[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Proposed Rules]
[Pages 64735-64837]
[FR Doc No: 2013-25126]

Vol. 78

Tuesday,

No. 209

October 29, 2013

Part V

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 16, 225, 500 et al.

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

Federal Register / Vol. 78 , No. 209 / Tuesday, October 29, 2013 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 225, 500, 507, and 579

[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.

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SUMMARY: The Food and Drug Administration (FDA) is proposing
regulations for domestic and foreign facilities that are required to
register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
to establish requirements for current good manufacturing practice in
manufacturing, processing, packing, and holding of animal food. FDA
also is proposing regulations to require that certain facilities
establish and implement hazard analysis and risk-based preventive
controls for food for animals. FDA is taking this action to provide
greater assurance that animal food is safe and will not cause illness
or injury to animals or humans and is intended to build an animal food
safety system for the future that makes modern, science and risk-based
preventive controls the norm across all sectors of the animal food
system.

DATES: Submit either electronic or written comments on the proposed
rule by February 26, 2014. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by November 29, 2013
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0922 and/or Regulatory Information Number (RIN) 0910-AG10 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 or CD-ROM
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 Agency name
and Docket No 2011-N-0922 and RIN 0910-AG10 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 Proposed Rule
    Summary of the Major Provisions of the Proposed Rule
    Costs and Benefits
I. Introduction
II. Background
    A. Current Approaches to Animal Food Safety
    B. The Food and Drug Administration Amendments Act of 2007
    C. FDA Food Safety Modernization Act
    D. Preventive Controls and Hazard Analysis and Critical Control
Points (HACCP) Systems
    E. Animal Food Safety Incidents: Examples and Monitoring
    F. The Role of Testing as a Verification Measure in a Food
Safety System
    G. The Role of Supplier Approval and Verification Programs in a
Food Safety System
III. Public Meeting and Preliminary Stakeholder Comments
IV. Summary of the Scope of the Proposed Rule
V. Highlights of the Proposed Rule
    A. Overview
    B. Proposed Subpart A--General Provisions
    C. Proposed Subpart B--Current Good Manufacturing Practice
    D. Proposed Subpart C--Hazard Analysis and Risk-Based Preventive
Controls
    E. Proposed Subpart D--Withdrawal of an Exemption Applicable to
a Qualified Facility
    F. Proposed Subpart F--Requirements Applying to Records That
Must Be Established and Maintained
VI. Compliance Dates
VII. Rulemaking Required by Section 103(c) of FSMA: On-Farm
Activities
    A. Section 103(c) of FSMA
    B. Qualitative Risk Assessment of On-Farm Activities Outside of
the Farm Definition
    C. Results of the Qualitative Risk Assessment
    D. Tentative Conclusions Regarding On-Farm Low-Risk Activity/
Animal Food Combinations Under Section 418 of the FD&C Act
    E. Tentative Conclusions Regarding On-Farm Low-Risk Activity/
Animal Food Combinations Under Section 421 of the FD&C Act
VIII. Proposed Subpart A--General Provisions
    A. Proposed Sec.  507.1--Applicability and Status
    B. Proposed Sec.  507.3--Definitions
    C. Proposed Sec.  507.5--Exemptions
    D. Proposed Sec.  507.7--Requirements That Apply to a Qualified
Facility
    E. Proposed Sec.  507.10--Applicability of Subpart C to a
Facility Solely Engaged in the Storage of Packaged Animal Food That
is Not Exposed to the Environment
IX. Proposed Subpart B--Current Good Manufacturing Practice
    A. Animal Food and Current Good Manufacturing Practices (CGMPs)
    B. Proposed Current Good Manufacturing Practices (CGMPs) for
Animal Food
    C. Alternative to Establish Requirements in Place of Guidance in
the Proposed Current Good Manufacturing Practices (CGMPs)
X. Proposed Subpart C--Hazard Analysis and Risk-Based Preventive
Controls
    A. Proposed Sec.  507. 30--Requirement for a Food Safety Plan
    B. Proposed Sec.  507.33--Hazard Analysis
    C. Proposed Sec.  507.36--Preventive Controls for Hazards That
are Reasonably Likely to Occur
    D. Proposed Sec.  507.38--Recall Plan for Animal Food with a
Hazard That is Reasonably Likely to Occur
    E. Proposed Sec.  507.39--Monitoring
    F. Proposed Sec.  507.42--Corrective Actions
    G. Proposed Sec.  507.45--Verification
    H. Proposed Sec.  507.48--Modified Requirements That Apply to a
Facility Solely Engaged in the Storage of Packaged Animal Food That
is Not Exposed to the Environment
    I. Proposed Sec.  507.50--Requirements Applicable to a Qualified
Individual
    J. Proposed Sec.  507.55--Records Required for Subpart C
    K. Request for Comment on Additional Preventive Controls and
Verification Procedures Not Being Proposed

    L. Request for Comment on Other Potential Provisions Not
Explicitly Included in Section 418 of the FD&C Act
XI. Proposed Subpart D--Withdrawal of an Exemption Applicable to a
Qualified Facility
    A. Requirements of Section 418 of the FD&C Act
    B. Proposed Sec.  507.60--Circumstances That May Lead FDA to
Withdraw an Exemption Applicable to a Qualified Facility
    C. Proposed Sec.  507.62--Issuance of an Order to Withdraw an
Exemption Applicable to a Qualified Facility
    D. Proposed 507.65--Contents of an Order to Withdraw an
Exemption Applicable to a Qualified Facility
    E. Proposed Sec.  507.67--Compliance With, or Appeal of, an
Order to Withdraw an Exemption Applicable to a Qualified Facility
    F. Proposed Sec.  507.69--Procedure for Submitting an Appeal
    G. Proposed Sec.  507.71--Procedure for Requesting an Informal
Hearing
    H. Proposed Sec.  507.73--Requirements Applicable to an Informal
Hearing
    I. Proposed Sec.  507.75--Presiding Officer for an Appeal and
for an Informal Hearing
    J. Proposed Sec.  507.77--Timeframe for Issuing a Decision on an
Appeal
    K. Proposed Sec.  507.80--Revocation of an Order to Withdraw an
Exemption Applicable to a Qualified Facility
    L. Proposed Sec.  507.84--Final Agency Action
    M. Conforming Amendment to 21 CFR Part 16
XII. Proposed Subpart F--Requirements Applying to Records That Must
Be Established and Maintained
    A. Relevant Statutory Provisions
    B. Proposed Sec.  507.100--Records Subject to the Requirements
of this Subpart F
    C. Proposed Sec.  507.102--General Requirements Applying to
Records
    D. Proposed Sec.  507.106--Additional Requirements Applying to
the Food Safety Plan
    E. Proposed Sec.  507.108--Requirements for Record Retention
XIII. FSMA's Rulemaking Provisions
XIV. Proposed Conforming Changes
XV. Legal Authority
    A. Current Good Manufacturing Practice Regulations
    B. Hazard Analysis and Risk-Based Preventive Controls
XVI. 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
    E. Public Access to the Analyses
XVII. Paperwork Reduction Act of 1995
XVIII. Analysis of Environmental Impact
XIX. Federalism
XX. Comments
XXI. References
Appendix
I. The Role of Testing as a Verification Measure in a Modern Food
Safety System
    A. Verification of Preventive Controls
    B. Scientifically Valid Sampling and Testing
    C. Verification Testing of Raw Materials and Ingredients
    D. Verification of Sanitation Controls to Significantly Minimize
or Prevent the Potential for an Environmental Pathogen To
Contaminate Food
    E. Role of Environmental Monitoring in Verifying the
Implementation and Effectiveness of Sanitation Controls in
Significantly Minimizing or Preventing the Potential for an
Environmental Pathogen To Contaminate Food
    F. The Role of Finished Product Testing in Verifying the
Implementation and Effectiveness of Preventive Controls
II. The Role of Supplier Approval and Verification Programs in a
Food Safety System
III. References

Executive Summary

Purpose and Coverage of the Proposed Rule

    The proposed rule would establish regulations regarding the
manufacturing, processing, packing, or holding of animal food in two
ways. First, it would create new current good manufacturing practice
(CGMP) regulations that specifically address the manufacturing,
processing, packing, and holding of animal food. Second, it would
include new preventive control provisions intended to implement section
103 of the FDA Food Safety Modernization Act (FSMA) for animal food. In
general, with some exceptions the new preventive control provisions
would apply to animal food facilities that are required to register
with FDA under FDA's current food facility registration regulations.
These preventive controls would include requirements for covered
facilities to maintain a food safety plan, perform a hazard analysis,
and institute preventive controls for the mitigation of those hazards.
Facilities would also be required to monitor their controls, verify
that they were effective, take any appropriate corrective actions, and
maintain records documenting these actions.
    To put these changes in context, and to provide legal, regulatory,
scientific, and technical information relevant to the new provisions,
the Agency provides several sections of background. This background
discusses the current approaches to animal food safety; summarizes the
Food and Drug Administration Amendments Act of 2007 (FDAAA) as it
applies to pet food; provides an overview of the provisions of FSMA
applicable to this proposed rule; and describes a variety of hazards
that have been associated with animal foods and animal food safety
problems (including outbreaks of foodborne illness) that have resulted
from these hazards. An Appendix also describes the role of testing as a
verification measure in a food safety system and the role of supplier
approval and verification programs in a food safety system.

Summary of the Major Provisions of the Proposed Rule

    The proposed rule would establish certain CGMP provisions to ensure
the safety and suitability of animal food. The implementation of these
practices and procedures would protect against the contamination of
animal food. The proposed CGMPs would establish procedures in areas
such as buildings and facilities, design and layout, cleaning and
maintenance, pest control, and personnel hygiene.
    The proposed rule also would implement the requirements of section
103 of FSMA for animal food facilities that must register under section
415 of the FD&C Act (21 U.S.C. 350d) to establish and implement a food
safety system that includes a hazard analysis and risk-based preventive
controls. Specifically, the proposed rule would establish requirements
for:
     A written food safety plan;
     Hazard analysis;
     Preventive controls for hazards that are reasonably likely
to occur;
     Monitoring;
     Corrective actions;
     Verification; and
     Associated records.
    The application of the preventive controls would be required only
in cases where facilities determine that hazards are reasonably likely
to occur. The Agency does not expect that all possible preventive
measures and verification procedures would be applied to all animal
foods at all facilities.
    The proposed rule would also establish a series of exemptions
(including modified requirements in some cases) from the requirements
for hazard analysis and preventive controls. Facilities that
manufacture, process, pack, or hold animal food and that are required
to register with FDA under section 415 of the FD&C Act would be
required to comply with the proposed regulation unless they are covered
by an exemption. The table immediately below summarizes these proposed
exemptions in general terms. Importantly, the table in this Executive
Summary does not include all the details that a facility must consider
to determine whether an exemption applies. The Agency provides those
details in the proposed rule (proposed Sec.  507.5) and explains them
in section VIII.C.

