[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58475-58521]
[FR Doc No: 2014-22445]

Vol. 79

Monday,

No. 188

September 29, 2014

Part III

 Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Parts 16, 117, and 507

 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals; Proposed Rule

Federal Register / Vol. 79 , No. 188 / Monday, September 29, 2014 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 117, and 507

[Docket No. FDA-2011-N-0922]
RIN 0910-AG10

Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; supplemental notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend our 2013 proposed rule for Current Good Manufacturing Practice
(CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food
for Animals. In that 2013 proposed rule, we proposed to add CGMP
requirements for animal food and to add requirements for certain
domestic and foreign facilities to establish and implement hazard
analysis and risk-based preventive controls for food for animals. We
are taking this action because the input we have received from public
comments has led to significant changes in our current thinking on
certain key provisions of this proposed rule. We are reopening the
comment period only with respect to specific issues identified in this
proposed rule.

DATES: Submit either electronic or written comments on the proposed
rule by December 15, 2014. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by December 15, 2014
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB) (see the ``Paperwork Reduction Act of 1995'' section of this
document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No
2011-N-0922 for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
    Purpose and Coverage of the Supplemental Notice of Proposed
Rulemaking
    Summary of the Major Provisions of the Supplemental Notice of
Proposed Rulemaking
    Costs and Benefits
I. Background
    A. Introduction
    B. 2013 Proposed Rule for Preventive Controls for Food for
Animals
II. Public Comments
    A. Opportunities for Public Comment
    B. Overview of Public Comments on the 2013 Proposed Rule for
Preventive Controls
    C. Our Decision To Issue a Supplemental Notice of Proposed
Rulemaking for Public Comment
III. Scope of the Supplemental Notice of Proposed Rulemaking and Our
Request for Public Comment
IV. Legal and Regulatory Framework Under Sections 415 and 418 of the
FD&C Act and Regulations Implementing Section 415 of the FD&C Act
V. The ``Farm'' Definition
    A. 2013 Proposed Definitions of ``Farm,'' ``Harvesting,''
``Holding,'' and ``Packing''
    B. Proposed Revisions to the Proposed Definitions of ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing''
    C. One General Physical Location
    D. Feed Mills Associated With Contract and Fully Vertically
Integrated Farming
VI. Definitions of ``Holding'' and ``Packing''
    A. 2013 Proposed Definition of ``Holding''
    B. 2013 Proposed Exemptions Relevant to the Definition of
``Holding''
    C. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of RACs (Other Than Fruits and Vegetables)
Intended for Further Distribution or Processing
    D. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of Packaged Food That Is Not Exposed to the
Environment
    E. Proposed Revisions to the Definition of ``Holding''
    F. Proposed Revisions to the Definition of ``Packing''
VII. Impact of the Proposed Revisions to the Farm-Related
Definitions on the Classification of On-Farm Activities
    A. Comments on the 2013 Organizing Principles for Classifying
Activities Conducted on Farms and on Farm Mixed-Type Facilities
    B. Updated Organizing Principles That Would Apply to the
``Farm'' Definition
    C. Changes to Classification of On-Farm Activities
VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Animal Food
Combinations
    A. The 2013 Proposed Exemptions
    B. Comments on the 2013 Proposed Exemptions for On-Farm Low-Risk
Activity/Animal Food Combinations
    C. Impact of the Proposed Revisions to the Definitions for
``Farm,'' ``Harvesting,'' Holding,'' and ``Packing'' on the 2013
Proposed Exemptions for On-Farm Low-Risk Activity/Animal Food
Combinations
IX. Proposed Applicability of Part 507 to the Holding and
Distribution of Human Food By-Products for Use in Animal Food
X. Proposed Revisions to Subpart B--Current Good Manufacturing
Practice
XI. Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls
    A. 2013 Proposed Overall Framework for Hazard Analysis and Risk-
Based Preventive Controls
    B. Comments on the ``Reasonably Likely To Occur'' Construct
Within the 2013 Overall Framework for Hazard Analysis and Risk-Based
Preventive Controls
    C. Proposed Revisions to the Overall Framework for Hazard
Analysis and Risk-Based Preventive Controls
XII. Potential Requirements for Product Testing and Environmental
Monitoring
    A. Our Request for Comment on Including Requirements for Product
Testing and Environmental Monitoring in a Final Rule
    B. Product Testing
    C. Environmental Monitoring
XIII. Potential Requirements for a Supplier Program
    A. Our Request for Comment on When and How Supplier Verification
Activities Are an Appropriate Means of Implementing the Statutory
Framework of Section 418 of the FD&C Act
    B. Comments on When and How Supplier Verification Activities Are
an Appropriate Means of Implementing the

Statutory Framework of Section 418 of the FD&C Act
    C. Potential Requirements for a Supplier Program
    D. Request for Additional Comment on Requirements To Address
Conflicts of Interest for Persons Conducting Verification Activities
XIV. Potential Requirements for the Hazard Analysis To Address
Economically Motivated Adulteration
    A. Our Request for Comment on Whether the Final Rule Should
Address Economically Motivated Adulteration
    B. Comments on Economically Motivated Adulteration
    C. Potential Requirements To Address Economically Motivated
Adulteration
XV. Provisions for Withdrawal of an Exemption for a Qualified
Facility
    A. 2013 Proposed Provisions for Withdrawal of an Exemption for a
Qualified Facility
    B. Proposed Clarification of What FDA Will Do Before Issuing an
Order and Proposed Mechanism for Re-Instating an Exemption
    C. Proposed Revisions to the Content of an Order To Withdraw an
Exemption
    D. Proposed Revisions to the Timeframes for a Facility To Comply
With, or Appeal, an Order
XVI. Definition of Very Small Business
    A. The 2013 Proposed Options for Definition of Very Small
Business
    B. Comments on the 2013 Proposed Options for Definition of Very
Small Business
    C. Proposed Revisions to the Definition of Very Small Business
XVII. Other New and Revised Proposed Provisions
    A. Proposed New Definitions
    B. Proposed Revisions to Definitions
    C. Proposed Editorial Changes
    D. Proposed Conforming Change to Proposed Part 117
XVIII. Preliminary Regulatory Impact Analysis
    A. Overview
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. Unfunded Mandates Reform Act of 1995
XIX. Paperwork Reduction Act of 1995
XX. Analysis of Environmental Impact
XXI. Comments
XXII. References

Executive Summary

Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking

    We previously proposed to add requirements for certain domestic and
foreign facilities to establish and implement hazard analysis and risk-
based preventive controls for food for animals, as required by the FDA
Food Safety Modernization Act (FSMA). The proposed requirements would
apply to establishments that are required to register with us as an
animal food ``facility.'' In this document we are proposing to revise
several previously proposed requirements, taking into account the
comments we have reviewed so far for the proposed rule for preventive
controls for food for animals and the proposed rule for preventive
controls for human food, because the extensive input we have received
from public comments has led to significant changes in our current
thinking on certain key provisions.
    In the 2013 proposed rule, we asked for comment on when and how
three provisions (i.e., product testing programs, environmental
monitoring programs, and supplier programs) are an appropriate means of
implementing the statutory directives of FSMA. We also requested
comment on whether a facility should be required to address potential
hazards that may be intentionally introduced for economic reasons. Some
comments received to the 2013 proposed rule assert that additional
public comment is warranted before consideration is given to whether a
final rule includes or does not include provisions that were discussed
in the 2013 proposal but for which we had not included regulatory text
in the 2013 proposal. In this document we are providing an opportunity
for such public comment on potential requirements for product testing
programs, environmental monitoring programs, and supplier programs, and
hazards that may be intentionally introduced for purposes of economic
gain, which take into account the comments we have reviewed so far. We
are seeking comment on whether such requirements should be included in
a final rule and, if so, what (if any) modifications to the proposed
regulatory text would be appropriate.
    In the 2013 proposed rule, we requested comment on three options
for classifying a facility as a ``very small business,'' with
consequences for facilities in terms of eligibility for exemptions and
the timeframe to comply with this rule. In this document we are
proposing a definition for ``very small business'' (i.e., a business
that has less than $2,500,000 in total annual sales of animal food
adjusted for inflation).
    We are proposing a revised version of the 2013 proposed current
good manufacturing practice regulations. In addition, we added a
section to the proposed current good manufacturing practice regulations
for holding and distribution of human food by-products for food for
animals. This would apply to human food facilities that hold and
distribute by-products from the human food production that are used for
food for animals.

Summary of the Major Provisions of the Supplemental Notice of Proposed
Rulemaking

    The previously proposed (2013) current good manufacturing practice
requirements (CGMPs) were based, in general, on FDA's existing human
food CGMP regulations. The revised proposed CGMPs for food for animals
would establish baseline standards for producing safe animal food that
are more applicable to the animal food industry and that provide
flexibility for the wide diversity in types of animal food facilities.
Human food processors already complying with FDA human food safety
requirements would not need to implement additional preventive controls
or Current Good Manufacturing Practice regulations when supplying a by-
product, except those proposed for the holding and distribution of
certain human food by-products for food for animals (e.g., ensuring by-
product is not co-mingled with garbage). Under the revised proposal,
all other requirements of part 507, including the hazard analysis and
preventive controls requirements, would not apply to these by-products
of human food production.
    The previously proposed requirements for hazard analysis and risk-
based preventive controls applied a construct previously used in our
Hazard Analysis and Critical Control Point (HACCP) regulations for
seafood and juice--i.e., whether a known or reasonably foreseeable
hazard was ``reasonably likely to occur.'' In general, our HACCP
regulations for seafood and juice focus on critical control points to
control hazards that are ``reasonably likely to occur.'' We are
proposing to eliminate the term ``hazard reasonably likely to occur''
throughout the proposed requirements to reduce the potential for a
misinterpretation that all necessary preventive controls must be
established at critical control points (CCPs). The revised regulations
would use a new term (``significant hazard'') in its place.
    The defined term ``significant hazard'' would be linked to the
facility's hazard analysis, which addresses risk (i.e., both the
severity of a potential hazard and the probability that the hazard will
occur). Thus, this term would reflect the risk-based nature of the
requirements. In addition, the revised regulations would provide
additional flexibility relative to the previous proposal by providing
that a facility can take into account the nature of a preventive
control in determining when and how to establish and implement
appropriate preventive control management components,

