Document ID: FDA-2011-N-0922-0002
Agency: fda
Document Type: Proposed Rule
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Posted Date: 2013-10-29T04:00Z

[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Proposed Rules]
[Pages 64735-64837]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25126]

[[Page 64735]]

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, 240-276-9207, email: kim.young@fda.hhs.gov.

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

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    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.

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  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

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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

[[Page 64740]]

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));

[[Page 64741]]

    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

[[Page 64742]]

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

[[Page 64743]]

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

[[Page 64744]]

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

[[Page 64745]]

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).

[[Page 64746]]

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

[[Page 64747]]

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

[[Page 64748]]

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

[[Page 64749]]

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;

[[Page 64750]]

     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,

[[Page 64751]]

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.

[[Page 64752]]

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

[[Page 64753]]

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 
cereals (including cereal grains, pseudo cereals, pulses, and other 
plants used in the same fashion) to be used in animal food. Examples of 
animal food grains include barley, dent- or flint-corn, sorghum, oats, 
rice, rye, wheat, and buckwheat. Oilseeds are the small, hard fruits or 
seeds of arable crops that are grown and processed mainly for the oil 
that is extracted from them. Examples of animal food oilseeds include 
soybean, cottonseed, and rapeseed. Grains and oilseeds are field-dried 
before harvest. Post-harvest drying or dehydrating that further reduces 
the moisture content of harvested grains and oilseeds for the purpose 
of storage or transportation is considered an activity separate from 
field drying done before harvest. In the lists that follow, the terms 
grain and oilseed are used in a general sense while the terms dried 
grain and dried oilseed are used to designate specifically those 
harvested grains and oilseeds that have been further dried or 
dehydrated for the purpose of storage or transportation.
1. List of Low-Risk On-Farm Packing and Holding Activity/Animal Food 
Combinations When Conducted on Animal Food Not Grown, Raised, or 
Consumed on That Farm or Another Farm Under the Same Ownership
    The section 103(c)(1)(C) draft RA identified the following low-risk 
packing and holding activity/animal food combinations when conducted on 
a farm on animal food not grown, raised, or consumed on that farm or 
another farm under the same ownership:
     Conveying, weighing, sorting, culling, or grading 
(incidental to storing):
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
     Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, 
sunflower);
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., almond, peanut or 
soybean hulls, citrus, other fruit including culled fruit, potatoes, or 
other vegetables including culled vegetables).
     Storing:
     Dried grain;
     Dried oilseed;
     Byproducts of dried grain or dried oilseed;
     Forage; or
     Other plants or plant byproducts.
     Packing:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage; or
     Other plants or plant byproducts.
     Mixing (incidental to packing or storing):
     Grain, whole; or
     Forage.
    The Agency notes that the same activities performed on a farm's own 
RACs, or animal food consumed on the farm or another farm under the 
same ownership, would be within the farm definition and therefore were 
outside the scope of the section 103(c)(1)(C) draft RA.
2. List of Low-Risk On-Farm Manufacturing/Processing Activity/Animal 
Food Combinations When Conducted on the Farm's Own Raw Agricultural 
Commodities for Distribution Into Commerce
    The section 103(c)(1)(C) draft RA identified the following low-risk 
manufacturing/processing activity/animal food combinations when 
conducted on a farm on the farm's own RACs distribution into commerce:
     Cracking, crimping, or flaking:
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
     Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, 
sunflower) ; or
     Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., such as almond, 
peanut, or soybean hulls, citrus, other fruit including culled fruit, 
potatoes, or other vegetables including culled vegetables).
     Making silage
     Chopping, or shredding hay.
     Extracting (mechanical) or wet rolling:
     Grain; or
     Oilseed.
3. List of Low-Risk On-Farm Manufacturing/Processing Activity/Animal 
Food Combinations When Conducted on Animal Food Other Than the Farm's 
Own Raw Agricultural Commodities for Distribution Into Commerce
    The section 103(c)(1)(C) draft RA identified the following low-risk 
manufacturing/processing activity/animal food combinations when 
conducted on animal food other than the farm's own RACs for 
distribution into commerce:
     Cracking, crimping, flaking, or shelling:
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);

[[Page 64754]]

     Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, 
sunflower) ; or
     Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., such as almond, 
peanut, or soybean hulls, citrus, other fruit including culled fruit, 
potatoes, or other vegetables including culled vegetables).
     Making silage.
     Chopping or shredding hay.
     Extracting (mechanical) or wet rolling:
     Grain; or
     Oilseed.
     Labeling:
     Grain, whole;
     Oilseed, whole;
     Sifting, separating, or sizing:
     Grain;
     Oilseed;
     Grain or oilseed byproducts; or
     Other plants or plant byproducts.

D. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Animal 
Food Combinations Under Section 418 of the FD&C Act

    Based on the results of the section 103(c)(1)(C) draft RA regarding 
on-farm low-risk activity/animal food combinations, the Agency is 
proposing in Sec.  507.5(e) and (f) to exempt farm mixed-type 
facilities that are small or very small businesses (as defined in 
proposed Sec.  507.3) from requirements under section 418 of the FD&C 
Act if the only activities subject to section 418 that the business 
conducts are low-risk activity/animal food combinations (see the 
discussion of these proposed exemptions in section VIII.C). The 
proposed exemptions would not exempt eligible facilities from the 
requirement to register under section 415 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

    The Agency tentatively concludes that it should consider the low-
risk on-farm activity/animal food combinations identified in the 
section 103(c)(1)(C) draft RA as a factor in identifying high-risk 
facilities that are small and very small businesses and allocating 
inspection resources under section 421 of the FD&C Act, Targeting of 
Inspectional Resources for Domestic Facilities. However, at this time, 
the Agency tentatively concludes 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/animal food 
combinations and is a small or very small business. Current data 
limitations impact the Agency's ability to accurately identify such 
facilities, and it must be able to identify such facilities in order to 
implement an exempted or modified inspection frequency schedule. The 
Agency requests comment on whether it should establish data submission 
requirements that would allow the Agency to identify these types of 
facilities in order to exempt such facilities from the inspection 
frequencies, or modify the inspection frequencies that apply to such 
facilities, under section 421 of the FD&C Act. Examples of data 
elements that the Agency might need in order to identify these 
facilities include: Identification of a facility as a farm mixed-type 
facility, annual monetary value of sales, number of employees, animal 
food category/activity type. The Agency also requests comment on these 
possible data elements and any other criteria that may be appropriate 
for the purposes of allocating inspection resources to these 
facilities.

VIII. Proposed Subpart A--General Provisions

A. Proposed Sec.  507.1--Applicability and Status

    FDA is proposing in Sec.  507.1(a) that the criteria and 
definitions in part 507 apply in determining whether an animal food is 
adulterated: (1) Within the meaning of section 402(a)(3) of the FD&C 
Act in that the animal food has been manufactured under such conditions 
that it is unfit for food; or (2) within the meaning of section 
402(a)(4) of the FD&C Act in that the animal food 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. Proposed Sec.  507.1(a) also would establish that the 
criteria and definitions in part 507 apply in determining whether an 
animal food is in violation of section 361 of the Public Health Service 
Act (the PHS Act) (42 U.S.C. 264). The Agency notes that section 418(a) 
of the FD&C Act provides that facilities subject to that section must 
``identify and implement preventive controls to . . . provide 
assurances that . . . food is not adulterated under section 402 [of the 
FD&C Act]'' and that similar references to preventing adulteration 
under section 402 of the FD&C Act also appear in section 418(c) and 
(e). The Agency tentatively concludes that the link between the 
proposed provisions and the potential for adulteration provides a basis 
for applying the criteria and definitions in proposed part 507 in 
determining whether, under particular circumstances, an animal food is 
adulterated under section 402(a)(3) or (a)(4) or in violation of 
section 361 of the PHS Act.
    Section 103(e) of FSMA amends section 301 of the FD&C Act by adding 
a new section--(uu)--to the list of acts and the causing thereof that 
are prohibited. Under section 301(uu), the following act, and the 
causing thereof, is prohibited:''[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].'' To clearly 
communicate that failure to comply with regulations established under 
section 418 is a prohibited act, proposed Sec.  507.1(b) would 
establish that the operation of a facility that manufactures, 
processes, packs, or holds animal food for sale in the United States if 
the owner, operator, or agent in charge of such facility is required to 
comply with, and is not in compliance with, section 418 of the FD&C Act 
or the regulations implementing section 418 [of the FD&C Act] in 
subparts C, D, or F of proposed part 507, and Sec.  507.7 of proposed 
part 507, is a prohibited act under section 301(uu) of the FD&C Act.
    Proposed Sec.  507.1(c) would establish that animal food covered by 
specific current good manufacturing practice regulations also is 
subject to the requirements of those regulations. FDA has established 
CGMP requirements for thermally processed low-acid foods packaged in 
hermetically sealed containers (proposed rule, 41 FR 30444, July 23, 
1976; final rule, 44 FR 16209, March 16, 1979; currently established in 
part 113; and 61 FR 37681, July 19, 1996; currently established in 
Sec.  500.23). Therefore, animal foods that are subject to 21 CFR 
500.23 and part 113 are subject to the requirements of Sec.  500.23 and 
part 113 even though they are foods covered by the current good 
manufacturing practice requirements of proposed part 507.
    Proposed Sec.  507.1(d) would apply to facilities that manufacture, 
process, pack, or hold animal food and human food. The Agency wanted to 
address the instances where a facility may handle both animal and human 
food in some form, to make it clear which proposed rule would apply for 
that facility manufacturing, processing, packing, or holding these 
foods. In addition, in some facilities, ``waste'' from human

[[Page 64755]]

food production, such as by-products that may not be edible for humans, 
or lack nutritional value for humans, are used or sold for animal food. 
Many species of animals have different digestive systems and 
nutritional requirements than humans, thus allowing for this use. For 
the human food manufactured, processed, packed, or held, the facility 
would need to comply with proposed part 117 (proposed rule for 
preventive controls for human food (78 FR 3646)), subparts B and C as 
applicable (facilities subject to subpart B may not also be subject to 
subpart C), and as subject to the exemptions for proposed part 117. For 
the animal food manufactured, processed, packed, or held, the facility 
may choose to comply with either proposed part 507 subparts B and C as 
applicable or proposed part 117 subparts B and C as applicable, so long 
as the food safety plan also addresses all hazards that are reasonably 
likely to occur in the animal food, including nutrient imbalances. 
``Food'' used in proposed part 117 would be read to include ``animal 
food'' when the facility is applying proposed part 117 to the animal 
food. For example, human food waste that is used for animal food would 
be treated as ``food'' for the purposes of its animal food use and as 
waste for the purposes of its role in human food production. The Agency 
tentatively concludes that this will provide facilities the flexibility 
to streamline their compliance efforts, while also ensuring human and 
animal food safety.
    FDA requests comment on the applicability of the requirements of 
this proposed rule to FSIS official establishments that manufacture, 
process, pack, or hold food for animals. And, if applicable, to what 
extent should the requirements apply to these establishments?

B. Proposed Sec.  507.3--Definitions

1. Definitions That FDA is Proposing
    In developing the following proposed definitions, FDA aimed to be 
consistent with proposed part 117 of the proposed rule for preventive 
controls for human food (see the document for the proposed rule for 
preventive controls for human food (78 FR 3646)). The Agency also 
considered how these currently existing and proposed definitions should 
be clarified for use in the animal food context.
    The Agency is proposing in Sec.  507.3 that the terms defined in 
section 201 of the FD&C Act would be applicable to such terms when used 
in this part, unless otherwise specified. Additional terms are listed, 
defined, and discussed in alphabetical order in this section. These 
definitions are based on the Agency's experience in regulating human 
food, animal food, common usage in the animal food industry, and 
definitions in section 418 of the FD&C Act.
    Proposed Sec.  507.3 defines ``adequate'' as that which is needed 
to accomplish the intended purpose in keeping with good public health 
practice.
    FDA is proposing to define the term ``affiliate'' as it is defined 
in section 418(l)(4)(A) of the FD&C Act to mean any facility that 
controls, is controlled by, or is under common control with another 
facility. This term relates to the determination of whether a facility 
meets the definition of a qualified facility.
    Proposed Sec.  507.3 defines ``animal food'' as food for animals 
other than man, and includes pet food, feed, and raw materials and 
ingredients. When used in this part, the phrase ``animal food'' does 
not refer to food derived from animals that is intended for human 
consumption.
    Proposed Sec.  507.3 defines ``batter'' to mean a semifluid 
substance, usually composed of flour and other ingredients, into which 
principal components of food are dipped or with which they are coated, 
or which may be used directly to form bakery foods.
    Proposed Sec.  507.3 defines ``blanching'' to mean, except for tree 
nuts and peanuts, a prepackaging heat treatment of foodstuffs for a 
sufficient time and at a sufficient temperature to partially or 
completely inactivate the naturally occurring enzymes and to effect 
other physical or biochemical changes in the food.
    Proposed Sec.  507.3 defines ``calendar day'' to mean every day 
shown on the calendar.
    Proposed Sec.  507.3 defines ``critical control point (CCP)'' as a 
point, step, or procedure in a food process at which control can be 
applied and is essential to prevent or eliminate a food safety hazard 
or reduce such hazard to an acceptable level.
    The Agency is proposing to define the term ``environmental 
pathogen'' to mean a microorganism that is of animal or human health 
significance and is capable of surviving and persisting within the 
manufacturing, processing, packing, or holding environment. Salmonella 
would be an example of an environmental pathogen, particularly in 
regards to pet food, given that it is a microorganism of animal or 
human health significance and is capable of surviving and persisting 
within the manufacturing, processing, packing, and holding. An animal 
food may be injurious to the health of animals if it is contaminated 
with a Salmonella serotype that is pathogenic to the animal species 
intended to consume the food. With respect to the risk to humans, pet 
food and pet treats that are intended to be fed to animals in homes and 
are contaminated with any Salmonella serotype may be injurious to human 
health, especially where the food is likely to be directly handled by 
the elderly or individuals with compromised immune systems, or be 
ingested by children. FDA requests comment on this definition and the 
types of organisms that should be considered environmental pathogens 
for animal food, including whether spores of pathogens such as 
Clostridium spp. and Bacillus anthracis should be considered 
environmental pathogens.
    FDA is proposing to define the term ``facility'' as it is defined 
in section 418(o)(2) of the FD&C Act to mean a domestic facility or a 
foreign facility that is required to register under section 415 of the 
FD&C Act, in accordance with part 1, subpart H. FDA tentatively 
concludes that the definition of facility should include a reference to 
the regulation that implements section 415 of the FD&C Act and proposed 
to update the definition in Sec.  1.227 in section VIII.E of the 
document for the proposed rule for preventive controls for human food 
(78 FR 3646). The regulation implementing section 415 of the FD&C Act 
provides important details to help firms determine whether they are 
required to register.
    The Agency is proposing to cross-reference the definition of 
``farm'' rather than to define it in proposed part 507 because the 
definition of ``farm,'' under both current Sec.  1.227(b)(3) and 
proposed Sec.  1.227 (found in section VIII.E of the document for the 
proposed rule for preventive controls for human food (78 FR 3646)) 
includes the word ``facility'' with a meaning that is broader than the 
meaning of ``facility'' in section 418(o)(2) of the FD&C Act. Under 
part I, subpart H, the term ``facility'' is not limited to entities 
that are required to register under section 415 of the FD&C Act. The 
Agency is proposing to cross-reference the definition of ``farm'' to 
reduce the potential confusion that could result if the Agency used the 
term ``facility'' to have two different meanings within proposed part 
507.
    Proposed Sec.  507.3 defines ``food'' to mean food as defined in 
section 201(f) of the FD&C Act and includes raw materials and 
ingredients.
    Proposed Sec.  507.3 defines ``food-contact surfaces'' as those 
surfaces that contact food and those surfaces from

[[Page 64756]]

which drainage, or other transfer, onto the food or onto surfaces that 
contact the food ordinarily occurs during the normal course of 
operations. ``Food-contact surfaces'' includes food-contact surfaces of 
utensils and equipment. The Agency is proposing this definition to 
clarify the meaning of the phrase ``food-contact surfaces'' when used 
in this proposed part.
    The Agency is proposing to define the term ``harvesting'' as 
follows: Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed by farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities on the 
farm on which they were grown or raised, or another farm under the same 
ownership. Harvesting does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the FD&C Act, 
into a processed food as defined in section 201(gg) of the FD&C Act. 
Gathering, washing, trimming of outer leaves of, removing stems and 
husks from, sifting, filtering, threshing, shelling, and cooling raw 
agricultural commodities grown on a farm or another farm under the same 
ownership are examples of harvesting. The Agency is proposing the same 
definition of ``harvesting'' here as in proposed Sec.  1.227 (see 
section VIII.E of the document for the proposed rule for preventive 
controls for human food (78 FR 3646)).
    The Agency is proposing to define ``hazard'' to mean any 
biological, chemical, physical, or radiological agent that is 
reasonably likely to cause illness or injury in animals or humans in 
the absence of its control. The phrase ``in animals or humans'' is 
included in this definition because a biological, chemical, physical, 
or radiological agent in animal food could cause injury and illness to 
not only animals, but to humans that handle the animal food, or eat 
products (such as milk, meat, or eggs) derived from animals that 
ingested the food. The Agency is proposing to include radiological 
agents to implement section 418(b)(1)(A) of the FD&C Act, which 
includes radiological hazards as an example of known or reasonably 
foreseeable hazards that may be associated with a facility. For further 
discussion on the definition of ``hazard'' and its consistency with 
HACCP, see section X.B of the document for the proposed rule for 
preventive controls for human food (78 FR 3646).
    The Agency is proposing to define the phrase ``hazard reasonably 
likely to occur'' to mean a hazard for which a prudent person who 
manufactures, processes, packs, or holds food would establish controls 
because experience, illness data, scientific reports, or other 
information provides a basis to conclude that there is a reasonable 
possibility that the hazard will occur in the type of food being 
manufactured, processed, packed, or held in the absence of those 
controls. For further discussion on the definition of ``hazard 
reasonably likely to occur'' and its consistency with HACCP, see 
section X.B of the document for the proposed rule for preventive 
controls for human food (78 FR 3646). This concept is used in FDA's 
HACCP regulations for juice (21 CFR 120.7(a)(2)) and seafood (Sec.  
123.6(a) (21 CFR 123.6(a))), and in the meat and poultry HACCP 
regulation (9 CFR 417.2(a)(1)).
    The Agency is proposing to define the term ``holding'' to mean 
storage of food. Holding facilities would include warehouses, cold 
storage facilities, storage silos, grain elevators, and liquid storage 
tanks. For farms and farm mixed-type facilities, holding would also 
include activities traditionally performed by farms for the safe or 
effective storage of raw agricultural commodities grown or raised on 
the same farm or another farm under the same ownership, but does not 
include activities that transform a raw agricultural commodity, as 
defined in section 201(r) of the FD&C Act, into a processed food as 
defined in section 201(gg) of the FD&C Act. The Agency is proposing the 
same definition of ``holding'' here as in proposed Sec.  1.227 (see 
section VIII.E of the document for the proposed rule for preventive 
controls for human (78 FR 3646)).
    The Agency is proposing to define the term ``lot'' to mean the food 
produced during a period of time indicated by a specific code.
    The Agency is proposing to define the term ``manufacturing/
processing'' to mean making food from one or more ingredients, or 
synthesizing, preparing, treating, modifying or manipulating food, 
including food crops or ingredients. The proposed definition would also 
state that examples of manufacturing/processing activities are cutting, 
peeling, trimming, washing, waxing, eviscerating, rendering, cooking, 
baking, freezing, cooling, pasteurizing, homogenizing, mixing, 
formulating, bottling, milling, grinding, extracting juice, distilling, 
labeling, or packaging. For farms and farm mixed-type facilities, 
manufacturing/processing would not include activities that are part of 
harvesting, packing, or holding. The Agency is proposing the same 
definition of ``manufacturing/processing'' here as in proposed Sec.  
1.227 (see section VIII.E of the document for the proposed rule for 
preventive controls for human food (78 FR 3646)).
    Proposed Sec.  507.3 defines ``microorganisms'' to mean yeasts, 
molds, bacteria, viruses, protozoa, and microscopic parasites and 
includes species having animal or human health significance. The term 
``undesirable microorganisms'' includes those microorganisms that are 
of animal and human health significance, that subject food to 
decomposition, that indicate that food is contaminated with filth, or 
that otherwise may cause food to be adulterated. FDA considers not only 
yeasts, molds, bacteria and viruses, but also protozoa and microscopic 
parasites, to be microorganisms of importance in the safe and sanitary 
production of animal food.
    The Agency is proposing to define the term ``mixed-type facility'' 
to mean an establishment that engages in both activities that are 
exempt from registration under section 415 of the FD&C Act and 
activities that require the establishment to be registered. An example 
of such a facility would be a ``farm mixed-type facility,'' which is an 
establishment that grows and harvests crops or raises animals and may 
conduct other activities within the farm definition, but also conducts 
activities that require the establishment to be registered. The Agency 
is proposing to use the same definition as would be established in 
proposed Sec.  1.227 (see section VIII.E of the document for the 
proposed rule for preventive controls for human (78 FR 3646)).
    The Agency is proposing to define the term ``monitor'' to mean to 
conduct a planned sequence of observations or measurements to assess 
whether a process, point, or procedure is under control and to produce 
an accurate record for use in verification. For further discussion on 
the definition of ``monitor'' and its consistency with HACCP, see 
section X.B of the document for the proposed rule for preventive 
controls for human (78 FR 3646)).
    The Agency is proposing to define the term ``packaging'', when used 
as a verb, to mean placing food into a container that directly contacts 
the food and that the consumer receives. This definition would match 
the definition of ``packaging'' in proposed Sec.  1.227 (see section 
VIII.E of the document for the proposed rule for preventive controls 
for human (78 FR 3646)). For purposes of animal food, the use of the 
term ``consumer'' refers to the person purchasing the animal food to 
feed to an

[[Page 64757]]

animal(s) and the animal(s) consuming the food.
    The Agency is proposing to define the term ``packing'' as it is 
defined in proposed Sec.  1.227 (see section VIII.E of the document for 
the proposed rule for preventive controls for human food (78 FR 3646) 
to mean placing food into a container other than packaging the food. 
For farms and farm mixed-type facilities, packing also includes 
activities traditionally performed by farms to prepare raw agricultural 
commodities grown or raised on the same farm or another farm under the 
same ownership for storage and transport, but does not include 
activities that transform a raw agricultural commodity, as defined in 
section 201(r) of the FD&C Act, into a processed food as defined in 
section 201(gg) of the FD&C Act.
    Proposed Sec.  507.3 defines ``pest'' to mean any objectionable 
animals or insects including, but not limited to, birds, rodents, 
flies, and larvae. For example, mice would be objectionable animals in 
the animal food manufacturing, processing, packing or holding 
environment because they can cause contamination of food and food 
contact surfaces with pathogens of animal or human health significance.
    Proposed Sec.  507.3 defines ``plant'' to mean the building or 
establishment or parts thereof, used for or in connection with the 
manufacturing, processing, packing, or holding of food.
    The Agency is proposing to define ``preventive controls'' to mean 
those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would employ to significantly 
minimize or prevent the hazards identified under the hazard analysis 
that are consistent with the current scientific understanding of safe 
food manufacturing, processing, packing, or holding at the time of the 
analysis. The proposed definition would incorporate the definition in 
section 418(o)(3) of the FD&C Act.
    Proposed Sec.  507.3 defines ``qualified end-user'' to mean, with 
respect to an animal food, the consumer of the food (where the term 
does not include a business); or a restaurant or retail food 
establishment (as those terms are defined in Sec.  1.227 of this 
chapter) that:
    a. Is located:
    [cir] In the same State as the qualified facility that sold the 
food to such restaurant establishment; or
    [cir] Not more than 275 miles from such facility; and
    b. Is purchasing the food for sale directly to consumers at such 
restaurant or retail food establishment.
    The proposed definition matches the definition in section 
418(l)(4)(B) of the FD&C Act. As discussed previously in this section 
of the document, for purposes of this proposed rule, the term 
``consumer'' refers to the purchaser of the animal food to feed to an 
animal(s), and the animal(s) consuming the food. With respect to animal 
food, restaurants include pet shelters, kennels and veterinary 
facilities in which animal food is provided to animals, as provided in 
Sec.  1.227 of this chapter.
    Proposed Sec.  507.3 defines ``qualified facility'' to mean (when 
including the sales by any subsidiary; affiliate; or subsidiaries or 
affiliates, collectively, of any entity of which the facility is a 
subsidiary or affiliate) a facility that is a very small business as 
defined in this part, or a facility as to which both of the following 
apply:
     During the 3-year period preceding the applicable calendar 
year, the average annual monetary value of the animal food 
manufactured, processed, packed, or held at such facility that is sold 
directly to qualified end-users (as defined in this part) during such 
period exceeded the average annual monetary value of the animal food 
sold by such facility to all other purchasers; and
     The average annual monetary value of the animal food sold 
during the 3-year period preceding the applicable calendar year was 
less than $500,000, adjusted for inflation.
    This definition is based on the criteria in section 418(l)(1) of 
the FD&C Act. The Agency is specifying ``animal food'' in this 
definition as it intends to only include the sale of food for animals 
and not the sale of human food in determining whether a facility meets 
the requirements in those cases where a facility sells both. The Agency 
requests comment on whether food for animals and humans should be 
aggregated in determining whether a facility that sells both meets the 
statutory criteria of a qualified facility.
    Proposed Sec.  507.3 defines ``qualified individual'' to mean a 
person who has successfully completed training in the development and 
application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum recognized as adequate by 
FDA or is otherwise qualified through job experience to develop and 
apply a food safety system. The Agency is proposing to define the term 
``qualified individual'' to have a concise term to use in proposed 
provisions that would require that an activity be performed by such an 
individual. The Agency is proposing to establish requirements for a 
qualified individual in proposed section Sec.  507.50 (see section 
X.J).
    Proposed Sec.  507.3 defines ``quality control operation'' to mean 
a planned and systematic procedure for taking all actions necessary to 
prevent food from being adulterated.
    Proposed Sec.  507.3 defines ``reasonably foreseeable hazard'' ``to 
mean a potential biological, chemical, physical, or radiological hazard 
that may be associated with the facility or the food. This term is used 
in FSMA and the concept is grounded in the hazard evaluation process in 
HACCP systems.
    Proposed Sec.  507.3 defines ``rework'' to mean clean, 
unadulterated food that has been removed from processing for reasons 
other than insanitary conditions or that has been successfully 
reconditioned by reprocessing and that is suitable for use as animal 
food.
    Proposed Sec.  507.3 defines ``safe moisture level'' as a level of 
moisture low enough to prevent the growth of undesirable microorganisms 
in the finished product under the intended conditions of manufacturing, 
processing, packing, and holding. The safe moisture level for food is 
related to its water activity (aw). An aw will be 
considered safe for a food if adequate data are available that 
demonstrate that the food at or below the given aw will not 
support the growth of undesirable microorganisms.
    Proposed Sec.  507.3 defines ``sanitize'' to mean to adequately 
treat cleaned food-contact surfaces by a process that is effective in 
destroying vegetative cells of microorganisms of animal and human 
health significance, and in substantially reducing numbers of other 
undesirable microorganisms, but without adversely affecting the product 
or its safety for animals or humans. For example, an appropriate 
sanitizing process for a facility that manufactures, processes, packs 
or holds animal food can be one that does not cause illness to the 
person implementing it and does not make the food unsafe for the 
intended animal species, person handling the food or humans consuming 
human food derived from animals that consume the animal food. It is 
well established that sanitizers can be inactivated by organic material 
and, thus, are not effective unless used on clean surfaces (Ref. 35). 
The Agency recognizes that in certain situations effective cleaning and 
sanitizing of food-contact surfaces for animal food helps protect the 
health of animals by controlling the transmission of animal diseases. 
Effective cleaning and sanitizing of food-contact surfaces for animal 
food can also protect human

[[Page 64758]]

health by preventing transmission of human diseases that occur through 
handling of the contaminated food.
    Proposed Sec.  507.3 defines ``should,'' explaining that ``should'' 
is used to state recommended or advisory procedures or identify 
recommended equipment. ``Should'' denotes non-binding guidance. 
Consistent with the Agency's good guidance practices regulation (21 CFR 
10.115), proposed provisions containing the word ``should'' are draft 
guidance at this stage. They do not create or confer any rights for or 
on any person and do not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.
    The Agency is proposing to define ``significantly minimize'' to 
mean to reduce to an acceptable level, including to eliminate. 
``Significantly minimize'' and ``preventive control'' are terms used in 
FSMA and are consistent with the definition of ``control measure'' in 
the National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF) HACCP guidelines, the Codex HACCP Annex, and FDA's HACCP 
regulation for juice. The NACMCF HACCP guidelines define ``control 
measure'' as any action or activity that can be used to prevent, 
eliminate or reduce a significant hazard (Ref. 29). The Codex HACCP 
Annex defines ``control measure'' as any action and activity that can 
be used to prevent or eliminate a food safety hazard or reduce it to an 
acceptable level (Ref. 36). For further discussion on the definition of 
``significantly minimize'' and its consistency with the term ``control 
measure'' as used in HACCP, see section X.B.4 of the document for the 
proposed rule for preventive controls for human food (78 FR 3646).
    The Agency is proposing to define the term ``small business'' to 
mean a business employing fewer than 500 persons. See section VIII.B.2 
for additional discussion of small business.
    The proposed limit of 500 employees would include all employees of 
the business rather than be limited to the employees at a particular 
facility. FDA conducted a study as required by section 418(l)(5) of the 
FD&C Act that was used to help determine this definition. That study is 
available in the docket established for this proposed rule (Ref. 16). 
The Agency requests comment on that study, particularly in regards to 
business size for animal food facilities. The Agency will consider 
comments regarding the study, as well as comments regarding its 
proposed definition for small business, in any final rule based on this 
proposed rule.
    The Agency is proposing to define the term ``subsidiary,'' as it is 
defined in section 418(l)(4)(D) of the FD&C Act, to mean any company 
that is owned or controlled directly or indirectly by another company.
    The Agency is proposing to define the term ``validation'' to mean 
that element of verification focused on collecting and evaluating 
scientific and technical information to determine whether the food 
safety plan, when properly implemented, will effectively control the 
identified hazards.
    The Agency is proposing to define the term ``verification'' to mean 
those activities, other than monitoring, that establish the validity of 
the food safety plan and that the system is operating according to the 
plan. For further discussion on the use of the terms ``validation'' and 
``verification'' in HACCP, see section X.B.4 of the document for the 
proposed rule for preventive controls for human food (78 FR 3646).
    The Agency is proposing to define the term ``very small business'' 
to mean, for purposes of this proposed part 507, a business that has 
less than $500,000 in total annual sales of animal foods, adjusted for 
inflation (Option 1 of co-proposal). As one co-proposal, the Agency is 
proposing to define the term ``very small business'' to mean a business 
that has less than $1,000,000 in total annual sales of animal foods, 
adjusted for inflation (Option 2). As another co-proposal, the Agency 
is proposing to define the term ``very small business'' to mean a 
business that has less than $2,500,000 in total annual sales of animal 
foods, adjusted for inflation (Option 3). See section VIII.B.2 for 
additional discussion of the definition of very small business.
    The Agency is proposing to define the term ``water activity 
(aw)'' to mean a measure of the free moisture in a food and 
is the quotient of the water vapor pressure of the substance divided by 
the vapor pressure of pure water at the same temperature.
2. Food Processing Sector Study and the Definitions of ``Small 
Business'' and ``Very Small Business''
    FDA conducted a Food Processing Sector Study as required by section 
418(l)(5) of the FD&C Act (Ref. 16). The purpose of that study was to 
make determinations in five areas as required by section 418(l)(5)(A) 
of the FD&C Act and to use the results of the study in defining the 
terms ``small business'' and ``very small business.'' 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. The Food 
Processing Sector Study provides information on the number of 
establishments and average sales per establishment by industry and size 
of operation. FDA's proposed definitions are informed by that study. 
The food processing sector study is available in the docket established 
for this proposed rule (Ref. 16). The Agency requests comment on that 
study. The Agency will consider comments regarding the study, as well 
as comments regarding its proposed definitions ``small business'' and 
``very small business,'' in any final rule based on this proposed rule.
    Section 418(l)(5)(B) of the FD&C Act required consideration of 
harvestable acres, income, the number of employees, and the volume of 
product in defining the terms ``small business'' and ``very small 
business.'' The Food Processing Sector Study (Ref. 16) concluded that 
there was no consistent pattern across food categories, including the 
pet food and animal feed categories, in terms of which sizes of 
establishments contribute most to foodborne illness risk. ``Harvestable 
acres,'' ``income,'' ``the number of employees,'' and ``the volume of 
food harvested'' are all ways to measure the size of an operation. 
Income does not appear to be the most relevant measure, since facility 
income may be derived from multiple sources, many of which are not 
food-related. ``Harvestable acres'' and ``volume of food harvested'' 
are similar measures that appear primarily relevant to the growing and 
harvesting of crops, which are activities not subject to this 
regulation. Harvestable acres and volume of food harvested do not 
provide a meaningful measure with respect to the risk from pet food or 
animal feed produced by a farm mixed-type facility (a pet food or 
animal feed facility co-located on a farm subject to this regulation); 
the Agency's qualitative risk assessment of manufacturing, processing, 
packing, and holding activities conducted in a facility co-located on a 
farm showed that risk was related to activity/animal food combinations; 
these animal foods could be harvested from large or small farms (see 
section VII.B for a discussion of that qualitative risk assessment). A 
high risk activity/animal food combination (i.e., a not low-risk 
activity/food combination) could be conducted on a farm with

[[Page 64759]]

many harvestable acres or very few harvestable acres. For example, an 
on-farm facility mixing and/or blending for the purpose of making a 
complete animal food (which would not be considered a low-risk 
activity/food combination) could be one that has very few acres, or the 
mixing and/or blending for the purpose of making a complete animal food 
could be a small component of a large farm operation. FDA has 
previously used both number of employees and annual sales as criteria 
for defining small and very small businesses, e.g., in Sec.  
120.1(b)(1) and (b)(2) (21 CFR 120.1(b)(1) and (b)(2)) for human food. 
However, FDA has not previously defined small or very small businesses 
with regard to pet food or animal feed businesses. The Agency has 
limited data on number of employees, income, and annual sales upon 
which to base its definitions of small and very small business for 
animal food, but no data for ``harvestable acres'' or ``the volume of 
food harvested.''
    a. Definition of ``Small Business.'' FDA is proposing to define the 
term ``small business'' to mean, for the purposes of part 507, a 
business employing fewer than 500 persons. The proposed limit of 500 
employees would include all employees of the business rather than be 
limited to the employees at a particular facility. The Agency is 
proposing to establish the same definition for small business as that 
which has been established by the U.S. Small Business Administration 
under 13 CFR part 121 for most food manufacturers. This is also the 
same definition for small business the Agency used to define a small 
business in its juice HACCP regulation (Sec.  120.1(b)(1)). The 
definition of small business is relevant to two provisions in the 
proposed rule. It would affect which facilities qualify for the 
exemption in proposed Sec.  507.5(e) for on-farm packing or holding, 
and the exemption in proposed Sec.  507.5(f) for on-farm manufacturing/
processing, of animal food by a small business if the only activities 
subject to section 418 of the FD&C Act are the specific low-risk 
activity/animal food combinations listed in those sections. It would 
also affect what the compliance date is for facilities that meet the 
definition.
Effect on Proposed Sec.  507.5(e) and (f)
    Under proposed Sec.  507.5(e) a farm mixed-type facility that meets 
the definition of a small business and only conducts specific packing 
or holding activity/animal food combinations would be eligible for an 
exemption from subpart C. Similarly, under proposed Sec.  507.5(f) a 
farm mixed-type facility that meets the definition of a small business 
and only conducts specific manufacturing/processing activity/animal 
food combinations would be eligible for an exemption from subpart C. 
Based on the Food Processing Sector Study, the Agency estimates that 
approximately 4,439 facilities would be part of a small business under 
the proposed definition and thus satisfy the size requirement of the 
exemption in proposed Sec.  507.5(e) and proposed Sec.  507.5(f). Of 
those facilities, the Agency estimates that approximately 188 would be 
co-located on farms. A subset of those facilities would qualify for the 
exemption from subpart C based on their manufacturing/processing and 
packing and holding activities.
Other Effects
    Based on the Food Processing Sector Study the Agency estimates that 
businesses employing fewer than 500 employees produce approximately 18 
percent (based on sales) of all manufactured food produced in the 
United States and 86.9 percent of all manufactured pet food and animal 
feed. As discussed in section VI, the compliance date for a small 
business would be 2 years after the date of publication of the final 
rule. Under this proposed definition, 4,439 facilities would be subject 
to this compliance date.
    b. Definition of ``Very Small Business.'' In addition to defining 
``small business,'' FDA is required to define ``very small business.'' 
FDA has not reached a tentative conclusion on how best to define ``very 
small business'' for the purposes of this rule. Consequently, the 
Agency is proposing three possible definitions based on annual sales of 
animal food of $500,000, $1,000,000, or $2,500,000 and requesting 
comment on which of these three options to include in a final rule. The 
Food Processing Sector Study provided information for the development 
of the three proposed definitions (Ref. 16). The Agency requests 
comment on whether a dollar amount of sales that is more than, or less 
than, the $500,000, $1,000,000, or $2,500,000 dollar amounts it is 
proposing would be appropriate. The Agency also requests comment on how 
a particular dollar amount of sales would be in keeping with 
Congressional intent, i.e., in light of the provisions in section 
418(l) of the FD&C Act regarding qualified facilities, including the 
statutory limitations on sales to qualified end-users.
    The definition of very small business is relevant to 3 provisions 
of the proposed rule. It would affect which facilities qualify for the 
exemption in Sec.  507.5(e) for on-farm packing or holding, and the 
exemption in Sec.  507.5(f) for on-farm manufacturing/processing, of 
animal food by a very small business if the only activities subject to 
section 418 of the FD&C Act are the specific low-risk activity/animal 
food combinations listed in those sections. It would also affect which 
facilities are automatically ``qualified'' facilities subject to the 
modified requirements in Sec.  507.7 and what the compliance date is 
for such facilities.
Effect on Proposed Sec.  507.5(e) and (f)
    The definition of very small business affects which facilities 
qualify for the exemption in Sec.  507.5(e) for on-farm packing or 
holding, and the exemption in Sec.  507.5(f) for on-farm manufacturing/
processing, of animal food by a very small business if the only 
activities subject to section 418 of the FD&C Act are the specific low-
risk activity/animal food combinations listed in those sections,
Other Effects
    The definition of very small business affects which facilities are 
automatically ``qualified'' facilities subject to the modified 
requirements in proposed Sec.  507.7, and the applicable compliance 
dates for such facilities. There are two ways a facility may be 
``qualified'' and thus subject to the modified requirements in proposed 
Sec.  507.7. The first, limited annual monetary value of sales, is 
based on fixed criteria set out in FSMA section 418(l)(1)(C). The 
second, as provided by section 418(l)(1)(B), is to be a very small 
business as defined by FDA. Therefore, the Agency discusses the effect 
of the proposed definitions for very small business in relation to the 
existing requirements for qualified facilities in section 418(l)(1)(C).
Less Than $500,000 in Total Annual Sales--Effect on Proposed Sec.  
507.5(e) and (f)
    One possible definition of the term ``very small business,'' for 
the purposes of proposed part 507, would be a business that has less 
than $500,000 in total annual sales of animal food, adjusted for 
inflation (Option 1 of the co-proposal). From the Food Processing 
Sector Study it is apparent that the number of co-located facilities is 
concentrated at the smaller end of the size spectrum. Using data from 
Dun & Bradstreet, FDA estimates that 3 co-located facilities would meet 
the size requirement for the exemptions in proposed Sec.  507.5(e) and 
(f). A subset of those facilities might then qualify for

[[Page 64760]]

the exemption from subpart C based on their manufacturing/processing, 
packing, or holding activities.
Less Than $500,000 in Total Annual Sales--Effect on Number of Qualified 
Facilities
    The proposed definition of $500,000 uses a dollar amount for sales 
that is, essentially, the same as the maximum dollar amount of sales by 
a qualified facility to end-users other than those that would satisfy 
the definition of ``qualified end-users,'' except unlike with section 
418(l)(1)(C) of the FD&C Act, there would be no requirement that more 
than half of sales must be to qualified end-users. The $500,000 
definition of very small business would add approximately 3 domestic 
facilities to the number of qualified facilities. FDA estimates that no 
additional domestic animal food facilities beyond these 3 domestic 
facilities would be qualified facilities under section 418(l)(1)(C) of 
the FD&C Act, leading to a total of 3 domestic qualified facilities. 
These 3 domestic qualified facilities would have a 3 year compliance 
date. As a group, businesses with less than $500,000 in total annual 
sales of animal food produce less than 0.003 percent of all animal food 
produced in the United States when measured by dollar value.
Less Than $1,000,000 in Total Annual Sales--Effect on Proposed Sec.  
507.5(e) and (f)
    One possible definition of the term ``very small business,'' for 
the purposes of proposed part 507, would be a business that has less 
than $1,000,000 in total annual sales of animal food, adjusted for 
inflation (Option 2 of the co-proposal). Using data from Dun & 
Bradstreet (in the Food Processing Sector Study), FDA estimates that 
the same 3 facilities that met the $500,000 exemption would meet this 
exemption level but no additional facilities would meet the size 
requirement for the exemptions in proposed Sec.  507.5(e) and proposed 
Sec.  507.5(f). A subset of those facilities might then qualify for the 
exemption from subpart C based on their manufacturing/processing, 
packing, or holding activities.
Less Than $1,000,000 in Total Annual Sales--Effect on Number of 
Qualified Facilities
    Defining very small business to mean a business that has less than 
$1,000,000 in total annual sales of animal food would add approximately 
619 domestic facilities to the number of qualified facilities. FDA 
estimates that no additional domestic pet food or animal feed 
facilities beyond these 619 domestic facilities would be qualified 
facilities under section 418(l)(1)(C) of the FD&C Act, leading to a 
total of 619 domestic qualified facilities. These 619 domestic 
qualified facilities would have a 3-year compliance date. As a group, 
businesses with less than $1,000,000 in total annual sales of animal 
food produce less than 1.71 percent of all pet food and animal feed 
produced in the United States when measured by dollar value.
Less Than $2,500,000 in Total Annual Sales--Effect on Proposed Sec.  
507.5(e) and (f)
    One possible definition of the term ``very small business,'' for 
the purposes of proposed part 507, would be a business that has less 
than $2,500,000 in total annual sales of animal food, adjusted for 
inflation (Option 3 of the co-proposal). Using data from Dun & 
Bradstreet, FDA estimates that the same 3 facilities that met the 
$500,000 and $1,000,000 exemption would met this exemption level but no 
additional facilities would meet the size requirement for the exemption 
in proposed Sec.  507.5(e) and proposed Sec.  507.5(f). A subset of 
those facilities might then qualify for the exemption from subpart C 
based on their manufacturing/processing, packing, or holding 
activities.
Less Than $2,500,000 in Total Annual Sales--Effect on Number of 
Qualified Facilities
    As compared to Option 2, defining very small business to mean a 
business that has less than $2,500,000 in total annual sales of animal 
food would add another approximately 2,880 domestic facilities to the 
number of qualified facilities. FDA estimates that no additional 
domestic pet food or animal feed facilities beyond these 3,499 (the 619 
facilities that qualify at the $1,000,000 exemption level plus the 
2,880 facilities that qualify at the $2,500,000 exemption level) 
domestic facilities would be qualified facilities under section 
418(l)(1)(C) of the FD&C Act, leading to a total of 3,499 domestic 
qualified facilities. These 3,499 domestic qualified facilities would 
have 3 year compliance date. As a group, businesses with less than 
$2,500,000 in total annual sales of animal food produce less than 20.8 
percent of all pet food and animal feed produced in the United States 
when measured by dollar value.
Differences From the Proposed Preventive Control Rule for Human Food
    FDA is proposing different annual gross sales levels for the three 
definition options of very small business for animal food facilities 
than proposed for human food facilities. In the proposed rule for 
preventive controls for human food (78 FR 3646), FDA proposed three 
options for annual gross sales levels for very small business. Option 1 
would be $250,000, Option 2 would be $500,000, and Option 3 would be $1 
million. For the proposed rule for preventive controls for animal food, 
FDA is proposing three different options for annual gross sales levels 
for very small business. Option 1 would be $500,000, Option 2 would be 
$1 million, and Option 3 would be $2.5 million. In general, the animal 
food industry sector is more heavily weighted toward the medium and 
larger facilities, when based on gross annual sales, than is the human 
food industry sector. For example, facilities producing livestock or 
poultry feed often buy and sell product measured in tons, resulting in 
high annual gross sales. Though the annual gross sales levels would be 
higher for each option in the proposed animal food rule, the percent of 
facilities and percent of sales exempted would be comparable to the 
annual gross sales levels for the three options for the proposed rule 
for human food.

C. Proposed Sec.  507.5--Exemptions

1. Proposed Sec.  507.5(a)--Exemption Applicable to Establishments Not 
Required To Register Under Section 415 of the FD&C Act
    Proposed Sec.  507.5(a) would exempt establishments not required to 
register under section 415 of the FD&C Act. According to section 
415(c)(1) of the FD&C Act, establishments that are not required to 
register include farms; restaurants; other retail food establishments; 
nonprofit food establishments in which food is prepared for or served 
directly to the consumer; or fishing vessels (except such vessels 
engaged in processing as defined in 21 CFR 123.3(k)). The Agency has 
interpreted these terms in Sec.  1.227. For example, in the animal food 
context, a ``restaurant'' includes pet shelters, kennels, and 
veterinary facilities in which food is provided to animals. A ``retail 
food establishment'' is an establishment that sells food directly to 
consumers as their primary business function, where the term 
``consumer'' does not include a business. A grocery store, including 
the pet food aisle, would be an example. In

[[Page 64761]]

addition, the Agency has interpreted ``nonprofit food establishment'' 
to include a charitable entity that provides food or meals for 
consumption by animals in the United States. To be considered a 
nonprofit food establishment, the establishment must meet the terms of 
section 501(c)(3) of the U.S. Internal Revenue Code. Certain nonprofit 
wildlife rehabilitation centers would likely fall into this category.
    In section VIII.B of the document for the proposed rule for 
preventive controls for human food (78 FR 3646), FDA proposed to 
further clarify the scope of the definition of ``farm'' for the 
purposes of section 415 of the FD&C Act to mean a facility in one 
general physical location devoted to the growing and harvesting of 
crops, the raising of animals (including seafood), or both. The term 
``farm'' would include: (1) Facilities that pack or hold food, provided 
that all food used in such activities is grown, raised, or consumed on 
that farm or another farm under the same ownership and (2) facilities 
that manufacture/process food, provided that all food used in such 
activities is consumed on that farm or another farm under the same 
ownership. Because this definition of ``farm'' reflects the Agency's 
interpretation of the term in section 415 of the FD&C Act, 
establishments that meet this definition would not be required to 
register under section 415 of the FD&C Act and would therefore be 
excluded from the scope of this rulemaking under proposed Sec.  
507.5(a). For example, a farm that manufactures/processes food, e.g., 
by using mobile equipment to mix grain and forage with a commercially 
produced protein/mineral supplement into a total-mixed ration to feed 
to dairy cattle on its farm, or another farm under the same ownership, 
would be exempt from this proposed rule. As another example, a crop 
farm that grows, harvests, and stores agronomic crops such as alfalfa 
hay, corn, and other feed grains for distribution into commerce as 
animal food would be exempt from the proposed rule.
    Similarly, the exemption in Sec.  507.5(a) would exempt activities 
of farm mixed-type facilities that fall within the farm definition 
previously mentioned. As discussed in section VIII.B of this document 
and section VIII.E.1 of the document for the proposed rule for 
preventive controls for human food (78 FR 3646), a ``mixed-type 
facility'' would be an establishment that engages in both activities 
that are exempt from registration under section 415 of the FD&C Act and 
activities that require the establishment to be registered. An example 
of such a facility would be a ``farm mixed-type facility,'' an 
establishment that grows and harvests crops or raises animals and may 
conduct other activities within the farm definition, but also conducts 
activities that require the establishment to be registered. FDA 
tentatively concludes that the portion of a farm mixed-type facility 
that is within the farm definition--and therefore the portion that is 
exempt from registration under section 415 of the FD&C Act--should be 
treated the same way for the purposes of proposed Sec.  507.5(a) as the 
same activities on farms that only conduct activities within the farm 
definition.
    Section 418 of the FD&C Act sets forth requirements for the owner, 
operator, or agent is in charge of a ``facility,'' defined in 418(o)(2) 
as a domestic facility or foreign facility that is required to register 
under section 415. Therefore section 418 of the FD&C Act only applies 
to establishments that are required to register under section 415.
    The Agency tentatively concludes that these facilities should not 
be subject to the CGMPs in proposed part 507 for several reasons. 
Establishments that are not required to register under section 415 of 
the FD&C Act are not commonly known to be sources of animal food 
adulteration, they do not commonly stockpile large inventories of 
animal food, and the rapid turnover of inventory further reduces the 
risk that these establishments will adulterate animal food products 
they use. In addition, most of the animals that are housed and cared 
for by this sector are not food-producing animals, narrowing the scope 
of the human health risk.
    Most of these establishments are already regulated by other 
agencies, often multiple agencies, who already address animal food 
safety to some degree. For example, many establishments that are not 
required to register under section 415 of the FD&C Act fall under the 
purview of the Animal Welfare Act (AWA), implemented by USDA. The AWA 
and its implementing regulations provide for safe food and housing for 
animals in indoor, outdoor and sheltered housing establishments, and 
those under the control of dealers and exhibitors, among others. 
Implementing regulations enforced by USDA specify that the food 
provided to animals in these establishments must be uncontaminated and 
wholesome (e.g., 9 CFR 3.9). In addition, veterinary clinics, among 
others of these types of establishments, are regulated by State 
governments.
    FDA also has other established regulations that incorporate feeding 
practices and animal food storage. For example, Sec.  589.2000, Animal 
Proteins Prohibited in Animal Feed, addresses, among other things, the 
feeding of ruminant animals. The Agency does inspect ruminant feeders, 
including farms and other establishments that may feed ruminant animals 
to ensure compliance with this regulation. Although the focus of the 
Agency's inspection work under this regulation is farms raising 
ruminant animals such as cattle, sheep, goats, elk, and bison intended 
to produce meat and milk for human consumption, the Agency also visits 
a small number of other establishments to make sure those industry 
sectors are aware of, and following, these regulations as they care for 
their ruminant animals.
    Certain establishments that are not required to register under 
section 415 of the FD&C Act conduct nonclinical laboratory studies in 
animals to support applications for research or marketing permits for 
products regulated by FDA, including food and color additives, animal 
food additives, human and animal drugs, medical devices for human use, 
biological products, and electronic products. These establishments must 
comply with Good Laboratory Practice regulations already in place in 
part 58 (21 CFR part 58), which include certain food safety measures. 
For example, Sec.  58.45 states ``there shall be storage areas, as 
needed, for feed, bedding, supplies, and equipment. Storage areas for 
feed and bedding shall be separated from areas housing the test systems 
and shall be protected against infestation or contamination. Perishable 
supplies shall be preserved by appropriate means.'' In addition, Sec.  
58.90(g) states ``feed and water used for the animals shall be analyzed 
periodically to ensure that contaminants known to be capable of 
interfering with the study and reasonably expected to be present in 
such feed or water are not present at levels above those specified in 
the protocol . . .''
    Finally, while establishments that are not required to register 
under section 415 of the FD&C Act would not need to comply with the 
proposed rule, they would still be subject to the adulteration 
provisions of section 402 of the FD&C Act.
2. Proposed Sec.  507.5(b)--Exemption Applicable to Animal Food Subject 
to Sec.  500.23 and Part 113-Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers
    Section 418(j)(1)(C) of the FD&C Act provides that section 418 of 
the FD&C Act shall not apply to a facility if the owner, operator, or 
agent in charge of such facility is required to comply with,

[[Page 64762]]

and is in compliance with, ``[t]he Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards of the [FDA] (or 
any successor standards).'' (The Agency interprets ``Thermally 
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers 
standards'' to mean the requirements of Sec.  500.23 and part 113. 
Section 500.23 establishes that part 113 also applies to food for 
animals.) Importantly, section 418(j)(2) of the FD&C Act limits the 
express exemption associated with Sec.  500.23 and part 113 to 
microbiological hazards that are regulated under Sec.  500.23 and part 
113 (or any successor regulations). FDA considers the language of 
section 418(j)(1)(C) of the FD&C Act to be ambiguous with regard to 
application of the exemption. The language of section 418(j)(1)(C) 
exempts a facility from section 418 of the FD&C Act if the owner, 
operator, or agent in charge of the facility is required to comply 
with, and is in compliance with, Sec.  500.23 and part 113 ``with 
respect to such facility[.]'' However, Sec.  500.23 and part 113 do not 
apply to ``facilities,'' establishments, or plants. Rather, they apply 
to the specified foods (low-acid canned foods) and to persons defined 
as ``commercial processors'' who conduct certain activities involving 
those foods. See, e.g., Sec.  113.3(d) (definition of ``Commercial 
processor''), and section 404 of the FD&C Act (21 U.S.C. 344), which 
provides FDA with legal authority to issue Sec.  500.23 and part 113 
(``[The Secretary] shall promulgate regulations providing for the 
issuance, to manufacturers, processors, or packers of such class of 
food [presenting specific risks defined in the section] in such 
locality of permits to which shall be attached such conditions 
governing the manufacture, processing, or packaging of such class of 
food . . .''). Thus, it is unclear for purposes of section 418(j)(1)(C) 
under what circumstances a low-acid canned food processor is required 
to comply with Sec.  500.23 and part 113 ``with respect to [a] 
facility,'' especially when such a person also conducts activities 
involving other foods not subject to Sec.  500.23 and part 113 at the 
same facility.
    The Agency tentatively concludes that it should interpret section 
418(j)(1)(C) to exempt those activities of a facility that are subject 
to Sec.  500.23 and part 113, and only those activities. Such an 
interpretation would fulfill the apparent goal of the exemption without 
being too narrow or too broad. The Agency also tentatively concludes 
that it should include the exemption provided in section 418(j)(1)(C) 
of the FD&C Act in the proposed rule to establish by regulation the 
reach of the exemption as the Agency has interpreted it. Proposed Sec.  
507.5(b) would provide that subpart C would not apply with respect to 
activities that are subject to Sec.  500.23 and part 113 (Thermally 
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at 
a facility if the owner, operator, or agent in charge of the facility 
is required to comply with, and is in compliance with, Sec.  500.23 and 
part 113 with respect to such activities. Consistent with section 
418(j)(2) of the FD&C Act, proposed Sec.  507.5(b) would establish that 
the exemption would be applicable only with respect to the 
microbiological hazards that are regulated under Sec.  500.23 and part 
113. A facility that is required to comply with, and is in compliance 
with, Sec.  500.23 and part 113 would be subject to the requirements in 
proposed subpart C for hazards such as chemical hazards (e.g., 
pesticide residues), physical hazards (e.g., metal fragments that could 
be introduced from equipment) and radiological hazards (e.g., high 
concentrations of radium-226, radium-228 or uranium in well water used 
in product). A facility that is required to comply with, and is in 
compliance with, Sec.  500.23 and part 113 also would be subject to the 
requirements in proposed subpart C for biological hazards not regulated 
under Sec.  500.23 and part 113. For example, the heat-stable toxin 
produced by the Staphylococcus aureus is a biological hazard that would 
not be inactivated or destroyed by the processing required under Sec.  
500.23 and part 113 (Ref. 37) (Ref. 38).
    The Agency requests comment on the criteria that should be used to 
determine whether a facility is in compliance with Sec.  500.23 and 
part 113.
3. Proposed Sec.  507.5(c)--Exemptions Applicable to Activities Subject 
to Standards for Produce Safety in Section 419 of the FD&C Act
    Section 418(k) of the FD&C Act provides that section 418 of the 
FD&C Act ``shall not apply to activities of a facility that are subject 
to section 419 [of the FD&C Act].'' Section 419, ``Standards for 
Produce Safety,'' requires FDA to establish by regulation ``science-
based minimum standards for the safe production and harvesting of those 
types of fruits and vegetables, including specific mixes or categories 
of fruits and vegetables, that are raw agricultural commodities for 
which [FDA] has determined that such standards minimize the risk of 
serious adverse health consequences or death.'' Section 419(h) of the 
FD&C Act provides that section 419 of the FD&C Act ``shall not apply to 
activities of a facility that are subject to section 418 [of the FD&C 
Act.]'' FDA issued a proposed rule to implement section 419 on January 
16, 2013 (78 FR 3504.) That proposed rule would apply section 419 to 
``farms'' (as would be defined in proposed Sec. Sec.  1.227 and 1.328 
of the proposed rule for preventive controls for human food (78 FR 
3646) that are not required to register under section 415 of the FD&C 
Act and to farms that conduct an activity (or activities) that triggers 
the section 415 registration requirement (``farm mixed-type 
facilities''), but only with respect to their activities that are 
within the farm definition and therefore do not trigger the 
registration requirement. The Agency tentatively concludes that it 
should include a provision implementing section 418(k) of the FD&C Act 
in the proposed rule for clarity and consistency, though section 419 of 
the FD&C Act applies only to human food. Proposed Sec.  507.5(c) would 
provide that subpart C would not apply to activities of a facility that 
are subject to section 419 of the FD&C Act (Standards for Produce 
Safety).
4. Proposed Sec.  507.5(d)--Exemption Applicable to a Qualified 
Facility
    Section 418(l) of the FD&C Act establishes modified requirements 
for ``qualified facilities.'' The Agency describes what a qualified 
facility is in section VIII.D, where the Agency proposes the 
requirements for such a facility (proposed Sec.  507.7). The Agency 
also defines the term ``qualified facility'' in proposed Sec.  507.3 
(see the discussion of definitions in section VIII.B). Section 
418(l)(2)(A) of the FD&C Act provides that a qualified facility ``shall 
not be subject to the requirements under [sections 418(a) through (i) 
and (n) of the FD&C Act];'' as a practical matter with respect to the 
provisions of this proposed rule, section 418(l)(2)(A) of the FD&C Act 
provides that a qualified facility would be exempt from the 
requirements of proposed subpart C. Importantly, section 418(l)(3) of 
the FD&C Act provides that the Secretary of HHS may withdraw the 
exemption provided in section 418(l)(2)(A) under certain circumstances. 
The Agency discusses the withdrawal provisions of section 418(l)(3), 
and its proposed provisions to implement section 418(l)(3) (proposed 
subpart D), in section XI.
    The Agency tentatively concludes that it should include the 
exemption provided in section 418(l)(2)(A) of the FD&C Act in the 
proposed rule to establish by regulation the reach of the provision. 
Proposed Sec.  507.5(d) would provide that subpart C would not apply