  Proposed Exemptions From the New Requirements for Hazard Analysis and
                     Risk-Based Preventive Controls
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  Who or what would be exempt from
    the  requirements for hazard
analysis  and risk-based preventive                 Notes
              controls
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``Qualified Facility'' as defined    FDA is proposing three options for
 by FSMA                              defining ``very small business''
 Business with average        and requests comment on which to
 annual sales of <$500,000 and at     adopt in a final rule.
 least half the sales to consumers   Modified requirements would apply--
 or local retailers or restaurants    i.e., a qualified facility would
 (within the same state or within     be required to:
 275 miles); or                       Notify FDA about its
 Very small business          status; and
[cir] Option 1: Total annual sales    Either:
 of <$500,000                        [cir] Notify FDA that it is
[cir] Option 2: Total annual sales    addressing hazards through
 of <$1,000,000                       preventive controls and
[cir] Option 3: Total annual sales    monitoring; or
 of <$2,500,000                      [cir] Notify FDA that it complies
                                      with applicable local regulations,
                                      and notify consumers of the name
                                      and complete business address of
                                      the facility where the animal food
                                      was manufactured or processed.
 Low risk, on farm           Small and very small on-farm
 activities performed by a small      businesses conducting these low
 business (<500 employees): or        risk activities would be exempt
 Low-risk, on-farm            from most of the rule's
 activities performed by a very       requirements.
 small business                      The Agency would define the low-
[cir] Option 1: very small =          risk activities that qualify for
 <$500,000                            the exemption, including the
[cir] Option 2: very small =          specific foods to which they
 <$1,000,000                          relate (such as re-packing intact
[cir] Option 3: very small =          fruits and vegetables, or grinding/
 <$2,500,000                          milling/cracking/crushing grains).
Activities that are subject to the    The exemption applies only
 ``low-acid canned food''             with respect to microbiological
 requirements of Sec.   500.23 (21    hazards.
 CFR 500.23) and part 113 (21 CFR     The facility must be in
 part 113)                            compliance with part 113.
Activities of a facility that are    Published in the Federal Register
 subject to section 419 of the FD&C   January 16, 2013 (78 FR 3504).
 Act (21 U.S.C. 350h) (Standards
 for Produce Safety)
Facilities that are solely engaged   A facility that stores raw
 in the storage of raw agricultural   agricultural commodities that are
 commodities (other than fruits and   fruits or vegetables would not be
 vegetables) intended for further     exempt.
 distribution or processing
Facilities solely engaged in the     Modified requirements would apply
 storage of packaged animal food      for the storage of refrigerated
 that is not exposed to the           packaged animal food.
 environment
------------------------------------------------------------------------

    The proposed rule also would establish the conditions under which
an exemption granted to a ``qualified facility'' could be withdrawn,
and the procedures that would be followed to withdraw such an
exemption. The proposed rule would establish requirements that would
apply to all records that would be required by the various proposed
provisions. The proposed recordkeeping provisions would implement
specific requirements of FSMA regarding records associated with the new
provisions for hazard analysis and risk-based preventive controls and
would allow facilities to show, and FDA to determine, compliance with
the regulatory requirements.
    The proposed rule would require that a qualified individual prepare
the food safety plan, validate preventive controls, review records for
implementation and effectiveness of preventive controls and the
appropriateness of corrective actions, and perform the required
reanalysis of a food safety plan. The proposed rule also would
establish minimum requirements for the ``qualified individual,'' who
would be required to successfully complete training with a standardized
curriculum or be otherwise qualified through job experience to develop
and apply a food safety system. Only a trained individual or individual
qualified by job experience is capable of effectively executing these
activities.
    FDA is requesting comment on when and how other elements of a
preventive controls system are an appropriate means of implementing the
statutory directives, including: A product testing program, an
environmental monitoring program, and a supplier approval and
verification program, as appropriate.

Costs and Benefits

    The summary of the costs and potential benefits of the proposed
rule are presented in the table that follows.

------------------------------------------------------------------------
                                                        Total domestic
                                                       costs annualized
                                                      at 7 per cent over
                                                           10 years
                                                          (millions)
------------------------------------------------------------------------
Proposed Rule with Very Small Business Defined as                    $95
 Less Than or Equal to $500,000 in Annual Revenue...
Proposed Rule with Very Small Business Defined as                     89
 Less Than or Equal to $1,000,000 in Annual Revenue.
Proposed Rule with Very Small Business Defined as                     65
 Less Than or Equal to $2,500,000 in Annual Revenue.
------------------------------------------------------------------------

I. Introduction

    On January 4, 2011, President Obama signed into law the FDA Food
Safety Modernization Act (FSMA) (Pub. L. 111-353). This law enables FDA
to better protect public health by helping to ensure the safety and
security of the human and animal food supply. FSMA enables the Agency
to focus more on preventing food safety problems rather than relying
primarily on reacting to problems after they occur. The law also
provides the Agency 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 the Agency important new tools to
better ensure the safety of imported human and animal foods and directs
the Agency to build an integrated national food safety system in

partnership with State, local, tribal, and territorial authorities.
    This new law continues efforts by the human and animal food
industries and government to protect and improve the safety of the
nation's food supply. At the Federal level, these efforts go back to
the Pure Food and Drug Act of 1906, the United States' first national
food safety law. FSMA carries forward the basic principle embodied in
the 1906 law that food establishments have the primary responsibility
and capacity to make food safe and that government's role is to set
standards for food safety and provide oversight to help ensure
standards are met.
    Since passage of the 1906 Act, and the most recent revision of its
basic food safety provisions in the Federal Food, Drug, and Cosmetic
Act of 1938, the combined efforts of the food industry and government
have produced a set of standards and practices that make the U.S. food
supply among the safest in the world. These efforts include the
development and adoption by FDA of CGMP standards for human food that
have long provided the regulatory foundation for human food safety.
They also include, in more recent years, the adoption for some elements
of the animal and human food supply of more targeted, risk-based
approaches, such as embodied in the Hazard Analysis and Critical
Control Points (HACCP) approach to food safety.
    HACCP was pioneered by the human food industry and reflects the
understanding that food safety is best assured if each producer and
processor understands the hazards that are reasonably likely to occur
in their particular product and operation and puts in place
scientifically sound preventive controls to significantly minimize or
eliminate the hazard. FDA has by regulation required seafood and juice
processors to implement the HACCP approach to preventive controls. The
U.S. Department of Agriculture (USDA) has also mandated HACCP for meat
and poultry processors, and many human food companies have implemented
such modern preventive control systems for other commodities.
    While these efforts have contributed to progress on food safety,
significant human and animal food safety challenges persist in today's
complex, dynamic, and global food system. Today's food supply is highly
diverse and increasingly complex, with many new foods in the
marketplace that pose new food safety challenges. New pathogens are
emerging, and the Agency is seeing commonly known pathogens appear in
foods where they have not been traditionally seen. The population of
individuals at greater risk for foodborne illness, such as those who
are immune-compromised, is increasing. When illness outbreaks occur,
they can have devastating impacts on public health and impose
substantial economic disruption and cost on the human and animal food
industry. The food safety challenge is only compounded by globalization
and the increasing amount of imported human and animal food.
    Congress responded to today's food safety challenges by enacting
FSMA. FSMA builds on past experience and the strong foundation provided
by the current food safety system, but it also marks an historic
turning point for food safety. FSMA directs FDA to build a food safety
system for the future that makes modern, science- and risk-based
preventive controls the norm across all sectors of the food system;
meets the food safety challenges of the global food system; and
establishes stronger partnerships for food safety across all levels of
government and with the private sector to ensure optimal use of public
and private resources. FDA has embarked on a comprehensive effort to
build the food safety system mandated by Congress, as described on its
FSMA implementation Web page at http://www.fda.gov/fsma.
    A top priority for FDA are those FSMA-required regulations that
provide the framework for industry's implementation of preventive
controls and FDA's ability to oversee their implementation for both
domestic and imported food. These include, among others, regulations
establishing preventive control standards for human food and animal
food facilities, produce safety standards, standards that define the
accountability of importers to verify the safety of food produced
overseas, and a new program for accrediting private bodies to provide
credible certifications that regulated entities are meeting U.S. safety
standards. A proposed rule on foreign supplier verification is closely
interconnected to this rule on preventive controls for animal food (and
the preventive controls proposed rule for human food), and published in
the Federal Register on July 29, 2013 (78 FR 45730).
    In this document, the Agency proposes standards to implement the
requirement in section 103 of FSMA for the adoption of preventive
controls in animal food facilities. This preamble provides information
on FDA's previous efforts in working to establish CGMPs and process
controls for animal food, because these past efforts are the critical
starting point and foundation for FSMA implementation. The preamble
explains and provides additional background on the rationale for the
Agency's proposed regulations implementing FSMA's preventive controls
requirement and new CGMPs for the animal food industry. The Agency is
seeking comments on all aspects of this proposal.
    The document for the proposed rule for preventive controls for
human food, published in the Federal Register January 16, 2013 (78 FR
3646), contains discussions that are relevant to animal food safety and
the development of preventive controls for food for animals. The Agency
has identified relevant discussion found in the human food preamble
throughout this preamble and references the published document for
proposed preventive controls for human food for additional information.

II. Background

    Ensuring the safety of animal food is complex in light of several
factors. Animal food is made for a wide variety of species, including
animals from which human foods are derived, pet animals, and laboratory
animals. Many animals consume one food as their sole source of
nutrition. Therefore, the food that they consume must be nutritionally
adequate or the food presents a safety hazard to the animals. Nutrient
deficiencies or excesses can raise safety concerns. Because different
species have different nutritional needs, certain quantities of a
nutrient that are needed by one species of animal could pose a health
risk to another species of animal. Therefore, safety issues for animal
food can be raised not only by biological, chemical, physical, or
radiological contaminates of the food that can cause animal or human
health concerns, but also by nutrient deficiencies (or excesses) for
the animals.
    Animal foods are also handled in a wide variety of settings. Some
foods are handled on farms or in feed mills. Other foods, like pet
foods, are handled in homes and often in the kitchen. If the pet food
is contaminated with a pathogen of human health concern, this could
result in secondary contamination of human food-contact surfaces or
human food. Humans could become ill from the pathogen through handling
the pet food or through these secondary contaminations.
    The discussion that follows explains current regulatory tools and
other approaches the Agency has explored to address the safety of
animal food for animals, the safety of food from food-producing animals
consumed by humans, and the safety of humans handling animal food.
    This proposed rule would implement needed controls for animal food.
This

proposed rule would also help respond to requests the Agency receives
from international standard-setting organizations (e.g., Codex
Alimentarius) and individual countries that ask feed-exporting
countries to operate animal food safety systems with clear regulatory
oversight.

A. Current Approaches to Animal Food Safety

1. Animal Feed Safety System Working Group
    The Agency's efforts to upgrade animal food safety in this country
are continually evolving. Historically, FDA's animal food program
focused on specific safety issues, such as unsafe tissue residues
resulting from feeding of medicated animal food, Bovine Spongiform
Encephalopathy (BSE), and Salmonella, but had not addressed animal food
safety in a comprehensive manner. In 2003, FDA introduced the concept
of an Animal Feed Safety System (AFSS). A working group, the AFSS
Working Group, was established and charged with reviewing the many
separate regulations and supporting programs related to regulation of
animal food by FDA and the States, and identifying gaps in the
regulation of animal food that need to be addressed. The goal of this
working group was, and remains, the development and implementation of a
comprehensive, risk-based program that describes how all animal food
(individual ingredients and mixtures of ingredients) should be
manufactured and distributed to ensure the safety of the food for
animal consumption, as well as the safety of human food derived from
these animals (e.g., meat, milk, and eggs). The working group's concept
for an AFSS covers the entire continuum of Agency activities including:
     Pre-approval of additives for use in animal food;
     Establishing limits for hazards in animal food;
     Providing education and training;
     Conducting research;
     Performing inspections;
     Taking enforcement for ensuring compliance with Agency
regulations; and
     Establishing partnerships with State regulators with
responsibility for animal food safety.
    The AFSS concept also includes oversight of animal food production,
including manufacture, labeling, storage, distribution and use of all
animal food at all stages of production and use. A key element of the
AFSS concept is a systems approach that includes best management
practices during the ``manufacturing, labeling, storage, and
distribution'' of all animal food, coupled with steps to identify
hazards and to minimize or eliminate, as appropriate, the occurrence of
those hazards.
    The AFSS Working Group held public meetings on the AFSS concept in
September 2003 and April 2005. The meetings were designed primarily to
give stakeholders an opportunity to present information to FDA about
the direction and scope of the AFSS. Three additional meetings, held in
September 2006, May 2007, and May 2008, informed stakeholders of the
risk assessment initiatives being undertaken by the AFSS Working Group.
Information on these meetings can be found at the Agency's Web site
(Ref. 1).
    The AFSS Working Group used a number of sources in developing its
current design of components comprising the AFSS, including comments
from the public solicited through public meetings and interactions with
State regulatory officials, industry representatives, veterinarians and
consumers. In addition, the working group reviewed some of the
approaches used by the Agency and by industry to ensure human food
safety, such as HACCP systems, Standard Operating Procedures (SOPs),
Sanitation Standard Operating Procedures (SSOPs), and CGMPs, to
determine their applicability and usefulness to animal food control and
regulatory oversight in a risk-based preventive system. The working
group also reviewed the Codex Code of Practice on Good Animal Feeding
as a comparison to help identify gaps in the Agency's current
regulatory approach to animal food safety (Ref. 2). The Codex Code was
accepted by the European Union along with other foreign entities and
the U.S. delegation, which was comprised of U.S. Federal and State
Government officials and industry advisors to the Codex's Task Force on
Good Animal Feeding Practices.
    The AFSS Working Group identified seven operating components to
comprise the AFSS. These components cover processes to ensure that:
     Ingredients used in animal food are safe;
     The methods used to make, store, and distribute animal
food result in safe products;
     The Agency acquires timely information about unsafe animal
food and, when appropriate, makes such information publicly available;
     The levels of regulatory oversight are commensurate with
risk to human and animal health;
     Training, education, and outreach activities keep the
Agency's partners and stakeholders well informed and ensure that the
Agency and State animal food regulatory personnel are adequately
trained; and
     An active and aggressive research program is employed to
generate data to aid in addressing animal food safety issues.
    With the assistance of regulated animal food industry, the public,
and State regulatory personnel, the working group identified gaps in
the regulation of labeling, processing, and distribution of animal food
products. The working group describes these gaps and ways to address
them in the fourth AFSS Framework Document dated January 2010, which
can be found on FDA's Web site (Ref. 3).
    One critical gap is the lack of Federal regulations to fully
address all aspects of producing safe animal food associated with the
receiving, manufacturing, processing, packing, holding and distribution
of animal food (including pet food, animal feed, and raw materials and
ingredients) that does not contain animal drugs (i.e., non-medicated
animal food). To fill this gap, the working group began developing a
process control standards proposed rule, which aimed to prevent,
eliminate, or reduce to acceptable levels the potential risks posed to
human and animal health through a systems approach in which adequate
control steps would be established throughout the animal food
manufacturing process. After the passage of FSMA, the Agency
incorporated the work begun on the proposed rule for process control
standards into this proposed rule for preventive controls for animal
food.
    In addition, the AFSS Working Group is developing and
systematically applying a method that ranks risks associated with all
identified hazards. The use of risk concepts is not new for the Agency,
as FDA routinely tries to estimate public health impact in deciding
where to focus regulatory effort in general. The Agency relies heavily
on evaluation of risk posed by hazards that occur in animal food when
making decisions about food safety. Information on the AFSS can be
found at the Agency's Web site (Ref. 4).
2. Section 402 of the FD&C Act
    Section 402 of the FD&C Act (21 U.S.C. 342) deems food, including
animal food, adulterated in several circumstances, including:
    a. If it bears or contains any poisonous or deleterious substance
which may render it injurious to health (section 402(a)(1));