including monitoring, corrections or corrective actions, verification,
and records. Table 6 in the document provides examples of flexibility
provided by the rule, including flexibility provided for a facility to
take into account the nature of the preventive control when determining
the appropriate preventive control management components.
    The potential product testing provisions would, if included in a
final rule, require that a facility conduct product testing as an
activity for verification of implementation and effectiveness as
appropriate to the facility, the animal food, and the nature of the
preventive control. The facility would be required to have written
procedures for product testing, corrective action procedures to address
the presence of a pathogen or appropriate indicator organism in
finished animal food detected as a result of product testing, and
records of product testing.
    The potential environmental monitoring provisions would, if
included in a final rule, require that a facility conduct environmental
monitoring as an activity for verification of implementation and
effectiveness as appropriate to the facility, the animal food, and the
nature of the preventive control if contamination of finished animal
food with an environmental pathogen is a significant hazard. The
facility would be required to have written procedures for environmental
monitoring, corrective action procedures to address the presence of an
environmental pathogen or appropriate indicator organism detected
through the environmental monitoring, and records of environmental
monitoring.
    The potential supplier program would, if included in a final rule,
require supplier controls when the facility's hazard analysis
identifies a significant hazard for a raw material or ingredient, and
that hazard is controlled before the facility receives the raw material
or ingredient (e.g., if a supplier tests a mineral mix for dioxin that
a facility would use to manufacture finished cattle feed). A facility
would not need to establish supplier controls if it controls that
hazard, or if its customer controls that hazard. The supplier program
would be written. With one exception, the receiving facility would have
flexibility to determine the appropriate verification activity (e.g.,
onsite audit; sampling and testing of the raw material or ingredient;
review of the supplier's food safety records; or other appropriate
verification activity). The exception would be when there is a
reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death to humans or animals. In
this circumstance, the receiving facility would be required to have
documentation of an onsite audit of the supplier before using the raw
material or ingredient from the supplier and at least annually
thereafter, unless the receiving facility determines and documents that
other verification activities and/or less frequent onsite auditing of
the supplier provide adequate assurance that the hazards are
controlled. Instead of an onsite audit, a receiving facility may rely
on the results of an inspection of the supplier by FDA or, for a
foreign supplier, by FDA or the food safety authority of a country
whose food safety system FDA has officially recognized as comparable or
has determined to be equivalent to that of the United States, provided
that the inspection was conducted within 1 year of the date that the
onsite audit would have been required to be conducted.
    The proposed requirements regarding potential hazards that may be
intentionally introduced for economic reasons would, if included in a
final rule, require that a facility consider in its hazard analysis
hazards that may be intentionally introduced for purposes of economic
gain.
    We seek comment on whether these potential requirements discussed
above should be included in a final rule.
    The previously proposed requirements provided for an exemption for
certain facilities defined by FSMA as ``qualified facilities.'' As
required by FSMA, the previously proposed requirements also included an
administrative procedure whereby we could withdraw that exemption under
certain circumstances. In this document, we are proposing a series of
modifications to the proposed withdrawal provisions. These
modifications include describing the steps we would take before
withdrawing an exemption, including advance notification to the
facility; a procedure for re-instatement of a withdrawn exemption; and
an additional 60 days for a facility whose exemption is withdrawn to
comply with the full requirements for hazard analysis and risk-based
preventive controls.

Costs and Benefits

    We summarize the domestic annualized costs of the proposed
regulation with the revised provisions, including the potential
requirements for product testing, environmental monitoring, a supplier
program, and potential requirements regarding hazards that may be
intentionally introduced for economic reasons, using a discount rate of
7 percent and discounted over a 10 year period in the following table.
The revised proposed regulation uses a very small business definition
of less than $2,500,000 of total annual sales of animal food, adjusted
for inflation, and includes potential additional requirements that
facilities subject to subpart C institute risk-based environmental
monitoring, product testing, and a supplier program as appropriate to
the animal food, the facility and the nature of the preventive
controls, and controls to help prevent hazards associated with
economically motivated adulteration. As described in the updated
Preliminary Regulatory Impact Analysis (PRIA), for the final rule we
anticipate making several modifications to our estimate of the cost of
our proposed rule (Ref. 1) (see section XVIII). As with the original
proposal, we lack sufficient data to quantify the potential benefits of
this supplemental notice of proposed rulemaking.
    A summary of the domestic costs and potential benefits of the
original and supplemental proposed rules is shown in the following
table.

 Original and Revised Estimated Total Domestic Costs Based on Additional
                               Provisions
[Very Small Business Defined as Annual Animal Food Sales < $2.5 million]
------------------------------------------------------------------------
                                                                Total
                                                              (million)
------------------------------------------------------------------------
Original Total Annualized Costs without additional                   $65
 provisions................................................
Additional costs because of potential new provisions.......            4
Revised Total Annualized Costs.............................           69
Benefits...................................................        (\1\)
------------------------------------------------------------------------
\1\ Unquantified.

    If foreign facilities are included, the total annualized cost of
this supplemental notice of proposed rulemaking is estimated at $93
million.

I. Background

A. Introduction

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
signed into law by President Obama on January 4, 2011, enables us to
better protect public (human and animal) health by helping to ensure
the safety and security of the food supply. FSMA enables us to focus
more on preventing food safety problems rather than relying primarily
on reacting to problems after they occur. The law also provides us with
new enforcement authorities to help achieve higher rates of compliance
with risk-

based, prevention-oriented safety standards and to better respond to
and contain problems when they do occur. In addition, the law gives us
important new tools to better ensure the safety of imported foods and
encourages us to form partnerships with State, local, tribal, and
territorial authorities. Table 1 identifies three additional proposed
rules, issued to implement FSMA, that we discuss in this document.

                          Table 1--Published Proposed Rules for Implementation of FSMA
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                Title                        Abbreviation                          Publication
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Current Good Manufacturing Practice    2013 proposed rule for   78 FR 64736, October 29, 2013.
 and Hazard Analysis and Risk-Based     preventive controls
 Preventive Controls for Food for       for food for animals.
 Animals.
Current Good Manufacturing Practice    2013 proposed rule for   78 FR 3646, January 16, 2013.
 and Hazard Analysis and Risk-Based     preventive controls
 Preventive Controls for Human Food.    for human food.
Standards for the Growing,             2013 proposed rule for   78 FR 3504, January 16, 2013.
 Harvesting, Packing, and Holding of    produce safety.
 Produce for Human Consumption.
Foreign Supplier Verification          2013 proposed rule for   78 FR 45730, July 29, 2013.
 Programs (FSVP) for Importers of       FSVP.
 Food for Humans and Animals.
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B. 2013 Proposed Rule for Preventive Controls for Food for Animals

    In the 2013 proposed rule for preventive controls, we:
     Proposed to add, in newly established part 507,
regulations for Current Good Manufacturing Practice In Manufacturing,
Processing, Packing, and Holding for Food for Animals (CGMPs);
     Proposed to add, in newly established part 507,
requirements for domestic and foreign facilities that are required to
register under section 415 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 350d) to establish and implement hazard
analysis and risk-based preventive controls for food for animals;
     Requested comment on when and how product testing
programs, environmental monitoring programs, and supplier approval and
verification are an appropriate means of implementing the statutory
framework of FSMA; and
     Requested comment on whether a final rule should address
potential hazards that may be intentionally introduced for economic
reasons.
    We proposed to establish the requirements for CGMPs, for hazard
analysis and risk-based preventive controls, and related requirements
in new part 507 as shown in Table 2:

               Table 2--Proposed Subparts in New Part 507
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             Subpart                               Title
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A................................  General Provisions.
B................................  Current Good Manufacturing Practice.
C................................  Hazard Analysis and Risk-Based
                                    Preventive Controls.
D................................  Withdrawal of an Exemption Applicable
                                    to a Qualified Facility.
E................................  Reserved.
F................................  Requirements Applying to Records That
                                    Must be Established and Maintained.
------------------------------------------------------------------------

    In the 2013 proposed rule for preventive controls, we provided
background discussing:
     The provisions of FSMA most directly applicable to the
proposed requirements, particularly the statutory provisions of section
103 of FSMA (established in section 418 of the FD&C Act);
     Hazard Analysis and Critical Control Points (HACCP)
Systems;
     Food Safety Problems Associated With Manufacturing,
Processing, Packing, and Holding Food for Animal Consumption;
     The Role of Testing as a Verification Measure in a Food
Safety System (including discussions about environmental monitoring as
well as testing raw materials, ingredients, and finished product),
largely in an Appendix to the 2013 proposed rule for preventive
controls (the Appendix)); and
     The Role of Supplier Approval and Verification Programs in
a Food Safety System (largely in the Appendix).
    We also issued for public comment a ``Draft Qualitative Risk
Assessment of Risk of Activity/Animal Food Combinations for Activities
(Outside the Farm Definition) Conducted in a Facility Co-Located on a
Farm'' (the draft risk assessment) (78 FR 64428, October 29, 2013). The
purpose of the draft risk assessment was to provide a science-based
risk analysis of those activity/animal food combinations that would be
considered low risk, when conducted in a facility co-located on a farm.
We used the tentative conclusions of the draft risk assessment to
propose to exempt animal food facilities that are small or very small
businesses that are engaged only in specific types of on-farm
manufacturing, processing, packing, or holding activities from the
requirements for hazard analysis and risk-based preventive controls.

II. Public Comments

A. Opportunities for Public Comment

    We requested comments on the 2013 proposed rule for preventive
controls by February 26, 2014. We extended the comment periods for the
2013 proposed rule for preventive controls, its information collection
provisions, and the draft risk assessment in response to several
requests that we do so (see Table 3).
    Since issuing the 2013 proposed rule for preventive controls, we
conducted numerous outreach activities. Three public meetings were held
to solicit oral stakeholder and public comments on the 2013 proposed
rule for preventive controls, inform the public about the rulemaking
process (including how to submit comments, data, and other information
to the rulemaking dockets), and respond to questions about the 2013
proposed rule for preventive controls (see Table 3) (Ref. 2, Ref. 3,
Ref. 4).

    Table 3--List of Federal Register Publications Regarding the 2013
                  Proposed Rule for Preventive Controls
------------------------------------------------------------------------
         Description                          Publication
------------------------------------------------------------------------
2013 proposed rule for         78 FR 64736, October 29, 2013.
 preventive controls,
 requesting comments by
 February 26, 2014.
Notice of availability of the  78 FR 64428 , October 29, 2013.
 draft risk assessment,
 requesting comments by
 February 26, 2014.
Notice of public meetings (to  78 FR 64425, October 29, 2013.
 be held in College Park, MD
 on November 21, 2013; in
 Chicago, IL on November 25,
 2013; and, in Sacramento, CA
 on December 6, 2013) on the
 2013 proposed rule for
 preventive controls.
Notice extending comment       79 FR 6111, February 3, 2014.
 period, until March 31, 2014
 , for the 2013 proposed rule
 for preventive controls and
 its information collections
 provisions.
Notice extending comment       79 FR 6116 , February 3, 2014.
 period, until March 31, 2014
 , for the draft risk
 assessment.
------------------------------------------------------------------------

B. Overview of Public Comments on the 2013 Proposed Rule for Preventive
Controls

    We received more than 2100 submissions by the close of the comment
period, each containing one or more comments. Submissions were received
from diverse members of the public, including in part, human and animal
food facilities; trade organizations; consulting firms; law firms; pet
owners; consumers; consumer groups; Congress, Federal, State, local and
tribal Government Agencies. Some submissions included signatures and
statements from multiple individuals.
    Comments address many provisions of the 2013 proposed rule for
preventive controls, including our requests for comment on including
additional provisions that we did not include in the proposed
regulatory text. Comments from some pet owners for the most part
indicated they were pleased that new requirements were being
established for the manufacture of pet food and that these requirements
were comparable to the requirements for human food, which were covered
by the 2013 proposed rule for preventive controls for human food. Some
comments questioned whether the proposed requirements reflected the
reality of production of food for animals with a particular concern
that the proposed risk-based approach focuses too heavily on pathogens
and not enough on other potential hazards in food for animals. Some
comments assert that additional public comment would be warranted
before any consideration on whether a final rule should or should not
include provisions discussed in the proposed rule, but for which we had
not included proposed regulatory text, such as potential requirements
for product testing, environmental monitoring, a supplier approval and
verification program, and potential hazards that may be intentionally
introduced for economic reasons. The comment period did not close until
March 31, 2014; we are still actively reviewing the comments.

C. Our Decision To Issue a Supplemental Notice of Proposed Rulemaking
for Public Comment

    In December 2013, we announced that we would propose revised rule
language for key provisions of the 2013 proposed rule for preventive
controls for human food. Because the 2013 proposed rule for preventive
controls for food for animals is a companion rule to the proposed rule
on human food, in March 2014, we announced our intent to publish
revised language for the 2013 proposed rule for preventive controls for
food for animals, as well (Ref. 5). Elsewhere in this issue of the
Federal Register, we are issuing a supplemental notice of proposed
rulemaking to the 2013 proposed rule for preventive controls for human
food. Many of the proposed provisions of the animal food preventive
controls rule match those in the human food rule. Section IX and X
discuss our reasons for changes to the proposed current good
manufacturing practice regulations. Additional information regarding
the basis of this supplemental notice of proposed rulemaking can be
found in the supplemental notice of proposed rulemaking for preventive
controls for human food.