[[Page 64763]]

to a qualified facility, except as provided by subpart E (i.e., except 
as provided by the proposed provisions for withdrawal), and that 
qualified facilities are subject to the requirements in Sec.  507.7.
5. Proposed Sec.  507.2(e) and (f)--Exemption Applicable to Certain On-
farm Manufacturing, Processing, Packing or Holding Food by a Small or 
Very Small Business
    a. Requirements of section 103 of FSMA. As discussed in section 
VII.A.1, section 103(c)(1)(A) of FSMA requires that the Secretary 
publish a proposed rule to issue 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 [FD&C Act]; 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 section 415.'' Section 103(c)(1)(B) of FSMA 
directs that the rulemaking ``shall enhance the implementation of such 
section 415 [of the FD&C Act] and clarify the activities that are 
included as part of the definition of the term ``facility'' under such 
section 415.'' In section VII, the Agency discusses clarifications of 
certain on-farm activities and whether they trigger the section 415 
registration requirement in order to enhance the implementation of 
section 415 by clarifying the treatment of various activities for 
purposes of section 415, including activities conducted on farms.
    In the proposed rule for preventive controls for human food (78 FR 
3646), FDA proposed adding a new definition of the term ``Mixed-type 
facility'' to Sec.  1.227. The proposed definition would also state 
that an example of such a facility is a ``farm mixed-type facility,'' 
which is an establishment that grows and harvests crops or raises 
animals, and may conduct other activities within the farm definition, 
but also conducts activities that require the establishment to be 
registered. Mixed-type facility would mean an establishment that 
engages in both activities that are exempt from registration under 
section 415 of the FD&C Act and activities that require the 
establishment to be registered. Because the specific classes of 
activities mentioned in FSMA section 103(c) are, by definition, on-farm 
activities that do not fall within the farm definition, Congress has 
explicitly directed FDA to engage in rulemaking addressing 
establishments that conduct activities that are outside the farm 
definition on farms. Accordingly, FDA proposed to define the term 
``farm mixed-type facility'' to refer to these establishments (78 FR 
3646).
    As discussed in section VII.A.2, section 103(c)(1)(C) of FSMA 
requires that the Secretary conduct a science-based risk analysis of 
``(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 animal 
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 
discussed in section VII.B, consistent with the requirements of section 
103(c)(1)(C) of FSMA the Agency has conducted a qualitative risk 
assessment related to activity/animal food combinations for the purpose 
of determining which activity/animal food combinations would be 
considered low risk.
    Section 103(c)(1)(D)(i) of FSMA requires that, in issuing the 
regulations under section 103(c)(1)(A), ``the Secretary shall consider 
the results of the science-based risk analysis conducted under [section 
103(c)(1)(C) of FSMA], and shall 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 in section 421 of [the FD&C Act] . . . or modify the 
requirements in [sections 418 or 421 of the FD&C Act], 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 ``[t]he exemptions or 
modifications under section 103(c)(1)(D)(i) of FSMA shall not include 
an exemption from the requirement to register under section 415 of the 
[FD&C Act] . . . 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 [FD&C Act].''
    b. FDA's interpretation of section 103(c)(1)(D)(i) of FSMA. FDA 
considers the language of section 103(c)(1)(D)(i) of FSMA to be 
unambiguous with regard to the reach of the exemption. The language of 
section 103(c)(1)(D)(i) includes the requirement ``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.'' FDA tentatively concludes that this 
language is unambiguous and means that Congress intended us to exempt a 
facility from, or modify the requirements of, section 418 of the FD&C 
Act under this authority if the facility only conducts a limited set of 
low-risk activity/animal food combinations that would otherwise be 
subject to section 418, that is, to the extent the facility is subject 
to section 418, it ``is engaged only in'' the identified activities 
involving the identified foods. This interpretation seems both 
protective of public health and consistent with the preventive purpose 
of section 418 of the FD&C Act. This interpretation would mean that a 
facility would be required to conduct a hazard analysis and establish 
and implement risk-based preventive controls for all activities 
conducted on all animal foods (including low-risk activity/animal food 
combinations) if a facility conducts a single activity subject to 
section 418 of the FD&C Act that is not a low-risk activity/animal food 
combination, unless the facility qualifies for another exemption from 
subpart C.
    c. Proposed Sec.  507.5(e)--Exemptions for on-farm low-risk packing 
or holding activity/food combinations. Proposed Sec.  507.5(e) would 
provide that subpart C would not apply to on-farm packing or holding of 
animal food by a small or very small business if the only packing and 
holding activities subject to section 418 of the FD&C Act that the 
business conducts are the following low-risk packing or holding 
activity/animal food combinations on animal food not grown, raised, or 
consumed on that farm mixed-type facility or another farm or farm 
mixed-type facility under the same ownership:
    1. Conveying, weighing, sorting, culling, or grading (incidental to 
storing):
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
     Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, 
sunflower);
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., almond, peanut, or 
soybean hulls, citrus, other fruit including culled fruit, potatoes, or 
other vegetables including culled vegetables).
    2. Storing:
     Dried grain;
     Dried oilseed;
     Byproducts of dried grain or dried oilseed;

[[Page 64764]]

     Forage; or
     Other plants or plant byproducts.
    3. Packing:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage; or
     Other plants or plant byproducts.
    4. Mixing (incidental to packing or storing):
     Grain, whole; or
     Forage.
    The low-risk on farm packing and holding activity/animal food 
combinations on food not grown, raised, or consumed on that farm mixed-
type facility or another farm or farm mixed-type facility under the 
same ownership reflect the findings of the analysis required by section 
103(c)(1)(C) of FSMA, discussed in sections VII.B and VII.C.
    For purposes of proposed Sec.  507.5(e) and (f), ``other plant 
byproducts'' includes such things as barley hulls, cottonseed hulls, 
corn cobs, oat hulls, rice hulls, and straw. Grain and oilseed 
byproducts can be considered part of ``grain and oilseed'' as a general 
matter, but FDA has addressed those foods separately for the purpose of 
the risk evaluation and the proposed Sec.  507.5(e) and (f) exemptions 
in order to accurately reflect differences in activity/animal food 
combinations likely to be performed on farm mixed-type facilities on 
grain and oilseed byproducts as compared to other grains and oilseeds, 
as well as differences in risk across those activity/animal food 
combinations.
    d. Proposed Sec.  507.5(f)--Exemptions for on-farm low-risk 
manufacturing/processing activity/animal food combinations. Proposed 
Sec.  507.5(f) would provide that subpart C would not apply to on-farm 
low-risk manufacturing/processing activities conducted by a small or 
very small business if the only manufacturing/processing activities 
subject to section 418 of the FD&C Act that the business conducts 
consists of the following:
    1. When conducted on a farm/farm mixed-typed facility's own (those 
grown or raised on that farm/farm mixed-type facility or another farm/
farm mixed-type facility under the same ownership) raw agricultural 
commodities for distribution into commerce:
     Cracking, crimping, flaking:
    [cir] Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
    [cir] Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, 
sunflower); or
    [cir] Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
    [cir] Grain;
    [cir] Oilseed;
    [cir] Grain or oilseed byproducts;
    [cir] Forage (e.g., hay or ensiled material); or
    [cir] Other plants or plant byproducts (e.g., such as almond, 
peanut, or soybean hulls, citrus, other fruit including culled fruit, 
potatoes, or other vegetables including culled vegetables).
     Making silage.
     Chopping, or shredding hay.
     Extracting (mechanical) or wet rolling:
    [cir] Grain; or
    [cir] Oilseed.
    2. When conducted on animal food other than the farm mixed-typed 
facility's own raw agriculture commodities for distribution into 
commerce:
     Cracking, crimping, flaking, or shelling:
    [cir] Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
    [cir] Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, 
sunflower); or
    [cir] Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
    [cir] Grain;
    [cir] Oilseed;
    [cir] Grain or oilseed byproducts;
    [cir] Forage (e.g., hay or ensiled material); or
    [cir] Other plants or plant byproducts (e.g., such as almond, 
peanut, or soybean hulls, citrus, other fruit including culled fruit, 
potatoes, or other vegetables including culled vegetables).
     Making silage.
     Chopping or shredding hay.
     Extracting (mechanical) or wet rolling:
    [cir] Grain; or
    [cir] Oilseed.
     Labeling:
    [cir] Grain whole; or
    [cir] Oilseed whole.
     Sifting, separating, or sizing:
    [cir] Grain;
    [cir] Oilseed;
    [cir] Grain or oilseed byproducts; or
    [cir] Other plants or plant byproducts.
    The low-risk on-farm manufacturing/processing activity/animal food 
combinations reflect the findings of the analysis required by section 
103(c)(1)(C) of FSMA, discussed in sections VII.B and VII.C.
6. Proposed Sec.  507.5(g) and (h)--Exemptions Applicable to Raw 
Agricultural Commodities (RACs)
    In Sec.  507.5(g), the Agency is proposing that subpart C would not 
apply to facilities solely engaged in the storage of raw agricultural 
commodities (other than fruits and vegetables) intended for further 
distribution or processing. And in Sec.  507.5(h), the Agency is 
proposing that subpart B would not apply to the holding or 
transportation of one or more ``raw agricultural commodities,'' as 
defined in section 201(r) of the FD&C Act.
    The current 21 CFR 110.19(a) for human food, provides that 
establishments engaged solely in the harvesting, storage, or 
distribution of one or more RACs, which are ordinarily cleaned, 
prepared, treated, or otherwise processed before being marketed to the 
consuming public, are exempt from the requirements of part 110 (21 CFR 
part 110). In section VIII.D of the document for the proposed rule for 
preventive controls for human food (78 FR 3646), the Agency discusses 
the meaning of the term raw agricultural commodity. The Agency 
tentatively concludes that the exemption for RACs from proposed part 
507 subpart B for animal food is consistent with the treatment of RACs 
for human food.
    Section 418(m) of the FD&C Act provides in relevant part that FDA 
may by regulation ``exempt or modify the requirements for compliance 
under [section 418 of the FD&C Act] with respect to facilities that are 
solely engaged in . . . the storage of raw agricultural commodities 
(other than fruits and vegetables) intended for further distribution or 
processing''.
    This provision would exempt, for example, facilities that only 
store whole grains (such as corn, wheat, barley, oats, and soybeans) 
for animal food from subpart C. This would include facilities such as 
grain elevators provided that such facilities do not conduct other 
activities subject to section 418 of the FD&C Act. Outbreaks of illness 
associated with feeding RACs to animals have not been traced back to 
storage facilities solely engaged in the storage of RACs. In addition, 
facilities that are solely engaged in the storage of RACs are exempt 
from the current part 110 CGMP regulations for human food, and FDA 
proposes to also exempt these facilities from the proposed CGMPs for 
animal food. Such facilities would remain subject to the requirements 
of the FD&C Act. For example, if animal food is stored under insanitary 
conditions whereby the animal food may become contaminated with filth 
or rendered injurious to health, the animal food would be adulterated 
under section 402(a)(4) of the FD&C Act.
    While outbreaks of illness associated with feeding RACs to animals 
have not been traced back to storage facilities solely engaged in the 
storage of RACs, FDA is aware of changes in feeding practices which 
might increase the risk associated with feeding RACs obtained

[[Page 64765]]

directly from storage facilities. FDA is aware that some farms function 
as animal feeding operations, growing no crops for animal food use, but 
simply purchasing animal food, raw agricultural commodities, or animal 
food ingredients for further manufacturing into animal food for animals 
held on that farm. In the animal food industry, raw agriculture 
commodities such as corn, wheat, oats, barley, rye, milo, rice, 
soybeans, peanuts, and canola are shipped directly from grain elevators 
to farms that raise animals for human food production such as poultry 
farms (broilers, layers), dairy farms, beef-feed lots, and swine farms. 
At these farms, the raw agricultural commodity received from the grain 
elevators is mixed (processed) into animal food rations.
    While the Agency tentatively concludes that animal food facilities 
such as grain elevators that are solely engaged in the storage of 
grains that are raw agricultural commodities should be exempt from 
proposed subpart B and proposed subpart C, the Agency does have some 
concerns. One of those concerns is the potential for mycotoxins, such 
as aflatoxins, fumonisins, and DON, to be present in RACs obtained by 
farms and fed to animals. This concern is largely mitigated for RACs 
intended for human food because RACs for human food routinely undergo 
further processing and are rarely consumed in the ``raw'' state.
    Mycotoxins are toxic by-products of mold that can develop in 
certain agricultural commodities pre-harvest or post-harvest while in 
storage. Mycotoxins can reduce animal productivity, cause sudden death 
if fed in large quantities, and can become a component of milk and eggs 
intended for human consumption.
    Mycotoxin contamination varies greatly from year to year and by 
geographic region of the country, depending on weather conditions that 
stress crops and predispose to mold growth. In regions of the country 
where conditions tend to favor mold growth, grain elevators and other 
buyers routinely monitor for this hazard and turn away producers whose 
crops exceed FDA's action levels for the various mycotoxins. For 
example, grain elevators will reject corn that tests higher than 20 
parts per billion for aflatoxin, the action level established by FDA 
for use in feed for animal species other than beef cattle, swine, 
poultry, or when the intended species is not known. Grain elevators in 
other regions of the country are familiar with the weather phenomena 
that predispose to mycotoxin production and monitor incoming shipments 
of grain accordingly. The grain industry is also familiar with proper 
drying and storing procedures to prevent mold growth and mycotoxin 
production. Therefore, due to controls already in place by the grain 
industry, and due to regulatory oversight by USDA under the United 
States Grain Standards Act, FDA has tentatively concluded to exempt 
facilities solely holding grains from preventive controls.
    However, the Agency is seeking comment on whether animal food 
facilities, such as grain elevators, that are solely engaged in the 
storage of grains that are raw agricultural commodities should be 
exempt from subpart B and subpart C of proposed part 507; how many of 
these types of facilities and operations are in the United States; and 
what is the best approach to ensure that the raw agricultural 
commodities distributed by these facilities to animal feeding 
operations are free of hazards that would be likely to cause illness or 
injury to animals or humans.
7. Applicability of Part 507 to Alcoholic Beverages
    In the proposed rule for preventive controls for human food (78 FR 
3646), the Agency is proposing that proposed subpart C, ``Hazard 
Analysis and Risk-Based Preventive Controls,'' would not apply to 
certain alcoholic beverages and a very narrow set of prepackaged other 
food at alcoholic beverage facilities, based on the Agency's 
interpretation of section 116 of FSMA. Under proposed Sec.  117.5(i), 
subpart C of the human food rule would not apply with respect to food 
that is not an alcoholic beverage at certain alcoholic beverage 
facilities, provided that such food (1) is in prepackaged form that 
prevents any direct human contact with such food, and (2) constitutes 
not more than 5 percent of the overall sales of the facility, as 
determined by the Secretary of the Treasury (see section X.C.7 of the 
document for the proposed rule for preventive controls for human food 
(78 FR 3646)). Section 116 of FSMA applies to animal food. However, the 
Agency is not aware of any animal food at alcoholic beverage facilities 
that would be exempt from section 418 of the FD&C Act under the 
proposed interpretation, and therefore is not aware of any animal food 
at alcoholic beverage facilities that would be exempt from proposed 
subpart C, ``Hazard Analysis and Risk-Based Preventive Controls,'' for 
animal food. For example, FDA understands that many breweries and 
distilleries sell spent grains, such as brewers dried grains and 
distillers dried grains, as animal food. Because those spent grains are 
not alcoholic beverages themselves, and they are not in a prepackaged 
form that prevents any direct human contact with the food, the Agency 
tentatively concludes that subpart C of this proposed rule would apply 
to them.

D. Proposed Sec.  507.7--Requirements That Apply to a Qualified 
Facility

1. Requirements of Section 418(l) of the FD&C Act
    Section 418(l) of the FD&C Act establishes modified requirements 
for ``qualified facilities.'' As discussed in section II.C, section 
418(l)(1) of the FD&C Act establishes the conditions for a facility to 
be a ``qualified facility'' based on either business size (section 
418(l)(1)(B) of the FD&C Act) or a combination of the average monetary 
value of the food sold and the value of food sold to qualified end 
users as compared to all other purchasers (section 418(l)(1)(C) of the 
FD&C Act), and proposed Sec.  507.3 would establish a definition for 
``qualified facility'' based on section 418(l)(1).
    Sections 418(l)(2)(A) and (B) of the FD&C Act provide that a 
qualified facility is exempt from the requirements of sections 418(a) 
through (i) and (n) of the FD&C Act (i.e., the requirements for hazard 
analysis and risk-based preventive controls), but must instead submit 
two types of documentation to the Secretary of HHS. The first type of 
required documentation relates to food safety practices at the 
facility, and section 418(l)(2)(B)(i) of the FD&C Act provides two 
options for satisfying this documentation requirement. Under section 
418(l)(2)(B)(i)(I) of the FD&C Act, the qualified facility may choose 
to submit documentation that demonstrates that the owner, operator, or 
agent in charge of the facility has identified potential hazards 
associated with the food being produced, is implementing preventive 
controls to address the hazards, and is monitoring the preventive 
controls to ensure that such controls are effective. Alternatively, 
under section 418(l)(2)(B)(i)(II) of the FD&C Act, the qualified 
facility may choose to submit documentation (which may include 
licenses, inspection reports, certificates, permits, credentials, 
certification by an appropriate agency (such as a State department of 
agriculture), or other evidence of oversight), as specified by the 
Secretary, that the facility is in compliance with State, local, 
county, or other applicable non-Federal food safety law.

[[Page 64766]]

    The second type of required documentation relates to whether the 
facility satisfies the definition of a qualified facility. Under 
section 418(l)(2)(B)(ii) of the FD&C Act, the facility must submit 
documentation, as specified by the Secretary in a guidance document, 
that the facility is a qualified facility under section 418(l)(1)(B) of 
the FD&C Act or section 418(l)(1)(C) of the FD&C Act.
    Section 418(l)(7)(A) of the FD&C Act requires that a qualified 
facility that is exempt from the requirements under sections 418 (a) 
through (i) and subsection (n), and that does not prepare documentation 
under section 418(l)(2)(B)(i)(I)of the FD&C Act, provide notification 
to consumers by one of two procedures, depending on whether a food 
packaging label is required on the food. With respect to an animal food 
for which an animal food packaging label is required by the Secretary 
of HHS under any other provision of the FD&C Act, section 
418(l)(7)(A)(i) of the FD&C Act requires that a qualified facility 
include prominently and conspicuously on such label the name and 
business address of the facility where the food was manufactured or 
processed. With respect to an animal food for which an animal food 
packaging label is not required by the Secretary of HHS under any other 
provisions of the FD&C Act, section 418(l)(7)(A)(ii) of the FD&C Act 
requires that a qualified facility prominently and conspicuously 
display, at the point of purchase, the name and business address of the 
facility where the food was manufactured or processed, on a label, 
poster, sign, placard, or documents delivered contemporaneously with 
the food in the normal course of business, or, in the case of Internet 
sales, in an electronic notice.
2. Proposed Sec.  507.7(a)--Documentation To Be Submitted
a. Proposed Sec.  507.7(a)(1)--Documentation That the Facility Is a 
Qualified Facility
    Proposed Sec.  507.7(a)(1) would require that a qualified facility 
submit to FDA documentation that the facility is a qualified facility. 
Consistent with the conditions in section 418(l)(1) of the FD&C Act for 
a facility to be a qualified facility, and the Agency's proposed 
definition (proposed Sec.  507.3) of ``qualified facility,'' the 
documentation would be directed to either the status of the facility as 
a very small business (as would be defined in proposed Sec.  507.3) or 
the applicability of conditions for average annual monetary value and 
the value of food sold to qualified end users as compared to other 
purchasers (as would be included in the definition of qualified 
facility in proposed Sec.  507.3). As discussed further in section 
VIII.D.5, FDA tentatively concludes that a statement from the owner, 
operator, or agent in charge of a qualified facility certifying that 
the facility is a very small business, otherwise meets the definition 
of a qualified facility under proposed Sec.  507.3, or both, would be 
acceptable for the purposes of satisfying the requirements that would 
be established in proposed Sec.  507.7(a)(1). The Agency would not, for 
example, require that a facility submit financial information to FDA 
demonstrating its total sales or to the proportion of sales to 
qualified end users.
    Proposed Sec.  507.7(a)(1) also would establish that, for the 
purpose of determining whether a facility satisfies the definition of 
qualified facility, the baseline year for calculating the adjustment 
for inflation is 2011. The conditions related to average annual 
monetary value established in section 418(l)(1)(C) of the FD&C Act, and 
the definition of very small business in proposed Sec.  507.3, allow 
adjustment for inflation. To establish a level playing field for all 
facilities that may satisfy definition of a qualified facility, the 
Agency is proposing to establish the baseline year for the calculation 
in proposed Sec.  507.7(a)(1). The Agency is proposing to establish 
2011 as the baseline year for inflation because 2011 is the year that 
FSMA was enacted into law. The Agency tentatively concludes that 
because Congress provided a specific dollar amount in section 
418(l)(1)(C)(ii)(II) of the FD&C Act, i.e., $500,000, and it provided 
that the dollar amount should be adjusted for inflation, it is 
reasonable to establish the baseline year as the year that the law was 
enacted.
b. Proposed Sec.  507.7(a)(2)--Documentation Related to Food Safety 
Practices at a Facility
    Proposed Sec.  507.7(a)(2) would provide two options for satisfying 
the documentation requirement in section 418(l)(2)(B)(i) of the FD&C 
Act related to food safety practices at the facility. Proposed Sec.  
507.7(a)(2)(i) would allow qualified facilities to submit documentation 
to demonstrate 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 to satisfy this requirement.
    Proposed Sec.  507.7(a)(2)(i) would implement the provisions of 
section 418(l)(2)(B)(i)(I) of the FD&C Act, except that proposed Sec.  
507.7(a)(2)(i) would specify monitoring the performance of the 
preventive controls to ensure that such controls are effective 
(emphasis added). As discussed in section II.C, under the overall 
framework of the proposed requirements that would be established in 
subpart C, monitoring is directed to performance of preventive 
controls. Thus, proposed Sec.  507.7(a)(2)(i) is consistent with the 
statute and the overall framework of this proposed rule.
    Proposed Sec.  507.7(a)(2)(ii) would provide another option for 
satisfying the documentation requirement in section 418(l)(2)(B)(i) of 
the FD&C Act related to food safety practices at the facility by 
allowing qualified facilities to submit documentation (which may 
include licenses, inspection reports, certificates, permits, 
credentials, certification by an appropriate agency (such as a State 
department of agriculture), or other evidence of oversight), 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. Proposed Sec.  507.7(a)(2)(ii) would 
implement the provisions of section 418(l)(2)(B)(i)(II) of the FD&C 
Act.
    FDA tentatively concludes that a statement from the owner, 
operator, or agent in charge of a qualified facility certifying that 
the facility: (1) Has identified the potential hazards associated with 
the animal food being produced, is implementing preventive controls to 
address the hazards, and is monitoring the implementation of the 
preventive controls to ensure that such controls are effective or (2) 
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, would be acceptable for the purposes 
of satisfying the requirements that would be established in proposed 
Sec.  507.7(a)(2). The Agency would not, for example, require that a 
facility submit documentation to FDA demonstrating the content of their 
hazard identification, preventive controls, or monitoring of the 
implementation of preventive controls; or copies of their non-Federal 
licenses, inspection reports, certificates, permits, credentials, or 
certifications.
3. Proposed Sec.  507.7(b)--Procedure for Submission
    Proposed Sec.  507.7(b) would require that qualified facilities 
submit the

[[Page 64767]]

documentation that would be required by proposed Sec.  507.7(a) by one 
of two procedures. Proposed Sec.  507.7(b)(1) would provide an option 
to submit documentation electronically at http://www.access.fda.gov by 
following the instructions to be provided on that Web page. Proposed 
Sec.  507.7(b)(1) would inform facilities that this Web site is 
available from wherever the Internet is accessible, including 
libraries, copy centers, schools, and Internet cafes. Although 
electronic submission is not required, proposed Sec.  507.7(b)(1) would 
encourage electronic submission, which is efficient for FDA and should 
also be efficient for facilities. Electronic submission generally would 
be available 24 hours a day, 7 days a week, unless the Web site is 
experiencing technical difficulties or is undergoing maintenance.
    Proposed Sec.  507.7(b)(2) would provide an option to submit 
documentation by mail. A qualified facility would have the option to 
submit documents in a paper format or in an electronic format on a CD-
ROM, by mail to the U.S. Food and Drug Administration, ATTN: Qualified 
Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 
20993. ``Mail'' would include the U.S. mail and businesses that can 
deliver documents to the address provided. The Agency would recommend 
that an owner, operator or agent in charge of a qualified facility 
submit by mail only if the qualified facility does not have reasonable 
access to the Internet. It is not efficient for FDA to receive such 
documents by mail.
    The Agency is not proposing to provide for submission by fax. The 
Agency expects that there may be technical difficulties or loss or mix-
up of some submitted information if the Agency were to allow for 
submission by fax.
4. Proposed Sec.  507.7(c)--Frequency of Submission
    Proposed Sec.  507.7(c)(1) would require that the documentation 
that would be required by section Sec.  507.7(a) be submitted to FDA 
initially within 90 days of the applicable compliance date of the rule. 
As discussed in section VI, the compliance date for a small business 
would be 2 years after the date of publication of the final rule and 
the compliance date for a very small business would be 3 years after 
the date of publication of the final rule.
    Proposed Sec.  507.7(c)(2) would require that the documentation 
that would be required by proposed Sec.  507.7(a) also must be 
resubmitted to FDA at least every 2 years, or whenever there is a 
material change to the information that would be described in proposed 
Sec.  507.7(a). For the purposes of proposed Sec.  507.7, a material 
change would be one that changes whether or not a facility is a 
``qualified facility.'' The status of a facility as a qualified 
facility has the potential to change materially on an annual basis. For 
example, if a facility reports that it is a very small business (i.e., 
under one option identified in proposed Sec.  507.3, has less than 
$500,000 in total annual sales of animal food, adjusted for inflation), 
its total annual sales of animal food likely would change on an annual 
basis, and could change so as to exceed $ 500,000. Likewise, if a 
facility reports that it otherwise satisfies the definition of a 
qualified facility, its total annual sales of animal food and value of 
animal food sold to qualified end users as compared to other purchasers 
likely would change on an annual basis, and could change so as to no 
longer satisfy the definition of a qualified facility.
5. Information That Would Be Submitted
    Consistent with section 418(l)(2)(B)(ii) of the FD&C Act, the 
Agency intends to issue guidance regarding documentation that would be 
submitted under proposed Sec.  507.7(a)(1) to demonstrate that a 
facility is a qualified facility. As discussed in sections VIII.D.2.a 
and VIII.D.2.b, the Agency tentatively concludes that certified 
statements from the owner, operator, or agent in charge of a qualified 
facility would be acceptable for the purposes of satisfying the 
requirements that would be established in proposed Sec.  507.7(a)(1) 
and (a)(2).
    To inform the guidance required under section 418(l)(2)(B)(ii) of 
the FD&C Act and any other guidance that may be useful in addressing 
questions regarding submission of documentation under this subpart, in 
this document the Agency requests comment on an option it is 
considering regarding the submission of documentation. Specifically, 
the Agency requests comment on the efficiency and practicality of 
submitting the required documentation using the existing mechanism for 
registration of food facilities, with added features to enable a 
facility to identify whether or not the facility is a qualified 
facility. A facility that does not identify itself as a qualified 
facility would not be prompted to provide additional information under 
proposed Sec.  507.7(a).
    A facility that identifies itself as a qualified facility would be 
prompted to provide the following information by checking items that 
apply. Such items could include:
     Whether the facility satisfies the conditions for a 
qualified facility:
    [cir] As a very small business as that term would be defined in 
proposed Sec.  507.3;
    [cir] As a facility that otherwise satisfies the definition of 
qualified facility in proposed Sec.  507.3 based on average monetary 
value of sales and value of animal food sold to qualified end users as 
compared to other purchasers; or
    [cir] Both of the conditions.
     Whether the facility:
    [cir] Has identified the potential hazards associated with the 
animal food being produced, is implementing preventive controls to 
address the hazards, and is monitoring the implementation of the 
preventive controls to ensure that such controls are effective;
    [cir] Is in compliance with State, local, county, or other 
applicable non-Federal food safety law, including relevant laws and 
regulations of foreign countries; or
    [cir] Both of the conditions.
    In essence, such a system would provide for self-certification that 
the facility has appropriate information demonstrating that the 
facility is a qualified facility and either has identified the 
potential hazards associated with the food being produced, is 
implementing preventive controls to address the hazards, and is 
monitoring the implementation of the preventive controls to ensure that 
such controls are effective; or is in compliance with State, local, 
county, or other applicable non-Federal food safety law, including 
relevant laws and regulations of foreign countries. Such a system may 
include a statement reminding submitters that anyone who makes a 
materially false, fictitious, or fraudulent statement to the U.S. 
Government is subject to criminal penalties under 18 U.S.C. 1001. Using 
such a system, a qualified facility could update the documentation 
required by proposed Sec.  507.7(a) during the biennial registration 
required by section 415(a)(3) of the FD&C Act.
6. Proposed Sec.  507.7(d)--Notification to Consumers
    Proposed Sec.  507.7(d) would require that a qualified facility 
that does submit the type of documentation directed to food safety 
practices described in Sec.  507.7(a)(2)(i) provide notification to 
consumers as to the name and complete business address of the facility 
where the animal food was manufactured or processed (including the 
street address or P.O. box, city, State, and zip code for domestic 
facilities, and comparable full address information for foreign 
facilities) consistent with section 418(l)(7) of the FD&C Act. If an 
animal

[[Page 64768]]

food packaging label is required, proposed Sec.  507.7(d)(1) would 
require that the required notification appear prominently and 
conspicuously on the label of the animal food. If an animal food 
packaging label is not required, proposed Sec.  507.7(d)(2) would 
require that the required notification appear prominently and 
conspicuously, at the point of purchase, on a label, poster, sign, 
placard, or documents delivered contemporaneously with the animal food 
in the normal course of business, or in an electronic notice, in the 
case of Internet sales.
    Proposed Sec.  507.7(d) would enable consumers to contact the 
facility where an animal food was manufactured or processed (e.g., if 
the consumer identifies or suspects a food safety problem with a 
product) irrespective of whether the animal food product bears a label. 
The use of the term ``business address'' in section 418(l)(7) of the 
FD&C Act contrasts with Congress' use of a different term, ``place of 
business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)). 
Section 403(e) provides that foods in package form are misbranded 
unless the product label bears the name and place of business of the 
manufacturer, packer, or distributor of the food. The Agency's 
regulations interpret ``place of business'' as requiring only the 
firm's city, state, and zip code to appear on the product label, as 
long as the firm's street address is listed in a current telephone 
directory or other city directory (21 CFR 501.5(d)). The Agency 
tentatively concludes that the use of the term ``business address'' in 
section 418(l)(7) demonstrates Congress' intent to require the 
facility's full address, including the street address or P.O. box, to 
appear on labels or other required notifications when the facility has 
opted to not submit documentation directed to food safety practices 
under section 418(l)(2)(B)(i)(I) of the FD&C Act. If Congress had 
considered the less complete address already required under section 
403(e)(1) of the FD&C Act and the ``place of business'' labeling 
regulation (Sec.  501.5(d)) to be adequate for notification to 
consumers for animal foods required to bear labels, there would have 
been no need to impose a new, more specific requirement in section 
418(l)(7) for the facility's ``business address'' to appear on the food 
label. When proposed Sec.  507.7(d) would apply to an animal food for 
which a food packaging label is required under any other provision of 
the FD&C Act, the complete business address would substitute for the 
``place of business'' required under section 403(e)(1) of the FD&C Act 
and Sec.  501.5(d) and would not impose any requirement for a label 
that would be in addition to any label required under any other 
provision of the FD&C Act. The Agency asks for comment on this 
interpretation.
7. Records
    Proposed Sec.  507.7(e) would require that a qualified facility 
maintain records relied upon to support the documentation that would be 
required by Sec.  507.7(a). Proposed Sec.  507.7(a) would not require 
that a qualified facility establish any new records, but merely retain 
those that the facility relied upon to support the documentation that 
would be required by proposed Sec.  507.7(a). Proposed Sec.  507.7(e) 
would establish that the records that a qualified facility must 
maintain are subject to the requirements of subpart F of part 507. As 
discussed in section XII, proposed subpart F would provide the general 
requirements that apply to all records required to be established and 
maintained by proposed part 507, including provisions for retention of 
records and for making records available for official review. Together, 
proposed Sec.  507.7(a) and (b) would make the underlying records 
qualified facilities would rely on to support their self-certifications 
available to FDA upon request. The Agency tentatively concludes that it 
is appropriate to require that the records relied upon to support a 
self-certified statement be retained and made available to FDA upon 
request.

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

1. Requirements of Section 418 of the FD&C Act
    Section 418(m) of the FD&C Act provides, in relevant part, that 
``[t]he Secretary may, by regulation, exempt or modify the requirements 
for compliance under [section 418 of the FD&C Act] with respect to 
facilities that are solely engaged in . . . the storage of packaged 
foods that are not exposed to the environment.''
2. Petition Relevant to Section 418(m) of the FD&C Act
    In a letter dated July 22, 2011, an industry coalition of the 
American Bakers Association, the American Frozen Food Institute, the 
Grocery Manufacturers Association, the International Bottled Water 
Association, the International Dairy Foods Association, the 
International Warehouse Logistics Association, the Peanut and Tree Nut 
Processors Association, and the Snack Food Association (the section 
418(m) petitioners) submitted a citizen petition (Docket No. FDA-2011-
P-0561). The petition requests that FDA issue regulations under section 
418(m) of the FD&C Act ``to exempt from compliance or modify the 
requirements for compliance under section 418 [of the FD&C Act] for 
facilities that are solely engaged in the storage of packaged foods 
that are not exposed to the environment, by allowing such facilities to 
satisfy the requirements of that section through compliance with the 
[CGMPs] mandated for such facilities by [current] Sec.  110.93.'' For 
full discussion of this petition, please see the discussion in section 
X.D of the document for the proposed rule for preventive controls for 
human food (78 FR 3646).
3. FDA's Tentative Response to the Petition
    The Agency tentatively agrees in part, and disagrees in part, with 
the section 418(m) petitioners. As discussed more fully in the 
paragraphs that follow, FDA agrees that it is appropriate for 
facilities solely engaged in the storage of unexposed packaged animal 
food to be exempt from the requirements that would be established in 
proposed subpart C, provided that the animal food does not require 
time/temperature control for safety. For unexposed packaged animal food 
that requires time/temperature control for safety, FDA disagrees that 
such an exemption is warranted, but tentatively concludes that 
unexposed packaged animal food that requires time/temperature control 
for safety could be subject to modified requirements rather than to the 
full requirements that would be established in proposed subpart C.
    The Agency disagrees that warehouse operators do not have access to 
information relevant to conducting a hazard analysis and establishing 
risk-based preventive controls. The principal hazard that would be 
identified in any hazard analysis for unexposed packaged animal food is 
the potential for the growth of, or toxin formation by, microorganisms 
of animal or human health significance when an unexposed refrigerated 
packaged animal food requires time/temperature control for safety. 
Information about this hazard and appropriate preventive controls for 
this hazard is widely available (Refs. 39, 40, and 41). For example, 
the 2009 Edition of FDA's Food Code defines ``Potentially Hazardous 
Food (Time/Temperature Control for Safety Food)'' as a food that 
requires time/temperature control for safety to limit pathogenic 
microorganism growth or toxin

[[Page 64769]]

formation (Ref. 39). Earlier editions (e.g., the 2001 Food Code) 
included a similar definition for ``potentially hazardous food''; since 
2005, the definition jointly refers to ``potentially hazardous food'' 
and ``time/temperature control for safety food'' (commonly referred to 
as TCS food) to emphasize the importance of temperature control in 
keeping food safe. Although FDA disagrees that warehouse operators do 
not have access to information relevant to conducting a hazard analysis 
and establishing risk-based preventive controls, the Agency agrees that 
it is not necessary for each facility solely engaged in the storage of 
unexposed packaged animal food to conduct its own hazard analysis to 
identify this hazard for unexposed refrigerated packaged animal food as 
reasonably likely to occur and for each such facility to determine that 
time/temperature control is the appropriate preventive control.
    FDA also disagrees that proposed Sec.  507.28 alone would be 
adequate for addressing environmental problems such as a flood in the 
facility and pest control problems, even though the animal food in 
question is not exposed to the environment and pest control problems 
with the container would likely be visible to the warehouse operator. 
However, FDA tentatively concludes that proposed Sec.  507.28, along 
with other applicable provisions of proposed part 507, subpart B, such 
as pest control in proposed Sec.  507.19, do adequately address most 
safety-related issues that may arise in facilities solely engaged in 
the storage of unexposed packaged animal food. FDA disagrees that 
proposed Sec.  507.28, or other provisions in proposed part 507, 
subpart B, justifies the exemption from all preventive control 
requirements sought by the petitioners in the specific case of 
unexposed refrigerated packaged animal food that requires time/
temperature control for safety (later in this document stated as 
unexposed refrigerated packaged TCS animal food). As discussed more 
fully in section X.I, such animal food requires the implementation of 
an appropriate preventive control (temperature), monitoring that 
control, taking corrective actions when there is a problem with that 
control, verifying that the control is consistently implemented, and 
establishing and maintaining records documenting the monitoring, 
corrective actions, and verification. FDA tentatively concludes that it 
is appropriate to distinguish between packaged animal food that 
requires such time/temperature control and packaged animal food that 
does not.
    FDA also disagrees that an exemption provided under section 418(m) 
of the FD&C Act should be established in a manner that has the 
potential to be interpreted more broadly than section 418(m) provides. 
The section 418(m) petitioners request that FDA establish a provision 
that ``A facility that is engaged solely in the storage, holding, 
warehousing, or distribution of packaged foods that are not exposed to 
the environment shall be exempt from the requirements of section 418 
[of the FD&C Act]'', whereas section 418(m) provides discretion for an 
exemption ``with respect to facilities that are solely engaged in . . . 
the storage of packaged foods that are not exposed to the 
environment.'' Under proposed Sec.  507.3, ``holding'' would mean 
storage of animal food, and holding facilities would include, relevant 
to unexposed packaged animal food, warehouses and cold storage 
facilities. To the extent that a facility that is engaged solely in 
``warehousing'' or ``distribution'' of unexposed packaged animal food 
is merely ``storing'' or ``holding'' the animal food, an exemption 
established using the language provided by section 418(m) would apply 
to that facility. However, to the extent that a facility that is 
engaged solely in ``warehousing'' or ``distribution'' of unexposed 
packaged animal food is not merely ``storing'' or ``holding'' the 
animal food, an exemption established using the language provided by 
section 418(m) would not apply to that facility.
    In response to the petition, FDA is proposing to establish an 
exemption from subpart C for facilities solely engaged in the storage 
of unexposed packaged animal food (proposed Sec.  507.10). FDA also is 
proposing to establish modified requirements at such facilities to 
require that the owner, operator, or agent in charge of such a facility 
comply with modified requirements for any unexposed refrigerated 
packaged TCS animal food (proposed Sec.  507.48). See the discussion of 
proposed Sec.  507.10 in the next section and the discussion of 
proposed Sec.  507.48 in section X.I.
4. Proposed Sec.  507.10--Applicability of Part 507 to a Facility 
Solely Engaged in the Storage of Packaged Animal Food That Is Not 
Exposed to the Environment
    Proposed Sec.  507.10(a) would provide that subpart C does not 
apply to a facility solely engaged in the storage of packaged animal 
food that is not exposed to the environment. Proposed Sec.  507.10(b) 
would establish that unexposed packaged animal food at such facilities 
is subject to modified requirements that would be established in 
proposed Sec.  507.48. As discussed more fully in section X.I, the 
modified requirements would mandate that such a facility establish and 
implement appropriate temperature controls, monitor the temperature 
controls, take corrective actions, verify that the temperature controls 
are consistently implemented, and establish and maintain records 
documenting the monitoring, corrective actions, and verification 
activities for unexposed refrigerated packaged TCS animal food. These 
modified requirements would be a subset of the proposed requirements 
that would be established in subpart C.
    There are limited routes of contamination for unexposed packaged 
animal food in a facility that solely stores unexposed packaged animal 
food (e.g., packaged animal food in containers in a warehouse). 
Contamination can occur, for example, if rodents gnaw through packages 
or if human waste from an improperly maintained toilet facility spills 
and seeps into paper-based packaging. However, with one exception, the 
CGMP requirements in proposed subpart B (e.g., proposed Sec. Sec.  
507.17, 507.19, 507.20, and 507.28) would apply to the storage of 
unexposed packaged animal food and be adequate to prevent such 
contamination so that it would not be necessary for the owner, 
operator, or agent in charge of a facility to address these routes of 
contamination by applying the hazard analysis and risk-based preventive 
controls that would be established in proposed subpart C. The exception 
would be for the rare circumstances in which RACs are packaged in a 
manner in which the RACs are not exposed to the environment. An 
establishment solely engaged in storing RACs would be exempt from CGMPs 
in proposed subpart B. Such an establishment would continue to be 
subject to section 402(a)(4) of the FD&C Act. An establishment that is 
solely engaged in the storage of packaged RACs that are not exposed to 
the environment may find the provisions of proposed subpart B helpful 
in ensuring compliance with section 402(a)(4) of the FD&C Act.
    Many of the requirements that would be established in proposed 
subpart C would be directed to manufacturing, processing, and packing 
animal food and would not apply to the storage of unexposed packaged 
animal food that does not require time/temperature control for safety. 
This is the case for:
     Process controls (proposed Sec.  507.36(d)(1));
     Sanitation controls (proposed Sec.  507.36(d)(2));

[[Page 64770]]

     Monitoring of process controls and sanitation controls 
(proposed Sec.  507.39);
     Corrective actions (proposed Sec.  507.42);
     Verification (including initial validation) of process 
controls (proposed Sec.  507.45); and
     A recall plan (proposed Sec.  507.38) (recalls generally 
are initiated by the manufacturer, processor, or packer of the animal 
food).
    FDA tentatively concludes that the outcome of a hazard analysis for 
storage of unexposed packaged animal food that does not require time/
temperature control for safety is that there are no hazards reasonably 
likely to occur. FDA also tentatively concludes that there would be 
little animal and human health benefit to requiring the owner, 
operator, or agent in charge of each facility solely engaged in the 
storage of such animal food to conduct its own hazard analysis and 
document that outcome in its own animal food safety plan. Likewise, FDA 
tentatively concludes that there would be no need for the facility to 
establish and implement preventive controls, with corresponding 
monitoring, corrective actions, or verification (including validation), 
because there would be no hazards reasonably likely to occur to trigger 
such activities. FDA also tentatively concludes that there would be no 
need for a qualified individual to conduct activities such as preparing 
the animal food safety plan (proposed Sec.  507.30(c)); validating the 
preventive controls (proposed Sec.  507.45(a)); reviewing records for 
implementation and effectiveness of preventive controls and 
appropriateness of corrective actions (proposed Sec.  507.45(c)); or 
performing reanalysis of the animal food safety plan (proposed Sec.  
507.45(e)(4)), because the facility would not need to conduct these 
activities. Thus, with the exception of the unexposed refrigerated 
packaged TCS animal food, FDA tentatively concludes that the animal 
food safety system that would be established in proposed subpart C is 
not needed to significantly minimize or prevent the occurrence of 
hazards that could affect unexposed packaged animal food at a facility 
solely engaged in the storage of such animal food.
    The purpose of proposed Sec.  507.10(b) is to make clear that 
although a facility solely engaged in the storage of unexposed packaged 
animal food is exempt from subpart C, such a facility is subject to 
modified requirements that would be established in proposed Sec.  
507.48. These requirements would apply to the storage of unexposed 
refrigerated packaged TCS animal food. The Agency explains the basis 
for those proposed requirements in section X.I.

IX. Proposed Subpart B--Current Good Manufacturing Practice

A. Animal Food and Current Good Manufacturing Practices (CGMPs)

    The preventive controls system will result in controls that are 
specific to each facility based on the hazards it identifies and the 
controls it determines are necessary to control such hazards. Although 
FDA has had general baseline controls that apply to most establishment 
manufacturing, processing, packing, and holding human food in its 
current good manufacturing regulations under part 110, FDA has not had 
such baseline controls for facilities manufacturing, processing, 
packing, and holding animal food. The animal food industry, as well as 
governmental entities and international bodies, have recognized the 
need for basic safety and sanitation measures that apply across the 
board to facilities handling animal food. The AAFCO passed its ``Model 
Good Manufacturing Practice Regulations for Feed and Feed Ingredients'' 
in August 2009 and published them in 2010 in the AAFCO Official 
Publication (Ref. 42). AAFCO is a voluntary membership association of 
State and Federal Agencies charged with the regulation, sale, and 
distribution of animal feeds. The goal of AAFCO is to provide a 
mechanism for developing and implementing uniform and equitable laws, 
regulations, standards, definitions, and enforcement policies for 
regulating the manufacture, labeling, distribution, and sale of animal 
feeds. AAFCO's Model CGMPs stipulate basic requirements for the 
production of safe animal food, and cover the following areas: 
Personnel; establishments, including construction, design, and grounds; 
maintenance and housekeeping, including pest control; equipment, 
including construction and design; receiving and storage for further 
manufacture; manufacturing; labeling; storage of finished feed and/or 
feed ingredients; inspection, sampling, and testing of incoming and 
finished feed and/or feed ingredients for adulterants; transportation 
of feed and/or feed ingredients; and voluntary recall/withdrawal. AAFCO 
is not an enforcement agency, however in States that adopt the model 
CGMPs into their State animal feed regulations, failure of an animal 
food facility to adhere to these CGMPs would be grounds for enforcement 
action by the state.
    The Codex Animal Production and Health Manual of Good Practices for 
the Feed Industry is a collaborative effort between the Food and 
Agriculture Organization (FAO) of the United Nations, and the 
International Feed Industry Federation, with significant contributions 
from members of a number of national feed industry trade associations, 
members of individual companies within the feed industry, and animal 
feed experts from universities. The good manufacturing practices (GMPs) 
described in Section 3 (Ref. 43) of the manual are practices and 
procedures intended to ensure the safety and suitability of animal food 
throughout the feed chain, and provide for such practices and 
procedures to be implemented in the following areas: Buildings and 
facilities; location of feed establishment; design and layout; internal 
structure and fittings; water supply; cleaning facilities; air quality, 
temperature and ventilation; lighting; equipment; personal hygiene; 
cleaning; maintenance; pest control; waste; drains; storage; transport; 
and training.
    The Prerequisite Programmes for Food Safety in the Manufacture of 
Food and Feed for Animals (Publicly Available Specification (PAS) 222) 
(Ref. 44) were prepared by the British Standard Institution and the PAS 
222 Steering Group, with sponsorship by Safe Supply of Affordable Food 
Everywhere. The British Standard Institution is an independent, 
private, non-governmental, non-industry organization that develops 
standards for a variety of industries. It is the standards setting body 
of the United Kingdom (Ref. 44). The steering group was made up of 
members from Agriculture Industries Confederation, Cargill, FAO, 
Foundation for Food Safety Certification, Land O'Lakes, Nestle, and 
Nutreco. PAS 222 specifies requirements addressing the following areas: 
Site and associated utilities; processes, including workspaces and 
employee facilities; supplies of air, water, and other utilities; 
supporting services, including waste disposal; suitability of equipment 
and accessibility for cleaning, maintenance, and preventive 
maintenance; management of ingredients; management of medications; 
measures for the prevention of contamination; sanitation; pest control; 
personnel hygiene; rework; product withdrawal procedures; warehousing 
and transportation; formulation of products; specifications for 
services; training and supervision of personnel; product information; 
and food defense, biovigilance, and bioterrorism.
    The GMPs described previously are the product of efforts by 
government, industry, and international animal health organizations. 
They are very

[[Page 64771]]

similar to each other and similar to the CGMPs that FDA is proposing in 
part 507 because they all have in common the goal of ensuring that all 
food, including animal food, is manufactured under conditions and 
practices that protect against contamination with undesirable 
biological, chemical, physical, and radiological agents. At least one 
organization, Codex, in the context of animal food, articulated the 
need for a facility to have a prerequisite program, such as CGMPs, 
before establishing a HACCP program (Ref. 43). FDA's adoption of animal 
food CGMPs would establish such a prerequisite program for the 
preventive controls program for animal food under section 418 of the 
FD&C Act. Such a prerequisite program already exists for human food.
    In addition to the risk to animals, the proposed animal food CGMPs 
address risks to human health from individuals handling animal foods or 
individuals consuming products from food-producing animals. The human 
food CGMPs in part 110 are designed to address risks to humans, and the 
Agency has experience and expertise in the human food CGMPs. Therefore, 
after considering the animal food CGMP documents from the previously 
mentioned organizations, and the Agency's CGMP regulations for human 
food, the Agency tentatively concludes that the human food CGMPs 
provide an appropriate starting point for the animal food CGMPs. The 
Agency requests comments on this tentative conclusion. The CGMPs 
proposed here in subpart B for animal food address the same areas as 
the current human food CGMPs in part 110 and the proposed revisions 
that would be incorporated into proposed part 117 (under the proposed 
rule for preventive controls for human food published (78 FR 3646)) and 
cover the following areas: Personnel; plant and grounds; sanitary 
operations; sanitary facilities and controls; equipment and utensils; 
processes and controls; and warehousing and distribution.
    The proposed animal food CGMPs are not identical to the current and 
proposed human food CGMPs. The proposed animal food CGMPs do not 
address ``cross-contact'', which for human foods is related to the 
inadvertent incorporation of allergens into foods. The Agency is not 
aware of evidence indicating that foodborne allergens pose a 
significant health risk to animals, or to humans through handling 
animal food. In addition, the proposed animal food CGMPs do not include 
a provision related to raw materials and ingredients, including rework 
susceptible to contamination with pests, undesirable microorganism, or 
extraneous materials complying with FDA regulations for natural or 
unavoidable defects if a manufacturer wishes to use such materials in 
manufacturing such food. Unlike for human food, there is no agency 
regulation for natural or unavoidable defects for animal foods at this 
time. The proposed animal food CGMPs do not include the limitation in 
the current human food CGMPs (part 110) that food manufacturing areas 
and equipment used for manufacturing human food must not be used to 
manufacture nonhuman food grade animal food or inedible products, 
unless there is no reasonable possibility for contamination of the 
human food. The Agency does not consider such a limitation necessary 
for ensuring the safety of animal food, if the animal food is subject 
to the proposed CGMPs.
    While FDA has tentatively concluded that CGMPs similar to those for 
human food would be appropriate for animal food, the Agency understands 
that animal food is produced in a wide diversity of facility types, 
from small portable animal food mixing units that travel from farm to 
farm, to large facilities that manufacture food for multiple species of 
livestock and pets. The Agency is also aware that once the animal food 
is produced, it may be fed to animals in environments and on surfaces 
that are not clean. However, basic sanitation measures for animal food 
are important. For example, the 2010 Salmonella Enteritidis outbreak in 
eggs coming from an egg producer and its associated facilities, 
demonstrated that Salmonella Enteritidis, once in the animal food, 
could contribute to maintaining the infection of the birds and the eggs 
they produce (Ref. 45). CDC reported over 1,900 human illnesses related 
to the outbreak, and FDA reported eggs were shipped to 22 states and 
Mexico by the initial producer identified in Iowa, and to 14 states by 
a second producer identified in Iowa (Ref. 46). This Salmonella 
contamination resulted in more than 500 million eggs being recalled. 
This incident alone demonstrates that the lack of control over the 
areas this rule is proposing to cover under CGMPs (personnel; plant and 
grounds; sanitary operations; sanitary facilities and controls; 
equipment and utensils; processes and controls; and warehousing and 
distribution), can and does lead to the spread of contamination of 
animal food within a facility. The loss of control in these areas 
resulted in the spread or recycling of the contamination, and at a very 
minimum, limited the ability of the producer to eliminate the 
contamination within the feed mill.
    To emphasize the need for required CGMPs in the animal food 
industry, the following are actual observations from the FDA 483, List 
of Observations for a feed mill associated with the Salmonella in eggs 
outbreak (Ref. 47). This feed mill supplied animal food to both 
facilities involved in the outbreak:
    ``8. On xx/xx/10, the following observations were noted at the 
****** Feed Mill located at *****, IA:
    Specifically,
     Birds were observed roosting and flying, chicks heard 
chirping in the storage and milling facility. In addition, nesting 
material was observed in the feed mill closed mixing system, ingredient 
storage and truck filling areas.
     Raw ingredient bins and feed sensors accessible from the 
roof of the facility had rusted holes and feed grain level sensors ajar 
in the outdoor environment. These include:
     Ingredient storage bin 12 containing slat, had a rusted 
gap about a \1/2\ inch wide the length of the lid of the roof level 
covered ingredient bin chute.
     Ingredient storage bin 21 containing ground corn had a 
hole approximately 3 inches by \1/2\ inch wide at the base of the roof 
level cover ingredient bin chute.
     At the base of the feed grain level sensor leading into 
ingredient storage bin 21, containing ground corn, there was an open 
hole.
     Feed grain level sensor leading into ingredient storage 
bin 7, containing meat and bone meal, was off to the side with 
approximately a 2 inch gap. Avian like feces was observed on top to 
this feed sensor.
     Finished feed tanks 4 and 18 did not have covers on top of 
the finished feed tank chutes.
     Outdoor whole kernel corn grain bins 4 and 6 observed to 
have the top side doors/lids open to the environment and pigeons were 
observed entering and leaving these opening. Birds were also observed 
sitting/flying around and over openings.''
    In addition to the previous observations, environmental samples 
collected from a top floor outlet location and two second floor covers 
all tested positive for Salmonella Enteritidis that the FDA laboratory 
confirmed as indistinguishable from the outbreak strain. The 
environmental positives at various levels within the feed mill are 
noteworthy because they illustrate the importance of overall sanitation 
within the facility. Without addressing worker hygiene practices, and 
other sanitary

[[Page 64772]]

practices detailed in the proposed CGMPs, a situation could arise 
whereby contamination could be spread throughout the facility by 
workers, equipment, and pests.
    Whether animal food was the source of this Salmonella Enteritidis 
outbreak was never determined, but it is clear that the lack of overall 
sanitation contributed to contaminated feed and infection in the laying 
flock. Adherence by this firm to CGMPs for animal food could have been 
critical in controlling Salmonella contamination of the poultry 
facility.
    As discussed in section II.E, the CDC reported that in a 2006-2007 
multi-state outbreak, 79 human cases of salmonellosis were subsequently 
linked to Salmonella Schwarzengrund in dry dog foods that were 
manufactured by a company in the United States (Ref. 24). The company 
stopped production at the facility on July 29, 2007, when it was 
alerted to a possible link between dry pet food produced at the plant 
and people infected with Salmonella Schwarzengrund. The facility 
immediately recalled the suspected product. The source or cause of the 
contamination at the facility was not determined, but the company 
stopped production at the facility, did extensive cleaning, and resumed 
production at the facility after the cleaning and sampling showed 
negative Salmonella results from environmental and equipment sampling. 
The company ultimately closed the facility in 2008 when subsequent 
finish product testing by the facility again revealed Salmonella 
Schwarzengrund (Ref. 24).
    The previous examples demonstrate that failure of an animal food 
facility to control the overall plant production environment, whether 
the plant manufactures, processes, packs, or holds food for pets or for 
food-producing animals, can and does result in human disease. In 
addition, regulations addressing the production of human food obtained 
from animals do not address the safety or production of animal food 
being fed to those food-producing animals. The Agency concludes that 
the previously described situations point to the need for this proposed 
rule for animal food, including the need for CGMPs.
    The Agency realizes that there is a spectrum of animal food 
producers and production facilities and that the hazards and risks can 
vary greatly. Therefore the Agency is requesting comment on its 
thinking that CGMPs similar to those for human food are appropriate for 
animal food. The Agency is also requesting comment on whether CGMP 
requirements that would be more appropriate for some types of animal 
food may not be appropriate for other types, and, if so, how the Agency 
can or should distinguish between those types during the various stages 
of animal food processing.
    The need for enforceable baseline standards for producing safe 
animal food was a major consideration in FDA's decision to propose 
CGMPs as part of its preventive controls regulations. Animal food 
facilities that are not subject to section 418 of the FD&C Act would be 
required to meet these baseline practices proposed in these CGMPs to 
prevent contamination of animal food. Facilities that are already 
adhering to trade association best practices, international standards 
described above, AAFCO model GMPs, or State animal feed regulations, 
may have their own strong quality control programs in place and may 
already be satisfying the CGMP requirements proposed here. Those firms 
that do not have such practices in place would have to implement them 
under this proposed rule, or be subject to enforcement action by FDA.

