Labeling that meets applicable FDA labeling regulations must accompany
or be affixed to the animal food and that the labeling must include,
when applicable, information and instructions for safely using the
product for the intended animal species. We have added the
clarification that it is ``when applicable,'' understanding that not
all animal food product will need information on its safe use. We have
deleted the requirement that labeling that identifies the product by
the common or usual name must be affixed to or accompany the animal
food in this section because it is already covered by current FDA
regulations.

E. Proposed Sec.  507.27(b)--Shipping Containers (Final Sec.
507.27(c))

    We proposed that shipping containers (for example, totes, drums,
and tubs) and bulk vehicles used to distribute animal food must be
inspected prior to use to ensure the container or vehicle will not
contaminate the animal food.
    (Comment 229) Some comments state that the requirement to inspect
shipping containers is not practical because containers are frequently
reused without intervening cleaning or because the animal food is
distributed in dedicated containers or vehicles. One comment says that
it is pointless to inspect the containers when the product being
distributed may be decayed and may be dumped on the ground for the
animals to eat. Other comments state that sometimes nobody is available
to inspect the vehicle when third-party transportation is used and that
third-party transportation vehicles may already contain animal food or
by-products because they are used to pick up from several facilities.
Some comments say that contractual provisions specify how third-party
shipping container may be used, and therefore inspection prior to each
load would not be necessary to manage this risk.
    (Response 229) Though we disagree with the comments, we are
revising the regulatory text in Sec. Sec.  507.27 and 507.28 to replace
the word ``inspected'' with ``examined''. We believe that the use of
the word ``examined'' provides more clarity for the animal food
industry because the term ``inspected'' often implies a regulatory
activity. This does not mean that the shipping container must be
cleaned prior to each use. The plant or facility is responsible for
examining shipping containers and bulk vehicles that it uses to
transport the animal food (e.g., the facility transports the animal
food, or arranges with a third-party to distribute the animal food to
the facility's customer). We expect the plant or facility personnel
involved in the process of loading the product into the shipping
container or vehicle to be aware of the condition of the shipping
container or vehicle, and consider whether its condition would
contaminate the animal food. This examination could include viewing the
shipping container or vehicle to observe whether there are any unusual
residues in it that may contaminate the animal food, or it could be
simply knowing what the shipping container or vehicle had previously
been used for and because of that, whether the container needed to be
cleaned prior to use. We do not expect a plant or facility to examine
the shipping container or bulk vehicle when a customer transports the
animal food or arranges for a third-party to pick up the animal food.
However, a plant or facility may choose to examine a customer's
shipping container or bulk vehicle as a business decision to ensure
that shipping container or bulk vehicle will not lead to the
contamination or adulteration of the animal food.

F. Proposed Sec.  507.27(c)--Returned Animal Food (Final Sec.
507.27(d))

    We proposed that animal food returned from distribution must be
assessed for animal food safety to determine the appropriate
disposition. Returned animal food must be identified as such and
segregated until assessed. We received no comments on this requirement
and are finalizing it as proposed.

G. Proposed Sec.  507.27(d)--Unpackaged Bulk Animal Food (Final Sec.
507.27(e))

    We proposed that unpackaged or bulk animal food must be held in a
manner that does not result in cross contamination with other animal
food. We received no comment on this requirement and are finalizing it
as proposed with one wording change. We have added the term ``unsafe''
to modify cross contamination to make it clear that this requirement
applies to cross contamination that would result in unsafe animal food.

XXII. Subpart B: Comments on Proposed Sec.  507.28--Holding and
Distribution of Human Food By-Products for Use as Animal Food

    We proposed to add provisions for human food by-products for use as
animal food. We proposed that the requirements of this part (with the
exception of proposed Sec.  507.28) would not apply to by-products of
human food production that are packed and held by that facility for
distribution as animal food if certain requirements were met (see
discussion in section XIII). The facility would only need to comply
with proposed Sec.  507.28 of this part and proposed Sec.  117.95 of
part 117 (which contains identical requirements).

A. Proposed Sec.  507.28(a)--Contamination

    We proposed that human food by-products held for distribution as
animal food must be held under conditions that will protect against
contamination.

    (Comment 230) Multiple comments request that the term ``human food
by-products,'' not ``animal food,'' be used throughout Sec. Sec.
507.28 and 117.95 (of part 117). These comments note that it is
important to make clear that human food by-products do not change from
human food to animal food until they are transferred to someone with
the intent to use it as an animal food.
    (Response 230) We disagree that human food by-products are not
animal food until they have been transferred to someone with the intent
to use it as animal food. Furthermore, we think that the use of the
term ``human food by-products'' would be more confusing here because
not all human food by-products are intended for use as animal food.
However, we have revised the regulatory text to use the term ``human
food by-products for use as animal food'' throughout this section to
differentiate it from other requirements in parts 117 and 507. The
purpose of these provisions in Sec. Sec.  507.28 and 117.95 is to
ensure that when the processer is holding and distributing human food
by-products for use as animal food, the by-products are recognized as
human food by-products for use as animal food by all employees and
treated as such.

B. Proposed Sec.  507.28(a)(1)--Containers

    We proposed that containers used to hold animal food before
distribution must be designed, constructed of appropriate material,
cleaned, and maintained to prevent the contamination of animal food.
    (Comment 231) Some comments state that the provisions about
containers are too prescriptive because by-products may be held and
conveyed in ways that do not use containers (such as using storage
silos, augers, pipes, chutes or conveyor belts to convey product
directly to transportation vehicles). Some comments request
clarification on cleaning the containers because they are frequently
reused for holding by-product without intervening cleaning procedures.
    (Response 231) We agree that human food by-products for use as
animal food may be held and conveyed using equipment instead of
containers. We have revised the regulatory text to add ``equipment'' in
addition to containers, and have added the words ``convey'' and
``cleaned as necessary'' (see regulatory text for Sec. Sec.
507.28(a)(1) and 117.95(a)(1)). We expect containers and equipment to
be cleaned at a frequency that protects against contamination of human
food by-products for use as animal food by contaminants that could be
harmful to the public (human and animal) health. This may not require
cleaning after each use.

C. Proposed Sec.  507.28(a)(2)--Protection From Contamination

    We proposed that animal food held for distribution must be held in
a way to prevent contamination from sources such as trash and garbage.
As discussed in Response 227, we have revised the regulatory text to
remove the term garbage. We did not receive additional comments related
to this paragraph and are finalizing the proposed language with changes
previously discussed. (See Responses 227 and 230.)

D. Proposed Sec.  507.28(a)(3)--Labeling

    We proposed that labeling identifying the product by the common or
usual name must be affixed to or accompany animal food.
    (Comment 232) Some comments state that by-products only need to be
reasonably identified while they are being held by the facility and
state that once they are ready for distribution, they should be labeled
in conformance with applicable regulatory requirements. One comment
states that what is considered the ``common and usual name'' varies
between the human food industry, the animal food industry, producers
and regulators. This comment suggests that FDA work with regulatory
partners to provide guidance on the proper ``common and usual name'' of
by-products to promote consistency.
    (Response 232) We agree in part with these comments. As with animal
food subject to all of part 507, we expect that while human food by-
product for use as animal food is being held in the human food
facility, it is accurately identified. (See Response 201.) We have
revised the regulatory text to clarify that the human food by-product
for use as animal food must be accurately identified while held in the
human food facility (see Sec.  507.28(a)(3) of the final rule). We
retained the requirement that when the human food by-product for use as
animal food is distributed, it must have labeling that identifies the
common or usual name of the product affixed to or accompanying it (see
Sec.  507.28(b) of the final rule).
    Our CPG Sec. 665.100 discusses common or usual names for animal
food ingredients (Ref. 25). There are also industry and other
regulatory resources that may assist facilities in determining the
common or usual name of the animal food. For example, USDA maintains
the National Nutrient Database for Standard Reference, a database that
includes a list of names for human food items (Ref. 30). We will take
into consideration these comments when determining whether to issue
additional guidance about the common or usual name of animal food.
    (Comment 233) One comment requests that FDA require human food
manufacturers to document the recipient's intended use of the by-
products so the by-products do not become ingredients of human food.
This comment also requests that these by-products be required to be
labeled with the statement ``For Use as Animal Feed Only.''
    (Response 233) We decline these requests. Human food is produced
under human food regulations, such as CGMPs, and HACCP regulations for
juice and seafood, and facilities must meet the applicable requirements
for food that is manufactured, processed, packed, or held to ensure the
safety of that human food. This requirement in Sec.  507.28 is meant
only for human food by-products for use as animal food that are only
held and distributed (i.e. not further processed). Human food by-
products may be used as human food ingredients as long as they are in
compliance with the applicable human food regulations. However, we
would not object if a facility labels the human food by-products for
use as animal food ``For Use as Animal Food Only.''

E. Proposed Sec.  507.28(b)--Shipping Containers

    We proposed that shipping containers (for example, totes, drums,
and tubs) and bulk vehicles used to distribute animal food must be
inspected prior to use to ensure the container or vehicle will not
contaminate the animal food. This provision is paragraph (c) of this
section in the final rule.
    (Comment 234) We received the same comments on Sec.  507.28(c) as
Sec.  507.27(c). (See Comment 229.)
    (Response 234) We are revising the regulatory text in Sec. Sec.
507.28(c) and 117.95(c). (See Response 229.)

XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and
Risk-Based Preventive Controls

    In the 2014 supplemental notice for preventive controls for animal
food, we proposed a series of changes to proposed subpart C and
reopened the comment period specifically with respect to these changes.
The proposed changes included: (1) Eliminating the term ``hazard
reasonably likely to occur'' throughout proposed subpart C (and, thus,
deleting the definition we had proposed for this term); (2) adding a
new defined term, ``significant hazard,'' and, in general, using this
new term instead of ``hazard reasonably likely to occur'' throughout
the re-

proposed regulations; (3) defining ``known or reasonably foreseeable
hazard'' in place of ``reasonably foreseeable hazard'' and clarifying
that the new term means a hazard ``that has the potential to be
associated with the facility or the food'' rather than ``a potential .
. . hazard that may be associated with the facility or the food''; and
(4) providing additional flexibility to address concerns about
rewriting existing plans or programs to conform with the requirement of
the preventive controls rule.
    We received many comments on the overall framework for hazard
analysis and risk-based preventive controls. We discuss each of these
comments in the discussion of the specific regulatory text applicable
to each comment. We show highlights of the changes we made after
considering these comments in table 9.