III. Scope of the Supplemental Notice of Proposed Rulemaking and Our
Request for Public Comment

    In this document, we are proposing:
     Revisions to several definitions we proposed to apply to
the requirements for hazard analysis and risk-based preventive
controls, including definitions for ``environmental pathogen,''
``reasonably foreseeable hazard,'' and ``very small business'';
     New definitions for ``significant hazard'' ``pathogen,''
and ``you'';
     Revisions to subpart B for current good manufacturing
practice regulations to make the requirements more applicable for
animal food facilities;
     To not subject human food by-products used for animal food
by human food facilities that are subject to and in compliance with
subpart B of proposed part 117 and other applicable human food safety
requirements of the FD&C Act (and implementing regulations) for the
human food if the by-products are not further processed at the facility
to hazard analysis and preventive controls requirements and only
require compliance for holding and distributing these by-products;
     Revisions to the proposed procedures that would govern
withdrawal of an exemption from a ``qualified facility,'' including
clarifications about the steps we would take before issuing an order to
withdraw the exemption, an expanded timeframe for a facility to comply
with an order withdrawing an exemption, and a mechanism for a withdrawn
exemption to be re-instated;
     A series of revisions to the proposed requirements for
hazard analysis and risk-based preventive controls (proposed subpart C)
to:
     Emphasize the risk-based nature of the preventive controls
and requirements for monitoring, corrective actions, and verification
activities;
     Reduce the potential for misinterpretation that the rule
requires that all necessary preventive controls be established at
critical control points (CCPs) for all hazards that a facility
addresses in its food safety plan;
     Change the wording in the ``Monitoring'' section to more
closely match the language of the statute and the proposed rule for
preventive controls for human food;
     Increase flexibility for a facility to determine, based on
the nature of a preventive control, when requirements for ``preventive
control management components'' (i.e., monitoring, corrective actions,
and verification) are appropriate;
     Substitute the pronoun ``you'' for ``the owner, operator,
or agent in charge of the facility'' throughout these proposed
requirements;
     Substitute the term ``adequate'' (which is a term we
proposed to define) in place of the term ``sufficient'' (which we did
not propose to define);

     Improve readability, through rearrangement of some of the
proposed regulatory text and editorial revisions (such as increased use
of active voice).
    In this document, we also are providing an opportunity for public
comment on potential requirements for product testing, environmental
monitoring, a supplier program, and hazards that may be intentionally
introduced for purposes of economic gain, including definitions of
terms (i.e., ``qualified auditor,'' ``receiving facility,'' and
``supplier'') that would be used in some of those potential
requirements. We are seeking comment on whether such requirements
should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate.
    We discuss these proposed requirements in sections V through XVI.
Because several of the proposed revisions relate to the overall
framework in subpart C for hazard analysis and risk-based preventive
controls, we are including the complete regulatory text for proposed
subpart C. However, in this document, we are reopening the comment
period only with respect to the issues specified in this section III.
    Importantly, the proposed revisions to the provisions we have
included in the regulatory text are based on preliminary review of
comments. We will complete our review of comments previously submitted
and consider the comments responsive to this Legal and Regulatory
Framework Under of proposed rulemaking in developing the final rule.

IV. Legal and Regulatory Framework Under Sections 415 and 418 of the
FD&C Act and Regulations Implementing Section 415 of the FD&C Act

    In the 2013 proposed rule for preventive controls for human food
(78 FR 3646), we described the current legal and regulatory framework
that governs the determination of when an establishment is required to
register as a food facility in accordance with the section 415
registration regulations (21 CFR part 1, subpart H; the section 415
registration regulations). We focused on the framework that governs
whether an establishment that grows and harvests crops satisfies the
definition of ``farm'' because the facility registration requirements
of section 415 of the FD&C Act do not apply to ``farms.'' When we
implemented the statutory requirements for registration of food
facilities, it established a definition for ``farm'' that first
describes a farm as a facility devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both (Sec.
1.227; 68 FR 58894, October 10, 2003). Although that definition of
``farm'' then provides that farms also pack or hold food, it limits
facilities that fall within the definition of ``farm'' to those that
pack or hold food grown, raised, or consumed on that farm or another
farm under the same ownership. Thus, under the current framework an
establishment that is devoted to the growing and harvesting of crops,
but also packs and holds food not grown or raised on that farm or on
another farm under the same ownership, would fall outside the
definition of ``farm'' and be required to register as a food facility.
Because an establishment that is required to register as a food
facility is subject to the requirements of section 418 of the FD&C Act,
under the current framework a determination of whether an establishment
devoted to the growing and harvesting of crops is subject to FSMA's
requirements for hazard analysis and risk-based preventive controls
depends, in part, on where the food that the establishment packs or
holds is grown or raised.
    Under the current framework, a key factor in whether an
establishment falls within the definition of ``farm,'' even with
respect to crops it grows and harvests itself, is whether the
activities conducted by the farm fall within definitions of
``harvesting,'' ``packing'' or ``holding'' (which are within the
``farm'' definition). As discussed in the 2013 proposed rule for
preventive controls for human food, section 103 of FSMA directs FDA to
conduct rulemaking to clarify the on-farm manufacturing, processing,
packing and holding activities that would trigger a requirement for a
farm to register as a food facility and, thus, be subject to the
requirements for hazard analysis and risk-based preventive controls (78
FR 3646 at 3674). In the 2013 proposed rule for preventive controls for
human food, we explained how the status of a food as a raw agricultural
commodity (RAC) or a processed food affects the requirements applicable
to a farm under sections 415 and 418 of the FD&C Act. For further
discussion see section IV of the preamble in the supplemental notice of
proposed rulemaking for preventive controls for human food, published
elsewhere in this Federal Register.
    In sections V and VI, we discuss the proposed revised definitions
for ``farm,'' ``harvesting,'' ``packing,'' and ``holding.''

V. The ``Farm'' Definition

    We are reopening the comment period, in the supplemental notice of
proposed rulemaking for preventive controls for human food published
elsewhere in this issue of the Federal Register, with respect to
``Farm,'' ``Harvesting,'' ``Holding,'' and ``Packing''.

A. 2013 Proposed Definitions of ``Farm,'' ``Harvesting,'' ``Holding,''
and ``Packing''

    Consistent with the organizing principles regarding classification
of activities on-farm and off-farm, in the proposed rule for preventive
controls for human food (78 FR 3646), we proposed to define
``harvesting,'' as a new definition in Sec. Sec.  1.227 and 1.328, to
apply to farms and farm mixed-type facilities and to mean activities
that are traditionally performed by farms for the purpose of removing
RACs from the place they were grown or raised and preparing them for
use as food. We proposed that harvesting be limited to activities
performed on the farm on which they were grown or raised, or another
farm under the same ownership, and that harvesting does not include
activities that transform a RAC into a processed food. The proposed
definition included examples of activities that would be harvesting. As
a conforming change to the proposed definition of ``harvesting,'' we
proposed, to revise the definition of ``farm'' in current Sec. Sec.
1.227(b)(3) and 1.328 to delete examples of harvesting that currently
appear in the ``farm'' definition.
    We also proposed, in the preventive controls proposed rule for
human food, to revise the definition of ``holding'' in Sec. Sec.  1.227
and 1.328 so that it would be a two-part definition that would include,
for farms and farm mixed-type facilities, activities traditionally
performed by farms for the safe or effective storage of RACs grown or
raised on the same farm or another farm under the same ownership, but
would not include activities that transform a RAC into a processed
food.
    We proposed, in the preventive controls proposed rule for human
food, to revise the definition of ``packing'' in Sec. Sec.  1.227 and
1.328 so that it would be a two-part definition that would include, for
farms and farm mixed-type facilities, activities (which may include
packaging) traditionally performed by farms to prepare RACs grown or
raised on a farm or another farm under the same ownership for storage
and transport, but would not include activities that transform a RAC
into a processed food.
    See section V in the supplemental notice of proposed rulemaking for
preventive controls for human food, published elsewhere in this Federal
Register for additional discussion RACs.

B. Proposed Revisions to the Proposed Definitions of ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing''

    In the supplemental notice of proposed rulemaking for preventive
controls for human food, published elsewhere in this Federal Register,
we are proposing to revise the ``farm'' definition so that it would no
longer limit establishments that fall within the ``farm'' definition to
those that pack or hold food grown, raised, or consumed on that farm or
another farm under the same ownership. Under the revised ``farm''
definition, an establishment devoted to the growing of crops, the
raising of animals, or both, would remain within the ``farm''
definition (and, thus, not be subject to the section 415 registration
regulations and the proposed requirements for hazard analysis and risk-
based preventive controls) even if it packs and holds raw agricultural
commodities grown on another farm. To limit the potential for confusion
related to the term ``facility,'' we are proposing to substitute the
term ``establishment'' for the term ``facility'' in the revised
definition of ``farm.'' We also are proposing that the packing
activities (which may include packaging) that it had proposed to
include in the expanded definition of ``packing'' for farms and farm
mixed-type facilities be included in the ``farm'' definition rather
than in an expanded definition of ``packing.'' Under the revised
``farm'' definition, it will be clear that an establishment devoted to
the growing of crops, the raising of animals, or both, can remain
within the ``farm'' definition if it packages RACs grown or raised on a
farm to prepare them for storage and transport, without additional
manufacturing/processing. The proposed revised definition of
``harvesting'' would also include ``field coring'' as an example of a
harvesting activity to make clear that on farm ``field coring'' of a
RAC (e.g., removing the core of lettuce in the field at the same time
the stem is cut and wrapper leaves removed) is a harvesting activity,
even though ``coring'' outside of ``field coring'' (e.g., during the
production of fresh-cut lettuce) is a manufacturing/processing
activity.
    For further discussion, please see section V in the supplemental
notice of proposed rulemaking for preventive controls for human food
published elsewhere in this issue of the Federal Register.

C. One General Physical Location

    We received some comments on the 2013 proposed rule for preventive
controls for human food stating that that farms throughout the country
are now made up of multiple, often non-contiguous fields due to
geographic and topographic conditions, local development patterns, and
the fact that a single ``farm'' today often derives from multiple
previous farms due to the need to achieve economic efficiencies. Some
comments explain that as farm land increasingly is partitioned into
smaller and smaller parcels through estate divisions or for other
reasons, farmers purchasing land find that they are rarely able to
purchase adjacent parcels. These comments ask us to modify or remove
the phrase ``in one general location'' in the ``farm'' definition.
    During the rulemaking to establish the ``farm'' definition in the
section 415 registration regulations, we explained that a farm may
consist of contiguous parcels of land, ponds located on contiguous
parcels of land, or, in the case of netted or penned areas located in
large bodies of water, contiguous nets or pens (68 FR 5378 at 5381,
February 3, 2003). However, we did not propose to include this
explanatory sentence in the regulatory text. Comments addressing ``one
general physical location'' focused on how specifying ``in one general
physical location'' would affect whether the farm would be subject to
the section 415 registration regulations. Our response to those
comments focused on the nature of the activities being conducted rather
than on the contiguous or non-contiguous nature of parcels of land or
nets (68 FR 58894 at 58906, October 10, 2003).
    The definition of ``facility'' in the section 415 registration
regulations likewise specifies that a facility means ``any
establishment, structure, or structures under one ownership at one
general physical location . . .'' However, this definition specifically
adds an explanatory statement that a facility may consist of one or
more contiguous structures (Sec.  1.227). During the rulemaking to
establish this definition of ``facility,'' we explained that we
proposed to include this explanatory sentence in the regulatory text as
a result of comments that we received during our early outreach efforts
(68 FR 5378 at 5381, February 3, 2003).
    We are requesting comment on whether we should retain, remove, or
modify the phrase ``in one general physical location'' in the ``farm''
definition. Elsewhere in this issue of the Federal Register, in the
supplemental notice of proposed rulemaking for preventive controls for
human food, we are also requesting comment on the phrase ``in one
general physical location'' in the ``farm'' definition. In responding
to our request for comment on this issue, we ask commenters to
carefully consider what, if any, impacts removing or modifying this
phrase could have on other rules that already include (or have proposed
to include) the same definition of ``farm'' as would be established in
the section 415 registration regulations, as well as how such impacts
would best be addressed. Please see section V.E in the supplemental
notice of proposed rulemaking for preventive controls for human food
published elsewhere in this issue of the Federal Register for further
discussion on this issue.