B. Proposed Current Good Manufacturing Practices (CGMPs) for Animal 
Food

1. Proposed Sec.  507.14--Personnel
    FDA is proposing in Sec.  507.14 to require that personnel in 
animal food facilities conform to hygienic practices and receive 
appropriate training to protect against contamination of animal food. 
Section 507.14(a) would require that employees with an illness or open 
lesion that could reasonably be a source of contamination of animal 
food report the condition to their supervisor and refrain from 
performing activities that could result in contamination of animal 
food.
    This proposed requirement is similar to PAS 222 at 13.5, which 
requires persons known or suspected to be infected with, or carrying, a 
disease or illness transmissible through animal feed intended for 
feeding within the home to be prevented from handling such food and 
food contract surfaces. Codex animal food CGMPs include a similar 
provision for all food employees who may be carriers for any disease or 
illness likely to be transmitted through animal food (Refs. 2 and 44).
    Proposed Sec.  507.14(a) would also require that while on duty 
employees maintain adequate personal cleanliness as appropriate for the 
activities they are performing. For example, employees would be 
required to wash their hands before starting work and at any other time 
when the hands become soiled or contaminated. The Agency is not 
proposing to require that employees wash their hands after each absence 
from the work station, as in the human food CGMPs, because in the 
animal food industry employee responsibilities are not typically 
limited to work stations. Employees would also need to secure jewelry 
and other objects such as personal belongings, tools, and writing 
implements to prevent them from falling into animal food, and store 
clothing and personal belongings in areas where they will not 
contaminate animal food. The Agency has received RFR reports of foreign 
objects such as pieces of a metal tape measure, plastic pieces from a 
hard hat, stainless steel shavings, and fragments of a soda can that 
were mixed into the animal food. In most of these reports, animal 
deaths occurred due to the consumption of the foreign objects in the 
food (Ref. 48).
    For animal food, the Agency is not proposing some of the 
requirements in the human food CGMPs as proposed part 117. FDA 
tentatively concludes that certain requirements are necessary for 
ensuring the safety of animal food across the board, while other 
precautions may be important for some animal food facilities and not 
others, depending on the type of animal food handled at the facility, 
the species for which the animal food is intended, and whether human 
consumers could come into direct contact with the animal food, among 
other considerations. For example, the Agency is not proposing specific 
requirements for: Employees to wear certain types of outer garments; 
maintenance of gloves; wearing, hair nets, beard covers, etc.; 
confining certain activities to areas other than where animal food may 
be exposed or where equipment or utensils are washed; or specifying the 
foreign substances for which necessary precautions must be taken to 
protect against contamination of animal food, animal food-contact 
surfaces, or animal food packaging materials. The animal food proposed 
rule includes a general provision that would require the establishment 
to take any other necessary precautions to protect against 
contamination of animal food, animal food-contacts, or animal food 
packing materials. This broad provision would allow the individual 
facility to determine if it needed to use outer garments, hairnets, 
etc. for the particular animal food being manufactured, processed, 
packed, or held at that facility. FDA tentatively concludes that this 
approach is appropriate when considering the diversity of the animal 
food industry.
    Both the PAS 222 and the Codex animal food CGMPs address these 
areas,

[[Page 64773]]

requiring personal hygiene for employees and requiring that items such 
as jewelry be secured. Unlike this proposed rule, the PAS 222 and the 
Codex animal food CGMPs provide for protective clothing and hair 
coverings where appropriate (Codex) and fit for the purpose (Refs. 2 
and 44).
    Proposed Sec.  507.14(b) would recommend that personnel responsible 
for identifying plant sanitation failures or animal food contamination 
should have a background of education or experience to provide a level 
of competency necessary for production of clean and safe animal food. 
It would also recommend that animal food handlers and supervisors 
receive appropriate training in proper food handling techniques, food-
protection principals, and be informed about the risks of poor personal 
hygiene and insanitary practices. The PAS 222, the AAFCO Model animal 
food CGMPs, and the Codex animal food CGMPs all provide for training of 
personnel in their areas of responsibility. As discussed in section 
IX.C, FDA is requesting comment on whether to change the 
recommendations to requirements for education or training in proper 
food handling techniques and food-protection principles.
    FDA is proposing in Sec.  507.14(c) that responsibility for 
ensuring compliance with all requirements in subpart B be clearly 
assigned to competent supervisory personnel.
2. Proposed Sec.  507.17--Plant and Grounds
    Plant, as defined in proposed Sec.  507.3, means the building or 
establishment or parts thereof used in connection with the 
manufacturing, processing, packing, or holding of animal food. FDA is 
proposing in Sec.  507.17(a) that the area around a plant be maintained 
so that it does not serve as a source of contamination of animal food.
    Methods for adequately maintaining the grounds around a plant 
include properly storing equipment, removing litter and waste, and 
cutting weeds and grass within the immediate vicinity of plant 
buildings and structures. Litter, waste, tall grass, weed, and old 
equipment around plants can harbor pests which will try to enter the 
facility and could contaminate animal food and ingredients. Roads, 
yards, parking lots, and other areas in the vicinity of the plant would 
be required to be maintained and adequately drained so as not to 
contribute to contamination of animal food by seepage, foot-borne 
filth, or providing a breeding place for pests. Water seepage into 
animal food ingredients and finished products can promote growth of 
mold which could produce mycotoxins in the animal food. The PAS 222 (p. 
4) contains a provision similar to proposed section 507.17(a). It 
provides the [s]ites to be maintained in good order. Vegetation shall 
be tended, removed or otherwise managed to address animal food safety 
hazards. Roads, yards and parking areas shall be drained to prevent 
standing water and shall be maintained (Ref. 44).
    Proposed Sec.  507.17(b) would require that the plant's size, 
construction and design allow for cleaning, maintenance, and exclusion 
of pests. Specifically, this proposed section would require that the 
size of the plant provide sufficient space to place equipment, store 
materials, and allow precautions to be taken to prevent contamination 
of animal food inside the plant and in outdoor bulk vessels. It would 
also require that construction of the plant be such that floors, walls, 
and ceilings can be kept clean and in good repair; that condensate from 
fixtures, ducts, and pipes not contaminate animal food; that there be 
enough space between equipment and walls to permit employees to perform 
their duties and protect against contaminating animal food; that 
lighting be adequate, and lighting fixtures, skylights, and other glass 
suspended over exposed food be of such construction that in case of 
breakage, glass does not contaminate animal food; that sufficient 
ventilation be provided to minimize odors and vapors without 
contaminating animal food; and that where necessary, adequate screening 
be provided to protect against pests. Proposed Sec.  507.17(b) would 
also require that the design and construction of buildings and 
structures allow for separation of operations, for example by location 
or time, to reduce the potential for contamination of animal food, 
animal food-contact surfaces, and animal food-packaging material with 
microorganisms, chemicals, filth, or other extraneous material.
    The Codex animal food CGMPs contain similar provisions that state 
that locations, design and construction of premises should deter pests 
and restrict access to pests to a minimum. Building and facilities 
should be designed to allow easy access for cleaning, including access 
to the inside of relevant equipment. There should be enough space to 
satisfactorily conduct all process operations and products inspections. 
Lighting sources should be sufficient to ensure that hygienic 
conditions are maintained throughout the product and storage areas. 
There should be protected lighting fixtures. There should be adequate 
means of ventilation to minimize airborne contamination of animal food 
from aerosols and condensation droplets (Ref. 2).
3. Proposed Sec.  507.19--Sanitary Operations
    Proposed Sec.  507.19(a) would require that buildings, fixtures, 
and other physical structures be maintained in sufficient sanitary 
condition and repair to prevent animal food from becoming adulterated. 
Equipment and utensils would need to be cleaned and sanitized to 
protect against contamination of animal food, animal food contact 
surfaces, and animal food packaging materials. Reports of animal food 
contamination continue to be reported to the Agency due to improper 
flushing (cleaning) of equipment. In one incident, a vitamin D 
supplement for a poultry food was carried over to a dog food. The 
excessive vitamin D levels in the pet food caused toxicity in the 
animals consuming the food (Ref. 48). In addition, during facility 
inspections, FDA has identified forklifts, carts and other material 
handling equipment as sources of cross contamination between raw 
ingredients and finished products.
    The PAS 222 provides for cleaning programs to be established and 
documented to maintain hygienic conditions. The Codex animal food CGMPs 
provide that cleaning should remove residues and dirt that may be a 
source of contamination. Sufficient standard of cleanliness should be 
employed to ensure that exposure to pests and pathogens is minimized at 
all stages of processing, storage, and handling of animal food (Ref. 
43).
    FDA is proposing in Sec.  507.19(b) that cleaning compounds and 
sanitizing agents must be free from undesirable microorganisms, and 
that they must be safe and adequate for the conditions of use. 
Compliance with this requirement could be verified by any effective 
means, including purchase of these substances under a supplier's 
guarantee or certification, or examination of these substances for 
contamination.
    In Sec.  507.19(c), the Agency proposes that only certain types of 
toxic materials, such as cleaning compounds, laboratory testing 
reagents, and lubrications for equipment, be used or stored in the 
plant. In addition these compounds must be identified, held, and stored 
in a manner that protects against contaminating animal food.
    Both the PAS 222 and the Codex animal food CGMPs provide for 
cleaning and sanitizing agents to be stored separately to minimize the 
risk of contaminating animal food.
    Proposed Sec.  507.19(d) would require that effective measures be 
taken to

[[Page 64774]]

exclude pests from the manufacturing, processing, packing, and holding 
areas. The use of insecticides or rodenticides would be permitted only 
under precautions and restrictions that will protect against the 
contamination of animal food, animal food-contact surfaces, and animal 
food-packaging materials. As in the human food context, pests can be 
vectors for disease through microbial contamination of animal food. The 
AAFCO, PAS 22, and the Codex CGMP documents all address the need to 
exclude pests from the facility.
    FDA is proposing in Sec.  507.19(e)(1) and (e)(2) that animal food 
contact surfaces be cleaned as frequently as necessary to protect 
against contamination of animal food. Cleaning requirements would vary 
depending, for example, on whether equipment and utensils are used for 
manufacturing or holding low-moisture animal food, used for wet 
processing operations, or used in continuous production operations.
    Proposed Sec.  507.19(e)(3) would recommend that single-service 
articles (such as paper cups or paper towels) be stored in appropriate 
containers. Section 507.19(e)(3) is also proposing that these single-
service articles be handled, dispensed, used, and disposed of in a 
manner that protects against contamination of animal food, animal food-
contact surfaces, or animal food-packaging materials. As discussed in 
section IX.C, FDA is requesting comment on whether to change the 
recommendations to requirements for the storage of the single-service 
articles in appropriate containers.
    Proposed Sec.  507.19(f) recommends that non-animal food-contact 
surfaces of equipment used in the operation of the plant be cleaned in 
a manner and as frequently as necessary to protect against 
contamination of animal food, animal food-contact surfaces, and animal 
food-packaging materials. As discussed in section IX.C, FDA also is 
requesting comment on whether to change proposed Sec.  507.19(f) to 
require rather than recommend that non-animal food-contact surfaces of 
equipment used in the operation of a food plant be cleaned in a manner 
and as frequently as necessary to protect against contamination of 
animal food, animal food-contact surfaces, and animal food-packaging 
materials.
    Proposed Sec.  507.19(g) would recommend that cleaned and sanitized 
portable equipment with animal food-contact surfaces be stored in a 
place and in a way that would protect any animal-food contact surfaces 
from contamination. As discussed in section IX.C, FDA also is 
requesting comment on whether to change proposed Sec.  507.19(g) to 
require rather than recommend that cleaned and sanitized portable 
equipment with animal food-contact surfaces and utensils be stored in a 
location and manner that protects animal food-contact surfaces from 
contamination.
4. Proposed Sec.  507.20--Sanitary Facilities and Controls
    In Sec.  507.20(a), the Agency is proposing that the plant's water 
supply be sufficient for the operations intended and derived from an 
adequate source. Any water that contacts animal food, animal food-
contact surfaces, or animal food-packaging materials would need to be 
safe and of adequate sanitary quality. For example, steam added to 
animal food during the pelleting process would be required to be from a 
water source that is not contaminated with chemicals, such as 
petroleum, or pesticides. Running water at a suitable temperature and 
pressure would need to be provided in all areas where required for the 
processing of animal food, for the cleaning of equipment, utensils, and 
animal food-packaging materials, or for employee sanitary facilities.
    Proposed Sec.  507.20(b) would require that plumbing in the plant 
be of adequate size and design and adequately installed and maintained 
to: (1) Carry sufficient quantities of water to required locations 
throughout the plant; (2) properly convey sewage and liquid disposable 
waste from the plant; (3) avoid constituting a source of contamination 
to animal food, water supplies, equipment, or utensils or creating an 
unsanitary condition; (4) provide adequate floor drainage in all areas 
where floors are subject to flooding-type cleaning or where normal 
operations release or discharge water or other liquid waste on the 
floor; and (5) ensure that there is not backflow from, or cross-
connection between piping systems that discharge waste water or sewage, 
and piping systems that carry water for animal food or animal food 
manufacturing.
    Proposed Sec.  507.20(c) would require that sewage be disposed of 
through an adequate sewerage system or through other adequate means.
    FDA is proposing in Sec.  507.20(d) that each plant provide its 
employees with adequate, readily accessible toilet facilities, and that 
the toilet facilities be kept clean and not serve as a potential source 
of contamination of animal food, animal food contact surfaces, or 
animal food-packaging materials. Proposed Sec.  507.20(e) would require 
that each plant provide hand-washing facilities that are adequate, 
convenient, and furnish running water at a suitable temperature to 
ensure that an employee's hands are not a source of contamination of 
animal food, animal food-contact surfaces, or animal food-packaging 
materials. Proposed Sec.  507.20(f) would require that rubbish be 
conveyed, stored, and disposed of in such a way that minimizes the 
development of odors and the potential to attract, harbor, or create a 
breeding place for pests.
    Sanitary facilities and controls are similarly addressed in PAS 222 
in sections 5.2 (water supply), 6.2 (containers for waste), 6.3 (waste 
management and removal), 6.4 (drains and drainage), and 13.2 (personnel 
hygiene facilities) (Ref. 44). Water supply, cleaning facilities, 
waste, and drains are also covered in the Codex animal food CGMPs (Ref. 
43). Many of the requirements in the proposed CGMPs follow closely to 
the PAS and CODEX provisions.
5. Proposed Sec.  507.22--Equipment and Utensils
    The Agency is proposing specific requirements for equipment and 
utensils used in animal food facilities. Proposed Sec.  507.22(a)(1), 
(a)(2), and (a)(4) through (a)(6) would require that plant equipment 
and utensils be designed and constructed to allow for the cleaning and 
maintenance necessary to ensure that animal food would not be 
contaminated with non-food-grade lubricants, fuel, metal fragments, 
contaminated water such as condensate, or other contaminants. These 
requirements would reduce the likelihood of hazards in the animal food 
that could come from equipment components, such as coolant from an 
electrical motor leaking onto food contact surfaces. Animal food 
contact surfaces of equipment and utensils used in the plant would need 
to be made of nontoxic materials and resist corrosion from contact with 
animal food or cleaning and sanitizing agents. Proposed Sec.  
507.22(a)(3) would recommend that equipment be installed and maintained 
in such a way to facilitate the cleaning of that equipment and the 
adjacent spaces. As discussed in section IX.C, FDA also is requesting 
comment on whether to change proposed Sec.  507.22(a)(3) to require 
rather than recommend that equipment be installed and maintained in 
such a way to facilitate the cleaning of that equipment and adjacent 
spaces.
    Proposed Sec.  507.22(b) would require that seams on food-contact 
surfaces be maintained to minimize accumulation of food particles, 
dirt, and organic matter and thus minimize the

[[Page 64775]]

opportunity for growth of microorganisms. Proposed Sec.  207.22(c) 
would require that equipment in the animal food manufacturing or 
handling area that does not come into contact with animal food be 
constructed in a way that enables it to be kept in a clean condition. 
Similarly, proposed Sec.  507.22(d) would require that systems such as 
holding, conveying, and manufacturing, be of a design that would enable 
them to be maintained in an appropriate sanitary condition.
    In Sec.  507.22(e), the Agency proposes that freezer and cold 
storage compartments must be fitted with an indicating thermometer or 
temperature recording device if the freezer or compartment will be used 
to store animal food cable of supporting growth of microorganisms.
    Proposed Sec.  507.22(f) would require the instruments and controls 
used for measuring, regulating, or recording various attributes such as 
temperature, pH, and water activity (aw), be accurate, 
precise, and adequately maintained. There also would need to be an 
adequate number of devices for their designated use.
    Proposed Sec.  507.22(g) would require that if compressed air or 
other gases are mechanically introduced into animal food or used to 
clean animal food-contact surfaces or equipment, the gas would need to 
be treated in a way that would not lead to contamination of animal 
food.
    The proposed requirements in Sec.  507.22 are similar to 
recommendations in the equipment sections of the AAFCO and Codex CGMPs 
that address the design, construction, and maintenance of equipment to 
prevent contamination of animal food (Refs. 42 and 43).
6. Proposed Sec.  507.25--Processes and Controls
    Proposed Sec.  507.25(a) addresses operations in the manufacturing, 
processing, packing and holding of animal food. It would require plant 
management to ensure that all such operations are conducted in 
accordance with adequate sanitation principles. In addition, it would 
require plant management to ensure that appropriate quality control 
operations are employed so that animal food-packaging materials are 
safe and suitable, that overall sanitation of the plant is under the 
supervision of one or more competent individuals assigned 
responsibility for this function, and that all reasonable precautions 
are taken so that production procedures do not contribute to 
contamination from any source. In multiple animal food recalls, the 
cause of the problem was determined to be Salmonella contamination of 
the finished product by raw ingredients when plant employees failed to 
properly separate finished product from raw ingredients. Under the 
proposed rule, chemical, microbial, or extraneous-material testing 
procedures would be required where necessary to identify sanitation 
failures or possible animal food contamination. Further, all animal 
food that has become contaminated to the extent that it is adulterated 
would be rejected, or if permissible, treated or processed to eliminate 
the contamination.
    Proposed Sec.  507.25(a) also addresses labeling controls. It would 
require that containers holding animal food, raw materials, or 
ingredients be labeled to accurately identify the contents. The Agency 
considers the correct identification of animal food, raw materials, and 
ingredients to be an important step in preventing or minimizing 
inappropriate handling or utilization of the animal food products 
during their manufacture, processing, packing, or holding. Labeling for 
finished animal food products would be required to contain the specific 
information and instructions needed so the food can be safely used for 
the intended animal species. Properly labeled finished product could 
prevent, for example, animal food containing micronutrients such as 
copper or selenium from being fed to animals for which these 
ingredients could be injurious to health.
    FDA's human food CGMPs, on which the Agency is modeling these 
animal food CGMPs, do not include labeling controls. However, the 
Agency tentatively concludes that such controls are necessary for 
animal food, because unlike human food, a finished animal food is often 
the animal's sole source of nutrition. Animals of different species can 
be adversely affected by too low or too high levels of certain 
nutrients in the food. Because of this, it is important that the 
labeling correctly reflects the contents of the product and provides 
the necessary information on how to use the product safely for the type 
of animals being fed.
    The AAFCO Model animal food CGMPs include labeling controls. It 
provides that a label or other unique identifier shall be affixed to, 
or accompany, feed and/or feed ingredients to maintain identity and 
facilitate safe and effective use. Labels shall be stored, handled and 
used in a manner that minimizes errors. Obsolete labels shall be 
discarded promptly (Ref. 42). The PAS 222 provides that information on 
content and intended use of animal food products shall be communicated 
to customers, for example, on a product label. It also requires that 
procedures be in place detailing the correct labeling of products in 
accordance with applicable regulations (Ref. 44).
    FDA is proposing in Sec.  507.25(b) that raw materials and 
ingredients be inspected and segregated or otherwise handled as 
necessary to ensure that they are clean and suitable for processing 
into animal food and stored under conditions that will protect against 
contamination and deterioration and that water used for washing, 
rising, or conveying animal food must be safe and of adequate sanitary 
quality. If water is reused, it must not increase the level of 
contamination of animal food. This section would also require that raw 
materials and ingredients including rework, be held in bulk, or in 
containers designed and constructed to protect against contamination, 
and be held at a temperature, relative humidity, and manner that would 
prevent the animal food from becoming adulterated. Material scheduled 
for rework would need to be identified as such. In addition, proposed 
paragraph (b) would require that raw materials and ingredients must 
either not contain levels of microorganisms that are reasonably likely 
to cause illness or injury to animals, or be processed or otherwise 
treated during manufacturing operations so that they no longer contain 
levels that would cause the product to be adulterated. Raw materials 
and ingredients susceptible to contamination with aflatoxin or other 
natural toxins would need to be in compliance with current FDA 
regulations for any poisonous or deleterious substances before these 
materials or ingredients are incorporated into finished animal food. 
Raw materials received frozen, such as raw meat for raw pet food, would 
need to be kept frozen until use. If thawing is required prior to use, 
it must be done in a manner that prevents the raw materials and 
ingredients from becoming adulterated. Raw materials received and 
stored in bulk form would need to be held in a manner that protects 
against contamination.
    Proposed Sec.  507.25(b)(1)(iv) would recommend that containers and 
carriers of raw materials be inspected on receipt to ensure that their 
condition has not contributed to contamination or deterioration of 
animal food. Visual inspection alone could identify certain physical 
hazards in incoming raw materials and ingredients and prevent certain 
contaminated ingredients from being added to animal food. As discussed 
in section IX.C, FDA also is

[[Page 64776]]

requesting comment on whether to change proposed Sec.  507.22(b)(1)(iv) 
to require rather than recommend that containers and carriers of raw 
materials and ingredients be inspected on receipt to ensure that their 
condition has not contributed to contamination or deterioration of 
animal food.
    Proposed Sec.  507.25(c) would require that equipment, utensils, 
and finished animal food containers used in manufacturing operations be 
maintained in an acceptable condition through appropriate cleaning and 
sanitizing, as necessary. All animal food manufacturing, processing, 
packing, and holding would need to be conducted under conditions that 
minimize the potential for the growth of microorganisms and 
contamination of animal food. Animal food that can support the rapid 
growth of undesirable microorganisms would be required to be held at 
temperatures that will prevent the animal food from becoming 
adulterated during manufacturing, processing, packing and holding. 
Measures such as sterilizing, irradiating, pasteurizing, cooking, 
freezing, refrigerating, controlling pH, or controlling water activity 
that are taken to destroy or prevent the growth of undesirable 
microorganisms would need to be adequate under the conditions of 
manufacturing, handling, and distribution to prevent animal food from 
being adulterated. Effective measures would also need to be taken to 
protect against the inclusion of metal or other extraneous material in 
animal food. Animal food, raw materials, and ingredients that are 
adulterated would need to be disposed of in a manner that protects 
against the contamination of other animal food or, if the adulterated 
animal food is capable of being reconditioned, be reconditioned using 
an effective method that has been proven to be safe.
    Proposed Sec.  507.25(c)(10) would recommend that animal food be 
protected from contaminants that my drip, drain, or be drawn into the 
food. Section 507.25(c)(11) is proposing to recommend that when heat 
blanching is required in the preparation of animal food, be effected by 
heating the animal food to the required temperature, holding it at this 
temperature for the required time, and then either rapidly cooling the 
animal food or passing it to subsequent manufacturing without delay. 
Proposed paragraph (c)(11) of this section also would recommend that 
thermophilic growth and contamination in blanchers be minimized by the 
use of adequate operating temperatures and by periodic cleaning. As 
discussed in section IX.C, FDA also is requesting comment on whether to 
change proposed Sec.  507.25(c)(10) and (c)(11) from recommendation to 
requirements.
7. Proposed Sec.  507.28--Warehousing and Distribution
    Proposed Sec.  507.28(a) would require storage and transportation 
of animal food to be conducted under conditions that will protect 
against biological, chemical, physical, and radiological contamination 
of animal food, as well as against deterioration of the animal food and 
the container. Establishing a process to control warehouse and 
distribution practices ensures that the inventory is depleted before 
the products have deteriorated or decomposed to the point where a 
hazard develops that would require a preventive control measure. 
Conveyances used to distribute animal food, including trucks or rail 
cars, would need to be in a condition that would not contaminate animal 
food. The Agency is concerned about animal food being adulterated due 
to improper clean out of conveyances. In one reported incident, 
recycled broken glass was not completely cleaned out of a tractor 
trailer used to ship a cattle feed resulting in the glass being 
dispersed throughout the animal food when it was delivered to the farm 
(Ref. 48). Additional incidents of incomplete truck clean out include 
urea contamination of cattle feed that resulted in illness and death to 
the animals that ingested it (Ref. 48). Animal food that is loaded into 
a conveyance concurrently with materials that could contaminate the 
food would need to be properly protected, or loaded onto a separate 
conveyance. Deterioration of the animal food leading to spoilage or 
loss of nutrient value would need to be prevented, for example by using 
properly enclosed conveyances with functioning refrigeration units for 
animal food requiring temperature control, and by using a stock 
rotation system during storage.
    The Codex animal food CGMPs provide that all means of transport 
should be appropriately cleaned to control and minimize the risk of 
contamination. Such vehicles should be subject to regular cleaning and 
sanitizing programs to ensure clean transport conditions and no 
accumulation of residual material (Ref. 2). The AAFCO Model animal food 
CGMPs provide that vehicles used to transport animal food be inspected 
for cleanliness and structural integrity prior to loading and that feed 
ingredients or other materials or substances that may pose a risk of 
adulterating feed or ingredients must not be loaded onto the same 
vehicle unless measures are taken to minimize such risk (Ref. 42).

C. Alternative To Establish Requirements in Place of Guidance in the 
Proposed Current Good Manufacturing Practices (CGMPs)

1. Overview
    In this section, the Agency requests comment on whether non-binding 
(should) provisions in proposed subpart B of proposed part 507, should 
be changed to required (must) provision in the final rule.
    The Agency believes that all of the proposed CGMP provisions, 
including the ``should'' provisions, are science-based and an important 
part of a modern food safety system. Because these non-binding 
provisions have been in place for decades for human food in current 
part 110, they are widely used and commonly accepted in many sectors of 
the human food industry. Similarly, the animal food industry is 
familiar with the principles behind these non-binding provisions. In 
addition, under section 418(o)(3) of the FD&C Act, the procedures, 
practices, and processes described in the definition of preventive 
controls may include sanitation procedures for food contact surfaces of 
utensils and equipment; supervisor, manager, and employee hygiene 
training; and CGMPs under part 110 (or any successor regulations).
    The costs related to a fully mandatory sanitary operations, 
process, and controls program would be for the additional time that 
workers spend in compliance with those parts of proposed Sec. Sec.  
507.19 and 507.20 that are changed from ``should'' to ``must.'' That 
alternative, when implemented as part of a preventive approach, would 
impose incremental annual costs to qualified facilities. Those 
incremental costs have not been estimated due to a lack of data on 
current compliance with this alternative at those facilities and the 
incremental work efforts that would be required with these changes. 
Most non-qualified facilities would have met the requirements by 
following the requirements for sanitation controls in subpart C. Those 
that do not have hazards that are reasonably likely to occur or those 
with sanitation controls that do not fully address the requirements of 
the sanitary operations, however, would need to review their operations 
and implement additional procedures.

[[Page 64777]]

2. Summary of Alternative To Establish Requirements in Place of 
Guidance in the Proposed CGMPs
    Table 1 identifies each of the potential differences in the CGMPs 
in proposed part 507 subpart B that would establish requirements 
(musts) instead of recommendations (shoulds) and either explains the 
reason for establishing the requirement or, for such differences with 
longer explanations, refers to the section where the potential 
requirement is explained.

 Table 1--Alternative To Establish Requirements in Place of Guidance in
                           the Proposed CGMPs
------------------------------------------------------------------------
                                 Alternative to
                                   establish a
                               requirement (must)
    Proposed designation          in place of a           Basis for
                                 recommendation          requirement
                               (should) (emphasis
                                     added)
------------------------------------------------------------------------
Sec.   507.14(b) (Education   Personnel             See explanation and
 and training).                responsible for       questions about
                               identifying           whether more detail
                               sanitation failures   would be
                               or animal food        appropriate in
                               contamination must    section IX.C.3.
                               have a background
                               of education or
                               experience, or a
                               combination
                               thereof, to provide
                               a level of
                               competency
                               necessary for
                               production of clean
                               and safe animal
                               food. Animal food
                               handlers and
                               supervisors must
                               receive appropriate
                               training in proper
                               food handling
                               techniques and food-
                               protection
                               principles and
                               should be informed
                               of the danger of
                               poor personal
                               hygiene and
                               insanitary
                               practices.
Sec.   507.19(e)(3)           Single-service        Failure to properly
 (Sanitation of animal food-   articles (such as     store such articles
 contact substances).          utensils intended     could lead to
                               for one-time use,     contamination of
                               paper cups, and       the articles and
                               paper towels) must    then to
                               be stored in          contamination of
                               appropriate           animal food if the
                               containers and must   articles come in
                               be handled,           contact with the
                               dispensed, used,      animal food.
                               and disposed of in
                               a manner that
                               protects against
                               contamination of
                               animal food, animal
                               food-contact
                               surfaces, or animal
                               food-packaging
                               materials.
Sec.   507.19(f) (Sanitation  Non-animal food-      Failure to clean non-
 of non-food-contact           contact surfaces of   animal food-contact
 substances).                  equipment used in     surfaces could lead
                               the operation of an   to contamination of
                               animal food plant     animal food-contact
                               must be cleaned in    surfaces of the
                               a manner and as       equipment and
                               frequently as         utensils and then
                               necessary to          to contamination of
                               protect against       animal food if the
                               contamination of      contaminated
                               animal food, animal   equipment and
                               food-contact          utensils come in
                               surfaces, and         contact with animal
                               animal food-          food. For example,
                               packaging materials.  cleaning non-animal
                                                     food-contact
                                                     surfaces is
                                                     essential to
                                                     prevent
                                                     contamination of
                                                     animal food from
                                                     environmental
                                                     pathogens such as
                                                     Salmonella spp.
Sec.   507.19(g) (Storage     Cleaned and           Failure to properly
 and handling of cleaned       sanitized portable    store and handle
 portable equipment and        equipment with        such equipment and
 utensils).                    animal food-contact   utensils could lead
                               surfaces and          to contamination of
                               utensils must be      the equipment and
                               stored in a           utensils and then
                               location and manner   to contamination of
                               that protects         animal food if the
                               animal food-contact   equipment and
                               surfaces from         utensils come in
                               contamination.        contact with animal
                                                     food.
Sec.   507.22(a)(3)           All equipment must    Failure to properly
 (Equipment and utensils).     be installed and      clean equipment and
                               maintained in such    adjacent spaces due
                               a way to facilitate   to improper
                               the cleaning of the   installation and
                               equipment and of      maintenance could
                               all adjacent spaces.  lead to
                                                     contamination of
                                                     the equipment and
                                                     then contamination
                                                     of animal food if
                                                     the equipment comes
                                                     in contact with the
                                                     animal food.
Sec.   507.25(b)(1)(iv)       Containers and        Containers and
 (Processes and controls--     carriers of raw       carriers of raw
 raw materials and             materials must be     materials not
 ingredients).                 inspected on          properly maintained
                               receipt to ensure     can lead to
                               that their            contamination or
                               condition has not     deterioration of
                               contributed to the    animal food.
                               contamination or
                               deterioration of
                               animal food.
Sec.   507.25(c)(10)          Animal food must be   There are no
 (Manufacturing operations).   protected from        circumstances where
                               contaminants that     it would not be
                               may drip, drain, or   necessary to
                               be drawn into the     provide adequate
                               animal food during    physical protection
                               manufacturing steps   of animal food from
                               such as washing,      contaminants that
                               peeling, trimming,    may drip, drain, or
                               cutting, sorting      be drawn into
                               and inspecting,       animal food.
                               mashing,
                               dewatering,
                               cooling, shredding,
                               extruding, drying,
                               defatting, and
                               forming.
Sec.   507.25(c)(11)          Heat blanching, when  Properly heating and
 (Manufacturing operations).   required in the       cooling animal food
                               preparation of        during blanching is
                               animal food, must     necessary to
                               be effected by        protect animal food
                               heating the animal    from contamination
                               food to the           and would apply in
                               required              all cases for
                               temperature,          animal food when
                               holding it at this    heat blanching is
                               temperature for the   required in the
                               required time, and    preparation.
                               then either rapidly
                               cooling the animal
                               food or passing it
                               to subsequent
                               manufacturing
                               without delay.
Sec.   507.25(c)(11)          Thermophilic growth   Adequate operating
 (Manufacturing operations).   and contamination     temperatures and
                               in blanchers must     proper cleaning are
                               be minimized by the   necessary for
                               use of adequate       controlling growth
                               operating             of thermophilic
                               temperatures and by   bacteria and
                               periodic cleaning.    contamination and
                                                     would apply in all
                                                     cases for animal
                                                     food when heat
                                                     blanching is
                                                     required in the
                                                     preparation.
------------------------------------------------------------------------

[[Page 64778]]

3. Alternative to the Proposed CGMPs To Establish Requirements (Must) 
in Place of Guidance (Should) for Education and Training
    Proposed Sec.  507.14(b), provides guidance that personnel 
responsible for identifying sanitation failures or animal food 
contamination should have a background of education or experience, or a 
combination thereof, to provide a level of competency necessary for 
production of clean and safe animal food. Proposed Sec.  507.14(b) 
further recommends that animal food handlers and supervisors receive 
appropriate training in proper animal food handling techniques and 
animal food-protection principles and should be informed of the danger 
of poor personal hygiene and insanitary practices.
    As discussed in section II.A.1 of the document for the proposed 
rule for preventive controls for human food (78 FR 3646), a CGMP 
Working Group Report identified specific areas that presented an 
opportunity to modernize the CGMP regulation for human food. One 
recommendation was to ``require appropriate training for supervisors 
and workers to ensure that they have the necessary knowledge and 
expertise in food hygiene, food protection, employee health and 
personal hygiene to produce safe food products. This training must be 
delivered in a manner that can be easily understood by the worker. Food 
processors must maintain a record of this training for each worker'' 
(Ref. 49). The Agency's analysis of human food recalls also indicates 
that ineffective employee training was a root cause of 32 percent of 
CGMP-related recalls in the 1999-2003 analysis (Ref. 50); deficiencies 
in training were identified as a contributing factor in 24 percent of 
CGMP-related primary recalls in the 2008-2009 analysis (Ref. 51). While 
the Agency does not currently have animal food CGMP regulations to 
enable it to analyze animal food recalls based on CGMP violations, it 
believes that these trends of recalls in the human food facilities due 
to ineffective employee training would be found in the animal food 
industry as well. In addition, as discussed with respect to the 
proposed definition of preventive controls (see section VIII.B), 
section 418(o)(3) of the FD&C Act recognizes the importance of both 
training and CGMPs in preventing hazards from occurring in foods in its 
definition of preventive controls, which identifies supervisor, 
manager, and employee hygiene training (section 418(o)(3)(B)) and CGMPs 
under part 110 (section 418(o)(3)(F)) as some of the procedures, 
practices, and processes that may be included as preventive controls.
    The vast majority of costs related to a mandatory education and 
training program would be for the time that workers would be training 
rather than in production. Lacking data on the education and training 
programs offered by animal food production facilities, FDA used 
responses to a 2010 survey of human food production facilities to gauge 
training needs. The Agency estimates that this alternative, when 
implemented as part of a preventive approach, could impose an annual 
cost of $1,136 for those facilities with 10 production employees to 
$18,300 for those with 200 production employees and that do not already 
comply with this alternative. This would result in an estimated total 
annual cost of $11.0 million for domestic and foreign animal food 
facilities (Ref. 52).
    The Agency requests comment on how best to revise proposed Sec.  
507.14(b) in light of section 418(o)(3) of the FD&C Act and the 
recommendations of the human food CGMP Working Group with respect to 
training. Should the Agency replace the proposed recommendations for 
personnel education and experience with requirements? Doing so would be 
consistent with the emphasis in section 418(o)(3) of the FD&C Act on 
the importance of both training and CGMPs in preventing hazards from 
occurring in animal foods in its definition of preventive controls and 
with the recommendation in the human food CGMP Working Group Report. If 
so, what is the appropriate level of specificity? For example, should 
the Agency simply replace the ``shoulds'' in the proposed Sec.  
507.14(b) with ``musts''? This would provide flexibility for each 
establishment to determine the type and frequency of education and 
training appropriate for its personnel.
    FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Specifying that each person engaged in animal food 
manufacturing, processing, packing, or holding (including temporary and 
seasonal personnel and supervisors) receive training as appropriate to 
the person's duties;
     Specifying the frequency of training (e.g., upon hiring 
and periodically thereafter);
     Specifying that training include the principles of animal 
food hygiene and animal food safety, including the importance of 
employee health and personal hygiene, as applied at the facility; and
     Specifying that records document required training of 
personnel and, if so, specifying minimum requirements for the 
documentation (e.g., the date of the training, the type of training, 
and the person(s) trained).
    The Agency also requests comment on whether to establish some or 
all of the potential requirements for education and training in subpart 
B, subpart C, or both. If the Agency establishes a requirement for 
education and training in subpart B, that requirement would apply to 
all persons who manufacture, process, pack, or hold animal food, with 
the exceptions of persons who would be exempt from subpart B (e.g., 
under proposed Sec.  507.5(a) and (h), a requirement in subpart B would 
not apply to farms, or the holding or transportation of one or more raw 
agricultural commodities as defined in section 201(r) of the FD&C Act). 
On the other hand, if the Agency establishes a requirement for 
education and training in subpart C, that requirement would not apply 
to persons who would be exempt from the requirements of proposed 
subpart C (e.g., qualified facilities).

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

A. Proposed Sec.  507. 30--Requirement for a Food Safety Plan

1. Requirements of Section 418 of the FD&C Act
    Section 418(h) of the FD&C Act requires that the owner, operator, 
or agent in charge of a facility shall prepare a written plan that 
documents and describes the procedures used by the facility to comply 
with the requirements of section 418 of the FD&C Act, including 
analyzing the hazards under section 418(b) of the FD&C Act and 
identifying the preventive controls adopted under section 418(c) of the 
FD&C Act] to address those hazards. Section 418(h) of the FD&C Act also 
requires such written plan, together with the documentation described 
in section 418(g) of the FD&C Act, shall be made promptly available to 
a duly authorized representative of the Secretary upon oral or written 
request.

2. Proposed Sec.  507.30--Requirement for a Food Safety Plan

    Proposed Sec.  507.30(a) would specify that the owner, operator, or 
agent in charge of a facility must prepare, or have prepared, and 
implement a written food safety plan. The Agency uses the term 
``written food safety plan'' in proposed Sec.  507.30(a) to mean the 
``written plan'' referred to in section 418(h) of the FD&C Act. To make 
clear that the written plan is related to animal

[[Page 64779]]

food safety rather than to other plans a facility may have (such as 
quality control plans or food defense plans), the Agency has designated 
the ``written plan'' to be a ``written food safety plan.''
    In drafting the proposed requirements for subpart C described in 
the paragraphs that follow, the Agency uses wording and formatting that 
is in some cases slightly different from analogous provisions in the 
proposed rule for preventive controls for human food published (78 FR 
3646). Two types of differences are meant to be substantive: Those 
relating to ready-to-eat food and those relating to food allergens. 
Both of those concepts are not applicable in the animal food context. 
In addition, proposed subpart C of proposed part 507 addresses nutrient 
imbalances, which are relevant to animal food but not, for the most 
part, to human food. Otherwise, provisions in proposed subpart C of 
proposed 507 are meant to have the same meaning as the analogous 
provisions in proposed subpart C of proposed rule for human food.
    Proposed Sec.  507.30(a) would require that the plan be written as 
is expressly required by section 418(h). A written food safety plan is 
essential for the facility to implement the plan consistently, train 
its employees, and periodically reanalyze and update the plan. It is 
also essential to a facility's food safety team, to auditors, and to 
inspectors. Proposed Sec.  507.30(a) would implement section 418(h) of 
the FD&C Act. Proposed Sec.  507.30(a) would provide flexibility for 
the owner, operator, or agent in charge of the facility to either 
prepare the written food safety plan or have that plan prepared, in 
whole or in part, on its behalf. In addition, proposed Sec.  507.30 
would provide flexibility for facilities in the development of their 
food safety plans by allowing facilities to group animal food types or 
production method types if the hazards, control measures, parameters, 
and required procedures such as monitoring are essentially identical.
    Proposed Sec.  507.30(a) would require that the owner, operator, or 
agent in charge of a facility implement the written food safety plan. 
Although section 418(h) of the FD&C Act is silent with respect to 
implementation of the required written plan, other provisions of 
section 418 address implementation. For example, section 418(c) of the 
FD&C Act requires, in relevant part, that the owner, operator, or agent 
in charge of a facility both establish and implement preventive 
controls (emphasis added). In addition, other provisions of section 418 
(e.g., section 418(d) regarding monitoring, section 418(e) regarding 
corrective actions, and section 418(f) regarding verification) all 
establish requirements related to the preventive controls required 
under section 418(c). As discussed later in this section of the 
document, the written food safety plan would include the hazard 
analysis required under section 418(b) of the FD&C Act, the preventive 
controls required under section 418(c) of the FD&C Act, the monitoring 
procedures required under section 418(d) of the FD&C Act, the 
corrective action procedures required under section 418(e) of the FD&C 
Act, the verification procedures required under section 418(f) of the 
FD&C Act, and the recall plan as authorized by section 418(o)(3)(E) of 
the FD&C Act. Specific provisions for implementing these sections of 
the statute would be established throughout proposed subpart C.
3. Proposed Sec.  507.30(b)--Preparation of the Food Safety Plan by a 
Qualified Individual
    Proposed Sec.  507.30(b) would specify the food safety plan must be 
prepared by (or its preparation overseen by) a qualified individual. 
(See the discussion in section X.J regarding the qualifications of a 
qualified individual as would be established in proposed Sec.  
507.50(b)). Section 418 of the FD&C Act requires that firms identify 
and implement preventive controls and that facilities monitor and 
verify the effectiveness of the preventive controls. A qualified 
individual must develop the food safety plan in order to ensure the 
preventive controls are effective. The plan must be designed to 
identify and to significantly minimize or prevent hazards in order to 
prevent illness or injury to animals or humans. Designing a plan 
requires an individual who is knowledgeable in the concepts of 
preventive controls, the hazards associated with a product and process, 
the appropriate preventive controls, with associated monitoring and 
corrective actions for those hazards, and appropriate verification 
activities for the applicable preventive controls. Such knowledge 
requires scientific and technical expertise developed through training, 
experience, or both.
    Section 418 of the FD&C Act does not address the qualifications of 
the individual who would prepare the food safety plan. However, 
proposed Sec.  507.30(b) is consistent with the Federal regulations for 
seafood, juice, and meat and poultry (parts 123 and 120 (21 CFR parts 
123 and 120) and 9 CFR part 417 respectively). One way to comply with 
proposed Sec.  507.30(b) could be for a team of individuals (for 
example, a ``HACCP team'' or a ``food safety team'') to develop the 
food safety plan under the oversight of a qualified individual. Each 
member of a HACCP or food safety team generally brings specific 
expertise important in developing the plan. For example, a 
microbiologist could provide knowledge of microbial hazards, an 
engineer could establish the critical parameters for delivery of heat 
treatments, and a maintenance supervisor could identify sources of 
metal contamination. Proposed Sec.  507.30 would not require that all 
such members of a food safety team satisfy the requirements in proposed 
Sec.  507.30(b) for a qualified individual. However, under proposed 
Sec.  507.30(b), a qualified individual must be responsible for 
ensuring that all components the food safety plan have been developed, 
including reviewing all information contained in the food safety plan, 
thereby verifying the hazard analysis and food safety plan developed by 
the food safety team.
4. Proposed Sec.  507.30(c)--Contents of a Food Safety Plan
    Proposed Sec.  507.30(c)(1) through (c)(6) would require that the 
contents of a written food safety plan include:
     The hazard analysis as required by Sec.  507.33;
     The preventive controls as required by Sec.  507.36;
     The recall plan as required by Sec.  507.38;
     The procedures, and the frequency with which these 
procedures will be performed, for monitoring the implementation of the 
preventive controls as required by Sec.  507.39;
     The corrective action procedures as required by Sec.  
507.42; and
     The verification procedures and the frequency with which 
they will be performed as required by Sec.  507.45.
    Section 418(h) requires that the written plan document and describe 
the procedures used by the facility to comply with the requirements of 
section 418, ``including analyzing the hazards under [section 418(b) of 
the FD&C Act] and identifying the preventive controls adopted under 
[section 418(c) of the FD&C Act] to address those hazards'' (emphasis 
added.) Although section 418(h) of the FD&C Act explicitly references 
sections 418(b) and (c), the term ``including,'' indicates that the 
contents of a food safety plan need not be limited to the provisions of 
sections 418(b) and (c) of the FD&C Act.
    FDA interprets the requirement in section 418(h) of the FD&C Act 
that the written plan document and describe the procedures used by the 
facility to comply with the requirements of section

[[Page 64780]]

418 of the FD&C Act to mean that the written food safety plan would 
include all procedures required under section 418 of the FD&C Act. As 
discussed in sections X.E.4.a, X.F.2, X.G.6, and X.D.2, the proposed 
rule would require written procedures for monitoring the implementation 
of the preventive controls (proposed Sec.  507.39); written corrective 
action procedures (proposed Sec.  507.42); written procedures for some 
verification activities (proposed Sec.  507.45); and a written recall 
plan (proposed Sec.  507.38).
    FDA interprets the requirement in section 418(h) that the written 
plan describe the procedures used by the facility to comply with the 
requirements of section 418, including analyzing the hazards and 
identifying the preventive controls adopted to address those hazards, 
to mean that the contents of the food safety plan must include the 
hazard analysis conducted by the facility and the preventive controls 
that a facility must establish for hazards that its hazard analysis 
identifies as reasonably likely to occur, rather than procedures for 
analyzing the hazards and procedures for identifying the preventive 
controls. The general requirement in section 418(a) of the act is 
directed, in relevant part, to evaluating the hazards that could affect 
animal food manufactured, processed, packed, or held by a facility, and 
identifying and implementing preventive controls to significantly 
minimize or prevent the occurrence of such hazards and provide 
assurances that such animal food is not adulterated under section 402 
of the FD&C Act. Review of the evaluation of hazards in the hazard 
analysis is sufficient to determine the adequacy of the hazard 
analysis. Written procedures for conducting the hazard analysis are not 
necessary. Similarly, the preventive controls identified by the 
facility can be reviewed fully for adequacy without having a separate 
procedures document.
5. Facility-Based Nature of the Written Food Safety Plan
    The overall framework of section 418 of the FD&C Act is directed to 
a facility rather than, for example, a corporate entity that may have 
multiple facilities. For example, under section 418(b) of the FD&C Act 
the owner, operator, or agent in charge of a facility must identify and 
evaluate known or reasonably foreseeable hazards that may be associated 
with the facility (emphasis added). Thus, proposed Sec.  507.30 
establishes a requirement for every animal food facility to have its 
own written food safety plan.
    Federal HACCP regulations for seafood juice, meat and poultry allow 
the HACCP plan to group food types or production method types if 
hazards, critical control points, critical limits, and required 
procedures such as monitoring, are essentially identical (Sec.  
123.6(b)(2), Sec.  120.8(a)(2), and 9 CFR 417.2(b)(2) respectively.) 
However, these do provide that any required features of the plan that 
are unique to a specific product or production method be clearly 
delineated in the plan and observed in practice. This type of grouping 
would be allowed under proposed Sec.  507.30, and thus would provide 
flexibility for facilities in the development of their food safety 
plans.

B. Proposed Sec.  507.33--Hazard Analysis

1. Requirements of Section 418 of the FD&C Act
    Section 418(b)(1) of the FD&C Act specifies, in relevant part, that 
the owner, operator, or agent in charge of a facility shall identify 
and evaluate known or reasonably foreseeable hazards that may be 
associated with the facility, including: (1) Biological, chemical, 
physical, and radiological hazards, natural toxins, pesticides, drug 
residues, decomposition, parasites, allergens, and unapproved food and 
color additives; and (2) hazards that occur naturally, or may be 
unintentionally introduced. Section 418(b)(3) of the FD&C Act 
specifies, in relevant part, that the owner, operator, or agent in 
charge of a facility shall develop a written analysis of the hazards.
    As discussed in section II.C.2.f, proposed part 507 is not intended 
to address ``hazards that may be intentionally introduced, including by 
acts of terrorism.'' Therefore, the Agency would not be implementing 
section 418(b)(2) of the FD&C Act in this proposed rule.
    Section 418(c)(1) of the FD&C Act specifies that the owner, 
operator, or agent in charge of a facility shall identify and implement 
preventive controls, including at critical control points, if any, to 
provide assurances that hazards identified in the hazard analysis 
conducted under section 418(b)(1) of the FD&C Act will be significantly 
minimized or prevented. Section 418(c)(3) of the FD&C Act specifies 
that the food manufactured, processed, packed, or held by such facility 
will not be adulterated under section 402 of the FD&C Act, or 
misbranded under section 403(w) of the FD&C Act.
    Section 403(w) of the FD&C Act addresses the labeling of major food 
allergens, as defined in 201(qq) of the FD&C Act. The misbranding 
provisions in section 403 of the FD&C Act, when read together with 
other provisions of the Food Allergen Labeling and Consumer Protection 
Act, appear to be intended for human food. Therefore, this proposed 
rule does not address section 403(w) misbranding.
    Sections 418(c)(1) and (c)(3) of the FD&C Act, which will be 
discussed more fully in section X.C.2, are relevant to the discussion 
of proposed Sec.  507.33(a) regarding the purpose of the hazard 
analysis required by section 418(b) of the FD&C Act.
2. Proposed Sec.  507.33(a)--Hazard Analysis
    a. Proposed Sec.  507.33(a)--Requirement to identify and evaluate 
hazards. Proposed Sec.  507.33(a) would require that the owner, 
operator, or agent in charge of a facility must 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. As 
discussed more fully in the remainder of this section, proposed Sec.  
507.33(a) would implement section 418(b)(1) of the FD&C Act.
    In developing the proposed requirement for a hazard analysis, the 
Agency considered the language of section 418(b)(1) of the FD&C Act 
describing the hazards that a facility would be required to identify 
and evaluate, i.e., ``known or reasonably foreseeable hazards that may 
be associated with the facility.'' The Agency considers the ``known or 
reasonably foreseeable hazards'' in section 418(b) of the FD&C Act to 
be analogous to the ``potential hazards'' discussed in the NACMCF HACCP 
guidelines, and the hazards that are required to be identified to 
determine if they are ``hazards that may be reasonably expected to 
occur at each step'' in the Codex HACCP Annex, or ``reasonably likely 
to occur'' in Federal HACCP regulations for seafood, juice, and meat 
and poultry (Refs. 29 and 36).
    Proposed Sec.  507.33(a) would establish the requirement to 
identify and evaluate hazards by conducting a hazard analysis. The 
specific requirements for the hazard identification are in proposed 
Sec.  507.33(b) (see section X.B.3) and specific requirements for the 
hazard evaluation in proposed Sec.  507.33(c) and (d) (see sections 
X.B.4 and X.B.5.)
    Proposed Sec.  507.33(a) would require that the identification and 
evaluation of hazards be done ``for each type of animal food 
manufactured, processed, packed, or held at the facility.'' In 
developing the proposed requirement

[[Page 64781]]

for a hazard analysis, the Agency considered the language of section 
418(b)(1) of the FD&C Act. The purpose of sections 418(b)(1) appears 
clear, i.e., that the owner, operator, or agent in charge of a facility 
identify and evaluate known or reasonably foreseeable hazards that may 
be associated with the food produced by the facility. The known or 
reasonably foreseeable hazards associated with the facility's food may 
differ based on the type of food.
    The process of identifying and evaluating the hazards that may 
occur for specific types of animal food handled in a facility provides 
an efficient means for keeping track of multiple hazards that may occur 
in a facility that handles several types of animal food. Such a process 
also provides an efficient means for ensuring that preventive controls 
are applied to specific animal food products when required. Thus, a 
facility may need to conduct multiple hazard analyses. For example, a 
facility that uses an animal protein blend (by-products derived from 
meat and animal production industries) as an ingredient in the 
manufacture of food intended for swine, poultry, dogs and cats, would 
be required by proposed Sec.  507.33 to identify the Salmonella 
serotypes to which swine, poultry, dogs, and cats are each susceptible 
(e.g., Salmonella Choleraesuis in food for swine; Salmonella Pullorum, 
Salmonella Gallinarum, or Salmonella Enteritidis in food for poultry) 
along with an evaluation of the adverse health effects each Salmonella 
serotype would cause in each of the animal species for which the food 
is intended (e.g., diarrhea, fever, or pneumonia in pigs caused by 
Salmonella Choleraesuis; diarrhea, gasping, or depression in poultry 
caused by Salmonella Pullorum) (Ref. 14). In addition, for the animal 
protein blend used in the manufacture of food for dogs and cats, a 
hazard analysis would need to include the hazards reasonably likely to 
occur related to the health of human handlers (e.g., pet owners) who 
are likely to come in contact with the finished food. In other words, 
if a facility manufactures food for multiple animal species, the Agency 
would consider the animal food intended for each animal species to be a 
type of animal food under proposed Sec.  507.33(a), each requiring its 
own hazard identification and evaluation, even if the animal food the 
facility produces for each animal species consists of the same primary 
ingredients. As with the example above, the same biological, chemical, 
physical, or radiological agent in different types of food intended for 
different animal species may lead to varied adverse health effects in 
each of the animal species consuming the food.
    To give another example, a facility that uses corn as a raw 
material in the manufacture of animal food intended for lactating dairy 
cows, beef cattle, swine, and poultry, would determine if aflatoxin is 
a reasonably foreseeable hazard that is reasonably likely to occur in 
the corn. An evaluation of the hazard would include the adverse health 
consequences to humans consuming milk and milk products from the dairy 
cows (See FDA Compliance Policy Guide (CPG) 683.100, Action Levels for 
Aflatoxins in Animal Feeds) (Ref. 15). This evaluation is likely to 
differ from the evaluation of aflatoxin in corn used to manufacture 
food for beef cattle, swine, and poultry, where higher levels of 
aflatoxin, to a point, would not be likely to cause illness or injury 
to the animals that consume the food or to humans consuming food 
products derived from those animals (Ref. 15). As a result, in 
evaluating the same hazard, the hazard analysis for the food for dairy 
cattle would lead to a different conclusion than the hazard analysis 
for the food for beef cattle, swine, and poultry.
    Proposed Sec.  507.33(a) would identify the purpose of the hazard 
analysis, i.e., to determine whether there are hazards that are 
reasonably likely to occur in animal food. Although section 418(b)(1) 
of the FD&C Act does not explicitly identify the purpose of the hazard 
analysis, the Agency interprets the combined requirements of sections 
418(b), (c)(1) and (c)(3) of the FD&C Act to reflect a purpose, i.e., 
to enable the facility to identify and, where necessary, implement 
preventive controls to provide assurances that hazards identified in 
the hazard analysis will be significantly minimized or prevented and 
the animal food manufactured, processed, packed or held by the facility 
will not be adulterated under section 402 of the FD&C Act. If, for 
example, a facility concludes during the hazard analysis that one or 
more (or even all) reasonably foreseeable hazards are not reasonably 
likely to occur in the facility, the facility could conclude that there 
is no need to implement preventive controls for those hazards. The 
purpose of the hazard analysis identified in proposed Sec.  507.33 is 
consistent with the purpose identified in the NACMCF HACCP guidelines, 
the Codex HACCP Annex, and Federal HACCP regulations for seafood, 
juice, and meat and poultry.
    b. Requirement for the hazard analysis to be written. Proposed 
Sec.  507.33(a) would require that the hazard analysis ``be written'' 
as required by section 418(b)(3) of the FD&C Act. A written hazard 
analysis can help the facility organize the scientific basis for the 
hazard analysis and would be essential to the facility's food safety 
team, auditors, and inspectors during review and evaluation of the 
hazard analysis. The facility's food safety team would need to fully 
understand the nature of the hazards in order to produce safe animal 
food. For example, although the facility's food safety plan would 
include corrective action procedures that address problems that can be 
anticipated, the food safety team would need to identify appropriate 
corrective actions when there is an unanticipated problem (see, e.g., 
the discussion of a proposed requirement (proposed Sec.  507.42) for 
corrective actions when there is an unanticipated problem in section 
X.F.3). The written hazard analysis would be useful at these times. 
Having a written hazard analysis available for auditors and for 
inspectors is essential for assessing the adequacy of the hazard 
analysis. A written hazard analysis would also be essential during 
reanalysis and updates of the hazard analysis, as would be required by 
proposed Sec.  507.45(e) so that the person doing the reanalysis or 
update has a baseline from which to start. A written hazard analysis 
would also be useful for training purposes as a tool to make employees 
aware of food safety hazards that are reasonably likely to occur.
    The written hazard analysis would include the justification for 
whatever conclusion the owner, operator, or agent in charge of a 
facility reaches, including a conclusion that no hazards are reasonably 
likely to occur. Thus, proposed Sec.  507.33(a) would not limit the 
requirement for a written hazard analysis to those circumstances where 
the owner, operator, or agent in charge of a facility identifies one or 
more hazards that are reasonably likely to occur. Under proposed Sec.  
507.33(a), a written hazard analysis would be required even if the 
conclusion of the analysis is that there are no hazards reasonably 
likely to occur.
3. Proposed Sec.  507.33(b)--Hazard Identification
    Proposed Sec.  507.33(b) would require that the hazard analysis 
consider hazards that may occur naturally or may be unintentionally 
introduced, including:
     Biological hazards, including microbiological hazards such 
as parasites, environmental pathogens, and other microorganisms of 
animal or human health significance (proposed Sec.  507.33(b)(1));

[[Page 64782]]

     Chemical hazards, including substances such as pesticide 
and drug residues, natural toxins, decomposition, unapproved food or 
color additives, and nutrient imbalances (proposed Sec.  507.33(b)(2));
     Physical hazards (proposed Sec.  507.33(b)(3)) ; and
     Radiological hazards (proposed Sec.  507.33(b)(4)).
    Proposed Sec.  507.33(b) would implement section 418(b)(1) of the 
FD&C Act and would establish four groups of hazards (i.e., biological, 
chemical, physical, and radiological).
Microbiological Hazards
    Proposed Sec.  507.33(b)(1) would include microbiological hazards 
within the category of biological hazards. Examples of microbiological 
hazards include:
     Parasites (which are required to be considered by section 
418(b)(1)(A) of the FD&C Act). A parasite is an organism that lives on 
or in an organism of another species (often called the host organism) 
and receives its nutritional requirements from that other species. 
Cryptosporidium spp., Giardia intestinalis, and Toxoplasma gondii are 
examples of parasites.
     Environmental pathogens (e.g., Salmonella spp.); and
     Other microorganisms of animal or human health 
significance, including molds (e.g., Aspergillus spp., Penicillium 
spp., and Fusarium spp.) and bacteria (e.g., Salmonella spp., 
Clostridium spp.)
Chemical Hazards
    Proposed Sec.  507.33(b)(2) would include substances such as 
pesticide and drug residues, natural toxins, decomposition, unapproved 
food or color additives, and nutrient imbalances (all of which except 
nutrient imbalances, are explicitly required to be considered by 
section 418(b)(1)(A) of the FD&C Act) within the category of chemical 
hazards. Pesticide residues may be present in animal food at levels in 
excess of a tolerance level established by the U.S. Environmental 
Protection Agency (EPA). Natural toxins such as aflatoxin and gossypol 
are well recognized as hazards in animal food products such as corn and 
cottonseed, respectively (Refs. 53 and 54. Residues of natural toxins 
such as aflatoxin may be present in human food (such as milk) derived 
from dairy cattle consuming animal food contaminated with the toxin in 
excess of a tolerance or safe level established and enforced by FDA 
(Ref. 15). Decomposition of animal food consists of microbial breakdown 
of the normal food product tissues and the subsequent enzyme-induced 
chemical changes. These changes are manifested by abnormal odors, 
taste, texture, color, etc., and can lead to reduced food intake or 
rejection of the food by the intended animal species, resulting in 
illness or death. For example, the metabolic activity of Fusarium 
graminearum growing in or on grain and grain products can lead to 
changes in the levels of grain nutrients such as carbohydrates, 
proteins, lipids, or vitamins and formation of deoxynivalenol (DON or 
vomitoxin). DON can cause diarrhea, vomiting and reduced weight gain in 
animals consuming food contaminated with the toxin. Swine can smell DON 
and refuse animal food contaminated with the substance (Ref. 55).
    Nutrient imbalance hazards can result from excessive levels of a 
nutrient in animal food leading to toxicity (e.g., copper poisoning in 
sheep consuming food with excessive levels of copper), or a nutrient 
deficiency in the food that can compromise the health of animals (e.g., 
chickens fed riboflavin deficient diets experience curled toe disease) 
(Refs. 56, 57, 58, and 59). Nutrient imbalances are particularly 
problematic for animal food, because often one animal food type is the 
sole source of an animal's diet. A nutrient imbalance hazard in animal 
food would pose a greater risk to the health of animals fed a sole 
source diet than animals receiving multiple types of animal food (like 
humans eat).
    Nutrient imbalance hazards can also result from diets containing 
essential nutrients in inappropriate proportions of essential 
nutrients. For example, an animal's calcium needs cannot be considered 
independently of phosphorus. Calcium, an essential mineral, may be 
adequate in forage (especially legumes) for grazing cattle. Phosphorus, 
however, can be deficient in the forages, and since calcium and 
phosphorus work hand in hand for the animal's muscle and metabolic 
functions, respectively, supplemental phosphorus at an appropriate 
level would be needed for cattle on forage-based diets. Calcium and 
phosphorus are also the major mineral constituents of bone. The calcium 
to phosphorus ratio in the animal food for cattle would need to be 
maintained in the desired range to prevent negative health effects 
associated with nutrient imbalance (e.g. rickets in young animals, 
osteomalacia in adult animals, reduced resistance to disease, overall 
reduced productivity including reduced food intake, reduced conception 
rates, or reduced milk production in cattle) (Refs. 60 and 61).
Physical Hazards
    Proposed Sec.  507.33(b)(3) would require that the hazard analysis 
consider physical hazards, which are required to be considered by 
section 418(b)(1)(A) of the FD&C Act. Examples of physical hazards 
include pieces of wood, stones, glass, or metal fragments that could 
inadvertently be introduced into animal food. Physical hazards may be 
associated with raw materials, especially raw agricultural products. 
The facility and equipment can also be a source of physical hazards 
(e.g., pieces of glass from glass container breakage and metal pieces 
such as nuts and bolts from equipment used during manufacturing/
processing).
Radiological Hazards
    Proposed Sec.  507.33(b)(4) would require that the hazard analysis 
consider radiological hazards. Examples of radiological hazards include 
radionuclides such as radium-226, radium-228, uranium, strontium-90 and 
iodine-131. Section 418(b)(1)(A) of the FD&C Act requires that 
radiological hazards be considered, and animal food may be subject to 
contamination with radiological hazards, e.g., if water used to 
manufacture the animal food contains a radionuclide.
4. Proposed Sec.  507.33(c)--Hazard Evaluation
    Proposed Sec.  507.33(c) would require that the hazard analysis 
contain an evaluation of the hazards identified in Sec.  507.33(b) of 
this section 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. Proposed Sec.  507.33(c) would implement 
sections 418(b)(1) and (c)(3) of the FD&C Act. Contamination of animal 
food with biological hazards often leads to immediate or near-term 
onset of illness or injury (e.g., gastrointestinal illness in humans 
after handling pet treats contaminated with Salmonella). Exposure to 
some biological hazards may have long-term consequences as well (e.g., 
human infections with Salmonella may lead to reactive arthritis). The 
health consequence of exposure to some biological hazards can be severe 
(e.g., acute enteritis that can cause severe abdominal pain, diarrhea 
or death in horses exposed to Salmonella spp. through consumption of 
contaminated food) (Refs. 62 and 63). Proposed Sec.  507.33(c) would 
require that such biological hazards be considered to determine whether 
they are reasonably likely to occur even if the biological hazard 
occurs infrequently.

