Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment, 3716-3718 [2016-01290]
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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations
and also includes re-packing and
activities performed incidental to
packing or re-packing a food (e.g.,
activities performed for the safe or
effective packing or re-packing of that
food (such as sorting, culling, grading,
and weighing or conveying incidental to
packing or re-packing)), 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.
*
*
*
*
*
Qualified end-user * * *
(1) Is located:
*
*
*
*
*
Small business means, for purposes of
this part, a business (including any
subsidiaries and affiliates) employing
fewer than 500 full-time equivalent
employees.
*
*
*
*
*
■ 7. In § 117.5, revise the first sentence
of paragraph (a), and revise paragraph
(h)(3)(v) to read as follows:
§ 117.5
Exemptions.
(a) Except as provided by subpart E of
this part, subparts C and G of this part
do not apply to a qualified facility.
* * *
*
*
*
*
*
(h) * * *
(3) * * *
(v) Extracting (including by pressing,
by distilling, and by solvent extraction)
dried/dehydrated herb and spice
products (e.g., dried mint), fresh herbs
(e.g., fresh mint), fruits and vegetables
(e.g., olives, avocados), grains (e.g.,
oilseeds), and other herb and spice
products (e.g., chopped fresh mint,
chopped dried mint);
*
*
*
*
*
■ 8. In § 117.136, revise paragraphs
(a)(2) introductory text, (a)(5), and (b)(5)
to read as follows:
mstockstill on DSK4VPTVN1PROD with RULES
§ 117.136 Circumstances in which the
owner, operator, or agent in charge of a
manufacturing/processing facility is not
required to implement a preventive control.
(a) * * *
(2) You rely on your customer who is
subject to the requirements for hazard
analysis and risk-based preventive
controls in this subpart to ensure that
the identified hazard will be
significantly minimized or prevented
and you:
*
*
*
*
*
(5) You have established,
documented, and implemented a system
that ensures control, at a subsequent
distribution step, of the hazards in the
food you distribute and you document
the implementation of that system.
(b) * * *
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16:27 Jan 21, 2016
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(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
food you distribute.
■ 9. In § 117.145, revise paragraph (a) to
read as follows:
§ 117.145
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01091 Filed 1–21–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Monitoring.
*
*
*
*
*
(a) Written procedures. You must
establish and implement written
procedures, including the frequency
with which they are to be performed, for
monitoring the preventive control; and
*
*
*
*
*
■ 10. In § 117.201, revise paragraphs
(b)(2)(i)(B) and (b)(2)(ii) to read as
follows:
Food and Drug Administration
21 CFR Part 507
[Docket No. FDA–2011–N–0922]
RIN 0910–AG10
§ 117.201 Modified requirements that
apply to a qualified facility.
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for
Animals; Technical Amendment
*
AGENCY:
*
*
*
*
(b) * * *
(2) * * *
(i) * * *
(B) Write to the U.S. Food and Drug
Administration (HFS–681), 5100 Paint
Branch Pkwy., College Park, MD 20740;
or
*
*
*
*
*
(ii) Send a paper Form FDA 3942a to
the U.S. Food and Drug Administration
(HFS–681), 5100 Paint Branch Pkwy.,
College Park, MD 20740. We
recommend that you submit a paper
copy only if your facility does not have
reasonable access to the Internet.
*
*
*
*
*
■ 11. In § 117.257, revise paragraph (e)
to read as follows:
§ 117.257 Contents of an order to withdraw
a qualified facility exemption.
*
*
*
*
*
(e) A statement that a facility may
request that FDA reinstate an exemption
that was withdrawn by following the
procedures in § 117.287;
*
*
*
*
*
■ 12. In § 117.264, revise paragraph
(a)(1) to read as follows:
§ 117.264
appeal.
Procedure for submitting an
(a) * * *
(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
Office of Compliance in the Center for
Food Safety and Applied Nutrition), 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; and
*
*
*
*
*
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Food and Drug Administration,
HHS.
