes for: (1) Submitting an order after an initial determination
that criteria for withdrawing an exemption are met; (2) approval or
denial by the FDA District Director; (3) issuing the withdrawal (with
automatic revocation of order if FDA does not issue the order within
the specified timeframe); and (4) delivery of the order to the owner,
operator, or agent in charge of the facility. Other comments recommend
that the procedures for issuing an order specify that we send the order
in a way that ensures its receipt, such as through certified mail with
confirmation of delivery to ensure the facility operator receives the
order.
(Response 411) We are not establishing timeframes for the steps we
take before a facility receives an order for withdrawal of an
exemption. The timeframes surrounding our internal
[[Page 56287]]
process for developing an order have no bearing on the time that a
facility will need to respond to the order or on the information it
will need to do so. We agree that it is appropriate to specify
timeframes for the procedural steps that follow a facility's receipt of
an order, and the withdrawal procedures include such timeframes.
We are not specifying that we send an order in a way that ensures
its receipt. Although certified mail with confirmation of delivery is
one way to ensure receipt, other methods are available, including
delivery through private carriers that provide mechanisms to document
receipt. In light of the provision (which we included in the 2014
supplemental notice) linking the timeframes for a facility to comply
with, or appeal, an order to the date of receipt of the order (rather
than to the date of the order), it will be up to us to deliver the
order in a way that provides us with evidence of receipt.
C. Proposed Sec. 507.65--Contents of an Order To Withdraw a Qualified
Facility Exemption
We proposed specific information that would be included in an order
to withdraw an exemption, including (1) The date of the order and the
name, address, and location of the qualified facility; (2) a brief,
general statement of the reasons for the order, including information
relevant to the circumstances that led us to issue the order; (3) a
statement that the facility must either comply with subpart C within
120 calendar days of receipt, or appeal the order within 10 calendar
days of receipt; (4) the text of section 418(l) of the FD&C Act and of
the withdrawal provisions in part 507, subpart D; (5) information about
an informal hearing on an appeal of the order; and (6) contact
information for appropriate senior FDA officials, as well as the name
and the title of the FDA representative who approved the order.
(Comment 412) Some comments recommend that the order specify which
of the two circumstances that could lead us to issue the order apply.
(Response 412) We have made editorial changes to the regulatory
text to make it more clear that the provision requires us to specify
which circumstance applies. (i.e., an active investigation of foodborne
illness, or conduct or conditions associated with the qualified
facility), or whether both of these two circumstances apply. See the
revised regulatory text for Sec. 507.65(c).
(Comment 413) Some comments ask us to add more specific
requirements for the content of an order to withdraw an exemption,
including specific evidence about the circumstances leading to the
order. The comments maintain that doing so would help the facility
respond with particularity to the facts and issues contained in the
order if the facility appeals the order. The comments also recommend
that the order include the evidence on which the order is based
including, as applicable, evidence linking the active investigation of
a foodborne illness outbreak directly to the facility or measurable
evidence (collected using generally accepted scientific standards)
indicating the presence in the facility of pathogens that pose an
imminent threat to public (human or animal) health, or conduct or
conditions that are material to the safety of animal food. The comments
also recommend that the order include, when applicable, a statement
explaining how altering the conduct or conditions would prevent or
mitigate a foodborne illness outbreak.
(Response 413) We agree that the order must provide sufficient
information to enable a facility to respond with particularity to
specific evidence about the circumstances leading to the order.
However, we disagree that the order must do so by including the
specific information recommended by the comments, and we have not
revised the proposed withdrawal provisions to incorporate the
suggestions of these comments. The comments appear to be more focused
on whether the circumstances that lead us to issue an order meet an
evidentiary standard than on explaining the problem so that a facility
can both understand the problem and respond with particularity to the
facts and issues contained in the order. The withdrawal provisions that
we are establishing in this provision require the order to include a
brief, general statement of the reasons for the order, including
information relevant to: (1) An active investigation of a foodborne
illness outbreak that is directly linked to the facility; or (2)
conditions or conduct associated with a qualified facility that are
material to the safety of the animal food manufactured, processed,
packed, or held at the facility. The requirements that we are
establishing in this provision would enable a qualified facility to
both understand the problem and respond to it. In addition, because
other requirements in these withdrawal provisions specify that we must
notify a qualified facility of circumstances that may lead us to
withdraw its exemption before we issue the actual order, the order
withdrawing the exemption would be the second time that the facility
hears about the problems (see Sec. 507.60(b)(2)). We intend that the
process of responding to the notification that we must send before
issuing an order to withdraw an exemption, including discussing the
problems with FDA as warranted, would provide additional information to
the facility to enable the facility to both understand the problem and
respond to it.
(Comment 414) Some comments ask us to provide 15 ``business days''
from date of receipt of the order, rather than the proposed 10 calendar
days from date of receipt of the order, for the facility to appeal the
order.
(Response 414) We have revised the provision to provide for 15
calendar days, rather than 15 business days, for a facility to appeal
the order. We also have made conforming changes to establish the same
15 calendar day timeframe in all provisions that specify the timeframe
to appeal the order (i.e., Sec. Sec. 507.67(a)(2), 507.69(a)(1), and
507.71(a)(2)). We also extended the timeframe for the hearing to be
held to be within 15 calendar days, rather than the proposed 10
calendar days, after the date the appeal is filed to provide more time
for the facility to prepare for the hearing (see Sec. 507.73(a)). The
timeframe for the hearing to be held continues to provide for an
alternative timeframe agreed upon in writing by both the facility and
FDA; a facility that would have preferred the proposed timeframe of 10
calendar days could request that the hearing be held more quickly than
15 calendar days.
The 15-day timeframe is the same as the timeframe for responding to
a warning letter. Circumstances that could lead us to withdraw a
qualified facility exemption require prompt action on the part of a
facility, just as circumstances that lead us to issue a warning letter
require prompt action.
(Comment 415) Some comments support the proposed timeframe of 120
calendar days for a qualified facility whose exemption has been
withdrawn to comply with the animal food preventive controls rule, but
ask us to make the timeframe for complying with a FSMA rule the same
regardless of whether the exemption is withdrawn from a qualified
facility subject to the animal food preventive controls rule or from a
farm subject to the produce safety rule. Other comments ask us to
extend the timeframe to come into compliance, e.g., to 1 or 2 years.
Some of these comments suggest that qualified facilities should have
120 days to develop a plan of action, but 2 years to fully comply. Some
of the comments argue that large farms and
[[Page 56288]]
manufacturers are given a year to come into compliance, and that
requiring small and very small businesses to comply in a shorter time
period would effectively drive them out of business. Other comments ask
us to consider provisions that would require compliance with only those
portions of the rule that formed the basis for the revocation.
(Response 415) We continue to believe that the 120-day timeframe is
adequate, but we have added flexibility such that a facility may
request, with a justification in writing to FDA, a reasonable timeframe
for compliance that exceeds 120 calendar days from the receipt of the
order. FDA must grant the request for the facility to receive the
extended timeframe. We are not generally extending the timeframe
because circumstances that could lead us to withdraw a qualified
facility exemption require prompt action on the part of a facility. A
qualified facility that receives an order to withdraw its exemption
would have received advance notification of the circumstances leading
to the order and would have had an opportunity to correct the problems
rather than have us proceed to issue the order (see Sec. 570.60(b)).
If the facility requests a hearing, more than 40 days could elapse
between the date that the facility receives the order and the date that
the presiding officer for the hearing confirms the order to withdraw
the exemption. Given that the circumstances that would lead us to issue
the order involve either: (1) An active investigation of a foodborne
illness outbreak that is directly linked to the qualified facility or
(2) a determination that withdrawal of the exemption is necessary to
protect the public (human or animal) health and prevent or mitigate a
foodborne illness outbreak based on conditions or conduct associated
with the qualified facility that are material to the safety of the
animal food manufactured, processed, packed, or held at the facility, a
delay of 1 to 2 years to comply with the rule is not warranted. We also
do not believe that it would be appropriate to require a facility to
come into compliance with only those provisions that formed the basis
of the revocation. The provisions of subparts C and E are interrelated
and operate as a system and therefore are not optimized through
piecemeal implementation. However, FDA may consider staggered
implementation as an option in granting a request for an extension of
the timeframe to comply with an order to withdraw the exemption for a
qualified facility.
As already discussed, the new requirements for hazard analysis and
risk-based preventive controls are not ``one-size-fits-all.'' Although
each facility subject to the rule must prepare and implement a food
safety plan, the preventive controls that the facility would establish
and implement would depend on the facility, the animal food, and the
outcome of the facility's hazard analysis. In addition, the preventive
control management components that a facility would establish and
implement for its preventive controls would be established as
appropriate to ensure the effectiveness of the preventive controls,
taking into account the nature of the preventive control and its role
in the facility's animal food safety system.
Although the produce safety rule is not yet final, we intend to
make the administrative procedures associated with withdrawal of an
exemption consistent to the extent practicable, including the timeframe
to comply with the applicable rule if an exemption is withdrawn.
(Comment 416) Some comments ask us to include in the order a
statement that a facility may request that FDA reinstate an exemption
that was withdrawn by following the procedures in Sec. 507.85.
(Response 416) We have revised the requirements for the contents of
an order as requested by these comments.
D. Proposed Sec. 507.67--Compliance With, or Appeal of, an Order To
Withdraw a Qualified Facility Exemption
We proposed that: (1) You must either comply with applicable
requirements of part 507 within 120 calendar days of receipt, or appeal
the order within 10 calendar days of receipt; (2) submission of an
appeal, including submission of a request for an informal hearing, will
not operate to delay or stay any administrative action unless the
Commissioner of FDA, as a matter of discretion, determines that delay
or a stay is in the public interest; and (3) if you appeal the order,
and we confirm the order, you must comply with applicable requirements
of part 507 within 120 calendar days of confirmation of receipt of the
order.
(Comment 417) Some comments ask us to specify that a qualified
facility that loses its exemption from the requirements for hazard
analysis and risk-based preventive controls would no longer need to
comply with the modified requirements that apply to qualified
facilities that have an active exemption.
(Response 417) A qualified facility that loses its exemption from
the requirements for hazard analysis and risk-based preventive controls
would no longer need to comply with the modified requirements that
apply to qualified facilities that have an active exemption. To make
this clearer, the final withdrawal procedures now include this
information (see the regulatory text for Sec. 507.67(c)).
E. Proposed Sec. 507.69--Procedure for Submitting an Appeal
We proposed that (1) To appeal an order, you must submit a written
appeal to FDA within 15 calendar days of receipt and respond with
particularity to the facts and issues contained in the order, including
any supporting documentation upon which you rely; and (2) In your
written appeal, you may include a written request for an informal
hearing.
(Comment 418) Some comments ask us to rely on records kept in the
normal course of business for documentation that will be sufficient to
respond to an order to withdraw a qualified facility's exemption,
rather than requiring a facility to ``respond with particularity to the
facts and issues contained in the order, including any supporting
documentation upon which the owner, operator or agent in charge of the
facility relies.'' These comments assert that we should not require a
facility that submits a written appeal to provide documents and records
that they are not required to keep.
(Response 418) We decline this request. In a withdrawal action, FDA
is providing a qualified facility multiple opportunities to persuade
FDA that withdrawal is not appropriate. If the facility relies on
documentation as part of its response, it is reasonable to require that
this documentation be provided to FDA.
F. Proposed Sec. 507.71--Procedure for Requesting an Informal Hearing
We proposed that if you appeal the order: (1) You may request an
informal hearing, and must do so together with your written appeal
(within 15 calendar days of the date of receipt of the order and (2) a
request for an informal hearing may be denied, in whole or in part, if
the presiding officer determines that no genuine and substantial issue
of material fact has been raised by the material submitted; you would
receive written notice of the presiding officer's determination,
explaining the reason for the denial.
(Comment 419) Some comments ask us to guarantee a hearing so that a
qualified facility can present its case in
[[Page 56289]]
person before having its exemption revoked.
(Response 419) We decline this request. We agree that a qualified
facility has a right to appeal an order to withdraw an exemption, and
we have provided for a right to appeal.
G. Proposed Sec. 507.73--Requirements Applicable to an Informal
Hearing
We proposed that if you request an informal hearing, and we grant
the request: (1) The hearing will be held within 10 calendar days after
the date the appeal is filed or, if applicable, within a timeframe
agreed upon in writing by you and by us; (2) the presiding officer may
require that the hearing be completed within 1 calendar day; and (3) we
must conduct the hearing in accordance with part 16 (21 CFR part 16),
with some specified modifications, including that no party shall have
the right, under Sec. 16.119, to petition FDA for reconsideration or a
stay of the presiding officer's final decision.
(Comment 420) Some comments object to our proposal that no party
shall have the right, under Sec. 16.119 to petition FDA for
reconsideration or a stay of the presiding officer's final decision.
These comments assert that our justification (i.e., that the
circumstances that would lead to a withdrawal merit prompt action and
that a facility has the opportunity for judicial review in accordance
with 21 CFR 10.45) is not a sufficient argument for justifying the
removal of the option to file a motion for reconsideration or stay.
These comments ask us to revise proposed Sec. 507.73(c)(6) to specify
that the qualified facility shall have the right to file a motion for
reconsideration or stay.
(Response 420) We decline this request. In the 2014 supplemental
controls notice, we proposed an additional mechanism for a qualified
facility to present its view that its exemption should not be
withdrawn, i.e., by providing advance written notification to a
qualified facility if we are considering withdrawing an exemption and
providing an opportunity for the facility to respond before we issue an
order to withdraw an exemption. We also proposed to provide an
opportunity for reinstatement of an exemption that had been withdrawn.
We believe the multiple opportunities now available to a facility
provide adequate opportunities for a facility's views to be considered,
and further mechanisms are not warranted.
H. Proposed Sec. 507.85--Reinstatement of a Qualified Facility
Exemption That Was Withdrawn
We proposed four provisions for reinstating a withdrawn qualified
facility exemption. First, we proposed that if the FDA District
Director in whose district your facility is located (or, in the case of
a foreign facility, the Director of the Division of Compliance in CVM)
determines that a facility has adequately resolved problems with the
conditions and conduct that are material to the safety of the animal
food manufactured, processed, packed, or held at the facility and that
continued withdrawal of the exemption is not necessary to protect
public health and prevent or mitigate a foodborne illness outbreak, the
FDA District Director in whose district your facility is located (or in
the case of a foreign facility, the Director of the Division of
Compliance in CVM) will, on his own initiative or on the request of a
facility, reinstate the exemption (proposed Sec. 507.85(a)).
Second, we proposed that you may ask FDA to reinstate an exemption
that has been withdrawn by following specific steps (Sec. 507.85(b)(1)
and (2)). Third, we proposed that if your exemption was withdrawn in
the event of an active investigation of a foodborne illness outbreak
that is directly linked to your facility and FDA later determines,
after finishing the active investigation of a foodborne illness
outbreak, that the outbreak is not directly linked to your facility,
FDA will reinstate your qualified facility exemption and will notify
you in writing that your exempt status has been reinstated.
We proposed that if your exemption was withdrawn both in the event
of an active investigation of a foodborne illness outbreak that is
directly linked to your facility and because FDA had determined that it
is necessary to protect the public (human or animal) health and prevent
or mitigate a foodborne illness outbreak based on conditions or conduct
associated with your facility that are material to the safety of the
animal food manufactured, processed, packed, or held at such facility,
and FDA later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will inform you of this finding, and you may ask FDA
to reinstate your qualified facility exemption.
(Comment 421) Some comments agree with our tentative conclusion
that the absence of a specific provision in section 418 of the FD&C Act
for the reinstatement of an exemption that is withdrawn does not
preclude us from providing for such a process (79 FR 58524 at 58553).
Other comments disagree with that tentative conclusion and assert that
Congress crafted the withdrawal provision as a ``one strike, you're
out'' provision. These comments also assert that including the
withdrawal provision as a ``one strike, you're out'' provision was an
essential part of the legislative agreement that allowed for adoption
of the qualified facility exemption. These comments also assert that
reinstatement would undermine the intent of the withdrawal provision
because it would reduce the incentive for small animal food processors
to ensure that the products they sell are as safe as possible. These
comments also assert that a recognized principle of statutory
interpretation provides that exemptions to statutes should be strictly
construed, particularly when the statute addresses public health and
safety, and that we are giving the exemption an impermissibly broad
construction.
Some comments ask why we believe that a business deserves a
``second bite of the apple'' in light of the understanding (under
proposed Sec. 507.60(b) and (c)) that we will first seek to correct
problems before considering withdrawal. These comments also question at
what point a facility would apply for reinstatement, and ask why we
would allow a facility that has already come into compliance with
FSMA's requirement to implement preventive controls to abandon those
controls in favor of reinstating its exempt status. These comments ask
us to eliminate the proposed provisions allowing for reinstatement.
Some comments do not support the proposed reinstatement provisions
when an animal food facility has been directly linked to a foodborne
illness outbreak. Some comments support the proposed reinstatement
provisions only when we determine, after finishing an active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to the facility that had its exemption withdrawn.
(Response 421) We disagree that the proposed reinstatement
provisions would give the exemption an impermissibly broad
construction. The express statutory language of section 418(l) of the
FD&C Act does not support the comments' assertion that the withdrawal
provision is a ``one strike, you're out'' provision. We also disagree
that reinstatement would undermine the intent of the withdrawal
provision because it would reduce the incentive for small animal food
processors to ensure that the products they sell are as
[[Page 56290]]
safe as possible. We expect that the withdrawal provision itself
provides a big incentive for small animal food processors to ensure
that the products they sell are as safe as possible because of the
business disruption that would occur if they are subject to withdrawal
of the exemption. We proposed that a facility would need to present
data and information to demonstrate that it has adequately resolved the
problems with the conditions or conduct that are material to the safety
of the animal food manufactured, processed, packed, or held at the
facility, such that continued withdrawal of the exemption is not
necessary to protect public (human or animal) health and prevent or
mitigate a foodborne illness outbreak.
We disagree that we should categorically refuse to consider
reinstating a qualified facility exemption if we had withdrawn the
exemption because an animal food facility had been directly linked to a
foodborne illness outbreak. First, if information later comes to light
to raise considerable doubt that a qualified facility had, indeed, been
directly linked to a foodborne illness outbreak, and conditions and
conduct at the facility do not otherwise warrant withdrawing the
facility's exemption, it would be appropriate for us to reinstate the
facility's exemption. Second, we would only reinstate the exemption if
we determined that a facility has adequately resolved any problems with
the conditions and conduct that are material to the safety of the
animal food manufactured, processed, packed, or held at the facility
and that continued withdrawal of the exemption is not necessary to
protect public (human or animal) health and prevent or mitigate a
foodborne illness outbreak.
(Comment 422) Some comments that support the reinstatement of a
withdrawn exemption ask us to establish a timeframe within which FDA
will reinstate an exemption. Some comments ask us to specify in the
regulatory text that the reinstatement would occur in a reasonable
period of time, both in circumstances where FDA has decided on its own
initiative to reinstate the exemption and in circumstances where a
facility submits a request for reinstatement. Some comments suggest 10
days is a reasonable period of time within which FDA should reinstate
an exemption.
(Response 422) We decline the requests to establish a timeframe for
reinstatement in the regulatory text. If we determine on our own
initiative to reinstate an exemption (e.g., because we later determine,
after finishing the active investigation of a foodborne illness
outbreak, that the outbreak is not directly linked to the facility),
our determination would be effective immediately. If we receive a
request to reinstate a withdrawn exemption, we intend to respond in a
reasonable timeframe consistent with available resources. In some
cases, we may respond that we need more information in order to
evaluate your request.
(Comment 423) Some comments ask that the process for reinstatement
include at least one level of administrative appeal if we deny a
facility's request for reinstatement.
(Response 423) We have not revised the regulatory text to provide
for an administrative appeal if we deny a facility's request for
reinstatement. Existing procedures allow a facility to ask for a
meeting with applicable FDA officials (see Sec. 10.65(c)) and appeal
our decision if we deny the request (see Sec. 10.75).
(Comment 424) Some comments ask us to establish a 1-year
probationary period before the withdrawn qualified facility exemption
could be fully reinstated.
(Response 424) We decline this request. We intend to act on a
request for reinstatement based on the merits of the data and
information presented in the request, not after a pre-determined
timeframe.
I. Conforming Amendment to 21 CFR Part 16
We proposed to amend Sec. 16.1(b)(2) to include part 507, subpart
D, relating to the withdrawal of an exemption applicable to a qualified
facility, to the list of regulatory provisions under which regulatory
hearings are available. We received no comments that disagreed with
this proposed provision, and are finalizing it as proposed.
J. Other Comments on the Withdrawal Provisions
(Comment 425) Several comments ask us to provide clarification
through guidance, issued for public comment, on a variety of topics
associated with the withdrawal provisions.
(Response 425) We will consider the need for guidance in the
future. At this time, we consider that withdrawing an exemption would
be both rare and dependent upon the circumstances. We need to direct
our resources to developing guidance on issues that would apply more
broadly, and more generally, than the withdrawal provisions.
(Comment 426) Some comments ask detailed questions about how we
would coordinate the withdrawal process with the States.
(Response 426) In general, we work with our State partners and
other government counterparts in dealing with enforcement actions,
including coordinating actions or deferring to each other when one
department has authority to swiftly act to protect the consumer. In the
specific case of this rule, we are working through the PFP to develop
and implement a national Integrated Food Safety System consistent with
FSMA's emphasis on establishing partnerships for achieving compliance
(see Response 2 and section 209(b) of FSMA).
(Comment 427) Some comments ask us to add provisions regarding
notification of the appropriate State regulatory agency when a
qualified facility exemption is withdrawn and reinstated.
(Response 427) We decline this request. As previously noted, we are
sensitive to the time required for various inspection activities and
intend to communicate with States regarding our expectations for how to
verify whether a facility is a qualified facility. The status of a
facility as a qualified facility principally affects the requirements
that it is subject to, and will be most useful to FDA and our food
safety partners when preparing for inspection. At this time we do not
intend to establish a system notifying the applicable State authorities
at a point in time when the status of a facility as a qualified
facility changes, whether as a result of withdrawal or reinstatement of
a qualified facility exemption or because the facility's business has
grown to the point where it exceeds the financial for very small
business.
XL. Subpart E: General Comments on Proposed Requirements for a Supply-
Chain Program
In the 2014 supplemental notice, we provided an opportunity for
public comment on potential requirements for a supplier program as a
preventive control. The supplier program for a receiving facility would
be limited to those raw materials and other ingredients for which the
receiving facility has identified a significant hazard (which we now
refer to as a ``hazard requiring a preventive control''). Under the
definitions established in this rule, ``supplier'' means the
establishment that manufactures/processes the food, raises the animal,
or grows the food that is provided to a receiving facility without
further manufacturing/processing by another establishment, except for
further manufacturing/processing that consists solely of the addition
of labeling or similar activity of a de
[[Page 56291]]
minimis nature; ``receiving facility'' means a facility that is subject
to subparts C and E and that manufactures/processes a raw material or
other ingredient that it receives from a supplier (see Sec. 507.3).
We previously explained our understanding that, particularly for
RACs, there may be multiple establishments, including cooperatives,
packing houses, and distributors, between a receiving facility and the
establishment that would be considered the supplier, which would make
supplier verification very challenging under certain circumstances (79
FR 58476 at 58497). We requested comment on what verification
activities would be appropriate for receiving facilities to conduct
when a raw material or ingredient passes through more than one facility
that would not be required to verify control of hazards if supplier
programs are limited to manufacturers/processors. We discussed an
example in which a receiving facility is a feed mill that receives oats
from a distributor, who receives grains from a cooperative, and neither
the distributor nor the cooperative is required to establish supplier
controls for the farms, where the hazards are being controlled, and
asked what supplier controls should be applied for the grains coming
from the farms. We requested comment on whether and how the
requirements for supplier verification should address such situations.
We also requested comment regarding whether (and, if so, how) the final
preventive controls rule for animal food should address the potential
for gaps in supplier controls when a hazard is controlled at Point A in
the supply chain, and Point B in the supply chain is a facility that
only packs or holds animal food, but does not manufacture/process
animal food (and therefore would not be required to have a supplier
program) before passing it on to Point C in the supply chain.
In the remainder of this section, we discuss comments that address
our request for comment on complex supply-chain scenarios such as those
described in the 2014 supplemental notice. We also describe our reasons
for revising the proposed requirements for a supplier program to
provide additional flexibility for an entity other than the receiving
facility to determine, conduct, and document the appropriate supplier
verification activities. When an entity other than the receiving
facility determines, conducts, or both determines and conducts the
appropriate supplier verification activities, the receiving facility
must review and assess that entity's applicable documentation, and
document the receiving facility's review and assessment. Providing this
additional flexibility required a series of changes to multiple
proposed provisions. To improve clarity and readability, we
redesignated proposed Sec. 507.36 into eight distinct sections of
regulatory text in a newly established subpart E (Supply-Chain
Program), with editorial changes associated with the new structure of
the redesignated regulations. See table 22 for the section numbers and
titles in subpart E. See table 23 for an overview of the major
revisions to the proposed requirements for a supply-chain program. See
sections XLI through XLVII for a discussion of the specific provisions
of the final requirements for a supply-chain program, and tables 24 to
29 for more detailed summaries of revisions to these specific
provisions. Because table 23 is an overview, the changes identified in
table 23 appear again in, tables 24 to 29. Because the editorial
changes associated with the redesignation are extensive, we do not list
them in table 31.
The title of subpart E is ``Supply-Chain Program'' rather than
``Supplier Program.'' As shown in table 23 and discussed in more detail
in section XLI.D, we have added one requirement applicable to non-
suppliers. ``Supply-chain program'' is a more appropriate term to
reflect a subpart that includes a requirement applicable to
nonsuppliers in addition to the requirements applicable to suppliers.
In the remainder of this document, we use the phrase ``supply-chain
program'' in section headings and when referring to the provisions of
the final rule. We continue to use the term ``supplier program'' when
describing the proposed provisions and the comments regarding the
proposed provisions.
Table 22.4--Redesignation of the Requirements for a Supply-Chain Program
in Subpart E
[Supply-chain program]
------------------------------------------------------------------------
Section Description
------------------------------------------------------------------------
507.105.............................. Requirement to establish and
implement a supply-chain
program.
507.110.............................. General requirements applicable
to a supply-chain program.
507.115.............................. Responsibilities of the receiving
facility.
507.120.............................. Using approved suppliers.
507.125.............................. Determining appropriate supplier
verification activities
(including determining the
frequency of conducting the
activity).
507.130.............................. Conducting supplier verification
activities for raw materials and
other ingredients.
507.135.............................. Onsite audit.
507.175.............................. Records documenting the supply-
chain program.
------------------------------------------------------------------------
Table 23.5--Overview of Revisions to the Proposed Requirements for a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
Proposed section
Final section designation designation Description Revision
----------------------------------------------------------------------------------------------------------------
Throughout........................ Throughout........... The type of preventive Refer to ``supply-chain-
control applicable to the applied control'' rather
supply-chain program. than ``preventive
control'' or variations
such as ``hazard
requiring a preventive
control when the hazard
is controlled before
receipt of the raw
material or other
ingredient.''
507.36(a)(2) (in subpart C)....... 507.37(a)(1)(ii)..... A supply-chain program is Shifted to be in
not required when the provisions outside the
hazard will be controlled framework of the supply-
by the receiving chain program in subpart
facility's customer in E.
the distribution chain.
[[Page 56292]]
507.105(a)(2)..................... N/A.................. Circumstances that do not The receiving facility
require a supply-chain does not need a supply-
program. chain program when the
receiving facility is an
importer, is in
compliance with the
forthcoming FSVP
requirements, and has
documentation of
verification activities
conducted under the
forthcoming FSVP
program.
507.105(a)(3)..................... N/A.................. Exemption from the Exemption for animal food
requirements for a supply- supplied for research or
chain program. evaluation.
507.105(c)........................ N/A.................. Requirements applicable to When a supply-chain-
non-suppliers. applied control is
applied by an entity
other than the receiving
facility's supplier
(e.g., when a
nonsupplier applies
controls to certain
produce (i.e., produce
that will be subject to
the forthcoming produce
safety rule), because
growing, harvesting, and
packing activities are
under different
management), the
receiving facility must
(1) verify the supply-
chain-applied control;
or (2) obtain
documentation of an
appropriate verification
activity from another
entity in the supply
chain, review and assess
the entity's applicable
documentation, and
document that review and
assessment.
507.110(c)........................ 507.37(a)(3)(ii)..... Purpose of the supply- Specify only that the
chain program. supply-chain program
must provide assurance
that a hazard requiring
a supply-chain-applied
control has been
significantly minimized
or prevented.
507.110(d)........................ 507.37(b)............ Factors that must be Clarification
considered in determining that these factors must
appropriate supplier be considered in
verification activities. approving suppliers, as
well as in determining
appropriate supplier
verification activities.
Flexibility in
the factors that must be
considered if a supplier
is a qualified facility,
a produce farm that will
not be subject to the
forthcoming produce
safety rule on the basis
of size and/or direct
farm marketing, or a
shell egg producer that
is not subject to the
requirements of 21 CFR
part 118 (production,
storage, and
transportation of shell
eggs) because it has
less than 3,000 laying
hens.
507.115(a)........................ N/A.................. Responsibilities of the Provide flexibility for
receiving facility. an entity other than the
receiving facility to
determine, conduct, and
document supplier
verification activities,
provided that the
receiving facility
reviews and assesses
applicable documentation
from that entity and
documents the receiving
facility's review and
assessment.
507.115(b)........................ N/A.................. Responsibilities of the Specify documentation
receiving facility. that a receiving
facility may not accept
from a supplier to
satisfy the receiving
facility's
responsibilities for its
supply-chain program.
507.120(a)........................ 507.37(a)(3)(i)...... Approval of suppliers..... Explicit requirement for
a receiving facility to
approve its suppliers.
507.120(b)........................ 507.37(a)(3)(i)...... Approval of suppliers..... Explicit requirement for
a receiving facility to
establish and follow
written procedures for
receiving raw materials
and other ingredients.
507.130(e)........................ N/A.................. Alternative supplier Provide for an
verification activity. alternative supplier
verification activity
when the supplier is a
shell egg producer with
less than 3,000 laying
hens.
507.130(f)........................ N/A.................. Independence of the Specify that there must
supplier. not be any financial
conflicts of interests
that influence the
results of the
verification activities
listed in Sec.
507.110(b) and payment
must not be related to
the results of the
activity.
[[Page 56293]]
507.135(c)(1)..................... 507.37(e)............ Substitution of an Provide additional
inspection for an audit. flexibility for domestic
inspection by
representatives of other
Federal Agencies (such
as USDA), or by
representatives of
State, local, tribal, or
territorial agencies.
507.175........................... 507.37(g)............ Records documenting the List additional records
supply-chain program. associated with the
revised provisions.
----------------------------------------------------------------------------------------------------------------
(Comment 428) Several comments ask us to issue guidance rather than
establish requirements for a supplier program in the rule. Some
comments assert that the benefits of a supplier verification program do
not outweigh the costs; that we did not consider the effects of such a
requirement on farms and small businesses; and that FSMA does not
actually contain a requirement for a supplier verification program.
Conversely, other comments support including a mandatory supplier
program in the rule for hazards that are controlled in raw materials
and other ingredients before receipt by the receiving facility,
although many comments assert that a supplier verification program
should be viewed as a verification activity rather than a preventive
control. Some comments assert that a mandatory domestic supplier
program is necessary to provide parity with the requirements of the
FSVP rule authorized by FSMA, while other comments assert that FSMA's
authorization of foreign supplier verification should not be used to
justify a domestic supplier program. Some of these comments single out
our request for comment, in the proposed FSVP rule, on whether to allow
an entity that would be both an importer (under the FSVP rule) and a
receiving facility (under the animal food preventive controls rule) to
be deemed in compliance with the FSVP rule if it was in compliance with
the supplier verification provisions of the animal food preventive
controls rule, and agree with such an approach (78 FR 45730 at 45748).
(Response 428) We agree that it is necessary to include a mandatory
supply-chain program in the rule to ensure the safety of animal food
where hazards are controlled in raw materials and other ingredients
before receipt by a receiving facility, and we are finalizing such a
requirement in this rule. The statute specifically identifies supplier
verification activities as a preventive control (see section 418(o)(3)
of the FD&C Act). Further, we believe a supply-chain program is a
measure that a person knowledgeable about food safety would establish
and implement in order to significantly minimize or prevent hazards
requiring a preventive control in an incoming raw material or other
ingredient.
Supplier verification is sufficiently important for the control of
hazards in both domestic and imported animal foods that FSMA contains
provisions for both domestic and foreign supplier verification
(sections 418(o)(3) and 805 of the FD&C Act). Because we have aligned
the provisions for supplier verification in the FSVP rule with the
provisions for a supply-chain program in this rule, we are allowing
importers and receiving facilities to take advantage of that fact in
considering compliance with both part 507 and our forthcoming FSVP
regulations that we proposed to establish in part 1, subpart L, so that
they do not have to duplicate verification activities (see Sec.
507.105(a)(2)).
(Comment 429) Some comments that addressed questions we asked in
the 2013 proposed preventive controls rule for animal food and the 2014
supplemental notice recommend that we add flexibility to the
requirements for a supplier program such that any entity in the supply
chain between the supplier and the receiving facility can perform
supplier verification activities. Some comments ask us to allow a
receiving facility to have a supplier program established for it by
another entity. Other comments assert that it would be too burdensome
for a receiving facility to consider any information related to the
supplier's supplier or to go further back in the supply chain beyond
the entity that is one back from the receiving facility. Other comments
assert that we should eliminate any requirements for a supplier program
from the rule because a supplier program involving more entities than
just the receiving facility and the supplier would become too complex.
Some comments express concern that we would be creating ``an
environment where our supply chain is required to be disclosed to our
customers via product testing, audits and supplier verification,''
asserting that this would discourage customers from buying from
entities such as repackers when they could go to the source. Some
comments state that we have not taken into account the low-risk nature
of some industries. Other comments ask us to confirm that distributors
and warehouses are not included in the requirements for a supplier
program because they would not likely meet the definition of a
receiving facility or a supplier.
(Response 429) We agree with comments recommending additional
flexibility in the supply-chain program with regard to who can perform
certain activities and have added this flexibility to the final rule
(see Sec. 507.115). Because the receiving facility and the supplier
may be separated by several entities in a supply chain, we are allowing
such entities (e.g., distributors, brokers, aggregators) to determine,
conduct, and document supplier verification activities as a service to
the receiving facility, provided that the receiving facility reviews
and assesses applicable documentation provided by the other entity and
documents that review and assessment. However, because the approval of
suppliers is ultimately the responsibility of the receiving facility,
the rule specifies that only a receiving facility can approve suppliers
(see Sec. Sec. 507.115(a)(1) and 507.120(a) and Response 430).
We disagree that complex supply chains make a supply-chain program
too difficult and that a receiving facility cannot be expected to reach
further back in a supply chain than the entity immediately before it in
the supply chain. Supply-chain programs are currently used by
facilities as a standard business practice and we understand that some
of those supply chains are complex, with entities between the receiving
facility and the supplier. We acknowledge that complex supply chains
present a challenge because information will need to flow through
several entities to allow the link between the receiving facility and
the
[[Page 56294]]
supplier. However, we believe a supply-chain program is a critical
preventive control for receiving facilities that will rely on suppliers
to control hazards in raw materials and other ingredients. Although
distributors, brokers, and other entities in the supply chain between a
receiving facility and its supplier are not required to have a role in
supplier verification, they have the option to determine, conduct, and
document supplier verification activities as a service to the receiving
facility if they so choose. If these entities choose not to participate
in supplier verification, the receiving facility will need to reach
back in the supply chain past them. In such situations, it may be
necessary for the entities between the receiving facility and the
supplier to provide the identity of the supplier to the receiving
facility, if that identity is not available on the raw material or
other ingredient or otherwise apparent. In such cases, the role that
distributors, brokers, aggregators and similar entities would play in
supplier verification would be minimal. We cannot determine whether
having to provide the identity of the supplier to the receiving
facility would change buying practices. However, we believe that
manufacturers consider a number of factors in determining who they will
purchase from, including the services provided, and that there will
continue to be a role for aggregators, repackers, brokers and others.
We have provided flexibility for these entities to play a role in
supplier verification if the receiving facility and the business entity
determine there is a benefit to do so.
See also the discussion in section XLIII regarding the specific
provisions of Sec. 507.115. Although comments focus on flexibility for
an entity in the supply chain between the supplier and the receiving
facility to perform supplier verification activities, and such entities
are the most likely to be determining, conducting, and documenting
supplier verification activities, the flexibility provided by the rule
is not limited to such entities.
(Comment 430) Some comments ask us to establish a general
requirement for a supplier program without specifying roles and
responsibilities for the various entities involved. Other comments ask
us to define ``supplier'' as the entity with which the receiving
facility has a commercial relationship.
(Response 430) We disagree that we should establish a general
requirement for a supply-chain program without specifying roles and
responsibilities for the various entities involved. Although we have
added flexibility to provide that an entity other than the receiving
facility may determine, conduct, and document supplier verification
activities (see Sec. 507.115), we continue to believe it is important
to clearly define two roles in the supply chain that share the primary
responsibility in the supplier verification process--i.e., the
receiving facility and the supplier. In all cases where we have added
flexibility for participation by an entity other than the receiving
facility, the responsibility for the supply-chain program is clearly
lodged with the receiving facility, and linked to the supplier (see
Sec. 507.115). To emphasize the responsibility of the receiving
facility and its link to the supplier, the final rule clearly states
that the receiving facility must approve its suppliers before receiving
raw materials and other ingredients (see Sec. 507.120(a)).
For the supply-chain program to be meaningful and robust, there
must be an exchange of information between these two entities--the
entity receiving the animal food and the entity that controlled the
hazard--even when an entity other than the receiving facility
participates by determining, conducting, and documenting some supplier
verification activities. The ultimate responsibility for supplier
verification rests with the receiving facility through its
determination in approving suppliers and in reviewing and assessing
applicable documentation provided by another entity. Therefore, we also
disagree that the definition of ``supplier'' should be revised to be
the next entity back in a supply chain (e.g., the entity with which a
receiving facility has a commercial relationship). The entity with
which a receiving facility has a commercial relationship might be a
distributor, broker or aggregator. A distributor, broker or aggregator
does not control an identified hazard and, therefore, cannot assume the
same role as an establishment that manufactures/processes the animal
food, raises the animal, or grows the food.
(Comment 431) Some comments ask us to provide flexibility in the
content of the supplier program. Some comments assert that specifying
the content of the supplier program would result in duplicative
requirements on suppliers, who must first comply with certain
regulations and then demonstrate that compliance in order to comply
with a different regulation.
(Response 431) We disagree that a requirement for a supply-chain
program in which compliance with an underlying regulation is
demonstrated is duplicative with the need to comply with the underlying
regulation. The requirement for a supply-chain program is not mandating
that the facility or farm comply twice with the animal food preventive
controls rule or the produce safety rule; it is merely requiring that
the compliance by the facility or the farm with the applicable
regulation be verified to ensure that hazards requiring a preventive
control are being controlled.
We are continuing to specify the basic content of a supply-chain
program, i.e., using approved suppliers; determining appropriate
supplier verification activities; conducting supplier verification
activities; and establishing records documenting these activities (see
Sec. 507.110(a)). However, the rule provides flexibility in the choice
of supplier verification activities and how often such activities must
be performed. (See Sec. Sec. 507.110(b)(4) and 507.130(b)(2), (c),
(d), and (e)). In addition, the rule provides for an alternative
supplier verification activity for certain entities (see Sec.
507.130(c), (d), and (e) regarding alternative supplier verification
activities for qualified facilities, certain produce farms, and certain
shell egg producers, respectively).
XLI. Subpart E: Comments on Requirement To Establish and Implement a
Supply-Chain Program
We proposed that the receiving facility must establish and
implement a risk-based supplier program for those raw materials and
ingredients for which the receiving facility has identified a
significant hazard when the hazard is controlled before receipt of the
raw material or ingredient (proposed Sec. 507.37(a)). We also proposed
circumstances when a receiving facility would not be required to have a
supplier program.
In the following sections, we discuss comments that ask us to
clarify the proposed requirement to establish and implement a written
supplier program or that disagree with, or suggest one or more changes
to, the proposed requirements. After considering these comments, we
have revised the regulatory text as shown in table 24.
[[Page 56295]]
Table 24--Revisions to the Proposed Requirements To Establish and Implement a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
Proposed section
Final section designation designation Description Revision
----------------------------------------------------------------------------------------------------------------
N/A............................... 507.37(a)(1)(ii)..... A supplier program is not Deleted as unnecessary.
required when there are
no hazards requiring a
preventive control.
N/A............................... 507.37(a)(1)(ii)..... A supplier program is not Deleted as unnecessary.
required when the
preventive controls at
the receiving facility
are adequate to
significantly minimize or
prevent each of the
hazards requiring a
preventive control.
507.36(a)(2)...................... 507.37(a)(1)(ii)..... A supplier program is not Shifted to be in
required when the hazard provisions outside the
will be controlled by the framework of the supply-
receiving facility's chain program in subpart
customer in the E.
distribution chain.
507.105(a)(2)..................... N/A.................. Circumstances that do not A receiving facility is
require a supply-chain an importer, is in
program even though the compliance with the FSVP
receiving facility's requirements, and has
hazard analysis documentation of
determines that a hazard verification activities
requires a supply-chain- conducted under the FSVP
applied control. program.
507.105(a)(3)..................... N/A.................. Exemption from the Exemption for animal food
requirements for a supply- supplied for research or
chain program. evaluation.
507.105(c)........................ N/A.................. Requirements applicable to When a supply-chain-
non-suppliers. applied control is
applied by an entity
other than the receiving
facility's supplier, the
receiving facility must
(1) verify the supply-
chain-applied control;
or (2) obtain
documentation of an
appropriate verification
activity from another
entity in the supply
chain, review and assess
the entity's applicable
documentation, and
document that review and
assessment.
----------------------------------------------------------------------------------------------------------------
A. Requirement for a Written Supply-Chain Program (Final Sec.
507.105(a)(1) and (b))
We proposed that the receiving facility must establish and
implement a risk-based supplier program for those raw materials and
ingredients for which the receiving facility has identified a
significant hazard when the hazard is controlled before receipt of the
raw material or ingredient. We also proposed that the supplier program
must be written. (See proposed Sec. 507.37(a)(1)(i) and (2).) To
improve clarity, we have revised the provision to substitute the phrase
``hazard requiring a supply-chain-applied control'' for the phrase
``significant hazard when the hazard is controlled before receipt of
the raw material or ingredient.'' We have added a definition for the
term ``supply-chain-applied control'' to mean a preventive control for
a hazard in a raw material or other ingredient when the hazard in the
raw material or other ingredient is controlled before its receipt (see
Sec. 507.3) and use the more specific term '' supply-chain-applied
control,'' rather than the broader term ``preventive control,''
throughout the provisions for a supply-chain program.
(Comment 432) As discussed in Comment 428, several comments ask us
to issue guidance rather than establish requirements for a supplier
program in the rule.
(Response 432) See Response 428 for a discussion of our reasons for
declining this request and establishing requirements for a supply-chain
program in the rule.
(Comment 433) Some comments ask us to revise the regulatory text to
remove the condition that all hazards be foreseeable so that the
supplier program can address economically motivated adulteration.
(Response 433) This comment is unclear. The requirement for a
supply-chain program applies when the outcome of a hazard analysis is
that a known or reasonably foreseeable hazard requires a preventive
control, and the hazard would be controlled by the receiving facility's
supplier. The requirement applies regardless of whether the hazard
requiring a preventive control is, or is not, a hazard that would be
introduced into a food for the purposes of economic gain.
