Other comments ask us to specify that a receiving facility need not
establish and implement a supplier program for raw materials and
ingredients intended for further processing.
    Some comments assert that the presence of low levels of pathogens
on a raw product that will be subject to a lethal process further
downstream does not pose a risk to the consumer, and should not be
considered a significant hazard (i.e., a hazard requiring a preventive
control). These comments also assert that if we maintain that
Salmonella contamination is a significant hazard for each member of the
supply chain, then we should allow the preventive control to be applied
in a subsequent step at another facility. Other comments ask us to
clarify that a facility would not need to develop preventive controls
where it produces raw materials or ingredients that are subject to
subsequent processing that will address known or reasonably foreseeable
hazards.
    (Response 285) We are establishing several provisions, specifically
applicable to the distribution chain of a manufacturer/processor, for
circumstances when a manufacturer/processor does not need to implement
a preventive control (Sec. Sec.  507.36(a)(2), (3), (4), and (5);
507.36(b)(2), (3), (4) and (5); 507.36(c); 507.36(c) and (d), 507.37;
and 507.215). See Response 284 for another new provision that applies
to the supply chain in addition to the distribution chain (Sec.
507.36(a)(1)).
    Under the first of these provisions (Sec.  507.36(a)(2)), a
manufacturer/processor is not required to implement a preventive
control if it relies on its customer (who is subject to the
requirements for hazard analysis and risk-based preventive controls in
subpart C) to ensure that the identified hazard will be significantly
minimized or prevented and: (1) Discloses in documents accompanying the
animal food, in accordance with the practice of the trade, that the
animal food is ``not processed to control [identified hazard]''; and
(2) annually obtains from its customer written assurance, subject to
the requirements of Sec.  507.37, that the customer has established and
is following procedures (identified in the written assurance) that will
significantly minimize or prevent the hazard. The manufacturer/
processor would include the specific hazard requiring a preventive
control (e.g., Salmonella) where the statement says ``[identified
hazard].'' A facility that provides the written assurance must act
consistently with the assurance and document its actions taken to
satisfy the written assurance (see new Sec.  507.37). The documents
could be bills of lading or other papers that accompany the animal food
or labels on the containers of the animal food.
    Under the second of these provisions, (Sec.  507.36(a)(3)), a
manufacturer/processor is not required to implement a preventive
control if it relies on its customer (who is not subject to the
requirements for hazard analysis and risk-based preventive controls in
subpart C), to provide assurance it is manufacturing, processing, or
preparing the animal food in accordance with applicable animal food
safety requirements and it: (1) Discloses in documents accompanying the
animal food, in accordance with the practice of the trade, that the
animal food is ``not processed to control [identified hazard]''; and
(2) annually obtains from its customer written assurance that it is
manufacturing, processing, or preparing the animal food in accordance
with applicable animal food safety requirements. By ``customer who is
not required to implement preventive controls under this part'' we mean
entities such as qualified facilities and retail food establishments.
    Under the third of these provisions (Sec.  507.36(a)(4)), a
manufacturer/processor is not required to implement a preventive
control if it relies on its customer to provide assurance that the
animal food will be processed to control the identified hazard by an
entity in the distribution chain subsequent to the customer and: (1)
Discloses in documents accompanying the animal food, in accordance with
the practice of the trade, that the animal food is ``not processed to
control [identified hazard]''; and (2) annually obtains from its
customer written assurance, subject to the requirements of Sec.
507.37, that the customer will disclose in documents accompanying the
animal food, in accordance with the practice of the trade, that the
animal food is ``not processed to control [identified hazard]''. The
manufacturer/processor also must obtain written assurance that its
customer will only sell to another entity that agrees, in writing, it
will either: (1) Follow procedures (identified in a written assurance)
that will significantly minimize or prevent the hazard (if the entity
is subject to the requirements for hazard analysis and risk-based
preventive controls in subpart C), or manufacture, process, or prepare
the animal food in accordance with applicable animal food safety
requirements (if the entity is not subject to the requirements for
hazard analysis and risk-based preventive controls in subpart C) or (2)
obtain a similar written assurance from the entity's customer.
    Under the fourth of these provisions (Sec.  507.36(a)(5)), a
manufacturer/processor is not required to implement a preventive
control if it has established, documented, and implemented a system
that ensures control, at a subsequent distribution step, of the hazards
in the animal food product it distributes and documents the
implementation of that system. Comments did not provide examples of
such a system, but we do not want to preclude the development of such
systems.
    We have added several other requirements related to the four new
provisions that we are specifically establishing as circumstances in
which a manufacturer/processor need not implement a preventive control.
As already noted in this response, new Sec.  507.37 requires that a
facility that provides a written assurance must act consistently with
the assurance and document its actions taken to satisfy the written
assurance. In addition, new Sec.  507.36(b)(2), (3), (4), and (5)
specify the records that a manufacturer/processor would need to satisfy
the documentation requirements established in new Sec.  507.36(a)(2),
(3), (4) and (5), and new Sec.  507.215 establishes requirements
applicable to the written assurance between a manufacturer/processor
and its customer. Taken together, the provisions of Sec. Sec.  507.37
and 507.215 establish legal responsibilities for a facility that
provides a written assurance under Sec.  507.36(a)(2), (3) or

(4), even if that facility is not a manufacturer/processor.
    The point of these provisions is to ensure that hazards that a
manufacturer/processor has determined, through its hazard analysis,
require a preventive control, but are not controlled in the supply
chain before the manufacturer/processor or by the manufacturer/
processor itself, are in fact controlled by a subsequent entity in the
distribution chain. With the assurance from the manufacturer/
processor's customer that the hazards will be controlled after the
animal food product leaves the manufacturer/processor it is not
necessary for the first manufacturer/processor to implement the
applicable preventive control. We continue to believe that annual
written assurance from a manufacturer/processor's direct customer is an
appropriate mechanism to ensure that its customer is aware of the
identified hazard and is taking steps to ensure that the animal food is
processed to control the identified hazard. We do not believe that a
manufacturers/processor will need all of the details of its customer's
process to satisfy the requirement to state in writing the procedures
the customer has established and is following to control the hazard.
For example, the customer could merely state that its manufacturing
processes include a lethality step for microbial pathogens of concern.
    We agree that it is appropriate to require that the manufacturer/
processor provide documentation to its customer indicating that the
animal food must be processed to control an identified hazard. Such
documentation will be a means of clear communication from the
manufacturer/processor to its customer. When the hazard will not be
controlled by the customer, the customer will still have documentation
that can be passed on to the entity that is expected to process the
animal food to control the identified hazard, so that it will be very
clear to that entity that the identified hazard still needs to be
controlled.
    We understand that not all identified hazards in an animal food
will be a hazard to all species of animals. For example, we consider
all serotypes of Salmonella to be a hazard for dog and cat food.
However, we would not consider Salmonella Heidelberg a hazard in food
for cattle. Therefore, we have added provisions to allow this
determination to be included in the customer's written assurance
regarding an identified hazard so that the customer will not be
required to assure it is controlling a hazard that it has determined
does not need to be controlled for a specific animal species.
    For the written assurance required by Sec.  507.36(a)(2)(ii), new
paragraph (c) of this section provides that if the customer has
determined that the identified hazard is not a hazard in the animal
food intended for use for a specific animal species, the customer's
written assurance may provide this determination (including animal
species and why the identified hazard is not a hazard) instead of
providing assurance of procedures established and followed that will
significantly minimize or prevent the identified hazard.
    For the written assurance required by Sec.  507.36(a)(4)(ii)(B),
new paragraph (d) of this section provides that if the entity in the
distribution chain subsequent to the customer is subject to subpart C
and has determined that the identified hazard is not a hazard in the
animal food intended for use for a specific animal species, that
entity's written assurance may provide this determination (including
animal species and why the identified hazard is not a hazard) in its
written assurance instead of providing assurance that the identified
hazard will be significantly minimized or prevented.
    (Comment 286) Some comments that ask us to delete the proposed
requirement to maintain the written assurance as a record. Other
comments ask us to revise the regulatory text of the documentation
requirement to focus on documentation that (1) the receiving facility
has notified its customers of the existence of actual or potential
hazards in animal food provided to them by the receiving facility; or
(2) the receiving facility has notified its customers of the existence
of actual or potential hazards in animal food provided to them by the
receiving facility and has received a written assurance that the
customer will evaluate the hazard and, if necessary, will follow
procedures to significantly minimize or prevent the hazard.
    (Response 286) We decline this request. As already discussed in
this section, it is the combination of requirements (i.e., for
documentation that the animal food is ``not processed to control
[identified hazard]''; assurance from customers regarding appropriate
procedures to ensure that the animal food will receive further
processing to control the identified hazards; and provisions relating
to accountability for written assurances) that will provide adequate
assurance that the animal food will be processed to control the
identified hazard before it reaches consumers. Records documenting the
written assurances are a key component of the provisions.

XXVIII. Subpart C: Comments on Proposed Sec.  507.38--Recall Plan

    We proposed that you must establish a written recall plan for
animal food with a significant hazard and that the recall plan must
include certain procedures. Some comments support the proposed
requirements without change. For example, some comments express the
view that a written recall plan is critical in the event of a system
breakdown where adulterated animal foods have been distributed. Some
comments that support the proposed requirements suggest alternative or
additional regulatory text or other changes.
    In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we are finalizing the requirements as proposed with the
conforming revision to use the term ``hazard requiring a preventive
control'' rather than ``significant hazard.'' See Response 62 and table
31. As discussed in section XXVII, we are establishing a provision
applying to certain assurances in Sec.  507.37.

