[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Rules and Regulations]
[Pages 3716-3718]
[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,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
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:

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

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