cereals (including cereal grains, pseudo cereals, pulses, and other
plants used in the same fashion) to be used in animal food. Examples of
animal food grains include barley, dent- or flint-corn, sorghum, oats,
rice, rye, wheat, and buckwheat. Oilseeds are the small, hard fruits or
seeds of arable crops that are grown and processed mainly for the oil
that is extracted from them. Examples of animal food oilseeds include
soybean, cottonseed, and rapeseed. Grains and oilseeds are field-dried
before harvest. Post-harvest drying or dehydrating that further reduces
the moisture content of harvested grains and oilseeds for the purpose
of storage or transportation is considered an activity separate from
field drying done before harvest. In the lists that follow, the terms
grain and oilseed are used in a general sense while the terms dried
grain and dried oilseed are used to designate specifically those
harvested grains and oilseeds that have been further dried or
dehydrated for the purpose of storage or transportation.
1. List of Low-Risk On-Farm Packing and Holding Activity/Animal Food
Combinations When Conducted on Animal Food Not Grown, Raised, or
Consumed on That Farm or Another Farm Under the Same Ownership
    The section 103(c)(1)(C) draft RA identified the following low-risk
packing and holding activity/animal food combinations when conducted on
a farm on animal food not grown, raised, or consumed on that farm or
another farm under the same ownership:
     Conveying, weighing, sorting, culling, or grading
(incidental to storing):
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
     Oilseed (e.g., cottonseed, linseed, rapeseed, soybean,
sunflower);
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., almond, peanut or
soybean hulls, citrus, other fruit including culled fruit, potatoes, or
other vegetables including culled vegetables).
     Storing:
     Dried grain;
     Dried oilseed;
     Byproducts of dried grain or dried oilseed;
     Forage; or
     Other plants or plant byproducts.
     Packing:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage; or
     Other plants or plant byproducts.
     Mixing (incidental to packing or storing):
     Grain, whole; or
     Forage.
    The Agency notes that the same activities performed on a farm's own
RACs, or animal food consumed on the farm or another farm under the
same ownership, would be within the farm definition and therefore were
outside the scope of the section 103(c)(1)(C) draft RA.
2. List of Low-Risk On-Farm Manufacturing/Processing Activity/Animal
Food Combinations When Conducted on the Farm's Own Raw Agricultural
Commodities for Distribution Into Commerce
    The section 103(c)(1)(C) draft RA identified the following low-risk
manufacturing/processing activity/animal food combinations when
conducted on a farm on the farm's own RACs distribution into commerce:
     Cracking, crimping, or flaking:
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
     Oilseed (e.g., cotton seed, linseed, rapeseed, soybean,
sunflower) ; or
     Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., such as almond,
peanut, or soybean hulls, citrus, other fruit including culled fruit,
potatoes, or other vegetables including culled vegetables).
     Making silage
     Chopping, or shredding hay.
     Extracting (mechanical) or wet rolling:
     Grain; or
     Oilseed.
3. List of Low-Risk On-Farm Manufacturing/Processing Activity/Animal
Food Combinations When Conducted on Animal Food Other Than the Farm's
Own Raw Agricultural Commodities for Distribution Into Commerce
    The section 103(c)(1)(C) draft RA identified the following low-risk
manufacturing/processing activity/animal food combinations when
conducted on animal food other than the farm's own RACs for
distribution into commerce:
     Cracking, crimping, flaking, or shelling:
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);

     Oilseed (e.g., cotton seed, linseed, rapeseed, soybean,
sunflower) ; or
     Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., such as almond,
peanut, or soybean hulls, citrus, other fruit including culled fruit,
potatoes, or other vegetables including culled vegetables).
     Making silage.
     Chopping or shredding hay.
     Extracting (mechanical) or wet rolling:
     Grain; or
     Oilseed.
     Labeling:
     Grain, whole;
     Oilseed, whole;
     Sifting, separating, or sizing:
     Grain;
     Oilseed;
     Grain or oilseed byproducts; or
     Other plants or plant byproducts.

D. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Animal
Food Combinations Under Section 418 of the FD&C Act

    Based on the results of the section 103(c)(1)(C) draft RA regarding
on-farm low-risk activity/animal food combinations, the Agency is
proposing in Sec.  507.5(e) and (f) to exempt farm mixed-type
facilities that are small or very small businesses (as defined in
proposed Sec.  507.3) from requirements under section 418 of the FD&C
Act if the only activities subject to section 418 that the business
conducts are low-risk activity/animal food combinations (see the
discussion of these proposed exemptions in section VIII.C). The
proposed exemptions would not exempt eligible facilities from the
requirement to register under section 415 of the FD&C Act.

E. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Animal
Food Combinations Under Section 421 of the FD&C Act

    The Agency tentatively concludes that it should consider the low-
risk on-farm activity/animal food combinations identified in the
section 103(c)(1)(C) draft RA as a factor in identifying high-risk
facilities that are small and very small businesses and allocating
inspection resources under section 421 of the FD&C Act, Targeting of
Inspectional Resources for Domestic Facilities. However, at this time,
the Agency tentatively concludes that it should not exempt or modify
the frequency requirements under section 421 based solely upon whether
a facility only engages in such low-risk activity/animal food
combinations and is a small or very small business. Current data
limitations impact the Agency's ability to accurately identify such
facilities, and it must be able to identify such facilities in order to
implement an exempted or modified inspection frequency schedule. The
Agency requests comment on whether it should establish data submission
requirements that would allow the Agency to identify these types of
facilities in order to exempt such facilities from the inspection
frequencies, or modify the inspection frequencies that apply to such
facilities, under section 421 of the FD&C Act. Examples of data
elements that the Agency might need in order to identify these
facilities include: Identification of a facility as a farm mixed-type
facility, annual monetary value of sales, number of employees, animal
food category/activity type. The Agency also requests comment on these
possible data elements and any other criteria that may be appropriate
for the purposes of allocating inspection resources to these
facilities.

VIII. Proposed Subpart A--General Provisions

A. Proposed Sec.  507.1--Applicability and Status

    FDA is proposing in Sec.  507.1(a) that the criteria and
definitions in part 507 apply in determining whether an animal food is
adulterated: (1) Within the meaning of section 402(a)(3) of the FD&C
Act in that the animal food has been manufactured under such conditions
that it is unfit for food; or (2) within the meaning of section
402(a)(4) of the FD&C Act in that the animal food has been prepared,
packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health. Proposed Sec.  507.1(a) also would establish that the
criteria and definitions in part 507 apply in determining whether an
animal food is in violation of section 361 of the Public Health Service
Act (the PHS Act) (42 U.S.C. 264). The Agency notes that section 418(a)
of the FD&C Act provides that facilities subject to that section must
``identify and implement preventive controls to . . . provide
assurances that . . . food is not adulterated under section 402 [of the
FD&C Act]'' and that similar references to preventing adulteration
under section 402 of the FD&C Act also appear in section 418(c) and
(e). The Agency tentatively concludes that the link between the
proposed provisions and the potential for adulteration provides a basis
for applying the criteria and definitions in proposed part 507 in
determining whether, under particular circumstances, an animal food is
adulterated under section 402(a)(3) or (a)(4) or in violation of
section 361 of the PHS Act.
    Section 103(e) of FSMA amends section 301 of the FD&C Act by adding
a new section--(uu)--to the list of acts and the causing thereof that
are prohibited. Under section 301(uu), the following act, and the
causing thereof, is prohibited:''[t]he operation of a facility that
manufactures, processes, packs, or holds food for sale in the United
States if the owner, operator, or agent in charge of such facility is
not in compliance with section 418 [of the FD&C Act].'' To clearly
communicate that failure to comply with regulations established under
section 418 is a prohibited act, proposed Sec.  507.1(b) would
establish that the operation of a facility that manufactures,
processes, packs, or holds animal food for sale in the United States if
the owner, operator, or agent in charge of such facility is required to
comply with, and is not in compliance with, section 418 of the FD&C Act
or the regulations implementing section 418 [of the FD&C Act] in
subparts C, D, or F of proposed part 507, and Sec.  507.7 of proposed
part 507, is a prohibited act under section 301(uu) of the FD&C Act.
    Proposed Sec.  507.1(c) would establish that animal food covered by
specific current good manufacturing practice regulations also is
subject to the requirements of those regulations. FDA has established
CGMP requirements for thermally processed low-acid foods packaged in
hermetically sealed containers (proposed rule, 41 FR 30444, July 23,
1976; final rule, 44 FR 16209, March 16, 1979; currently established in
part 113; and 61 FR 37681, July 19, 1996; currently established in
Sec.  500.23). Therefore, animal foods that are subject to 21 CFR
500.23 and part 113 are subject to the requirements of Sec.  500.23 and
part 113 even though they are foods covered by the current good
manufacturing practice requirements of proposed part 507.
    Proposed Sec.  507.1(d) would apply to facilities that manufacture,
process, pack, or hold animal food and human food. The Agency wanted to
address the instances where a facility may handle both animal and human
food in some form, to make it clear which proposed rule would apply for
that facility manufacturing, processing, packing, or holding these
foods. In addition, in some facilities, ``waste'' from human

