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)

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.

[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]


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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.

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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