D. Feed Mills Associated With Contract and Fully Vertically Integrated
Farming

    We received some comments requesting clarification of whether all
feed mills associated with contract farming or fully vertically
integrated farming models would be required to comply with the proposed
rule.
    We are aware that there are a variety of farming models for raising
animals. In one model, often referred to as contract farming, one
entity owns the feed mill and the animals, but contracts with another
entity that owns the establishment devoted to raising the animals. In
this model, the feed mill would not be considered part of a farm under
the current definition in 21 CFR 1.227 (see 68 FR 58894 at 58907 (Oct.
10, 2003) and 68 FR 5378 at 5382 (Feb. 3, 2003)). The feed mill also
would not be considered part of a farm under the proposed revised
definition of farm in the supplemental notice of proposed rulemaking
for preventive controls for human food published elsewhere in this
issue of the Federal Register. Therefore, the feed mill would be
required to register as a food facility under section 415 of the FD&C
Act and would be subject to the proposed rule for preventive controls.
    In a second model, often referred to as fully vertically integrated
farming, one entity owns the feed mill, the animals, and the
establishment devoted to raising the animals. In this model, the feed
mill would be considered part of a farm under the current definition in
21 CFR 1.227 (68 FR 58894 at 58907), and the proposed revised
definition. Therefore, the feed mill would be exempt from registering
as a food facility under section 415 of the FD&C Act and would not be
subject to the proposed rule for preventive controls rule.
    Cooperative farming is another model and depending on how the
cooperative is structured, it can resemble the contract model or the
fully vertically integrated model. How the cooperative is structured
determines whether the

feed mill is required to register as a food facility under section 415
of the FD&C Act.
    We have no evidence that the safety of animal food varies depending
on whether a feed mill is associated with vertically integrated or
contract farming. Therefore, we are asking for comment on whether feed
mills associated with fully vertically integrated farming operations,
including cooperatives that fit this model, that meet the farm
definition (current or proposed revision) should be required to
register as a food facility under section 415 of the FD&C Act. If so,
how should we revise the farm definition so the feed mills associated
with these fully vertically integrated farming operations would not be
considered farms, would be required to register under section 415, and
thus would be subject to the proposed rule. Registration under section
415 of the FD&C Act would also subject these feed mills to additional
statutory requirements under the FD&C Act, for example, recordkeeping
requirements under section 414, requirements for the Reportable Food
Registry under section 417, and requirements for mandatory recall under
section 423.
    If these fully vertical farming feed mills would be required to
register under section 415 of the FD&C Act, we also request comment on
whether there should be an exemption from registration under section
415 for some of these feed mills based on size, such as number of
animals being fed or the amount of animal food being fed (based on
tonnage, monetary value, or some other factor).
    Under the fully integrated vertical farming operations and certain
contract farming operations, there would be no total annual sales
figure for the animal food that could be used to determine whether a
facility is a qualified facility (and thus exempt from proposed subpart
C). With regard to these feed mills, we request comment on how to value
the animal food being fed to animals for purposes of determining
whether the feed mill would be a qualified facility (proposed Sec.
507.7) and in particular a very small business. Qualified facilities
would be exempt from the requirements of subpart C (hazard analysis and
risk-based preventive controls).

VI. Definitions of ``Holding'' and ``Packing''

A. 2013 Proposed Definition of ``Holding''

    In the 2013 proposed rule for preventive controls for human food,
we proposed to revise the definition of ``holding'' in Sec. Sec.  1.227
and 1.328 (see section V.A).

B. 2013 Proposed Exemptions Relevant to the Definition of ``Holding''

    We proposed two exemptions directed to facilities ``solely
engaged'' in the storage (i.e., holding) of certain types of animal
food, and explained our reasons for doing so.
    First, we proposed to exempt facilities that are solely engaged in
the storage of RACs (other than fruits and vegetables) intended for
further distribution or processing from the requirements for hazard
analysis and risk-based preventive controls, and explained our reasons
for proposing to do so (proposed Sec.  507.5(g); see discussion at 78
FR 64736 at 64764). We intended this provision to exempt, for example,
facilities that only store whole grains (such as corn, wheat, barley,
rye, grain sorghum, oats, rice, wild rice, and soybeans) from the
requirements for hazard analysis and risk-based preventive controls,
provided that such facilities do not conduct other activities subject
to FSMA's requirements for hazard analysis and risk-based preventive
controls (78 FR 64736 at 64764).
    Second, we proposed to exempt a ``facility solely engaged in the
storage of packaged food for animals that is not exposed to the
environment'' from the requirements for hazard analysis and risk-based
preventive controls that would be established in subpart C (proposed
Sec.  507.10(a); see discussion at 78 FR 64736 at 64768). We intended
this provision to exempt, for example, facilities that store packaged
animal food in containers in a warehouse. However, a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment and that requires time/temperature control to
significantly minimize or prevent the growth of, or toxin production
by, pathogens would be subject to modified requirements (see proposed
Sec. Sec.  507.10(b) and 507.51.
    In this section of this document, we are proposing revisions to the
definition of ``holding'' in addition to the revisions, discussed in
section V.B, that would be conforming amendments in light of the
revised ``farm'' definition. In this section of this document, we are
reopening the comment period with respect to the revised definition of
``holding'' (proposed Sec.  507.3).

C. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of RACs (Other Than Fruits and Vegetables)
Intended for Further Distribution or Processing

    Some comments support for the proposed exemption for a facility
solely engaged in the storage of RACs (other than fruits and
vegetables) intended for further distribution or processing. However,
some stakeholders expressed concern, during outreach activities such as
the public meetings and in written comments, that the proposed
definition of ``holding'' would preclude facilities such as grain
elevators from being eligible for the exemption in proposed Sec.
507.5(g) because most such facilities conduct a variety of activities
in addition to ``storage.'' For example, grain elevators typically
conduct the following activities that could be characterized as being
practical necessities, either for the purposes of safe or effective
storage or for meeting customer specifications:
     Fumigate grain to control pest infestation during storage;
     Clean grain using various mechanisms (sifting, sieving,
and screening);
     Convey grain throughout the facility;
     Dry grain received with high moisture content; and
     Blend lots of grain.
    Some comments recommended that we modify the proposed definition
for ``holding'' to (1) encompass activities performed for the safe or
effective storage of RACs (such as drying, screening, conditioning, and
fumigating) off-farm and (2) encompass activities performed on RACs as
a practical necessity for product distribution (such as blending
different lots of the same commodity to meet a customer's quality
specifications).

D. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of Packaged Food That Is Not Exposed to the
Environment

    Some comments received during the public meetings for the 2013
proposed rule for preventive controls for animal food and received
under the 2013 proposed rule for preventive controls for human food
support the proposed exemption for a facility ``solely engaged in the
storage of packaged food that is not exposed to the environment.''
These comments note that warehouses typically conduct the following
activities that could be characterized as being practical necessities,
either for the purposes of storage or for product distribution,
including:

     Affix tracking labels;
     Transport to a storage location in the warehouse;
     Hold non-food products, including toys and grooming aids
for pets;
     Break down pallets of packaged animal food for
distribution to the retail level in less-than-pallet quantities;
     Assemble ``sales kits'' for use in fundraising drives;
     Assemble variety packs by packing; and
     Use packaged food to build store displays.
    Some of these comments we received recommend that we modify the
proposed definition for ``holding'' to encompass activities that are
performed on packaged food that is not exposed to the environment (1)
incidental to storage of the animal food (such as transport and storage
of non-animal food products); and (2) as a practical necessity for
product distribution (such as affixing tracking labels, breaking down
pallets, assembling sales kits and variety packs, and building store
displays).

E. Proposed Revisions to the Definition of ``Holding''

    Taking into account the comments we have reviewed so far for the
2013 proposed rules for preventive controls, we tentatively conclude
that we should revise the definition of ``holding'' to encompass
activities performed incidental to storage of animal food (e.g.,
activities performed for the safe or effective storage of that animal
food and activities performed as a practical necessity for the
distribution of that animal food). In addition to the activities
specifically identified in the comments, we are aware of other
activities (Ref. 6) that can be considered incidental to storage of
RACs, either for the purposes of safe or effective storage or for
meeting customer specifications, including:
     Treating stored grain with protectant chemicals and
pesticide alternatives (other than by fumigation) to control
infestation;
     Using modified atmosphere treatments to control pests;
     Using biological controls for pests;
     Applying chemical preservatives to grain to prevent growth
of mycotoxin-producing molds;
     Weighing grain;
     Sampling and grading grain; and
     Aerating grain to control temperature.
    In this document, we are proposing to revise the definition of
holding to:
     Clarify that holding also includes activities performed
incidental to storage of an animal food (e.g., activities performed for
the safe or effective storage of that animal food and activities
performed as a practical necessity for the distribution of that animal
food (such as blending of the same commodity));
     Broaden ``activities . . . performed for the safe or
effective storage of raw agricultural commodities'' to apply to all
animal food, not just RACs;
     Broaden ``activities . . . performed for the safe or
effective storage'' to apply to all establishments that hold animal
food, not just farms and farm mixed-type activities;
     Add ``breaking down pallets'' to the examples in the
revised definition of ``holding'' so that the examples reflect
activities conducted on packaged animal food as well as activities
conducted on RACs; and
     Specify that holding facilities ``could'' include the
listed types of facilities to clarify that some of these facilities
might not meet the definition of a holding facility if they perform
other activities not included in the definition of holding (e.g., if a
grain elevator mixes different commodities to prepare animal food).
    As discussed in section V.B, the revised definition of ``holding''
also would remove limitations on where the food is grown or raised (as
a conforming change to the revised definition of ``farm'' found in the
supplemental notice of proposed rulemaking for preventive controls for
human food, published elsewhere in this issue of the Federal Register.
The revised definition of ``holding'' would now be a one-part
definition that applies to all facilities that hold animal food, rather
than a two-part definition that first specifies activities that are
within the definition regardless of the type of establishment and then
specifies additional activities that would apply only to establishments
that are farms or farm mixed-type facilities.
    With this revised definition of ``holding,'' facilities such as
grain elevators and silos would, in most cases, satisfy the criteria
for the proposed exemption for facilities solely engaged in the storage
of RACs (other than fruits and vegetables) intended for further
distribution or processing (proposed Sec.  507.5(g)), because the
definition would encompass activities performed as a practical
necessity for the distribution of RACs. Other facilities that conduct
operations similar to those conducted at grain elevators and silos,
such as facilities that package and sell seed for crops, but sell the
leftover seed for animal food, also may satisfy these criteria for
exemption.
    With this revised definition of ``holding,'' facilities such as
warehouses would, in many cases, satisfy the criteria for the proposed
exemption for facilities solely engaged in the storage of packaged
animal food that is not exposed to the environment (proposed Sec.
507.10(a)), because the definition would encompass activities that are
a practical necessity for product distribution (such as breaking down
pallets and affixing tracking labels). We are adding ``breaking down
pallets'' to the examples in the revised definition of ``holding'' so
that the examples reflect activities conducted on packaged animal food
as well as activities conducted on RACs. Although we are not adding
more examples to reflect activities conducted on packaged animal food,
the revised definition of ``holding'' also would include activities
such as assembling sales kits and variety packs, because such
activities are similar to breaking down pallets except that the order
of activities is reversed.

