animal food, the facility, and the nature of the control.
    The framework established by ``significant hazard'' also would
incorporate the concept of risk by specifying that ``significant
hazards'' are based on the outcome of a hazard

analysis. The hazard analysis would require an evaluation of known or
reasonably foreseeable hazards to assess two key aspects of risk--i.e.,
the severity of the illness or injury to humans or animals if the
hazard were to occur and the probability that the hazard will occur in
the absence of preventive controls.
    See the revised regulatory text for the proposed new definition of
``significant hazard'' (proposed Sec.  507.3). The term ``significant
hazard'' has sometimes been used in the context of HACCP to refer to
the hazards to be addressed in a HACCP plan through CCPs. However, this
term is not used in the seafood, juice or meat and poultry HACCP
regulations, which focus on ``hazards reasonably likely to occur.'' We
request comment on both the proposed name of the term and the proposed
meaning of the term. See also the proposed new provision for the use of
existing records (proposed Sec.  507.212, which would be established in
subpart F). Table 6 provides some examples of the flexibility that a
facility would have in complying with the revised requirements that
would be established in subpart C.

Table 6--Examples of Flexibility for Complying With the Requirements for
    Hazard Analysis and Risk-Based Preventive Controls in the Revised
                   Requirements in Proposed Subpart C
------------------------------------------------------------------------
      Flexibility related to . . .                    Example
------------------------------------------------------------------------
Controls other than those at CCPs.......  Dividing a facility into zones
                                           based on the risk with
                                           respect to contamination of
                                           product can be a preventive
                                           control, but would not have a
                                           CCP.
Controls other than those at CCPs.......  Preventive maintenance that
                                           inspects and changes pre-
                                           conditioner blades for a
                                           single screw extruder system
                                           at regular intervals may be
                                           considered a PC in some
                                           instances but would not have
                                           a CCP.
Circumstances that do not require         Supplier controls.
 process controls.
Monitoring activity that generally would  Monitoring for pieces of
 not require records.                      ferrous metal with magnets.
Corrections that generally would not      Re-cleaning inadequately
 require records.                          cleaned animal food contact
                                           surfaces before start up.
Preventive controls that would not        Zoning controls.
 require validation.
Preventive controls that would not        Segregation of animal food
 require validation.                       intended for different
                                           species during storage.
Preventive controls that would not        Training.
 require validation.
Preventive controls that would not        Preventive maintenance.
 require validation.
Preventive controls that would not        Refrigerated storage.
 require validation.
Corrective action that generally would    Replacement of equipment.
 not require verification.
------------------------------------------------------------------------

XII. Potential Requirements for Product Testing and Environmental
Monitoring

A. Our Request for Comment on Including Requirements for Product
Testing and Environmental Monitoring in a Final Rule

    In the 2013 proposed rule for preventive controls, we described the
statutory framework of FSMA for product testing and environmental
monitoring as verification measures. We also requested comment on when
and how product testing programs and environmental monitoring are an
appropriate means of implementing section 418 of the FD&C Act (78 FR
64736 at 64836 and 78 FR 3646 at 3762-3765). We specifically requested
comment on including requirements for product testing programs and
environmental monitoring in a final rule. Although we did not propose
specific regulatory text, we asked a series of questions about what
such requirements should include. Our discussions and questions about
``product testing'' focused on ``finished product testing.'' The
Appendix contained extensive background on the role of testing as a
verification measure in a modern food safety system (78 FR 64736 at
64834).

B. Product Testing

1. Comments on Product Testing
    Some comments support product testing as a verification activity
and make recommendations for what should be tested, how testing could
be tied to risk, and how product testing could be used in a food safety
plan. Some of these comments emphasize that product testing would not
be appropriate as a control measure. Other comments do not support
including requirements for ``finished product testing'' as a
verification measure, but support including requirements for ``product
testing'' in the final rule if the focus is broader than ``finished
product testing,'' the use of product testing is tied to risk, and the
regulations provide flexibility in how product testing is used in a
food safety plan. Commenters with varying views on the issue
nonetheless requested that FDA include proposed regulatory text for
consideration.
    For a full discussion of comments received to the 2013 proposed
rule for preventive controls for human food, see section X.B.1 of the
supplemental notice of proposed rulemaking for preventive controls for
human food published elsewhere in this issue of the Federal Register.
2. Potential Requirements for Product Testing
    We acknowledge that there are limitations to product testing.
Nonetheless, product testing programs, when implemented appropriately
based on the facility, the animal food, and the nature of the
preventive control, could be used to verify that the preventive
controls are effectively and significantly minimizing or preventing the
occurrence of identified hazards. Taking into account the comments we
have reviewed so far, we are providing an opportunity for public
comment on potential requirements for product testing. Such
requirements would be tied to risk and addressed through flexible
written procedures that would address both test procedures and
corrective action plans.
    In this section of this document, we are reopening the comment
period with respect to our previous request for comment on when and how
product testing programs are an appropriate means of implementing FSMA.
We are seeking comment on whether requirements for product testing
should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate. The
proposed regulatory

text would, if included in a final rule, establish requirements for:
     Product testing as an activity for verification of
implementation and effectiveness as appropriate to the facility, the
animal food, and the nature of the preventive control (proposed Sec.
507.49(a)(2));
     Written procedures for product testing (proposed Sec.
507.49(b)(2));
     Corrective action procedures for product testing (proposed
Sec.  507.42(a)(1)(ii)(A)); and
     Records of product testing (proposed Sec.  507.45(b));
    See the proposed regulatory text for proposed subpart C for the
full text of such potential requirements. Consistent with the requests
of the comments, proposed regulatory text would provide flexibility for
a facility to make risk-based decisions on when product testing would
be appropriate by providing that the facility can take into account the
facility, the animal food, and the nature of the preventive control
(e.g., whether the control is a kill step) rather than prescribe
product testing in specific circumstance, or require that all types of
facilities (including warehouses) conduct product testing. For
supplementary information relevant to product testing, see the 2013
proposed rule for preventive controls (78 FR 64736 at 64805-64806), the
Appendix in that proposed rule (78 FR 64736 at 64834-64836), and
section X.B in the supplemental notice of proposed rulemaking for
preventive controls for human food published elsewhere in this issue of
the Federal Register.

C. Environmental Monitoring

1. Comments on Environmental Monitoring
    Some comments support environmental monitoring as a verification
activity. In general, these comments recommend that the final rule
specifically require environmental monitoring when ready to eat product
(for human food) is exposed to the environment prior to packaging and
the packaged food does not receive a treatment that would significantly
minimize an environmental pathogen that could contaminate the animal
food when it is exposed (note that under the 2013 preventive controls
rule for animal food, the term ready to eat (RTE) is not used. All
finished animal food is considered ready to eat, but it may not require
packaging.) Comments emphasize the need for flexible requirements that
would allow facilities to tailor their programs based on risk.
    Some comments that generally support environmental monitoring as a
verification activity nonetheless express concern about the potential
for such requirements to be overly prescriptive. Comments particularly
express concern about potentially prescriptive requirements for
corrective actions if an environmental pathogen or appropriate
indicator organism is detected.
    Some comments do not support including requirements for
environmental monitoring as a verification measure. Some of these
comments assert that requirements for environmental monitoring would
not be in accord with guidelines issued by the Codex Alimentarius
Commission (Codex). Some comments note that environmental monitoring
would not be relevant to all products, such as products that will be
heat-treated or subject to a kill-step. Other comments note that
environmental monitoring would not be relevant to facilities such as
food distributors, due to the low likelihood of product contamination
occurring in storage and distribution centers. Some of these comments
express concern about broad requirements that would require
environmental monitoring in a manner that was not risk-based, such as
when an environmental pathogen is not reasonably likely to occur. Some
commenters with varying views on the issue nonetheless asked FDA to
issue proposed regulatory text for environmental monitoring for
consideration.
2. Potential Requirements for Environmental Monitoring
    Although the HACCP Annex of the Codex General Principles of Food
Hygiene (Ref. 17) does not specifically recommend environmental
monitoring as a verification activity in HACCP systems, the Codex
General Principles of Food Hygiene (Ref. 18) does indicate that
sanitation systems should be monitored for effectiveness and
periodically verified, where appropriate, by microbiological sampling
of environment and food contact surfaces, and regularly reviewed and
adapted to reflect changed circumstances. Currently available data and
information support the role of environmental monitoring in a food
safety system that incorporates hazard analysis and risk-based
preventive controls. (See, e.g., the 2013 proposed rules for preventive
controls for animal food and human food (78 FR 64736 at 64806-64807 and
78 FR 3646 at 3764-3765 respectively) and the Appendices in the animal
food and human food 2013 proposed rules (78 FR 64736 at 64834-64836 and
78 FR 3646 at 3812-3820 respectively.) See also and section X.C.2 of
the supplemental notice of proposed rulemaking for preventive controls
for human food published elsewhere in this issue of the Federal
Register.). Environmental monitoring programs, when implemented
appropriately based on the facility, the animal food, and the nature of
the preventive control, could be used to verify that the preventive
controls are effectively and significantly minimizing or preventing the
occurrence of identified hazards.
    Taking into account the comments we have reviewed so far, we are
providing an opportunity for public comment on potential requirements
for environmental monitoring. The potential requirements would provide
flexibility for animal food facilities to tailor their environmental
monitoring programs based on risk. Environmental monitoring would be
required in the specific circumstances where an animal food product is
exposed to the environment prior to packaging, such as dog and cat food
kibble, and the packaged animal food does not receive a treatment that
would significantly minimize an environmental pathogen that could
contaminate the animal food when it is exposed. However, the potential
requirements would not otherwise specify circumstances where
environmental monitoring would be required and would instead require
that the animal food facility conduct environmental monitoring as
appropriate to the facility, the animal food, and the nature of the
preventive control. The potential requirements would also not be
prescriptive in the types of corrective actions needed in response to
detecting an environmental pathogen or appropriate indicator organism
in the environment; they would provide flexibility for facilities to
establish and implement written corrective action procedures to
identify and correct the 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.
    In this section of this document, we are reopening the comment
period with respect to our previous request for comment on when and how
environmental monitoring is an appropriate means of implementing FSMA.
We are seeking comment on whether requirements for environmental
monitoring should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate. The
proposed regulatory text would, if

included in a final rule, establish requirements for:
     Performing, as part of the hazard evaluation, an
evaluation of environmental pathogens whenever an animal food is
exposed to the environment prior to packaging and the packaged food
does not receive a treatment that would significantly minimize the
pathogen (proposed Sec.  507.33(c)(2));
     Environmental monitoring, for an environmental pathogen
(e.g., Salmonella spp) or for an appropriate indicator organism (e.g.,
Listeria spp for L. monocytogenes), as an activity for verification of
implementation and effectiveness as appropriate to the facility, the
food, and the nature of the preventive control, if contamination of an
animal food with an environmental pathogen is a significant hazard
(proposed Sec.  507.49(a)(3));
     Records of environmental monitoring (proposed Sec.
507.45(b));
     Written procedures for environmental monitoring (proposed
Sec.  507.49(b)(3)); and
     Corrective action procedures for environmental monitoring
(proposed Sec.  507.42(a)(1)(ii))(B).
    See the proposed regulatory text for proposed subpart C for the
full text of such potential requirements. For supplementary information
relevant to environmental monitoring programs, see the 2013 proposed
rules for preventive controls for animal food and human food (78 FR
64736 at 64806-64807 and 78 FR 3646 at 3764-3765), the Appendices for
animal food and human food (78 FR 64736 at 64834-64836 and 78 FR 17142
at 17143-17151), and section X.C.2 of the supplemental notice of
proposed rulemaking for preventive controls for human food published
elsewhere in this issue of the Federal Register.