Table 9--Revisions to the Overall Framework for Hazard Analysis and Risk-
                        Based Preventive Controls
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.3.........................  Definition of      Revise the proposed
                                 ``significant      term ``significant
                                 hazard``.          hazard'' to ``hazard
                                                    requiring a
                                                    preventive control''
                                                    and revise the
                                                    definition to
                                                    emphasize the role
                                                    of risk in
                                                    determining whether
                                                    a hazard requires a
                                                    preventive control.
507.3.........................  Definition of      Define the term
                                 ``corrections``.   ``correction'' to
                                                    distinguish
                                                    ``corrections'' from
                                                    ``corrective
                                                    actions.''
507.34(c)(1), 507.39(a),        Flexibility in     Clarify that
 507.40, 507.45(a), 507.47(a),   preventive         preventive control
 507.49(a), 507.49(b).           controls and       management
                                 preventive         components depend on
                                 control            the role of a
                                 management         preventive control
                                 components for     in the facility's
                                 monitoring,        food safety system,
                                 corrective         as well as the
                                 actions and        nature of the
                                 corrections, and   preventive control.
                                 verification.
507.33(b)(1)..................  Hazard             Emphasize that the
507.33(b)(2)..................   identification.    hazard
                                                    identification
                                                    focuses on known or
                                                    reasonably
                                                    foreseeable hazards
                                                    (rather than on all
                                                    hazards).
507.40(c)(2)..................  Monitoring         Provide for the use
                                 records.           of ``exception
                                                    records'' for
                                                    monitoring
                                                    preventive controls.
507.42(a).....................  Corrective action  Clarify that
                                 procedures.        corrective action
                                                    procedures depend on
                                                    the nature of the
                                                    hazard.
507.42(c).....................  Corrections......  Provide for
                                                    additional
                                                    circumstances when
                                                    corrections, rather
                                                    than corrective
                                                    actions, are
                                                    warranted.
507.47(c).....................  Preventive         Clarify that a list
                                 controls that do   of preventive
                                 not require        controls that do not
                                 validation.        require validation
                                                    is not an exhaustive
                                                    list.
507.49(a)(5)..................  Activities to      Clarify that there
                                 verify             could be alternative
                                 implementation     verification
                                 and                activities of
                                 effectiveness.     implementation and
                                                    effectiveness other
                                                    than those that we
                                                    specify in the rule.
507.49(b).....................  Written            Clarify that written
                                 procedures for     procedures for
                                 verification of    verification of
                                 implementation     implementation and
                                 and                effectiveness are
                                 effectiveness.     established and
                                                    implemented as
                                                    appropriate to the
                                                    role of the
                                                    preventive control
                                                    in the facility's
                                                    food safety system,
                                                    as well as
                                                    appropriate to the
                                                    facility, the animal
                                                    food, and the nature
                                                    of the preventive
                                                    control.
507.50(b).....................  Reanalysis.......  Provide for
                                                    reanalysis of an
                                                    applicable portion
                                                    of the food safety
                                                    plan (rather than
                                                    the complete food
                                                    safety plan) in
                                                    specified
                                                    circumstances.
------------------------------------------------------------------------

XXIV. Subpart C: Comments on Proposed Sec.  507.31--Food Safety Plan

    We proposed requirements for a food safety plan. Some comments
support the proposed requirements without change. Some comments that
support the proposed provisions suggest alternative or additional
regulatory text or ask us to clarify how we will interpret the
provision.
    In the following sections, we discuss comments that ask us to
clarify the proposed requirements, or disagree with, or suggest one or
more changes to the proposed requirements. After considering these
comments, we are finalizing the provisions as proposed, with editorial
and conforming changes as shown in table 31.
    We proposed that the food safety plan be under the oversight of one
or more ``qualified individuals.'' As discussed in section VIII.A.24,
we have changed the proposed term ``qualified individual'' to
``preventive controls qualified individual'' because we are
establishing a new definition for ``qualified individual,'' with a
meaning distinct from ``preventive controls qualified individual.'' To
minimize the potential for confusion for when the term ``qualified
individual'' refers to the proposed meaning of the term and when the
term ``qualified individual'' refers to the meaning of that term as
finalized in this rule, in the remainder of this document we substitute
the new term ``preventive controls qualified individual'' for the
proposed term ``qualified individual,'' even though the proposed rule
used the term ``qualified individual.'' Likewise, we substitute the new
term ``preventive controls qualified individual'' for the proposed term
``qualified individual'' when describing the comments to the proposed
rule, even though those comments use the term ``qualified individual.''
    We proposed that several other provisions of subpart C be under the
oversight of a ``qualified individual'' (now ``preventive controls
qualified individual''), and also proposed requirements that would
apply to the ``qualified individual'' (now ``preventive controls
qualified individual''). See, e.g., Sec. Sec.  507.47, 507.49, 507.50,
507.51, 507.53, and 507.55). As discussed in the preceding paragraph,
in the remainder of this document, we substitute the new term
``preventive controls qualified individual'' for the proposed term
``qualified individual,'' when describing these proposed provisions and
the comments to these proposed provisions.

A. Proposed Sec.  507.31(a)--Requirement for a Food Safety Plan

    We proposed that you must prepare, or have prepared, and implement
a written food safety plan.
    (Comment 235) Some comments ask us to develop a final preventive
controls

rule with separate requirements for food safety plans for manufacturers
of livestock food and for manufactures of food for other animal
species.
    (Response 235) We decline this request. The required elements of
the food safety plan listed in Sec.  507.31(c) apply to each type of
animal food manufactured at a facility. Animal food types or production
method types may be grouped together if the hazards, preventive
controls, parameters, and management components (monitoring, corrective
actions and corrections, and verification) necessary to ensure the
effectiveness of the preventive controls are essentially identical. We
have provided additional flexibility within the required elements of
the food safety plan in the final rule. Therefore the same requirements
for a food safety plan are applicable to a facility that makes food for
livestock and one that makes food for other animal species.
    (Comment 236) Some comments ask us to add regulatory text to this
section stating that an existing written food safety plan, including
any plan intended to satisfy the requirements of a foreign jurisdiction
or that complies with existing standards developed by other
organizations (such as PAS 222 (Ref. 27)), satisfies the requirements
of this section if it contains the information specified by Sec.
507.31(c).
    (Response 236) To the extent that an existing food safety plan
includes all required information, a facility can use such plans to
meet the requirements of this rule. We expect that many existing plans
will need only minor supplementation to fully comply with these
requirements. Relying on existing records, with supplementation as
necessary to satisfy the requirements of the preventive controls rule,
is acceptable (see Sec.  507.212).
    (Comment 237) Some comments agree with our previous statements that
facilities should be able to group animal food types or production
method types if hazards, control measures, parameters, and required
procedures, such as monitoring, are identical (78 FR 64736 at 64779).
Some comments ask us to emphasize that each facility needs only one
food safety plan, regardless of how many animal species it makes food
for, or how many different types of food it makes. These comments
further state that facilities are under the impression that any given
facility will need multiple food safety plans if they make many food
types or make food for multiple animal species.
    (Response 237) We are requiring that a facility have a written food
safety plan that covers all types of animal food it manufactures,
processes, packs, or holds and all of the animal species for which the
food is intended. We recognize that, to the extent that the controls
are the same, there may be common controls that broadly apply to some
or all of a facility's animal food products. However, any product-,
process-, or animal species-specific differences must be carefully
delineated and observed in practice.
    In some facilities with limited types of animal food products or
animal species for which the food is intended, the written food safety
plan may contain a single set of procedures that addresses all of the
products produced. For other facilities, there may not be a practical
way to group the products and the written food safety plan may need to
contain more than one set of procedures to address all of its products.
    (Comment 238) Some comments ask us to emphasize that ``written''
means ``any type of recordable and reproducible format'' (e.g., as
paper or electronic documents). Some comments ask us to specify that
the components of the food safety plan need not be in a single document
or stored in one place.
    (Response 238) A ``written'' food safety plan can be either a paper
document or an electronic document, as provided for by Sec.
507.202(a). The final rule specifies that required information (which
would include the food safety plan) does not need to be kept in one set
of records (see Sec.  507.212(b)), and a food safety plan may be
prepared as a set of documents kept in different locations within the
facility (e.g., based on where they will be used), provided that each
set of documents is onsite. As provided in the recordkeeping
provisions, electronic records are considered to be onsite if they are
accessible from an onsite location.
    (Comment 239) Some comments ask us to provide that the food safety
plan be handled at the corporate level rather than the facility level
if a corporation owns many facilities.
    (Response 239) A corporation may designate an individual at the
corporate level as the owner, operator, or agent in charge of a
particular facility. In addition, an employee of the corporation,
whether at headquarters or at another facility owned by the
corporation, may provide input into a particular facility's food safety
plan. As previously discussed, the food safety plan does need to be
facility specific (see the discussion of the facility-based nature of
the food safety plan in the 2013 proposed preventive controls rule for
animal food, 78 FR 64736 at 64780). For example, even if a corporation
makes similar products at two separate facilities, it is unlikely that
the two facilities have exactly the same equipment and layout.
Procedural instructions must be tailored to the equipment being used,
and the layout of a facility may affect its approach to preventive
controls.
    (Comment 240) Some comments assert that a food safety plan should
only be required for high-risk processing facilities because adhering
to CGMPs is sufficient for low-risk facilities. Some comments assert
that FSMA does not authorize us to require farms to develop food safety
plans.
    (Response 240) We decline the request to establish additional
exemptions based on risk, other than the exemptions for on-farm low-
risk activity/animal food combinations provided by section 103(c)(1)(D)
of FSMA (Sec.  507.5(e) and (f)). The applicability of the requirements
of the preventive controls rule to facilities that are required to
register is required by the statute (see the definition of facility in
section 418(o)(2) of the FD&C Act). Section 418(h) of the FD&C Act
requires that a facility prepare and implement a food safety plan,
unless an exemption applies. Neither FSMA nor this rule establishes an
exemption for ``low-risk'' facilities, including ``low-risk''
facilities that are regularly inspected by State, local, or tribal
government Agencies. A farm is not subject to this rule for activities
within the ``farm'' definition. A farm mixed-type facility that is a
small or very small business and only conducts the low-risk activity/
animal food combinations specified in Sec.  507.5(e) and (f) is exempt
from the requirements of subparts C and E, including the requirement
for a food safety plan.
    (Comment 241) Some comments ask us to clarify that a food safety
plan is not required when a facility is exempt as a qualified facility
(Sec.  507.7(a)) or as a facility solely engaged in the storage of
packaged food that is not exposed to the environment (Sec.  507.10)
    (Response 241) A qualified facility is exempt from the requirements
of subparts C and E, including the requirement to prepare and implement
a food safety plan, and is instead subject to the requirements in Sec.
507.7. Likewise, a facility solely engaged in the storage of packaged
animal food that is not exposed to the environment and does not require
time/temperature control to significantly minimize or prevent the
growth of, or toxin production by, pathogens is exempt from the
requirements of subparts C and E, including the requirement to prepare
and implement a food safety plan. See Response 242 for unexposed,
packaged TCS animal food.