[[Page 64783]]

    Contamination of animal food with chemical hazards may also lead to 
immediate or near-term obvious onset of illness, e.g., mycotoxins in 
large doses can be the primary agent causing acute health or production 
problems such as diarrhea, metritis, mastitis, or reduced conception 
rates in a dairy herd (Ref. 64). In other instances, the focus of the 
evaluation for chemical hazards would be directed to their long term 
effects, such as liver diseases in animals or humans exposed to 
aflatoxin over long periods (Refs. 65 and 66). Proposed Sec.  507.33(c) 
would require that such chemical hazards be considered to determine 
whether they are reasonably likely to occur even if the chemical hazard 
occurs infrequently.
    Physical hazards such as hard and sharp foreign objects that may be 
present in animal food can pose a health risk to the animals that 
consume the food. Hard or sharp foreign objects in animal food may 
cause traumatic injury, including laceration and perforation of tissues 
of the throat, stomach and intestine (Ref. 67). Although physical 
hazards may occur infrequently, under proposed Sec.  507.33(c) the 
potential for severe consequences would require consideration of these 
physical hazards to determine whether they are reasonably likely to 
occur. Factors relevant to an evaluation of the severity of illness or 
injury caused by a physical hazard include the potential size of the 
object, the nature of the food, and whether the intended animal species 
or production class is susceptible to the physical hazard (Ref. 68).
    Contamination of animal food with radiological hazards generally is 
evaluated for long-term effects such as the potential for cancer (Ref. 
69). A significant radiation dose could be received as a result of 
consumption of animal food contaminated as a result of an accident at a 
nuclear power plant or other types of accidents (Ref. 69) (see also 63 
FR 43402, August 13, 1998). Foods may contain unsafe levels of 
radionuclides (Ref. 70). Thus, although radiological hazards occur 
infrequently, under proposed Sec.  507.33(c) the potential for severe 
consequences would require consideration of radiological hazards to 
determine whether they are reasonably likely to occur for a particular 
food or facility, especially when circumstances arise that could lead 
to contamination of food with radiological hazards.
    The purpose of section 418(b)(1) and (c)(3) of the FD&C Act seems 
clear, i.e., that the owner, operator, or agent in charge of a facility 
identify and evaluate known or reasonably foreseeable hazards for the 
purpose of identifying and implementing preventive controls to provide 
assurances that identified hazards will be significantly minimized or 
prevented and that animal food manufactured, processed, packed or held 
by the facility will not be adulterated under section 402 of the FD&C 
Act. The process of evaluating animal food hazards to determine which 
potential hazards require preventive controls must take into account 
the consequences of exposure (i.e., severity of illness or injury) as 
well as the probability of occurrence (i.e., frequency) to provide 
assurances that the animal food manufactured, processed, packed, or 
held by the facility will not be adulterated under section 402 of the 
FD&C Act. Proposed Sec.  507.33(c) would implement this statutory 
direction.
5. Proposed Sec.  507.33(d)--Effect on Finished Food
    Proposed Sec.  507.33(d) would require that, in conducting the 
hazard evaluation, the qualified individual must consider the effect of 
the following on the safety of the finished animal food, including:
     The formulation of the animal food;
     The condition, function, and design of the facility and 
equipment;
     Raw materials and ingredients;
     Transportation practices;
     Manufacturing/processing procedures;
     Packaging activities and labeling activities;
     Storage and distribution;
     Intended or reasonably foreseeable use;
     Sanitation, including employee hygiene; and
     Any other relevant factors.
    The Agency tentatively concludes that these are factors that a 
prudent person who manufactures, processes, packs, or holds animal food 
would consider when evaluating identified hazards to determine whether 
they are reasonably likely to occur. As the Agency indicated when 
proposing FDA's HACCP regulation for juice, a prudent processor should 
consider factors such as these in doing a hazard analysis (63 FR 20450 
at 20468, April 24, 1998).
    Proposed Sec.  507.33(d)(1) would require that the hazard 
evaluation consider the formulation of the animal food. The addition of 
certain ingredients such as acids and preservatives may be critical to 
the safety of the food, since they may inhibit growth of, or even kill, 
microorganisms of animal and health significance. This could impact the 
evaluation of the potential for growth of pathogens in the animal food 
during manufacturing, processing, packing or holding. A multi-component 
food may have individual ingredients that on their own do not support 
growth of undesirable microorganisms, e.g., because of their oil 
content or salt content that affects aw, but when these 
ingredients are combined the finished food may have an aw 
that supports microorganism growth. Under proposed Sec.  507.33(d)(1), 
the interaction of the individual ingredients must be evaluated as part 
of the formulation of the animal food.
    Proposed Sec.  507.33(d)(2) would require that the hazard 
evaluation consider the condition, function, and design of the facility 
and equipment. The condition, function, or design of a facility or its 
equipment could potentially result in the introduction of hazards into 
animal food. For example, older equipment (e.g., older belt, bucket 
elevator, or auger conveying equipment) may be more difficult to clean 
(e.g., with close fitting components or hollow parts) and, thus, 
provide more opportunities for pathogens to become established in a 
niche environment than modern equipment designed to address the problem 
of pathogen proliferation in niche environments. Proposed Sec.  
507.33(d)(2) would require that facilities with such equipment consider 
the impact of the equipment on the potential for a pathogen to be a 
hazard that is reasonably likely to occur; in those situations, a 
preventive control such as enhanced sanitation controls may be 
appropriate, particularly if the equipment is used in production of 
animal food products that would not undergo further processing to 
eliminate pathogens prior to consumption. Equipment designed such that 
there is metal-to-metal contact may generate metal fragments. Proposed 
Sec.  507.33(d)(2) would require that facilities with such equipment 
consider the impact of the equipment on the potential for generation of 
such metal fragments to be a hazard that is reasonably likely to occur; 
if so, a preventive control such as metal detectors may be appropriate.
    Proposed Sec.  507.33(d)(3) would require that the hazard 
evaluation consider the effect of raw materials and ingredients on the 
safety of the finished animal food. While there is an overlap between 
raw materials and ingredients, not all raw materials are ingredients. 
Before being used in the manufacturing process, raw materials are often 
altered to be used in different processes. For example, molasses, a 
thick, dark syrup, is a byproduct of sugar refining that is used as an 
ingredient in animal food for cattle. Briefly, to make molasses from 
sugar cane, washed cane stalks are shredded into short pieces and cane

[[Page 64784]]

juice separated from the stalks by mechanical (pressing through 
rollers) or solvent (water or lime juice) extraction methods. The juice 
is then subjected to a series of processes including filtration, vacuum 
boiling, and centrifugation to clarify the juice, crystallize out, and 
separate the sugar leaving the thick syrup (molasses). Because the 
production process transforms sugar cane stalks, the raw materials, 
into molasses, those raw materials generally would not be viewed as 
``ingredients'' of the final product, molasses. Likewise, if a facility 
that manufactures animal food for cattle mixes molasses with other food 
products to make the food, the facility would view molasses as an 
ingredient of its cattle food product, but would not view the sugar 
cane stalks used to produce molasses as ingredients of its cattle food 
product. Animal food can become contaminated through the use of 
contaminated raw materials or ingredients. For example, corn grown 
under severely hot and dry weather conditions often becomes infected 
with Aspergillus flavus. Under these environmental conditions, this 
fungus is likely to produce aflatoxins, resulting in aflatoxin 
contaminated corn. Corn is one of the most frequently used ingredients 
in animal food, and corn contaminated with aflatoxins can cause illness 
in animals consuming food made with the corn and in humans consuming 
milk derived from dairy cattle consuming food made with the 
contaminated corn (Refs. 71 and 53).
    Production and harvesting practices may impact whether raw 
materials and ingredients contain hazards. For example, machine-
harvested forage or hay is more likely to be contaminated with physical 
hazards than hand-harvested forage or hay, because the machinery often 
picks up foreign material from the field. For this reason, machine-
harvested forage or hay may lead to increased incidence of hardware 
disease in cattle (e.g., traumatic reticuloperitonitis developing as a 
result of perforation of the reticulum), which often occurs when 
animals consume food contaminated with physical hazards. Cattle 
commonly ingest heavy, sharp foreign objects because they take large 
mouthfuls of food and do not completely chew food before swallowing. 
The disease is common when greenchop, silage, and hay are made from 
fields that contain old rusting fences or baling wire, because these 
foods are often machine-harvested. The grain ration may also be a 
source of physical hazards due to accidental addition of metal such as 
nails, nuts, or bolts during the production process (Ref. 67).
    Proposed Sec.  507.33(d)(4) would require that the hazard 
evaluation consider the effects of transportation practices on the 
safety of the finished animal food. Animal food can become unsafe as a 
result of poor transportation practices. For example, failure to 
adequately control temperature during transportation could make animal 
food unsafe if the product requires time and temperature controls to 
ensure safety. Distributing animal food in bulk without adequate 
protective packaging can make the food susceptible to contamination 
during transportation, e.g., from pathogens or chemicals present in an 
inadequately cleaned vehicle or from other inadequately protected foods 
that are being co-transported and are potential sources of 
contamination (Ref. 72).
    The Sanitary Food Transportation Act of 2005 (SFTA) gives FDA 
authority to require shippers, carriers by motor vehicle or rail 
vehicle, receivers, and other persons engaged in the transportation of 
food to use sanitary transportation practices to ensure that food is 
not transported under conditions that may render the food adulterated. 
The Agency published an Advance Notice of Proposed Rulemaking on April 
30, 2010 (75 FR 22713), to request data and information on the food 
transportation industry and its practices and expects to issue a 
separate proposed rule to implement the SFTA. FDA does not expect a 
future rulemaking implementing the SFTA to eliminate the need for the 
owner, operator, or agent in charge of a facility to consider 
transportation practices when determining whether a hazard is 
reasonably likely to occur.
    Proposed Sec.  507.33(d)(5) would require that the hazard 
evaluation consider the effects of manufacturing/processing procedures 
on the safety of finished animal food. For example, hazards may arise 
from manufacturing/processing operations such as cooling or holding of 
certain animal food products due to the potential for germination of 
pathogenic spore forming bacteria such as Clostridium spp. and Bacillus 
spp. (which may be present in animal food ingredients) as a cooked 
product is cooled and reaches a temperature that would promote 
germination and outgrowth of the spores. Hazards may also arise from 
animal food manufacturing/processing activities such as acidification 
due to the potential for bacterial contamination if the acidification 
is not done correctly. Physical hazards may occur from metal fragments 
generated during the manufacture of animal food on equipment in which 
metal (e.g., a blade, saw, or knife) is used to cut products during 
manufacturing.
    Proposed Sec.  507.33(d)(6) would require that the hazard 
evaluation consider the effects of packaging activities and labeling 
activities on the safety of finished animal food. For example, the 
hazards that are reasonably likely to occur would be different 
depending on whether the animal food product is distributed in bulk 
form or packaged in bags. Labels on food for livestock would direct the 
person feeding animals to use the correct food product for the intended 
animal species. For example, it is well known that feeding food 
products to sheep that were intended for other ruminant animal species 
such as cattle can lead to copper toxicity (poisoning); proper labeling 
would help to guard against sheep being fed animal food products that 
are unsafe for sheep.
    Proposed Sec.  507.33(d)(7) would require that the hazard 
evaluation consider the effects of storage and distribution on the 
safety of finished animal food. For example, biological hazards are 
more likely to be a hazard that is reasonably likely to occur during 
storage and distribution in animal food products that require 
refrigerated storage to maintain safety than in shelf-stable foods. 
Shelf-stable foods are designed such that biological hazards are 
controlled.
    Proposed Sec.  507.33(d)(8) would require that the hazard 
evaluation consider the intended or reasonably foreseeable use on the 
safety of finished animal food. For example, gossypol, a natural toxin 
commonly occurs in cottonseed food products, can cause severe illness 
in immature ruminants and young pigs, but the older animals can 
tolerate low levels of the chemical hazard in their diets. Therefore 
gossypol would be identified as a hazard of concern if it is reasonably 
likely to occur at low levels in food for immature ruminants and young 
pigs but less of a concern in food for older ruminants and for mature 
pigs.
    Proposed Sec.  507.33(d)(9) would require that the hazard 
evaluation consider the effects of sanitation, including employee 
hygiene, on the safety of finished animal food. Sanitation measures and 
practices can impact the likelihood of a hazard being introduced into 
animal food. For example, the frequency with which a production line in 
a pet food facility is shut down for a complete cleaning can impact the 
potential for food residues to transfer pathogens from equipment to 
foods (e.g., pathogens present on raw meat products that could carry 
over into the next production cycle on a line). Practices directed at 
worker health and

[[Page 64785]]

hygiene can reduce the potential for transfer of pathogens such as 
Salmonella. To the extent that these controls are necessary for the 
safety of the animal food product, they may need to be listed as 
preventive controls.
    Proposed Sec.  507.33(d)(10) would require that the hazard 
evaluation consider the effect of any other relevant factors that might 
potentially affect the safety of the finished animal food. For example, 
an unexpected natural disaster could flood some or all of a facility, 
creating insanitary conditions and potentially contaminating the 
facility with harmful microorganisms or chemical residues. Following a 
natural disaster, environmental contaminants that could be brought into 
the facility could be hazards reasonably likely to occur in a facility 
that manufactures, processes, packs, or holds animal food.
    Further discussion of the hazard analysis, including comparison to 
HACCP, can be found in section XII.B of the document for the proposed 
rule for preventive controls for human food (78 FR 3646).

C. Proposed Sec.  507.36--Preventive Controls for Hazards That Are 
Reasonably Likely To Occur

1. Requirements of Section 418 of the FD&C Act
    Section 418(c)(1) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall identify 
and implement preventive controls, including at critical control 
points, if any, to provide assurances that hazards identified in the 
hazard analysis conducted under section 418(b)(1) of the FD&C Act will 
be significantly minimized or prevented. Section 418(c)(1)(3) of the 
FD&C Act, in relevant part, specifies that the food manufactured, 
processed, packed, or held by such facility will not be adulterated 
under section 402 of the FD&C Act
    Section 418(o)(3) of the FD&C Act defines preventive controls and 
proposed Sec.  507.3 would include the statutory definition in proposed 
part 507. Under section 418(o)(3), the procedures, practices, and 
processes described in the definition of preventive controls may 
include the following:
     Sanitation procedures for food contact surfaces and 
utensils and food-contact surfaces of equipment (section 418(o)(3)(A) 
of the FD&C Act);
     Supervisor, manager, and employee hygiene training 
(section 418(o)(3)(B) of the FD&C Act);
     An environmental monitoring program to verify the 
effectiveness of pathogen controls in processes where a food is exposed 
to a potential contaminant in the environment (section 418(o)(3)(C) of 
the FD&C Act);
     A recall plan (section 418(o)(3)(E) of the FD&C Act);
     CGMPs under part 110 or any successor regulations (section 
418(o)(3)(F) of the FD&C Act); and
     Supplier verification activities that relate to the safety 
of food (section 418(o)(3)(G) of the FD&C Act).
2. Proposed Sec.  507.36(a)--Requirement To Identify and Implement 
Preventive Controls for Hazards That Are Reasonably Likely To Occur
    Proposed Sec.  507.36(a) would require that the owner, operator, or 
agent in charge of a facility identify and implement preventive 
controls, including at critical control points (CCPs), if any, to 
provide assurances that hazards identified in the hazard analysis as 
reasonably likely to occur will be significantly minimized or prevented 
and the animal food manufactured, processed, packed or held by such 
facility will not be adulterated under section 402 of the FD&C Act.
    As discussed in section X.B, proposed Sec.  507.33(a) would require 
that the owner, operator, or agent in charge of a facility conduct a 
hazard analysis to 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.'' Under proposed 
Sec.  507.36(a), a facility that determines through its hazard analysis 
that there are hazards that are reasonably likely to occur would then 
be required to identify and implement preventive controls for those 
hazards. Preventive controls would be required when applicable hazards 
are identified as reasonably likely to occur. The types of preventive 
controls implemented would depend on the facility and the animal food 
it produces. Most hazards would be addressed through process controls 
and sanitation controls. For any type of preventive control, a facility 
would have the flexibility to identify and implement preventive 
controls from among all procedures, practices, and processes available 
to it that would provide the assurances that would be required by 
proposed Sec.  507.36(a).
    Proposed Sec.  507.36(a) would implement section 418(c) of the FD&C 
Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP 
Annex, and Federal HACCP regulations for juice, seafood, and meat and 
poultry, although there are some differences between HACCP systems and 
the preventive control system established by section 418 of the FD&C 
Act. It differs in part in that preventive controls may be required at 
points other than at CCPs and critical limits would not be required for 
all preventive controls. Under proposed Sec.  507.36(a), a processor 
could address hazards that are reasonably likely to occur through 
preventive controls that would be applied at CCPs, but doing so would 
not be the only option available to the facility in all circumstances. 
In some cases adequate assurances could be achieved via preventive 
controls implemented through other procedures and practices of a 
facility, such as its control parameters for the occurrence of nutrient 
imbalance hazards, which may not have specific CCPs.
    Whatever types of preventive controls a facility chooses to apply 
in its operations, the requirement in proposed Sec.  507.36(a) would be 
risk-based. Establishing risk-based preventive controls involves 
consideration of the available scientific data and information related 
to animal food safety risks. Typically, the hazard evaluation will 
enable the facility to determine appropriate risk-based preventive 
controls for the hazard based on the severity of the hazard and the 
likelihood of its occurrence.
    For example, as discussed in section II.F.4 of this document, 
Salmonella spp. is an environmental pathogen that can establish a 
harborage in the environment such as on a production line used in 
manufacturing. Once established, Salmonella spp. can intermittently 
contaminate products on the production line. When a hazard analysis 
identifies Salmonella spp. as a hazard that is reasonably likely to 
occur in an animal food, the facility would establish sanitation 
controls to prevent Salmonella spp. from establishing itself in a 
harborage site. In addition to such sanitation controls, a facility may 
consider applying a bactericidal process step (i.e., a process control 
applied to adequately reduce levels of Salmonella spp.) in animal foods 
that are handled in the home.
3. Proposed Sec.  507.36(b)--Requirement for Written Preventive 
Controls
    Proposed Sec.  507.36(b) would require that preventive controls for 
hazards identified in the hazard analysis as reasonably likely to occur 
be written. Proposed Sec.  507.36(b) would implement section 418(h) of 
the FD&C Act which, as discussed in section X.A.1, requires that the 
owner, operator, or agent in charge of a facility prepare a written 
food safety plan that, among other things, identifies the preventive 
controls

[[Page 64786]]

within the plan. Written preventive controls are essential for the 
facility to implement the preventive controls consistently and 
essential for the facility's food safety team, auditors, and to 
inspectors. Written preventive controls also would be essential for 
training purposes and during reanalysis and updates of the preventive 
controls.
4. Proposed Sec.  507.36(c)--Requirement for Parameters Associated With 
the Control of Hazards That Are Reasonably Likely To Occur
    Proposed Sec.  507.36(c)(1) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include, as appropriate to the facility and the animal food, 
parameters associated with the control of the hazard, such as 
parameters associated with heat processing, irradiating, and 
refrigerating animal foods. The parameters are those factors that must 
be controlled to ensure the hazard will be significantly minimized or 
prevented. The specific parameters required, and how they would be 
controlled, would depend on the facility and the animal food. For 
example, for a heat process, parameters such as temperature and time 
must be controlled. The heating temperature may be controlled through 
controls on oven temperature (as when heating product in an oven). The 
heating time may be controlled by the belt speed for the conveyor on a 
continuous oven. A facility would have flexibility to establish 
controls on heating temperature and time through these or other 
mechanisms.
    Some preventive controls may not have specific parameters 
associated with them. For example, preventive controls for metal may 
include an equipment preventive maintenance program and a metal 
detector on the packaging line. These programs may not have specific 
factors that must be controlled to prevent metal contamination. 
Sanitation procedures may include scrubbing certain pieces of equipment 
by hand; this may not require the identification of specific 
parameters.
    Proposed Sec.  507.36(c)(2) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include, as appropriate to the facility and the animal food, 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. Some of the preventive controls a facility 
may implement may be based upon scientific studies or other information 
that demonstrate the effectiveness of the control measure at specific 
values of a biological, chemical, physical, or radiological parameter 
e.g., the application of heat to animal food at a specific time/
temperature combination to adequately reduce pathogens. Proposed Sec.  
507.36(c) would also require that a facility that establishes such a 
preventive control specify values of the essential parameters to be 
applied in implementing the control. Specifying these values would 
enable the facility to implement them consistently and would facilitate 
validation of the preventive controls as would be required by proposed 
Sec.  507.45(a). Proposed Sec.  507.36(c)(1) and (c)(2) would implement 
section 418(c) of the FD&C Act and are consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal regulations for seafood, 
juice, and meat and poultry, although there are some differences 
related to the differences between HACCP systems and the preventive 
control system established by section 418 of the FD&C Act. FSMA does 
not use the term ``critical limit.'' Critical limits may not be 
appropriate for preventive controls that are not applied at CCPs. Thus, 
proposed Sec.  507.36(c)(1) and (c)(2) use a broader term, i.e., 
parameter, to encompass preventive controls that may or may not apply 
at CCPs.
5. Proposed Sec.  507.36(d)(1)--Process Controls
    Proposed Sec.  507.36(d)(1) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include process controls that include those procedures, 
practices, and processes performed on an animal food during 
manufacturing/processing that are employed to significantly minimize or 
prevent hazards that are reasonably likely to occur. Process controls 
do not include those procedures, practices, and processes that are not 
applied to the animal food itself, e.g., controls of personnel or the 
environment that may be used to significantly minimize or prevent 
hazards that are reasonably likely to occur but are not applied to the 
food itself. Specifying that process controls are employed during 
manufacturing/processing to significantly minimize or prevent hazards 
that are reasonably likely to occur would distinguish those controls 
applied in manufacturing/processing that significantly minimize or 
prevent hazards (e.g., screening, drying, cooking, and, irradiating) 
from other types of controls that may be applied in manufacturing/
processing to provide the desired product (e.g., controls for product 
size and shape).
    As discussed in section X.C.4 of this document, proposed Sec.  
507.36(c)(2) would require that preventive controls for hazards 
identified in the hazard analysis as reasonably likely to occur 
include, when applicable, the maximum or minimum value, or combination 
of values, to which any biological, chemical, physical, or radiological 
parameter must be controlled. (For process controls in particular, the 
term ``parameter'' used in proposed Sec.  507.36(c)(1), and the value 
associated with the parameter in proposed Sec.  507.36(c)(2), are 
associated with the term ``critical limit'' used in HACCP systems.)
    For example, a facility that holds shelled corn in bulk storage 
units for an extended time period until it is sold or mixed into an 
animal food may identify the potential for growth of aflatoxin-
producing molds on the corn as a hazard reasonably likely to occur. As 
a process control to prevent such molds from growing on the corn during 
storage, the facility may elect to dry the corn to a specific moisture 
content (e.g., no more than 15 percent) prior to placing the corn in 
storage. The process control would be ``drying'' and the associated 
parameter would be moisture level, with its maximum value, or limit, 
being 15 percent.
6. Proposed Sec.  507.36(d)(2)--Sanitation Controls
    Proposed Sec.  507.36(d)(2)(i)(A) and (B) would establish two 
requirements for sanitation controls where necessary to significantly 
minimize or prevent hazards that are reasonably likely to occur. 
Proposed Sec.  507.36(d)(2)(i)(A) would require that the owner, 
operator or agent in charge of the facility implement, where relevant 
to hazards that are reasonably likely to occur, sanitation controls 
that would include procedures for the cleanliness of animal food-
contact surfaces, including animal food-contact surfaces of utensils 
and equipment. Examples of such sanitation controls include cleaning 
and sanitizing procedures (including appropriate frequencies for these 
procedures, concentrations of cleaning and sanitizing compounds, method 
of application, and contact time). Such controls can prevent 
contamination of animal food with microorganisms of animal or human 
health significance, including environmental pathogens that result from 
inadequate cleaning of animal food-contact surfaces.
    Proposed Sec.  507.36(d)(2)(i)(B) would require that the owner, 
operator or agent

[[Page 64787]]

in charge of a facility implement, where relevant to hazards that are 
reasonably likely to occur, sanitation controls that include procedures 
for the prevention of cross-contamination from insanitary objects to 
animal food, animal food packaging material, and other animal food-
contact surfaces and from raw product to processed product. Examples of 
such controls to prevent cross-contamination include procedures for 
ensuring that personnel do not touch insanitary objects such as waste 
and waste bins and then animal food, animal food contact surfaces, or 
animal food packaging material; procedures for protecting animal food 
packaging material from environmental contamination; procedures for 
protecting exposed animal food products from contamination from the 
environment; and procedures for controlling traffic (including traffic 
of people and traffic of equipment such as forklifts) between the raw 
and finished sides of the operation. Any time an animal food is exposed 
to the environment during a manufacturing, processing, packing, or 
holding activity, there is the potential for the animal food to be 
contaminated. Appropriate sanitation controls can minimize the presence 
and transfer of contaminants, including environmental pathogens, to 
animal food. (See section I.D and I.E of the Appendix to this document 
for a discussion on the importance of controlling environmental 
pathogens.) Proposed Sec.  507.36(d)(2)(i)(A) and (B) would implement 
section 418(c) of the FD&C Act. For a discussion on sanitation controls 
under HACCP, see section XII.C.7 for the proposed rule for preventive 
controls for human food (78 FR 3646).
    Proposed Sec.  507.36(d)(2)(ii) would require that the owner, 
operator, or agent in charge of a facility take action to correct, in a 
timely manner, conditions and practices that are not consistent with 
the procedures that would be established in proposed Sec.  
507.36(d)(2)(i)(A) or (B) or that result in insanitary conditions that 
could lead to cross-contamination with a hazard.
    Proposed Sec.  507.36(d)(2)(iii) would provide that the owner, 
operator, or agent in charge of a facility is not required to follow 
the corrective actions that would be established in proposed Sec.  
507.42(a) and (b) when the owner, operator, or agent in charge of a 
facility takes action, in accordance with proposed Sec.  
507.36(d)(2)(ii), to correct conditions and practices that are not 
consistent with the procedures in proposed Sec.  507.36(d)(2)(i) (A) or 
(B). As discussed in section X.F, proposed Sec.  507.42(a) would 
require that the owner, operator or agent in charge of a facility 
establish and implement written corrective action procedures that must 
be taken if preventive controls are not properly implemented, and 
outlines specific components that must be included. Proposed Sec.  
507.42(b) would require specific actions in the event of an 
unanticipated problem when a preventive control is not properly 
implemented and a specific corrective action procedure has not been 
established or a preventive control is found to be ineffective. For 
sanitation controls, proposed Sec.  507.36(d)(2)(ii) would require that 
the owner, operator or agent in charge of a facility take action to 
correct, in a timely manner, conditions and practices that are not 
consistent with the established sanitation control practices.
    There are many different ways in which conditions and practices for 
sanitation can deviate from the established procedures. In many 
instances the actions taken will be the same, regardless of the 
deviation. The corrective actions will generally involve re-
establishing sanitary conditions (e.g., re-cleaning a piece of 
equipment) and/or retraining personnel to carry out the procedures 
correctly. In many instances the procedural deviations are not 
reasonably likely to impact product (e.g., insanitary animal food-
contact surfaces are usually detected by a pre-production inspection of 
the equipment by plant personnel; deviations in cleaning solution 
strength rarely result in the production of unsafe product if other 
cleaning and sanitizing procedures were properly carried out). Thus, 
there is rarely a need to evaluate the impact of the sanitation failure 
on animal food and to prevent animal food from entering commerce, as 
would be required by proposed Sec.  507.42(a)(2) and (a)(3). Because 
the corrective actions that will need to be taken for most sanitation 
controls are so general, the Agency sees little benefit in requiring a 
facility to develop written corrective action procedures for the many 
sanitation deviations that could occur. The Agency does expect the 
facility to take action to correct conditions and practices as 
appropriate to the situation as would be required by proposed Sec.  
507.36(d)(2)(ii). The requirement in proposed Sec.  507.36(d)(2)(ii) to 
take action to correct, in a timely manner, sanitation conditions and 
practices that are not in accordance with procedures is consistent with 
proposed Sec.  507.42(a)(1), which would require that appropriate 
action be taken to identify and correct a problem with implementation 
of a preventive control to reduce the likelihood that the problem will 
recur.
    Proposed Sec.  507.36(d)(2)(iv) would require that all corrective 
actions taken in accordance with proposed Sec.  507.36(d)(2)(ii) be 
documented in records that would be subject to verification in 
accordance with proposed Sec.  507.45(b)(2) and records review in 
accordance with proposed Sec.  507.45(c)(1)(i) and (c)(2). The records 
that document corrective actions would be used to verify that 
appropriate decisions about corrective actions are being made and 
appropriate corrective actions are being taken.
7. Proposed Sec.  507.36(d)(3)--Recall Plan
    Proposed Sec.  507.36(d)(3) would require that preventive controls 
include, as appropriate, a recall plan as would be required by proposed 
Sec.  507.38. Proposed Sec.  507.36(d)(3) would incorporate the 
statutory definition of ``preventive controls'' from section 
418(o)(3)(E) of the FD&C Act, which establishes that preventive 
controls may include a recall plan. The Agency includes the details of 
the recall plan in proposed Sec.  507.38 and discusses it in section 
X.D of this document.
8. Proposed Sec.  507.36(d)(4)--Other Controls
    Proposed Sec.  507.36(d)(4) would require that preventive controls 
for hazards identified in the hazard analysis as reasonably likely to 
occur include any other controls necessary to satisfy the requirements 
of proposed Sec.  507.36(a), i.e., to significantly minimize or prevent 
hazards identified in the hazard analysis and to provide assurance that 
the animal food manufactured, processed, packed or held by such 
facility will not be adulterated under section 402 of the FD&C Act.
    FDA notes that some of the controls listed in section 418(o) of the 
FD&C Act are not explicitly identified in proposed Sec.  507.36. As 
discussed in section X.B, the Agency is not interpreting misbranding 
under section 403(w), major allergens, to apply to animal food. 
Therefore, the proposed preventive controls for animal food do not 
include allergen controls. In section X.K, the Agency requests comment 
on an environmental monitoring program (which section 418(o)(3)(C) of 
the FD&C Act indicates is one of the procedures, practices, and 
processes that preventive controls may include, and which section 
418(f)(4) of the FD&C Act identifies as a verification activity.) In 
section X.L, the Agency also requests comment on a supplier approval 
and verification program as one of the procedures, practices, and 
processes

[[Page 64788]]

that preventive controls my include (section 418(o)(3)(G)). In section 
IX.C, the Agency requests comment on supervisor, manager, and employee 
hygiene training. There is a full discussion on CGMPs in section IX of 
this document. Further, as discussed in section IX.A of this document, 
such controls are traditionally considered to be part of prerequisite 
programs, essential to effective preventive controls but often not part 
of them. FDA expects that compliance with those requirements in 
proposed part 507, subpart B will be sufficient. However, a facility 
may determine that in some circumstances it would be appropriate to 
include certain Current Good Manufacturing Practice provisions among 
their preventive controls (i.e., as ``other controls'' in proposed 
Sec.  507.36(d)(4).
9. Proposed Sec.  507.36(e)--Applicability of Monitoring, Corrective 
Actions, and Verification
    Proposed Sec.  507.36(e)(1)(i) through (iii) would specify that, 
except as provided by proposed Sec.  507.36(e)(2), the preventive 
controls required under this section would be subject to monitoring as 
would be required by proposed Sec.  507.39; corrective actions as would 
be required by proposed Sec.  507.42; and verification as would be 
required by proposed Sec.  507.45. Proposed Sec.  507.36(e)(1)(i) 
through (iii) would restate the requirements of proposed Sec. Sec.  
507.39, 507.42, and 507.45 to clearly communicate the applicability of 
proposed Sec. Sec.  507.39, 507.42, and 507.45 to the preventive 
controls that would be required under proposed Sec.  507.36 and would 
establish no new requirements.
    Proposed Sec.  507.36(e)(2) would provide that the recall plan that 
would be established in proposed Sec.  507.38 would not be subject to 
the requirements of proposed Sec.  507.36(e)(1). A recall plan would 
address animal food that had left the facility, whereas the proposed 
requirements for monitoring, corrective actions, and verification would 
all be directed at animal food while it remains at the facility. Thus, 
as proposed, the requirements for monitoring, corrective actions, and 
verification have limited applicability to a recall plan. However, a 
``mock recall'' (i.e., a simulated recall situation) is a verification 
activity that could identify problems with a recall plan, enable a 
facility to correct the problems, and provide reasonable assurance that 
the recall plan would be effective in removing products from commerce. 
FDA requests comments on whether to include a requirement for a mock 
recall as verification activity in the final rule.

D. Proposed Sec.  507.38--Recall Plan for Animal Food With a Hazard 
That Is Reasonably Likely to Occur

1. Requirements of Section 418 of the FD&C Act
    Section 418(c) of the FD&C Act specifies that the owner, operator, 
or agent in charge of a facility shall identify and implement 
preventive controls, including at critical control points, if any, to 
provide assurances that:
     Hazards identified in the hazard analysis conducted under 
section 418(b)(1) of the FD&C Act will be significantly minimized or 
prevented (section 418(c)(1) of the FD&C Act); and
     The food manufactured, processed, packed, or held by such 
facility will not be adulterated under section 402 of the FD&C Act 
(section 418(c)(3) of the FD&C Act).
    Under section 418(o)(3)(D), the procedures, practices, and 
processes described in the definition of preventive controls may 
include, in relevant part, a recall plan.
2. Proposed Sec.  507.38--Recall Plan for Animal Food With a Hazard 
That Is Reasonably Likely to Occur
    Proposed Sec.  507.38(a) would require that the owner, operator, or 
agent in charge of a facility establish a written recall plan for 
animal food with a hazard that is reasonably likely to occur. Although 
a recall is different from other preventive controls in that it is 
carried out after a product is distributed, it shares the purpose of 
significantly minimizing or preventing hazards, which is accomplished 
by limiting feeding of the affected animal food. Time is critical 
during a recall. A written recall plan is essential to minimizing the 
time needed to accomplish a recall; additional time during which the 
animal food is on the market can result in additional animal (or human) 
exposure. Following an existing plan that addresses all necessary 
elements of a recall helps minimize delay created by uncertainty as to 
the appropriate actions to take and helps ensure critical actions are 
not overlooked.
    Proposed Sec.  507.38(a) would implement sections 418(c)(1) and (3) 
of the FD&C Act and 418(o)(3)(E) of the FD&C Act. Recommendations for 
addressing a recall, applicable to both human food and animal food, can 
be found in FDA's general guidance on policy, procedures, and industry 
responsibilities regarding recalls in part 7 (21 CFR part 7), subpart C 
(Sec. Sec.  7.40 through 7.59). The guidance advises firms to prepare 
and maintain a current written contingency plan for use in initiating 
and effecting a recall (Sec.  7.59). Section 507.38(a) would require 
that the owner, operator, or agent in charge of a facility develop a 
written recall plan and assign responsibility for performing all 
actions in the plan.
    Proposed Sec.  507.38(b) would require that the written recall plan 
include procedures to perform the following actions:
     Directly notify the direct consignees of the product being 
recalled and how to return or dispose of the affected product (proposed 
Sec.  507.38(b)(1));
     Notify the public about any hazard presented by the animal 
food when appropriate to protect animal or human health (proposed Sec.  
507.38(b)(2));
     Conduct effectiveness checks to verify that the recall is 
carried out (proposed Sec.  507.38(b)(3)); and
     Appropriately dispose of recalled product, e.g., through 
destroying the product, reprocessing, or diverting to a use that does 
not present a safety concern (proposed Sec.  507.38(b)(4)).
    Procedures that describe the action to be taken would enable a 
facility to act promptly by following its plan when the facility 
determines that a recall is warranted rather than developing a plan of 
action after the need for a recall is identified. Procedures that 
assign responsibility for taking those steps would save the time needed 
to make such determinations during a recall and enable the owner, 
operator, or agent in charge of a facility to clearly communicate such 
responsibilities to applicable managers or staff so that such managers 
or staff can take action as soon as the decision to conduct a recall is 
made.
    Directly notifying direct consignees about the recall (proposed 
Sec.  507.38(b)(1)) is the most effective mechanism to ensure direct 
consignees know that the product is being recalled and is consistent 
with FDA's general guidance on recall communications in Sec.  7.49(a). 
Further, instructing direct consignees how to return or dispose of an 
affected product minimizes the chance the affected product will be 
disposed of improperly and allows direct consignees to act quickly. 
Further, it is consistent with FDA's guidance on the content of recall 
communications in Sec.  7.49(c)(4). FDA has provided guidance to 
industry on a model recall letter (Ref. 73). This guidance may be 
useful in developing procedures for directly notifying direct 
consignees about the recall and on how

[[Page 64789]]

to return or dispose of an affected product.
    Notification procedures could identify a variety of communication 
means, including email, telephone, fax, text messaging, and urgent mail 
delivery. Notification procedures that would establish only a general 
notification to the public (e.g., through a press release or through 
information posted on a facility's Web site), without procedures for 
concurrent contact directly with direct consignees about how to access 
the general notification, would not satisfy proposed Sec.  
507.38(b)(1); a general notification to the public would rely on the 
chance that the direct consignees would see the information and may not 
be effective.
    Notifying the public about any hazard presented by the animal food 
when appropriate to protect human or animal health is a common practice 
(e.g., see FDA's Web site that provides information gathered from press 
releases and other public notices about recalls of animal food, Animal 
& Veterinary Recalls & Withdrawals) (Ref. 74). Notifying the public in 
such circumstances is consistent with the Agency's guidance on a recall 
strategy that the purpose of a public warning is to alert the public 
that a product being recalled presents a hazard to human or animal 
health (Sec.  7.42(b)). Notifying the public, in addition to direct 
consignees, may not be necessary to protect the public if, for example, 
the animal food being recalled was all distributed to animal feeding 
operations (who were notified as a direct consignee) and not 
distributed for retail sale. Procedures in the recall plan for 
notifying the public could include model press releases and procedures 
for disseminating information to the public though press releases or 
other means, such as by information posted on the facility's Web site 
or provided to end users of the animal food using social media. FDA has 
provided guidance to industry with a model press release for the 
presence of Salmonella in pet food and pet treats (Ref. 75).
    An effectiveness check is a procedure designed to verify that all 
notified consignees have received notification about the recall and 
have taken appropriate action; procedures to conduct effectiveness 
checks would be consistent with FDA's guidance on a recall strategy in 
Sec.  7.42(c)(3). Procedures to conduct an effectiveness check could 
expand on the procedures used to directly contact consignees about the 
recall, e.g., to include forms for consignees to provide information 
about the amount of recalled product on hand, to include information on 
follow up contacts via phone or email, or to include personal visits to 
consignees by sales representatives. FDA has provided guidance to 
industry on conducting effectiveness checks (Ref. 73). This guidance 
includes a model effectiveness check letter, a model effectiveness 
check response form that could be sent to a consignee, and a model 
questionnaire to be used during effectiveness checks conducted by 
telephone or by personal visit.
    A facility that receives recalled product from its customers must 
appropriately dispose of the product, e.g., through reprocessing, 
reworking, diverting to a use that does not present a safety concern, 
or by destroying the product. These types of disposition actions are 
similar to the disposition actions that a facility would consider as a 
corrective action as a result of a problem that is discovered before 
the product leaves the facility (see, e.g., the discussion of 
corrective actions in the final rule to establish FDA's HACCP 
regulation for seafood; 60 FR 65095 at 65127). Procedures for 
disposition of a product can help the facility ensure that disposition 
of recalled product will be appropriate and will not present a risk to 
animals. Implementation of such procedures is part of determining 
whether a recall can be considered terminated. Thus, having procedures 
in place can result in more efficient completion of a recall. Under 
Sec.  7.55, appropriate disposition of recalled product is a 
consideration in determining whether a recall is terminated.
    FDA requests comment on whether the procedures to be included in 
the recall plan (i.e., to directly notify consignees, to notify the 
public, to conduct effectiveness checks, and to appropriately dispose 
of recalled product) are appropriate for all types of facilities or if 
they should be modified for certain facilities.
    FDA requests comment on whether the Agency should require a recall 
plan to include procedures and assignments of responsibility for 
notifying FDA of recalls subject to the plan. Notifying FDA could 
enhance the effectiveness of a recall by allowing FDA to take 
appropriate steps to minimize the risk of illness or injury related to 
recalled products. As discussed in section II.E of this document, 
notifying FDA of a reportable food (including animal food) is required 
by section 417 of the FD&C Act. Reportable food reports include 
information about whether a reportable food is being recalled. Thus, in 
some cases, reporting a recall to FDA could be accomplished by 
submitting a reportable food report required under section 417. In 
other cases, facilities could notify the local FDA district office of 
the recall.

E. Proposed Sec.  507.39--Monitoring

1. Requirements of Section 418 of the FD&C Act
    Section 418(a) of the FD&C Act specifies that the owner, operator, 
or agent in charge of a facility shall monitor the performance of the 
preventive controls. Section 418(d) of the FD&C Act specifies that the 
owner, operator, or agent in charge of a facility shall monitor the 
effectiveness of the preventive controls implemented under section 
418(c) of the FD&C Act to provide assurances that the outcomes 
described in section 418(c) shall be achieved. The outcomes relevant to 
this proposal are those that provide assurances that hazards identified 
in the hazard analysis will be significantly minimized or prevented and 
that food manufactured, processed, packed or held by a facility will 
not be adulterated under section 402 of the FD&C Act.
    Section 418(g) of the FD&C Act requires, in relevant part, that the 
owner, operator, or agent in charge of a facility maintain records 
documenting the monitoring of the preventive controls implemented under 
section 418(c) of the FD&C Act.
    Section 418(h) of the FD&C Act requires, in relevant part, that the 
owner, operator, or agent in charge of a facility prepare a written 
plan that documents and describes the procedures used by the facility 
to comply with the requirements of section 418 of the FD&C Act.
2. Monitoring, Verification, and Their Relationship
    Proposed Sec.  504.3 would define ``monitor'' to mean ``to conduct 
a planned sequence of observations or measurements to assess whether a 
process, point, or procedure is under control and to produce an 
accurate record for use in verification.'' Monitoring is essential to 
managing food safety because it facilitates tracking of the operation 
(i.e., the ``process, point, or procedure'' that is being controlled). 
This provides ongoing information about whether the process, point, or 
procedure is under control (i.e., operating according to plan), and can 
provide information about shifts away from control. If monitoring 
indicates that there is a trend towards loss of control, a facility can 
take action to bring the process back into control before a deviation 
from a maximum or minimum value (critical limit) occurs. For example, 
if the minimum oven

[[Page 64790]]

temperature needed to ensure pathogen elimination during baking of a 
particular size pet treat is 300[emsp14][deg]F for a specific time and 
the procedure for baking pet treats calls for an operating temperature 
of 375 [deg]F, monitoring would detect that the temperature in the oven 
was dropping and enable the facility to identify and fix the problem 
with the temperature before the temperature drops to 300 [deg]F. In 
addition, monitoring is used to determine when a deviation occurs at a 
critical control point (i.e., exceeding or not meeting a critical 
limit), indicating there is loss of control. In the previous example, 
there would be loss of control if the temperature drops to 299 [deg]F. 
When a deviation occurs, an appropriate corrective action must be 
taken, e.g., stop the baking process until the temperature in the oven 
can be maintained above 300 [deg]F and reprocess the pet treats that 
were not baked at the appropriate temperature. Also, monitoring 
provides written documentation for use in verification. For example, if 
the facility monitors the temperature of the oven continuously, using a 
temperature recording device, the output of the temperature recording 
device is available during the verification activity of review of 
records. Under this approach, monitoring is directed to evaluating 
implementation of the preventive controls, and the written 
documentation of the monitoring is then used in verification.
    Proposed Sec.  507.3 would define ``verification'' to mean those 
``activities, other than monitoring, that establish the validity of the 
food safety plan and that the system is operating according to the 
plan.'' One aspect of verification, as proposed, is the initial 
validation of a food safety plan to determine that the plan is 
scientifically and technically sound, that all hazards have been 
identified, and that if the food safety plan is properly implemented 
these hazards will be effectively controlled. Another aspect of 
verification is evaluating whether the facility's food safety system is 
functioning according to the food safety plan. Both of these aspects 
are directed at the effectiveness of a preventive control; they 
establish that the preventive control is scientifically valid for 
controlling the hazard and verify that the preventive control is 
accomplishing its intended purpose. Examples of verification activities 
include review of monitoring records and review of records for 
deviations and corrective actions. The Agency discusses verification 
activities in more detail during its discussion of proposed Sec.  
507.45 (Verification) in section X.G.
    Monitoring and verification are closely related; both address the 
performance of preventive controls, and verification relies in part on 
monitoring records to establish that preventive controls developed to 
significantly minimize or prevent hazards are being implemented 
according to plan. Three provisions of section 418(f) of the FD&C Act 
(Verification) are particularly relevant when considering the role of 
monitoring. First, section 418(f)(1) of the FD&C Act requires that the 
owner, operator, or agent in charge of a facility verify that ``the 
preventive controls implemented . . . are adequate to control the 
hazards identified . . . '' Second, section 418(f)(2) of the FD&C Act 
requires that the owner, operator, or agent in charge of a facility 
verify that ``the owner, operator, or agent is conducting monitoring . 
. .'' Third, section 418(f)(4) of the FD&C Act requires that the owner, 
operator, or agent in charge of a facility verify that ``the preventive 
controls implemented . . . are effectively and significantly minimizing 
or preventing the occurrence of identified hazards . . .''
3. Monitoring the Performance of Preventive Controls
    Section 418(a) requires monitoring the ``performance'' of 
preventive controls whereas section 418(d) requires monitoring their 
``effectiveness.'' The Agency tentatively concludes that the language 
of section 418 regarding monitoring is ambiguous and that it would be 
appropriate to require monitoring of the performance of preventive 
controls. ``Performance'' means ``the execution or accomplishment of an 
action, operation, or process undertaken or ordered'' (Shorter Oxford 
English Dictionary, Fifth Ed. (2002), p. 2157) and is consistent with 
use of ``monitoring'' in traditional HACCP. Monitoring the performance 
of preventive controls would be undertaken to determine whether a 
facility is implementing its preventive controls and would generate 
records that would be used to verify implementation of the controls. 
For example, monitoring performance could include visual observation 
and measurements of temperature, time, pH, and moisture level. In 
contrast, ``effectiveness'' refers to the quality of ``having an effect 
or result'' (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 
794) and is not consistent with use of the term ``monitoring in 
traditional HACCP. The term ``verification,'' not ``monitoring'' is 
used to refer to effectiveness in traditional HACCP systems. Monitoring 
the effectiveness of preventive controls would evaluate whether the 
preventive controls were working.
    Requiring monitoring of the effectiveness of the preventive 
controls would be redundant with required verification activities. 
Section 418(f) requires verification that the preventive controls are 
``effectively and significantly minimizing the occurrence of the 
identified hazards . . .'' The activities necessary for such 
verification are the same as would be required for monitoring the 
effectiveness of the preventive controls. Requiring monitoring of 
effectiveness rather than performance of the preventive controls would 
create a significant gap in the preventive controls system. In 
contrast, monitoring the performance of preventive controls would 
provide evidence that the preventive controls established to control 
the identified hazards are implemented appropriately and thereby are 
effectively and significantly minimizing or preventing hazards.
    Section 418(n)(5) of the FD&C Act directs the Secretary, in issuing 
these regulations, to review hazard analysis and preventive control 
programs in existence to ensure that this regulation is consistent to 
the extent practicable with applicable domestic and internationally-
recognized standards in existence. Requiring monitoring of the 
performance of preventive controls is consistent with applicable 
domestic and internationally recognized standards.
    Therefore, the Agency tentatively concludes that this 
interpretation is reasonable and proposes to adopt it in the proposed 
requirements implementing section 418(d) of the FD&C Act. The Agency 
requests comment on this interpretation.
4. Proposed Sec.  507.39--Monitoring
    a. Proposed Sec.  507.39(a)--Requirement for written procedures for 
monitoring. Proposed Sec.  507.39(a) would require that the owner, 
operator, or agent in charge of a facility establish and implement 
written procedures, including the frequency with which they are to be 
performed, for monitoring the preventive controls. Proposed Sec.  
507.39(a) would implement section 418(d) and (h) of the FD&C Act.
    Proposed Sec.  507.39(a) would require that the monitoring 
procedures be written. Under section 418(d) of the FD&C Act, the owner, 
operator, or agent in charge of a facility must monitor the 
effectiveness of the preventive controls implemented under section 
418(c) of the FD&C Act. Under section 418(h) of the FD&C Act, the 
procedures used by the

[[Page 64791]]

facility to comply with the requirements of section 418 of the FD&C Act 
must be included in the written plan.
    Proposed Sec.  507.39(a) would facilitate tracking the 
implementation of the preventive controls to provide assurance that 
they are consistently performed; if monitoring indicates that there is 
a trend towards loss of control, a facility can take action to bring 
the process back into control before a preventive control is not 
properly implemented and potentially unsafe product is produced. 
Further, if monitoring is conducted with sufficient frequency to ensure 
preventive controls are consistently performed, it will detect if a 
preventive control is not properly implemented (e.g., if the 
temperature of an oven falls below the temperature needed to ensure 
safety), indicating loss of control and signaling the need for an 
appropriate corrective action. Finally, the proposed monitoring 
requirement would result in written documentation for use in 
verification.
    To assist the animal food industry in developing their food safety 
plan, the Agency, in proposed Sec.  507.39(a)(1) through (a)(6), lists 
the monitoring procedures that it tentatively considers to be the 
minimum information needed to provide assurances that the outcomes 
described in proposed Sec.  507.36, ``Preventive controls for hazards 
that are reasonably likely to occur,'' are achieved. The owner, 
operator, or agent in charge of the facility, in their written 
monitoring procedures would need to include the preventive controls 
that will be monitored. The procedures would also need to include who 
will perform the monitoring, how the monitoring will be performed, what 
parameter will be measured if applicable, the frequency of monitoring, 
and any additional information needed to endure proper monitoring of 
the preventive controls.
    b. Proposed Sec.  507.39(b)--Frequency of monitoring. Proposed 
Sec.  507.39(b) would require that the owner, operator, or agent in 
charge of a facility monitor the preventive controls with sufficient 
frequency to provide assurance that they are consistently performed. 
Proposed Sec.  507.39(b) does not specify a single monitoring frequency 
applicable to all facilities and processes. Rather, it requires 
monitoring with ``sufficient frequency'' to assure that the preventive 
controls are consistently performed. Proposed Sec.  507.39(b) would 
implement section 418(d) of the FD&C Act and is consistent with the 
NACMCF HACCP guidelines and the Codex HACCP Annex.
    Continuous monitoring is possible with many types of physical and 
chemical parameters. For example, the temperature and time for many 
thermal processes can be recorded continuously on temperature recording 
charts. If the temperature falls below the scheduled temperature or the 
time is insufficient, as recorded on the chart, the affected product 
can be retained and evaluated to determine the appropriate disposition. 
Examples of other parameters that can be monitored continuously include 
pressure, flow rate, and pH.
    Continuous monitoring may not be possible, or even necessary, in 
all cases. For example, it may not be practical to continuously monitor 
the size of particles in a food to ensure they do not exceed the 
maximum dimensions that are required to ensure a process such as 
cooking, cooling, or acidification can be properly implemented. If 
monitoring is not continuous, it may be difficult to ensure that the 
preventive controls are consistently implemented and a problem has not 
occurred. Thus, according to NACMCF, the frequency of non-continuous 
monitoring must be sufficient to ensure that a CCP (or, in the case of 
this proposed rule, a preventive control) is under control (Ref. 31). 
The Codex HACCP Annex also notes that, if monitoring is not continuous, 
then the amount or frequency of monitoring must be sufficient to 
guarantee the CCP is in control (Ref. 36). The frequency of non-
continuous monitoring would depend on factors such as the proximity of 
operating conditions to the conditions needed to ensure safety and the 
variability of the process. For example, if the temperature needed to 
ensure safety of baked pet treats is 300 [deg]F, non-continuous 
monitoring would need to be more frequent when an oven for baking pet 
treats is operated at 350 [deg]F than when the oven is operated at 400 
[deg]F. As another example, if temperatures vary by 30 [deg]F during 
processing, monitoring would need to be more frequent than if the 
variation is only 10-15 degrees.
    c. Proposed Sec.  507.39(c)--Requirement for records. Proposed 
Sec.  507.39(c) would require that all monitoring of preventive 
controls in accordance with proposed Sec.  507.39 be documented in 
records that are subject to verification in accordance with Sec.  
507.45(b)(1) and records review in accordance with 507.45(c)(1)(i) and 
(c)(2). Proposed Sec.  507.39(c) would implement section 418(g) of the 
FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex 
HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat 
and poultry. Further discussion monitoring under HACCP systems can be 
found in section XII.E of the proposed rule for preventive controls for 
human food (78 FR 3646).
    The monitoring records would be used to verify that the preventive 
controls are adequate, as would be required by proposed Sec.  
507.45(a), and to verify that the preventive controls are effectively 
and significantly minimizing or preventing the hazards that are 
reasonably likely to occur, as would be required by proposed Sec.  
507.45(d).
    Together, proposed Sec. Sec.  507.39(a), (b), and (c) and 
507.45(a), (b), and (d) would establish a system that would provide 
assurance that hazards identified in the hazard analysis conducted 
under section 418(b)(1) of the FD&C Act will be significantly minimized 
or prevented and that food manufactured, processed, packed or held by 
such facility will not be adulterated under section 402 of the FD&C 
Act.

F. Proposed Sec.  507.42--Corrective Actions

1. Requirements of Section 418 of the FD&C Act
    Section 418(h) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall prepare a 
written plan that documents and describes the procedures used by the 
facility to comply with the requirements of section 418 of the FD&C 
Act. Section 418(e) specifies that the owner, operator, or agent in 
charge of a facility shall establish procedures to ensure that, if the 
preventive controls implemented under section 418(c) of the FD&C Act 
are not properly implemented or are found to be ineffective:
     Appropriate action is taken to reduce the likelihood of 
recurrence of the implementation failure (section 418(e)(1) of the FD&C 
Act);
     All affected food is evaluated for safety (section 
418(e)(2) of the FD&C Act); and
     All affected food is prevented from entering into commerce 
if the owner, operator or agent in charge of such facility cannot 
ensure that the affected food is not adulterated under section 402 of 
the FD&C Act (section 418(e)(3) of the FD&C Act).
    Section 418(f)(4) of the FD&C Act requires, in relevant part, that 
the owner, operator, or agent in charge of a facility verify that the 
preventive controls implemented under section 418(c) of the FD&C Act 
are effectively and significantly minimizing or preventing the 
occurrence of identified hazards.
2. Proposed Sec.  507.42(a)--Corrective Action Procedures
    Proposed Sec.  507.42(a) would require that the owner, operator, or 
agent in

[[Page 64792]]

charge of a facility establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented. Having written procedures in place would enable facilities 
to act quickly and appropriately when preventive controls are not 
properly implemented, e.g., when a parameter associated with heat 
processing exceeds a maximum value or falls below a minimum value. 
Proposed Sec.  507.42(a) would implement section 418(e) of the FD&C 
Act. A discussion on the use of corrective actions in HACCP can be 
found in section XII.F.2 of the proposed rule for preventive controls 
for human food (78 FR 3646). As discussed in section X.C.4, the 
proposed rule would establish requirements for preventive controls 
(which may be at critical control points), and proposed Sec.  
507.36(c)(2) would require that the preventive controls include, as 
appropriate to the facility and the animal food, the maximum or minimum 
value, or combination of values, to which any physical, biological, 
radiological, or chemical parameter must be controlled to significantly 
minimize or prevent a hazard that is reasonably likely to occur. For 
example, if a parameter associated with heat processing falls below a 
minimum value, corrective action would be triggered.
    The benefits from identifying corrective action procedures in 
advance of the need to actually take corrective action largely derive 
from having the procedures in written form. Written corrective action 
procedures would be essential to the facility's animal food safety 
team, to auditors, and to inspectors. The facility's animal food safety 
team will be responsible for ensuring that appropriate corrective 
actions are taken if preventive controls are not properly implemented. 
Having access to appropriate, written corrective action procedures 
determined in advance of the need for such action can ensure that 
correct and complete actions are taken in a timely fashion without the 
need for the team to meet and decide on the appropriate action. Having 
written corrective action procedures available for auditors and for 
inspectors is essential for them to assess the adequacy of the animal 
food safety plan; the procedures a facility will use to address 
implementation failures are essential to the production of safe food, 
and without them a complete assessment cannot be made. Written 
corrective action procedures also would be useful for training 
purposes, so that employees who would need to implement the corrective 
action procedures will be prepared for what they would need to do.
    Proposed Sec.  507.42(a) would implement section 418(e) of the FD&C 
Act (i.e., that the owner, operator, or agent in charge of a facility 
must establish corrective action procedures) and section 418(h) of the 
FD&C Act (i.e., that the owner, operator, or agent in charge of a 
facility must prepare a written plan).
    Proposed Sec.  507.42(a) would require that corrective action 
procedures describe the steps to be taken to ensure that:
     Appropriate action is taken to identify and correct a 
problem with implementation of a preventive control to reduce the 
likelihood that the problem will recur (proposed Sec.  507.42(a)(1));
     All affected animal food is evaluated for safety (proposed 
Sec.  507.42(a)(2)); and
     All affected animal food is prevented from entering into 
commerce, if the owner, operator or agent in charge of such facility 
cannot ensure that the affected food is not adulterated under section 
402 of the FD&C Act (proposed Sec.  507.42(a)(3)).
    The hazard analysis and risk-based preventive controls in this 
proposed rule are designed to identify hazards that are reasonably 
likely to occur, and to significantly minimize or prevent the 
occurrence of such hazards and provide assurances that such animal food 
is not adulterated under section 402 of the FD&C Act. However, a 
preventive controls system accounts for the possibility of 
implementation and effectiveness problems and includes procedures for 
addressing those problems and any affected food.
    Proposed Sec.  507.42(a) would implement section 418(e)(1) through 
(e)(3) of the FD&C Act. Section 418(e)(1) of the FD&C Act and is 
consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and 
Federal HACCP regulations for seafood, juice, and meat and poultry. 
Section 418(e)(1) and proposed Sec.  507.42(a)(1) explicitly require 
that action be taken to reduce the likelihood of recurrence of the 
implementation failure. Although not prescribed by proposed Sec.  
507.42(a)(1), reducing the likelihood of recurrence of an 
implementation failure is best accomplished by identifying the root 
cause of failure and then taking action to address that root cause. If 
the root cause is not identified and corrected, it is more likely that 
the failure will recur. For example, if the temperature of a heat 
process cannot be maintained, a corrective action to raise the 
temperature using the controller may correct the problem short-term. 
However, if the root cause is a lack of boiler capacity to run multiple 
heating units at the same time, corrective action should address 
replacing the boiler to increase capacity.
    Proposed Sec.  507.42(a)(2) and (a)(3), would require that 
corrective action procedures include an evaluation of all food affected 
by a problem and procedures for ensuring that affected food is 
prevented from entering into commerce if the owner, operator or agent 
in charge of the facility cannot ensure that the affected food is not 
adulterated under section 402 of the FD&C Act. Such an evaluation is 
implicit in the Agency's HACCP regulations for seafood and juice 
(Sec. Sec.  123.7(b) and 120.10(a)) in that these sections do not 
explicitly require that food affected by the problem be evaluated, but 
do require that steps be taken to ensure that product that is injurious 
to health or otherwise adulterated does not enter commerce. Although 
the Agency's HACCP regulations for seafood and juice do not specify the 
steps that must be described in a corrective action plan, the 
regulations require that specific steps be taken when a deviation from 
a critical limit occurs and the processor does not have a corrective 
action plan that is appropriate for that deviation (Sec. Sec.  123.7(c) 
and 120.10(b), respectively). Under the seafood and juice HACCP 
regulations, required steps include segregating and holding affected 
product, performing or obtaining a review to determine the 
acceptability of the affected product for distribution and taking 
corrective action, when necessary, to ensure that no product enters 
commerce that is either injurious to health or is otherwise adulterated 
as a result of the deviation.
3. Proposed Sec.  507.42(b)--Corrective Action in the Event of an 
Unanticipated Problem
    Proposed Sec.  507.42(b)(1) through (b)(3) would require that if a 
preventive control is not properly implemented and a specific 
corrective action has not been established, or a preventive control is 
found to be ineffective, the owner, operator, or agent in charge of a 
facility take corrective action to identify and correct the problem, 
evaluate all affected food for safety, and, as necessary, prevent 
affected food from entering commerce as would be done following the 
corrective action procedure under proposed Sec.  507.42(a)(3). However, 
a facility might not anticipate all of the problems that may occur, and 
a facility may

[[Page 64793]]

experience an implementation failure for which a corrective action 
procedure has not been established. Regardless of whether a problem was 
anticipated and a corrective action procedure was developed in advance, 
corrective actions to accomplish the steps that would have been 
included in a corrective action procedure are necessary. Likewise, a 
facility might determine (e.g., as a verification activity in 
accordance with proposed Sec.  507.45(c), discussed in section X.G of 
this document), that a preventive control is ineffective. For example, 
detecting a pathogen in pet food may signal that preventive controls 
for that pathogen are ineffective. As in the case of an unanticipated 
implementation failure of a preventive control, corrective actions 
would be necessary if a preventive control is found to be ineffective.
    Proposed Sec.  507.42(b)(4) would require that the owner, operator, 
or agent in charge of a facility reanalyze the food safety plan in 
accordance with proposed Sec.  507.45(e) to determine whether 
modification of the food safety plan is required if a preventive 
control is not properly implemented and a specific corrective action 
has not been established, or if a preventive control is found to be 
ineffective. (The Agency uses the term ``reanalyze'' when it refers to 
a reassessment of the validity of a preventive control or the food 
safety plan to control a hazard.) Under proposed Sec.  507.45(a), the 
verification required by section 418(f) of the FD&C Act would include 
validation of the food safety plan, referring to whether it is 
effectively controlling the hazards or ``working correctly.'' See 
section X.G of this document for a discussion of proposed requirements 
for verification (including validation and reanalysis) under section 
418(f) of the FD&C Act. Proposed Sec.  507.42(b)(4) would apply to 
unanticipated food safety problems, and the unanticipated nature of the 
problems is relevant to the reanalysis of the food safety plan. If the 
owner, operator, or agent in charge of a facility has assessed its 
procedures, practices, and processed and has not identified a specific 
failure as a foreseeable occurrence, the owner, operator, or agent in 
charge must assess whether the problem is simply an implementation 
failure that could be expected to occur in the normal course of 
manufacturing, processing, packing or holding the food, or the result 
of a system-wide problem that is not being properly addressed by the 
plan (e.g., ineffective preventive controls.) If the problem is simply 
an implementation failure, and such a failure is now a foreseeable 
circumstance, reanalysis of the food safety plan would be necessary to 
determine whether a corrective action procedure should be established 
for that foreseeable failure. Likewise, if the problem is the result of 
a system-wide problem that is not being properly addressed by the plan 
(or is otherwise a result of ineffective preventive controls), 
reanalysis of the food safety plan would be necessary to identify 
effective preventive controls. Either way, reanalyzing the food safety 
plan and modifying it as necessary would be necessary to reduce the 
risk of recurrence of the problem. Proposed Sec.  507.42(b)(4) is 
consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and 
Federal HACCP regulations for seafood, juice, and meat and poultry.
4. Proposed Sec.  507.42(c)--Documentation
    Proposed Sec.  507.42(c) would require that all corrective actions 
taken in accordance with this section be documented in records that are 
subject to verification in accordance with Sec.  507.45(b)(2) and 
records review in accordance with Sec.  507.45(c)(1)(i) and (c)(2). The 
records that document corrective actions would be used to verify that 
appropriate decisions about corrective actions are being made and 
appropriate corrective actions are being taken.