Final rule, technical
amendment.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending a final rule that published in
the Federal Register of September 17,
2015. That final rule established
requirements for domestic and foreign
facilities required to register under the
Federal Food, Drug, and Cosmetic Act
for current good manufacturing practice,
hazard analysis, and risk-based
preventive controls for food for animals.
The final rule published with some
editorial and inadvertent errors. This
document corrects those errors.
DATES: Effective January 22, 2016.
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: In the
Federal Register of Thursday,
September 17, 2015 (80 FR 56170), FDA
published the final rule ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals’’ with
some editorial and inadvertent errors.
This action is being taken to correct
those errors by making the following
correcting amendments.
SUMMARY:
List of Subjects in 21 CFR Part 507
Animal foods, Labeling, Packaging
and containers, Reporting and
recordkeeping requirements.
Accordingly, FDA is amending 21
CFR part 507 with the following
technical amendments:
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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations
PART 507—CURRENT GOOD
MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISKBASED PREVENTIVE CONTROLS FOR
FOOD FOR ANIMALS
1. The authority citation for 21 CFR
part 507 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.
2. In § 507.3, revise the definitions of
‘‘audit’’, ‘‘harvesting’’, ‘‘hazard requiring
a preventive control’’, and ‘‘small
business’’ to read as follows:
■
§ 507.3
Definitions.
mstockstill on DSK4VPTVN1PROD with RULES
*
*
*
*
*
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 an audited entity’s food safety
processes and procedures.
*
*
*
*
*
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,
shelling, sifting, threshing, trimming of
outer leaves of, and washing raw
agricultural commodities grown on a
farm.
*
*
*
*
*
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
the outcome of a hazard analysis (which
includes an assessment of the severity of
VerDate Sep<11>2014
16:27 Jan 21, 2016
Jkt 238001
the illness or injury to humans or
animals 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.
*
*
*
*
*
Small business means, for purposes of
this part, a business (including any
subsidiaries and affiliates) employing
fewer than 500 full-time equivalent
employees.
*
*
*
*
*
■ 3. In § 507.5, revise paragraph (e)(5) to
read as follows:
3717
animal food-contact surfaces may have
become contaminated.
*
*
*
*
*
■ 6. In § 507.27, revise paragraph (b) to
read as follows:
§ 507.27
Holding and distribution.
*
*
*
*
*
(b) The labeling for the animal food
ready for distribution must contain,
when applicable, information and
instructions for safely using the animal
food for the intended animal species.
*
*
*
*
*
■ 7. In § 507.33, revise paragraph (c)(1)
to read as follows:
507.33
Hazard analysis.
*
*
*
*
*
(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 to humans or animals
if the hazard were to occur and the
probability that the hazard will occur in
the absence of preventive controls.
*
*
*
*
*
■ 8. In § 507.36, revise paragraphs (a)(2)
introductory text and (3) introductory
text and paragraphs (a)(5) and (b)(5) to
read as follows:
§ 507.7 Requirements that apply to a
qualified facility.
§ 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.
§ 507.5
Exemptions.
*
*
*
*
(e) * * *
(5) Molasses (e.g., processed sugar
cane, sugar beets, and citrus);
*
*
*
*
*
■ 4. In § 507.7, revise paragraphs
(b)(2)(i)(B) and (b)(2)(ii) to read as
follows:
*
*
*
*
*
(b) * * *
(2) * * *
(i) * * *
(B) Write to the U.S. Food and Drug
Administration (HFS–681), 5100 Paint
Branch Pkwy., College Park, MD 20740;
or
*
*
*
*
*
(ii) Send a paper Form FDA 3942b to
the U.S. Food and Drug Administration
(HFS–681), 5100 Paint Branch Pkwy.,
College Park, MD 20740. We
recommend that you submit a paper
copy only if your facility does not have
reasonable access to the Internet.
*
*
*
*
*
■ 5. In § 507.19, revise paragraph (b)(2)
to read as follows:
§ 507.19
Sanitation.