XIII. Potential Requirements for a Supplier Program

A. Our Request for Comment on When and How Supplier Verification
Activities Are an Appropriate Means of Implementing the Statutory
Framework of Section 418 of the FD&C Act

    In the 2013 proposed rule for preventive controls, we described the
statutory framework of FSMA for supplier controls, i.e., the supplier
verification activities that section 418 of the FD&C Act includes as an
example of preventive controls. We also requested comment on when and
how supplier verification activities are an appropriate means of
implementing section 418 (78 FR 64736 at 64804-64809). We specifically
requested comment on including requirements for supplier approval and
other verification activities in a final rule. Although we did not
propose specific regulatory text, we asked a series of questions about
what such requirements should include. The Appendix contained extensive
background on the role of supplier programs in a modern food safety
system (78 FR 64736 at 64836-64837).

B. Comments on When and How Supplier Verification Activities Are an
Appropriate Means of Implementing the Statutory Framework of Section
418 of the FD&C Act

    Some comments support including requirements for a supplier program
in a final rule. These comments emphasize the need for flexible
requirements that would allow facilities to tailor their programs based
on risk, including risk inherent to raw materials and ingredients and
risk that may be associated with a particular supplier (e.g., as
reflected by the supplier's performance history). These comments
provide many specific recommendations for what such requirements
should--and should not--include. We summarize these recommendations in
Table 7.

  Table 7--Summary of Specific Recommendations in Comments That Support
                   Requirements for a Supplier Program
------------------------------------------------------------------------
                                          Most comments do not support a
  Most comments support a requirement:             requirement:
------------------------------------------------------------------------
For receiving raw material and           For a written list of approved
 ingredients from approved suppliers.     suppliers (because the list
                                          would be subject to frequent
                                          (perhaps daily) change).
For verification of a facility's         For verification of the
 immediate supplier.                      supplier's supplier (because
                                          the facility has the greatest
                                          knowledge, leverage and
                                          ability to conduct meaningful
                                          oversight of its immediate
                                          supplier and because it is the
                                          supplier who is accountable to
                                          verify back one more step).
For records documenting that the basic   For documents such as an
 requirements are being carried out.      underlying audit report
                                          (because of concerns about
                                          confidential information).
For audits as a verification activity,   Prescribing the frequency of
 provided that the requirements are       audits (particularly an annual
 flexible and audits are not over-        frequency) (because an audit
 emphasized at the expense of other       is only one tool and audits
 verification activities.                 should be based on risk and on
                                          the performance of the
                                          supplier).
Limiting a supplier program to           Specifying that some hazards
 facilities that manufacture or process   require more than one
 food.                                    verification activity (because
                                          doing so would be too
                                          prescriptive and would not
                                          allow the facility the
                                          flexibility to determine the
                                          appropriate risk-based
                                          approach).
For oversight of a supplier program by   For a receiving facility to
 a qualified individual.                  identify the regulations to
                                          which the supplier is subject
                                          (because the distinction would
                                          not be material to food
                                          safety).
That would be consistent with the
 Foreign Supplier Verification Program
 being established in a separate
 rulemaking.
Specifying that a supplier program may
 be managed at a corporate level
 (rather than by specific facilities),
 because supplier programs are often
 managed at the corporate level. Some
 comments specifically recommend that
 inspection of a supplier program take
 place at the location where the
 program is managed, including at a
 corporate location rather than at an
 individual facility.
------------------------------------------------------------------------

    Comments also address several other issues, such as whether the
final rule should:
     Be limited to circumstances where a hazard is controlled
by the supplier, or be required even if the hazard would be controlled
by the receiving facility or by the receiving facility's customer.

     Include requirements for specific types of verification
activities based only on the seriousness of hazards. Although some
comments support such requirements, other comments do not because the
basis should be risk (which includes probability as well as severity).
     Allow substitution of an inspection (e.g., by FDA) for an
audit. Although some comments support such a substitution, others do
not because they assert that an inspection and an audit are different
in nature.
     Require a receiving facility to consider relevant
regulatory information about the supplier. Although some comments
support such requirements, others do not (e.g., because the information
(which can be part of an overall supplier assessment) may not be
available in a timely manner, is narrow in scope, and would diminish
the importance of the supplier's food safety plan and the effectiveness
of its implementation).
     Include requirements related to supplier non-conformance.
Although some comments support such requirements, others maintain that
supplier non-conformance would be better suited to guidance. Some
comments specifically oppose a requirement for ``discontinuing use of
the supplier'' and recommend flexibility for how a receiving facility
would address supplier non-conformance.
     Provide for alternative verification requirements when a
supplier is a qualified facility (which is subject to modified
requirements; see proposed Sec.  507.7 in the 2013 proposed rule for
preventive controls). Although some comments support alternative
requirements for suppliers that are qualified facilities, others
express concern about whether alternative requirements can be
practically implemented. Some comments state that the supplier
verification requirements should not prevent facilities from sourcing
ingredients from suppliers that are qualified facilities.
    In general, comments that simply oppose including a supplier
program in the final rule express concern about cost, ingredient
diversity, and duplication of efforts. Some of these comments recommend
that we issue guidance on supplier verification activities rather than
establish requirements in the final rule. Some commenters, including
those with varying views about the issue, nonetheless requested that
FDA propose regulatory language for consideration.

C. Potential Requirements for a Supplier Program

    Section 418 of the FD&C Act specifically identifies supplier
verification activities as a preventive control (see section 418(o)(3)
of the FD&C Act). Supplier controls, when implemented appropriately,
are an important preventive control that can ensure that significant
hazards will be significantly minimized or prevented for those raw
materials and ingredients for which the receiving facility has
identified a significant hazard when the hazard is controlled before
receipt of the raw material or ingredient. Taking into account the
comments reviewed so far, we are providing an opportunity for public
comment on potential requirements for a supplier program as a
preventive control. In this section of this document, we are reopening
the comment period with respect to our previous request for comment on
when and how supplier programs are an appropriate means of implementing
FSMA. We are seeking comment on whether requirements for a supplier
program should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate.
Elsewhere in this issue of the Federal Register, we are issuing a
supplemental notice of proposed rulemaking to amend the 2013 proposed
FSVP rule. In that supplemental notice we request comment, in light of
the statutory provisions, on the manner and extent to which the FSVP
and any preventive controls supplier verification provisions--as well
as other aspects of the FSVP and preventive controls regulations--
should be aligned in the final rules.
    See the proposed regulatory text (proposed Sec.  507.37 and the
applicable definitions in proposed Sec.  507.3) for the full text of
such potential requirements. Briefly, the proposed regulatory text
would, if included in a final rule:
     Establish definitions for terms used in the potential
requirements for a supplier program (i.e., receiving facility;
supplier; and qualified auditor) (proposed Sec.  507.3)
     Establish a risk-based requirement for a written supplier
program that:
     Would require, with some exceptions, a supplier program
for raw materials and ingredients for which the receiving facility has
identified a significant hazard when the hazard is controlled before
receipt of raw material or ingredient (proposed Sec.  507.37(a)(1)
and(a)(2)); and
     Would not apply to raw materials and ingredients for which
there are no significant hazards, the preventive controls at the
receiving facility are adequate, or the receiving facility relies on
the customer and obtains written assurance (proposed Sec.
507.37(a)(1)(ii));
     Require verification activities, as appropriate to the
hazard, and documentation of such activities, to ensure raw materials
and ingredients are received only from suppliers approved for control
of the hazard(s) in that raw material or ingredient (or, when necessary
and appropriate, on a temporary basis, from unapproved suppliers whose
raw materials or ingredients the receiving facility subjects to
adequate verification activities before acceptance for use) (proposed
Sec.  507.37(a)(3)(i));
     Require verification activities to verify that the hazard
is significantly minimized or prevented, the incoming raw material or
ingredient is not adulterated under section 402 of the FD&C Act, and
the incoming raw material or ingredient is produced in compliance with
the requirements of applicable FDA food safety regulations (proposed
Sec.  507.37(a)(3)(ii));
     Provide flexibility for a receiving facility to determine
and document the appropriate verification activities for raw materials
and ingredients from particular suppliers, based on a series of
factors, except when there is a reasonable probability that exposure to
a significant hazard will result in serious adverse health consequences
or death to humans or animals (proposed Sec. Sec.  507.37(b) and
507.37(c)(1)) (see next bullet);
     Require an annual audit as a verification activity when
there is a reasonable probability that exposure to the hazard will
result in serious adverse health consequences or death to humans or
animals, unless the receiving facility documents its determination that
other verification activities and/or less frequent onsite auditing of
the supplier provide adequate assurance that the hazards are controlled
(proposed Sec.  507.37(c)(2));
     Provide for an alternative verification activity when the
supplier is a qualified facility (proposed Sec.  507.37(c)(3));
     Provide for alternative verification activities when the
supplier is a farm that would not be subject to the requirements in the
final produce safety rule under proposed Sec.  112.4 (proposed Sec.
507.37(c)(4));
     Require that an audit be conducted by a qualified
individual who has technical expertise obtained by a combination of
training and experience appropriate to perform the auditing

