212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L.
104-121) will be better suited to helping qualified facilities
understand the requirements of the rule than information presented on a
submission form.

E. Proposed Sec.  507.7(c)--Frequency of Determination and Submission

    We proposed that the documentation must be: (1) Submitted to FDA
initially within 90 days of the applicable compliance date and (2)
resubmitted at least every 2 years, or whenever there is a material
change to the information applicable to determining the status of a
facility.
    (Comment 139) Some comments assert that the proposed timeframe of
90 days to submit the required documentation would not provide
sufficient time to gather and submit the required documentation and ask
us to extend the timeframe, e.g., to 120 or 180 days.
    (Response 139) We are retaining the proposed timeframe for the
initial

submission (within 90 days of the applicable compliance date). The only
documentation that the qualified facility will need to submit is an
attestation, which does not need to be gathered. Importantly, however,
documentation supporting the attestation must be available for
inspection by September 17, 2019. As discussed in Response 76, the
compliance date for a facility to retain records to support its status
as a qualified facility is January 1, 2017. As a companion change, we
are explicitly requiring that a facility determine and document its
status as a qualified facility on an annual basis by no later than July
1of each calendar year (see Sec.  507.7(c)(1)).
    In addition, we have revised proposed Sec.  507.7(c)(1) (which we
are finalizing as Sec.  507.7(c)(2)(i)(A), (B), and (C)) to specify the
timeframe for the initial submission for three distinct circumstances:
(A) By December 16, 2019 for a facility that begins manufacturing,
processing, packing, or holding animal food before September 17, 2019;
(B) Before beginning operations, for a facility that begins
manufacturing, processing, packing or holding animal food after
September 17, 2019; or (C) By July 31 of the applicable calendar year,
when the status of a facility changes from ``not a qualified facility''
to ``qualified facility'' based on the annual determination required by
paragraph (c)(1) of this section. See the discussion in Response 76
regarding the approach we intend to take in a number of circumstances
that could lead to a facility having records to support its status as a
qualified facility for fewer than 3 preceding calendar years.
    We have revised the provision to specify that the required biennial
submissions of the attestations must be made during a timeframe that
will coincide with the required biennial updates to facility
registration (see section 102 of FSMA), i.e., during the period
beginning on October 1 and ending on December 31, beginning in 2020. In
determining that 2020 would be the first year for the required biennial
submissions of the attestations, we first considered that the first
submission of an attestation would be approximately December 2019 for
qualified facilities that are operating as of the date of this final
rule (i.e., approximately 90 days after the date of publication of this
rule). For qualified facilities that do not begin operations until
after December 2019, the first biennial submission will be required in
a timeframe less than 2 years, but once the qualified facility has made
its first submission the subsequent biennial submissions will all be at
2-year intervals. Coordinating the biennial submissions of the required
attestations with the biennial registration will reduce the cumulative
economic impact on the animal food industry of complying with two
separate requirements because qualified facilities that choose to
submit electronically will be able to submit electronically while
accessing the same electronic portal used for facility registration.
    (Comment 140) Some comments ask us to include an option within the
system to notify us when a facility's status as a ``qualified
facility'' changes, e.g., because its business expands or changes.
    (Response 140) Notifying us when there is a material change in the
facility's status from ``qualified facility'' to ``not a qualified
facility'' is a requirement rather than an option. We included this
requirement in the proposed rule, and are establishing it in this final
rule. We made editorial changes to the provision to make this clearer.
    We also established a series of dates associated with the
facility's change in status from ``qualified facility'' to ``not a
qualified facility.'' First, we are specifying that when the status of
a facility changes from ``qualified facility'' to ``not a qualified
facility'' based on the required annual determination, the facility
must notify FDA of that change in status using Form FDA 3942b by July
31 of the applicable calendar year (see Sec.  507.7(c)(3)). We have
provided the facility with flexibility to wait until July 1 of a given
calendar year to determine whether its status changes (see Sec.
507.7(c)(1)); 30 days is an adequate timeframe to submit the form
notifying us of the change in status.
    Second, we are specifying that when the status of a facility
changes from ``qualified facility'' to ``not a qualified facility,''
the facility must comply with subparts C and E no later than December
31 of the applicable calendar year unless otherwise agreed to by FDA
and the facility (see Sec.  507.7(d)). In essence, this provision can
provide a facility with up to a full year to comply with the full
requirements for hazard analysis and risk-based preventive controls
when the facility determines its change in status early in the calendar
year. A facility that does not determine that change in status until
the required date of July 1 would still have 6 months to comply with
the full requirements for hazard analysis and risk-based preventive
controls. As we have done in the case of a qualified exemption being
withdrawn (see Sec.  507.65(d)(1)), we are providing flexibility for a
facility to comply in an alternative timeframe if agreed to by FDA and
the facility.
    (Comment 141) One comment asks us to specify that the required
attestations be submitted every 5 years rather than every 2 years. This
comment asserts that doing so would be consistent with the statutory
direction of section 201 of FSMA (Targeting of Inspection Resources)
for non-high risk food facilities. This comment also asserts that we
did not provide specific reasons for the proposed 2-year timeframe and
that resubmitting the attestations every 2 years will increase cost in
time and labor.
    (Response 141) We decline the request. The rule requires
resubmission whenever there is a material change to the information
that changes the status of a facility as a qualified facility.
Therefore, if the facility's sales change its status, so that it is no
longer a qualified facility, the rule requires that facility to notify
us when its status changes. (Note that the definition of very small
business established in this rule bases the threshold dollar amount for
a very small business on an average (of sales plus the market value of
animal food held without sale) during the 3-year period preceding the
applicable calendar year, rather than on annual sales plus market
value. A biennial submission is adequate to otherwise require a
qualified facility to affirmatively attest that it continues to satisfy
the criteria for being a qualified facility. A biennial submission is
not overly burdensome, because a facility can coordinate its biennial
submission with its biennial update to its facility registration. The
suggested 5-year submission based on the targeted inspection frequency
for non-high risk animal food facilities implies that all qualified
facilities produce such animal foods, which is not the case.

F. Proposed Sec.  507.7(d)--Notification to Consumers (Final Sec.
507.7(e))

    We proposed that a qualified facility that does not submit
documentation of its food safety practices must provide notification to
consumers as to the name and complete business address of the facility
where the animal food was manufactured or processed (including the
street address, or P.O. Box, city, state, and zip code for domestic
facilities, and comparable full address information for foreign
facilities).
    (Comment 142) One comment recommends that information giving the
location of the manufacturing site, and not just the corporation
contact information, be provided on the animal food labels. Other
comments state that specifically for pet food and pet treats, the
manufacturer should be required to include the co-packer information on

the product labels to include the co-packer's name, private label
contact information, address, and co-packer's contact information
(phone and/or email).
    (Response 142) Section 418(l)(7) of the FD&C Act specifically
mandates for a qualified facility that ``the name and business address
of the facility where the food was manufactured or processed,'' not the
corporate contact information, be included on a label for a food for
which a food packaging label is required. It does not require co-packer
information. The statute makes no requirements for non-qualified
facilities.

G. Proposed Sec.  507.7(e)--Records (Final Sec.  507.7(f))

    We proposed that a qualified facility must maintain those records
relied upon to support the required documentation. We also proposed
that the records that a qualified facility must maintain would be
subject to the requirements that would be established in subpart F of
this rule. As discussed in Response 124, after considering comments we
have revised the rule to specify that a qualified facility must
maintain those records relied upon to support the required attestations
(rather than the required documentation).
    (Comment 143) Some comments ask us to explicitly specify that we
have access to documents that establish a facility as a qualified
facility. Some comments assert that a facility may reasonably assume
that records such as financial records would not be available to us
because such records are excluded from the records that we have access
to under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act), and as provided by Sec.
1.362.
    (Response 143) The rule explicitly specifies that we have access to
records that are required by the rule (see Sec.  507.200). If a
facility relies on financial records to demonstrate its status as a
qualified facility, we will have access to those financial records. The
exemption referred to by the comments for financial records (Sec.
1.362) is narrowly targeted to records required by the section 414
recordkeeping regulations and does not apply to records required by
this preventive controls rule for animal food.

XII. Subpart A: Comments on Proposed Sec.  507.10--Applicability of
Part 507 to a Facility Solely Engaged in the Storage of Unexposed
Packaged Animal Food

    We proposed that subpart C would not apply to a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment and does not require time/temperature control to ensure
the safety of the animal food (proposed Sec.  507.10(a)). We also
proposed that a facility solely engaged in the storage of packaged
animal food that is not exposed to the environment but requires time/
temperature control for safety would be subject to the modified
requirements that would be established in proposed Sec.  507.48 of
subpart C (proposed Sec.  507.10(b)).
    Some comments support these proposed provisions without change. For
example, one comment expresses the view that a facility solely engaged
in the storage of packaged animal food that does not require time/
temperature control for safety does not need to conduct its own hazard
analysis, nor establish and implement preventive controls because there
would be no hazards to trigger such activities. Other comments that
support the proposed provisions ask us to clarify some aspects of the
provisions or to clarify how the provisions will apply in particular
circumstances. Other comments that support the proposed provisions ask
us to broaden them.
    In the following paragraphs, we discuss comments that disagree
with, or suggest one or more changes to, the proposed provisions. After
considering these comments, we have revised the proposed requirements
as shown in table 8 with editorial and conforming changes as shown in
table 31. A key conforming change that affects Sec.  507.10 is that it
includes an exemption from the requirements of subpart E, as well as
subpart C. As discussed in section XL, the final rule establishes the
requirements for a supply-chain program in subpart E, rather than
within subpart C as proposed.

   Table 8--Revisions to the Proposed Applicability of Subpart C to a
Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.10(b).....................  Applicability of   Clarification that
                                 modified           Sec.   507.51 of
                                 requirements in    subpart C only
                                 Sec.   507.51 of   applies to those
                                 subpart C.         unexposed packaged
                                                    animal foods that
                                                    require time/
                                                    temperature control
                                                    to significantly
                                                    minimize or prevent
                                                    the growth of, or
                                                    toxin production by,
                                                    pathogens.
------------------------------------------------------------------------

    (Comment 144) Some comments ask us to clarify that temperature
controls should be implemented when determined to be necessary by the
facility or preventive controls qualified individual. Some comments ask
us to clarify that if a facility stores both TCS food and non-TCS food
(i.e., unexposed packaged animal food that does not require time/
temperature control for safety), then the modified requirements only
apply for the portion of the facility that holds the TCS foods.
    (Response 144) We have revised Sec.  507.10(b) to clarify that a
facility solely engaged in the storage of unexposed packaged animal
food, including unexposed packaged animal food that requires time/
temperature control to significantly minimize or prevent the growth of,
or toxin production by, pathogens is subject to the modified
requirements in Sec.  507.51 of subpart C of this part for any
unexposed packaged food that requires time/temperature control to
significantly minimize or prevent the growth of, or toxin production
by, pathogens.
    (Comment 145) Some comments ask us to revise the regulatory text to
be explicit that frozen unexposed packaged food is not a TCS food
subject to modified requirements.
    (Response 145) We decline this request. In the 2013 proposed animal
food preventive controls rule, we tentatively concluded that it would
be rare for a frozen animal food to be a TCS food (78 FR 64736 at
64802), and we affirm that conclusion in this document. However,
specifying in the regulatory text that a frozen animal food is not a
TCS food would require us to conclude that a frozen animal food would
``never'' (rather than ``rarely'') be a TCS food, and we lack
information to support ``never.''
    (Comment 146) Some comments ask us to apply the exemption to
storage areas of facilities that also engage in food processing
activities, e.g., for distributors that are engaged in limited food
processing, such as blending seeds to make bird food. These comments