*
*
*
*
*
(b) * * *
(2) In wet processing of animal food,
when cleaning and sanitizing are
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
PO 00000
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Fmt 4700
Sfmt 4700
*
(a) * * *
(2) You rely on your customer who is
subject to the requirements for hazard
analysis and risk-based preventive
controls in this subpart to ensure that
the identified hazard will be
significantly minimized or prevented;
and you:
*
*
*
*
*
(3) You rely on your customer who is
not subject to the requirements for
hazard analysis and risk-based
preventive controls in this subpart to
provide assurance it is manufacturing,
processing, or preparing the animal food
in accordance with applicable animal
food safety requirements and you:
*
*
*
*
*
(5) You have established,
documented, and implemented a system
that ensures control, at a subsequent
distribution step, of the hazards in the
animal food you distribute and you
document the implementation of that
system.
*
*
*
*
*
(b) * * *
(5) Your system, in accordance with
paragraph (a)(5) of this section, that
ensures control, at a subsequent
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3718
Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations
distribution step, of the hazards in the
animal food you distribute.
*
*
*
*
*
■ 9. In § 507.47, revise paragraphs
(b)(1)(i)(A) and (b)(1)(i)(B)(1) to read as
follows:
§ 507.47
Validation.
*
*
*
*
*
(b) * * *
(1) * * *
(i)(A) Prior to implementation of the
food safety plan; or
(B) * * *
(1) Within 90 calendar days after
production of the applicable animal
food first begins; or
*
*
*
*
*
■ 10. In § 507.50, revise paragraph (c)(1)
to read as follows:
§ 507.50
*
*
*
*
(c) * * *
(1) Before any change in activities
(including any change in preventive
control) at the facility is operative; or
*
*
*
*
*
■ 11. In § 507.51, revise paragraph
(a)(4)(iii) to read as follows:
*
*
*
*
*
(e) A statement that a facility may
request that FDA reinstate an exemption
that was withdrawn by following the
procedures in § 507.85;
*
*
*
*
*
■ 13. In § 507.69, revise paragraph (a)(1)
to read as follows:
mstockstill on DSK4VPTVN1PROD with RULES
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Department of the Navy, DoD.
Final rule.
The Department of the Navy
(DoN) is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS), to reflect that
the Deputy Assistant Judge Advocate
General (DAJAG) (Admiralty and
Maritime Law) has determined that USS
MONTGOMERY (LCS 8) is a vessel of
the Navy which, due to its special
construction and purpose, cannot fully
comply with certain provisions of the 72
COLREGS without interfering with its
special function as a naval ship. The
intended effect of this rule is to warn
mariners in waters where 72 COLREGS
apply.
DATES: This rule is effective January 22,
2016 and is applicable beginning
December 15, 2015.
FOR FURTHER INFORMATION CONTACT:
Commander Theron R. Korsak, JAGC,
U.S. Navy, Admiralty Attorney,
(Admiralty and Maritime Law), Office of
the Judge Advocate General, Department
of the Navy, 1322 Patterson Ave. SE.,
Suite 3000, Washington Navy Yard, DC
20374–5066, telephone number: 202–
685–5040.
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
1605, the DoN amends 32 CFR part 706.
This amendment provides notice that
the DAJAG (Admiralty and Maritime
Law), under authority delegated by the
Secretary of the Navy, has certified that
USS MONTGOMERY (LCS 8) is a vessel
of the Navy which, due to its special
construction and purpose, cannot fully
comply with the following specific
provisions of 72 COLREGS without
SUMMARY:
§ 507.65 Contents of an order to withdraw
a qualified facility exemption.
Procedure for submitting an
(a) * * *
(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
Jkt 238001
BILLING CODE 4164–01–P
ACTION:
(a) * * *
(4) * * *
(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; and
*
*
*
*
*
■ 12. In § 507.65, revise paragraph (e) to
read as follows:
16:27 Jan 21, 2016
[FR Doc. 2016–01290 Filed 1–21–16; 8:45 am]
AGENCY:
§ 507.51 Modified requirements that apply
to a facility solely engaged in the storage
of unexposed packaged animal food.