F. Proposed Revisions to the Definition of ``Packing''

    Just as there are some activities that are performed incidental to
storing food for animals, there are some activities that are performed
incidental to packing an animal food. For example, sorting, culling,
and grading RACs could be an activity incidental to packing on a farm
or farm mixed-type facility, whereas off-farm some sorting or similar
activities such as culling or grading may be required to ensure that
like items are packed together, or to remove damaged items. As another
example, animal food may need to be conveyed (moved) about an
establishment for the purpose of packing it, and may need to be weighed
to ensure that appropriate amounts are packed. We tentatively conclude
that we should revise the definition of ``packing'' so that it includes
activities performed incidental to packing food for animals. In this
document, we are proposing to revise the definition of packing to:
     Clarify that packing also includes activities performed
incidental to packing animal food (e.g., activities performed for the
safe or effective packing of that animal food (such as sorting, culling
and grading));
     Provide that activities performed incidental to packing an
animal food would apply to all establishments that pack animal food,
not just to farms and farm mixed-type facilities; and
     Delete the provision, in the 2013 proposed rule for
preventive controls, that packing would include activities (which may
include packaging) traditionally performed on a farm on

RACs grown on a farm for storage or transport, because this issue would
be addressed in the revised ``farm'' definition in the supplemental
notice of proposed rulemaking for preventive controls for human food,
published elsewhere in this Federal Register.

VII. Impact of the Proposed Revisions to the Farm-Related Definitions
on the Classification of On-Farm Activities

A. Comments on the 2013 Organizing Principles for Classifying
Activities Conducted on Farms and on Farm Mixed-Type Facilities

    See the supplemental notice of proposed rulemaking for preventive
controls for human food, published elsewhere in this Federal Register,
for discussion of comments.

B. Updated Organizing Principles That Would Apply to the ``Farm''
Definition

    We articulated the 2013 organizing principles for classifying on-
farm activities to operate within the framework, already established in
the section 415 registration regulations, in which an establishment
that packs and holds others' RACs would be outside the ``farm''
definition and, thus, be required to register as a food facility. Our
proposed revisions to the ``farm'' definition, found in the
supplemental notice of proposed rulemaking for preventive controls for
human food, published elsewhere in this Federal Register, would change
that framework and, as a consequence, require that we reconsider those
organizing principles.
    Organizing Principles Nos. 1, 3, and 5 remain consistent with the
proposed revisions to the ``farm'' definition. However, there would be
no need to specify, in Organizing Principle No. 2, that activities that
farms traditionally do relate only to their own RACs. In addition,
Organizing Principle No. 4 would no longer apply, because the revised
``farm'' definition would no longer classify an activity as within (or
outside of) the ``farm'' definition based, in part, on whether an
activity is conducted on a farm's own RACs or on others' RACs.
Therefore, we tentatively conclude it is appropriate to delete
Organizing Principle No. 4 in light of the proposed revisions to the
``farm'' definition.
    Table 4 shows our current thinking regarding the organizing
principles applicable to the revised ``farm'' definition.

 Table 4--Updated Organizing Principles That Would Apply to the Revised
                           ``Farm'' Definition
------------------------------------------------------------------------
                  No.                          Organizing principle
------------------------------------------------------------------------
1......................................  The basic purpose of farms is
                                          to produce RACs, and RACs are
                                          the essential products of
                                          farms.
2......................................  Activities that involve RACs
                                          and that farms traditionally
                                          do for the purposes of growing
                                          RACs, removing them from the
                                          growing areas, and preparing
                                          them for use as a food RAC,
                                          and for packing, holding and
                                          transporting them, should all
                                          be within the definition of
                                          ``farm.''
3......................................  Activities should be classified
                                          based in part on whether the
                                          food operated on is a RAC or a
                                          processed food, and on whether
                                          the activity transforms a RAC
                                          into a processed food.
4......................................  Manufacturing/processing,
                                          packing, or holding food--
                                          whether RACs or processed
                                          foods, from any source--for
                                          consumption on the farm should
                                          remain within the farm
                                          definition.
------------------------------------------------------------------------

C. Changes to Classification of On-Farm Activities

    We reconsidered the classification of specific activities as
harvesting, packing, holding, or manufacturing/processing, when
conducted on farms or on farm mixed-type facilities. See the Appendix
to this document for a comprehensive table comparing the classification
of on-farm activities as harvesting, packing, holding, or
manufacturing/processing in the 2013 proposed rule for preventive
controls to our current thinking on the classification of these on-farm
activities. As can be seen in the Appendix, several on-farm activities
can be classified in more than one way, and most of the changes in
activity classification merely reflect additional activities (relative
to the 2013 proposed rule for preventive controls) that could be
classified in more than one way. For example, in the 2013 proposed rule
for preventive controls, we classified ``removing stems and husks'' as
a harvesting activity (e.g., if RACs are husked while they are being
removed from the field). In this supplemental notice of proposed
rulemaking, we also consider ``removing stems and husks'' to be a
packing activity (e.g., if RACs are husked after the RACs have been
removed from the field).
    See Table 5 in this document for a list of the activity
classifications that would change in light of the proposed revisions to
the ``farm'' definition and our reconsideration of activity
classification. As shown in Table 5, changes in activity classification
as a result of the proposed revisions to the ``farm'' definition would
result in a single circumstance (drying/dehydrating RACs to create a
distinct commodity without additional manufacturing/processing) where a
farm conducting manufacturing/processing would no longer be required to
register as an animal food facility. Importantly, the revised ``farm''
definition would not result in any new circumstance where a farm would
now be required to register as a food facility.
    Table 5 includes one activity (i.e., using pesticides on RACs as a
packing activity) that we did not address in the 2013 proposed rule for
preventive controls and excludes a number of activities (e.g., cooling
RACs and coating RACs with wax/oil/resin) that were classified in the
appendix of the draft risk assessment (Ref. 7) but are not performed on
animal food.
    Table 5 includes one activity (i.e., drying/dehydrating (incidental
to holding)) that we now would classify in fewer ways than we did in
the 2013 proposed rule for preventive controls. In the 2013 proposed
rule for preventive controls, we classified drying/dehydrating (for
purposes of storage or transport, rather than to create a distinct
commodity) (e.g., drying alfalfa) as being either a packing activity or
a holding activity, depending on when the drying/dehydrating took
place. After reconsidering all of the activity classifications, we
tentatively conclude that such drying/dehydrating should continue to be
classified as ``holding,'' but does not constitute ``packing.'' We
request comment on this narrowed classification of drying/dehydrating
when the drying/dehydrating does not create a distinct commodity.

  Table 5--Changes in Classification of Activities Conducted on Farms or on Farm Mixed-Type Facilities Based on
                                the Proposed Revisions to the ``Farm'' Definition
----------------------------------------------------------------------------------------------------------------
                                                                                Why would the re-
                                                                                classification
                                          Classified in 2013         Classified in       represent a change from
               Activity                   proposed rule for      supplemental notice of   the 2013 proposed rule
                                         preventive controls      proposed rulemaking    for preventive controls
                                                                                for animal food? \2\
----------------------------------------------------------------------------------------------------------------
Cooling..............................  Harvesting; (Sec.         Mfg/processing  Acknowledge that field
                                        507.3); Mfg \1\ /        (e.g., cooling of        cooling of animal food
                                        Processing (Sec.         processed animal food).  RACs is not done.
                                        507.3).
Drying/dehydrating (incidental to      Packing or Holding        Holding (e.g.,  Because we would no
 holding).                              (Tables 1 and 15 of      drying hay or alfalfa).  longer consider drying/
                                        the draft risk                                    dehydrating to be a
                                        assessment (RA)) (Ref.                            packing activity.
                                        7).
Drying/dehydrating to create a         Mfg/Processing (Table     Mfg/processing  Because we are
 distinct commodity (transforms a RAC   15 of the draft RA)      (e.g., drying grapes     including this
 into a processed animal food).         (Ref. 7).                to create raisins, and   specific mfg/
                                                                 drying herbs to create   processing activity
                                                                 a distinct commodity)    within the ``farm''
                                                                 (because it transforms   definition, provided
                                                                 a RAC into a processed   that there is no
                                                                 animal food) (but        additional
                                                                 allowed within the       manufacturing/
                                                                 farm definition).        processing.
Filtering............................  Harvesting (Sec.          Harvesting      Acknowledge that
                                        507.3).                  (e.g., filtering         filtering is not done
                                                                 honey).                  on animal food RACs.
Removing stems and husks.............  Harvesting (Sec.          Harvesting      Acknowledge that
                                        507.3).                  (e.g., in the field).    removing stems/husks
                                                                 Packing (e.g.,   can occur during more
                                                                 in a packing shed).      than harvesting
                                                                                operations.
Sifting..............................  Harvesting (Sec.          Harvesting      Acknowledge that
                                        507.3).                  (e.g., in the field).    sifting can occur
                                                                 Packing (e.g.,   during more than
                                                                 in a packing shed).      harvesting operations.
Using pesticides on RACs.............  Harvesting (Tables 1      Harvesting      Acknowledge that
                                        and 15 of the draft RA   (e.g., in the field).    pesticides may be used
                                        discussed only           Packing (e.g.,   at various points in
                                        fumigation ) (Ref. 7 ).  in a packing shed).      preparation of RACs
Washing..............................  Harvesting (Sec.          Harvesting      Acknowledge that field
                                        507.3), and Mfg/         (e.g., washing in the    washing of animal RACs
                                        Processing (Sec.         field was deleted).      does not occur but
                                        507.3).                  Mfg/processing   washing during
                                                                 (e.g., during            processing may occur.
                                                                 production of an
                                                                 animal food).
----------------------------------------------------------------------------------------------------------------
\1\ Mfg = Manufacturing.
\2\ This table focuses on any change in classification in this document compared to the classification, in the
  2013 proposed rule for preventive controls for food for animals, for activities conducted on a farm's own
  RACs. The proposed revisions to the ``farm'' definition would make the distinction between whether a farm
  conducted an activity on its own RACs or on others' RACs irrelevant.

VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Animal Food
Combinations

A. The 2013 Proposed Exemptions

    In the 2013 proposed rule, we described provisions of FSMA that
direct us to (1) conduct a science-based risk analysis to cover
specific types of on-farm packing, holding, and manufacturing/
processing activities that would be outside the ``farm'' definition
and, thus, subject to the requirements for hazard analysis and risk-
based preventive controls (78 FR 64736 at 64751 and 64752-64754); and
(2) consider the results of that science-based risk analysis and exempt
facilities that are small or very small businesses from these
requirements (or modify these requirements, as we determine
appropriate), if such facilities are engaged only in specific types of
activities that we determine to be low risk involving specific animal
foods that we determine to be low risk. Consistent with this statutory
direction, we developed the draft risk assessment and made it available
for public comment (Ref. 7 and 78 FR 64428); and proposed three
exemptions for on-farm activity/animal food combinations conducted by
farm-mixed-type facilities that are small or very small businesses
(proposed Sec.  507.5(e), (f)(1), and (f)(2)).