assert that the intent of the term ``solely'' is to make clear that a
facility that conducts an activity subject to the exemption does not
escape responsibility for complying with the requirements for hazard
analysis and risk-based preventive controls when conducting activities
that are not exempt.
    (Response 146) We disagree with the comment's interpretation of the
term ``solely.'' The plain meaning of ``solely'' is only, completely,
entirely; without another or others; singly; alone (Ref. 24). The
facility described in the comment is not ``solely'' engaged in the
storage of unexposed packaged animal food.
    Such a facility must conduct a hazard analysis that addresses all
activities conducted by the facility. The preventive controls that the
facility would establish and implement would depend on the facility,
the animal food, and the outcome of the facility's hazard analysis and
any preventive control management components associated with a
facility's preventive controls would be established as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control and its role in the
facility's food safety system. A facility that stores unexposed
packaged animal food that is not a TCS animal food could, for example,
determine that no preventive controls and associated management
components would be necessary. A facility that stores unexposed
refrigerated packaged TCS animal food could, for example, determine
that preventive controls and management components patterned after the
modified requirements in Sec.  507.51 are adequate to address
significant hazards associated with that animal food.
    (Comment 147) Some comments ask us to allow a facility to designate
a storage area as a separate facility for purposes of compliance with
the requirements for hazard analysis and risk-based preventive
controls. In the comments' view, an area solely engaged in the storage
of unexposed packaged food could fall within the exemption in Sec.
507.10 even though other areas would be subject to the requirements for
hazard analysis and risk-based preventive controls.
    (Response 147) We disagree that a designated storage area in an
establishment that conducts manufacturing, processing, or packing in
addition to storage can fall within the exemption for facilities
``solely engaged in . . . storage.'' The statute provides authority for
us to exempt or modify the requirements for compliance with respect to
``facilities'' that are solely engaged in the storage of packaged foods
that are not exposed to the environment (section 418(m) of the FD&C
Act). The statute defines ``facility'' as a domestic facility or a
foreign facility that is required to register under section 415 of the
FD&C Act (section 418(o)(2) of the FD&C Act). The section 415
registration regulations define facility as ``any establishment,
structure, or structures under one ownership at one general physical
location . . .'' The comment's interpretation that we could view
``areas'' of registered facilities to be ``facilities that are solely
engaged in the storage of packaged foods that are not exposed to the
environment'' is inconsistent with the statutory and regulatory
framework under sections 415 and 418 of the FD&C Act.
    (Comment 148) Some comments ask us to consider an alternative to
the exemption for unexposed packaged foods when a facility conducts
manufacturing, processing, packing, or holding activities in addition
to storing unexposed packaged food. Specifically, these comments ask us
to recognize that the minimal risks of storing unexposed packaged foods
can be addressed through a combination of compliance with the modified
requirements for TCS foods (if applicable) and the CGMPs in subpart B
and state that doing so would be consistent with our discussion in the
2013 proposed animal food preventive controls rule.
    (Response 148) These comments appear to suggest the outcome of a
facility's hazard analysis and food safety plan for storing unexposed
packaged animal food, i.e., that the only significant hazards are the
potential for growth of pathogens in refrigerated unexposed packaged
animal foods and that the preventive controls and preventive control
management components specified in the modified requirements for TCS
animal food are adequate to address such hazards. It is the
responsibility of the facility's preventive controls qualified
individual to identify the significant hazards associated with the
facility and the animal food it stores, as well as the appropriate
preventive controls and preventive control management components.
However, we agree that in some cases the approach suggested in these
comments would be appropriate.
    (Comment 149) Some comments assert that it is difficult to identify
TCS foods. These comments ask us to work with industry and professional
organizations to develop guidance on when the modified requirements
apply.
    (Response 149) This document does not include guidance on whether
specific animal foods are TCS foods. We will consider including
guidance on animal foods that are TCS foods in the implementing
guidances we are developing (see Response 1). A facility solely engaged
in storage of unexposed packaged animal food can work with the
manufacturer of the food to identify TCS food. Alternatively, such a
facility could simply treat any refrigerated food as a TCS food.

XIII. Subpart A: Comments on Proposed Sec.  507.12--Applicability of
Part 507 to the 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 would not
apply to by-products of human food production that are packed or held
by that human food facility for distribution as animal food if: the
facility is subject to and in compliance with subpart B of part 117
(the CGMPs in the proposed preventive controls rule for human food) and
in compliance with all other applicable human food safety requirements
of the FD&C Act and implementing regulations; and the facility does not
further manufacture or process the by-products intended for use as
animal food. Proposed Sec.  507.12(b) would require that once the
animal food was separated from the human food, the facility would need
to comply with proposed Sec. Sec.  507.28 and 117.95 of part 117 for
the holding and distribution of that animal food. We also proposed
Sec.  117.95 be added to the proposed preventive controls rule for
human food and asked for comment on whether the requirements should be
placed in both Sec.  117.95 and Sec.  507.28.
    Section 507.12 does not apply to human food by-products when
contamination or other adulteration has occurred that is materially
related to food safety. We handle requests for diversion of these
products for animal food use on a case-by-case basis. Additional
information on diversion of contaminated or adulterated food for animal
food use is available in compliance policy guidances (CPG) CPG Sec.
675.100 ``Diversion of Contaminated Food for Animal Use'' and CPG Sec.
675.200 ``Diversion of Adulterated Food to Acceptable Animal Feed Use''
(Refs. 25 and 26). We asked for comment on whether we should include
regulations for these types of requests.
    Many comments generally support the concept that certain human food
by-products intended for use as animal food which do not undergo
further processing by the human food

manufacturer only need to comply with proposed Sec.  507.28 for holding
and distribution of human food by-products for use as animal food. Some
of these comments note that human food by-products are an important
source of animal food. Other comments agree but request changes and/or
additional exemptions.
    We have modified Sec.  507.12 to clarify that the requirements of
part 507 do not apply to off-farm packing and holding of RACs packed or
held by a human food facility for distribution as animal food provided
certain conditions are met. For off-farm packing and holding of produce
(as defined in part 112 of this chapter), if the human food facility is
subject to and in compliance with Sec.  117.8 of part 117 of this
chapter and in compliance with all applicable human food safety
requirements of the FD&C Act and implementing regulations, and the
human food facility does not further manufacture or process the by-
products intended for use as animal food, then the requirements of part
507 do not apply to the by-products.
    (Comment 150) Some comments request that the proposed provisions be
included in both this rule and the final rule for preventive controls
for human food so that it would be easier for human food processors to
understand the requirements for human food by-products intended for use
as animal food. One comment does not support placing these provisions
in both of the final rules, preferring that all animal food provisions
be in part 507, and that part 117 should pertain only to human food.
    (Response 150) Section 117.95--``Holding and distribution of human
food by-products for use as animal food'' is established in this rule.
Section 117.95 will appear in 21 CFR part 117, preventive controls for
human food. The by-products holding and distribution provisions also
will appear in Sec.  507.28, the animal food CGMPs. The requirements of
Sec.  117.95 and Sec.  507.28 are identical and appear in both places
for the convenience of the facilities to which the provisions would
apply.
    (Comment 151) Two comments state it must be clear in the rule that
not only by-products but also products which are already authorized for
food like gelatin or collagen must be authorized for food for animals,
without further requirements and additional CGMP implementation.
    (Response 151) We understand this comment to be stating that a
human food product that also may be used as an animal food should not
be required to comply with part 507 if it is in compliance with human
food requirements. We agree with this comment. A facility that
manufactures and sells a food just for human consumption is not subject
to part 507, even if the purchaser of that food may use it for animal
food.
    If a facility manufactures, processes, packs, or holds human food
and animal food, and is subject to subpart C of part 117, it can comply
with subpart C of part 117 for the animal food, but needs to address
any hazards unique to the animal food that require a preventive
control, if applicable. Except as provided by Sec.  507.12 for human
food by-products, if a facility is required to comply with subpart B of
part 507 and also subpart B of part 117 because the facility
manufactures, processes, packs, or holds human food and animal food,
then the facility may comply with the requirements in subpart B of part
117, instead of subpart B of part 507, as to the manufacturing,
processing, packing, and holding of animal food at that facility (see
the regulatory text for Sec.  507.1(d)).
    (Comment 152) Some comments request that facilities regulated by
the United States Department of Agriculture (USDA) Food Safety and
Inspection Service (FSIS) not be required to comply with part 507 for
animal-derived human food by-products intended for use as animal food.
Some comments state the requirements are duplicative and are
unnecessary because FSIS food safety requirements are already in place,
and that oftentimes the FSIS establishment is unaware of what purpose
or animal species the purchaser will use the by-product for as animal
food.
    (Response 152) Only animal food facilities that are required to
register as a food facility under section 415 of the FD&C Act are
required to comply with this rule. Establishments regulated exclusively
throughout by FSIS under the Federal Meat Inspection Act, the Poultry
Products Inspection Act, or the Egg Products Inspection Act, i.e.,
establishments handling only meat, poultry, or certain egg products,
are exempt from registration under section 415 of the FD&C Act (see
Sec.  1.226(g) (21 CFR 1.226(g))). Therefore, these establishments are
not subject to this rule.
    (Comment 153) Some comments state we did not provide support for
the tentative conclusion that animal-derived by-products carry
different risks than other by-products, and therefore did not provide a
basis for why animal-derived by-products should be subject to all of
part 507 while other human food by-products are subject to only Sec.
507.28.
    (Response 153) As explained in Response 152, animal-derived by-
products from establishments that are not required to register as food
facilities would not be subject to part 507.
    Facilities may be jointly regulated by FDA and FSIS if they produce
some products that are under FDA jurisdiction and some that are under
FSIS jurisdiction. Such facilities may be required to register as a
food facility under section 415 of the FD&C Act. Examples of facilities
jointly regulated by FDA and FSIS include FSIS establishments that also
process animal food (such as certain pet food), and facilities that
process meat and nonmeat products (such as frozen entrees, some of
which contain meat and are regulated by FSIS, and some of which do not
contain meat but which contain seafood or vegetables that are regulated
by FDA).
    FSIS establishments that are required to register with FDA because
they also process FDA-regulated human food, must follow Sec. Sec.
507.28 and 117.95 for the holding and distribution of their FDA-
regulated human food by-products for use as animal food, if the
establishments meet the requirements of Sec.  507.12(a). FSIS
establishments that are required to register with FDA because they also
process FDA-regulated animal food must comply with the provisions in
the preventive controls rule for animal food (part 507).
    (Comment 154) Some comments assert that requiring FSIS-regulated
establishments to comply with part 507 would result in more by-products
being diverted to other disposal methods which might have an economic
or environmental impact.
    (Response 154) We do not agree that compliance with part 507 will
likely result in substantially less use of human food by-products as
animal food because it applies only to those establishments that are
required to register under section 415 of the FD&C Act. Furthermore,
other disposal methods for these products may be more cost prohibitive
than compliance with these regulations.
    (Comment 155) One comment requests the wording in proposed Sec.
507.12 be revised to explicitly exclude animal-derived human food by-
products for use as animal food because of pathogen risk.
    (Response 155) Animal-derived human food by-products have a long
history of use in the animal food industry. These human food by-
products typically are sold from the human food facility to an animal
food manufacturer/processor, such as a pet food manufacturer, that uses
the by-products as an ingredient in a finished animal food. These
manufacturers/processors are required to comply with