function (proposed Sec.  507.37(d)(1)) and proposed Sec.  507.53);
     Provide that inspection by FDA or an officially recognized
or equivalent food safety authority may substitute for an audit
(proposed Sec.  507.37(e));
     Require action to address supplier non-conformance
(proposed Sec.  507.37(f)); and
     Require documentation of verification activities in
records (listed in proposed Sec.  507.37(g)), including minimum
requirements for records documenting an audit, records of sampling and
testing, and records documenting a review by the receiving facility of
the supplier's relevant food safety records (proposed Sec.
507.37(g)(5), (g)(6), and (g)(7), respectively).
    In addition, the potential addition of requirements for a supplier
program would require conforming amendments to other provisions of the
rule, including the requirements for a food safety plan, preventive
controls, validation, verification of implementation and effectiveness,
and the list of implementation records for subpart C (see proposed
Sec. Sec.  507.31(c)(3), 507.36(c)(3), 507.39(b), 507.47(b)(3),
507.49(a)(4), and 507.55(a)(4) respectively). For supplementary
information relevant to a supplier program, see the 2013 proposed rule
for preventive controls (78 FR 64736 at 64807-64809), Appendix (78 FR
64736 at 64836-64837) and section XI.C of the supplemental notice of
proposed rulemaking for the preventive controls for human food
published elsewhere in this issue of the Federal Register. In the
following paragraphs, we provide additional information about the
potential requirements for a supplier program.
    Reflecting the risk-based (including severity as well as
probability) nature of a potential supplier program, a receiving
facility's program would be limited to those raw materials and
ingredients for which the receiving facility has identified a
significant hazard. As discussed in section XI.C, ``significant
hazard'' would be defined in the rule. Under the definition, hazards
are determined to be significant based on the outcome of a hazard
analysis and, thus the determination would incorporate the concept of
risk. In addition, a receiving facility would establish and implement a
supplier program only when a significant hazard is controlled before
receipt; a receiving facility would not be required to establish and
implement a supplier program if the receiving facility, or the
receiving facility's customer, controls the hazard (and the customer
provides assurances as to the control). Under this risk-based approach,
a pet food manufacturer generally would be required to establish a
supplier program for hazards associated with the minerals it processes
(which would be controlled by the supplier during manufacture), but a
manufacturer of dry pet food would not be required to establish a
supplier program for microbial hazards in poultry by-products that it
uses to produce the dry pet food if it will control that hazard for the
poultry by-products during manufacture of the pet food (e.g., through a
heat kill step such as the extrusion process).
    The potential supplier program would include requirements
applicable to a ``receiving facility'' and the proposed definition of
``receiving facility'' would describe a receiving facility as a
facility that manufactures/processes a raw material or ingredient that
it receives from a supplier. A supplier would be defined as the
establishment that manufactures/processes the food, raises the animal,
or harvests the food that is provided to a receiving facility without
further manufacturing/processing by another establishment, except for
further manufacturing/processing that consist solely of the addition of
labeling or similar activity of a de minimis nature. The supplier could
be an ``establishment'' rather than a ``facility'' because a supplier
may be an entity that is not required to register under section 415 of
the act and, thus, would not be a ``facility'' as that term would be
defined for the purpose of this rule. Under this definition, a facility
that packs or holds the animal food without any type of manufacturing/
processing would not be a supplier. Under this approach, a facility
would not be required to establish a supplier program for animal food
products that it only packs or distributes. For example, a receiving
facility might receive a raw material or ingredient from a distribution
center that receives the raw material or ingredient from a
manufacturing facility or a farm. The distribution center, which is the
immediate previous source of the raw material or ingredient, would not
be required to establish a supplier program and would not be considered
the supplier; rather the supplier would be the manufacturer or the farm
(which manufactured/processed the food or harvested the food that was
provided to the distribution center and subsequently to the receiving
facility). In such instance, if the receiving facility has identified a
significant hazard for the raw material or ingredient, and that hazard
is controlled by the supplier (the manufacturer or the farm), the
receiving facility would establish verification activities related to
the manufacturer or the farm that provided the raw material or
ingredient to the distribution center.
    If a facility receives an ingredient from a supplier, but the
control of the hazard is by the supplier's supplier, under a potential
supplier verification program, the receiving facility would conduct
supplier verification activities that would include verifying that the
supplier has conducted appropriate verification that its supplier has
controlled the hazard, i.e., the receiving facility would review the
supplier's food safety records for its supplier's control of the
hazard. For example, if a feed mill is receiving animal protein from a
protein blender that receives meat and bone meal from a rendering
facility, the feed mill could conduct verification activities related
to the rendering plant controls at the rendering facility by reviewing
the supplier program of, and verification activities conducted by, the
protein blender for its supplier, the renderer (in addition to
verifying the protein blender's control of pathogens).
    We understand that, particularly for RACs, there may be multiple
establishments, including cooperatives, packing houses, and
distributers, between a receiving facility and the establishment that
would be considered the supplier, which would make potential supplier
verification very challenging under certain circumstances. We request
comment on what verification activities would be appropriate for
receiving facilities to conduct, should a supplier verification program
be included in any final rule, when a raw material or ingredient passes
through more than one facility that would not be required to verify
control of hazards if supplier programs are limited to manufacturers/
processors. For example if a receiving facility is a feed mill that
receives oats from a distributor, who receives grains from a
cooperative, and neither the distributor nor the cooperative is
required to establish supplier controls for the farms, where the
hazards are being controlled, what supplier controls should be applied
for the grains coming from the farms? We request comment on whether and
how any potential supplier verification should address such situations.
    In addition, we seek comment regarding whether (and, if so, how)
the final preventive controls rule should address the potential for
gaps in supplier controls when a hazard is controlled at Point A in the
supply chain and Point B in the supply chain is a facility that only
packs or holds

animal food, but does not manufacture/process animal food (and
therefore would not be required to have a supplier program) before
passing it on to Point C in the supply chain.
    The potential supplier program would be included in the food safety
plan and, thus, would be prepared (or overseen) by a qualified
individual (see proposed Sec.  507.31(b)). A supplier program could be
established and maintained by a facility's corporate headquarters or
parent entity. The recordkeeping requirements would specify that
electronic records are considered to be onsite if they are accessible
from an onsite location, and we expect that many records for the
supplier program would be in electronic form (and thus easily
retrievable by a facility during an inspection).
    Rather than specifically require a written list of approved
suppliers, the potential requirements would specify that the supplier
program be written, and include verification activities, as appropriate
to the hazard, and documentation of such activities, to ensure products
are received only from suppliers approved for control of the hazard(s)
in that raw material or ingredient (or, when necessary and appropriate,
on a temporary basis from unapproved suppliers whose raw materials or
ingredients the receiving facility subjects to adequate verification
activities before acceptance for use). Such a program could include,
for example, written procedures for approving suppliers, for approving
(or rejecting) specific raw materials and ingredients, and for
documenting that raw materials or ingredients are only received from
approved suppliers. The potential requirements would recognize that
there can be circumstances that would require a facility to receive raw
materials or ingredients on a temporary basis from an unapproved
supplier (e.g., if there is a disruption in delivery of raw materials
and ingredients from approved suppliers due to circumstances such as
localized flooding or malfunctioning equipment). We request comment on
examples of circumstances when it would be necessary and appropriate to
receive raw materials and ingredients on a temporary basis from an
unapproved supplier and on the types of verification activities that a
facility should conduct on animal food from an unapproved supplier.
    The potential requirements would provide flexibility for the
verification activities that the receiving facility would conduct for
raw materials and ingredients. With one exception, the receiving
facility would have flexibility to select one or more of four possible
activities: (1) Onsite audit; (2) sampling and testing of the raw
material or ingredient, which could be conducted by either the supplier
or the receiving facility; (3) review by the receiving facility of the
supplier's relevant food safety records; and (4) other appropriate
supplier verification activities based on the risk associated with the
ingredient and the supplier. To determine which option is appropriate,
the receiving facility could consider (1) the severity of the hazards;
(2) where the preventive controls for those hazards are applied (such
as at the supplier or the supplier's supplier); (3) the supplier's
procedures, processes, and practices related to the safety of the raw
materials and ingredients; (4) applicable FDA food safety regulations
and information relevant to the supplier's compliance with those
regulations, including an FDA warning letter or import alert relating
to the safety of the animal food; (5) the supplier's animal food safety
performance history relevant to the raw materials or ingredients that
the receiving facility receives from the supplier, including available
information about results from testing raw materials or ingredients for
hazards, audit results relating to the safety of the animal food, and
responsiveness of supplier in correcting problems; and (6) any other
factors as appropriate and necessary, such as storage and
transportation. Thus, a receiving facility would have flexibility to
select a verification activity based on the circumstances.
    The exception would be when there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals. In this circumstance, under
the potential supplier program, the receiving facility would be
required to have documentation of an onsite audit of the supplier
before using the raw material or ingredient from the supplier and at
least annually thereafter. The potential requirement for an annual
audit is limited to when there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals. Further, the receiving
facility could select less frequent audits or a different verification
activity, if it documented its determination that the less frequent
onsite auditing or other verification activity provides adequate
assurance that the hazards are controlled. The potential recordkeeping
requirements that would apply to audits would identify specific
information that the records must provide about the audit, including
the conclusions of the audit, but would not specify that the underlying
audit report is part of the required documentation of an audit.
    A person who conducts an audit would need to be qualified to do so.
To be qualified, a person who conducts an audit (``qualified auditor'')
would be required to satisfy the criteria for a ``qualified
individual'' (a person who has successfully completed training in the
development and application of risk-based preventive controls
equivalent to that of an FDA-recognized standardized curriculum or is
otherwise qualified through job experience to develop and apply a food
safety system) and have technical expertise obtained by a combination
of training and experience appropriate to perform the auditing
function.
    The potential supplier program would require the receiving facility
to know the FDA food safety regulations that apply to the supplier, and
relevant information about the supplier's compliance with those
regulations. The focus of section 418 of the FD&C Act is on preventing
food safety problems rather than on reacting to them. Section 418 of
the FD&C Act requires the owner, operator, or agent in charge of a
facility to establish and implement preventive controls to
significantly minimize or prevent known or reasonably foreseeable
hazards. By specifying that supplier verification activities are a
preventive control, section 418 requires the receiving facility to take
necessary actions to ensure that raw materials and ingredients are not
adulterated. To determine whether incoming raw materials and
ingredients are adulterated, a receiving facility would need to know
the regulatory framework that applies to the raw materials and
ingredients, and to have confidence that its supplier is complying with
that regulatory framework.
    The potential supplier program would include provisions to address
non-conformance by a supplier. This potential requirement would not
prescribe when a particular corrective action (such as discontinuing a
supplier) is necessary. A facility could substitute an inspection
(whether by FDA or by the food safety authority of a country whose
animal food safety system FDA has officially recognized as comparable
or determined to be equivalent to that of the United States) for an
audit. Even though inspection procedures and audit procedures are not
identical, we tentatively conclude that a facility should have
flexibility to determine whether an inspection could substitute for an
audit based on characteristics such as the severity of