B. Comments on the Proposed Exemptions for On-Farm Low-Risk Activity/
Animal Food Combinations

    Some comments received to the proposed rule for preventive controls
for human food (78 FR 3646) request clarification on whether an
establishment that conducts more than one activity/food combination
listed in the proposed exemptions for on-farm low-risk activity/food
combinations would be eligible for the exemption. Other comments
recommend including additional on-farm packing and holding activity/
food combinations, or on-farm manufacturing/processing activity/food
combinations, as low-risk activity/food combinations eligible for
inclusion in the proposed exemptions.
    We are confirming that an establishment that conducts more than one
activity/animal food combination listed in the proposed exemptions for
on-farm low-risk activity/animal food combinations would be eligible
for the exemption. The regulatory text is written in the plural (e.g.,
``if the only packing and holding activities . . . that the business
conducts are the following low-risk packing or holding activity/animal
food combinations''; and ``if the only manufacturing/processing
activities . . . that the business conducts are the following'').
    We have not fully completed our review of comments on the 2013
proposed rule for preventive controls and the draft risk assessment. It
is possible we may include additional activity/animal food combinations
in these exemptions when we issue the final rule.

C. Impact of the Proposed Revisions to the Definitions for ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing'' on the 2013 Proposed
Exemptions for On-Farm Low-Risk Activity/Animal Food Combinations

    The proposed revisions to the definitions of ``farm,''
``harvesting,'' ``holding,'' and ``packing,'' if finalized, would have
three principal effects on the proposed exemptions.
     First, the proposed exemption for on-farm packing or
holding of animal food by a small or very small business would no
longer identify any packing or holding activities for any RACs, because
an on-farm establishment would no longer be subject to the requirements
for hazard analysis and risk-based preventive controls when it packs or
holds RACs, regardless of whether it is packing and holding its own
RACs or others' RACs. The proposed exemption would continue to apply
on-farm packing and holding of processed animal foods (e.g., packing
and holding of silage when conducted by a farm mixed-type facility).
     Second, the proposed exemption for on-farm low-risk
manufacturing/

processing activities conducted by a small or very small business would
no longer distinguish between manufacturing/processing activities
conducted on a farm mixed-type facility's own RACs and manufacturing/
processing activities conducted on animal food other than the farm
mixed-type facility's own RACs.
     Third, the proposed exemption for on-farm low-risk
manufacturing/processing activities conducted by a small or very small
business would be revised to eliminate activities, conducted on others'
RACs, which would no longer be classified as manufacturing/processing
and instead would be classified as harvesting, packing, or holding. For
example, blending different lots of the same RACs such as whole grains
would remain within the ``farm'' definition, and not be considered
manufacturing/processing, regardless of whether the RACs being blended
are the farm's own RACs or others' RACs. However, mixing forage to make
silage would be considered manufacturing/processing and, thus, would
continue to be considered a low-risk manufacturing/processing activity
listed within the exemption for on-farm low-risk manufacturing/
processing activities conducted by a small or very small business.
    We will update these proposed exemptions when we issue the final
rule, after considering comments, and reaching a decision in light of
those comments, on the proposed revisions to the definitions that
impact the proposed exemptions for low-risk activity/animal food
combinations.

IX. Proposed Applicability of Part 507 to the Holding and Distribution
of Human Food By-Products for Use in Animal Food

    Historically, many facilities that manufacture/process or pack
human food also provide by-products from that human food production for
use as animal food (Ref. 8). These by-products are a significant source
of animal food or animal food ingredients. While these by-products may
not be nutritious, suitable, or desirable for human consumption, they
can be a source of energy and nutrition for certain species of animals,
many of which have different digestive systems, physiology, and
nutritional requirements than humans (e.g., ruminants such as cattle
and sheep). The differences enable these animals to digest and
metabolize the by-products in a way humans cannot.
    Some of the by-products do not undergo further processing (such as
drying, grinding, pelleting, etc.) at the human food facility before
being used for animal food. Examples of these by-products include
culls, peels, trimmings, and pulp from fruit and vegetable
manufacturing/processing; chaff, bran, and middlings from grain
milling; wet brewers grains from beverage brewing operations; and
liquid whey from dairy facilities. Some of the by-products from these
facilities are human food products that did not meet quality
specifications for human food use. These out-of-specification products
may be, for example, the wrong size, shape, or texture for human food,
but are safe for use as animal food. Examples of these types of by-
products include potato chips, cookies, bread, pastry products and
pasta. Facilities may distribute the human food by-products directly
for use as livestock food, or may distribute them to another facility
for further processing for food for animals.
    Human food facilities are currently subject to the current good
manufacturing practices (CGMPs) regulations found in 21 CFR part 110
and would be subject to the proposed preventive controls for human
food, found in proposed 21 CFR part 117, subpart C, if finalized. In
the 2013 proposed rule for preventive controls for food for animals, we
addressed human food facilities that also provide food for animals (78
FR 64736 at 64754). Proposed Sec.  507.1(d) would have applied to these
facilities and allowed them, for the animal food, the choice of
complying with proposed part 507 for food for animals, subparts B and C
as applicable, or proposed part 117 for human food, subparts B and C as
applicable, so long as the facility addressed any hazards specific to
the animal food.
    In the 2013 proposed rule for preventive controls, we also
addressed breweries and distilleries that make alcoholic beverages (78
FR 64736 at 64765). Many of these facilities provide the spent grains
from the brewing or distilling process for use as animal food. In the
2013 proposed rule for preventive controls for human food (78 FR 3646),
we proposed that subpart C, ``Hazard Analysis and Risk-Based Preventive
Controls,'' would not apply to certain alcoholic beverages and a very
narrow set of prepackaged other food at alcoholic beverage facilities,
based on the our interpretation of section 116 of FSMA. Section 116(b)
of FSMA (21 U.S.C. 2206(b)) provides that section 116(a) of FSMA
``shall not apply to a facility engaged in the receipt and distribution
of any non-alcohol food, except that [section 116(a) of FSMA] shall
apply to a facility described in [section 116(a) of FSMA] that receives
and distributes non-alcohol food, provided such food is received and
distributed: (1) In a prepackaged form that prevents any direct human
contact with such food; and (2) in amounts that constitute not more
than 5 percent of the overall sales of such facility, as determined by
the Secretary of the Treasury.'' We stated in the proposed rule for
preventive controls for food for animals that we were not aware of any
animal food at any alcoholic beverage facility that would be exempt
from proposed subpart C, ``Hazard Analysis and Risk-Based Preventive
Controls,'' for food for animals as the spent grains for animal food is
not an alcoholic beverage and is not in a prepackaged form as provided
by section 116 of FSMA.
    We have received comments from our stakeholders at public meetings
and through comments to the proposed rule. Some comments stated that
the requirements in proposed Sec.  507.1(d) would potentially create a
need for two separate food safety plans, one for human food and one for
animal food. Some commented that requiring the facility to be subject
to human food and animal food regulations would be a cost burden and as
a result, some facilities would destroy their by-products, most likely
by landfill, instead of complying with the rule for food for animals.
Others commented that by-products used for animal food would not be a
food safety concern because the human food is manufactured/processed or
packed under CGMPs and many of these facilities also would be subject
to the proposed rule for preventive controls for human food. Comments
also said that the hazards that would be reasonably foreseeable for
animal food (e.g., mycotoxins) would also be a hazard reasonably
foreseeable for the human food and thus would be controlled by the
facility by following CGMPs or implementing a food safety plan for the
human food.
    Based on comments reviewed to date and on comments made during
public meetings, we considered other possible approaches to regulating
packing and holding of by-products by a human food facility for
distribution as animal food. We first conducted a review of the
potential biological, chemical (including radiological), and physical
hazards for these human food by-products used for animal food. We did
not include hazards associated with human food by-products derived from
animal products, including poultry and seafood (but did include dairy
and egg products). We further limited our review to hazards associated
with human food by-products that were not further processed

at the facility once separated from the human food because these
processes could introduce hazards that would need to be addressed in a
food safety plan. We reviewed the FDA Reportable Food Registry,
published information about animal food recalls, as well as information
from the CVM Feed Contaminants Program (Ref. 9). In addition, we
conducted a scientific literature review on these by-products used as
animal food (Ref.10).
    Though there was not a large volume of data on human food by-
products used as animal food, we tentatively conclude that while there
are biological, chemical, and physical hazards that may be present in
the human food by-products, the information reviewed indicates these
hazards rarely occur.
    For example, the reviewed information did not identify any
instances of biological hazards in human food by-products (falling
under the scope of the memorandum) used as animal food. Protein
ingredients derived from meat, offal, poultry, and oil seed meal were
found to be the most common source of biological hazards in animal
food. Facilities providing by-products from these sources for use as
animal food would be subject to proposed part 507, as explained in the
discussion of proposed Sec.  507.12 in this section. Chemical hazards
such as mycotoxins or pesticides are known to be present in human food
ingredients as well as animal food. We have tentatively concluded that
these hazards would be controlled by the human food facilities for the
human food, either under CGMPs or the proposed preventive controls for
human food when finalized. The reviewed information did not identify
any instances of chemical hazards from radionuclides in by-products
used for animal food. The reviewed information did not identify any
instances of physical hazards in human food by-products used as animal
food except instances when the by-products were mistaken for trash and
trash was added to them. We request comment, including additional data,
on the findings of our research on biological, chemical, and physical
hazards of human food by-product used as animal food.
    Biological, chemical, or physical hazards in human food by-products
used as animal food, as indicated by the reviewed information, were
either hazards that are not known or reasonably foreseeable, are
prevented or significantly minimized through the human food facility's
compliance with current human food CGMP regulations, or would be
prevented or significantly minimized through the human food facility's
compliance with the proposed preventive controls regulations for human
food, when finalized. The current CGMPs (and the proposed update to
these requirements in the 2013 proposed rule for preventive controls
for human food) as well as other applicable FDA human food safety
regulations, are either the same as or more stringent than the proposed
requirements for animal food. Therefore, we tentatively conclude that a
facility's compliance with proposed subpart B of part 117 and all other
applicable human food safety requirements of the FD&C Act and
implementing regulations are sufficient to help provide animal food
safety until the point of separation from the human food. We request
comments on this tentative conclusion.
    The review conducted did not include a search for hazards
associated with seafood by-products. We request comment on how these
by-products are used for animal food, including without further
processing, and if these by-products should be subject to the
requirements for animal food under proposed part 507.
    Once the by-product is separated from the human food and is merely
packed and/or held by the human food facility for distribution, the
facility would need to take measures to ensure the animal food does not
become contaminated. For example, during the time the animal food is
held, the facility would need to ensure that the animal food is not
treated like trash or garbage. The facility would need to protect the
animal food from contamination with physical hazards such as floor
sweepings containing glass or metal fragments and from chemical hazards
such as equipment oil, cleaning chemicals, or pesticides used in the
facility. Any of these could be inadvertently incorporated into the
animal food if it was mistaken for trash.
    As discussed in further detail in section X of this preamble, we
are also proposing revisions to the proposed CGMPs for animal food.
Particularly, we are proposing a section of CGMPs that would apply to
the packing and holding of by-products in a human food facility for
distribution as animal food. Once the by-product is separated from the
human food, these proposed CGMPs for holding and distribution of the
by-product intended for animal food would prevent or significantly
minimize the known or reasonably foreseeable chemical and physical
hazards that may occur after that separation. We tentatively conclude
that biological and certain chemical hazards, such as mycotoxins and
radionuclides, would not be known or reasonably foreseeable hazards in
the by-products, given how unlikely those are to occur based on the
review. We request comment on these conclusions. Based on the above
conclusions, we have determined that, except for proposed Sec.  507.28
regarding holding and distribution of human food by-products as animal
food, proposed part 507 should not be applicable to these human food
by-products used as animal food. Applying all the requirements set out
in proposed part 507 for these by-products at human food facilities
would not seem to provide any additional animal food safety benefit.
Therefore, in this supplemental notice of proposed rulemaking, we are
proposing revised requirements for human food facilities and the human
food by-products they provide for animal food.
    Proposed Sec.  507.12 ``Applicability of this part to the holding
and distribution of human food by-products for use in animal food,''
would address the applicability of part 507 to the holding and
distribution of human food by-products for animal food. Except as
provided in proposed Sec.  507.12(b), the requirements of part 507
would not apply to by-products of human food production that are packed
and held by that facility for distribution as animal food if the
facility is subject to and in compliance with subpart B of part 117 and
all other applicable human food safety requirements of the FD&C Act and
implementing regulations and the facility does not further process the
by-products intended for use as animal food. Proposed Sec.  507.12(b)
would require that once the animal food was separated from the human
food, the facility would need to comply with proposed Sec.  507.28 for
the holding and distribution of that animal food.
    A human food facility that further processes the human food by-
product for animal food would be subject to proposed part 507 for those
by-products. This would include by-products that undergo drying,
pelleting, or heat-treatment such as dried brewers' grains, dried whey,
or pelleted citrus pulp. These processes could introduce hazards that
would need to be addressed in a food safety plan.
    Proposed Sec.  507.12 would not apply to human food products when
contamination or adulteration has occurred that is materially related
to food safety. We currently have two compliance policy guides that
provide information to facilities that want to divert contaminated or
adulterated human food for animal food use (Ref. 11, Ref.12). We handle
the diversion requests on an individual basis and may not grant a
request after review. Against the backdrop of proposed part 507, we