part 507 and must address any potential pathogens. Furthermore, 21 CFR
589.2000 prohibits the use of mammalian protein in the manufacture of
animal food given to ruminant animals, such as cows, sheep, and goats,
and regulations issued under the Swine Health Protection Act (7 U.S.C.
3801 et seq.) are intended to ensure that food waste containing meat
does not contain active disease organisms that pose a risk to swine who
eat it (see 9 CFR part 166).
    (Comment 156) A few comments state that USDA, not FDA, should issue
any regulations concerning the food safety of animal-derived by-
products intended for use as animal food.
    (Response 156) The FD&C Act gives FDA certain authority to regulate
food, which includes food for animals. As explained in section XV of
the 2013 proposed preventive controls rule for animal food, the FD&C
Act authorizes FDA to issue CGMP and preventive controls regulations to
enhance the safety of animal food, including human food by-products
that are intended for use as animal food. We decline to address what
USDA's role in animal food safety should be as is it out of the scope
of this rulemaking.
    (Comment 157) One comment suggests an alternative approach to
animal-derived human food by-products. The comment suggests that we
consider a provision that would allow the purchaser to take legal
responsibility for evaluating and mitigating risk associated with by-
products intended for use as animal food if both parties agree.
    (Response 157) For facilities subject to subpart C, the supply-
chain program in subpart E is required when the receiving facility's
hazard analysis identifies a hazard requiring a supply-chain-applied
control and the receiving facility's manufacturing/processing will not
control the hazard. However, when a manufacturer/processor identifies a
hazard requiring a preventive control, but can demonstrate and document
that the hazard will be controlled by an entity in its distribution
chain (e.g., its customer), then the manufacturer/processor is not
required to implement a preventive control (see Sec. Sec.  507.36 and
507.37). For a discussion of these provisions, see section XXVII. For
facilities exempt from the requirements of subpart C, we are aware that
parties may enter into purchase contracts that include specifications
or information for the animal food purchased.
    (Comment 158) The comments support seafood, dietary supplements,
and infant formula by-products intended for use as animal food without
further processing be subject only to the holding and distribution
provisions in proposed Sec.  507.28.
    (Response 158) We agree with these comments. We did not receive
comments indicating by-products from these human foods have specific
problems if used as animal food. Facilities that process seafood,
dietary supplements, and infant formula that meet the requirements of
Sec.  507.12(a) must follow the requirements of Sec.  507.28 and Sec.
117.95 for human food by-products for use as animal food.
    (Comment 159) Some comments state that all human food by-products,
including those further processed, should only have to comply with the
holding and distribution requirements in proposed Sec.  507.28. Other
comments support the requirement that human food by-products which are
further processed should be required to comply with all of proposed
part 507. Some comments request clarification about what constitutes
further processing.
    (Response 159) We decline the request to exempt human food by-
products that are further processed from the requirements of part 507
because following CGMPs for the processing will help ensure the animal
food's safety and because processing can introduce hazards requiring
preventive controls. Further processing includes any manufacturing/
processing as defined in Sec.  507.3 and includes activities such as
cooking, freezing, pelleting, and milling. Some passive activities such
as dewatering by holding a by-product in a container with a screened
bottom which allows water to escape, or holding in a perforated
container which allows natural drying to occur are not considered
further processing. Holding by-products at particular temperature to
facilitate easier transportation of the by-products is not considered
further processing; however, cooking or freezing a by-product to
prevent deterioration or adulteration is considered further processing.
Facilities holding human food by-products for use as animal food must
follow the requirements of Sec.  507.28.
    (Comment 160) Some comments state we should not include diversion
requests for contaminated or adulterated human food to animal food in
the regulations; that the information contained in the guidance
documents should remain in guidance and be handled on a case-by-case
basis. However, some comments request that the existing compliance
policy guidances be reviewed and updated and provide suggested changes.
    (Response 160) We have not included regulations for diversion of
contaminated or adulterated human food for animal food use in this
final rule. We will continue to handle diversion requests on an
individual basis. We will consider reviewing and revising the current
compliance policy guidances, CPG Sec. 675.100, ``Diversion of
Contaminated Food for Animal Use'' and CPG Sec. 675.200, ``Diversion of
Adulterated Food to Acceptable Animal Feed Use'' (Refs. 25 and 26).
    (Comment 161) One comment requests clarification on whether these
provisions would apply to retail outlets such as grocery stores or
bakeries. One comment asserts that when a pig farmer gets outdated milk
from a dairy processing bottling plant after the plant takes it back
from grocery stores that the dairy processor (the human food
manufacturer) would be exempt from the animal food preventive controls
final rule.
    (Response 161) Retail food establishments such as grocery stores
and bakeries are not required to register as food facilities (see
Sec. Sec.  1.226(c) and 1.227(b)(11)) and as a result are not required
to comply with part 507. However, the products they distribute for
animal food must not be adulterated.
    If milk has been returned to a processing plant because it is
contaminated or adulterated, the facility must follow our compliance
policy guidances for requests to divert human food for use as animal
food (Refs. 25 and 26). If the returned milk is not contaminated or
adulterated, but is returned for a quality reason, the facility must
follow the holding and distribution requirements of Sec.  507.28 and
Sec.  117.95, but would be exempt from the other provisions in subpart
B and subpart C of part 507.
    (Comment 162) One comment requests clarification on whether a
facility that is producing human food by-products intended for animal
food that fall under proposed Sec.  507.12 has to state in its food
safety plan that Sec.  507.12 applies.
    (Response 162) If the human food processor meets the requirements
in Sec.  507.12(a), the facility only needs to comply with Sec.  507.28
and Sec.  117.95, for the holding and distribution of the human food
by-products for use as animal food. The facility does not need to
include this information in its food safety plan for the human food,
but may choose to include it so that employees and other individuals
viewing the food safety plan understand what regulatory requirements
the human food processor is applying to those human food by-products
intended for animal food.

XIV. Subpart B: General Comments on Proposed Subpart B--Current Good
Manufacturing Practice

    In the 2014 supplemental proposed rule we revised the proposed
CGMPs to be more appropriate for the animal food industry. Following
are comments on the proposed CGMP requirements.
    (Comment 163) Some comments state that the risks for pet food,
especially with respect to pathogens, are different than the risks for
livestock feed, and therefore FDA should issue two sets of CGMPs. Some
comments say that CGMPs for pet food should be modeled after the human
food CGMPs because of the high level of care people provide and demand
for their pets, pets may eat or sleep with humans, and pet owners often
store pet food close to human food.
    (Response 163) We believe the single set of CGMPs can serve as
baseline standards for producing safe animal food across all types of
animal food facilities and animal food. We considered the diverse needs
of industry and the ultimate goal of animal food safety as we finalized
the CGMP regulations. We believe the final requirements are flexible
enough to be applied appropriately in various animal food production
settings. For example, Sec.  507.19(b) contains requirements for the
cleaning of animal food-contact surfaces of equipment and utensils to
protect against contamination of animal food. We do not specify exactly
how this is to be done (except some requirements for cleaning with wet
processing of animal food), knowing that what constitutes adequate
cleaning will depend on the plant and the animal food. (See Response
182).
    As discussed in the 2013 proposed rule for preventive controls for
animal food, in 2003 we introduced the concept of the Animal Feed
Safety System (AFSS) which was intended to address the safety of all
animal food at all stages of production and use. After obtaining input
from the general public, State regulatory officials, industry,
veterinarians, and consumers, the AFSS working group began developing a
proposed rule for process controls for animal food, prior to FSMA, that
was intended to apply to all animal food (including pet food, livestock
feed, and raw materials and other ingredients) (78 FR 64736 at 64740).
    When we revised the proposed CGMPs in the 2014 supplemental notice,
we not only consulted the human food CGMPs and their development
history, but also reviewed the draft AFSS process controls proposed
rule. We also reviewed CGMPs developed by organizations such as the
British Standards Institute's Publicly Available Specification (PAS)
222 and the Association of American Feed Control Officials (AAFCO)
model GMPs for feed and feed ingredients (which are adopted by many
states for regulation of animal food) (Refs. 27 and 28). Both PAS 222
and AAFCO GMPs apply to pet food and other animal food such as feed for
livestock. Many of the raw materials and other ingredients used in
making finished animal food are used by multiple types of animal food
manufacturers producing a variety of animal food products. It would not
be feasible to enforce different sets of standards for pet food and
livestock feed in a plant supplying the same ingredients to a pet food
manufacturer and a livestock feed manufacturer. We expect our CGMP
requirements to be applied appropriately in all facilities
manufacturing and processing animal food.
    (Comment 164) Some comments say that CGMP requirements for animal
food in general are not appropriate for some products used in animal
food. Comments provide examples such as rendered products, which are
thermally processed before being used as ingredients in animal food;
humic products because raw mined materials are low risk; and oilseed
products because they have not been associated with any significant
food safety risks and are intermediate ingredients that will undergo a
subsequent kill step.
    (Response 164) We understand that some ingredients utilized in the
production of animal food may pose a low risk. Nevertheless, facilities
that are required to register under section 415 of the FD&C Act and are
suppliers of ingredients used in animal food will be required to meet
the CGMP requirements being finalized in this rule. We believe these
CGMPs provide a great deal of flexibility in establishing baseline
standards for safely manufacturing, processing, packing, or holding the
wide diversity of ingredients used in animal food.
    (Comment 165) One comment suggests that a new section be added at
the end of subpart B that would eliminate the need to comply with the
CGMPs if a facility showed that the hazard analysis and risk-based
preventive controls required by subpart C had been properly conducted,
implemented and validated.
    (Response 165) We decline this request. The requested change is
counter to the intent of this regulation, that the CGMPs in subpart B
provide baseline safety and sanitation standards, while hazards
specific to a facility and the animal food it produces are identified
and controlled under subpart C. We consider CGMPs to be a prerequisite
program important for effective preventive controls, and believe that
the CGMPs being finalized in this rule provide enough flexibility for a
facility to use CGMPs to address certain hazards so they do not become
hazards that would require a preventive control.
    (Comment 166) One comment from a foreign government says that
minimum requirements for recordkeeping and traceability, which are
recommended in the CODEX Code of Practice on Good Animal Feeding, might
be appropriate in subpart B so that they would apply to establishments
exempt from subpart C.
    (Response 166) We agree that traceability and associated
recordkeeping are important tools for a facility to use for tracing
animal food in the event of a recall or foodborne illness outbreak.
Recordkeeping requirements currently exist in the Bioterrorism Act, and
implementing regulations in part 1 subpart J for persons who
manufacture, process, pack, transport, distribute, receive, hold, or
import food in the United States. In addition, the responsible party at
any food facility required to register under section 415 of the FD&C
Act (domestic and foreign) is subject to the RFR requirements under
section 417 of the FD&C Act. Section 417 requires under certain
circumstances that the responsible party notify the previous source and
subsequent recipient of the article of reportable food, providing
traceability.
    (Comment 167) Some comments request that we use the term
``adulteration'' instead of ``contamination'' in subpart B of the final
rule because ``adulteration'' of food is the regulatory standard for
action, whereas contamination is currently undefined. These comments
state that the term contamination should carry a different meaning than
in part 117 because what is considered a contaminant in human food may
differ from what is considered a contaminant in animal food.
    (Response 167) We decline this request. Section 402(a)(3) and (4)
of the FD&C Act were added to expand our bases for initiating
enforcement proceedings against adulterated food, particularly to allow
us to act where a food has been prepared, packed, or held under
insanitary conditions, whereby it may have become contaminated. In
other words, a food need not be shown to contain contaminants to be
adulterated; a showing that the food was prepared, packed, or held
under

conditions whereby it may become contaminated is sufficient to prove
adulteration. Thus, the word ``contamination'' serves a necessary
purpose in the context of adulteration. The CGMPs in this final rule
are intended to help protect against the contamination of animal food,
so that it will not become adulterated.
    The word ``contamination'' is used widely in FDA regulations,
including our Current Good Manufacturing Practice for Medicated Feeds
(21 CFR part 225), Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers (21 CFR part 113), and the Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
(21 CFR part 110, and updated and included in the final rule for
preventive controls for human food, 21 CFR part 117, published
elsewhere in this Federal Register). In addition, ``contamination'' is
used in Codex Good Practices for the Feed Industry and PAS 222 (Ref.
27). Because of the wide use of the term throughout current FDA
regulations and in international standards, we conclude that industry
is familiar with the word ``contamination'' and it is an appropriate
word to use in this final rule.
    We recognize that it may not always be possible to prevent
contamination of animal food. Therefore, we have changed the regulatory
text throughout subpart B to stress that the goal of the regulations is
to ``protect against'' or ``minimize'' the contamination of animal
food. We recognize that what is considered contamination of human food
may not be considered contamination in animal food.
    (Comment 168) Some comments object to the use of the terms
``sanitize'' and ``sanitation'' in the CGMPs, saying that the
destruction of microorganisms is not always necessary in animal food
facilities and therefore ``cleaning'' or ``housekeeping'' should be
used instead of ``sanitizing.'' Some of these comments also ask that we
change the title of proposed Sec.  507.19 from ``Sanitation'' to
``Cleaning and Housekeeping.''
    (Response 168) We decline this request. We use the term
``sanitation'' in a general way that we believe is well understood by
the animal food industry and does not mean the destruction of
microorganisms. For example, the term ``sanitation'' is defined in PAS-
222 (Ref. 27). When the destruction of vegetative cells of pathogens
and substantial reduction of numbers of other undesirable
microorganisms is required, we use the terms ``sanitize'' or
``sanitizing,'' not ``sanitation,'' which is consistent with how these
terms are used throughout our current regulations for human and animal
food. The only requirement for sanitizing in subpart B is in regards to
wet processing (see regulatory text for Sec.  507.19(b)(2)). Therefore,
we believe that ``sanitation'' is a word that is commonly understood by
industry and is used in this final rule in a way that is consistent
with how it is used in our other regulations relating to human and
animal food.
    (Comment 169) Some comments request that we use ``tools'' instead
of ``utensils'' in the CGMPs to better fit the terminology used in the
animal food industry.
    (Response 169) We decline this request. We recognize that
``utensil'' is not commonly used in the animal food industry; however,
we believe it is well understood. The term ``utensil'' is used in PAS-
222 and Codex Good Practices for the Feed Industry, as well as in the
CGMPs for human food in part 110 and in the revised CGMPs in the final
rule for preventive controls for human food, part 117 (Refs. 27 and
29). Further, because ``tools'' is broadly used to refer to such things
as construction equipment, software, educational material, and even
laws and regulations, we believe it is not a good substitute for
``utensils.''
    (Comment 170) A number of comments request that wherever we require
measures to protect against contamination of animal food, animal food-
contact surfaces, and animal food-packaging materials, that we delete
animal food-contact surfaces and animal food-packaging materials
because the focus should be solely on the animal food.
    (Response 170) We decline this request. While the ultimate goal of
the CGMP requirements is to protect against contamination of animal
food, we believe that protecting animal food-contact surfaces and
animal food-packaging material from contamination is a necessary step
to achieve this goal because the surfaces and packaging can be a source
of contamination.