the hazard, how the supplier controls the hazard, and the supplier's
performance history. For example, a facility that receives animal feed
ingredients from a facility subject to the BSE feed regulations in 21
CFR 589.2000 may conclude that an FDA inspection for compliance with
the BSE regulations (concluding that no action is indicated) provides
adequate assurance that the facility is producing an animal food
ingredient in compliance with the requirements of applicable FDA food
safety regulations and is not adulterated under section 402 of the FD&C
Act. For additional discussion of our reasons for tentatively
concluding that it would be appropriate to substitute an inspection
(whether by FDA or by the food safety authority of a country whose food
safety system FDA has officially recognized as comparable or determined
to be equivalent to that of the United States) for an audit, see the
discussion in the proposed FSVP rule (78 FR 45730 at 45758). In
addition, we are asking for comment on whether it would be appropriate
to substitute an inspection in another country (Country A) for an audit
when, for example, it is the food safety authority of Country B (whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States) that
conducted the inspection in Country A.
    The potential requirements would provide for alternative
verification requirements when a supplier subject to the requirements
of section 418 of the FD&C Act is a qualified facility subject to the
requirements of proposed Sec.  507.7. Section 418 provides different
requirements for qualified facilities, which are reflected in the
different potential verification requirements for such facilities.
Although the potential requirements would allow a receiving facility to
conduct an alternative verification activity when the supplier is a
qualified facility, they would not require this.
    Likewise, the potential requirements would provide for alternative
verification requirements when a supplier is a farm that would not be
subject to the requirements of proposed Sec.  112.4 regarding the raw
material or ingredient that the receiving facility receives from the
farm. Some of these farms would be not be subject to the requirements
of proposed Sec.  112.4 because they satisfy the criteria, in section
419(f) of the FD&C Act, for an exemption for direct farm marketing.
Other farms would not be subject to the requirements of proposed Sec.
112.4 because the crops they grow would not be covered by the proposed
produce safety rule, either based on the findings of a qualitative
assessment of risk associated with growing, harvesting, packing, and
holding of produce (see the discussion of this qualitative assessment
of risk in the 2013 proposed produce safety rule, 78 FR 3504 at 3508
and 3522-3529) or because they account for a very small percentage of
covered produce (see proposed Sec.  112.4 and the discussion at 78 FR
3504 at 3549). Although the potential requirements would allow a
receiving facility to conduct an alternative verification activity for
such farms, they would not require this. Although the potential
requirements would provide for alternative verification requirements
for farms that would not be subject to the produce safety rule, we
would not issue a final rule on such alternative verification
requirements until we issue the final produce safety rule.

D. Request for Additional Comment on Requirements To Address Conflicts
of Interest for Persons Conducting Verification Activities

    In the 2013 proposed FSVP rule, we tentatively concluded that it
would be appropriate to address the independence of individuals
conducting verification activities (78 FR 45730 at 45759). We proposed
that an individual who conducts any verification activity must not have
a financial interest in the foreign supplier and payment must not be
related to the results of the activity, and provided that this would
not prohibit an importer, or the importer's employee, from conducting
the verification activity (proposed Sec.  1.506(g)). As discussed in
the 2013 proposed FSVP rule, we considered such requirements necessary
to prevent bias, or the appearance of bias, on the part of a person
conducting a verification activity (78 FR 45730 at 45759).
    We request comment on whether we should include in the final
preventive controls rule requirements to address conflicts of interest
for individuals conducting verification activities and, if so, the
scope of such requirements. For example, should such requirements be
directed to a subset of persons who conduct verification activities
(such as auditors) or should they be directed more broadly? Would a
requirement such as in the 2013 proposed FSVP rule be appropriate, or
would some other requirement be more appropriate (such as a requirement
that persons be free of conflicts of interest that are relevant to the
outcome of the activity)? What would constitute a financial interest in
a company sufficient to constitute a conflict of interest for a person
conducting a supplier verification activity (e.g., conducting an audit
of that company or conducting laboratory tests of that company's food)?

XIV. Potential Requirements for the Hazard Analysis To Address
Economically Motivated Adulteration

A. Our Request for Comment on Whether the Final Rule Should Address
Economically Motivated Adulteration

    In the 2013 proposed rule for preventive controls, we announced our
intent to implement the statutory requirements for hazards that may be
intentionally introduced, including by acts of terrorism, in a separate
rulemaking rather than include them in the requirements for hazard
analysis and risk-based preventive controls (78 FR 64736 at 64745). We
tentatively concluded that intentional hazards, which are not addressed
in traditional HACCP or other food safety systems, likely will require
different kinds of controls and would be best addressed in a separate
rulemaking. However, we also acknowledged that some kinds of
intentional adulterants could be viewed as reasonably likely to occur,
e.g., in foods concerning which there is a widely recognized risk of
economically motivated adulteration in certain circumstances. We
provided an example of this kind of hazard, i.e., the addition of the
chemical melamine to certain food products, apparently to enhance the
measured protein content and/or perceived quality of the product. We
requested comment on whether to include potential hazards that may be
intentionally introduced for economic reasons. We also requested
comment on when an economically motivated adulterant can be considered
reasonably likely to occur.
    When we developed the 2013 proposed intentional contamination rule,
we tentatively concluded that economically motivated adulteration would
be best addressed through the approach in the preventive controls rules
for human food and for animal food (including hazard analysis,
preventive controls, monitoring, corrective action, verification, and
recordkeeping) rather than through the vulnerability assessment-type
approach for intentional adulteration, where the intent is to cause
wide-spread public health harm, such as acts of terrorism (see the 2013
proposed intentional adulteration rule, 78 FR 78014 at 78020). We also
explained our view that the primary purpose of economically motivated
adulteration is to obtain economic gain rather than to impact

public health, although public health harm may occur (78 FR 78014 at
78020).

B. Comments on Economically Motivated Adulteration

    Some comments oppose including requirements directed to
economically motivated adulteration in the preventive controls rule.
These comments assert that the vast majority of economically motivated
adulterants affect quality and value rather than safety. These comments
also point out that the majority of food products could, in theory, be
subject to economically motivated adulteration but that it would be
difficult to determine if such adulteration is reasonably foreseeable.
One comment recommends that we draw a clear distinction between hazards
that are intentionally introduced and those that are not. Another
comment expresses the view that food fraud is fundamentally different
from both food safety and food defense. However, some comments do
support including ``expected intentional adulterants'' in the
preventive controls rule.

C. Potential Requirements To Address Economically Motivated
Adulteration

    Taking into account the comments we have reviewed so far for the
proposed preventive controls rules for human food and for animal food,
we are providing an opportunity for public comment on a potential
requirement for the hazard identification to consider hazards that may
be intentionally introduced for purposes of economic gain (see proposed
Sec.  507.33(b)(2)(iii) in proposed subpart C). In this section of this
document, we are reopening the comment period with respect to our
previous request for comment on whether to include potential hazards
that may be intentionally introduced for economic reasons. We are
seeking comment on whether this preventive controls rule would be the
most appropriate rule to address FSMA's requirements to address hazards
that may be intentionally introduced (for purposes of economic gain)
and, if so, what (if any) modifications to the proposed regulatory text
would be appropriate. We note that the preliminary regulatory impact
analysis (PRIA) that presents the benefits and costs of this proposed
rule (Ref. 1) describes certain assumptions we are making about the
preventive controls, and their implementation, that would be
established and implemented by a facility that identifies a potential
hazard that may be intentionally introduced for economic reasons as a
significant hazard. We are seeking comment on alternative ways to
control such hazards.
    Under the definitions that would be established in the rule, a
hazard would be an agent that is reasonably likely to cause illness or
injury in the absence of its control. Thus, the focus of the potential
requirement would be on those economically motivated adulterants that
are reasonably likely to cause illness or injury in the absence of
their control, not on economically motivated adulterants that solely
affect quality and value with little or no potential for public (human
or animal) health harm.
    We believe that it is practicable to determine whether economically
motivated adulteration is reasonably foreseeable. Importantly, we would
not expect facilities to consider hypothetical economically motivated
adulteration scenarios for their animal food products. As discussed in
the 2013 proposed intentional adulteration rule, we would expect
facilities to focus on circumstances where there has been a pattern of
such adulteration in the past, suggesting a potential for intentional
adulteration even though the past occurrences may not be associated
with the specific supplier or the specific food product (78 FR 78014 at
78027). For example, in the 2013 proposed rule for preventive controls
we discussed a widespread incident of economically motivated
adulteration in which two ingredient suppliers added melamine, a
nitrogen-rich industrial by-product (a non-protein nitrogen), to wheat
gluten and rice protein concentrate to increase the apparent protein
content (78 FR 64736 at 64746). The wheat gluten was imported by a U.S.
broker and sold to U.S. pet food manufacturers and at least one
distributor who then sold it to other pet food manufacturers. The
melamine adulterated products later made their way into food for swine,
poultry, and fish. This adulteration resulted in significant public
health consequences for animals as well as concerns for human health
from products produced from swine, poultry, and fish that had consumed
melamine contaminated foods (72 FR 30014).
    In light of this incident, a prudent person would include in its
hazard analysis the potential for melamine to be an economically
motivated adulterant in its animal food products when using certain
protein ingredients for animal food and, based on the outcome of its
hazard analysis, determine whether melamine is a hazard that must be
addressed in the food safety plan.
    There are other well-known substances that have been economically
motivated adulterants and have potential to cause public (human and
animal) health harm. The U.S. Pharmacopeial Convention (USP) has a free
on-line food fraud database (Ref. 19) and a recent report from the
Congressional Research Service provides additional information on
economically motivated adulteration of food and food ingredients (Ref.
20).

XV. Provisions for Withdrawal of an Exemption for a Qualified Facility

A. 2013 Proposed Provisions for Withdrawal of an Exemption for a
Qualified Facility

    In the 2013 proposed rule for preventive controls, we explained the
provisions of FSMA that establish criteria for a facility to be a
qualified facility, establish an exemption for qualified facilities,
establish requirements for qualified facilities, and provide that we
may withdraw the exemption otherwise granted to qualified facilities in
specified circumstances (section 418(l) of the FD&C Act; see 78 FR
64736 at 64743). We proposed to establish:
     Definitions relevant to these provisions (proposed Sec.
507.3);
     An exemption from the requirements for hazard analysis and
risk-based preventive controls for qualified facilities (proposed Sec.
507.5(d));
     Requirements for qualified facilities (proposed Sec.
507.7); and
     Procedural requirements that would govern our withdrawal
of an exemption for a qualified facility (proposed subpart D; the 2013
proposed withdrawal provisions) (see 78 FR 64736 at 64762, 64765, and
64810).
    The 2013 proposed withdrawal provisions would:
     Specify the circumstances under which we would withdraw an
exemption for a qualified facility (proposed Sec.  507.60);
     Establish procedures for us to issue an order to withdraw
the exemption, including information that would be in the order
(proposed Sec. Sec.  507.62 and 507.65);
     Establish procedures whereby a qualified facility may
submit a written appeal of our order to withdraw an exemption (proposed
Sec.  507.67 and 507.69);
     Establish procedures for appeals, hearings, and decisions
on appeals and hearings (proposed Sec. Sec.  507.71, 507.73, 507.75,
and 507.77); and
     Specify the circumstances in which an order to withdraw an
exemption is revoked (proposed Sec.  507.80).