A. Proposed Sec.  507.38(a)--Requirement for a Written Recall Plan

    We proposed that you must establish a written recall plan for
animal food with a significant hazard.
    (Comment 287) Some comments ask us to require a written recall plan
for all animal food (rather than just for animal food with a
significant hazard) and to establish the requirements for a written
recall plan as CGMP requirements in subpart B rather than as part of
the requirements for hazard analysis and risk-based preventive controls
in subpart C. These comments assert that all products can be subject to
a recall. These comments contrast recall plans with other preventive
controls in that recall plans are often specific to a firm or facility,
but rarely are specific to particular animal foods. In addition, these
comments note that a recall may be administered and managed at the
corporate office rather than at the specific manufacturing facility
that produced the animal food.
    Some comments note the requirements for a written recall plan are
sufficiently different from other provisions in subpart C that we
proposed to specify that the recall plan would not be subject to the
preventive control management requirements for monitoring, corrective
actions, and verification (see Sec.  507.39(c)). Other

comments assert that a recall plan is not a preventive control because
it deals with products after they have been produced. Some comments
note that facilities that are exempt from the requirements of subpart
C, but remain subject to the CGMP requirements, would not be required
to have a recall plan unless we establish the requirements in subpart
B. Other comments note that the requirement for a recall plan is only
if there is a hazard that requires a preventive control, but assert
that a recall should only be initiated if a hazard has actually been
identified to be present in the product.
    Some comments note that our authority to require recall plans is
not limited to section 418 of the FD&C Act and that we can use other
legal authority to impose a requirement for recall plans in subpart B.
Some comments note that FSMA specifically amended the FD&C Act to
provide us with the authority to mandate a food recall (section 423 of
the FD&C Act). These comments assert that it would be reasonable for us
to conclude that in order to efficiently carry out section 423 of the
FD&C Act we should issue requirements governing the conduct of recalls,
because section 423 of the FD&C Act requires that we provide a firm
with an opportunity to voluntarily recall a product before issuing an
order to the firm to cease distribution and recall a product.
    (Response 287) We decline the request to establish requirements for
a written recall plan as a CGMP requirement in subpart B and are
establishing the requirements as a preventive control in subpart C as
proposed. We acknowledge that a recall plan would be useful to all
animal food establishments, and we encourage all animal food
establishments to have a recall plan. However, the report issued by the
human food CGMP Modernization Working Group did not identify the lack
of a written recall plan as something that needed to be changed (Ref.
41). (See 78 FR 3646 at 3651, the proposed rule for preventive controls
for human food, for a discussion of the CGMP Modernization Working
Group and the process leading to its report.) However, going forward we
intend to monitor whether the lack of a broader requirement for a
recall plan leads to problems when animal food establishments that are
not subject to the requirements of subpart C are faced with recall
situations. As we gain experience with the impact of the new
requirement for a recall plan on those facilities subject to subpart C,
we can reassess at a later date whether to conduct rulemaking to
broaden the requirement to apply to all animal food establishments
subject to the CGMP requirements in subpart B. For now, animal food
establishments that are not subject to subpart C can continue to follow
our longstanding recall policy in part 7 (21 CFR part 7).
    Consistent with the overall framework of FSMA, a recall plan (like
other preventive controls) is only required when the facility has
identified a hazard requiring a preventive control. A facility could
establish a recall plan that applies to other animal foods it
manufactures. We recognize that recalls may be managed by the corporate
office of a firm rather than at the specific manufacturing facility
that produced the animal food. Nothing in the rule precludes this
approach. In such cases the corporate recall policy would be reflected
in a facility's recall plan. (See also Response 239.) In addition, a
facility that identifies one or more hazards requiring a preventive
control in multiple animal food products could use the same recall plan
for all applicable animal food products.
    The rule specifies that the requirements for preventive control
management components (i.e., monitoring, corrective actions and
corrections, and verification) apply as appropriate to ensure the
effectiveness of the preventive control, taking into account the nature
of the preventive control (Sec.  507.39(a)). As previously discussed,
the preventive control management components are directed at animal
food that remains at the facility, whereas the recall plan addresses
animal food that has left the facility (78 FR 64736 at 64788). Our
determination that the nature of the recall plan does not require these
preventive control management components demonstrates the flexibility
provided by FSMA and this rule, not that the recall plan must be
considered a CGMP rather than a preventive control.
    We have not yet made a determination of whether we should issue
requirements governing the conduct of recalls, rather than rely on the
guidelines in part 7, in order to fully implement section 423 of the
FD&C Act. However, we have issued a draft guidance entitled ``Draft
Guidance for Industry: Questions and Answers Regarding Mandatory Food
Recalls'' which, when finalized, would address topics such as the
criteria for a mandatory recall and the process that FDA must follow
for a mandatory recall (Ref. 42).
    (Comment 288) Some comments ask us to cross-reference the
provisions of part 7 (21 CFR part 7) rather than establish requirements
that these comments assert would be duplicative with the provisions of
part 7. These comments ask us to address any more substantive
requirements than are already in part 7 as part of a review of part 7.
These comments assert that part 507 should require a written recall
plan, but not require a written recall plan for the animal food, to be
consistent with the approach of part 7.
    (Response 288) We decline these requests. Part 7 addresses
enforcement policy and the provisions for recalls in subpart C of part
7 are ``Guidance on Policy, Procedures, and Industry
Responsibilities.'' These recall provisions do not establish
requirements and are not binding on industry. They also are broadly
directed to recalls for all FDA-regulated products, not just food. As
already discussed in Response 284, nothing in this rule would prevent a
facility that establishes a recall plan for a particular animal food
from using that recall plan for any animal food product that the
facility decides to recall.
    (Comment 289) Some comments request that we have separate recall
program requirements for human food by-products so that by-products
produced during the manufacture of food and sold, or otherwise
provided, for use in animal food would not be recalled if the product
for people is recalled. Other comments assert we will need to define
the criteria for an animal food recall in guidance.
    (Response 289) We decline the request to have separate recall
program requirements for human food by-products for use as animal food.
Whether or not the by-product of a human food that is recalled should
itself be recalled may depend on assessment of several factors such as
what the hazard is, whether the hazard for which the human food is
recalled is also a hazard for the animal(s) that consume the by-
product, and where the hazard occurred in the manufacturing process. We
have previously addressed the request for guidance. (See Response 1.)

B. Proposed Sec.  507.38(b)--Procedures That Describe the Steps To Be
Taken, and Assign Responsibility for Taking Those Steps

    We proposed that the recall plan must include procedures that
describe the steps to be taken, and assign responsibility for taking
those steps, to perform the following actions as appropriate to the
facility: (1) Directly notify the direct consignees of the animal food
being recalled, including how to return or dispose of the affected
animal food; (2) notify the public about any hazard presented by the
animal

food when appropriate to protect human or animal health; (3) conduct
effectiveness checks to verify that the recall is carried out; and (4)
appropriately dispose of recalled animal food (e.g., through
reprocessing, reworking, diverting to another use that would not
present a safety concern, or destroying). We requested comment on
whether: (1) The proposed procedures are appropriate for all types of
facilities; (2) we should require a recall plan to include procedures
and assignment of responsibility for notifying FDA of recalls subject
to the plan; and (3) we should include a requirement for a mock recall
as a verification activity.
    (Comment 290) Some comments ask us to delete the proposed
requirement that the recall plan include procedures for a facility to
notify the public about any hazard presented by the animal food when
appropriate to protect public health. These comments assert that such a
requirement would be highly subjective and create a nebulous regulatory
burden that could subject facilities to unnecessary regulatory
oversight and enforcement actions. Other comments indicate that the
requirement for notifying the public should specifically prevent silent
recalls when manufacturers pull products from store shelves without
consumer notification.
    (Response 290) We decline this request. Our guidance for a recall
strategy has long recommended issuing a public warning to alert the
public that a product being recalled presents a serious hazard to
health in urgent situations where other means for preventing use of the
recalled product appear inadequate (Sec.  7.42(b)(2)). Operationally,
such notification to the public is so common that our current home page
on our Internet site (Ref. 43) gives prominence to recall information
and we have established a free email subscription service for updates
on recalls (Ref. 44). Consistent with the longstanding recall policy in
part 7, subpart C, the proposed requirement qualifies that the
notification to the public is ``when appropriate to protect public
health.'' A market withdrawal of a product (see Sec.  7.3(j)) is not a
recall that would be subject to public notification.
    (Comment 291) Some comments ask us to specify that the procedures
require facilities to notify us about a recall to ensure that all
suppliers, retailers, and consumers will have adequate notification of
the recall action. Other comments agree that it is important for
facilities to involve us in a recall situation as soon as possible, but
assert that the best way to address such a notification is through the
existing RFR system. These comments assert that additional procedures
or means to notify us would involve unnecessary additional steps and be
duplicative, with no improvement to the public health. Some comments
assert that if the recall is issued by a foreign facility, the
responsibility should be with the importer of the product for notifying
FDA. Some comments ask us to specify that the appropriate State
regulatory Agency with inspection jurisdiction be notified in the event
of a recall.
    (Response 291) We agree with comments that it is important to
notify us about a recall and that doing so can help to ensure that
suppliers, retailers, and consumers will have adequate notification of
the recall action. We also agree that the existing procedures to notify
us through the RFR system can accomplish this goal when an animal food
presents a risk of serious adverse health consequences or death and
that it therefore is not necessary to duplicate the notification
procedures already established in the RFR system in part 507. However,
we encourage facilities to include in their recall plan any procedures
they have to comply with the RFR or to include a cross-reference to
those procedures. Doing so may save time, which is critical during a
recall. When the recalled animal food does not present a risk of
serious adverse health consequences or death (and, thus, there is not a
report to the RFR), our guidance entitled ``Guidance for Industry:
Product Recalls, Including Removals and Corrections'' recommends that
recalling firms notify the local FDA District Recall Coordinator as
soon as a decision is made that a recall is appropriate and prior to
the issuance of press or written notification to customers (Ref. 45).
Including this guidance with the facility's recall procedures may also
save time.
    We decline the request to designate that it is solely the importer
of a food manufactured by a foreign facility who must notify FDA if the
food is recalled by the foreign facility. We are not requiring that a
recall plan include procedures and assignments of responsibility for
notifying FDA of recalls subject to the recall plan. Facilities should
refer to our guidance in part 7 entitled ``Guidance for Industry:
Product Recalls, Including Removals and Corrections'' for
recommendations on conducting recalls of food that does not present a
risk of serious adverse health consequences or death, including
notification to FDA (Ref. 45). If the recalled food is a reportable
food (i.e., it does present a reasonable probability that use will
cause serious adverse health consequences or death to humans or
animals), then section 417 of the FD&C Act requires that the
responsible party, as defined in section 417, submit a report to FDA.
    We agree with comments that it is important to notify appropriate
State regulatory Agencies about a recall. We generally request that FDA
District Offices notify State control officials of recalls issued by
animal food manufacturers. Also, State officials with responsibilities
for regulating animal food can access our Web site for ``Animal and
Veterinary Recalls and Withdrawals'' where we post the current and most
recent recalls of animal products, including animal food (Ref. 46). We
note that whatever methods are used to dispose of adulterated animal
food, the methods should comply with State and local requirements.
    (Comment 292) Some comments ask us to add a requirement for mock
recalls on a regular basis, such as biannually. Some of these comments
state that mock recalls would familiarize the staff and communications
network(s) with the recall process and would improve the facility's
capacity to conduct effective and efficient recalls in the event of a
contamination event. Other comments assert that mock recalls would be
the only way to determine the effectiveness of a recall program. Some
comments note that mock recalls would be particularly critical for
manufacturers that have limited experience in actual recalls.
    Some comments acknowledge that a mock recall could be an important
element of a recall plan but recommend that mock recalls remain
voluntary, such as by including mock recalls as an example of how
verification may be accomplished. Other comments note that the current
recall procedures in part 7 do not recommend mock recalls. Some
comments assert that a requirement to include a mock recall as a
verification activity would be an excessive and inappropriate burden;
that any gain in the protection of public health will not offset the
resource requirements to accomplish a mock recall; that resources are
better dedicated to developing a robust plan; and, use of a mock recall
should be addressed in FDA guidance.
    Some comments ask us to clarify the ``metrics'' for a mock recall,
particularly with respect to the consequences of failing to meet an
appropriate metric if a mock recall is conducted as a verification
activity.
    (Response 292) We agree that a mock recall would familiarize the
facility with the recall process, could improve the facility's capacity
to conduct effective

and efficient recalls during a contamination event, may be particularly
helpful for manufacturers that have limited experience in actual
recalls, and could support the development of guidance on best
practices for recalls, and we encourage facilities to conduct one or
more mock recalls to accomplish these goals. However, as previously
discussed, a recall plan would address food that had left the facility,
whereas the proposed requirements for monitoring, corrective actions,
and verification would all be directed at food while it remains at the
facility. Comments are mixed regarding whether the rule should require
a mock recall as a verification activity for the recall plan, and we
have decided to not require a facility to conduct a mock recall as a
verification activity for its recall plan so that the focus of the
monitoring, corrective actions, and verification in the rule remains
focused on food being produced rather than on food that is distributed
in commerce. We acknowledge that requiring mock recalls would go beyond
our longstanding policies established in part 7. A facility that
voluntarily conducts a mock recall would establish metrics appropriate
to its plan and take action (such as modifications to its procedures,
or additional training for its employees) if it is not satisfied with
the results of the mock recall.
    We note that retail companies are not subject to this rule and,
thus, are not subject to the requirement to have a written recall plan.