XV. Subpart B: Comments on Proposed Sec.  507.14--Personnel

    We proposed that plant management must take all reasonable measures
and precautions to ensure that all persons working in direct contact
with animal food, animal food-contact surfaces, and animal food-
packaging materials conform to hygienic practices to the extent
necessary to protect against the contamination of animal food. We are
finalizing this provision with the discussed changes in Sec.
507.14(a). We have changed ``plant'' to ``establishment'' for clarity.
We are finalizing the proposed list of methods for maintaining
cleanliness that were proposed in Sec.  507.14(a)(1) through (5) in new
Sec.  507.14(b)(1) through (5). We have added paragraph (b) to read:
``the methods for conforming to hygienic practices and maintaining
cleanliness include.''
    (Comment 171) Some comments ask us to remove ``all'' because it is
too extreme and prescriptive.
    (Response 171) We have revised the regulatory text to delete
``all''. We disagree that the term ``all'' is too extreme and
prescriptive, but conclude that the term ``all'' is not necessary to
communicate the intent of the requirement.

A. Proposed Sec.  507.14(a)(1)--Personal Cleanliness (Final Sec.
507.14(b)(1))

    We proposed that the methods for maintaining cleanliness include
maintaining adequate personal cleanliness. We did not receive comments
specific to this provision and are finalizing it as proposed.

B. Proposed Sec.  507.14(a)(2)--Hand Washing (Final Sec.  507.14(b)(2))

    We proposed that the methods for maintaining cleanliness include
washing hands thoroughly in an adequate hand-washing facility as
necessary and appropriate to prevent contamination.
    (Comment 172) One comment disagrees with FDA's decision to revise
the language from the 2013 proposed rule by removing the parenthetic
statement about sanitizing hands if necessary to protect against
contamination with undesirable organisms. The comment recommends that
FDA add a qualifying statement that if hand washing facilities are not
readily available, the use of hand sanitizers is permitted.
    (Response 172) We decline this request. We deleted the parenthetic
statement because we did not intend to require hand sanitizing after
hand washing. We are providing flexibility for plant management to
determine if hand sanitizing after washing is necessary to protect
against contamination of animal food with undesirable microorganisms.
We recognize that there may be some situations where hand washing
facilities are not readily available. The use of waterless hand
cleaners (including hand sanitizers) may be adequate under these
circumstances.

C. Proposed Sec.  507.14(a)(3)--Unsecured Jewelry and Other Objects
(Final Sec.  507.14(b)(3))

    We proposed that personnel be required to remove or secure jewelry
and other objects that might fall into animal food, equipment, or
containers.
    (Comment 173) One comment says this requirement is unnecessary
since the proposed CGMPs contain numerous other provisions that require
facilities to protect against the adulteration of products. The focus
placed on jewelry and other items that may potentially fall into
products is unwarranted due to the limited risk of such occurrences.
    (Response 173) We believe that a specific provision to protect
against jewelry and other personal items falling into animal food is
appropriate, and is not redundant to other requirements in the CGMPs
that are intended to protect against adulteration of animal food.

D. Proposed Sec.  507.14(a)(4)--Storing Clothing and Personal
Belongings (Final Sec.  507.14(b)(4))

    We proposed requiring personnel to store clothing and other
personal belongings in areas other than where animal food is exposed or
where equipment or utensils are cleaned.
    (Comment 174) One comment says that the requirement is not
practical or necessary to ensure the safety of animal food. The comment
states that the temperature in a facility can be highly variable, so it
would be unreasonable to require an employee to store clothing outside
of areas where animal food is exposed.
    (Response 174) We understand that personnel may need layers of
clothing in certain plants that are exposed to varying temperatures.
However, when clothing is removed, it needs to be stored away from
exposed animal food so it does not become a source of contamination. We
believe storing clothing and other personal belongings in areas other
than where animal food is exposed is a reasonable protection.

E. Proposed Sec.  507.14(a)(5)--Taking Other Necessary Precautions
(Final Sec.  507.14(b)(5))

    We proposed that personnel must take any other necessary
precautions to protect against the contamination of animal food, animal
food-contact surfaces, or animal food-packaging materials.
    (Comment 175) One comment requests that we provide examples in a
guidance document for the requirement to take ``any other necessary
precautions to protect against contamination of animal food, animal
food contact surfaces, or animal food packaging materials.''
    (Response 175) We believe this provision indicates that the listed
requirements are not meant to be exhaustive and provides needed
flexibility for the diverse animal food industry to implement
precautions specific to their operations to protect against the
contamination of animal food. We will consider providing examples in
any future guidance.

XVI. Subpart B: Comments on Proposed Sec.  507.17--Plant and Grounds

A. Proposed Sec.  507.17(a)--Grounds Surrounding an Animal Food Plant

    We proposed that the grounds surrounding an animal food plant under
the control of the operator must be kept in a condition that will
protect against the contamination of animal food, including provisions
to keep areas from being a harborage for pests, maintaining areas so
they are not a source of contamination, adequately draining areas, and
treating and disposing of waste so it is not a source of contamination.
    (Comment 176) One comment says that the term ``surrounding'' the
plant is too ambiguous, and that we should specify the distance from a
plant that must be controlled to prevent animal food contamination.
    (Response 176) We decline to specify a distance from the plant
because the area that could impact plant operations is highly variable
from plant to plant. We have replaced the word ``surrounding'' with the
word ``around,'' meaning the grounds of the plant under control of the
plant management that could impact plant operations.
    (Comment 177) Some comments say that the requirements are highly
prescriptive and should be more flexible. Other comments state that the
general language that requires the grounds to be kept in a condition
that will protect against the contamination of animal food is
sufficient and that the specific requirements should be
recommendations.
    (Response 177) The specific requirements provide the baseline
expectations we have for plants to maintain their grounds in a way that
does not result in the contamination of animal food. The specific
requirements are common to most plants and provide necessary
information to the plant management about what it must do to comply
with this final rule. However, the requirements do not preclude a plant
from addressing unique circumstances that could lead to the
contamination of animal food.

B. Proposed Sec.  507.17(b)(1)--Adequate Space Between Equipment,
Walls, and Stored Materials

    We proposed that the buildings, structures, fixtures, and other
physical facilities of the plant must be suitable in size,
construction, and design to facilitate cleaning, maintenance, and pest
control to reduce the potential for contamination of animal food,
animal food-contract surfaces, and animal food-packaging materials. We
also proposed that the plant must provide adequate space between
equipment, walls, and stored materials to permit employees to perform
their duties and to allow cleaning and maintenance of equipment.
    (Comment 178) Two comments disagree with this requirement. One
comment says that the focus is on equipment design and not protecting
against animal food contamination. The other comment suggests
simplifying the requirement to provide access between equipment and
walls.
    (Response 178) We believe protecting animal food from contamination
requires proper plant design. We decline the request to change the
requirement by deleting the reference to stored materials because we do
not agree that stored materials should be allowed to prevent employees
from performing their duties or inhibit the cleaning and maintenance of
equipment. We did modify the language in paragraph (b) to replace
``buildings, structures, fixtures, and other physical facilities of the
plant'' with ``the plant'' because the plant would include its
buildings, structures, fixtures, and physical facilities.

C. Proposed Sec.  507.17(b)(2)--Dripping and Condensation

    We proposed that the plant must be constructed in a manner such
that drip or condensate from fixtures, ducts, and pipes does not serve
as a source of contamination.
    (Comment 179) One comment asks that we allow for facilities to be
``constructed or maintained,'' rather than ``constructed'' only, to
ensure that drip or condensate does not serve as a source of animal
food contamination. Another comment asks that the requirement be
deleted, since it is generally not relevant and is redundant to the
opening statement in proposed paragraph (b). Other comments say that
requirements pertaining to the construction of buildings and structures
are too prescriptive and should specify only that the plant be
constructed in such a manner as to protect against adulteration of
animal food.

    (Response 179) We decline the requests to revise or delete this
requirement. The requirements in (b)(1) to (5) are some of the specific
requirements that we believe are needed to meet the general requirement
in paragraph (b) that the plant be designed and constructed to reduce
the potential for contamination. We believe it is important to specify
that fixtures, ducts, and pipes be constructed so that they do not
serve as a source of contamination because condensate and drip may
serve as a source of contamination. As specified in Sec.  507.20(b)(3),
plumbing must be maintained to avoid being a source of contamination to
animal food. In addition, as specified in 507.19(a), the fixtures and
physical facilities of the plant must be kept in good repair to prevent
animal food from becoming adulterated. This would include fixtures,
ducts, and pipes. Thus, we agree that one way to manage dripping and
condensation is through maintenance or repair to the plumbing or
structure, and do not intend that existing plants must be redesigned or
reconstructed.

D. Proposed Sec.  507.17(b)(3)--Ventilation

    We proposed that the plant must provide adequate ventilation or
control equipment to minimize vapors (for example, steam) and fumes in
areas where they may contaminate animal food, and locate and operate
fans and other air-blowing equipment in a manner that minimizes the
potential for contaminating animal food.
    (Comment 180) One comment says that while steam is a key
manufacturing component, it is unlikely to be a source of potentially
hazardous contaminants. Several comments state that steam is not
commonly used in animal food processing, and should not be specified in
the rule, or language stating ``where appropriate and necessary''
should be included in the regulatory text. Other comments suggest
additional alternative language.
    (Response 180) We agree that not all plants use steam and the
phrase ``where appropriate and necessary'' provides that distinction
and have added it to the regulatory text. We also recognize that animal
food facilities commonly rely on natural ventilation. As a result, we
have added the parenthetical (mechanical or natural) to the regulatory
text to read: ``Provide adequate ventilation (mechanical or natural) .
. .''

E. Proposed Sec.  507.17(b)(4)--Lighting

    We proposed that the plant must provide adequate lighting in hand-
washing areas, toilet rooms, areas where animal food is received,
manufactured, processed, packed, or held, and areas where equipment or
utensils are cleaned. We received no comments on this provision and are
finalizing it as proposed.

F. Proposed Sec.  507.17(b)(5)--Glass

    We proposed that the plant must provide safety-type light bulbs,
fixtures, and skylights, or other glass items suspended over exposed
animal food in any step of preparation, to protect against the
contamination of animal food in case of glass breakage. We did not
receive specific comments on this paragraph. However, for clarity, we
have replaced the term ``safety-type'' with ``shatter-resistant.''