    (Comment 242) Some comments ask us to clarify that a food safety
plan is not required for facilities that store unexposed, refrigerated,
packaged TCS animal foods.
    (Response 242) We agree that a facility ``solely engaged'' in the
storage of unexposed, refrigerated, packaged TCS animal food is exempt
from the requirements of subparts C and E, including the requirement to
prepare and implement a food safety plan, and instead is subject to the
modified requirements in Sec.  507.51 (see Sec.  507.10). However, if a
facility engages in other activities in addition to the storage of
unexposed, refrigerated, packaged TCS animal food, the exemption does
not apply. In such a case, the facility must prepare and implement a
food safety plan. However, the modified requirements of Sec.  507.51
can be informative with respect to what the food safety plan could
include regarding the storage of unexposed, refrigerated, packaged TCS
animal food.

B. Proposed Sec.  507.31(b)--Preparation of the Food Safety Plan by a
Preventive Controls Qualified Individual

    We proposed that the food safety plan must be prepared, or its
preparation overseen, by one or more preventive controls qualified
individuals.
    (Comment 243) Some comments ask us to provide for a group of
qualified individuals to prepare, or oversee the preparation of, a food
safety plan.
    (Response 243) The proposed regulatory text included in the 2014
supplemental notice provides for the food safety plan to be prepared,
or its preparation overseen, by one or more preventive controls
qualified individuals, and we are finalizing it as proposed.

C. Proposed Sec.  507.31(c)--Contents of a Food Safety Plan

    We proposed that the written food safety plan must include the
written hazard analysis, preventive controls (including the supplier
program and recall plan), procedures for monitoring the implementation
of the preventive controls, corrective action procedures, and
verification procedures. As discussed in more detail in section XL, we
have revised the phrase ``supplier program'' to ``supply-chain
program'' throughout the regulatory text. In the remainder of this
document, we use the phrase ``supply-chain program'' in section
headings and when referring to the provisions of the final rule. We
continue to use the term ``supplier program'' when describing the
proposed provisions and the comments regarding the proposed provisions.
    (Comment 244) Some comments ask us to specify that sanitation
controls must be in the food safety plan. Some comments ask us to
require that the food safety plan include the qualifications of the
preventive controls qualified individual.
    (Response 244) Sanitation controls are one type of preventive
control. As appropriate to the facility and the animal food (e.g., to
control hazards such as environmental pathogens), sanitation controls
for cleanliness of animal food-contact surfaces and prevention of cross
contamination are required to be in the food safety plan (Sec.
507.34(c)(2)).
    We are requiring that you document all applicable training taken by
the preventive controls qualified individual (see Sec.  507.53(d)).
This documentation must be established and maintained (see Sec.
507.55(a)(6)).

D. Proposed Sec.  507.31(d)--Records

    We proposed that the food safety plan is a record that is subject
to the recordkeeping requirements of subpart F. We received no comments
that disagreed with this proposed requirement and are finalizing it as
proposed.

E. Comments on Potential Requirements for Submission of a Facility
Profile to FDA

    We requested comment on whether to require submission to FDA of a
subset of the information that would be in a food safety plan (78 FR
64736 at 64809). This information, which could be referred to as a
``facility profile,'' could be submitted through an electronic form
using a menu selection approach at the same time as facility
registration and updated biennially simultaneously with the required
biennial update of the food facility registration. We described
potential benefits to having a facility's food safety plan in advance
of an inspection, such as aiding in the efficient oversight of
preventive controls by allowing us to better target inspectional
activities to facilities that produce foods that have an increased
potential for contamination (particularly with biological hazards). We
noted that facilities could benefit from our advance preparation
through interaction with better-informed investigators and potentially
reduced inspection time. We requested 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. We also
requested comment on any additional benefits that might be obtained
from using such an approach and any potential concerns with this
approach.
    We noted that we had 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 (Federal Register of May 11, 2012, 77 FR
27779). In contrast to the voluntary submission of food facility
profile information described in that document, in the 2013 proposed
preventive controls rule for animal food we requested comment on
whether the submission of such information should be required.
    (Comment 245) Some comments state that submission of a facility
profile would be useful and support requiring such a submission.
However, most of the comments that addressed our request for comments
on such a submission express concern. Some comments assert that
requiring submission of a facility profile is outside of FDA's
statutory authority under FSMA. Other comments assert that submitting a
facility profile would not advance food safety goals or have a
commensurate benefit to food safety. Some comments express concern
about protection of confidential information. Other comments express
concerns that we would misinterpret the submitted information in the
absence of discussion with the facility. Some comments assert that
receiving and evaluating the submitted information would be too time-
consuming for FDA, whereas other comments assert that submitting the
information would be too time-consuming for the facility. Some comments
state that a subset of the information that would be submitted could be
found in the Establishment Inspection Reports. Some comments assert
that we could use information already available through the RFR to
identify facilities that have needed to address a serious food safety
violation and target our inspectional resources to those facilities.
Some comments state that a facility profile is a not a static document
and would be very difficult to keep up to date. Other comments state
that such a profile would be of limited or no use to FDA because
information regarding hazards and preventive controls is best assessed
in the context of a full food safety plan and related documentation.
These comments further state that food safety plans will constantly
evolve as facilities undertake new activities and refine their
processes; a profile would present only a static picture of the food
safety measures in place at a given time; FDA has already implemented
changes to the

registration process that require facilities to provide more
information about the activities at the facility. One comment asks us
to refrain from requiring written or electronic submission of facility
profiles.
    (Response 245) We have decided that we will not establish a
requirement for submission of a facility profile. We will explore other
mechanisms to achieve the goals we described in the 2013 proposed
preventive controls rule for animal food.

XXV. Subpart C: Comments on Proposed Sec.  507.33--Hazard Analysis

    We proposed requirements for hazard analysis, including hazard
identification and hazard evaluation. Some comments support the
proposed requirements without change. For example, some comments
support our proposal for the hazard analysis to address ``known or
reasonably foreseeable hazards'' because this is consistent with Codex.
Other comments agree that the hazard analysis should address both the
severity of the potential hazard and the probability that the hazard
will be present in an animal food product. Other comments state that
testing for environmental pathogens may be impractical in certain
situations for facilities in chemical plants that also produce food
additives and that the proposed requirements for hazard evaluation make
it clear that in such facilities environmental monitoring would not be
required. Some comments that support the proposed provisions suggest
alternative or additional regulatory text or ask us to clarify how we
will interpret the provision.
    In the following sections, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
10 with editorial and conforming changes as shown in table 31.

  Table 10--Revisions to the Proposed Requirements for Hazard Analysis
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.33(a)(1)..................  Requirement for a  Specify that a
                                 hazard analysis.   facility must
                                                    ``conduct a hazard
                                                    analysis'' to
                                                    identify and
                                                    evaluate known or
                                                    reasonably
                                                    foreseeable hazards,
                                                    rather than merely
                                                    specify that a
                                                    facility must
                                                    ``identify and
                                                    evaluate'' known or
                                                    reasonably
                                                    foreseeable hazards.
507.33(a)(2)..................  Requirement for    Clarify that the
                                 the hazard         hazard analysis must
                                 analysis to be     be written,
                                 written.           regardless of its
                                                    outcome.
507.33(b)(1) and (b)(2).......  Hazard             Emphasize that the
                                 identification.    hazard
                                                    identification
                                                    focuses on known or
                                                    reasonably
                                                    foreseeable hazards
                                                    (rather than on all
                                                    hazards).
507.33(b)(1)(ii)..............  Hazard             Replace
                                 identification.    ``imbalances''
                                                    with'' deficiencies
                                                    or toxicities'' and
                                                    provide examples of
                                                    these hazards.
507.33(b)(1)(iii).............  Hazard             Add examples of
                                 identification.    physical hazards.
507.33(c)(2)..................  Hazard evaluation  Provide that hazard
                                                    evaluation does not
                                                    need to include an
                                                    evaluation of
                                                    environmental
                                                    pathogens whenever
                                                    finished animal food
                                                    is exposed to the
                                                    environment prior to
                                                    packaging if the
                                                    packaged food
                                                    includes a control
                                                    measure (such as a
                                                    formulation lethal
                                                    to the pathogen)
                                                    that would
                                                    significantly
                                                    minimize the
                                                    pathogen.
507.33(d)(10).................  Hazard evaluation  Provide an example of
                                                    ``other relevant
                                                    factor'' that the
                                                    hazard evaluation
                                                    must consider (the
                                                    example is the
                                                    temporal (e.g.,
                                                    weather-related)
                                                    nature of some
                                                    hazards (e.g.,
                                                    levels of some
                                                    natural toxins)).
------------------------------------------------------------------------