XXIX. Comments on Proposed Sec.  507.39--Preventive Control Management
Components

    We proposed preventive control management components as appropriate
to ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control. Most of the comments that
support the proposed provisions suggest alternative or additional
regulatory text.
    In the following sections, we discuss comments that disagree with,
or suggest one or more changes to, the proposed requirements. After
considering these comments, we have revised the proposed requirements
as shown in table 13 with editorial and conforming changes as shown in
table 31.

          Table 13--Revisions to the Proposed Requirements for Preventive Control Management Components
----------------------------------------------------------------------------------------------------------------
               Section                       Description                            Revision
----------------------------------------------------------------------------------------------------------------
507.39...............................  Flexible requirements    Provide that preventive control management
                                        for preventive control   components take into account both the nature of
                                        management components.   the preventive control and its role in the
                                                                 facility's food safety system.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  507.39(a)--Flexible Requirements for Monitoring,
Corrective Actions and Corrections, and Verification

    We proposed that, with some exceptions, the preventive controls
would be subject to three preventive control management components as
appropriate to ensure the effectiveness of the preventive controls,
taking into account the nature of the preventive control: Monitoring,
corrective actions and corrections, and verification.
    (Comment 293) Some comments support our proposal to provide
flexibility in the oversight and management of preventive controls,
including the explicit provision that preventive control management
components take into account the nature of the preventive control. Some
of these comments state that the provisions for the preventive control
management components will allow facilities to tailor their food safety
plans to their specific facility, product, and process and ensure that
the regulatory requirements are risk-based. Other comments state that
the proposed approach acknowledges the safety benefits derived from the
use of prerequisite programs, such as CGMPs, and provides for a
framework whereby appropriate decisions may be reached regarding
hazards that require management controls that may include monitoring,
corrections or corrective actions, verification, and records. Other
comments state that the provisions will allow businesses to allocate
resources to spend the most time and resources controlling and
monitoring those hazards that pose the greatest risk to public health.
    However, many of these comments also ask us to convey not only that
the application of a particular management component be appropriate
(i.e., capable of being applied), but also that it be necessary for
food safety (i.e., to meet the overall FSMA food safety goals or to
ensure a particular control is effective) by specifying that the
preventive control management components take into account both the
nature of the preventive control and its role within the facility's
overall food safety system. Some of these comments ask us to make
companion changes reflecting that the preventive control management
components take into account both the nature of the preventive control
and its role within the facility's overall food safety system
throughout applicable provisions of the rule, such as the definition of
``significant hazard'' (which we now refer to as ``hazard requiring a
preventive control'') and in the requirements for preventive controls,
monitoring, corrective actions and corrections, and verification. Some
comments ask us to consistently refer to ``the nature of the preventive
control'' (rather than simply to ``the preventive control'') when
communicating the flexibility that a facility has in identifying
preventive controls and associated preventive control management
components.
    (Response 293) We agree that preventive control management
components should take into account both the nature of the preventive
control and its role in the facility's food safety system and have
modified the regulatory text of Sec.  507.39 to incorporate this
suggestion. We reviewed the full regulatory text of proposed subpart C
and made similar modifications to the regulatory text for the
definition of ``hazard requiring a preventive control'' (Sec.  507.3);
process controls (Sec.  507.34(c)(1)); monitoring (Sec.  507.40);
verification (Sec.  507.45); validation (Sec.  507.47); and
verification of implementation and effectiveness (Sec.  507.49).
    (Comment 294) Some comments assert that the flexibility explicitly
provided in the regulatory text could result in some facilities taking
a broad approach to significant hazards and other facilities taking a
more detailed approach. These comments express concern that inspectors
will view the detailed approach (e.g., with more preventive controls),
as the standard to judge compliance with the rule. Other comments
express concern that identifying a large number of preventive controls
could also undermine the value of HACCP programs because treating too
many controls as CCPs will pull

resources from those controls that are truly critical.
    (Response 294) We agree that facilities are likely to take
different approaches to complying with the rule. A facility-specific
approach is consistent with FSMA, which places responsibility for
hazard analysis and risk-based preventive controls on the owner,
operator, or agent in charge of the facility (section 418(a) of the
FD&C Act). We agree that having too many CCPs could dilute their
significance, but not every hazard will require a CCP to be controlled.
See table 6 in the 2014 supplemental notice for examples of preventive
controls that would not be CCPs (79 FR 58476 at 58493).
    During the initial stages of implementation, we expect that our
investigators will ask subject matter experts in CVM to review the
outcome of the facility's hazard analysis, the preventive controls
established by the facility, and the associated preventive control
management components that the facility has established and
implemented. Over time, as our investigators gain experience, we expect
that there will be fewer circumstances in which our investigators would
consult CVM about such an outcome. (See also Response 2 and section LIV
regarding our approach to compliance.)
    (Comment 295) Some comments state that USDA's regulations (in 7 CFR
205.201(a)(3)) for the National Organic Program include regulatory text
to ``ensure the effectiveness'' of measures in that program and that
this regulatory text is similar to regulatory text in the requirements
for preventive control management components. These comments assert
that this type of regulatory text has created compliance challenges and
ask us to consult with USDA about its experience with implementing
effectiveness language associated with monitoring practices and
procedures and ensure that the final rule uses regulatory text that
will be clearly understood and readily implementable by those subject
to its provisions.
    (Response 295) Under the USDA regulation cited by these comments,
an organic production or handling system plan must include a
description of the monitoring practices and procedures to be performed
and maintained, including the frequency with which they will be
performed, to ``verify that the plan is effectively implemented.'' We
have not consulted with USDA regarding its experience in evaluating
compliance with this requirement because we addressed the issue likely
to cause these compliance challenges for monitoring practices and
procedures in an organic production or handling system plan when we
established our requirements for monitoring preventive controls.
Specifically, we require that a facility monitor the preventive
controls with adequate frequency to ``provide assurance that they are
consistently performed,'' not to ``verify that the plan is effectively
implemented.'' Our requirements more clearly distinguish the purpose of
monitoring and verification activities. See our previous discussion of
the relationship between monitoring and verification, and our tentative
conclusion to require monitoring of the performance of the preventive
controls (78 FR 64736 at 64790). We are affirming that conclusion in
this rule. (See Response 297.)

B. Proposed Sec.  507.39(b)--Applicability of Preventive Control
Management Components to the Supply-Chain Program

    We proposed that the supplier program (which we now refer to as
``supply-chain program'') would be subject to the following preventive
control management components as appropriate to ensure the
effectiveness of the supplier program, taking into account the nature
of the hazard controlled before receipt of the raw material or
ingredient: (1) Corrective actions and corrections, taking into account
the nature of any supplier non-conformance; (2) review of records; and
(3) reanalysis. We address comments on the supply-chain program in
sections XL through XLVII. We are finalizing the applicability of
preventive control management components to the supply-chain program as
proposed.

C. Proposed Sec.  507.39(c)--Recall Plan Is Not Subject to Preventive
Control Management Components

    We proposed that the recall plan that would be established in Sec.
507.38 would not be subject to the preventive control management
components.
    (Comment 296) As discussed in Comment 287, some comments ask us to
establish requirements for a written recall plan as a CGMP requirement
in subpart B rather than as a preventive control in subpart C. As a
companion change, some of these comments ask us to delete our proposed
provision that the recall plan would not be subject to the preventive
control management components.
    (Response 296) As discussed in Response 287, we are establishing
the requirements as a preventive control in subpart C as proposed.
Therefore, we are finalizing the provision that the recall plan not be
subject to the preventive control management components.
    For further discussion on comments on preventive control management
components, see section XXIX in the final rule for preventive controls
for human food, published elsewhere in this issue of the Federal
Register.

XXX. Subpart C: Comments on Proposed Sec.  507.40--Monitoring

    We proposed to establish requirements for monitoring the preventive
controls. We also discussed our tentative conclusion that the language
of section 418 of the FD&C Act regarding monitoring is ambiguous and
that it would be appropriate to require monitoring of the
``performance'' of preventive controls.
    Some comments agree with our tentative conclusion regarding the
ambiguous nature of section 418. For example, some comments state that
our interpretation seems appropriate because requiring monitoring of
the ``effectiveness'' of the preventive controls would be redundant
with required verification activities. In addition, requiring
monitoring of the performance of preventive controls is consistent with
applicable domestic and internationally recognized standards.
    Some comments agree that facilities must be required to maintain
records; but disagree regarding the scope of monitoring. One comment
agrees that monitoring the performance of preventive controls would
provide evidence that the preventive controls established to control
the identified hazards are implemented appropriately. Some comments
support the proposed provisions without change. Some comments ask us to
clarify how we will interpret the provision.
    In the following paragraphs, we discuss comments that disagree with
our tentative conclusion or with the proposed requirements, or ask us
to clarify the proposed requirements or suggest one or more changes to
the proposed requirements. After considering these comments, we are
affirming our tentative conclusion that the language of section 418 of
the FD&C Act regarding monitoring is ambiguous and that it would be
appropriate to require monitoring of the ``performance'' of preventive
controls. We also have revised the proposed requirements as shown in
table 14, with editorial and conforming changes as shown in table 31.