food production, such as by-products that may not be edible for humans,
or lack nutritional value for humans, are used or sold for animal food.
Many species of animals have different digestive systems and
nutritional requirements than humans, thus allowing for this use. For
the human food manufactured, processed, packed, or held, the facility
would need to comply with proposed part 117 (proposed rule for
preventive controls for human food (78 FR 3646)), subparts B and C as
applicable (facilities subject to subpart B may not also be subject to
subpart C), and as subject to the exemptions for proposed part 117. For
the animal food manufactured, processed, packed, or held, the facility
may choose to comply with either proposed part 507 subparts B and C as
applicable or proposed part 117 subparts B and C as applicable, so long
as the food safety plan also addresses all hazards that are reasonably
likely to occur in the animal food, including nutrient imbalances.
``Food'' used in proposed part 117 would be read to include ``animal
food'' when the facility is applying proposed part 117 to the animal
food. For example, human food waste that is used for animal food would
be treated as ``food'' for the purposes of its animal food use and as
waste for the purposes of its role in human food production. The Agency
tentatively concludes that this will provide facilities the flexibility
to streamline their compliance efforts, while also ensuring human and
animal food safety.
    FDA requests comment on the applicability of the requirements of
this proposed rule to FSIS official establishments that manufacture,
process, pack, or hold food for animals. And, if applicable, to what
extent should the requirements apply to these establishments?

B. Proposed Sec.  507.3--Definitions

1. Definitions That FDA is Proposing
    In developing the following proposed definitions, FDA aimed to be
consistent with proposed part 117 of the proposed rule for preventive
controls for human food (see the document for the proposed rule for
preventive controls for human food (78 FR 3646)). The Agency also
considered how these currently existing and proposed definitions should
be clarified for use in the animal food context.
    The Agency is proposing in Sec.  507.3 that the terms defined in
section 201 of the FD&C Act would be applicable to such terms when used
in this part, unless otherwise specified. Additional terms are listed,
defined, and discussed in alphabetical order in this section. These
definitions are based on the Agency's experience in regulating human
food, animal food, common usage in the animal food industry, and
definitions in section 418 of the FD&C Act.
    Proposed Sec.  507.3 defines ``adequate'' as that which is needed
to accomplish the intended purpose in keeping with good public health
practice.
    FDA is proposing to define the term ``affiliate'' as it is defined
in section 418(l)(4)(A) of the FD&C Act to mean any facility that
controls, is controlled by, or is under common control with another
facility. This term relates to the determination of whether a facility
meets the definition of a qualified facility.
    Proposed Sec.  507.3 defines ``animal food'' as food for animals
other than man, and includes pet food, feed, and raw materials and
ingredients. When used in this part, the phrase ``animal food'' does
not refer to food derived from animals that is intended for human
consumption.
    Proposed Sec.  507.3 defines ``batter'' to mean a semifluid
substance, usually composed of flour and other ingredients, into which
principal components of food are dipped or with which they are coated,
or which may be used directly to form bakery foods.
    Proposed Sec.  507.3 defines ``blanching'' to mean, except for tree
nuts and peanuts, a prepackaging heat treatment of foodstuffs for a
sufficient time and at a sufficient temperature to partially or
completely inactivate the naturally occurring enzymes and to effect
other physical or biochemical changes in the food.
    Proposed Sec.  507.3 defines ``calendar day'' to mean every day
shown on the calendar.
    Proposed Sec.  507.3 defines ``critical control point (CCP)'' as a
point, step, or procedure in a food process at which control can be
applied and is essential to prevent or eliminate a food safety hazard
or reduce such hazard to an acceptable level.
    The Agency is proposing to define the term ``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. Salmonella
would be an example of an environmental pathogen, particularly in
regards to pet food, given that it is a microorganism of animal or
human health significance and is capable of surviving and persisting
within the manufacturing, processing, packing, and holding. An animal
food may be injurious to the health of animals if it is contaminated
with a Salmonella serotype that is pathogenic to the animal species
intended to consume the food. With respect to the risk to humans, pet
food and pet treats that are intended to be fed to animals in homes and
are contaminated with any Salmonella serotype may be injurious to human
health, especially where the food is likely to be directly handled by
the elderly or individuals with compromised immune systems, or be
ingested by children. FDA requests comment on this definition and the
types of organisms that should be considered environmental pathogens
for animal food, including whether spores of pathogens such as
Clostridium spp. and Bacillus anthracis should be considered
environmental pathogens.
    FDA is proposing to define the term ``facility'' as it is defined
in section 418(o)(2) of the FD&C Act to mean a domestic facility or a
foreign facility that is required to register under section 415 of the
FD&C Act, in accordance with part 1, subpart H. FDA tentatively
concludes that the definition of facility should include a reference to
the regulation that implements section 415 of the FD&C Act and proposed
to update the definition in Sec.  1.227 in section VIII.E of the
document for the proposed rule for preventive controls for human food
(78 FR 3646). The regulation implementing section 415 of the FD&C Act
provides important details to help firms determine whether they are
required to register.
    The Agency is proposing to cross-reference the definition of
``farm'' rather than to define it in proposed part 507 because the
definition of ``farm,'' under both current Sec.  1.227(b)(3) and
proposed Sec.  1.227 (found in section VIII.E of the document for the
proposed rule for preventive controls for human food (78 FR 3646))
includes the word ``facility'' with a meaning that is broader than the
meaning of ``facility'' in section 418(o)(2) of the FD&C Act. Under
part I, subpart H, the term ``facility'' is not limited to entities
that are required to register under section 415 of the FD&C Act. The
Agency is proposing to cross-reference the definition of ``farm'' to
reduce the potential confusion that could result if the Agency used the
term ``facility'' to have two different meanings within proposed part
507.
    Proposed Sec.  507.3 defines ``food'' to mean food as defined in
section 201(f) of the FD&C Act and includes raw materials and
ingredients.
    Proposed Sec.  507.3 defines ``food-contact surfaces'' as those
surfaces that contact food and those surfaces from