    b. If it bears or contains a pesticide chemical residue that is
unsafe within the meaning of section 408(a) of the FD&C Act (21 U.S.C.
346a) (section 402(a)(2)(B));
    c. If it bears or contains an unapproved food additive or an
unapproved new animal drug (section 402(a)(2)(C));
    d. If it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food (section
402(a)(3)); and
    e. If it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health (section
402(a)(4)).
    While the Agency has issued regulations related to the safety of
specific types of animal food and the use of certain food substances in
animal food, as will be described further in this preamble, section 402
of the FD&C Act applies to all animal food in interstate commerce.
3. Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers (LACF)
    Animal foods that are thermally processed low-acid foods packaged
in hermetically sealed containers are subject to the regulations in 21
CFR 500.23, which in turn states the provisions of part 113 (21 CFR
part 113) applies to animal food. Part 113 establishes the criteria by
which FDA determines whether the facilities, methods, practices, and
controls used by the commercial processor in the manufacture,
processing, or packing of low-acid foods in hermetically sealed
containers are operated or administered in a manner adequate to protect
the public health.
4. Animal Proteins Prohibited From Use in Animal Feeds
    The regulation in Sec.  589.2000 (21 CFR 589.2000), prohibiting the
use of certain animal proteins in ruminant feed, was published on June
5, 1997 (62 FR 30936). It was designed to prevent the establishment and
amplification of BSE, through animal food, by prohibiting the use of
certain proteins derived from mammalian tissue in the feeding of
ruminant animals. This BSE regulation affects renderers, protein
blenders, commercial animal food manufacturers, distributors (including
retailers), transporters of animal food and ingredients, on-farm animal
food mixers, and ruminant feeders.
    On December 7, 2000, the USDA/Animal and Plant Health Inspection
Service (USDA/APHIS) enacted regulations prohibiting the importation
into the United States of all meat and bone meal (MBM), meat meal, bone
meal, blood meal, tankage, offal, tallow, or any product containing
such, which originated directly from countries identified as having
BSE, or from countries having inadequate systems in place to prevent
BSE (9 CFR 94.18 and 95.4). The prohibitions include all rendered
products of animal origin including poultry meal and fishmeal that are
processed in these countries, regardless of species of origin, unless
the material is from a non-ruminant species and meets certain
conditions assuring no contamination with ruminant material. These
prohibitions were deemed necessary by APHIS because of the possibility
of cross contamination with the BSE agent. Subsequently, on January 20,
2001, FDA issued Import Alert 99-25, ``Detention Without
Physical Examination of Animal Feed, Animal Feed Ingredients and Other
Products for Animal Use Consisting or Containing Ingredients of Animal
Origin'' (Ref. 5).
    On April 25, 2008, FDA published a final rule in the Federal
Register, amending the BSE regulations to prohibit the use of certain
cattle origin material in the food or feed of all animals (73 FR
22720). This final rule established new regulations entitled ``Cattle
Materials Prohibited in Animal Food or Feed to Prevent the Transmission
of Bovine Spongiform Encephalopathy''. The new regulation, Sec.
589.2001 (21 CFR 589.2001), prohibits the use of certain cattle
materials in the feed of all animals and is aimed primarily at
rendering operations. This new rule also amended the BSE regulation in
21 CFR 589.2000.
    FDA assesses compliance of the BSE regulations through the Agency's
BSE/Ruminant Feed Ban Inspection Program (7371.009) (Ref. 6). This
program is designed to assess an animal food facility's operational
practices and procedures in preventing the spread of BSE through
inspectional observations and sampling.
5. Medicated Feeds CGMP
    Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B))
provides that a drug (including a drug contained in a medicated feed)
shall be deemed to be adulterated if the methods used in, or the
facilities or controls used for, its manufacture, processing, packing,
or holding do not conform to or are not operated or administered in
conformity with current good manufacturing practice to assure that such
drug meets the requirement of the FD&C Act as to safety, and has the
identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess.
    In May 1965, the Agency issued Current Good Manufacturing Practice
for Medicated Feeds, which implemented section 501(a)(2)(B) of the FD&C
Act for medicated animal food (30 FR 6475). The purpose of this
medicated feed regulation, part 225 (21 CFR part 225), was to establish
specific criteria for CGMPs that would ensure the safety, identity,
strength, and the quality and purity characteristics of medicated feed.
Medicated feed that is not manufactured, processed, packed, or held in
conformity with part 225 is adulterated under section 501(a)(2)(B) of
the FD&C Act.
    The medicated feed CGMPs ensure a pure, safe drug product through
requiring specific preventive measures during manufacturing,
processing, packing, and holding. In general, the CGMPs in part 225 do
not apply to the manufacturing, processing, packing, and holding of
non-medicated animal food, even if manufactured in the same facility.
However, non-medicated feed would be deemed adulterated under section
402(a)(2)(C)(ii) of the FD&C Act if contaminated with a new animal
drug.
6. Animal Food Labeling
    FDA regulations that establish animal food labeling standards in
part 501 (21 CFR part 501) include requirements for a statement of
identity, net quantity statement, manufacturer's name and address, and
proper listing of ingredients. In addition, the FDAAA required FDA to
issue regulations to update the standards for pet food labeling. These
implementing regulations are currently being developed by FDA. Further
discussion of FDAAA is presented in section II.B.
7. Generally Accepted as Safe (GRAS) Lists and GRAS Notifications
    GRAS is an acronym for the phrase Generally Recognized as Safe.
Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a substance is
not a food additive if it is generally recognized, among qualified
experts, as having been adequately shown to be safe under the
conditions of its intended use, or unless the use of the substance is
otherwise excluded from the definition of a food additive. A listing of
substances that are considered by the Agency to be generally recognized
as safe for specific intended uses in animal food is found in 21 CFR
parts 582 and 584.
    Under section 201(s) of the FD&C Act and 21 CFR 570.30, a substance
may be deemed to be GRAS if it is generally

recognized as having been adequately shown to be safe under the
conditions of its intended use in food through scientific procedures
or, for a substance used in food before 1958, through experience based
on common use in food.
    A GRAS substance is not subject to premarket review and approval by
FDA. A firm may market a GRAS substance intended for use in animal food
based on its own determination that the intended use is GRAS. If the
intended use of the substance is not GRAS, the substance and firm
marketing it for this use may be subject to enforcement action by FDA.
    Although not required to do so, firms that have determined that the
intended use of a substance in animal food is GRAS may petition FDA to
affirm that a substance is GRAS under certain conditions of use under
21 CFR 570.35(c). Alternatively, they may participate in FDA's GRAS
notification pilot program. On June 4, 2010, FDA announced that it
would begin a voluntary pilot program for GRAS notifications for
substances added to animal food (75 FR 31800). This program is based on
an April 17, 1997 proposed rule on GRAS notification (62 FR 18938).
8. Approved Food Additives
    Under section 201(s) of the FD&C Act, a food additive means ``any
substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristics of any food (including any
substance intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food; and including any source of radiation intended for any such use),
if such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as having
been adequately shown through scientific procedures (or in the case of
a substance used in food prior to January 1, 1958, through scientific
procedures or experience based on common use in food) to be safe under
the conditions of its intended use. . .''. Other substances that are
excluded from the definition of a food additive include pesticide
chemical residues, pesticide chemicals, color additives, prior
sanctioned substances, and new animal drugs.
    Many substances added to an animal food are food additives, varying
by composition and intended use. A food additive generally provides one
or more of the following attributes: nutrition, aroma/flavor,
stabilization, emulsification, and preservation. A listing of food
additives permitted in animal food, including drinking water for
animals, is found in 21 CFR part 573.
    To market a food additive, a sponsor must first petition FDA by
submitting information that includes all relevant data bearing on the
effect the additive is intended to have in or on food and full reports
of investigations made with respect to the safety of the food additive.
If FDA approves the petition, FDA publishes a regulation prescribing
the conditions of use under which the additive may be safely used. The
regulations that apply to food additives used in animal foods and that
describe the food additive petition process are published in 21 CFR
part 571.
9. Approved Color Additives
    A color additive, as defined in 201(t)(1) of the FD&C Act, includes
a dye, pigment, or other substance made by a process of synthesis or
similar artifice, or extracted, isolated, or otherwise derived, with or
without intermediate or final change of identity, from a vegetable,
animal, mineral, or other source that is capable of imparting color
when added or applied to food. The listing of approved human and animal
food color additives is found in 21 CFR parts 73 and 74.
    A color additive must be shown to be safe and be listed in the Code
of Federal Regulations before it may be used to color foods. An
interested person may petition FDA for the listing of a color additive,
which includes the submission of data demonstrating the color additive
is safe and suitable for the proposed use, as described in 21 CFR part
71. The FDA will, upon written request, advise on the adequacy of
studies planned to yield these data (21 CFR 70.42(c)).
10. Animal Food Sampling Program
    The Agency's Feed Contaminants Program (FCP) is an animal food
sampling and inspection program that addresses most animal food
contaminants, including pesticides, industrial chemicals, dioxins,
heavy metals, mycotoxins, and pathogens. It does not address drug
residues and agents that cause BSE and other transmissible spongiform
encephalopathies (TSEs), as those contaminants are tested for under
other programs. Under the FCP, FDA conducts random surveillance sample
collections and inspections as well as followup investigations when an
animal food sample is found to contain violative levels of
contaminants.
    The contaminants addressed by the FCP can be hazardous to livestock
health and production, pet health, and to human health through residues
in animal-derived human food. Many of the more frequently identified
contaminants in animal food are toxic, carcinogenic, mutagenic,
teratogenic, or otherwise deleterious to animals, humans, or both.
    Animal food facilities are inspected by FDA and State Agencies.
Many of the inspections are performed for FDA by states that have
entered into a contract to conduct inspections in accordance with the
Agency's procedures. Under State partnership and cooperative
agreements, States agree to conduct inspections under their own
authorities and to share the results with FDA. Inspections of animal
food facilities play an important role in ensuring the safety of the
nation's animal food supply.
11. Animal Food Safety Guidance to Industry
    FDA has issued numerous guidance documents (hereinafter,
``guidance'' or ``guidances'') to assist the animal food industry in
implementing food safety regulatory requirements under FDA's
jurisdiction. The Agency issues guidances, in accordance with its
regulations in Sec.  10.115 (21 CFR 10.115) for ``good guidance
practices,'' to describe its interpretation of or policy on a
regulatory issue. Guidances do not establish legally enforceable rights
or responsibilities and do not legally bind the public or FDA (Sec.
10.115(d)(1)). Accordingly, regulated industry is not required to
employ the approaches contained in a guidance and instead may choose to
use an alternative approach, provided that the alternative approach
complies with the relevant statutes and regulations (Sec.
10.115(d)(2)). Although guidances do not legally bind FDA, they
represent the Agency's current thinking on a particular interpretation
of or policy regarding a given regulatory issue (Sec.  10.115(d)(3)).
Under Sec.  10.115(c)(1) and (g), FDA publishes a guidance in draft
form for public comment before issuing the guidance in final form,
except where prior public participation is not feasible or appropriate,
if the guidance: (1) Sets forth initial interpretations of statutory or
regulatory requirements, (2) sets forth changes in interpretation or
policy that are of more than a minor nature; (3) includes complex
scientific issues, or (4) covers highly controversial issues.
    FDA generally issues guidance to industry for the purpose of
communicating the Agency's policy decisions and interpretations of its
regulatory requirements so that regulated industry better understands

