81 FR 3716 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 14 (January 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 14 (January 22, 2016)
| Page Range | 3716-3718 | |
| FR Document | 2016-01290 |
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)] [Rules and Regulations] [Pages 3716-3718] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
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and also includes re-packing and (5) Your system, in accordance with Dated: January 14, 2016.
activities performed incidental to paragraph (a)(5) of this section, that Leslie Kux,
packing or re-packing a food (e.g., ensures control, at a subsequent Associate Commissioner for Policy.
activities performed for the safe or distribution step, of the hazards in the [FR Doc. 2016–01091 Filed 1–21–16; 8:45 am]
effective packing or re-packing of that food you distribute. BILLING CODE 4164–01–P
food (such as sorting, culling, grading, ■ 9. In § 117.145, revise paragraph (a) to
and weighing or conveying incidental to read as follows:
packing or re-packing)), but does not DEPARTMENT OF HEALTH AND
include activities that transform a raw § 117.145 Monitoring. HUMAN SERVICES
agricultural commodity into a processed * * * * *
food as defined in section 201(gg) of the (a) Written procedures. You must Food and Drug Administration
Federal Food, Drug, and Cosmetic Act. establish and implement written
* * * * * procedures, including the frequency 21 CFR Part 507
Qualified end-user * * * with which they are to be performed, for
(1) Is located: monitoring the preventive control; and [Docket No. FDA–2011–N–0922]
* * * * * * * * * *
Small business means, for purposes of ■ 10. In § 117.201, revise paragraphs RIN 0910–AG10
this part, a business (including any (b)(2)(i)(B) and (b)(2)(ii) to read as
subsidiaries and affiliates) employing Current Good Manufacturing Practice,
follows:
fewer than 500 full-time equivalent Hazard Analysis, and Risk-Based
employees. § 117.201 Modified requirements that Preventive Controls for Food for
* * * * * apply to a qualified facility. Animals; Technical Amendment
■ 7. In § 117.5, revise the first sentence * * * * * AGENCY: Food and Drug Administration,
of paragraph (a), and revise paragraph (b) * * * HHS.
(h)(3)(v) to read as follows: (2) * * *
Final rule, technical
ACTION:
(i) * * * amendment.
§ 117.5 Exemptions. (B) Write to the U.S. Food and Drug
(a) Except as provided by subpart E of Administration (HFS–681), 5100 Paint SUMMARY: The Food and Drug
this part, subparts C and G of this part Branch Pkwy., College Park, MD 20740; Administration (FDA or we) is
do not apply to a qualified facility. or amending a final rule that published in
* * * * * * * * the Federal Register of September 17,
* * * * * (ii) Send a paper Form FDA 3942a to 2015. That final rule established
(h) * * * the U.S. Food and Drug Administration requirements for domestic and foreign
(3) * * * (HFS–681), 5100 Paint Branch Pkwy., facilities required to register under the
(v) Extracting (including by pressing, College Park, MD 20740. We Federal Food, Drug, and Cosmetic Act
by distilling, and by solvent extraction) recommend that you submit a paper for current good manufacturing practice,
dried/dehydrated herb and spice copy only if your facility does not have hazard analysis, and risk-based
products (e.g., dried mint), fresh herbs reasonable access to the Internet. preventive controls for food for animals.
(e.g., fresh mint), fruits and vegetables The final rule published with some
* * * * *
(e.g., olives, avocados), grains (e.g., editorial and inadvertent errors. This
oilseeds), and other herb and spice ■ 11. In § 117.257, revise paragraph (e)
document corrects those errors.
products (e.g., chopped fresh mint, to read as follows:
DATES: Effective January 22, 2016.
chopped dried mint); § 117.257 Contents of an order to withdraw FOR FURTHER INFORMATION CONTACT:
* * * * * a qualified facility exemption. Jeanette Murphy, Center for Veterinary
■ 8. In § 117.136, revise paragraphs * * * * * Medicine (HFV–200), Food and Drug
(a)(2) introductory text, (a)(5), and (b)(5) (e) A statement that a facility may Administration, 7519 Standish Pl.,
to read as follows: request that FDA reinstate an exemption Rockville, MD 20855, 240–402–6246,
that was withdrawn by following the email: jenny.murphy@fda.hhs.gov.
