[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Proposed Rules]
[Pages 64736-64837]
From the Federal Register Online via the Government Publishing 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
[[Page 64736]]
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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: [email protected].
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
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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.
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Total domestic
costs annualized
at 7 per cent over
10 years
(millions)
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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.
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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));
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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).
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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
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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
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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
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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;
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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
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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
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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