(Comment 434) Some comments ask us to specify that a Certificate of
Analysis or other documentation of the existence and/or level of a
hazard could be provided to the receiving facility to indicate the
potential for an actual existence of a hazard so that the receiving
facility could evaluate whether the hazard requires a preventive
control. Some comments state that chemical hazards such as nutrient
imbalances are not controlled through easily described ``procedures''
but are instead controlled through factors such as product formulation
(e.g., controlling the levels of required or contaminating chemicals in
each ingredient depending on the proportion of the ingredient in the
finished animal food) and the amount fed. For example, some comments
explain that mineral content of certain raw materials or ingredients
may require control in some situations (e.g., copper content in food
for sheep) but not in other situations (e.g., copper content in swine
food). One comment expresses concern about whether customers would be
willing to provide the receiving facility with confidential information
about the customer's own hazard analysis with respect to sensitive
topics. Furthermore, in such cases the receiving facility will not even
know whether the chemical contaminant constitutes an actual ``hazard''
for the purposes of the customer's finished food. This comment also
asserts that a Certificate of Analysis provided to a receiving facility
constitutes ``control before receipt of the raw material or
ingredient.''
(Response 434) We do not understand the concern of this comment. A
receiving facility and a supplier do not need to share all of the
details of product formulation for a receiving facility to communicate
its requirements to a supplier. In the example provided by the comment,
the receiving facility could provide the supplier with a
[[Page 56296]]
written specification for a contaminant such as lead, and the supplier
could demonstrate that it satisfied the receiving facility's
specification by providing a Certificate of Analysis showing the
results of laboratory testing for lead. Neither the written
specification provided by the receiving facility, nor the Certificate
of Analysis provided by the supplier, would disclose confidential
information about the formulations or procedures of either entity.
This comment also appears to misunderstand the applicability of the
supply-chain program. The rule requires a supply-chain program when the
receiving facility has identified, through its hazard analysis, that
there is a hazard requiring a supplier-applied control. In the
circumstances described by the comment, a Certificate of Analysis or
other documentation of test results from the supplier to the receiving
facility could demonstrate that the supplier has controlled the hazard
to the receiving facility's specifications, but would not overturn the
outcome of the receiving facility's hazard analysis that there is a
hazard requiring a preventive control, and that the appropriate control
is applied by the supplier. On the contrary, the Certificate of
Analysis simply demonstrates that the supply-chain-applied control
functioned as intended.
(Comment 435) One comment asks us to specify in the regulatory text
that the supplier program must be written ``if required'' because there
are specified circumstances when a supplier program is not required.
(Response 435) We decline this request. Although the rule provides
circumstances when a supply-chain program is not required (see Sec.
507.105(a)(2)), it is not necessary to specify, for all other
provisions of the supply-chain program, that the provision only applies
``if required.''
B. Circumstances That Do Not Require a Written Supply-Chain Program
(Final Sec. 507.105(a)(2))
We proposed that the receiving facility is not required to
establish and implement a supplier program for raw materials and
ingredients for which there are no significant hazards; the preventive
controls at the receiving facility are adequate to significantly
minimize or prevent each of the significant hazards; or the receiving
facility relies on its customer to control the hazard and annually
obtains from its customer written assurance that the customer has
established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the hazard. (See
proposed Sec. 507.37(a)(1)(ii)(A), (B), and (C).)
We are deleting the proposed provision that a supplier program is
not required for raw materials and ingredients for which there are no
``significant hazards'' (which we now refer to as ``hazards requiring a
preventive control'') because it is unnecessary. The supply-chain
program is required when a hazard identified in the receiving
facility's hazard analysis identifies a hazard requiring a supply-
chain-applied control; it is not necessary to also state the converse.
Likewise, we are deleting the proposed provision that a supplier
program is not required if the preventive controls at the receiving
facility are adequate to significantly minimize or prevent each of the
significant hazards. In such a case, the outcome of the hazard analysis
would not be that the hazard requires a supply-chain-applied control.
As discussed in section XXVII, after considering comments, we are
shifting the provision in which the receiving facility relies on its
customer to control the hazard from the requirements for a supply-chain
program to a series of provisions that apply when a manufacturer/
processor identifies a hazard requiring a preventive control, but can
demonstrate and document that the hazard will be controlled by an
entity in its distribution chain (see Sec. Sec. 507.36 and 507.37).
However, as discussed in Response 428 and section XLI.C, we also are
establishing two additional circumstances when a supply-chain program
is not required (see Sec. 507.105(a)(2) and (3)).
(Comment 436) As noted in Comment 428, some comments single out our
request for comment, in the proposed FSVP rule, on whether to allow an
entity that would be both an importer (under the FSVP rule) and a
receiving facility (under animal food the preventive controls rule) to
be deemed in compliance with the FSVP rule if it was in compliance with
the supplier verification provisions of the animal food preventive
controls rule, and agree with such an approach (78 FR 45730 at 45748).
(Response 436) As noted in Response 428, we have aligned the
provisions for supplier verification in the FSVP rule with the
provisions for a supply-chain program in this rule, and we are allowing
importers and receiving facilities to take advantage of that fact in
considering compliance with our forthcoming FSVP regulations that we
proposed to establish in in part 1, subpart L, so that they do not have
to duplicate verification activities (see Sec. 507.105(a)(2)).
(Comment 437) Some comments support the specified criteria for when
a receiving facility would not be required to establish and implement a
supplier program. Other comments express concern that these criteria
suggest no supplier verification is needed at all in some circumstances
despite supplier verification activities being potentially informative
about a particular supplier. These comments ask us to establish some
general requirement to perform verification activities for all
suppliers.
(Response 437) We decline this request because it is neither risk-
based nor consistent with the nature and purpose of the supply-chain
program, which is to provide assurance that a hazard requiring a
supply-chain-applied control has been significantly minimized or
prevented (see the regulatory text of Sec. 507.110(c)). We agree that
some degree of verification of all suppliers may prove useful to a
receiving facility for various purposes, and the rule would not prevent
a receiving facility from establishing a supply-chain program for all
of its suppliers regardless of risk and regardless of whether the
applicable hazard in a raw material or other ingredient is controlled
before its receipt.
(Comment 438) Some comments ask us to specify that a ``kill step''
would be an adequate indicator to significantly minimize or prevent
significant hazards identified by the receiving facility when the
receiving facility controls the hazard.
(Response 438) These comments appear to misunderstand the
applicability of the supply-chain program. The rule requires a supply-
chain program when the receiving facility has identified, through its
hazard analysis, that there is a hazard requiring a preventive control
and the receiving facility's manufacturing/processing will not control
the hazard. In the circumstances described by the comment, the
receiving facility is controlling the hazard and a supply-chain program
for the raw material or other ingredient is not required. It is not
necessary to specify the types of controls that the receiving facility
may use to control the hazard.
(Comment 439) Some comments ask us to specify that a receiving
facility need not establish and implement a supplier program for raw
materials and ingredients if those raw materials or ingredients were
received from an affiliated party within the same corporate or
controlling entity.
[[Page 56297]]
(Response 439) We decline this request. With the revisions we have
made to the proposed requirements for a supplier program, the supply-
chain program that we are establishing in this rule provides ample
opportunities for an affiliated party within the same corporate or
controlling entity to establish and implement a supply-chain program
that is suited to its relationship to these entities. For example, as
discussed in Response 458, a receiving facility might be able to
determine and document a justification for a supplier verification
activity other than an annual audit when a supplier is an affiliated
party based on the receiving facility's knowledge of the corporate
policies regarding animal food safety practices (see Sec.
507.130(b)(2)). In addition, as discussed in Response 461, we have
agreed that the corporate parent of a facility can be active in
developing and implementing the facility's food safety plan (see
section XXIV.A). If, for example, a corporate headquarters establishes
and implements a supply-chain program for use company-wide, a receiving
facility could rely on supplier verification activities conducted by
its corporate headquarters, with applicable documentation available
during inspection.
C. Exemption for Animal Food Supplied for Research or Evaluation (Final
Sec. 507.105(a)(3))
We are establishing an exemption from the requirement for a
receiving facility to establish and implement a supply-chain program
when it receives animal food for the purposes of research or
evaluation, provided that certain conditions are met (see Sec.
507.105(a)(3)). Those conditions are that the animal food: (1) Is not
intended for retail sale and is not sold or distributed to the public;
(2) is labeled with the statement ``Animal food for research or
evaluation use''; (3) is supplied in a small quantity that is
consistent with a research, analysis, or quality assurance purpose, the
animal food is used only for this purpose, and any unused quantity is
properly disposed of; and (4) is accompanied with documents, in
accordance with the practice of the trade, stating that the animal food
will be used for research or evaluation purposes and cannot be sold or
distributed to the public. The exemption is analogous to an exemption
we proposed for the FSVP rule under section 805(f) of the FD&C Act.
(See proposed Sec. 1.501(c), 78 FR 45730 at 45745.) We believe it is
not necessary to conduct supplier verification activities when animal
food is obtained in this limited circumstance.
D. Additional Requirements for Non-Suppliers (Final Sec. 507.105(c))
As discussed in section IV.B of this rule and in section IV.B of
the final rule for preventive controls for human food as published
elsewhere in this addition of the Federal Register, the final rule for
preventive controls for human food includes several revisions to the
``farm'' definition in response to comments. One change includes adding
a new definition for a ``secondary activities farm,'' which provides
for practices such as packing by cooperatives and packing houses under
the ownership of multiple growers to remain within the ``farm''
definition (see Response 25 in the final rule for preventive controls
for human food). Another change to the ``farm'' definition accommodates
business models in which one operation grows crops but does not harvest
them, and another operation, not under the same management, harvests
crops but does not grow them (see Response 32 in the final rule for
preventive controls for human food). This revision is a change from the
``farm'' definition established in the section 415 registration
regulations in 2003, and the proposed revisions to the ``farm''
definition in the 2013 proposed human food preventive controls rule and
the 2014 supplemental human food preventive controls notice, which all
describe a ``farm'' as an entity ``devoted to the growing and
harvesting of crops'' (emphasis added).
We proposed the requirements for a supplier program in the context
of a single business entity ``devoted to the growing and harvesting of
crops'' (emphasis added) in which packing operations were often done by
that same business entity. The final ``farm'' definition accommodates
business models where growing, harvesting, and packing operations will
be done by different business entities. Harvesting and packing
operations include some supply-chain-applied controls, such as controls
on worker hygiene, quality of water used during harvesting and packing
operations, and establishing and following water-change schedules for
recirculated water, even though the harvesting and packing operations
do not fall within the definition of ``supplier.''
A receiving facility has an obligation to identify and implement
preventive controls to provide assurances that any hazards requiring a
preventive control will be significantly minimized or prevented and the
animal food manufactured, processed, packed, or held by the facility
will not be adulterated under section 402 of the FD&C Act (see section
418(c) of the FD&C Act and Sec. 507.34(a)). That obligation includes
responsibilities for raw materials and other ingredients when a supply-
chain-applied control is applied by an entity other than the receiving
facility's supplier. To clarify the receiving facility's
responsibilities when a supply-chain-applied control is applied by a
non-supplier, we are establishing a requirement specifying that when a
supply-chain-applied control is applied by an entity other than the
receiving facility's supplier, the receiving facility must: (1) Verify
the supply-chain-applied control or (2) obtain documentation of an
appropriate verification activity from another entity in the supply
chain, review and assess the entity's applicable documentation, and
document that review and assessment. See Sec. 507.105(c). Because
Sec. 507.105(c) refers to provisions in a future produce safety rule,
we will publish a document in the Federal Register announcing the
effective date of that provision when we finalize the produce safety
rule.
We do not expect the receiving facility to follow all of the
requirements of subpart E applicable to ``suppliers'' when verifying a
control by a ``non-supplier,'' as required by Sec. 507.105(c).
Instead, we expect the receiving facility to take steps such as a
review of the non-supplier's applicable food safety records. For
example, if a receiving facility receives produce from a supply chain
that includes a separate grower, harvester, and packer, the grower is
the supplier and the requirements of subpart E applicable to
``suppliers'' apply to the grower. To verify controls applied by the
harvester, the receiving facility could review the harvester's records,
such as records of training for harvest workers and records of
agricultural water quality used in harvest operations. To verify
controls applied by the packer, the receiving facility could review the
packer's records, such as records of agricultural water quality used in
packing operations. As discussed in Response 429, we are allowing
entities such as distributors, brokers, and aggregators to determine,
conduct, and document verification activities that apply to suppliers
as a service to the receiving facility, provided that the receiving
facility reviews and assesses applicable documentation provided by the
other entity and documents that review and assessment. Likewise, under
Sec. 507.105(c)(2) a receiving facility could obtain documentation of
review of applicable records maintained by the harvester or packer from
another entity, review and assess the entity's applicable
[[Page 56298]]
documentation, and document that review and assessment.
We recognize that 507.105(c) may have limited applicability to raw
material and other ingredients used in animal food. At this time, we do
not have an example of when we would expect an animal food manufacturer
to verify non-supplier controls for its raw materials or other
ingredients. Although we do not have examples and expect limited
applicability of Sec. 507.105(c)(2), we have included these provisions
to provide for instances when an animal food facility identifies
situations in which controls applied by a ``non-supplier'' need to be
verified as part of the facility's supply-chain program.
E. Proposed General Requirements for the Supply-Chain Program That We
Are Not Including in the Final Rule (Proposed Sec. 507.37(a)(4) and
(5))
We proposed that when supplier verification activities are required
for more than one type of hazard in a food, the receiving facility must
conduct the verification activity or activities appropriate for each of
those hazards. We also proposed that for some hazards, in some
situations it will be necessary to conduct more than one verification
activity and/or to increase the frequency of one or more verification
activities to provide adequate assurances that the hazard is
significantly minimized or prevented. We have concluded that these
provisions are largely self-evident and need not be included in the
regulatory text. Therefore, we are not finalizing these proposed
provisions. We will consider whether it will add value to discuss the
principles in these proposed provisions in guidance that we intend to
develop for the supply-chain program.
XLII. Subpart E: Comments on General Requirements for the Supply-Chain
Program
We proposed several requirements generally applicable to the
supplier program (such as factors to consider in determining
appropriate supplier verification activities (proposed Sec.
507.37(b)), as well as several requirements more narrowly targeted to
specific aspects of the supplier program (such as requirements
applicable to onsite audits). As part of the redesignation of proposed
Sec. 507.37 into subpart E, with eight distinct sections, we are
establishing the more general requirements in Sec. 507.110 (see table
25).
Most comments that support the proposed provisions suggest
alternative or additional regulatory text. In the following sections,
we discuss comments that ask us to clarify the proposed requirements or
that disagree with, or suggest one or more changes to, the proposed
requirements. After considering these comments, we have revised the
regulatory text as shown in table 25.
Table 25--Revisions to the Proposed General Requirements Applicable to a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
Proposed section
Final section designation designation Description Revision
----------------------------------------------------------------------------------------------------------------
507.110(a)......................... 507.37(a)(3).......... What the supply-chain Add that the supply-chain
program must include. program includes, when
applicable, verifying a
supply-chain-applied
control applied by an
entity other than the
receiving facility's
supplier and documenting
that verification, or
obtaining documentation of
an appropriate
verification activity from
another entity, reviewing
and assessing that
documentation, and
documenting the review and
assessment.
507.110(b)......................... 507.37(c)(1).......... Appropriate supplier N/A.
verification
activities.
507.110(c)......................... 507.37(a)(3)(ii)...... Purpose of supplier Specify only that the
verification supply-chain program must
activities for raw provide assurance that a
materials and other hazard requiring a supply-
ingredients. chain-applied control has
been significantly
minimized or prevented.
507.110(d)......................... 507.37(b)............. Factors that must be Clarify that the factors
considered when apply in approving
approving suppliers suppliers, as well as in
and determining determining appropriate
appropriate supplier supplier verification
verification activities.
activities for raw
materials and other
ingredients.
507.110(d)......................... 507.37(b)............. Factors that must be Specify that three
considered when of the factors relate to
approving suppliers ``supplier performance''
and determining Specify ``The
appropriate supplier entity or entities that
verification will be applying controls
activities for raw for the hazards requiring
materials and other a supply-chain-applied
ingredients; Supplier control'' rather than
performance.. ``Where the preventive
controls for those hazards
are applied for the raw
material and ingredients--
such as at the supplier or
the supplier's supplier''.
Add ``other FDA
compliance actions related
to food safety'' as an
example of information
relevant to the supplier's
compliance with applicable
FDA food safety
regulations.
Clarify that
consideration of supplier
performance includes, when
applicable, relevant laws
and regulations of a
country whose food safety
system FDA has officially
recognized as comparable
or has determined to be
equivalent to that of the
United States and
information relevant to
the supplier's compliance
with those laws and
regulations.
[[Page 56299]]
Provide
flexibility in the factors
that must be considered if
a supplier is a qualified
facility, a produce farm
that will not be subject
to the forthcoming produce
safety rule on the basis
of size and/or direct farm
marketing, or a shell egg
producer that is not
subject to the
requirements of 21 CFR
part 118 (production,
storage, and
transportation of shell
eggs) because it has less
than 3,000 laying hens.
507.110(e)......................... 507.37(f)............. Supplier non- N/A.
conformance.
----------------------------------------------------------------------------------------------------------------
A. Description of What the Supply-Chain Program Must Include (Final
Sec. 507.110(a))
We proposed to require that a supplier program include verification
activities, as appropriate to the hazard, and documentation of these
activities, to ensure raw materials and ingredients are received only
from suppliers approved for control of the hazard(s) in that raw
material or ingredient (or, when necessary and appropriate, on a
temporary basis from unapproved suppliers) (proposed Sec.
507.37(a)(3)(i)). We also proposed to require that a supplier program
include verification activities, as appropriate to the hazard, and
documentation of these activities. We also proposed requirements
applicable to the determination and documentation of appropriate
supplier verification activities (proposed Sec. 507.37(b)). We also
proposed specific documentation requirements for records associated
with the supplier program (proposed Sec. 507.37(g)).
The final rule specifies that the supply-chain program must
include: (1) Using approved suppliers; (2) determining appropriate
supplier verification activities (including determining the frequency
of conducting the activity); (3) conducting supplier verification
activities; and (4) documenting supplier verification activities. For
clarity, Sec. 507.110(a) states this general requirement for the
supply-chain program and Sec. Sec. 507.120, 507.125, 507.130, 507.135,
and 507.175 provide the specific requirements for using approved
suppliers, determining appropriate supplier verification activities,
conducting verification activities, specific requirements for onsite
audits, and records, respectively. See the discussion of the specific
requirements of Sec. Sec. 507.120, 507.125, 507.130, 507.135, and
507.175 in sections XLIV, XLV, XLVI, and XLVII, respectively.
As discussed in section XLI.D, the final rule establishes a
verification requirement when a supply-chain-applied control is applied
by an entity other than the receiving facility's supplier (see Sec.
507.105(c)). For clarity, Sec. 507.110(a) states this general
requirement for the supply-chain program in Sec. 507.105(a)(5), and
Sec. 507.105(c) provides the specific requirements that apply when a
supply-chain-applied control is applied by an entity other than the
receiving facility's supplier.
B. Appropriate Supplier Verification Activities ((Final Sec.
507.110(b))
We proposed to require that appropriate supplier verification
activities include: (1) Onsite audits; (2) sampling and testing of the
raw material or ingredient, which may be conducted by either the
supplier or receiving facility; (3) review by the receiving facility of
the supplier's relevant food safety records; or (4) other appropriate
supplier verification activities based on the risk associated with the
ingredient and the supplier (proposed Sec. 507.37(c)(1)).
(Comment 440) Some comments support the inclusion of onsite audits
as an appropriate supplier verification activity. However, other
comments oppose it, and ask us to remove the onsite audit requirement
from the supplier verification program, stating that Congress
prohibited FDA from requiring third parties to verify or audit
compliance with the rules. These comments express concern that the
supplier verification program effectively imposes an ``entire second
layer of regulation'' on farms that are supplying ingredients to
processors, and claim this is an unnecessary burden that is not
authorized by FSMA.
(Response 440) We are retaining onsite audits as an appropriate
supplier verification activity. Onsite audits may be less commonly used
by the animal food industry than the human food industry. However,
onsite audits provide the opportunity to review the food safety plan
and written procedures and to observe the implementation of animal food
safety procedures, as well as to review the records related to the past
application of control measures, including laboratory test results.
Audits also provide the opportunity to interview employees to assess
their understanding of the animal food safety measures for which they
are responsible. Thus, an audit can provide for a more comprehensive
assessment of animal food safety implementation by a facility. Comments
that oppose including onsite audits as a verification activity are
concerned that farms will be required to have audits to verify that
they are in compliance with produce safety standards or facilities will
be required to have audits to verify preventive controls. These
comments apparently refer to the provision in section 419(c)(1)(E) of
the FD&C Act that the regulation issuing standards for the safety of
produce ``not require a business to hire a consultant or other third
party to identify, implement, certify compliance with these procedures,
processes and practices,'' or the provision in section 418(n)(3)(D) of
the FD&C Act that the preventive controls regulation ``not require a
facility to hire a consultant or other third party to identify,
implement, certify or audit preventative controls.'' The regulations
proposed under section 419 of the FD&C Act would not impose such
requirements. The requirements for supplier verification in this rule
(under section 418 of the FD&C Act) provide for audits as one supplier
verification activity. Although the rule does specify an annual onsite
audit as the appropriate supplier verification activity when a hazard
in a raw material or other ingredient will be controlled by the
supplier and is one for which there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals, the receiving facility is
not required to hire a third
[[Page 56300]]
party to conduct the audit. Any qualified auditor, other than the
supplier, may conduct the audit, including an employee of the receiving
facility or another entity, such as an entity in the supply chain
between the supplier and the receiving facility. The rule also provides
that a receiving facility may determine and document that other
verification activities and/or less frequent onsite auditing of the
supplier provide adequate assurance that the hazards are controlled
(see Sec. 507.130(b)(1) and (2)). Audits already conducted on a
supplier's facility or operation for other business purposes may meet
the requirement for supplier verification. In addition, the rule
provides alternative requirements for verification of suppliers that
are farms that grow produce and are not a covered farm under part 112
in accordance with Sec. 112.4(a), or in accordance with Sec. Sec.
112.4(b) and 112.5 (see Sec. 507.130(d)). Finally, we have also
provided that inspections may substitute for an audit under specified
circumstances (see Sec. 507.135(c)).
While we realize that some farms may receive audits under the
supplier verification provisions of part 507, we anticipate that onsite
audits will be used as a verification activity more frequently for non-
farm facilities because hazards associated with commercial animal food
production are not typically controlled by the farm, but rather during
manufacture or processing of the animal food.
(Comment 441) Some comments support the inclusion of sampling and
testing of the raw material or other ingredient as an appropriate
supplier verification activity, and note that verification testing is
more effective when conducted by the supplier than the receiving
facility because the supplier can control the lot of product tested.
However, other comments oppose it, stating that sampling and testing is
not useful for products for various reasons such as the non-homogeneous
distribution of some hazards, or statistical limitations because of
practical limits on number of samples or limited shelf life of some
products.
(Response 441) We are retaining sampling and testing as an
appropriate supplier verification activity. As noted in the FDA
memorandum on supplier programs, sampling and testing are commonly used
by industry in the verification of supplier performance (Ref. 53). We
have previously discussed factors that impact the utility and frequency
of raw material/ingredient testing (see the Appendix published in the
2013 proposed preventive controls rule for animal food (78 FR 64736 at
64836)). We agree that there are benefits in having sampling and
testing conducted by the supplier, because the supplier can then take
appropriate action with respect to the findings, including not shipping
contaminated product. However, because contamination with some hazards
is likely to be non-homogeneous and for microbial pathogens or
microbial toxins the numbers are likely to be low, a negative test
result does not guarantee the absence of contamination. This should be
taken into account when deciding which verification activity (or
activities) is appropriate. Because of the limitations of sampling and
testing, the controls the supplier has in place to minimize
contamination, and the management of those controls, are key in
determining when sampling and testing is appropriate as a verification
activity. For short shelf life products, where holding product pending
test results can negatively impact product quality and usefulness, an
onsite audit to verify control of hazards may be more appropriate than
sampling and testing.
(Comment 442) Some comments ask us to specify in the regulatory
text that sampling and testing can be conducted by or on behalf of the
supplier or the receiving facility.
(Response 442) The provisions of Sec. 507.115 specify the
responsibilities of the receiving facility, and allow a receiving
facility to conduct all supplier verification activities, including
sampling and testing. These provisions also provide that a supplier, or
an entity other than the receiving facility (such as an entity in the
supply chain between the supplier and the receiving facility), can
conduct sampling and testing, provided that the receiving facility
reviews and assesses the documentation provided by the supplier. The
rule places no restrictions on when a receiving facility, a supplier,
or an entity other than the receiving facility could have a business
relationship with a third party (such as a contract laboratory) to
conduct sampling and testing.
(Comment 443) Some comments suggest that, for a facility regularly
undergoing audits, reviewing a ``supplier's relevant food safety
records'' should allow for the receiving facility to review
documentation related to pre-existing audits. These comments ask us to
revise the provision to add ``including, but not limited to, records
related to audits previously performed on the supplier's facility.''
(Response 443) We decline this request. The comment misinterprets
what we mean by a ``supplier's relevant food safety records.'' The rule
provides for onsite audits as a verification activity, as well as
reviewing a ``supplier's relevant food safety records.'' When an annual
audit is determined to be an appropriate verification activity (see
Sec. 507.130(b)(1)), the audit would be reviewed by the receiving
facility, but a review of this audit is not what we meant by a
``supplier's relevant food safety records.'' As described in an FDA
memorandum on supplier programs, food safety records are records
documenting that the food safety procedures that have been established
to control hazards are being followed and are adequately controlling
such hazards (Ref. 53). Thus, a receiving facility may obtain
documentation of a supplier's control measures for a particular lot of
a raw material or other ingredient provided to the receiving facility,
such as the records created when a process control measure was applied.
The food safety records may also include supplier records that show
that the supplier's supplier has controlled a hazard. Such records may
include audits, for example, when the supplier's supplier controls the
hazard and the supplier's records include records of an audit conducted
with respect to the hazard control activities of the supplier's
supplier. To emphasize that the review of a supplier's relevant food
safety records can include records other than records of audits, we
have revised the documentation requirements applicable to review of a
supplier's food safety records to specify that the documentation must
include the general nature of the records reviewed (see Sec.
507.175(c)(9)). By ``general nature of the records reviewed'', we mean
information such as ``records of process controls.''
(Comment 444) Some comments support the inclusion of other
appropriate supplier verification activities based on the risks
associated with the ingredient and the supplier, because it provides
flexibility for facilities to design risk-based programs that are
appropriate for their operations. Comments suggest other verification
activities may include receiving raw materials and other ingredients
from a supplier without a full audit report if the supplier maintains
certification to a standard recognized by the Global Food Safety
Initiative (GFSI); providing for documentary verification (such as
fact-specific questionnaires and representations exchanged between the
supplier and the receiving facility); and confirming that a facility,
especially a small manufacturing facility, is licensed
[[Page 56301]]
by the appropriate State or local regulatory authority.
(Response 444) We are retaining this provision to allow other
appropriate supplier verification activities based on supplier
performance and the risk associated with the raw material or other
ingredient (Sec. 507.110(b)(4)). We have revised the regulatory text
to refer to ``supplier performance and the risk associated with the raw
material or other ingredient'' because ``supplier performance'' is more
appropriate than ``risk associated with the supplier.'' We use the term
``risk'' as defined by the Codex Alimentarius Commission to be ``a
function of the probability of an adverse health effect and the
severity of that effect, consequential to a hazard(s) in food'' (Ref.
54). As discussed in section XLII.D, the considerations for supplier
performance, which can be related to the probability of a hazard in the
raw material or ingredient and the severity of adverse health effects
that can result, are broader than this.
We do not believe that a supplier maintaining certification to an
industry standard would, by itself, serve as verification that a
supplier is controlling the hazard; however we agree that this can be a
consideration in the determination of the type and frequency of the
verification activity conducted. Similarly, fact-specific
questionnaires and representations exchanged between the supplier and
the receiving facility can be a consideration in the determination of
the type and frequency of the verification activity conducted.
Confirming that a facility is licensed by the appropriate State or
local regulatory authority should not serve as the only verification
that a supplier is controlling the hazard, because the requirements for
a license and the degree of inspectional oversight could vary greatly.
We do provide for modified supplier verification activities for
qualified facilities, which are very small businesses (Sec.
507.130(c)).
C. Purpose of Supplier Verification Activities for Raw Materials and
Other Ingredients (Final Sec. 507.110(c))
We proposed to require that a supplier program include verification
activities, as appropriate to the hazard, and documentation of these
activities, to verify that: (1) The hazard is significantly minimized
or prevented; (2) the incoming raw material or ingredient is not
adulterated under section 402 of the FD&C Act of the FD&C Act; and (3)
the incoming raw material or ingredient is produced in compliance with
the requirements of applicable FDA food safety regulations (proposed
Sec. 507.37(a)(3)(ii)). We have revised the provision to specify that
the supply-chain program must provide assurance that a hazard requiring
a supply-chain-applied control has been significantly minimized or
prevented. If the supply-chain program provides assurance that a hazard
requiring a supply-chain-applied control has been significantly
minimized or prevented, it is not necessary to also specify that the
incoming raw material or ingredient is not adulterated under section
402 of the FD&C Act. We also have deleted the requirement that the
verification activities must verify that the incoming raw material or
ingredient is produced in compliance with the requirements of
applicable FDA food safety regulations and instead focused that
requirement as a factor that must be considered in approving suppliers
and determining the appropriate supplier verification activities and
the frequency with which they are conducted rather than as one of the
stated purposes of the supply-chain program. See the regulatory text of
Sec. 507.110(d)(i)(iii)(B).
(Comment 445) Some comments ask us to revise this provision to
state that the receiving facility's use of the incoming raw material or
ingredient will not cause the finished food to be adulterated under
section 402 of the FD&C Act. These comments assert that FSMA does not
mandate, nor is it reasonable to expect, that incoming raw materials
and ingredients will not be adulterated under section 402, and that it
is acceptable for a receiving facility to control the ``adulterating
hazard,'' even if it relies on the supplier to control other hazards.
(Response 445) We decline this request. We acknowledge that in some
circumstances a receiving facility may rely on the supplier to control
certain hazards, while controlling other hazards itself. For example, a
receiving facility that produces dry dog food that contains corn could
rely on its supplier for the control of the chemical hazard aflatoxin,
but control the biological hazard Salmonella through its own heat-
treatment process. However, the supply-chain program applies to hazards
requiring a supply-chain-applied control, and the purpose relates to
those hazards. In the example where the receiving facility is relying
on the supplier to control aflatoxin, the provision would require the
receiving facility to verify that the hazard (aflatoxin) has been
significantly minimized or prevented by the supplier and that the level
of aflatoxin in the corn does not render it adulterated under the FD&C
Act.
D. Factors That Must Be Considered When Approving Suppliers and
Determining Appropriate Supplier Verification Activities for Raw
Materials and Other Ingredients (Final Sec. 507.110(d))
We proposed that in determining and documenting the appropriate
verification activities, the receiving facility must consider the
following: (1) The hazard analysis, including the nature of the hazard,
applicable to the raw material and ingredients; (2) where the
preventive controls for those hazards are applied for the raw material
and ingredients, such as at the supplier or the supplier's supplier;
(3) the supplier's procedures, processes, and practices related to the
safety of the raw material and ingredients; (4) applicable FDA food
safety regulations and information relevant to the supplier's
compliance with those regulations, including an FDA warning letter or
import alert relating to the safety of the animal food; (5) the
supplier's food safety performance history relevant to the raw
materials or ingredients that the receiving facility receives from the
supplier, including available information about results from testing
raw materials or ingredients for hazards, audit results relating to the
safety of the food, and responsiveness of the supplier in correcting
problems; and (6) any other factors as appropriate and necessary, such
as storage and transportation practices (proposed Sec. 507.37(b)).
As discussed in Responses 429 and 430 and section XLIV.A, we have
revised the regulatory text regarding use of approved suppliers to more
explicitly state that the receiving facility must approve suppliers.
The factors that must be considered in determining the appropriate
supplier verification activities are equally relevant to approving
suppliers, and the final rule requires that these factors must be
considered in approving suppliers, as well as in determining
appropriate supplier verification activities. For clarity and
consistency with terms used throughout the final provisions for a
supply-chain program, the final rule specifies ``the entity or entities
that will be applying controls for the hazards requiring a supply-
chain-applied control'' rather than ``Where the preventive controls for
those hazards are applied for the raw material and ingredients--such as
at the supplier or the supplier's supplier.''
As discussed in Response 444, we are using the term ``supplier
performance,'' rather than ``risk of supplier,'' when discussing
factors associated with
[[Page 56302]]
suppliers. The final rule groups three of the proposed factors as
``supplier performance.'' As a companion change to emphasize that
``supplier performance'' applies to all three of these factors, we
refer to the supplier's ``food safety history'' rather than ``food
safety performance history.''
We also have revised the regulatory text to clarify that
consideration of supplier performance includes, when applicable,
relevant laws and regulations of a country whose food safety system FDA
has officially recognized as comparable or has determined to be
equivalent to that of the United States and information relevant to the
supplier's compliance with those laws and regulations. We made this
change because the final rule includes several provisions that
acknowledge that some animal food establishments, including animal food
establishments that are ``suppliers'' as that term is defined in this
rule, operate in a foreign country. (See, e.g., the definition of
``qualified auditor'' in Sec. 507.3 and Sec. Sec. 507.7(a)(2)(ii),
507.7(e), 507.105(a)(2), 507.130(c), 507.135(c)(1)(ii), 507.135(c)(2),
and 507.175(c)(15)). Some of these provisions (e.g., Sec. Sec.
507.105(a)(2), 507.130(c), 507.135(c)(1)(ii), 507.135(c)(2), and
507.175(c)(15)) are in the requirements for a supply-chain program.
When the supplier is in a foreign country whose food safety system FDA
has officially recognized as comparable or determined to be equivalent
to that of the United States, a receiving facility may substitute the
written results of an inspection by the applicable food safety
authority for an audit, provided that certain conditions are met (see
Sec. 507.135(c)(1)(ii) and (2)). However, as of August 30, 2015, FDA
has not developed a systems recognition program for animal food;
therefore, we have no signed systems recognition agreements with any
foreign food safety authority relating to animal food. The currently
existing systems recognition agreement relates solely to human food and
does not apply to animal food. The final rule provides flexibility for
alternative verification requirements for certain entities (see Sec.
507.130(c), (d), and (e)). We have revised the factors that must be
considered regarding supplier performance to reflect the flexibility
the rule provides for conducting supplier verification activities for
these entities (see Sec. 507.110(d)(2)).
(Comment 446) Some comments support the flexibility for receiving
facilities to determine the appropriate supplier verification
activities and frequency with which to conduct these activities. Some
comments state that not all of the factors that we proposed a receiving
facility consider are relevant for the process of selecting the
verification activity. These comments suggest changing the regulatory
text to require a receiving facility to consider ``both food and
supplier related risks, including the following, as appropriate'' and
then listing the factors as proposed. Other comments suggested similar
changes to the regulatory text.
(Response 446) We disagree that not all of the factors that we
proposed a receiving facility to consider are relevant to determining
the appropriate verification activity. Every factor might not be
determinative in all cases, and our requirement merely to consider each
factor does not assume so. However, any one of these factors could be
crucial depending on the animal food, the hazard, and the nature of the
preventive control. We continue to consider it appropriate to require
receiving facilities to consider each of these factors in making their
determinations about the appropriate verification activities.
(Comment 447) Some comments ask us to clarify that the phrase ``the
nature of the hazard'' means the nature of the hazard requiring
control.
(Response 447) We have revised the regulatory text to specify ``the
nature of the hazard controlled before receipt of the raw material or
other ingredient.'' The revised regulatory text is consistent with
regulatory text in the provisions for the preventive control management
components (see Sec. 507.39(b), which specifies ``taking into account
the nature of the hazard controlled before receipt of the raw material
or other ingredient'').
(Comment 448) Some comments agree that a receiving facility must
consider where the preventive controls for hazards are applied for the
raw materials and ingredients, such as at the supplier or the
supplier's supplier. Other comments assert that this consideration
should not be used to determine if supplier oversight is needed. Other
comments state that it may be hard to review the procedures used by a
supplier's supplier and beyond and ask us to provide clear flexibility
regarding requirements for the content and performance of a receiving
facility's supplier program.
(Response 448) The purpose of the requirement to consider where the
hazard is controlled is to assist a receiving facility in determining
what supplier verification activities are appropriate, not to determine
whether supplier oversight is needed. Once a receiving facility has
determined that a hazard requiring a preventive control is controlled
before receipt of a raw material or other ingredient, supplier
oversight is needed.
We recognize that there is need for additional flexibility
regarding conducting supplier verification activities. As discussed in
Response 429, we are providing significant additional flexibility to
address this situation in the final rule.
(Comment 449) Some comments object to the proposed requirement to
consider applicable FDA food safety regulations and information
relevant to the supplier's compliance with those regulations, including
an FDA warning letter or import alert relating to the safety of the
food. These comments assert that it is difficult for a receiving
facility to know a supplier's compliance status, because it is not easy
to obtain this kind of information in a timely fashion. Some comments
ask us to develop an online database to house this information to help
make it easier to find. Some comments ask us to replace the broad
requirement to consider applicable FDA food safety regulations and
information relevant to the supplier's compliance with those
regulations with a narrower requirement to only consider any FDA
warning letter or import alert relating to the safety of the food.
(Response 449) We are retaining the broad requirement to consider
applicable FDA food safety regulations and information relevant to the
supplier's compliance with those regulations. Such information is
relevant to supplier performance regardless of whether there is an
applicable warning letter or import alert.
We currently have a searchable online database for warning letters
(Ref. 55) and another searchable online database for import alerts
(Ref. 56). Both of these databases are available to the public from our
homepage at https://www.fda.gov. We also publicize actions to suspend a
facility's registration, such as in our 2012 suspension of registration
due to Salmonella contamination of nut butter and nut products
(including ingredients used in animal foods) manufactured, processed,
packed, and held by the facility (Ref. 57). Under the requirement to
consider supplier performance with respect to applicable food safety
regulations, a receiving facility cannot ignore published information
relating to a supplier's compliance with applicable FDA food safety
regulations in determining the appropriate verification activities,
such as publicized information regarding suspension of registration. To
[[Page 56303]]
emphasize this point, we have revised the regulatory text to specify
that the applicable information includes ``other FDA compliance actions
related to animal food safety.'' We also have revised the regulatory
text to specify that the compliance relates to an FDA warning letter or
import alert relating to the ``safety of animal food,'' rather than the
``safety of the animal food,'' to provide flexibility for a receiving
facility to identify information that may raise a question about a
supplier's compliance history in a more general way, rather than only
with respect to a particular animal food.
(Comment 450) Some comments state we should only require
consideration of the supplier's food safety performance history
relevant to the hazards requiring control in the raw materials or
ingredients that the receiving facility receives from the supplier.
(Response 450) Consideration of the supplier's animal food safety
history relevant to the raw materials or other ingredients that the
receiving facility receives from the supplier will be focused on the
hazard that the supplier is controlling because that is the food safety
information the receiving facility will consider to be relevant and for
which the receiving facility would develop a history. The information
could indicate that certain verification activities may be more
appropriate than others for verifying the control of the hazard at that
particular supplier or provide information useful in determining a
frequency for the verification activity. However, we decline to revise
the provision to specify that consideration should be limited to the
hazards requiring control. Even though this is the most relevant
information, a facility may become aware of information with respect to
a raw material or other ingredient provided to another customer of the
supplier that may suggest the need to conduct a different verification
activity. For example, if the receiving facility is obtaining mineral
premix from a supplier that is controlling for a nutrient imbalance of
copper and molybdenum and becomes aware that mineral premixes from this
supplier have been associated with a recall due to contamination with a
physical hazard, the receiving facility would determine that it should
implement verification activities related to controlling for physical
hazards.
(Comment 451) Some comments ask us to replace the phrase ``examples
of factors that a receiving facility may determine are appropriate and
necessary are storage and transportation'' with ``such as storage and
transportation.''
(Response 451) We have made this editorial change.
E. Supplier Non-Conformance (Final Sec. 507.110(e))
We proposed that if the owner, operator, or agent in charge of a
receiving facility determines through auditing, verification testing,
relevant consumer, customer or other complaints, or otherwise that the
supplier is not controlling hazards that the receiving facility has
identified as significant, the receiving facility must take and
document prompt action in accordance with Sec. 507.42 to ensure that
raw materials or ingredients from the supplier do not cause food that
is manufactured or processed by the receiving facility to be
adulterated under section 402 of the FD&C Act (proposed Sec.
507.37(f)).
(Comment 452) Some comments object to the use of the word
``significant'' in this proposed provision, recommending that we
replace it with ``requiring control by the supplier.'' These comments
reason that these activities are only necessary if the receiving
facility is relying on the supplier to control the specific hazards.
(Response 452) We have revised the regulatory text to state ``a
hazard requiring a supply-chain-applied control'' rather than
``significant.''
XLIII. Subpart E: New Requirement Specifying the Responsibilities of
the Receiving Facility (Final Sec. 507.115)
As discussed in Response 429, after considering comments we are
providing flexibility for an entity other than the receiving facility
to determine, conduct, and document the appropriate supplier
verification activities, provided that the receiving facility reviews
and assesses the entity's applicable documentation, and documents the
receiving facility's review and assessment. We are specifying that
flexibility in Sec. 507.115. We have titled this section
``Responsibilities of the receiving facility'' to emphasize the
responsibility of the receiving facility for its supply-chain program.
(See Responses 429 and 430.) Although comments focus on flexibility for
an entity in the supply chain between the supplier and the receiving
facility to perform supplier verification activities, and such entities
are the most likely entities to be the entities determining,
conducting, and documenting supplier verification activities, the
flexibility provided by the rule is not limited to such entities.
The rule does, however, set some bounds on the flexibility for
determining, conducting, and documenting appropriate supplier
verification activities. For example, as discussed in Responses 429 and
430, only the receiving facility can approve its suppliers. As another
example, although it would not be appropriate for a supplier to
determine the appropriate supplier verification activities for itself,
we had proposed that it would be appropriate for a supplier to conduct
sampling and testing of raw materials and ingredients as a supplier
verification activity (proposed Sec. 507.37(c)(1)(ii)), and we are
retaining that provision in the final rule (see Sec. 507.115(a)(4)).
Likewise, it is common industry practice for a supplier to arrange for
an audit by a third party (Ref. 53), and the new flexibility provision
does not prohibit a receiving facility from relying on an audit
provided by its supplier when the audit of the supplier was conducted
by a third-party qualified auditor in accordance with the requirements
of the rule applicable to audits (Sec. 507.135). See Sec. 507.115 for
the full text of this new flexibility provision.
XLIV. Subpart E: Comments on Using Approved Suppliers and Determining
Appropriate Supplier Verification Activities
We proposed requirements for the use of approved suppliers
(proposed Sec. 507.37(a)(3)(i)) and for determining and documenting
appropriate supplier verification activities (proposed Sec.
507.37(b)). See table 26 for a description of the final provisions and
the changes we have made to clarify the requirements.
