Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment, 3716-3718 [2016-01290]

Download as PDF 3716 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) * * * VerDate Sep<11>2014 16:27 Jan 21, 2016 Jkt 238001 (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 * * * * * PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 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: E:\FR\FM\22JAR1.SGM 22JAR1 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 Frm 00019 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 E:\FR\FM\22JAR1.SGM 22JAR1 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