G. Proposed Sec.  507.17(b)(6)--Outdoor Storage

    We proposed that animal food stored outdoors in bulk be protected
by any effective means, including using protective coverings,
controlling areas over and around the bulk animal food to eliminate
harborages for pests, and checking on a regular basis for pests and
pest infestation.
    (Comment 181) Several comments say that protecting animal food
stored outdoors is better addressed in proposed Sec.  507.19
(Sanitation). One comment says that at livestock facilities and farms
animal food such as hay, silage, grain, human food by-products, and
other commodities are commonly stored outside with no cover. Another
comment requests that the regulation be revised to recommend rather
than require the provisions.
    (Response 181) While we disagree with the recommendation to move
this requirement to Sec.  507.19 (Sanitation), we moved it from
proposed paragraph (b) to new paragraph (c) in Sec.  507.17 because
paragraph (b) pertains to buildings and structures and this requirement
is about animal food stored outside of the building or structure. We
have revised the regulatory text in paragraph (c)(1) to read ``Using
protective coverings where necessary and appropriate'' to account for
the situations that may not require protective coverings. In addition,
we have added checking for product condition related to the safety of
the animal food in paragraph (c)(3) to ensure that if the animal food
is not covered, animal food safety is maintained. We decline to specify
under what circumstance protective coverage is required (such as, to
protect against adverse weather conditions) since there could be
several reasons for needing protective coverage to help protect against
contamination of the animal food.

XVII. Subpart B: Comments on Proposed Sec.  507.19--Sanitation

A. Proposed Sec.  507.19(a)--Buildings

    We proposed that buildings, structures, fixtures, and other
physical facilities of the plant must be kept clean and in good repair
to prevent animal food from becoming contaminated. We received no
comments on this provision, however we are replacing ``contaminated''
with the broader standard ``adulterated'' as proposed in the 2013
proposed preventive controls rule for animal food.

B. Proposed Sec.  507.19(b)--Cleaning

    We proposed that animal food-contact and non-contact surfaces of
utensils and equipment must be cleaned and maintained and utensils and
equipment stored as necessary and appropriate to protect against the
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials, and that when necessary, equipment be
disassembled for thorough cleaning.
    (Comment 182) Two comments state that the proposed provision is too
prescriptive because of the requirement to disassemble equipment for
cleaning when necessary.
    (Response 182) We believe the language provides flexibility for
plants to prevent contamination of animal food contact and non-contact
surfaces of utensils and equipment. The language ``when necessary''
provides the plant the option whether to disassemble the equipment for
cleaning based on the manufacturer's knowledge and experience of when
this cleaning procedure is necessary to protect against the
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials.

C. Proposed Sec.  507.19(b)(1)--Wet Cleaning

    We proposed that when it is necessary to wet-clean animal food-
contact surfaces used for manufacturing, processing, packing, or
holding low-moisture animal food, the surfaces must be thoroughly dried
before subsequent use.
    (Comment 183) One comment states that ``low-moisture animal food''
is not defined, so for clarity we should either define it or replace it
with ``safe moisture level animal food'' because ``safe moisture
level'' is already defined in the proposed rule.
    (Response 183) We agree that the term ``low-moisture'' is not well
known when applied to the animal food industry as a whole and we have
removed the term. We believe that in most cases, animal

food contact surfaces must be thoroughly dried after wet cleaning
because the moisture could provide an environment for growth of
undesirable microorganisms. However, we also understand that in some
situations, for example in wet processing areas, it would not be
necessary to dry surfaces thoroughly before subsequent use in order to
protect against contamination. Therefore, we have inserted ``when
necessary,'' so that the requirement is appropriate for all types of
animal food facilities.
    (Comment 184) Two comments note that the proposed rule includes
explicit requirements for wet cleaning, but none for dry cleaning. One
comment suggests adding language to paragraph (b) for dry cleaning,
including vacuuming or sweeping. The second comment suggests adding
language for dry cleaning when used solely for low-moisture feed
ingredients.
    (Response 184) We decline these requests. The regulatory text in
paragraph (b) requires that utensils and equipment be cleaned and
maintained, but it does not specify the exact procedures. Adequate
cleanout of so-called dry feeds has been an important CGMP requirement
applicable to medicated feed for more than 40 years and, as such, some
of the animal food industry is well aware of this practice. The dry
cleaning procedures suggested in the comments would be allowable
methods of cleaning and maintaining where appropriate to protect
against the contamination of animal food. We do not believe additional
language is necessary in the regulatory text for dry cleaning. The
provisions in paragraph (b)(1) for wet cleaning are in addition to the
more general requirements in paragraph (b) to help ensure that water
from the wet-cleaning process does not result in subsequent
contamination of animal food.

D. Proposed Sec.  507.19(b)(2)--Wet Processing

    We proposed that in wet processing, when cleaning and sanitizing is
necessary to protect against the introduction of undesirable
microorganisms into animal food, all animal food-contact surfaces must
be cleaned and sanitized before use and after any interruption during
which the animal food-contact surfaces may have become contaminated.
    (Comment 185) One comment says the proposed requirements for
cleaning in wet processing areas should be more flexible and suggests
the additional wording ``as necessary to protect against adulteration
of animal food.''
    (Response 185) We believe this requirement is sufficiently flexible
because it applies only when necessary to protect against the
introduction of undesirable microorganisms into animal food.

E. Proposed Sec.  507.19(c)--Cleaning Compounds and Sanitizing Agents

    We proposed that cleaning compounds and sanitizing agents must be
safe and adequate under the conditions of use. We received no comments
on this provision and are finalizing it as proposed.

F. Proposed Sec.  507.19(d)(1)--Toxic Materials

    We proposed that only certain toxic materials may be used or stored
in a plant where animal food is manufactured, processed, or exposed,
i.e., those that are required to maintain clean and sanitary
conditions, those necessary for use in laboratory testing procedures,
those necessary for plant and equipment maintenance and operation, and
those necessary for use in the plant's operations.
    (Comment 186) Some comments say that the proposed regulation would
require an absolute prohibition of any potentially toxic materials that
are stored but not used by an animal food plant. The comments note that
animal food plants that hold and distribute materials such as
fertilizers and pesticides would either need to discontinue this
practice or construct new storage buildings, which may be expensive.
Several comments suggest alternative language to allow toxic materials
to be held and distributed in a way that would not require significant
physical improvements to the plant.
    (Response 186) We agree that it might be common for an animal food
plant to have toxic materials not identified in paragraph (d)(1), such
as fertilizers or other non-plant chemicals, as part of its business
inventory. However, we disagree with the comments that state the
provisions in the rule would require new investments in storage
buildings. The intent of the provision is to keep toxic chemical
categories not listed in paragraph (d)(1) out of the plant area so
animal food is not exposed. We revised the regulatory text to add
paragraph (d)(3), which reads ``Other toxic materials (such as
fertilizers and pesticides not included in paragraph (d)(1) of this
section) must be stored in an area of the plant where animal food is
not manufactured, processed, or exposed.'' We expect that this will
result in toxic materials not identified in paragraph (d)(1) being
separated from animal food either by sufficient space or a sufficient
physical barrier such that they are not able to contaminate the animal
food. With this clarification, we do not believe that establishments
will need to make significant investments to their buildings and
structures to comply with these requirements.

G. Proposed Sec.  507.19(d)(2)--Identification, Use, and Storage of
Toxic Materials

    We proposed that toxic materials described in paragraph (d)(1) of
this section (for example, cleaning compounds, sanitizing agents, and
pesticide chemicals) must be identified, used, and stored in a manner
that protects against the contamination of animal food, animal food-
contact surfaces, or animal food-packaging materials.
    (Comment 187) A number of comments object to the use of ``toxic''
in proposed paragraph (d)(2). Several comments suggest that ``cleaning
materials'' rather than ``toxic cleaning compounds'' be used in
paragraph (d)(2) because any substance may be considered ``toxic'' if
handled or used inappropriately. One comment asks that the term ``toxic
materials'' be deleted and requirements established instead for the
control of substances that are not approved for use in animal food.
    (Response 187) We decline the request. The term ``toxic'' is
important to specify that this paragraph applies to toxic cleaning
compounds. The term ``cleaning compounds'' would be too general and
might include materials that would not need to be handled as specified
in these requirements to protect against the contamination of animal
food. For example, water could be considered a cleaning compound, but
it is not considered toxic at regular use levels and we would not
expect a plant to treat its use of cleaning water in a manner
consistent with this requirement. We decline the request to substitute
``substances that are not approved for use in animal food'' for ``toxic
materials.'' Not all animal food ingredients have been or must be
preapproved by the Agency before being used to produce animal food.
Additionally, ingredients that have not been approved by the Agency
would not necessarily be toxic.

H. Proposed Sec.  507.19(e)--Pest Control

    We proposed that effective measures must be taken to exclude pests
from the manufacturing, processing, packing, and holding areas and to
protect against the contamination of animal food by pests. The use of
insecticides and rodenticides in the plant is permitted only under
precautions and restrictions that will

protect against the contamination of animal food, animal food-contact
surfaces, and animal food-packaging materials. We received no comments
on this provision. We have replaced the words ``insecticides and
rodenticides'' with ``pesticides'' for simplicity and because we have
defined pest as ``any objectionable animals or insects including birds,
rodents, flies, and larvae.'' Thus, pests are not limited to insects
and rodents.

I. Proposed Sec.  507.19(f)--Trash and Garbage

    We proposed that trash and garbage must be conveyed, stored, and
disposed of in a way that protects against the contamination of animal
food, animal food-contact surfaces, animal food-packaging materials,
water supplies, and ground surfaces, and minimizes the potential for
the trash and garbage to become an attractant and harborage or breeding
place for pests. We received no comments on this provision; however we
are removing the term ``garbage.'' (See Response 227).

XVIII. Subpart B: Comments on Proposed Sec.  507.20--Water Supply and
Plumbing

A. Proposed Sec.  507.20(a)--Water Supply (Final Sec.  507.20(a)(1)-
(4))

    We proposed that the water supply must be adequate for the
operations and must be derived from a suitable source. Running water at
a suitable temperature, and under suitable pressure as needed, must be
provided in all areas where required for the manufacturing or
processing of animal food, for the cleaning of equipment, utensils, and
animal food-packaging materials, or for employee hand-washing
facilities. Water that contacts animal food, animal food-contact
surfaces, or animal food-packaging materials must be safe for its
intended use. Water may be reused for washing, rinsing, or conveying
animal food if it does not increase the level of contamination of the
animal food.
    (Comment 188) One comment suggests that we develop an enforcement
plan for water quality that takes into account the intended use of the
animal food being manufactured. Another comment says that many of the
details contained in this paragraph of the proposed regulation should
be handled as guidance rather than regulation.
    (Response 188) We believe that the details contained in this
paragraph should remain requirements because they are important to
helping ensure the safety of animal food and to provide the regulated
facility with information about what is expected of the water supply
for the plant and the animal food being manufactured, processed, packed
or held. We will consider including water supply in any future
guidance.
    (Comment 189) Two comments say that that the requirements
pertaining to the water supply are overly prescriptive and we should
require only that the water supply be adequate for the operations. Two
comments suggest that the requirement about the reuse of water be
reworded to provide more clarification on the recycling of water within
the plant.
    (Response 189) We believe the source of the water is relevant to
ensuring that animal food is protected from contamination. We also
believe specifying that water be safe for its intended use, and that it
be provided at a suitable temperature and pressure where it is needed
for manufacturing, processing, cleaning, and hand washing helps protect
against animal food contamination. With respect to reuse of water, we
believe our statement that water may be reused for washing, rinsing, or
conveying animal food if it does not increase the level of
contamination of the animal food allows flexibility for recycling water
within the plant. Additional clarification could have the unintended
effect of reducing flexibility.

B. Proposed Sec.  507.20(b)--Plumbing

    We proposed that plumbing be designed, installed, and maintained to
carry adequate quantities of water to required locations throughout the
plant; properly convey sewage and liquid disposable waste from the
plant; avoid being a source of contamination to animal food, animal
food-contact surfaces, or animal food-packaging materials, water
supplies, equipment, or utensils, or creating an unsanitary condition;
provide adequate floor drainage in all areas where floors are subject
to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and ensure there is
no backflow or cross-connections between piping for water for
processing and for waste water.
    (Comment 190) One comment says we are proposing to establish
specific requirements for plumbing design, installation, and
maintenance that are not necessary to prevent the adulteration of
animal food, and suggests deleting the plumbing design section
entirely. Two comments say that floor drains are not the only way to
remove water or other fluids from floors, and suggest we allow other
options such as vacuuming, mopping, or fans.
    (Response 190) We decline these requests. We believe these are
basic and necessary requirements for helping ensure production of safe
animal food. The regulatory text requires adequate floor drainage for
areas where floors are subject to flooding-type cleaning or where
normal operations release or discharge water or other liquid waste on
the floor. Plants that do not perform these activities as part of their
normal operations would not be expected to have floor drainage and
vacuuming or mopping may be adequate.