Table 26--Revisions to the Proposed Requirements for Approving Suppliers and for Determining and Documenting
Appropriate Supplier Verification Activities
----------------------------------------------------------------------------------------------------------------
Proposed section
Final section designation designation Description Revision
----------------------------------------------------------------------------------------------------------------
507.120(a)........................ 507.37(a)(3)(i)...... The receiving facility Explicit statement of
must approve suppliers this requirement.
and document that
approval.
[[Page 56304]]
507.120(b)(1)..................... 507.37(a)(3)(i)...... Written procedures for Explicit requirement for
receiving raw materials written procedures.
and other ingredients
must be established and
followed.
507.120(b)(2)..................... ..................... The purpose of the written N/A.
procedures is to ensure
that raw materials and
other ingredients are
received only from
approved suppliers (or,
when necessary and
appropriate, on a
temporary basis from
unapproved suppliers
whose raw materials or
other ingredients the
receiving facility
subjects to adequate
verification activities
before acceptance for
use).
507.120(b)(3)..................... 507.37(a)(3)(i)...... Use of the written Conforming change
procedures for receiving associated with the
raw materials and other explicit requirement to
ingredients must be establish and follow
documented. written procedures.
507.125........................... 507.37(b)............ Requirement to determine N/A.
and document appropriate
supplier verification
activities.
----------------------------------------------------------------------------------------------------------------
A. Using Approved Suppliers (Final Sec. Sec. 507.120)
We proposed to require that a supplier program include verification
activities, as appropriate to the hazard, and documentation of these
activities, to ensure raw materials and ingredients are received only
from suppliers approved for control of the hazard(s) in that raw
material or ingredient (or, when necessary and appropriate, on a
temporary basis from unapproved suppliers whose raw materials or
ingredients the receiving facility subjects to adequate verification
activities before acceptance for use) (proposed Sec. 507.37(a)(i)).
This proposed requirement included an implicit requirement that a
facility must approve suppliers. For clarity, we make that requirement,
and documentation of that approval, explicit in the final rule. (See
Sec. 507.120(a)).
The rule continues to require that a receiving facility ensure raw
materials and other ingredients are received only from suppliers
approved for control of the hazard(s) in that raw material or other
ingredient (or, when necessary and appropriate, on a temporary basis
from unapproved suppliers whose raw materials or other ingredients are
subject to adequate verification activities before acceptance for use),
but we revised the provision to specify that the receiving facility
must do so by establishing and following written procedures, and
require documentation that these procedures were followed. To simplify
the provisions, we also established a definition for the term ``written
procedures for receiving raw materials and other ingredients'' to mean
written procedures to ensure that raw materials and other ingredients
are received only from suppliers approved by the receiving facility
(or, when necessary and appropriate, on a temporary basis from
unapproved suppliers whose raw materials or other ingredients are
subjected to adequate verification activities before acceptance for
use), and use that term throughout subpart E. For example, a facility
could design a checklist for employees to use when raw materials and
other ingredients are delivered to the facility. We decided to specify
use of written procedures for receiving raw materials and other
ingredients in light of the flexibility the final rule provides for an
entity other than the receiving facility (such as an entity in the
supply chain between the supplier) to conduct this activity (see Sec.
507.115(a)(2)). Although we agree that such an entity can do this as a
service to the receiving facility, a written procedure is appropriate
to ensure a robust and meaningful verification. As a companion change,
we revised the associated documentation requirement to specify
documentation of use of the written procedures.
(Comment 453) Some comments support the requirement to approve
suppliers. Other comments ask us to provide guidance for use of
unapproved suppliers on a temporary basis, because the use of
unapproved suppliers could be a high risk situation. Other comments
emphasize that if the final supplier approval process is significantly
changed compared to the proposed supplier approval process, industry
must have enough time to plan and develop supplier verification plans
and a process for unapproved sources.
(Response 453) We will consider including guidance for use of
unapproved suppliers on a temporary basis in guidance that we intend to
issue regarding the supply-chain program. We do not believe that the
final requirements regarding the use of approved suppliers will require
increased implementation time. The principal change is to allow
flexibility for entities in the supply chain other than the receiving
facility to establish written procedures for receiving raw materials
and other ingredients and document that written procedures for
receiving raw materials and other ingredients are being followed.
B. Determining Appropriate Verification Activities (Final Sec.
507.125)
The rule requires that a supply-chain program include determining
appropriate supplier verification activities (including determining the
frequency of conducting the activity) (see Sec. 507.110(a)(2)).
Comments that addressed the proposed provision for determining
appropriate verification activities (which provides flexibility to the
facility to determine the appropriate verification activities) did not
disagree with it. The rule also requires that certain factors must be
considered in determining appropriate verification activities (Sec.
507.110(d)). We discuss those factors, and comments that addressed
those factors, in section XLII.D. Both of these provisions (i.e., Sec.
507.110(a)(2) and Sec. 507.110(d)) derive from the proposed
requirement regarding factors that must be considered in determining
appropriate supplier verification activities (proposed Sec.
507.37(b)). To give prominence to both the responsibility and the
flexibility to determine appropriate supplier verification activities,
and emphasize the factors
[[Page 56305]]
that must be considered in addressing this responsibility, new Sec.
507.125 specifies that appropriate supplier verification activities
(including the frequency of conducting the activity) must be determined
in accordance with the requirements of Sec. 507.110(d).
XLV. Subpart E: Comments on Conducting Supplier Verification Activities
for Raw Materials and Other Ingredients
We proposed requirements applicable to conducting supplier
verification activities (proposed Sec. 507.37(c)). Most comments that
support the proposed provisions suggest alternative or additional
regulatory text or ask us to clarify how we will interpret the
provision. In the following sections, we discuss comments that ask us
to clarify the proposed requirements or that disagree with, or suggest
one or more changes to, the proposed requirements. After considering
these comments, we have revised the proposed requirements as shown in
table 27.
Table 27--Revisions to the Proposed Requirements for Conducting Supplier Verification Activities for Raw
Materials and Other Ingredients
----------------------------------------------------------------------------------------------------------------
Proposed section
Final section designation designation Description Revision
----------------------------------------------------------------------------------------------------------------
507.130(a)........................ 507.37(c)(1)......... Requirement to conduct one Add reference to an
or more appropriate additional provision
supplier verification that provides for
activities. alternative supplier
verification activities
for shell egg producers
that have less than
3,000 laying hens.
507.130(b)(1)..................... 507.37(c)(2)(i)...... Requirement to conduct an N/A.
onsite audit as the
supplier verification
activity when the hazard
being controlled by the
supplier is one for which
there is a reasonable
probability that exposure
to the hazard will result
in serious adverse health
consequences or death to
humans or animals.
507.130(b)(2)..................... 507.37(c)(2)(ii)..... Exception to the N/A.
requirement to conduct an
annual onsite audit with
a written determination.
507.130(c)........................ 507.37(c)(3)......... Alternative supplier Modify the
verification activity regulatory text to
when the supplier is a better align with the
qualified facility. responsibilities of a
qualified facility to
submit an attestation to
FDA about its food
safety practices or its
compliance with State,
local, county, tribal,
or other applicable non-
Federal food safety law,
including relevant laws
and regulations of
foreign countries.
Clarify that the
date for a receiving
facility to obtain
written assurance that a
supplier is a qualified
facility is before first
approving the supplier
for an applicable
calendar year, and on an
annual basis thereafter,
by December 31 of each
calendar year for the
following calendar year.
Provide for
written assurance that,
when applicable, the
supplier is producing
the raw material or
other ingredient in
compliance with relevant
laws and regulations of
a country whose food
safety system FDA has
officially recognized as
comparable or has
determined to be
equivalent to that of
the United States.
507.130(d)........................ 507.37(c)(4)......... Alternative supplier Clarify that the
verification activity applicable farms are
when the supplier is a ``not covered farms''
farm that is not a rather than ``not
``covered farm'' under subject to part 112''
part 112 in accordance because some of these
with Sec. 112.4(a) or farms are subject to
in accordance with Sec. modified requirements in
Sec. 112.4(b) and 112.5. Sec. 112.6.
Clarify that the
date for a receiving
facility to obtain
written assurance from
the farm about its
status is before first
approving the supplier
for an applicable
calendar year, and on an
annual basis thereafter,
by December 31 of each
calendar year for the
following calendar year.
[[Page 56306]]
Clarify that the
written assurance from
the farm is an
acknowledgement that its
food is subject to
section 402 of the
Federal Food, Drug, and
Cosmetic Act (or, when
applicable, that its
food is subject to
relevant laws and
regulations of a country
whose food safety system
FDA has officially
recognized as comparable
or has determined to be
equivalent to that of
the United States).
507.130(e)........................ N/A.................. Alternative supplier Specify an additional
verification activity situation where the
when the supplier is a receiving facility can
shell egg producer that consider an alternative
has fewer than 3,000 supplier verification
laying hens. activity.
----------------------------------------------------------------------------------------------------------------
A. Requirement To Conduct One or More Supplier Verification Activities
(Final Sec. 507.130(a))
With two exceptions, we proposed that the receiving facility must
conduct and document one or more specified supplier verification
activities for each supplier before using the raw material or
ingredient and periodically thereafter (proposed Sec. 507.37(c)(1)).
See section XLII.B for a discussion of comments regarding the
appropriate verification activities (i.e., onsite audits, sampling and
testing, records review, and other appropriate supplier verification
activities based on supplier performance and the risk associated with
the raw material or other ingredient). See sections XLV.C and XLV.D for
a discussion of the proposed exceptions to this requirement to conduct
and document verification activities. As discussed in section XLV.E,
the final rule provides for an additional circumstance in which an
alternative supplier verification activity may be conducted, i.e., when
the supplier is a shell egg producer that has fewer than 3,000 laying
hens.
B. Requirement for an Onsite Audit as a Verification Activity When a
Hazard Has a Reasonable Probability of Resulting in Serious Adverse
Health Consequences or Death to Humans or Animals (Final Sec.
507.130(b))
We proposed that when a hazard in a raw material or ingredient will
be controlled by the supplier and is one for which there is a
reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death to humans or animals, the
receiving facility must have documentation of an onsite audit of the
supplier before using the raw material or ingredient from the supplier
and at least annually thereafter. We also proposed that this
requirement does not apply if the receiving facility documents its
determination that other verification activities and/or less frequent
onsite auditing of the supplier provide adequate assurance that the
hazards are controlled. (Proposed Sec. 507.37(c)(2)).
(Comment 454) Some comments support the provision for audits when
there is a reasonable probability that exposure to the hazard will
result in serious adverse health consequences or death to humans or
animals. Some of these comments state that audits should be the default
verification activity in order to eliminate facilities choosing the
lowest cost option regardless of whether it was best for food safety.
Other comments state that audits would be the best option for
facilities that cannot visit each supplier annually and that onsite
inspection can identify problems in ways that paperwork reviews cannot.
However, other comments oppose this requirement. Some of these
comments state that facilities should have flexibility in choosing
verification activities, regardless of whether or not the hazards could
result in serious adverse health consequences or death to humans or
animals and express concern that this requirement does not allow the
necessary flexibility for a facility to tailor an effective supplier
program based upon risk. Other comments express concern that the
provision sets a precedent that annual audits are the preferred or most
effective verification measure and that other verification activities
often can help paint a more accurate picture of a supplier over time.
Other comments express concern that audits only give a ``snapshot'' of
a supplier's performance at a given time and ask that we not
overemphasize audits.
(Response 454) We are retaining this provision as proposed. As we
indicated in the Appendix of our 2013 proposed preventive controls
rule, an increasing number of establishments are requiring, as a
condition of doing business, that their suppliers become certified to
food safety management schemes that involve third-party audits (78 FR
64736 at 64836 through 64837). We agree that onsite audits can identify
problems in ways that paperwork reviews cannot. Because an audit
involves more than simply observing the facility producing an animal
food product, we believe it is more than just a ``snapshot'' of the
supplier's programs. As discussed in Response 440, onsite audits can
include observations, records review and employee interviews.
The requirement to conduct an annual audit in specified
circumstances is risk-based because the specified circumstances are
limited to situations where there is a reasonable probability that
exposure to the hazard in the raw material or other ingredient will
result in serious adverse health consequences or death to humans or
animals. The food safety controls applied by suppliers of such raw
materials or other ingredients are more important than for other types
of hazards because of the serious adverse health consequences that can
occur if the hazards are not controlled. Annual audits are required of
certification schemes that are benchmarked to the Global Food Safety
Initiative Guidance Document for GFSI recognition (Ref. 58). We
disagree that this requirement does not provide flexibility in choosing
verification activities; in recognition that other verification
activities can help paint a more accurate picture of a supplier over
time, we have provided for alternative verification activities or audit
frequencies if the receiving facility documents its determination that
other verification activities and/or less frequent onsite auditing of
the supplier provide adequate assurance that the hazards are controlled
(see Sec. 507.130(b)(2)).
[[Page 56307]]
(Comment 455) Some comments ask us to define those products that
may trigger the requirement for an audit, especially with respect to
farms. These comments question how to assess whether a hazard could
result in serious adverse health consequences or death to humans or
animals.
(Response 455) We decline this request. Any list of such products
would be extensive and it is unlikely we could capture all the
circumstances in which this could apply. Hazards for which there is a
reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death are those for which a
recall of a violative product posing such a hazard is designated as
``Class 1'' under 21 CFR 7.3(m)(1). Examples of such hazards that, in
some circumstances, have resulted in serious adverse health
consequences or death to humans or animals include pathogens or their
toxins in animal food. Animal food containing a hazard for which there
is a reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death to humans or animals are
considered reportable foods; examples of foods FDA has considered to
present a reasonable probability of serious adverse health consequences
or death can be found in our Guidance for Industry: Questions and
Answers Regarding the Reportable Food Registry as Established by the
Food and Drug Administration Amendments Act of 2007 (Refs. 19 and 20).
(Comment 456) Some comments ask us to clarify the role of third-
party audits and the Good Agricultural Practice (GAP) program and ask
us to allow GAPs to be a voluntary mechanism to satisfy buyer demands
for food safety certification.
(Response 456) Although the rule would not require a receiving
facility to hire a third party to conduct an audit, onsite audits can
include third-party audits. There are likely to be benefits for
suppliers having a third-party audit, because the same audit may be
acceptable to multiple receiving facilities as an appropriate supplier
verification activity. For farms, GAPs audits may be viewed as an
appropriate supplier verification activity. GAPs audits and other
third-party audits would need to comply with the requirements of this
rule applicable to onsite audits (see Sec. 507.135).
(Comment 457) Some comments assert that we should delete this
provision entirely, stating that this requirement for an audit is
``outside the scope of FSMA.''
(Response 457) We disagree that a requirement for an audit is
``outside the scope of FSMA.'' See the discussion in Response 440
regarding the provision in section 419(c)(1)(E) of the FD&C Act that
the regulation issuing standards for the safety of produce ``not
require a business to hire a consultant or other third party to
identify, implement, certify compliance with the procedures, processes
and practices'' and the provision in section 418(n)(3)(D) of the FD&C
Act that the preventive controls regulation ``not require a facility to
hire a consultant or other third party to identify, implement, certify
or audit preventive controls.'' As noted in that response, a facility
is not required to hire a third party to conduct an audit.
(Comment 458) Some comments support the flexibility to not conduct
an annual onsite audit if the receiving facility documents its
determination that other verification activities and/or less frequent
onsite auditing of the supplier provide adequate assurance that the
hazards are controlled. Other comments question how a facility would
prove that alternative measures are equally effective as an annual
audit, when it is not known how effective an annual audit is. Other
comments assert that the provision is meaningless because a farm or
facility would not take the legal risk of verifying it has received
``adequate assurance,'' because this would be subject to an FDA
inspector's interpretation.
(Response 458) This provision requires a facility to use a
verification activity that provides adequate assurance that a hazard is
controlled, not to determine how effective an audit is and assess
whether alternative measures are equally effective.
As an example of using an alternative approach to an annual onsite
audit, consider the situation in which a receiving facility is part of
a large corporation, is making a pet food, and obtains meat and bone
meal from a supplier that is a subsidiary of the corporation and is
operating under the same food safety system as the receiving facility.
The receiving facility could determine that the food safety
requirements established by the parent company and applied at the
subsidiary provide the needed assurance that Salmonella in meat and
bone meal is adequately controlled. The facility could support its
decision by documenting this determination, including the procedures in
effect at the supplier and the activities used by the corporation to
verify that the subsidiary operates in accordance with corporate food
safety policies and practices to ensure that hazards are adequately
controlled.
We disagree that the provision is meaningless because a farm or
facility would see a legal risk in using an alternative to annual
onsite audits as a supplier verification activity. First, a farm would
be a supplier and would not be the entity that would determine whether
an onsite audit or some other supplier verification activity is
appropriate. As established in Sec. 507.115, determining the
appropriate supplier verification activity would be the responsibility
of a receiving facility, and although appropriate supplier verification
activities could be determined by another entity in the receiving
facility's supply chain as a service, the supplier verification
activities could not be determined by the supplier itself. Second,
although there is always a potential for differences in interpretation
between an FDA inspector and an inspected firm, we are establishing a
new inspection paradigm focused on whether firms are implementing
systems that effectively prevent food contamination, requiring
fundamentally different approaches to food safety inspection and
compliance. For example, FDA intends to deploy specialized
investigators, backed up by technical experts, to assess the soundness
and performance of a facility's food safety system (Ref. 10). In
addition, a central element of FDA's strategy to gain industry
compliance is to help make available to farmers, food processors, and
importers, especially small businesses, the education and technical
assistance they need to understand and implement FSMA's new prevention-
oriented standards (Ref. 5). The new inspection paradigm and the
assistance and training for industry should help minimize different
interpretations between industry and regulators.
(Comment 459) Some comments ask us to require facilities to notify
us when they determine that an alternative to an audit is an
appropriate supplier verification activity and be able to justify and
document how an alternative verification activity provides the same
level of assurance as an onsite audit.
(Response 459) We decline this request. We will assess a facility's
supplier verification activities during a facility inspection,
including the documentation that an alternative verification activity
provides the same level of assurance as an onsite audit.
(Comment 460) Some comments ask us to specify the type of
documentation required for our investigators to determine when the
activities are ``in
[[Page 56308]]
compliance with the law and sufficient to protect public health.''
(Response 460) We decline this request. The facility's approach to
the determination, and the applicable documentation required to support
that determination, would depend on the circumstances. For example, in
Response 458, we discuss a possible approach in a situation in which a
receiving facility is part of a corporation and obtains an ingredient
from a supplier that is a subsidiary of the corporation and is
operating under the same food safety system as the receiving facility.
Another situation could be when a receiving facility has many years of
experience with the same supplier, but the approach and documentation
in that situation likely would be different from an approach and
documentation used when the supplier and the receiving facility are
part of the same corporation.
(Comment 461) Some comments ask that we not limit the determination
for a supplier verification activity other than an onsite audit to a
determination by the receiving facility. These comments explain that
the corporate parent of a facility can be the entity that makes this
determination. These comments suggest that we can account for the role
of the corporation by specifying that a facility documents ``the
determination'' (rather than ``its'' determination).
(Response 461) We have agreed that the corporate parent of a
facility can be active in developing and implementing the facility's
food safety plan (see section XXIV.A). However, the specific suggestion
of these comments is not necessary to achieve the outcome requested by
the comments because of editorial changes we made to provide for
entities other than the receiving facility to determine and conduct the
appropriate supplier verification activities.
C. Alternative Verification Activity When the Supplier Is a Qualified
Facility (Final Sec. 507.130(c))
We proposed that if a supplier is a qualified facility the
receiving facility need not comply with the specified verification
requirements if the receiving facility: (1) Documents, at the end of
each calendar year, that the supplier is a qualified facility and (2)
obtains written assurance, at least every 2 years, that the supplier is
producing the raw material or ingredient in compliance with applicable
FDA food safety regulations and that the raw material or ingredient is
not adulterated under section 402 of the FD&C Act. The written
assurance must include a brief description of the processes and
procedures that the supplier is following to ensure the safety of the
animal food.
This rule has several provisions that require written assurances.
We have established specific elements that each of these written
assurances must include, i.e., the effective date; printed names and
signatures of authorized officials; and the applicable assurance (see
Sec. 507.215).
We have revised the provision to clarify that the receiving
facility must have written assurance that a facility is a qualified
facility: (1) Before first approving the supplier for an applicable
calendar year and (2) by December 31 of each calendar year (rather than
``at the end of the calendar year'') and that the written assurance is
regarding the status of the qualified facility for the following
calendar year. By specifying ``by December 31,'' a receiving facility
can work with each applicable supplier to determine the specific date
within a calendar year for that supplier to annually notify the
receiving facility about its status. See also Responses 76, 139, 140,
the requirements in Sec. 507.7(a) for an annual determination of the
status of a facility as a qualified facility, and the requirements in
Sec. 507.7(d) that apply when the status of a facility changes from
``qualified facility'' to ``not a qualified facility.'' A receiving
facility and its suppliers have flexibility to approach the potential
for the status of a facility to shift between ``qualified facility''
and ``not a qualified facility'' (or vice versa) in a way that works
best for their specific business relationship.
As discussed in section XLII.D, we have revised the requirements
for considering supplier performance to provide that the receiving
facility may, when applicable, consider relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States, and information relevant to the supplier's compliance with
those laws and regulations, rather than consider applicable FDA food
safety regulations and information relevant to the supplier's
compliance with applicable FDA food safety regulations. We have made a
conforming change to the alternative verification activities for a
qualified facility (see the regulatory text of Sec. 507.130(c)(2)).
(Comment 462) Some comments support this alternative supplier
verification activity because it provides flexibility. Other comments
ask us to revise the provision so that it only requires that the
supplier document its status as a qualified facility. Still other
comments ask us to remove all provisions on qualified facilities
because they view these provisions as effectively adding a second layer
of regulations on produce farms, and claim this is not authorized by
FSMA. Other comments ask us to delete the requirement that the written
assurance include a brief description of the processes and procedures
that the supplier is following to ensure the safety of the food.
(Response 462) We have revised the provisions for an alternative
verification activity for a qualified facility to better align with the
responsibilities of a qualified facility to submit an attestation to
FDA about its food safety practices (Sec. 507.7(a)(2)(i)) or its
compliance with State, local, county, tribal, or other applicable non-
Federal food safety law, including relevant laws and regulations of
foreign countries (Sec. 507.7(a)(2)(ii)) (see the regulatory text of
Sec. 507.130(c)). Importantly, a qualified facility is still subject
to CGMPs and the FD&C Act, and, if the qualified facility is a supplier
controlling a hazard, it is reasonable for a receiving facility to
expect the qualified facility to provide to the receiving facility, an
assurance that reflects an attestation the facility has made to FDA. As
modified, one possibility is for a qualified facility to provide a
receiving facility with a brief description of the preventive controls
it is implementing to control the applicable hazard, consistent with an
attestation of its food safety practices in accordance with Sec.
507.7(a)(2)(i). For example, the qualified facility could state that
its manufacturing processes include a lethality step for microbial
pathogens of concern. As required by Sec. 507.7(f), a qualified
facility that submits an attestation to FDA about its animal food
safety practices would have documentation of those practices to support
its attestation to FDA and, thus, would have documentation to support
its written assurance to the receiving facility. Although a qualified
facility that submits an attestation to FDA about its food safety
practices also would have documentation of monitoring the performance
of the preventive controls to ensure that such controls are effective
as required by Sec. 507.7(a)(2)(i), we are not requiring the qualified
facility to describe its monitoring of the performance of preventive
controls to ensure that they are effective. Alternatively, a qualified
facility could provide a receiving facility with a statement that the
facility is in compliance with State, local, county, tribal, or other
applicable non-Federal
[[Page 56309]]
food safety law, including relevant laws and regulations of foreign
countries.
We disagree that the alternative verification activity for produce
farms would add a second layer of regulations on produce farms and are
retaining this provision.
(Comment 463) Some comments ask us to remove the requirement that
the written assurance be obtained at least every 2 years. Other
comments ask us to revise the purpose of the written assurance from
``the raw material or ingredient is not adulterated'' to ``the
receiving facility's use of the raw material or ingredient will not
cause the finished food to be adulterated.''
(Response 463) We decline these requests. A supplier verification
activity needs to consider supplier performance on an ongoing basis.
Procedures and practices evolve over time, and it is appropriate for a
receiving facility that is obtaining written assurance from a supplier
as an alternative verification activity to be aware of both procedures
and practices that have changed, as well as procedures and practices
that have stayed the same. The specified timeframe for updating the
written assurance, i.e., at least every two years, is reasonable.
A supplier can only provide assurance about raw materials and other
ingredients that it supplies to the receiving facility, not about the
animal food product that the receiving facility will produce using the
supplier's raw material or other ingredients.
D. Alternative Verification Activity When the Supplier Is a Produce
Farm That Is Not a ``Covered Farm'' for the Purposes of the Future
Produce Safety Rule (Final Sec. 507.130(d))
We proposed that if a supplier is a farm that is not subject to the
requirements that we have proposed to be established in the produce
safety rule in accordance with proposed Sec. 112.4 regarding the raw
material or ingredient that the receiving facility receives from the
farm, the receiving facility does not need to comply with the
verification requirements if the receiving facility: (1) Documents, at
the end of each calendar year, that the raw material or ingredient
provided by the supplier is not subject to the produce safety rule and
(2) obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the FD&C Act. See
also Sec. 507.215, which establishes specific elements that this
written assurance must include, i.e., the effective date; printed names
and signatures of authorized officials; and the applicable assurance.
Produce farms that are not ``covered farms'' under Sec. 112.4 of
the forthcoming produce safety rule have less than $25,000 in annual
sales averaged over the previous 3-year period, or satisfy the
requirements for a qualified exemption in Sec. 112.5 and associated
modified requirements in Sec. 112.6 based on average monetary value of
all food sold (less than $500,000) and direct farm marketing (during
the previous 3-year period, the average annual monetary value of food
sold directly to qualified end users exceeded the average annual
monetary value of the food sold to all other buyers). In the 2014
supplemental notice, we erroneously referred to these farms as farms
``not subject to the requirements established in part 112.'' While
produce farms that make less than $25,000 are not subject to the
requirements in part 112, produce farms that satisfy the requirements
for a qualified exemption are not subject to the full requirements of
part 112, but they do have certain modified requirements that they must
meet, as described in Sec. 112.6. We have corrected the description of
these farms in Sec. 507.130(d).
We have revised the provision to clarify that the receiving
facility must have documentation that the raw material or other
ingredient provided by the supplier is not subject to part 112 in
accordance with Sec. 112.4(a), or in accordance with Sec. Sec.
112.4(b) and 112.5: (1) Before first approving the supplier for an
applicable calendar year and (2) by December 31 of each calendar year
(rather than ``at the end of the calendar year'') and that the
documentation is regarding the status of supplier for the following
calendar year. By specifying ``by December 31,'' a receiving facility
can work with each applicable supplier to determine the specific date
within a calendar year for that supplier to annually notify the
receiving facility about its status. See also the discussion in section
XLV.C regarding a similar revision we made when the supplier is a
qualified facility.
(Comment 464) Some comments support the proposed alternative
supplier verification activity. Other comments support applying the
proposed alternative supplier verification activity more broadly, i.e.,
to any farm that will not be subject to part 112 (e.g., a farm that
grows wheat), stating that both small and large non-produce farms
should have the same option as farms that are exempted under Sec.
112.4. Some comments ask us to revise the alternative verification
requirements to apply to raw materials from farms that do not grow and
harvest ``produce'' as we proposed to define it in Sec. 112.3(c) so
that the alternative verification requirements would apply to grain.
Some comments assert that it is not possible to receive ``written
assurances'' of compliance from growers of grain because there is no
safety standard for grain growers, and that any such documents would be
essentially meaningless.
Some comments ask us to revise the requirement to obtain written
assurance so that it does not apply to ``food not subject to the
requirements of part 112 of this chapter pursuant to part 112.2.''
Other comments assert that a documentation requirement for commodities
that will be exempt from the produce safety rule would increase
recordkeeping burdens without added benefit because produce that will
be exempt from the produce safety rule is low risk.
Some comments assert that farms should not have to provide written
assurances because the requirement is ambiguous. These comments assert
that exempt farmers are small-scale producers who are subject primarily
to state and local laws and this provision would require them to
provide written assurances that they are complying with unspecified
Federal regulations. The comments claim that, without seeking legal
counsel, many exempt farmers would be unable to provide such
assurances, limiting the ability of these farmers to market their
products to non-exempt facilities (the overwhelming majority of the
food market).
(Response 464) We have revised the to specify that the written
assurance from the farm must state that the farm acknowledges that its
food is subject to section 402 of the FD&C Act (or, when applicable,
that its food is subject to relevant laws and regulations of a country
whose food safety system FDA has officially recognized as comparable or
has determined to be equivalent to that of the United States). Any
business that introduces food into interstate commerce is subject the
prohibited acts provisions in section 301 of the FD&C Act, and is
accountable if it produces food that is adulterated.
As discussed in Response 284, new Sec. 507.36(a) allows a
manufacturer/processor to not implement a preventive control if it
determines and documents that the type of animal food (e.g., soybeans)
could not be consumed without application of the appropriate control.
We believe most receiving facilities will take advantage of this
provision, and not establish supply-chain controls under the supply-
chain
[[Page 56310]]
program in subpart E for some specific RACs.
This alternative supplier verification activity is intended to
minimize the burden on suppliers that are small farms. The amount of
food produced by such farms is small, and the exposure to food from
such farms therefore is low. We disagree that a written assurance from
such a farm would be meaningless. Any business that distributes food in
interstate commerce is subject to the FD&C Act, and must produce food
that is in compliance with the FD&C Act, regardless of whether FDA has
established a specific regulation governing the production of the food.
(Comment 465) Some comments ask us to delete this alternative
supplier verification activity because they see it as a contradiction
to the traceability provisions of the Bioterrorism Act and FSMA,
because ``trace back'' is only required for ``one step back'' or for a
single supplier for a particular shipment of food.
(Response 465) The supply-chain program that is being established
in this rule is a preventive control for the ongoing production of safe
animal food, not a ``trace back'' provision, established under the
Bioterrorism Act, to help address credible threats relating to food
that is reasonably believed to be adulterated and to present a threat
of serious adverse health consequences or death to humans or animals.
(Comment 466) Some comments ask us to specify 3 options for
verification if a supplier is a farm subject to the requirements of
part 112: (1) Documentation at the end of each calendar year that the
raw material or ingredient provided by the supplier is subject to part
112; (2) written assurance, at least every 2 years, that the supplier
is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under the FD&C Act; or (3) evidence that
the supplier is certified to a recognized third-party GAP/GHP/GMP/HACCP
audit scheme. (We note that we are assuming that ``GHP'' is an
abbreviation for ``Good Hygienic Practice.'')
(Response 466) We decline this request. Documenting that a raw
material or other ingredient is subject to the produce safety rule has
no bearing on whether the farm is complying with that rule to control
the hazards. With respect to all farms subject to the requirements of
part 112 providing a written assurance, as discussed in Response 464,
the amount of food produced by the small farms that could provide
written assurance to a receiving facility is small, and the exposure to
food from such farms therefore is low. We disagree that it is
appropriate to extend this alternative supplier verification activity
to larger farms because such farms provide a larger volume of produce.
A farm that has been subject to an audit that complies with the
requirements of this rule can provide the results of the audit; a mere
statement that the farm has been certified based on an audit is
insufficient.
E. Alternative Verification Activity When the Supplier Is a Shell Egg
Producer That Has Less Than 3,000 Laying Hens (Final Sec. 507.130(e))
We are establishing an additional alternative supplier verification
activity when a supplier is a shell egg producer that is not subject to
the requirements of 21 CFR part 118 because it has less than 3,000
laying hens. See the regulatory text of Sec. 507.130(e). The provision
is analogous to the alternative supplier verification activity when a
supplier is a farm that meets the criteria in Sec. 507.130(d) and
would account for a very small amount of eggs in the food supply. See
also Sec. 507.215, which establishes specific elements that the
required written assurance must include, i.e., the effective date;
printed names and signatures of authorized officials; and the
applicable assurance.
F. Independence of Persons Who Conduct Supplier Verification Activities
(Final Sec. 507.130(f))
In the 2014 supplemental notice, we requested comment on whether we
should include in the final preventive controls rule requirements to
address conflicts of interest for individuals conducting verification
activities and, if so, the scope of such requirements.
(Comment 467) Some comments request that requirements to address
conflicts of interest should not be implemented or ask that conflict of
interest provisions not be written too broadly, and be limited to
circumstances where the individual employee carrying out the
verification activities has a direct personal financial interest in or
financial ties to the supplier (e.g., owns a substantial amount of
stock in the supplier or is personally paid directly by the supplier).
Comments state that it would not be uncommon for a receiving facility
to have a shared financial interest in the supplier (e.g., partial
ownership of one by the other or both being owned by the same parent
company). Thus, employees that have an indirect financial interest
(e.g., owning stock in a supplier because they own stock in their own
company, which in turn owns an interest in the supplier) should not be
disqualified from performing verification activities. Comments also
indicate that a laboratory analyst performing ingredient testing should
not be precluded from testing ingredients from a supplier in which the
analyst has a potential conflict of interest, as long as the analyst is
not aware of the identity of the supplier at the time the test is
performed.
(Response 467) We are establishing a requirement that there must
not be any financial conflicts of interests that influence the results
of the verification activities listed in Sec. 507.110(b) and payment
must not be related to the results of the activity. This does not
prohibit employees of a supplier from performing the functions
specified in Sec. 507.115 in accordance with Sec. 507.115. For
example, this provision would not prohibit an employee of a supplier
from conducting sampling and testing so that the supplier could provide
the results in documentation provided to the receiving facility. The
provisions would not prevent a person who is employed by a receiving
facility from having an indirect financial interest in a supplier
(e.g., if a company in which the employee owns stock owns an interest
in the supplier).
(Comment 468) Comments ask that we not preclude a supplier from
hiring an outside party to perform onsite audits, food certifications,
or sampling and testing.
(Response 468) We have specified that the requirements do not
prohibit a receiving facility from relying on an audit provided by its
supplier when the audit of the supplier was conducted by a third-party
qualified auditor (see Sec. 507.115(c)). We also have specified that a
supplier may conduct and document sampling and testing of raw materials
and other ingredients, for the hazard controlled by the supplier, as a
supplier verification activity for a particular lot of product and
provide the documentation to the receiving facility (see Sec.
507.115(a)(4)). This acknowledges that it is common for suppliers to
include Certificates of Analysis for tests conducted on specific lots
of product along with the shipment to the receiving facility.
XLVI. Subpart E: Comments on Onsite Audit
We proposed requirements that would apply to an onsite audit. Most
comments that support the proposed provisions suggest alternative or
additional regulatory text or ask us to clarify how we will interpret
the provision. In the following sections, we
[[Page 56311]]
discuss comments that ask us to clarify the proposed requirements or
that disagree with, or suggest one or more changes to, the proposed
requirements. After considering these comments, we have revised the
proposed requirements as shown in table 28.
Table 28--Revisions to the Proposed Requirements for Onsite Audits
----------------------------------------------------------------------------------------------------------------
Final section designation Proposed section designation Description Revision
----------------------------------------------------------------------------------------------------------------
507.135(a)..................... 507.37(d)(1)........................ An onsite audit N/A.
of a supplier
must be
performed by a
qualified
auditor.
507.135(b)..................... 507.37(d)(2)........................ An onsite audit Clarify that, when
must consider applicable, an onsite
applicable FDA audit may consider
regulations. relevant laws and
regulations of a
country whose food
safety system FDA has
officially recognized
as comparable or has
determined to be
equivalent to that of
the United States.
507.135(c)(1)(i)............... 507.37(e)(1)........................ Substitution of Broaden the list of
inspection for applicable
domestic inspections to
suppliers. include inspections
by representatives of
other Federal
Agencies (such as the
United States
Department of
Agriculture), or by
representatives of
State, local, tribal,
or territorial
agencies.
507.135(c)(1)(ii) and 507.37(e)(2)........................ Substitution of N/A.
507.135(c)(2). inspection for
foreign
suppliers.
507.135(d)..................... N/A................................. Use of a third- If the onsite audit is
party auditor solely conducted to
that has been meet the requirements
accredited in of the animal food
accordance with preventive controls
regulations that rule by an audit
will be agent of a
established in certification body
the forthcoming that is accredited in
third-party accordance with
certification regulations that will
rule. be established in
part 1, subpart M,
the audit is not
subject to the
requirements in those
regulations.
----------------------------------------------------------------------------------------------------------------
A. Requirements Applicable to an Onsite Audit (Final Sec. 507.135(a)
and (b))
We proposed that an onsite audit of a supplier must be performed by
a qualified auditor. If the raw material or ingredient at the supplier
is subject to one or more FDA food safety regulations, an onsite audit
would need to consider such regulations and include a review of the
supplier's written plan (e.g., HACCP plan or other food safety plan),
if any, including its implementation, for the hazard being audited
(proposed Sec. 507.37(d)). We have revised ``including its
implementation'' to ``and its implementation'' to emphasize that
implementation of the plan is distinct from the plan itself (e.g.,
Sec. 507.31(c) establishes the recordkeeping requirement for the food
safety ``plan,'' and Sec. 507.55 lists implementation records.)
As discussed in section XLII.D, we have revised the requirements
for considering supplier performance to provide that the receiving
facility may, when applicable, consider relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States, and information relevant to the supplier's compliance with
those laws and regulations, rather than consider applicable FDA food
safety regulations and information relevant to the supplier's
compliance with applicable FDA food safety regulations. We have made a
conforming change to the requirements for an onsite audit to clarify
that an onsite audit may consider relevant laws and regulations of a
country whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States. However, as of August 30, 2015, FDA has not developed a systems
recognition program for animal food; therefore, we have no signed
systems recognition agreements with any foreign food safety authority
relating to animal food. The currently existing systems recognition
agreement relates solely to human food and does not apply to animal
food.
(Comment 469) Comments support a requirement that an onsite audit
be performed by a qualified auditor, provided that we finalize
provisions (in proposed Sec. 507.37(e)) whereby an inspection by
certain authorities could substitute for an audit. Some comments ask us
to specify that the rule permits the use of audits conducted by private
third-party food safety auditing firms. Other comments ask us to
provide a list of recognized private third-party food safety schemes
and consider making third-party food safety certification to a
recognized audit scheme mandatory for all food operations that grow,
pack, hold and manufacture/process food for wholesale markets. Other
comments ask us to further specify that FDA will audit all food
facilities no less than once every 5 years to verify that private
third-party audits are consistent with FDA audits and findings.
(Response 469) See our discussion in section XLVI.B of the final
provisions governing substitution of inspection for an audit. We agree
that onsite audits may be conducted by third parties, but disagree that
it is necessary to specify this in the rule. Nothing in this rule
prevents a facility from hiring a third party to conduct audits.
We decline the requests to provide a list of recognized private
third-party food safety schemes or to make third-party food safety
certification to a recognized audit scheme mandatory for all food
operations that grow, pack, hold and manufacture/process animal food
for wholesale markets. The rule provides flexibility regarding use of
third-party auditors and the information is easily obtained from other
sources.
[[Page 56312]]
Private third-party food safety audit schemes are a function of the
private sector, not a function of the Federal government. Likewise, we
decline the request to specify that FDA will ``audit'' all food
facilities no less than once every 5 years to verify that private
third-party audits are consistent with FDA audits and findings. We will
inspect food facilities for compliance with this rule, not to verify
the findings of a third-party audit, with a frequency consistent with
our responsibilities under the FD&C Act.
(Comment 470) Some comments express concern about the multiple
audits that facilities are subject to each year and ask us to encourage
those subject to the rule to accept an audit performed by any of the
``bona fide authorities'' where it is warranted. Other comments note
that food manufacturers conduct their own audits and have developed
extensive expertise in doing so, and oppose any supplier verification
requirement that would affect those audits. Other comments ask us to
allow audits to industry standards (such as GFSI or ISO) to satisfy
supplier verification requirements to avoid adding a new audit to
audits currently being conducted. Some comments assert that audits to
industry standards (such as GFSI or ISO) and other similarly accredited
audits should be considered equivalent to onsite audits. Some comments
express concern that requiring a new audit in addition to audits
already being conducted could lead to auditor shortages and unnecessary
additional costs.
(Response 470) We expect that a facility will adopt an approach to
audits that works best for the facility and minimizes the number of
audits conducted for the same facility. An employee of a receiving
facility may perform an audit, provided that the employee satisfies the
criteria established in the rule for qualified auditors. Under Sec.
507.3 and Sec. 507.53, a qualified auditor is a qualified individual
(as defined in Sec. 507.3) and has technical expertise obtained
through education, training, or experience (or a combination thereof)
necessary to perform the auditing function. For additional information,
see Response 700 in the final rule for preventive controls for human
food published elsewhere in this issue of the Federal Register, in
which we discuss auditor qualifications with respect to the GFSI's
auditor competency model.
(Comment 471) Some comments ask us to delete the proposed
requirement for a review of the supplier's written plan as part of an
audit because review of the supplier's food safety plan should be part
of an overall supplier verification program when the supplier is
controlling a hazard that could cause serious adverse health
consequences or death, but should not be tied to an audit. These
comments state that receiving facilities may choose to use an
unannounced audit program where the auditor spends time focusing on the
actual conditions on the production floor, with a review of the
supplier's food safety plan being done as a separate verification
activity.
(Response 471) We decline this request. We agree that review of an
applicable food safety plan should be part of an overall supplier
verification program and that the review of the food safety plan may be
conducted separately from the observation of actual conditions on the
production floor, provided that both are conducted within the annual
timeframe. However, we believe it important that the audit address
whether the food safety plan is being implemented as designed and other
comments to this rule support that view. For example, as discussed in
Comment 493 regarding our inspection of a food facility, some comments
assert that our access to company records must be conducted onsite in
the course of an authorized inspection so that we may understand the
full context of what the records show. Thus, the onsite observations
and the food safety plan review cannot be entirely separated, as the
comment seems to suggest.
We note that the requirement to include a review of the supplier's
food safety plan only applies when the supplier has a food safety plan.
For example, we did not propose a requirement for a farm that would be
subject to the forthcoming produce safety rule to have a food safety
plan.
B. Substitution of Inspection by FDA or an Officially Recognized or
Equivalent Food Safety Authority
We proposed that instead of an onsite audit, a receiving facility
may rely on the results of an inspection of the supplier by FDA or, for
a foreign supplier, by FDA or the food safety authority of a country
whose food safety system FDA has officially recognized as comparable or
has determined to be equivalent to that of the United States, provided
that the inspection was conducted within 1 year of the date that the
onsite audit would have been required to be conducted. For inspections
conducted by the food safety authority of a country whose food safety
system FDA has officially recognized as comparable or determined to be
equivalent to that of the United States, the food that is the subject
of the onsite audit would need to be within the scope of the official
recognition or equivalence determination, and the foreign supplier
would need to be in, and under the regulatory oversight of, such
country (proposed Sec. 507.37(e)).
As of August 30 2015, FDA has not developed a systems recognition
program for animal food; therefore, we have no signed systems
recognition agreements with any foreign food safety authority for
animal food. A signed systems recognition agreement for human food does
not apply to animal food.
(Comment 472) Some comments ask us to allow State or local
inspection reports, as well as FDA inspection reports, to substitute
for an onsite audit for small and very small facilities. Other comments
ask us to create a ``safe harbor'' provision in which a supplier
providing a copy of permits obtained from the most recent inspection
done by Federal, State, or local health authorities satisfies the
supplier verification requirement; if there are no permits, review of
relevant records and/or sampling of raw material based on scale of
production should be adequate.