§ 117.136 Circumstances in which the
owner, operator, or agent in charge of a procedures in § 117.287; SUPPLEMENTARY INFORMATION: In the
manufacturing/processing facility is not * * * * * Federal Register of Thursday,
required to implement a preventive control. ■ 12. In § 117.264, revise paragraph September 17, 2015 (80 FR 56170), FDA
(a) * * * (a)(1) to read as follows: published the final rule ‘‘Current Good
(2) You rely on your customer who is Manufacturing Practice, Hazard
subject to the requirements for hazard § 117.264 Procedure for submitting an Analysis, and Risk-Based Preventive
analysis and risk-based preventive appeal. Controls for Food for Animals’’ with
controls in this subpart to ensure that (a) * * * some editorial and inadvertent errors.
the identified hazard will be (1) Submit the appeal in writing to the This action is being taken to correct
significantly minimized or prevented FDA District Director in whose district those errors by making the following
and you: the facility is located (or, in the case of correcting amendments.
* * * * * a foreign facility, the Director of the
List of Subjects in 21 CFR Part 507
mstockstill on DSK4VPTVN1PROD with RULES
(5) You have established, Office of Compliance in the Center for
documented, and implemented a system Food Safety and Applied Nutrition), at Animal foods, Labeling, Packaging
that ensures control, at a subsequent the mailing address, email address, or and containers, Reporting and
distribution step, of the hazards in the facsimile number identified in the order recordkeeping requirements.
food you distribute and you document within 15 calendar days of the date of Accordingly, FDA is amending 21
the implementation of that system. receipt of confirmation of the order; and CFR part 507 with the following
(b) * * * * * * * * technical amendments:
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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 Division of Compliance in the Center for interfering with its special function as a
animal food you distribute. Veterinary Medicine), at the mailing naval ship: Annex I paragraph 2(a)(i),
* * * * * address, email address, or facsimile pertaining to the location of the forward
■ 9. In § 507.47, revise paragraphs
number identified in the order within masthead light at a height not less than
(b)(1)(i)(A) and (b)(1)(i)(B)(1) to read as 15 calendar days of the date of receipt 12 meters above the hull; Annex I,
follows: of confirmation of the order; and paragraph 2(f)(i), pertaining to the
* * * * * placement of the masthead light or
§ 507.47 Validation. lights above and clear of all other lights
Dated: January 15, 2016.
* * * * * and obstructions; Annex I, paragraph
Leslie Kux, 3(a), pertaining to the location of the
(b) * * *
Associate Commissioner for Policy. forward masthead light in the forward
(1) * * *
(i)(A) Prior to implementation of the [FR Doc. 2016–01290 Filed 1–21–16; 8:45 am] quarter of the ship, and the horizontal
food safety plan; or BILLING CODE 4164–01–P distance between the forward and after
(B) * * * masthead light; Annex I, paragraph 3(c),
(1) Within 90 calendar days after pertaining to the task light’s horizontal
production of the applicable animal DEPARTMENT OF DEFENSE distance from the fore and aft centerline
food first begins; or of the vessel in the athwartship
Department of the Navy direction. The DAJAG (Admiralty and
* * * * *
■ 10. In § 507.50, revise paragraph (c)(1)
Maritime Law) has also certified that the
32 CFR Part 706 lights involved are located in closest
to read as follows:
possible compliance with the applicable
§ 507.50 Reanalysis.
Certifications and Exemptions Under 72 COLREGS requirements.
the International Regulations for
* * * * * Preventing Collisions at Sea, 1972 Moreover, it has been determined, in
(c) * * * accordance with 32 CFR parts 296 and
(1) Before any change in activities AGENCY: Department of the Navy, DoD. 701, that publication of this amendment
(including any change in preventive ACTION: Final rule. for public comment prior to adoption is
control) at the facility is operative; or impracticable, unnecessary, and
SUMMARY: The Department of the Navy contrary to public interest since it is
* * * * *
(DoN) is amending its certifications and based on technical findings that the
■ 11. In § 507.51, revise paragraph exemptions under the International
(a)(4)(iii) to read as follows: placement of lights on this vessel in a
Regulations for Preventing Collisions at manner differently from that prescribed
§ 507.51 Modified requirements that apply Sea, 1972 (72 COLREGS), to reflect that herein will adversely affect the vessel’s
to a facility solely engaged in the storage the Deputy Assistant Judge Advocate ability to perform its military functions.