A. Proposed Sec.  507.33(a)--Requirement for a Written Hazard Analysis

    We proposed that you must identify and evaluate, based on
experience, illness data, scientific reports, and other information,
known or reasonably foreseeable hazards for each type of animal food
manufactured, processed, packed, or held at your facility to determine
whether there are significant hazards. We also proposed that the hazard
analysis must be written.
    As discussed in Response 62, we have revised the term ``significant
hazard'' to ``hazard requiring a preventive control.'' In addition, we
have revised the regulatory text to specify that the outcome of a
hazard analysis is to determine whether there are any hazards requiring
a preventive control.
    (Comment 246) Some comments ask us to specify that the rule
requires a written hazard analysis even if the hazard analysis
concludes that no hazards exist.
    (Response 246) As proposed, the regulatory text would require a
written hazard analysis even if the hazard analysis concludes that no
hazards exist. To make this clearer, we have made two revisions to the
regulatory text. First, we have revised the regulatory text to specify
that a facility must ``conduct a hazard analysis'' to identify and
evaluate known or reasonably foreseeable hazards, rather than merely
specify that a facility must ``identify and evaluate'' known or
reasonably foreseeable hazards. Second, we have revised the regulatory
text to specify that the hazard analysis must be written regardless of
its outcome.
    (Comment 247) Some comments assert that a facility should not be
able to conclude that no hazard exists in its production process and
that any such conclusion reached should be a ``red flag'' to FDA
investigators.
    (Response 247) The purpose of a hazard analysis is to identify and
evaluate known or reasonably foreseeable hazards to determine whether
there are any hazards requiring a preventive control. If a facility
appropriately determines, under the oversight of a preventive controls
qualified individual, that no such hazards exist, then that is the
outcome of its hazard analysis, and the facility must document that
outcome in its written hazard analysis.
    We expect that there will be many circumstances in which a facility
appropriately determines that certain biological, chemical, or physical
hazards are not hazards requiring a preventive control that must be
addressed in the food safety plan. The provisions of the rule that
allow a facility to appropriately determine that a particular hazard is
not a hazard requiring a preventive control in certain animal food
products are not equivalent to an exemption from the rule. For example,
a facility that appropriately determines that there are no hazards
requiring a preventive control associated with its animal food products

must document that determination in its written hazard analysis (Sec.
507.33); however, no preventive controls, including supplier
verification activities, and associated management components would be
required in such a situation. There are several types of animal food
products for which a facility may determine that there are no hazards
requiring a preventive control. Such products include, but are not
limited to: alfalfa cubes, vegetable oils, and molasses.
    However, we agree that our investigators should take appropriate
steps to evaluate a facility's hazard analysis when the outcome is that
there are no hazards requiring a preventive control. We expect that our
investigators would both review the facility's written hazard analysis
and discuss the outcome with the facility. During the initial stages of
implementation, we also expect that our investigators will ask subject
matter experts in our Center for Veterinary Medicine (CVM) to review
such a hazard analysis. Over time, as our investigators gain experience
with appropriate determinations that there are no hazards requiring a
preventive control, we expect that there will be fewer circumstances in
which our investigators would consult CVM about such an outcome.
    (Comment 248) Some comments ask us to require that the hazard
analysis be re-evaluated every 3 years and updated as needed.
    (Response 248) The written hazard analysis is one component of the
food safety plan, and the food safety plan is subject to reanalysis at
least once every 3 years, and sooner under certain circumstances (see
Sec.  507.50).
    (Comment 249) Some comments ask us to modify the provision to
specify that the hazard analysis identify and evaluate known or
reasonably foreseeable hazards for each type of animal food
manufactured, processed, packed, or held at the facility, including
hazards in the raw materials and ingredients used in the animal food
(emphasis added).
    (Response 249) We decline this request. Other provisions in the
requirements for hazard analysis specify that the hazard evaluation
must consider raw materials and ingredients (see Sec.  507.33(d)(3)).
It is not necessary to repeat the specific requirements associated with
the hazard evaluation in the provision that directs each facility to
conduct a hazard analysis.
    (Comment 250) Some comments state that the standard for hazard
analysis in the preventive controls rule should both align with the
reproposed requirements for hazard analysis set forth in the
supplemental FSVP notice and be consistent with the statutory standard
for hazard analysis in section 418(b)(1) of the FD&C Act.
    (Response 250) We have aligned the requirements of the animal food
preventive controls rule and the proposed FSVP rule to the extent
practicable, consistent with the applicable statutory requirements.

B. Proposed Sec.  507.33(b)--Hazard Identification

    We proposed that the hazard identification must consider hazards
that include biological, chemical, and physical hazards. We proposed
examples of biological hazards (e.g., microbiological hazards such as
parasites, environmental pathogens, and other pathogens) and chemical
hazards (e.g., radiological hazards and substances such as pesticide
and drug residues, natural toxins, decomposition, unapproved food or
color additives, and nutrient imbalances).
    In the preamble for the 2013 proposed preventive controls rule for
animal food, we explained that nutrient imbalance hazards can result
from excessive levels of a nutrient in animal food resulting in
toxicity to the animal, or a nutrient deficiency in the animal food
that can compromise the health of an animal and provided examples (78
FR 64736 at 64782). These nutrient imbalance hazards are of particular
concern for animals that consume one animal food type as their sole
source of nutrition. Because different species have different
nutritional needs, certain quantities of a nutrient that are needed by
one species of animal could pose a health risk to another species of
animal.
    In the preamble for the 2013 proposed preventive controls rule for
animal food we also provided examples of physical hazards (e.g.,
stones, glass, or metal fragments that could inadvertently be
introduced into animal food) (78 FR 64736 at 64782) but did not include
these examples in the proposed regulatory text.
    We also proposed that the hazard identification must consider
hazards that may be present in the animal food if they occur naturally
or may be unintentionally introduced. In the 2014 preventive controls
supplemental notice for animal food we proposed to add that the hazard
analysis also must consider hazards that may be intentionally
introduced for purposes of economic gain (proposed Sec.
507.33(b)(2)(iii)).
    (Comment 251) As discussed in Comment 62, some comments express
concern that the rule would refer to multiple levels of hazards (i.e.,
``hazard,'' ``known or reasonably foreseeable hazard,'' and
``significant hazard'' (which we now refer to as ``hazard requiring a
preventive control'') and ask us to provide sufficient clarity to be
able to distinguish between these types of hazards.
    (Response 251) As discussed in Response 62, we have revised the
requirements for hazard identification to emphasize that the hazard
identification focuses on known or reasonably foreseeable hazards
(rather than on all hazards).
    (Comment 252) Some comments ask us to include examples of physical
hazards in the regulatory text.
    (Response 252) We have added stones, glass, and metal fragments as
examples of physical hazards in the regulatory text. This is consistent
with the regulatory text for biological and chemical hazards, even
though the hazards listed in section 418(b)(1) of the FD&C Act include
examples of chemical and biological hazards but do not include examples
of physical hazards.
    (Comment 253) Some comments ask us to separately list some hazards
(such as parasites and drug residues) rather than include them as
examples of biological hazards and chemical hazards.
    (Response 253) We decline this request. Although section
418(b)(1)(A) of the FD&C Act lists such items separately, we believe it
is clearer to acknowledge that some of the hazards listed in the
statute are in fact a subset of the broader categories of biological
and chemical hazards.
    (Comment 254) Some comments ask us to rephrase the requirement for
hazard identification to specify ``The hazard analysis must identify
hazards'' rather than ``The hazard identification must consider
hazards.''
    (Response 254) We decline this request. The provision is directed
to the first step of a hazard analysis, i.e., hazard identification,
rather than to the overall hazard analysis (which is addressed in Sec.
507.33(a)). The purpose of the hazard identification is to consider the
types of hazards listed as a step in determining whether there are any
hazards requiring a preventive control; the suggestion of the comments
implies that such hazards will always be identified. As discussed in
Response 247, the outcome of a hazard analysis for an animal food
product could be that there are no hazards requiring a preventive
control.
    (Comment 255) Some comments ask us to revise the chemical hazard
examples by replacing the term ``nutrient imbalances'' with ``nutrient
deficiencies or toxicities.''

    (Response 255) We agree that the suggested revision adds clarity
and have modified the regulatory text to replace ``nutrient
imbalances'' with ``nutrient deficiencies or toxicities,'' and provide
examples, such as ``inadequate thiamine in cat food,'' ``excessive
vitamin D in dog food'', and ``excessive copper in food for sheep.''
    (Comment 256) Some comments assert that nutrient imbalances should
not be addressed in an animal food safety plan because they pose no
threat to humans.
    (Response 256) We disagree with these comments. The preventive
controls rule for animal food is intended to protect animal health, as
well as human health. Section 418 of the FD&C Act, which authorizes the
preventive controls rules, applies to facilities registered under
section 415 of the FD&C Act, which includes facilities that
manufacture, process, pack, and hold animal food.
    (Comment 257) Some comments assert that while serious, ongoing
imbalances of nutrients such as copper and selenium must be avoided
with checks and balances, and perhaps product testing, there could be a
multitude of other incidents that could occur without serious
consequences and to address every possible scenario, by species, when
the Agency is aware of a limited number of rare cases, is unreasonable.
Some comments state that the notion that nutrient deficiencies or
toxicities for animals are hazards likely to occur in the manufacture
of animal food seems like a poor fit in this set of food safety
regulations.
    (Response 257) The Agency has a history of animal food incidents
resulting in recall of animal food and in animal illnesses and deaths
from nutrient deficiencies or toxicities.
    From 2012 to 2014, FDA received multiple reports through its RFR
that were attributable to animal food associated with nutrient
deficiencies or toxicities. For example, during the 2010/2011 reporting
period, 3.57 percent of 224 primary (industry and voluntary) RFR
entries were associated with nutrient deficiencies or toxicities in
animal food. During the 2012/2013 period, 2.97 percent of 202 entries
were attributable to nutrient imbalances or toxicities in animal food
(Refs. 14 and 16). Reports included low levels of thiamine in cat food;
high levels of vitamin D in dog food; low levels of vitamin D in food
for swine; high levels of vitamin D in food for guinea pigs, fish, and
other animal species; high levels of calcium and phosphorus in food for
broiler chickens and turkeys causing the death of several hundred young
birds (Refs. 13 to 16); high levels of salt in food for broilers; high
levels of protein/urea in food for cattle; and high levels of copper in
food for sheep. Many of these animal foods with nutrient imbalances
(deficiencies or toxicities) resulted in a recall of the affected
animal food (Refs. 31 to 39).
    Moreover, an analysis of thiamin levels in randomly selected
commercial canned cat foods was conducted during a period from December
2012 through January 2013 (Ref. 40). The study found 13.3 percent of
the cat foods tested fell below the minimum set for thiamine by AAFCO
and 15.6 percent were below the recommended allowance of the National
Research Council.
    We also disagree with the implication that facilities must address
every possible hazard. Facilities must identify and evaluate known or
reasonably foreseeable hazards for each type of animal food
manufactured, processed, packed, or held at the facility to determine
whether there are any hazards requiring a preventive control.
    (Comment 258) Some comments suggest that nutrient imbalances should
be addressed through CGMPs.
    (Response 258) We disagree with these comments. We consider
nutrient deficiencies and toxicities to be a type of chemical hazard
that are appropriately addressed through preventive controls. If a
facility identifies a nutrient deficiency or toxicity as a hazard that
is known or reasonably foreseeable in an animal food and is a hazard
that requires a preventive control, the facility must implement
preventive controls for that hazard. The facility has flexibility in
determining what preventive controls it needs to implement to control
the hazard. Preventive controls for identified nutrient toxicity or
deficiency hazards can include CGMPs, but the specific CGMP needs to be
included in the food safety plan (or for a qualified facility, the
documentation supporting an attestation under Sec.  507.7(a)(2)).
    (Comment 259) Some comments ask us to consider revising the
proposed rule to include food allergens in animal food much in the same
way that they have been proposed in the human food rule.
    (Response 259) We decline this request. We are not aware of
evidence indicating that foodborne allergens pose a significant health
risk to animals (78 FR 64736 at 64771). Animals with actual food
allergies typically have digestive disorders or dermatologic
conditions, not the anaphylactic reaction that humans have to the major
food allergens (defined in section 201(qq) of the FD&C Act).
    (Comment 260) Some comments assert that physical hazards in animal
food are not likely to cause any serious injuries to humans as the
contaminant is not assimilated into edible tissue.
    (Response 260) We disagree with these comments. The rule defines
the term hazard to include a physical agent that has the potential to
cause injury or illness in animals, as well as humans. Physical hazards
in animal food can cause illness or injury in animals.
    (Comment 261) Some comments ask us to delete ``decomposition'' from
the list of chemical hazards in this provision.
    (Response 261) We decline this request. As discussed previously,
decomposition of animal food consists of microbial breakdown of the
normal food product tissues and the subsequent enzyme-induced chemical
changes. These changes are manifested by abnormal odors, taste,
texture, color, etc., and can lead to reduced food intake or rejection
of the food by the intended animal species, resulting in illness or
death (see 78 FR 64736 at 64782).
    (Comment 262) Some comments assert that we should not require all
food safety plans to specifically address the likelihood of
radiological hazards.
    (Response 262) The rule only requires that a facility consider
whether radiological hazards are known or reasonably foreseeable, and
we have described situations where radiological hazards could be
considered to be known or reasonably foreseeable. A facility that
appropriately determines that no radiological hazards are known or
reasonably foreseeable would document that determination in its written
hazard analysis but would not need to establish preventive controls and
associated preventive control management components to address
radiological hazards.
    (Comment 263) Some comments assert that predictable intentional
hazards should be in the food safety plan but unexpected intentional
hazards should be part of a food defense plan.
    (Response 263) This rule only requires a facility to consider
intentionally introduced hazards when such hazards are introduced for
purposes of economic gain. Hazards that may be intentionally introduced
by acts of terrorism are the subject of the 2013 proposed intentional
adulteration rule (78 FR 78014, December 24, 2013), which applies only
to human foods.
    (Comment 264) Some comments disagree that the animal food
preventive controls rule should address hazards that are intentionally
introduced for purposes of economic gain (economically motivated
adulteration).