(Response 472) We have revised the regulatory text to provide for
an appropriate inspection of the supplier for compliance with
applicable FDA food safety regulations by FDA, by representatives of
other Federal Agencies (such as USDA), or by representatives of State,
local, tribal, or territorial agencies. We are specifying that the
inspection must be ``appropriate'' and be conducted for compliance
``with applicable FDA food safety regulations'' to make clear that the
inspection must be sufficiently relevant to an onsite audit to credibly
substitute for an onsite audit. For example, inspection by USDA to
determine whether a farm satisfies the requirements of the produce
safety rule could constitute an appropriate inspection that could
substitute for an audit, but an inspection by USDA to determine whether
a farm satisfies the requirements of the National Organic Program could
not.
We have not provided for substitution of a ``permit obtained from
the most recent inspection'' for an onsite audit. We do not see how a
``permit'' could shed light on whether a business is complying with
specific applicable FDA regulations. We have provided for an
alternative verification activity to the annual onsite audit (such as a
review of relevant records and/or sampling of raw material) with a
written justification (see Sec. 507.130(b)). The rule would not
preclude an appropriate review of records, or sampling and testing of
raw
[[Page 56313]]
materials, by other Federal Agencies, or by representatives of State,
local, tribal, or territorial agencies, provided that the receiving
facility satisfies the requirements for an adequate written
justification.
(Comment 473) Some comments ask us to clarify what we mean by
``food safety authority of a country whose food safety system FDA has
officially recognized as comparable or has determined to be equivalent
to that of the United States.'' These comments also ask whether a
specific country qualifies and whether HACCP certificates issued by a
specific foreign government agency would replace an onsite audit.
(Response 473) A country whose food safety system FDA has
officially recognized as ``comparable'' to that of the United States
would be one for which there is a signed systems recognition
arrangement or other agreement between FDA and the country establishing
official recognition of the foreign food safety system. Information on
FDA systems recognition can be found on the FDA Web site (Ref. 59). As
of August 30 2015, FDA has not developed a systems recognition program
for animal food; therefore, we have no signed systems recognition
agreements with any foreign food safety authority relating to animal
food. The currently existing systems recognition agreement relates
solely to human food and does not apply to animal food. We would not
accept a HACCP certificate issued by a foreign government as a
substitute for an onsite audit, but a receiving facility could consider
whether such a certificate could be part of its justification for
conducting another supplier verification activity in lieu of an annual
onsite audit, or for conducting an audit on a less frequent basis than
annually.
(Comment 474) Some comments ask us to clarify that the applicable
standards will be those applied by the food safety authority of a
country with a food safety system recognized as comparable or
equivalent rather than having to achieve compliance with the applicable
U.S. FDA food safety regulations.
(Response 474) The applicable standards will be those applied by
the food safety authority of a country with a food safety system
recognized as comparable or equivalent to that of the United States. As
of August 30, 2015, FDA has not developed a systems recognition program
for animal food; therefore, we have no signed systems recognition
agreements with any foreign food safety authority relating to animal
food. The currently existing systems recognition agreement relates
solely to human food and does not apply to animal food.
C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of
Section 808 of the FD&C Act
We have proposed to establish regulations (in part 1, subpart M) to
provide for accreditation of third-party auditors/certification bodies
to conduct food safety audits of foreign food entities, including
registered foreign food facilities, and to issue food and facility
certifications (78 FR 45782, July 29, 2013). The purpose of the
proposed third-party certification rule is to help us ensure the
competence and independence of third-party auditors/certification
bodies who conduct foreign food safety audits and to help ensure the
reliability of food and facility certifications issued by third-party
auditors/certification bodies that we will use in making certain
decisions relating to imported animal food, such as animal food
certifications required by FDA as a condition of granting admission to
an animal food determined to pose a safety risk.
(Comment 475) Comments support use of third-party auditors, but
emphasize that such auditors need not be accredited under the
requirements to be established under our forthcoming third-party
certification rule.
(Response 475) We agree that a third-party auditor who conducts an
audit as a supplier verification activity to satisfy the requirements
of this rule need not be accredited under our forthcoming third-party
certification rule. In addition, we see no reason that any requirements
of our forthcoming third-party certification rule should apply to an
audit merely because it was conducted by a person who had been
accredited under that rule. To make this clear, we have added a
provision to specify that if an onsite audit is solely conducted to
meet the requirements of this rule by an audit agent of a certification
body that is accredited in accordance with regulations in part 1,
subpart M, the audit is not subject to the requirements in those
regulations. See Sec. 507.135(d). Because Sec. 507.135(d) refers to
provisions in a future third-party certification rule, we will publish
a document in the Federal Register announcing the effective date of
Sec. 507.135(d) when we finalize the third-party certification rule.
XLVII. Subpart E: Comments on Records Documenting the Supply-Chain
Program (Final Sec. 507.175)
We proposed to require documentation of verification activities in
records, including minimum requirements for records documenting an
audit, records of sampling and testing, and records documenting a
review by the receiving facility of the supplier's relevant food safety
records. We also proposed that the receiving facility must review such
records in accordance with the requirements applicable to review of
records as a verification activity (i.e., in accordance with Sec.
507.49(a)(4)).
We did not receive comments on the documentation requirements
associated with a written supplier program, determination of
appropriate supplier verification activities, review of records,
supplier verification activities other than an annual onsite audit when
the hazard being controlled by the supplier is one for which there is a
reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death to humans or animals,
alternative supplier verification activity when the supplier is a
qualified facility, substitution of inspection for an audit, or
supplier nonconformance (proposed Sec. 507.37(g)(1), (2), (7), (9),
(10), (12), and (13), respectively). We are finalizing these
documentation requirements with editorial and conforming changes
associated with the final requirements of the supply-chain program.
The supply-chain program includes two provisions that are explicit
requirements of the final animal food preventive controls rule, but had
been implicit requirements of the 2014 supplemental notice. The first
of these provisions is the explicit requirement that the receiving
facility must approve suppliers in accordance with the requirements of
Sec. 507.110(d), and document that approval, before receiving raw
materials and other ingredients from those suppliers (see Sec.
507.120(a)). The second of these requirements is that written
procedures for receiving raw materials and other ingredients must be
established and followed (see Sec. 507.120(b)(1)). We are including in
Sec. 507.175 the documentation associated with these requirements (see
Sec. 507.175(c)(3) and (4)).
The supply-chain program includes four provisions that were not in
the 2014 supplemental notice: (1) A receiving facility that is an
importer can comply with the foreign supplier verification requirements
in the FSVP rule rather than conduct supplier verification activities
for that raw material or other ingredient under this rule (Sec.
507.105(a)(2)); (2) a receiving facility may use an alternative
verification activity for a supplier that is
[[Page 56314]]
a shell egg producer that is not subject to the requirements
established in part 118 because it has less than 3,000 laying hens
(Sec. 507.130(e)); (3) when applicable, a receiving facility must
verify a supply-chain-applied control applied by an entity other than
the receiving facility's supplier (Sec. 507.105(c)); and (4) entities
other than the receiving facility may determine, conduct, and document
certain specified supplier verification activities, provided that the
receiving facility reviews and assesses the other entity's applicable
documentation, and documents its review and assessment (Sec. 507.115).
We are establishing the associated documentation requirements in Sec.
507.175(c)(2), (14), (17), and (18), respectively.
In the following sections, we discuss comments on the proposed
records for the supplier program. After considering these comments, we
have revised the proposed requirements as shown in table 29.
Table 29--Revisions to the Proposed Requirements for Records for the Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
Did we revise
the
documentation
requirement
other than
Did we receive editorial and
Final section Proposed section Description comments regarding conforming
designation designation the proposed changes
requirement? associated with
the final
requirements for
the supply-
chain program?
----------------------------------------------------------------------------------------------------------------
507.175(a)............... N/A...................... The records N/A.................. Consequential
documenting the change
supply-chain associated with
program are establishing
subject to the the
requirements of requirements
subpart F. for a supplier
in subpart E
rather than
subpart C.
507.175(b)............... 507.37(g)................ The receiving Yes.................. No.
facility must
review the
records in
accordance with
Sec.
507.49(a)(4).
507.175(c)(1)............ 507.37(g)(1)............. The written No................... N/A.
supply-chain
program.
507.36(b)(2)............. 507.37(g)(3)............. Annual written Yes.................. Shifted to be in
assurance from a provisions
receiving outside the
facility's framework of
customer. the supply-
chain program
in subpart E.
507.175(c)(2)............ N/A...................... Documentation N/A.................. N/A.
obtained from an
importer.
507.175(c)(3)............ 507.37(g)(1)............. Documentation of No................... No.
the approval of
a supplier.
507.175(c)(4)............ 507.37(g)(1)............. Written No................... No.
procedures for
receiving raw
materials and
other
ingredients.
507.175(c)(5)............ 507.37(g)(4)............. Documentation Yes.................. Yes.
demonstrating
use of the
written
procedures for
receiving raw
materials and
other
ingredients.
507.175(c)(6)............ 507.37(g)(2)............. Documentation of No................... No.
the
determination of
the appropriate
supplier
verification
activities for
raw materials
and other
ingredients.
507.175(c)(7)............ 507.37(g)(5)............. Documentation of Yes.................. Added a
the conduct of requirement for
an onsite audit. the
documentation
to include the
name of the
supplier
subject to the
onsite audit.
507.175(c)(8)............ 507.37(g)(6)............. Documentation of Yes.................. Specify that the
sampling and documentation
testing include the
conducted as a date(s) on
supplier which the
verification test(s) were
activity. conducted and
the date of the
report.
507.175(c)(9)............ 507.37(g)(7)............. Documentation of No................... Specify that the
the review of documentation
the supplier's must include
relevant food the general
safety records. nature of the
records
reviewed and
conclusions of
the review.
507.175(c)(10)........... 507.37(g)(8)............. Documentation of Yes.................. Specify that the
other other
appropriate appropriate
supplier supplier
verification verification
activities. activities are
based on
supplier
performance and
the risk
associated with
the raw
material or
other
ingredient.
507.175(c)(11)........... 507.37(g)(9)............. Documentation of No................... No.
any
determination
that
verification
activities other
than an onsite
audit, and/or
less frequent
onsite auditing
of a supplier,
provide adequate
assurance that
the hazards are
controlled when
a hazard in a
raw material or
other ingredient
will be
controlled by
the supplier and
is one for which
there is a
reasonable
probability that
exposure to the
hazard will
result in
serious adverse
health
consequences or
death to humans
or animals.
[[Page 56315]]
507.175(c)(12)........... 507.37(g)(10)............ Documentation of No................... Provide for
an alternative documentation,
verification when
activity for a applicable, of
supplier that is a written
a qualified assurance that
facility. the supplier is
producing the
raw material or
other
ingredient in
compliance with
relevant laws
and regulations
of a country
whose food
safety system
FDA has
officially
recognized as
comparable or
has determined
to be
equivalent to
that of the
United States.
507.175(c)(13)........... 507.37(g)(11)............ Documentation of Yes.................. No.
an alternative
verification
activity for a
supplier that is
a farm that
supplies a raw
material or
other ingredient
that would not
be a covered
farm subject to
the forthcoming
produce safety
rule.
507.175(c)(14)........... N/A...................... Documentation of N/A.................. N/A.
an alternative
verification
activity for a
supplier that is
a shell egg
producer that is
not subject to
the requirements
established in
part 118 because
it has less than
3,000 laying
hens.
507.175(c)(15)........... 507.37(g)(12)............ The written No................... No.
results of an
appropriate
inspection of
the supplier by
FDA, by
representatives
of other Federal
Agencies (such
as USDA), or by
representatives
from State,
local, tribal,
or territorial
Agencies, or the
food safety
authority of
another country
when the results
of such an
inspection is
substituted for
an onsite audit.
507.175(c)(16)........... 507.37(g)(13)............ Documentation of No................... No.
actions taken
with respect to
supplier non-
conformance.
507.175(c)(17)........... N/A...................... Documentation of N/A.................. N/A.
verification of
a supply-chain-
applied control
applied by an
entity other
than the
receiving
facility's
supplier.
507.175(c)(18)........... N/A...................... When applicable, N/A.................. N/A.
documentation of
the receiving
facility's
review and
assessment of
documentation of
a supplier
verification
activity
provided by a
supplier or by
an entity other
than the
receiving
facility.
----------------------------------------------------------------------------------------------------------------
A. Applicability of the Recordkeeping Requirements of Subpart F
We have added new Sec. 507.175(a) to specify that the records
documenting the supply-chain program in subpart E are subject to the
requirements of subpart F. Under the 2014 supplemental notice, the
documentation requirements would have been in subpart C, and the
applicability of subpart F was specified in Sec. 507.55 in subpart C.
The new provision specifying the applicability of subpart F to the
records associated with the supply-chain program is a consequential
change associated with establishing the requirements for a supply-chain
program in subpart E, rather than in subpart C.
B. Requirement To Review Records of the Supply-Chain Program (Final
Sec. 507.175(b))
We proposed that a receiving facility must review records
documenting the supplier program in accordance with the requirements
applicable to review of records as a verification activity (i.e., in
accordance with Sec. 507.49(a)(4)). (Proposed Sec. 507.37(g).)
(Comment 476) Some comments ask us to provide consideration for
records associated with the supplier program to be administered and
maintained at corporate headquarters rather than at individual
facilities, because this is common industry practice.
(Response 476) We are aware that certain programs are administered,
and records are maintained, at corporate headquarters rather than at
individual facilities. The rule provides that offsite storage of
records is permitted if such records can be retrieved and provided
onsite within 24 hours of request for official review and electronic
records are considered to be onsite if they are accessible from an
onsite location (see Sec. 507.208(c)). We expect that the facility
would be able to access information and records relevant to the supply-
chain program within 24 hours (e.g., electronically) when the records
are maintained at corporate headquarters. As necessary and appropriate,
we intend to work with facilities on a case-by-case basis to determine
the best way to review records associated with the supply-chain program
when the supply-chain program is administered at the corporate level.
[[Page 56316]]
(Comment 477) Some comments ask us to clarify in the regulatory
text that the required records are ``as appropriate to the supplier
program.''
(Response 477) We have revised the regulatory text to specify that
the required records are ``as applicable to its supply-chain program''
(see Sec. 507.175(c)).
C. Documentation Demonstrating Use of the Written Procedures for
Receiving Raw Materials and Other Ingredients (Final Sec.
507.175(c)(5))
We proposed to require documentation demonstrating that products
are received only from approved suppliers (proposed Sec.
507.37(g)(4)).
(Comment 478) Some comments support the proposed requirement with
no changes. Other comments ask us to specify ``raw materials and
ingredients'' rather than ``products'' in the regulatory text.
(Response 478) We have revised the regulatory text to specify ``raw
materials and other ingredients'' with associated conforming changes.
D. Documentation of the Conduct of an Onsite Audit (Final Sec.
507.175(c)(7))
We proposed to require documentation of an onsite audit. This
documentation must include: (1) Documentation of audit procedures; (2)
the dates the audit was conducted; (3) the conclusions of the audit;
(4) corrective actions taken in response to significant deficiencies
identified during the audit; and (5) documentation that the audit was
conducted by a qualified auditor. For clarity, we have revised the
regulatory text to specify documentation of the ``conduct'' of an audit
and added a requirement for the documentation to include the name of
the supplier subject to the onsite audit.
(Comment 479) Some comments ask that we add ``if applicable'' to
the requirement to maintain documentation of an audit because an audit
may not be necessary if a receiving facility has documented that other
verification activities are appropriate.
(Response 479) We decline this request. The documentation is always
necessary if an audit is used as a verification activity. The provision
is about maintaining documentation when an audit is conducted, not
about when an audit needs to be conducted.
(Comment 480) Some comments ask us to maintain the confidentiality
of audit reports and exempt such audit reports from disclosure under
the Freedom of Information Act (FOIA).
(Response 480) These comments are similar to comments we received
related to disclosure of other records required by this part (see
Comments 490 and 491). We would establish the status of supply-chain
program records, such as audit reports, as available for, or protected
from, public disclosure on a case-by-case basis. As discussed in
Response 491, we primarily intend to copy such records when we conduct
an inspection for cause or if the preliminary assessment by our
investigator during a routine inspection is that regulatory followup
may be appropriate (e.g., if the report indicates that a significant
food safety problem was noted). See Response 491 for a discussion of
situations in which records would, or would not, be protected from
disclosure.
(Comment 481) Some comments express concern about maintaining
documentation of the conclusions of an audit and documentation of
corrective actions taken in response to significant deficiencies
identified during the audit. These comments explain that FDA's access
to such documentation during inspection might discourage suppliers from
allowing unannounced audits. These comments ask us to delete these
proposed requirements. If the requirement regarding documentation of
corrective actions remains in the final rule, these comments ask us to
limit such documentation to situations in which the identified
deficiencies posed a risk to public health.
(Response 481) We are retaining these documentation requirements as
proposed. These comments appear to be suggesting that documentation
requirements be established based on whether a business entity would
want us to see information during inspection rather than on the utility
and value of the documentation. We expect that receiving facilities, in
general, maintain documentation of the conclusions of audits that they
have conducted or arranged to have conducted. A receiving facility must
approve all of its suppliers, and documentation of corrective actions
taken in response to significant deficiencies identified during an
audit has value to a receiving facility in determining whether to
approve a supplier before first receiving any raw materials or other
ingredients and then on an ongoing basis.
The rule does not require that onsite audits be unannounced,
although we acknowledge that some receiving facilities may see value in
unannounced audits. We decline the request to require a receiving
facility to maintain documentation of corrective actions only if the
identified deficiencies posed a risk to public (human and animal)
health. The purpose of an audit, like the purpose of all the supplier
verification activities, is broader than identifying deficiencies that
pose a risk to public (human and animal) health and includes verifying
whether a raw material or other ingredient is adulterated under section
402 of the FD&C Act and is produced in compliance with applicable FDA
food safety regulations (see Sec. 507.110(c)). If, for example, a
supplier's facility has filthy conditions or the raw materials and
other ingredients it supplies are contaminated with filth, a receiving
facility may find it inappropriate to approve that supplier. Even
though filth often does not pose a risk to public (human and animal)
health, a food may be deemed to be adulterated under section 402(a)(4)
of the FD&C Act if it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with
filth.
E. Documentation of Sampling and Testing (Final Sec. 507.175(c)(8))
We proposed to require records of sampling and testing. These
records must include: (1) Identification of the raw material or
ingredient tested (including lot number, as appropriate) and the number
of samples tested; (2) identification of the test(s) conducted,
including the analytical method(s) used; (3) the date(s) on which the
test(s) were conducted and the date of the report; (4) the results of
the testing; (5) corrective actions taken in response to detection of
hazards; and (6) information identifying the laboratory conducting the
testing.
(Comment 482) Some comments ask us to not apply the requirement to
maintain records related to sampling and testing to the receipt of RACs
because sampling and testing of RACs is neither common nor effective
for detecting biological or chemical hazards, especially in raw, intact
produce.
(Response 482) We decline this request. These comments appear to
suggest that documentation requirements be established based on the
frequency and utility of sampling and testing a particular commodity
rather than on a determination by a receiving facility that sampling
and testing is an appropriate supplier verification activity for a
particular supplier. We disagree with such a suggestion. A receiving
facility that has determined that sampling and testing is an
appropriate supplier verification activity needs to maintain records of
those results as it would for any other supplier verification activity.
To the extent that these comments are concerned that the supply-chain
[[Page 56317]]
program requires sampling and testing of RACs, we emphasize that this
is not the case. See also Response 350 for a discussion of the
usefulness of sampling and testing as a verification measure for RACs.
(Comment 483) Some comments ask us to allow documentation of
testing to include the date the test results were reported as an
alternative to the date(s) on which the test(s) were conducted.
(Response 483) We have revised the provision to require ``The
date(s) on which the test(s) were conducted and the date of the
report.'' We agree that the date on which the test results are reported
can be important, but it should not be a replacement for the date of
the test.
(Comment 484) Some comments ask us to add ``if necessary'' to the
end of the proposed requirement for documentation of corrective actions
taken in response to detection of hazards.
(Response 484) We decline this request. The documentation is always
necessary if corrective actions are taken. The provision is about
maintaining documentation when corrective actions are taken, not about
the fact that corrective actions may not always be needed.
F. Documentation of Other Appropriate Supplier Verification Activity
(Final Sec. 507.175(c)(10))
We proposed to require records of other appropriate verification
activities based on the risk associated with the ingredient. For
clarity and consistency, we have revised the proposed requirement to
specify ``documentation'' of the other appropriate supplier
verification activity rather than ``records'' of the activity. As a
conforming change associated with using the term ``supplier
performance,'' rather than ``risk of supplier,'' when discussing
factors associated with suppliers, the final requirement specifies that
the other appropriate supplier verification activities are based on the
supplier performance and the risk associated with the raw material or
other ingredient.
(Comment 485) Some comments ask us to also specify that an
``other'' appropriate supplier verification activity be based on the
risk associated with raw materials and suppliers.
(Response 485) We have revised the regulatory text to specify
``Documentation of other appropriate supplier verification activities
based on the supplier performance and the risk associated with the raw
material or other ingredient.'' The revised regulatory text of the
documentation tracks the regulatory text of this ``other'' appropriate
supplier verification activity (see Sec. 507.110(b)(4)). As discussed
in Response 444, ``supplier performance'' is more appropriate than
``risk associated with the supplier.''
G. Documentation of an Alternative Verification Activity for a Supplier
That Is a Farm That Is Not a ``Covered Farm'' for the Purposes of the
Future Produce Safety Rule (Final Sec. 507.175(c)(13))
We proposed to require documentation of an alternative verification
activity for a supplier that is a farm that is not a ``covered farm''
for the purposes of the future produce safety rule, including: (1) The
documentation that the raw material or ingredient provided by the
supplier is not subject to the produce safety rule and (2) the written
assurance that the supplier is producing the raw material or ingredient
in compliance with applicable FDA food safety regulations and that the
raw material or ingredient is not adulterated under section 402 of the
FD&C Act. We have revised the documentation to reflect the final
requirements of Sec. 507.130(d)--i.e., to require: (1) Written
assurance that the supplier is not a covered farm under part 112 in
accordance with Sec. 112.4(a), or in accordance with Sec. Sec.
112.4(b) and 112.5, before approving the supplier and on an annual
basis thereafter and (2) the written assurance that the farm
acknowledges that its food is subject to section 402 of the FD&C Act
(or, when applicable, that its food is subject to relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or has determined to be equivalent to that of
the United States). However as of August 30, 2015, FDA has not
developed a systems recognition program for animal food; therefore, we
have no signed systems recognition agreements with any foreign food
safety authority relating to animal food. The currently existing
systems recognition agreement relates solely to human food and does not
apply to animal food.
(Comment 486) Some comments ask us to delete this documentation
requirement because RACs except fruits and vegetables should be exempt
from supplier verification.
(Response 486) See Response 464. This alternative supplier
verification activity is intended to minimize the burden on suppliers
that are small farms.
(Comment 487) Some comments ask us to include a cross-reference to
the applicable requirement.
(Response 487) We have not added this cross-reference. We agree
that adding the cross-reference has the potential to be helpful, but it
also has the potential to clutter the regulatory text. We considered it
would be more useful to specify what the documentation needs to be
rather than to specify the cross-reference to the applicable
alternative supplier verification activity.
XLVIII. Subpart F: Comments on Proposed New Recordkeeping Requirements
We proposed to establish in subpart F requirements that would apply
to all records that would be required by the various provisions of
proposed part 507, including general requirements related to the
content and form of records; additional requirements specific to the
food safety plan; requirements for record retention; requirements for
official review of records by FDA; and public disclosure.
Some comments support the proposed requirements without change.
Some comments that support the proposed provisions suggest alternative
or additional regulatory text or ask us to clarify how we will
interpret the provision.
In the following paragraphs, we discuss comments that disagree with
or suggest one or more changes to the proposed requirements. After
considering these comments, we have revised the proposed requirements
as shown in table 30 with editorial and conforming changes as shown in
table 31.
Table 30--Revisions to the Proposed Recordkeeping Requirements
------------------------------------------------------------------------
Section Description Revision
------------------------------------------------------------------------
507.200(b).................... Requirements for Specify that the
public requirement applies
disclosure. to records
``obtained by FDA.''
507.200(c).................... Requirements for Clarify that FDA may
official review. copy records upon
oral or written
request by a duly
authorized
representative of
the Secretary of
Health and Human
Services.
[[Page 56318]]
507.202(b).................... General Provide that the time
requirements of an activity being
applying to documented only
records. include the time of
the activity when
appropriate.
507.202(c).................... General Specify that
requirements electronic records
applying to are exempt from the
records. requirements of 21
CFR part 11.
507.208(a)(2)................. Requirements for Specify that records
record retention. that a facility
relies on during the
3-year period
preceding the
applicable calendar
year to support its
status as a
qualified facility
must be retained at
the facility for as
long as necessary to
support the status
of a facility as a
qualified facility
during the
applicable calendar
year.
507.208(c).................... Requirements for Provide for offsite
record retention. storage of all
records other than
the food safety
plan, provided that
the offsite records
can be retrieved and
provided onsite
within 24 hours of
request for official
review.
507.208(d).................... Requirements for Provide that the food
record retention. safety plan may be
transferred to some
other reasonably
accessible location
if the plant or
facility is closed
for a prolonged
period, provided
that it is returned
to the plant or
facility within 24
hours of request for
official review.
507.215....................... Special Establish
requirements requirements
applicable to a applicable to all
written written assurances
assurance. required by the
rule.
Establish
additional
requirements
applicable to
written assurances
that are required
when a food product
distributed by
manufacturer/
processor requires
further processing
for food safety by a
subsequent
manufacturer.
------------------------------------------------------------------------
A. Proposed Sec. 507.200--Records Subject to the Requirements of
Subpart F and Requirements for Official Review
We proposed that all records required by part 507 would be subject
to all requirements of subpart F, except that certain specific
requirements (proposed Sec. 507.206) would apply only to the written
food safety plan. We also proposed that certain proposed requirements
(e.g., for records to contain the actual values and observations
obtained during monitoring and, as appropriate, during verification
activities) would not apply to the records that would be kept by
qualified facilities. We proposed that records required by proposed
part 507 are subject to the disclosure requirements under part 20 (21
CFR part 20). We proposed that all records required by proposed part
507 be made promptly available to a duly authorized representative of
the Secretary of HHS upon oral or written request. We also asked for
comment on whether we should require a facility to send records to us
rather than make the records available for review at a facility's place
of business and, if so, whether we should require that the records be
submitted electronically.
(Comment 488) Some comments disagree with the proposal to exempt
the records that would be kept by qualified facilities from
requirements to keep accurate, detailed records. The comments note that
the proposed exemption would apply to qualified facilities regardless
of whether they operate under the first option for documentation (i.e.,
food safety practices) plans or under the second option for
documentation (i.e. compliance with non-Federal food safety laws).
These comments assert that the proposed detailed record keeping
requirements should apply to records relating to monitoring food safety
practices and ask us to revise the proposed requirements so that this
exemption would apply only to those qualified facilities that operate
under non-Federal food safety laws.
(Response 488) We decline this request. We based the proposed
exemption on a statutory provision that a qualified facility is not
subject to certain requirements, including the statutory recordkeeping
requirements (see section 418(l)(2) of the FD&C Act). Although the
requirements that apply to a qualified facility require submission of
certain attestations to FDA (see Sec. 507.7(a) and (b)), and these
attestations must be supported by documentation (see Sec. 507.7(f)),
the rule does not require that records kept by a qualified facility to
support its attestations be the same type of records that would be kept
by a facility subject to subparts C and E. For example, if the facility
attests that it has identified the potential hazards associated with
the animal food being produced, implemented preventive controls to
address the hazards, and is monitoring the performance of the
preventive controls, the qualified facility might support its
attestation by having a standard operating procedure for monitoring
preventive controls rather than detailed records of actual monitoring.
(Comment 489) Some comments assert that the proposed requirements
governing public disclosure are not aligned with other risk-based
preventive controls programs, such as HACCP programs. These comments
argue that these proposed requirements should be realigned with other
risk-based preventive controls programs to preserve the privacy of
information maintained in required records unless that information has
been otherwise made publicly available. Some comments suggest that we
revise the proposed requirements to be analogous to the public
disclosure requirements in our HACCP regulations for seafood and juice
(see Sec. Sec. 123.9(d) and 120.12(f), respectively).
(Response 489) We disagree that the proposed provisions governing
public disclosure are not aligned with the public disclosure provisions
of our HACCP regulations for seafood and juice. Our regulations in part
20 regarding public information apply to all Agency records, regardless
of whether a particular recordkeeping requirement says so. In the case
of the recordkeeping requirements for our HACCP regulations for seafood
and juice, we framed the provisions regarding public disclosure by
providing specific details about how particular provisions in part 20
(i.e., Sec. 20.61 (Trade secrets and commercial or financial
information which is privileged or confidential) and Sec. 20.81 (Data
and information previously disclosed to the public)) would apply to the
applicable records. In the case of the recordkeeping requirements for
this
[[Page 56319]]
rule, we framed the provisions regarding public disclosure by more
broadly referring to all the requirements of part 20, consistent with
our more recent approach for framing the provisions regarding public
disclosure in the rule ``Prevention of Salmonella Enteritidis in Shell
Eggs During Production, Storage, and Transportation'' (part 118; see
Sec. 118.10(f)). Provisions such as Sec. 20.20 (Policy on disclosure
of Food and Drug Administration records) apply to all records that we
have in our system, including HACCP records, even though the HACCP
regulations do not specify that this is the case.
(Comment 490) Some comments ask us to clarify that the disclosure
requirements of part 20 include protections for trade secrets and
privileged or confidential commercial information and financial
information. Other comments ask us to clarify that written food safety
plans and associated records are not subject to public disclosure
because they represent trade secret or confidential commercial
information. Other comments ask us to clarify how the disclosure
requirements of part 20 would apply to verification records (such as
testing records).
(Response 490) The questions raised in these comments are similar
to some of the questions raised during the rulemaking to establish
FDA's HACCP regulation for seafood (see the discussion at 60 FR 65096
at 65137 through 65140, December 18, 1995). FDA's experience in
conducting CGMP inspections in processing plants, our experience with
enforcing the HACCP regulations for seafood and juice, and our
understanding from the Final Regulatory Impact Analysis (FRIA) for this
rule (Ref. 60) make it clear that food safety plans will take each
facility some time and money to develop. Thus, we conclude that food
safety plans generally will meet the definition of trade secret,
including the court's definition in Public Citizen Health Research
Group v. FDA, 704 F.2d 1280 (D.C. Cir. 1983). Plans that incorporate
unique regimens or parameters to achieve product safety, which are the
result of considerable research and effort, will surely meet this
definition.
We would establish the status of verification records, such as the
results of product testing and environmental monitoring, as available
for, or protected from, public disclosure on a case by case basis. As
discussed in Response 491, we primarily intend to copy such records
when we conduct an inspection for cause. We also intend to copy such
records if the preliminary assessment by our investigator during a
routine inspection is that regulatory followup may be appropriate
(e.g., if these records demonstrate that an environmental pathogen has
become established in a niche environment in an animal food processing
plant).
(Comment 491) Some comments assert that we should not copy
documents as part of routine investigations so as to prevent critical
documents from release under the FOIA. These comments are particularly
concerned that our ability to copy verification records (such as
testing records) and potentially release these records under the FOIA
would discourage facilities from testing as a verification activity.
These comments also express concern that some facilities would include
in their food safety plans elements, not required by the proposed rule,
that address food defense, as well as food safety, and that disclosure
of such a food safety plan without proper redaction could provide
useful information to persons seeking to defeat the facility's food
defense strategies. In addition, these comments express concern that
the task of reviewing all of these records and redacting trade secrets
and confidential information would further set back FDA's already
overburdened FOIA offices and create even longer delays in responding
to FOIA requests.
(Response 491) We have revised the proposed requirement to specify
that all required records must be made promptly available ``for
official review and copying'' to increase the alignment of the
recordkeeping requirements of this rule with those of our HACCP
regulations for seafood and juice. The issues raised by these comments
are similar to some of the issues raised by comments during the
rulemaking to establish our HACCP regulations for seafood (see the
discussion at 60 FR 65096 at 65137 through 65140) and our regulations
in part 118 for the prevention of Salmonella Enteritidis in shell eggs.
We intend to copy records on a case-by-case basis as necessary and
appropriate. We may consider it necessary to copy records when, for
example, our investigators may need assistance in reviewing a certain
record from relevant experts in headquarters. If we are unable to copy
the records, we would have to rely solely on our investigators' notes
and reports when drawing conclusions. In addition, copying records will
facilitate followup regulatory actions.
We primarily intend to copy records such as the results of product
testing or environmental monitoring when we conduct an inspection for
cause, e.g., as a result of an outbreak investigation, violative sample
results, or followup to a consumer complaint. See Response 490 for a
discussion of how the FOIA would apply to records, such as records of
testing as a verification activity, that we copy during an inspection
and maintain in our system.
(Comment 492) Some comments ask us to modify the proposed
requirement to clarify that it is ``records required by this part and
provided to the Agency,'' rather than ``records obtained by the
Agency'' that are subject to public disclosure.
(Response 492) We agree that it is appropriate to specify that the
disclosure requirements of this rule apply to information that we
maintain as a record (see the description of ``record'' in Sec.
20.20(e)). (See also the discussion (in the proposed rule to establish
our seafood HACCP regulation, 59 FR 4142 at 4160, January 28, 1994)
that there are significant legal and practical questions as to whether
FDA has the authority to require disclosure of industry records that
are not in FDA's possession.) However, we see no meaningful distinction
between records ``provided to FDA'' and records ``obtained by FDA,''
and have revised the provision to specify that records obtained by FDA
in accordance with this part are subject to the disclosure requirements
under part 20. The revised regulatory text makes clear that the
requirements of part 20 attach to those documents obtained by FDA. To
the extent that these comments are addressing the difference between
records provided during inspection and records submitted to us, as
already discussed we have decided not to require submission of certain
records to us (see Response 493).
(Comment 493) Some comments strongly oppose any requirement for
submission of records to FDA remotely and assert that there is no basis
in FSMA for such a requirement. Some comments express concern about our
ability to protect confidential information (such as supplier and
customer records received by a facility under the protection of
confidentiality agreements) that is transmitted electronically (e.g.,
the information that might be released through computer hacking or
leaks). Some comments note that inadvertent disclosure of information
related to specific products, hazards, and preventive controls
implemented at food facilities could both prove harmful from a
commercial or competitive standpoint and expose existing
vulnerabilities in the U.S. food supply, thus potentially rendering
food facilities susceptible to malicious attack.
Some comments express concern over any potential requirements to
submit
[[Page 56320]]
reports from third-party audits to FDA. The comments state that a
requirement to submit audit reports, which may be included as voluntary
or required components of a facility's food safety plan, would not be
of public health benefit and could potentially impact a facility's
willingness to use audits in their food safety program.
Some comments offered that instead of submission of the food safety
plan, a facility should submit a ``certification'' that the facility
has a food safety plan during the course of the facility registration
process.
Some comments oppose the concept of a ``desk audit'' whereby our
investigators conduct their inspections from a remote office without
actually visiting the facility and assert that our access to company
records must be conducted on-site in the course of an authorized
inspection so that we may understand the full context of what the
records show. Some comments point out that there would be challenges
associated with credential validation when we asked for records to be
sent remotely, such as in an email request. Some comments ask that we
modify the proposed requirement to specify that records would only be
made available to us during a facility inspection.
(Response 493) We have decided not to establish any requirements
for a facility to send records to us. We will review records when we
are onsite in the course of an authorized inspection, and copy records
as necessary and appropriate.
We are not modifying the proposed requirement to specify that
records would only be made available to us during a facility inspection
because it is not necessary to do so. The regulatory text specifying
that the records be made available to a duly authorized representative
of the Secretary of HHS provides the context that the records would be
made available during inspection.
B. Proposed Sec. 507.202--General Requirements Applying to Records
We proposed that the records must: (1) Be kept as original records,
true copies, or electronic records (and that electronic records must be
kept in accordance with part 11 (21 CFR part 11)); (2) contain the
actual values and observations obtained during monitoring and, as
appropriate, during verification activities; (3) be accurate,
indelible, and legible; (4) be created concurrently with performance of
the activity documented; (5) be as detailed as necessary to provide
history of work performed; and (6) include the name and location of the
plant or facility, the date and time of the activity documented, the
signature or initials of the person performing the activity, and, where
appropriate, the identity of the product and the production code, if
any.
We have revised the provision to require information adequate to
identify the plant or facility (e.g., the name, and when necessary, the
location of the plant or facility) rather than to always require both
the name and location of the plant or facility (see Sec.
507.202(b)(1)). In some cases, the name of the plant or facility will
be adequate to identify it, e.g., when a plant or facility is not part
of a larger corporation that has facilities at more than one location.
In other cases, the name of the plant or facility may not, by itself,
be adequate to identify the plant or facility, e.g., when a plant or
facility is part of a larger corporation with more than one location
and the ``name'' of each plant or facility is the same.
(Comment 494) Some comments express concern about ``apparent
mandates'' that we will require records to be kept as paper copies,
even if the records were generated electronically, for 2 years.
(Response 494) We did not propose to require that all records must
be kept as paper copies. A facility has the choice to keep records as
original records, true copies, or electronic records.
(Comment 495) Some comments assert that compliance with part 11 for
the secure operation of many systems currently in use is unnecessary
and would create the need to redesign and recreate existing systems,
thus leading to considerable cost and complexity. These comments
identify the requirement for hardware and software to be validated as a
key cost concern and assert that validation activities would be
difficult to maintain and would not deliver added value. As an example,
these comments explain that an expectation for validation of electronic
recordkeeping software and hardware would be particularly problematic
because software patches and security updates are distributed on a
nearly weekly basis, and express the view that validation procedures
are most appropriately applied before use of a new system and after
major software changes or updates. These comments also assert that it
would be costly, burdensome, and require specialized resources to
modify or replace existing electronic systems to comply with part 11.
These comments provide an example in which a facility needed more than
9 months to upgrade one system alone to comply with part 11, and note
that it would not be unusual for companies to employ multiple systems,
so the burden and cost would exponentially increase. These comments ask
us to instead require facilities that use electronic records to a use
secure system that ensures records are trustworthy, reliable, and
generally equivalent to paper records and handwritten signatures
executed on paper.
Other comments express concern about the financial burden for small
facilities such as farm mixed-type facilities and ask us to either
modify requirements for farm mixed-type facilities, very small
businesses, and small businesses or provide that such facilities be
fully exempt from part 11 requirements for electronic records. Other
comments state that, as with the recordkeeping requirements under the
Bioterrorism Act, such requirements are disproportionate to the
regulatory need.
Some comments state that major advances in software technology have
been made since part 11 published in 1997, and such advances must be
carefully considered in evaluating any potential expansion or new
applications of part 11. These comments also state that we already are
in the process of reevaluating part 11 for the regulations for which it
currently applies, citing industry guidance issued more than 10 years
ago in which we acknowledged that part 11 is unworkable in many
respects and decided to exercise enforcement discretion for part of the
regulations and announced plans to reexamine part 11 as a whole.
Some comments recommend that we develop guidance, with input from
key stakeholders, to describe the kinds of systems and steps that can
be used to assure records meet the required standard. This guidance
should clearly establish that specific security needs will depend on
the circumstances, including the system at issue, its intended use, the
criticality of the preventive control or other food safety measure it
is used to manage, and other relevant factors. For example, these
comments explain that a quality system used to manage CCP documentation
would have greater security needs than a review of a Certificate of
Analysis for a non-sensitive ingredient.
(Response 495) In light of the substantial burden that could be
created by the need to redesign large numbers of already existing
electronic records and recordkeeping, we are providing in new Sec.
507.202(c) that records that are established or maintained to satisfy
the requirements of part 507 and that meet the definition of electronic
records in Sec. 11.3(b)(6) are exempt from the requirements of part
11. As we did in the section 414 recordkeeping
[[Page 56321]]
regulations, we also are specifying that records that satisfy the
requirements of part 507, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11. The rule provides that a facility may rely on existing records to
satisfy the requirements of this rule, and this rule does not change
the status under part 11 of any such records if those records are
currently subject to part 11. As we did in the rulemaking to establish
the section 414 recordkeeping regulations, we are establishing a
conforming change in part 11 to specify in new Sec. 11.1(j) that part
11 does not apply to records required to be established or maintained
under part 507, and that records that satisfy the requirements of part
507, but that also are required under other applicable statutory
provisions or regulations, remain subject to part 11.
Although we are not specifying that part 11 applies, facilities
should take appropriate measures to ensure that records are
trustworthy, reliable, and generally equivalent to paper records and
handwritten signatures executed on paper.
(Comment 496) Some comments assert that certain production and
associated activities are not time-sensitive and would not require
documentation of the time the activity is performed. These comments ask
us to modify the proposed requirements so that the records would only
require the time of the activity documented where appropriate for food
safety.
(Response 496) We agree that certain activities (e.g., record
review and verification activities) are not time-sensitive and, thus,
would not need to include the time that the activity was performed. The
final rule provides flexibility for the facility to determine when to
document the time by specifying that the time be documented ``when
appropriate'' (see Sec. 507.202(b)(2)).
(Comment 497) Some comments assert that concurrent record creation
will prove difficult in many animal food-processing environments. These
comments ask us to modify the proposed requirement that records be
created concurrently with the performance of the activity documented to
qualify that the requirement only applies where feasible, and that the
records could be created as soon as possible thereafter under
circumstances where concurrent record creation is not feasible.
(Response 497) We decline this request. The comments did not
provide any examples of activities where concurrent record creation in
animal food manufacturing/processing, packing, or holding environments
would prove difficult, and we are not aware of any such example. For
example, we are not aware of any difficulty complying with longstanding
similar requirements associated with our HACCP regulations for seafood
and juice (see Sec. Sec. 123.9(a)(4) and 120.12(b)(4), respectively).
C. Proposed Sec. 507.206--Additional Requirements Applying to the Food
Safety Plan
We proposed that the food safety plan must be signed and dated by
the owner, operator, or agent in charge of the facility upon initial
completion and upon any modification.
(Comment 498) Some comments ask for clarification on who can sign
and date the food safety plan. Some comments state that the proposed
rule would exclude the preventive controls qualified individual from
signing and dating the food safety plan unless the preventive controls
qualified individual is the owner, operator, or agent in charge of the
facility. These comments ask us to revise the rule to allow the
preventive controls qualified individual to sign and date the food
safety plan (e.g., because it is the preventive controls qualified
individual who prepares (or oversees the preparation of) the food
safety plan). One comment suggests that ``agent in charge'' be defined
to include all preventive controls qualified individuals. Some comments
ask us to require that any preventive controls qualified individuals
who prepare (or oversee the preparation of) specific sections of the
food safety plan sign and date applicable sections.
(Response 498) We decline these requests. The statute expressly
directs the owner, operator, or agent in charge of a facility to
prepare the food safety plan (see section 418(h) of the FD&C Act). As
previously discussed, such a signature would provide direct evidence of
the owner, operator or agent's acceptance of the plan and commitment to
implementation of the plan (78 FR 64736 at 64816). A facility has
flexibility to require the signature of one or more preventive controls
qualified individuals who prepared, or oversaw the preparation of, its
food safety plan in addition to the minimum signature requirement
specified in the rule. Likewise, a facility also has flexibility to
require the signature of one or more members of its food safety team
who contributed to the preparation of the food safety plan, even if
those individuals are not serving as the preventive controls qualified
individual for the facility.