B. Proposed Clarification of What FDA Will Do Before Issuing an Order
and Proposed Mechanism for Re-Instating an Exemption

    For a full discussion on the comments received for provisions on
withdrawal of an exemption for a qualified facility under the 2013
proposed rule for preventive controls for human food, see section
XIII.B of the preamble for the supplemental notice of proposed
rulemaking for preventive controls for human food published elsewhere
in this Federal Register. See the revised regulatory text for proposed
subpart D for the full text of the proposed requirements.

C. Proposed Revisions to the Content of an Order To Withdraw an
Exemption

    Based on comments reviewed to date for the proposed preventive
controls rule for human food, which appear relevant to animal food, in
this section of this document, we are reopening the comment period with
respect to proposed Sec.  507.65(d).
    Some comments received under the 2013 proposed rule for preventive
controls for human food recommend that the order explicitly state that
the facility has the option to either comply with the order or appeal
the order (with a request for an informal hearing) within 10 calendar
days.
    We tentatively conclude that it would be useful for the order to
itself specify the two options that a facility has upon receipt of the
order, even though the order would otherwise include this information
(because the order will contain the full text of the withdrawal
provisions). Therefore, we are proposing to revise the requirements for
the contents of an order to explicitly mention these two options. See
the revised regulatory text of proposed Sec.  507.65(d).

D. Proposed Revisions to the Timeframes for a Facility To Comply With,
or Appeal, an Order

    In this section of this document, we are reopening the comment
period with respect to the timeframes in proposed Sec. Sec.  507.65(d)
and 507.67(a) and (c).
1. Comments
    Some comments received under the 2013 proposed rule for preventive
controls for human food ask us to specify that a facility's timeframe
for taking action begins when the facility receives the order, not when
we issue the order. Other comments address the timeframes for a
facility to compile information needed to appeal an order for
withdrawal. These comments assert that the proposed timeframe of 10
days is insufficient, and recommend timeframes such as 30 days or 90
days.
    Some comments contrast the proposed 60-day timeframe to comply with
the requirements for hazard analysis and risk-based preventive controls
when a facility loses its exemption as a qualified facility with the
timeframe that a facility would have to comply with these requirements
when the final rule first becomes effective. As discussed in the 2013
proposed rule for preventive controls, we proposed compliance dates
that would be 2 years and 3 years after the date of the final rule for
small and very small businesses, respectively (78 FR 64736 at 64751).
The comments assert that these two situations are parallel, because a
qualified facility that has had its exemption withdrawn would be coming
into compliance with the full requirements for hazard analysis and
risk-based preventive controls for the first time. These comments
recommend that we change the timeframes in the 2013 proposed withdrawal
provisions to better align with the compliance dates contemplated by
the proposed rule and by FSMA for small and very small businesses. Some
of the comments recommend that a small business have 6 months, and that
a very small business have 18 months, to comply with the order. Other
comments recommend that any business (whether small or very small) have
two years to comply with the order. Some of these comments recommend
that the timeframe be tied to the date of the final determination
rather than to the date of the order.
2. Proposed Revisions to Timeframes
    We tentatively conclude that the nature of what a facility would
need to do to comply with an order, i.e., comply with the full
requirements for hazard analysis and risk-based preventive controls--
makes the timeframes in the 2013 proposed withdrawal provisions
insufficient. However, it is relevant that in contrast to the general
compliance dates, the proposed withdrawal provisions would only apply
when a significant public health (human and animal) concern has been
identified for a particular facility.
    We also tentatively conclude that it is appropriate to link the
timeframe for compliance to the date of receipt of the order, rather
than to the date the order was issued. Doing so would be consistent
with our other administrative procedures, such as appeal of an order
for administrative detention (Sec.  1.402).
    Taking into account the comments reviewed so far for the proposed
rule for preventive controls for human food, which appear relevant to
animal food, we are proposing to require that a facility comply with an
order to withdraw an exemption within 120 days of the date of receipt
of the order. See the revised regulatory text for proposed Sec. Sec.
507.65(d) and 507.67(a) and (c).

XVI. Definition of Very Small Business

A. The 2013 Proposed Options for Definition of Very Small Business

    We proposed three options for the definition of a very small
business based on total annual sales of animal food, adjusted for
inflation: Option 1, $500,000; Option 2, $1,000,000; and Option 3,
$2,500,000. The 2013 proposed rule for preventive controls contained
several provisions relevant to very small businesses, including
exemptions from subpart C in Sec. Sec.  507.5(e) and 507.5(f) for very
small (and small) facilities engaged only in specific types of on-farm
activities involving low-risk activity/animal food combinations, the
exemption in Sec.  507.5(d) and requirements in Sec.  507.7 for a very
small business as a qualified facility, and extended time to comply
with the rule. In defining a very small business, we took into
consideration the study of the food processing sector required by
section 418(l)(5) of the FD&C Act (``Food Processing Sector Study''
(Ref. 21); see 78 FR 64736 at 64758-64759). In the 2013 proposed rule
for preventive controls, we requested comment regarding the three
proposed options for the definition of ``very small business.'' We also
requested comment on whether a dollar amount of sales that is more
than, or less than, the $500,000; $1,000,000; or $2,500,000 amounts
would be appropriate.

B. Comments on the 2013 Proposed Options for Definition of Very Small
Business

    Comments support a variety of dollar limits of total annual sales
of animal food for defining a very small business, including each of
the three proposed options ($500,000, $1,000,000, and $2,500,000) as
well as other dollar limits that we did not include as proposed options
(e.g., less than $10,000). Some comments assert that very small
facilities will incur a large portion of the costs associated with
implementing the 2013 proposed rule for preventive controls rule
because very small facilities lack experience with HACCP-based models.
    Some comments support defining a very small business as one with
total annual animal food sales up to $2,500,000. Some of these comments
express concern that using lower dollar

sales amounts to define a very small business would discourage growth
of very small processing facilities (especially those co-located on a
farm), would unfairly burden very small facilities, and could cause
them to fail due to the estimated high cost of compliance; whereas
setting a higher dollar sales amount would encourage growth, innovation
and diversification. Some of these comments note that adopting the
threshold of $2,500,000 would establish that the full preventive
controls requirements would apply to the businesses that produce the
vast majority of animal food products and that modified requirements
would apply to smaller businesses that represent the majority of
producers but the minority of the animal food supply.
    Other comments support no amount of annual animal food sales for
defining very small business stating that the requirements should apply
uniformly to all facilities. Some comments state that even a $2,500,000
threshold would result in very few of certain types of animal food
facilities qualifying as a very small business.

C. Proposed Revisions to the Definition of Very Small Business

    In this supplemental notice of proposed rulemaking, we are
proposing the definition of very small business as a business that has
less than $2,500,000 in total annual sales of animal food adjusted for
inflation. The statutory construct does not prevent us from
establishing a definition for very small business that would include
more facilities than those that would be included under the statutory
provision that considers sales to qualified end-users (section
418(l)(1)(C) of the FD&C Act). Section 418(n)(1)(B) of the FD&C Act
directs FDA to define the term ``very small business'' for the purposes
of determining whether a facility is a ``qualified facility'' eligible
for modified requirements. Further, section 418(n)(1)(B) requires us to
consider the Food Processing Sector Study for the purpose of defining
``very small business.'' FDA notes that section 418 of the FD&C Act
does not otherwise limit how FDA may define ``very small business.''
    We tentatively conclude that it is not necessary for the dollar
limit in the definition of ``very small business'' to be $500,000 or
less to protect public health (human and animal). In the 2013 proposed
rule for preventive controls, we estimated the number of facilities
that would be affected by the size specified in the definition of
``very small business.'' The size specified in the definition of ``very
small business'' would affect the compliance dates, the exemptions for
qualified facilities, and the exemptions for on-farm low-risk packing
and holding activity/animal food combinations and on-farm low-risk
manufacturing/processing activity/animal food combinations (proposed
Sec. Sec.  507.5(d), (e), and (f), respectively) (see 78 FR 64736 at
64762-64763). As a group, businesses with less than $2,500,000 in total
annual sales of animal foods produce less than two percent of all
animal food produced in the United States when measured by dollar
value. (In the 2013 proposed rule, this was stated as businesses with
less than $2,500,000 in as total annual sales of animal food produce
less than 20.8 percent of all pet food and animal feed produced in the
United States when measured by dollar value (78 FR 64736 at 64760).
This was an error and should have said less than 2 percent of all pet
food and animal feed produced in the United States when measured by
dollar value.) We acknowledge that this estimate of all animal food
produced in the United States is higher than the estimates for lower
dollar limits (less than one percent of all animal food produced in the
United States, or less than one-half of one percent of all animal food
produced in the United States, for limits of $1,000,000 or $500,000,
respectively). Regardless, under the revised definition, the businesses
that would be exempt from the requirements for hazard analysis and
risk-based preventive controls would represent a small portion of the
potential risk of foodborne illness.
    We tentatively conclude that the definition of very small business
should exempt from the rule only a small percent of animal food to
minimize the risk of foodborne illness and, thus, are proposing a very
small business definition of $2,500,000, which would exempt less than
two percent of the dollar value of animal food produced in the United
States. We request comment on this tentative conclusion and whether we
should consider other dollar limits for very small business.
    A dollar limit in the definition of ``very small business'' greater
than $500,000 would not necessarily exempt those companies whose
practices would be most improved by complying with the requirements for
hazard analysis and risk-based preventive controls. The Food Processing
Sector Study (Ref. 21) concluded that there was no consistent pattern
across food categories, including the pet food and animal feed
categories, in terms of which sizes of establishments contribute most
to foodborne illness risk (78 FR 64736 at 64758). Moreover, the
facilities that would be classified as qualified facilities would be
subject to modified requirements (see proposed Sec.  507.7).
Furthermore, all facilities that would be exempt from the requirements
for hazard analysis and risk-based preventive controls would continue
to be subject to the prohibitions in the Federal Food, Drug, and
Cosmetic Act against causing animal food to be adulterated or
misbranded and against distributing such animal food, and to inspection
by FDA.
    We are not proposing that the definition of ``very small business''
consider number of employees as well as dollar limits, be based on
number of employees for consistency with the definition of ``small
business,'' or be based on volume of animal food sold rather than on
dollar limits associated with sales of animal food. There are two
alternative sets of criteria to be a qualified facility. The criteria
in section 418(l)(1)(C) of the FD&C Act are set out with regard to
sales. We believe it is appropriate for the other criteria (related to
being a ``very small business'') similarly to be related to sales. As
discussed in the 2013 proposed rule for preventive controls, we
proposed number of employees for the definition of ``small business''
in part because it would be the same definition for small business as
that which has been established by the U.S. Small Business
Administration under 13 CFR 121 for most food manufacturers. We
continue to believe that the proposed definition of ``small business,''
based on number of employees, is appropriate.
    We are not proposing that the definition of ``very small business''
consider the risk associated with the animal food manufactured,
processed, packed, or held by the facility. The description ``very
small'' addresses size of a business, not risk associated with animal
food that the facility manufactures, processes, packs, or holds.