Some of these comments assert that economically motivated adulteration
is not a good fit for the hazard analysis and preventive controls
framework because it is, in all but the rarest of circumstances, an
issue of product integrity and quality, whereas food safety systems are
designed and built to prevent or mitigate food safety hazards. Some
comments state that traditional food safety hazards are primarily both
identified and addressed at the facility level, but economically
motivated adulteration is typically handled by the corporate parent
company, where supply-chain management programs are typically located.
These comments also assert that food safety-related economically
motivated adulteration is extremely rare and that predicting
economically motivated adulteration to prevent it is extremely
difficult. Some comments assert there will be no measurable benefit to
food safety by imposing requirements to consider economically motivated
adulteration as part of a food safety plan and that doing so will
consume limited resources without a corresponding increase in consumer
protection. Other comments assert that there is no need to require a
facility to identify hazards intentionally introduced for purposes of
economic gain because the misbranding and adulteration provisions of
the FD&C Act already sufficiently provide safeguards against economic
gain.
    (Response 264) We agree with the comments that state that the
requirement to consider hazards intentionally introduced for purposes
of economic gain is narrow. Such hazards will be identified in rare
circumstances, usually in cases where there has been a pattern of
economically motivated adulteration in the past. In addition, we define
hazards to only include those agents that have the potential to cause
illness or injury. Economically motivated adulteration that affects
product integrity or quality, for example, but not animal food safety,
is out of the scope of this rule. We continue to believe that there is
benefit in taking this preventive approach to economically motivated
adulteration and not relying solely on enforcing the preexisting
misbranding and adulteration provisions of the FD&C Act after a
violation occurs.
    As discussed in sections XL through XLVII, we are finalizing
supply-chain program provisions. It is consistent with the framework of
this rule for a facility to address hazards requiring a preventive
control that may be intentionally introduced for purposes of economic
gain through the facility's supply-chain program.
    (Comment 265) Some comments express concern about identifying
hazards that may be intentionally introduced for purposes of economic
gain because there are potentially an unlimited number of unknown or
yet-to-be identified hazards that could be intentionally introduced for
purposes of economic gain by an unscrupulous supplier. These comments
disagree with our attempt to narrow the field of potential scenarios
for economically motivated adulteration to circumstances where there
has been a pattern of such adulteration in the past.
    Some comments assert that our attempt to narrow the field of
potential scenarios for economically motivated adulteration is both too
broad and too narrow at the same time. These comments assert that our
attempt is too broad, because we expect facilities to consider patterns
of adulteration from the past ``even though the past occurrences may
not be associated with the specific supplier or the specific food
product'' and a requirement to consider every potential product and
potential supplier makes the task open ended. These comments further
assert that our attempt is too narrow, because a focus on patterns of
adulteration in the past is unlikely to reveal potential future
instances of economically motivated adulteration and because those
intending to defraud purchasers for economic gain are trying to avoid
detection. According to these comments, once an animal food safety
related instance of economically motivated adulteration is uncovered,
perpetrators quickly move to carry out their fraudulent activities in a
different way. Some comments assert that there are alternative ways to
control hazards that may be intentionally introduced for purposes of
economic gain without specific regulatory requirements, such as by
having an effective supplier approval program with appropriate
qualification and verification activities; through business-to-business
relations, expectations, and contracts; and through a vulnerability
assessment and control plan tailored specifically to economically
motivated adulteration.
    (Response 265) We disagree that the requirement is too broad. A
facility must conduct a hazard analysis for each type of animal food
manufactured, processed, packed, or held at the facility. There is no
requirement to consider every potential product or potential supplier.
We also disagree that the requirement is too narrow. Some individuals
intending to defraud purchasers for economic gain will develop entirely
novel ways of adulterating food to suit their purposes. We agree that
these circumstances may not lend themselves to the preventive approach
required here. We encourage, but do not mandate, that facilities adopt
other measures they deem appropriate to mitigate the risks of
economically motivated adulteration that this rulemaking does not
address. Still, the repeated use of melamine over the years, in animal
foods and in foods for people, demonstrates that patterns of
economically motivated adulteration can emerge and should be considered
as part of a hazard analysis.
    (Comment 266) Some comments ask us to limit the requirement to
identify hazards that may be introduced for purposes of economic gain
to only those hazards that pose a risk to public health for which there
has been a pattern in the past. Some comments assert that in those few
instances where a hazard was intentionally introduced the underlying
intention was to defraud rather than to cause harm, and the food safety
hazard was an unintended consequence. Some comments ask us to focus the
hazard identification solely on inbound products, because it is obvious
that hazards introduced by the facility itself will not be prevented
through a hazard analysis. Some comments ask us to narrow the scope of
the requirement by specifying that facilities focus on three
situations: (1) Situations in which there has been a pattern of similar
adulteration in the past; (2) animal foods or ingredients for which
quality assurance methods may not sufficiently characterize the animal
food or ingredient to assure its identity, and; (3) animal foods or
ingredients for which there are substitutes that are likely to be
harmful that would be considered obvious to one skilled in food
science.
    (Response 266) We decline to make the changes suggested in these
comments because they are unnecessary. Because of our definition of
hazard, the requirement is already limited to economically motivated
adulteration that is reasonably likely to cause illness or injury.
Under the final rule, a facility does not need to identify a hazard
related to economically motivated adulteration when there is no risk to
public health or when the economically motivated adulteration is not
known or reasonably foreseeable.
    We agree that the three circumstances suggested by the comments are
an appropriate focus for facilities who seek guidance on how to
approach the requirements, but decline the request to specify these
limitations of the scope in the regulatory text. As already noted, some
comments assert that our attempt to narrow the field of potential
scenarios for economically motivated adulteration

is both too broad and too narrow at the same time. (See Comment 265.)
Although we continue to believe that the instances in which a facility
will identify a hazard intentionally introduced for economic gain will
be rare, we also consider that limiting the scope of the requirement in
the regulatory text would be both prejudging the future and
inconsistent with the public health objectives of this rule.
    (Comment 267) Some comments ask us to allow implementation of the
major provisions in FSMA before establishing requirements to address
economically motivated adulteration. These comments assert that
economically motivated adulteration requires a completely different
paradigm than unintentional adulteration. In addition, because
economically motivated adulteration is typically addressed through
product specifications, supplier relationships, and good business
practices, implementation of these other provisions of the animal food
preventive controls rule are likely to have a positive effect on
preventing economically motivated adulteration.
    (Response 267) We disagree that economically motivated adulteration
requires a completely different paradigm than unintentional
adulteration. Hazards intentionally introduced for economic gain are
addressed here with the same preventive framework as every other
hazard. As such, we do not see a compelling reason to delay
implementation of the requirements to address economically motivated
adulteration.