which drainage, or other transfer, onto the food or onto surfaces that
contact the food ordinarily occurs during the normal course of
operations. ``Food-contact surfaces'' includes food-contact surfaces of
utensils and equipment. The Agency is proposing this definition to
clarify the meaning of the phrase ``food-contact surfaces'' when used
in this proposed part.
    The Agency is proposing to define the term ``harvesting'' as
follows: Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed by farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities on the
farm on which they were grown or raised, or another farm under the same
ownership. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the FD&C Act,
into a processed food as defined in section 201(gg) of the FD&C Act.
Gathering, washing, trimming of outer leaves of, removing stems and
husks from, sifting, filtering, threshing, shelling, and cooling raw
agricultural commodities grown on a farm or another farm under the same
ownership are examples of harvesting. The Agency is proposing the same
definition of ``harvesting'' here as in proposed Sec.  1.227 (see
section VIII.E of the document for the proposed rule for preventive
controls for human food (78 FR 3646)).
    The Agency is proposing to define ``hazard'' to mean any
biological, chemical, physical, or radiological agent that is
reasonably likely to cause illness or injury in animals or humans in
the absence of its control. The phrase ``in animals or humans'' is
included in this definition because a biological, chemical, physical,
or radiological agent in animal food could cause injury and illness to
not only animals, but to humans that handle the animal food, or eat
products (such as milk, meat, or eggs) derived from animals that
ingested the food. The Agency is proposing to include radiological
agents to implement section 418(b)(1)(A) of the FD&C Act, which
includes radiological hazards as an example of known or reasonably
foreseeable hazards that may be associated with a facility. For further
discussion on the definition of ``hazard'' and its consistency with
HACCP, see section X.B of the document for the proposed rule for
preventive controls for human food (78 FR 3646).
    The Agency is proposing to define the phrase ``hazard reasonably
likely to occur'' to mean a hazard for which a prudent person who
manufactures, processes, packs, or holds food would establish controls
because experience, illness data, scientific reports, or other
information provides a basis to conclude that there is a reasonable
possibility that the hazard will occur in the type of food being
manufactured, processed, packed, or held in the absence of those
controls. For further discussion on the definition of ``hazard
reasonably likely to occur'' and its consistency with HACCP, see
section X.B of the document for the proposed rule for preventive
controls for human food (78 FR 3646). This concept is used in FDA's
HACCP regulations for juice (21 CFR 120.7(a)(2)) and seafood (Sec.
123.6(a) (21 CFR 123.6(a))), and in the meat and poultry HACCP
regulation (9 CFR 417.2(a)(1)).
    The Agency is proposing to define the term ``holding'' to mean
storage of food. Holding facilities would include warehouses, cold
storage facilities, storage silos, grain elevators, and liquid storage
tanks. For farms and farm mixed-type facilities, holding would also
include activities traditionally performed by farms for the safe or
effective storage of raw agricultural commodities grown or raised on
the same farm or another farm under the same ownership, but does not
include activities that transform a raw agricultural commodity, as
defined in section 201(r) of the FD&C Act, into a processed food as
defined in section 201(gg) of the FD&C Act. The Agency is proposing the