how to comply with those requirements. In some cases, the Agency issues
guidance specifically targeted to assisting industry in complying with
a particular food safety regulation. For example, the Agency has issued
several guidances to assist industry in complying with the regulatory
requirements for BSE (Sec. Sec.  589.2000 and 589.2001) (Refs. 7, 8, 9,
10, and 11). In other cases, the Agency issued guidance that is more
narrowly focused in scope or is not directly targeted to assisting
industry in complying with a particular food safety regulation. For
example, the Agency has issued guidance that addresses deoxynivalenol
(DON), also known as vomitoxin, in grain and grain by-products used for
animal food (Ref. 12) and guidance on measures to address the risk for
contamination by Salmonella spp. in raw meat foods for companion and
captive non-companion carnivores and omnivores (Ref. 13).
12. Animal Food Safety Compliance Policy Guides
    FDA issues guidance to its staff in the form of a compliance policy
guide (CPG). The primary purpose of a CPG is to explain FDA's policy on
regulatory issues related to the statutes and regulations that FDA is
responsible for implementing. CPGs advise FDA field inspection and
compliance personnel as to FDA's standards and procedures to be applied
when determining industry compliance with our regulatory requirements.
FDA issues CPGs in accordance with its regulation for good guidance
practices in Sec.  10.115 and makes the CPGs available to the public,
thereby providing regulated industry with additional insight into how
the Agency interprets the statutes and regulations it is responsible
for implementing for purposes of assessing compliance with the Agency's
regulatory requirements. In general, FDA's animal food safety CPGs are
relatively focused in scope. For example, the Agency has issued a CPG
regarding Salmonella contamination in all food for animals (Ref. 14),
and a CPG that sets forth the criteria that are to be used by FDA
personnel to determine whether to take action on animal foods
containing aflatoxins (Ref. 15).

B. The Food and Drug Administration Amendments Act of 2007

    On September 27, 2007, the FDAAA (21 U.S.C. 2102) was signed into
law (Pub. L. 110-85). Section 1002(a) of Title X (Food Safety) of the
FDAAA requires the Secretary of Health and Human Services (HHS), in
consultation with relevant stakeholder groups, including the
Association of American Feed Control Officials (AAFCO), veterinary
medical associations, animal health organizations, and pet food
manufacturers, to issue new regulations establishing, among other
things, processing standards for pet foods. A public meeting that
included representatives for the previously mentioned stakeholders was
held May 13, 2008, after publication of a notice in the Federal
Register on April 21, 2008 (73 FR 21357).
    Neither the FDAAA, nor its legislative history, described what
Congress meant by ``processing standards'' for pet food. In many
instances the same ingredients and manufacturing processes are used to
produce animal food for both non-food-producing animals, including
pets, and food-producing animals. FDA determined that it would not be
feasible to implement or enforce processing standards that only applied
to one segment of the industry (i.e., pet food.)
    The proposed rule for process control standards that the Agency was
developing (see the discussion in section II.A.1) included all animal
food. After FDAAA was signed into law, a discussion of FDAAA and the
requirements for processing standards for pet food was added to the
preamble of the proposed rule for process controls standards to clarify
that the proposed rule would satisfy these requirements for pet food.
After FSMA was enacted, the Agency decided to issue one rule that would
satisfy the mandate of section 1002(a) of FDAAA and section 103 of
FSMA.

C. FDA Food Safety Modernization Act

1. Requirements for Food Facilities
    FSMA was signed into law by the President on January 4, 2011 (Pub.
L. 111-353). Section 103 of FSMA, Hazard Analysis and Risk-Based
Preventive Controls, amends the FD&C Act to create a new section 418
(21 U.S.C. 350g) with the same name. Many of the provisions in section
103 of FSMA that are relevant to this rulemaking are codified in
section 418 of the FD&C Act.
    a. General requirements. Section 418 of the FD&C Act contains
requirements applicable to food facilities and mandates Agency
rulemaking. Section 418(a) is a general provision that requires the
owner, operator, or agent in charge of a facility to evaluate the
hazards that could affect food (including animal food) manufactured,
processed, packed, or held by the facility, identify and implement
preventive controls, monitor the performance of those controls, and
maintain records of the monitoring. Section 418(a) specifies that the
purpose of the preventive controls is to ``prevent the occurrence of
such hazards and provide assurances that such food is not adulterated
under section 402 [of the FD&C Act]. . . .''
    In addition to those areas specified in section 418(a) of the FD&C
Act, sections 418(b) through (i) contain more specific requirements
applicable to facilities. These include corrective actions (section
418(e)), verification (section 418(f)), a written plan and
documentation (section 418(h)), and reanalysis of hazards (section
418(i)). Section 103(e) of FSMA creates a new section 301(uu) in the
FD&C Act (21 U.S.C. 331(uu)) to prohibit ``[t]he operation of a
facility that manufactures, processes, packs, or holds food for sale in
the United States if the owner, operator, or agent in charge of such
facility is not in compliance with section 418 [of the FD&C Act].''
Section X discusses proposed requirements (proposed subpart C) that
would implement these provisions of section 418 of the FD&C Act.
    b. Qualified facilities. Section 418(l) of the FD&C Act (Modified
Requirements for Qualified Facilities) establishes criteria for a
facility to be a qualified facility, establishes an exemption for
qualified facilities, establishes modified requirements for qualified
facilities, and provides that the Secretary may withdraw the exemption
otherwise granted to qualified facilities in specified circumstances.
Under section 418(l)(1) of the FD&C Act, a facility is a qualified
facility if: (1) It is a very small business as the term would be
defined by this rulemaking or (2) it falls within specified limitations
on the average annual monetary value of its sales and types of
customers. Section 418(l)(2)(A) of the FD&C Act exempts a qualified
facility from the requirements for hazard analysis and risk-based
preventive controls as set forth in sections 418(a) through (i) of the
FD&C Act, as well as the requirements issued under section 418(n) of
the FD&C Act. Section 418(l)(2)(B) of the FD&C Act requires a qualified
facility to submit documentation to the Secretary of HHS (the
Secretary) related to its qualified status and also submit either
documentation of the facility's implementation and monitoring of
preventive controls or documentation of its compliance with other
appropriate non-Federal food safety laws. Section 418(l)(3) of the FD&C
Act authorizes the Secretary to withdraw the exemption from a qualified
facility in specified circumstances. Section VIII.C discusses a
proposed exemption for qualified facilities (proposed Sec.  507.5(d)).
Section XI discusses a proposed process for withdrawing an exemption
for a

qualified facility (proposed subpart D). Section VIII.D discusses
proposed requirements that apply to qualified facilities (proposed
Sec.  507.7).
    c. Exemptions and exceptions. In addition to the exemption for
qualified facilities in section 418(l)(2)(A) of the FD&C Act, there are
several other exemptions and exceptions to the requirements specified
in section 418 of the FD&C Act. Section 418(j) of the FD&C Act provides
an exemption for facilities that are required to comply and are in
compliance with the regulations for seafood HACCP, juice HACCP, or
thermally processed low-acid foods packed in hermetically sealed
containers. Section 418(k) of the FD&C Act provides an exception for
activities of facilities subject to section 419 of the FD&C Act
(Standards for Produce Safety). Section 103(g) of FSMA provides an
exemption for certain activities regarding a dietary supplement that is
in compliance with section 402(g)(2) of the FD&C Act and section 761 of
the FD&C Act (21 U.S.C. 379aa-1). For animal food facilities, only two
of those exemptions are relevant: activities that are subject to the
requirements for thermally processed low-acid foods packed in
hermetically sealed containers (proposed Sec.  507.5(b)), and section
419 of the FD&C Act (proposed Sec.  507.5(c)) as discussed in section
VIII.C.
2. Requirements for Agency Rulemaking
    Section 103 of FSMA contains two separate rulemaking provisions.
Section 103(a) of FSMA requires rulemaking related to the hazard
analysis and risk-based preventive controls required by section 418 of
the FD&C Act. In addition, section 103(c) of FSMA requires rulemaking
in two areas: (1) Clarification of certain aspects of the definition of
the term ``farm'' under section 415 of the FD&C Act (Registration of
Food Facilities) and (2) possible exemption from or modification of
requirements of section 418 and section 421 of the FD&C Act (21 U.S.C.
350j) (Targeting of Inspection Resources for Domestic Facilities,
Foreign Facilities, and Ports of Entry; Annual Report) for certain
facilities as the Secretary deems appropriate and as further specified
in section 103(c)(1)(D) of FSMA.
    a. General rulemaking requirements. Section 418(n)(1)(A) of the
FD&C Act requires that not later than 18 months after the date of
FSMA's enactment, the Secretary issue regulations ``to establish
science-based minimum standards for conducting a hazard analysis,
documenting hazards, implementing preventive controls, and documenting
the implementation of the preventive controls. . . .''
    b. Definition of small and very small business. Section 418(l)(5)
of the FD&C Act requires the Secretary, in consultation with the
Secretary of Agriculture, to conduct a study of the food processing
sector regulated by the Secretary and to make determinations in five
areas. These areas include, in part: (1) Distribution of food
production by type and size of operation, (2) the proportion of food
produced by each type and size of operation, (3) the number and types
of food facilities co-located on farms, (4) the incidence of foodborne
illness originating from each size and type of operation, and (5) the
effect on foodborne illness risk associated with certain activities
regarding food.
    Section 418(n)(1)(B) of the FD&C Act requires that the regulations
define the terms ``small business'' and ``very small business,'' taking
into consideration the study of the food processing sector required by
section 418(l)(5) of the FD&C Act. These terms are significant because
section 103 of FSMA contains several provisions specific to such
entities.
     Small and very small businesses are subject to
modifications or exemptions from requirements under section 418 or 421
of the FD&C Act for facilities engaged only in specific types of on-
farm activities and involving foods that the Secretary determines to be
low risk (section 103(c)(1)(D) of FSMA).
     Small and very small businesses are not subject to section
418 of the FD&C Act until 6 months (small businesses) or 18 months
(very small businesses) after the effective date of FDA's final rule
(section 103(i) of FSMA).
     A very small business is deemed a ``qualified facility''
and would, therefore, qualify for the exemptions as discussed in
section VIII.C.1. (section 418(l)(1)(B) of the FD&C Act).
    Consistent with section 418(l)(5) of the FD&C Act, FDA has
consulted with the USDA during its study of the food processing sector.
The study is available in the docket established for this proposed rule
(Ref. 16). The Agency requests comment on that study. Section VIII.B
discusses the proposed definitions for small business and very small
business for animal food facilities. FDA will consider comments
regarding the study, as well as comments regarding the proposed
definitions for small and very small business, in any final rule based
on this proposed rule.
    c. Clarification of the term ``facility.'' Generally, section 418
of the FD&C Act applies to the owner, operator, or agent in charge of a
``facility.'' Section 418(o)(2) of the FD&C Act defines ``facility'' as
``a domestic facility or a foreign facility that is required to
register under section 415.'' Section 415 of the FD&C Act, in turn,
requires any facility engaged in manufacturing, processing, packing, or
holding food for consumption in the United States to register with the
Secretary.
    The requirement in section 415 of the FD&C Act that a facility must
register does not apply to farms. FDA's implementing regulations for
section 415 (21 CFR part 1, subpart H; later in this document stated as
the section 415 registration regulations) define ``farm,'' in relevant
part, as ``a facility in one general physical location devoted to the
growing and harvesting of crops, the raising of animals (including
seafood), or both'' (Sec.  1.227(b)(3)) (21 CFR 1.227(b)(3)).
    The term ``farm'' includes a facility that packs or holds food,
provided that all food used in such activities is grown, raised, or
consumed on that farm or another farm under the same ownership (Sec.
1.227(b)(3)(i)). Under that same definition, the term ``farm'' also
includes a facility that manufactures/processes food, provided that all
food used in such activities is consumed on that farm or another farm
under the same ownership (Sec.  1.227(b)(3)(ii)).
    Section 103(c)(1)(A) of FSMA requires that not later than 9 months
after the date of enactment, the Secretary publish a notice of proposed
rulemaking in the Federal Register to issue regulations for purposes of
section 415 of the FD&C Act with respect to ``activities that
constitute on-farm packing or holding of food that is not grown,
raised, or consumed on such farm or another farm under the same
ownership'' and ``activities that constitute on-farm manufacturing or
processing of food that is not consumed on that farm or on another farm
under common ownership.'' The regulation is intended to ``enhance the
implementation'' of section 415 and ``clarify the activities that are
included within the definition of the term ``facility'' (section
301(c)(1)(B) of FSMA). In section VIII.E of the document for the
proposed rule for preventive controls for human food (78 FR 3646), the
Agency discusses the proposal to revise the section 415 registration
regulations to enhance the implementation of section 415 and to clarify
the definition of the term ``facility.'' That discussion applies to
activities related to animal food and animal food facilities as well.
    d. Science-based risk analysis and requirements under sections 418
and 421 of the FD&C Act. Section 103(c)(1)(C) of FSMA requires that in