C. Proposed Sec.  507.33(c) and (d)--Evaluation of Whether a Hazard
Requires a Preventive Control

    We proposed that the hazard analysis must include an evaluation of
the identified hazards to assess the severity of the illness or injury
if the hazard were to occur and the probability that the hazard will
occur in the absence of preventive controls; and environmental
pathogens whenever an animal food is exposed to the environment prior
to packaging and the packaged animal food does not receive a treatment
that would significantly minimize the pathogen (proposed Sec.
507.33(c)(2)). We also proposed that the hazard evaluation must
consider the effect of the following on the safety of the finished
animal food for the intended consumer: (1) The formulation of the
animal food; (2) the condition, function, and design of the facility
and equipment; (3) raw materials and ingredients; (4) transportation
practices; (5) manufacturing/processing procedures; (6) packaging
activities and labeling activities; (7) storage and distribution; (8)
intended or reasonably foreseeable use; (9) sanitation, including
employee hygiene; and (10) any other relevant factors (proposed Sec.
507.33(d)(1) through (10)).
    (Comment 268) Some comments ask us to revise the requirement to
include an evaluation of environmental pathogens to avoid the
implication that an intervention is needed when there may be other
controls (such as pH or formulation) that would significantly minimize
or prevent the pathogen. These comments suggest that we revise the
provision to require that a hazard evaluation include an evaluation of
environmental pathogens whenever a food is exposed to the environment
prior to packaging and the packaged food does not receive a treatment
``or otherwise include a control measure'' that would significantly
minimize the pathogen.
    (Response 268) We have revised the provision on the hazard
evaluation for environmental pathogens to specify that the packaged
animal food does not receive a treatment or otherwise include a control
measure (such as a formulation lethal to the pathogen) that would
significantly minimize the pathogen. We agree that controls such as
formulation can function as a ``kill step'' and that the provision
should make clear that such controls can be used in lieu of
``treatment.''
    (Comment 269) Some comments ask us to clarify what we meant by
``other relevant factors'' and note that natural disasters (which we
previously discussed) (78 FR 64736 at 64785) are ``usually exceptional
events'' that are best managed in a facility crisis management plan.
Other comments ask us to specify that the hazard evaluation must
consider any relevant geographic, temporal, agricultural, or other
factors that may affect the severity or probability of the hazard.
    (Response 269) We included ``other relevant factors'' to emphasize
that the list of factors in the provision is not an exhaustive list and
that a facility is responsible for considering those factors that play
a role in its determination of whether a potential hazard is a hazard
requiring a preventive control, regardless of whether those factors are
listed in the provision. A facility that already addresses
circumstances such as natural disasters in other plans may consider the
applicable part of those plans to be part of its food safety plan (see
Sec.  507.212).
    We agree that geographic, temporal, and agricultural factors are
examples of ``other relevant factors.'' For example, hazards such as
aflatoxin are subject to a weather-dependent effect in that aflatoxin
levels in some RACs are more of a problem in some years than in others.
We have added the temporal nature of some hazards associated with some
RACs as an example of ``other relevant factors'' to consider (see Sec.
507.33(d)(10)).
    (Comment 270) Some comments ask us to specify that the hazard
evaluation be more specific about issues relevant to raw materials and
ingredients, including how raw materials are selected and shipped, how
suppliers are evaluated, and how shipments are inspected on receipt.
    (Response 270) We decline this request. When a hazard requiring a
preventive control in a raw material or other ingredient is controlled
before receipt, the receiving facility would address such specifics in
the supply-chain program that would be required as a preventive control
(see subpart E).
    (Comment 271) Some comments assert that the proposed requirements
for hazard evaluation could be interpreted in many ways. For example, a
facility could conclude that the presence of a hand sink or boot dip
prior to entering the processing area will reduce the likelihood of
environmental pathogens and that environmental pathogens are not a
significant hazard, whereas a regulator could interpret this provision
to mean that a facility must always consider an environmental pathogen
to be a significant hazard when the criteria in the provision are met,
unless the facility can provide evidence to the contrary.
    (Response 271) We agree that the requirements for hazard evaluation
are subject to alternative interpretations. This is often the case,
particularly when a regulation is new. The provision specifies that a
facility must evaluate whether an environmental pathogens is a hazard
requiring a preventive control in particular circumstances, i.e.,
whenever a finished animal food (for which an environmental pathogen is
identified as a hazard) is exposed to the environment prior to
packaging and the packaged animal food does not receive a treatment or
otherwise include a control measure (such as a formulation lethal to
the pathogen) that would significantly minimize the pathogen. The
written hazard analysis must be prepared (or its preparation overseen
by) a preventive controls qualified individual (see Sec.  507.31(b) and
(c)(1)). The preventive controls qualified individual for a facility
that determines that an environmental pathogen is not a hazard
requiring a preventive control in

such circumstances must document that determination, and a regulator
would consider the adequacy of the documented determination before
reaching a conclusion as to whether the facility had failed to satisfy
the requirements. However, the use of a hand sink or boot dip prior to
entering the processing areas to reduce the likelihood of environmental
pathogens may also be considered to be part of the sanitation controls
for the environmental pathogen.
    (Comment 272) Some comments ask us to focus on language that will
clearly differentiate between functions, processes, and controls for
facilities with food safety plans that identify microbial hazards and
those that do not identify microbial hazards, and other known or
reasonably foreseeable hazards. These comments assert that sanitation
of objects and surfaces may be appropriate for the former, but not
necessarily for the latter.
    (Response 272) The facility is responsible for conducting a hazard
analysis, and if hazards are identified that require a preventive
control, the facility must consider the effect of sanitation on the
safety of the finished animal food for the intended animal (see Sec.
507.33(d)). Based on the outcome of its hazard evaluation, the facility
may determine that sanitation is not an appropriate preventive control
for the hazards it identified.
    (Comment 273) Some comments assert that a food safety plan and
hazard analysis should not include numerous hazards and hazard analysis
steps. Some comments assert that hazard analysis should not be as
detailed (stringent) for animal food as it is for human food. These
comments maintain that prerequisite programs, which reduce the
likelihood of a potential hazard to the point where the hazard is not
reasonably likely to occur, would satisfy the requirement that the
hazard be adequately controlled, making it unnecessary for a facility
to include the identified hazards in its hazard analysis and preventive
controls. Other comments assert that many hazards can be exclusively
controlled through prerequisite programs without a need for CCPs.
    (Response 273) While known and reasonably foreseeable hazards and
the outcome of a hazard analysis for human food and animal food may not
be identical, in each case the purpose of a hazard analysis is to
identify and evaluate known or reasonably foreseeable hazards for the
type of food manufactured, processed, packed, or held to determine
whether there are any hazards requiring a preventive control. As
previously discussed in the 2013 animal food preventive control
proposed rule (78 FR 64736 at 64781), the process of identifying and
evaluating the hazards that may occur for specific types of animal food
handled in a facility provides an efficient means for keeping track of
multiple hazards that may occur in a facility that handles several
types of animal food. Such a process also provides an efficient means
for ensuring that preventive controls are applied to specific animal
food products when required. If a facility identifies a hazard
requiring a preventive control, the facility must determine an
appropriate preventive control and include that preventive control in
its food safety plan. A facility that establishes other controls (such
as those that the comments describe as ``prerequisite programs'') for
hazards that are not, based on the outcome of the facility's hazard
analysis, ``hazards requiring a preventive control'' would not need to
establish preventive control management components for such controls.
However, some controls previously established in ``prerequisite
programs'' would be considered ``preventive controls.'' We provide some
flexibility for facilities with respect to how they manage preventive
controls, and the preventive control management components may be
different for hazards that have been managed as ``prerequisite
programs'' compared to those managed with CCPs. The same principles
would apply for the hazards a facility identifies as needing a
preventive control.
    (Comment 274) Some comments assert that the statutory language
within FSMA does not mandate that covered animal food and pet food
facilities implement regulatory HACCP plans. These comments further
urge us to remove reference to HACCP.
    (Response 274) We agree that section 103 of FSMA does not mandate
HACCP regulations; however, we have concluded that HACCP is the
appropriate framework to reference in interpreting and implementing
section 103 of FSMA. For discussion, see section II.C.2. of the 2013
proposed preventive controls rule for human food (78 FR 3646 at 3660).
    (Comment 275) Some comments ask us to allow consideration of both
severity and probability in the scientific hazard analysis as this
would be consistent with international standards.
    (Response 275) Section 507.33(c)(1) requires that a hazard
evaluation must include an assessment of the severity of the injury or
illness if a hazard were to occur and the probability that the hazard
will occur in the absence of preventive controls.
    For additional discussion of comments on hazard analysis, see
section XXV in the final rule for preventive controls for human food
published elsewhere in this issue of the Federal Register.

XXVI. Subpart C: Comments on Proposed Sec.  507.36--Preventive Controls
(Final Sec.  507.34)

    We proposed requirements to identify and implement preventive
controls to provide assurances that significant hazards will be
significantly minimized or prevented and the animal food manufactured,
processed, packed, or held by the facility will not be adulterated
under section 402 of the FD&C Act. Some comments support the proposed
requirements without change. For example, some comments agree that
preventive controls must be written and include process controls,
sanitation controls, a recall plan, and other controls as appropriate
and necessary. Some comments that support the proposed provisions
suggest alternative or additional regulatory text or ask us to clarify
how we will interpret the provision.
    In the following sections, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
11, with editorial and conforming changes as shown in table 31.

Table 11--Revisions to the Proposed Requirements for Preventive Controls
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.34(c)(1)..................  Process controls.  Clarify that the
                                                    requirements for
                                                    process controls
                                                    depend on the role
                                                    of the process
                                                    control in the food
                                                    safety system.
------------------------------------------------------------------------

A. Proposed Sec.  507.36(a)--Requirement To Identify and Implement
Preventive Controls (Final Sec.  507.34(a))

    We proposed that you must identify and implement preventive
controls, including at critical control points, if any, to provide
assurances that significant hazards will be significantly minimized or
prevented and the animal food manufactured, processed, packed, or held
by your facility will not be adulterated under section 402 of the FD&C
Act. We also proposed that these preventive controls include controls
at CCPs, if there are any CCPs, and controls, other than those at CCPs,
that are also appropriate for animal food safety.
    Some comments support the flexibility provided to facilities to
implement preventive controls that are appropriate to the facility and
the animal food. Other comments support the clarification, in the 2014
supplemental notice, that not all preventive controls are established
at CCPs and that some food safety plans will not have CCPs. We are
finalizing the provision as proposed with the editorial and conforming
changes in table 31.

B. Proposed Sec.  507.36(b)--Requirement for Written Preventive
Controls (Final Sec.  507.34(b))

    We proposed that preventive controls must be written.
    (Comment 276) Some comments ask us to clarify whether documentation
of treatment by a ``custom processor'' would be accepted as a ``written
preventive control'' when the ``custom processor'' controls the hazard.
    (Response 276) The question posed by these comments highlights the
difference between the records required in the food safety plan and the
records documenting the implementation of the food safety plan. The
``written preventive controls'' are part of the food safety plan,
whereas the records documenting treatment are implementation records.
Implementation records documenting treatment, whether by a facility or
its ``custom processor,'' would not satisfy the requirements for
written preventive controls. However, specifying that the preventive
control for a specific hazard is a particular treatment by a ``custom
processor,'' along with information that describes the treatment, would
satisfy the requirement for written preventive controls.

