F would establish requirements that would apply to all records that
would be required under part 507. FDA describes the requirements of
proposed subpart F in section XII. Proposed Sec.  507.48(b) is
analogous to proposed Sec.  507.55(b) in subpart C.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

L. Proposed Sec.  507.84--Final Agency Action

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

M. Conforming Amendment to 21 CFR Part 16

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

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

A. Relevant Statutory Provisions

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

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

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

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

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

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

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

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

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

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

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

XIII. FSMA's Rulemaking Provisions

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

XIV. Proposed Conforming Changes

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

XV. Legal Authority

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

A. Current Good Manufacturing Practice Regulations

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

B. Hazard Analysis and Risk-Based Preventive Controls

    Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive
Controls, amends the FD&C Act to create a new section 418, which
mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that
the Secretary issue regulations to establish science-based minimum
standards for conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the implementation of
the preventive controls. Section 418(n)(1)(B) of the FD&C Act requires
that the regulations define the terms ``small business'' and ``very
small business,'' taking into consideration the study of the food
processing sector required by section 418(l)(5) of the FD&C Act.
Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act
(21 U.S.C. 331(uu)) to prohibit the operation of a facility that
manufactures, processes, packs, or holds food for sale in the United
States if the owner, operator, or agent in charge of such facility is
not in compliance with section 418 of the FD&C Act.
    In addition to rulemaking requirements, section 418 contains
requirements applicable to the owner, operator, or agent in charge of a
facility required to register under section 415. Section 418(a) is a
general provision that requires the owner, operator, or agent in charge
of a facility to evaluate the hazards that could affect food
manufactured, processed, packed, or held by the facility, identify and
implement preventive controls, monitor the performance of those
controls, and maintain records of the monitoring. Section 418(a)
specifies that the purpose of the preventive controls is, in relevant
part, to prevent the occurrence of such hazards and provide assurances
that such food is not adulterated under section 402 of the FD&C Act. In
addition to the general requirements in section 418(a) of the FD&C Act,
sections 418(b)-(i) contain more specific requirements applicable to
facilities. These include hazard analysis (Sec.  418(b)), preventive
controls (Sec.  418(c)), monitoring (Sec.  418(d)), corrective actions
(Sec.  418(e)), verification (Sec.  418(f)), recordkeeping (Sec.
418(g)), a written plan and documentation (Sec.  418(h)), and
reanalysis of hazards (Sec.  418(i)). Proposed requirements (proposed
subparts C and F) that would implement these provisions of section 418
of the FD&C Act are discussed in sections X and XII.
    The Agency is proposing certain requirements in order to
efficiently enforce these requirements of section 418. For example,
section 418(g) and (h) of the FD&C Act prescribe certain recordkeeping,
maintenance, and access requirements for certain kinds of records. As
discussed in section XII, the Agency is proposing to establish one set
of requirements that would apply to all records that would be required
under the proposed rule. This approach will facilitate compliance with
the rule on the part of facilities, and will allow for

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

XVI. Preliminary Regulatory Impact Analysis

A. Overview

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

B. Regulatory Flexibility Act

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

C. Small Business Regulatory Enforcement Fairness Act of 1996

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

D. Unfunded Mandates Reform Act of 1995

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

E. Public Access to the Analyses

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

XVII. Paperwork Reduction Act of 1995

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

XVIII. Analysis of Environmental Impact

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

XIX. Federalism

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

XX. Comments

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

XXI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
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24, 2013 (accessed on August 22, 2013).
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and International Feed Industry Federation (IFIF), ``Good practices
for the feed industry--Implementing the Codex Alimentarius Code of
Practice on Good Animal Feeding'' 2010.
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24, 2013 (accessed on August 23, 2013).
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Examination of Animal Feed, Animal Feed Ingredients and Other
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Renderers'' February 1998.
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Protein Blenders, Feed Manufacturers, and Distributors'' February
1998.
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Feeders of Ruminant Animals with On-Farm Feed Mixing Operations''
February 1998.
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Regulation'' July 1998.
    11. FDA, ``GFI 158, Use of Material from Deer and Elk
in Animal Feed'' September 2003.
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Finished Wheat Products for Human Consumption and Grains and Grain
By-products for Animal Feed'' June 2010.
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Meat Foods for Companion and Captive Noncompanion Carnivores and
Omnivores'' November 2004.
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    15. FDA, ``Compliance Policy Guide Sec. 683.100 Action Levels
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17. Cianciolo, R. E., K. Bischoff, J. G. Ebel, et al.,
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Inadvertently Exposed to Pet Food Contaminated with Melamine and
Cyanuric Acid'', JAVMA, 233, 729-737, 2008.
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Animal Feeds'' (http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm127724.htm), October 14, 1997, Page Last Updated: May
21, 2013 (accessed on August 27, 2013).
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Recalled'' (http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm135055.htm), March 22, 2002, Page Last Updated: May
24, 2013 (accessed on August 27, 2013).
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Crisis and Its Effects on Agricultural Production and Exports'', In:
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C.125-136, 2003.
22. Kennedy, J., L. Delaney, A. McGloin, et al., ``Public
Perceptions of the Dioxin Crisis in Irish Pork'' June 2009.
23. FDA, ``CVM Update: FDA Investigation of Diamond Pet Foods Finds
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Recall of Dry Dog and Cat Food Products Associated with Human
Salmonella Schwarzengrund Infections--United States, 2008'' In:
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(DEFRA), G. A. H. F. a. F. G., ``Salmonella typhimurium DT 191A
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Salmonella I 4,[5],12:i:-Infections Associated with Frozen Rodents''
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14, 2012, Page Last Updated August 27, 2013 (accessed on August 27,
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Establishment and Application of Microbiological Criteria for Foods,
CAC/GL 21-1997'', 1997.
31. International Commission on Microbiological Specifications for
Foods, ``Microbiological Hazards and Their Control'', In:
Microorganisms in Foods 7: Microbiological Testing in Food Safety
Management, edited by Tompkin, R. B., L. Gram, T. A. Roberts, R. L.
Buchanan, et al., 1-21, 2002.
32. International Commission on Microbiological Specifications for
Foods, ``Selection and Use of Acceptance Criteria'', In:
Microorganisms in Foods 7: Microbiological Testing in Food Safety
Management, edited by Tompkin, R. B., L. Gram, T. A. Roberts, R. L.
Buchanan, et al., 79-97, 2002.
33. FDA, ``Qualitative Risk Assessment Risk of Activity/Animal Food
Combinations for Activities (Outside the Farm Definition) Conducted
in a Facility Co-Located on a Farm,'' 2012.
34. Codex Alimentarius Commission, ``Recommended International Code
of Practice General Principles of Food Hygiene, CAC/RCP 1-1969 (Rev.
4-2003)'', 2003.
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