G. Proposed Sec.  507.45--Verification

1. Requirements of Section 418 of the FD&C Act
    Section 418(f) of the FD&C Act requires that the owner, operator, 
or agent in charge of a facility verify that:
     The preventive controls implemented under section 418(c) 
of the FD&C Act are adequate to control the hazards identified under 
section 418(b) of the FD&C Act (section 418(f)(1) of the FD&C Act);
     The owner, operator, or agent is conducting monitoring in 
accordance with section 418(d) of the FD&C Act (section 418(f)(2) of 
the FD&C Act);
     The owner, operator, or agent is making appropriate 
decisions about corrective actions taken under section 418(e) of the 
FD&C Act (section 418(f)(3) of the FD&C Act);
     The preventive controls implemented under section 418(c) 
of the FD&C Act are effectively and significantly minimizing or 
preventing the occurrence of identified hazards, including through the 
use of environmental and product testing programs and other appropriate 
means (section 418(f)(4) of the FD&C Act); and
     There is documented, periodic reanalysis of the plan under 
section 418(i) of the FD&C Act to ensure that the plan is still 
relevant to the raw materials, conditions and processes in the 
facility, and new and emerging threats (section 418(f)(5) of the FD&C 
Act).
    In addition, section 418(g) of the FD&C Act specifies, in relevant 
part, that the owner, operator, or agent in charge of a facility shall 
maintain, for not less than 2 years, records documenting the monitoring 
of the preventive controls implemented under section 418(c) of the FD&C 
Act, instances of nonconformance material to food safety, the results 
of testing and other appropriate means of verification under section 
418(f)(4) of the FD&C Act, instances when corrective actions were 
implemented, and the efficacy of preventive controls and corrective 
actions.
    Further, section 418(i) of the FD&C Act specifies that the owner, 
operator, or agent in charge of a facility shall conduct a reanalysis 
under section 418(b) of the FD&C Act (the requirement to identify and 
evaluate known or reasonably foreseeable hazards) whenever a 
significant change is made in the activities conducted at a facility 
operated by such owner, operator, or agent if the change creates a 
reasonable potential for a new hazard or a significant increase in a 
previously identified hazard or not less frequently than once every 3 
years, whichever is earlier. Such reanalysis shall be completed and 
additional preventive controls needed to address the hazard identified, 
if any, shall be implemented before the change in activities at the 
facility is operative. The owner, operator, or agent shall revise the 
written plan required under section 418(h) of the FD&C Act if such a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. The 
Secretary may require a reanalysis under section 418(i) of the FD&C Act 
to respond to new hazards and developments in scientific understanding, 
including, as appropriate, results from the Department of Homeland 
Security biological, chemical, radiological, or other terrorism risk 
assessment.
2. Proposed Requirements for Validation
    a. Proposed Sec.  507.45(a)--Validation that preventive controls 
are adequate to control the hazard. Proposed Sec.  507.45(a) would 
require that, except as provided by paragraph (a)(3), the owner, 
operator, or agent in charge of a facility validate that the preventive 
controls identified

[[Page 64794]]

and implemented in accordance with Sec.  507.36 to control the hazards 
identified in the hazard analysis as reasonably likely to occur are 
adequate to do so. Proposed Sec.  507.45(a) would implement section 
418(f)(1) of the FD&C Act. A discussion on validation and how it is 
used in HACCP systems can be found in the proposed rule for preventive 
controls for human food (78 FR 3646).
    b. Proposed Sec.  507.45(a)(1)--Validation by a qualified 
individual prior to implementation and on reanalysis. Proposed Sec.  
507.45(a)(1) would require that the validation of the preventive 
controls be performed (or overseen) by a qualified individual. The 
preventive controls must be adequate to control the hazards identified 
in the hazard analysis as reasonably likely to occur. Determining 
whether specific preventive controls are adequate requires an 
individual who is knowledgeable in the hazards associated with a 
product and process and the appropriate preventive controls for those 
hazards. Such knowledge requires scientific and technical expertise 
developed through training, experience or both.
    Proposed Sec.  507.45(a)(1)(i) would require that validation occur 
prior to implementation of the food safety plan or, when necessary, 
during the first six weeks of production. The validation of preventive 
controls includes collecting and evaluating scientific and technical 
information (or, when such information is not available or is 
insufficient, conducting studies), as discussed in the next section of 
this document. The collected data or information, or the studies, would 
establish a scientific and technical basis for the preventive controls 
used, in particular those that involve critical control points. This 
scientific and technical basis largely must be established prior to 
producing a product to ensure that the animal food produced using those 
preventive controls will be safe. However, as a practical matter, the 
scientific and technical basis for some aspects of a preventive control 
may require production conditions and, thus, would be established by 
the collection of data or information during, rather than before, 
producing a product. For example, ensuring that limits for control 
parameters can be met during production would be done under production 
conditions. FDA tentatively concludes that preventive controls that 
require the collection of data or information, or studies, during 
production conditions are part of validation, and, thus proposed Sec.  
507.45(a)(1)(i) would require that the validation of preventive 
controls be performed, when necessary, during the first 6 weeks of 
production. The Agency selected six weeks as a time interval that would 
be adequate to allow facilities to methodically collect data and 
information during production, yet would be close to implementation of 
a preventive control.
    FDA requests comment on whether the proposed timeframe for 
validation should be shorter or longer. Comments should provide the 
basis for an alternative timeframe.
    Proposed Sec.  507.45(a)(1)(ii) would require that the validation 
of the preventive controls be performed whenever a reanalysis of the 
food safety plan reveals the need to do so. The circumstances under 
which a reanalysis would be required are addressed in proposed Sec.  
507.45(e)(1). Proposed Sec.  507.45(e)(2) would require that the owner, 
operator, or agent in charge of a facility complete such reanalysis and 
implement any additional preventive controls needed to address the 
hazard identified, if any, before the change in activities at the 
facility is operative, or, when necessary, during the first 6 weeks of 
production. All preventive controls established to address a hazard 
identified as reasonably likely to occur must have a scientific and 
technical basis; establishing that scientific and technical basis is a 
validation activity regardless of whether the preventive control is 
established in the facility's initial food safety plan or as a result 
of reanalysis of the food safety plan.
    c. Proposed Sec.  507.45(a)(2)--Validation based on scientific and 
technical information. Proposed Sec.  507.45(a)(2) would require that, 
except as provided by paragraph (a)(3) of this section, the validation 
of preventive controls include collecting and evaluating scientific and 
technical information or, when such information is not available or is 
insufficient, conducting studies to determine whether the preventive 
controls, when properly implemented, will effectively control the 
hazards that are reasonably likely to occur.
    The scientific and technical information that would be evaluated to 
determine whether preventive controls effectively control the hazards 
that are reasonably likely to occur may include scientific 
publications, government documents, predictive mathematical models and 
other risk-based models, and technical information from equipment 
manufacturers, trade associations, and other sources. If the qualified 
individual conducting the validation relies on sources such as 
scientific publications, the qualified individual would need to ensure 
during validation that the conditions used by the facility are 
consistent with those described in the publication that is being used 
to support the adequacy of the preventive control measure to control 
the hazard. For example, if a study demonstrates adequate inactivation 
of Salmonella spp. during the manufacturing of dry dog and cat food, 
conditions such as ingredient matrix, temperature, and heating time, 
that were critical to achieving inactivation in the study must be the 
same when the facility manufactures the dry dog and cat food (or any 
change in the critical parameters must be such that the same or greater 
lethality is achieved). Documents published by FDA, such as the Food 
Code (Ref. 76), the Pasteurized Milk Ordinance (Ref. 77), and the Fish 
and Fisheries Products Hazards and Controls Guidance (Ref. 78) may 
provide scientific and technical information useful in establishing the 
validity of a preventive control measure, such as times and 
temperatures for heating animal food in which bacterial pathogens may 
be eliminated, or minimum water activities (aw), minimum pH 
values, and minimum temperatures for the elimination of a variety of 
pathogens.
    Predictive mathematical models that describe the growth, survival, 
or inactivation of microorganisms in foods may provide scientific and 
technical information useful in determining whether a process would be 
adequate to reduce microorganisms of public health concern (Refs. 79 
and 80). Other risk-based models may examine the impact of a control 
measure on a hazard and may be useful if appropriately validated for a 
specific animal food. If the model is for a different food, it may 
still provide useful validation information that could be supplemented 
by additional data. For example, there are many mathematical models for 
thermal resistance of Salmonella spp. If a model for the thermal 
resistance of Salmonella spp. is developed for the same type of food as 
the animal food being produced, and the animal food being produced has 
the same critical parameters such as pH and aw that were 
used in developing the thermal resistance model, then heat processes 
based on the model would generally be considered validated. If the 
model is for thermal resistance of Salmonella spp. in a type of animal 
food that is only similar to the animal food being produced, or has 
different critical parameters than were used in developing the thermal 
resistance model, it would be necessary to conduct additional thermal 
resistance studies in

[[Page 64795]]

the animal food being produced to provide the data needed to show that 
a heat process adequately reduces Salmonella spp. in that animal food 
and to establish the critical parameters for the process. For example, 
a model for thermal resistance of Salmonella spp. on meat and bone meal 
may not apply to poultry meal, even though the foods are similar in 
that both are animal by-products. The extent of such studies would, 
however, be less than the extent of such studies if there were no data 
on the heat resistance of Salmonella spp. in a similar animal food. For 
example, if the thermal resistance of Salmonella spp. in initial 
studies with canola meal is similar to that for soybean meal then a 
thermal resistance study used to develop data for canola meal could 
investigate fewer times and temperatures, or use fewer replicates, than 
would be the case in the absence of the information about the thermal 
resistance of Salmonella spp. in soybean meal.
    A process validation study would establish the relationship between 
parameters such as process times and temperatures and other factors and 
the rate at which pathogens are reduced, and a prevalence study would 
determine the levels at which pathogens may occur in the raw material, 
ingredient, or animal food product to establish the cumulative amount 
of pathogen reduction that would be required to adequately reduce the 
risk of illness from that pathogen. Such studies are typically 
published or otherwise broadly disseminated within the scientific 
community and, when properly designed and carried out, are generally 
regarded by experts as scientifically definitive with respect to the 
matters addressed by the study. However, if scientific and technical 
information is not available or is insufficient to support the adequacy 
of a preventive control measure to control the hazard, the owner, 
operator or agent in charge of a facility would need to conduct 
controlled scientific studies to establish that a preventive control 
measure is adequate to control the hazard.
    Information is available in the literature that can assist in the 
design of studies to support the adequacy of preventive control 
measures. For example, NACMCF has published information on ``Parameters 
for Determining Inoculated Pack/Challenge Study Protocols'' (Ref. 80). 
Studies to validate preventive control measures must be conducted by 
persons with experience and expertise relevant to the product, process 
and hazard to be controlled. Under proposed Sec.  507.45(a)(1), any 
studies needed to provide the scientific and technical information to 
establish the validity of the plan would either be conducted by a 
qualified individual (as would be defined in proposed Sec.  507.3) or 
would be overseen by a qualified individual. In other words, the 
qualified individual need not have the experience and expertise to 
conduct validation studies, but must have sufficient expertise in risk-
based preventive controls to understand the studies and how they 
support the validity of the preventive controls with respect to the 
hazard of concern.
    d. Proposed Sec.  507.45(a)(3)--Preventive controls for which 
validation is not required. Proposed Sec.  507.45(a)(3)(i) and (ii) 
would provide that validation need not address:
     The sanitation controls that would be established in 
proposed Sec.  507.36(d)(2); and
     The recall plan that would be established in proposed 
Sec.  507.38.
    According to NACMCF, verification involves activities to determine 
the validity of the HACCP plan and that the system is operating 
according to the plan (Ref. 29). Thus, validation is a verification 
activity. The purpose of validation is to provide the scientific and 
technical basis for ensuring that the preventive controls implemented 
are adequate to control the hazards identified as reasonably likely to 
occur. FDA tentatively concludes that validation, i.e., the evaluation 
of scientific and technical information, is either not an essential 
activity, is not practical or is not relevant, for the controls 
identified in proposed Sec.  507.45(a)(3).
    As discussed in section X.C.6, proposed Sec.  507.36(d)(2)(i)(A) 
would require that, where relevant to hazards that are reasonably 
likely to occur, sanitation controls include procedures for the 
cleanliness of animal food-contact surfaces, including food-contact 
surfaces of utensils and equipment. Traditionally, sanitarians employed 
by the facility, or experts employed by companies that supply cleaning 
and sanitizing compounds, will establish critical parameters and 
associated limits for cleaning and sanitation, including the choice and 
strength of the cleaning and sanitizing chemicals, contact time, and 
temperature requirements, based on studies conducted by the 
manufacturers of the products. Antimicrobial solutions applied to 
animal food processing equipment and utensils to sanitize such objects 
after they have been washed are included in the definition of 
``pesticide chemical'' and therefore, are subject to regulation by EPA 
under section 408 of the FD&C Act. Chapter 4 (Additional Considerations 
for Antimicrobial Products) of EPA's ``Pesticide Registration Manual'' 
(Refs. 81 and 82) outlines EPA's requirements and recommendations for 
registration of antimicrobial substances, including testing against a 
validated protocol to be granted EPA-registered claims for pathogen 
reduction. Thus, FDA tentatively concludes that this proposed rule 
should not propose to require validation of the adequacy of the 
sanitation controls that would be required by proposed Sec.  
507.36(d)(2)(i)(A). Monitoring activities to ensure the procedures are 
followed will provide assurance that the controls are functioning as 
intended to prevent hazards from insanitary animal food-contact 
surfaces. The Agency requests comment on this approach.
    As discussed in section X.C.6, proposed Sec.  507.36(d)(2)(i)(B) 
would require that, where relevant to hazards that are reasonably 
likely to occur, sanitation controls include procedures for the 
prevention of cross-contamination from insanitary objects and from 
employees to animal food, animal food packaging material, and other 
animal food-contact surfaces and from raw product to processed product. 
As already discussed with respect to proposed Sec.  507.36(d)(2)(i)(A), 
sanitation controls to prevent cross-contamination can be established 
by companies that supply cleaning and sanitizing compounds without the 
need for validation.
    As discussed in section X.D.7, a recall plan can significantly 
minimize or prevent hazards by limiting consumption of affected animal 
food during a recall. Following an existing plan that addresses all 
necessary elements of a recall helps minimize delay created by 
uncertainty as to the appropriate actions to take and helps ensure 
critical actions are not overlooked. The proposed requirement to 
validate a preventive control by collecting and evaluating scientific 
and technical information or by conducting studies simply does not 
apply to such a plan. Thus, FDA tentatively concludes that this 
proposed rule should not propose to require validation of the recall 
plan that would be required by proposed Sec.  507.38.
3. Proposed Sec.  507.45(b)(1)--Verification of Monitoring
    Proposed Sec.  507.45(b)(1) would require that the owner, operator, 
or agent in charge of a facility verify that monitoring is being 
conducted, as would be required by proposed Sec.  507.39. One example 
of verification

[[Page 64796]]

that monitoring is being conducted is a periodic observation of the 
monitoring activity, e.g., by a supervisor. Another example of such a 
verification activity is an independent test made by a person other 
than the person doing the monitoring. For example, if the line operator 
is verifying the operation of a metal detector by running test pieces 
through the metal detector every 2 hours to verify it rejects them, a 
quality assurance technician could periodically run a similar test, 
e.g., once per shift. Proposed Sec.  507.45(b)(1) does not address the 
review of monitoring records, which would be required under proposed 
Sec.  507.45(c)(1)(i) (see the discussion later in this section of the 
document). Proposed Sec.  507.45(b)(1) would implement section 
418(f)(2) of the FD&C Act.
    Proposed Sec.  507.45(b)(1) would not specify the verification 
activities that must be conducted for monitoring. The Agency requests 
comment on whether proposed Sec.  507.45(b)(1) should do so, and if so, 
what verification activities should be required.
4. Proposed Sec.  507.45(b)(2)--Verification of Corrective Actions
    Proposed Sec.  507.45(b)(2) would require that the owner, operator, 
or agent in charge of a facility verify that appropriate decisions 
about corrective actions are being made, as would be required by 
proposed Sec.  507.42 and by proposed Sec.  507.36(d)(2)(ii). An 
example of verification that appropriate decisions about corrective 
actions are being made is observation of the corrective actions being 
taken, e.g., by a supervisor. Proposed Sec.  507.45(b)(2) would 
implement section 418(f)(3) of the FD&C Act.
    Proposed Sec.  507.45(b)(2) would not specify the verification 
activities that must be conducted for corrective actions. The Agency 
requests comment on whether proposed Sec.  507.45(b)(2) should do so, 
and if so, what verification activities should be required.
5. Proposed Sec.  507.45(b)(3)--Implementation and Effectiveness
    Proposed Sec.  507.45(b)(3) would require that the owner, operator, 
or agent in charge of a facility verify the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the hazards that are reasonably likely to 
occur, including the requirements in proposed Sec.  507.45(b)(3) and 
Sec.  507.45(c), as appropriate to the facility and the animal food. 
Proposed Sec.  507.45(b)(3) and (c) would implement section 418(f)(4) 
of the FD&C Act, which requires in relevant part verification by 
``appropriate means'' that the preventive controls ``are effectively 
and significantly minimizing or preventing the occurrence of identified 
hazards.''
    a. Proposed Sec.  507.45(b)(4)--Calibration. Proposed Sec.  
507.45(b)(4) would require calibration of process monitoring 
instruments and verification instruments. The combination of monitoring 
(proposed Sec.  507.39(a)), recordkeeping (proposed Sec.  507.55), and 
verification (proposed Sec.  507.45(a), (b)(4), and (c)) would 
establish a system that would provide assurance that hazards identified 
in the hazard analysis conducted under section 418(b)(1) of the FD&C 
Act would be significantly minimized or prevented and that animal food 
manufactured, processed, packed, or held by such facility would not be 
adulterated under section 402 of the FD&C Act. In many instances, 
monitoring and verification activities rely on instruments (such as a 
weigh scale or a thermometer) that must be calibrated. Calibration 
provides assurance that an instrument is measuring accurately. If these 
instruments are not properly calibrated, the values they provide may 
not provide the necessary assurance that hazards will be significantly 
minimized or prevented. If an instrument is calibrated against a known 
reference, the reference standard may also need periodic calibration 
(e.g., the standard reference thermometer used to calibrate a 
thermometer used in processing equipment will itself also need to be 
calibrated periodically).
    Instrument calibration is performed on a regular or periodic basis 
based upon the type of instrument being used and its sensitivity to 
factors such as the operating environment and the wear and tear of 
ongoing use. The type of instruments used in a particular facility and 
the manner of their use will largely determine the need for, and the 
frequency of, calibration, and the frequency of calibration is often 
prescribed by the instrument manufacturer. Therefore, proposed Sec.  
507.45(b)(4) would not specify a frequency for calibration.
    b. Proposed Sec.  507.45(c)--Records review. Proposed Sec.  
507.45(c) would require a review of specific records related to 
monitoring, corrective actions, and other verification activities 
within specified timeframes, by (or under the oversight of) a qualified 
individual, to ensure that the records are complete, the activities 
reflected in the records occurred in accordance with the food safety 
plan, the preventive controls are effective, and appropriate decisions 
were made about corrective actions. Proposed Sec.  507.45(c)(1)(i) 
would require review of the monitoring and corrective action records 
within a week after the records are made. Proposed Sec.  
507.45(c)(1)(ii) would require review of the records related to 
calibration of instruments within a reasonable time after the records 
are made. (As discussed in section X.J, proposed Sec.  507.55 would 
list the records that facilities must establish and maintain, including 
records that document the monitoring of preventive controls as required 
by Sec.  507.39(c), corrective actions as required by Sec.  507.42(d), 
and verification activities as required by Sec.  507.45(f)). Proposed 
Sec.  507.45(c) would implement section 418(f) of the FD&C Act and is 
consistent with the NACMCF HACCP guidelines, the Codex HACCP 
guidelines, and Federal HACCP regulations for seafood, juice, and meat 
and poultry.
    Proposed Sec.  507.45(c) would establish that the purpose of the 
review of records would be to ensure that the records are complete, the 
activities reflected in the records occurred in accordance with the 
food safety plan, the preventive controls are effective, and 
appropriate decision were made about corrective actions. The Agency 
tentatively concludes that review of the records required by proposed 
Sec.  507.45(c)(1)(i) and (ii) would accomplish these purposes. 
Reviewing monitoring records can reveal whether they contain 
information on all the parameters that were to be monitored to 
determine whether a process is delivered in accordance with the food 
safety plan. For example, if the size of the animal food to be baked 
and the temperature and the time of baking are critical to the safety 
of the animal food, review of the monitoring records would demonstrate 
whether all three parameters were monitored and whether the values were 
within specified parameter values. Reviewing monitoring records can 
reveal whether a process followed the procedures specified in the 
facility's food safety plan (e.g., if the monitoring records show the 
temperature of every other batch of a baked animal food when the plan 
specified the measurement of every batch). Review of monitoring records 
also can reveal whether any information is missing, e.g., a designated 
lot number, so that the missing information can be quickly identified 
and added to the record if necessary. The Agency seeks comment on this 
proposal.
    If the review of the records reveals that the records do not 
contain all information specified by the food safety plan, or that the 
procedure in the food safety plan was not followed, the facility will 
not be able to conclude that its

[[Page 64797]]

preventive controls were implemented in accordance with its food safety 
plan for those activities. Because the food safety plan establishes the 
procedures needed to ensure preventive controls are effective, if the 
records review indicates that the plan is not being followed, e.g., the 
records are missing critical information or the activities were not 
performed as specified in the plan, the facility will not be able to 
conclude its preventive controls were effective. For example, if the 
records show that animal food particle size is not being determined or 
that the particles are too large, the minimum temperature of all parts 
of the particle may not occur to ensure control of pathogens such as 
Salmonella spp. If the plan requires determination of the baking 
temperature and time of each batch of product but the records do not 
show that the temperature was measured on all batches, the facility 
cannot be sure that the internal temperature of those batches is 
correct, again posing a potential risk from Salmonella spp. As a 
result, the facility would not be able to verify that its preventive 
controls are effectively and significantly minimizing or preventing the 
occurrence of identified hazards as required by section 418(f) of the 
FD&C Act.
    Review of records can also reveal whether appropriate decisions 
were made about corrective actions. The review should determine whether 
all the corrective action procedures required by proposed Sec.  
507.42(a) have been followed, e.g., that actions are taken to prevent 
recurrence of the problem, that affected animal food has been evaluated 
for safety, and that affected animal food is prevented from entering 
commerce unless it can be determined that the animal food is not 
adulterated under section 402 of the FD&C Act. For example, a food 
safety plan may require that each package of product pass through a 
properly functioning metal detector and that the operator determine 
every two hours whether metal test pieces of a specified type and size 
are rejected when passed through the metal detector. If one of the test 
pieces was not rejected but production continued until a supervisor 
doing a verification check noted the problem, then corrective actions 
should have been taken and a corrective action record produced. A 
review of the corrective action records should reveal that all packages 
of product that passed through the metal detector since the last test 
showing the metal detector was functioning appropriately were held and 
passed through a functioning metal detector before being released into 
commerce. The records should also show that the metal detector was 
adjusted to reject the metal test pieces before it was used again to 
check product during production.
    Proposed Sec.  507.45(c) would require that the review of records 
be performed by (or under the oversight of) a qualified individual (see 
the discussion in section X.I regarding the activities that must be 
performed (or overseen) by a qualified individual as would be 
established in proposed Sec.  507.50). The review of records is 
critical to assessing the facility's application of the preventive 
controls system and, thus, is fundamental to ensuring its successful 
operation.
    Proposed Sec.  507.45(c)(1)(i) would require review of the 
monitoring and corrective action records within a week after the 
records are made. Although proposed Sec.  507.45(c)(1)(i) would 
establish a more frequent review of these records than recommended in 
the NACMCF guidelines (which recommend monthly verification of 
monitoring records and corrective action records), it is consistent 
with the Agency's HACCP regulations for seafood (Sec.  123.8(a)(3)(i) 
and (ii)) and juice (Sec.  120.11(a)(1)(iv)(A) and (B)), which require 
that the review of monitoring records and corrective action records 
occur within one week of the day that the records are made. Even for 
shelf-stable foods (e.g., low-acid canned foods and acidified foods) 
the Agency's experience has demonstrated that review of these kinds of 
records is a critical verification tool (60 FR 65096 at 65133, December 
18, 1995). As discussed in the seafood HACCP final rule (60 FR 65096 at 
65132), review of records needs to occur with sufficient frequency so 
as to ensure that any problems in the design and implementation of the 
HACCP plan are uncovered promptly and to facilitate prompt 
modifications. The concept is roughly that of a ``feedback loop,'' with 
information coming out of the record review process in such a timely 
manner that it can have impact on the production of subsequent lots of 
the product. If a problem with product is discovered during a review of 
records, all product since the last review could be affected. Although 
verification prior to shipment provides a valuable added assurance, FDA 
explained in the preamble to the seafood HACCP final rule (60 FR 65096 
at 65132) that with highly perishable products this is not always 
possible and that a weekly review of monitoring and corrective action 
records would provide for timely feedback of information and limit the 
amount of product impacted by any problems identified during the review 
of the records.
    Proposed Sec.  507.45(c)(1)(ii) would require review of the records 
related to calibration, within a reasonable time after the records are 
made. The review of calibration records will depend in part on the 
frequency with which calibrations occur, which will be established in 
the food safety plan. If calibrations occur daily, it would be 
reasonable to review these records weekly. Where several instruments 
are calibrated each month, a monthly review of all the calibrations 
would be reasonable. Consequently, FDA tentatively concludes that 
setting a specific frequency for review of these records is not 
warranted.
    As noted previously, proposed Sec.  507.45(c) would require a 
review of records in part to determine whether the preventive controls 
are effective. A review should determine whether monitoring and 
corrective actions have been done in accordance with the food safety 
plan and whether the instruments used in monitoring and verification 
were properly calibrated. If food safety activities appropriate to the 
facility have been conducted in accordance with the plan and this is 
reflected in the records, the facility thus verifies the preventive 
controls are effective, i.e., that its preventive controls are 
effectively and significantly minimizing or preventing the occurrence 
of identified hazards as required by Section 418(f) of the FD&C Act.
6. Proposed Sec.  507.45(d)--Written Procedures for Verification 
Activities
    Proposed Sec.  507.45(d) would require that the owner, operator, or 
agent in charge of a facility establish and implement written 
procedures for the frequency of calibrating process monitoring 
instruments and verification instruments. The Agency is proposing to 
require written procedures for the frequency of calibration because the 
frequency of calibration will vary depending on the instrument and the 
process or verification activity that it pertains to.
    The Agency is not proposing to require that written procedures be 
developed for all verification procedures. In some instances the 
records of verification activities provide the information needed to 
understand how the verification activity has been carried out and to 
assess whether the verification activity is adequately demonstrating 
that the preventive controls are effective in significantly minimizing 
or preventing the hazards reasonably likely to occur. For example, the 
Agency is not proposing to require

[[Page 64798]]

written procedures for validation, verification of monitoring and 
corrective actions, or calibration of process monitoring instruments 
and verification instruments (other than for the frequency of 
calibration). Validation involves a variety of procedures, including 
evaluation of scientific and technical information and conducting 
laboratory and in-plant studies that generally do not follow a 
standardized protocol or approach. Records of monitoring and corrective 
actions provide the information needed to understand how the 
verification activity was carried out. In many instances the 
calibration of process monitoring instruments and verification 
instruments will be done by contract with other entities and the 
facility would not have access to the procedures used; having 
instruments calibrated and documenting the calibration provides the 
necessary assurance that such instruments will be accurate. However, 
the frequency of calibration must be specified to ensure that the 
instruments are calibrated on a schedule appropriate to the instrument 
and the process it controls.
    Section 418(f) of the FD&C Act establishes certain requirements for 
verification, and section 418(h) of the FD&C Act requires that the 
procedures used by the facility to comply with the requirements of 
section 418 be included in the written plan. Requiring verification 
procedures to be written implements the requirements in section 418 of 
the FD&C Act and is consistent with the requirements in HACCP 
regulations for seafood, juice, and meat/poultry. For further 
discussion, see section XII.B.6 of the document for the proposed rule 
for preventive controls for human food (78 FR 3646).
7. Proposed Sec.  507.45(e)--Reanalysis
    a. Proposed Sec.  507.45(e)--Reanalysis on the initiative of the 
owner, operator, or agent in charge of a facility. Proposed Sec.  
507.45(e)(1) would require that the owner, operator, or agent in charge 
of a facility conduct a reanalysis of the food safety plan:
     At least once every 3 years (proposed Sec.  
507.45(e)(1)(i));
     Whenever a significant change is made in the activities 
conducted at a facility operated by such owner, operator, or agent in 
charge if the change creates a reasonable potential for a new hazard or 
creates a significant increase in a previously identified hazard 
(proposed Sec.  507.45(e)(1)(ii));
     Whenever the owner, operator or agent in charge becomes 
aware of new information about potential hazards associated with the 
animal food (proposed Sec.  507.45(e)(1)(iii));
     Whenever a preventive control is not properly implemented 
and a specific corrective action procedure has not been established 
(proposed Sec.  507.45(e)(1)(iv));
     Whenever a preventive control is found to be ineffective 
(proposed Sec.  507.45(e)(1)(v)); and
     Whenever FDA requires a reanalysis in response to newly 
identified hazards and developments in scientific understanding 
(proposed Sec.  507.45(e)(1)(vi).
    For example, if a facility that conducts baking operations for pet 
treats makes design changes to its oven to increase product throughput, 
the facility would be required to reanalyze its food safety plan 
because a design change to equipment that is used to control a hazard 
that is reasonably likely to occur would be a significant change in the 
activities conducted at the facility.
    The owner, operator or agent in charge of a facility may become 
aware of a problem due to the finding of a hazard in an animal food as 
the result of testing by a regulatory agency (Federal, State, tribal, 
or foreign government) that would require an analysis of the food 
safety plan to ensure the hazard is significantly minimized or 
prevented by appropriate preventive controls. In addition, new hazards 
can emerge, e.g., as identified through the investigation of outbreaks. 
For example in 2006-2007 there was an outbreak of salmonellosis due to 
contamination of peanut butter with Salmonella Tennessee (Ref. 83). 
This was the first outbreak of food borne illness caused by peanut 
butter consumption in the U.S. and it demonstrated the need for 
manufacturers to address the hazard of Salmonella spp. in this product 
and in products into which peanut butter is added, such as pet treats. 
Information about outbreaks and ensuing product recalls is widely 
disseminated, including on FDA's Web site, and modern communication 
tools make it possible for the owner, operator, or agent in charge of a 
facility to receive such information automatically. For additional 
discussion related to the proposed requirement that the owner, 
operator, or agent in charge of a facility conduct a reanalysis 
whenever such owner, operator or agent becomes aware of new information 
about potential hazards associated with the food, see the discussion in 
section X.G.7.b of proposed Sec.  507.45(e)(1)(vi), which would provide 
that FDA may require a reanalysis of the food safety plan to respond to 
new hazards and developments in scientific understanding.
    As noted in section X.F of this preamble, proposed Sec.  
507.42(b)(4) would require that the owner, operator, or agent in charge 
of a facility reanalyze the food safety plan in accordance with 
proposed Sec.  507.45(e) to determine whether modification of the food 
safety plan is required if a preventive control is not properly 
implemented or is found to be ineffective, and a specific corrective 
action has not been established. If the owner, operator, or agent in 
charge of a facility has not identified a specific failure as a 
foreseeable occurrence, the deviation may be the result of a system-
wide problem that is not being properly addressed by the food safety 
plan (e.g., ineffective preventive controls). Thus, an unforeseen 
failure for which a corrective action was not identified may indicate 
an ineffective preventive control, and a reanalysis of the food safety 
plan is warranted. Similarly, when information arises indicating that 
the preventive control has not been effective in significantly 
minimizing or preventing a hazard from occurring, a reanalysis must be 
conducted to determine if the food safety plan should be modified to 
ensure that the preventive controls implemented are adequate to 
significantly minimize or prevent a hazard identified as reasonably 
likely to occur.
    Proposed Sec.  507.45(e) would implement section 418(f)(5) and (i) 
of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the 
Codex HACCP guidelines, the Codex validation guidelines, and Federal 
HACCP regulations for seafood, juice, and meat and poultry. A 
discussion on ``reanalysis'' (or ``reassessment of the hazard 
analysis'' as it is called) in HACCP systems can be found in section 
XII.G.7 of the document for the proposed rule for preventive controls 
for human food (78 FR 3646).
    The requirement in proposed Sec.  507.45(e)(1) that the periodic 
reanalysis of the food safety plan occur at least once every 3 years is 
explicitly required by section 418(i) of the FD&C Act. The Agency 
tentatively concludes that, as a practical matter, the proposed 
requirement for reanalysis whenever a significant change is made in the 
activities conducted at a facility if the change creates a reasonable 
potential for a new hazard or a significant increase in a previously 
identified hazard makes it likely that reanalysis would occur more 
frequently than every 3 years because such changes are likely to occur 
more frequently than every 3 years.

[[Page 64799]]

    b. Proposed Sec.  507.45(e)(1)(vi)--Reanalysis on the initiative of 
FDA. Proposed Sec.  507.45(e)(1)(vi) establishes that FDA may require a 
reanalysis of the food safety plan to respond to new hazards and 
developments in scientific understanding. Proposed Sec.  
507.45(e)(1)(vi) would implement section 418(i) of the FD&C Act, which 
provides in relevant part that ``[t]he Secretary may require a 
reanalysis . . . to respond to new hazards and developments in 
scientific understanding . . . .'' As discussed in section X.G.7.a, new 
hazards can emerge, e.g., as identified through the investigation of 
outbreaks of foodborne illness by CDC or other public health agencies. 
In addition, new developments can occur in the scientific understanding 
of existing or potential hazards, e.g., if scientists and animal food 
safety regulatory agencies develop a better understanding of the causes 
of these events. For example, the outbreak from Salmonella Tennessee in 
peanut butter resulted in a greater understanding of the risks posed by 
environmental contamination and the importance of control of water in 
facilities producing low-moisture foods (Refs. 84 and 85. Information 
submitted to the RFR, which is a relatively recent addition to the 
regulatory framework for food safety, has the potential to identify new 
hazards or routes of contamination even before outbreaks occur.
    c. Proposed Sec.  507.45(e)(2)--Implementation of additional 
controls. Proposed Sec.  507.45(e)(2) would require that the owner, 
operator, or agent in charge of a facility complete the required 
reanalysis and implement any additional preventive controls needed to 
address the hazard identified, if any, before the change in activities 
at the facility is operative or, when necessary, during the first 6 
weeks of production. The purpose of the reanalysis is to identify the 
need for, and implement, preventive controls in light of a reasonable 
potential for a new hazard, or a significant increase in a previously 
identified hazard, that is reasonably likely to occur. It follows that 
the preventive controls must be in place before making the change that 
creates the potential for a new hazard or a significant increase in a 
previously identified hazard. As with initial validation in proposed 
Sec.  507.45(a)(1)(i), the Agency is proposing to provide the first 6 
weeks of production, when necessary, to implement any additional 
preventive controls to allow facilities to methodically collect data 
and information during production to ensure the needed change can be 
implemented in the facility. The Agency seeks comment on this 
timeframe. Proposed Sec.  507.45(e)(2) would implement section 418(i) 
of the FD&C Act.
    d. Proposed Sec.  507.45(e)(3)--Revision of the food safety plan. 
Proposed Sec.  507.45(e)(3) would require that the owner, operator, or 
agent in charge of a facility revise the written food safety plan if a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed. Proposed 
Sec.  507.45(e)(3) would implement section 418(i) of the FD&C Act, 
which requires that the written plan be revised ``if . . . a 
significant change is made or document the basis for the conclusion 
that no additional or revised preventive controls are needed.'' As 
discussed in section X.B of this document, the written hazard analysis 
is required even if the conclusion of the analysis is that there are no 
hazards reasonably likely to occur. It is also important to document 
that a reanalysis has been conducted even if no change has been made, 
as required by section 418(i) of the FD&C Act. Such documentation 
demonstrates that a facility has considered all relevant information on 
the safety of the products being produced, including new information 
that has become available since the last analysis, and determined that 
current procedures for implementing preventive controls are adequate to 
significantly minimize or prevent hazards that are reasonably likely to 
occur.
    e. Proposed Sec.  507.45(e)(4)--Requirement for a qualified 
individual. Proposed Sec.  507.45(e)(4) would require that the 
reanalysis be performed, or overseen, by a qualified individual. 
Proposed Sec.  507.45(e)(4) is consistent with proposed Sec.  507.30(b) 
which would require that the food safety plan be developed by a 
qualified individual. The Agency tentatively concludes that the same 
qualifications are needed whether initially conducting a hazard 
analysis and establishing a food safety plan, or reanalyzing a hazard 
analysis and plan.
8. Proposed Sec.  507.45(f)--Requirement for Records for Verification
    Proposed Sec.  507.45(f) would require that all verification 
activities taken in accordance with this section be documented in 
records and would implement section 418(g) of the FD&C Act.

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

1. Requirements of Section 418 of the FD&C Act
    Briefly, as relevant to proposed Sec.  507.48, specific provisions 
of section 418 of the FD&C Act require, in relevant part, that the 
owner, operator, or agent in charge of a facility:
     Identify and evaluate known or reasonably foreseeable 
hazards that may be associated with the facility and develop a written 
analysis of the hazards (section 418(b) of the FD&C Act);
     Identify and implement preventive controls to provide 
assurances that hazards identified in the hazard analysis will be 
significantly minimized or prevented and the food manufactured, 
processed, packed, or held by such facility will not be adulterated 
under section 402 of the FD&C Act (section 418(c) of the FD&C Act);
     Monitor the effectiveness of the preventive controls 
implemented under section 418 (c) of the FD&C Act to provide assurances 
that the outcomes described in section 418(c) shall be achieved 
(section 418(d) of the FD&C Act);
     Establish procedures to ensure that, if the preventive 
controls implemented under section 418(c) of the FD&C Act are not 
properly implemented or are found to be ineffective, appropriate action 
is taken to reduce the likelihood of recurrence of the implementation 
failure; all affected food is evaluated for safety; and all affected 
food is prevented from entering into commerce if the owner, operator or 
agent in charge of such facility cannot ensure that the affected food 
is not adulterated under section 402 of the FD&C Act (section 418(e) of 
the FD&C Act);
     Verify that the preventive controls are adequate to 
control the hazards the owner, operator, or agent is conducting 
monitoring and is making appropriate decisions about corrective actions 
and the preventive controls are effectively and significantly 
minimizing or preventing the occurrence of identified hazards and there 
is documented, periodic reanalysis of the plan under section 418(i) of 
the FD&C Act to ensure that the plan is still relevant to the raw 
materials, conditions and processes in the facility, and new and 
emerging threats (section 418(f) of the FD&C Act);
     Maintain, for not less than 2 years, records documenting 
the monitoring of the preventive controls instances of nonconformance 
material to food safety

[[Page 64800]]

and instances when corrective actions were implemented (section 418(g) 
of the FD&C Act);
     Prepare a written plan that documents and describes the 
procedures used by the facility to comply with the requirements of 
section 418 of the FD&C Act, including analyzing the hazards and 
identifying the preventive controls adopted to address those hazards 
section 418(h) of the FD&C Act);
     Conduct a reanalysis under section 418(b) of the FD&C Act 
whenever a significant change is made in the activities conducted at a 
facility operated by such owner, operator, or agent if the change 
creates a reasonable potential for a new hazard or a significant 
increase in a previously identified hazard or not less frequently than 
once every 3 years, whichever is earlier (section 418(i) of the FD&C 
Act).
    In addition to these requirements directed to the owner, operator, 
or agent in charge of a facility, section 418(m) of the FD&C Act 
provides, in relevant part, that the Secretary may, by regulation, 
exempt or modify the requirements for compliance under section 418 of 
the FD&C Act with respect to facilities that are solely engaged in the 
storage of packaged foods that are not exposed to the environment.
2. Approach to Modified Requirements Under Section 418(m) of the FD&C 
Act
    As discussed in section VIII.E of this document, proposed Sec.  
507.10 would both provide that proposed part 507 subpart C does not 
apply to a facility solely engaged in the storage of packaged animal 
food that is not exposed to the environment (proposed Sec.  507.10(a)) 
and establish that such a facility is subject to modified requirements 
in proposed Sec.  507.48 (proposed Sec.  507.10(b)). In the remainder 
of the discussion of these modified requirements, the Agency refers to 
``packaged food that is not exposed to the environment'' as ``unexposed 
packaged animal food,'' and to ``unexposed refrigerated packaged animal 
food that requires time/temperature control for safety'' as ``unexposed 
refrigerated packaged TCS animal food.'' As noted in section VIII.E, 
the Agency considers ``not exposed to the environment'' and 
``unexposed'' to mean that the animal food is in a form that prevents 
any direct human contact with the food. The modified requirements in 
proposed Sec.  507.48 would apply to unexposed refrigerated packaged 
TCS animal food. In essence, proposed Sec.  507.48 distinguishes 
between unexposed packaged animal food and unexposed refrigerated 
packaged TCS animal food. This distinction is based on hazards that are 
reasonably likely to occur during the storage of unexposed refrigerated 
packaged TCS animal food, but are not reasonably likely to occur during 
the storage of unexposed packaged animal food that does not require 
time/temperature control for safety.
    When an unexposed packaged animal food is a refrigerated TCS animal 
food, the principal hazard for the unexposed refrigerated packaged TCS 
animal food is the potential for the growth of, or toxin production by, 
microorganisms of animal or human health significance. Information 
about this hazard for TCS foods in general (i.e., not limited to 
unexposed packaged animal food) is widely available (Refs. 39, 40, and 
86). In brief, the need for time/temperature control is primarily 
determined by: (1) The potential for contamination with microorganisms 
of animal or human health significance and (2) the potential for 
subsequent growth and/or toxin production. Refrigeration has long been 
used to retard deterioration of the flavor, color, and texture of foods 
including animal food. More importantly, refrigeration helps maintain 
the microbiological safety of potentially hazardous foods (62 FR 8248; 
February 24, 1997).
    Failure to maintain animal food at appropriate temperatures may 
result in the growth of microorganisms that may have contaminated the 
food before, or at the time of, harvest or during processing, handling, 
or storage. The rate of growth of these microorganisms is reduced as 
the storage temperature is lowered. Proper refrigeration, therefore, 
prevents or slows the growth of animal and human pathogens and spoilage 
microorganisms and reduces the likelihood of foodborne illness (62 FR 
8248). A review of the factors that influence microbial growth and an 
analysis of microbial hazards related to time/temperature control of 
foods for safety can be found in a report (issued by the Institute of 
Food Technologists (IFT) under contract to FDA) on the Evaluation and 
Definition of Potentially Hazardous Foods (Ref. 86). The IFT report 
describes properties of common food commodities and the microbiological 
hazards that may occur from consuming particular food commodities, 
emphasizing microbial concerns that would be associated with 
temperature abuse of the products. The IFT report discusses foods for 
which time/temperature control may be necessary for safety (Ref. 86). 
Most types of animal food that are stored refrigerated have not been 
processed to eliminate pathogenic sporeformers, including Clostridium 
botulinum, and Bacillus spp. If refrigerated animal food is exposed to 
high enough temperatures for sufficient time, these sporeformers may 
begin to grow and produce toxins. Some strains of C. botulinum and 
Bacillus spp. can grow at refrigeration temperatures, e.g., some 
strains of B. cereus grow at 39 [deg]F (4 [deg]C) and some strains of 
C. botulinum grow at 38 [deg]F (3.3 [deg]C) (Ref. 87).
    Examples of refrigerated foods that are capable of supporting the 
growth of pathogenic sporeformers such as Bacillus, spp. and C. 
botulinum include many refrigerated food for dogs and cats. Producers 
of refrigerated animal food minimize the contamination of the food with 
pathogens to the extent possible, particularly if the pathogen can grow 
under refrigeration conditions. Growth of pathogens is very slow under 
refrigeration, and the lower the temperature the longer the time for 
growth (Ref. 86). Conversely, as refrigeration temperature increases, 
the growth rate of strains of pathogens that grow slowly under 
refrigeration increases and animal food temperatures may get high 
enough that pathogens that cannot grow at normal refrigeration 
temperatures (generally in the range of 41-45 [deg]F (5 [deg]C-7 
[deg]C)) begin to grow (Ref. 86). For example, the strains of C. 
botulinum that have caused most of the outbreaks in the United States 
do not grow and produce toxin until the temperature reaches 50 [deg]F 
(10 [deg]C) (Ref. 78). Additional information about the time/
temperature control of food to address the potential for microorganisms 
of animal or human health significance to grow or produce toxins is 
available in books on food microbiology that are available for 
purchase.
    Such information is sufficiently well-known and accepted that the 
Agency tentatively concludes that the outcome of each individual hazard 
analysis for an unexposed refrigerated packaged TCS animal food, 
conducted by the owner, operator, or agent in charge of each individual 
facility solely engaged in the storage of unexposed packaged animal 
food, would be the same. That outcome would be that the potential for 
the growth of, or toxin production by, microorganisms of animal or 
human health significance is a hazard reasonably likely to occur in any 
unexposed refrigerated packaged TCS animal food. Likewise, information 
about appropriate preventive controls for this hazard is widely 
available (Refs. 41 and 78). Such information is sufficiently well-
known and accepted that the Agency tentatively concludes that the 
appropriate preventive control

[[Page 64801]]

selected by each individual facility solely engaged in the storage of 
unexposed packaged animal food would be adequate controls on the 
temperature of any unexposed refrigerated packaged TCS animal food.
    In light of the general recognition of the hazard that is 
reasonably likely to occur in a refrigerated packaged TCS animal food 
and the appropriate preventive control for that hazard, the Agency 
tentatively concludes that it is appropriate to specify the hazard and 
appropriate preventive control in the regulation. Under this approach, 
it would not be necessary for each individual facility solely engaged 
in the storage of unexposed packaged animal food to conduct its own 
hazard analysis and reach its own conclusion about the hazard and the 
appropriateness of temperature control to significantly minimize or 
prevent the growth of, or toxin production by, microorganisms of animal 
or human health significance. Instead, what would remain for the 
facility to do to comply with section 418 of the FD&C Act for the 
activity of storing an unexposed refrigerated packaged TCS animal food 
would be a subset of the requirements for hazard analysis and risk-
based preventive controls that would be established in proposed subpart 
C to implement section 418 of the FD&C Act. None of these requirements 
would require a qualified individual. This subset of requirements would 
be to:
     Implement temperature controls (section 418(c) of the FD&C 
Act);
     Monitor temperature (section 418(d) of the FD&C Act);
     Take appropriate corrective actions when there is a 
problem with temperature control (section 418(e) of the FD&C Act);
     Conduct applicable verification activities (review of 
records) (section 418(f) of the FD&C Act); and
     Establish and maintain certain records (section 418(g) of 
the FD&C Act).
    The Agency seeks comment on the proposed list of modified 
requirements.
    The Agency also tentatively concludes that it would not be 
necessary for each individual facility solely engaged in the storage of 
unexposed packaged animal food to conduct the reanalysis specified in 
section 418(i) of the FD&C Act with respect to storing an unexposed 
refrigerated packaged TCS animal food. As discussed in section X.G of 
this document, reanalysis would apply in determining whether to apply 
any additional preventive controls and in determining whether to update 
the written plan. Under this approach, FDA would have identified the 
preventive control, and it would be FDA's responsibility, through 
rulemaking, to require any additional preventive control. Likewise, 
under FDA's approach, the facility would not be required to develop a 
food safety plan and, therefore, would not need to update the plan. If, 
for example, the facility changes its procedures for temperature 
control, the specific activities that the facility would be required to 
conduct (monitoring temperature; taking appropriate corrective actions 
if there is a problem with temperature control; conducting applicable 
verification activities; and establishing and maintaining appropriate 
records) would be adequate to address the change in procedure for 
temperature control.
3. 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
    Proposed Sec.  507.48(a) would 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. Briefly, those activities would encompass:
     Establishing and implementing temperature controls 
(proposed Sec.  507.48(a)(1));
     Monitoring the temperature controls (proposed Sec.  
507.48(a)(2));
     If there is a problem with the temperature controls for 
such refrigerated packaged animal food, taking appropriate corrective 
actions (proposed Sec.  507.48(a)(3));
     Verifying that temperature controls are consistently 
implemented (proposed Sec.  507.48(a)(4)); and
     Establishing and maintaining certain records (proposed 
Sec.  507.48(a)(5)).
    More specifically, proposed Sec.  507.48(a)(1) would require that 
the owner, operator, or agent in charge of a facility subject to 
proposed Sec.  507.48 establish and implement temperature controls 
adequate to significantly minimize or prevent the growth of, or toxin 
production by, microorganisms of animal or human health significance in 
an unexposed refrigerated packaged TCS animal food. There are two 
fundamental questions that the owner, operator, or agent in charge of a 
facility subject to proposed Sec.  507.48 would need to know the 
answers to in order to comply with proposed Sec.  507.48 for any given 
unexposed refrigerated packaged animal food:
     Is the animal food a TCS food?
     If the animal food is a TCS food, what is the appropriate 
temperature for storage of the food?
    The two primary ways in which the owner, operator, or agent in 
charge of a facility subject to proposed Sec.  507.48 can obtain the 
answers to these questions are through: (1) Information provided by the 
manufacturer, processor, or packer of the animal food, either in 
documents exchanged between the parties in the course of business or by 
label statements placed on the animal food by the manufacturer, 
processor, or packer of the food and (2) applicable scientific and 
technical support literature.
    As discussed in section VIII.E, a citizen petition submitted to FDA 
(Docket No. FDA-2011-P-0561) asserted that facilities work closely with 
the food manufacturers to understand the conditions and controls that 
need to be utilized to ensure the quality of the foods they store and 
distribute and, in many cases, those conditions and controls are 
formalized in written contracts. If the conditions for storage are not 
formalized in written contracts or by other means (e.g., through 
documents of the trade that travel with a food product when it moves 
within the supply chain), information relevant to safe storage of the 
food may be provided by the manufacturer, processor, or packer of the 
food on the food label. For example, in 1997 FDA published guidelines 
for labeling food that needs refrigeration by consumers due to the 
potential for the food to be rendered unsafe due to the growth of 
infectious or toxigenic microorganisms if ``temperature abused'' (62 FR 
8248). FDA recommended that foods requiring refrigeration by the 
consumer for safety be labeled ``IMPORTANT Must be Kept Refrigerated to 
Maintain Safety'' (62 FR 8248 at 8251) and that foods that are intended 
to be refrigerated but that do not pose a safety hazard if temperature 
abused be labeled more simply, e.g.; ``Keep refrigerated.'' Such 
labeling can provide facilities with the information to identify TCS 
animal food. The Agency tentatively concludes that similar food safety 
principles applied in human food storage would be relevant to animal 
food. Further, the Agency tentatively concludes that it would be rare 
for a facility solely engaged in the storage of unexposed packaged 
animal food to not have information regarding whether a refrigerated 
packaged food requires time/temperature control for

[[Page 64802]]

safety and, if so, what specific temperature controls are necessary for 
safe storage of the food. The Agency requests comment on this tentative 
conclusion.
    In a situation where the owner, operator or agent in charge of a 
facility does not have information from the manufacturer, processor, or 
packer of the food about whether an unexposed refrigerated packaged 
animal food requires time/temperature control for safety and, if so, 
what specific temperature controls are necessary for safe storage of 
the food, the owner, operator, or agent in charge of the facility could 
either consult the scientific and technical literature to determine 
whether a particular food is a TCS animal food or assume that any 
unexposed refrigerated packaged food is a TCS animal food. Information 
about food that is TCS animal food, and about the appropriate 
temperatures to address the potential for microorganisms of animal or 
human health significance to grow or produce toxin, in food are well-
established in the scientific literature. Documents prepared by or on 
behalf of FDA regarding appropriate time/temperature controls for 
safety (Refs. 86 and 87) provide numerous references to the primary 
scientific literature and serve as the basis for time/temperature 
controls for a variety of foods including animal food. The two 
temperatures commonly cited in these documents as maximum temperatures 
for safe storage of refrigerated food are 41 [deg]F (5 [deg]C) and 45 
[deg]F (7 [deg]C). The cited maximum temperature depends on the type of 
food; in some cases, a maximum storage temperature is established 
through rulemaking in a regulation. For example:
     FDA regulations for the prevention of Salmonella 
Enteritidis in shell eggs during production, storage, and 
transportation (Sec.  118.4(e) (21 CFR 118.4(e))) and for refrigeration 
of shell eggs held for retail distribution (21 CFR 115.50(b)(2)) 
require that eggs be held and transported at a temperature not to 
exceed 45 [deg]F (7 [deg]C).
     The PMO provides for pasteurized Grade ``A'' milk and milk 
products to be held at 45 [deg]F (7 [deg]C) (Ref. 77).
     The FDA Food Code, which has been widely adopted in state 
laws, recommends holding most potentially hazardous (TCS) food at 41 
[deg]F (7 [deg]C) or lower (Ref. 88).
    Storage of refrigerated food at or below one of these two 
temperatures (i.e., 41 [deg]F (5 [deg]C) or 45 [deg]F (7 [deg]C)) 
consistent with storage temperatures required by regulation or 
recommended in widely adopted documents such as the PMO and the FDA 
Food Code would satisfy proposed Sec.  507.48(a).
    The Agency considers frozen animal food to be a subset of 
refrigerated animal food. The temperature and time required for a 
frozen animal food to become unsafe would result in significant quality 
issues for such food. Although there have been occasional problems with 
frozen animal food being subject to temperatures that allow some 
thawing in storage and distribution, the Agency is not aware of 
situations in which frozen animal food has been associated with the 
food becoming unsafe. Thus, the Agency tentatively concludes that it 
would be rare for an unexposed frozen packaged animal food to be a TCS 
animal food.
    Proposed Sec.  507.48(a)(2) would require that the owner, operator, 
or agent in charge of a facility solely engaged in the storage of 
unexposed packaged animal food monitor the temperature controls 
established for unexposed refrigerated packaged TCS animal food with 
sufficient frequency to provide assurance that they are consistently 
performed. Monitoring can be done by use of a continuous temperature-
recording device (e.g., a recording thermometer) that indicates and 
records the temperature accurately within the refrigeration compartment 
with a visual check of the recorded data at least once per day. 
Monitoring as would be required by proposed Sec.  507.48(a)(2) would 
provide the owner, operator, or agent in charge of the facility with 
factual information with which to judge whether the temperature control 
is operating as intended. Proposed Sec.  507.48(a)(2) is modified 
relative to the analogous monitoring requirement that would be 
established in proposed Sec.  507.39(a) in subpart C in that proposed 
Sec.  507.48(a)(2) would not require written procedures for monitoring. 
The records of monitoring (which would be required by proposed Sec.  
507.48(a)(5)(i)) would demonstrate the frequency of monitoring. The 
Agency requests comment on whether there would be a benefit to 
requiring a facility to develop written procedures for monitoring 
temperature.
    Proposed Sec.  507.48(a)(3) would require that, if there is a 
problem with the temperature controls for unexposed refrigerated 
packaged TCS animal food, the owner, operator, or agent in charge of a 
facility solely engaged in the storage of unexposed packaged animal 
food take appropriate corrective actions to correct a problem with the 
control of temperature for any refrigerated packaged animal food and 
reduce the likelihood that the problem will recur (proposed Sec.  
507.48(a)(3)(i)); evaluate all affected animal food for safety 
(proposed Sec.  507.48(a)(3)(ii)); and prevent the animal food from 
entering commerce, if the owner, operator, or agent in charge of a 
facility cannot ensure the affected animal food is not adulterated 
under section 402 of the FD&C Act (proposed Sec.  507.48(a)(3)(iii)). 
Such corrective actions would be necessary if, for example, there was a 
failure to maintain adequate temperature control. Proposed Sec.  
507.48(a)(3) is modified relative to the analogous proposed requirement 
for corrective actions that would be established in proposed Sec.  
507.42(a) in subpart C in that proposed Sec.  507.48(a)(3) would not 
require written procedures for corrective actions. In essence, there is 
a single action to correct the problem (i.e., to restore temperature 
control), followed by the need to evaluate the animal food for safety 
and to prevent animal food from entering commerce when appropriate. The 
corrective actions taken, including information to document that 
product was not exposed to temperatures and times that would compromise 
the safety of the product, would be documented in records subject to 
agency review. It may be necessary for the owner, operator, or agent in 
charge of the facility to consult with the applicable manufacturer, 
processor, or packer of the animal food to determine the appropriate 
disposition of the food.
    Proposed Sec.  507.48(a)(4)(i) would require that the owner, 
operator, or agent in charge of a facility solely engaged in the 
storage of unexposed packaged animal food verify that temperature 
controls are consistently implemented by calibrating temperature 
monitoring and recording devices. As discussed in section X.G.5.b of 
this document, calibration provides assurance that an instrument is 
measuring accurately. If these instruments are not properly calibrated, 
the values they provide may not provide the necessary assurance 
temperatures are adequate to significantly minimize or prevent the 
growth of, or toxin production by, microorganisms of animal or human 
health significance in an unexposed refrigerated packaged TCS animal 
food. Proposed Sec.  507.48(a)(4)(i) is analogous to proposed Sec.  
507.45(b)(3)(ii) in subpart C, which would establish a verification 
requirement for calibration of process monitoring instruments and 
verification instruments.
    Proposed Sec.  507.48(a)(4)(ii) would require that the owner, 
operator, or agent in charge of a facility solely engaged in storage of 
unexposed packaged animal food verify that temperature controls are 
consistently

[[Page 64803]]

implemented by reviewing records of calibration within a reasonable 
time after the records are made. As discussed in section X.G.5.e of 
this document, the purpose of the review of records would be to ensure 
that the records are complete and that the preventive controls are 
effective. If temperature monitoring and recording devices are not 
properly calibrated, the temperature controls may not be effective. As 
discussed in section X.G.5.e, the review of calibration records will 
depend in part on the frequency with which calibrations occur.
    Proposed Sec.  507.48(a)(4)(iii) would require that the owner, 
operator, or agent in charge of a facility solely engaged in storage of 
unexposed packaged animal food verify that temperature controls are 
consistently implemented by reviewing the records of monitoring and 
actions taken to correct a problem with the control of temperature 
within a week after the records are made. As discussed in section 
X.G.5.e, the purpose of the review of records would be to ensure that 
the records are complete, that the temperatures recorded were adequate 
to significantly minimize or prevent the growth of, or toxin production 
by, microorganisms of public animal or human significance in an 
unexposed refrigerated packaged TCS animal food, and that appropriate 
actions were taken to correct any problem with the control of 
temperature for any unexposed refrigerated packaged TCS animal food. A 
weekly review of monitoring and corrective action records would provide 
for timely feedback of information and limit the amount of product 
impacted by any problems identified during the review of the records. 
Proposed Sec.  507.48(a)(4)(iii) is analogous to proposed Sec.  
507.45(c)(1)(i) in subpart C, which would establish a verification 
requirement for review of records of monitoring and corrective action 
records within a week after the records are made.
    Proposed Sec.  507.48(a)(4) is modified relative to the analogous 
proposed verification requirements in proposed Sec.  507.45 in that 
proposed Sec.  507.48(a)(4) would not require validation or reanalysis. 
There is a single control to verify, which limits the need for many of 
the verification procedures that might otherwise apply. As noted above, 
the temperatures to control growth of microbial pathogens are well 
documented and do not require validation that they are effective in 
controlling the potential for microorganisms of animal or human health 
significance to grow, or produce toxin, in animal food The reasons for 
not requiring reanalysis were discussed previously in this section. 
Proposed Sec.  507.48(a)(4) is also modified relative to the analogous 
proposed verification requirements in proposed Sec.  507.45 in that 
proposed Sec.  507.48(a)(4) would not require that a qualified 
individual perform or oversee the review of records of calibration or 
records of monitoring and actions taken to correct a problem with the 
control of temperature. The nature of these records does not require 
the qualifications that would be required under proposed Sec.  
507.50(b).
    Proposed Sec.  507.48(a)(5) would require that the owner, operator, 
or agent in charge of a facility solely engaged in storage of unexposed 
packaged animal food establish and maintain records documenting the 
monitoring of temperature controls for any unexposed refrigerated 
packaged TCS animal food (proposed Sec.  507.48(a)(5)(i)); records of 
corrective actions taken when there is a problem with the control of 
temperature for any unexposed refrigerated packaged TCS animal food 
(proposed Sec.  507.48(a)(5)(ii)); and records documenting verification 
activities (proposed Sec.  507.48(a)(5)(iii)). The records that 
document monitoring would be used to verify that the temperature 
controls are effectively and significantly minimizing or preventing the 
growth of, or toxin production by, microorganisms of animal or human 
health significance. The records that document corrective actions would 
be used to verify that appropriate decisions about corrective actions 
are being made and appropriate corrective actions are being taken. The 
records that document verification activities would be used to document 
that this key element of a food safety plan has been implemented. These 
records would be necessary to demonstrate compliance with the 
requirements and as such would be useful to inspectors and auditors. 
Proposed Sec.  507.48 (a)(5) is analogous to provisions in proposed 
Sec. Sec.  507.36(d)(2)(iv), 507.39(c), and 507.45(e) in subpart C, 
which would require documentation of monitoring, corrective actions, 
and verification activities, respectively.
    Proposed Sec.  507.48(b) would establish that the records that a 
facility must establish and maintain under proposed Sec.  507.48(a)(5) 
are subject to the requirements of proposed subpart F. Proposed subpart 
F would establish requirements that would apply to all records that 
would be required under part 507. FDA describes the requirements of 
proposed subpart F in section XII. Proposed Sec.  507.48(b) is 
analogous to proposed Sec.  507.55(b) in subpart C.