issuing the proposed rule the Secretary conduct a science-based risk
analysis of:
     ``Specific types of on-farm packing or holding of food
that is not grown, raised, or consumed on such farm or another farm
under the same ownership, as such packing and holding relates to
specific foods; and
     Specific on-farm manufacturing and processing activities
as such activities relate to specific foods that are not consumed on
that farm or on another farm under common ownership.''
    As part of the rulemaking, the Secretary is required to consider
the results of the science-based risk analysis and exempt certain
facilities from the requirements in sections 418 and 421 of the FD&C
Act or modify those requirements, as the Secretary determines
appropriate, if such facilities are only engaged in specific types of
on-farm manufacturing, processing, packing, or holding activities the
Secretary determines to be low risk, and involving specific foods that
the Secretary determines to be low risk (section 103(c)(1)(D)(i) of
FSMA). Any exemption or modification is limited to small and very small
businesses (section 103(c)(1)(D)(ii) of FSMA).
    Section VII discusses the Agency's approach to the requirement in
FSMA section 103(c) for a science-based risk analysis of the types of
on-farm manufacturing, processing, packing, or holding operations that
can involve animal food that is not consumed on that farm or on another
farm under common ownership for purposes of section 415 of the FD&C Act
and request comment on that approach. The final approach will consider
comments received to this proposed rule.
    Section VIII.C discusses proposed exemptions for small and very
small businesses that are solely engaged in certain types of ``low
risk'' activities involving the on-farm manufacturing, processing,
packing, and holding of certain ``low risk'' animal foods from the
requirements of section 418 of the FD&C Act (proposed Sec.  507.5(e)
and (f)). The Agency also discusses its tentative conclusion that it
should not exempt or modify the frequency requirements under section
421 based solely upon whether a facility only engages in such low-risk
activity/food combinations and is a small or very small business.
    e. Exemption or modification of requirements for certain
facilities. Under section 418(m) of the FD&C Act, the Secretary may
exempt or modify the requirements for compliance of section 418 of the
FD&C Act for hazard analysis and preventive controls for facilities
that are solely engaged in the storage of raw agricultural commodities
(RACs) (other than fruits and vegetables) intended for further
distribution or processing. As discussed in section VIII.C, in
accordance with the discretionary language of section 418(m), FDA
tentatively concludes that facilities solely engaged in the storage of
RACs for animal food, other than fruits and vegetables, intended for
further distribution or processing should be exempt from the
requirements for hazard analysis and preventive controls that the
Agency is proposing in subpart C of part 507. However, as discussed in
section VIII.C, the Agency is asking for comment on whether facilities
solely engaged in the storage of grains that are RACs for animal food
should be included in the final rule.
    Section 418(m) of the FD&C Act also authorizes the Secretary to
exempt or modify the requirements for compliance with section 418 for
facilities that are solely engaged in the storage of packaged foods
that are not exposed to the environment. Section VIII.E describes the
proposal for how the requirements of proposed part 507 would apply to
such facilities that store animal food (proposed Sec.  507.10). Section
X.I discusses the proposed modified requirements for such facilities,
directed at the storage of packaged animal foods that are not exposed
to the environment and that require time/temperature control to limit
the growth of, or toxin formation by, microorganisms of animal and
human health significance (proposed Sec.  507.48).
    FDA proposes to implement section 103 of FSMA in several
regulations, rather than a single regulation that covers all food and
hazards subject to preventive controls. This proposal is applicable to
certain hazards that may be associated with a food facility that
manufactures, processes, packs or holds animal food. Section 103 of
FSMA applies to ``food,'' which is not limited to human food. Section
201(f) of the FD&C Act defines ``food'' to include ``articles used for
food or drink for man or other animals.'' FDA tentatively concludes
that the differences between human and animal food are best addressed
through separate rulemakings. Section 418(m) of the FD&C Act authorizes
the Secretary, by regulation, to modify the requirements for compliance
under the section with respect to facilities that are engaged solely in
the production of food for animals other than man. The Agency has
tentatively concluded that the requirements of section 418 of the FD&C
Act are needed to ensure the safety of animal food and in turn the
health of animals, the health of humans who are exposed to animal food,
and the safety of animal derived products for human consumption.
Therefore, the Agency is proposing requirements to implement section
418 of the FD&C Act for animal food with only few modifications (e.g.,
no allergen controls.) The Agency requests comment on whether the
requirements in section 418 of the FD&C Act should be modified further
for facilities that are solely engaged in the production of food for
animals other than man, based on scientific and public health
principles.
    f. Intentional adulteration. This proposed rulemaking is not
intended to address ``hazards that may be intentionally introduced,
including by acts of terrorism'' (section 418(b)(2) of the FD&C Act).
FDA plans to address section 103 of FSMA regarding such hazards in a
separate rulemaking in the future. FDA tentatively concludes that
intentional hazards, which are not addressed in traditional HACCP or
other food safety systems, likely will require different kinds of
controls and would be best addressed in a separate rulemaking. However,
FDA also recognizes that some kinds of intentional adulterants could be
viewed as reasonably likely to occur, e.g., in animal foods concerning
which there is a widely recognized risk of economically motivated
adulteration in certain circumstances. An example of this kind of
hazard is the addition of melamine to certain food products apparently
to enhance perceived quality and/or protein content. The Agency
requests comment on whether to include potential hazards that may be
intentionally introduced for economic reasons. The Agency also requests
comment on when an economically motivated adulterant can be considered
reasonably likely to occur.

D. Preventive Controls and Hazard Analysis and Critical Control Points
(HACCP) Systems

    HACCP is a preventive strategy for food safety that involves a
systematic approach to the identification and assessment of the risk
(likelihood of occurrence and severity) of hazards from a particular
food or food production process or practice and the control of those
hazards. FDA tentatively concludes for several reasons that HACCP is
the appropriate framework to reference in interpreting and implementing
section 103 of FSMA. For a full discussion of HACCP and preventive
controls systems comparisons, please see section II.C of the document
for the proposed rule for the preventive controls for human food (78 FR
3646).

E. Animal Food Safety Incidents: Examples and Monitoring

1. Examples of Animal Food Safety Incidents
    Historically, the Agency has focused on specific animal food safety
issues as problems arise, typically after the distribution of the
contaminated animal food. Examples include safety issues related to
BSE, chronic wasting disease, mycotoxins (especially aflatoxin in
animal food intended for lactating dairy cattle), dioxins, melamine,
and microbial contamination in pet foods.
    The massive pet food recall due to adulteration of pet food with
melamine and cyanuric acid (chemicals called triazines) in 2007 is a
prime example. The actions taken by two protein suppliers in China to
intentionally adulterate wheat gluten and rice protein concentrate for
economic reasons affected a large number of pet food facilities in the
United States and created a nationwide problem by causing illness and
death in many dogs and cats. The addition of melamine to wheat gluten
and rice protein concentrate resulted in a high nitrogen reading during
Kjeldahl testing, a test method used to estimate protein levels in
foods. By adding the melamine, a non-protein source of nitrogen, the
suppliers created a falsely high estimate of protein in their products.
While melamine by itself is relatively non-toxic to mammals, the
melamine used to adulterate the wheat gluten and rice protein
concentrate in this incident had been combined with cyanuric acid,
creating a mixture that became toxic. The presence of cyanuric acid
with melamine resulted in a precipitation of crystals (melamine
cyanurate) when mixed in a solution (Ref. 17). When the animals
ingested the adulterated food, the mix of these two chemicals was
absorbed into the blood stream and ultimately created an accumulation
of crystals in the tubules of the animals' kidneys, leading to kidney
disease and death in many animals.
    By the time the cause of the illness and deaths was identified,
melamine and cyanuric acid contaminated ingredients resulted in the
adulteration of millions of individual servings of pet food. Checks to
ensure the safety of the imported ingredients had not been conducted by
the importer or by the pet food manufacturers that incorporated the
ingredients into pet food.
    During the investigation, FDA determined that leftovers from the
production of pet food (commonly called fines) and salvaged, finished
pet food products were routinely used in the production of feed for
some food-producing animals (e.g., swine and poultry). It was
ultimately discovered that some of these fines and salvaged pet food
were adulterated with melamine (and other triazine analogs). Urine from
swine (that were being raised for human food consumption) that had
eaten this contaminated food was tested and found to contain melamine.
This discovery resulted in the holding of animals before their
marketing for human food in order to provide time for the U.S.
government to conduct a risk assessment to ensure the safety of the
meat for human consumption. It was ultimately determined there was no
risk to human health from eating meat from these animals due to the
small amounts of contaminants in the animal feed eaten.
    The contaminated wheat gluten was also used in the manufacture of
fish food used in fish hatcheries for food-producing fish. As a result,
there was a recall of the affected fish food. These situations with
food-producing animals emphasized the link between adulterated animal
food (and ingredients) and the potential for adverse effects on human
health.
    The melamine incident underscored the difficulty in tracing an
adulterated ingredient that has been used in a large number of food
products. The list of recalled animal foods was constantly updated for
multiple weeks after the initial identification of the adulterated
ingredients as the distribution of those ingredients was traced. Pet
food companies who thought their pet foods were safe because their
formulations did not included the use of wheat gluten or rice protein
concentrate were surprised to find some of their products were indeed
adulterated with the melamine and cyanuric acid. An FDA investigation
revealed that a contracted pet food manufacturer was substituting rice
protein concentrate for other sources of protein called for in these
formulations without contacting the parent company.
    Additional incidents of animal food contamination not discovered
until after the food was distributed include the detection of dioxin in
feed. Dioxin has been linked to adverse health effects in humans, such
as cancer, immune suppression, and reproductive or developmental
effects. Dioxin is a concern in food-producing animals because human
dioxin exposure in the United States comes primarily from the
consumption of animal products. In 1997, the USDA's Food Safety and
Inspection Service, through their dioxin sampling survey, identified
dioxins in poultry tissue. Through a multi-agency investigation, the
FDA traced this contamination to high levels of dioxins present in an
anti-caking agent (ball clay) used in animal food. That same year, FDA
issued a statement to users of ball clay products in animal feed
requesting those companies to cease the use of ball clay products in
animal feeds and feed ingredients (Ref. 18). In 2002, a foreign
government identified high dioxin levels in a mineral product intended
for animal food imported from the United States (Ref. 19). The source
of the dioxin was related to the high temperature used in the mineral
manufacturing process. In 2003, another dioxin incident in minerals was
identified as a result of an FDA food sampling assignment. In this
case, the mineral premix manufacturer purchased a trace mineral that
was a by-product of a metal smelting process (Ref. 20).
Internationally, in 1999, animal feed contaminated with dioxin and
polychlorinated biphenyls in Belgium resulted in animal and human
exposure in Europe. The Belgium government estimated the economic
impact of the dioxin crisis cost $493 million, of which $106 million
was lost in the swine industry alone. The total cost is much greater
when factoring in the impact that occurred to the animal and human food
industries in European countries that imported contaminated animal food
(livestock feed) or human food from Belgium (Ref. 21). In 2009, a
dioxin incident occurred in Ireland involving swine feed that resulted
in a global recall of Irish pork. This incident resulted in the Irish
government providing [euro] 200 million ($266 million) compensation
packages for the Irish pork industry due to their economic losses (Ref.
22). These incidents raised public awareness of the problem of dioxin
contamination in animal food.
    Another animal food contaminant that can cause illness and injury
to animals and humans is aflatoxin. Aflatoxins are naturally occurring
mycotoxins that are produced by many species of the fungus Aspergillus
on certain agricultural commodities. Since their discovery in the early
1960's, aflatoxins have been shown to be toxic to animals and humans.
Aflatoxins have also been shown to be carcinogenic to laboratory test
animals. After consumption, aflatoxins are metabolized by the liver to
a reactive intermediate and eliminated as aflatoxin M1 in milk or as
aflatoxicol in urine. High level aflatoxin exposure produces acute
damage and cirrhosis of the liver as well as cancer of the liver. It
appears that no animal species, including humans, is immune to the
acute toxic effects of aflatoxins. In 2005, a pet food company in South