C. Proposed Sec.  507.20(c)--Sewage

    We proposed that sewage must be disposed of through an adequate
sewerage system or through other adequate means.
    (Comment 191) Some comments say that the requirement to provide an
adequate sewer system is covered by the requirement in proposed Sec.
507.20(b)(2) for plumbing and that one of the requirements should be
deleted to eliminate this redundancy.
    (Response 191) The requirement in paragraph (b)(2) is intended to
make sure the plumbing in the plant is sufficient to remove sewage and
liquid disposable waste from the points at which it is generated within
the plant, while the requirement in paragraph (c) is intended to make
sure that the sewage and liquid disposable waste created by the plant
is delivered to a wastewater system, such as a sewer or septic system,
which has a capacity adequate to ensure that this wastewater does not
contaminate the animal food.

D. Proposed Sec.  507.20(d)--Toilet Facilities

    We proposed that each plant must provide employees with adequate,
readily accessible toilet facilities, and that the toilet facilities be
kept clean and not be a potential source of contamination of animal
food, animal food-contact surfaces, or animal food-packaging materials.
    (Comment 192) Some comments suggest adding ``as appropriate'' to
the requirement to provide adequate toilet facilities for plant
employees.
    (Response 192) We decline this request. We understand that there
may be an exception where toilet facilities are not inside a plant, but
we believe it is important that toilet facilities are available near
the plant for employee use, and the requirement as proposed provides
this flexibility.

E. Proposed Sec.  507.20(e)--Hand-Washing Facilities

    We proposed that each plant must provide hand-washing facilities

designed to ensure that an employee's hands are not a source of
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials.
    (Comment 193) Some comments suggest adding the words ``as
appropriate'' to the requirement to provide flexibility for those
plants that may not need hand-washing facilities. Another comment asks
that we add an option that allows for the use of hand sanitizing in
plants that may not need hand-washing facilities.
    (Response 193) We understand that there may not be running water in
every plant, but we believe it is important that hand-washing
facilities be available to employees. We understand that in some cases
hand-washing facilities might consist of waterless hand cleaners
(including hand sanitizers).

XIX. Subpart B: Comments on Proposed Sec.  507.22--Equipment and
Utensils

A. Proposed Sec.  507.22(a)(1)--Plant Equipment and Utensils

    We proposed that all plant equipment and utensils must be designed
and of such material and workmanship to be adequately cleanable, and
must be properly maintained.
    (Comment 194) Some comments suggest that this be a recommendation
rather than a requirement because it is too prescriptive and applies to
all equipment in a plant, rather than only to equipment used in the
production of animal food.
    (Response 194) We decline this request. We believe that all plant
equipment with the potential to contaminate animal food must be
cleanable and maintained. To clarify this requirement, we have added
language stating that this requirement applies to equipment and
utensils used in manufacturing, processing, packing, and holding animal
food, as well as equipment and utensils that do not come in contact
with animal food but could still serve as a source of contamination of
animal food.

B. Proposed Sec.  507.22(a)(2)--Design of Equipment and Utensils

    We proposed that the design, construction, and use of equipment and
utensils must preclude the contamination of animal food with
lubricants, fuel, metal fragments, contaminated water, or any other
contaminants.
    (Comment 195) Some comments say that this requirement is too
prescriptive because equipment and utensils are designed and
constructed by entities independent of the animal food manufacturers/
processers. Some comments also say that we should clarify that we are
not requiring the use of food-grade lubricants.
    (Response 195) We understand that plants do not normally design and
construct the equipment they use. However, we believe it is the plant's
responsibility to select equipment and utensils that when used will not
adulterate animal food. We have revised the text to clarify that the
presence of non-food grade lubricants, fuel, metal fragments,
contaminated water, or other contaminants in animal food may render it
adulterated. We also have revised the wording for easier reading. We
are not requiring that only food grade lubricants be used in the plant,
but food grade lubricants must be used on equipment that comes in
contact with animal food. When a non-food grade lubricant is used on
non-food contact equipment, it must not adulterate the animal food. We
have added the term ``non-food grade'' for lubricants to clarify this.

C. Proposed Sec.  507.22(a)(3)--Equipment Installation

    We proposed that equipment should be installed and maintained in
such a way as to facilitate the cleaning of the equipment and adjacent
spaces. This provision has been revised to be a requirement, not a
recommendation as it is a requirement, not guidance.
    (Comment 196) One comment suggests that we combine proposed
Sec. Sec.  507.22(a)(1) and 507.22(a)(3).
    (Response 196) We decline this request. The first provision
requires that equipment be properly designed and constructed, and the
second requires that it be installed in a way that facilitates cleaning
and maintenance. We have revised the wording in (a)(3) for clarity.

D. Proposed Sec.  507.22(a)(4)--Animal Food Contact Surfaces

    We proposed that animal food-contact surfaces must be made of
materials that withstand the environment of their use and the action of
animal food, and, if applicable, the action of cleaning compounds, and
sanitizing agents; be made of nontoxic materials; and maintained to
protect animal food from being contaminated.
    (Comment 197) Some comments ask us to specify that food-contact
surfaces must be designed to withstand cleaning procedures.
    (Response 197) We have revised the regulatory text to include
cleaning procedures. For example animal food-contact surfaces must be
designed to withstand the actions of scrubbing utensils that could
damage the equipment.

E. Proposed Sec.  507.22(a)(5)--Non-Animal Food Contact Equipment
(Final Sec.  507.22(a)(1))

    We proposed that equipment in the animal food in manufacturing/
processing area, that does not come into contact with animal food must
be constructed in such a way that it can be kept in a clean condition.
    (Comment 198) One comment says that this requirement should be
deleted because it is highly prescriptive, redundant to proposed
paragraph (a)(1), and not performance based or necessary. Further, the
comment states FDA's focus should be on whether the area is adequately
cleaned, not on whether equipment that does not come in contact with
animal food is properly designed.
    (Response 198) We disagree that the requirement is too
prescriptive. However, we agree that there is some redundancy between
proposed paragraphs (a)(1) and (a)(5). We have removed proposed
paragraph (a)(5) and have modified the regulatory text in paragraph
(a)(1) as discussed in section XIX.A.

F. Proposed Sec.  507.22(b)--System Design and Construction

    We proposed that holding, conveying, manufacturing, and processing
systems, including gravimetric, pneumatic, closed, and automated
systems, must be designed, constructed, and maintained in a way that
does not contaminate animal food.
    (Comment 199) Several comments suggest that this requirement be
revised or deleted to allow plants the flexibility to maintain their
equipment in a manner that is appropriate for their facility, and
because it is redundant to proposed Sec.  507.22(a)(1) through (4).
    (Response 199) We decline to revise or eliminate this provision.
The requirements in Sec.  507.22(a) are specific to individual pieces
of equipment. The requirement in Sec.  507.22(b) is meant to address
entire systems that may contain multiple pieces of equipment. While an
individual piece of equipment may be designed, constructed and
maintained so that it protects against the contamination of animal
food, when that piece of equipment becomes part of a system, its use in
the system must be in a manner that protects against the contamination
of animal food. (See Response 167.)

G. Proposed Sec.  507.22(c)--Monitoring Cold Storage Temperatures

    We proposed that each freezer and cold storage compartment used to
hold animal food must be fitted with an accurate temperature-monitoring
device.
    (Comment 200) Some comments state requiring monitoring devices for
each compartment goes too far. Facilities should have flexibility in
controlling temperatures in freezers and cold storage compartments. One
comment says this requirement should not require the use of continuous
temperature-monitoring devices.
    (Response 200) We believe that a temperature-measuring device for
each compartment is necessary because the temperature may be different
in each compartment. We have replaced the term ``temperature -
monitoring device'' with ``temperature-measuring device'' as we do not
intend the establishment to use a continuous monitoring device or
temperature recording device.

H. Proposed Sec.  507.22(d)--Instruments

    We proposed that instruments and controls used for measuring,
regulating, or recording temperatures, pH, aw, or other
conditions that control or prevent the growth of undesirable
microorganisms in animal food must be accurate, precise, adequately
maintained, and adequate in number for their designated uses. We
received no comments on this provision and are finalizing it as
proposed.

I. Proposed Sec.  507.22(e)--Compressed Air

    We proposed that compressed air or other gases mechanically
introduced into animal food or used to clean animal food-contact
surfaces or equipment must be used in such a way so animal food is not
contaminated. We received no comments on this provision and are
finalizing it as proposed with the revision ``to protect against the
contamination of animal food.'' (See Response 167.)

XX. Subpart B: Comments on Proposed Sec.  507.25--Plant Operations

A. Proposed Sec.  507.25(a)(1)--CGMPs

    We proposed that plant management must ensure that all operations
in the manufacturing, processing, packing, and holding of animal food
are conducted in accordance with the CGMP requirements of this subpart.
We received no comments on this provision. We are revising paragraph
(a) to read ``Management of the establishment must ensure that:'' based
on the definition of ``plant'' (see section VIII.A.23).

B. Proposed Sec.  507.25(a)(2)--Identifying Contents of Containers

    We proposed that plant management must ensure that containers
holding animal food, including raw materials, other ingredients, or
rework, accurately identify the contents.
    (Comment 201) Some comments suggest that we revise the proposed
requirements by clarifying that the contents of containers, not the
containers themselves, are accurately identified, and that we clarify
that bulk silos and bins are not required to be placarded, because this
is impractical and not industry practice.
    (Response 201) We agree that the animal food in the containers is
what must be identified and have clarified the language in the
regulatory text to require management to ensure animal food, including
raw materials, other ingredients, or rework is accurately identified.
We recognize that a variety of systems are used by establishments to
identify animal food within the plant including labeling, computer
systems, paper records, chalkboards, and other methods. It is necessary
that plant personnel be able to accurately identify animal food,
including raw materials, other ingredients, or rework within the plant
so that animal food is not commingled, substituted, or incorrectly
formulated in a manner that results in adulterated animal food.

C. Proposed Sec.  507.25(a)(3)--Labeling of Finished Product (Final
Sec.  507.27(b))

    We proposed that plant management must ensure that the labeling for
finished animal food product contains information and instructions for
safely using the product for the intended animal species.
    (Comment 202) Many comments suggest that instead of specifying that
labeling for the finished animal food product contains information and
instructions for safely using the product for the intended animal
species we specify only that labeling for finished animal food products
conforms to requirements in existing FDA regulations. One comment asks
that we clarify that finished product means the product that the animal
receives.
    (Response 202) We decline the request. We do not intend ``finished
animal food product'' to mean only product that the animal receives. A
finished animal food product could be ready-to-eat animal food or it
could be an ingredient or mixture of ingredients that will be further
processed, mixed, or blended before it is suitable for feeding to
animals.
    Labeling containing information and instructions for safe use is
important for both the person feeding the animal(s) and the downstream
facilities that may use an ingredient or mixture of ingredients to
further process, mix, or blend into an animal food product. Some animal
food products may pose a food safety concern for some species for which
the food is not intended, or may pose a food safety concern for an
intended species if not used properly. For example, the manufacturer of
a copper product might include the use levels for food for different
species or a labeling statement specifying the maximum safe level of
copper in an animal food intended for sheep.
    We have moved this requirement to paragraph (b) in Sec.  507.27
``Holding and Distribution.'' We believe that this move helps to
clarify that the labeling is intended for finished animal food leaving
the plant. We have renumbered the other requirements in this section
accordingly.

D. Proposed Sec.  507.25(a)(4)--Animal Food Packaging Material (Final
Sec.  507.25(a)(3))

    We proposed that plant management must ensure that animal food-
packaging materials are safe and suitable.
    (Comment 203) One comment suggests that instead of requiring that
animal food-packaging materials are safe and suitable, we require that
they are safe and suitable for the intended use.
    (Response 203) We disagree that this clarification is needed
because the intended use is inherent in the current wording of this
regulation.