C. Proposed Sec.  507.36(c)(1)--Process Controls (Final Sec.
507.34(c)(1))

    We proposed that preventive controls include process controls as
appropriate to the facility and the animal food. Process controls
include procedures, practices, and processes to ensure the control of
parameters during operations such as heat processing, irradiating, and
refrigerating animal foods. Process controls must include, as
appropriate to the applicable control, parameters associated with the
control of the hazard, and the maximum or minimum value, or combination
of values, to which any biological, chemical, or physical parameter
must be controlled to significantly minimize or prevent a significant
hazard.
    (Comment 277) Some comments state that assigning a parameter and
associated minimum and maximum values for some process controls (such
as refrigeration (including freezing), or water activity) may be
possible, but not be necessary for food safety. These comments ask us
to require minimum and maximum values to be assessed against the
applicable food safety need, or otherwise make clear that the
implications of not controlling minimum and maximum values must be
assessed in light of the circumstances. Other comments express concern
that ``as appropriate to the applicable control'' could be interpreted
as suggesting that if it is merely feasible to establish parameters for
a process control, they must be established. Other comments express
concern that the proposed requirement suggests that if a parameter is
not ``controlled,'' a regulator could conclude that the facility is not
in compliance with the rule because it necessarily has not
significantly minimized or prevented a significant hazard.
    Some comments recommend incorporating recognition that the degree
of rigor in application of subpart C parameters should be applied on a
sliding scale, commensurate with the nature of the risk and the
preventive control used. The comments request that the language in this
section is altered to indicate that the parameters will not always be
applicable.
    (Response 277) See Response 293. We have revised the regulatory
text to specify that process controls must include parameters and
minimum or maximum values as appropriate to both the nature of the
applicable control and its role in the facility's food safety system.
We decline the request to indicate that parameters of subpart C will
not always be applicable, as the revised regulatory text provides
adequate flexibility for a facility to determine what preventive
controls, including process controls, are appropriate to the facility
and its animal food, if a hazard requiring a preventive control is
identified.
    (Comment 278) Some comments ask us to delete the phrase ``to
significantly minimize or prevent a significant hazard.''
    (Response 278) We decline this request. ``Significantly minimize or
prevent a significant hazard'' (which we have revised to
``significantly minimize or prevent a hazard requiring a process
control'') is the standard for controlling the hazards. Although the
phrase could be viewed as redundant with the standard in the
requirement to identify and implement preventive controls (Sec.
507.34(a)(1)), repeating that standard in the requirements for
parameters and the minimum or maximum values associated with control of
the hazard emphasizes the standard, which is appropriate for process
controls.

D. Proposed Sec.  507.36(c)(2)--Sanitation Controls (Final Sec.
507.34(c)(2))

    We proposed that preventive controls include, as appropriate to the
facility and the animal food, sanitation controls that include
procedures, practices, and processes to ensure that the facility is
maintained in a sanitary condition adequate to significantly minimize
or prevent hazards such as environmental pathogens and biological
hazards due to employee handling. We also proposed that sanitation
controls must include procedures, practices, and processes for the
cleanliness of animal food-contact surfaces, including animal food-
contact surfaces of utensils and equipment, and procedures for the
prevention of cross-contamination from insanitary objects and from
personnel to animal food, animal food packaging material, and other
animal food-contact surfaces and from raw product to processed product.
    (Comment 279) One comment states that sanitation is not always a
feasible step for facilities handling animal food, especially in dry
blending facilities and dry storage operations. The comment asks us to
remove the reference to ``sanitary condition'' and replace it with
language consistent with the GMP section such as ``to ensure the
facility is adequately cleaned and properly maintained to significantly
minimize or prevent hazards.''
    (Response 279) We decline this request. The sanitation controls are
flexible so that a facility can determine what sanitation controls are
necessary for their facility and animal food if they identify a hazard
requiring sanitation controls as a preventive control. Replacing the
term ``sanitary condition'' with the suggested language would not
improve the flexibility of the sanitation control requirements.

    (Comment 280) Some comments assert that sanitation controls are not
necessary to prevent any hazards in distribution facilities where
animal food-contact surfaces are not present. Other comments assert
that sanitation controls should be required in all cases (rather than
``as appropriate'') given their central importance.
    (Response 280) Under the framework established by FSMA, and
implemented in this rule, each facility determines through its hazard
analysis when sanitation controls are necessary to control a hazard
requiring a preventive control. The rule neither establishes
circumstances (such as in distribution centers) where sanitation
controls are not necessary nor prejudges whether sanitation controls
are necessary in specific circumstances. Although we do not expect that
facilities such as distribution centers would determine through their
hazard analysis that sanitation controls are required, we do expect all
animal food establishments that are subject to the CGMP requirements
established in subpart B to fully comply with the applicable
requirements for sanitation.
    (Comment 281) One comment states that sanitation is discussed in
two sections, as a CGMP and as a preventive control, and asks that all
of the discussion related to sanitation is moved to one section.
    (Response 281) The two sections discuss sanitation for different
purposes. The requirements for general sanitation are located in the
CGMP regulations, which may be considered prerequisites to the
preventive controls. The requirements for sanitation as a preventive
control are specific for controlling an identified hazard. Sanitation
activities conducted at a facility may be different depending on
whether the sanitation activity is used as general facility sanitation
or specifically to control a hazard. Also, sanitation as a preventive
control is subject to the management components of Sec.  507.39.

E. Proposed Sec.  507.36(c)(3)--Supplier Controls (Final Sec.
507.34(c)(3))

    We proposed that supplier controls include the supplier program.
See the discussion of comments on the supply-chain program, now in
subpart E, in sections XL through XLVII.

F. Proposed Sec.  507.36(c)(4)--Recall Plan (Final Sec.  507.34(c)(4))

    We proposed that preventive controls include, as appropriate, a
recall plan as would be required by proposed Sec.  507.38. See the
discussion of comments on the recall plan in section XXVIII.

G. Proposed Sec.  507.36(c)(5)--Other Controls (Final Sec.
507.34(c)(5))

    We proposed that preventive controls include any other procedures,
practices, and processes necessary to satisfy the requirements of
paragraph (a) of this section. Examples of other controls include
hygiene training and other current good manufacturing practices.
    (Comment 282) Some comments ask us to specify that preventive
controls include controls on raw materials and other ingredients.
    (Response 282) The final rule specifies that preventive controls
include supply-chain controls as appropriate to the facility and the
animal food. The request of these comments is addressed by the
requirements for the supply-chain program (see Sec.  507.34(c)(3) and
subpart E).
    (Comment 283) One comment asks us to require compliance with the
good manufacturing and feeding practices that apply to GRAS substances,
found in Sec.  582.1(b), as a preventive control.
    (Response 283) Facilities required to register that manufacture,
process, pack, or hold GRAS substances are subject to this final rule,
including applicable preventive controls requirements. Preventive
controls are intended to address certain known or reasonably
foreseeable hazards, not an animal food facility's compliance with the
good manufacturing and feeding practices of Sec.  582.1(b), although a
facility may determine that a good manufacturing practice is a
preventive control for a particular hazard.

XXVII. Subpart C: Circumstances in Which the Owner, Operator or Agent
in Charge of a Manufacturing/Processing Facility Is Not Required To
Implement a Preventive Control (Final Sec. Sec.  507.36 and 507.37)

    In the 2014 supplemental notice, we provided an opportunity for
public comment on potential requirements for a supplier program as a
preventive control, including comments on when a supplier program would
not be required. As discussed in more detail in section XL, we have
revised the phrase ``supplier program'' to ``supply-chain program''
throughout the regulatory text. As summarized in table 12 and discussed
more fully in the following paragraphs, after considering comments on
when a supplier program would not be required, we are establishing two
new provisions. Although both sets of provisions have an effect on the
required supply-chain program, they will be implemented outside the
framework of a supply-chain program.

     Table 12--Summary of Applicable Provisions Regarding When the Owner, Operator, or Agent in Charge of a
               Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control
----------------------------------------------------------------------------------------------------------------
  Final section designation        Proposed section designation            Description             Revision
----------------------------------------------------------------------------------------------------------------
507.36(a)(1)................  N/A..................................  A manufacturer/          N/A.
                                                                      processor is not
                                                                      required to implement
                                                                      a preventive control
                                                                      if it determines and
                                                                      documents that the
                                                                      type of animal food
                                                                      could not be consumed
                                                                      without application of
                                                                      an appropriate control.
507.36(a)(2)................  507.37(a)(1)(ii)(C)..................  A manufacturer/          Includes a
                                                                      processor is not         requirement for
                                                                      required to implement    documentation
                                                                      a preventive control     that the animal
                                                                      if it relies on its      food is ``not
                                                                      customer, who is         processed to
                                                                      subject to the           control
                                                                      requirements for         [identified
                                                                      hazard analysis and      hazard].''
                                                                      risk-based preventive
                                                                      controls in subpart C,
                                                                      to ensure that the
                                                                      identified hazard will
                                                                      be significantly
                                                                      minimized or prevented
                                                                      and both: (1)
                                                                      Discloses in documents
                                                                      accompanying the
                                                                      animal food that the
                                                                      animal food is ``not
                                                                      processed to control
                                                                      [identified hazard]''
                                                                      and (2) annually
                                                                      obtains from its
                                                                      customer written
                                                                      assurance that the
                                                                      customer has
                                                                      established and is
                                                                      following procedures
                                                                      that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard.