I. Proposed Sec.  507.50--Requirements Applicable to a Qualified 
Individual

    Proposed Sec.  507.50(a) would require that one or more qualified 
individuals prepare the food safety plan (proposed Sec.  507.30), 
validate the preventive controls (proposed Sec.  507.45(a)), review 
records for implementation and effectiveness of preventive controls 
(proposed Sec.  507.45(c)), and perform reanalysis of the food safety 
plan (proposed Sec.  507.45(e)). The Agency has discussed the basis for 
requiring that a trained individual perform or oversee these functions 
in its discussion of each applicable proposed provision. The Agency is 
listing the functions that must be performed by a trained individual in 
Sec.  507.50(a) for simplicity and are not imposing any additional 
requirement through this list. A single individual with appropriate 
qualifications could perform all of the listed functions, but there 
would be no requirement for the same individual to perform all the 
listed functions.
    Proposed Sec.  507.50(b) would establish the qualification 
requirements applicable to a qualified individual. To be qualified, an 
individual must have successfully completed training in the development 
and application of risk-based preventive controls at least equivalent 
to that received under a standardized curriculum recognized as adequate 
by the FDA, or be otherwise qualified through job experience to develop 
and apply a food safety system. Training or job experience is essential 
to the effective development and implementation of a hazard analysis 
and risk-based preventive controls. Only a trained individual or 
individual qualified by job experience is capable of effectively 
executing certain activities, such as identifying hazards that are 
reasonably likely to occur; identifying preventive controls that will 
address those hazards; evaluating scientific and technical information 
to determine whether the food safety plan, when properly implemented, 
will effectively control the hazards that are reasonably likely to 
occur; determining 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; determining whether 
monitoring procedures and corrective action procedures are appropriate; 
and determining whether specific corrective actions have been 
appropriate and effective. In addition, the products produced by the 
animal food industry are diverse, and the hazards that are

[[Page 64804]]

reasonably likely to occur in a particular facility depend on a range 
of factors that vary from one facility to the next. The Agency requests 
comment on the scope of the qualifications identified.
    FDA will be working with an animal food alliance to develop a 
standardized curriculum for any final rule establishing requirements 
for hazard analysis and risk-based preventive controls. Having a 
standardized curriculum on which facilities, as well as private 
organizations and academia that conduct training, can base their 
materials and training would provide a framework to ensure minimum 
training requirements are met.
    Proposed Sec.  507.50(b) also would provide that the qualified 
individual may be, but is not required to be, an employee of the 
facility. FDA expects that some facilities may rely on assistance from 
qualified individuals that are not employees of the facility, such as 
individuals associated with universities, trade associations, and 
consulting companies. Proposed Sec.  507.50(b) is consistent with HACCP 
regulations for seafood and juice, which have virtually identical 
requirements (Sec. Sec.  123.10 and 120.13(b), respectively). The 
option in proposed Sec.  507.50(b) would provide flexibility to 
facilities subject to the rule. Such flexibility may be particularly 
important for those facilities that have limited technical expertise.
    Proposed Sec.  507.50(c) would require that all applicable training 
be documented in records, including the date of the training, the type 
of training, and the person(s) trained. Such records would be a simple 
mechanism to demonstrate that a person has successfully completed 
training in the development and application of risk-based preventive 
controls at least equivalent to that received under a standardized 
curriculum recognized as adequate by the FDA, as would be required 
under proposed Sec.  507.50(b) should the qualified individual not be 
otherwise qualified through job experience to develop and apply an 
animal food safety system.

J. Proposed Sec.  507.55--Records Required for Subpart C

1. Requirements of Section 418 of the FD&C Act
    Section 418(g) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall maintain, 
for not less than 2 years, records documenting the monitoring of the 
preventive controls implemented under section 418(c) of the FD&C Act, 
instances of nonconformance material to food safety, the results of 
testing and other appropriate means of verification under section 
418(f)(4) of the FD&C Act, instances when corrective actions were 
implemented, and the efficacy of preventive controls and corrective 
actions.
    Section 418(h) of the FD&C Act, in relevant part, specifies that 
the owner, operator, or agent in charge of a facility shall prepare a 
written plan that documents and describes the procedures used by the 
facility to comply with the requirements of section 418 of the FD&C 
Act, including analyzing the hazards under section 418(b) of the FD&C 
Act and identifying the preventive controls adopted under section 
418(c) of the FD&C Act to address those hazards. Section 418(h) of the 
FD&C Act also specifies that the written plan, together with the 
documentation described in section 418(g) of the FD&C Act, shall be 
made promptly available to a duly authorized representative of the 
Secretary upon oral or written request.
2. Proposed Sec.  507.5--Records Required for Subpart C
    Proposed Sec.  507.55(a)(1) through (a)(5) would require that the 
owner, operator, or agent in charge of a facility establish and 
maintain the following records:
     The written food safety plan, including the written hazard 
analysis, preventive controls, monitoring procedures, corrective action 
procedures, verification procedures, and recall plan;
     Records that document the monitoring of preventive 
controls;
     Records that document corrective actions;
     Records that document verification, including, as 
applicable, those related to validation; monitoring; corrective 
actions; calibration of process monitoring and verification 
instruments; records review; and reanalysis; and
     Records that document applicable training for the 
qualified individual.
    Proposed Sec.  507.55(a) would not establish any new requirements, 
but merely make it obvious at a glance what records are required under 
proposed part 507, subpart C.
    Proposed Sec.  507.55(b) would provide that the records that the 
owner, operator, or agent in charge of a facility must establish and 
maintain are subject to the requirements of proposed part 507, subpart 
F. As discussed in section XII, proposed subpart F would provide the 
general requirements that apply to all records required to be 
established and maintained by proposed part 507, including provisions 
for retention of records and for making records available for official 
review.

K. Request for Comment on Additional Preventive Controls and 
Verification Procedures Not Being Proposed

1. Overview
    As discussed in section II.C.2, section 418(n) requires FDA to 
establish science-based minimum standards for, among other things, 
implementing preventive controls. In addition, section 418(f) requires 
certain verification of those preventive controls. In this section of 
the preamble, the Agency discusses several preventive controls (i.e., 
supplier controls) and verification measures (i.e., environmental and 
product testing programs) that FDA is not including as provisions in 
proposed part 507, subpart C.
    As the Agency discussed in section X.C.1, section 418(c) requires 
the owner, operator, or agent in charge of a facility to identify and 
implement preventive controls. Section 418(o)(3) defines ``preventive 
controls'' to mean ``those risk-based, reasonably appropriate 
procedures, practices and processes that a person knowledgeable about 
the safe manufacturing, processing, packing, or holding of food would 
employ to significantly minimize or prevent [identified hazards] and 
that are consistent with current scientific understanding of safe food 
manufacturing, processing, packing, or holding . . . .'' Section 
418(o)(3) indicates that those procedures, practices, and processes may 
include environmental monitoring, supplier verification activities, and 
certain sanitation controls. In addition, environmental and product 
testing programs are set out in section 418(f)(4): Section 418(f)(4) 
requires that the owner, operator, or agent in charge of a facility 
``verify that . . . the preventive controls . . . are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards, including through the use of environmental and product testing 
programs and other appropriate means.''
    The Agency believes that the preventive controls and verification 
measures discussed in this section are an important part of a modern 
animal food safety system. The Agency believes that the preventive 
controls discussed in this section (i.e., a supplier approval and 
verification program), when implemented appropriately in particular 
facilities, are ``risk-based, reasonably appropriate procedures, 
practices, and processes that a person knowledgeable about the safe 
manufacturing, processing, packing, or holding of food

[[Page 64805]]

would employ to significantly minimize or prevent [identified hazards] 
and that are consistent with current scientific understanding of safe 
food manufacturing, processing, packing, or holding . . . .'' The 
verification procedures discussed in this section (i.e., environmental 
and product testing programs), when implemented appropriately in 
particular facilities, could be used to verify that the preventive 
controls are effectively and significantly minimizing or preventing the 
occurrence of identified hazards. The use of and need for these 
preventive controls and verification measures, which are science-based, 
are widespread and commonly accepted in many sectors of the food 
industry. The Agency requests comment on these conclusions.
    As discussed (see section I of this document), animal food safety 
is best assured if each facility understands the hazards that are 
reasonably likely to occur in its particular product and operation and 
puts in place scientifically sound preventive controls to significantly 
minimize or eliminate those hazards. From a regulatory perspective, 
specifying the circumstances and manner in which these controls and 
practices are to be applied must take into account the wide array of 
factors, including the diversity among animal food products, the wide 
variety of manufacturing and processing methods used to produce the 
animal food, the variety of sources for raw materials and ingredients, 
variations in the nature and types of hazards associated with 
manufacturing, processing, packing, and holding animal food, and the 
possibility that different mitigation methods may achieve the same end. 
Further, regulatory requirements should make clear when one of these 
preventive controls or verification measures is necessary yet also be 
sufficiently flexible to account for a vast number of animal food and 
facility combinations and circumstances.
    Although the Agency is not including provisions for environmental 
and product testing programs or a supplier approval and verification 
program in this proposed rule, the Agency recognizes that these 
preventive controls and verification measures, when implemented 
appropriately in particular facilities, can play important roles in 
effective animal food safety programs. The role and need for these 
measures varies depending on the type of products and activities of the 
facility. To facilitate comment and share the Agency's current 
thinking, the Agency discusses the topics of environmental and product 
testing programs and a supplier approval and verification program 
immediately below. See the Appendix to this document for additional 
background information relevant to these topics.
2. Product Testing
    As discussed in section X.G.1, section 418(f)(4) of the FD&C Act 
states that the owner, operator, or agent in charge of a facility shall 
verify that ``the preventive controls implemented under [section 418(c) 
of the FD&C Act] are effectively and significantly minimizing or 
preventing the occurrence of identified hazards, including through the 
use of environmental and product testing programs and other appropriate 
means'' The statute does not indicate the specific circumstances where 
product testing would be required or the specific manner in which such 
testing should be performed. FDA believes that the role and need for 
these measures varies depending on the type of products and activities 
of a facility. FDA further believes that the owner, operator, or agent 
in charge of a facility could consider a number of factors to establish 
a product testing program.
    Although finished product testing is rarely considered a preventive 
control, it plays a very important role as a verification measure in 
ensuring the safety of animal food, when implemented appropriately in 
particular facilities. Similarly, testing of raw materials or 
ingredients by a facility that is receiving the product often plays an 
important role in verification of hazard control that is performed by 
its supplier. Thus, an important purpose of testing is to verify that 
preventive controls, including those related to suppliers and those 
related to environmental monitoring, are controlling the hazard (Refs. 
31 and 32). Testing is used in conjunction with other verification 
measures in the animal 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.
    Finished product testing is more important and useful when there is 
a reasonable probability that exposure to an identified hazard will 
result in serious adverse health consequences or death to humans or 
animals. FDA believes that there are certain situations in which 
finished product testing is particularly useful as a verification 
measure, including the following circumstances:
     The outcome of the hazard analysis conducted under 
proposed Sec.  507.33 is that a biological hazard is reasonably likely 
to occur in an ingredient and the preventive controls established and 
implemented under proposed Sec.  507.36 do not include a process 
control that will significantly minimize the hazard. An example is a 
dry blending operation that mixes a variety of ingredients such as 
seeds, nuts that may be contaminated with Salmonella spp., dried fruit, 
and algae meal to make bird food.
     The outcome of the hazard analysis conducted under 
proposed Sec.  507.33 is that a biological hazard is reasonably likely 
to occur in an ingredient that is added during manufacturing after the 
stage that applies a process control to significantly minimize 
biological hazards. An example is pet food (such as dry pet food and 
pet treats) in which untreated flavorings that may contain Salmonella 
spp. are applied after the pet food has undergone a heat treatment.
     The outcome of the hazard analysis conducted under 
proposed Sec.  507.33 is that a biological hazard is reasonably likely 
to occur as a result of handling of a product or exposure of a product 
to the environment after a process control that significantly minimizes 
a hazard such that a hazard could be introduced or re-introduced into 
the product. An example is the manufacture of pet treats, such as pig 
ears, that after heat treating become contaminated with Salmonella spp. 
from the processing environment.
    In addition, the frequency of testing and the number of samples 
tested must be determined and needs to take into account a variety of 
hazard/commodity/facility considerations. FDA believes that factors to 
consider include whether ingredients that may contain a hazard have 
been tested, the extent of any environmental monitoring program, and 
whether other programs established by the facility provide added 
assurance that the potential for hazards has been minimized. The 
frequency of testing and the number of samples tested should have a 
scientific basis. Sampling plans and their performance have been 
described in the literature (Refs. 89, 90, and 91) and are included in 
several Codex documents (Refs. 92 and 93). The Agency discusses likely 
considerations that could impact finished product verification testing 
in more detail in section I.F of the Appendix.
    Although the Agency is not including a testing provision in this 
proposed rule, the Agency estimates that a requirement for a finished 
product testing program, when implemented appropriately in particular 
facilities, could impose an incremental annual cost of $15,000-$28,000 
per facility based on size

[[Page 64806]]

(number of employees) that adopts a testing and holding regime. This 
would result in an estimated aggregate cost of $2.88 million, of which 
about 73 percent would be for domestic facilities. The facilities that 
would adopt a testing and holding regime are facilities producing 
products for which finished product testing would be particularly 
useful as a verification measure, e.g., the production process does not 
have a step that will eliminate or reduce hazards to an acceptable 
level. This estimate excludes facilities that would be exempt under 
this proposed rule (using a definition of $500,000 for a very small 
business) and facilities that are already conducting finished product 
testing. Further details are provided in the ``Analysis of 
Alternatives'' section of FDA's Preliminary Regulatory Impact Analysis 
(PRIA) (Ref. 52).
    FDA requests comment on when and how product testing programs are 
an appropriate means of implementing the statutory directives set out 
above. Although the Agency has not included these provisions in the 
proposed rule, the Agency requests comment on their inclusion in a 
final rule. Should a product testing program be limited to finished 
product testing or include raw material testing? What is the 
appropriate level of specificity for a product testing program? For 
example, should the Agency simply require that the owner, operator, or 
agent in charge conduct, as appropriate to the facility and the animal 
food, finished product testing, when appropriate based on risk, to 
assess whether the preventive controls significantly minimize or 
prevent the hazards that are reasonably likely to occur? This would 
provide flexibility to account for the wide diversity of animal food 
and animal food manufacturing, processing, packing, and holding systems 
subject to this rule and be consistent with the discussions within this 
proposed rule.
    FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Specifying particular hazards, situations or product types 
for which finished product testing would be required;
     Specifying the frequency of testing and, if so, whether 
this frequency should depend on the type of product;
     Identifying appropriate sampling plans for finished 
product testing;
     Requiring periodic testing for trend analysis and 
statistical process control; and
     Requiring written procedures for conducting finished 
product testing and, if so, also require that procedures for finished 
product testing be scientifically valid and include the procedures for 
sampling and the sampling frequency.
    FDA also requests comment on the impact of product testing 
requirements on small businesses and on whether any product testing 
verification requirements should differ based on the size of the 
operation.
3. Environmental Monitoring
    As discussed in section X.G.1 of this document, section 418(f)(4) 
of the FD&C Act states that the owner, operator, or agent in charge of 
a facility shall verify that ``the preventive controls implemented 
under [section 418(c) of the FD&C Act] are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards, including through the use of environmental and product testing 
programs and other appropriate means.'' In addition, section 418(o)(3) 
indicates that preventive controls may include environmental monitoring 
to verify the effectiveness of pathogen controls is an example of 
preventive controls. The statute does not indicate the specific 
circumstances where environmental testing would be required or the 
specific manner in which such testing should be performed. 
Nevertheless, FDA believes that this testing can form an important 
component of a modern animal food safety system. FDA believes that the 
role and need for these measures varies depending on the type of 
products and activities of a facility. FDA further believes that the 
performance of environmental monitoring, for an appropriate 
microorganism of public health significance or for an appropriate 
indicator organism, is particularly useful as a verification measure 
for preventive controls (i.e., sanitation controls) when contamination 
of animal food with an environmental pathogen is a hazard reasonably 
likely to occur.
    As discussed in section X.B.3, proposed Sec.  507.33(b) would 
require a hazard identification that must consider hazards that may 
occur naturally or may be unintentionally introduced. The data from 
recalls and the RFR support a conclusion that Salmonella spp. is a 
hazard in animal pet treats and pet food products. When certain animal 
food, such as dry pet food, is exposed to the environment prior to 
packaging, FDA believes that most facilities producing such animal 
foods would identify Salmonella spp. as a known or reasonably 
foreseeable hazard under proposed Sec.  507.33(b). A robust 
environmental monitoring program for Salmonella spp. can verify the 
effectiveness of sanitation controls designed to prevent Salmonella 
spp. from contaminating animal food-contact surfaces and animal food 
(Ref. 94).
    As discussed in section I.E.2 of the Appendix to this document, the 
Agency is also aware that listeriosis occurs in a number of animal 
species, especially ruminant animals, and is asking for comment on 
whether L. monocytogenes is an environmental pathogen of concern for 
animal food facilities. FDA's current thinking is that Listeria spp. 
may be an appropriate indicator organism for L. monocytogenes, because 
tests for Listeria spp. will detect multiple species of Listeria, 
including L. monocytogenes. However, FDA's current thinking is that 
there are no currently available indicator organisms for Salmonella 
spp. The Agency requests comment on these findings and conclusions.
    Although the Agency is not including an environmental testing 
provision in this proposed rule, the Agency estimates that an 
environmental monitoring program for Salmonella spp., when implemented 
appropriately in certain animal food facilities, could impose an annual 
cost of about $3,500 per facility. These costs assume that facilities 
will collect approximately 15 environmental samples per month, based on 
facility size. FDA used the sampling time, testing time, and capital 
cost to estimate a cost of $19.20 per sample tested using a quick time 
test that is performed at the facility. FDA estimates that about 261 
facilities (including foreign facilities) would be subject to this 
requirement. FDA used the current compliance estimates from the human 
foods manufacturer survey to estimate the total that would need to 
begin environmental monitoring would be about 184. This would result in 
estimated total annual testing costs of about $636,000.
    The facilities that could adopt environmental monitoring programs 
are facilities producing animal food products, such as dry pet food, 
exposed to the environment prior to packaging, whereby they may become 
contaminated and for which such testing would be particularly useful as 
a verification measure for sanitation controls.
    FDA requests comment on when and how environmental testing is an 
appropriate means of implementing the statutory directives set out 
above. Although the Agency has not included these provisions in the 
proposed rule, the Agency requests comment on their inclusion in a 
final rule. If they are included, what is the appropriate level of 
specificity? For example, should the Agency simply require the 
performance of environmental monitoring, for an

[[Page 64807]]

appropriate microorganism of public health significance or for an 
appropriate indicator organism, if contamination of animal food with an 
environmental pathogen is a hazard reasonably likely to occur? FDA also 
requests comment on whether more detail would be appropriate, by, for 
example:
     Specifying the environmental pathogen or the indicator 
organism for which the samples must be tested;
     Specifying the corrective actions that should be taken if 
environmental testing identifies the presence of an environmental 
pathogen, such as;
     Conducting microbial sampling and testing of surrounding 
surfaces and areas to determine the extent of the contamination and the 
potential source of the contamination;
     Cleaning and sanitizing the contaminated surfaces and 
surrounding areas to eliminate the test organism;
     Conducting additional microbial sampling and testing to 
determine whether the contamination has been eliminated; and
     Conducting finished product testing.
     Specifying the locations within the facility at which 
samples must be collected;
     Specifying the frequency of collection of environmental 
samples (e.g., weekly or monthly depending on risk). For example, 
should the frequency of collection:
     Be greatest for animal foods that are likely to be handled 
by certain vulnerable populations, such as children, the elderly, and 
individuals with compromised immune systems after a minimal treatment 
that may not adequately reduce the environmental pathogen?
     Be greater for an environmental pathogen that is 
frequently introduced into a facility (e.g., Salmonella spp., which is 
ubiquitous in the environment and can be continually introduced into a 
facility from many routes, including ingredients, people and objects 
(Ref. 94)) than for an environmental pathogen that is less frequently 
introduced?
     Be greater for products that undergo significant handling 
and exposure to the environment than for products that undergo limited 
or no handling or have little exposure to the environment?
     Increase as a result of finding the environmental pathogen 
or an indicator of the environmental pathogen or as a result of 
situations that pose an increased risk of contamination, e.g., 
construction? (Refs. 94 and 95).
     Requiring written procedures for conducting environmental 
testing and, if so, also requiring that procedures for environmental 
testing be scientifically valid and include the procedures for sampling 
and the sampling frequency;
     Requiring data analysis to detect trends.
    The Agency further requests comment on whether there is benefit in 
conducting routine environmental monitoring for other organisms in 
addition to, or instead of, the environmental pathogen of concern.
4. Supplier Approval and Verification Program
    Section 418(c) of the FD&C Act specifies, in relevant part, that 
the owner, operator, or agent in charge of a facility shall identify 
and implement preventive controls, including at critical control 
points, if any, to provide assurances that:
     Hazards identified in the hazard analysis conducted under 
section 418(b)(1) of the FD&C Act will be significantly minimized or 
prevented; and
     The animal food manufactured, processed, packed, or held 
by such facility will not be adulterated under section 402 of the FD&C 
Act.
    Section 418(o)(3)(G) of the FD&C Act indicates that the procedures, 
practices, and processes described in the definition of preventive 
controls may include supplier verification activities that relate to 
the safety of food. While FSMA refers only to supplier verification 
activities, supplier approval, together with supplier verification, is 
widely accepted in the domestic and international food safety 
community. The development of a supplier approval and verification 
program can be part of a preventive approach. The NACMCF HACCP 
guidelines describe supplier controls as one of the common prerequisite 
programs for the safe production of food products and recommend that 
each facility assure that its suppliers have in place effective CGMP 
and food safety programs (Ref. 29). Likewise, Codex addresses the 
safety of ingredients in the General Principles of Food Hygiene and 
recommends that, where appropriate, specifications for raw materials be 
identified and applied and laboratory tests be conducted to establish 
fitness for use (Ref. 34).
    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 can help ensure that 
raw materials and ingredients are procured from those suppliers that 
can meet company specifications and have appropriate programs in place 
to address 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 can help provide initial and 
ongoing assurance that suppliers are complying with practices to 
achieve adequate control of hazards in raw materials or ingredients.
    The statute does not indicate the specific circumstances where 
supplier verification would be required or the specific manner in which 
supplier verification should be performed, and FDA is not including 
provisions for such verification in this proposed rule. FDA believes 
that the role and need for these measures varies depending on the type 
of products and activities of a facility. FDA further believes that the 
owner, operator, or agent in charge of a facility could consider a 
number of factors to determine the specific circumstances and manner 
where it would be appropriate to perform supplier verification. FDA 
believes that factors to consider include:
     The nature of the adverse consequences associated with the 
hazard, such as whether consumption or handling of animal food 
containing the hazard may result in serious adverse health consequences 
or death to humans or animals; and
     The establishment that would be controlling the hazard 
associated with the raw material or ingredient (e.g., the facility that 
receives the raw material or ingredient, the supplier of that raw 
material or ingredient, or even a supplier to the supplier of the raw 
material or ingredient).
    The vast majority of costs related to a supplier approval and 
verification program are due to verification activities such as audits 
and testing of raw materials and ingredients, which would likely be 
selected based on the hazard associated with the raw material or 
ingredient and where the hazard is controlled. Although the Agency is 
not including a provision for such a program in this proposed rule, the 
Agency estimates that a requirement for a supplier approval and 
verification program, if implemented as part of a

[[Page 64808]]

preventive approach, could impose an incremental annual cost of $3,300-
$4,400 per supplier facility based on size (number of employees) that 
undergoes an annual audit. This would result in an estimated aggregate 
cost of $218,000 for domestic facilities and an estimated aggregate 
cost of $82,000 for foreign facilities. Further details are provided in 
the ``Analysis of Alternatives'' section of the PRIA (Ref. 52).
    FDA requests comment on when and how supplier approval and 
verification is an appropriate means of implementing the statutory 
directives set out previously. Although the Agency has not included 
these provisions in the proposed rule, the Agency requests comment on 
their inclusion in a final rule. If they are included, what is the 
appropriate level of specificity? Should the requirement be very 
general, for example, requiring a supplier approval and verification 
program as appropriate to the facility and the animal food, when 
appropriate based on risk? FDA also requests comment on who a supplier 
approval and verification program should apply to, e.g., should it 
apply to all facilities that manufacture, process, pack, or hold animal 
food, or be limited (such as to facilities that manufacture or process 
animal food)?
    FDA also requests comment on whether more detail would be 
appropriate, by, for example:
     Requiring that the supplier approval and verification 
program include a written list of approved suppliers;
     Requiring that, in determining appropriate verification 
activities, the owner, operator, or agent in charge of a facility 
consider relevant regulatory information regarding the supplier, 
including whether the raw material or ingredient is the subject of an 
FDA warning letter or import alert relating to the safety of the animal 
food.
     Specifying circumstances when a supplier approval and 
verification program would not be required, e.g., when the preventive 
controls at the receiving facility are adequate to significantly 
minimize or prevent each of the hazards the receiving facility has 
identified as reasonably likely to occur; or when the receiving 
facility obtains from its customer written assurance that the customer 
has established and is following procedures that will significantly 
minimize or prevent the hazard.
     Specifying that the type of verification activity be 
linked to the seriousness of the hazard, e.g., whether to:
     Require an onsite audit when there is a reasonable 
probability that exposure to the hazard will result in serious adverse 
health consequences or death to humans or animals;
     Provide more flexibility with respect to hazards for which 
there is not a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans or 
animals, e.g., periodic onsite audits, periodic or lot-by-lot sampling 
and testing of the raw material or ingredient, and periodic review of 
the supplier's animal food safety records;
     Specifying requirements for audits, e.g., the 
qualifications (including training, experience, and conflict of 
interest) for persons who conduct audits; content of an audit (such as 
compliance with applicable animal food safety regulations and, when 
applicable, compliance with a facility's food safety plan);
     Specifying the frequency of verification activities (e.g., 
initially, annually, or periodically);
     Specifying whether, for some hazards, it will be necessary 
to conduct more than one verification activity to provide adequate 
assurances that the hazard is significantly minimized or prevented;
     Providing for alternative requirements if a supplier is a 
qualified facility, e.g., documenting that the supplier is a qualified 
facility and obtaining written assurance that the supplier is producing 
the raw material or ingredient in compliance with sections 402 of the 
FD&C Act;
     Specifying those records that would be appropriate for a 
supplier approval and verification program;
     Providing for substitution of a regulatory inspection 
(e.g., by FDA or a comparable State regulatory agency or foreign animal 
food safety authority), for an onsite audit; and
     Specifying that a receiving facility take appropriate 
action (e.g., discontinuing use of a supplier) if the facility 
determines that the supplier is not controlling hazards that the 
receiving facility has identified as reasonably likely to occur.
    FDA is aware that many firms that could be affected by supplier 
verification may be importing their ingredients. The Agency believes 
that these firms are interested in how a supplier verification 
component of preventive controls will interface with the regulations 
FDA is required to implement foreign supplier verification under new 
section 805 of the FD&C Act (21 U.S.C. 384a). Section 805 requires FDA 
to issue regulations to require importers to implement foreign supplier 
verification programs (FSVPs) that are adequate to provide assurances 
that the importer's foreign suppliers produce food, including animal 
food, in compliance with processes and procedures, including risk-based 
preventive controls, that provide the same level of animal and human 
health protection as those required under section 418 (concerning 
hazard analysis and preventive controls) of the FD&C Act, and in 
compliance with section 402 (concerning adulteration) of the FD&C Act.
    On July 29, 2013, FDA published in the Federal Register proposed 
regulations implementing section 805 (78 FR 45730). FDA intends to 
align regulations implementing supplier verification under section 418 
and regulations implementing FSVP under section 805 to the fullest 
extent so the Agency does not impose duplicative or unjustified 
requirements under those two regulations. For example, if a facility 
imports ingredients, the Agency would not want to subject it to 
duplicative requirements under a supplier verification provision and an 
FSVP regulation.
    Likewise, FDA is aware that there is great interest from its 
trading partners on, among other things, the potential overlap between 
the supplier verification requirements in preventive controls and in 
FSVP. FDA believes that the approach to harmonization between supplier 
verification and FSVP described above would adequately address this and 
comports with its obligations under the World Trade Organization trade 
agreements, including adherence to the principles of the Sanitary and 
Phytosanitary (SPS) Agreement.
    FDA is committed to meeting the requirements of the SPS Agreement 
and to complying with its obligations under that Agreement as the 
Agency implements FSMA. In enacting FSMA, Congress explicitly 
recognized the importance of compliance with international agreements 
by providing in section 404 of FSMA that ``[n]othing in [FSMA] shall be 
construed in a manner inconsistent with the agreement establishing the 
World Trade Organization or any other treaty or international agreement 
to which the United States is a party.'' While the statutory provisions 
in FSMA governing supplier verification by domestic facilities and 
foreign supplier verification by importers differ in some respects, 
they are based on common risk-based principles. Implementation of these 
risk-based principles will assure a general consistency of approach 
with respect to foreign and domestic facilities

[[Page 64809]]

regarding, for example, when on-site audits are required. 
Implementation of FSMA's risk-based principles will also ensure that 
measures applicable to imports are not more trade-restrictive than 
required to achieve the appropriate level of sanitary or phytosanitary 
protection of the United States, taking into account technical and 
economic feasibility, as required by paragraph 6 of Article 5 of the 
SPS Agreement. The Agency invites comments to assist it in issuing 
final rules that protect animal and human health and satisfy both FSMA 
and FDA's international obligations.

L. Request for Comment on Other Potential Provisions Not Explicitly 
Included in Section 418 of the FD&C Act

1. Overview
    This section discusses two measures (review of consumer, customer, 
and other complaints, and submission of a food safety profile) that FDA 
is not proposing as specific provisions in proposed part 507, subpart 
C. Although these measures are not explicitly included in section 418, 
the Agency believes that the preventive controls and verification 
measures discussed in this section are an important part of a modern 
food safety system.
2. Complaints
    The role of consumer complaints in evaluating the effectiveness of 
a food safety plan is reflected in the HACCP regulations for seafood 
and juice. The HACCP regulation for seafood (Sec.  123.8(a)(2)(i)) 
requires that verification activities include a review of any consumer 
complaints that have been received by the processor to determine 
whether they relate to the performance of critical control points or 
reveal the existence of unidentified critical control points. The HACCP 
regulation for juice (Sec.  120.11(a)(1)(i)) requires that verification 
activities include a review of any consumer complaints that have been 
received by the processor to determine whether the complaints relate to 
the performance of the HACCP plan or reveal the existence of 
unidentified critical control points. FDA notes that the role of 
consumer complaints is not discussed in the NACMCF guidelines or the 
Codex guidelines, and their review is not required by the FSIS HACCP 
regulation for meat and poultry. However, as discussed in the seafood 
HACCP proposed rule (59 FR 4142 at 4157, January 28, 1994), no system 
is foolproof, and consumer complaints may be the first alert for a 
processor that deviations are occurring and are not being prevented or 
uncovered by the processor's HACCP controls.
    Further, although most consumer complaints will be related to 
quality issues, recent experience has demonstrated the value that 
consumer and customer complaints can provide in bringing attention to 
possible problems within a facility's preventive controls activities. 
FDA has received a number of animal food submissions to the RFR (Ref. 
48) that have suggested that environmental pathogens hazards were not 
adequately addressed in a supplier's food safety plan. Some of these 
were identified through customer verification testing and others 
through complaints from consumers to a facility. A facility may also 
receive alerts as a result of state surveillance and testing programs.
    Although this proposed rule does not include a provision regarding 
a review of complaints, the Agency estimates that a requirement that 
facility personnel review consumer, customer, or other complaints could 
impose an additional annual cost of $2,800 per facility. This would 
result in an estimated total annual cost of $1,767,000 for domestic 
facilities.
    The Agency requests comment on whether and how a facility's review 
of complaints, including complaints from consumers, customers, or other 
parties, should be required as a component of its activities to verify 
that its preventive controls are effectively minimizing the occurrence 
of hazards.
3. Submission of a Facility Profile to FDA
    Proposed Sec.  507.30 would require that the owner, operator, or 
agent in charge of a facility prepare, or have prepared, a written food 
safety plan. The food safety plan would include the hazard analysis, 
preventive controls, and other records. Currently, information of this 
type is not reviewed by FDA investigators until they are physically 
present at a facility and have begun an inspection. In light of the 
large number of facilities that would be covered by this proposal, FDA 
recognizes several potential benefits to having a facility's food 
safety plan in advance of an inspection, if the Agency were to require 
facilities to do so. Having such plans could aid in the efficient 
oversight of preventive controls by allowing FDA to better target 
inspectional activities to facilities that produce animal foods that 
have an increased potential for contamination (particularly with 
biological hazards) and to improve on-site inspections by focusing 
attention on hazards and preventive controls for which the facility 
appears to have deficiencies. Facilities would benefit from the 
Agency's advance preparation through interaction with better-informed 
investigators and potentially reduced inspection time. The Agency could 
also more quickly identify facilities that had not established 
preventive controls for specific hazards of concern to the Agency and 
advise them to fill such gaps to prevent a problem before it occurs. 
Also, FDA could use the plans in evaluating the need for guidance on 
specific hazards or controls and prioritizing guidance to areas where 
it is needed most.
    FDA believes that there are significant obstacles to realizing 
these benefits from submission of food safety plans, however. The 
agency would expect to receive a very large number of plans. Further, 
these plans would be expected to vary significantly in content and 
format. Assimilating the underlying information in a way that would be 
useful to the Agency would be an immense challenge. Moreover, not all 
of the information in such plans may be essential to realizing the 
potential benefits described above. Therefore, to most efficiently 
realize the potential benefits of having certain information prior to 
an inspection, the Agency requests comment on whether to require 
submission to FDA of a subset of the information that would be in a 
food safety plan. This information, which could be referred to as a 
``facility profile,'' could be submitted through an electronic form 
using a menu selection approach. The use of an electronic form would 
enhance the Agency's ability to store the information in a searchable 
form. Ideally, a searchable electronic system could allow FDA to assess 
information when a problem occurs with certain types of foods or 
controls, so that the Agency could target inspections to facilities 
that manufacture, process, or pack, animal food types that are at 
increased risk for a food safety problem; to facilities that appear to 
have insufficient controls to prevent a problem; or to facilities using 
a control the Agency concludes is ineffective at controlling hazards. 
The data elements for a facility profile could include some or all of 
the following:
     Contact information;
     Facility type;
     Products;
     Hazards identified for each product;
     Preventive controls established for each of the identified 
hazards;
     Third-party audit information (have you had one and which 
audit firm(s));
     Preventive control employee training conducted;
     Facility size (square footage);
     Full time operation or seasonal;
     Operations schedule.

[[Page 64810]]

    This information could be submitted at the same time as facility 
registration and updated biennially simultaneously with the required 
biennial update of the food facility registration. FDA requests comment 
on the utility and necessity of such an approach and on the specific 
types of information that would be useful in developing a facility 
profile. The Agency also requests comment on any additional benefits 
that might be obtained from using such an approach and any potential 
concerns with this approach.
    The Agency has previously announced an opportunity for public 
comment on the proposed collection of additional food facility profile 
information on a voluntary basis from firms that complete the FDA food 
facility registration process (77 FR 27779, May 11, 2012). In that 
notice, the Agency noted that FSMA added section 421 of the FD&C Act 
(21 U.S.C. 350j), which directed FDA to allocate resources to inspect 
facilities according to the known safety risks of the facilities. The 
Agency also noted that food facility profile information voluntarily 
provided to FDA would help FDA to determine whether a firm is high-risk 
or non-high-risk and that the Agency will use the profile information 
to assist in determining the frequency at which it will inspect the 
firm. In contrast to the voluntary submission of food facility profile 
information described in that notice, in this document, the Agency is 
also requesting comment on whether the submission of such information 
should be required.

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

A. Requirements of Section 418 of the FD&C Act

    Section 418(l)(3)(A) of the FD&C Act specifies that, in the event 
of an active investigation of a foodborne illness outbreak that is 
directly linked to a qualified facility subject to an exemption under 
section 418(l) of the FD&C Act, or if the Secretary determines that it 
is necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or conditions associated 
with a qualified facility that are material to the safety of the food 
manufactured, processed, packed, or held at such facility, the 
Secretary may withdraw the exemption provided to such facility under 
section 418(l) of the FD&C Act. Section 418 does not expressly 
prescribe the procedures for withdrawing an exemption provided to a 
qualified facility under section 418(l). The Agency tentatively 
concludes that it is appropriate to be transparent about the process it 
would use to withdraw an exemption and that the Agency should include 
the process in the proposed rule.

B. Proposed Sec.  507.60--Circumstances That May Lead FDA To Withdraw 
an Exemption Applicable to a Qualified Facility

1. Proposed Sec.  507.60(a)--Withdrawal of an Exemption in the Event of 
an Active Investigation of a Foodborne Illness Outbreak
    Proposed Sec.  507.60(a) would provide that FDA may withdraw the 
exemption that would be applicable to a qualified facility under 
proposed Sec.  507.5(c) in the event of an active investigation of a 
foodborne illness outbreak that is directly linked to the qualified 
facility. Proposed Sec.  507.60(a) would implement the statutory 
language of section 418(l)(3)(A) of the FD&C Act. An outbreak of 
foodborne illness is the occurrence of two or more cases of a similar 
illness resulting from the ingestion of a common food (or exposure to a 
common food in the case of microbiological illness in humans from 
handling animal food.) Animal food can become contaminated at many 
different steps: On the farm; in packing, manufacturing/processing, or 
distribution facilities; during storage or transit; at retail 
establishments; and at the location of the animal. When foodborne 
illness is associated with food, a traceback investigation may enable 
FDA to directly link the illness to the facility or facilities that 
manufactured, processed, packed, and/or held the animal food. See 
section XIV.B.1 of the document for the proposed rule for preventive 
controls for human food (78 FR 3646) for a discussion of an FDA 
traceback investigation.
2. Proposed Sec.  507.60(b)--Withdrawal of an Exemption Based on 
Conduct or Conditions Associated With a Qualified Facility
    Proposed Sec.  507.60(b) would provide that FDA may withdraw the 
exemption applicable to a qualified facility under proposed Sec.  
507.5(c) if FDA determines that it is necessary to protect animal or 
human health and prevent or mitigate a foodborne illness outbreak based 
on conduct or conditions associated with a qualified facility that are 
material to the safety of the animal food manufactured, processed, 
packed, or held at such facility. As an example, FDA may receive 
reports to the RFR under section 417 of the FD&C Act about 
contamination of an animal food, and the reports may lead the Agency to 
investigate a qualified facility that manufactured, processed, packed 
or held the animal food. If the investigation finds conduct or 
conditions associated with the facility that are material to the safety 
of the animal food (for example, conduct or conditions that likely led 
to the contamination of the animal food), FDA would consider 
withdrawing the exemption applicable to the facility under proposed 
Sec.  507.5(c) if doing so would be necessary to protect animal or 
human health and prevent or mitigate a foodborne illness outbreak. 
Likewise, if during a routine inspection of a qualified facility, FDA 
discovers conditions and practices that are likely to lead to 
contamination of animal food with microorganisms of animal or human 
health significance, such as Salmonella, the Agency would consider 
withdrawing the exemption provided to the facility under proposed Sec.  
507.5(c) if doing so would be necessary to protect animal or human 
health and prevent or mitigate a foodborne illness outbreak.

C. Proposed Sec.  507.62--Issuance of an Order To Withdraw an Exemption 
Applicable to a Qualified Facility

    Proposed Sec.  507.62(a) would provide that, if FDA determines that 
an exemption applicable to a qualified facility under Sec.  507.5(c) 
should be withdrawn, any officer or qualified employee of FDA may issue 
an order to withdraw the exemption. The Agency intends to create and 
maintain a written record of a determination that the withdrawal of an 
exemption is warranted and to include the basis for the determination 
in the written record.
    Proposed Sec.  507.62(b) would require that an FDA District 
Director in whose district the qualified facility is located (or, in 
the case of a foreign facility, the Director of the Division of 
Compliance in the Center for Veterinary Medicine), or an FDA official 
senior to such Director, must approve an order to withdraw the 
exemption as part of the withdrawal determination procedure before the 
order is issued. A Regional Food and Drug Director is an example of an 
FDA official senior to a District Director. The Deputy Director and 
Director of the Office of Surveillance and Compliance at the Center for 
Veterinary Medicine are examples of an FDA official senior to the 
Director of the Division of Compliance. Requiring prior approval of a 
withdrawal order by a District Director or an FDA official senior to a 
District Director is consistent with the approval requirement for a 
detention order in part 1, subpart K

[[Page 64811]]

(Administrative Detention of Food for Human or Animal Consumption). 
Requiring prior approval of a withdrawal order by the Director of the 
Division of Compliance in the Center for Veterinary Medicine is 
consistent with current FDA practices when dealing with foreign firms.
    Proposed Sec.  507.62(c) would require that FDA issue an order to 
withdraw the exemption to the owner, operator, or agent in charge of 
the qualified facility. The requirements of section 418 of the FD&C Act 
are directed to the owner, operator, or agent in charge of a facility. 
The Agency tentatively concludes that the statutory language of section 
418 enables FDA to issue an exemption withdrawal order to any of these 
persons.
    Proposed Sec.  507.62(d) would require that FDA issue an order to 
withdraw the exemption in writing, signed and dated by the officer or 
qualified employee of FDA who is issuing the order.

D. Proposed 507.65--Contents of an Order To Withdraw an Exemption 
Applicable to a Qualified Facility

    Proposed Sec.  507.65(a) through (i) would require that an order to 
withdraw an exemption applicable to a qualified facility under Sec.  
507.5(c) include the following information:

 The date of the order (proposed Sec.  507.65(a));
 The name, address, and location of the qualified facility 
(proposed Sec.  507.65(b));
 A brief, general statement of the reasons for the order, 
including information relevant to:
    [cir] An active investigation of a foodborne illness outbreak that 
is directly linked to the facility; or
    [cir] Conduct or conditions associated with a qualified facility 
that are material to the safety of the animal food manufactured, 
processed, packed, or held at such facility (proposed Sec.  507.65(c)).
 A statement that the facility must comply with subpart C of 
this part on the date that is 60 calendar days after the date of the 
order (proposed Sec.  507.65(d));
 The text of section 418(l) of the FD&C Act and of this subpart 
D (proposed Sec.  507.65(e));
 A statement that any informal hearing on an appeal of the 
order must be conducted as a regulatory hearing under part 16 of this 
chapter (21 CFR part 16), with certain exceptions described in proposed 
Sec.  507.73 (proposed Sec.  507.65(f));
 The mailing address, telephone number, email address, and 
facsimile number of the FDA district office and the name of the FDA 
District Director in whose district the facility is located (or, in the 
case of a foreign facility, the same information for the Director of 
the Division of Compliance in the Center for Veterinary Medicine); 
(proposed Sec.  507.65(g)); and
 The name and the title of the FDA representative who approved 
the order (proposed Sec.  507.65(h)).

    FDA tentatively concludes that the requirements that it proposes in 
Sec.  507.65 would provide the owner, operator, or agent in charge of a 
qualified facility subject to a withdrawal with adequate notice of the 
basis for the Agency's determination to withdraw the exemption and of 
their opportunity to appeal the Agency's determination and to request 
an informal hearing. The proposed notification procedures are similar 
to and consistent with the notification requirements in other 
regulations involving administrative action, such as administrative 
detention of food under Sec.  1.393 orders for diversion or destruction 
of shell eggs under the PHS Act under Sec.  118.12(a)(i), and with 
procedures for an informal hearing in part 16.

E. Proposed Sec.  507.67--Compliance With, or Appeal of, an Order To 
Withdraw an Exemption Applicable to a Qualified Facility

    Proposed Sec.  507.67(a) would require that the owner, operator, or 
agent in charge of a qualified facility that receives an order to 
withdraw an exemption applicable to that facility under Sec.  507.5(c) 
either comply with applicable requirements of this part within 60 
calendar days of the date of the order; or appeal the order within 10 
calendar days of the date of the order in accordance with the 
requirements of Sec.  507.69. The Agency tentatively concludes that 
either of the two circumstances that could result in the determination 
that an exemption should be withdrawn (as described in proposed Sec.  
507.60) warrant prompt compliance with the rule in the interest of 
animal or human health. The Agency tentatively concludes that 10 
calendar days for the submission of an appeal from the date of the 
receipt of a withdrawal order is appropriate for purposes of the 
efficient adjudication of the appeal of a withdrawal order and would 
provide reasonable due process that comes to closure sufficiently in 
advance of the effective date of the order to provide an opportunity 
for the facility to come into compliance if the Agency denies the 
appeal.
    Proposed Sec.  507.67(b) would establish that submission of an 
appeal, including submission of a request for an informal hearing, will 
not delay or stay any administrative action, including enforcement 
action by FDA, unless the Commissioner of Food and Drugs, as a matter 
of discretion, determines that delay or a stay is in the public 
interest. For example, the submission of an appeal of a withdrawal 
order with a request for an informal hearing under proposed Sec.  
507.67(b) would not prevent FDA from simultaneously detaining animal 
food from the facility under section 304(h) of the FD&C Act, seizing 
animal food from the facility under section 304(a) of the FD&C Act, or 
seeking or enforcing an injunction under section 302 of the FD&C Act.
    Proposed Sec.  507.67(c) would require that, if the owner, 
operator, or agent in charge of the qualified facility appeals the 
order, and FDA confirms the order, the owner, operator, or agent in 
charge of the facility must comply with applicable requirements of this 
part within 60 calendar days of the date of the order. Proposed Sec.  
507.67(c) would make clear that the 60 calendar day timeframe for 
compliance applies regardless of whether the owner, operator, or agent 
in charge of a facility requests, and FDA grants, a hearing. As already 
discussed, FDA tentatively concludes that the circumstances that lead 
to a determination that an exemption should be withdrawn warrant prompt 
compliance in the interest of animal or human health.

F. Proposed Sec.  507.69--Procedure for Submitting an Appeal

    Proposed Sec.  507.69(a) would require that, to appeal an order to 
withdraw an exemption applicable to a qualified facility under Sec.  
507.5(c), the owner, operator, or agent in charge of the facility must: 
(1) Submit the appeal in writing to the FDA District Director in whose 
district the facility is located (or, in the case of a foreign 
facility, the same information for the Director of the Division of 
Compliance in the Center for Veterinary Medicine), at the mailing 
address, email address, or facsimile number identified in the order 
within 10 calendar days of the date of the order and (2) respond with 
particularity to the facts and issues contained in the order, including 
any supporting documentation upon which the owner, operator or agent in 
charge of the facility relies.
    Allowing the owner, operator, or agent in charge of the facility to 
submit an appeal in person, by mail, email, or fax would provide for 
flexibility as well as speed. For example, submitting in person would 
give the owner, operator, or agent in charge direct knowledge that

[[Page 64812]]

the request for appeal had been delivered and received. Email and fax 
are instantaneous, and overnight mail delivery services are readily 
available to those who choose to use them; however, the 10 day 
timeframe for appeal of the order would not require the use of 
overnight mail delivery. For clarity, proposed Sec.  507.69(a) would 
repeat the 10 calendar day timeframe that would be established in 
proposed Sec.  507.67(a)(2) and would not establish any new 
requirement. Any appeal would need to be written in order for FDA to 
evaluate the basis for the appeal. The Agency is proposing that a 
written appeal would need to address with particularity all of the 
issues raised in the withdrawal order and include all supporting 
documentation so that the Agency would be able to issue a final 
determination as to the disposition of the appeal solely on the basis 
of the materials submitted as part of the written appeal.
    Proposed Sec.  507.69(b) would provide that, in a written appeal of 
the order withdrawing an exemption provided under Sec.  507.5(c), the 
owner, operator, or agent in charge of the facility may include a 
written request for an informal hearing as provided in Sec.  507.71. 
Requesting an informal hearing does not mean that a hearing will be 
held, because FDA may deny the request (see discussion of proposed 
Sec.  507.71(b) in the next section of this document). However, if the 
owner, operator, or agent in charge of the facility does not request an 
informal hearing at the time the written appeal is submitted, the 
owner, operator, or agent in charge of the facility will not be 
entitled to an informal hearing. Instead, FDA will make a final 
decision based on the written appeal and its supporting materials.

G. Proposed Sec.  507.71--Procedure for Requesting an Informal Hearing

    Proposed Sec.  507.71(a)(1) would provide that, if the owner, 
operator, or agent in charge of the facility appeals the order, the 
owner, operator, or agent in charge of the facility may request an 
informal hearing. Proposed Sec.  507.71(a)(1) would restate an option 
that would be included in proposed Sec.  507.69(b) to highlight the 
opportunity to request an informal hearing. Proposed Sec.  507.71(a)(2) 
would require that, if the owner, operator, or agent in charge of the 
facility appeals the order, the owner, operator, or agent in charge of 
the facility must submit any request for an informal hearing together 
with its written appeal submitted in accordance with Sec.  507.69 
within 10 calendar days of the date of the order. The Agency 
tentatively concludes that requiring submission of a request for an 
informal hearing in writing at the time that the owner, operator, or 
agent in charge of the facility would be required to submit a written 
appeal is appropriate for purposes of the efficient adjudication of the 
appeal of a withdrawal order and would provide reasonable due process 
that would come to closure sufficiently in advance of the effective 
date of the order to provide an opportunity for the facility to come 
into compliance if FDA denies the appeal.
    Proposed Sec.  507.71(b) would establish that a request for an 
informal hearing may be denied, in whole or in part, if the presiding 
officer determines that no genuine and substantial issue of material 
fact has been raised by the material submitted. Proposed Sec.  
507.71(b) would also provide that if the presiding officer determines 
that a hearing is not justified, written notice of the determination 
will be given to the owner, operator, or agent in charge of the 
facility explaining the reason for the denial. Under proposed Sec.  
507.69(a), a written appeal would be required to respond with 
particularity to the facts and issues contained in the withdrawal 
order, including any supporting documentation upon which the owner, 
operator or agent in charge of the facility relies. If the materials 
submitted do not directly address the facts and issues contained in the 
withdrawal order in a manner that suggests that there is a dispute 
regarding the material facts contained in the order, the presiding 
officer may determine that an informal hearing is not warranted. The 
presiding officer may include written notice of the determination that 
a hearing is not justified as part of the final decision on the appeal.

H. Proposed Sec.  507.73--Requirements Applicable to an Informal 
Hearing

    Proposed Sec.  507.73(a) would establish that, if the owner, 
operator or agent in charge of the facility requests an informal 
hearing, and FDA grants the request, the hearing will be held within 10 
calendar days after the date the appeal is filed or, if applicable, 
within a timeframe agreed upon in writing by the owner, operator, or 
agent in charge of the facility and FDA. The Agency tentatively 
concludes that, if it grants a request for an informal hearing, holding 
the hearing within 10 calendar days, or within an alternative timeframe 
as agreed upon in writing, is appropriate for purposes of the efficient 
adjudication of the appeal of a withdrawal order and would provide 
reasonable due process that would come to closure sufficiently in 
advance of the effective date of the order to provide an opportunity 
for the facility to come into compliance if the Agency denies the 
appeal.
    Proposed Sec.  507.73(b) would establish that the presiding officer 
may require that a hearing conducted under this subpart E be completed 
within 1 calendar day, if appropriate. The Agency tentatively concludes 
that, if it grants a request for an informal hearing, limiting the time 
for the hearing itself to be completed within 1 calendar day is 
appropriate for purposes of the efficient adjudication of the appeal of 
a withdrawal order and would provide reasonable due process that would 
come to closure sufficiently in advance of the effective date of the 
order to provide an opportunity for the facility to come into 
compliance if the Agency denies the appeal.
    Proposed Sec.  507.73(c)(1) through (c)(7) would establish that, if 
the owner, operator or agent in charge of the facility requests an 
informal hearing, and FDA grants the request, FDA must conduct the 
hearing in accordance with part 16, except that:
     The order withdrawing an exemption under Sec. Sec.  507.62 
and 507.65, rather than the notice under Sec.  16.22(a), provides 
notice of opportunity for a hearing under this section and is part of 
the administrative record of the regulatory hearing under Sec.  
16.80(a) of this chapter.
     A request for a hearing under this subpart D must be 
addressed to the FDA District Director (or, in the case of a foreign 
facility, the Director of the Division of Compliance in the Center for 
Veterinary Medicine) as provided in the order withdrawing an exemption.
     Section 507.75, rather than Sec.  16.42(a), describes the 
FDA employees who preside at hearings under this subpart.
     Section 16.60(e) and (f) of this chapter does not apply to 
a hearing under this subpart. The presiding officer must prepare a 
written report of the hearing. All written material presented at the 
hearing will be attached to the report. The presiding officer must 
include as part of the report of the hearing a finding on the 
credibility of witnesses (other than expert witnesses) whenever 
credibility is a material issue, and must include a proposed decision, 
with a statement of reasons. The hearing participant may review and 
comment on the presiding officer's report within 2 calendar days of 
issuance of the report. The presiding officer will then issue the final 
decision.
     Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding

[[Page 64813]]

officer's report of the hearing and any comments on the report by the 
hearing participant under Sec.  507.73(c)(4) are part of the 
administrative record.
     No party shall have the right, under Sec.  16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
     If FDA grants a request for an informal hearing on an 
appeal of an order withdrawing an exemption, the hearing must be 
conducted as a regulatory hearing under part 16, except that Sec.  
16.95(b) does not apply to a hearing under this subpart. With respect 
to a regulatory hearing under this subpart, the administrative record 
of the hearing specified in Sec. Sec.  16.80(a)(1), (a)(2), (a)(3), and 
(a)(5), and 507.73(c)(5) constitutes the exclusive record for the 
presiding officer's final decision. For purposes of judicial review 
under Sec.  10.45 (21 CFR 10.45), the record of the administrative 
proceeding consists of the record of the hearing and the presiding 
officer's final decision.
    Under Sec.  16.1(b), the procedures in part 16 apply when a 
regulation provides a person with an opportunity for a hearing on a 
regulatory action under part 16. Section 418 of the FD&C Act does not 
expressly provide for a hearing if circumstances lead FDA to determine 
that an exemption provided to a qualified facility under proposed Sec.  
507.5(c) should be withdrawn. However, the Agency tentatively concludes 
as a matter of agency discretion that providing an opportunity for a 
hearing by regulation in this subpart of the proposed rule would 
provide appropriate process to the owner, operator, or agent in charge 
of a qualified facility subject to withdrawal of the facility's 
exemption. The Agency also tentatively concludes that the modified part 
16 procedures contained in this proposed rule would provide the owner, 
operator, or agent in charge of a qualified facility subject to a 
withdrawal order sufficient fairness and due process while enabling FDA 
to expeditiously adjudicate an appeal of a withdrawal order for which 
an informal hearing has been granted.
    Section 16.119 provides that, after any final administrative action 
that is the subject of a hearing under part 16, any party may petition 
the Commissioner for reconsideration of any part or all of the decision 
or action under Sec.  10.33 or may petition for a stay of the decision 
or action under Sec.  10.35. Proposed Sec.  507.73(c)(6) would specify 
that these procedures for reconsideration and stay would not apply to 
the process of withdrawing an exemption provided under proposed Sec.  
507.5(c). The circumstances that may lead FDA to withdraw an exemption 
include an active investigation of a foodborne illness outbreak that is 
directly linked to a qualified facility, or the Agency's determination 
that it is necessary to protect animal or human health and prevent or 
mitigate a foodborne illness outbreak based on conduct or conditions 
associated with a qualified facility that are material to the safety of 
the animal food manufactured, processed, packed, or held at such 
facility. Such circumstances require prompt action. Under Sec.  16.120, 
a qualified facility that disagrees with FDA's decision to withdraw an 
exemption provided under Sec.  507.5(c) has an opportunity for judicial 
review in accordance with Sec.  10.45.