VerDate Sep<11>2014
Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972
Reanalysis.
*
§ 507.69
appeal.
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; and
*
*
*
*
*
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
interfering with its special function as a
naval ship: Annex I paragraph 2(a)(i),
pertaining to the location of the forward
masthead light at a height not less than
12 meters above the hull; Annex I,
paragraph 2(f)(i), pertaining to the
placement of the masthead light or
lights above and clear of all other lights
and obstructions; Annex I, paragraph
3(a), pertaining to the location of the
forward masthead light in the forward
quarter of the ship, and the horizontal
distance between the forward and after
masthead light; Annex I, paragraph 3(c),
pertaining to the task light’s horizontal
distance from the fore and aft centerline
of the vessel in the athwartship
direction. The DAJAG (Admiralty and
Maritime Law) has also certified that the
lights involved are located in closest
possible compliance with the applicable
72 COLREGS requirements.
Moreover, it has been determined, in
accordance with 32 CFR parts 296 and
701, that publication of this amendment
for public comment prior to adoption is
impracticable, unnecessary, and
contrary to public interest since it is
based on technical findings that the
placement of lights on this vessel in a
manner differently from that prescribed
herein will adversely affect the vessel’s
ability to perform its military functions.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and
Vessels.
For the reasons set forth in the
preamble, the DoN amends part 706 of
title 32 of the Code of Federal
Regulations as follows:
PART 706—CERTIFICATIONS AND
EXEMPTIONS UNDER THE
INTERNATIONAL REGULATIONS FOR
PREVENTING COLLISIONS AT SEA,
1972
1. The authority citation for part 706
continues to read as follows:
■
Authority: 33 U.S.C. 1605.
2. Section 706.2 is amended by:
a. In Table One, adding, in alpha
numerical order, by vessel number, an
entry for USS MONTGOMERY (LCS 8);
■ b. In Table Four, under paragraph 15,
adding, in alpha numerical order, by
vessel number, an entry for USS
MONTGOMERY (LCS 8);
■ c. In Table Four, under paragraph 16,
adding, in alpha numerical order, by
vessel number, an entry for USS
MONTGOMERY (LCS 8); and
■ d. In Table Five, adding, in alpha
numerical order, by vessel number, an
entry for USS MONTGOMERY (LCS 8).
■
■
E:\FR\FM\22JAR1.SGM
22JAR1
]]>Agencies
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Rules and Regulations]
[Pages 3716-3718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 507
[Docket No. FDA-2011-N-0922]
RIN 0910-AG10
Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending a
final rule that published in the Federal Register of September 17,
2015. That final rule established requirements for domestic and foreign
facilities required to register under the Federal Food, Drug, and
Cosmetic Act for current good manufacturing practice, hazard analysis,
and risk-based preventive controls for food for animals. The final rule
published with some editorial and inadvertent errors. This document
corrects those errors.
DATES: Effective January 22, 2016.
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: In the Federal Register of Thursday,
September 17, 2015 (80 FR 56170), FDA published the final rule
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals'' with some editorial and
inadvertent errors. This action is being taken to correct those errors
by making the following correcting amendments.
List of Subjects in 21 CFR Part 507
Animal foods, Labeling, Packaging and containers, Reporting and
recordkeeping requirements.
Accordingly, FDA is amending 21 CFR part 507 with the following
technical amendments:
[[Page 3717]]
PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
0
1. The authority citation for 21 CFR part 507 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
2. In Sec. 507.3, revise the definitions of ``audit'', ``harvesting'',
``hazard requiring a preventive control'', and ``small business'' to
read as follows:
Sec. 507.3 Definitions.
* * * * *
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 an audited entity's food safety
processes and procedures.
* * * * *
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, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
* * * * *
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 the outcome of a hazard analysis (which includes an assessment
of the severity of the illness or injury to humans or animals 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.
* * * * *
Small business means, for purposes of this part, a business
(including any subsidiaries and affiliates) employing fewer than 500
full-time equivalent employees.
* * * * *
0
3. In Sec. 507.5, revise paragraph (e)(5) to read as follows:
Sec. 507.5 Exemptions.