D. Proposed Sec. 507.208--Requirements for Record Retention
We proposed that: (1) All required records must be retained at the
plant or facility for at least 2 years after the date they were
prepared; (2) records relating to the general adequacy of equipment or
processes being used by a facility, including the results of scientific
studies and evaluations, must be retained at the facility for at least
2 years after their use is discontinued; (3) except for the food safety
plan, offsite storage of records is permitted after 6 months following
the date that the records were made if such records can be retrieved
and provided onsite within 24 hours of request for official review; and
(4) if the plant or facility is closed for a prolonged period, the
records may be transferred to some other reasonably accessible location
but must be returned to the plant or facility within 24 hours for
official review upon request.
(Comment 499) Some comments ask us to clarify that the 2-year
record retention requirement only applies to records created after the
compliance date for the final rule.
(Response 499) The retention requirements only apply to records
created after the applicable compliance date for the final rule. See
Response 76 and section LIII.A, which explain that the compliance date
for a facility to retain records to support its status as a qualified
facility is January 1, 2017. See also Response 502, which explains that
we have revised the record retention provisions to specify that records
that a facility relies on during the 3-year period preceding the
applicable calendar year to support its status as a qualified facility
must be retained at the facility for as long as necessary to support
the status of facility as a qualified facility during the applicable
calendar year.
(Comment 500) Some comments ask us to delete the proposed
requirement to keep records on site for 6 months or 2 years (depending
on the record) and assert that it should suffice to require that
records be available within 24 hours of request or within a reasonable
period of time. Some comments assert that records should be able to be
kept in the location where they are created, which may be at corporate
headquarters. Other comments state that it may be difficult to obtain
records within 24 hours and requested additional time. Comments also
assert that specifying the location for record storage will increase
costs but will not contribute to improvements in public health. Some
[[Page 56322]]
comments ask us to permit offsite storage for all records over 6 months
old, in contrast to the 2-year retention period we proposed for records
relating to the general adequacy of equipment or processes being used
by a facility, including the results of scientific studies and
evaluations.
(Response 500) We have revised the provisions to provide for
offsite storage of all records (except the food safety plan), provided
that the records can be retrieved and made available to us within 24
hours of request for official review. We have determined that in order
to maintain inspectional efficiency, 24 hours is a reasonable period to
allow for retrieval of any offsite records. We expect that many records
will be electronic records that are accessible from an onsite location
and, thus, would be classified as being onsite (see Sec. 507.208(c)).
As a companion change, we have revised the proposed provision directed
to the special circumstance of storing records when a facility is
closed for prolonged periods of time so that it only relates to the
offsite storage of the food safety plan in such circumstances (see
Sec. 507.208(d)).
(Comment 501) Some comments assert that a 2-year retention period
for records is much longer than needed for animal food products, as
animal food is often consumed within a short time after manufacture.
These comments ask us to establish a 1-year period for record
retention, which would be similar to record retention periods required
in other FDA regulations. Some comments assert that records should be
required to be kept for the shelf life of the product plus an
additional 6 months, for certain animal foods such as pet foods.
(Response 501) We decline these requests. The proposed 2-year
retention period is authorized by the statute (see section 418(g) of
the FD&C Act). Moreover, the reasons discussed by the comments for
linking the retention period to shelf life are more relevant to the
record retention requirements for the purpose of tracking potentially
contaminated food (part 1, subpart J; see Sec. 1.360) than to the
record retention requirements for the purpose of evaluating compliance
with this rule.
(Comment 502) Some comments ask us to require that qualified
facilities keep financial and sales records for 3 or 4 years, because a
qualified facility must document that the average value of food it sold
over the prior 3 years did not exceed $500,000 annually.
(Response 502) We have revised the record retention provisions to
specify that records that a facility relies on during the 3-year period
preceding the applicable calendar year to support its status as a
qualified facility must be retained at the facility as long as
necessary to support the status of a facility as a qualified facility
during the applicable calendar year. As discussed in section VIII.A,
the definition of very small business established in this rule is based
on an average (of sales plus market value of animal food held without
sale) during the 3-year period preceding the applicable calendar year.
Thus, both of the criteria for the qualified facility exemption are
based on financial records associated with the preceding 3-year period.
The actual retention time necessary to support the status of a
qualified facility during the applicable calendar year could be as long
as 4 years. For example, if we inspect a facility on May 1, 2024, the
facility would have retained the records from 2021 to 2023 for 3 years
and 4 months. If we inspect the facility on December 28, 2024, the
facility would have retained the records from 2021 to 2023 for nearly 4
years.
E. Proposed Sec. 507.212--Use of Existing Records
We proposed that existing records (e.g., records that are kept to
comply with other Federal, State, or local regulations, or for any
other reason) do not need to be duplicated if they contain all of the
required information and satisfy the requirements of subpart F.
Existing records may be supplemented as necessary to include all of the
required information and satisfy the requirements of subpart F. We also
proposed that the information required by part 507 does not need to be
kept in one set of records. If existing records contain some of the
required information, any new information required by part 507 may be
kept either separately or combined with the existing records.
Comments that address this proposed requirement support it. For
example, some comments state that this provision would provide
flexibility to facilities to comply with the record requirements in an
efficient manner. Other comments state that this provision would
prevent companies from having to duplicate records or create new
records solely to satisfy recordkeeping requirements.
(Comment 503) Some comments state that food safety plan records are
a ``web of related documents'' that may be used in other programs and
cannot be collected or reduced to a ``binder.''
(Response 503) We agree that food safety plan records could be
considered a ``web of related documents,'' i.e., a set of records that
could include documents used in other programs. We also agree that the
food safety plan records need not be collected in a single location or
``reduced to a binder.'' Likewise, the records documenting
implementation of the plan could be a ``web of related documents.'' For
example, a facility that collects samples of product and sends them to
a laboratory for testing would have records documenting its collection
of samples, as well as records documenting the laboratory's test
results. Consistent with the requirements of the rule for written
procedures for product testing (Sec. 507.49(b)(2)) and the general
recordkeeping requirements of subpart F (Sec. 507.202), the sampling
records would contain information such as the name and location of the
facility, the date when the samples were collected, the signature or
initials of the person collecting the samples, and the identity and lot
code of the sampled product.
Likewise, the laboratory report would contain information
identifying the laboratory, the product tested (and associated lot
code), the test analyte, the test(s) conducted (including the
analytical method(s) used), the date of the test(s), the test results,
and the signature or initials of the person who conducted the test.
Alternatively, it would be acceptable to have the signature or initials
of the person who approved the release of the test results from the
laboratory. Together, these records contain all the required
information to associate them with a facility, a specific lot of
product, and the results of laboratory testing on that product.
Although the provisions for use of existing records provide
flexibility, there are some limitations. For example, monitoring
records must be created concurrently with the monitoring activity and
contain the signature or initials of the person conducting the
monitoring. If the facility has an existing form that it uses to
document the monitoring activity, and that form does not provide (or
have space to add) information adequate to identify the plant or
facility (e.g., the name and, when necessary, the location of the
facility), and does have (or have space to add) a place for the
signature of the person performing the activity, we expect the facility
to modify the form rather than use the existing form. The provisions
for ``supplementing'' existing records do not extend to providing
information identifying the facility, or signatures, on separate pages.
(Comment 504) Some comments state that our review of records should
be limited to issues under our jurisdiction, regardless of the other
information that may be contained in the record. Other
[[Page 56323]]
comments ask us to ensure that inspectors are adequately trained on how
to review facility records for the requisite information across
multiple sets of documents, as needed.
(Response 504) Section 418(h) of the FD&C Act requires that the
written plan that documents and describes the procedures used by the
facility to comply with the requirements of section 418, together with
the documentation of monitoring of preventive controls, instances of
nonconformance material to food safety, the results of testing and
other means of verification, instances when corrective actions were
implemented and the efficacy of preventive controls and corrective
actions, be made available to FDA. Our inspectors will be trained to
focus on the written food safety plan and the records documenting
implementation of the plan during inspections. Our inspectors have
experience in the review of records that an animal food business
establishes and maintains for more than one purpose--e.g., during the
review of records kept under the section 414 recordkeeping regulations
during the investigation of an outbreak of foodborne illness.
For further discussion of comments received on recordkeeping
requirements, see section XLI in the final rulemaking for preventive
controls for human food published elsewhere in this issue of the
Federal Register.
F. Final Sec. 507.215--Special Requirements Applicable to a Written
Assurance
As discussed in section XXVII, new Sec. 507.215 establishes
requirements applicable to the written assurance a manufacturer/
processor obtains from its customer. New Sec. 507.215(a) applies to
all written assurances required by the rule, i.e., the assurance must
contain the effective date; printed names and signatures of authorized
officials; and the applicable assurance.
The provisions of Sec. 507.215(b), together with another new
provision (Sec. 507.37), establish legal responsibilities under the
rule for a facility that provides a written assurance regarding a food
product that a manufacturer/processor distributes without application
of a preventive control that is needed to control a hazard. This
responsibility exists even for a facility that is not itself a
manufacturer/processor, such as for a facility that is a distributor.
We are establishing legal responsibilities for the facilities that
provide these written assurances because following these assurances is
critical to ensuring that required preventive controls are applied to
the food by an entity in the distribution chain before the food reaches
consumers.
XLIX. Comments by Foreign Governments and Foreign Businesses
We received several comments from foreign governments and foreign
businesses covering a wide range of issues. Many of those comments were
similar to comments made on certain topics by domestic stakeholders, so
we are addressing those comments in other sections throughout this
preamble. In this section, we are responding to comments that are
primarily focused on international issues, such as the obligations of
the United States under the World Trade Organization Agreement (WTO).
(Comment 505) Some comments by foreign government representatives
ask us to provide extended periods of time for the implementation of
the rule for facilities in foreign countries.
(Response 505) The concept of special and differential treatment is
incorporated in the WTO Agreements. Article 10.2 of the WTO Sanitary
and Phytosanitary (SPS) Agreement states: ``Where the appropriate level
of sanitary or phytosanitary protection allows scope for the phased
introduction . . . longer timeframes for compliance should be accorded
on products of interest to developing country Members so as to maintain
opportunities for their exports.''
In 2001, at the WTO Ministerial Conference in Doha, WTO Members
issued a Ministerial Decision that interpreted the special and
differential obligations of the SPS Agreement (Ref. 61). The
Ministerial Decision defined ``longer timeframe for compliance'' to
normally mean a period of not less than 6 months.
We recognize that businesses of all sizes may need more time to
comply with the new requirements established under this rule. As
discussed in section LIII, the compliance date for implementation of
subpart C, Hazard Analysis and Preventive Controls is extended one year
beyond the compliance date for the implementation of subpart B, Current
Good Manufacturing Practice. Businesses other than small and very small
businesses will have 1 year after the date of publication to comply
with the CGMP requirements and 2 years after publication to comply with
preventive controls requirements. Small businesses will have 2 years
after publication to comply with the CGMP requirements and 3 years
after publication to comply with preventive controls requirements. Very
small businesses will have 3 years after publication to comply with the
CGMP requirements and 4 years after publication to comply with
preventive controls requirements. We anticipate that these extended
implementation periods for small businesses and very small businesses
will apply to a number of businesses in developing countries. Because
all of these time periods are longer than the 6 month minimum defined
in the WTO Ministerial Decision, we believe these implementation
periods are sufficient to address the needs of businesses in developing
countries, particularly for small and very small businesses in such
countries.
In addition to the extended time periods for compliance for small
and very small businesses, we have also established modified
requirements for very small businesses, which we define as a business
(including any subsidiaries; and affiliates) averaging less than
$2,500,000, adjusted for inflation, per year, during the 3-year period
preceding the applicable calendar year, in sales of animal food plus
the market value of animal food manufactured, processed, packed, or
held without sale (e.g., held for a fee or supplied to a farm without
sale). These modified requirements for very small businesses are less
burdensome and are described in Sec. 507.7 of this regulation.
In addition to the extended and staggered time periods for
compliance for all firms, and modified requirements for very small
businesses, we intend to work with the animal food industry, education
organizations, USDA, the United States Agency for International
Development, and foreign governments to develop tools and training
programs to facilitate implementation of this rule.
(Comment 506) Some comments assert that the food safety systems of
the European Union and other countries afford a similar level of food
safety protection and must therefore be recognized by FDA as equivalent
under the WTO SPS Agreement. These comments urge FDA to accept the
HACCP plans and other steps taken to comply with European food safety
laws as being sufficient to comply with this rule.
(Response 506) The concept of ``equivalence'' for food safety
regulatory measures is contained in Article 4 of the World Trade
Organization Agreement on the Application of Sanitary and Phytosanitary
Measures (the ``SPS Agreement'') (Ref. 62). That article provides that
WTO Member countries ``shall accept the sanitary or phytosanitary
measures of other Members as equivalent, even if these measures differ
from their own or from
[[Page 56324]]
those used by other Members trading in the same product, if the
exporting Member objectively demonstrates to the importing Member that
its measures achieve the importing Member's appropriate level of
sanitary or phytosanitary protection.'' This provision of the SPS
Agreement envisions a process in which the exporting country provides
evidence to the food safety regulator in the importing country in order
to ``objectively demonstrate'' that the food safety system in the
exporting member meets the level of food safety protection established
by the importing country. To date, FDA has considered equivalence as
most appropriately applied to the assessment of a foreign government's
specific programs for specific types of foods, such as shellfish and
dairy products. In that context, the equivalence assessment provides a
very detailed comparison of each measure that a country applies in
controlling risks associated with the particular commodity under
review. FDA continues to have latitude to engage in equivalence
determinations for market access and as required by our regulations for
certain commodities.
In contrast to the assessment of equivalence for the regulation of
specific foods based upon a detailed review of an individual food
safety measure or group of measures applied to a specific food, FDA has
established a process of assessing foreign food safety systems to
identify systems that offer a comparable level of public health
protection as the U.S. food safety system for FDA regulated foods. We
refer to that process as ``systems recognition,'' which we discuss in
Response 507.
(Comment 507) Some comments urge FDA to include a provision in this
rule that would reflect a determination made by FDA in the ``systems
recognition'' process so that FDA's compliance framework, including
audit and inspection activities, takes into account the effectiveness
of the regulatory or administrative control of food safety systems.
These comments ask us to include a provision in this rule establishing
that an affirmative systems recognition determination by FDA for an
exporting country would be a sufficient basis to exempt exporting
businesses from that country from their obligation to comply with the
requirements of this rule. Another comment urges FDA to utilize the
systems recognition process to recognize the effectiveness of the
European Union (EU) system in order to avoid unnecessary or duplicative
requirements and controls on food imports from the EU. Another comment
requests that FDA coordinate inspection and audits with the relevant
competent authority.
(Response 507) We agree, in part, with this comment. We agree that
the systems recognition program can allow FDA to take into account the
effectiveness of a foreign food safety regulatory system as we develop
a compliance framework for imported foods from a country for which we
have made an affirmative determination of comparability via the systems
recognition program. While we decline to add an exemption for food
imported from a country with affirmative systems recognition
determination by FDA, we note that the systems recognition program is
based upon the concept that foreign food businesses can meet U.S. food
safety requirements by providing assurances that these foods are
produced according to the food safety standards of a country that FDA
has found to be comparable or equivalent to that of the United States.
Several provisions of the supply-chain program specifically provide for
consideration of relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States (see
Sec. Sec. 507.110(d)(1)(iii)(B); 507.130(c)(2), (d)(2), and (e)(2);
and 507.135(b) and (c)(1)(ii)). However, as of August 30, 2015, FDA has
not developed a systems recognition program for animal food; therefore,
we have no signed systems recognition agreements with any foreign food
safety authority relating to animal food. The currently existing
systems recognition agreement relates solely to human food and does not
apply to animal food. For further discussion of the systems recognition
program, see Response 718 of the final rule for preventive controls for
human food, published elsewhere in this issue of the Federal Register.
We also note that we intend to publish a final FSVP rule in the
near future. There, we intend to establish modified requirements for
food imported from a foreign supplier in, and under the regulatory
oversight of, a country whose food safety system FDA has officially
recognized as ``comparable'' to that of the United States.
Section 507.105(a)(2) of this rule provides the option for a
receiving facility that is an importer to comply with the supplier
verification requirements in this rule or with the foreign supplier
verification program requirements that we will establish in part 1,
subpart L for a raw material or other ingredient. We intend that the
final FSVP rule will contain a similar provision (derived from proposed
Sec. 1.502), so that only one supplier verification procedure needs to
be undertaken in order to comply with both rules when the specified
conditions are met.
(Comment 508) Some comments assert that a proper harmonization is
needed with international standards and ask us to harmonize the FSMA
requirements for the food safety plan with international and domestic
HACCP programs. These comments also ask us to explain any differences
between the FSMA food safety plan and the existing HACCP programs and
ask us to provide exporters with background information and specific
examples of differences, including how firms are directed to set their
CCPs and critical limits.
(Response 508) We currently have no HACCP requirements applicable
to animal food. For discussion of this comment, see Response 725 in the
final rule for preventive controls for human food, published elsewhere
in this issue of the Federal Register.
L. Editorial and Conforming Changes
The revised regulatory text includes several changes that we have
made to make the requirements more clear and improve readability. The
revised regulatory text also includes several conforming changes that
we have made when a change to one provision affects other provisions.
We summarize the principal editorial and conforming changes in table
31.
[[Page 56325]]
Table 31--Principal Editorial and Conforming Changes
------------------------------------------------------------------------
Designation in the revised
regulatory text (Sec. ) Revision Explanation
------------------------------------------------------------------------
11.1(j).............. Specify that part Conforming change
11 does not associated with the
apply to records recordkeeping
required to be requirements in Sec.
established or 507.202, which
maintained under provide that part 11
part 507, and does not apply to
that records records required to
that satisfy the be established or
requirements of maintained under
part 507, but part 507.
that also are
required under
other applicable
statutory
provisions or
regulations,
remain subject
to part 11.
Throughout part 507........... Conforming change
Substitute the associated with our
term proposal, in the
``adequate'' for 2014 supplemental
the term animal preventive
``sufficient''. controls notice, to
make this
Substitute the substitution so that
term the rule
``inadequate'' consistently uses
for the term the term
``insufficient''. ``adequate.''
Throughout part 507........... Substitute the Conforming change
term associated with the
``pathogen'' for definition of
the term ``pathogen.''
``microorganism
of public health
significance''.
Throughout part 507........... Substitute the Conforming change
term associated with
``preventive adding the term
controls ``preventive
qualified controls qualified
individual'' for individual''.
the term
``qualified
individual''.
Throughout part 507........... Substitute the Conforming change
term ``unexposed associated with the
packaged animal definition of
food'' for the ``unexposed packaged
phrase animal food''.
``packaged
animal food that
is not exposed
to the
environment''.
Throughout part 507........... Substitute the Conforming change
phrase associated with the
``chemical definition of
(including ``hazard''.
radiological)
hazards'' for
phrases such as
``chemical and
radiological
hazards''.
Throughout part 507........... Substitute the Conforming change
term ``hazard associated with the
requiring a proposed definition
preventive of ``significant
control'' for hazard'' (which we
the term now refer to as
``significant ``hazard requiring a
hazard''. preventive
control'').
Throughout part 507........... Shorten ``raw Conforming change
agricultural associated with the
commodity as new definition of
defined in ``raw agricultural
section 201(r) commodity''.
of the Federal
Food, Drug, and
Cosmetic Act''
to ``raw
agricultural
commodity''.
507.1(a)...................... Redesignate Improve clarity.
subparagraphs to
distinguish
between applying
the provisions
in determining
whether animal
food is
adulterated and
applying the
provisions in
determining
whether there is
a violation of
the PHS Act.
507.3......................... Substitute Improve clarity.
``apply'' for
``are
applicable'' in
the introductory
paragraph.
507.3......................... Alphabetize the Improve clarity.
examples of
harvesting
activities in
the definition
of
``harvesting''.
507.3......................... Alphabetize the Improve clarity.
examples of
manufacturing/
processing
activities in
the definition
of
``manufacturing/
processing''.
507.3......................... Specify that the Give prominence to
definition of this aspect of the
``very small definition of ``very
business'' small business.''
includes any The relevance of
subsidiaries and subsidiaries and
affiliates. affiliates to the
definition of ``very
small business'' is
established in the
definition of
``qualified
facility,'' but
including it again
in the definition of
``very small
business'' will help
to ensure that it is
considered when
determining whether
the business is
within the dollar
threshold
established in the
definition of ``very
small business''.
507.3................ Substitute Conforming change
507.5................ ``subparts C and associated with the
507.7(d)............. E'' for redesignation of the
507.10(a)............ ``subpart C''. requirements for a
507.65(d)(1)......... supply-chain program
in new subpart E.
[[Page 56326]]
507.7(a)(2)(ii)............... Editorial change Improve clarity.
to place the
clause
``including an
attestation
based on
licenses,
inspection
reports,
certificates,
permits,
credentials,
certification by
an appropriate
agency (such as
a State
department of
agriculture), or
other evidence
of oversight''
at the end of
the provision,
rather than in a
parenthetical at
the beginning of
the provision.
507.14............... Conforming The definition of
507.17(a)............ changes ``plant'' focuses on
507.20(d)............ associated with the building,
507.202(b)........... the definition structure, or parts
of ``plant''. thereof, used for or
in connection with
the manufacturing,
processing, packing,
or holding of animal
food. The term
``establishment''
focuses on a
business entity
rather than on
buildings or other
structures.
507.20(d)..................... Refer to Editorial change.
``employees''
rather than
``its
employees''.
507.25(a)(2) Changes to Conforming change
through(b)(1). consistently with preventive
507.33(d)(3)......... refer to raw controls rule for
507.105(a)(1)........ materials and human food.
507.110(b) through ``other
(e). ingredients''.
507.115(a)...........
507.120(a) and (b)...
507.130..............
507.175(c)...........
507.31(b)(3), 507.34(c)(3), Refer to ``supply- Conforming change
507.39(b), 507.47(c)(3), chain program'' associated with the
507.55(a)(5). rather than title of final
``supplier subpart E (proposed
program''. Sec. 507.37).
507.47(b)(2)......... Conforming Improve clarity;
507.50(b)(4)......... changes consistency with the
associated with requirements for
the definition validation.
of
``validation''.
507.49(a)(4)(ii).............. Refer to ``supply- Consequential change
chain as a result of the
verification requirement in Sec.
activities,'' as 507.105(c) for
well as verification of an
``supplier entity that is in
verification the supply-chain but
activities''. is not a supplier.
507.49(b)(1).................. Changes to Conforming change
require written associated with the
procedures for requirements to
method and calibrate process
frequency of monitoring
accuracy checks instruments and
for process verification
monitoring instruments (or
instruments and check them for
verification accuracy).
instruments.
507.50(c)(2).................. Conforming Consistency with the
changes requirements for
associated with validating
the timeframe preventive controls.
for validating
preventive
controls.
507.50(d)..................... Editorial changes Improve clarity.
to the
requirement to
revise the
written food
safety plan or
document why
revisions are
not needed.
507.51(a)(2).................. Editorial change Improve clarity.
to specify
``provide
assurance that
the temperature
controls are
consistently
performed''
rather than
``provide
assurance that
they are
consistently
performed''.
507.51(a)(4)(ii)..... Substitute the Consistency with
507.51(a)(4)(iii).... phrase ``records other recordkeeping
are created'' requirements of the
for the phrase rule.
``records are
made''.
507.51(a)(4)(iii)............. Change ``within a Conforming change
week'' to associated with
``within 7 review of records of
working days''. monitoring and
corrective action
records.
507.53(a)(3).................. Change to specify Conforming change
the role of the associated with
preventive flexibility to
controls determine the
qualified timeframe for
individual in validation of a
determining an preventive control.
alternative
timeframe for
validation.
507.53(a)(4).................. Change to specify Conforming change
the role of the associated with
preventive flexibility to
controls determine that
qualified validation of a
individual in preventive control
determining that is not required.
validation is
not required.
507.53(a)(6).................. Change to specify Conforming change
the role of the associated with
preventive flexibility to
controls determine the
qualified timeframe for review
individual in of records of
determining an monitoring and
alternative corrective actions.
timeframe for
review of
records of
monitoring and
corrective
actions.
[[Page 56327]]
507.53(a)(8).................. Change to specify Conforming change
the role of the associated with
preventive flexibility to
controls determine the
qualified timeframe for
individual in completing
determining an reanalysis.
alternative
timeframe for
completing
reanalysis.
Subpart D (title)............. Substitute the Conforming change
507.60........................ term ``qualified associated with the
507.62........................ facility definition of
507.65........................ exemption'' for ``qualified facility
507.67........................ the phrase exemption''.
507.80........................ ``exemption
507.85........................ applicable to a
qualified
facility'' or
the phrase
``exemption
applicable to a
qualified
facility under
Sec.
507.5(d)''.
507.60(b)(1).................. Change ``import Align with statutory
alert'' to language regarding
``refusal of imports rather than
animal food with specific
offered for procedures that FDA
import''. uses for refusing
admission to animal
foods offered for
import.
507.62(a)..................... Change ``FDA The provision refers
official senior to two ``Directors''
to such and the clause
Director'' to applies to either
``FDA official Director.
senior to either
such Director''.
507.65(c)(2).................. Refer to Consistency with
``conditions or regulatory text in
conduct'' rather Sec. 507.60(a)(2).
than ``conduct
or conditions''.
507.67(a)(2)......... Change ``within Conforming change to
507.69(a)(1)......... 10 calendar reflect a timeframe
507.71(a)(2),........ days'' to of 15 calendar days,
507.73(a)............ ``within 15 rather than 10
calendar days''. calendar days, in
the order
withdrawing a
qualified facility
exemption.
507.85(a)............ Specify ``any Clarify that
507.85(b)(2)......... problems with reinstatement of a
the conditions qualified exemption
and conduct'' that was withdrawn
rather than requires resolution
``problems with of any problems,
the conditions regardless of
and conduct'' or whether the problems
``problems with related to
the conditions conditions, conduct,
or conduct''. or both conditions
and conduct.
507.202....................... Refer to ``lot Consistency with the
code'' rather definition of
than ``lot''.
``production
code''.
507.206....................... Editorial changes Improve clarity.
to present the
requirement in
active voice.
------------------------------------------------------------------------
LI. Comments on FSMA's Rulemaking Provisions
A. Comments on Section 418(m) of the FDA&C Act Regarding Modified
Requirements for Facilities Solely Engaged in the Production of Food
for Animals Other Than Man
Section 418(m) of the FD&C Act authorizes the Secretary, by
regulation, to modify the requirements for compliance under the section
with respect to facilities that are solely engaged in the production of
food for animals other than man. We tentatively concluded that the
requirements of section 418 of the FD&C Act are needed to ensure the
safety of animal food and in turn the health of animals, the health of
humans who are exposed to animal food, and the safety of animal derived
products for human consumption. We proposed certain limited exemptions,
described elsewhere in this rule, as provided by section 103 of FSMA.
We sought comment on whether the requirements in section 418 of the
FD&C Act should be modified further for facilities that are solely
engaged in the production of food for animals other than man, based on
scientific and public health principles (78 FR 64736 at 64745).
(Comment 509) Some comments agree with our proposal to establish
only minor modifications to the requirements of section 418 of the FD&C
Act for facilities solely engaged in the production of food for animals
other than man. Other comments ask that we consider proposing more
extensive modified requirements for animal food, or exempting feed
mills, using the authority under section 418(m).
(Response 509) We did not receive comments that provided sufficient
data and rationale to support changing our proposed modifications to
the requirements in section 418 of the FD&C Act. However, the final
rule provides risk-based flexibility in the preventive controls
requirements and their management components by recognizing the
importance of the facility, the food, the nature of the preventive
control, and its role in the facility's food safety system. For our
approach to feed mills, see our discussion in section IV.
B. Comments on Requirements in Section 418(n)(3) of the FD&C Act
Regarding Content
FSMA specifies that this rule acknowledge differences in risk and
minimize, as appropriate, the number of separate standards that apply
to separate foods (section 418(n)(3)(C) of the FD&C Act).
(Comment 510) Some comments agree that the proposed preventive
controls requirements reflect a risk-based approach and recognition
that a ``one-size-fits-all'' approach is not appropriate in the
application of hazard analysis and risk-based preventive controls
across the entire domestic and international food industry. These
comments ask us to retain this flexibility in the final rule by
describing the required and expected results of the program, but not
going as far as prescribing the process and methodology taken to get
there. Other comments emphasize that the final rule must provide
sufficient flexibility to allow facilities to adopt practices that are
practical and effective for their specific, individual operations. One
comment expressed the opinion that
[[Page 56328]]
different manufacturing and distribution practices are necessary to
ensure the safety of human food, pet food, and livestock food.
(Response 510) The final rule directs the owner, operator, or agent
in charge of a facility to establish and implement a food safety plan
that includes a written hazard analysis, preventive controls that the
facility identifies to control hazards requiring a preventive control,
and establish and implement appropriate preventive control management
components to ensure the effectiveness of the preventive controls,
taking into account the facility, the food, the nature of the hazard,
the nature of the preventive control and its role in the facility's
food safety system. As requested by the comments, the rule does not
prescribe the process and methodology to ``get there.''
(Comment 511) Some comments interpret the statutory direction in
section 418(n)(3)(C) of the FD&C Act to mean that Congress granted us
authority to provide flexibility for businesses of all sizes and types
(i.e., not just small businesses), as well as to acknowledge
differences in risk. These comments assert that section 418(n)(3)(C)
grants us authority to exempt distribution centers from the
requirements for hazard analysis and risk-based preventive controls
because: (1) Distribution centers are very low-risk facilities and (2)
requiring distribution centers to comply with those requirements would
not be practicable.
(Response 511) We disagree with these comments. A pet food
distribution center must register as a food facility because it holds
food for animal consumption and does not satisfy any of the criteria
for entities that are not required to register (see Sec. 1.226). The
preventive controls that such a facility would establish and implement
would depend on the facility, the animal food, and the outcome of the
facility's hazard analysis, and any preventive control management
components associated with a facility's preventive controls would be
established as appropriate to ensure the effectiveness of the
preventive controls, taking into account the nature of the preventive
control and its role in the facility's food safety system. In the case
of a facility that is a pet food distribution center, the facility
would, as part of its evaluation, determine whether any preventive
controls are necessary for unexposed, non-refrigerated packaged animal
foods. The facility might determine that the modified requirements in
Sec. 507.51 for unexposed, refrigerated, packaged TCS animal foods are
appropriate to apply to such foods that it holds. If so, the facility
could establish its food safety plan by building on the provisions
established in Sec. 507.51.
LII. Comments on Proposed Conforming Amendments
We proposed a series of conforming amendments to current
regulations to add a reference to part 507. The affected sections in
Title 21 CFR Chapter 1 are:
Sec. 11.1 Scope;
Sec. 16.1 Scope;
Sec. 117.95 Holding and distribution of human food by-
products for use as animal food;
Sec. 225.1 Current good manufacturing practice;
Sec. 500.23 Thermally processed low-acid foods packaged
in hermetically sealed containers; and
Sec. 579.12 Incorporation of regulations in part 179.
We received no comments that disagree with the proposed conforming
changes. Therefore, at this time we are amending each of these current
regulations so that they refer to part 507 except for the amendment to
part 225. We proposed to add a new paragraph (d) in Sec. 225.1 stating
that ``In addition, nonmedicated feed is subject to part 507 of this
chapter.'' All animal food facilities that are required to register as
a food facility under section 415 of the FD&C Act are subject to the
requirements of part 507. This would include those facilities that
manufacture medicated animal feed, nonmedicated animal feed, or both.
Because of this, we do not think the conforming change to part 225 is
necessary and we are not finalizing this conforming change.
LIII. Effective and Compliance Dates
A. Effective and Compliance Dates for Part 507
We proposed that the final rule based on proposed part 507 would
become effective 60 days after its date of publication in the Federal
Register, with staggered compliance dates (78 FR 64736 at 64751). We
tentatively concluded that it was reasonable to allow for 1 year after
the date of publication of the final rule for businesses other than
small and very small businesses to comply with the rule. We also
tentatively concluded that it was reasonable to allow for 2 years after
the date of publication of the final rule for small businesses to
comply with the rule, and 3 years after the date of publication of the
final rule for very small businesses to comply with the rule.
We received one comment agreeing with our proposed compliance
dates. In the following paragraphs, we discuss comments that disagree
with, or suggest one or more changes to, these proposed compliance
dates. After considering these comments, we have concluded that
additional time is needed for the animal food industry to comply with
this final rule. Therefore, the compliance date for implementation of
subpart C, Hazard Analysis and Preventive Controls and subpart E,
Supply-Chain Program, is extended one year beyond the compliance date
for the implementation of subpart B, Current Good Manufacturing
Practice. Businesses other than small and very small businesses will
have 1 year after the date of publication to comply with the CGMP
requirements and 2 years after publication to comply with preventive
controls and supply-chain requirements. Small businesses will have 2
years after publication to comply with the CGMP requirements and 3
years after publication to comply with preventive controls and supply-
chain requirements. Very small businesses will have 3 years after
publication to comply with the CGMP requirements and 4 years after
publication to comply with preventive controls requirements.
In addition, we are establishing an earlier compliance date for the
financial records that a facility maintains to support its status as a
very small business that is eligible for the qualified facility
exemption in Sec. 507.5(d). Specifically, the compliance date for a
facility to retain records to support its status as a qualified
facility is January 1, 2017. (See Response 76.)
We are also establishing separate compliance dates for the supply-
chain program provisions. As discussed in Response 515, a receiving
facility's compliance date for the supply-chain program provisions of
this rule is the later of: (1) The receiving facility's compliance date
for the other preventive controls requirements under this rulemaking;
(2) for a raw material or other ingredient from a supplier subject to
the preventive controls requirements of this rule, six months after the
receiving facility's supplier of that raw material or ingredient is
required to comply with the preventive controls requirements of this
rule; or (3) for a raw material or other ingredient that from a
supplier subject to CGMPs, but not the preventive controls requirements
of this rule, 6 months after the receiving facility's supplier of that
animal food is required to comply with the CGMP requirements of this
rule. See tables 32 and 33 for a summary of these compliance dates.
[[Page 56329]]
Table 32--Compliance Dates for the Requirements of Part 507 Other Than
the Requirements for a Supply-Chain Program (Subpart E)
------------------------------------------------------------------------
Compliance date
for subpart B Compliance date for
Size of business and related subpart C and Sec.
requirements 507.7
------------------------------------------------------------------------
Qualified facility (including September 17, September 17, 2019,
very small business) as 2018. except that the
defined in Sec. 507.3. compliance date for
a facility to
retain records to
support its status
as a qualified
facility is January
1, 2017.
Small business as defined in September 18, September 17, 2018.
Sec. 507.3. 2017.
All other businesses........... September 19, September 18, 2017.
2016.
------------------------------------------------------------------------
Table 33--Compliance Dates for the Requirements of the Supply-Chain
Program (Subpart E)
------------------------------------------------------------------------
Situation Compliance date:
------------------------------------------------------------------------
A receiving facility is a small 6 months after the receiving
business and its supplier will be facility's supplier of that
subject to the CGMPs, but not the raw material or other
preventive control requirements, of ingredient is required to
the animal food preventive controls comply with the CGMP
rule. requirements of this rule.
A receiving facility is a small The later of: September 17,
business and its supplier is subject 2018 or 6 months after the
to the animal food preventive controls receiving facility's supplier
rule. of that raw material or other
ingredient is required to
comply with this rule.
A receiving facility is not a small 6 months after the receiving
business or a very small business and facility's supplier of that
its supplier will be subject to CGMPs, raw material or other
but not the preventive control ingredient is required to
requirements, of the animal food comply with the CGMP
preventive controls rule. requirements of this rule.
A receiving facility is not a small The later of: September 18,
business or a very small business and 2017 or 6 months after the
its supplier will be subject to the receiving facility's supplier
animal food preventive controls rule. of that raw material or other
ingredient is required to
comply with the applicable
rule.
------------------------------------------------------------------------
We also are establishing two additional compliance dates applicable
to qualified facilities. We are establishing December 16, 2019 first as
the compliance date for the initial submission of the attestation by a
facility that it is a qualified facility (see Sec. 507.7(a)(1)) and
the attestation by a qualified facility about its food safety practices
(see Sec. 507.7(a)(2)(i)), or that it is in compliance with non-
Federal food safety law (see Sec. 507.7(a)(2)(ii)), and second as the
compliance date for the notification requirement of Sec. 507.7(e)(1).
A qualified facility that submits an attestation that it is in
compliance with applicable non-Federal food safety law must notify
consumers as to the name and complete business address of the facility
where the animal food was manufactured or processed (see Sec.
507.7(e)). If an animal food packaging label is required, the required
notification must appear prominently and conspicuously on the label of
the animal food (see Sec. 507.7(e)(1)). This notification requirement
may require some qualified facilities to update the labels of their
packaged animal food products.
(Comment 512) Some comments disagree with the proposed compliance
dates and our tentative conclusion that concepts in the CGMP
regulations would not be new to the animal food industry. Comments
state that both large and small facilities would need to expend
considerable resources to implement the practices and procedures to
comply with the new requirements. A few comments note that the
complexity of the proposed regulation presents a challenge for
compliance within the proposed timeframes. Because both CGMPs and
preventive controls are new for the animal food industry, comments
request additional time to comply with the regulations. Some comments
also note that manufacturers of human food have had many years to
comply with CGMPs, and the expectation that the animal food industry
will comply with both CGMP and preventive controls requirements in a
narrow timeframe is not reasonable. The majority of comments agree that
the implementation dates for the CGMP regulations should come before
the implementation date of the preventive controls regulations.
(Response 512) We agree with the comments and are extending the
compliance date for implementation of the preventive controls
regulations 1 year beyond the compliance date for the implementation of
CGMP requirements. Because both the CGMP and preventive controls
regulations are new to the animal food industry, we understand that
these facilities would have been learning and implementing many new
requirements during the proposed timeframe. With an extra year before
they must implement preventive controls requirements, animal food
facilities will be able to focus on developing and implementing the
applicable CGMPs for their facilities. Many of these CGMPs are
considered prerequisites for a preventive controls program. Having
CGMPs well in place before having to implement the preventive controls
requirements will provide the facility with a better understanding of
the additional controls that might be needed to significantly minimize
or prevent any significant hazards associated with the animal food that
the facility has identified. In addition, facilities will have more
time to educate and train their employees on the preventive controls
requirements the facility will need to implement. FDA intends to work
closely with the animal food industry, extension and education
organizations, and state partners to develop the tools and training
programs needed to facilitate implementation of the final rule.
(Comment 513) Some comments recommend that compliance dates for the
preventive controls rule for animal food be set for 3 years after the
60-day effective date of the rule, regardless of firm size.
(Response 513) We disagree with this comment. Although the
requirements in this final regulation are new for the animal food
industry, some individual animal food facilities, either individually
or through feed industry associations, have implemented some procedures
that are consistent with the proposed requirements. Not all concepts
[[Page 56330]]
and processes are new to the entire animal food industry, especially
the larger facilities. Therefore, we conclude that these larger
facilities should not need 3 years to comply with the requirements of
this final regulation, in contrast to some of the very small
businesses.
(Comment 514) Some comments ask us to clarify when a very small
business would need to comply with the rule if the business starts up
after the rule goes into effect.
(Response 514) A very small business that is operating as of the
date of publication of the final rule, or begins operating any time
before the compliance date for very small businesses, must comply with
the rule by the compliance date for very small businesses. A very small
business that begins operation any time after the compliance date for
very small businesses must comply with the rule when it begins
operation, and should plan accordingly.
(Comment 515) Some comments request that compliance dates for the
proposed preventive controls rule coincide with the requirements of the
proposed foreign supplier verification program rule.
(Response 515) We are finalizing separate compliance dates for the
supply-chain program provisions of this rule. While this adds
complexity, we are doing this for two main reasons. First, we are
aligning, to the extent feasible, the compliance dates of the supply-
chain program provisions of this rule with the compliance dates of the
forthcoming FSVP rule, which we intend to publish in the coming months.
This will provide greater coordination across the programs,
particularly with respect to the verification of domestic and imported
raw materials and other ingredients. Second, we want to minimize the
likelihood that a receiving facility will be required to comply with
the supply-chain program provisions of this rulemaking before its
supplier is required to comply with applicable new food safety
regulations implementing FSMA. Our goal is to avoid a situation in
which a receiving facility would be required to develop a supply-chain
program for an animal food from a particular supplier and then be
required to revise this supply-chain program shortly thereafter once
the supplier is subject to an applicable new food safety regulation--
specifically, the preventive controls rule for animal food. Therefore,
the compliance dates for the supply-chain program have been revised. A
receiving facility's compliance date for the supply-chain program
provisions of this rule is the later of: (1) The receiving facility's
compliance date for the other preventive controls requirements under
this rulemaking; (2) for a raw material or other ingredient from a
supplier subject to the preventive controls requirements of this rule,
6 months after the receiving facility's supplier of that raw material
or ingredient is required to comply with the preventive controls
requirements of this rule; or (3) for a raw material or other
ingredient that from a supplier subject to CGMPs, but not the
preventive controls requirements of this rule, 6 months after the
receiving facility's supplier of that animal food is required to comply
with the CGMP requirements of this rule.
B. Effective Dates for Conforming Amendments
The conforming amendments to regulations in parts 500 and 579 are
technical amendments that add a cross-reference to part 507. The
conforming amendment to part 11 adds a reference to the scope of part
11 that the records required under part 507 are not subject to part 11.
The conforming amendment to part 16 adds a reference to the scope of
part 16 for new procedures in part 507, subpart D that provide a person
with an opportunity for a hearing under part 16. These conforming
amendments are effective on November 16, 2015, the same date as the
effective date of part 507. We are not establishing compliance dates
for these conforming amendments. As a practical matter, compliance
dates will be determined by the dates for compliance with part 507.
C. Delayed Effective Dates for Provisions That Refer to the Forthcoming
Rules for Produce Safety and Third-Party Certification
The following provisions refer to provisions we intend to establish
in the near future in part 112 (Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption): Sec. Sec.
507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and
507.175(c)(13). In addition, paragraph (2) of the definition of
``qualified auditor'' in Sec. 507.3 and Sec. 507.135(d) refers to
provisions we intend to establish in the near future in part 1, subpart
M (Accredited Third-Party Food Safety Audits and Food or Facility
Certification). In addition, Sec. Sec. 507.105(a)(2) and 507.175(c)(2)
refer to provisions we intend to establish in the near future in part
1, subpart L (Foreign Supplier Verification Programs for Food
Importers). We will publish a document in the Federal Register
announcing the effective dates of paragraph (2) of the definition of
``qualified auditor'' in Sec. 507.3, and Sec. Sec. 507.12(a)(1)(ii),
507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d),
507.175(c)(2) and 507.175(c)(13).
LIV. Compliance and Enforcement
Gaining industry compliance with the provisions of this rule is as
important as establishing the provisions. A central element of our
strategy to gain industry compliance is to help make available to
facilities subject to this rule the education and technical assistance
they need to understand and implement the requirements (Ref. 5). Within
the Agency we are establishing a Food Safety Technical Assistance
Network and seeking funding to increase FDA staffing to provide a
central source of information to support industry understanding and
implementation of FSMA standards (Ref. 5). This will allow us to
respond in a timely and consistent way to industry questions on
preventive controls technical and compliance issues (Ref. 5).
We also are working in collaboration with the FSPCA to develop
training materials and establish training and technical assistance
programs (Ref. 4) and (Ref. 6). The FSPCA includes members from FDA,
State food protection agencies, the animal food industry, and academia.