     Table 14--Revisions to the Proposed Requirements for Monitoring
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.40........................  Flexibility in     Provide that
                                 requirements for   monitoring take into
                                 monitoring.        account both the
                                                    nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
507.40(c)(2)(i)...............  Records of         Provide that records
                                 monitoring.        of refrigeration
                                                    temperature during
                                                    storage of animal
                                                    food that requires
                                                    time/temperature
                                                    control to
                                                    significantly
                                                    minimize or prevent
                                                    the growth of, or
                                                    toxin production by,
                                                    pathogens may be
                                                    affirmative records
                                                    demonstrating
                                                    temperature is
                                                    controlled or
                                                    exception records
                                                    demonstrating loss
                                                    of temperature
                                                    control.
507.40(c)(2)(ii)..............  Records of         Provide for exception
                                 monitoring.        records for
                                                    monitoring of
                                                    preventive controls
                                                    other than
                                                    refrigeration.
------------------------------------------------------------------------

A. Our Tentative Conclusion To Require Monitoring of the Performance of
Preventive Controls

    (Comment 297) Some comments disagree with our tentative conclusion
that it would be appropriate to require monitoring of the
``performance'' of preventive controls and assert that the concept of
``performance evaluation'' is too complex to be included in the rule.
    (Response 297) These comments may have misinterpreted what we meant
by ``monitoring performance of preventive controls.'' We used the term
``performance'' to mean ``the execution or accomplishment of an action,
operation, or process undertaken or ordered'' (78 FR 64736 at 64790).
We acknowledge that the definition of ``monitoring'' that we are
establishing in this rule includes that the purpose of observations or
measurements conducted as part of monitoring is to ``assess'' whether
control measures are operating as intended. However, we provided
examples showing that this assessment is a straightforward
determination of whether a process is operating as intended and is not
a complex evaluation as asserted by the comments. (See, e.g., the
discussion of monitoring oven temperature to ensure pathogen
elimination during baking of a pet treat 78 FR 64736 at 64789 through
64790.)
    (Comment 298) Some comments that support monitoring the performance
of preventive controls assert that our proposed definition of
``monitoring'' (proposed Sec.  507.3), and our preamble discussions of
``monitoring,'' have the potential to confuse ``monitoring the
performance of preventive controls'' with verification activities that
address ongoing implementation of control measures.
    (Response 298) See Response 47 in which we discuss comments on the
definition of monitoring and describe the changes we have made to that
definition to address concerns about the potential to confuse
``monitoring the performance of preventive controls'' with verification
activities that address ongoing implementation of control measures.
    (Comment 299) Some comments assert that authority should be
explicitly granted to the States to conduct food safety monitoring and
that we should maintain our responsibilities for product tracing.
    (Response 299) These comments misinterpret the provisions of
section 418 of the FD&C Act and this rule. Section 418 places the
responsibility for establishing and implementing a food safety system
(including hazard analysis, risk-based preventive controls, preventive
control management components (including monitoring, corrective action
procedures, and verification), and recordkeeping) on the owner,
operator, or agent in charge of a facility, not on FDA or any other
regulatory authority. This requirement for monitoring within the
framework of hazard analysis and risk-based preventive controls is
distinct from regulatory oversight of animal food safety, such as
during inspections and investigations of outbreaks of foodborne
illness, which generally involve product tracing. We agree that it is
important to coordinate regulatory oversight of animal food safety with
the States and other food safety partners. As discussed in Response 2,
we are working through the PFP to develop and implement a national
Integrated Food Safety System consistent with FSMA's emphasis on
establishing partnerships for achieving compliance (see section 209(b)
of FSMA).
    (Comment 300) One comment requests that routine monitoring not be
required for feed mills unless they manufacture pet food.
    (Response 300) We decline this request. We assume this comment is
based on a presumption that pet food is a higher risk product than
livestock or poultry food. The exemptions from preventive control
requirements that we are establishing are specifically provided by
section 103 of FSMA and we decline to apply the rule only to animal
foods deemed to be of higher risk. Instead, several provisions of the
rule expressly qualify that the requirements apply as appropriate to
the facility, the animal food, the nature of the preventive control,
and its role in the facility's food safety system, the nature of the
hazard, or a combination of these factors (e.g., monitoring procedures
must be established as appropriate to the nature of the preventive
control and its role in the facility's food safety system). For
example, the hazards in a facility and historical information on the
consistency of the control measure can be factors in determining the
frequency of monitoring.

B. Proposed Sec.  507.40(a) and (b)--Flexibility in Requirements for
Monitoring

    We proposed that, as appropriate to the preventive control, you
must establish and implement written procedures, including the
frequency with which they are to be performed, for monitoring the
preventive controls, and monitor the preventive controls with adequate
frequency to provide assurance that they are consistently performed.
    (Comment 301) Some comments agree that frequency and areas to be
tested and monitored need to be determined based on each product and
facility and ask us to allow each individual facility to determine the
frequency and areas to be monitored based on a completed risk
assessment. Some comments ask us to specify that the frequency of
monitoring preventive controls must have a scientific basis.
    (Response 301) It is unclear whether the comment agreeing that
monitoring frequency and areas to be tested need to be determined based
on each product and facility was directed to the monitoring provision
or to environmental monitoring. Regardless, by requiring written
procedures for monitoring, and specifying that the

procedures include the frequency with which the procedures are to be
performed, the rule provides that each facility must determine the
frequency of monitoring, as well as details such as the areas to be
monitored. However, we decline the request to specify that these
procedures be based on a completed ``risk assessment.'' The rule
requires the facility to conduct a hazard analysis, which determines
whether there are any hazards requiring a preventive control, and the
facility would establish preventive controls for such hazards as
appropriate to the facility and the animal food. The facility must
consider factors associated with risk (i.e., the severity of the
illness or injury if the hazard were to occur and the probability that
the hazard will occur in the absence of preventive controls) in
evaluating whether any potential hazard is a hazard requiring a
preventive control (Sec.  507.33(c)). Risk could be relevant to a
facility's identification of appropriate preventive controls for a
particular hazard requiring a preventive control. However, it is the
nature of the preventive control, rather than the risk associated with
the hazard, that is more relevant to the frequency of monitoring and
the areas to be monitored. Accordingly, the rule specifies that the
facility establish written procedures, and conduct monitoring, as
appropriate to the preventive control rather than based on risk
associated with the hazard. (See, e.g., the discussion of monitoring
oven temperature to ensure pathogen elimination during baking of a pet
treat 78 FR 64736 at 64789 through 64790.)
    We decline the request to specify that the frequency of monitoring
preventive controls must have a scientific basis. Monitoring should
take place with sufficient frequency to detect a problem in the
performance of a preventive control. The importance of the preventive
control to the safety of the animal food can be one factor in setting a
frequency. We acknowledge that scientific information may be
appropriate in determining the frequency of monitoring in some cases.
For example, the frequency may be statistically based, such as with
statistical process control. However, in some cases, factors other than
scientific information may be appropriate in determining the frequency
of monitoring. For example, historical information on the consistency
of the control measure can be a factor in determining frequency. When
variability of the process is low, the frequency may be less than with
a process that has more variability. As another example, a process that
is operated at a point close to a food safety parameter limit may be
monitored more frequently than one where there is a large safety margin
built into the process.

C. Proposed Sec.  507.40(c)--Records

    We proposed that all monitoring of preventive controls must be
documented in records that are subject to verification and records
review.
    (Comment 302) Some comments point out that table 6 in the 2014
supplemental notice includes an example of a monitoring activity that
generally would not require monitoring records (i.e., monitoring for
pieces of ferrous material with magnets) (see 79 FR 585476 at 58493).
These comments assert that this example is in conflict with the
proposed regulatory text and ask us to modify the regulatory text to
provide the flexibility we acknowledged in the 2014 supplemental
notice. One comment states the examples provided by FDA for monitoring
performance of preventive controls pertain to preventive controls that
have specific parameters. The comment states in the absence of specific
parameters for a preventive control, monitoring is neither necessary
nor appropriate. Other comments ask us to specify that monitoring must
be documented as appropriate to the nature of the preventive control.
    Some comments ask us to recognize the acceptability of monitoring
systems that exclusively provide exception reports. These comments
describe exception reporting as a structure where automated systems are
designed to alert operators and management on an exception basis, i.e.,
only when a deviation from food safety parameter limits are observed by
the system. These comments assert that, in many cases, monitoring of
preventive controls can be done by automated systems that provide
exception reporting in a much more efficient manner than if performed
by operators and that automated monitoring allows for increased
sampling frequency (often continuous) and reduction of human error. The
comments provide an example of a refrigeration temperature control that
notifies on exception (e.g., high temperature alarm) and may only
record temperatures that exceed the specified temperature (without
recording temperatures that meet control requirements). These comments
acknowledge that such systems must be validated and periodically
verified to ensure they are working properly. These comments ask us to
clarify in the preamble to the final rule that monitoring systems can
work affirmatively or by exception and that both types of systems and
their related documentation are acceptable.
    (Response 302) We have made several revisions to the regulatory
text, with associated editorial changes, to clarify that monitoring
records may not always be necessary. We agree that the exception
reporting described in these comments, including validation and
periodic verification to ensure that the system is working properly,
would be an acceptable monitoring system in the circumstances provided
in the comments, i.e., for monitoring refrigeration temperature.
Therefore, we have revised the regulatory text to provide that records
of refrigeration temperature during storage of food that requires time/
temperature control to significantly minimize or prevent the growth of,
or toxin production by, pathogens may be affirmative records
demonstrating temperature is controlled or exception records
demonstrating loss of temperature control. Although the comments
specifically requested that we clarify our view on exception records in
the preamble, we believe that clarifying the regulatory text will be
more useful, both to facilities and to regulatory agencies that conduct
inspections for compliance with the rule. If a facility uses
``exception records,'' the facility must have evidence that the system
is working as intended, such as a record that the system has been
challenged by increasing the temperature to a point at which an
``exception record'' is generated.
    We also have revised the regulatory text to provide that exception
records may be adequate in circumstances other than monitoring of
refrigeration temperature. For example, in table 6 of the 2014
supplemental notice the example we provided of a monitoring activity
that generally would not require monitoring records is monitoring for
pieces of ferrous material with magnets. We believe that a magnet
system that monitors for ferrous material would result in a record only
when the system detects ferrous material.

XXXI. Subpart C: Comments on Proposed Sec.  507.42--Corrective Actions
and Corrections

    We proposed to establish requirements for corrective actions and
corrections. Some comments support the proposed requirements without
change. For example, some comments assert that there is virtually no
reason to have a food safety plan unless there are proper corrective
actions in place so the product can be properly disposed of. Some
comments agree that there should

be written procedures for corrective actions and note the importance of
identifying and evaluating the problem, correcting it, and documenting
the corrective action. Some comments express the view that the proposed
requirement for clear corrective action in the event of an
unanticipated problem, and documenting all corrective actions,
contributes to a comprehensive safety plan. Some comments that support
the proposed provisions suggest alternative or additional regulatory
text.
    In the following paragraphs, we discuss comments that disagree
with, or suggest one or more changes to, the proposed requirements.
After considering these comments, we have revised the proposed
requirements as shown in table 15 with editorial and conforming changes
as shown in table 31.