E. Proposed Sec.  507.25(a)(5)--Responsibility for Overall Plant
Cleanliness (Final Sec.  507.25(a)(4))

    We proposed that plant management must ensure that overall
cleanliness of the plant is under the supervision of one or more
competent individuals assigned responsibility for this function.
    (Comment 204) One comment suggests that we require that the
competent individuals responsible for overall cleanliness of the plant
be ``qualified competent individuals.''
    (Response 204) As discussed in Response 92, we expect all
individuals who perform activities required under part 507 to know how
to do their jobs; thus, we are establishing new Sec.  507.4(b), which
specifies that all individuals who perform activities required under
part 507 must be ``qualified individuals'' as that term is defined in
Sec.  507.3 (i.e., a person who has the necessary education, training,
and experience to perform an activity required under part 507). A
qualified individual may be, but is not required to be, an employee of
the establishment.

F. Proposed Sec.  507.25(a)(6)--Contamination Precautions (Final Sec.
507.25(a)(5))

    We proposed that plant management must ensure that reasonable
precautions are taken so that plant operations do not contribute to the
contamination of animal food, animal food-contact surfaces, and animal
food packaging materials. We received no comments on this provision. We
did replace the term ``reasonable'' with the term ``adequate'' to be
more consistent with the rest of the regulatory text in subpart B.

G. Proposed Sec.  507.25(a)(7)--Testing Procedures (Final Sec.
507.25(a)(6))

    We proposed that plant management must ensure that chemical,
microbial, or extraneous-material testing procedures are used where
necessary to identify sanitation failures or possible animal food
contamination.
    (Comment 205) Some comments say that the need for chemical,
microbial, or extraneous-material testing should be determined by a
facility when identifying hazards and controls under subpart C, and
therefore it should not be required under CGMPs. One comment says that
it should be deleted because it is already addressed under the testing
provisions in subpart C.
    (Response 205) The CGMP regulations in subpart B are intended to
establish baseline requirements that apply to all plants that
manufacture, process, pack, or hold animal food (and thus are required
to register as food facilities in accordance with Sec.  415 of the FD&C
Act). Using testing procedures, where necessary, to identify sanitation
failures or to identify contaminated animal food may be an important
component of manufacturing, processing, packing, or holding animal
food. This type of testing may be independent of the requirements of
subpart C, hazard analysis and risk based preventive controls, and
therefore we have included it in the CGMP regulations. The provision
provides flexibility for management to determine when testing is
required by providing that testing be used ``where necessary.''

H. Proposed Sec.  507.25(a)(8)--Contaminated Product (Final Sec.
507.25(a)(7))

    We proposed that plant management must ensure that animal food that
has become contaminated to the extent that it is adulterated is
rejected, disposed of, or if permissible, treated or processed to
eliminate the adulteration. If disposed of, it must be done in a manner
that protects against the contamination of other animal food. Whatever
methods are used to dispose of adulterated animal food, the methods
should comply with state and local requirements.
    (Comment 206) One comment requests that if we require
reconditioning of an animal found to be adulterated, that we clarify
that such a requirement does not apply to grains subject to the review
inspection provisions provided for by 7 CFR 800.125 and 800.135.
    (Response 206) In most cases, grains subject to the review
inspection provisions provided for by 7 CFR 800.125 and 800.135 are
RACs that are being held or transported and subpart B (including Sec.
507.25(a)(7)) would not apply to the grains (see Sec.  507.5(h)). In
addition this provision only applies to animal food that has actually
been found to be adulterated. The provisions provided for by 7 CFR
800.125 and 800.135 are administered by USDA's Federal Grain Inspection
Service and relate to their mission of facilitating the marketing of
grains and related commodities.

I. Proposed Sec.  507.25(a)(9)--Protecting Against Contamination (Final
Sec.  507.25(a)(8))

    We proposed that plant management must ensure that all animal food
manufacturing, processing, packing, and holding is conducted under such
conditions and controls as are necessary to minimize the potential for
the growth of undesirable microorganisms or for the contamination of
animal food.
    (Comment 207) Some comments suggest that we remove the requirement
to minimize the potential for the growth of undesirable microorganisms,
so that the requirement would be to minimize contamination of animal
food or protecting against adulteration of animal food.
    (Response 207) We decline this request. In addition to other
contaminants, we conclude that it is important for an establishment to
address undesirable microorganisms because they are a common source of
contamination (78 FR 64736 at 64747).

J. Proposed Sec.  507.25(b)(1)--Raw Materials and Ingredients

    We proposed that raw materials and ingredients must be inspected to
ensure that they are suitable for manufacturing/processing into animal
food and handled under conditions that protect against contamination
and minimize deterioration. We are revising the phrase ``raw materials
and ingredients'' to read ``raw materials and other ingredients'' to
make it clear that raw materials are ingredients.
    (Comment 208) Some comments ask that we insert ``as appropriate and
necessary'' into the requirement to inspect raw materials and
ingredients to ensure that they are suitable for manufacturing/
processing into animal food. Another comment says that ``minimize
deterioration'' and ``deterioration'' are highly subjective and should
be deleted.
    (Response 208) We decline the requests. However, we have revised
the regulatory text by replacing ``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. We believe such an examination is necessary to
protect against contamination of animal food. An examination of raw
materials and other ingredients may include basic activities such as a
simple visual examination of the product (e.g., looking for broken
bags), or performing a chemical or microbial analysis. Deterioration of
animal food includes the loss of palatability or nutritive value
typically associated with the animal food and we believe this could be
a safety concern because animals are often fed the same food containing
the same ingredients for prolonged periods of time. As a result, food
refusal or consumption of animal food containing fewer nutrients than
the animal food is expected to provide may result in poor animal
productivity or health issues. Furthermore, deterioration can indicate
that the animal food has been held under conditions that would also
support the growth of undesirable microorganisms.

K. Proposed Sec.  507.25(b)(1)(i)--Shipping Containers

    We proposed that shipping containers (for example, totes, drums,
and tubs) and bulk vehicles holding raw materials and other ingredients
must be inspected upon receipt to determine whether contamination or
deterioration of animal food has occurred.
    (Comment 209) Some comments say that inspection of shipping
containers should be as appropriate and necessary, or at a frequency
appropriate and necessary.
    (Response 209) We decline this request. We have revised the
regulatory text by replacing ``inspected'' with ``examined.'' We
believe this change better conveys our intent that incoming containers
consistently be checked to make sure there is no gross visible
contamination or deterioration of animal food.

L. Proposed Sec.  507.25(b)(1)(ii)--Raw Materials

    We proposed that raw materials must be cleaned as necessary to
minimize soil or other contamination.
    (Comment 210) Many comments say that it is not always necessary to
minimize soil contamination of raw materials because livestock
routinely ingest soil when consuming pasture plants, hay, and other
feeds without adverse consequences. Recommendations are to delete
reference to soil or else insert ``as appropriate.''
    (Response 210) We agree. We have revised the regulatory text to
remove the words ``soil or other'' from the requirement.

M. Proposed Sec.  507.25(b)(1)(iii)--Raw Materials

    We proposed that raw materials and ingredients must be stored under
conditions that will protect against contamination and deterioration.
    (Comment 211) One comment suggests that the requirement that raw
materials be stored under conditions that will protect against
contamination and deterioration be qualified to say ``unreasonable
contamination'' and ``excessive deterioration'' to be more appropriate
for raw materials that will be rendered. One comment asks that we
delete ``and deterioration.'' Another comment suggests that a new
section be added to require that air flow be controlled so that
contamination does not spread from the raw material areas into the
finished product areas of the plant.
    (Response 211) We believe the rule as proposed is clear, and that
the qualifiers suggested do not help reduce subjectivity and may create
confusion about what is considered unreasonable or excessive. We
decline to add a requirement that specifically addresses air flow,
because ventilation is addressed in Sec.  507.17(b)(3). Also, the broad
language requires that raw materials and other ingredients must be
stored under conditions that will protect against contamination, which
would include protection from airborne contaminants. We have
determined, however, that it is logical from a food safety standpoint
to include rework in this provision. Therefore, we have incorporated
proposed Sec.  507.25(b)(3) into this requirement.

N. Proposed Sec.  507.25(b)(2)--Raw Materials Susceptible to Mycotoxins

    We proposed that raw materials and ingredients susceptible to
contamination with mycotoxins or other natural toxins must be evaluated
and used in a manner that does not result in animal food that can cause
injury or illness to animals or humans.
    (Comment 212) Several comments suggest that we eliminate this
requirement because this activity belongs in subpart C, not subpart B.
Other comments say that the requirement could be interpreted to mean
that every load of incoming cereal grains must be evaluated for
mycotoxins, which would not always be necessary. Other suggestions are
to remove ``evaluated'' from the requirement, leaving only the
requirement that raw materials and ingredients susceptible to mycotoxin
contamination be used in a manner that does not result in harm to
humans or animals.
    (Response 212) We are locating requirements that are common to most
establishments and plants and serve as a baseline for animal food
safety in subpart B, current good manufacturing practice. Also, we do
not intend that every load of grain received must be tested before it
can be used. We intend for ``evaluation'' to be broad and flexible
enough to consider any information that allows the plant to use the raw
materials and other ingredients in a manner that does not result in
harm to humans or animals. For example, an evaluation could be based on
a general review of the weather conditions during the growing season
and whether it could result in mycotoxins.
    (Comment 213) One comment disagrees with our decision in the 2014
supplemental proposed rule to remove a requirement in Sec.
507.25(b)(2) of the 2013 proposed rule for preventive controls for
animal food that raw materials and ingredients not contain
microorganisms injurious to human or animal health. This comment says
that we should have modified the regulatory text to require that raw
materials that are expected to contain levels of microorganisms that
may be injurious to animal or human health, such as materials to be
rendered, be stored and handled in a way that prevents contaminating
the facility and finished product, and that the materials be treated
(e.g., heat treated) during manufacturing operations so that they no
longer contain levels that would cause the product to be adulterated.
    (Response 213) Incoming raw materials and other ingredients may
contain microorganisms injurious to human or animal health. As we
stated in the 2014 supplemental notice for animal food, we proposed to
remove this requirement because we did not intend that incoming raw
materials and other ingredients must be tested for pathogens. Instead,
we have included requirements that are meant to minimize the growth of
undesirable microorganisms, and protect animal food from the
contamination with undesirable microorganisms from raw materials and
other ingredients, including those that may be injurious to human or
animal health. We believe these requirements are sufficient to help
ensure the safety of animal food.

O. Proposed Sec.  507.25(b)(3)--Raw Materials and Rework (Final Sec.
507.25(b)(1)(iii))

    We proposed that raw materials and ingredients and all rework must
be held in containers designed and constructed in a way that protects
against contamination, and must be held under conditions, e.g.,
appropriate temperature and relative humidity, that will minimize the
potential for growth of undesirable microorganisms and in a manner that
prevents the animal food from becoming adulterated.
    (Comment 214) Some comments say that requiring that rework be held
under conditions that will minimize the potential for growth of
undesirable microorganisms is too prescriptive, and suggest that the
requirement be modified to require that all rework must be held in a
manner that prevents the animal food from becoming adulterated. Some
comments say that this requirement should be addressed in subpart C
rather than subpart B.
    (Response 214).We disagree that the requirement should be addressed
in subpart C instead of subpart B because we consider this to be a
baseline requirement that should apply to all establishments that
manufacture, process, pack, or hold animal food. However, we have
decided that proposed paragraph (b)(3) contains requirements that are
similar to proposed Sec.  507.25(b)(1)(iii). We have moved this
provision and included it in paragraph (b)(1)(iii) in the final rule.

P. Proposed Sec.  507.25(b)(4)--Frozen Raw Materials (Final Sec.
507.25(b)(3))

    We proposed that raw materials and ingredients, if frozen, must be
kept frozen. If thawing is required prior to use, it must be done in a
manner that minimizes the potential for the growth of undesirable
microorganisms.
    (Comment 215) One comment says that the requirement to keep frozen
raw materials frozen or thaw them in a manner that minimizes the
potential for the growth of undesirable microorganisms is redundant to
other requirements in Sec.  507.25(b)(1) and therefore should be
deleted.