of unexposed packaged animal food. General (DAJAG) (Admiralty and
Maritime Law) has determined that USS List of Subjects in 32 CFR Part 706
(a) * * *
(4) * * * MONTGOMERY (LCS 8) is a vessel of Marine safety, Navigation (water), and
(iii) Reviewing records of monitoring the Navy which, due to its special Vessels.
and corrective actions taken to correct a construction and purpose, cannot fully
comply with certain provisions of the 72 For the reasons set forth in the
problem with the control of temperature
COLREGS without interfering with its preamble, the DoN amends part 706 of
within 7-working days after the records
special function as a naval ship. The title 32 of the Code of Federal
are created or within a reasonable
intended effect of this rule is to warn Regulations as follows:
timeframe, provided that the preventive
controls qualified individual prepares mariners in waters where 72 COLREGS
apply. PART 706—CERTIFICATIONS AND
(or oversees the preparation of) a written EXEMPTIONS UNDER THE
justification for a timeframe that DATES: This rule is effective January 22,
INTERNATIONAL REGULATIONS FOR
exceeds 7-working days; and 2016 and is applicable beginning PREVENTING COLLISIONS AT SEA,
* * * * * December 15, 2015. 1972
■ 12. In § 507.65, revise paragraph (e) to FOR FURTHER INFORMATION CONTACT:
read as follows: Commander Theron R. Korsak, JAGC, ■ 1. The authority citation for part 706
U.S. Navy, Admiralty Attorney, continues to read as follows:
§ 507.65 Contents of an order to withdraw (Admiralty and Maritime Law), Office of
a qualified facility exemption. Authority: 33 U.S.C. 1605.
the Judge Advocate General, Department
* * * * * of the Navy, 1322 Patterson Ave. SE., ■ 2. Section 706.2 is amended by:
(e) A statement that a facility may Suite 3000, Washington Navy Yard, DC
■ a. In Table One, adding, in alpha
request that FDA reinstate an exemption 20374–5066, telephone number: 202–
numerical order, by vessel number, an
that was withdrawn by following the 685–5040.
entry for USS MONTGOMERY (LCS 8);
procedures in § 507.85; SUPPLEMENTARY INFORMATION: Pursuant
■ b. In Table Four, under paragraph 15,
* * * * * to the authority granted in 33 U.S.C.
1605, the DoN amends 32 CFR part 706. adding, in alpha numerical order, by
■ 13. In § 507.69, revise paragraph (a)(1) vessel number, an entry for USS
to read as follows: This amendment provides notice that
the DAJAG (Admiralty and Maritime MONTGOMERY (LCS 8);
mstockstill on DSK4VPTVN1PROD with RULES
§ 507.69 Procedure for submitting an Law), under authority delegated by the ■ c. In Table Four, under paragraph 16,
appeal. Secretary of the Navy, has certified that adding, in alpha numerical order, by
(a) * * * USS MONTGOMERY (LCS 8) is a vessel vessel number, an entry for USS
(1) Submit the appeal in writing to the of the Navy which, due to its special MONTGOMERY (LCS 8); and
FDA District Director in whose district construction and purpose, cannot fully ■ d. In Table Five, adding, in alpha
the facility is located (or, in the case of comply with the following specific numerical order, by vessel number, an
a foreign facility, the Director of the provisions of 72 COLREGS without entry for USS MONTGOMERY (LCS 8).
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Document Created: 2016-01-22 01:16:52
Document Modified: 2016-01-22 01:16:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule, technical amendment. | |
| Dates | Effective January 22, 2016. | |
| Contact | Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, email: [email protected] | |
| FR Citation | 81 FR 3716 | |
| RIN Number | 0910-AG10 | |
| CFR Associated | Animal Foods; Labeling; Packaging and Containers and Reporting and Recordkeeping Requirements |
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