Carolina recalled dog food that was contaminated with aflatoxin (Ref.
23). The Agency received reports from 4 states of illness in over 40
dogs, including 23 deaths, associated with the consumption of the
contaminated pet food. In addition, the company's contaminated pet food
was exported to at least 29 foreign countries. The source of this
contamination was traced to local corn, which had been contaminated
with aflatoxin before entering the pet food facility.
    Microbial contamination of animal food is also a high concern for
the Agency, not only for animals consuming the contaminated food, but
also for humans that handle that contaminated animal food. In 2007, FDA
identified S. Schwarzengrund, a rare serotype of Salmonella associated
with human illness, in a pet food. The Center for Disease Control and
Prevention (CDC) traced this rare strain of Salmonella to a pet food
manufacturing facility located in Pennsylvania. Analytical tests
conducted by FDA confirmed S. Schwarzengrund at the Pennsylvania
facility. A recall was issued for two brands of dry dog food and the
manufacturing facility ceased operations for 5 months for cleaning and
disinfecting. Despite the facility's efforts, additional S.
Schwarzengrund illnesses in humans were reported to CDC. After further
investigations by FDA, the pet food manufacturing facility issued a
nationwide voluntary recall of all dry dog and cat food products
produced at the facility over a 5 month period. This recall involved
approximately 23,109 tons of dry pet foods, representing 105 brands.
While no pets were reported sick, 79 people in 21 states were reported
ill due to the handling of pet food contaminated with this Salmonella
strain (Ref. 24).
    In 2010, the CDC notified FDA of an outbreak of salmonellosis
(Salmonella infection) in people in the United Kingdom and the United
States. News reports from the United Kingdom indicated over 200 people
had become ill, all from the same strain of Salmonella (Ref. 25). UK
officials had determined patients in the United Kingdom had been
exposed to frozen rodents used as animal food for reptiles and
determined these frozen rodents were contaminated with the same strain
of Salmonella that was causing the human illness outbreak. U.K.
officials traced the origin of these contaminated frozen rodents to a
supplier in the United States. UK officials then contacted the CDC. The
CDC determined from illness reports that 34 patients in 17 states in
the United States were diagnosed with salmonellosis associated with the
same strain of Salmonella as the patients in the United Kingdom and of
that found in the frozen rodents (Ref. 26). FDA inspected the facility
producing the frozen rodents and isolated the same strain of Salmonella
from frozen rodent products sampled at the facility. The facility had
distributed frozen rodents as animal food worldwide.
    In June of 2008, following an inspection, FDA initiated a mass
seizure of animal food at a pet food distribution center after finding
the animal food products were vulnerable to contamination, such as
microbial contamination, as a result of infestation of the facility by
rodents, birds and other pests. Rodent pellets, rodent urine stains,
and bird droppings were found throughout the facility, including on
bags and pouches of pet food. Rodents had chewed holes in some of the
bags of dry dog and cat food and bird seed. The facility was not taking
measures to control pest infestation.
    Another mass seizure of animal food was executed in August of 2009
at a feed mill because of similar violations. In both cases, the seized
products violated section 402(a)(4) of the FD&C Act because the animal
food was being held under insanitary conditions whereby it may have
become contaminated with filth or rendered injurious to health.
    In April 2012, epidemiologic and laboratory investigations
conducted by officials in local, state, and federal public health,
agriculture, and regulatory agencies linked a Salmonella Infantis
outbreak to contaminated dry dog food produced by a single production
facility located in South Carolina. A total of 49 people (47
individuals in 20 states and 2 individuals in Canada) were reported
infected with Salmonella Infantis. Among the 24 human patients with
available information, 10 were hospitalized. The results from product
testing by multiple agencies along with production codes provided by
ill persons, led to multiple recalls by several companies with animal
food products manufactured at the implicated production facility. The
recalls included 17 brands representing over 30,000 tons of dry dog and
cat food produced at the facility. This was the second documented
outbreak of human salmonellosis linked to dry pet food in the United
States (Ref. 27) (Ref. 28).
    These examples demonstrate that the safe production and
distribution of animal food and ingredients, along with safe meat,
milk, and eggs derived from animals that consume this food is an
important public health concern, both domestically and globally. The
Agency needs to assure the consumer, both here and abroad, that it has
a regulatory system designed to ensure production of safe animal food
in the United States. Requiring facilities to manufacture, process,
pack, or hold animal food under these proposed CGMPs and proposed
preventive controls program would help provide that assurance. In
addition, the U.S. Government, the animal food industry, animal
producers, pet owners and consumers need to have assurance that animal
food imported into the United States is safe.
2. Monitoring and Recalls
    FDA monitors adverse food events through various means, such as
FDA's Reportable Food Registry, FDA's Pet Food Early Warning
Surveillance System, consumer complaints, tracking industry recalls and
FDA and State inspection findings. From fiscal year (October through
September) 2006 through 2012, there were 2,277 animal food product
recalls. In 2007 alone, 1,054 animal food products were recalled due to
contamination with melamine. Reasons for other animal food recalls
include contamination with aflatoxins, dioxins, Salmonella, or metal
fragments; improper labeling, such as no BSE warning; and subpotent or
superpotent nutrient levels, such as elevated levels of vitamin D,
copper, zinc, or urea and low levels of potassium, vitamin D, or
thiamine. In fiscal year 2012, there were 191 consumer complaints of
ill pets reported to FDA related to the dog food contaminated with
Salmonella Infantis, discussed previously in this section.
    For calendar years 2008 through 2012, over 2,500 consumer
complaints were called into FDA's district offices regarding animal
food for pets and livestock. The complaints ranged from animals
refusing to eat their food to animal illness and deaths associated with
consumption of an animal food. During the melamine contamination
incident in 2007, FDA received over 13,000 consumer complaints about
pet food, and over 18,000 calls. Many of these consumer complaints were
associated with recalled pet food products contaminated with melamine
and cyanuric acid (a contamination that was linked by laboratory
testing to illness and deaths in animals as discussed in section
II.E.1).
    In September of 2009, the Agency established the Reportable Food
Registry (RFR), where manufacturers, processors, packers, and holders
of human or animal food are required to report to the Agency if there
is reasonable probability that an article of

human or animal food will cause serious adverse health consequences or
death to humans or animals. From September 2009 through September 2012
the Agency received 71 primary animal food RFR reports. A primary
report is the initial report concerning a reportable food from either
industry or public health officials, such as federal, state or local
regulators. The hazards identified in the primary animal food reports
consisted of 27 microbial hazards, 5 physical hazards, and 39 chemical
hazards. The microbial hazards were almost exclusively Salmonella
bacteria found in the finished product. The physical hazards included
glass, metal or plastic in the finished animal food, some of which
reportedly resulted in animal injury or death. The largest number of
animal illnesses and deaths reported to FDA through the RFR and
attributable to animal food were associated with a subset of chemical
hazards, nutrient imbalances. Some examples of nutrient imbalances
associated with animal illnesses and deaths include excessive levels of
urea in cattle food, excessive levels of copper in sheep food,
inadequate levels of thiamine in cat food, inadequate levels of vitamin
D in swine food. In addition, toxic levels of medication (new animal
drugs) have been found in non-medicated animal food.
    In May, 2010, the Agency implemented the Safety Reporting Portal,
where consumers can submit complaints regarding adverse events in
animals associated with the consumption of pet food products. From May
2010 through September 2012 the Agency received over 2,900 consumer
complaints for pet food through the Safety Reporting Portal and all
were reviewed and evaluated by FDA.

F. The Role of Testing as a Verification Measure in a Food Safety
System

    The safety of food is principally ensured by the effective
implementation of scientifically valid preventive control measures
throughout the food chain (Refs. 29 and 30). Prevention of hazards in
animal food is much more effective than trying to differentiate safe
from unsafe food using testing. Although testing is rarely considered a
control measure, it plays a very important role in ensuring the safety
of food. An important purpose of testing is to verify that control
measures, including those related to suppliers and those verified
through environmental monitoring, are controlling the hazard (Refs. 31
and 32). Testing is used in conjunction with other verification
measures in the food safety system, such as audits of suppliers,
observations of whether activities are being conducted according to the
food safety plan, and reviewing records to determine whether process
controls are meeting specified limits for parameters established in the
food safety plan. As discussed in the Appendix to this document (see
sections I.C, I.E, and I.F of the Appendix), microbial testing may
include:
     Testing raw materials and ingredients to verify that
suppliers have significantly minimized or prevented hazards reasonably
likely to occur in the raw materials and ingredients;
     Testing the environment to verify that sanitation controls
have significantly minimized or prevented the potential for
environmental pathogens to contaminate animal food; and
     Testing finished product to verify that preventive
controls have significantly minimized or prevented hazards reasonably
likely to occur in the animal food.
    Each type of testing provides information applicable to managing
hazards in animal foods, depending on the animal food and process. The
Agency discusses the role of testing as a verification measure in a
food safety system in section I of the Appendix to this document.

G. The Role of Supplier Approval and Verification Programs in a Food
Safety System

    An animal food can become contaminated through the use of
contaminated raw materials or ingredients as evident by the large
recall of pet food because of contamination of wheat gluten with
melamine (see discussion in section II.E.1). The development of a
supplier approval and verification program is part of a preventive
approach. Because many facilities acting as suppliers procure their raw
materials and ingredients from other suppliers, there is often a chain
of suppliers before a raw material or other ingredient reaches the
manufacturer/processor. Using a preventive approach, a facility
receiving raw materials or ingredients from a supplier can help ensure
that the supplier (or a supplier to the supplier) has implemented
preventive controls to significantly minimize or prevent hazards that
the receiving facility has identified as reasonably likely to occur in
that raw material or other ingredient unless the receiving facility
will itself control the identified hazard.
    A supplier approval and verification program is a means of ensuring
that raw materials and ingredients are procured from those suppliers
that can meet facility specifications and have appropriate programs in
place, including those related to the safety of the raw materials and
ingredients. A supplier approval program can ensure a methodical
approach to identifying such suppliers. A supplier verification program
is essential to provide initial and ongoing assurance that suppliers
are complying with practices to achieve adequate control of hazards in
raw materials or ingredients. The Agency discusses supplier approval
and verification programs in more detail in section II of the Appendix
to this document.

III. Public Meeting and Preliminary Stakeholder Comments

    On April 20, 2011, FDA held a public meeting entitled ``FDA Food
Safety Modernization Act: Focus on Preventive Controls for Facilities''
(notice of the meeting published in the Federal Register on April 13,
2011; 76 FR 20588). The purpose of the public meeting was to provide
interested persons with an opportunity to discuss implementation of the
provisions in section 418 of the FD&C Act. A discussion of this meeting
can be found in section IV of the document for the proposed rule for
preventive controls for human food (78 FR 3646).