 Table 15--Revisions to the Proposed Requirements for Corrective Actions
                             and Corrections
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.42(a).....................  Corrective action  Clarify that
                                 procedures.        corrective action
                                                    procedures depend on
                                                    the nature of the
                                                    hazard, as well as
                                                    the nature of the
                                                    preventive control.
507.42(a)(1)..................  Corrective action  Clarify that the
                                 procedures.        specified list of
                                                    corrective action
                                                    procedures is not
                                                    intended to be
                                                    finite.
507.42(b).....................  Corrective action  Specify that the
                                 in the event of    requirement applies
                                 an unanticipated   when ``a corrective
                                 food safety        action procedure''
                                 problem.           (rather than ``a
                                                    specific corrective
                                                    action procedure'')
                                                    has not been
                                                    established.
507.42(b)(1)(ii)..............  Corrective action  Specify that the
                                 in the event of    requirement applies
                                 an unanticipated   when a preventive
                                 food safety        control, combination
                                 problem.           of preventive
                                                    controls, or the
                                                    food safety plan as
                                                    a whole is found to
                                                    be ineffective
                                                    (rather than just
                                                    when a single
                                                    preventive control
                                                    has been found to be
                                                    ineffective).
507.42(c)(2)..................  Corrections......  Provide for
                                                    additional
                                                    circumstances when
                                                    corrections, rather
                                                    than corrective
                                                    actions, are
                                                    warranted.
------------------------------------------------------------------------

A. Proposed Sec.  507.42(a)(1)--Requirement To Establish and Implement
Corrective Action Procedures

    We proposed that, with some exceptions, as appropriate to the
preventive control you must establish and implement written corrective
action procedures that must be taken if preventive controls are not
properly implemented. The corrective action procedures must include
procedures to address, as appropriate, the presence of a pathogen or
appropriate indicator organism in animal food detected as a result of
product testing, as well as the presence of an environmental pathogen
or appropriate indicator organism detected through environmental
monitoring.
    (Comment 303) Some comments note that we proposed to list two
circumstances that require written corrective active procedures (i.e.,
product testing and environmental monitoring) and that it is not clear
whether this list is intended to be exhaustive or not (i.e., whether
written corrective action procedures are required in only these two
circumstances, or whether there may be other circumstances that require
written corrective action procedures). These comments ask us to insert
``but are not limited to'' after ``must include,'' if we intend that
the list is not exhaustive. Likewise, other comments state our proposal
to specifically require corrective action procedures may result in a
misunderstanding by some facilities about the need to take corrective
actions in circumstances other than in response to testing results,
other non-conformances, or other types of verification activities.
These comments assert that it would be better for food safety if the
regulatory requirements took a more principled approach and generally
required corrective action procedures, with the importance of
corrective action procedures for testing programs addressed through
guidance. If, however, we conclude that specific requirements for
corrective action procedures for testing programs are necessary, these
comments ask us to clarify that the nature and extent of any corrective
actions should be proportional to the nature of the test findings.
    (Response 303) We have revised the regulatory text, with associated
editorial revisions and redesignations, to clarify that the specified
list of corrective action procedures is not intended to be exhaustive
(i.e., not limited to the two corrective action procedures that we
specified in the 2014 supplemental notice). The approach we used in the
modified regulatory text (i.e., ``You must establish and implement
written corrective action procedures . . ., including procedures to
address, as appropriate . . .'') is similar to the approach used in
several other provisions of the rule. (See, e.g., sanitation controls
(Sec.  507.34(c)(2)); and monitoring (Sec.  507.40(a)). We decline the
suggestion to modify the regulatory text by adding ``but is not limited
to'' after ``includes''. The word ``includes'' means to have (someone
or something) as part of a group or total; to contain (someone or
something) in a group or as a part of something (Ref. 47). The word
``includes'' does not need to be followed by ``but is not limited to''
to clearly communicate that a following list is not complete. We agree
that the nature and extent of any corrective actions in response to the
findings of testing programs should be proportional to the nature of
the test findings. (See Response 304.)
    (Comment 304) Some comments state that the nature and extent of the
corrective actions should be proportional to the nature of the testing
results. These comments ask us to require that a facility establish and
implement corrective action procedures that must be taken if preventive
controls are not properly implemented as appropriate to the nature of
the hazard, the nature of the control measure, and the extent of the
deviation.
    (Response 304) We have revised the regulatory text to specify that
the corrective action procedures are established and implemented based
on the nature of the hazard in addition to the nature of the preventive
control. We agree that the nature of the hazard plays a key role in the
corrective actions that a facility would take. Although a facility's
corrective action procedures likely would specify actions to take based
on the extent of the deviation, we consider this a detail that does not
need to be specified in the rule.
    (Comment 305) Some comments ask us to revise the provisions to
clarify that corrective action procedures are not always necessary when
testing detects the presence of a pathogen or indicator organism. These
comments assert that

the extent of the corrective actions should be proportional to the
nature of the testing results themselves because the level of
contamination matters for those microorganisms with thresholds that
need to be taken into account and because the location of contamination
in the food processing environment matters (e.g., the zone in the
facility where the contamination is detected). (For information about
zones associated with environmental monitoring, see 78 FR 3646 at
3816.)
    (Response 305) We decline this request. These comments appear to be
confusing the requirement to establish and implement corrective action
procedures with the content of the corrective action procedures. These
comments also appear to assume that a requirement to have corrective
action procedures (which describe the steps to be taken to ensure that
appropriate action is taken to identify and correct a problem and, when
necessary, to reduce the likelihood that the problem will recur; that
all affected animal food is evaluated for safety; and that all affected
animal food is prevented from entering into commerce when appropriate)
pre-determines the outcome of following the corrective action
procedures. This is not the case. If, as the comments assert, a
facility concludes, for example, that the nature of some test results
do not warrant steps to reduce the likelihood that a problem will recur
and that affected animal food is safe and lawful (or, in the case of
finding a pathogen in some zones in the facility, that no animal food
is affected), then that is what its corrective action procedures would
say. The reason to have corrective action procedures is to consider the
likely scenarios in advance, with appropriate input from the facility's
food safety team and preventive controls qualified individual, rather
than react to these scenarios on an ad hoc basis.
    (Comment 306) Some comments ask us to require that corrective
actions include an analysis to determine the root cause of a problem,
not only identify it. These comments also ask us to require follow-up
actions to ensure the corrective action was effective and assert that
although the requirements address the need to reanalyze the food safety
plan they do not appear to specifically address a review of the
corrective action.
    (Response 306) The requests of these comments do not require any
revisions to the regulatory text. The rule does not use the term ``root
cause'' but it does require the facility to take appropriate action,
when necessary, to reduce the likelihood that the problem will recur
(see Sec.  507.42(a)(2)(ii)). Root cause analysis is simply part of a
common approach to complying with this requirement. (Knowing the root
cause is key to reducing the likelihood that a problem will happen
again.) The rule also requires a review of records of corrective
actions, but does so as a verification activity rather than as part of
the corrective action procedures (see Sec.  507.49(a)(4)).
    (Comment 307) Some comments ask us to revise the proposed rule to
address corrective actions in a more general way and then outline areas
where specific corrective action procedures would be helpful, such as
for testing programs, in guidance.
    (Response 307) The proposed provisions do not prescribe the outcome
of the corrective action procedures, but merely direct the facility to
the types of actions that the procedures must address. In essence, the
proposed provisions already do, as the comments request, address
corrective actions in a general way.
    (Comment 308) Some comments ask us to specify that the requirements
to establish and implement written corrective action procedures also
apply when a preventive control is found to be ineffective.
    (Response 308) We have not revised the regulatory text as requested
by these comments. The appropriate action when a preventive control is
found to be ineffective is to reanalyze the food safety plan and to
establish and implement a preventive control that is effective, not
follow a corrective action procedure. A corrective action procedure is
intended to address a problem that happens when following the
procedures in a food safety plan that previously was verified to be
valid, not to fix problems on an ongoing basis when a preventive
control is ineffective (and, thus, the food safety plan is not valid).
We agree that some of the steps that apply to corrective actions may
need to be taken, such as evaluating affected animal food for safety
and ensuring that adulterated animal food does not enter commerce. This
is addressed by the provisions for corrective actions in the event of
an unanticipated problem (Sec.  507.42(b)(1)), which require specific
corrective actions to be taken (Sec.  507.42(b)(2)).
    (Comment 309) Some comments requests flexibility as every facility
is different from the next so prescriptive corrective actions required
by rules may not be applicable or possible in all cases. Some
commenters requested that documentation be maintained for corrective
actions only if the corrective action was made to address an animal
food safety issue. Other comments say that the animal food safety plan
should outline when a corrective action is required, as well as the
procedure to be followed and the requirement should only focus on
animal food safety issues and not quality issues.
    (Response 309) As stated in Response 304, we have revised the
regulatory text to specify that the corrective action procedures are
established and implemented based on the nature of the hazard in
addition to the nature of the preventive control. We agree that the
nature of the hazard plays a key role in the corrective actions that a
facility would take. The requirement is intended to address hazards and
therefore would not address animal food quality issues unless they
would present a hazard (e.g., if insufficient mixing would present the
potential for nutrient deficiencies or toxicities). All corrective
actions must be documented in records (see Sec.  507.42(d)).

B. Proposed Sec.  507.42(a)(2)--Content of Corrective Action Procedures

    We proposed that corrective action procedures must describe the
steps to be taken to ensure that: (1) Appropriate action is taken to
identify and correct a problem that has occurred with implementation of
a preventive control; (2) appropriate action is taken to reduce the
likelihood that the problem will recur; (3) all affected animal food is
evaluated for safety; and (4) all affected animal food is prevented
from entering into commerce, if you cannot ensure that the affected
animal food is not adulterated under section 402 of the FD&C Act.
    (Comment 310) Some comments assert that the corrective action
procedures should not consider food to be ``affected'' if it is
immediately subjected to an additional (or repeat) preventive control
after determining that the initial preventive control was not properly
implemented. These comments discuss an example in which there is a
temperature deviation below accepted parameter limits for a given
process, and the incorrectly processed product is re-processed
correctly, and assert that it would be illogical to consider the food
to be ``affected'' in the circumstance. Other comments ask us to modify
the requirements to specify that they apply to all affected food ``if
any.'' One comment states the use of the term ``all'' with ``affected''
is redundant and may contribute to unwarranted and unnecessary
regulatory emphasis and requests that the word ``all'' be removed.
    (Response 310) We decline the requests to modify the regulatory
text to remove the word ``all'' or specify that

the requirements apply to all affected animal food ``if any.'' Animal
food is ``affected'' if a preventive control is not properly
implemented during its production. However, the rule does not pre-
determine the consequences when animal food is ``affected.'' Instead,
the rule provides for the facility to evaluate the affected animal food
for safety. If, as in the example described by the comments, the
facility reapplies the preventive control such that the animal food is
safe and is not adulterated under section 402 of the FD&C Act, there
would be no need to take steps to prevent that animal food from
entering commerce.
    (Comment 311) Some comments ask us to provide that requirements for
corrective actions be principle-based (e.g., affected product
containment, control restored to operation before commencing
production) rather than prescriptive.
    (Response 311) The requirements for corrective actions established
by this rule are principle-based in that they require the facility to
describe the steps it will take rather than prescribe the steps it will
take.
    (Comment 312) Some comments ask us to revise the provision to make
resampling and/or retesting one of the first steps in a corrective
action procedure to take into account human error. These comments
assert that mishandling during sampling, transport, and testing can
contribute to a false positive result and that if the results of a
followup test are negative, then the previous test could be considered
an anomaly that could be ignored.
    (Response 312) We decline this request. We disagree that an
appropriate approach to positive findings of a test for contamination
is to resample and retest and to consider positive findings to be an
anomaly if subsequent test results are negative. Many animal food
products are not homogeneous and contamination is localized. Even for
homogeneous animal food products (such as liquids), the problem could
be the sensitivity of the method if the level of contamination is low.
For further discussion on our current thinking on presumptive positive
results and additional testing, see our guidance entitled ``Guidance
for Industry: Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods'' (Ref. 48).