507.36(a)(3)................  .....................................  A manufacturer/          N/A.
                                                                      processor is not
                                                                      required to implement
                                                                      a preventive control
                                                                      if it relies on its
                                                                      customer who is not
                                                                      subject to the
                                                                      requirements for
                                                                      hazard analysis and
                                                                      risk-based preventive
                                                                      controls in subpart C
                                                                      to provide assurance
                                                                      it is manufacturing,
                                                                      processing, or
                                                                      preparing the animal
                                                                      food in accordance
                                                                      with applicable animal
                                                                      food safety
                                                                      requirements and it:
                                                                      (1) Discloses in
                                                                      documents accompanying
                                                                      the animal food, in
                                                                      accordance with the
                                                                      practice of the trade,
                                                                      that the animal food
                                                                      is ``not processed to
                                                                      control [identified
                                                                      hazard]'' and (2)
                                                                      annually obtains from
                                                                      its customer written
                                                                      assurance that it is
                                                                      manufacturing,
                                                                      processing, or
                                                                      preparing the animal
                                                                      food in accordance
                                                                      with applicable animal
                                                                      food safety
                                                                      requirements.
507.36(a)(4)................  507.37(a)(1)(ii)(C)..................  A manufacturer/           Addresses
                                                                      processor is not         the circumstance
                                                                      required to implement    where an entity
                                                                      a preventive control     (other than the
                                                                      if it relies on its      facility's
                                                                      customer to ensure       customer) in the
                                                                      that the animal food     distribution
                                                                      will be processed to     chain controls
                                                                      control the identified   the hazard
                                                                      hazard by an entity in   Includes
                                                                      the distribution chain   a requirement for
                                                                      subsequent to the        documentation
                                                                      customer and both: (1)   that the animal
                                                                      Discloses in documents   food is ``not
                                                                      accompanying the         processed to
                                                                      animal food that the     control
                                                                      animal food is ``not     [identified
                                                                      processed to control     hazard].''
                                                                      [identified hazard]''
                                                                      and (2) annually
                                                                      obtains from its
                                                                      customer written
                                                                      assurance that the
                                                                      customer will both
                                                                      disclose the
                                                                      information that the
                                                                      animal food is ``not
                                                                      processed to control
                                                                      [identified hazard]''
                                                                      and will only sell to
                                                                      another entity that
                                                                      agrees, in writing, it
                                                                      will either follow
                                                                      procedures that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard (if
                                                                      the entity is subject
                                                                      to subject to the
                                                                      requirements for
                                                                      hazard analysis and
                                                                      risk-based preventive
                                                                      controls in subpart C)
                                                                      or manufacture,
                                                                      process, or prepare
                                                                      the animal food in
                                                                      accordance with
                                                                      applicable animal food
                                                                      safety requirements
                                                                      (if the entity is not
                                                                      subject to the
                                                                      requirements for
                                                                      hazard analysis and
                                                                      risk-based preventive
                                                                      controls in subpart C)
                                                                      or obtain a similar
                                                                      written assurance from
                                                                      the entity's customer.
507.36(a)(5)................  N/A..................................  A manufacturer/          N/A.
                                                                      processor is not
                                                                      required to implement
                                                                      a preventive control
                                                                      if it has established,
                                                                      documented, and
                                                                      implemented a system
                                                                      that ensures control,
                                                                      at a subsequent
                                                                      distribution step, of
                                                                      the hazards in the
                                                                      animal food product it
                                                                      distributes and
                                                                      documents the
                                                                      implementation of that
                                                                      system.
507.36(b)...................  507.37(g)(3).........................  Records documenting the  Includes a
                                                                      applicable               requirement for
                                                                      circumstances in Sec.    documentation of
                                                                       507.36(a).              the additional
                                                                                circumstances in
                                                                                which a
                                                                                manufacturer/
                                                                                processor is not
                                                                                required to
                                                                                implement a
                                                                                preventive
                                                                                control.
507.36(c)...................  N/A..................................  If a customer of the     N/A.
                                                                      manufacturer/processer
                                                                      has determined that
                                                                      the identified hazard
                                                                      is not a hazard in the
                                                                      animal food intended
                                                                      for use for a specific
                                                                      animal species, the
                                                                      customer may provide
                                                                      this determination
                                                                      (including animal
                                                                      species and why the
                                                                      identified hazard is
                                                                      not a hazard) in its
                                                                      written assurance
                                                                      under Sec.
                                                                      507.36(a)(2)(ii)
                                                                      instead of providing
                                                                      assurance of
                                                                      procedures established
                                                                      and followed that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard.
507.36(d)...................  N/A..................................  If a customer of the     N/A.
                                                                      customer of the
                                                                      manufacturer/processer
                                                                      (i.e., another entity
                                                                      in the distribution
                                                                      chain) has determined
                                                                      that the identified
                                                                      hazard is not a hazard
                                                                      in the animal food
                                                                      intended for use for a
                                                                      specific animal
                                                                      species, the entity
                                                                      may provide this
                                                                      determination
                                                                      (including animal
                                                                      species and why the
                                                                      identified hazard is
                                                                      not a hazard) in its
                                                                      written assurance
                                                                      under Sec.
                                                                      507.36(a)(4)(ii)(B
                                                                      instead of providing
                                                                      assurance of
                                                                      procedures established
                                                                      and followed that will
                                                                      significantly minimize
                                                                      or prevent the
                                                                      identified hazard.

507.37......................  N/A..................................  A facility that          N/A.
                                                                      provides a written
                                                                      assurance under Sec.
                                                                      507.36(a)(2), (3), or
                                                                      (4) must act
                                                                      consistently with the
                                                                      assurance and document
                                                                      its actions taken to
                                                                      satisfy the written
                                                                      assurance.
----------------------------------------------------------------------------------------------------------------

    The first provision allows a manufacturer/processor to not
implement a preventive control if the manufacturer/processor determines
and documents that the type of animal food could not be consumed
without application of the appropriate control by an entity in the
supply or distribution chain other than that manufacturer/processor
(see Sec.  507.36(a)(1)). We describe comments leading to this
provision, and our response to those comments, in Comment 284 and
Response 284 respectively. Although we are establishing these
provisions outside the framework of the supply-chain program, these
provisions continue to play a role in the requirements for a supply-
chain program, because they also provide an exception to the
requirements for a manufacturer/processor to establish and implement a
supply-chain program.
    The second provision relates to comments we received on a proposed
exception to the requirement for a manufacturer/processor to establish
and implement a supplier program (proposed Sec.  507.37(a)(1)(ii)(C)).
(See Comment 285). Under proposed Sec.  507.37(a)(1)(ii)(C), a
receiving facility would not have been required to have a supplier
program if it relied on its customer to control the hazard and annually
obtained from its customer written assurance that the customer has
established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the hazard. As
discussed in Response 285, we are replacing this provision with several
provisions that apply when a manufacturer/processor identifies a hazard
requiring a preventive control (``identified hazard''), does not
control the identified hazard, but can demonstrate and document that
the identified hazard will be controlled by an entity in its
distribution chain. A manufacturer/processor that satisfies the
criteria in these provisions will not be required to implement a
preventive control for the identified hazard. Under these provisions,
the combination of three requirements will provide adequate assurance
that the animal food will be processed to control the identified hazard
before it reaches consumers. These requirements are: (1) Documentation
provided by the manufacturer/processor to its direct customer that the
animal food is ``not processed to control [identified hazard]''; (2)
written assurances from customers regarding appropriate procedures to
ensure that the animal food will receive further processing to control
the identified hazards; and (3) provisions relating to accountability
for written assurances. (In these provisions, ``customer'' means a
commercial customer, not a consumer.)
    (Comment 284) Some comments express concern about the ability for
distributors/cooperatives identify the individual raw material or other
ingredient supplier when the supplier that applied the control is more
than one step back in the food chain. Some comments assert that
receiving facilities should not be required to verify suppliers with
which they do not have a direct commercial relationship. For example,
in the case of the soybean supply chain, the U.S. processing facility
likely has no direct relationship with the many farms involved in the
growing and harvesting of the soybeans. Some comments ask for an
exemption from supplier verification activities for animal foods such
as soybeans because it is problematic to have a requirement that
potentially could necessitate trace back to farms.
    (Response 284) We are establishing a provision, applicable to both
the supply chain and the distribution chain of a manufacturer/
processor, for a circumstance when a manufacturer/processor does not
need to implement a preventive control. We are providing that a
manufacturer/processor does not need to implement a preventive control
if it determines and documents that the type of animal food could not
be consumed without application of the appropriate control (see Sec.
507.36(a)(1)). However, depending on the facility, the raw material or
other ingredient, and the type of animal food produced by the
manufacturer/processor, there may be some circumstances where a
manufacturer/processor could determine that a particular animal food
that passes through its facility satisfies the criterion ``could not be
consumed without application of the appropriate control.'' In other
cases, a facility may have determined through its hazard analysis that
there are no hazards requiring a preventive control, and will not
consider whether one of the circumstances in new Sec.  507.36 apply.
    As a consequential addition, new Sec.  507.36(b) specifies the
records that a manufacturer/processor would need to satisfy the
documentation requirements established in new Sec.  507.36(a)(1), and
we have added new Sec.  507.36(b) to the list of implementation records
(Sec.  507.55) that are subject to the recordkeeping requirements of
subpart F.
    See also Comment 429, in which we discuss comments asking us to add
flexibility to the requirements for a supply-chain program such that
any entity other than the receiving facility can perform supplier
verification activities. As discussed in Response 429, the rule
provides additional flexibility in the supply-chain program with regard
to who can perform certain activities (see Sec.  507.115).
    (Comment 285) Some comments ask us to delete the criterion for
control of the hazard by the receiving facility's customer, with annual
written assurance that the customer had established and was following
procedures (identified in the written assurance) that would
significantly minimize or prevent the hazard. The stated reasons
varied. For example, some comments state that a receiving facility may
have so many customers that it is not possible to obtain written
assurance annually from all customers. Other comments express concern
that a customer may be unwilling to describe confidential trade secrets
in order to identify in writing the procedures the customer has
established and is following to control the hazard. Other comments
express concern about ``legal issues'' when a receiving facility needs
to assess the adequacy of the customers' procedures for controlling a
hazard because under current business practices a vendor can provide
assurance to a buyer (its customer), but buyers do not typically
provide such

assurance to vendors. Some comments express concern that written
assurance does not guarantee that the customer is actually doing
anything to significantly minimize or prevent the hazard.
    Some comments ask us to provide an alternative that would allow the
receiving facility to provide documentation to its customer about a
hazard that needs a preventive control at a processing facility later
in the distribution chain rather than obtain written assurance that its
customer will control a hazard. If written assurance must be required,
these comments ask us to allow the written assurance provided by the
customer to state that the customer would evaluate the hazard and if
necessary establish and follow procedures to significantly minimize or
prevent the hazard.
    Some comments state the receiving facility may not know the
identity of all its ultimate customers, particularly if the receiving
facility sells its products to a distributor who then sells to other
entities. Some comments ask us to provide flexibility for facilities to
determine whether annual updates of written assurance are necessary.