It is funded by a grant to the Illinois Institute of Technology's
Institute for Food Safety and Health, a nationally-recognized leader in
food safety. In addition to developing a standardized preventive
controls training curriculum, the FSPCA is developing selected sections
of model food safety plans for several animal food types that will
provide needed instructional examples. Although we have provided
funding to the FSPCA to develop a standardized preventive controls
training curriculum, we are unable to fund training for individual
groups who might need particular training materials.
We also are partnering with the NIFA of USDA to administer the
FSMA-mandated National Food Safety Training, Education, Extension,
Outreach, and Technical Assistance Program, a grant program to provide
technical assistance for FSMA compliance to owners and operators of
small and medium-size farms and small food processors (Ref. 7). Such
efforts will help ensure widespread voluntary compliance by encouraging
greater understanding and adoption of established food safety
standards, guidance, and protocols.
With regard to inspections, we will conduct regular inspections of
domestic facilities to ensure that facilities subject to this rule are
adequately implementing
[[Page 56331]]
the required preventive controls and supply-chain program, pursuant to
our inspection authority under section 704 of the FD&C Act. Our
inspections will verify that such facilities are implementing systems
that effectively protect against animal food contamination, and in
particular, that they comply with the rule by implementing preventive
controls, including supply-chain programs, to provide assurances that
any hazard requiring a preventive control or supply-chain applied
control has been significantly minimized or prevented.
In order to effectively carry out this new paradigm of animal food
safety, we will need to reorient and retrain our staff. To this end, we
are seeking additional funding, including for the training of more than
2,000 FDA inspectors, compliance officers, and other staff involved in
food safety activities (Ref. 10).
We also plan to leverage the resources of State, local, tribal, and
territorial governments to conduct domestic verification activities. We
are working with officials from these governments through the PFP to
develop and implement a national Integrated Food Safety System, which
will focus on establishing partnerships for achieving compliance (see
section 209(b) of FSMA), and which will allow us to utilize the
thousands of State, local, and tribal inspectors available to help with
the domestic verification process.
Section 201 of FSMA mandates that FDA inspect domestic high-risk
facilities no less than once every 3 years. Consistent with FSMA, FDA
will use its current resources, new resources that it obtains, and its
partnerships to conduct regular inspections of covered facilities,
focusing on those facilities that pose the highest risk to animal food
safety.
LV. Executive Order 13175
In accordance with Executive Order 13175, FDA has consulted with
tribal government officials. A tribal summary impact statement has been
prepared that includes a summary of tribal officials' concerns and how
FDA has addressed them (Ref. 63). Persons with access to the Internet
may obtain the tribal consultation report at https://www.fda.gov/pcafrule or at https://www.regulations.gov. Copies of the tribal summary
impact statement also may be obtained by contacting the person listed
under FOR FURTHER INFORMATION CONTACT.
LVI. Economic Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). Executive Order 13563 emphasizes the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. FDA has developed an FRIA that presents the
benefits and costs of this final rule (Ref. 60). The Office of
Management and Budget (OMB) has determined that this final rule is an
economically significant regulatory action as defined by Executive
Order 12866.
The summary analysis of benefits and costs included in this
document is drawn from the detailed FRIA (Ref. 60) which is available
at https://www.regulations.gov (enter Docket No. FDA-2011-N-0922), and
is also available on FDA's Web site at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on a substantial number of small entities. Because the final rule would
impose annualized costs that range from $25,000 to $34,000 on many
small entities, the Agency determined that the final rule will have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before finalizing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA expects this final
rule will likely result in a 1-year expenditure that will meet or
exceed this amount.
LVII. Analysis of Environmental Impact
FDA has determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment (Ref. 64). Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
LVIII. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
provisions are shown in this section with an estimate of the annual
reporting, recordkeeping, and third-party disclosure burden. Included
in the estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
Title: Current Good Manufacturing Practice, Hazard Analysis and
Risk-Based Preventive Controls for Food for Animals.
Description: Regulations issued in the final rule entitled,
``Current Good Manufacturing Practice, Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals,'' implement section 418 of
the FD&C Act, as amended by the FDA Food Safety Modernization Act
(FSMA). The regulations establish science-based minimum standards for
conducting a hazard analysis, documenting hazards requiring preventive
controls, implementing preventive controls, and documenting the
implementation of the preventive controls by domestic and foreign
animal food facilities registered with FDA under section 415 of the
FD&C Act. The regulations also establish current good manufacturing
practice for the manufacturing, processing, packing, and holding of
animal food.
The preventive controls regulations require animal food facilities
to have a written food safety plan that includes a hazard analysis; a
description of preventive controls (including recall procedures); a
supply-chain program, a description of procedures for monitoring the
preventive controls; corrective action if preventive controls are not
properly implemented; and a description of procedures for verifying
implementation and effectiveness of the preventive controls.
[[Page 56332]]
The regulations further require facilities to establish and
implement verification procedures for product testing and environmental
monitoring, and require that the hazard analysis and risk-based
preventive controls for animal food take into account the possibility
of economically motivated adulteration of animal food. Facilities that
manufacture, process, pack, or hold food for animals and foods for
human consumption and are subject to part 117 (as finalized elsewhere
in this issue of the Federal Register) may choose to comply with part
117 with respect to the animal food, provided the food safety plan
addresses the hazards specific to animal food where applicable.
The final rule also establishes certain exemptions, under
applicable regulations. The rule imposes specific reporting
requirements on facilities claiming the very small business qualified
facility exemption.
Description of Respondents: Facilities that manufacture, process,
pack, or hold food for animals. Generally, a facility is required to
register if it manufactures, processes, packs, or holds animal food for
consumption in the United States. At the time of this analysis, the
number of animal food facilities registered with the Agency was 7,469.
In the Federal Register of October 29, 2013 (78 FR 64736), FDA
published a proposed rule including a Paperwork Reduction Act (PRA)
analysis of the information collection provisions found in the
regulations. In the Federal Register of September 29, 2014 (79 FR
58476), FDA published a supplemental notice of proposed rulemaking also
including a PRA analysis. Although FDA did not receive comments
specifically addressing the four information collection topics
solicited in both the 2013 proposed preventive controls rule for animal
food and the 2014 supplemental notice, we have revised our burden
estimate consistent with finalization of the rule's requirements.
FDA estimates the burden for this information collection as
follows:
Reporting Burden
Table 34 shows the total estimated annual reporting burden
associated with this final rule. This estimate is a revision from
reporting estimates found in our proposed rulemaking, reflecting an
updated count of the number of facilities registered with the Agency as
animal food facilities, and resulting in an overall decrease from our
previous estimate.
Table 34--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR Section; activity respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
507.7 exemption: submit 1,120 .5 560 *.5 280
attestation that facility is a
qualified facility and
attestation of preventive
controls or compliance with non-
Federal food safety laws.......
507.67, 507.69, and 507.71; 1 1 1 4 4
submission of an appeal,
including submission of a
request for an informal hearing
507.85(b); requests for 1 1 1 2 2
reinstatement of exemption.....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 286
----------------------------------------------------------------------------------------------------------------
\1\ Capital and other costs of implementation and compliance for this final rule are discussed in the FRIA (Ref.
60).
* (30 minutes).
Out of 7,469 animal food facilities registered with FDA, we
estimate approximately 15% (1,120) could be ``qualified'' facilities
under the ``very small business'' definition as discussed in the FRIA
(Ref. 60), and thus eligible for certain limited exemptions under the
applicable regulations. Section 507.5 exempts qualified facilities from
subpart C and E of the regulations, which includes all of the hazard
analysis and preventive controls requirements, including supply-chain
program requirements. The number of respondents in table 34, row 1 is
derived from Agency estimates of the number of qualified animal food
facilities that must report their status as such a facility every 2
years. The number of total annual responses is calculated by
multiplying the number of respondents by the number of responses
submitted annually. The average hourly time burden per response found
in table 34, column 5 is based on FDA's assumption that a facility will
report its status electronically through a Web portal maintained by
FDA, and that this will take approximately 0.5 hours (30 minutes).
The estimated burden associated with the requirements under
Sec. Sec. 507.67, 507.69, and 507.71 of the regulations is reflected
in table 34, row 2. Based on the limited data on foodborne illness
outbreaks originating at very small animal food facilities, FDA does
not expect to withdraw many qualified facility exemptions and expects
the number of appeals to be even fewer. The estimated number of
respondents is based on the Agency's expectation that the number of
appeals will be very few. The number of responses per respondent
reflects that the rule only requires one submission per appeal. Given
that facilities must respond with particularity to the facts and issues
contained in the withdrawal order, the Agency estimates an average
burden of 4 hours per response.
The estimated burden associated with the requirements under Sec.
507.85(b) is reflected in table 34, row 3. The Agency expects few, if
any, requests for reinstatement of an exemption that has been withdrawn
under the regulations and thus is providing an estimate of only 1 per
year at this time. We estimate the time necessary for making such a
request to be no more than 2 hours, which includes submitting the
written request and presenting information that the animal food safety
problems were adequately resolved and continued withdrawal of the
exemption is not necessary to protect public (human and animal) health.
Recordkeeping Burden
Table 35 shows the total estimated annual recordkeeping burden
associated with this final rule. This estimate is a revision from the
recordkeeping estimates found in our proposed rulemaking, reflecting an
updated count of the number of registered animal food facilities, as
well as additional recordkeeping requirements associated with the
various preventive control provisions and recordkeeping
[[Page 56333]]
requirements associated with the supply-chain program implemented at
Subpart E.
Table 35--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 507; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.7(e); records attesting that the facility 1,120 .5 560 .1 (6 minutes)........................ 56
is a ``qualified'' facility.
507.4(d); documentation of animal food safety 7,469 0.75 5,579 0.04 (2 minutes)...................... 279
and hygiene training.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.31-507.55; food safety plan, including 7,469 519 3,876,411 .10 (6 minutes)....................... 387,641
hazard analysis, preventive controls, and
procedures for monitoring, corrective
actions, and verification; recall plan;
validation; reanalysis; modifications; and
implementation records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart E--Supply-Chain Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.105-507.175; written supply-chain 7,469 519 3,876,411 .10 (6 minutes)....................... 387,641
program, including records documenting
program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart F--Requirements Applying to Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.200-507.215; general requirements, 7,469 519 3,876,411 .10 (6 minutes)....................... 387,641
additional requirements applying to food
safety plan, requirements for record
retention, use of existing records, and
special requirements applicable to written
assurance.
----------------------------------------------------------------------------------------------------------
Total.................................... ............... ............... 11,629,793 ...................................... 1,163,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Capital and other costs of implementation and compliance with this final rule are discussed in the FRIA (Ref. 60).
Under the final rule, we estimate a total of 7,469 respondents (the
number of registered animal food facilities) are subject to
recordkeeping requirements found in the applicable regulations.
Although FDA believes that, in some cases, all respondents will incur
new recordkeeping activities as a result of the final rule (e.g.,
documentation of training in the principles of animal food hygiene and
safety), we believe other provisions may apply only to certain
respondents (e.g., documentation of a supply-chain program), depending
upon the applicable regulation. With regard to the hazard-analysis and
risk-based preventive controls, the supply-chain program, and the
requirements applying to records under part 507 subparts C, E, and F,
respectively, we have provided a cumulative burden and averaged burden
per recordkeeping that we believe will be incurred by the respondents
under this final rule based on information available to us at this
time. After allowing for implementation of the final rule and upon
seeking reauthorization for its information collection provisions, FDA
will reassess its burden estimate accordingly.
Third-Party Disclosure Burden
Table 36 shows the total estimated third-party disclosure burden
associated with the final rule. This figure has been revised from the
third-party disclosure estimates found in our proposed rulemaking. This
revision reflects fewer than anticipated third-party disclosure
requirements under the final rule and results in an overall decrease to
our total estimated annual third-party disclosure burden by 36,315
hours.
Table 36--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section; activity Number of disclosures per Total annual Average burden per disclosure (in Total hours
respondents respondent disclosures hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the animal food product 330 10 3,300 0.25 (15 minutes)................... 825
contains the specific information and
instructions needed so the food can be safely
used for the intended animal species.
507.7(e)(1); change labels on products with 1,526 4 6,104 1................................... 6,104
labels.
507.7(e)(2); change address on labeling (sales 1,329 1 1,329 1................................... 1,329
documents) for qualified facilities.
507.25(a)(2); animal food, including raw 330 312 102,960 .01 (1 minute)...................... 1,030
materials, other ingredients, and rework, is
accurately identified.
[[Page 56334]]
507.28(b); holding and distribution of human 40,798 2 81,596 0.25 (15 minutes)................... 20,399
food byproducts for use as animal food.
--------------------------------------------------------------------------------------------------------
Total...................................... ............... ............... ............... .................................... 29,687
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Capital and other costs of implementation and compliance for this final rule are discussed in the FRIAs (Ref. 60).
Under the final rule, we estimate all (7,469) respondents are
subject to third-party disclosure requirements found in the applicable
regulations. The number in column 2 represents an estimated annual
number of those respondents we believe will incur third-party
disclosure burdens under the respective regulation shown in column 1.
This figure is derived from our familiarity with third-party burden
associated with similar FDA regulations. Upon implementation of the
final rule, the Agency will reevaluate its estimate accordingly.
To calculate the number of annual disclosures, we multiplied the
number of respondents in column 2 by an estimated number of disclosures
in column 3. This figure represents the estimated annual number of
disclosures per respondent we attribute for the respective requirement.
To calculate the annual hourly burden, we multiplied the number of
annual disclosures by an estimated hourly burden in column 5. This
figure represents the amount of time we attribute to conducting the
respective disclosure activities identified in column 1.
Section 507.7(a)(2) provides that qualified facilities must either
submit to FDA attestation of hazard identification, preventive controls
implementation, and monitoring, or attestation that the facility is in
compliance with applicable non-Federal food safety law.
Section 507.7(e) requires a qualified facility that chose the
latter to notify consumers of the name and business address of the
facility where the animal food was manufactured or processed: (1) On
the label if a package label is required by other provisions of the
FD&C Act or (2) on labeling at the point of purchase if no label is
required.
Section 507.25(a)(2) provides that the management of the plant must
ensure that animal food, including raw materials, other ingredients, or
rework, is accurately identified as part of plant operations. (See
Sec. Sec. 7.49 and 7.42(b)(1) and (2) (21 CFR 7.49 and 7.42(b)(1) and
(2)).)
Section 507.38(b)(1) and (2) does not add to the estimated hourly
burden because facilities initiating recalls may notify consignees and
the public. (See Sec. Sec. 7.49 and 7.42(b)(1) and (2)).)
Under section 507.28(b), labeling that identifies the product by
the common or usual name must be affixed to or accompany the human food
by-product for use as animal food when distributed. The estimated
number of disclosures per respondent and average burden per disclosure
assumes that 60 percent of the 67,996 domestic human food manufacturing
facilities (Ref. 65) or 40,798 facilities are affected, and that two
sets of labeling per facility per year will be required. We estimate
0.25 hours per disclosure to prepare labeling, and affix to the
containers, for a total of 20,399 burden hours.
The information collection provisions of this final rule have been
submitted to OMB for review. Prior to the effective date of this final
rule, FDA will publish a notice in the Federal Register announcing
OMB's decision to approve, modify, or disapprove the information
collection provisions in this final rule. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
LIX. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
LX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site addresses in this section, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
1. FDA, ``Record of Outreach for Proposed Rule for PC Animal Food,''
2014.
2. FDA, `` Record of Outreach for Supplemental Rule for PC Animal
Food,'' 2015.
3. FDA, `` Qualitative Risk Assessment: Risk of Activity/Animal Food
Combinations for Activities (Outside the Farm Definition) Conducted
in a Facility Co-Located on a Farm,'' 2015.
4. FDA, ``Technical Staffing and Guidance Development at FDA,''
(https://www.fda.gov/Food/GuidanceRegulation/FSMA/UCM436592.pdf),
2015 Accessed on June 19, 2015.
5. FDA, ``Education and Technical Assistance for Industry,'' (https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM436593.pdf),
March 5, 2015. Accessed on June 19, 2015.
6. FDA, ``Food Safety Preventive Controls Alliance,'' (https://www.fda.gov/food/guidanceregulation/fsma/ucm284406.htm), November
12, 2013. Accessed on June 19, 2015.
7. FDA, ``FDA Announces Competitive Grant Program with NIFA to Fund
Food Safety Training, Education and Technical Assistance,'' (https://www.fda.gov/food/newsevents/constituentupdates/ucm430492.htm),
January 15, 2015. Accessed on June 19, 2015.
8. Partnership for Food Protection National Workplan Workgroup,
``Model for Local Federal/State Planning and Coordination of Field
Operations and Training: A Partnership for Food Protection ``Best
Practice'','' (https://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373333.pdf)
October, 2013. Accessed on August 10, 2015.
9. FDA, ``Operational Strategy for Implementing the FDA Food Safety
Modernization Act (FSMA),'' (https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm), May 2, 2014. Accessed on
June 25, 2015.
10. FDA, ``Inspection Modernization and Training: Key Investments
for
[[Page 56335]]
Implementing the FDA Food Safety Modernization Act (FSMA),'' (https://www.fda.gov/food/guidanceregulation/fsma/ucm432576.htm), 2015.
Accessed on June 25, 2015.
11. FDA, ``Draft Qualitative Risk Assessment Risk of Activity/Animal
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm,'' 2012. See Reference
33 to the 2013 proposed rule for preventive controls for animal
food.
12. Muth, M. K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator,
``Food Processing Sector Study,'' 2011. See Reference 21 to the 2014
supplemental notice.
13. FDA, ``The Reportable Food Registry: A New Approach to Targeting
Inspection Resources and Identifying Patterns of Adulteration--First
Annual Report: September 8, 2009-September 7, 2010,'' (https://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM291297.pdf),
January, 2011. Accessed on June 29, 2015. See Reference 48 to the
2013 proposed rule for preventive controls for animal food.
14. FDA, ``The Reportable Food Registry: Targeting Inspection
Resources and Identifying Patterns of Adulteration--Second Annual
Report: September 8, 2010-September 7, 2011,'' (https://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM301013.pdf), April 19, 2012.
Accessed on June 29, 2015.
15. FDA, ``The Reportable Food Registry: Targeting Inspection
Resources and Identifying Patterns of Adulteration--Third Annual
Report: September 8, 2011-September 7, 2012,'' (https://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM349856.pdf), May 1,
2013. Accessed on June 29, 2015.
16. FDA, ``The Reportable Food Registry: Targeting Inspection
Resources and Identifying Patterns of Adulteration--Fourth Annual
Report: September 8, 2012-September 7, 2013,'' (https://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM395684.pdf), May 5,
2014. Accessed on June 29, 2015.
17. FDA, ``Bravo Issues Nationwide Recall of Pet Food for Dogs and
Cats,'' (https://www.fda.gov/Safety/Recalls/ucm397362.htm), May 14,
2014. Accessed on June 26, 2015.
18. FDA, ``J.J. Fuds, Inc. Issues Recall of Pet Food,'' (https://www.fda.gov/Safety/Recalls/ucm431432.htm), January 20, 2015.
Accessed on July 1, 2015.
19. FDA, ``Draft Guidance for Industry: Questions and Answers
Regarding the Reportable Food Registry as Established by the Food
and Drug Administration Amendments Act of 2007 (Edition 2),''
(https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM213214.pdf), May, 2010. Accessed on June 29, 2015.
20. FDA, ``Guidance for Industry: Questions and Answers Regarding
the Reportable Food Registry as Established by the Food and Drug
Administration Amendments Act of 2007,'' (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm180761.htm), September, 2009. Accessed on June 29, 2015.
21. Capogrossi, K., L. Calvin, M. Coglaiti, D. Hinman, S. Karns, A.
Lasher, T. Minor, M.K. Muth, V. Nigh, P. Vardon, C. Viator and C.
Zhen, ``Food Processing Sector Study, (Contract HHSF-223-2011-
10005B, Task Order 20), Final Report,'' 2015.
22. Codex Alimentarius Commission, ``Guidelines for the Validation
of Food Safety Control Measures, CAC/GL 69-2008,'' (https://www.codexalimentarius.org/input/download/standards/11022/CXG_069e.pdf), 2008. Accessed on June 29, 2015. See Reference 79 to
the 2013 proposed rule for preventive controls for animal food.
23. FDA, ``Guidance for Industry: Questions and Answers Regarding
Food Facility Registration (Sixth Edition),'' (https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf), 2014. Accessed and
printed on June 29, 2015.
24. Dictionary.com, ``Definition of ``Solely'','' (https://dictionary.reference.com/browse/solely), 2015. Accessed on June 11,
2015.
25. FDA, ``Compliance Policy Guide Sec.675.100 Diversion of
Contaminated Food for Animal Use,'' (https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074693.htm)
Revised: March 1995, Page Last Updated: December 15, 2009. Accessed
on September 5, 2014. See Reference 11 to the 2014 supplemental
notice.
26. FDA, ``Compliance Policy Guide Sec.675.200 Diversion of
Adulterated Food to Acceptable Animal Feed Use.'' (https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074694.htm) Revised: March 1995. Page Last Updated: December 15,
2009. Accessed on September 5, 2014). See Reference 12 to the 2014
supplemental notice.
27. British Standards Institute (BSI), ``Publicly Available
Specification (PAS)222:2011 Prerequisite Programmes for Food Safety
in the Manufacture of Food and Feed for Animals,'' 2011. See
Reference 44 to the 2013 proposed rule for preventive controls for
animal food.
28. Association of American Feed Control Officials (AAFCO), ``Model
Good Manufacturing Practice Regulations for Feed and Feed
Ingredients'', In: AAFCO Official Publication, 210-215, 2010. See
Reference 42 to the 2013 proposed rule for preventive controls for
animal food.
29. Food and Agriculture Organization of the United Nations (FAO)
and World Health Organization (WHO), ``Good Practices for the Feed
Industry--Implementing the Codex Alimentarius Code of Practice on
Good Animal Feeding--Section 3 Good Production Practices,'' (https://www.fao.org/docrep/012/i1379e/i1379e00.htm), 2010. Accessed on June
29, 2015. See Reference 14 in the 2014 supplemental notice.
30. USDA National Nutrient Database for Standard Reference, (https://ndb.nal.usda.gov/), 2011. Accessed on June 29, 2015.
31. FDA, ``P&G Recalls Specific Canned Cat Foods Due to Low Levels
of Thiamine (Vitamin B1),'' (https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm214996.htm), June 9, 2010. Accessed on June
30, 2015.
32. FDA, ``Ridley Block Operations Announces Voluntary Recall in
Oklahoma and Texas,'' (https://www.fda.gov/Safety/Recalls/ucm266082.htm), July 29, 2011. Accessed on June 30, 2015.
33. FDA, ``Expanded Voluntary Recall of Mazuri and LabDiet Feed
Products Due to Potential Elevated Vitamin D Level,'' (https://www.fda.gov/safety/recalls/ucm312988.htm), July 20, 2012. Accessed
on June 30, 2015.
34. FDA, ``ADM Alliance Nutrition Recalling MoorMan's ShowTec 18
Elite Lamb Feed,'' (https://www.fda.gov/Safety/Recalls/ucm333676.htm), December 28, 2012. Accessed on June 30, 2015.
35. FDA, ``PGG/HSC Feed Company LLC Issues Voluntary Recall of
Champion Lamb Texturized Feed B30, Lot-88022114M908840,'' (https://www.fda.gov/Safety/Recalls/ucm399978.htm), June 4, 2014. Accessed on
June 30, 2015.
36. FDA, ``Cargill Conducts Voluntary Recall of Select
Nutrena[supreg] NatureWise Meatbird Feed Due to Possible Animal
Health Risk,'' (https://www.fda.gov/Safety/Recalls/ucm403829.htm),
July 1, 2014. Accessed on June 30, 2015.
37. FDA, ``Natura Pet Recalls 5 Lots of Dry Cat and Dry Ferret Food
due to Vitamin Insufficiency,'' (https://www.fda.gov/Safety/Recalls/ucm424607.htm), November 24, 2014. Accessed on June 30, 2015.
38. FDA, ``Primal Pet Foods Voluntarily Recalls A Single Lot of Raw
Frozen Cat Food,'' (https://www.fda.gov/Safety/Recalls/ucm438183.htm), March 13, 2015. Accessed on June 30, 2015.
39. FDA, ``Ainsworth Pet Nutrition Voluntarily Recalls Five Nutrish
Wet Cat Food Varieties for Potentially Elevated Vitamin D Levels,''
(https://www.fda.gov/Safety/Recalls/ucm449841.htm), June 4, 2015.
Accessed on June 30, 2015.
40. Markovich, J.E., Freeman, L.M., and Heinze, C.R., ``Analysis of
thiamine concentrations in commercial canned foods formulated for
cats,'' Journal of the American Veterinary Medical Association, Vol.
244, No. 2, January 15, 2014.
41. FDA, ``Food CGMP Modernization--A Focus on Food Safety,''
(https://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/ucm207458.htm), November 2,
2005. Accessed on June 29, 2015. See Reference 49 to the 2013
proposed rule for preventive controls for animal food.
42. FDA, ``Draft Guidance for Industry: Questions and Answers
Regarding Mandatory Food Recalls,'' (https://www.fda.gov/Food/
GuidanceRegulation/
[[Page 56336]]
GuidanceDocumentsRegulatoryInformation/ucm445428.htm), May, 2015.
Accessed on June 30, 2015.
43. FDA, ``FDA Homepage,'' (https://www.fda.gov/), March 25, 2015.
Accessed and printed on June 30, 2015.
44. FDA, ``Recalls, Market Withdrawals, & Safety Alerts (FDA Email
Sign-up Web page),'' (https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_48), 2015. Accessed on June 30,
2015.
45. FDA, ``Guidance for Industry: Product Recalls, Including
Removals and Corrections,'' (https://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm), November 3, 2003. Accessed on June
30, 2015.
46. FDA, ``Animal and Veterinary Recalls and Withdrawals Web page,''
(https://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm2015), 2015. Accessed on June 30,
2015.
47. Merriam-Webster.com, ``Definition of ``Include'','' (https://www.merriam-webster.com/dictionary/include), 2015. Accessed on June
30, 2015.
48. FDA, ``Guidance for Industry: Testing for Salmonella in Human
Foods and Direct-Human-Contact Animal Foods,'' (https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/salmonella/ucm295271.htm), March, 2012. Accessed on June 30, 2015.
49. National Advisory Committee on Microbiological Criteria for
Foods, ``Hazard Analysis and Critical Control Point Principles and
Application Guidelines,'' Journal of Food Protection, 61:1246-1259,
1998. See Reference 29 to the 2013 proposed preventive controls rule
for animal food.
50. USDA Food Safety and Inspection Service, ``Compliance Guideline
HACCP Systems Validation,'' (https://www.fsis.usda.gov/shared/PDF/HACCP_Systems_Validation.pdf), May 2013. Accessed on June 30, 2015.
51. FDA, ``Memorandum on Environmental Monitoring,'' 2014. See
Reference 23 to the 2014 supplemental human preventive controls
notice, Docket No. FDA-2011-N-0920.
52. FDA, ``Memorandum on Product Testing,'' 2014. See Reference 18
to the 2014 supplemental human preventive controls notice, Docket
No. FDA-2011-N-0920.
53. FDA, ``Memorandum on Supplier Programs,'' 2014. See Reference 24
to the 2014 supplemental human preventive controls notice, Docket
No. FDA-2011-N-0920.
54. Codex Alimentarius Commission, ``Codex Alimentarius Commission
Procedural Manual, 23rd Edition,'' (ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_23e.pdf), 2015. Accessed on June 30,
2015.
55. FDA, ``Inspections, Compliance, Enforcement, and Criminal
Investigations: Warning Letters,'' (https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm), March 26, 2015.
Accessed on June 30, 2015.
56. FDA, ``Import Alerts,'' (https://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm), 2015. Accessed on June 30,
2015.
57. FDA, ``Letter to Sunland Inc. Concerning Suspension of Food
Facility Registration; Notice of Opportunity for Hearing,'' (https://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/cfsanfoiaelectronicreadingroom/ucm329370.htm), November 26, 2012.
Accessed June 30, 2015.
58. Global Food Safety Initiative, ``GFSI Guidance Document, Version
6.3,'' (https://www.mygfsi.com/images/mygfsi/gfsifiles/gfsi_guidance/GFSI_Guidance_Document_Over.pdf), 2013. Accessed on June 30, 2015.
59. FDA, ``Information for Foreign Governments: Frequently Asked
Questions on Systems Recognition,'' (https://www.fda.gov/Food/InternationalInteragencyCoordination/ucm367400.htm), September 5,
2013. Accessed on July 1, 2015.
60. FDA, ``FSMA Final Rulemaking for Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for
Food for Animals Final Regulatory Impact Analysis,'' 2015.
61. World Trade Organization, ``WTO Ministerial Conference:
Implementation-Related Issues and Concerns,'' (https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.pdf),
November 20, 2001. Accessed on July 1, 2015.
62. World Trade Organization, ``The WTO Agreement on the Application
of Sanitary and Phytosanitary Measures (SPS Agreement),'' (https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm), April 15, 1994.
Accessed on July 1, 2015.
63. FDA, ``Tribal Summary Impact Statement,'' 2015.
64. Environmental Review of Final Rule: Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for
Food for Animals, August 28, 2015.
65. FDA, ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-based Preventive Controls for Human Food--Preliminary
Regulatory Impact Analysis,'' 2013. See Reference 23 in the 2014
supplemental notice.
List of Subjects
21 CFR Part 11
Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 117
Food packaging, Foods.
21 CFR Part 500
Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCB's).
21 CFR Part 507
Animal foods, Labeling, Packaging and containers, Reporting and
recordkeeping requirements.
21 CFR Part 579
Animal feeds, Animal foods, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is amended as follows:
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
0
1. The authority citation for 21 CFR part 11 continues to read as
follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
0
2. In Sec. 11.1, add paragraph (j) to read as follows:
Sec. 11.1 Scope.
* * * * *
(j) This part does not apply to records required to be established
or maintained by part 507 of this chapter. Records that satisfy the
requirements of part 507 of this chapter, but that also are required
under other applicable statutory provisions or regulations, remain
subject to this part.
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
3. The authority citation for 21 CFR part 16 continues to read as
follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
4. In Sec. 16.1(b)(2), add the following entry in numerical order to
read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
Sec. Sec. 507.60 through 507.85 (part 507, subpart D of this
chapter) relating to withdrawal of a qualified facility exemption.
* * * * *
[[Page 56337]]
PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
0
5. The authority citation for 21 CFR part 117 continues to read as
follows:
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.
0
6. Add Sec. 117.95 to subpart B to read as follows:
Sec. 117.95 Holding and distribution of human food by-products for
use as animal food.
(a) Human food by-products held for distribution as animal food
without additional manufacturing or processing by the human food
processor, as identified in Sec. 507.12 of this chapter, must be held
under conditions that will protect against contamination, including the
following:
(1) Containers and equipment used to convey or hold human food by-
products for use as animal food before distribution must be designed,
constructed of appropriate material, cleaned as necessary, and
maintained to protect against the contamination of human food by-
products for use as animal food;
(2) Human food by-products for use as animal food held for
distribution must be held in a way to protect against contamination
from sources such as trash; and
(3) During holding, human food by-products for use as animal food
must be accurately identified.
(b) Labeling that identifies the by-product by the common or usual
name must be affixed to or accompany human food by-products for use as
animal food when distributed.
(c) Shipping containers (e.g., totes, drums, and tubs) and bulk
vehicles used to distribute human food by-products for use as animal
food must be examined prior to use to protect against contamination of
the human food by-products for use as animal food from the container or
vehicle when the facility is responsible for transporting the human
food by-products for use as animal food itself or arranges with a third
party to transport the human food by-products for use as animal food.
PART 500--GENERAL
0
7. The authority citation for 21 CFR part 500 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.
0
8. Revise Sec. 500.23 to read as follows:
Sec. 500.23 Thermally processed low-acid foods packaged in
hermetically sealed containers.
Except as provided in Sec. 507.5(b) of this chapter, the
provisions of parts 507 and 113 of this chapter apply to the
manufacturing, processing, or packing of low-acid foods in hermetically
sealed containers, and intended for use as food for animals.
0
9. Add part 507 to read as follows:
PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
Subpart A--General Provisions
Sec.
507.1 Applicability and status.
507.3 Definitions.
507.4 Qualifications of individuals who manufacture, process, pack,
or hold animal food.
507.5 Exemptions.
507.7 Requirements that apply to a qualified facility.
507.10 Applicability of subparts C and E of this part to a facility
solely engaged in the storage of unexposed packaged animal food.
507.12 Applicability of this part to the holding and distribution of
human food by-products for use as animal food.
Subpart B--Current Good Manufacturing Practice
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitation.
507.20 Water supply and plumbing.
507.22 Equipment and utensils.
507.25 Plant operations.
507.27 Holding and distribution.
507.28 Holding and distribution of human food by-products for use as
animal food.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
507.31 Food safety plan.
507.33 Hazard analysis.
507.34 Preventive controls.
507.36 Circumstances in which the owner, operator, or agent in
charge of a manufacturing/processing facility is not required to
implement a preventive control.
507.37 Provision of assurances required under Sec. 507.36(a)(2),
(3), and (4).
507.38 Recall plan.
507.39 Preventive control management components.
507.40 Monitoring.
507.42 Corrective actions and corrections.
507.45 Verification.
507.47 Validation.
507.49 Verification of implementation and effectiveness.
507.50 Reanalysis.
507.51 Modified requirements that apply to a facility solely engaged
in the storage of unexposed packaged animal food.
507.53 Requirements applicable to a preventive controls qualified
individual and a qualified auditor.
507.55 Implementation records required for this subpart.
Subpart D--Withdrawal of a Qualified Facility Exemption
507.60 Circumstances that may lead FDA to withdraw a qualified
facility exemption.
507.62 Issuance of an order to withdraw a qualified facility
exemption.
507.65 Contents of an order to withdraw a qualified facility
exemption.
507.67 Compliance with, or appeal of, an order to withdraw a
qualified facility exemption.
507.69 Procedure for submitting an appeal.
507.71 Procedure for requesting an informal hearing.
507.73 Requirements applicable to an informal hearing.
507.75 Presiding officer for an appeal and for an informal hearing.
507.77 Timeframe for issuing a decision on an appeal.
507.80 Revocation of an order to withdraw a qualified facility
exemption.
507.83 Final agency action.
507.85 Reinstatement of a qualified facility exemption that was
withdrawn.
Subpart E--Supply-Chain Program
507.105 Requirement to establish and implement a supply-chain
program.
507.110 General requirements applicable to a supply-chain program.
507.115 Responsibilities of the receiving facility.
507.120 Using approved suppliers.
507.125 Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).
507.130 Conducting supplier verification activities for raw
materials and other ingredients.
507.135 Onsite audit.
507.175 Records documenting the supply-chain program.
Subpart F--Requirements Applying to Records That Must Be Established
and Maintained
507.200 Records subject to the requirements of this subpart.
507.202 General requirements applying to records.
507.206 Additional requirements applying to the food safety plan.
507.208 Requirements for record retention.
507.212 Use of existing records.
507.215 Special requirements applicable to a written assurance.
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.
Subpart A--General Provisions
Sec. 507.1 Applicability and status.
(a) The criteria and definitions in this part apply in determining
whether an animal food is:
[[Page 56338]]
(1) Adulterated within the meaning of:
(i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act
in that the food has been manufactured under such conditions that it is
unfit for food; or
(ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act
in that the food has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health; and
(2) In violation of section 361 of the Public Health Service Act
(42 U.S.C. 264).
(b) The operation of a facility that manufactures, processes,
packs, or holds animal food for sale in the United States if the owner,
operator, or agent in charge of such facility is required to comply
with, and is not in compliance with, section 418 of the Federal Food,
Drug, and Cosmetic Act or subparts C, D, E, or F of this part and Sec.
507.7 is a prohibited act under section 301(uu) of the Federal Food,
Drug, and Cosmetic Act.
(c) Animal food covered by specific current good manufacturing
practice regulations also is subject to the requirements of those
regulations.
(d) Except as provided by Sec. 507.12, if a facility is required
to comply with subpart B of part 507 and is also required to comply
with subpart B of part 117 of this chapter because the facility
manufactures, processes, packs, or holds human food and animal food,
then the facility may choose to comply with the requirements in subpart
B of part 117, instead of subpart B of part 507, as to the
manufacturing, processing, packing, and holding of animal food at that
facility. If a facility is required to comply with subpart C of part
507 and is also required to comply with subpart C of part 117 of this
chapter, then the facility may choose to comply with the requirements
in subpart C of part 117 as to the manufacturing, processing, packing,
and holding of animal food at the facility, instead of subpart C of
part 507, provided the food safety plan also addresses hazards for the
animal food, if applicable, that require a preventive control. When
applying the requirements of part 117 of this chapter to animal food,
the term ``food'' in part 117 includes animal food.
Sec. 507.3 Definitions.
The definitions and interpretations contained in section 201 of the
Federal Food, Drug, and Cosmetic Act apply to such terms when used in
this part. The following definitions also apply:
Adequate means that which is needed to accomplish the intended
purpose in keeping with good public (human and animal) health practice.
Affiliate means any facility that controls, is controlled by, or is
under common control with another facility.
Animal food means food for animals other than man and includes pet
food, animal feed, and raw materials and ingredients.
Audit means the systematic, independent, and documented examination
(through observation, investigation, records review, discussions with
employees of the audited entity, and, as appropriate, sampling and
laboratory analysis) to assess a supplier's food safety processes and
procedures.
Calendar day means every day shown on the calendar.
Correction means an action to identify and correct a problem that
occurred during the production of animal food, without other actions
associated with a corrective action procedure (such as actions to
reduce the likelihood that the problem will recur, evaluate all
affected animal food for safety, and prevent affected animal food from
entering commerce).
Critical control point means a point, step, or procedure in a food
process at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce such hazard to an acceptable
level.
Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food for animals may be contaminated and may
result in foodborne illness if that animal food is not treated to
significantly minimize or prevent the environmental pathogen. Examples
of environmental pathogens for the purposes of this part include
Listeria monocytogenes and Salmonella spp. but do not include the
spores of pathogenic sporeforming bacteria.
Facility means a domestic facility or a foreign facility that is
required to register under section 415 of the Federal Food, Drug, and
Cosmetic Act, in accordance with the requirements of part 1, subpart H
of this chapter.
Farm means farm as defined in Sec. 1.227 of this chapter.
FDA means the Food and Drug Administration.
Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act and includes raw materials and ingredients.
Food-contact surfaces are those surfaces that contact animal food
and those surfaces from which drainage, or other transfer, onto the
animal food or onto surfaces that contact the animal food ordinarily
occurs during the normal course of operations. ``Food-contact
surfaces'' includes utensils and animal food-contact surfaces of
equipment.
Full-time equivalent employee is a term used to represent the
number of employees of a business entity for the purpose of determining
whether the business qualifies for the small business exemption. The
number of full-time equivalent employees is determined by dividing the
total number of hours of salary or wages paid directly to employees of
the business entity and of all of its affiliates and subsidiaries by
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52
weeks). If the result is not a whole number, round down to the next
lowest whole number.
Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as animal food.
Harvesting is limited to activities performed on raw agricultural
commodities, or on processed foods created by drying/dehydrating a raw
agricultural commodity without additional manufacturing/processing, on
a farm. Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, removing stems and husks from,
shelling, sifting, threshing, trimming of outer leaves of, and washing
raw agricultural commodities grown on a farm.
Hazard means any biological, chemical (including radiological), or
physical agent that has the potential to cause illness or injury in
humans or animals.
Hazard requiring a preventive control means a known or reasonably
foreseeable hazard for which a person knowledgeable about the safe
manufacturing, processing, packing, or holding of animal food would,
based on
[[Page 56339]]
the outcome of a hazard analysis (which includes an assessment of the
severity of the illness or injury if the hazard were to occur and the
probability that the hazard will occur in the absence of preventive
controls), establish one or more preventive controls to significantly
minimize or prevent the hazard in an animal food and components to
manage those controls (such as monitoring, corrections or corrective
actions, verification, and records) as appropriate to the animal food,
the facility, and the nature of the preventive control and its role in
the facility's food safety system.
Holding means storage of animal food and also includes activities
performed incidental to storage of an animal food (e.g., activities
performed for the safe or effective storage of that animal food, such
as fumigating animal food during storage, and drying/dehydrating raw
agricultural commodities when the drying/dehydrating does not create a
distinct commodity (such as drying/dehydrating hay or alfalfa)).
Holding also includes activities performed as a practical necessity for
the distribution of that animal food (such as blending of the same raw
agricultural commodity and breaking down pallets), but does not include
activities that transform a raw agricultural commodity into a processed
food as defined in section 201(gg) of the Federal Food, Drug, and
Cosmetic Act. Holding facilities could include warehouses, cold storage
facilities, storage silos, grain elevators, and liquid-storage tanks.
Known or reasonably foreseeable hazard means a biological, chemical
(including radiological), or physical hazard that is known to be, or
has the potential to be, associated with the facility or the animal
food.
Lot means the animal food produced during a period of time and
identified by an establishment's specific code.
Manufacturing/processing means making animal food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating animal food, including food crops or ingredients. Examples
of manufacturing/processing activities include: Baking, boiling,
bottling, canning, cooking, cooling, cutting, distilling, drying/
dehydrating raw agricultural commodities to create a distinct commodity
(such as drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, extruding, formulating, freezing,
grinding, homogenizing, irradiating, labeling, milling, mixing,
packaging (including modified atmosphere packaging), pasteurizing,
peeling, pelleting, rendering, treating to manipulate ripening,
trimming, washing, or waxing. For farms and farm mixed-type facilities,
manufacturing/processing does not include activities that are part of
harvesting, packing, or holding.
Microorganisms means yeasts, molds, bacteria, viruses, protozoa,
and microscopic parasites and includes species that are pathogens. The
term ``undesirable microorganisms'' includes those microorganisms that
are pathogens, that subject animal food to decomposition, that indicate
that animal food is contaminated with filth, or that otherwise may
cause animal food to be adulterated.
Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
Monitor means to conduct a planned sequence of observations or
measurements to assess whether control measures are operating as
intended.
Packing means placing animal food into a container other than
packaging the animal food and also includes repacking and activities
performed incidental to packing or repacking an animal food (e.g.,
activities performed for the safe or effective packing or repacking of
that animal food (such as sorting, culling, grading, and weighing or
conveying incidental to packing or repacking)), but does not include
activities that transform a raw agricultural commodity into a processed
food as defined in section 201(gg) of the Federal Food, Drug, and
Cosmetic Act.
Pathogen means a microorganism of public (human or animal) health
significance.
Pest refers to any objectionable animals or insects including
birds, rodents, flies, and larvae.
Plant means the building or structure, or parts thereof, used for
or in connection with the manufacturing, processing, packing, or
holding of animal food.
Preventive controls means those risk-based, reasonably appropriate
procedures, practices, and processes that a person knowledgeable about
the safe manufacturing, processing, packing, or holding of animal food
would employ to significantly minimize or prevent the hazards
identified under the hazard analysis that are consistent with the
current scientific understanding of safe food manufacturing,
processing, packing, or holding at the time of the analysis.
Preventive controls qualified individual means a qualified
individual who has successfully completed training in the development
and application of risk-based preventive controls at least equivalent
to that received under a standardized curriculum recognized as adequate
by FDA, or is otherwise qualified through job experience to develop and
apply a food safety system.
Qualified auditor means a person who is a qualified individual as
defined in this part and has technical expertise obtained through
education, training, or experience (or the combination thereof)
necessary to perform the auditing function. Examples of potential
qualified auditors include:
(1) A government employee, including a foreign government employee;
and
(2) An audit agent of a certification body that is accredited in
accordance with regulations in part 1, subpart M of this chapter.