C. Proposed Sec.  507.42(b)--Corrective Action in the Event of an
Unanticipated Problem

    With some exceptions, we proposed that you must take corrective
action to identify and correct a problem, reduce the likelihood that
the problem will recur, evaluate all affected animal food for safety,
and, as necessary, prevent affected animal food from entering commerce
as would be done following a corrective action procedure if any of the
following circumstances apply: (1) A preventive control is not properly
implemented and a specific corrective action has not been established;
(2) a preventive control is found to be ineffective; or (3) a review of
records finds that the records are not complete, the activities
conducted did not occur in accordance with the food safety plan, or
appropriate decisions were not made about corrective actions. We also
proposed that if any of these circumstances apply, when appropriate you
must reanalyze the food safety plan to determine whether modification
of the food safety plan is required.
    (Comment 313) Some comments ask us to delete the proposed
requirement that a facility must reanalyze the food safety plan in the
event of an unanticipated problem. These comments argue that FSMA does
not specify reanalysis in the event of an unanticipated problem. In
addition, these comments assert that the proposed requirement for
reanalysis in the event of an unanticipated problem would be redundant
with the proposed requirements for reanalysis as a verification
activity (proposed Sec.  507.50) and would not add value for food
safety. These comments also assert that the term ``problem'' is
ambiguous and ask us to replace ``problem'' with ``food safety issue''
if we retain the provision in the final rule.
    (Response 313) We acknowledge that section 418 of the FD&C Act does
not explicitly specify that a facility must reanalyze its food safety
plan in the event of an unanticipated problem. In the 2014 supplemental
notice, we clarified that reanalysis would be conducted ``when
appropriate.'' For example, if a problem occurs because personnel did
not understand the procedures or carry out the procedures correctly,
additional training for applicable personnel may be warranted, but
there likely would be no need to reanalyze the food safety plan.
    We disagree that the term ``problem'' is ambiguous. The term
``problem'' signifies that something is wrong, whereas the term
suggested by the comments (i.e., ``issue'') may or may not signify that
something is wrong. We agree that the requirements are directed to
problems related to animal food safety.
    We agree that there is a relationship between the requirements for
corrective actions in the event of an unanticipated food safety problem
and the requirements for reanalysis. To reduce redundant regulatory
text, in the 2014 supplemental notice we proposed to modify the
regulatory text of the requirements for reanalysis to specify that
reanalysis is required when appropriate after an unanticipated food
safety problem, and we are establishing that modified provision in this
final rule. Importantly, the provisions for reanalysis continue to
require reanalysis when a preventive control is found to be
ineffective. We are not aware of any circumstances in which it would
not be appropriate to reanalyze the food safety plan if a preventive
control is found to be ineffective.
    (Comment 314) Some comments assert that the word ``specific'' is
not appropriate as a modifier for ``corrective action procedure''
because many preventive controls will have corrective action procedures
that allow flexibility based upon the nature of the hazard and control.
These comments also state that the term ``specific'' in this context is
more appropriate for a CCP control in a HACCP system.
    (Response 314) We have revised the regulatory text to delete the
word ``specific.''
    (Comment 315) Some comments ask us to emphasize that reanalysis is
required only when a combination of two events occurs (i.e., a
preventive control is not properly implemented and the facility has not
established a corrective action procedure).
    (Response 315) In the 2014 supplemental notice, we proposed
revisions to the regulatory text to clearly specify the circumstances
requiring reanalysis. One such circumstance is when a preventive
control is not properly implemented and a corrective action procedure
has not been established, as stated in Sec.  507.42(b)(1)(i)). The
final provision includes the revisions included in the 2014
supplemental notice and is consistent with the request of these
comments.
    (Comment 316) Some comments ask us to add that corrective actions
in the event of an unanticipated problem also apply when a preventive
control is ``missing.''
    (Response 316) We have revised the regulatory text to require
corrective actions whenever a preventive control, combination of
preventive controls, or the food safety plan as a whole, is
ineffective. (See Sec.  507.42(b)(1)(ii).) In assessing what the
comment might mean by a preventive control that is ``missing,'' we
concluded that an unanticipated problem could, in some cases, mean that
a combination of

preventive controls, or the facility's food safety plan as a whole
(rather than a single preventive control), simply was not effective. If
this is the case, reanalysis would be appropriate, and we also have
modified the requirements for reanalysis to specify that a facility
must reanalyze its food safety plan whenever it finds that a preventive
control, combination of preventive controls, or the food safety plan as
a whole is ineffective.
    (Comment 317) Some comments ask us to replace the term
``reanalyze'' with the term ``reassess.''
    (Response 317) We decline this request. Reanalysis goes beyond
assessing the validity of a preventive control or food safety plan to
control a hazard. Reanalysis can also include assessing whether all
hazards have been identified, whether established procedures are
practical and effective, and other factors.

D. Proposed Sec.  507.42(c)--Corrections

    We proposed that you do not need to comply with the requirements
for corrective actions and corrections for conditions and practices
that are not consistent with specified sanitation if you take action,
in a timely manner, to correct such conditions and practices.
    (Comment 318) Some comments support our proposal to provide for
corrections, rather than corrective actions, for sanitation controls in
some circumstances. Other comments assert that situations in which
``corrections'' can be applied are not limited to sanitation controls
and could include actions to address other preventive controls such as
preventive maintenance controls or CGMPs. As discussed in Comment 82,
some comments emphasize the importance of distinguishing between the
terms ``correction'' and ``corrective action.''
    (Response 318) We have revised the regulatory text, with associated
editorial revisions and redesignations, to provide for corrections,
rather than corrective actions and corrective action procedures, for
minor and isolated problems that do not directly impact product safety.
As discussed in Response 82, we also have defined the term
``correction'' to mean an action to identify and correct a problem that
occurred during the production of animal food, without other actions
associated with a corrective action procedure (such as actions to
reduce the likelihood that the problem will recur, evaluate all
affected animal food for safety, and prevent affected animal food from
entering commerce).

E. Proposed Sec.  507.42(d)--Records

    We proposed that all corrective actions (and, when appropriate,
corrections) must be documented in records and that these records are
subject to the verification requirements in Sec. Sec.  507.45(a)(3) and
507.49(a)(4)(i). We received no comments that disagreed with this
proposed requirement and are finalizing it as proposed.

XXXII. Subpart C: Comments on Proposed Sec.  507.45--Verification

    In the 2013 proposed preventive controls rule for animal food, we
proposed verification activities that would include validation,
verification of monitoring, verification of corrective actions,
verification of implementation and effectiveness, written procedures,
reanalysis, and documentation of all verification activities. We also
requested comment on whether we should specify the verification
activities that must be conducted for verification of monitoring (78 FR
64736 at 64796) and for verification of corrective actions (78 FR 64736
at 64796), and if so, what verification activities should be required.
    To improve clarity and readability, in the 2014 supplemental notice
we proposed to move the more extensive verification requirements for
validation, implementation and effectiveness, and reanalysis from the
single proposed section (proposed Sec.  507.45) to separate sections
(proposed Sec. Sec.  507.47, 507.49, and 507.50, respectively). In
addition, to address comments that asked us to provide more flexibility
to facilities, including flexibility in determining whether and how to
conduct verification activities, in the 2014 supplemental notice we
proposed that the verification activities be performed ``as appropriate
to the preventive control.''
    In this section, we discuss the proposed requirements for
verification of monitoring, verification of corrective actions, and
documentation of verification activities. See sections XXXIII through
XXXV for comments on the proposed requirements for validation,
verification of implementation and effectiveness, written procedures,
and reanalysis. See tables 17, 18, and 19 for a summary of the
revisions to those proposed requirements.
    Some comments support the proposed requirements for verification of
monitoring, verification of corrective actions, and documentation of
verification activities without change. For example, comments support
the documentation of verification activities (see section XXXI.C). In
the following paragraphs, we discuss comments on the flexibility
provided for a facility to conduct verification activities as
appropriate to the nature of the preventive control. We also discuss
comments that address our request for comment on whether we should
revise the regulatory text to specify the verification activities that
must be conducted for verification of monitoring and for verification
of corrective actions, or express concern that the requirements as
proposed are too prescriptive. After considering these comments, we
have revised the verification requirements described in Sec.  507.45 as
shown in table 16.

    Table 16--Revisions to the Proposed Requirements for Verification
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.45(a).....................  Flexibility to     Provide that
                                 conduct            verification
                                 verification       activities take into
                                 activities.        account both the
                                                    nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
------------------------------------------------------------------------

A. Flexibility in Requirements for Verification

    (Comment 319) Some comments support the flexibility provided by use
of the phrase ``as appropriate to the preventive control'' in the
requirement that verification activities must include, as appropriate
to the preventive control, specified verification activities (i.e.,
validation, verification that monitoring is being conducted,
verification that appropriate decisions about corrective actions are
being made, verification of implementation and effectiveness, and
reanalysis). These comments emphasize that verification activities must
be tailored to the preventive control and assert that the use of the
word ``must'' is potentially confusing in light of this flexibility,
e.g., because not all preventive controls must be validated

for food safety, and those preventive controls that do not need
monitoring would not need verification of monitoring. Other comments
ask us to allow facilities flexibility to verify that preventive
controls are effective in the manner prescribed by FSMA, i.e., such
controls should be deemed to be effective by an appropriate means as
determined and supported by the facility within its food safety plan.
    (Response 319) The provisions for preventive control management
components make clear that all preventive control management
components, including verification, are required as appropriate to
ensure the effectiveness of the preventive control, taking into account
the nature of the preventive control and its role in the facility's
food safety system (see Sec.  507.39). Likewise, the provisions for
each of the preventive control management components (i.e., monitoring,
corrective actions and corrections, and verification) individually
provide flexibility, either by specifying that the provisions apply as
appropriate to the nature of the preventive control and its role in the
facility's food safety system (i.e., for monitoring and verification)
or both the nature of the preventive control and the nature of the
hazard (i.e., for corrective actions and corrections). The word
``must'' specifies the type of activities that a facility can use to
satisfy the requirements for a particular preventive control management
component.
    We are retaining the term ``must.'' However, we agree that the rule
should provide flexibility for additional verification of
implementation and effectiveness. To provide that additional
flexibility, we have revised the specific requirements for verification
of implementation and effectiveness to provide for other activities
appropriate for verification of implementation and effectiveness (see
Sec.  507.49(a)(5)). As a conforming revision, we have revised the
requirement for review of records to include a review of records of
other verification activities within a reasonable time after the
records are created (see Sec.  507.49(a)(4)(ii)).