    (Response 215) We decline this request. The requirements in Sec.
507.25(b)(1) and 507.25(b)(1)(iii) address raw material and other
ingredient inspection, storage and handling in general. This
requirement speaks specifically to the storage and handling of frozen
raw materials. We believe it is important for those establishments that
use frozen raw material to thaw that material safely to minimize the
potential for the growth of undesirable microorganisms during the
thawing process.

Q. Proposed Sec.  507.25(c)(1)--Appropriate Conditions for Animal Food

    We proposed that animal food must be maintained under conditions,
e.g., appropriate temperature and relative humidity, that will minimize
the potential for growth of undesirable microorganisms and prevent the
animal food from becoming adulterated during manufacturing, processing,
packing, and holding.
    (Comment 216) Some comments say that the requirement to hold and
manufacture products at a temperatures and relative humidity that will
minimize the potential for growth of undesirable microorganisms should
be deleted because it is not relevant to most animal food facilities.
With this deletion, the requirement would be that animal food be
maintained under conditions that would prevent the animal food from
becoming adulterated during manufacturing, processing, packing, and
holding.
    (Response 216) Temperature and relative humidity are examples of
conditions and may not apply to all plants and animal food. This
requirement is important for animal food safety in plants that produce
animal food that must be handled under specific processing, packing or
holding conditions to prevent the growth of undesirable microorganisms
and adulteration.

R. Proposed Sec.  507.25(c)(2)--Control of Undesirable Microorganisms

    We proposed that measures taken during manufacturing, processing,
packing, and holding of animal food to significantly minimize or
prevent the growth of undesirable microorganisms (for example, heat
treating, freezing, refrigerating, irradiating, controlling pH, or
controlling aw) must be adequate to prevent adulteration of
animal food.
    (Comment 217) Most of the comments say that measures to
significantly minimize or prevent the growth of undesirable
microorganisms should be addressed under subpart C, and that this
requirement should be removed from the CGMPs. One comment recommends
deleting only the examples of measures that might be taken. Another
comment recommends deleting the term ``significantly'' as this term is
not defined and is difficult to quantify.
    (Response 217) We disagree that the requirement should be addressed
in subpart C instead of subpart B. We consider controlling undesirable
microorganisms to be a baseline requirement that should apply to all
establishments that manufacture, process, pack, or hold animal food. We
also decline the request to remove the examples of measures that can be
used to significantly minimize or prevent the growth of undesirable
microorganisms because they are examples of practical solutions already
used by industry. We decline to delete the term ``significantly.'' The
term ``significantly minimize'' is defined in Sec.  507.3 and means to
reduce to an acceptable level, including to eliminate.

S. Proposed Sec.  507.25(c)(3)--Work-in-Process and Rework

    We proposed that work-in-process and rework must be handled in such
a way that it is protected against contamination and the growth of
undesirable microorganisms.
    (Comment 218) Some comments request that we delete ``and the growth
of undesirable microorganisms'' and require only that work-in-process
and rework be handled in such a way that it is protected against
adulteration.
    (Response 218) We decline this request. Because undesirable
microorganisms are a common source of contamination of animal food,
including work-in-process and rework, we have decided to specify that
establishments must protect against the growth of undesirable
microorganisms, as well as other contamination.

T. Proposed Sec.  507.25(c)(4)--Processing Steps

    We proposed that steps such as cutting, drying, defatting,
grinding, mixing, extruding, pelleting, and cooling, must be performed
in a way that protects against the contamination of animal food.
    (Comment 219) One comment suggests that we revise the requirement
to say that steps be performed in a way that protects against animal
food adulteration rather than protects against animal food
contamination. Another comment suggests that the requirement be deleted
because it is redundant to other requirements in the proposed rule.
    (Response 219) As discussed in Response 167, we believe
contamination is the better word to use in this context. These specific
requirements provide a level of detail that we believe is important
because these activities are common in the animal food industry and can
contribute to the contamination of animal food. We believe that this
requirement for these activities is not redundant to other requirements
in this final rule.

U. Proposed Sec.  507.25(c)(5)--Processing Operations

    We proposed that filling, assembling, packaging, and other
operations must be performed in such a way that protects against the
contamination of animal food and the growth of undesirable
microorganisms.
    (Comment 220) One comment requests that we delete ``and the growth
of undesirable microorganisms'' and require only that operations be
performed in such a way that the animal food is protected against
adulteration. Another comment suggests that the requirement be deleted
because it is redundant, but does not identify the redundant section.
    (Response 220) As discussed in Response 167, we believe
contamination is the better word to use in this context. These specific
requirements, including the requirement for the protection against the
growth of undesirable microorganisms, provide a level of detail that we
believe is important because these activities are common in the animal
food industry and can contribute to the contamination of animal food.
We believe that these requirements for these activities are not
redundant with other requirements in this final rule.

V. Proposed Sec.  507.25(c)(6)--Controlling Water Activity
(aw)

    We proposed that animal food that relies on the control of water
activity for preventing the growth of undesirable microorganisms must
be processed to and maintained at a safe moisture level.
    (Comment 221) Some comments request that we delete the requirement
because controlling water activity belongs in subpart C, not in the
CGMP regulations. Another comment says that controlling moisture level
is not sufficient and the requirement should be revised to require that
animal food that relies on the control of water activity for preventing
the growth of undesirable microorganisms be processed to and maintained
at a suitable water activity, not a safe moisture level. We also
received comments asserting that water activity may not be the only
factor responsible for preventing the growth of undesirable

microorganisms in dry products and that we should modify the regulatory
text to take into account other synergistic barriers for microbial
growth and toxin formation.
    (Response 221) We disagree that controlling water activity belongs
in subpart C. While not all animal food establishments rely on the
control of water activity for preventing the growth of undesirable
microorganisms in their animal food, we have determined it is important
to have this requirement in CGMP regulations for those establishments
that do, considering the potential public health significance of
undesirable microorganisms. We agree that the term ``safe water
activity level'' is more commonly understood by the animal food
industry than ``safe moisture level'' and we have revised the
regulatory text accordingly. We agree with the comment that water
activity may not be the only factor responsible for preventing growth
of undesirable microorganisms in certain animal food and have revised
the regulatory text to clarify that such products rely ``principally''
on the control of water activity.

W. Proposed Sec.  507.25(c)(7)--Controlling pH

    We proposed that animal food that relies principally on the control
of pH for preventing the growth of undesirable microorganisms must be
monitored and maintained at the appropriate pH.
    (Comment 222) Some comments request that we delete this proposed
requirement because controlling pH belongs in subpart C, not in subpart
B. One comment also says that it is too prescriptive and duplicative of
protections against adulteration in other proposed sections of subpart
B.
    (Response 222) We decline the request. While not all animal food
establishments principally rely on the control of pH for preventing the
growth of undesirable microorganisms in their animal food, we have
determined it is important to have this requirement in the CGMP
regulations for those establishments that do, considering the potential
public health significance of undesirable microorganisms.

X. Proposed Sec.  507.25(c)(8)--Ice

    We proposed that when ice is used in contact with animal food, it
must be made from water that is safe and must be used only if it has
been manufactured in accordance with current good manufacturing
practice as outlined in this subpart.
    (Comment 223) One comment suggests that this requirement be deleted
because ice is rarely used in the manufacturing/processing of animal
food.
    (Response 223) We decline this request. We have established this
requirement to help ensure that when ice is used for the manufacture of
animal food, the ice is made from water that is safe so that it does
not contaminate the animal food it contacts.

XXI. Subpart B: Comments on Proposed Sec.  507.27--Holding and
Distribution

A. Proposed Sec.  507.27(a)--Holding and Distribution

    We proposed that animal food held for distribution must be held
under conditions that will protect against contamination and minimize
deterioration.
    (Comment 224) A few comments request that we remove ``minimize
deterioration'' from this requirement. These comments say that although
deterioration may lead to animals refusing food, an animal's refusal of
food does not necessarily mean that the food has deteriorated. The
comments suggest that we instead use the phrase ``ensure product
integrity throughout the intended shelf life,'' or that we clarify the
definition of deterioration if we do not remove it.
    (Response 224) We decline this request. We believe it is important
that animal food be held and distributed in manner that does not lead
to deterioration. Deterioration of animal food includes the loss of
palatability or nutritive value typically associated with the animal
food and we believe this could be a safety concern because animals are
often fed the same food containing the same ingredients for prolonged
periods of time. As a result, food refusal or consumption of animal
food containing fewer nutrients than the animal food is expected to
provide may result in poor animal productivity or health issues.
Furthermore, deterioration can indicate that the animal food has been
held under conditions that would also support the growth of undesirable
microorganisms.

B. Proposed Sec.  507.27(a)(1)--Containers

    We proposed that containers used for holding animal food for
distribution must be designed, constructed of appropriate material,
cleaned, and maintained to prevent contamination of animal food.
    (Comment 225) A few comments request that the terms ``designed''
and ``constructed of appropriate material,'' which may have different
interpretations, be replaced by ``fit for purpose'' a term recognized
by the animal food industry.
    (Response 225) We decline the request. We believe the terms
``designed'' and ``constructed of appropriate material'' are well
understood by the animal food industry and ``fit for purpose'' does not
improve clarity.
    (Comment 226) A few comments note containers used to hold animal
food may include bins, totes or other intermediate storage containers,
each of which may require differing levels and frequency of cleaning.
Some of these comments ask that we add the phrase ``where necessary''
when discussing cleaning to provide flexibility.
    (Response 226) We agree that containers used to hold animal food
will require different cleaning methods and frequency of cleaning.
These differences may result from the types of containers used, the
amount and type of animal food held, the frequency at which containers
are reused, as well as other factors. As a result, we agree that it is
appropriate to include language that indicates that different methods
and frequencies of cleaning may be appropriate to protect against
contamination of the animal food and we have revised the regulatory
text to add ``as necessary'' after cleaned.

C. Proposed Sec.  507.27(a)(2)--Protection From Contamination

    We proposed that animal food held for distribution must be held in
a way that prevents contamination from sources such as trash and
garbage.
    (Comment 227) A few comments request that the phrase ``from sources
such as trash and garbage'' be deleted. A few comments request that the
term ``garbage'' not be used because some products that may be
considered garbage may actually be suitable for use as animal food.
Some of these comments suggested alternative language.
    (Response 227) We agree in part with this comment. The mistaken
inclusion of trash or garbage into animal food could be a potential
source of contamination. The terms ``trash'' and ``garbage'' are
intended in their general sense and refer to items that are not
suitable for animal food, or are not intended for animal food. However,
under the Swine Health Protection Act, ``garbage'' as defined by the
act is prohibited for use as food for swine, unless it is treated to
kill disease organisms. For this reason, and because the terms can be
considered synonyms, we are removing the term ``garbage'' throughout
subpart B to avoid confusion.

D. Proposed Sec.  507.27(a)(3)--Labeling of Animal Food Held for
Distribution (Final Sec.  507.27(b))

    We proposed that labeling identifying the product by the common or
usual name must be affixed to or accompany the animal food.
    (Comment 228) Some comments support the labeling requirement
because accurate identification of animal food throughout the
distribution chain is an important food safety step and loss of
identity can have serious animal and human health implications. One
comment suggests that this requirement be revised to specify that the
proposed labeling be required during holding and distribution of both
packaged animal food and bulk animal food. One comment says that FDA's
primary interest should be identification, not labeling, because
labeling for animal food being held for distribution in bulk is
impractical. The comment also notes that plants may use a central
computer system or other method to identify animal food location. A few
comments suggest that we should require that animal food held for
distribution be labeled as required by regulations for finished
products.
    (Response 228) We agree that animal food may be identified in the
plant through methods other than labeling. We expect that while animal
food is being processed in the plant that the animal food is accurately
identified as required in Sec.  507.25(a)(2) of this final rule.
    We have moved the requirement that labeling must include
information and instructions for safely using the animal food product
for the intended animal species from proposed Sec.  507.25(a)(3)
``Plant operations'' in the 2014 supplemental proposed rule to Sec.
507.27(b) of ``Holding and distribution'' to clarify that this labeling
information must be included when the product is ready for
distribution. We think that placing the labeling requirements for
animal food products ready for distribution under ``Holding and
distribution'' will help reduce confusion and make these requirements
for labeling for distribution easier to find in the final rule.