Qualified end-user, with respect to food, means the consumer of the
food (where the term consumer does not include a business); or a
restaurant or retail food establishment (as those terms are defined in
Sec. 1.227 of this chapter) that:
(1) Is located:
(i) In the same State or the same Indian reservation as the
qualified facility that sold the food to such restaurant or retail food
establishment; or
(ii) Not more than 275 miles from such facility; and
(2) Is purchasing the food for sale directly to consumers at such
restaurant or retail food establishment.
Qualified facility means (when including the sales by any
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of
any entity of which the facility is a subsidiary or affiliate) a
facility that is a very small business as defined in this part, or a
facility to which both of the following apply:
(1) During the 3-year period preceding the applicable calendar
year, the average annual monetary value of the food manufactured,
processed, packed, or held at such facility that is sold directly to
qualified end-users (as defined in this part) during such period
exceeded the average annual monetary value of the food sold by such
facility to all other purchasers; and
(2) The average annual monetary value of all food sold during the
3-year period preceding the applicable
[[Page 56340]]
calendar year was less than $500,000, adjusted for inflation.
Qualified facility exemption means an exemption applicable to a
qualified facility under Sec. 507.5(d).
Qualified individual means a person who has the education,
training, or experience (or a combination thereof) necessary to
manufacture, process, pack, or hold safe animal food as appropriate to
the individual's assigned duties. A qualified individual may be, but is
not required to be, an employee of the establishment.
Raw agricultural commodity has the meaning given in section 201(r)
of the Federal Food, Drug, and Cosmetic Act.
Receiving facility means a facility that is subject to subparts C
and E of this part and that manufactures/processes a raw material or
other ingredient that it receives from a supplier.
Rework means clean, unadulterated animal food that has been removed
from processing for reasons other than insanitary conditions or that
has been successfully reconditioned by reprocessing and that is
suitable for use as animal food.
Sanitize means to adequately treat cleaned surfaces by a process
that is effective in destroying vegetative cells of pathogens, and in
substantially reducing numbers of other undesirable microorganisms, but
without adversely affecting the product or its safety for animals or
humans.
Significantly minimize means to reduce to an acceptable level,
including to eliminate.
Small business means, for purposes of this part, a business
employing fewer than 500 full-time equivalent employees.
Subsidiary means any company which is owned or controlled directly
or indirectly by another company.
Supplier means the establishment that manufactures/processes the
animal food, raises the animal, or grows the food that is provided to a
receiving facility without further manufacturing/processing by another
establishment, except for further manufacturing/processing that
consists solely of the addition of labeling or similar activity of a de
minimis nature.
Supply-chain-applied control means a preventive control for a
hazard in a raw material or other ingredient when the hazard in the raw
material or other ingredient is controlled before its receipt.
Unexposed packaged animal food means packaged animal food that is
not exposed to the environment.
Validation means obtaining and evaluating scientific and technical
evidence that a control measure, combination of control measures, or
the food safety plan as a whole, when properly implemented, is capable
of effectively controlling the identified hazards.
Verification means the application of methods, procedures, tests
and other evaluations, in addition to monitoring, to determine whether
a control measure or combination of control measures is or has been
operating as intended and to establish the validity of the food safety
plan.
Very small business means, for purposes of this part, a business
(including any subsidiaries and affiliates) averaging less than
$2,500,000, adjusted for inflation, per year, during the 3-year period
preceding the applicable calendar year in sales of animal food plus the
market value of animal food manufactured, processed, packed, or held
without sale (e.g., held for a fee or supplied to a farm without sale).
Water activity (aw) means a measure of the free moisture
in an animal food and is the quotient of the water vapor pressure of
the substance divided by the vapor pressure of pure water at the same
temperature.
Written procedures for receiving raw materials and other
ingredients means written procedures to ensure that raw materials and
other ingredients are received only from suppliers approved by the
receiving facility (or, when necessary and appropriate, on a temporary
basis from unapproved suppliers whose raw materials or other
ingredients are subjected to adequate verification activities before
acceptance for use).
You means, for purposes of this part, the owner, operator, or agent
in charge of a facility.
Sec. 507.4 Qualifications of individuals who manufacture, process,
pack, or hold animal food.
(a)(1) The management of an establishment must ensure that all
individuals who manufacture, process, pack, or hold animal food subject
to subparts B and F of this part are qualified to perform their
assigned duties; and
(2) The owner, operator, or agent in charge of a facility must
ensure that all individuals who manufacture, process, pack, or hold
animal food subject to subparts C, D, E, or F of this part are
qualified to perform their assigned duties.
(b) Each individual engaged in manufacturing, processing, packing,
or holding animal food (including temporary and seasonal personnel) or
in the supervision thereof must:
(1) Be a qualified individual as that term is defined in Sec.
507.3, i.e., have the education, training, or experience (or a
combination thereof) necessary to manufacture, process, pack, or hold
safe animal food as appropriate to the individual's assigned duties;
and
(2) Receive training in the principles of animal food hygiene and
animal food safety, including the importance of employee health and
personal hygiene, as appropriate to the animal food, the facility and
the individual's assigned duties.
(c) Responsibility for ensuring compliance by individuals with the
requirements of this part must be clearly assigned to supervisory
personnel who have the education, training, or experience (or a
combination thereof) necessary to supervise the production of safe
animal food.
(d) Records that document training required by paragraph (b)(2) of
this section must be established and maintained and are subject to the
recordkeeping requirements in subpart F of this part.
Sec. 507.5 Exemptions.
(a) This part does not apply to establishments, including ``farms''
(as defined in Sec. 1.227 of this chapter), that are not required to
register under section 415 of the Federal Food, Drug, and Cosmetic Act.
(b)(1) Subparts C and E of this part do not apply with respect to
activities that are subject to Sec. 500.23 and part 113 of this
chapter (Thermally Processed Low-Acid Foods Packaged in Hermetically
Sealed Containers) at an animal food facility if you are required to
comply with, and are in compliance with, part 113 of this chapter with
respect to those activities.
(2) The exemption in paragraph (b)(1) of this section is applicable
only with respect to those microbiological hazards regulated under part
113 of this chapter.
(c) Subparts C and E of this part do not apply to activities of a
facility that are subject to section 419 of the Federal Food, Drug, and
Cosmetic Act (Standards for Produce Safety).
(d) Except as provided in subpart D of this part, subparts C and E
of this part do not apply to a qualified facility. Qualified facilities
are subject to the requirements in Sec. 507.7.
(e) For a farm mixed-type facility that is a small or very small
business, subparts C and E of this part do not apply to on-farm packing
or holding of processed animal food, and Sec. 507.7 does not apply to
on-farm packing or holding of processed animal food by a very small
business, if the only packing or holding activities subject to section
418
[[Page 56341]]
of the Federal Food, Drug, and Cosmetic Act that the business conducts
are the following low-risk packing or holding activity/animal food
combinations--i.e., packing (or repacking) (including weighing or
conveying incidental to packing or repacking); sorting, culling, or
grading incidental to packing or storing; and storing (ambient, cold
and controlled atmosphere) of:
(1) Roughage products (e.g., alfalfa meal, entire plant meal, stem
meal, pomace, and pulp);
(2) Plant protein meals (e.g., algae, coconut (copra), guar, and
peanut);
(3) Grain by-products and processed grain products (e.g., bran,
flour, germ meal, grits, groats, hominy feed, malt sprouts, middlings,
pearled grain, polished grain, brewers grain, distillers grain, and
gluten meal);
(4) Oilseed products (e.g., oil and meal of safflower, soybean, or
sunflower);
(5) Molasses (e.g., processed sugar cane, sugar beets, and
citrus).;
(6) Animal protein meals (e.g., blood, feather, meat, meat and
bone, and marine (e.g., crab, fish, shrimp));
(7) Milk products (e.g., casein, cheese rind, and lactalbumin);
(8) Animal tissue-derived products (e.g., fat);
(9) Vitamins, minerals, and concentrates;
(10) Processing aids (e.g., enzymes, preservatives, and
stabilizers); and
(11) Any other processed animal food that does not require time/
temperature control for safety.
(f) For a farm mixed-type facility that is a small or very small
business, subparts C and E of this part do not apply to on-farm
manufacturing/processing activities conducted by a small or very small
business for distribution into commerce, and Sec. 507.7 does not apply
to on-farm manufacturing/processing activities conducted by a very
small business for distribution into commerce, if the only
manufacturing/processing activities subject to section 418 of the
Federal Food, Drug, and Cosmetic Act that the business conducts
consists of the following low-risk manufacturing/processing activity/
animal food combinations:
(1) Chopping or shredding hay;
(2) Cracking, crimping, flaking, pearling, peeling, shelling, or
wafering--grain (e.g., barley, sorghum, corn, oats, rice, rye, and
wheat) or oilseed (e.g., beans, canola, cottonseed, linseed, soybeans,
and sunflowers);
(3) Crushing, dry rolling, grinding, milling, pulverizing--grain,
oilseed, grain by-products and processed grain products, oilseed
products, hay, ensiled material, culled fruits and vegetables, roughage
(e.g., cobs, hulls, husks, and straws), or roughage products;
(4) Ensiling (including chopping, shredding, mixing, storing, or
fermenting), that is, making silage or haylage from forage (e.g.,
sorghum (milo), corn (maize), alfalfa, and grass), grain, culled fruits
and vegetables, or roughage;
(5) Extracting (mechanical) or wet rolling grain, oilseed, brewers
grain by-products, or distillers grain by-products;
(6) Labeling roughage products, plant protein meals, grain by-
products and processed grain products, oilseed products, molasses,
animal protein meals, milk products, animal tissue-derived products,
vitamins, minerals, concentrates, processing aids, finished animal
food, including animal food ready for consumption, or any other
processed animal food that does not require time/temperature control
for safety; and
(7) Packaging roughage products, plant protein meals, grain by-
products and processed grain products, oilseed products, molasses,
animal protein meals, milk products, animal tissue-derived products,
vitamins, minerals, concentrates, processing aids, finished animal
food, including animal food ready for consumption, or any other
processed animal food that does not require time/temperature control
for safety.
(g) Subparts C and E of this part do not apply to facilities that
are solely engaged in the storage of raw agricultural commodities
(other than fruits and vegetables) intended for further distribution or
processing.
(h) Subpart B of this part does not apply to any of the following:
(1) Establishments solely engaged in the holding and/or
transportation of one or more raw agricultural commodities;
(2) Establishments solely engaged in hulling, shelling, drying,
packing, and/or holding nuts and hulls (without manufacturing/
processing, such as grinding shells or roasting nuts); and
(3) Establishments solely engaged in ginning of cotton (without
manufacturing/processing, such as extracting oil from cottonseed).
Sec. 507.7 Requirements that apply to a qualified facility.
(a) A qualified facility must submit the following attestations to
FDA:
(1) An attestation that the facility is a qualified facility as
defined in Sec. 507.3. For the purpose of determining whether a
facility satisfies the definition of qualified facility, the baseline
year for calculating the adjustment for inflation is 2011; and
(2)(i) An attestation that you have identified the potential
hazards associated with the animal food being produced, are
implementing preventive controls to address the hazards, and are
monitoring the performance of the preventive controls to ensure that
such controls are effective; or
(ii) An attestation that the facility is in compliance with State,
local, county, tribal, or other applicable non-Federal food safety law,
including relevant laws and regulations of foreign countries, including
an attestation based on licenses, inspection reports, certificates,
permits, credentials, certification by an appropriate agency (such as a
State department of agriculture), or other evidence of oversight.
(b) The attestations required by paragraph (a) of this section must
be submitted to FDA by any one of the following means:
(1) Electronic submission. To submit electronically, go to https://www.fda.gov/furls and follow the instructions. This Web site is
available from wherever the Internet is accessible, including
libraries, copy centers, schools, and Internet cafes. FDA encourages
electronic submission.
(2) Submission by mail. (i) You must use Form FDA 3942b. You may
obtain a copy of this form by any of the following mechanisms:
(A) Download it from https://www.fda.gov/pcafrule;
(B) Write to the U.S. Food and Drug Administration (HFS-681), 5100
Paint Branch Parkway, College Park, MD 20550; or
(C) Request a copy of this form by phone at 1-800-216-7331 or 301-
575-0156.
(ii) Send a paper Form FDA 3942b to the U.S. Food and Drug
Administration (HFS-681), 5100 Paint Branch Parkway, College Park, MD
20550. We recommend that you submit a paper copy only if your facility
does not have reasonable access to the Internet.
(c)(1) A facility must determine and document its status as a
qualified facility on an annual basis no later than July 1 of each
calendar year.
(2) The attestations required by paragraph (a) of this section must
be:
(i) Submitted to FDA initially:
(A) By December 16, 2019 for a facility that begins manufacturing,
processing, packing, or holding animal food before September 17, 2019;
(B) Before beginning operations, for a facility that begins
manufacturing, processing, packing, or holding animal food after
September 17, 2019; or
(C) By July 31 of the applicable calendar year, when the status of
a facility changes from ``not a qualified
[[Page 56342]]
facility'' to ``qualified facility'' based on the annual determination
required by paragraph (c)(1) of this section; and
(ii) Beginning in 2020, submitted to FDA every 2 years during the
period beginning on October 1 and ending on December 31.
(3) When the status of a facility changes from ``qualified
facility'' to ``not a qualified facility'' based on the annual
determination required by paragraph (c)(1) of this section, the
facility must notify FDA of that change in status using Form FDA 3942b
by July 31 of the applicable calendar year.
(d) When the status of a facility changes from ``qualified
facility'' to ``not a qualified facility,'' the facility must comply
with subparts C and E of this part no later than December 31 of the
applicable calendar year unless otherwise agreed to by FDA and the
facility.
(e) A qualified facility that does not submit attestations under
paragraph (a)(2)(i) of this section must provide notification to
consumers as to the name and complete business address of the facility
where the animal food was manufactured or processed (including the
street address or P.O. Box, city, state, and zip code for domestic
facilities, and comparable full address information for foreign
facilities) as follows:
(1) If an animal food packaging label is required, the notification
required by paragraph (e) of this section must appear prominently and
conspicuously on the label of the animal food.
(2) If an animal food packaging label is not required, the
notification required by paragraph (e) of this section must appear
prominently and conspicuously, at the point of purchase, on a label,
poster, sign, placard, or documents delivered contemporaneously with
the animal food in the normal course of business, or in an electronic
notice, in the case of Internet sales.
(f)(1) A qualified facility must maintain those records relied upon
to support the attestations that are required by paragraph (a) of this
section.
(2) The records that a qualified facility must maintain are subject
to the requirements of subpart F of this part.
Sec. 507.10 Applicability of subparts C and E of this part to a
facility solely engaged in the storage of unexposed packaged animal
food.
(a) Subparts C and E of this part do not apply to a facility solely
engaged in the storage of unexposed packaged animal food that does not
require time/temperature control to significantly minimize or prevent
the growth of, or toxin production by, pathogens.
(b) A facility solely engaged in the storage of unexposed packaged
animal food, including unexposed packaged animal food that requires
time/temperature control to significantly minimize or prevent the
growth of, or toxin production by, pathogens is subject to the modified
requirements in Sec. 507.51 for any unexposed packaged animal food
that requires time/temperature control to significantly minimize or
prevent the growth of, or toxin production by, pathogens.
Sec. 507.12 Applicability of this part to the holding and
distribution of human food by-products for use as animal food.
(a) Except as provided by paragraph (b) of this section, the
requirements of this part do not apply to by-products of human food
production, or the off-farm packing and holding of raw agricultural
commodities, that are packed or held by that human food facility for
distribution as animal food if:
(1)(i) The human food facility is subject to and in compliance with
subpart B of part 117 of this chapter and in compliance with all
applicable human food safety requirements of the Federal Food, Drug,
and Cosmetic Act and implementing regulations; or
(ii) For the off-farm packing and holding of produce (as defined in
part 112 of this chapter), the human food facility is subject to and in
compliance with Sec. 117.8 of this chapter and in compliance with all
applicable human food safety requirements of the Federal Food, Drug,
and Cosmetic Act and implementing regulations; and
(2) The human food facility does not further manufacture or process
the by-products intended for use as animal food.
(b) The human food by-products for use as animal food identified in
paragraph (a) of this section must be held and distributed by that
facility in accordance with Sec. 507.28 and Sec. 117.95 of this
chapter.
Subpart B--Current Good Manufacturing Practice
Sec. 507.14 Personnel.
(a) The management of the establishment must take reasonable
measures and precautions to ensure that all persons working in direct
contact with animal food, animal food-contact surfaces, and animal
food-packaging materials conform to hygienic practices to the extent
necessary to protect against the contamination of animal food.
(b) The methods for conforming to hygienic practices and
maintaining cleanliness include:
(1) Maintaining adequate personal cleanliness;
(2) Washing hands thoroughly in an adequate hand-washing facility
as necessary and appropriate to protect against contamination;
(3) Removing or securing jewelry and other objects that might fall
into animal food, equipment, or containers;
(4) Storing clothing or other personal belongings in areas other
than where animal food is exposed or where equipment or utensils are
cleaned; and
(5) Taking any other necessary precautions to protect against the
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials.
Sec. 507.17 Plant and grounds.
(a) The grounds around an animal food plant under the control of
the management of the establishment must be kept in a condition that
will protect against the contamination of animal food. Maintenance of
grounds must include:
(1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant that
may constitute an attractant, breeding place, or harborage for pests;
(2) Maintaining driveways, yards, and parking areas so that they do
not constitute a source of contamination in areas where animal food is
exposed;
(3) Adequately draining areas that may contribute to contamination
of animal food; and
(4) Treating and disposing of waste so that it does not constitute
a source of contamination in areas where animal food is exposed.
(b) The plant must be suitable in size, construction, and design to
facilitate cleaning, maintenance, and pest control to reduce the
potential for contamination of animal food, animal food-contact
surfaces, and animal food-packaging materials, including that the plant
must:
(1) Provide adequate space between equipment, walls, and stored
materials to permit employees to perform their duties and to allow
cleaning and maintenance of equipment;
(2) Be constructed in a manner such that drip or condensate from
fixtures, ducts, and pipes does not serve as a source of contamination;
(3) Provide adequate ventilation (mechanical or natural) where
necessary and appropriate to minimize vapors (e.g., steam) and fumes in
areas where they may contaminate animal food and in a manner that
minimizes the potential for contaminating animal food;
(4) Provide adequate lighting in hand-washing areas, toilet rooms,
areas where animal food is received, manufactured,
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processed, packed, or held, and areas where equipment or utensils are
cleaned; and
(5) Provide shatter-resistant light bulbs, fixtures, and skylights,
or other glass items suspended over exposed animal food in any step of
preparation, to protect against the contamination of animal food in
case of glass breakage.
(c) The plant must protect animal food stored outdoors in bulk from
contamination by any effective means, including:
(1) Using protective coverings where necessary and appropriate;
(2) Controlling areas over and around the bulk animal food to
eliminate harborages for pests; and
(3) Checking on a regular basis for pests, pest infestation, and
product condition related to safety of the animal food.
Sec. 507.19 Sanitation.
(a) Buildings, structures, fixtures, and other physical facilities
of the plant must be kept clean and in good repair to prevent animal
food from becoming adulterated.
(b) Animal food-contact and non-contact surfaces of utensils and
equipment must be cleaned and maintained and utensils and equipment
stored as necessary to protect against the contamination of animal
food, animal food-contact surfaces, or animal food-packaging materials.
When necessary, equipment must be disassembled for thorough cleaning.
In addition:
(1) When animal food-contact surfaces used for manufacturing,
processing, packing, or holding animal food are wet-cleaned, the
surfaces must, when necessary, be thoroughly dried before subsequent
use; and
(2) In wet processing of animal food, when cleaning and sanitizing
is necessary to protect against the introduction of undesirable
microorganisms into animal food, all animal food-contact surfaces must
be cleaned and sanitized before use and after any interruption during
which the animal food-contact surfaces may have become contaminated.
(c) Cleaning compounds and sanitizing agents must be safe and
adequate under the conditions of use.
(d) The following applies to toxic materials:
(1) Only the following toxic materials may be used or stored in the
plant area where animal food is manufactured, processed, or exposed:
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in laboratory testing procedures;
(iii) Those necessary for plant and equipment maintenance and
operation; and
(iv) Those necessary for use in the plant's operations.
(2) Toxic materials described in paragraph (d)(1) of this section
(e.g., cleaning compounds, sanitizing agents, and pesticide chemicals)
must be identified, used, and stored in a manner that protects against
the contamination of animal food, animal food-contact surfaces, or
animal food-packaging materials; and
(3) Other toxic materials (such as fertilizers and pesticides not
included in paragraph (d)(1) of this section) must be stored in an area
of the plant where animal food is not manufactured, processed, or
exposed.
(e) Effective measures must be taken to exclude pests from the
manufacturing, processing, packing, and holding areas and to protect
against the contamination of animal food by pests. The use of
pesticides in the plant is permitted only under precautions and
restrictions that will protect against the contamination of animal
food, animal food-contact surfaces, and animal food-packaging
materials.
(f) Trash must be conveyed, stored, and disposed of in a way that
protects against the contamination of animal food, animal food-contact
surfaces, animal food-packaging materials, water supplies, and ground
surfaces, and minimizes the potential for the trash to become an
attractant and harborage or breeding place for pests.
Sec. 507.20 Water supply and plumbing.
(a) The following apply to the water supply:
(1) Water must be adequate for the operations and must be derived
from an adequate source;
(2) Running water at a suitable temperature, and under suitable
pressure as needed, must be provided in all areas where required for
the manufacturing, processing, packing, or holding of animal food, for
the cleaning of equipment, utensils, and animal food-packaging
materials, or for employee hand-washing facilities;
(3) Water that contacts animal food, animal food-contact surfaces,
or animal food-packaging materials must be safe for its intended use;
and
(4) Water may be reused for washing, rinsing, or conveying animal
food if it does not increase the level of contamination of the animal
food.
(b) Plumbing must be designed, installed, and maintained to:
(1) Carry adequate quantities of water to required locations
throughout the plant;
(2) Properly convey sewage and liquid disposable waste from the
plant;
(3) Avoid being a source of contamination to animal food, water
supplies, equipment, or utensils, or creating an unsanitary condition;
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and
(5) Ensure that there is no backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for animal food or animal food manufacturing.
(c) Sewage and liquid disposal waste must be disposed of through an
adequate sewerage system or through other adequate means.
(d) Each plant must provide employees with adequate, readily
accessible toilet facilities. Toilet facilities must be kept clean and
must not be a potential source of contamination of animal food, animal
food-contact surfaces, or animal food-packaging materials.
(e) Each plant must provide hand-washing facilities designed to
ensure that an employee's hands are not a potential source of
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials.
Sec. 507.22 Equipment and utensils.
(a) The following apply to plant equipment and utensils used in
manufacturing, processing, packing, and holding animal food:
(1) All plant equipment and utensils, including equipment and
utensils that do not come in contact with animal food, must be designed
and constructed of such material and workmanship to be adequately
cleanable, and must be properly maintained;
(2) Equipment and utensils must be designed, constructed, and used
appropriately to avoid the adulteration of animal food with non-food
grade lubricants, fuel, metal fragments, contaminated water, or any
other contaminants;
(3) Equipment must be installed so as to facilitate the cleaning
and maintenance of the equipment and adjacent spaces;
(4) Animal food-contact surfaces must be:
(i) Made of materials that withstand the environment of their use
and the action of animal food, and, if applicable, the action of
cleaning compounds, cleaning procedures, and sanitizing agents;
(ii) Made of nontoxic materials; and
[[Page 56344]]
(iii) Maintained to protect animal food from being contaminated.
(b) Holding, conveying, manufacturing, and processing systems,
including gravimetric, pneumatic, closed, and automated systems, must
be designed, constructed, and maintained in a way to protect against
the contamination of animal food.
(c) Each freezer and cold storage compartment used to hold animal
food must be fitted with an accurate temperature-measuring device.
(d) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, aw, or other conditions that
control or prevent the growth of undesirable microorganisms in animal
food must be accurate, precise, adequately maintained, and adequate in
number for their designated uses.
(e) Compressed air or other gases mechanically introduced into
animal food or used to clean animal food-contact surfaces or equipment
must be used in such a way to protect against the contamination of
animal food.
Sec. 507.25 Plant operations.
(a) Management of the establishment must ensure that:
(1) All operations in the manufacturing, processing, packing, and
holding of animal food (including operations directed to receiving,
inspecting, transporting, and segregating) are conducted in accordance
with the current good manufacturing practice requirements of this
subpart;
(2) Animal food, including raw materials, other ingredients, or
rework is accurately identified;
(3) Animal food-packaging materials are safe and suitable;
(4) The overall cleanliness of the plant is under the supervision
of one or more competent individuals assigned responsibility for this
function;
(5) Adequate precautions are taken so that plant operations do not
contribute to contamination of animal food, animal food-contact
surfaces, and animal food-packaging materials;
(6) Chemical, microbial, or extraneous-material testing procedures
are used where necessary to identify sanitation failures or possible
animal food contamination;
(7) Animal food that has become adulterated is rejected, disposed
of, or if appropriate, treated or processed to eliminate the
adulteration. If disposed of, it must be done in a manner that protects
against the contamination of other animal food; and
(8) All animal food manufacturing, processing, packing, and holding
is conducted under such conditions and controls as are necessary to
minimize the potential for the growth of undesirable microorganisms to
protect against the contamination of animal food.
(b) Raw materials and other ingredients:
(1) Must be examined to ensure that they are suitable for
manufacturing and processing into animal food and must be handled under
conditions that will protect against contamination and minimize
deterioration. In addition:
(i) Shipping containers (e.g., totes, drums, and tubs) and bulk
vehicles holding raw materials and other ingredients must be examined
upon receipt to determine whether contamination or deterioration of
animal food has occurred;
(ii) Raw materials must be cleaned as necessary to minimize
contamination; and
(iii) Raw materials and other ingredients, including rework, must
be stored in containers designed and constructed in a way that protects
against contamination and deterioration, and held under conditions,
e.g., appropriate temperature and relative humidity, that will minimize
the potential for growth of undesirable microorganisms and prevent the
animal food from becoming adulterated;
(2) Susceptible to contamination with mycotoxins or other natural
toxins must be evaluated and used in a manner that does not result in
animal food that can cause injury or illness to animals or humans; and
(3) If frozen, must be kept frozen. If thawing is required prior to
use, it must be done in a manner that minimizes the potential for the
growth of undesirable microorganisms.
(c) For the purposes of manufacturing, processing, packing, and
holding operations, the following apply:
(1) Animal food must be maintained under conditions, e.g.,
appropriate temperature and relative humidity, that will minimize the
potential for growth of undesirable microorganisms and prevent the
animal food from becoming adulterated during manufacturing, processing,
packing, and holding;
(2) Measures taken during manufacturing, processing, packing, and
holding of animal food to significantly minimize or prevent the growth
of undesirable microorganisms (e.g., heat treating, freezing,
refrigerating, irradiating, controlling pH, or controlling
aw) must be adequate to prevent adulteration of animal food;
(3) Work-in-process and rework must be handled in such a way that
it is protected against contamination and the growth of undesirable
microorganisms;
(4) Steps such as cutting, drying, defatting, grinding, mixing,
extruding, pelleting, and cooling, must be performed in a way that
protects against the contamination of animal food;
(5) Filling, assembling, packaging, and other operations must be
performed in such a way that protects against the contamination of
animal food and the growth of undesirable microorganisms;
(6) Animal food that relies principally on the control of water
activity (aw) for preventing the growth of undesirable
microorganisms must be processed to and maintained at a safe
aw level;
(7) Animal food that relies principally on the control of pH for
preventing the growth of undesirable microorganisms must be monitored
and maintained at the appropriate pH; and
(8) When ice is used in contact with animal food, it must be made
from water that is safe and must be used only if it has been
manufactured in accordance with current good manufacturing practice as
outlined in this subpart.
Sec. 507.27 Holding and distribution.
(a) Animal food held for distribution must be held under conditions
that will protect against contamination and minimize deterioration,
including the following:
(1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned as necessary,
and maintained to protect against the contamination of animal food; and
(2) Animal food held for distribution must be held in a way that
protects against contamination from sources such as trash.
(b) The labeling for the animal food product ready for distribution
must contain, when applicable, information and instructions for safely
using the animal food product for the intended animal species.
(c) Shipping containers (e.g., totes, drums, and tubs) and bulk
vehicles used to distribute animal food must be examined prior to use
to protect against the contamination of animal food from the container
or vehicle when the facility is responsible for transporting the animal
food itself or arranges with a third party to transport the animal
food.
(d) Animal food returned from distribution must be assessed for
animal food safety to determine the appropriate disposition. Returned
animal food must be identified as such and segregated until assessed.
(e) Unpackaged or bulk animal food must be held in a manner that
does not
[[Page 56345]]
result in unsafe cross contamination with other animal food.
Sec. 507.28 Holding and distribution of human food by-products for
use as animal food.
(a) Human food by-products held for distribution as animal food
must be held under conditions that will protect against contamination,
including the following:
(1) Containers and equipment used to convey or hold human food by-
products for use as animal food before distribution must be designed,
constructed of appropriate material, cleaned as necessary, and
maintained to protect against the contamination of human food by-
products for use as animal food;
(2) Human food by-products for use as animal food held for
distribution must be held in a way to protect against contamination
from sources such as trash; and
(3) During holding, human food by-products for use as animal food
must be accurately identified.
(b) Labeling that identifies the product by the common or usual
name must be affixed to or accompany the human food by-products for use
as animal food when distributed.
(c) Shipping containers (e.g., totes, drums, and tubs) and bulk
vehicles used to distribute human food by-products for use as animal
food must be examined prior to use to protect against the contamination
of animal food from the container or vehicle when the facility is
responsible for transporting the human food by-products for use as
animal food itself or arranges with a third party to transport the
human food by-products for use as animal food.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
Sec. 507.31 Food safety plan.
(a) You must prepare, or have prepared, and implement a written
food safety plan.
(b) One or more preventive controls qualified individuals must
prepare, or oversee the preparation of, the food safety plan.
(c) The written food safety plan must include:
(1) The written hazard analysis as required by Sec. 507.33(a)(2);
(2) The written preventive controls as required by Sec. 507.34(b);
(3) The written supply-chain program as required by subpart E of
this part;
(4) The written recall plan as required by Sec. 507.38(a)(1);
(5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec. 507.40(a)(1);
(6) The written corrective action procedures as required by Sec.
507.42(a)(1); and
(7) The written verification procedures as required by Sec.
507.49(b).
(d) The food safety plan required by this section is a record that
is subject to the requirements of subpart F of this part.
Sec. 507.33 Hazard analysis.
(a)(1) You must conduct a hazard analysis to identify and evaluate,
based on experience, illness data, scientific reports, and other
information, known or reasonably foreseeable hazards for each type of
animal food manufactured, processed, packed, or held at your facility
to determine whether there are any hazards requiring a preventive
control; and
(2) The hazard analysis must be written regardless of its outcome.
(b) The hazard identification must consider:
(1) Known or reasonably foreseeable hazards that include:
(i) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other pathogens;
(ii) Chemical hazards, including radiological hazards, substances
such as pesticide and drug residues, natural toxins, decomposition,
unapproved food or color additives, and nutrient deficiencies or
toxicities (such as inadequate thiamine in cat food, excessive vitamin
D in dog food, and excessive copper in food for sheep); and
(iii) Physical hazards (such as stones, glass, and metal
fragments); and
(2) Known or reasonably foreseeable hazards that may be present in
the animal food for any of the following reasons:
(i) The hazard occurs naturally;
(ii) The hazard may be unintentionally introduced; or
(iii) The hazard may be intentionally introduced for purposes of
economic gain.
(c)(1) The hazard analysis must include an evaluation of the
hazards identified in paragraph (b) of this section to assess the
severity of the illness or injury if the hazard were to occur and the
probability that the hazard will occur in the absence of preventive
controls.
(2) The hazard evaluation required by paragraph (c)(1) of this
section must include an evaluation of environmental pathogens whenever
an animal food is exposed to the environment prior to packaging and the
packaged animal food does not receive a treatment or otherwise include
a control measure (such as a formulation lethal to the pathogen) that
would significantly minimize the pathogen.
(d) The hazard evaluation must consider the effect of the following
on the safety of the finished animal food for the intended animal:
(1) The formulation of the animal food;
(2) The condition, function, and design of the facility and
equipment;
(3) Raw materials and other ingredients;
(4) Transportation practices;
(5) Manufacturing/processing procedures;
(6) Packaging activities and labeling activities;
(7) Storage and distribution;
(8) Intended or reasonably foreseeable use;
(9) Sanitation, including employee hygiene; and
(10) Any other relevant factors such as the temporal (e.g.,
weather-related) nature of some hazards (e.g., levels of some natural
toxins).
Sec. 507.34 Preventive controls.
(a)(1) You must identify and implement preventive controls to
provide assurances that any hazards requiring a preventive control will
be significantly minimized or prevented and the animal food
manufactured, processed, packed, or held by your facility will not be
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act; and
(2) Preventive controls required by paragraph (a)(1) of this
section include:
(i) Controls at critical control points (CCPs), if there are any
CCPs; and
(ii) Controls, other than those at CCPs, that are also appropriate
for animal food safety.
(b) Preventive controls must be written.
(c) Preventive controls include, as appropriate to the facility and
animal food:
(1) Process controls. Process controls include procedures,
practices, and processes to ensure the control of parameters during
operations such as heat processing, irradiating, and refrigerating
animal food. Process controls must include, as appropriate to the
nature of the applicable control and its role in the facility's food
safety system:
(i) Parameters associated with the control of the hazard; and
(ii) The maximum or minimum value, or combination of values, to
which any biological, chemical, or physical parameter must be
controlled to significantly minimize or prevent a hazard requiring a
process control.
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(2) Sanitation controls. Sanitation controls include procedures,
practices, and processes to ensure that the facility is maintained in a
sanitary condition adequate to significantly minimize or prevent
hazards such as environmental pathogens and biological hazards due to
employee handling. Sanitation controls must include, as appropriate to
the facility and the animal food, procedures, practices, and processes
for the:
(i) Cleanliness of animal food-contact surfaces, including animal
food-contact surfaces of utensils and equipment; and
(ii) Prevention of cross-contamination from insanitary objects and
from personnel to animal food, animal food-packaging material, and
other animal food-contact surfaces and from raw product to processed
product.
(3) Supply-chain controls. Supply-chain controls include the
supply-chain program as required by subpart E of this part;
(4) A recall plan as required by Sec. 507.38; and
(5) Other preventive controls. These include any other procedures,
practices, and processes necessary to satisfy the requirements of
paragraph (a) of this section. Examples of other controls include
hygiene training and other current good manufacturing practices.
Sec. 507.36 Circumstances in which the owner, operator, or agent in
charge of a manufacturing/processing facility is not required to
implement a preventive control.
(a) If you are a manufacturer/processor, you are not required to
implement a preventive control when you identify a hazard requiring a
preventive control (identified hazard) and any of the following
circumstances apply:
(1) You determine and document that the type of animal food could
not be consumed without application of an appropriate control;
(2) You rely on your customer who is subject to the requirements
for hazard analysis and risk-based preventive controls in subpart C of
this part to ensure that the identified hazard will be significantly
minimized or prevented; and you:
(i) Disclose in documents accompanying the animal food, in
accordance with the practice of the trade, that the animal food is
``not processed to control [identified hazard]''; and
(ii) Annually obtain from your customer written assurance, subject
to the requirements of Sec. 507.37, that the customer has established
and is following procedures (identified in the written assurance) that
will significantly minimize or prevent the identified hazard (except as
provided in paragraph (c) of this section);
(3) You rely on your customer who is not subject to the
requirements for hazard analysis and risk-based preventive controls in
subpart C of this part to provide assurance it is manufacturing,
processing, or preparing the animal food in accordance with applicable
animal food safety requirements and you:
(i) Disclose in documents accompanying the animal food, in
accordance with the practice of the trade, that the animal food is
``not processed to control [identified hazard]''; and
(ii) Annually obtain from your customer written assurance that it
is manufacturing, processing, or preparing the animal food in
accordance with applicable animal food safety requirements;
(4) You rely on your customer to provide assurance that the animal
food will be processed to control the identified hazard by an entity in
the distribution chain subsequent to the customer and you:
(i) Disclose in documents accompanying the animal food, in
accordance with the practice of the trade, that the animal food is
``not processed to control [identified hazard]''; and
(ii) Annually obtain from your customer written assurance, subject
to the requirements of Sec. 507.37, that your customer:
(A) Will disclose in documents accompanying the animal food, in
accordance with the practice of the trade, that the animal food is
``not processed to control [identified hazard]''; and
(B) Will only sell to another entity that agrees, in writing, it
will:
(1) Follow procedures (identified in a written assurance) that will
significantly minimize or prevent the identified hazard (if the entity
is subject to the requirements for hazard analysis and risk-based
preventive controls in subpart C of this part), except as provided in
paragraph (d) of this section, or manufacture, process, or prepare the
animal food in accordance with applicable animal food safety
requirements (if the entity is not subject to the requirements for
hazard analysis and risk-based preventive controls in subpart C of this
part); or
(2) Obtain a similar written assurance from the entity's customer,
subject to the requirements of Sec. 507.37, as in paragraphs
(a)(4)(ii)(A) and (B) of this section, as appropriate; or
(5)You have established, documented, and implemented a system that
ensures control, at a subsequent distribution step, of the hazards in
the animal food product you distribute and you document the
implementation of that system.
(b) You must document any circumstance specified in paragraph (a)
of this section that applies to you, including:
(1) A determination in accordance with paragraph (a) of this
section that the type of animal food could not be consumed without
application of an appropriate control;
(2) The annual written assurance from your customer in accordance
with paragraph (a)(2) of this section;
(3) The annual written assurance from your customer in accordance
with paragraph (a)(3) of this section;
(4) The annual written assurance from your customer in accordance
with paragraph (a)(4) of this section; and
(5) Your system, in accordance with paragraph (a)(5) of this
section, that ensures control, at a subsequent distribution step, of
the hazards in the animal food product you distribute.
(c) For the written assurance required by paragraph (a)(2)(ii) of
this section, if your customer has determined that the identified
hazard in paragraph (a) of this section is not a hazard in the animal
food intended for use for a specific animal species, your customer's
written assurance may provide this determination (including animal
species and why the identified hazard is not a hazard) instead of
providing assurance of procedures established and followed that will
significantly minimize or prevent the identified hazard.
(d) For the written assurance required by paragraph (a)(4)(ii)(B)
of this section, if the entity in the distribution chain subsequent to
your customer is subject to subpart C of this part and has determined
that the identified hazard in paragraph (a) of this section is not a
hazard in the animal food intended for use for a specific animal
species, that entity's written assurance may provide this determination
(including animal species and why the identified hazard is not a
hazard) instead of providing assurance that the identified hazard will
be significantly minimized or prevented.
Sec. 507.37 Provision of assurances required under Sec.
507.36(a)(2), (3), and (4).
A facility that provides a written assurance under Sec.
507.36(a)(2), (3), or (4) must act consistently with the assurance and
document its actions taken to satisfy the written assurance.
Sec. 507.38 Recall plan.
(a) For animal food with a hazard requiring a preventive control
you must:
[[Page 56347]]
(1) Establish a written recall plan for the animal food; and
(2) Assign responsibility for performing all procedures in the
recall plan.
(b) The written recall plan must include procedures that describe
the steps to perform the following actions as appropriate to the
facility:
(1) Directly notify direct consignees about the animal food being
recalled, including how to return or dispose of the affected animal
food;
(2) Notify the public about any hazard presented by the animal food
when appropriate to protect human and animal health;
(3) Conduct effectiveness checks to verify the recall has been
carried out; and
(4) Appropriately dispose of recalled animal food, e.g., through
reprocessing, reworking, diverting to another use that would not
present a safety concern, or destroying the animal food.
Sec. 507.39 Preventive control management components.
(a) Except as provided by paragraphs (b) and (c) of this section,
the preventive controls required under Sec. 507.34 are subject to the
following preventive control management components as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control and its role in the
facility's food safety system:
(1) Monitoring in accordance with Sec. 507.40;
(2) Corrective actions and corrections in accordance with Sec.
507.42; and
(3) Verification in accordance with Sec. 507.45.
(b) The supply-chain program established in subpart E of this part
is subject to the following preventive control management components as
appropriate to ensure the effectiveness of the supply-chain program,
taking into account the nature of the hazard controlled before receipt
of the raw material or other ingredient:
(1) Corrective actions and corrections in accordance with Sec.
507.42, taking into account the nature of any supplier non-conformance;
(2) Review of records in accordance with Sec. 507.49(a)(4)(ii);
and
(3) Reanalysis in accordance with Sec. 507.50.
(c) The recall plan established in Sec. 507.38 is not subject to
the requirements of paragraph (a) of this section.
Sec. 507.40 Monitoring.
As appropriate to the nature of the preventive control and its role
in the facility's food safety system you must:
(a) Establish and implement written procedures, including the
frequency with which they are to be performed, for monitoring the
preventive controls; and
(b) Monitor the preventive controls with adequate frequency to
provide assurance that they are consistently performed.
(c)(1) You must document the monitoring of preventive controls in
accordance with this section in records that are subject to
verification in accordance with Sec. 507.45(a)(2) and records review
in accordance with Sec. 507.49(a)(4)(i);
(2)(i) Records of refrigeration temperature during storage of
animal food that requires time/temperature control to significantly
minimize or prevent the growth of, or toxin production by, pathogens
may be affirmative records demonstrating temperature is controlled or
exception records demonstrating loss of temperature control; and
(ii) Exception records may be adequate in circumstances other than
monitoring of refrigeration temperature.
Sec. 507.42 Corrective actions and corrections.
(a) As appropriate to the nature of the hazard and the nature of
the preventive control, except as provided by paragraph (c) of this
section:
(1) You must establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented, including procedures to address, as appropriate:
(i) The presence of a pathogen or appropriate indicator organism in
animal food detected as a result of product testing conducted in
accordance with Sec. 507.49(a)(2); and
(ii) The presence of an environmental pathogen or appropriate
indicator organism detected through the environmental monitoring
conducted in accordance with Sec. 507.49(a)(3).
(2) The corrective action procedures must describe the steps to be
taken to ensure that:
(i) Appropriate action is taken to identify and correct a problem
that has occurred with implementation of a preventive control;
(ii) Appropriate action is taken when necessary, to reduce the
likelihood that the problem will recur;
(iii) All affected animal food is evaluated for safety; and
(iv) All affected animal food is prevented from entering into
commerce if you cannot ensure the affected animal food is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act.
(b)(1) Except as provided by paragraph (c) of this section, you are
subject to the requirements of paragraph (b)(2) of this section if any
of the following circumstances apply:
(i) A preventive control is not properly implemented and a
corrective action procedure has not been established;
(ii) A preventive control, combination of preventive controls, or
the food safety plan as a whole is found to be ineffective; or
(iii) A review of records in accordance with Sec. 507.49(a)(4)
finds that the records are not complete, the activities conducted did
not occur in accordance with the food safety plan, or appropriate
decisions were not made about corrective actions.
(2) If any of the circumstances listed in paragraph (b)(1) of this
section apply, you must:
(i) Take corrective action to identify and correct the problem;
(ii) Reduce the likelihood that the problem will recur;
(iii) Evaluate all affected animal food for safety;
(iv) As necessary, prevent affected animal food from entering
commerce as would be done following the corrective action procedure
under paragraph (a)(2) of this section; and
(v) When appropriate, reanalyze the food safety plan in accordance
with Sec. 507.50 to determine whether modification of the food safety
plan is required.