XVII. Other New and Revised Proposed Provisions

A. Proposed New Definitions

1. Proposed Definition of ``Pathogen''
    In the 2013 proposed rule for preventive controls for food for
animals, we proposed to define ``environmental pathogen'' to mean a
microorganism that is of animal or human health significance and is
capable of surviving and persisting within the manufacturing,
processing, packing, or holding environment. Variations of the phrase
``microorganism of animal or human health significance'' appear in
several places in the 2013 proposed

rule. To both simplify the regulations and use the same term (i.e.,
``pathogen'') when we mean a microorganism of animal or human
significance, we are proposing to define the term ``pathogen'' to mean
a microorganism that is of public (human or animal) health significance
and to replace variations of the phrase ``microorganism of animal or
human health significance'' with ``pathogen'' throughout the
regulations.
2. Proposed Definition of ``You''
    We acknowledge the potential for confusion if the phrase ``owner,
operator, or agent in charge'' applies to both plant management and
operators in proposed subpart B and to the ``owner, operator, or agent
in charge of a facility'' in proposed subpart C. Most of the provisions
of proposed subpart B do not specify the role of ``plant management''
or the ``operator'' of a plant or establishment. To prevent confusion,
we tentatively conclude it is prudent to retain terms such as ``plant
management'' and ``operator'' in proposed subpart B.
    However, we tentatively conclude that we can simplify the
regulations directed to the ``owner, operator, or agent in charge of a
facility'' in provisions in subparts A, C and D by using pronouns,
without creating confusion, if we (1) define the term ``you'' to mean,
for purposes of part 507, the owner, operator, or agent in charge of a
facility and (2) limit use of the term ``you'' to provisions in
proposed subparts A, C and D. See the revised regulatory text for the
definition of you (in proposed Sec.  507.3) and its use throughout
revised subpart C.
3. Proposed Definition of ``Significant Hazard''
    As discussed in section XI.C, we are proposing to delete the
proposed definition ``hazard reasonably likely to occur'' and instead
establish a definition for ``significant hazard.'' See the revised
regulatory text in proposed Sec.  507.3.
4. Proposed Definition of ``Known or Reasonably Foreseeable Hazard''
    As discussed in section XI.C, we are proposing to delete the
proposed definition ``reasonably foreseeable hazard'' and instead
establish a definition for ``known or reasonably foreseeable hazard.''
See the revised regulatory text in proposed Sec.  507.3.
5. Potential Definitions of ``Qualified Auditor,'' ``Receiving
Facility,'' and ``Supplier''
    As discussed in section XIII.C, we are providing an opportunity for
public comment on potential requirements for a supplier program. If
such requirements are included in a final rule, we would establish
definitions for three terms used in the potential requirements for a
supplier program, i.e., ``qualified auditor,'' ``receiving facility,''
and ``supplier.'' See the proposed regulatory text in proposed Sec.
507.3.

B. Proposed Revisions to Definitions

    In the 2013 proposed rule for preventive controls, we proposed to
establish several new definitions.
1. Revised Definition of ``Hazard'' and ``Reasonably Foreseeable
Hazard''
    Some comments received under the 2013 proposed rule for preventive
controls for human food recommended that we include radiological
hazards as a subset of chemical hazards in the definition ``hazard.''
Although radiological hazards would not be common, we believe that
facilities in the past have considered them as chemical hazards when
conducting a hazard analysis for the development of HACCP plans. The
revised regulatory text uses the phrase ``chemical (including
radiological)'' in the definition of ``hazard'' and as applicable
throughout the regulations. As a conforming change, we are proposing to
revise the definition of ``reasonably foreseeable hazard'' to mean a
potential biological, chemical (including radiological), or physical
hazard that may be associated with the facility or the food.
2. Revised Definition of Environmental Pathogen
    We proposed to define the term ``environmental pathogen'' to mean a
microorganism that is of public (human or animal) health significance
and is capable of surviving and persisting within the manufacturing,
processing, packing, or holding environment. We identified Salmonella
spp. and Listeria monocytogenes as examples of environmental pathogens.
There was some concern that our proposed definition of ``environmental
pathogen'' would capture organisms such as pathogenic sporeformers
whose presence in and of itself would not constitute a risk to public
(human or animal) health.
    We are proposing to revise the definition of an environmental
pathogen to mean a pathogen capable of surviving and persisting within
the manufacturing, processing, packing, or holding environment such
that animal food may be contaminated and may result in foodborne
illness if that animal food is consumed (or in the case of pet food,
handled by a human) without treatment at the facility to significantly
minimize the environmental pathogen. The revised definition of
``environmental pathogen'' would specify that an environmental pathogen
does not include the spores of pathogenic sporeformers and, thus,
recognizes that consumption of animal food contaminated by the spores
of a pathogenic sporeformer that is in the environment may not result
in foodborne illness. For example, if animal food is contaminated with
spores of Clostridium botulinum, the microorganism would not produce
the botulinum toxin that causes illness unless these spores are subject
to conditions that allow them to germinate into vegetative cells that
produce the toxin. Pathogenic sporeformers are normally present in
animal foods, and unless the foods are subjected to conditions that
allow multiplication, they present minimal risk of causing illness.

C. Proposed Editorial Changes

    The revised regulatory text includes several changes that we are
making to make the requirements more clear and improve readability. We
summarize the principal editorial changes in Table 8.

                   Table 8--Proposed Editorial Changes
------------------------------------------------------------------------
 Designation in the revised
 regulatory text  (Proposed     Proposed revision        Explanation
          Sec.   )
------------------------------------------------------------------------
Throughout part 507.........  Substitute the term   For the purposes of
                               ``adequate'' for      part 507, there is
                               the term              no meaningful
                               ``sufficient''.       difference between
                                                     ``adequate'' and
                                                     ``sufficient.'' We
                                                     proposed a
                                                     definition of
                                                     ``adequate'' but
                                                     did not propose to
                                                     define
                                                     ``sufficient.'' We
                                                     tentatively
                                                     conclude that the
                                                     regulations will be
                                                     clearer if we use
                                                     the single term
                                                     ``adequate''
                                                     throughout the
                                                     regulations.

Throughout subparts A, C,     Substitute the        Improve clarity and
 and D.                        defined term          readability.
                               ``you'' for
                               ``owner, operator,
                               or agent in charge
                               of a facility''.
507.31......................  Redesignate the       Accommodate
                               section number from   insertions of new
                               the original          Sec.   507.28 to
                               section number in     subpart B.
                               the 2013 proposed
                               preventive controls
                               rule (proposed
                               507.30).
507.31(d)...................  Specify that the      Distinguish the
                               food safety plan is   requirements for
                               a record that is      the contents of the
                               subject to the        food safety plan
                               requirements of       from implementation
                               subpart F within      records, which
                               the requirements      continue to be
                               for the food safety   listed in Sec.
                               plan (Sec.            507.55.
                               507.31) rather than
                               together with the
                               requirements for
                               other records
                               required by the
                               rule (Sec.
                               507.55).
507.33(b)...................  Reordered the         We tentatively
                               provisions in         conclude that it is
                               paragraph (b).        more logical to
                                                     specify what
                                                     hazards must be
                                                     considered (i.e.,
                                                     biological,
                                                     chemical (including
                                                     radiological), and
                                                     physical) before
                                                     specifying the
                                                     reasons for how the
                                                     hazards could get
                                                     into the food
                                                     products (i.e.,
                                                     naturally
                                                     occurring,
                                                     unintentionally
                                                     introduced, or
                                                     intentionally
                                                     introduced for
                                                     purposes of
                                                     economic gain).
507.36......................  Shorten the title     Simplify the
                               from ``Preventive     presentation of the
                               controls for          requirements and
                               hazards that are      conform with the
                               reasonably likely     proposed deletion
                               to occur'' to         of the term
                               ``Preventive          ``hazards that are
                               Controls''.           reasonably likely
                                                     to occur''.
507.36(c)(1)................  Rearrange the         It is more logical
                               requirements for      to place these
                               (i) parameters        requirements with
                               associated with the   process controls
                               control of the        since their
                               hazard and (ii) the   parameters and
                               maximum or minimum    their values are
                               value, or             associated with
                               combination of        process controls.
                               values, to which
                               any biological,
                               chemical, or
                               physical parameter
                               must be controlled
                               to be associated
                               with process
                               controls rather
                               than be a
                               standalone
                               requirement.
507.36(c)(2) and 507.42(c)..  Move requirements     Improve clarity and
                               for corrections for   readability.
                               sanitation controls
                               from the
                               requirements for
                               preventive controls
                               (proposed Sec.
                               507.36) to the
                               requirements for
                               corrective actions
                               (proposed Sec.
                               507.42).
507.38......................  Shorten the title     Simplify the
                               from ``Recall plan    presentation of the
                               for animal food       requirements and
                               with a hazard that    conform with the
                               is reasonably         proposed deletion
                               likely to occur''     of the term
                               to ``Recall plan''.   ``animal food with
                                                     a hazard that is
                                                     reasonably likely
                                                     to occur''.
507.40......................  Redesignate the       Accommodate
                               section number from   insertions of new
                               the original          Sec.   507.37
                               section number in     (supplier program)
                               the 2013 proposed     and new Sec.
                               preventive controls   507.39 (preventive
                               rule (proposed Sec.   control management
                                 507.39) and         components) and
                               modify the language.  reword to more
                                                     closely match the
                                                     statutory language.
507.45, 507.47, 507.49, and   Move the more         Improve clarity and
 507.50.                       extensive             readability.
                               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).
507.50(a)(4)................  Revise the            Simplify the
                               requirements for      presentation of
                               reanalysis of the     requirements and
                               food safety plan      reduce redundancy
                               after an              in regulatory text
                               unanticipated event   for inter-related
                               in which a            requirements.
                               preventive control
                               is not properly
                               implemented to
                               refer to the
                               requirements for
                               corrective actions
                               in light of such an
                               event rather than
                               repeat the full
                               text of those
                               requirements for
                               corrective actions.
507.50(c)...................  Specify ``document    Improve clarity and
                               the basis for the     readability.
                               conclusion that no
                               revisions are
                               needed'' rather
                               than ``document the
                               basis for the
                               conclusion that no
                               additional or
                               revised preventive
                               controls are
                               needed''.
507.50(e)...................  Specify ``You must    Improve clarity by
                               conduct a             specifying what the
                               reanalysis of the     owner, operator, or
                               food safety plan      agent in charge of
                               when FDA determines   the facility must
                               it is necessary to    do in certain
                               respond to new        circumstances
                               hazards and           rather than what
                               developments in       FDA may require.
                               scientific
                               understanding''
                               rather than ``FDA
                               may require a
                               reanalysis of the
                               food safety plan to
                               respond to new
                               hazards and
                               developments in
                               scientific
                               understanding.''.
507.55......................  Change the title      Accurately reflect
                               from ``Records        the nature of the
                               required for          listed records
                               subpart C'' to        after moving
                               ``Implementation      recordkeeping
                               records''.            requirements for
                                                     the food safety
                                                     plan to Sec.
                                                     507.31.
507.55(a)(3)(ii) and (iii)..  Add ``verification    Distinguish these
                               of'' in front of      requirements for
                               ``monitoring'' and    records applying to
                               ``corrective          ``verification of
                               actions''.            monitoring'' and
                                                     ``verification of
                                                     corrective
                                                     actions'' from
                                                     other requirements
                                                     for ``records of
                                                     monitoring'' and
                                                     ``records of
                                                     corrective
                                                     actions''.
------------------------------------------------------------------------