I. Proposed Sec.  507.75--Presiding Officer for an Appeal and for an 
Informal Hearing

    Proposed Sec.  507.75 would require that the presiding officer for 
an appeal, and for an informal hearing, must be an FDA Regional Food 
and Drug Director or another FDA official senior to an FDA District 
Director. Under Sec.  16.42(b), an officer presiding over an informal 
hearing is to be free from bias or prejudice and may not have 
participated in the investigation or action that is the subject of the 
hearing or be subordinate to a person, other than the Commissioner, who 
has participated in such investigation or action. An order for the 
withdrawal of an exemption applicable to a qualified facility must be 
approved by a District Director or an official senior to a District 
Director. It is therefore necessary that appeals of a decision to issue 
a withdrawal order should be handled by persons in positions senior to 
the District Directors. The Regional Food and Drug Director is such a 
person and could be from the same region where the facility is located, 
provided that the Regional Food and Drug Director did not participate 
in the determination that an exemption should be withdrawn and is 
otherwise free from bias or prejudice. Alternatively, the Regional Food 
and Drug Director could be from a different region than the region 
where the facility is located, for example in the event the Regional 
Food and Drug Director for the region in which the facility is located 
is the FDA official who approved the withdrawal order.

J. Proposed Sec.  507.77--Timeframe for Issuing a Decision on an Appeal

    Proposed Sec.  507.77(a) would require that, if the owner, 
operator, or agent in charge of a facility appeals the order without 
requesting a hearing, the presiding officer must issue a written report 
that includes a final decision confirming or revoking the withdrawal by 
the tenth calendar day after the appeal is filed. Under proposed Sec.  
507.60, FDA would issue a withdrawal order either in the event of an 
active investigation of a foodborne illness outbreak that is directly 
linked to a qualified facility or if FDA determines that an exemption 
withdrawal is necessary to protect animal or human health and prevent 
or mitigate a foodborne illness outbreak based on conduct or conditions 
associated with a qualified facility that are material to the safety of 
the animal food located at the facility. The Agency tentatively 
concludes that it will need 10 calendar days to review the written 
appeal and the materials submitted with the written appeal, and that a 
final decision confirming or revoking a withdrawal order should be 
issued as quickly as possible in the interest of the public health and 
to provide reasonable due process that would come to closure 
sufficiently in advance of the effective date of the order to provide 
an opportunity for the facility to come into compliance if the Agency 
denies the appeal.
    Proposed Sec.  507.77(b)(1) would require that, if the owner, 
operator, or agent in charge of a facility appeals the order and 
requests an informal hearing and, if FDA grants the request for a 
hearing and the hearing is held, the presiding officer must provide a 2 
calendar day opportunity for the hearing participants to review and 
submit comments on the report of the hearing under Sec.  507.73(c)(4), 
and must issue a final decision within the 10 calendar day period after 
the hearing is held. The Agency tentatively concludes that it is 
appropriate to grant the owner, operator, or agent in charge of a 
qualified facility subject to a withdrawal order the opportunity to 
review and submit comments to the presiding officer's report because 
the report is part of the record of a final agency action (see 
discussion of proposed Sec.  507.83 in this section of the document) 
that is not subject to further reconsideration by FDA. The presiding 
officer would have discretion to determine whether to revise the report 
of the hearing in light of any comments that might be submitted by any 
of the hearing participants.
    Proposed Sec.  507.77(b)(2) would require that, if the owner, 
operator, or agent in charge of a facility appeals the order and 
requests an informal hearing and if FDA denies the request for a 
hearing, the presiding officer must issue a final decision on the 
appeal confirming or

[[Page 64814]]

revoking the withdrawal within 10 calendar days after the date the 
appeal is filed. The Agency tentatively concludes that ten calendar 
days for the presiding officer to issue a final decision is appropriate 
for purposes of the efficient adjudication of the appeal of a 
withdrawal order, would provide reasonable due process that would come 
to closure sufficiently in advance of the effective date of the order 
to provide an opportunity for the facility to come into compliance if 
the Agency denies the appeal, and is in the interest of animal or human 
health.

K. Proposed Sec.  507.80--Revocation of an Order To Withdraw an 
Exemption Applicable to a Qualified Facility

    Proposed Sec.  507.80(a) through (c) would establish that an order 
to withdraw an exemption applicable to a qualified facility under Sec.  
507.5(c) is revoked if:
     The owner, operator, or agent in charge of the facility 
appeals the order and requests an informal hearing, FDA grants the 
request for an informal hearing, and the presiding officer does not 
confirm the order within the 10 calendar days after the hearing, or 
issues a decision revoking the order within that time; or
     The owner, operator, or agent in charge of the facility 
appeals the order and requests an informal hearing, FDA denies the 
request for an informal hearing, and FDA does not confirm the order 
within the 10 calendar days after the appeal is filed, or issues a 
decision revoking the order within that time; or
     The owner, operator, or agent in charge of the facility 
appeals the order without requesting an informal hearing, and FDA does 
not confirm the order within the 10 calendar days after the appeal is 
filed, or issues a decision revoking the order within that time.
    The Agency tentatively concludes that an order to withdraw an 
exemption may be revoked in one of two manners. First, the Agency is 
proposing that the FDA officer responsible for adjudicating the appeal 
and presiding over a hearing, if one is granted, may expressly issue a 
written decision revoking the order within the specified 10 calendar 
day timeframes. Second, the Agency is proposing that the failure of the 
FDA officer responsible for adjudicating an appeal to issue a final 
decision expressly confirming the order within the specified timeframes 
will also serve to revoke the order. The Agency tentatively concludes 
that fairness would warrant the revocation of a withdrawal order if FDA 
is unable to meet the proposed deadlines for expressly confirming an 
order.

L. Proposed Sec.  507.84--Final Agency Action

    Proposed Sec.  507.84 would establish that confirmation of a 
withdrawal order by the presiding officer is considered a final agency 
action for purposes of section 702 of title 5 of the United States Code 
(5 U.S.C. 702). A confirmation of an order withdrawing an exemption 
therefore would be reviewable by the courts under section 702 of title 
5 and in accordance with Sec.  10.45.

M. Conforming Amendment to 21 CFR Part 16

    The Agency proposes to amend Sec.  16.1(b)(2) to include part 507, 
subpart D, relating to the withdrawal of an exemption applicable to a 
qualified facility, to the list of regulatory provisions under which 
regulatory hearings are available.

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

A. Relevant Statutory Provisions

    FDA is proposing to create a new subpart F to establish 
requirements applying to records that must be established and 
maintained according to the requirements of this proposed rule. As 
discussed in section X.J, section 418 of the FD&C Act prescribes 
several requirements relevant to recordkeeping. The statutory 
provisions that are most relevant to proposed subpart F are:
     Section 418(a) of the FD&C Act, which requires, in 
relevant part, that the owner, operator, or agent in charge of a 
facility maintain records of monitoring the performance of preventive 
controls as a matter of routine practice;
     Section 418(b)(3) of the FD&C Act, which requires, in 
relevant part, that the owner, operator, or agent in charge of a 
facility develop a written analysis of the hazards;
     Section 418(g) of the FD&C Act, which requires, in 
relevant part, that the owner, operator, or agent in charge of a 
facility maintain certain records for not less than 2 years. The 
records identified in section 418(g) include records documenting the 
monitoring of the preventive controls implemented under section 418(c) 
of the FD&C Act, instances of nonconformance material to food safety, 
the results of testing and other appropriate means of verification 
under section 418(f)(4) of the FD&C Act, instances when corrective 
actions were implemented, and the efficacy of preventive controls and 
corrective actions;
     Section 418(h) of the FD&C Act, which requires, in 
relevant part, that the owner, operator, or agent in charge of a 
facility prepare a written plan that documents and describes the 
procedures used by the facility to comply with the requirements of this 
section and that such written plan, together with documentation 
described in section 418(g) of the FD&C Act, shall be made promptly 
available to a duly authorized representative of the Secretary upon 
oral or written request;
     Section 418(n)(1)(A) of the FD&C Act, which provides, in 
relevant part, that FDA shall issue regulations to establish science-
based minimum standards for documenting hazards and documenting the 
implementation of the preventive controls under this section;
     Section 402(a)(4) of the FD&C Act, which provides that 
food is adulterated 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 701(a) of the FD&C Act 21 U.S.C. 371(a), which 
provides FDA with authority to issue regulations for the efficient 
enforcement of the FD&C Act;
     Section 361(a) of the Public Health Service Act (42 U.S.C. 
264(a)), which provides FDA with authority to make and enforce such 
regulations as in FDA's judgment are necessary to prevent the 
introduction, transmission, or spread of communicable diseases from 
foreign countries into the States or possessions, or from one State or 
possession into any other State or possession; and
     Section 418(l)(2)(B) of the FD&C Act, which requires a 
qualified facility to submit documentation to 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.

B. Proposed Sec.  507.100--Records Subject to the Requirements of This 
Subpart F

    Proposed Sec.  507.100(a) would establish that, except as provided 
by proposed Sec.  507.100(d) and (e), all records required by proposed 
part 507 would be subject to all requirements of proposed subpart F. 
FDA tentatively concludes that the requirements in proposed subpart F 
describing how records must be established and maintained, including 
the general requirements, record retention requirements, and 
requirements for official review and public disclosure, are applicable 
to all records that would be required under all subparts, because 
records that would be required under each of the subparts aid

[[Page 64815]]

plants and facilities in compliance with the requirements of proposed 
part 507; and allow plants and facilities to show, and FDA to 
determine, compliance with the requirements of proposed part 507.
    Proposed Sec.  507.100(b) would establish that all records required 
by proposed part 507 are subject to the disclosure requirements under 
part 20 (21 CFR part 20). FDA's regulations in part 20, the Freedom of 
Information Act (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 1905), 
and the FD&C Act, govern FDA's disclosures of information, including 
treatment of commercial confidential information and trade secret 
information. The Agency's general policies, procedures, and practices 
relating to the protection of confidential information received from 
third parties would apply to information received under this rule.
    Proposed Sec.  507.100(c) would require that all records required 
by part 507 be made promptly available to a duly authorized 
representative of the Secretary upon oral or written request. Proposed 
Sec.  507.100(c) implements subsection 418(h) of the FD&C Act and is 
necessary in order for FDA to determine compliance with the 
requirements of part 507.
    Proposed Sec.  507.100(c) does not explicitly require a facility to 
send records to the Agency rather than making the records available for 
review at a facility's place of business. FDA requests comments on 
whether proposed Sec.  507.100(c) should be modified to explicitly 
address this circumstance, and if so, whether FDA should require that 
the records be submitted electronically. Obtaining a facility's food 
safety plan without going to a facility could be useful to FDA in a 
number of different circumstances, such as to determine whether a 
recently identified hazard is being addressed by affected facilities.
    Proposed Sec.  507.100(d) would establish that the requirements of 
proposed Sec.  507.100 apply only to the written food safety plan and 
is discussed in more detail in section XII.D.
    Proposed Sec.  507.100(e) would provide that the requirements of 
Sec.  507.102(a)(2), (a)(4), and (a)(5) and (b) do not apply to the 
records required by proposed Sec.  507.7(e) pertaining to qualified 
facilities. As discussed in section VIII.D, proposed Sec.  507.7(e) 
would require that a qualified facility maintain records relied upon to 
support the self-certification that would be required by proposed Sec.  
507.7(a). Such documentation would be directed to the financial basis 
(and, when applicable, percentage of sales to qualified end users) as 
well as to food safety practices at the qualified facility, and could 
range from invoices to a food safety plan to an operating license 
issued by a state or local authority. Such records would not be 
expected to satisfy the provisions of proposed Sec.  507.102(a)(2), 
(a)(4), and (a)(5) and (b) (which are discussed in the next section). 
To make clear that a qualified facility need not comply with provisions 
that do not apply to its records, the Agency is proposing to specify 
that those provisions do not apply to such records.

C. Proposed Sec.  507.102--General Requirements Applying to Records

    Proposed Sec.  507.102 contains general requirements that would 
apply to records that would be required under proposed part 507, 
including the format for required records, the recording of actual 
values and observations obtained during monitoring, when records must 
be created, and information that must be included in each record.
1. Proposed Sec.  507.102(a)
    Proposed Sec.  507.102(a)(1) would require that the records be kept 
as original records, true copies (such as photocopies, pictures, 
scanned copies, microfilm, microfiche, or other accurate reproductions 
of the original records), or electronic records. True copies of records 
should be of sufficient quality to detect whether the original record 
was changed or corrected in a manner that obscured the original entry 
(e.g., through the use of white-out). Proposed Sec.  507.102(a)(1) 
would provide flexibility for mechanisms for keeping records while 
maintaining the integrity of the recordkeeping system. The proposed 
requirement allowing true copies provides options that may be 
compatible with the way records are currently being kept in plants and 
facilities.
    Proposed Sec.  507.102(a)(1) also would require that electronic 
records be kept in accordance with part 11 (21 CFR part 11). Part 11 
provides criteria for acceptance by FDA, under certain circumstances, 
of electronic records, electronic signatures, and handwritten 
signatures executed to electronic records as equivalent to paper 
records and handwritten signatures executed on paper. The proposed 
requirement clarifies and acknowledges that records required by part 
507 may be retained electronically, provided that they comply with part 
11.
    FDA tentatively concludes that it is appropriate to apply the 
requirements of part 11 to the records that would be required to be 
kept under proposed part 507. However, the Agency requests comment on 
whether there are any circumstances that would warrant not applying 
part 11 to records that would be kept under proposed part 507. For 
example, would a requirement that electronic records be kept according 
to part 11 mean that current electronic records and recordkeeping 
systems would have to be recreated and redesigned, which the Agency 
determined to be the case in the regulation ``Establishment and 
Maintenance of Records Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002'' (69 FR 71562, 
December 9, 2004 (the BT records regulation)). For the purposes of the 
records requirements in the BT records regulation, the Agency concluded 
that it was not necessary for new recordkeeping systems to be 
established as long as current practices would satisfy the requirements 
of the Act and, therefore, the Agency exempted the records from the 
requirements of part 11 (Sec.  1.329(b)). The Agency also exempted 
records related to certain cattle materials prohibited from use in 
human food and cosmetics from part 11 (21 CFR 189.5(c)(7) and 
700.27(c)(7), respectively). The Agency also seeks comment on whether 
it should allow additional time for electronic records to be kept in 
accordance with part 11. Comments should provide the basis for any view 
that the requirements of part 11 are not warranted.
2. Proposed Sec.  507.102(a)(2)
    Proposed Sec.  507.102(a)(2)would require that records contain the 
actual values and observations obtained during monitoring. It is 
neither possible to derive the full benefits of a preventive controls 
system, nor to verify the operation of the system, without recording 
actual values and observations to produce an accurate record. Notations 
that monitoring measurements, such as heat treatment temperatures, are 
``satisfactory'' or ``unsatisfactory,'' without recording the actual 
times and temperatures, are vague and subject to varying 
interpretations and, thus, will not ensure that controls are working 
properly. In addition, it is not possible to discern a trend toward 
loss of control without actual measurement values.
3. Proposed Sec.  507.102(a)(3), (a)(4), and (a)(5)
    Proposed Sec.  507.102(a)(3), (a)(4), and (a)(5) would require that 
records be accurate, indelible, and legible (proposed Sec.  
507.102(a)(3)); be created concurrently with performance of the 
activity documented (proposed

[[Page 64816]]

Sec.  507.102(a)(4)); and be as detailed as necessary to provide a 
history of work performed (proposed Sec.  507.102(a)(5)). Proposed 
Sec.  507.102(a)(3) and (a)(4) would ensure that the records are useful 
to the owner, operator, or agent in charge of a plant or facility in 
complying with the requirements of proposed part 507, for example, in 
documenting compliance with monitoring requirements and verifying 
compliance with the food safety plan. These proposed requirements would 
also ensure that the records would be useful to FDA in determining 
compliance with the requirements of proposed part 507. Proposed Sec.  
507.102(a)(5) would provide flexibility to plants and facilities to 
tailor the amount of detail to the nature of the record.
4. Proposed Sec.  507.102(b)
    Proposed Sec.  507.102(b)would require that the records include: 
(1) The name and location of the plant or facility; (2) the date and 
time of the activity documented; (3) the signature or initials of the 
person performing the activity; and (4) where appropriate, the identity 
of the product and the production code, if any. The name and location 
of the plant or facility and the date and time would allow the owner, 
operator, or agent in charge of a plant or facility (and, during 
inspection, an FDA investigator) to assess whether the record is 
current, to identify when and where any deviation occurred, and to 
track corrective actions. The signature of the individual who made the 
observation would ensure responsibility and accountability. In 
addition, if there is a question about the record, a signature would 
ensure that the source of the record will be known. Linking a record to 
a specific product (and, when applicable, the production code) would 
enable the owner, operator, or agent in charge of a facility to isolate 
product that has not been processed properly when there has been a 
problem, thereby limiting the impact of the problem (such as the need 
to reprocess product or to recall product) to only those lots with the 
problem.

D. Proposed Sec.  507.106--Additional Requirements Applying to the Food 
Safety Plan

    Proposed Sec.  507.106 would require that the owner, operator, or 
agent in charge of a facility sign and date the food safety plan upon 
initial completion and upon any modification. Such a signature would 
provide direct evidence of the owner, operator, or agent's acceptance 
of the plan and commitment to implementation of the plan. Additionally, 
the signature, along with the date of signing, would serve to minimize 
potential confusion over the authenticity of any differing versions or 
editions of the document that might exist.

E. Proposed Sec.  507.108--Requirements for Record Retention

    Proposed Sec.  507.108 contains requirements on the length of time 
records that would be required under proposed part 507 must be retained 
and allowances for offsite storage of records under certain 
circumstances.
1. Proposed Sec.  507.108(a) and (b)
    Proposed Sec.  507.108(a) would require that all records that would 
be required by proposed part 507 be retained at the plant or facility 
for at least 2 years after the date they were prepared. Proposed Sec.  
507.108(b) would require that records that relate to the general 
adequacy of the equipment or processes being used by a facility, 
including the results of scientific studies and evaluations, must be 
retained at the facility for at least 2 years after their use is 
discontinued (e.g., because the facility has updated the written food 
safety plan (Sec.  507.30) or records that document validation of the 
written food safety plan (Sec.  507.45(a)). Proposed Sec.  507.108(a) 
and (b) implement subsection 418(g) of the FD&C Act, which requires 
certain records to be maintained for not less than 2 years.
    While FDA established shorter records retention requirements for 
records related to perishable foods in the BT records, seafood HACCP, 
and juice HACCP regulations, in this case Congress determined and 
specified in section 418(g) of the FD&C Act that the minimum retention 
period for the majority of the records required under the implementing 
regulations for all foods, regardless of perishability, be 2 years. 
Therefore, FDA tentatively concludes that the same requirement should 
apply to all records required under this section, regardless of the 
perishability of the food to which the record relates. This would 
simplify plants' or facilities' duties in compliance because there 
would only be one 2-year retention period to apply to any record 
required under proposed part 507. This 2-year retention period would 
run either from the date the record was prepared, for day-to-day 
operational records; or from the date at which use of the record is 
discontinued, for records relating to the general adequacy or equipment 
or processes (e.g., the written food safety plan and records that 
document validation of the written food safety plan). The Agency 
requests comments on the record keeping requirements for animal food, 
including whether the Agency should use its authority in section 418(m) 
of the FD&C Act to modify these requirements with respect to facilities 
that are solely engaged in the production of food for animals other 
than man.
2. Proposed Sec.  507.108(c)
    Proposed Sec.  507.108(c) would provide that, except for the food 
safety plan, use of offsite storage for records is permitted after 6 
months following the date that the record was made if such records can 
be retrieved and provided onsite within 24 hours of request for 
official review. The food safety plan would be required to remain 
onsite. FDA realizes that the proposed requirements for recordkeeping 
could require some plants or facilities to store a significant quantity 
of records, and that there may not be adequate storage space in the 
plant or facility for all of these records. Providing for offsite 
storage of most records after 6 months would enable a facility to 
comply with the proposed requirements for record retention while 
reducing the amount of space needed for onsite storage of the records 
without interfering with the purpose of record retention, because the 
records will be readily available.
    Proposed Sec.  507.108(c) would also provide that electronic 
records are considered to be onsite if they are accessible from an 
onsite location. Computerized systems within corporations can be 
networked, allowing for the sending and receiving of information in a 
secure fashion to all of the different food processing facilities of 
that corporation worldwide. This type of system can be used to provide 
access at multiple locations to records from multiple plants or 
facilities.
3. Proposed Sec.  507.108(d)
    Proposed Sec.  507.108(d) would provide that if the plant or 
facility is closed for a prolonged period, the records may be 
transferred to some other reasonably accessible location but must be 
returned to the plant or facility within 24 hours for official review 
upon request. Allowing for transfer of records will give practical 
storage relief to seasonal operations or those closed for other reasons 
for prolonged periods.

XIII. FSMA's Rulemaking Provisions

    Please see this discussion in section XVI of the document for the 
proposed rule for preventive controls for human food (78 FR 3646).

[[Page 64817]]

XIV. Proposed Conforming Changes

    FDA is proposing conforming changes to several applicable sections 
of the CFR that would add a reference to part 507. The affected 
sections in title 21 CFR are:
     Sec.  225.1 Current good manufacturing practice;
     Sec.  500.23 Thermally processed low-acid foods packaged 
in hermetically sealed containers; and
     Sec.  579.12 Incorporation of regulations in part 179.

XV. Legal Authority

    FDA is proposing the CGMP regulations under the FD&C Act and the 
Public Health Service Act. FDA is proposing all other requirements 
under the FDA Food Safety Modernization Act, the FD&C Act, the Public 
Health Service Act, and the FDAAA of 2007.

A. Current Good Manufacturing Practice Regulations

    FDA is proposing CGMP requirements in proposed subparts A, B, and 
F. FDA's legal authority to require CGMPs derives from sections 
402(a)(3), 402(a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 
342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that 
a food is adulterated 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)(4) of the FD&C Act provides that a food is adulterated 
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. Under section 701(a) of the 
FD&C Act, FDA is authorized to issue regulations for the efficient 
enforcement of the FD&C Act. The proposed rule also includes new 
requirements necessary to prevent food from being adulterated (either 
because it consists in whole or in part of a filthy, putrid, or 
decomposed substance, because it is otherwise unfit for food, or 
because it has been held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health). A regulation that requires measures to 
prevent food from being held under insanitary conditions whereby either 
of the proscribed results may occur allows for the efficient 
enforcement of the FD&C Act. See, e.g., regulations to require HACCP 
systems for fish and fishery products (part 123) and juice (part 120), 
regulations to require a safe handling statement on cartons of shell 
eggs that have not been treated to destroy Salmonella organisms and to 
require refrigeration of shell eggs held for retail distribution (part 
101 and 21 CFR part 115), and regulations for the production, storage, 
and transportation of shell eggs (21 CFR part 118).
    In addition to the FD&C Act, FDA's legal authority for the proposed 
CGMP requirements derives from the PHS Act to the extent such measures 
are related to communicable disease. Authority under the PHS Act for 
the proposed regulations is derived from the provisions of sections 
311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to 
communicable disease. The PHS Act authorizes the Secretary to make and 
enforce such regulations as ``are necessary to prevent the 
introduction, transmission, or spread of communicable diseases from 
foreign countries into the States . . . or from one State . . . into 
any other State'' (section 361(a) of the PHS Act). (See sec. 1, Reorg. 
Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the 
Surgeon General to the Secretary.) Many provisions in the proposed rule 
are necessary to prevent animal food from being contaminated with 
microorganisms of human health significance, such as Salmonella, and 
therefore to prevent the introduction, transmission, or spread of 
communicable disease from foreign countries into the United States, or 
from one state in the United States to another. As discussed in section 
II.E and X.C.6, lack of adequate sanitation in food establishments can 
lead to the contamination of food with pathogens, increasing the 
likelihood of illness in humans consuming products derived from animals 
(such as milk and eggs) and illness in humans handling animal food, 
particularly in the household setting. The Agency tentatively concludes 
that the proposed CGMPs are necessary to prevent the spread of 
communicable disease and to prevent animal food from containing filthy, 
putrid, or decomposed substances, being otherwise unfit for food, or 
being 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.

B. Hazard Analysis and Risk-Based Preventive Controls

    Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive 
Controls, amends the FD&C Act to create a new section 418, which 
mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that 
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. 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. 
Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act 
(21 U.S.C. 331(uu)) to prohibit the 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.
    In addition to rulemaking requirements, section 418 contains 
requirements applicable to the owner, operator, or agent in charge of a 
facility required to register under section 415. 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 
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, in relevant 
part, 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 the general requirements in section 418(a) of the FD&C Act, 
sections 418(b)-(i) contain more specific requirements applicable to 
facilities. These include hazard analysis (Sec.  418(b)), preventive 
controls (Sec.  418(c)), monitoring (Sec.  418(d)), corrective actions 
(Sec.  418(e)), verification (Sec.  418(f)), recordkeeping (Sec.  
418(g)), a written plan and documentation (Sec.  418(h)), and 
reanalysis of hazards (Sec.  418(i)). Proposed requirements (proposed 
subparts C and F) that would implement these provisions of section 418 
of the FD&C Act are discussed in sections X and XII.
    The Agency is proposing certain requirements in order to 
efficiently enforce these requirements of section 418. For example, 
section 418(g) and (h) of the FD&C Act prescribe certain recordkeeping, 
maintenance, and access requirements for certain kinds of records. As 
discussed in section XII, the Agency is proposing to establish one set 
of requirements that would apply to all records that would be required 
under the proposed rule. This approach will facilitate compliance with 
the rule on the part of facilities, and will allow for

[[Page 64818]]

efficient enforcement of the requirements of the FD&C Act.
    Section 418(j) through (m) of the FD&C Act and section 103(c)(1)(D) 
and (g) of FSMA provide authority for certain exemptions and 
modifications to the requirements of section 418 of the FD&C Act. These 
include provisions related to low-acid canned food (section 418(j)); 
activities of facilities subject to section 419 of the FD&C Act 
(Standards for Produce Safety) (section 418(k)); qualified facilities 
(section 418(l)); facilities that are solely engaged in the production 
of food for animals other than man, the storage of raw agricultural 
commodities (other than fruits and vegetables) intended for further 
distribution or processing, or the storage of packaged foods that are 
not exposed to the environment (section 418(m)); and facilities engaged 
only in certain low-risk on-farm activities on certain foods conducted 
by small or very small businesses (section 103(c)(1)(D) of FSMA). 
Proposed provisions that would implement these provisions of section 
418 of the FD&C Act and section 103 of FSMA are discussed in sections 
VII, VIII, and X.
    FDA tentatively concludes that the provisions in proposed subpart C 
and related requirements in proposed subparts A, D, and F should be 
applicable to activities that are intrastate in character. Facilities 
are required to register under section 415 of the FD&C Act regardless 
of whether the food from the facility enters interstate commerce (Sec.  
1.225(b)). The plain language of section 418 of the FD&C Act applies to 
facilities that are required to register under section 415 (section 
418(o)(2) of the FD&C Act) and does not exclude a facility because food 
from such a facility is not in interstate commerce. Section 301(uu) of 
the FD&C Act provides that ``the 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'', or the causing thereof, is a 
prohibited act.
    FDA also is proposing the provisions in subpart C and related 
requirements in subparts A, D, and F, under sections 402(a)(3), (a)(4), 
and 701(a) of the FD&C Act to the extent such requirements are 
necessary to prevent food from being held under insanitary conditions 
whereby it may become contaminated with filth or rendered injurious to 
health, or being unfit for food. FDA is also proposing those provisions 
under sections 311, 361, and 368 of the PHS Act relating to 
communicable disease to the extent those provisions are necessary to 
prevent the interstate spread of communicable disease.
    The animal food safety system that the Agency is proposing would 
require a facility to conduct a hazard analysis to determine those 
hazards that are reasonably likely to occur and establish and implement 
preventive controls for those hazards. To ensure that controls are 
properly implemented and effectively controlling the hazards, the 
proposed animal food safety system would establish requirements for 
monitoring, corrective actions, and verification, including validation 
that the preventive controls are adequate to control the identified 
hazards. The proposed animal food safety system also would require a 
recall plan. Certain activities would be required to be conducted (or 
overseen) by a qualified individual and certain activities would be 
required to be documented. A written food safety plan would include the 
hazard analysis, the preventive controls that would be established and 
implemented to address those hazards determined to be reasonably likely 
to occur, procedures for monitoring, corrective actions, and 
verification; and a recall plan. The written plan and other 
documentation would be required to be made promptly available to a duly 
authorized representative of the Secretary upon oral or written 
request. FDA tentatively concludes that, taken as a whole, the animal 
food safety system described here is necessary to help prevent food 
safety problems associated with biological, chemical, physical, and 
radiological hazards in animal foods. Therefore, the proposed system is 
necessary to prevent animal food from being adulterated because it is 
unfit for food or because it has been held under insanitary conditions 
whereby it may become contaminated with filth or may be rendered 
injurious to health and to prevent the spread of communicable disease.
    Finally, FDA is proposing the provisions in subparts B and C and 
related requirements in subparts A, D, and F, under section 1002(a) of 
Title X of the FDAAA of 2007 (21 U.S.C. 2102), which requires the 
Secretary to establish processing standards for pet food. The proposed 
animal food safety system would require tailored standards for 
facilities processing animal food (including animal feed, pet food, and 
their raw materials and ingredients).

XVI. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). FDA has developed a PRIA that presents the benefits and costs 
of this proposed rule (Ref. 52). FDA believes that the proposed rule 
will be a significant regulatory action as defined by Executive Order 
12866. FDA requests comments on the PRIA.
    The summary analysis of benefits and costs included in this 
document is drawn from the detailed PRIA (Ref. 52) which is available 
at http://www.regulations.gov (enter Docket No. FDA-2011-N-0922), and 
is also available on FDA's Web site at http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM366905.pdf.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because many small businesses will need to implement 
a number of new preventive controls, FDA acknowledges that the final 
rules resulting from this proposed rule will have a significant 
economic impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Pub. L. 104-121) defines a major rule for the purpose of congressional 
review as having caused or being likely to cause one or more of the 
following: An annual effect on the economy of $100 million or more; a 
major increase in costs or prices; significant adverse effects on 
competition, employment, productivity, or innovation; or significant 
adverse effects on the ability of United States-based enterprises to 
compete with foreign-based enterprises in domestic or export markets. 
In accordance with the Small Business Regulatory Enforcement Fairness 
Act, the Office of Management and Budget (OMB) has determined that this 
proposed rule is a major rule for the purpose of congressional review.

[[Page 64819]]

D. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects that the 
proposed rule will result in a 1-year expenditure that would exceed 
this amount.

E. Public Access to the Analyses

    The analyses that FDA has performed in order to examine the impacts 
of this proposed rule under Executive Order 12866, Executive Order 
13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) are available to 
the public in the docket for this proposed rule (Ref. 52).

XVII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in the proposed 
rule have been submitted to OMB for review under section 3507(d) of the 
Paperwork Reduction Act of 1995. FDA invites comments on: (1) Whether 
the proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. All comments should be 
identified with the title ``Current Good Manufacturing Practice And 
Hazard Analysis And Risk-Based Preventive Controls For Food For 
Animals.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.
    The analyses that FDA has performed in order to examine the impacts 
of this proposed rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520) is available to the public in the docket (Docket No. 
FDA-2011-N-0922) for this proposed rule (Ref. 96).

XVIII. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

XIX. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

XX. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XXI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
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Food for Animals'' July 2013.

[[Page 64820]]

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on August 27, 2013).
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on August 27, 2013).
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and World Health Organization (WHO), ``Good practices for the feed 
industry--Implementing the Codex Alimentarius Code of Practice on 
Good Animal Feeding Section 3 Good Production Practices'' 2011.
44. British Standards Institute (BSI), ``Publicly Available 
Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety 
in the Manufacture of Food and Feed for Animals,'' 2011.
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August 27, 2013, (Accessed on August 27, 2013).
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August, 2010.
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Approach to Targeting Inspection Resources and Identifying Patterns 
of Adulteration. First Annual Report: September 8, 2009-September 7, 
2010,'' January, 2011.
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2, 2005, Page Last Updated: June 17, 2013 (accessed on August 27, 
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[[Page 64821]]

50. FDA Memorandum, ``Food GMP Modernization Working Group: Summary 
of Food Recalls, 1999-2003,'' 2004.
51. FDA Memorandum, ``Analysis of Food Recalls Initiated in 2008-
2009 by an FDA CGMP Working Group,'' 2012.
52. FDA, ``Preliminary Regulatory Impact Analysis,'' 2013.
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fumonisin contamination of corn (maize, Zea mays) hybrids in 
Arkansas,'' Crop Protection, 25, 1-9, 2006.
54. European Food Safety Authority, ``Gossypol as undesirable 
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55. Rotter, B. A., D. B. Prelusky, and James J. Pestka, ``Invited 
Review: Toxicology of Deoxynivalenol (Vomitoxin), '' Journal of 
Toxicology and Environmental Health, Part A, 48, 1-34, 1996.
56. Johnson, W. D. and R. W. Storts, ``Peripheral Neuropathy 
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57. Gries, C. L. and M. L. Scott, ``The Pathology of Thiamin, 
Riboflavin, Pantothenic Acid and Niacin Deficiencies in the Chick,'' 
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58. Phillips, P. H. and R. W. Engel, ``The Histopathology of 
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During 1998 and 1999 and Detection of Salmonella spp in Grain and 
Concentrate Sources on Equine Operations,'' JAVMA, 217, 226-230, 
2000.
63. Fedorka-Cray, P. J., A. Hogg, J. T. Gray, et al., ``Feed and 
Feed Trucks as Sources of Salmonella Contamination in Swine,'' Swine 
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64. D'Mello, J. P. F. and A. M. C. Macdonald, ``Mycotoxins,'' Animal 
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of Mycotoxins in Europe,'' Toxicology Letters, 127, 19-28, 2002.
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Journal, 182, 176-786, 2009.
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[[Page 64822]]

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143, 2002.
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Environment on Salmonellae Contamination of Dry Milk Products'', 
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96. FDA,''Paperwork Reduction Act Analysis,'' 2013.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 225

    Animal drugs, Animal feeds, Labeling, Packaging and containers, 
Reporting and recordkeeping requirements.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCB's).

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 579

    Animal feeds, Animal foods, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR chapter I be amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. In Sec.  16.1, in paragraph (b)(2) add the following entry in 
numerical order to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  507.60 through 507.83 (part 507, subpart D) relating to 
withdrawal of exemption applicable to a qualified facility.
* * * * *

PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

0
3. The authority citation for 21 CFR part 225 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360b, 371, 374.

0
4. In Sec.  225.1, add paragraph (d) to read as follows:

Sec.  225.1  Current good manufacturing practice.

* * * * *
    (d) In addition, non-medicated feed is subject to part 507 of this 
chapter.

PART 500--GENERAL

0
5. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.

0
6. Revise Sec.  500.23 to read as follows:

Sec.  500.23  Thermally processed low-acid foods packaged in 
hermetically sealed containers.

    Except as provided in Sec.  507.5(b), the provisions of parts 507 
and 113 of this chapter apply to the manufacturing, processing, or 
packing of low-acid foods in hermetically sealed containers, and 
intended for use as food for animals.
0
7. Add part 507 to read as follows:

PART 507--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS 
AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

Subpart A--General Provisions
Sec.
507.1 Applicability and status.
507.3 Definitions.
507.5 Exemptions.
507.7 Requirements that apply to a qualified facility.
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.
Subpart B--Current Good Manufacturing Practice
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitary operations.
507.20 Sanitary facilities and controls.
507.22 Equipment and utensils.
507.25 Processes and controls.
507.28 Warehousing and distribution.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
507.30 Requirement for a food safety plan.
507.33 Hazard analysis.
507.36 Preventive controls for hazards that are reasonably likely to 
occur.
507.38 Recall plan for animal food with a hazard that is reasonably 
likely to occur.
507.39 Monitoring.
507.42 Corrective actions.
507.45 Verification.
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.
507.50 Requirements applicable to a qualified individual.
507.55 Records required for this subpart C.
Subpart D--Withdrawal of an Exemption Applicable to a Qualified 
Facility
507.60 Circumstances that may lead FDA to withdraw an exemption 
applicable to a qualified facility.
507.62 Issuance of an order to withdraw an exemption applicable to a 
qualified facility.
507.65 Contents of an order to withdraw an exemption applicable to a 
qualified facility.
507.67 Compliance with, or appeal of, an order to withdraw an 
exemption applicable to a qualified facility.
507.69 Procedure for submitting an appeal.
507.71 Procedure for requesting an informal hearing.
507.73 Requirements applicable to an informal hearing.
507.75 Presiding officer for an appeal and for an informal hearing.
507.77 Timeframe for issuing a decision on an appeal.
507.80 Revocation of an order to withdraw an exemption applicable to 
a qualified facility.
507.83 Final agency action.
Subpart E--[Reserved]
Subpart F--Requirements Applying to Records That Must Be Established 
and Maintained
507.100 Records subject to the requirements of this subpart F.
507.102 General requirements applying to records.
507.106 Additional requirements applying to the food safety plan.
507.108 Requirements for record retention.

    Authority: 21 U.S.C. 321, 331, 342, 350c, 350d note, 350g, 350g 
note, 371, 374; 42 U.S.C. 243, 264, 271.

Subpart A--General Provisions

Sec.  507.1  Applicability and status.

    (a) The criteria and definitions in this part will apply in 
determining whether an animal food is adulterated:
    (1) Within the meaning of section 402(a)(3) of the Federal Food, 
Drug, and

[[Page 64823]]

Cosmetic Act in that the food has been manufactured under such 
conditions that it is unfit for food; or
    (2) Within the meaning of section 402(a)(4) of the Federal Food, 
Drug, and Cosmetic Act in that the food 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. The criteria and definitions in this part also apply in 
determining whether an animal food is in violation of section 361 of 
the Public Health Service Act (42 U.S.C. 264).
    (b) The operation of a facility that manufactures, processes, 
packs, or holds animal food for sale in the United States if the owner, 
operator, or agent in charge of such facility is required to comply 
with and is not in compliance with section 418 of the Federal Food, 
Drug, and Cosmetic Act or subparts C, D, and F of this part and Sec.  
507.7 is a prohibited act under section 301(uu) of the Federal Food, 
Drug, and Cosmetic Act.
    (c) Animal food covered by specific current good manufacturing 
practice regulations also is subject to the requirements of those 
regulations.
    (d) Animal food for sale in the United States must be manufactured, 
processed, packed, and held in accordance with the requirements in this 
part, subject to the exemptions in Sec.  507.5. If a facility is 
required to comply with subpart B of this part and is also required to 
comply with subpart B of part 117 of this chapter because the facility 
manufactures, processes, packs, or holds human food, then the facility 
may choose to comply with the requirements in subpart B of part 117, 
instead of subpart B of part 507, as to the manufacturing, processing, 
packing, and holding of animal food at that facility. If a facility is 
required to comply with subpart C of part 507 and is also required to 
comply with subpart C of part 117 of this chapter, then the facility 
may choose to comply with the requirements in subpart C of part 117 as 
to the manufacturing, processing, packing, and holding of animal food 
at the facility, instead of subpart C of part 507, so long as the food 
safety plan also addresses all hazards that are reasonably likely to 
occur in the animal food, including nutrient imbalances. In both 
instances, when applying the requirements of part 117 of this chapter 
to animal food, the term ``food'' in part 117 includes animal food.

Sec.  507.3  Definitions.

    The definitions and interpretations contained in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Affiliate means any facility that controls, is controlled by, or is 
under common control with another facility.
    Animal food means food for animals other than man and includes pet 
food, animal feed, and raw materials and ingredients.
    Batter means a semifluid substance, usually composed of flour and 
other ingredients, into which principal components of food are dipped 
or with which they are coated, or which may be used directly to form 
bakery foods.
    Blanching, except for tree nuts and peanuts, means a prepackaging 
heat treatment of foodstuffs for a sufficient time and at a sufficient 
temperature to partially or completely inactivate the naturally 
occurring enzymes and to effect other physical or biochemical changes 
in the food.
    Calendar day means every day shown on the calendar.
    Critical control point means a point, step, or procedure in a food 
process at which control can be applied and is essential to prevent or 
eliminate a food safety hazard or reduce such hazard to an acceptable 
level.
    Environmental pathogen means a microorganism that is of animal or 
human health significance and is capable of surviving and persisting 
within the manufacturing, processing, packing, or holding environment.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of 21 CFR part 1, 
subpart H.
    Farm means farm as defined in Sec.  1.227(b) of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food-contact surfaces are those surfaces that contact animal food 
and those surfaces from which drainage, or other transfer, onto the 
food or onto surfaces that contact the food ordinarily occurs during 
the normal course of operations. ``Food-contact surfaces'' include 
food-contact surfaces of utensils and equipment.
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed by farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities on the 
farm on which they were grown or raised, or another farm under the same 
ownership. Harvesting does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in 
section 201(gg). Gathering, washing, trimming of outer leaves of, 
removing stems and husks from, sifting, filtering, threshing, shelling, 
and cooling raw agricultural commodities grown on a farm or another 
farm under the same ownership are examples of harvesting.
    Hazard means any biological, chemical, physical, or radiological 
agent that is reasonably likely to cause illness or injury in animals 
or humans in the absence of its control.
    Hazard reasonably likely to occur means a hazard for which a 
prudent person who manufactures, processes, packs, or holds food would 
establish controls because experience, illness data, scientific 
reports, or other information provides a basis to conclude that there 
is a reasonable possibility that the hazard will occur in the type of 
food being manufactured, processed, packed, or held in the absence of 
those controls.
    Holding means storage of food. Holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, 
and liquid storage tanks. For farms and farm mixed-type facilities, 
holding also includes activities traditionally performed by farms for 
the safe or effective storage of raw agricultural commodities grown or 
raised on the same farm or another farm under the same ownership, but 
does not include activities that transform a raw agricultural 
commodity, as defined in section 201(r) of the Federal Food, Drug, and 
Cosmetic Act, into a processed food as defined in section 201(gg).
    Lot means the food produced during a period of time indicated by a 
specific code.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or 
packaging. For farms and farm mixed-

[[Page 64824]]

type facilities, manufacturing/processing does not include activities 
that are part of harvesting, packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, 
and microscopic parasites and includes species having animal or human 
health significance. The term ``undesirable microorganisms'' includes 
those microorganisms that are of animal or human health significance, 
that subject food to decomposition, that indicate that food is 
contaminated with filth, or that otherwise may cause food to be 
adulterated.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that grows and 
harvests crops or raises animals and may conduct other activities 
within the farm definition, but also conducts activities that require 
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether a process, point, or procedure is under 
control and to produce an accurate record for use in verification.
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging 
the food. For farms and farm mixed-type facilities, packing also 
includes activities traditionally performed by farms to prepare raw 
agricultural commodities grown or raised on the same farm or another 
farm under the same ownership for storage and transport, but does not 
include activities that transform a raw agricultural commodity, as 
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, 
into a processed food as defined in section 201(gg).
    Pest refers to any objectionable animals or insects including 
birds, rodents, flies, and larvae.
    Plant means the building or establishment, or parts thereof, used 
for or in connection with the manufacturing, processing, packing, or 
holding of animal food.
    Preventive controls means those risk-based, reasonably appropriate 
procedures, practices, and processes that a person knowledgeable about 
the safe manufacturing, processing, packing, or holding of food would 
employ to significantly minimize or prevent the hazards identified 
under the hazard analysis that are consistent with the current 
scientific understanding of safe food manufacturing, processing, 
packing, or holding at the time of the analysis.
    Qualified end-user, with respect to an animal food, means the 
consumer of the food (where the term does not include a business); or a 
restaurant or retail food establishment (as those terms are defined in 
Sec.  1.227(b) of this chapter) that:
    (1) Is located:
    (i) In the same State as the qualified facility that sold the food 
to such restaurant or retail food establishment; or
    (ii) Not more than 275 miles from such facility; and
    (2) Is purchasing the food for sale directly to consumers at such 
restaurant or retail food establishment.
    Qualified facility means (when including the sales by any 
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of 
any entity of which the facility is a subsidiary or affiliate) a 
facility that is a very small business as defined in this part, or a 
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar 
year, the average annual monetary value of the animal food 
manufactured, processed, packed, or held at such facility that is sold 
directly to qualified end-users (as defined in this part) during such 
period exceeded the average annual monetary value of the animal food 
sold by such facility to all other purchasers; and
    (2) The average annual monetary value of all animal food sold 
during the 3-year period preceding the applicable calendar year was 
less than $500,000, adjusted for inflation.
    Qualified individual means a person who has successfully completed 
training in the development and application of risk-based preventive 
controls at least equivalent to that received under a standardized 
curriculum recognized as adequate by FDA, or is otherwise qualified 
through job experience to develop and apply a food safety system.
    Quality control operation means a planned and systematic procedure 
for taking all actions necessary to prevent food from being 
adulterated.
    Reasonably foreseeable hazard means a potential biological, 
chemical, physical, or radiological hazard that may be associated with 
the facility, or the food.
    Rework means clean, unadulterated food that has been removed from 
processing for reasons other than insanitary conditions or that has 
been successfully reconditioned by reprocessing and that is suitable 
for use as food.
    Safe moisture level is a level of moisture low enough to prevent 
the growth of undesirable microorganisms in the finished product under 
the intended conditions of manufacturing, processing, packing, and 
holding. The safe moisture level for a food is related to its water 
activity (aw). An aw will be considered safe for 
a food if adequate data are available that demonstrate that the food at 
or below the given aw will not support the growth of 
undesirable microorganisms.
    Sanitize means to adequately treat cleaned food-contact surfaces by 
a process that is effective in destroying vegetative cells of 
microorganisms of animal or human health significance, and in 
substantially reducing numbers of other undesirable microorganisms, but 
without adversely affecting the product or its safety for animals or 
humans.
    Should is used to state recommended or advisory procedures or 
identify recommended equipment. Should denotes non-binding guidance.
    Significantly minimize means to reduce to an acceptable level, 
including to eliminate.
    Small business means, for purposes of this part, a business 
employing fewer than 500 persons.
    Subsidiary means any company that is owned or controlled directly 
or indirectly by another company.
    Validation means that element of verification focused on collecting 
and evaluating scientific and technical information to determine 
whether the food safety plan, when properly implemented, will 
effectively control the identified hazards.
    Verification means those activities, other than monitoring, that 
establish the validity of the food safety plan and that the system is 
operating according to the plan.

Option 1 for Definition of ``Very Small Business''

    Very small business means, for purposes of this part, a business 
that has less than $500,000 in total annual sales of animal food, 
adjusted for inflation.

Option 2 for Definition of ``Very Small Business''

    Very small business means, for purposes of this part, a business 
that has less than $1,000,000 in total annual sales of animal food, 
adjusted for inflation.

[[Page 64825]]

Option 3 for Definition of ``Very Small Business''

    Very small business means, for purposes of this part, a business 
that has less than $2,500,000 in total annual sales of animal food, 
adjusted for inflation.
    Water activity (aw) means a measure of the free moisture 
in a food and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.

Sec.  507.5  Exemptions.

    (a) This part does not apply to establishments (including ``farms'' 
as defined in Sec.  1.227(b) of this chapter) that are not required to 
register under section 415 of the Federal Food, Drug, and Cosmetic Act.
    (b) Activities in animal food facilities that are regulated under, 
and are in compliance with, Sec.  500.23 and part 113 of this chapter 
(Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed 
Containers) are exempt from subpart C of part 507 only with respect to 
those microbiological hazards regulated under part 113. The facilities 
must comply with subparts C and F of this part regarding all other 
potential hazards and must comply with subparts A and B of this part.
    (c) Subpart C of this part does not apply to activities of a 
facility that are subject to section 419 of the Federal Food, Drug, and 
Cosmetic Act (Standards for Produce Safety).
    (d) Except as provided in subpart D of this part, qualified 
facilities are exempt from subpart C of this part if they comply with 
the requirements in Sec.  507.7.
    (e) Subpart C of this part does not apply to on-farm packing or 
holding of animal food by a small or very small business if the only 
packing and holding activities subject to section 418 of the Federal 
Food, Drug, and Cosmetic Act that the business conducts are the 
following low-risk packing or holding activity/animal food combinations 
on animal food not grown, raised, or consumed on that farm mixed-type 
facility or another farm or farm mixed-type facility under the same 
ownership:
    (1) Conveying, weighing, sorting, culling, or grading (incidental 
to storing):
    (i) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
    (ii) Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, 
sunflower);
    (iii) Grain or oilseed byproducts;
    (iv) Forage (e.g., hay or ensiled material); or
    (v) Other plants or plant byproducts (e.g., almond, peanut, or 
soybean hulls, citrus, other fruit including culled fruit, potatoes, or 
other vegetables including culled vegetables).
    (2) Storing:
    (i) Dried grain;
    (ii) Dried oilseed;
    (iii) Byproducts of dried grain or dried oilseed;
    (iv) Forage; or
    (v) Other plants or plant byproducts.
    (3) Packing:
    (i) Grain;
    (ii) Oilseed;
    (iii) Grain or oilseed byproducts;
    (iv) Forage; or
    (v) Other plants or plant byproducts.
    (4) Mixing (incidental to packing or storing):
    (i) Grain, whole; or
    (ii) Forage.
    (f) Subpart C does not apply to on-farm low-risk manufacturing/
processing activities conducted by a small or very small business if 
the only manufacturing/processing activities subject to section 418 of 
the Federal Food, Drug, and Cosmetic Act that the business conducts 
consists of the following:
    (1) When conducted on a farm mixed-typed facility's own raw 
agriculture commodities as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, (those grown or raised on that farm 
mixed-type facility or another farm/farm mixed-typed facility under the 
same ownership) for distribution into commerce:
    (i) Cracking, crimping, or flaking:
    (A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
    (B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, 
sunflower); or
    (C) Grain or oilseed byproducts.
    (ii) Crushing, grinding, milling, pulverizing, or dry rolling:
    (A) Grain;
    (B) Oilseed;
    (C) Grain or oilseed byproducts;
    (D) Forage (e.g., hay or ensiled material); or
    (E) Other plants or plant byproducts (e.g., such as almond, peanut, 
or soybean hulls, citrus, other fruit including culled fruit, potatoes, 
or other vegetables including culled vegetables).
    (iii) Making silage.
    (iv) Chopping or shredding hay.
    (v) Extracting (mechanical) or wet rolling:
    (A) Grain; or
    (B) Oilseed.
    (2) When conducted on animal food other than the farm mixed-typed 
facility's own raw agriculture commodities for distribution into 
commerce:
    (i) Cracking, crimping, flaking, or shelling:
    (A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, 
wheat);
    (B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, 
sunflower); or
    (C) Grain or oilseed byproducts.
    (ii) Crushing, grinding, milling, pulverizing, or dry rolling:
    (A) Grain;
    (B) Oilseed;
    (C) Grain or oilseed byproducts;
    (D) Forage (e.g., hay or ensiled material); or
    (E) Other plants or plant byproducts (e.g., such as almond, peanut, 
or soybean hulls, citrus, other fruit including culled fruit, potatoes, 
or other vegetables including culled vegetables).
    (iii) Making silage.
    (iv) Chopping or shredding hay.
    (v) Extracting (mechanical) or wet rolling:
    (A) Grain; or
    (B) Oilseed.
    (vi) Labeling:
    (A) Grain whole; or
    (B) Oilseed whole.
    (vii) Sifting, separating, or sizing:
    (A) Grain;
    (B) Oilseed;
    (C) Grain or oilseed byproducts; or
    (D) Other plants or plant byproducts.
    (g) Subpart C of this part does not apply to facilities that are 
solely engaged in the storage of raw agricultural commodities (other 
than fruits and vegetables) intended for further distribution or 
processing.
    (h) Subpart B of this part does not apply to the holding or 
transportation of one or more raw agricultural commodities as defined 
in section 201(r) of the Federal Food, Drug, and Cosmetic Act.

Sec.  507.7  Requirements that apply to a qualified facility.

    (a) A qualified facility is exempt from subpart C of this part 
provided that for the calendar year in which it is to be considered a 
qualified facility, the facility has submitted to FDA documentation 
that:
    (1) Demonstrates the facility is a qualified facility as defined in 
Sec.  507.3. For the purpose of determining whether a facility 
satisfies the definition of qualified facility, the baseline year for 
calculating the adjustment for inflation is 2011; and
    (2)(i) Demonstrates the owner, operator, or agent in charge of the 
facility has identified the potential hazards associated with the 
animal food being manufactured, processed, packed, or held at the 
facility, 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

[[Page 64826]]

    (ii) Demonstrates the facility is in compliance with state, local, 
county, or other applicable non-Federal food safety law. This 
documentation may include inspection reports, certification by an 
appropriate agency (such as a State department of agriculture), or 
other documentation deemed appropriate by FDA.
    (b) The documentation required by paragraph (a) of this section 
must be submitted to FDA by any one of the following means:
    (1) To submit electronically, go to http://www.access.fda.gov and 
follow the instructions. This Web site is available from wherever the 
Internet is accessible, including libraries, copy centers, schools, and 
Internet cafes. FDA encourages electronic submission.
    (2) To submit documents in a paper format or in an electronic 
format on a CD-ROM, mail these to the U.S. Food and Drug 
Administration, ATTN: Qualified Facility Coordinator, 10903 New 
Hampshire Ave., Silver Spring, MD 20993. We recommend that an owner, 
operator, or agent in charge of a facility submit by mail only if the 
facility does not have reasonable access to the Internet.
    (c) The documentation required by paragraph (a) of this section 
must be:
    (1) Submitted to FDA initially within 90 days of the applicable 
compliance date of this part; and
    (2) Resubmitted at least every 2 years, or whenever there is a 
material change to the information described in paragraph (a) of this 
section. For the purpose of this section, a material change is one that 
changes whether or not a facility is a ``qualified facility''.
    (d) A qualified facility that does not submit documentation under 
paragraph (a)(2)(i) of this section must provide notification to 
consumers as to the name and complete business address (the street 
address, city, state, and ZIP code for domestic facilities, and 
comparable full address information for foreign facilities) of the 
facility where the animal food was manufactured or processed as 
follows:
    (1) Such notification must appear in a prominent and conspicuous 
location on the label for animal food required to bear a package label 
under any other provision of the Federal Food, Drug, and Cosmetic Act.
    (2) For animal food that is not required to bear a food packaging 
label, the notification must appear prominently and conspicuously, at 
the point of purchase, on a label, poster, sign, placard, or documents 
delivered contemporaneously with the food in the normal course of 
business, or in an electronic notice, in the case of Internet sales.
    (e) A qualified facility must maintain those records relied upon to 
support the documentation required by Sec.  507.7(a)(2). These records 
are subject to the requirements of subpart F of this part.

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.

    (a) Subpart C of this part does not apply to a facility solely 
engaged in the storage of packaged animal food that is not exposed to 
the environment and does not require time/temperature control to ensure 
the safety of the animal food.
    (b) A facility solely engaged in the storage of packaged animal 
food that is not exposed to the environment but requires time/
temperature control is subject to the modified requirements in Sec.  
507.48.

Subpart B--Current Good Manufacturing Practice

Sec.  507.14  Personnel.

    (a) Plant management must take all reasonable measures and 
precautions to ensure that:
    (1) Any person who, by his own acknowledgement, by medical 
examination, or by supervisory observation, is shown to have, or 
appears to have any illness, open skin lesion, or other source of 
abnormal microbial contamination by which there is a reasonable 
possibility of animal food, animal food-contact surfaces, or animal 
food-packaging materials becoming contaminated, is excluded from any 
operations which may be expected to result in such contamination until 
the condition is resolved;
    (2) Personnel have been instructed to report such health conditions 
to their supervisors;
    (3) All persons working in direct contact with animal food, animal 
food-contact surfaces, and animal food-packaging materials conform to 
hygienic practices while on duty to the extent necessary to protect 
against contamination of animal food. The methods for maintaining 
cleanliness include:
    (i) Maintaining adequate personal cleanliness;
    (ii) Washing hands thoroughly (and sanitizing if necessary to 
protect against contamination with undesirable microorganisms) in an 
adequate hand-washing facility before starting work and at any other 
time when the hands may have become soiled or contaminated;
    (iii) Removing all unsecured jewelry and other objects that might 
fall into animal food, equipment, or containers;
    (iv) Storing clothing or other personal belongings in areas other 
than where animal food is exposed or where equipment or utensils are 
washed; and
    (v) Taking any other necessary precautions to protect against 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials with microorganisms or foreign substances.
    (b) Personnel responsible for identifying sanitation failures or 
animal food contamination should have a background of education or 
experience, or a combination thereof, to provide a level of competency 
necessary for production of clean and safe animal food. Animal food 
handlers and supervisors should receive appropriate training in proper 
food handling techniques and food-protection principles and should be 
informed of the danger of poor personal hygiene and unsanitary 
practices.
    (c) Responsibility for ensuring compliance by all personnel with 
all requirements of this subpart must be clearly assigned to competent 
supervisory personnel.

Sec.  507.17  Plant and grounds.

    (a) The grounds about an animal food plant under the control of the 
operator must be kept in a condition that will protect against the 
contamination of animal food. The methods for adequate maintenance of 
grounds must include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant that 
may constitute an attractant, breeding place, or harborage for pests;
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where animal food is 
exposed;
    (3) Adequately draining areas that may contribute to contamination 
of animal food by seepage, foot-borne filth, or providing a breeding 
place for pests; and
    (4) Treating and disposing of waste so that it does not constitute 
a source of contamination in areas where animal food is exposed. If the 
plant grounds are bordered by grounds not under the operator's control 
and not maintained in the manner described in paragraph (a)(1) through 
(a)(3) of this section, care must be exercised in the plant by 
inspection, extermination, or other means to exclude pests, dirt, and 
filth that may be a source of animal food contamination.