IV. Summary of the Scope of the Proposed Rule

    This proposed rule would apply to animal facilities required to
register with FDA under section 415 of the FD&C Act, unless subject to
an exemption. This would include manufacturing, processing, packing,
and holding of finished products that are intended to be fed to
animals, including livestock, pets, and other captive animals, as well
as the manufacturing, processing, packing, and holding of ingredients
that may be used in animal foods. Some industry sectors, such as
renderers and grain and oilseed processors, have long been considered
animal food manufacturers and would be subject to the proposed rule. In
addition, industry sectors that are newer, such as biofuel
manufacturing (suppliers of distillers grain for animal food), or other
entities that may not have been thought of as animal food manufacturers
in the past, such as mineral refining and manufacturing, would be
subject to the proposed rule to the extent that they are engaged in
manufacturing, processing, packing, or holding of animal food.
    This proposed rule would not apply to farms. For example, farms
manufacturing, processing, packing, and

holding food for consumption by their own animals would not be required
to register under section 415 of the FD&C Act and therefore would not
be required to comply with the proposed rule. However, if the farm
operates an animal food manufacturing business (in addition to its
traditional farm activities) that requires registration under section
415 of the FD&C Act, that food manufacturing business would likely need
to comply with this proposed rule.
    In complying with the Hazard Analysis and Risk-Based Preventive
Controls section of the proposed rule (subpart C), facilities that
manufacture, process, pack, or hold animal food for a single species of
animal would focus on hazards most likely to be associated with the
ingredients they use, as well as hazards most likely to occur during
manufacturing, processing, packing, or holding at the facility,
relevant to that species of animal. Facilities that manufacture,
process, pack, or hold an ingredient would focus on reducing hazards
associated with the ingredient and those species of animal that may
consume animal food containing that ingredient. Facilities that
manufacture, process, pack, or hold animal food for a range of species
or variety of uses would need to consider a more diverse number and
type of hazards. In addition to focusing on hazards associated with
their incoming ingredients or the types of equipment they use, a feed
mill that manufactures food for multiple species would need to be aware
of nutritional sensitivities of the animals for which it makes food.
For example, a manufacturer that makes food for swine, which can
tolerate a relatively large amount of copper in their diet, and food
for sheep, which are very sensitive to copper, would need to adopt
controls that would ensure that the sheep food it does not contains
levels of copper that are unsafe for sheep.
    Pet foods usually contain ingredients from the same sources used to
make food for livestock and pet foods are sometimes manufactured in the
same facilities as food for livestock. For these reasons the Agency has
not proposed different rules for these different types of facilities.
However, the hazards associated with pet food may be significantly
different from the risks associated with food for livestock, and the
facility manufacturing, processing, packing, or holding would need to
identify and address these hazards. Pet foods usually come into the
home, so in addition to being safe for pets to eat, they also would
need to be safe for the pet owner to handle. For example, pet foods and
treats have been known to carry Salmonella (see section II.E). A
facility manufacturing pet food would need to address the potential for
injury or illness (including death) from the Salmonella hazard in not
only animals, but in humans handling that pet food (especially the
young, old, or immunocompromised.)

V. Highlights of the Proposed Rule

A. Overview

    The proposed rule would establish part 507 and contains regulations
regarding the manufacturing, processing, packing, or holding of animal
food. The proposed rule would establish new provisions for CGMPs for
animal food and ingredients, and it would establish new provisions for
risk-based preventive controls.
    Under the proposed rule, part 507 would be divided into the
following subparts:
     Subpart A--General Provisions;
     Subpart B--Current Good Manufacturing Practice;
     Subpart C--Hazard Analysis and Risk-Based Preventive
Controls;
     Subpart D--Withdrawal of an Exemption Applicable to a
Qualified Facility;
     Subpart E is Reserved; and
     Subpart F--Requirements Applying to Records That Must Be
Established and Maintained.

B. Proposed Subpart A--General Provisions

    The proposed rule would establish general provisions under subpart
A of part 507. These provisions include the applicability and status,
definitions, specified exemptions for certain facilities from the
requirements of proposed subpart C (hazard analysis and risk-based
preventive controls), and specified exemptions for certain
establishments from the requirements from subpart B (current good
manufacturing practice). The proposed exemptions from subpart C would
be consistent with the requirements established by FSMA or the
discretion provided by FSMA. The subjects of the specified exemptions
relate to:
     Animal food establishments that do not have to register
under section 415 of the FD&C Act;
     Activities subject to existing Agency regulations
governing microbiological hazards for low acid canned animal foods;
     Activities subject to the Standards for Produce Safety in
section 419 of the FD&C Act;
     A ``qualified'' facility;
     Certain low-risk packing or holding activity/animal food
combinations conducted on a farm by a small or very small business;
     Certain low-risk manufacturing/processing activity/animal
food combinations conducted on a farm by a small or very small
business;
     Facilities that are solely engaged in the storage of RACs
(other than fruits and vegetables) intended for further distribution or
processing;
     Facilities that are solely engaged in the holding or
transportation of RACs; and
     Facilities solely engaged in the storage of packaged
animal food that is not exposed to the environment, although the
storage of such food that requires time/temperature control to prevent
the growth of, or toxin formation by, pathogenic microorganisms would
be subject to modified requirements that would be established in
proposed subpart C.
    Proposed subpart A would also implement certain provisions in
sections 418(l) and (m) of the FD&C Act for modified requirements with
respect to implementing the modified requirements specified in section
418(l) of the FD&C Act for facilities that satisfy the statutory
criteria for a ``qualified facility.'' The Agency proposes to establish
requirements that include:
     Submission to FDA of documentation that the facility is a
qualified facility; and
     Submission to FDA of documentation demonstrating that the
owner, operator, or agent in charge of the facility has identified the
potential hazards associated with the food being produced, is
implementing preventive controls to address the hazards, and is
monitoring the performance of the preventive controls to ensure that
such controls are effective; or
     Submission to FDA of documentation that the facility is in
compliance with State, local, county, or other applicable non-Federal
food safety law, including relevant laws and regulations of foreign
countries.

C. Proposed Subpart B--Current Good Manufacturing Practice

    Proposed subpart B would establish general baseline good
manufacturing practices for facilities manufacturing, processing,
packing, and holding animal food. These provisions would include
specific requirements for:
     Personnel in animal food facilities such as following good
hygiene practices, and protection of food from contamination from
personal effects;
     The plant and grounds including proper cleaning,
maintenance, and elimination of pests;

     Sanitary operations including maintaining clean and
sanitary conditions of food contact surfaces, proper use and storage of
toxic cleaning compounds, and exclusion of pests;
     Sanitary facilities and controls such as the plant's water
supply, plumbing, and toilet and hand-washing facilities;
     Equipment and utensils including the cleaning and
maintenance of such items and protecting animal food from
contamination;
     Processes and controls including following adequate
sanitation principles, proper labeling of ingredients and finished
animal food, ensuring the safety of raw materials, and prevention of
contamination of animal food during processing; and
     Warehousing and distribution to protect animal food
against contamination and deterioration.

D. Proposed Subpart C--Hazard Analysis and Risk-Based Preventive
Controls

1. Written Food Safety Plan
    The Agency proposes to require that the owner, operator, or agent
in charge of a facility have and implement a written food safety plan
that includes as applicable:
     A hazard analysis;
     Preventive controls;
     Monitoring procedures;
     Corrective Action procedures;
     Verification procedures; and
     A recall plan.
2. Written Hazard Analysis
    The Agency proposes to require that the written hazard analysis
identify and evaluate known or reasonably foreseeable hazards for each
type of animal food manufactured, processed, packed, or held at the
facility to determine whether there are hazards that are reasonably
likely to occur, including biological, chemical, physical, and
radiological hazards. The hazard analysis would include an evaluation
of the identified hazards to determine whether the hazards are
reasonably likely to occur, including an assessment of the severity of
the illness or injury if the hazard were to occur.
3. Written Preventive Controls
    The Agency proposes to require that the owner, operator, or agent
in charge of a facility identify and implement preventive controls
(including at critical control points, if any) to provide assurances
that hazards that are reasonably likely to occur will be significantly
minimized or prevented and that the animal food manufactured,
processed, packed, or held by such facility will not be adulterated
under section 402 of the FD&C Act. The preventive controls would
include, as appropriate:
     Parameters associated with the control of the hazard and
the maximum or minimum value, or combination of values, to which any
biological, chemical, physical, or radiological parameter must be
controlled to significantly minimize or prevent a hazard that is
reasonably likely to occur;
     Process controls;
     Sanitation controls;
     A recall plan; and
     Any other necessary controls.
4. Written Recall Plan
    The Agency proposes to require that the written recall plan be
developed for animal food with hazards that are reasonably likely to
occur.
5. Monitoring
    The Agency proposes to require the monitoring of the preventive
controls to provide assurance that they are consistently performed,
including requirements to establish and implement written monitoring
procedures and establish and maintain records documenting the
implementation of the monitoring procedures.
6. Corrective Actions
    The Agency proposes to require that facilities establish and
implement written corrective action procedures that would be used if
preventive controls are not properly implemented and take corrective
actions in the event of an unanticipated problem.
7. Verification
    The Agency proposes to require that facilities conduct certain
verification activities, including:
     Validation of a subset of the preventive controls;
     Verification that monitoring is being conducted;
     Verification that appropriate decisions about corrective
actions are being made; and
     Verification that the preventive controls are consistently
implemented and are effectively and significantly minimizing or
preventing the hazards that are reasonably likely to occur.
    The Agency also proposes to require reanalysis of the food safety
plan at least once every 3 years and more often when circumstances
warrant.
8. Modified Requirements for a Facility Solely Engaged in the Storage
of Packaged Animal Food That is Not Exposed to the Environment
    Acting on the discretion provided to FDA by section 418(m) of the
FD&C Act, the Agency proposes to require that the owner, operator, or
agent in charge of a facility solely engaged in the storage of packaged
animal food that is not exposed to the environment conduct certain
activities for any such refrigerated packaged animal food that requires
time/temperature control to significantly minimize or prevent the
growth of, or toxin production by, microorganisms of animal or human
health significance, including:
     Establishing and implementing temperature controls;
     Monitoring the temperature controls;
     Taking appropriate corrective actions when there is a
problem with temperature controls;
     Verifying that temperature controls are consistently
implemented; and
     Establishing and maintaining the following records:
     Records documenting the monitoring of temperature
controls;
     Records of corrective actions; and
     Records documenting verification activities.
    The Agency requests comments on these proposed requirements.
9. Qualified Individual
    The Agency proposes to establish qualification requirements for a
``qualified individual,'' who would be required to do or oversee the
preparation of the food safety plan, validation of preventive controls,
review records for implementation and effectiveness of preventive
controls and the appropriateness of corrective actions, and perform the
reanalysis of a food safety plan. A ``qualified individual'' would be
required to successfully complete training with a standardized
curriculum or be otherwise qualified through job experience to develop
and apply a food safety system. Job experience may qualify an
individual to perform these functions if such experience has provided
an individual with knowledge at least equivalent to that provided
through the standardized curriculum.
10. List of Required Records
    The Agency proposes to establish a list of records that would be
required under proposed subpart C, including the written food safety
plan and records documenting monitoring of preventive controls,
corrective actions, verification,

and applicable training for the qualified individual.

E. Proposed Subpart D--Withdrawal of an Exemption Applicable to a
Qualified Facility

    Proposed subpart D would implement the provisions of section
418(l)(3) of the FD&C Act and establish the conditions under which an
exemption granted to a ``qualified facility'' could be withdrawn, and
the procedures that would be followed to withdraw such an exemption.

F. Proposed Subpart F--Requirements Applying to Records That Must Be
Established and Maintained

    Proposed subpart F would establish requirements that would apply to
all records that would be required by the various proposed provisions
of proposed part 507, including:
     General requirements related to the content and form of
records;
     Additional requirements specific to the food safety plan;
     Requirements for record retention;
     Requirements for official review of records by FDA; and
     Public disclosure.