request comment on our compliance policy guides for diversion of
adulterated human food products for animal food and whether we should
include regulations for these types of requests.
    Proposed Sec.  507.12(b) would not apply to human food by-products
derived from animal products (other than dairy and eggs), such as meat,
offal, or poultry. We tentatively conclude that the hazards,
particularly biological hazards, potentially associated with by-
products from these animal products could be more substantial than
those for the by-products addressed in the memorandum. We request
comment on this conclusion.
    Proposed Sec.  117.145 of the supplemental notice of proposed
rulemaking for preventive controls for human food, published elsewhere
in this issue of the Federal Register, addresses proposed corrective
actions and corrections for human food. If a preventive control was
found to be ineffective or was not properly implemented, steps would
need to be taken to evaluate the food for safety and prevent affected
food from entering into commerce if the facility cannot ensure the food
is not adulterated. We request comment on how the facility would
address by-products linked to the affected human food, especially if
the preventive control problem was not discovered until after the
separation of the by-products from the human food and possibly after
the by-products have entered into commerce for use as animal food.
    We are also proposing a conforming change to the 2013 proposed rule
for preventive controls for human food part 117 by adding proposed
Sec.  117.95. This proposed section would contain the same requirements
as those contained in proposed Sec.  507.28, but would allow the human
food processor to reference one part of the Code of Federal Regulations
(i.e., part 117, if finalized) to determine the requirements applicable
to the human food by-products used for animal food. We request comment
on this approach. We also request comment on whether proposed Sec.
507.28 should be removed from part 507, if finalized, if proposed Sec.
117.95 is added to part 117, if finalized.
    We request comment on these proposed requirements for human food
by-products going to animal food use and request comment on any
additional information available on the known or reasonably foreseeable
hazards in human food by-products packed or held by human facilities
for distribution as animal food. We also request comment on whether by-
products from human dietary supplement and infant formula production
are used for animal food, and if so, how these by-products should be
addressed to help ensure safety of the animal food.

X. Proposed Revisions to Subpart B--Current Good Manufacturing Practice

    In this supplemental notice of proposed rulemaking, we are
proposing revisions to the requirements for current good manufacturing
practice regulations (CGMPs) as proposed in the 2013 preventive
controls rule for food for animals. We are proposing these revisions to
the CGMPs based on stakeholder input and initial review of some
comments received in response to the 2013 proposed rule for preventive
controls. In the 2013 proposed rule for preventive controls, we
discussed several sets of CGMPs that had already been developed by
regulatory and animal health organizations, both domestic and
international, that we believed could serve as a starting point for our
proposed CGMPs for manufacturing, processing, packing, and holding food
for animals (78 FR 64736 at 64772). These existing CGMPs included FDA's
CGMP regulations for human food and medicated animal feed (21 CFR part
110 and part 225 respectively), the Association of American Feed
Control Officials (AAFCO) model GMPs for feed and feed ingredients,
best practices recommended by Codex for the feed industry, and the GMPs
recommended in Publicly Available Specification (PAS) 222 (Ref.13, Ref.
14, Ref. 15). We concluded this discussion by saying that because of
our experience and expertise with the human food CGMPs, we tentatively
concluded that our human food CGMPs were the appropriate starting point
for the animal food CGMPs. We then requested comment on whether CGMPs
similar to those for human food are appropriate for animal food, and
whether CGMP requirements appropriate for some types of animal food
might be inappropriate for other types.
    Specifically, a major concern we wanted to address with the
proposed revisions is the difficulty of applying one set of CGMPs to
both pet food facilities and livestock feed facilities. Some pet food
facilities, depending on the type of product being manufactured,
resemble human food facilities in that they use wet cleaning procedures
to clean and sanitize food contact surfaces. They also must maintain
high sanitation standards so that their finished product, which will be
handled by pet owners, is free of pathogenic microorganisms. Livestock
feed manufacturers on the other hand avoid the use of water and liquid
cleaning compounds because of the need to maintain dry surfaces in
facilities that predominantly move dry grains, oilseeds, and other dry
ingredients through mixing operations that produce dry finished
products. Sanitizing surfaces is thought to be unnecessary in most
livestock feed facilities because the environment is much less
conducive to microbial growth. We have tentatively concluded that these
proposed revised CGMPs are more applicable to the animal food industry,
provide flexibility for a wide diversity in types of animal food
facilities, and still meet our objectives of establishing enforceable
baseline standards for producing safe animal food. We request comment
on this conclusion.
    Proposed Sec.  507.27 ``Holding and distribution'' originated from
Sec.  507.28 ``Warehousing and distribution'' in the 2013 proposed rule
for preventive controls for food for animals. We have retitled the
section ``Holding and distribution'' to better indicate the
requirements would apply to animal food plants in general, not simply
warehouses or distributors/distribution centers. The very general
requirement previously proposed that animal food be protected against
deterioration and biological, chemical, physical, and radiological
contamination during storage and transportation was revised to be more
specific.
    Proposed Sec.  507.27(a) would require that animal food held for
distribution must be held under conditions that will protect against
contamination and minimize deterioration of the animal food.
Deterioration of animal food refers to loss of taste, aroma, or
nutritive value typically associated with the animal food. For animal
foods, taste and aroma are linked to palatability and deterioration in
these properties can result in food refusal and wastage. Deterioration
of nutritive value refers to loss of nutrients below amounts that the
food is typically expected to provide. Both food refusal and
consumption of animal food containing fewer nutrients than expected
could result in states of undernourishment that may cause poor
performance and ill health. Animals are typically fed the same food
containing the same ingredients for prolonged periods, making
consistent delivery of expected nutrient content important to prevent
nutritional deficiencies or imbalances.
    Contamination of a food can result from biological, chemical, or
physical agents with biological and chemical being the agents most
likely to contribute to deterioration of

palatability, aroma, and nutritive value of animal food. Microorganism
contamination can lead to production of a chemical hazard, such as when
animal food is contaminated with a mold that subsequently produces a
mycotoxin in the animal food. Holding under appropriate conditions that
minimize the potential for growth of undesirable microorganisms is
particularly important when the animal food is not itself shelf stable
or could be subjected to conditions that adversely impact product
stability. (e.g., raw or frozen pet food). Proposed paragraph (a)(1)
would require that containers used to hold animal food before
distribution be designed, constructed of appropriate material, cleaned,
and maintained to prevent the contamination of animal food.
    Proposed paragraph (a)(2) would require that animal food held for
distribution be held in a way that would prevent contamination from
sources such as trash and garbage. This is particularly important when
the animal food is held in bulk containers that could be mistaken for
trash bins.
    Proposed paragraph (a)(3) would require that labeling that
identifies the product by the common or usual name be affixed to or
accompany the animal food. The common or usual name is one that is
readily recognized, for example, oats, corn, corn gluten meal, poultry
by-product meal, meat, or dried whey. For byproducts from processing
human food, the names in the AAFCO Official Publication are commonly
used and recognized by industry and state feed programs, and in
Compliance Policy Guide 665.100 ``Common or Usual Names for Animal Feed
Ingredients,'' FDA has generally regarded the AAFCO feed ingredient
definitions as establishing common or usual name of ingredients (Ref.
16). We tentatively conclude that this labeling requirement would
enable the animal producer to use the animal food appropriately or an
establishment receiving the animal food for further manufacture to use
it appropriately. We also tentatively conclude that this labeling
requirement would help prevent accidental comingling or mix-ups of
products at the facility.
    Proposed Sec.  507.27(b) would require that shipping containers
such as totes, drums, and tubs, as well as bulk vehicles, used to
distribute animal food be inspected prior to use to ensure the
container or vehicle will not contaminate the animal food. The purpose
of this proposed paragraph would be to help ensure that such articles
for holding and conveying animal food are not a source of contamination
of animal food products.
    Proposed Sec.  507.27(c) would require that animal food returned
from distribution be assessed for safety to determine the appropriate
disposition of the animal food and be identified and segregated until
assessed. The animal food plant or facility would not know how that
animal food had been handled prior to return so the animal food could
have been exposed to potential hazards, e.g., the growth of mycotoxin
producing microorganisms if held in a high humidity area. This returned
animal food could contain hazards resulting in contamination that could
result in a food safety concern. If redistributed prior to assessment,
depending on the nature and severity of the contamination, it could
result in injury (or death) to animals.
    Proposed Sec.  507.27(d) would require that unpackaged or bulk
animal food be held in a manner that does not result in cross
contamination with other animal food. The purpose of paragraph (d) is
to prevent instances of cross contamination such as food for swine that
contains mammalian protein (that is prohibited for use in food for
ruminants) contaminating food intended for cattle.
    Revised proposed Sec.  507.28 is now titled ``Holding and
distribution of human food by-products for use as animal food.'' The
revised proposed requirements are a subset of those in proposed Sec.
507.27 and would specifically apply to human food processers that have
certain by-products (as identified in proposed Sec.  507.12) as a
result of manufacturing human food and pack or hold the by-products for
distribution for use as animal food. Since the human food would be
subject to proposed part 117 subpart B and any other applicable FDA
human food safety requirements of the FD&C Act and implementing
regulations, we have tentatively concluded that hazards would be
adequately controlled by these requirements in conjunction with the
requirements of proposed Sec.  507.28. Proposed Sec.  507.28 would
contain the CGMPs we tentatively conclude would be necessary for animal
food safety once the by-products are separated from human food and
become animal food.
    As discussed in section IX, we are proposing a new Sec.  507.12 for
the applicability of part 507 to human food by-products used for animal
food. Under proposed Sec.  507.12, part 507 would not apply to by-
products of human food production meeting the requirements of proposed
Sec.  507.12(a), except as provided in Sec.  507.12(b). Proposed Sec.
507.12(b) would require that the animal food from by-products
identified in proposed Sec.  507.12(a), be held and distributed by that
facility in accordance with Sec.  507.28 of part 507 and proposed Sec.
117.95 of part 117.
    The following is a brief summary of the proposed revisions to the
CGMPs in proposed subpart B. In making the revisions, we also found it
necessary to rearrange and retitle some of the sections, and make
wording changes that we felt simplified the requirements and improved
clarity. The details of these proposed requirements are in the re-
proposed regulatory text for proposed subpart B.