B. Proposed Sec.  507.45(a)--Verification Activities

1. Proposed Sec.  507.45(a)(1)--Validation
    We proposed that verification activities must include, as
appropriate to the preventive control, validation in accordance with
Sec.  507.47. See section XXXIII for comments on validation as a
verification activity.
2. Proposed Sec.  507.45(a)(2)--Verification of Monitoring
    We proposed that verification activities must include, as
appropriate to the preventive control, verification that monitoring is
being conducted in accordance with Sec.  507.40. We requested comment
on whether we should specify the verification activities that must be
conducted for monitoring, and if so, what verification activities
should be required.
    (Comment 320) Comments that address our request for comment on
whether we should specify the verification activities that must be
conducted for monitoring ask us to not do so because this prescriptive
approach would be too limiting. These comments ask us to instead
provide flexibility for the facility to determine the appropriate
verification activities.
    (Response 320) We agree that we should provide flexibility for the
facility to determine these verification activities, and are not
specifying the verification activities that must be conducted for
monitoring.
3. Proposed Sec.  507.45(a)(3)--Verification of Corrective Actions
    We proposed that verification activities must include, as
appropriate to the preventive control, verification that appropriate
decisions about corrective actions are being made in accordance with
Sec.  507.42. We requested comment on whether this section should
specify the verification activities that must be conducted for
corrective actions, and if so, what verification activities should be
required.
    (Comment 321) Some comments ask us not to specify the verification
activities that must be conducted for corrective actions because this
approach would be too limiting. These comments ask us to instead
provide flexibility for the facility to determine the appropriate
verification activities.
    (Response 321) We agree that we should provide flexibility for the
facility to determine the appropriate verification activities for
corrective actions, and are not specifying the verification activities
that must be conducted for corrective actions.
4. Proposed Sec.  507.45(a)(4)--Verification of Implementation and
Effectiveness
    We proposed that verification activities must include, as
appropriate to the preventive control, verification of implementation
and effectiveness in accordance with Sec.  507.49. See section XXXIV
for comments on verification of implementation and effectiveness.
    (Comment 322) One comment contends that animal food facilities
should not be required to conduct product testing or environmental
monitoring to verify implementation and effectiveness of preventive
controls. The comment states that product testing and environmental
monitoring at a facility that is not using appropriate controls will
not normally discover potential hazards. The comment also states that
all of the safety requirements necessary to protect the health of
animals are already being met because this is necessary as a good
business practice and is required by customers.
    (Response 322) When a food safety plan is completed by a preventive
controls qualified individual, they must ensure that the preventive
controls in place are adequate to provide assurance that any hazards
requiring a preventive control will be significantly minimized or
prevented. We have provided adequate flexibility for a preventive
controls qualified individual in an animal food facility to determine
if product testing or environmental monitoring is necessary considering
the facility, the animal food, the nature of the preventive control,
and its role in the facility's food safety system (for further
discussion see section XXXIV.C and XXXIV.E).
    We disagree that all food safety measures necessary to protect the
health of animals are always being followed. Each year, animal food is
recalled, often due to a hazard that could cause serious health
consequences or death. Animal food from a facility that is required to
register and for which there is a reasonable probability that use of or
exposure to the food would cause serious adverse health consequences or
death to humans or animals is subject to reporting to FDA under section
417 of the FD&C Act (Reportable Food Registry).
5. Proposed Sec.  507.45(a)(5)--Reanalysis
    We proposed that verification activities must include, as
appropriate to the preventive control, reanalysis in accordance with
Sec.  507.50. See section XXXV for comments on reanalysis as a
verification activity.

C. Proposed Sec.  507.45(b)--Documentation of Verification Activities

    We proposed that all verification activities must be documented in
records. We received no comments that disagreed with this proposed
requirement and are finalizing it as proposed.

D. Comments on Potential Requirements Regarding Complaints

    We requested comment on whether and how a facility's review of

complaints, including complaints from consumers, customers, or other
parties, should be required as a component of its activities to verify
that its preventive controls are effectively minimizing the occurrence
of hazards (78 FR 64736 at 64809).
    (Comment 323) Some comments ask us to require review of consumer
complaints as a verification activity and note that our HACCP
regulations for seafood and juice require that verification activities
include a review of consumer complaints to determine whether they
relate to the performance of the HACCP plan or reveal the existence of
unidentified CCPs. Some comments note circumstances in which consumer
complaints have identified food safety problems that resulted in a
company report to the RFR. Other comments assert that review of
customer complaint data should not be required in the rule to verify
that a facility's preventive controls are effectively minimizing the
occurrence of hazards.
    Some comments state that the frequency and type of complaints a
facility receives is a very good indicator of the underlying issues
associated with food production, reviewing these records would provide
valuable insight into the type of issues that should be investigated,
and this type of verification activity could therefore be extremely
effective with little to no cost because the facility would already be
performing this type of activity. Some comments state that many
foodborne outbreaks have been identified through complaints and a
review of complaints is a critical component of a food safety system.
One comment says that many times customer complaints may be the first
and only clue that problems exist in animal food because animal
illnesses are not subject to the same reporting requirements as human
illnesses, resulting in a much weaker basis for identifying, tracing,
and correcting foodborne problems.
    Other comments state that a food safety review of complaints is a
prudent part of a food safety program but that the value of such a
review is in providing information and feedback for continuous
improvement of the food safety management system rather than as a
verification of preventive controls. These comments caution against use
of consumer complaints as a regulatory requirement for verification of
the food safety plan because most complaints relate to product quality.
If such a requirement is nonetheless established in the final rule,
these comments recommend that the rule only require followup and
documentation for the rare occurrences where consumer complaints relate
to food safety issues.
    Other comments ask us not to require review of complaints as a
verification activity. Some of these comments assert that complaints
rarely relate to food safety or yield information that leads to
discovery of a food safety issue. Some comments assert that requiring
review of consumer complaints could result in unnecessary time and
effort being spent on an activity with a limited correlation to food
safety. Some comments assert that the provision would provide FDA
access unnecessarily to all complaint files and lead to unproductive
and subjective evaluations as to whether a given complaint pertains to
the performance of the food safety plan. Other comments assert that
complaints would be acted upon immediately for business reasons, and
that waiting to react to complaints until conducting a review of
records as a verification activity would be too late. Other comments
assert that complaints are sensitive business information. Other
comments assert that some consumer complaints are false or emotional
(rather than factual) and have no place in development of preventive
controls. Some comments assert that FSMA does not expressly direct us
to require review of complaints. Some comments assert that review of
complaints is not a precise scientific process, and that consumer
comments are often open to different interpretations.
    Some comments discuss the feasibility of consumer complaint review.
Comments state that consumer complaint records are often kept at a
corporate level rather than at the individual facility. One comment
requests mandatory complaint monitoring for animal food manufacturers.
One comment points out FDA already has access to records, including
complaint files, associated with animal food, which the Agency
reasonably believes to be adulterated and presenting a threat of
serious adverse health consequences.
    (Response 323) We are not establishing a requirement for a review
of complaints as a verification activity. We agree that review of
complaints is more likely to be useful in providing information and
feedback for continuous improvement of the food safety system rather
than as a verification of preventive controls. However, we encourage
facilities to do such a review, as they occasionally do uncover animal
food safety issues.

XXXIII. Subpart C: Comments on Proposed Sec.  507.47--Validation

    We proposed to establish requirements for validation of preventive
controls. Some comments support the proposed requirements without
change. For example, some comments agree that validation must be
performed by (or overseen by) a preventive controls qualified
individual and that some preventive controls (e.g., sanitation controls
and recall plans) do not require validation. Some comments that support
the proposed provisions suggest alternative or additional regulatory
text or ask us to clarify how we will interpret the provision.
    In the following paragraphs, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed requirements as shown in table
17, with editorial and conforming changes as shown in table 31.

     Table 17--Revisions to the Proposed Requirements for Validation
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
507.47(a).....................  Flexibility for    Provide that
                                 validating         validation be
                                 preventive         conducted as
                                 controls.          appropriate to both
                                                    the nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
507.47(b)(1)..................  Circumstances      Provide that, when
                                 requiring          necessary to
                                 validation.        demonstrate the
                                                    control measures can
                                                    be implemented as
                                                    designed, validation
                                                    may be performed (1)
                                                    Within 90 calendar
                                                    days after
                                                    production of the
                                                    applicable animal
                                                    food first begins or
                                                    (2) within a
                                                    reasonable
                                                    timeframe, provided
                                                    that the preventive
                                                    controls qualified
                                                    individual prepares
                                                    (or oversees the
                                                    preparation of) a
                                                    written
                                                    justification.

507.47(b)(1)..................  Circumstances      Add an additional
                                 requiring          circumstance
                                 validation.        requiring
                                                    validation, i.e.,
                                                    whenever a change to
                                                    a control measure or
                                                    combination of
                                                    control measures
                                                    could impact whether
                                                    the control measure
                                                    or combination of
                                                    control measures,
                                                    when properly
                                                    implemented, will
                                                    effectively control
                                                    the hazards
                                                    requiring a
                                                    preventive control.
507.47(c).....................  Preventive         Clarify that a list
                                 controls that do   of preventive
                                 not require        controls that do not
                                 validation.        require validation
                                                    is not an exhaustive
                                                    list.
------------------------------------------------------------------------

A. Flexibility in the Requirements To Validate Preventive Controls

    With some exceptions (see discussion of proposed Sec.  507.47(b)(3)
in section XXXIII.D), we proposed that you must validate that the
preventive controls identified and implemented in accordance with
proposed Sec.  507.36 to control the significant hazards are adequate
to do (proposed Sec.  507.47(a)).
    (Comment 324) Some comments assert that the regulatory text is in
conflict with the preamble discussion in the 2014 supplemental notice
because the regulatory text (i.e., ``(e)xcept as provided by . . .'')
narrowly provides exceptions only for validation of sanitation
controls, supplier controls, and the recall plan, whereas the preamble
discussion provides other examples of preventive controls that would
not require validation (i.e., zoning, training, preventive maintenance,
and refrigerated storage). These comments also assert that although the
regulatory text specifies that validation requirements apply ``as
appropriate to the nature of the preventive control,'' that phrase
could be interpreted to mean that only the validation act itself can be
tailored and that the facility does not have the flexibility to
conclude that validation isn't necessary.
    Some comments assert that the proposed regulatory text would
prevent us from requiring validation of specific sanitation controls
where it may be prudent to do so, either now or in the future as a
result of a newly identified hazard, or the development of a tool, such
as a test method, that would enable validation of the control for the
specific hazard.
    (Response 324) We have deleted ``except as provided by paragraph
(b)(3) of this section'' from proposed Sec.  507.47(a) to remove the
limitation seen by the comments on the exceptions to the requirement
for validation of preventive controls. We also have revised the
regulatory text of Sec.  507.47(c) to provide that a facility does not
need to validate other preventive controls, if the preventive controls
qualified individual prepares (or oversees the preparation of) a
written justification that validation is not applicable based on
factors such as the nature of the hazard, and the nature of the
preventive control and its role in the facility's food safety system.
We specified that the determination that validation is not required
must be made by the preventive controls qualified individual to
emphasize that specialized experience is necessary to evaluate whether
validation is required. We made a conforming revision to the list of
responsibilities of the preventive controls qualified individual (see
Sec.  507.53(a)).
    (Comment 325) Some comments ask us to separate requirements for
validation from requirements for verification because verification and
validation are two different concepts and combining them is confusing.
One comment said that we reversed the definitions of validation and
verification, compared to the common use of the terms in HACCP
activities. Some comments point out that while section 418(f)(1) of the
FD&C Act explicitly requires verification, it does not require
validation. Some of these comments assert that our proposed
requirements for validation exceed the mandate of FSMA while others
argue that the lack of explicit language in section 418 of the FD&C Act
gives us legal flexibility in determining whether and how to require
validation.
    (Response 325) Our approach is consistent with section 418 of the
FD&C Act. Section 418(f)(1) of the FD&C Act requires verification of
the preventive controls, and validation is an element of verification
(see both the NACMCF HACCP guidelines (Ref. 49) and our HACCP
regulation for juice (Sec.  120.3(p)). We agree that the purpose of
validation is different from the purpose of other verification
activities, and we have revised the definitions of both terms to make
this clearer. Although we are establishing a separate regulatory
section for the validation requirements, we did so to improve clarity
and readability rather than as a substantive change relevant to the
issues discussed in these comments. (See Response 75.)
    (Comment 326) Some comments assert that validation is more
appropriate for a HACCP regulation and that requiring the validation of
all preventive controls does not reflect the flexibility mandated by
section 418(n)(3)(A) of FSMA. Other comments assert that effective
preventive measures may be identified in the future that are not
amenable to validation and it would be counterproductive for them not
to be employed in food safety plans because they cannot meet the
validation requirements. These comments explain that certain control
measures are not suitable for validation activities due to the nature
of the activity or previous validation by another entity (e.g., a
supplier).
    (Response 326) The 2013 proposed preventive controls rule for
animal food would not have required the validation of all preventive
controls. For example, we specifically proposed that the validation of
preventive controls need not address sanitation controls and the recall
plan. To emphasize that a facility has flexibility in determining which
other preventive controls require validation, in the 2014 supplemental
notice we revised the proposed regulatory text to require validation
``as appropriate to the nature of the preventive control.'' See
Response 324 for additional revisions we have made to the regulatory
text to provide flexibility for a facility to determine that validation
is not necessary.
    (Comment 327) Some comments ask us to allow validation of the whole
system instead of individual controls.
    (Response 327) See the discussion of the definition of validation
in Response 75. Under the definition, validation can be directed to a
control measure, combination of control measures, or the food safety
plan as a whole.
    (Comment 328) Some comments ask us to align validation requirements
with the relative risk of operations.
    (Response 328) Validation requirements apply only to preventive
controls that are established and implemented based on the outcome of a
hazard analysis, which requires consideration of risk. We also require