VI. Compliance Dates

    Section 103(i)(1) of FSMA, General Rule, provides that ``[t]he
amendments made by this section shall take effect 18 months after the
date of enactment'' (i.e., by July 4, 2012). Section 103(i)(2) of FSMA,
Flexibility for Small Businesses, provides that ``[n]otwithstanding
paragraph (1),'' the amendments made by this section ``shall apply'' to
a small business and very small business beginning on the dates that
are 6 months and 18 months, respectively, ``after the effective date''
of FDA's final regulation.
    FDA is implementing the amendments made by section 103 to the FD&C
Act through this rulemaking for animal food (except as they relate to
intentional contamination). FDA tentatively concludes that it is
appropriate to provide a sufficient time period following publication
of the final regulation for facilities to come into compliance. The
final regulation will contain provisions that affect which facilities
are subject to section 418 and which provisions apply to particular
facilities. Without these provisions of the regulation in effect,
facilities would be uncertain as to the applicability of certain
requirements to them. Further, FDA tentatively concludes that
compliance with section 418 will be facilitated greatly by the detail
and explanation that will be provided by the final regulation.
    Most animal food facilities have not been subject to CGMPs and no
animal food facility has been subject to preventive controls as put
forth in this proposed rule. However, individual animal food
facilities, either individually or through feed industry associations
have implemented SOPs that are likely to be sufficient to satisfy some
of the proposed requirements. The Agency tentatively concludes that the
concepts in the proposed CGMPs will not be new to the animal food
industry. Still, the Agency expects that the majority of facilities
will need to make substantial changes if the proposed regulations are
adopted. FDA recognizes that it can take time to implement a food
safety system for animal food that would require among other things,
CGMPs, performance of a hazard analysis, development of preventive
controls, and monitoring of preventive controls.
    FDA is proposing that the final rule would be effective 60 days
after publication in the Federal Register, with staggered compliance
dates (see section VI.) However, the Agency recognizes that animal food
businesses of all sizes may need more time to comply with the new
requirements. FDA believes that it is reasonable to allow for 1 year
after the date of publication of the final rule for businesses other
than small and very small businesses to come into compliance with the
new requirements established under FSMA. FDA also believes that it is
reasonable to allow for 2 years after the date of publication of the
final rule for small businesses to come into compliance with the new
requirements established under FSMA, and 3 years after the date of
publication of the final rule for very small businesses to come into
compliance with the new requirements. FDA intends to work closely with
the animal food industry, extension and education organizations, and
state partners to develop the tools and training programs needed to
facilitate implementation of the final rule.

VII. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c) of FSMA

1. Clarification of the Activities That Are Included As Part of the
Definition of the Term ``Facility'' under Section 415 of the FD&C Act
    Section 103(c)(1)(A) of FSMA requires the Secretary to ``publish a
notice of proposed rulemaking in the Federal Register to promulgate
regulations with respect to--(i) activities that constitute on-farm
packing or holding of food that is not grown, raised, or consumed on
such farm or another farm under the same ownership for purposes of
section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C
350d), as amended by [FSMA]; and (ii) activities that constitute on-
farm manufacturing or processing of food that is not consumed on that
farm or on another farm under common ownership for purposes of such
section 415.'' Section 103(c)(1)(B) of FSMA stipulates that such
rulemaking ``shall enhance the implementation of such section 415 and
clarify the activities that are included as part of the definition of
the term ``facility'' under such section.'' Section 415 of the FD&C
Act, in turn, directs the Secretary to require by regulation that any
facility engaged in manufacturing, processing, packing, or holding food
for consumption in the United States be registered with the Secretary.
The registration requirement in section 415 of the FD&C Act does not
apply to farms. FDA regulations that implement section 415 and require
food facilities to register with FDA are established in part 1 (21 CFR
part 1), subpart H (Registration of Food Facilities) (the section 415
registration regulations).
    A discussion of the Agency's clarification of the treatment of
activities that are included as part of the definition of the term
``facility'' in section 415 as well as proposed changes to definitions
in the section 415 registration regulations can be found in section
VIII of the document for the proposed rule for preventive controls for
human food (78 FR 3646).
2. Science-Based Risk Analysis Covering Specific Types of On-Farm
Packing, Holding, Manufacturing, Processing, Packing and Holding
Activities
    Section 103(c)(1)(C) of FSMA directs the Secretary to conduct a
science-based risk analysis as part of the section 103(c) rulemaking.
The science-based risk analysis is to cover ``(i) specific types of on-
farm packing or holding of food that is not grown, raised, or consumed
on such farm or another farm under the same ownership, as such packing
and holding relates to specific foods; and (ii) specific on-farm
manufacturing and processing activities as such activities relate to
specific foods that are not consumed on that farm or on another farm
under common ownership.'' Section VII.B describes a draft Qualitative
Risk Assessment (the section 103(c)(1)(C) draft RA) (Ref. 33) the
Agency performed to satisfy this requirement.

3. Exemptions and Modified Requirements for Certain Facilities
    Section 103(c)(1)(D)(i) of FSMA requires that, as part of the
section 103(c) rulemaking, ``the Secretary shall consider the results
of the science-based risk analysis . . . and shall exempt certain
facilities from the requirements in section 418 of the Federal Food,
Drug, and Cosmetic Act (as added by [section 103 of FSMA]) including
hazard analysis and preventive controls, and the mandatory inspection
frequency in section 421 of such Act (as added by section 201 [of
FSMA]), or modify the requirements in such sections 418 or 421, as the
Secretary determines appropriate, if such facilities are engaged only
in specific types of on-farm manufacturing, processing, packing, or
holding activities that the Secretary determines to be low risk
involving specific foods the Secretary determines to be low risk.''
Section 103(c)(1)(D)(ii) of FSMA provides that the exemptions or
modifications described in section 103(c)(1)(D)(i) ``shall not include
an exemption from the requirement to register under section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by
[FSMA], if applicable, and shall apply only to small businesses and
very small businesses, as defined in the regulation promulgated under
section 418(n) of the Federal Food, Drug, and Cosmetic Act.'' Section
VII.C discusses the results of the section 103(c)(1)(C) draft RA. In
section VII.D, the Agency sets forth its tentative conclusions
regarding combinations of on-farm manufacturing, processing, packing,
and holding activities and animal foods determined to be low risk,
considering the results of the section 103(c)(1)(C) draft RA. In
section VII.E, the Agency discusses a proposed approach to using the
results of the section 103(c)(1)(C) draft RA for the purposes of
section 421 of the FD&C Act. Section VIII.C. discusses the Agency's
proposal to exempt low-risk combinations of activities and animal foods
from the requirements of section 418 of the FD&C Act when performed by
farm mixed-type facilities that are small or very small businesses as
would be defined in proposed Sec.  507.3.
    For a complete discussion of FSMA section 103(c) and on-farm
activities, please refer to section VIII.B through VIII.D of the
document for the proposed rule for preventive controls for human food
(78 FR 3646).

B. Qualitative Risk Assessment of On-Farm Activities Outside of the
Farm Definition

    As discussed in section VII.A, section 103(c)(1)(C) of FSMA directs
the Secretary to conduct a science-based risk analysis as part of the
section 103(c) rulemaking. The science-based risk analysis is to cover
``(i) specific types of on-farm packing or holding of food that is not
grown, raised, or consumed on such farm or another farm under the same
ownership, as such packing and holding relates to specific foods; and
(ii) specific on-farm manufacturing and processing activities as such
activities relate to specific foods that are not consumed on that farm
or on another farm under common ownership.''
    As used in section 103(c)(1) of FSMA, the term ``risk analysis'' is
ambiguous. One interpretation is that the common meaning of the term is
intended--a simple evaluation of whether activity/animal food
combinations are likely to result in the consumer (animals in relation
to food for animals) becoming ill. Another interpretation is that the
``risk analysis'' should be consistent with the formal definition and
related terms used by Codex with respect to food safety (Ref. 34):
     Risk is a function of the probability of an adverse health
effect and the severity of that effect, consequential to a hazard(s) in
food.
     Risk analysis is a process consisting of three components:
risk assessment, risk management and risk communication.
     Risk assessment is a scientifically-based process
consisting of hazard identification, hazard characterization, exposure
assessment, and risk characterization.
     Risk management is the process, distinct from risk
assessment, of weighing policy alternatives, in consultation with
interested parties, considering risk assessment and other factors
relevant for the health protection of consumers and for the promotion
of fair trade practices, and, if needed, selecting appropriate
prevention and control options.
     Risk communication is the interactive exchange of
information and opinions throughout the risk analysis process
concerning risk, risk-related factors and risk perceptions, among risk
assessors, risk managers, consumers, industry, the academic community
and other interested parties, including the explanation of risk
assessment findings and the basis of risk management decisions.
    Because section 103(c)(1)(C) of FSMA calls for a science-based risk
analysis, the Agency is applying the Codex definitions to the extent
possible. It is not clear whether the requirement of section
103(c)(1)(C) of FSMA to conduct a science-based risk analysis was
intended to encompass all three components of risk analysis. Section
103(c)(1)(D) of FSMA requires the Secretary to consider the results of
the science-based risk analysis and exempt certain facilities from the
requirements in section 418 of the FD&C Act, including hazard analysis
and preventive controls, and the mandatory inspection frequency of
section 421, or to modify those requirements for facilities engaged in
on-farm manufacturing, processing, packing, or holding activities
determined to be low risk involving animal foods determined to be low
risk. Thus, section 103(c)(1)(D) of FSMA is focused on ensuring that
the Agency's risk management decisions with respect to exempting or
modifying requirements applicable to low-risk on-farm activity/animal
food combinations under sections 418 and 421 are science-based, as
determined by an analysis of the risk of specific types of on-farm
activity/animal food combinations required by section 103(c)(1)(C). The
Agency therefore tentatively concludes that the analysis required by
section 103(c)(1)(C) should be limited to an assessment of the risk of
specific types of on-farm activity/animal food combinations for the
purposes of making the risk management decisions required by section
103(c)(1)(D). The risk communication component of the risk analysis is
accomplished through the discussion of that assessment in this
document, the opportunities for public comment (on the risk assessment
and on this proposed rule), and the Agency's evaluation of, and
response to, comments in a final rule.
    Consistent with this approach, the Agency conducted a qualitative
risk assessment (Ref. 33) (``section 103(C)(1)(C) draft RA'') related
to activity/animal food combinations for the purpose of determining
which activity/animal food combinations would be considered low risk.
The Agency focused on activity/animal food combinations that were
identified as being conducted on farms (and, thus, might be conducted
by farm mixed-type facilities), but the Agency did not consider
activity/animal food combinations that would be solely within the farm
definition (such as the growing and harvesting of crops) and, thus, are
not relevant to the requirements of section 103 of FSMA. The Agency
focused on considering the risk of activity/animal food

combinations rather than separately considering the risk of specific
animal food categories because doing so better enabled the Agency to
focus on whether a specific manufacturing, processing, packing, or
holding activity conducted on animal food by a farm mixed-type facility
warranted an exemption from, or modified requirements for, the
provisions of section 418 of the FD&C Act.
    Elsewhere in this issue of the Federal Register, FDA is making the
section 103(C)(1)(C) draft RA for animal food available for public
comment in the docket established for this proposed rule (Ref. 33). The
Agency will consider comments regarding the section 103(C)(1)(C) draft
RA in preparing a final version of the RA and will announce the
availability of the final version of the RA when it is available. The
final preventive controls rule for animal food will take into account
the final version of the section 103(C)(1)(C) draft RA.

C. Results of the Qualitative Risk Assessment

    In this section, the Agency reports the results of the section
103(C)(1)(C) draft RA, arranged in three lists. References to ``farms''
in these lists should be understood to include farm mixed-type
facilities. The lists are shaped by the proposed definitions for
harvesting, manufacturing/processing, packing, or holding in the
section 415 registration regulations (discussed in section VIII.E of
the document for the proposed rule for preventive controls for human
food (78 FR 3646), the organizing principles (discussed in section
VIII.D of the document for the proposed rule for preventive controls
for human food) that form the basis for those proposed definitions, and
the examples of activity classifications. As discussed in section
VIII.E of the document for the proposed rule for preventive controls
for human food, the same activity may be classified differently (among
the categories of harvesting, manufacturing/processing, packing, or
holding) depending on whether the animal food being operated upon is a
RAC and whether the RAC was grown or raised on the farm or farm mixed-
type facility performing the activity or a farm under the same
ownership and whether the animal food is consumed on the farm that
produced it or another farm under the same ownership. The Agency
requests comment on the lists in sections VII.C.1, VII.C.2, and
VII.C.3.
    For purposes of this document, grains are the small, hard fruits or
seeds of arable crops, or the crops bearing these fruits or seeds, that
are grown and processed for use as meal, flour, baked goods, and