* * * * *
(e) * * *
(5) Molasses (e.g., processed sugar cane, sugar beets, and citrus);
* * * * *
0
4. In Sec. 507.7, revise paragraphs (b)(2)(i)(B) and (b)(2)(ii) to
read as follows:
Sec. 507.7 Requirements that apply to a qualified facility.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(B) Write to the U.S. Food and Drug Administration (HFS-681), 5100
Paint Branch Pkwy., College Park, MD 20740; or
* * * * *
(ii) Send a paper Form FDA 3942b to the U.S. Food and Drug
Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD
20740. We recommend that you submit a paper copy only if your facility
does not have reasonable access to the Internet.
* * * * *
0
5. In Sec. 507.19, revise paragraph (b)(2) to read as follows:
Sec. 507.19 Sanitation.
* * * * *
(b) * * *
(2) In wet processing of animal food, when cleaning and sanitizing
are 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.
* * * * *
0
6. In Sec. 507.27, revise paragraph (b) to read as follows:
Sec. 507.27 Holding and distribution.
* * * * *
(b) The labeling for the animal food ready for distribution must
contain, when applicable, information and instructions for safely using
the animal food for the intended animal species.
* * * * *
0
7. In Sec. 507.33, revise paragraph (c)(1) to read as follows:
507.33 Hazard analysis.
* * * * *
(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 to humans or animals if the hazard
were to occur and the probability that the hazard will occur in the
absence of preventive controls.
* * * * *
0
8. In Sec. 507.36, revise paragraphs (a)(2) introductory text and (3)
introductory text and paragraphs (a)(5) and (b)(5) to read as follows:
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) * * *
(2) You rely on your customer who is subject to the requirements
for hazard analysis and risk-based preventive controls in this subpart
to ensure that the identified hazard will be significantly minimized or
prevented; and you:
* * * * *
(3) You rely on your customer who is not subject to the
requirements for hazard analysis and risk-based preventive controls in
this subpart to provide assurance it is manufacturing, processing, or
preparing the animal food in accordance with applicable animal food
safety requirements and you:
* * * * *
(5) You have established, documented, and implemented a system that
ensures control, at a subsequent distribution step, of the hazards in
the animal food you distribute and you document the implementation of
that system.
* * * * *
(b) * * *
(5) Your system, in accordance with paragraph (a)(5) of this
section, that ensures control, at a subsequent
[[Page 3718]]
distribution step, of the hazards in the animal food you distribute.
* * * * *
0
9. In Sec. 507.47, revise paragraphs (b)(1)(i)(A) and (b)(1)(i)(B)(1)
to read as follows:
Sec. 507.47 Validation.
* * * * *
(b) * * *
(1) * * *
(i)(A) Prior to implementation of the food safety plan; or
(B) * * *
(1) Within 90 calendar days after production of the applicable
animal food first begins; or
* * * * *
0
10. In Sec. 507.50, revise paragraph (c)(1) to read as follows:
Sec. 507.50 Reanalysis.
* * * * *
(c) * * *
(1) Before any change in activities (including any change in
preventive control) at the facility is operative; or
* * * * *
0
11. In Sec. 507.51, revise paragraph (a)(4)(iii) to read as follows:
Sec. 507.51 Modified requirements that apply to a facility solely
engaged in the storage of unexposed packaged animal food.
(a) * * *
(4) * * *
(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; and
* * * * *
0
12. In Sec. 507.65, revise paragraph (e) to read as follows:
Sec. 507.65 Contents of an order to withdraw a qualified facility
exemption.
* * * * *
(e) A statement that a facility may request that FDA reinstate an
exemption that was withdrawn by following the procedures in Sec.
507.85;
* * * * *
0
13. In Sec. 507.69, revise paragraph (a)(1) to read as follows:
Sec. 507.69 Procedure for submitting an appeal.
(a) * * *
(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; and
* * * * *
Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01290 Filed 1-21-16; 8:45 am]
BILLING CODE 4164-01-P