validation as appropriate to the nature of the preventive control and
its role in the facility's food safety system. This provides
flexibility with respect to validation and allows consideration of
risk.
    (Comment 329) Some comments ask us to provide guidance and
clarification on topics relevant to validation, especially for small
facilities that may lack the resources needed to generate studies and
scientific data to validate processes. Some comments ask us to clarify
our expectations for a validated process and on conducting studies for
validation purposes. Some comments ask us to provide resources for
validation, noting that some preventive controls will be difficult to
validate and that no scientific research or data are available for
certain controls. Some comments indicate that validation information
provided by FDA should be in the form of non-binding guidance
documents. Some comments ask us to delay enforcement for the validation
requirements until a readily accessible repository of validated
processes, and scientific and technical information, can be created to
assist stakeholders in complying with the validation requirements.
    (Response 329) We intend that the guidance we are developing will
address topics such as those recommended in the comments. (See Response
1). In addition, the FSPCA is developing information for training,
which may be useful to animal food facilities. We are not requiring
facilities to comply with the requirements of subparts C and E of this
rule, including the validation requirements, for 2, 3, or 4 years
depending on the size of the facility. We expect that segments of the
animal food industry will work together and with the FSPCA to develop
scientific and technical information that can be used as evidence to
validate a variety of preventive controls, and will be helpful to
facilities.
    (Comment 330) Some comments indicate that the rule lacked
specifications for, and was unclear on, the process that FDA would
utilize to approve or accept validation data and/or studies. Some
comments ask us to develop a mechanism for industry to make sure their
approach and studies meet the requirements of the rule, such as
certification of process authorities or the establishment of a liaison
between FDA and industry to ensure validation protocols are in
compliance.
    (Response 330) As discussed in Response 1, we are developing
several guidance documents within FDA, including guidance on
validation. In addition, as part of a collaborative effort with the
FSPCA we are obtaining technical information useful for developing
guidelines for preventive controls and outreach to industry, and we
intend that effort to include guidance on approaches to satisfy the
validation requirements of the rule. We do not intend to develop a
mechanism for certification of process authorities or establish a
liaison between FDA and industry to ensure validation protocols are in
compliance. The guidance we are developing on validation should help
industry determine whether their validation approaches are likely to be
acceptable to us.

B. Proposed Sec.  507.47(b)(1)--When Validation Must Be Performed and
Role of Preventive Controls Qualified Individual in Validation

    We proposed that validation of the preventive controls must be
performed by (or overseen by) a preventive controls qualified
individual prior to implementation of the food safety plan (or, when
necessary, during the first 6 weeks of production) and whenever a
reanalysis of the food safety plan reveals the need to do so.
    (Comment 331) Some comments ask us to clarify whether an individual
attending food safety training by an entity such as a cooperative
extension or a State department of agriculture could be a ``preventive
controls qualified individual'' for the purpose of performing or
overseeing the validation of preventive controls.
    (Response 331) See the discussion in section XXXVII.B for
additional information about training applicable to a preventive
controls qualified individual. We have not specified additional
requirements for a preventive controls qualified individual with
respect to validation. A person may be a preventive controls qualified
individual through job experience, as well as training. Food safety
training provided by an entity such as a cooperative extension
specialist or a State department of agriculture could be appropriate
training for many of the functions of the preventive controls qualified
individual if the training is consistent with the standardized
curriculum being developed by the FSPCA.
    (Comment 332) Some comments question whether 6 weeks is enough time
to perform all applicable validation studies that would address the
execution element of validation. Some comments ask us to explain the
basis for the proposed 6-week timeframe. Some comments ask us to align
with the 90-day timeframe in the FSIS Validation Guidelines (Ref. 50).
Some comments note that the seasonal nature of production of some food
products may make it impractical to perform all required validations
within 6 weeks. Some comments suggest that validation be performed
within a specified number of production batches, such as 10 production
batches. Some comments emphasize the need for flexibility and ask us to
both adopt a 90-day timeframe and provide for a longer timeframe with a
written justification, or provide for ongoing evidence of process
validation. One comment recommends removing a required timeframe for
validation or providing a compliance extension until such time as we
could better support the requirements, such as in guidance. One comment
asserts that the timeframe should be prior to implementation of the
food safety plan. Some comments ask as us to specify that validation be
performed within a reasonable time as justified by the preventive
controls qualified individual. Some comments ask for more time for
small businesses to perform validation studies.
    (Response 332) We note that the 90-day timeframe for validation is
established in FSIS' regulations at 9 CFR 304.3(b) and (c) and 9 CFR
381.22(b) and (c) (Conditions for receiving inspection for meat and
meat products and poultry and poultry products, respectively). The FSIS
Validation Guidelines are a companion to those regulations. We have
revised the regulatory text, with associated editorial changes, to make
two changes to the proposed 6-week timeframe for validation of
preventive controls. First, we have adopted the 90-day timeframe
already established in the FSIS' regulations by specifying that when
necessary to demonstrate the control measures can be implemented as
designed, validation may be performed within 90 days after production
of the applicable animal food first begins. Although we had proposed a
6-week timeframe based on the 3 to 6 week timeframe suggested in the
Codex Guidelines for the Validation of Food Safety Control Measures
(Ref. 22), we agree that practical limitations associated with the
production of some animal food products may make it difficult to
perform validation within 6 weeks. The 90-day timeframe in FSIS'
regulations, and incorporated into the FSIS Validation Guidelines,
reflects more than 15 years of experience with validating HACCP systems
for meat and poultry. Although we have provided for validation to be
performed within 90 days after production of the applicable food first
begins, we do not believe it would take a full 90-days of production

to determine whether the facility can provide assurances that a control
measure is working as intended to control the hazard.
    Second, we have provided for validation within a reasonable
timeframe, provided that the preventive controls qualified individual
prepares (or oversees the preparation of) a written justification for a
timeframe that exceeds 90 days after production of the applicable
animal food first begins. We acknowledge that practical limitations
such as those described in the comments could prevent a facility from
performing the validation within 90 days after production of the
applicable animal food first begins. A timeframe that exceeds 90 days
after production of the applicable animal food first begins will be the
exception rather than the norm and we are requiring that the preventive
controls qualified individual provide (or oversee the preparation of) a
written justification for such a timeframe. We made a conforming
revision to the list of responsibilities of the preventive controls
qualified individual (see Sec.  507.53(a)).
    (Comment 333) Some comments ask us to add another circumstance when
validation would be required, i.e., whenever a change is made to the
control being applied.
    (Response 333) We have revised the regulatory text to require
validation whenever a change to a control measure or combination of
control measures could impact whether the control measure or
combination of control measures, when properly implemented, will
effectively control the hazards requiring a preventive control. Under
this provision, a facility would revalidate a preventive control if,
for example, a different type of equipment is used to deliver a heat
process, because it would be necessary to determine that the new
equipment can consistently achieve the required temperature and time of
the process. However, a facility would not need to revalidate a
preventive control if, for example, a thermal process is changed by
increasing the time or temperature, because a less stringent thermal
process would already have been validated.
    (Comment 334) Some comments ask us to require validation both
before production and 6 weeks after production begins.
    (Response 334) We decline this request. A facility has flexibility
to perform validation as appropriate to the nature of the preventive
controls, whether before production (e.g., by obtaining and evaluating
generally available scientific and technical information or by
conducting studies), after production begins (to demonstrate the
control measures can be implemented as designed during full-scale
production), or both.

C. Proposed Sec.  507.47(b)(2)--What Validation Must Include

    We proposed that the validation of preventive controls must include
collecting and evaluating scientific and technical information (or,
when such information is not available or is inadequate, conducting
studies) to determine whether the preventive controls, when properly
implemented, will effectively control the significant hazards.
    (Comment 335) Some comments assert that our discussion of
validation refers to ``scientific proof'' for the validation of a
processing step and ask us to define what is and is not considered
scientific proof for validation.
    (Response 335) We used terms such as ``scientific and technical
information'' and ``scientific and technical basis'' rather than
``scientific proof'' when discussing validation. For information about
what we mean by ``scientific and technical information,'' (see 78 FR
64736 at 64794 through 64795).
    (Comment 336) Some comments ask us to clarify expectations of
validations for basic sanitary processes. Another comment asks us to
exempt the validation of CGMPs.
    (Response 336) The requirements for validation only apply to
preventive controls. Any practice governed by CGMPs only requires
validation if a facility identifies that practice as a preventive
control for a hazard. To the extent that the comment is referring to
sanitary practices governed by CGMPs (such as in Sec.  507.19), the
validation requirements would not apply. To the extent that the comment
is referring to sanitation controls established as a preventive
control, those sanitation controls are excluded from the validation
requirements (see Sec.  507.47(c)).
    (Comment 337) Some comments ask that we not require further
validation of well-accepted preventive controls, such as refrigeration
temperature.
    (Response 337) A facility may rely on generally available
scientific and technical information to demonstrate the adequacy of
controls such as refrigeration but must obtain that information and
establish it as a record (see Sec.  507.45(b)).
    (Comment 338) Some comments express concern that specific methods
are not available to enable validation. Some comments express concern
that the requirement to ``conduct studies'' might be intended, or could
be interpreted, to mean that firms are required to develop or validate
analytical methods (either in general or for specific food matrices).
These comments assert that any such requirement would incur extreme
costs and burdens without delivering commensurate public health