 Sec.  507.14--Personnel
     Removed paragraphs (a)(1) and (a)(2) pertaining to ill
employees and the requirement for employees to report illnesses to
their supervisors. This change was made because we are not aware of any
evidence of disease being transmitted from ill employees involved in
manufacturing animal food to animals through the animal food.
 Sec.  507.17--Plant and grounds
     Primarily wording changes to consolidate requirements.
 Sec.  507.19--Sanitary operations
     Changed section title to ``Sanitation'';
     Divided paragraph (a) into two categories--(a) pertaining
to buildings, fixtures, and other physical facilities, and (b)
pertaining to utensils and equipment;
     Changed the wording in new paragraph (b) to say that
utensils and equipment must be cleaned, maintained, and stored as
necessary and appropriate to protect against contamination of animal
food, animal food-contact surfaces, or animal food-packaging materials;
     Consolidated requirements, changed the order to group like
requirements, and simplified the wording; and
     Eliminated the requirement pertaining to single-service
articles, which are not typically used in animal food facilities.
 Sec.  507.20--Sanitary facilities and controls
     The title was changed to ``Water supply and plumbing'';
     This section contains only requirements related to the
water supply and plumbing. The rubbish (reworded to trash and garbage)
requirement was moved to Sec.  507.19 Sanitation; and
     Wording changes were made for simplification.

 Sec.  507.22--Equipment and utensils
     Requirements consolidated; and
     Wording changes made for simplification.
 Sec.  507.25--Processes and controls
     Title changed to ``Plant operations'';
     Changed paragraph (a)(1) to require that plant operations
be conducted in accordance with the CGMPs in subpart B rather than in
accordance with adequate sanitation principles;
     Added requirements in paragraph (a)(9) that all animal
food manufacturing, processing, packing, and holding must be conducted
under such conditions and controls as are necessary to minimize the
potential for the growth of microorganisms or for the contamination of
animal food;
     Omitted the requirement in paragraph (b)(2) that raw
materials and ingredients must not contain microorganisms injurious to
human or animal health, or the raw materials and ingredients must be
treated to eliminate them. This change was made because we do not
intend that incoming raw materials and ingredients must be tested for
pathogens, though the facility may choose to do so;
     Requirements pertaining to processes and products used for
human food but not animal food, such as heat blanching, batters,
breading, sauces, and dressings were omitted; and
     Requirements consolidated and wording simplified.
 Sec.  507.28--Warehousing and distribution
     Section renumbered to Sec.  507.27;
     Title changed to ``Holding and distribution'';
     The very general requirement previously proposed that
animal food be protected against deterioration and biological,
chemical, physical, and radiological contamination during storage and
transportation was revised to be more specific. We are now proposing
that the following requirements apply to animal food held for
distribution:
     Animal food held for distribution must be held under
conditions (for example, appropriate temperature, relative humidity,
appropriate holding time) that minimize the potential for growth of
undesirable microorganisms;
     Containers used to hold animal food before distribution
must be designed, constructed of appropriate material, cleaned, and
maintained to prevent the contamination of animal food;
     Animal food held for distribution must be held in a way
that prevents contamination from sources such as trash and garbage;
     Labeling identifying the product by the common or usual
name must be affixed to or accompany the animal food;
     Shipping containers (e.g., totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food;
     Animal food returned from distribution must be assessed
for animal food safety to determine the appropriate disposition.
Returned animal food must be identified as such and segregated until
assessed; and
     Unpackaged or bulk animal food must be held in a manner
that does not result in cross contamination with other animal food.
 Sec.  507.28--Holding and distribution of human food by-
products for use as animal food
     The following new requirements were added:
     Human food by-products held for distribution as animal
food must be held under conditions that will protect against
contamination, including the following:
     Containers used to hold animal food before distribution
must be designed, constructed of appropriate material, cleaned, and
maintained to prevent the contamination of animal food;
     Animal food held for distribution must be held in a way to
prevent contamination from sources such as trash and garbage;
     Labeling identifying the by-product by the common or usual
name must be affixed to or accompany animal food;
     Shipping containers (for example, totes, drums, and tubs)
and bulk vehicles used to distribute animal food must be inspected
prior to use to ensure the container or vehicle will not contaminate
the animal food; and
    We request comments on these proposed revisions to subpart B.
    XI. Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls

A. 2013 Proposed Overall Framework for Hazard Analysis and Risk-Based
Preventive Controls

    In general, in the 2013 proposed rule for preventive controls, we
proposed that the owner, operator, or agent in charge of a facility:
     Prepare and implement a food safety plan, which would
include documentation such as a written hazard analysis and various
written procedures;
     Conduct a hazard analysis to identify and evaluate known
or reasonably foreseeable hazards to determine whether there are
hazards that are ``reasonably likely to occur'';
     Identify and implement preventive controls, including at
CCPs, if any, to provide assurances that hazards identified as
``reasonably likely to occur'' will be significantly minimized or
prevented;
     Establish a written recall plan for animal food with a
hazard identified as ``reasonably likely to occur'';
     Monitor the preventive controls with adequate frequency to
provide assurance that they are consistently performed;
     Establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented;
     Take appropriate corrective action in the event of an
unanticipated problem if a preventive control is not properly
implemented and a specific corrective action procedure has not been
established;
     Conduct certain verification activities; and
     Establish and maintain certain records.
    These proposed provisions applied a construct we previously used in
our Hazard Analysis and Critical Control Point (HACCP) regulations for
seafood (21 CFR part 123) and juice (21 CFR part 120), i.e., whether a
known or reasonably foreseeable hazard was ``reasonably likely to
occur.'' In general, our HACCP regulations for seafood and juice focus
on CCPs to control hazards that are ``reasonably likely to occur.''

B. Comments on the ``Reasonably Likely To Occur'' Construct Within the
2013 Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls

    Some stakeholders expressed concern, during outreach activities
such as the public meetings and in written comments, about including
the ``reasonably likely to occur'' approach in the 2013 proposed rules
for preventive controls for human and animal food. The concern was that
using the phrase ``reasonably likely to occur'' in two different
contexts (i.e., within our HACCP regulations as well as in its proposed
preventive controls regulations for human and animal food) would be
confusing. Some comments received under the proposed rule for
preventive controls for human food considered that the ``reasonably
likely to

occur'' approach was already so closely linked to our HACCP regulations
that the 2013 proposed rules for preventive controls for human and
animal food would be interpreted as requiring that all necessary
preventive controls be established at CCPs. These comments note that
such an interpretation would be inconsistent with FSMA. For example,
FSMA requires that the owner, operator, or agent in charge of a
facility identify and implement preventive controls, including at
critical control points, if any (emphasis added) (section 418(c) of the
FD&C Act). In addition, the definition of ``preventive controls'' in
FSMA is broader than CCPs (section 418(o)(3) of the FD&C Act). The
comments ask that we more explicitly provide for implementation of a
range of preventive controls (not just at CCPs). These comments also
express concern that a facility that already had established controls
to address hazards--but not at CCPs--would need to revise its food
safety plan, re-create any applicable records (e.g., various written
procedures) to satisfy the recordkeeping requirements of the rule,
which would add costs but no food safety benefits. For further
discussion of these comments, please see supplemental notice of
proposed rulemaking for preventive controls for human food published
elsewhere in this issue of the Federal Register.

C. Proposed Revisions to the Overall Framework for Hazard Analysis and
Risk-Based Preventive Controls

    The 2013 proposed rule for preventive controls would not have
required that all preventive controls be established at CCPs. However,
we acknowledge that it could be confusing to use the same phrase
``reasonably likely to occur'' in both the our HACCP regulations and in
the regulations we are proposing to establish to implement FSMA's
requirements for hazard analysis and risk-based preventive controls,
because the phrase ``reasonably likely to occur'' has been used as the
basis for determining hazards that need to be addressed in a HACCP plan
at CCPs.
    Likewise, the 2013 proposed rule for preventive controls would not
have limited a facility's flexibility to develop and implement a food
safety system that was indeed risk-based. However, we acknowledge that
some specific changes to the proposed regulatory text could help to
clarify the risk-based nature of all provisions of subpart C.
    We have not used the term ``prerequisite program'' in the proposed
regulatory text because, like ``hazard reasonably likely to occur,'' it
has a connotation with respect to our seafood and juice HACCP programs,
that is, it connotes activities that a facility may do that have an
impact on product safety but which are outside the scope of the
regulatory program. However, comments are not suggesting that
prerequisite programs that are essential to ensuring food safety should
be outside the scope of this proposed regulatory scheme. In fact,
comments asking that we recognize the role of prerequisite programs in
the management of hazards point out that preventive controls include
control measures that do not include CCPs and that companies would
consider many of these to be prerequisite programs. We acknowledge that
oftentimes preventive controls, other than those at critical control
points, are important parts of a food safety system, and must therefore
be included in the food safety plan that would be required by this
proposed rule. We attempted to make that clear in the proposed
requirement for preventive controls in Sec.  507.36(a) by incorporating
reference to ``controls, other than those at critical control points,
that are necessary for food safety.''
    We did not intend to require that a facility re-create or duplicate
existing records associated with controls; we simply laid out in the
2013 proposed rule for preventive controls the activities for which we
expect there to be records and the information we expect to find in
those records.
    Taking into account the comments we have reviewed so far, we are
proposing a series of revisions to proposed subpart C and are reopening
the comment period specifically with respect to these proposed
revisions. These proposed revisions include:
     Eliminating the term ``hazard reasonably likely to occur''
throughout proposed subpart C (and, thus, deleting the definition we
had proposed for this term).
     Adding a new defined term, ``significant hazard,'' and, in
general, using this new term instead of ``hazard reasonably likely to
occur'' throughout the proposed regulations. ``Significant hazard''
would mean 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, establish 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 control.
     Defining ``known or reasonably foreseeable hazard'' in
place of ``reasonably foreseeable hazard'' and clarifying that the new
term means a hazard ``that has the potential to be associated with the
facility or the food'' rather than ``a potential . . . hazard that may
be associated with the facility or the animal food'';
     Providing additional flexibility to address concerns about
re-writing existing plans or programs to conform with the requirement
of the preventive controls rule by explicitly providing that:
     Preventive controls include controls, other than those at
critical control points, that knowledgeable persons commonly recognize
as appropriate for animal food safety;
     The preventive control management components (i.e.,
monitoring, corrective actions, and verification) depend on the nature
of the control; and
     The recordkeeping requirements do not require duplication
of existing records if those records contain all of the required
information and satisfy the recordkeeping requirements of the
regulation. Existing records may supplemented as necessary to include
all of the required information. In addition, the required information
does not need to be kept in one set of records. If existing records
contain some of the required information, any new information required
by the preventive controls rule may be kept either separately or
combined with the existing records.
    The framework provided by ``significant hazard'' would reflect a
two-part analysis on the part of a facility. First, the facility would
narrow ``hazards'' to those hazards that are known or reasonably
foreseeable--i.e., those biological, chemical (including radiological),
or physical hazards that have the potential to be associated with the
facility or the food. Second, the facility would narrow the known or
reasonably foreseeable hazards to those that a person knowledgeable
about the safe manufacturing, processing, packing, or holding of food
would, based on the outcome of a hazard analysis, establish controls to
significantly minimize or prevent the hazard in an animal food, as well
as components to manage those controls (such as monitoring, corrections
or corrective actions, verification, and records) as appropriate to the