(c) You do not need to comply with the requirements of paragraphs
(a) and (b) of this section if:
(1) You take action, in a timely manner, to identify and correct
conditions and practices that are not consistent with the sanitation
controls in Sec. 507.34(c)(2)(i) or (ii); or
(2) You take action, in a timely manner, to identify and correct a
minor and isolated problem that does not directly impact product
safety.
(d) All corrective actions (and, when appropriate, corrections)
taken in accordance with this section must be documented in records.
These records are subject to verification in accordance with Sec.
507.45(a)(3) and records review in accordance with Sec.
507.49(a)(4)(i).
Sec. 507.45 Verification.
(a) Verification activities must include, as appropriate to the
nature of the preventive control and its role in the facility's food
safety system:
(1) Validation in accordance with Sec. 507.47;
(2) Verification that monitoring is being conducted as required by
Sec. 507.39 (and in accordance with Sec. 507.40);
[[Page 56348]]
(3) Verification that appropriate decisions about corrective
actions are being made as required by Sec. 507.39 (and in accordance
with Sec. 507.42);
(4) Verification of implementation and effectiveness in accordance
with Sec. 507.49; and
(5) Reanalysis in accordance with Sec. 507.50.
(b) All verification activities conducted in accordance with this
section must be documented in records.
Sec. 507.47 Validation.
(a) You must validate that the preventive controls identified and
implemented in accordance with Sec. 507.34 are adequate to control the
hazard as appropriate to the nature of the preventive control and its
role in the facility's food safety system.
(b) The validation of the preventive controls:
(1) Must be performed (or overseen) by a preventive controls
qualified individual:
(i)(A) Prior to implementation of the food safety plan or;
(B) When necessary to demonstrate the control measures can be
implemented as designed:
(1) Within 90 calendar days after production of the applicable
animal food first begins;
(2) Within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation of)
a written justification for a timeframe that exceeds 90 calendar days
after production of the applicable animal food first begins;
(ii) Whenever a change to a control measure or combination of
control measures could impact whether the control measure or
combination of control measures, when properly implemented, will
effectively control the hazards; and
(iii) Whenever a reanalysis of the food safety plan reveals the
need to do so.
(2) Must include obtaining and evaluating scientific and technical
evidence (or, when such evidence is not available or is inadequate,
conducting studies) to determine whether the preventive controls, when
properly implemented, will effectively control the hazards.
(c) You do not need to validate:
(1) The sanitation controls in Sec. 507.34(c)(2);
(2) The recall plan in Sec. 507.38;
(3) The supply-chain program in subpart E of this part; and
(4) Other preventive controls, if the preventive controls qualified
individual prepares (or oversees the preparation of) a written
justification that validation is not applicable based on factors such
as the nature of the hazard, and the nature of the preventive control
and its role in the facility's food safety system.
Sec. 507.49 Verification of implementation and effectiveness.
(a) You must verify that the preventive controls are consistently
implemented and are effectively and significantly minimizing or
preventing the hazards. To do so, you must conduct activities that
include the following, as appropriate to the facility, the animal food,
and the nature of the preventive control and its role in the facility's
food safety system:
(1) Calibration of process monitoring and verification instruments
(or checking them for accuracy);
(2) Product testing for a pathogen (or appropriate indicator
organism) or other hazard;
(3) Environmental monitoring, for an environmental pathogen or for
an appropriate indicator organism, if contamination of an animal food
with an environmental pathogen is a hazard requiring a preventive
control, by collecting and testing environmental samples; and
(4) Review of the following records within the specified
timeframes, by (or under the oversight of) a preventive controls
qualified individual, to ensure the records are complete, the
activities reflected in the records occurred in accordance with the
food safety plan, the preventive controls are effective, and
appropriate decisions were made about corrective actions:
(i) Monitoring and corrective action records within 7-working days
after the records are created or within a reasonable timeframe,
provided that the preventive controls qualified individual prepares (or
oversees the preparation of) a written justification for a timeframe
that exceeds 7-working days; and
(ii) Records of calibration, testing (e.g., product testing,
environmental monitoring), and supplier and supply-chain verification
activities, and other verification activities within a reasonable time
after the records are created; and
(5) Other activities appropriate for verification of implementation
and effectiveness.
(b) As appropriate to the facility, the food, the nature of the
preventive control, and the role of the preventive control in the
facility's food safety system, you must establish and implement written
procedures for the following activities:
(1) The method and frequency of calibrating process monitoring
instruments and verification instruments (or checking them for
accuracy) as required by paragraph (a)(1) of this section;
(2) Product testing as required by paragraph (a)(2) of this
section. Procedures for product testing must:
(i) Be scientifically valid;
(ii) Identify the test microorganism(s) or other analyte(s);
(iii) Specify the procedures for identifying samples, including
their relationship to specific lots of product;
(iv) Include the procedures for sampling, including the number of
samples and the sampling frequency;
(v) Identify the test(s) conducted, including the analytical
method(s) used;
(vi) Identify the laboratory conducting the testing; and
(vii) Include the corrective action procedures required by Sec.
507.42(a)(1).
(3) Environmental monitoring as required by paragraph (a)(3) of
this section. Procedures for environmental monitoring must:
(i) Be scientifically valid;
(ii) Identify the test microorganism(s);
(iii) Identify the locations from which samples will be collected
and the number of sites to be tested during routine environmental
monitoring. The number and location of sampling sites must be adequate
to determine whether preventive controls are effective;
(iv) Identify the timing and frequency for collecting and testing
samples. The timing and frequency for collecting and testing samples
must be adequate to determine whether preventive controls are
effective;
(v) Identify the test(s) conducted, including the analytical
method(s) used;
(vi) Identify the laboratory conducting the testing; and
(vii) Include the corrective action procedures required by Sec.
507.42(a)(1)(ii).
Sec. 507.50 Reanalysis.
(a) You must conduct a reanalysis of the food safety plan as a
whole at least once every 3 years.
(b) You must conduct a reanalysis of the food safety plan as a
whole, or the applicable portion of the food safety plan:
(1) Whenever a significant change in the activities conducted at
your facility creates a reasonable potential for a new hazard or
creates a significant increase in a previously identified hazard;
(2) Whenever you become aware of new information about potential
hazards associated with the animal food;
(3) Whenever appropriate after an unanticipated animal food safety
problem in accordance with Sec. 507.42(b); and
[[Page 56349]]
(4) Whenever you find that a preventive control, combination of
preventive controls, or the food safety plan as a whole is ineffective.
(c) You must complete the reanalysis required by paragraphs (a) and
(b) of this section and validate, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
any additional preventive controls needed to address the hazard
identified:
(1) Before any change in activities (including any change in
preventive control) at the facility is operative; or,
(2) When necessary to demonstrate the control measures can be
implemented as designed:
(i) Within 90 calendar days after production of the applicable
animal food first begins; or
(ii) Within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation of)
a written justification for a timeframe that exceeds 90 calendar days
after production of the applicable animal food first begins.
(d) You must revise the written food safety plan if a significant
change in the activities conducted at your facility creates a
reasonable potential for a new hazard or a significant increase in a
previously identified hazard, or document the basis for the conclusion
that no revisions are needed.
(e) A preventive controls qualified individual must perform (or
oversee) the reanalysis.
(f) You must conduct a reanalysis of the food safety plan when FDA
determines it is necessary to respond to new hazards and developments
in scientific understanding.
Sec. 507.51 Modified requirements that apply to a facility solely
engaged in the storage of unexposed packaged animal food.
(a) If a facility that is solely engaged in the storage of
unexposed packaged animal food stores any such refrigerated packaged
animal food that requires time/temperature control to significantly
minimize or prevent the growth of, or toxin formation by pathogens, the
facility must conduct the following activities as appropriate to ensure
the effectiveness of the temperature controls:
(1) Establish and implement temperature controls adequate to
significantly minimize or prevent the growth of, or toxin formation by,
pathogens;
(2) Monitor the temperature controls with adequate frequency to
provide assurance that the temperature controls are consistently
performed;
(3) If there is a loss of temperature control that may impact the
safety of such refrigerated packaged animal food, take appropriate
corrective actions to:
(i) Correct the problem and reduce the likelihood that the problem
will recur;
(ii) Evaluate all affected animal food for safety; and
(iii) Prevent the animal food from entering commerce, if you cannot
ensure the affected animal food is not adulterated under section 402 of
the Federal Food, Drug, and Cosmetic Act;
(4) Verify that temperature controls are consistently implemented
by:
(i) Calibrating temperature monitoring and recording devices (or
checking them for accuracy);
(ii) Reviewing records of calibration within a reasonable time
after the records are created; and
(iii) Reviewing records of monitoring and corrective actions taken
to correct a problem with the control of temperature within 7-working
days after the records are created or within a reasonable timeframe,
provided that the preventive controls qualified individual prepares (or
oversees the preparation of) a written justification for a timeframe
that exceeds 7-working days;
(5) Establish and maintain the following records:
(i) Records (whether affirmative records demonstrating temperature
is controlled or exception records demonstrating loss of temperature
control) documenting the monitoring of temperature controls for any
such refrigerated packaged animal food;
(ii) Records of corrective actions taken when there is a loss of
temperature control that may impact the safety of any such refrigerated
packaged animal food; and
(iii) Records documenting the verification activities.
(b) The records that a facility must establish and maintain under
paragraph (a)(5) of this section are subject to the requirements of
subpart F of this part.
Sec. 507.53 Requirements applicable to a preventive controls
qualified individual and a qualified auditor.
(a) One or more preventive controls qualified individuals must do
or oversee the following:
(1) Preparation of the food safety plan (Sec. 507.31(b));
(2) Validation of the preventive controls (Sec. 507.47(b)(1));
(3) Written justification for validation to be performed in a
timeframe that exceeds the first 90 calendar days of production of the
applicable animal food;
(4) Determination that validation is not required (Sec.
507.47(c)(4));
(5) Review of records (Sec. 507.49(a)(4));
(6) Written justification for review of records of monitoring and
corrective actions within a timeframe that exceeds 7-working days;
(7) Reanalysis of the food safety plan (Sec. 507.50(d)); and
(8) Determination that reanalysis can be completed, and additional
preventive controls validated, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
in a timeframe that exceeds the first 90 calendar days of production of
the applicable animal food.
(b) A qualified auditor must conduct an onsite audit (Sec.
507.135(a)).
(c)(1) To be a preventive controls qualified individual, the
individual must have successfully completed training in the development
and application of risk-based preventive controls at least equivalent
to that received under a standardized curriculum recognized as adequate
by FDA or be otherwise qualified through job experience to develop and
apply a food safety system. Job experience may qualify an individual to
perform these functions if such experience has provided an individual
with knowledge at least equivalent to that provided through the
standardized curriculum. This individual may be, but is not required to
be, an employee of the facility; and
(2) To be a qualified auditor, a qualified individual must have
technical expertise obtained through education, training, or experience
(or a combination thereof) necessary to perform the auditing function.
(d) All applicable training in the development and application of
risk-based preventive controls must be documented in records, including
the date of the training, the type of training, and the person(s)
trained.
Sec. 507.55 Implementation records required for this subpart.
(a) You must establish and maintain the following records
documenting implementation of the food safety plan:
(1) Documentation, as required by Sec. 507.36(b), of the basis for
not establishing a preventive control in accordance with Sec.
507.36(a);
(2) Records that document the monitoring of preventive controls;
(3) Records that document corrective actions;
(4) Records that document verification, including, as applicable,
those related to:
(i) Validation;
(ii) Verification of monitoring;
(iii) Verification of corrective actions;
(iv) Calibration of process monitoring and verification
instruments;
[[Page 56350]]
(v) Product testing;
(vi) Environmental monitoring;
(vii) Records review; and
(viii) Reanalysis;
(5) Records that document the supply-chain program; and
(6) Records that document applicable training for the preventive
controls qualified individual and the qualified auditor.
(b) The records that you must establish and maintain are subject to
the requirements of subpart F of this part.
Subpart D--Withdrawal of a Qualified Facility Exemption
Sec. 507.60 Circumstances that may lead FDA to withdraw a qualified
facility exemption.
(a) FDA may withdraw a qualified facility exemption under Sec.
507.5(d):
(1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
(2) If FDA determines that it is necessary to protect the public
(human or animal) health and prevent or mitigate a foodborne illness
outbreak based on conditions or conduct associated with the qualified
facility that are material to the safety of the animal food
manufactured, processed, packed, or held at such facility.
(b) Before FDA issues an order to withdraw a qualified facility
exemption, FDA:
(1) May consider one or more other actions to protect the public
(human or animal) health or mitigate a foodborne illness outbreak,
including, a warning letter, recall, administrative detention,
suspension of registration, refusal of animal food offered for import,
seizure, and injunction;
(2) Must notify the owner, operator, or agent in charge of the
facility, in writing of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the facility to respond in writing, within 15 calendar
days of the date of receipt of the notification, to FDA's notification;
and
(3) Must consider the actions taken by the facility to address the
circumstances that may lead FDA to withdraw the exemption.
Sec. 507.62 Issuance of an order to withdraw a qualified facility
exemption.
(a) An FDA District Director in whose district the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine), or an FDA official senior to either such Director, must
approve an order to withdraw the exemption before the order is issued.
(b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
(c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the facility.
(d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.
Sec. 507.65 Contents of an order to withdraw a qualified facility
exemption.
An order to withdraw a qualified facility exemption under Sec.
507.5(d) must include the following information:
(a) The date of the order;
(b) The name, address, and location of the qualified facility;
(c) A brief, general statement of the reasons for the order,
including information relevant to one or both of the following
circumstances that leads FDA to issue the order:
(1) An active investigation of a foodborne illness outbreak that is
directly linked to the facility; or
(2) Conditions or conduct associated with a qualified facility that
are material to the safety of the animal food manufactured, processed,
packed, or held at such facility.
(d) A statement that the facility must either:
(1) Comply with subparts C and E of this part on the date that is
120 calendar days after the date of receipt of the order or within a
reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; or
(2) Appeal the order within 15 calendar days of the date of receipt
of the order in accordance with the requirements of Sec. 507.69.
(e) A statement that a facility may request that FDA reinstate an
exemption that was withdrawn by following the procedures in Sec.
507.85.
(f) The text of section 418(l) of the Federal Food, Drug, and
Cosmetic Act and of this subpart;
(g) A statement that any informal hearing on an appeal of the order
must be conducted as a regulatory hearing under part 16 of this
chapter, with certain exceptions described in Sec. 507.73;
(h) The mailing address, telephone number, email address, and
facsimile number of the FDA district office and the name of the FDA
District Director in whose district the facility is located (or, in the
case of a foreign facility, the same information for the Director of
the Division of Compliance in the Center for Veterinary Medicine); and
(i) The name and the title of the FDA representative who approved
the order.
Sec. 507.67 Compliance with, or appeal of, an order to withdraw a
qualified facility exemption.
(a) If you receive an order under Sec. 507.65 to withdraw a
qualified facility exemption, you must either:
(1) Comply with applicable requirements of this part within 120
calendar days of the date of receipt of the order, or within a
reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; or
(2) Appeal the order within 15 calendar days of the date of receipt
of the order in accordance with the requirements of Sec. 507.69.
(b) Submission of an appeal, including submission of a request for
an informal hearing, will not operate to delay or stay any
administrative action, including enforcement action by FDA, unless the
Commissioner of Food and Drugs, as a matter of discretion, determines
that delay or a stay is in the public interest.
(c) If you appeal the order, and FDA confirms the order:
(1) You must comply with applicable requirements of this part
within 120 calendar days of the date of receipt of the order, or within
a reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; and
(2) You are no longer subject to the requirements in Sec. 507.7.
Sec. 507.69 Procedure for submitting an appeal.
(a) To appeal an order to withdraw a qualified facility exemption,
you must:
(1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine), at the mailing address, email address, or
facsimile number identified in the order within 15 calendar days of the
date of receipt of confirmation of the order;
(2) Respond with particularity to the facts and issues contained in
the order, including any supporting documentation upon which you rely.
(b) In a written appeal of the order withdrawing an exemption
provided under Sec. 507.5(d), you may include a
[[Page 56351]]
written request for an informal hearing as provided in Sec. 507.71.
Sec. 507.71 Procedure for requesting an informal hearing.
(a) If you appeal the order, you:
(1) May request an informal hearing; and
(2) Must submit any request for an informal hearing together with
your written appeal submitted in accordance with Sec. 507.69 within 15
calendar days of the date of receipt of the order.
(b) A request for an informal hearing may be denied, in whole or in
part, if the presiding officer determines that no genuine and
substantial issue of material fact has been raised by the material
submitted. If the presiding officer determines that a hearing is not
justified, written notice of the determination will be given to you
explaining the reason for the denial.
Sec. 507.73 Requirements applicable to an informal hearing.
If you request an informal hearing, and FDA grants the request:
(a) The hearing will be held within 15 calendar days after the date
the appeal is filed or, if applicable, within a timeframe agreed upon
in writing by you and FDA.
(b) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 calendar day, as appropriate.
(c) FDA must conduct the hearing in accordance with part 16 of this
chapter, except that:
(1) The order withdrawing an exemption under Sec. Sec. 507.62 and
507.65, rather than the notice under Sec. 16.22(a) of this chapter,
provides notice of opportunity for a hearing under this section and is
part of the administrative record of the regulatory hearing under Sec.
16.80(a) of this chapter.
(2) A request for a hearing under this subpart must be addressed to
the FDA District Director (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) as provided in the order withdrawing an exemption.
(3) Section 507.75, rather than Sec. 16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart.
(4) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 2 calendar days of
issuance of the report. The presiding officer will then issue the final
decision.
(5) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under paragraph (c)(4) of this section are part of the
administrative record.
(6) No party shall have the right, under Sec. 16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final decision.
(7) If FDA grants a request for an informal hearing on an appeal of
an order withdrawing an exemption, the hearing must be conducted as a
regulatory hearing under a regulation in accordance with part 16 of
this chapter, except that Sec. 16.95(b) does not apply to a hearing
under this subpart. With respect to a regulatory hearing under this
subpart, the administrative record of the hearing specified in
Sec. Sec. 16.80(a)(1) through (3), and (a)(5), of this chapter, and
507.73(c)(5) constitutes the exclusive record for the presiding
officer's final decision. For purposes of judicial review under Sec.
10.45 of this chapter, the record of the administrative proceeding
consists of the record of the hearing and the presiding officer's final
decision.
Sec. 507.75 Presiding officer for an appeal and for an informal
hearing.
The presiding officer for an appeal, and for an informal hearing,
must be an FDA Regional Food and Drug Director or another FDA official
senior to an FDA District Director.
Sec. 507.77 Timeframe for issuing a decision on an appeal.
(a) If you appeal the order without requesting a hearing, the
presiding officer must issue a written report that includes a final
decision confirming or revoking the withdrawal by the 10th calendar day
after the appeal is filed.
(b) If you appeal the order and request an informal hearing:
(1) If FDA grants the request for a hearing and the hearing is
held, the presiding officer must provide a 2 calendar day opportunity
for the hearing participants to review and submit comments on the
report of the hearing under Sec. 507.73(c)(4), and must issue a final
decision within 10 calendar days after the hearing is held; or
(2) If FDA denies the request for a hearing, the presiding officer
must issue a final decision on the appeal confirming or revoking the
withdrawal within 10 calendar days after the date the appeal is filed.
Sec. 507.80 Revocation of an order to withdraw a qualified facility
exemption.
An order to withdraw a qualified facility exemption is revoked if:
(a) You appeal the order and request an informal hearing, FDA
grants the request for an informal hearing, and the presiding officer
does not confirm the order within the 10 calendar days after the
hearing, or issues a decision revoking the order within that time; or
(b) You appeal the order and request an informal hearing, FDA
denies the request for an informal hearing, and FDA does not confirm
the order within the 10 calendar days after the appeal is filed, or
issues a decision revoking the order within that time; or
(c) You appeal the order without requesting an informal hearing,
and FDA does not confirm the order within the 10 calendar days after
the appeal is filed, or issues a decision revoking the order within
that time.
Sec. 507.83 Final agency action.
Confirmation of a withdrawal order by the presiding officer is
considered a final agency action for purposes of 5 U.S.C. 702.
Sec. 507.85 Reinstatement of a qualified facility exemption that was
withdrawn.
(a) If the FDA District Director in whose district your facility is
located (or, in the case of a foreign facility, the Director of the
Division of Compliance in the Center for Veterinary Medicine)
determines that a facility has adequately resolved any problems with
the conditions and conduct that are material to the safety of the
animal food manufactured, processed, packed, or held at the facility
and that continued withdrawal of the exemption is not necessary to
protect public (human and animal) health and prevent or mitigate a
foodborne illness outbreak, the FDA District Director in whose district
your facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) will, on his own initiative or on the request of a facility,
reinstate the exemption.
(b) You may ask FDA to reinstate an exemption that has been
withdrawn under the procedures of this subpart as follows:
(1) Submit a request, in writing, to the FDA District Director in
whose district your facility is located (or, in the case
[[Page 56352]]
of a foreign facility, the Director of the Division of Compliance in
the Center for Veterinary Medicine); and
(2) Present data and information to demonstrate that you have
adequately resolved any problems with the conditions and conduct that
are material to the safety of the animal food manufactured, processed,
packed, or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public (human and animal) health
and prevent or mitigate a foodborne illness outbreak.
(c) If your exemption was withdrawn under Sec. 507.60(a)(1) and
FDA later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will reinstate your exemption under Sec. 507.5(d),
and FDA will notify you in writing that your exempt status has been
reinstated.
(d) If your exemption was withdrawn under both Sec. 507.60(a)(1)
and (2) and FDA later determines, after finishing the active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to your facility, FDA will inform you of this finding
and you may ask FDA to reinstate your exemption under Sec. 507.5(d) in
accordance with the requirements of paragraph (b) of this section.
Subpart E--Supply-Chain Program
Sec. 507.105 Requirement to establish and implement a supply-chain
program.
(a)(1) Except as provided by paragraphs (a)(2) and (3) of this
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other
ingredients for which the receiving facility has identified a hazard
requiring a supply-chain-applied control.
(2) A receiving facility that is an importer, is in compliance with
the foreign supplier verification requirements under part 1, subpart L
of this chapter, and has documentation of verification activities
conducted under Sec. 1.506(e) of this chapter (which provides
assurance that the hazards requiring a supply-chain-applied control for
the raw material or other ingredient have been significantly minimized
or prevented) need not conduct supplier verification activities for
that raw material or other ingredient.
(3) The requirements in this subpart do not apply to animal food
that is supplied for research or evaluation use, provided that such
animal food:
(i) Is not intended for retail sale and is not sold or distributed
to the public;
(ii) Is labeled with the statement ``Animal food for research or
evaluation use'';
(iii) Is supplied in a small quantity that is consistent with a
research, analysis, or quality assurance purpose, the animal food is
used only for this purpose, and any unused quantity is properly
disposed of; and
(iv) Is accompanied with documents, in accordance with the practice
of the trade, stating that the animal food will be used for research or
evaluation purposes and cannot be sold or distributed to the public.
(b) The supply-chain program must be written.
(c) When a supply-chain-applied control is applied by an entity
other than the receiving facility's supplier (e.g., when a non-supplier
applies controls to certain produce (i.e., produce covered by part 112
of this chapter), because growing, harvesting, and packing activities
are under different management), the receiving facility must:
(1) Verify the supply-chain-applied control; or
(2) Obtain documentation of an appropriate verification activity
from another entity, review and assess the entity's applicable
documentation, and document that review and assessment.
Sec. 507.110 General requirements applicable to a supply-chain
program.
(a) The supply-chain program must include:
(1) Using approved suppliers as required by Sec. 507.120;
(2) Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity) as
required by Sec. 507.125;
(3) Conducting supplier verification activities as required by
Sec. Sec. 507.130 and 507.135;
(4) Documenting supplier verification activities as required by
Sec. 507.175; and
(5) When applicable, verifying a supply-chain-applied control
applied by an entity other than the receiving facility's supplier and
documenting that verification as required by Sec. 507.175, or
obtaining documentation of an appropriate verification activity from
another entity, reviewing and assessing that documentation, and
documenting the review and assessment as required by Sec. 507.175.
(b) The following are appropriate supplier verification activities
for raw materials and other ingredients:
(1) Onsite audits;
(2) Sampling and testing of the raw material or other ingredient;
(3) Review of the supplier's relevant food safety records; and
(4) Other appropriate supplier verification activities based on
supplier performance and the risk associated with the raw material or
other ingredient.
(c) The supply-chain program must provide assurance that a hazard
requiring a supply-chain-applied control has been significantly
minimized or prevented.
(d)(1) Except as provided by paragraph (d)(2) of this section, in
approving suppliers and determining the appropriate supplier
verification activities and the frequency with which they are
conducted, the following must be considered:
(i) The hazard analysis of the animal food, including the nature of
the hazard controlled before receipt of the raw material or other
ingredient, applicable to the raw material and other ingredients;
(ii) The entity or entities that will be applying controls for the
hazards requiring a supply-chain-applied control;
(iii) Supplier performance, including:
(A) The supplier's procedures, processes, and practices related to
the safety of the raw material and other ingredients;
(B) Applicable FDA food safety regulations and information relevant
to the supplier's compliance with those regulations, including an FDA
warning letter or import alert relating to the safety of animal food
and other FDA compliance actions related to animal food safety (or,
when applicable, relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States, and
information relevant to the supplier's compliance with those laws and
regulations); and
(C) The supplier's food safety history relevant to the raw
materials or other ingredients that the receiving facility receives
from the supplier, including available information about results from
testing raw materials or other ingredients for hazards, audit results
relating to the safety of the animal food, and responsiveness of the
supplier in correcting problems; and
(iv) Any other factors as appropriate and necessary, such as
storage and transportation practices.
(2) Considering supplier performance can be limited to the
supplier's compliance history as required by paragraph (d)(1)(iii)(B)
of this section, if the supplier is:
(i) A qualified facility as defined by Sec. 507.3;
[[Page 56353]]
(ii) A farm that grows produce and is not a covered farm under part
112 of this chapter in accordance with Sec. 112.4(a), or in accordance
with Sec. Sec. 112.4(b) and 112.5; or
(iii) A shell egg producer that is not subject to the requirements
of part 118 of this chapter because it has less than 3,000 laying hens.
(e) If the owner, operator, or agent in charge of a receiving
facility determines through auditing, verification testing, document
review, relevant consumer, customer, or other complaints, or otherwise
that the supplier is not controlling hazards that the receiving
facility has identified as requiring a supply-chain-applied control,
the receiving facility must take and document prompt action in
accordance with Sec. 507.42 to ensure that raw materials or other
ingredients from the supplier do not cause animal food that is
manufactured or processed by the receiving facility to be adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
Sec. 507.115 Responsibilities of the receiving facility.
(a)(1) The receiving facility must approve suppliers.
(2) Except as provided by paragraphs (a)(3) and (4) of this
section, the receiving facility must determine and conduct appropriate
supplier verification activities, and satisfy all documentation
requirements of this subpart.
(3) An entity other than the receiving facility may do any of the
following, provided that the receiving facility reviews and assesses
the entity's applicable documentation, and documents that review and
assessment:
(i) Establish written procedures for receiving raw materials and
other ingredients by the entity;
(ii) Document that written procedures for receiving raw materials
and other ingredients are being followed by the entity; and
(iii) Determine, conduct, or both determine and conduct, the
appropriate supplier verification activities, with appropriate
documentation.
(4) The supplier may conduct and document sampling and testing of
raw materials and other ingredients, for the hazard controlled by the
supplier, as a supplier verification activity for a particular lot of
product and provide such documentation to the receiving facility,
provided that the receiving facility reviews and assesses that
documentation, and documents that review and assessment.
(b) For the purposes of this subpart, a receiving facility may not
accept any of the following as a supplier verification activity:
(1) A determination by its supplier of the appropriate supplier
verification activities for that supplier;
(2) An audit conducted by its supplier;
(3) A review by its supplier of that supplier's own relevant food
safety records; or
(4) The conduct by its supplier of other appropriate supplier
verification activities for that supplier within the meaning of Sec.
507.110(b)(4).
(c) The requirements of this section do not prohibit a receiving
facility from relying on an audit provided by its supplier when the
audit of the supplier was conducted by a third-party qualified auditor
in accordance with Sec. Sec. 507.130(f) and 507.135.
Sec. 507.120 Using approved suppliers.
(a) The receiving facility must approve suppliers in accordance
with the requirements of Sec. 507.110(d), and document that approval,
before receiving raw materials and other ingredients received from
those suppliers;
(b)(1) Written procedures for receiving raw materials and other
ingredients must be established and followed;
(2) The written procedures for receiving raw materials and other
ingredients must ensure that raw materials and other ingredients are
received only from approved suppliers (or, when necessary and
appropriate, on a temporary basis from unapproved suppliers whose raw
materials or other ingredients are subjected to adequate verification
activities before acceptance for use); and
(3) Use of the written procedures for receiving raw materials and
other ingredients must be documented.
Sec. 507.125 Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).
Appropriate supplier verification activities (including the
frequency of conducting the activity) must be determined in accordance
with the requirements of Sec. 507.110(d).
Sec. 507.130 Conducting supplier verification activities for raw
materials and other ingredients.
(a) Except as provided by paragraphs (c), (d), or (e) of this
section, one or more of the supplier verification activities specified
in Sec. 507.110(b), as determined under Sec. 507.110(d), must be
conducted for each supplier before using the raw material or other
ingredient from that supplier and periodically thereafter.
(b)(1) Except as provided by paragraph (b)(2) of this section, when
a hazard in a raw material or other ingredient will be controlled by
the supplier and is one for which there is a reasonable probability
that exposure to the hazard will result in serious adverse health
consequences or death to humans or animals:
(i) The appropriate supplier verification activity is an onsite
audit of the supplier; and
(ii) The audit must be conducted before using the raw material or
other ingredient from the supplier and at least annually thereafter.
(2) The requirements of paragraph (b)(1) of this section do not
apply if there is a written determination that other verification
activities and/or less frequent onsite auditing of the supplier provide
adequate assurance that the hazards are controlled.
(c) If a supplier is a qualified facility as defined by Sec.
507.3, the receiving facility does not need to comply with paragraphs
(a) and (b) of this section if the receiving facility:
(1) Obtains written assurance that the supplier is a qualified
facility as defined by Sec. 507.3:
(i) Before first approving the supplier for an applicable calendar
year; and
(ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
(2) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or other ingredient in
compliance with applicable FDA food safety regulations (or, when
applicable, relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States). The written
assurance must include either:
(i) A brief description of the preventive controls that the
supplier is implementing to control the applicable hazard in the animal
food; or
(ii) A statement that the facility is in compliance with State,
local, county, tribal or other applicable non-Federal food safety laws,
including relevant laws and regulations of foreign counties.
(d) If a supplier is a farm that grows produce and is not a covered
farm under part 112 of this chapter in accordance with Sec. 112.4(a),
or in accordance with Sec. Sec. 112.4(b) and 112.5, the receiving
facility does not need to comply with paragraphs (a) and (b) of this
section for produce that the receiving facility receives from the farm
as a raw material or other ingredient if the receiving facility:
[[Page 56354]]
(1) Obtains written assurance that the raw material or other
ingredient provided by the supplier is not subject to part 112 of this
chapter in accordance with Sec. 112.4(a), or in accordance with
Sec. Sec. 112.4(b) and 112.5:
(i) Before first approving the supplier for an applicable calendar
year; and
(ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
(2) Obtains written assurance, at least every 2 years, that the
farm acknowledges that its food is subject to section 402 of the
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its
food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States).
(e) If a supplier is a shell egg producer that is not subject to
the requirements of part 118 of this chapter because it has less than
3,000 laying hens, the receiving facility does not need to comply with
paragraphs (a) and (b) of this section if the receiving facility:
(1) Obtains written assurance that the shell eggs produced by the
supplier are not subject to part 118 because the shell egg producer has
less than 3,000 laying hens:
(i) Before first approving the supplier for an applicable calendar
year; and
(ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
(2) Obtains written assurance, at least every 2 years, that the
shell egg producer acknowledges that its food is subject to section 402
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that
its food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States).
(f) There must not be any financial conflicts of interest that
influence the results of the verification activities listed in Sec.
507.110(b) and payment must not be related to the results of the
activity.
Sec. 507.135 Onsite audit.
(a) An onsite audit of a supplier must be performed by a qualified
auditor.
(b) If the raw material or other ingredient at the supplier is
subject to one or more FDA food safety regulations, an onsite audit
must consider such regulations and include a review of the supplier's
written plan (e.g., Hazard Analysis and Critical Control Point (HACCP)
plan or other food safety plan), if any, and its implementation, for
the hazard being controlled (or, when applicable, an onsite audit may
consider relevant laws and regulations of a country whose food safety
system FDA has officially recognized as comparable or has determined to
be equivalent to that of the United States).
(c)(1) The following may be substituted for an onsite audit,
provided that the inspection was conducted within 1 year of the date
that the onsite audit would have been required to be conducted:
(i) The written results of an appropriate inspection of the
supplier for compliance with applicable FDA food safety regulations by
FDA, by representatives of other Federal Agencies (such as the United
States Department of Agriculture), or by representatives of State,
local, tribal, or territorial agencies; or
(ii) For a foreign supplier, the written results of an inspection
by FDA or the food safety authority of a country whose food safety
system FDA has officially recognized as comparable or has determined to
be equivalent to that of the United States.
(2) For inspections conducted by the food safety authority of a
country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent, the animal food that is the
subject of the onsite audit must be within the scope of the official
recognition or equivalence determination, and the foreign supplier must
be in, and under the regulatory oversight of, such country.
(d) If the onsite audit is solely conducted to meet the
requirements of this subpart by an audit agent of a certification body
that is accredited in accordance with regulations in part 1, subpart M
of this chapter, the audit is not subject to the requirements in those
regulations.
Sec. 507.175 Records documenting the supply-chain program.
(a) The records documenting the supply-chain program are subject to
the requirements of subpart F of this part.
(b) The receiving facility must review the records listed in
paragraph (c) of this section in accordance with Sec. 507.49(a)(4).
(c) The receiving facility must document the following in records
as applicable to its supply-chain program:
(1) The written supply-chain program;
(2) Documentation that a receiving facility that is an importer is
in compliance with the foreign supplier verification program
requirements under part 1, subpart L of this chapter, including
documentation of verification activities conducted under Sec. 1.506(e)
of this chapter;
(3) Documentation of the approval of a supplier;
(4) Written procedures for receiving raw materials and other
ingredients;
(5) Documentation demonstrating use of the written procedures for
receiving raw materials and other ingredients;
(6) Documentation of the determination of the appropriate supplier
verification activities for raw materials and other ingredients;
(7) Documentation of the conduct of an onsite audit. This
documentation must include:
(i) The name of the supplier subject to the onsite audit;
(ii) Documentation of audit procedures;
(iii) The dates the audit was conducted;
(iv) The conclusions of the audit;
(v) Corrective actions taken in response to significant
deficiencies identified during the audit; and
(vi) Documentation that the audit was conducted by a qualified
auditor;
(8) Documentation of sampling and testing conducted as a supplier
verification activity. This documentation must include:
(i) Identification of the raw material or other ingredient tested
(including lot number, as appropriate) and the number of samples
tested;
(ii) Identification of the test(s) conducted, including the
analytical method(s) used;
(iii) The date(s) on which the test(s) were conducted and the date
of the report;
(iv) The results of the testing;
(v) Corrective actions taken in response to detection of hazards;
and
(vi) Information identifying the laboratory conducting the testing;
(9) Documentation of the review of the supplier's relevant food
safety records. This documentation must include:
(i) The name of the supplier whose records were reviewed;
(ii) The date(s) of review;
(iii) The general nature of the records reviewed;
(iv) The conclusions of the review; and
(v) Corrective actions taken in response to significant
deficiencies identified during the review;
(10) Documentation of other appropriate supplier verification
activities based on the supplier performance and the risk associated
with the raw material or other ingredient;
(11) Documentation of any determination that verification
activities
[[Page 56355]]
other than an onsite audit, and/or less frequent onsite auditing of a
supplier, provide adequate assurance that the hazards are controlled
when a hazard in a raw material or other ingredient will be controlled
by the supplier and is one for which there is a reasonable probability
that exposure to the hazard will result in serious adverse health
consequences or death to humans or animals;
(12) The following documentation of an alternative verification
activity for a supplier that is a qualified facility:
(i) The written assurance that the supplier is a qualified facility
as defined by Sec. 507.3; and
(ii) The written assurance that the supplier is producing the raw
material or other ingredient in compliance with applicable FDA food
safety regulations (or, when applicable, relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States);
(13) The following documentation of an alternative verification
activity for a supplier that is a farm that supplies a raw material or
other ingredient and is not a covered farm under part 112 of this
chapter:
(i) The written assurance that supplier is not a covered farm under
part 112 of this chapter in accordance with Sec. 112.4(a), or in
accordance with Sec. Sec. 112.4(b) and 112.5; and
(ii) The written assurance that the farm acknowledges that its food
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act
(or, when applicable, that its food is subject to relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or has determined to be equivalent to that of
the United States);
(14) The following documentation of an alternative verification
activity for a supplier that is a shell egg producer that is not
subject to the requirements established in part 118 of this chapter
because it has less than 3,000 laying hens:
(i) The written assurance that the shell eggs provided by the
supplier are not subject to part 118 of this chapter because the
supplier has less than 3,000 laying hens; and
(ii) The written assurance that the shell egg producer acknowledges
that its food is subject to section 402 of the Federal Food, Drug, and
Cosmetic Act (or, when applicable, that its food is subject to relevant
laws and regulations of a country whose safety system FDA has
officially recognized as comparable or has determined to be equivalent
to that of the United States);
(15) The written results of an appropriate inspection of the
supplier for compliance with applicable FDA food safety regulations by
FDA, by representatives of other Federal Agencies (such as the United
States Department of Agriculture), or by representatives from State,
local, tribal, or territorial agencies, or the food safety authority of
another country when the results of such an inspection is substituted
for an onsite audit;
(16) Documentation of actions taken with respect to supplier non-
conformance;
(17) Documentation of verification of a supply-chain-applied
control applied by an entity other than the receiving facility's
supplier; and
(18) When applicable, documentation of the receiving facility's
review and assessment of:
(i) Applicable documentation from an entity other than the
receiving facility that written procedures for receiving raw materials
and other ingredients are being followed;
(ii) Applicable documentation, from an entity other than the
receiving facility, of the determination of the appropriate supplier
verification activities for raw materials and other ingredients;
(iii) Applicable documentation, from an entity other than the
receiving facility, of conducting the appropriate supplier verification
activities for raw materials and other ingredients;
(iv) Applicable documentation, from its supplier, of:
(A) The results of sampling and testing conducted by the supplier;
or
(B) The results of an audit conducted by a third-party qualified
auditor in accordance with Sec. Sec. 507.130(f) and 507.135; and
(v) Applicable documentation, from an entity other than the
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving
facility's supplier.
Subpart F--Requirements Applying to Records That Must Be
Established and Maintained
Sec. 507.200 Records subject to the requirements of this subpart.
(a) Except as provided by paragraphs (d) and (e) of this section,
all records required by this part are subject to all requirements of
this subpart.
(b) Records obtained by FDA in accordance with this part are
subject to the disclosure requirements under part 20 of this chapter.
(c) All records required by this part must be made promptly
available to a duly authorized representative of the Secretary of
Health and Human Services for official review and copying upon oral or
written request.
(d) The requirements of Sec. 507.206 apply only to the written
food safety plan.
(e) The requirements of Sec. 507.202(a)(2), (4), and (5) and (b)
do not apply to the records required by Sec. 507.7.
Sec. 507.202 General requirements applying to records.
(a) Records must:
(1) Be kept as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records;
(2) Contain the actual values and observations obtained during
monitoring and as appropriate, during verification activities;
(3) Be accurate, indelible, and legible;
(4) Be created concurrently with performance of the activity
documented; and
(5) Be as detailed as necessary to provide history of work
performed.
(b) All records must include:
(1) Information adequate to identify the plant or facility (e.g.,
the name, and when necessary, the location of the plant or facility);
(2) The date and, when appropriate, the time of the activity
documented;
(3) The signature or initials of the person performing the
activity; and
(4) Where appropriate, the identity of the product and the lot
code, if any.
(c) Records that are established or maintained to satisfy the
requirements of this part and that meet the definition of electronic
records in Sec. 11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this part, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.
Sec. 507.206 Additional requirements applying to the food safety
plan.
The owner, operator, or agent in charge of the facility must sign
and date the food safety plan upon initial completion and upon any
modification.
Sec. 507.208 Requirements for record retention.
(a)(1) All records required by this part must be retained at the
plant or facility for at least 2 years after the date they were
prepared.
(2) Records that a facility relies on during the 3-year period
preceding the
[[Page 56356]]
applicable calendar year to support its status as a qualified facility
must be retained at the facility as long as necessary to support the
status of a facility as a qualified facility during the applicable
calendar year.
(b) Records that relate to the general adequacy of the equipment or
processes being used by a facility, including the results of scientific
studies and evaluations, must be retained by the facility for at least
2 years after their use is discontinued (e.g., because the facility has
updated the written food safety plan (Sec. 507.31) or records that
document validation of the written food safety plan (Sec. 507.45(b))).
(c) Except for the food safety plan, offsite storage of records is
permitted if such records can be retrieved and provided onsite within
24 hours of request for official review. The food safety plan must
remain onsite. Electronic records are considered to be onsite if they
are accessible from an onsite location.
(d) If the plant or facility is closed for a prolonged period, the
food safety plan may be transferred to some other reasonably accessible
location but must be returned to the plant or facility within 24 hours
for official review upon request.
Sec. 507.212 Use of existing records.
(a) Existing records (e.g., records that are kept to comply with
other Federal, State, or local regulations, or for any other reason) do
not need to be duplicated if they contain all of the required
information and satisfy the requirements of this subpart. Existing
records may be supplemented as necessary to include all of the required
information and satisfy the requirements of this subpart.
(b) The information required by this part does not need to be kept
in one set of records. If existing records contain some of the required
information, any new information required by this part may be kept
either separately or combined with the existing records.
Sec. 507.215 Special requirements applicable to a written assurance.
(a) Any written assurance required by this part must contain the
following elements:
(1) Effective date;
(2) Printed names and signatures of authorized officials;
(3) The applicable assurance under:
(i) Sec. 507.36(a)(2);
(ii) Sec. 507.36(a)(3);
(iii) Sec. 507.36(a)(4);
(iv) Sec. 507.130(c)(2);
(v) Sec. 507.130(d)(2); or
(vi) Sec. 507.130(e)(2).
(b) A written assurance required under Sec. 507.36(a)(2), (3) or
(4) must include:
(1) Acknowledgement that the facility that provides the written
assurance assumes legal responsibility to act consistently with the
assurance and document its actions taken to satisfy the written
assurance; and
(2) Provision that if the assurance is terminated in writing by
either entity, responsibility for compliance with the applicable
provisions of this part reverts to the manufacturer/processor as of the
date of termination.
PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING
OF ANIMAL FEED AND PET FOOD
0
10. The authority citation for 21 CFR part 579 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371.
0
11. In Sec. 579.12, add the following sentence to the end of the
paragraph to read as follows:
Sec. 579.12 Incorporation of regulations in part 179.
* * * Any facility that treats animal feed and pet food with
ionizing radiation must comply with the requirements of part 507 of
this chapter and other applicable regulations.
Dated:August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21921 Filed 9-10-15; 8:45 am]
BILLING CODE 4164-01-P