[[Page 64827]]

    (b) The plant's buildings and structures must be suitable in size, 
construction, and design to facilitate maintenance and sanitary 
operations for animal food-production purposes (i.e., manufacturing, 
processing, packing, and holding). The plant must:
    (1) Provide sufficient space for such placement of equipment and 
storage of materials as is necessary for the maintenance of sanitary 
operations and the production of safe animal food.
    (2) Permit the taking of proper precautions to reduce the potential 
for contamination of animal food, animal food-contact surfaces, or 
animal food-packaging materials with microorganisms, chemicals, filth, 
and other extraneous material. The potential for contamination may be 
reduced by adequate food safety controls and operating practices or 
effective design, including the separation of operations in which 
contamination is likely to occur, by one or more of the following 
means: Location, time, partition, air flow, enclosed systems, or other 
effective means.
    (3) Permit the taking of proper precautions to protect animal food 
in outdoor bulk vessels by any effective means, including:
    (i) Using protective coverings;
    (ii) Controlling areas over and around the vessels to eliminate 
harborages for pests;
    (iii) Checking on a regular basis for pests and pest infestation; 
and
    (iv) Skimming fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and 
ceilings may be adequately cleaned and kept clean and kept in good 
repair; that drip or condensate from fixtures, ducts, and pipes does 
not contaminate animal food, animal food-contact surfaces, or animal 
food-packaging materials; and that aisles or working spaces are 
provided between equipment and walls and are adequately unobstructed 
and of adequate width to permit employees to perform their duties and 
to protect against contaminating animal food, animal food-contact 
surfaces, or animal food-packaging materials.
    (5) Provide adequate lighting in hand-washing areas, toilet rooms, 
areas where animal food is examined, processed, or stored, and areas 
where equipment or utensils are cleaned; and provide safety-type light 
bulbs, fixtures, and skylights, or other glass items suspended over 
exposed animal food in any step of preparation, or otherwise protect 
against animal food contamination in case of glass breakage.
    (6) Provide adequate ventilation or control equipment to minimize 
odors and vapors (including steam and noxious fumes) in areas where 
they may contaminate animal food; and locate and operate fans and other 
air-blowing equipment in a manner that minimizes the potential for 
contaminating animal food, animal food-packaging materials, and animal 
food-contact surfaces.
    (7) Provide, where necessary, adequate screening or other 
protection against pests.

Sec.  507.19  Sanitary operations.

    (a) Buildings, fixtures, and other physical facilities of the plant 
must be maintained in a sanitary condition and must be kept in repair 
sufficient to prevent animal food from becoming adulterated. Cleaning 
and sanitizing of utensils and equipment must be conducted in a manner 
that protects against contamination of animal food, animal food-contact 
surfaces, or animal food-packaging materials.
    (b) Cleaning compounds and sanitizing agents must be free from 
undesirable microorganisms and must be safe and adequate under the 
conditions of use. Compliance with this requirement may be verified by 
any effective means, including purchase of these substances under a 
supplier's guarantee or certification or examination of these 
substances for contamination.
    (c) The following applies to toxic materials:
    (1) Only the following toxic materials may be used or stored in a 
plant where animal food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide 
chemicals must be identified, held, and stored in a manner that 
protects against contamination of animal food, animal food-contact 
surfaces, or animal food-packaging materials.
    (d) Effective measures must be taken to exclude pests from the 
manufacturing, processing, packing, and holding areas and to protect 
against the contamination of animal food on the premises by pests. The 
use of insecticides or rodenticides is permitted only under precautions 
and restrictions that will protect against the contamination of animal 
food, animal food-contact surfaces, and animal food-packaging 
materials.
    (e) All animal food-contact surfaces, including utensils and animal 
food-contact surfaces of equipment, must be cleaned as frequently as 
necessary to protect against contamination of animal food.
    (1) Animal food-contact surfaces used for manufacturing, processing 
or holding low-moisture animal food must be in a clean, dry, sanitary 
condition at the time of use. When the surfaces are wet-cleaned, they 
must, when necessary, be sanitized and thoroughly dried before 
subsequent use.
    (2) In wet processing, when cleaning is necessary to protect 
against the introduction of microorganisms into animal food, all animal 
food-contact surfaces must be cleaned and sanitized before use and 
after any interruption during which the animal food-contact surfaces 
may have become contaminated. Where equipment and utensils are used in 
a continuous production operation, the utensils and animal food-contact 
surfaces of the equipment must be cleaned and sanitized as necessary.
    (3) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) should be stored in appropriate 
containers and must be handled, dispensed, used, and disposed of in a 
manner that protects against contamination of animal food, animal food-
contact surfaces, or animal food-packaging materials.
    (f) Non-animal food-contact surfaces of equipment used in the 
operation of an animal food plant should be cleaned in a manner and as 
frequently as necessary to protect against contamination of animal 
food, animal food-contact surfaces, and animal food-packaging 
materials.
    (g) Cleaned and sanitized portable equipment with animal food-
contact surfaces and utensils should be stored in a location and manner 
that protects animal food-contact surfaces from contamination.

Sec.  507.20  Sanitary facilities and controls.

    (a) The water supply must be sufficient for the operations intended 
and must be derived from an adequate source. Any water that contacts 
animal food, animal food-contact surfaces, or animal food-packaging 
materials must be safe and of adequate sanitary quality. Running water 
at a suitable temperature, and under pressure as needed, must be 
provided in all areas where required for the processing of animal food, 
for the cleaning of equipment, utensils, and animal food-packaging 
materials, or for employee sanitary facilities.

[[Page 64828]]

    (b) Plumbing must be of adequate size and design and adequately 
installed and maintained to:
    (1) Carry sufficient quantities of water to required locations 
throughout the plant;
    (2) Properly convey sewage and liquid disposable waste from the 
plant;
    (3) Avoid constituting a source of contamination to animal food, 
water supplies, equipment, or utensils or creating an unsanitary 
condition;
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor; and
    (5) Provide that there is not backflow from, or cross-connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water for animal food or animal food manufacturing.
    (c) Sewage must be disposed of through an adequate sewerage system 
or through other adequate means.
    (d) Each plant must provide its employees with adequate, readily 
accessible toilet facilities. Toilet facilities must be kept clean and 
must not be a potential source of contamination of animal food, animal 
food-contact surfaces, or animal food-packaging materials.
    (e) Each plant must provide hand-washing facilities designed to 
ensure that an employee's hands are not a source of contamination of 
animal food, animal food-contact surfaces, or animal food-packaging 
materials, by providing facilities that are adequate, convenient, and 
furnish running water at a suitable temperature.
    (f) Rubbish must be conveyed, stored, and disposed of in a way to 
minimize the development of odor, minimize the potential for the waste 
becoming an attractant and harborage or breeding place for pests, and 
protect against contamination of animal food, animal food-contact 
surfaces, animal food-packaging materials, water supplies, and ground 
surfaces.

Sec.  507.22  Equipment and utensils.

    (a)(1) All plant equipment and utensils must be designed and of 
such material and workmanship to be adequately cleanable, and must be 
properly maintained;
    (2) The design, construction, and use of equipment and utensils 
must preclude the adulteration of animal food with lubricants, fuel, 
metal fragments, contaminated water, or any other contaminants;
    (3) All equipment should be installed and maintained in such a way 
to facilitate the cleaning of the equipment and all adjacent spaces;
    (4) Animal food-contact surfaces must be made of materials that 
resist corrosion when in contact with animal food;
    (5) Animal food-contact surfaces must be made of nontoxic materials 
and designed to withstand the environment of their intended use and the 
action of animal food, and, if applicable, the action of cleaning 
compounds and sanitizing agents; and
    (6) Animal food-contact surfaces must be maintained to protect 
animal food from being contaminated.
    (b) Seams on animal food-contact surfaces must be maintained so as 
to minimize accumulation of food particles, dirt, and organic matter, 
and thus minimize the opportunity for growth of microorganisms.
    (c) Equipment in the animal food manufacturing or handling area 
that does not come into contact with animal food must be constructed in 
such a way that it can be kept in a clean condition.
    (d) Holding, conveying, and manufacturing systems, including 
gravimetric, pneumatic, closed, and automated systems, must be of a 
design and construction that enables them to be maintained in an 
appropriate sanitary condition.
    (e) Each freezer and cold storage compartment used to store and 
hold animal food capable of supporting growth of microorganisms must be 
fitted with an indicating thermometer, temperature-measuring device, or 
temperature-recording device installed to show the temperature 
accurately within the compartment.
    (f) Instruments and controls used for measuring, regulating, or 
recording temperatures, pH, aw, or other conditions that 
control or prevent the growth of undesirable microorganisms in animal 
food must be accurate and precise and adequately maintained, and 
adequate in number for their designated uses.
    (g) Compressed air or other gases mechanically introduced into 
animal food or used to clean animal food-contact surfaces or equipment 
must be treated in such a way that animal food is not contaminated.

Sec.  507.25  Processes and controls.

    (a) Plant management must ensure that:
    (1) All operations in the manufacturing, processing, packing, and 
holding of animal food (including operations directed to receiving, 
inspecting, transporting, and segregating) are conducted in accordance 
with adequate sanitation principles;
    (2) Containers holding animal food, raw materials, or ingredients 
are labeled to accurately identify the contents;
    (3) The labeling for the finished animal food product contains the 
specific information and instructions needed so the food can be safely 
used for the intended animal species;
    (4) Appropriate quality control operations are employed so that 
animal food-packaging materials are safe and suitable;
    (5) The overall sanitation of the plant is under the supervision of 
one or more competent individuals assigned responsibility for this 
function;
    (6) All reasonable precautions are taken so that production 
procedures do not contribute to contamination from any source;
    (7) Chemical, microbial, or extraneous-material testing procedures 
are used where necessary to identify sanitation failures or possible 
animal food contamination; and
    (8) All animal food that has become contaminated to the extent that 
it is adulterated is rejected, or if permissible, treated or processed 
to eliminate the contamination.
    (b) Raw materials and ingredients:
    (1) Must be inspected and segregated or otherwise handled as 
necessary to ensure that they are clean and suitable for processing 
into animal food and must be stored under conditions that will protect 
against contamination and minimize deterioration. In addition:
    (i) Raw materials must be washed or cleaned as necessary to remove 
soil or other contamination;
    (ii) Water used for washing, rinsing, or conveying animal food must 
be safe and of adequate sanitary quality;
    (iii) Water may be reused for washing, rinsing, or conveying animal 
food if it does not increase the level of contamination of the animal 
food; and
    (iv) Containers and carriers of raw materials should be inspected 
on receipt to ensure that their condition has not contributed to 
contamination or deterioration of animal food.
    (2) Must not contain levels of microorganisms that may render the 
food injurious to the health of animals or humans, or they must be 
treated (e.g., heat) during manufacturing operations so that they no 
longer contain levels that would cause the product to be adulterated;
    (3) Susceptible to contamination with aflatoxin or other natural 
toxins must comply with current FDA regulations for poisonous or 
deleterious substances before these materials or ingredients are 
incorporated into finished animal food;

[[Page 64829]]

    (4) Including rework, must be held in bulk, or in containers 
designed and constructed in a way that protects against contamination, 
and must be held at a temperature and relative humidity and in a manner 
that prevents the animal food from becoming adulterated. Material 
scheduled for rework must be identified as such;
    (5) If frozen, must be kept frozen. If thawing is required prior to 
use, it must be done in a manner that prevents the raw materials and 
ingredients from becoming adulterated; and
    (6) Whether liquid or dry, received and stored in bulk form must be 
held in a manner that protects against contamination.
    (c) For the purposes of manufacturing operations, the following 
apply:
    (1) Equipment, utensils, and finished animal food containers must 
be maintained in an acceptable condition through appropriate cleaning 
and sanitizing, as necessary. When necessary, equipment must be taken 
apart for thorough cleaning;
    (2) All animal food manufacturing, processing, packing, and holding 
must be conducted under such conditions and controls as are necessary 
to minimize the potential for the growth of microorganisms or for the 
contamination of animal food;
    (3) Animal food that can support the rapid growth of undesirable 
microorganisms must be held at temperatures that will prevent the 
animal food from becoming adulterated during manufacturing, processing, 
packing, and holding;
    (4) Measures taken to destroy or prevent the growth of undesirable 
microorganisms, such as sterilizing, irradiating, pasteurizing, 
cooking, freezing, refrigerating, controlling pH, or controlling 
aw, must be adequate under the conditions of manufacture, 
handling, and distribution to prevent animal food from being 
adulterated;
    (5) Work-in-process and rework must be handled in a manner that 
protects against contamination and the growth of undesirable 
microorganisms;
    (6) Effective measures must be taken to protect finished animal 
food from contamination by raw materials, ingredients, or refuse. When 
raw materials, ingredients, or refuse are unprotected, they must not be 
handled simultaneously in a receiving, loading, or shipping area if 
that handling could result in contaminated animal food. Animal food 
transported by conveyor must be protected against contamination as 
necessary;
    (7) Equipment, containers, and utensils used to convey, hold, or 
store raw materials, work-in-process, rework, or animal food must be 
constructed, handled, and maintained during manufacturing, processing, 
packing, or holding in a manner that protects against contamination of 
animal food;
    (8) Effective measures must be taken to protect against the 
inclusion of metal or other extraneous material in animal food;
    (9) Adulterated animal food, raw materials, and ingredients must be 
disposed of in a manner that protects against the contamination of 
other animal food or, if the adulterated animal food, raw materials, or 
ingredients are capable of being reconditioned, they must be 
reconditioned using a method that has been proven to be effective;
    (10) Steps such as washing, peeling, trimming, cutting, sorting and 
inspecting, mashing, dewatering, cooling, shredding, extruding, drying, 
defatting, and forming must be performed in a way that protects animal 
food against contamination. Animal food should be protected from 
contaminants that may drip, drain, or be drawn into the animal food;
    (11) Heat blanching, when required in the preparation of animal 
food, should be effected by heating the animal food to the required 
temperature, holding it at this temperature for the required time, and 
then either rapidly cooling the animal food or passing it to subsequent 
manufacturing without delay. Thermophilic growth and contamination in 
blanchers should be minimized by the use of adequate operating 
temperatures and by periodic cleaning;
    (12) Batters, breading, sauces, gravies, dressings, and other 
similar preparations must be treated or maintained in such a manner 
that they are protected against contamination;
    (13) Filling, assembling, packaging, and other operations must be 
performed in such a way that the animal food is protected against 
contamination and growth of undesirable microorganisms;
    (14) Animal food, including dry mixes, nuts, intermediate moisture 
animal food, and dehydrated animal food, that relies on the control of 
aw for preventing the growth of undesirable microorganisms 
must be processed to and maintained at a safe moisture level;
    (15) Animal food that relies principally on the control of pH for 
preventing the growth of undesirable microorganisms must be monitored 
and maintained at the appropriate pH; and
    (16) When ice is used in contact with animal food, it must be made 
from water that is safe and of adequate sanitary quality, and must be 
used only if it has been manufactured in accordance with current good 
manufacturing practice as outlined in this part.

Sec.  507.28  Warehousing and distribution.

    Storage and transportation of animal food must be conducted under 
conditions that will protect against biological, chemical, physical, 
and radiological contamination of animal food as well as against 
deterioration of the animal food and the container.

Subpart C--Hazard Analysis and Risk-Based Preventive Controls

Sec.  507.30  Requirement for a food safety plan.

    (a) The owner, operator, or agent in charge of a facility must 
prepare, or have prepared, and implement a written food safety plan.
    (b) The written food safety plan must be prepared by (or its 
preparation overseen by) a qualified individual.
    (c) The written food safety plan must include:
    (1) The hazard analysis as required by Sec.  507.33;
    (2) The preventive controls as required by Sec.  507.36;
    (3) The recall plan as required by Sec.  507.38;
    (4) The procedures and the frequency with which these procedures 
will be conducted for monitoring the performance of the preventive 
controls as required by Sec.  507.39;
    (5) The corrective action procedures as required by Sec.  507.42; 
and
    (6) The verification procedures and the frequency with which they 
will be performed as required by Sec.  507.45.

Sec.  507.33  Hazard analysis.

    (a) The owner, operator, or agent in charge of a facility must 
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 and develop a written hazard analysis.
    (b) The hazard analysis must consider hazards that may occur 
naturally or may be unintentionally introduced including:
    (1) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other microorganisms of animal 
or human health significance;
    (2) Chemical hazards, including substances such as pesticide and 
drug residues, natural toxins, decomposition, unapproved food or color 
additives, and nutrient imbalances;
    (3) Physical hazards; and
    (4) Radiological hazards.

[[Page 64830]]

    (c) The hazard analysis must contain an evaluation of the hazards 
identified in paragraph (b) of this section 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.
    (d) The hazard analysis must consider the effect of the following 
on the safety of the finished animal food:
    (1) The formulation of the animal food;
    (2) The condition, function, and design of the facility and 
equipment;
    (3) Raw materials and ingredients;
    (4) Transportation practices;
    (5) Manufacturing/processing procedures;
    (6) Packaging activities and labeling activities;
    (7) Storage and distribution;
    (8) Intended or reasonably foreseeable use;
    (9) Sanitation, including employee hygiene; and
    (10) Any other relevant factors.

Sec.  507.36  Preventive controls for hazards that are reasonably 
likely to occur.

    For hazards identified in the hazard analysis as reasonably likely 
to occur:
    (a) The owner, operator, or agent in charge of a facility must 
identify and implement preventive controls, including at critical 
control points, if any, to provide assurances that hazards identified 
in the hazard analysis as reasonably likely to occur will be 
significantly minimized or prevented and the animal food manufactured, 
processed, packed, or held by such facility will not be adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act.
    (b) Preventive controls must be written.
    (c) Preventive controls must include, as appropriate to the 
facility and animal food:
    (1) Parameters associated with the control of the hazard, such as 
parameters associated with heat processing, irradiating, and 
refrigerating animal foods; and
    (2) 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.
    (d) Preventive controls must include, as appropriate:
    (1) Process controls that include those procedures, practices, and 
processes performed on an animal food during manufacturing/processing 
that are employed to significantly minimize or prevent hazards that are 
reasonably likely to occur;
    (2) Sanitation controls:
    (i) Where necessary to significantly minimize or prevent hazards 
that are reasonably likely to occur, procedures for the:
    (A) Cleanliness of animal food-contact surfaces, including animal 
food-contact surfaces of utensils and equipment; and
    (B) Prevention of cross-contamination from insanitary objects and 
from personnel to animal food, animal food packaging material, and 
other animal food-contact surfaces and from raw product to processed 
product.
    (ii) The owner, operator, or agent in charge must take action to 
correct, in a timely manner, conditions and practices that are not 
consistent with the procedures in paragraph (d)(2)(i)(A) or 
(d)(2)(i)(B) of this section.
    (iii) The owner, operator, or agent in charge of the facility is 
not required to follow the corrective actions described in Sec.  
507.42(a) and (b) when the owner, operator, or agent in charge of a 
facility takes action, in accordance with paragraph (d)(2)(ii) of this 
section, to correct conditions and practices that are not consistent 
with the procedures in paragraph (d)(2)(i)(A) or (d)(2)(i)(B) of this 
section.
    (iv) All corrective actions taken in accordance with paragraph 
(d)(2)(ii) of this section must be documented in records that are 
subject to verification in accordance with Sec.  507.45(b)(2) and 
records review in accordance with Sec.  507.45(c)(1)(i) and (c)(2).
    (3) A recall plan as required by Sec.  507.38; and
    (4) Any other controls necessary to satisfy the requirements of 
paragraph (a) of this section.
    (e)(1) Except as provided by paragraph (e)(2) of this section, the 
preventive controls required under this section are subject to:
    (i) Monitoring as required by Sec.  507.39;
    (ii) Corrective actions as required by Sec.  507.42; and
    (iii) Verification as required by Sec.  507.45.
    (2) The recall plan established in Sec.  507.38 is not subject to 
the requirements of paragraph (e)(1) of this section.

Sec.  507.38  Recall plan for animal food with a hazard that is 
reasonably likely to occur.

    (a) The owner, operator, or agent in charge of a facility must 
develop a written recall plan for animal food with a hazard that is 
reasonably likely to occur and assign responsibility for performing all 
actions in the plan.
    (b) The written recall plan must include procedures for:
    (1) Directly notifying direct consignees about the animal food 
being recalled, including how to return or dispose of the affected 
animal food;
    (2) Notifying the public about any hazard presented by the animal 
food when appropriate to protect animal and human health;
    (3) Conducting effectiveness checks (as described in part 7 of this 
chapter) to verify the recall has been carried out; and
    (4) The proper disposition (e.g., destroying, reprocessing, or 
diverting to another use that would not present a safety concern) of 
the recalled animal food.

Sec.  507.39  Monitoring.

    (a) The owner, operator, or agent in charge of a facility must 
establish and implement written procedures for monitoring the 
preventive controls. These procedures must include:
    (1) What preventive controls will be monitored;
    (2) Who will perform the monitoring;
    (3) How the monitoring will be performed;
    (4) What parameter will be measured, if applicable;
    (5) Frequency with which the monitoring will be performed; and
    (6) Any additional information needed to ensure appropriate 
monitoring of the preventive controls.
    (b) The owner, operator, or agent in charge of a facility must 
monitor the preventive controls with sufficient frequency to provide 
assurance that the preventive controls are consistently performed.
    (c) Monitoring of preventive controls in accordance with this 
section must be documented in records that are subject to verification 
in accordance with Sec.  507.45(b)(1) and records review in accordance 
with Sec.  507.45(c)(1)(i) and (c)(2).

Sec.  507.42  Corrective actions.

    (a) The owner, operator, or agent in charge of a facility must 
establish and implement written corrective action procedures that must 
be taken if preventive controls are not properly implemented. The 
corrective active procedures must describe the steps to be taken to 
ensure:
    (1) Appropriate action is taken to identify and correct a problem 
with implementation of a preventive control to reduce the likelihood 
that the problem will recur;
    (2) All affected animal food is evaluated for safety; and
    (3) All affected animal food is prevented from entering into 
commerce if the owner, operator, or agent in charge of the facility 
cannot ensure the affected animal food is not adulterated under

[[Page 64831]]

section 402 of the Federal Food, Drug, and Cosmetic Act.
    (b) If a preventive control is not properly implemented and a 
specific corrective action procedure has not been established, or a 
preventive control is found to be ineffective, the owner, operator, or 
agent in charge of a facility must:
    (1) Take corrective action to identify and correct the problem to 
reduce the likelihood that the problem will recur;
    (2) Evaluate all affected animal food for safety;
    (3) As necessary, prevent affected animal food from entering 
commerce as would be done following the corrective action procedure 
under paragraph (a)(3) of this section; and
    (4) Reanalyze the food safety plan in accordance with Sec.  
507.45(e) to determine whether modification of the food safety plan is 
required.
    (c) When corrective actions are taken, they must be documented in 
written records. These records are subject to verification in 
accordance with Sec.  507.45(b)(2) and records review in accordance 
with Sec.  507.45(c)(1)(i) and (c)(2).

Sec.  507.45  Verification.

    (a) Except as provided by paragraph (a)(3) of this section, the 
owner, operator, or agent in charge of a facility must validate that 
the preventive controls identified and implemented in accordance with 
Sec.  507.36 to control the hazards identified in the hazard analysis 
as reasonably likely to occur are adequate to do so. The validation of 
the preventive controls:
    (1) Must be performed (or overseen) by a qualified individual:
    (i) Prior to implementation of the food safety plan or, when 
necessary, during the first 6 weeks of production; and
    (ii) Whenever a reanalysis of the food safety plan reveals the need 
to do so;
    (2) Must include collecting and evaluating scientific and technical 
information (or, when such information is not available or is 
insufficient, conducting studies) to determine whether the preventive 
controls, when properly implemented, will effectively control the 
hazards that are reasonably likely to occur; and
    (3) Need not address:
    (i) The sanitation controls in Sec.  507.36(d)(2); and
    (ii) The recall plan in Sec.  507.38.
    (b) The owner, operator, or agent in charge of a facility must 
verify that:
    (1) Monitoring is conducted as required by Sec.  507.39;
    (2) Appropriate decisions about corrective actions are being made 
as required by Sec.  507.42;
    (3) The preventive controls are consistently implemented and are 
effectively and significantly minimizing or preventing the hazards that 
are reasonably likely to occur; and
    (4) The activities conducted must include, as appropriate to the 
facility and the animal food, calibration of process monitoring and 
verification instruments.
    (c) The owner, operator, or agent in charge of a facility must 
verify that the preventive controls are consistently implemented and 
are effectively and significantly minimizing or preventing the hazards 
that are reasonably likely to occur by ensuring that a qualified 
individual is conducting (or overseeing):
    (1) A review of the following records in the timeframe specified:
    (i) Monitoring and corrective action records within 1 week after 
the records are made; and
    (ii) Records of calibration of instruments within a reasonable time 
after the records are created.
    (2) A review of the records in paragraphs (c)(1)(i) and (c)(1)(ii) 
of this section to ensure:
    (i) The records are complete;
    (ii) The activities reflected in the records occurred in accordance 
with the food safety plan;
    (iii) The preventive controls are effective; and
    (iv) Appropriate decisions were made about corrective actions.
    (d) The owner, operator, or agent in charge of a facility must 
establish and implement written procedures, as appropriate to the 
facility and the animal food, for the frequency of calibrating process 
monitoring and verification instruments.
    (e) The owner, operator, or agent in charge of a facility must:
    (1) Conduct a reanalysis of the food safety plan:
    (i) At least once every 3 years;
    (ii) Whenever a significant change is made in the activities 
conducted at the facility operated by such owner, operator, or agent in 
charge if the change creates a reasonable potential for a new hazard or 
creates a significant increase in a previously identified hazard;
    (iii) Whenever the owner, operator, or agent in charge becomes 
aware of new information about potential hazards associated with the 
animal food;
    (iv) Whenever a preventive control is not properly implemented and 
a specific corrective action procedure has not been established;
    (v) Whenever a preventive control is found to be ineffective; and
    (vi) Whenever FDA requires a reanalysis in response to newly 
identified hazards and developments in scientific understanding.
    (2) Complete the reanalysis and implement any additional preventive 
controls needed to address the hazard identified before the change in 
activities at the facility is operative or, when necessary, during the 
first 6 weeks of production;
    (3) Revise the written food safety plan if a significant change is 
made, or document the basis for the conclusion that no additional or 
revised preventive controls are needed; and
    (4) Ensure the reanalysis is performed (or overseen) by a qualified 
individual.
    (f) All verification activities taken in accordance with this 
section must be documented in records.

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.

    (a) 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 must conduct the following activities for any such 
refrigerated packaged animal food that requires time/temperature 
control to significantly minimize or prevent the growth of, or toxin 
formation by, microorganisms of animal or human health significance:
    (1) Establish and implement temperature controls adequate to 
significantly minimize or prevent the growth of, or toxin formation by, 
microorganisms of animal or human health significance;
    (2) Monitor the temperature controls with sufficient frequency to 
provide assurance they are consistently performed;
    (3) Take appropriate corrective actions if there is a problem with 
the temperature controls for such refrigerated packaged animal food to:
    (i) Correct the problem and reduce the likelihood that the problem 
will recur;
    (ii) Evaluate all affected animal food for safety; and
    (iii) Prevent the animal food from entering commerce, if the owner, 
operator, or agent in charge of the facility cannot ensure the affected 
animal food is not adulterated under section 402 of the Federal Food, 
Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented 
by:
    (i) Calibrating temperature monitoring and recording devices;
    (ii) Reviewing records of calibration within a reasonable time 
after the records are made; and
    (iii) Reviewing records of monitoring and corrective actions taken 
to correct a

[[Page 64832]]

problem with the control of temperature within a week after the records 
are made;
    (5) Establish and maintain the following records:
    (i) Records documenting the monitoring of temperature controls for 
any such refrigerated packaged animal food;
    (ii) Records of corrective actions taken when there is a problem 
with the control of temperature for any such refrigerated packaged 
animal food; and
    (iii) Records documenting the verification activities.
    (b) The records that a facility must establish and maintain under 
paragraph (a)(5) of this section are subject to the requirements of 
subpart F of this part.

Sec.  507.50  Requirements applicable to a qualified individual.

    (a) One or more qualified individuals must do or oversee the 
following:
    (1) Prepare the food safety plan (Sec.  507.30));
    (2) Validate the preventive controls (Sec.  507.45(a));
    (3) Conduct a review of records for implementation and 
effectiveness of preventive controls and appropriateness of corrective 
actions (Sec.  507.45(c));
    (4) Perform a reanalysis of the food safety plan (Sec.  507.45(e)).
    (b) To be qualified, an individual must have successfully completed 
training in the development and application of risk-based preventive 
controls at least equivalent to that received under a standardized 
curriculum recognized as adequate by FDA 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. This 
individual may be, but is not required to be, an employee of the 
facility.
    (c) All applicable training must be documented in records, 
including the date of the training, the type of training, and the 
person(s) trained.

Sec.  507.55  Records required for this subpart C.

    (a) The owner, operator, or agent in charge of a facility must 
establish and maintain the following records:
    (1) The written food safety plan, including the written hazard 
analysis, preventive controls, monitoring procedures, corrective action 
procedures, verification procedures, and recall plan;
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable, 
those related to:
    (i) Validation;
    (ii) Monitoring;
    (iii) Corrective actions;
    (iv) Calibration of process monitoring and verification 
instruments;
    (v) Records review; and
    (vi) Reanalysis; and
    (5) Records that document applicable training for the qualified 
individual.
    (b) The records that the owner, operator, or agent in charge of a 
facility must establish and maintain are subject to the requirements of 
subpart F of this part.

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

Sec.  507.60  Circumstances that may lead FDA to withdraw an exemption 
applicable to a qualified facility.

    FDA may withdraw the exemption applicable to a qualified facility 
under Sec.  507.5(d):
    (a) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to the qualified facility; or
    (b) If FDA determines that it is necessary to protect the animal or 
human health and prevent or mitigate a foodborne illness outbreak based 
on conduct or conditions associated with the qualified facility that 
are material to the safety of the animal food manufactured, processed, 
packed, or held at such facility.

Sec.  507.62  Issuance of an order to withdraw an exemption applicable 
to a qualified facility.

    (a) If FDA determines that an exemption applicable to a qualified 
facility under Sec.  507.5(d) should be withdrawn, any officer or 
qualified employee of FDA may issue an order to withdraw the exemption.
    (b) An FDA District Director in whose district the qualified 
facility is located (or, in the case of a foreign facility, the 
Director of the Division of Compliance in the Center for Veterinary 
Medicine), or an FDA official senior to such Director, must approve an 
order to withdraw the exemption.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.

Sec.  507.65  Contents of an order to withdraw an exemption applicable 
to a qualified facility.

    An order to withdraw an exemption applicable to a qualified 
facility under Sec.  507.5(d) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the facility; or
    (2) Conduct or conditions associated with a qualified facility that 
are material to the safety of the animal food manufactured, processed, 
packed, or held at such facility.
    (d) A statement that the facility must comply with subpart C of 
this part on the date that is 60 calendar days after the date of the 
order;
    (e) The text of section 418(l) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart D;
    (f) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this 
chapter, with certain exceptions described in Sec.  507.73;
    (g) The mailing address, telephone number, email address, and 
facsimile number of the FDA district office and the name of the FDA 
District Director in whose district the facility is located (or, in the 
case of a foreign facility, the same information for the Director of 
the Division of Compliance in the Center for Veterinary Medicine); and
    (h) The name and the title of the FDA representative who approved 
the order.

Sec.  507.67  Compliance with, or appeal of, an order to withdraw an 
exemption applicable to a qualified facility.

    (a) The owner, operator, or agent in charge of a qualified facility 
that receives an order under Sec.  507.60 to withdraw an exemption 
applicable to that facility under Sec.  507.5(d) must either:
    (1) Comply with applicable requirements of this part within 60 
calendar days of the date of the order; or
    (2) Appeal the order within 10 calendar days of the date of the 
order in accordance with the requirements of Sec.  507.69.
    (b) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner, as a matter of discretion, determines that delay or a 
stay is in the public interest.

[[Page 64833]]

    (c) If the owner, operator, or agent in charge of the qualified 
facility appeals the order, and FDA confirms the order, the owner, 
operator, or agent in charge of the facility must comply with 
applicable requirements of this part within 60 calendar days of the 
date of the order.

Sec.  507.69  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw an exemption applicable to a 
qualified facility under Sec.  507.5(d), the owner, operator, or agent 
in charge of the facility must:
    (1) Submit the appeal in writing to the FDA District Director in 
whose district the facility is located (or, in the case of a foreign 
facility, the Director of the Division of Compliance in the Center for 
Veterinary Medicine), at the mailing address, email address, or 
facsimile number identified in the order within 10 calendar days of the 
date of the order;
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which the owner, 
operator, or agent in charge of the facility relies.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec.  507.5(d), the owner, operator, or agent in charge 
of the facility may include a written request for an informal hearing 
as provided in Sec.  507.71.

Sec.  507.71  Procedure for requesting an informal hearing.

    (a) If the owner, operator, or agent in charge of the facility 
appeals the order, the owner, operator, or agent in charge of the 
facility:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
its written appeal submitted in accordance with Sec.  507.69 within 10 
calendar days of the date of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, written notice of the determination will be given to the 
owner, operator, or agent in charge of the facility explaining the 
reason for the denial.

Sec.  507.73  Requirements applicable to an informal hearing.

    If the owner, operator, or agent in charge of the facility requests 
an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 10 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon 
in writing by the owner, operator, or agent in charge of the facility 
and FDA.
    (b) The presiding officer may require that a hearing conducted 
under this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec.  507.62 and 
507.65, rather than the notice under Sec.  16.22(a) of this chapter, 
provides notice of opportunity for a hearing under this section and is 
part of the administrative record of the regulatory hearing under Sec.  
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA District Director (or, in the case of a foreign facility, the 
Director of the Division of Compliance in the Center for Veterinary 
Medicine) as provided in the order withdrawing an exemption.
    (3) Section 507.75, rather than Sec.  16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a 
written report of the hearing. All written material presented at the 
hearing will be attached to the report. The presiding officer must 
include as part of the report of the hearing a finding on the 
credibility of witnesses (other than expert witnesses) whenever 
credibility is a material issue, and must include a proposed decision, 
with a statement of reasons. The hearing participant may review and 
comment on the presiding officer's report within 2 calendar days of 
issuance of the report. The presiding officer will then issue the final 
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report 
of the hearing and any comments on the report by the hearing 
participant under Sec.  507.73(c)(4) are part of the administrative 
record.
    (6) No party shall have the right, under Sec.  16.119 of this 
chapter to petition the Commissioner for reconsideration or a stay of 
the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under part 16 of this chapter, except that Sec.  
16.95(b) does not apply to a hearing under this subpart. With respect 
to a regulatory hearing under this subpart, the administrative record 
of the hearing specified in Sec. Sec.  16.80(a)(1), (a)(2), (a)(3), and 
(a)(5), and 507.73(c)(5) constitutes the exclusive record for the 
presiding officer's final decision. For purposes of judicial review 
under Sec.  10.45 of this chapter, the record of the administrative 
proceeding consists of the record of the hearing and the presiding 
officer's final decision.

Sec.  507.75  Presiding officer for an appeal and for an informal 
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an FDA Regional Food and Drug Director or another FDA official 
senior to an FDA District Director.

Sec.  507.77  Timeframe for issuing a decision on an appeal.

    (a) If the owner, operator, or agent in charge of a facility 
appeals the order without requesting a hearing, the presiding officer 
must issue a written report that includes a final decision confirming 
or revoking the withdrawal by the 10th calendar day after the appeal is 
filed.
    (b) If the owner, operator, or agent in charge of a facility 
appeals the order and requests an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is 
held, the presiding officer must provide a 2 calendar day opportunity 
for the hearing participants to review and submit comments on the 
report of the hearing under Sec.  507.73(c)(4), and must issue a final 
decision within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.

Sec.  507.80  Revocation of an order to withdraw an exemption 
applicable to a qualified facility.

    An order to withdraw an exemption applicable to a qualified 
facility under Sec.  507.5(d) is revoked if:
    (a) The owner, operator, or agent in charge of the facility appeals 
the order and requests an informal hearing, FDA grants the request for 
an informal hearing, and the presiding officer does not confirm the 
order within the 10 calendar days after the hearing, or issues a 
decision revoking the order within that time; or
    (b) The owner, operator, or agent in charge of the facility appeals 
the order and requests an informal hearing, FDA

[[Page 64834]]

denies the request for an informal hearing, and FDA does not confirm 
the order within the 10 calendar days after the appeal is filed, or 
issues a decision revoking the order within that time; or
    (c) The owner, operator, or agent in charge of the facility appeals 
the order without requesting an informal hearing, and FDA does not 
confirm the order within the 10 calendar days after the appeal is 
filed, or issues a decision revoking the order within that time.

Sec.  507.83  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.

Subpart E--[Reserved]

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

Sec.  507.100  Records subject to the requirements of this subpart F.

    (a) Except as provided by paragraphs (d) and (e) of this section, 
all records required by this part are subject to all requirements of 
this subpart F.
    (b) Records required by this part are subject to the disclosure 
requirements under part 20 of this chapter.
    (c) All records required by this part must be made promptly 
available to a duly authorized representative of the Secretary of 
Health and Human Services upon oral or written request.
    (d) The requirements of Sec.  507.106 apply only to the written 
food safety plan.
    (e) The requirements of Sec.  507.102(a)(2), (a)(4), and (a)(5) and 
(b) do not apply to the records required by Sec.  507.7(e) pertaining 
to qualified facilities.

Sec.  507.102  General requirements applying to records.

    (a) Records must:
    (1) Be kept as original records, true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records), or electronic records, which 
must be kept in accordance with part 11 of this chapter;
    (2) Contain the actual values and observations obtained during 
monitoring;
    (3) Be accurate, indelible, and legible;
    (4) Be created concurrently with performance of the activity 
documented; and
    (5) Be as detailed as necessary to provide history of work 
performed.
    (b) All records must include:
    (1) The name and location of the plant or facility;
    (2) The date and time of the activity documented;
    (3) The signature or initials of the person performing the 
activity; and
    (4) Where appropriate, the identity of the product and the 
production code, if any.

Sec.  507.106  Additional requirements applying to the food safety 
plan.

    The food safety plan must be signed and dated by the owner, 
operator, or agent in charge of the facility upon initial completion 
and upon any modification.

Sec.  507.108  Requirements for record retention.

    (a) All records required by this part must be retained at the plant 
or facility for at least 2 years after the date they were prepared.
    (b) Records that relate to the general adequacy of the equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained at the facility for at least 
2 years after their use is discontinued (e.g., because the facility has 
updated the written food safety plan (Sec.  507.30) or records that 
document validation of the written food safety plan (Sec.  507.45(a)).
    (c) Except for the food safety plan, offsite storage of records is 
permitted after 6 months following the date that the record was made if 
such records can be retrieved and provided onsite within 24 hours of 
request for official review. The food safety plan must remain onsite. 
Electronic records are considered to be onsite if they are accessible 
from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the 
records may be transferred to some other reasonably accessible 
location, but must be returned to the plant or facility within 24 hours 
for official review upon request.

PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING 
OF ANIMAL FEED AND PET FOOD

0
8. The authority citation for 21 CFR part 579 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 343, 348, 371.

0
9. In Sec.  579.12, add the following sentence to the end of the 
paragraph to read as follows:

Sec.  579.12  Incorporation of regulations in part 179.

    * * * Any facility that treats animal feed and pet food with 
ionizing radiation must comply with the requirements of part 507 of 
this chapter and other applicable regulations.

    Note:  The following appendix will not appear in the Code of 
Federal Regulations.

Appendix

    Although the proposed rule that is the subject of this document 
does not include provisions for environmental monitoring or finished 
product testing, the Agency believes that these regimes can play a 
critical role in a modern food safety system. In sections XI.K and 
XI.L, the Agency requests comment on when and how these types of 
testing are an appropriate means of implementing the statutory 
directives set out in section 418 of the FD&C Act. In this Appendix, 
the Agency provides background material on these testing measures.

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

A. Verification of Preventive Controls

    In some respects, animal food safety is a more complex subject 
than human food safety in that the feeding of multiple and diverse 
animal species is involved, many of which are associated with human 
food in the form of meat, milk and eggs. However, the core 
principles and approaches used to assess and prevent hazards that 
are reasonably likely to occur in animal food are similar to those 
used during the manufacture of food for humans, despite differences 
in production practices and levels of sanitation involved (Ref. 1).
    The safety of food is principally ensured by the effective 
implementation of scientifically valid preventive control measures 
throughout the food chain (Ref. 2) (Ref. 3). Prevention of hazards 
in animal food is much more effective than trying to differentiate 
safe from unsafe animal food using testing. Although testing is 
rarely considered a control measure, it plays a very important role 
in ensuring the safety of animal 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 (Ref. 4) (Ref. 5). 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. Although testing may be conducted for biological, 
chemical, physical, or radiological hazards, the most common testing 
is for microbiological hazards. Thus, much of the testing described 
below focuses on microbial testing, but many of the issues discussed 
apply to testing for other hazards as well. The Agency focuses more 
of its discussion below on verification testing of the environment 
because of the increasing recognition of the benefits of such 
testing in identifying conditions that could result in environmental 
pathogens contaminating animal food; thus such verification testing 
is important in preventing contamination in animal food, whereas 
verification testing of raw materials,

[[Page 64835]]

ingredients, and finished products is used to detect contamination 
that has already occurred.
    As discussed in sections I.C, I.E, and I.F of this 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.
    Further discussion of verification of preventive controls can be 
found in section I.A of the Appendix of the document for the 
proposed rule for preventive controls for human food (78 FR 3646).

B. Scientifically Valid Sampling and Testing

    Consistent with the Agency's discussion of the term 
``scientifically valid'' in the proposed rule to establish CGMP 
requirements for dietary ingredients and dietary supplements for 
humans (68 FR 12158 at 12198), the Agency uses the term 
``scientifically valid'' with respect to testing to mean using an 
approach to both sampling and testing that is based on scientific 
information, data, or results published in, for example, scientific 
journals, references, text books, or proprietary research. A 
scientifically valid analytical method is one that is based on 
scientific data or results published in, for example, scientific 
journals, references, text books, or proprietary research (68 FR 
12158 at 12198). Sampling and testing used for verification in a 
food safety system must be scientifically valid if they are to 
provide assurance that preventive controls are effective.

C. Verification Testing of Raw Materials and Ingredients

    Raw materials and ingredients are often tested as part of a 
supplier approval and verification program, as one of the 
verification activities when a preventive control that is adequate 
to significantly minimize or prevent the hazard is not applied at 
the receiving facility. The utility and frequency of raw material 
and ingredient testing for verification of supplier controls depend 
on many factors, including:
     The hazard and its association with the raw material or 
ingredient;
     The likelihood that the animal, or person handling the 
animal food, would become ill if the hazard were present in the raw 
material or ingredient;
     How that raw material or ingredient will be used by the 
receiving facility (e.g., the effect of processing on the hazard); 
and
     The potential for contamination of the facility's 
environment with the hazard in the raw material or ingredient.
    Further discussion of verification testing of raw materials and 
ingredients can be found in section I.C of the Appendix of the 
document for the proposed rule for preventive controls for human 
food (78 FR 3646).

D. Verification of Sanitation Controls to Significantly Minimize or 
Prevent the Potential for an Environmental Pathogen To Contaminate 
Animal Food

1. Environmental Pathogens in Animal Food

    Animal food can become contaminated with pathogenic 
microorganisms at many different steps: on the farm; in packing, 
manufacturing/processing, or distribution facilities; during storage 
or transit; at retail establishments; and at the location of the 
animal. Any time animal food is exposed to the environment during a 
manufacturing, processing, packing, or holding activity, there is 
the potential for the food to be contaminated with pathogenic 
microorganisms. As discussed in section VIII.B of the preamble, 
proposed Sec.  507.3 would define the term ``environmental 
pathogen'' to mean a microorganism that is of animal or human health 
significance and is capable of surviving and persisting within the 
manufacturing, processing, packing, or holding environment. The 
environmental pathogens most frequently involved in the 
contamination of animal food leading to foodborne illness are 
Salmonella spp.

2. Salmonella spp. as an Environmental Pathogen

    The Agency discusses Salmonella spp. in section II.E of the 
preamble of this document and in section I.D.2 of the Appendix of 
the document for the proposed rule for preventive controls for human 
food (78 FR 3646). Salmonella has been isolated from a variety of 
foods and it can get into food by a variety of mechanisms. The focus 
here is on Salmonella contamination from the environment, 
particularly as a hazard associated with low-moisture animal food 
such as protein meals and dry animal food (Ref. 6). In the first RFR 
Annual Report, 86 of the primary RFR entries reported for human and 
animal food were a result of Salmonella contaminations. Almost half 
of these were from low-moisture foods and 13 of these were animal 
food (Ref. 7).

3. Environmental Pathogens in the Plant Environment

    Environmental pathogens may be introduced into a facility 
through raw materials or ingredients, people, or objects. Once in 
the facility, environmental pathogens can be a source of 
contamination of animal food. Further discussion of ``Environmental 
pathogens in the plant environment'' can be found in section I.D.4 
of the Appendix of the document for the proposed rule for preventive 
controls for human food (78 FR 3646).

4. Contamination of Animal Food With Salmonella spp. From the Plant 
Environment

    The available data and information associate insanitary 
conditions in animal and human food facilities with contamination of 
a number of foods with the environmental pathogen Salmonella spp. 
Such contamination has led to recalls and to outbreaks of foodborne 
illness.
    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 the 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 as becoming ill due to 
the handling of pet food contaminated with this Salmonella strain 
(Ref. 8).
    In 2008-2009, an outbreak was linked to Salmonella Typhimurium 
in peanut butter and peanut paste (Ref. 9) (Ref. 10). This outbreak 
resulted in an estimated 714 illnesses, 166 hospitalizations, and 9 
deaths (Ref. 10). Inspections conducted by FDA at the two implicated 
ingredient manufacturing facilities (which shared ingredients) 
revealed lack of controls to prevent product contamination from 
pests, from an insanitary air-circulation system, from insanitary 
food-contact surfaces, and from the processing environment (Ref. 11) 
(Ref. 12). Several strains of Salmonella spp. were found in multiple 
products and in the plant environment (Ref. 12). This outbreak led 
to the recall of more than 3900 animal (including pet food) and 
human food products containing peanut-derived ingredients (Ref. 11).

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 
Animal Food

1. Purpose of Environmental Monitoring

    The purpose of monitoring for environmental pathogens in 
facilities where animal food is manufactured, processed, packed, or 
held is to verify the implementation and effectiveness of sanitation 
controls intended to significantly minimize or prevent the potential 
for an environmental pathogen to contaminate animal food. In so 
doing, environmental monitoring can find sources of environmental 
pathogens that remain in the facility after routine cleaning and 
sanitizing so that the environmental pathogens can be eliminated by 
appropriate corrective actions (e.g., intensified cleaning and 
sanitizing, sometimes involving equipment disassembly). For further 
discussion, see section I.E. of the Appendix of the document for the 
proposed rule for preventive controls for human food (78 FR 3646).

2. Indicator Organisms

    The term ``indicator organism'' can have different meanings, 
depending on the

[[Page 64836]]

purpose of using an indicator organism. As discussed in the 
scientific literature, the term ``indicator organism'' means a 
microorganism or group of microorganisms that is indicative that (1) 
a food has been exposed to conditions that pose an increased risk 
for contamination of the food with a pathogen or (2) a food has been 
exposed to conditions under which a pathogen can increase in numbers 
(Ref. 13). This definition in the scientific literature is 
consistent with a definition of indicator organism established by 
NACMCF as one that indicates a state or condition and an index 
organism as one for which the concentration or frequency correlates 
with the concentration or frequency of another microorganism of 
concern (Ref. 14). FDA considers the NACMCF definition of an 
indicator organism to be an appropriate working definition for the 
purpose of this document.
    Listeria spp. is an appropriate indicator organism for L. 
monocytogenes. The Agency is aware that listeriosis occurs in a 
number of animal species, especially ruminant animals, and is asking 
for comment on whether L. monocytogenes is an environmental pathogen 
of concern for animal food facilities. FDA's current thinking is 
that there is no currently available indicator organism for 
Salmonella spp. The Agency requests data, information, and other 
comment bearing on whether there is a currently available indicator 
organism for Salmonella spp. that could be used for environmental 
monitoring.
    For additional discussion on indicator organisms, monitoring 
procedures, and corrective actions, see section I.E.2 through 5 of 
the Appendix for the proposed rule for preventive controls for human 
food (78 FR 3646).

F. The Role of Finished Product Testing in Verifying the Implementation 
and Effectiveness of Preventive Controls

    Although FDA is not including a provision for finished product 
testing in this proposed rule, here the Agency sets out some 
considerations regarding the appropriate use of such testing. The 
utility of finished product testing for verification depends on many 
factors that industry currently considers in determining whether 
finished product testing is an appropriate approach to reducing the 
risk of: animals consuming contaminated food, humans handling 
contaminated food, and humans consuming food derived from animals 
that consumed contaminated food. The first such consideration is the 
nature of the hazard and whether there is evidence of adverse health 
consequences from that hazard in the animal food being produced or 
in a similar animal food. If the hazard were to be present in the 
animal food, how likely is it that illness will occur and how 
serious would the consequences be? The more likely and severe the 
illness, the greater the frequency of conducting verification 
testing should be. For example, Salmonella spp. is a hazard that 
could cause serious illness, particularly in children and the 
elderly who might get exposed to it through handling pet food 
products contaminated with the organism. In contrast, in situations 
where unlawful pesticide residues are considered reasonably likely 
to occur, the presence of a pesticide residue that is not approved 
for a specific commodity, but that is within the tolerance approved 
for other commodities, while deemed unsafe as a matter of law, may 
not actually result in illness. Thus, a firm is more likely to 
conduct finished product testing to verify Salmonella spp. control 
than to verify control of pesticides.
    Another consideration in determining whether finished product 
testing is appropriate is the intended ``consumer'' of the animal 
food and whether indirect exposure of a susceptible population may 
occur. The greater the sensitivity of the intended ``consumer'' (as 
would be the case, for example, for dioxin contamination), the 
greater the likelihood that finished product testing would be used 
as a verification activity.
    Another consideration in determining whether finished product 
testing is appropriate is the impact of the animal food on the 
contaminant. For example, depending on the animal food, pathogens 
may survive in the food, increase in number, or die off. Finished 
product testing generally is not conducted if pathogens that may be 
in an animal food would die off in a relatively short period of time 
(e.g., before the food reaches the ``consumer'').
    Additional considerations in determining whether finished 
product testing is appropriate are the intended use of the animal 
food; the types of controls the supplier has implemented to minimize 
the potential for the hazard to be present (e.g., whether the 
supplier has a kill step for a pathogen); the effect of processing 
on the hazard; and whether a hazard can be reintroduced into a food 
that has been treated to significantly minimize the hazard (e.g., 
Salmonella in dry or low-moisture pet food when a flavoring is 
applied after heat treatment).
    For an extensive discussion on finished product testing and 
metrics for microbiological risk management, see sections I.F and 
I.G of the Appendix for the proposed rule for human food (78 FR 
3646).

II. 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 as a result of contamination of wheat gluten with 
melamine (see discussion in section II.E.1of the preamble).
    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. To ensure 
safe animal food and minimize the potential for contaminated animal 
food to reach the consumer, each supplier in the chain must 
implement preventive controls appropriate to the animal food and 
operation for hazards reasonably likely to occur in the raw material 
or other ingredient. A facility receiving raw materials or 
ingredients from a supplier must 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 company 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 provides initial and ongoing assurance that 
suppliers are complying with practices to achieve adequate control 
of hazards in raw materials or ingredients.
    Supplier approval and verification is widely accepted in the 
domestic and international food safety community. The NACMCF HACCP 
guidelines describe Supplier Control as one of the common 
prerequisite programs for the safe production of food products and 
recommend that each facility should ensure that its suppliers have 
in place effective GMP and food safety programs (Ref. 14). Codex 
specifies that no raw material or ingredient should be accepted by 
an establishment if it is known to contain parasites, undesirable 
microorganisms, pesticides, veterinary drugs or toxic, decomposed or 
extraneous substances which would not be reduced to an acceptable 
level by normal sorting and/or processing (Ref. 15). Codex also 
specifies that, where appropriate, specifications for raw materials 
should be identified and applied and that, where necessary, 
laboratory tests should be made to establish fitness for use (Ref. 
15).
    Supplier verification activities include auditing a supplier to 
ensure the supplier is complying with applicable food safety 
requirements, such as requirements under proposed part 507. Audit 
activities may include a range of activities, such as on-site 
examinations of establishments, review of records, review of quality 
assurance systems, and examination or laboratory testing of product 
samples (Ref. 16). Other supplier verification activities include 
conducting testing or requiring supplier certificates of analysis 
(COAs), review of food safety plans and records, or combinations of 
activities such as audits and periodic testing.
    An increasing number of establishments that sell food are 
independently requiring, as a condition of doing business, that 
their suppliers, both foreign and domestic, become certified as 
meeting safety (as well as other) standards. In addition, domestic 
and foreign suppliers (such as producers, co-manufacturers, or re-
packers) are increasingly looking to third-party certification 
programs to assist them in meeting U.S. regulatory requirements 
(Ref. 16). There are many established third-party certification 
programs designed for various reasons that are currently being used 
by industry. Many third party audit schemes used to assess the

[[Page 64837]]

industry's food safety management systems incorporate requirements 
for manufacturers and processors to establish supplier approval 
programs. An example of a food safety standard that was specifically 
developed for the animal food industry is Publicly Available 
Specification (PAS) 222:2011 (Ref. 1). This standard was developed 
for the animal food industry by the British Standards Institution 
(BSI) to specify requirements for prerequisite programs (PRPs) to 
assist in controlling hazards in animal food. The PAS 222:2011 
requirements can be used either in conjunction with ISO 22000, food 
safety management systems, or as a stand-alone document.
    To ensure confidence in the delivery of safe food for animals 
and humans worldwide, the Global Food Safety Initiative (GFSI), a 
benchmarking organization, was established in 2000 to drive 
continuous improvement in food safety management systems. Their 
objectives include reducing risk by delivering equivalence and 
convergence between effective food safety management systems and 
managing cost in the global food system by eliminating redundancy 
and improving operational efficiency (Ref. 17). GFSI has developed a 
guidance document as a tool that fulfills the GFSI objectives of 
determining equivalency between food safety management systems (Ref. 
17). The document is not a food safety standard, but rather 
specifies a process by which food safety schemes may gain 
recognition, the requirements to be put in place for a food safety 
scheme seeking recognition by GFSI, and the key elements for 
production of safe food or feed, or for service provision (e.g., 
contract sanitation services or food transportation) in relation to 
food safety (Ref. 17). This benchmark document has provisions 
relevant to supplier approval and verification programs. For 
example, it specifies that a food safety standard must require that 
the organization control purchasing processes to ensure that all 
externally sourced materials and services that have an effect on 
food safety conform to requirements. It also specifies that a food 
safety standard must require that the organization establish, 
implement, and maintain procedures for the evaluation, approval and 
continued monitoring of suppliers that have an effect on food 
safety. Thus, all current GFSI-recognized schemes require supplier 
controls to ensure that the raw materials and ingredients that have 
an impact on food safety conform to specified requirements. The GFSI 
guidance document also requires audit scheme owners to have a 
clearly defined and documented audit frequency program, which must 
ensure a minimum audit frequency of one audit per year of an 
organization's facility (Ref. 17).
    Because GFSI is a document that outlines elements of a food 
safety management system for benchmarking a variety of standards, it 
does not have details about how facilities should comply with the 
elements. This type of information is found in the food safety 
schemes that are the basis for certification programs. For example, 
the Safe Quality Food (SQF) 2000 Code, a HACCP-based supplier 
assurance code for the food industry, specifies that raw materials 
and services that impact on finished product safety be supplied by 
an Approved Supplier. SQF 2000 specifies that the responsibility and 
methods for selecting, evaluating, approving and monitoring an 
Approved Supplier be documented and implemented, and that a register 
of Approved Suppliers and records of inspections and audits of 
Approved Suppliers be maintained. SQF 2000 requires that the 
Approved Supplier Program contain, among other items, agreed 
specifications; methods for granting Approved Supplier status; 
methods and frequency of monitoring Approved Suppliers; and details 
of certificates of analysis if required.
    According to SQF, the monitoring of Approved Suppliers is to be 
based on the prior good performance of a supplier and the risk level 
of the raw materials supplied. The monitoring and assessment of 
Approved Suppliers can include:
     The inspection of raw materials received;
     The provision of certificates of analysis;
     Third party certification of an Approved Supplier; or
     The completion of 2nd party supplier audits.

III. References

1. British Standards Institute (BSI), ``Publicly Available 
Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety 
in the Manufacture of Food and Feed for Animals,'' 2011.
2. National Advisory Committee on Microbiological Criteria for 
Foods, ``Hazard Analysis and Critical Control Point Principles and 
Application Guidelines,'' Journal of Food Protection, 61, 1246-1259, 
1998.
3. Codex Alimentarius Commission, ``Principles for the Establishment 
and Application of Microbiological Criteria for Foods, CAC/GL 21-
1997,'' 1997.
4. International Commission on Microbiological Specifications for 
Foods, ``Microbiological Hazards and Their Control,'' In: 
Microorganisms in Foods 7: Microbiological Testing in Food Safety 
Management, edited by Tompkin, R. B., L. Gram, T. A. Roberts, R. L. 
Buchanan, et al.,1-21, 2002.
5. International Commission on Microbiological Specifications for 
Foods, ``Selection and Use of Acceptance Criteria,'' In: 
Microorganisms in Foods 7: Microbiological Testing in Food Safety 
Management, edited by Tompkin, R. B., L. Gram, T. A. Roberts, R. L. 
Buchanan, et al., 79-97, 2002.
6. Scott, V. N., C. Yuhuan, T. A. Freier, et al., ``Control of 
Salmonella in low-moisture foods I: Minimizing entry of Salmonella 
into a processing facility,'' Food Protection Trends, 29, 342-353, 
2009.
7. FDA, ``FDA Foods Program, The Reportable Food Registry: A New 
Approach to Targeting Inspection Resources and Identifying Patterns 
of Adulteration. First Annual Report: September 8, 2009-September 7, 
2010,'' January, 2011.
8. Centers for Disease Control and Prevention (CDC), ``Update: 
Recall of Dry Dog and Cat Food Products Associated with Human 
Salmonella Schwarzengrund Infections--United States, 2008,'' In: 
Morbidity and Mortality Weekly Report November 2008, (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5744a2.htm), Date Last Reviewed: 
November 6, 2008 (accessed on August 27, 2013).
9. Centers for Disease Control and Prevention (CDC), ``Multistate 
Outbreak of Salmonella Infections Associated with Peanut Butter and 
Peanut Butter-Containing Products-United States, 2008-2009,'' In: 
Morbidity and Mortality Weekly Report February 2009, (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5804a4.htm), Date Last Reviewed: 
February 4, 2009 (accessed on August 27, 2013).
10. Cavallaro, E., K. Date, C. Medus, et al., ``Salmonella 
Typhimurium Infections Associated with Peanut Products,'' New 
England Journal of Medicine, 365, 601-610, 2011.
11. FDA, ``Peanut Products Recall'' (http://www.fda.gov/Safety/Recalls/MajorProductRecalls/Peanut/default.htm), Page Last Updated: 
June 19, 2009 (accessed on August 27, 2013).
12. FDA, ``Amended Form 483 (Inspectional Observations) for Peanut 
Corporation of America, Blakely, GA, 02/05/2009,'' February 2009.
13. Buchanan, R. L., ``Acquisition of Microbiological Data to 
Enhance Food Safety,'' Journal of Food Protection, 63, 832-838, 
2000.
14. National Advisory Committee on Microbiological Criteria for 
Foods, ``Response to the Questions Posed by FSIS Regarding 
Performance Standards with Particular Reference to Ground Beef 
Products'' (http://www.fsis.usda.gov/OPHS/NACMCF/2002/rep_stand2.pdf), Submitted: October 8, 2002 (accessed on August 28, 
2013).
15. Codex Alimentarius Commission, ``Recommended International Code 
of Practice General Principles of Food Hygiene, CAC/RCP 1-1969 (Rev. 
4-2003),'' 2003.
16. FDA, ``Guidance for Industry--Voluntary Third-Party 
Certification Programs for Foods and Feeds,'' January 2009.
17. Global Food Safety Initiative, ``GFSI Guidance Document, Version 
6.1.'' August 2011.

    Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25126 Filed 10-25-13; 8:45 am]
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