D. Proposed Conforming Change to Proposed Part 117

    As discussed in section IX, we are proposing a conforming change to
proposed part 117, the preventive controls rule for human food. We are
proposing to add Sec.  117.95 to proposed subpart B that would add
current good manufacturing practice requirements that would apply to
human food manufacturers/processors when by-products from human food
production are packed and held for animal food.

XVIII. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). FDA has developed a PRIA that presents the benefits and costs
of this proposed rule (Ref. 1). FDA believes that the proposed rule
will be a significant regulatory action as defined by Executive Order
12866. FDA requests comments on the PRIA.
    The summary analysis of benefits and costs included in this
document is drawn from the detailed PRIA (Ref. 1) which is available at
http://www.regulations.gov (enter Docket No. FDA-2011-N-0922), and is
also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

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

C. Small Business Regulatory Enforcement Fairness Act of 1996

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

D. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA expects that the
proposed rule will result in a 1-year expenditure that would exceed
this amount.

XIX. Paperwork Reduction Act of 1995

    This supplemental notice of proposed rulemaking contains
information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520). A description of these provisions is
given in the Description section with an estimate of the annual
recordkeeping, reporting, and third-party disclosure burden. Included
in the estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Title: Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Food for Animals.
    Description: FDA is proposing to amend its 2013 proposed rule for
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals to add requirements for
domestic and foreign facilities that are required to register under
section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The amendments include potential provisions that would require
facilities to establish and implement, as necessary, the following
verification activities: product testing, environmental monitoring, and
a supplier program. In addition, FDA is amending its proposed rule to
require that the hazard analysis (HA) and risk-based preventive
controls for animal food take into account the possibility of
economically motivated adulteration (EMA) of animal food.
    Description of Respondents: Section 418 of the FD&C Act is
applicable to the owner, operator or agent in charge of a food facility
required to register under section 415 of the FD&C Act. Generally, a
facility is required to register if it manufactures, processes, packs,
or holds food for consumption in the United States.
    The information collection estimate for the supplemental proposal
for preventive controls for food for animals may increase if the
potential requirements (the addition of provisions for product testing,
environmental monitoring, a supplier program, and identifying and
evaluating any potential hazards caused because of economically
motivated adulteration) are finalized. Additionally, proposed labeling
requirements have been added for animal food, including labeling of
human food by-products used for animal food.

Information Collection Burden Estimate

Supplemental Notice of Proposed Rulemaking Burden

Recordkeeping Burden

    FDA estimates the burden for this information collection, should
the potential provisions in this proposed rule be included in any final
rule, as follows:

                                                Table 9--Estimated Potential Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average
                                             Number of       Number of     Total  annual    burden per                    Capital  costs   Operating and
       21 CFR part 507, subpart C             record-       records per       records     record-keeping   Total  hours         \2\         maintenance
                                            keepers \1\    record-keeper                     (in hours)                                        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potential product testing written                     20            0.33             6.6            5.33              35  ..............          [sup1]
 procedures (small pet food                                                                                $131,400
 manufacturers) (potential Sec.
 507.49(a)(2))..........................
Potential product testing written                     10            0.33             3.3            5.33              18  ..............      ( [sup4] )
 procedures (small ingredient
 manufacturers) (potential Sec.
 507.49(a)(2))..........................
Potential environmental monitoring                   105            0.33              35            5.33             187  ..............  [sup2] 368,200
 written procedures (potential Sec.
 507.49(a)(3))..........................
Potential supplier program written                 4,325            0.33           1,428            5.33           7,611      $4,018,100  [sup2] 162,200
 procedures (potential Sec.
 507.37(a)(2))..........................
Sec.   507.37(c)(3) and (c)(4) qualified             134             0.5              67               2             134  ..............  ..............
 or exempt suppliers' assurances........
Sec.   507.33(b)(2)(iii) written HA for            4,325            0.33           1,428               3           4,284        $627,800          [sup2]
 EMA....................................                                                                                4,227,300
Sec.   507.33(b)(2)(iii) updating                  4,325             0.5           2,163             0.1             216      ( [sup5] )      ( [sup5] )
 written HA for EMA.....................
Sec.   507.49(a)(4)(ii) verification--               952              12          11,424             0.5           5,712  ..............  [sup1] 258,400
 review of records......................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr                -----------------------------------------------------------------------------------------------
    Total...............................  ..............  ..............  ..............  ..............          18,197      $4,645,900       5,147,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ From 2014 PRIA (Ref. 1).
\2\ These numbers were obtained from FDA economics staff.
\3\ Costs for product testing and EMA are broken out across 2 rows.
\4\ Included in row 1 costs.\3\
\5\ Included in row 6 costs.\3\

    Table 9 indicates the potential hourly and cost burden for
complying with the supplemental notice of proposed rulemaking: i.e.,
product testing, environmental monitoring, the supplier program,
economically motivated adulteration, and verification review of
records.
    Should the potential provisions in this proposed rule be included
in any final rule, we estimate 8,130 facilities would be subject to
subpart C--Hazard Analysis and Risk-Based Preventive Controls. We also
estimate the number of non-qualified facilities would be 4,325 and the
number of qualified facilities would be 3,805.
    Should the potential product testing provision be included in a
final rule, product testing would be an activity for verification of
implementation and effectiveness FDA estimates that 102 non-qualified
small pet food manufacturers and 67 non-qualified small ingredient
suppliers exist. The Eastern Research Group (ERG) cost model reports
that only these categories contain facilities subject to Subpart C that
do not currently test animal food products for Salmonella but that
might do so under proposed Sec.  507.49(a)(2). The ERG also estimates
that 20% of facilities are out of perfect compliance and would need to
develop and record written procedures. In Table 9, to obtain the amount
for total records for product testing for small pet food manufacturers,
20 small pet food manufacturers (recordkeepers) (20% of 102) multiplied
by 0.33 records per recordkeeper (1 written procedure during the 3-year
PRA approval period) equals 6.6 total records annually. Then, to obtain
total hours, 6.6 total records multiplied by 5.33 average burden per
record in hours (time needed according to FDA subject matter experts
(SMEs)) equals 35 hours annually. For small ingredient manufacturers
(Table 9, row 2), to obtain the total number of records, 10
recordkeepers (20% of 67 rounded down to 10) multiplied by 0.33 records
per recordkeeper (1 written procedure during the 3-year PRA approval
period) equals 3.3 total records. Then, to obtain the total number of
hours, 3.3 total records multiplied by 5.33 average burden per record
in hours (time needed according to FDA SMEs) equals 18 hours annually.
    Should the potential environmental monitoring provision be
finalized, FDA estimates 105 recordkeepers would need to include
environmental monitoring procedures as a verification activity,
creating one written procedure per facility. In Table 9, to obtain the
number of annual records, 105 recordkeepers multiplied by 0.33
environmental monitoring procedures per facility (over 3 years of the
PRA approval period) equals 35 annual records. Then, to obtain the
total number of hours, 35 total records multiplied by 5.33 average
burden per record in hours (time needed according to FDA SMEs) equals
187 total hours annually.

    Should the potential supplier program previously discussed be
included in a final rule, a receiving facility establish and implement
a risk-based supplier program for those raw materials and ingredients
for which the receiving facility has identified a significant hazard
when the hazard is controlled before receipt of the raw material or
ingredient, a receiving facility would not be required to establish and
implement a supplier program for raw materials and ingredients for
which there are no significant hazards, for which the preventive
controls at the receiving facility are adequate to significantly
minimize or prevent each of the significant hazards, or for which the
receiving facility relies on its customer to control the hazard and
annually obtains from its customer written assurance that the customer
has established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the hazard. The
potential procedures for the supplier program would need to be written
should this provision be included in a final rule. FDA estimates that
all facilities would need to develop a written supplier program. In
Table 9, to obtain the total number of records, 4325 recordkeepers
(keeping written records of written assurances) multiplied by 0.33
records per facility per year (during the three year PRA approval)
equals 1,428 records annually. Then 1,428 multiplied by 5.33 hours to
create each record (time needed according to FDA SMEs) equals 7,611
total hours annually.
    Should the potential supplier program be finalized, suppliers that
would be qualified facilities and suppliers that are farms not subject
to the requirements in proposed 21 CFR part 112 regarding the raw
material or ingredient that the receiving facility receives from the
farm would need to create at least every 2 years a written assurance to
be given to their receiving facility customers. This assurance would
need to describe the processes and procedures that the supplier is
following to ensure the safety of the animal food. FDA estimates that
these few suppliers would require about two hours to create this
documentation to be submitted to their receiving facility customers. To
obtain the total number of records, 134 recordkeepers multiplied by 0.5
records per year (submitted every 2 years) equals 67 records annually.
To obtain the total number of hours, 67 records multiplied by 2 hours
per record equals 134 hours annually.
    For proposed Sec.  507.33(b)(2)(iii), FDA estimated an average of 3
hours additional time for the hazard analysis in order to account for
the possibility of economically motivated adulteration. To obtain the
total number of records, 4,325 recordkeepers multiplied by 1 record per
facility (or 0.33 records annually for the 3-year PRA approval) for
writing and developing the initial hazard analysis equals 1,428 total
records annually. Then 1,428 multiplied by an additional 3 hours per
hazard analysis equals 4,284 total hours annually. In the 2013 PRIA
(Ref. 22), FDA estimated that on average, facilities will need to
update their hazard analysis every two years. In addition, FDA
estimates 0.1 hours additional time would be needed to update the
hazard analysis. To obtain the total number of records, 4,325
recordkeepers multiplied by 0.5 records per year equals 2,163 total
records. Then 2,163 total records multiplied by 0.1 hours per record
equals 216 hours annually.
    The potential supplier program would require verification of
implementation and effectiveness, including review of records for
product testing, environmental monitoring, and supplier verification
activities. Based on the responses to the ERG survey of human food
production facilities, FDA estimates that the percentage of animal food
facilities without these verification records varies from about 39% of
those with fewer than 20 employees, to less than one percent for those
with 100 or more employees. This equates to about 952 facilities, all
of which would be out of compliance with the record review verification
requirements.
    To obtain the total number of records, 952 multiplied by 12 records
per year (or 1 record per month) equals 11,424 records. To obtain the
total number of hours, 11,424 records multiplied by 0.5 hours per
record (time needed according to FDA SMEs) equals 5,712 hours annually.

Reporting Burden

    There is no reporting burden in this information collection.

Third Party Disclosure Burden

    Under proposed Sec.  507.27(a)(3), labeling identifying the product
by the common or usual name would need to be affixed to or accompany
the animal food. The number of disclosures per respondent and the
average burden per disclosure in Table 10 below were obtained by
consulting FDA SMEs.
    FDA estimates the burden for this information collection as
follows:

                                                  Table 10--Estimated Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                     21 CFR part 507, subpart B                         Number of     disclosures per   Total  annual   per  disclosure    Total  hours
                                                                       respondents       respondent      disclosures       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   507.27 Holding and distribution.............................            8130               20          162,600             0.25           40,650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    There are 8,130 facilities which each would have 20 sets of
labeling per facility to affix to or accompany the animal food for a
total number of 162,600 disclosures (labeling) per year. To obtain
total number of hours, 162,600 disclosures multiplied by 0.25 hour to
print labeling, and affix to the containers if labels, equals 40,650
total hours annually.
    Under proposed Sec.  507.28(a)(3), labeling identifying the human
food by-product by the common or usual name would need to be affixed to
or accompany the animal food. The number of disclosures per respondent
and the average burden per disclosure in Table 11 were obtained from
FDA SMEs.
    FDA estimates the burden for this information collection as
follows:

                                                  Table 11--Estimated Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                     21 CFR part 507, subpart B                         Number of     disclosures per   Total  annual   per  disclosure    Total  hours
                                                                       respondents       respondent      disclosures       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   507.28(a)(3) Holding and distribution of human food by-               40,798                2           81,596             0.25           20,399
 products for use as animal food...................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    According to FDA SMEs, an estimated 60 percent of the 67,996
domestic human food manufacturing facilities (Ref. 23) or 40,798
facilities would be affected, with two sets of labeling per facility
per year expected, equals 81,596 disclosures (labeling). To obtain the
number of total hours, 81,596 disclosures multiplied by 0.25 hours to
prepare labeling, and affix to the containers if labels, equals 20,399
total hours.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should
be identified with the title, ``Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this supplemental notice of proposed rulemaking to OMB
for review. These requirements will not be effective until FDA obtains
OMB approval. FDA will publish a notice concerning OMB approval of
these requirements in the Federal Register.

XX. Analysis of Environmental Impact

    As with the 2013 preventive controls proposed rule, we determined
under 21 CFR 25.30(j) that this supplemental notice of proposed
rulemaking is an action of a type that does not individually or
cumulatively have a significant effect on the human environment (Ref.
24). Therefore, neither an environmental assessment nor an
environmental impact statement is required.

XXI. Comments

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

XXII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA, ``FSMA Supplemental Notice of Proposed Rulemaking for
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals. Preliminary
Regulatory Impact Analysis,'' 2014.
2. FDA, ``Transcript: FSMA Proposed Rule on Preventive Controls for
Animal Food (PCAF) Facilities Public Meeting, November 21, 2013.''
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm368989.htm and in Docket No. FDA-2011-N-0922 (accessed on
September 5, 2014).
3. FDA, ``Transcript: FSMA Proposed Rule on Preventive Controls for
Animal Food (PCAF) Facilities Public Meeting, November 25, 2013.''
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm368988.htm and in Docket No. FDA-2011-N-0922 (accessed on
September 5, 2014).
4. FDA, ``Transcript: FSMA Proposed Rule on Preventive Controls for
Animal Food (PCAF) Facilities Public Meeting, December 6, 2013.''
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm371844.htm and in Docket No. FDA-2011-N-0922 (accessed on
September 5, 2014).
5. FDA, ``Update on Proposed Rules under the FDA Food Safety
Modernization Act (March 19, 2014).'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm389696.htm and in Docket
No. FDA-2011-N-0922 (accessed on September 5, 2014).
6. Cooperative Extension Service, Division of Agricultural Sciences
and Natural Resources, Oklahoma State University; USDA, Federal
Grain Inspection Service; USDA, Extension Service; USDA, Animal and
Plant Health Inspection Service, ``Stored Product Management,''
Circular No. E-912, January 1995. Available at http://entomology.k-
state.edu/doc/extension-crop-pests/
E912AllStoredProductMay3.pdf
(accessed on September 5, 2014).
7. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/Animal
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm,'' 2013.
8. Grasser, L.A., J.G. Fadel, I. Garnett, and E.J. DePeters,
``Quantity and Economic Importance of Nine Selected By-Products Used
in California Dairy Rations,'' Journal of Dairy Science, 78:962-971,
1995.
9. FDA, ``Compliance Program 7371.003, Feed Contaminants'' December
13, 2005.
10. FDA Memorandum, ``Biological, Chemical, and Physical Hazards
Associated With Human Food By-Products Used for Animal Food,'' 2014.
11. FDA, ``Compliance Policy Guide Sec. 675.100 Diversion of
Contaminated Food for Animal Use'' Available at http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074693.htm. Revised: March 1995, Page Last Updated: December 15,
2009 (accessed on September 5, 2014).
12. FDA, ``Compliance Policy Guide Sec. 675.200 Diversion of
Adulterated Food to Acceptable Animal Feed Use'' Available at http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074694.htm. Revised: March 1995, Page Last Updated: December 15,
2009 (accessed on September 5, 2014).
13. Association of American Feed Control Officials (AAFCO), ``Model
Good Manufacturing Practice Regulations for Feed and Feed
Ingredients'', In: AAFCO Official Publication, 210-215, 2010.
14. Food and Agriculture Organization of the United Nations (FAO)
and World Health Organization (WHO), ``Good Practices for the Feed
Industry--Implementing the Codex Alimentarius Code of Practice on
Good Animal Feeding--Section 3 Good Production Practices,'' 2010.
15. British Standards Institute (BSI), ``Publicly Available
Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety
in the Manufacture of Food and Feed for Animals,'' 2011
16. FDA, ``Compliance Policy Guide Sec. 665.100 Common or Usual
Names for Animal Feed Ingredients'' Available at

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074687.htm. Revised: March 1995,
Page Last Updated: December 16, 2009 (accessed on September 5,
2014).
17. Codex Alimentarius Commission, ``Hazard Analysis And Critical
Control Point (HACCP) System And Guidelines For Its Application.
Annex to CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
18. Codex Alimentarius Commission, ``General Principles of Food
Hygiene, CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
19. U.S.Pharmacopeial Convention, ``U.S. Pharmacopeial Convention
(USP) Food Fraud Database,'' March 6, 2014. Available at http://www.usp.org/food-ingredients/food-fraud-database (accessed on
September 5, 2014).
20. Congressional Research Service, ``Food Fraud and Economically
Motivated Adulteration of Food and Food Ingredients,'' January 10,
2014. Available at http://www.fas.org/sgp/crs/misc/R43358.pdf.
(accessed on September 5, 2014).
21. Muth, M. K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator,
``Food Processing Sector Study, Contract HHSF<PHONE_NUMBER>5G, Task
Order 13, Final Report,'' 2011.
22. FDA, ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-based Preventive Controls for Food for Animals--Preliminary
Regulatory Impact Analysis,'' 2013.
23. FDA, ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-based Preventive Controls for Human Food--Preliminary
Regulatory Impact Analysis,'' 2013. Docket No. FDA-2011-N-0920.
24. FDA, ``Re-proposal of Select Provisions of the Proposed Rule:
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals,'' 2014.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I be amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. In Sec.  16.1 amend the entry in paragraph (b)(2), as proposed to be
amended on October 29, 2013 (78 FR 64736), to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  507.60 through 507.85 (part 507, subpart D) relating to
withdrawal of exemption applicable to a qualified facility.
* * * * *

PART 117--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS
AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
3. The authority citation for 21 CFR part 117, as proposed to be added
on January 16, 2013 (78 FR 3646), continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.

0
4. In part 117, as proposed to be added on January 16, 2013 (78 FR
3646), add Sec.  117.95 to read as follows:

Sec.  117.95  Holding and distribution of human food by-products for
use in animal food.

    (a) Human food by-products held for distribution as animal food
without additional manufacturing/processing by the human food
processor, as identified in Sec.  507.12 of this chapter, must be held
under conditions that will protect against contamination, including the
following:
    (1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned, and maintained
to prevent the contamination of animal food;
    (2) Animal food held for distribution must be held in a way to
prevent contamination from sources such as trash and garbage; and
    (3) Labeling identifying the by-product by the common and usual
name must be affixed to or accompany animal food.
    (b) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food.

PART 507--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS
AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

0
5. The authority citation for part 507, as proposed to be added on
October 29, 2013 (78 FR 64736), continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 342, 350c, 350d note, 350g, 350g
note, 371, 374; 42 U.S.C. 243, 264, 271.

Subpart A--General Provisions

0
6. Amend Sec.  507.1, as proposed to be added on October 29, 2013 (78
FR 64736), by removing paragraph (d).
0
7. Amend Sec.  507.3, as proposed to be added on October 29, 2013 (78
FR 64736), as follows:
0
a. By removing definitions for ``Hazard reasonably likely to occur''
and ``Reasonably foreseeable hazard'';
0
b. By alphabetically adding new definitions for ``Known or reasonably
foreseeable hazard''; ``Pathogen''; ``Qualified auditor''; ``Receiving
facility''; ``Significant hazard''; ``Supplier''; and ``You''; and
0