same definition of ``holding'' here as in proposed Sec.  1.227 (see
section VIII.E of the document for the proposed rule for preventive
controls for human (78 FR 3646)).
    The Agency is proposing to define the term ``lot'' to mean the food
produced during a period of time indicated by a specific code.
    The Agency is proposing to define the term ``manufacturing/
processing'' to mean making food from one or more ingredients, or
synthesizing, preparing, treating, modifying or manipulating food,
including food crops or ingredients. The proposed definition would also
state that examples of manufacturing/processing activities are cutting,
peeling, trimming, washing, waxing, eviscerating, rendering, cooking,
baking, freezing, cooling, pasteurizing, homogenizing, mixing,
formulating, bottling, milling, grinding, extracting juice, distilling,
labeling, or packaging. For farms and farm mixed-type facilities,
manufacturing/processing would not include activities that are part of
harvesting, packing, or holding. The Agency is proposing the same
definition of ``manufacturing/processing'' here as in proposed Sec.
1.227 (see section VIII.E of the document for the proposed rule for
preventive controls for human food (78 FR 3646)).
    Proposed Sec.  507.3 defines ``microorganisms'' to mean yeasts,
molds, bacteria, viruses, protozoa, and microscopic parasites and
includes species having animal or human health significance. The term
``undesirable microorganisms'' includes those microorganisms that are
of animal and human health significance, that subject food to
decomposition, that indicate that food is contaminated with filth, or
that otherwise may cause food to be adulterated. FDA considers not only
yeasts, molds, bacteria and viruses, but also protozoa and microscopic
parasites, to be microorganisms of importance in the safe and sanitary
production of animal food.
    The Agency is proposing to define the term ``mixed-type facility''
to mean an establishment that engages in both activities that are
exempt from registration under section 415 of the FD&C Act and
activities that require the establishment to be registered. An example
of such a facility would be a ``farm mixed-type facility,'' which is an
establishment that grows and harvests crops or raises animals and may
conduct other activities within the farm definition, but also conducts
activities that require the establishment to be registered. The Agency
is proposing to use the same definition as would be established in
proposed Sec.  1.227 (see section VIII.E of the document for the
proposed rule for preventive controls for human (78 FR 3646)).
    The Agency is proposing to define the term ``monitor'' to mean to
conduct a planned sequence of observations or measurements to assess
whether a process, point, or procedure is under control and to produce
an accurate record for use in verification. For further discussion on
the definition of ``monitor'' and its consistency with HACCP, see
section X.B of the document for the proposed rule for preventive
controls for human (78 FR 3646)).
    The Agency is proposing to define the term ``packaging'', when used
as a verb, to mean placing food into a container that directly contacts
the food and that the consumer receives. This definition would match
the definition of ``packaging'' in proposed Sec.  1.227 (see section
VIII.E of the document for the proposed rule for preventive controls
for human (78 FR 3646)). For purposes of animal food, the use of the
term ``consumer'' refers to the person purchasing the animal food to
feed to an

animal(s) and the animal(s) consuming the food.
    The Agency is proposing to define the term ``packing'' as it is
defined in proposed Sec.  1.227 (see section VIII.E of the document for
the proposed rule for preventive controls for human food (78 FR 3646)
to mean placing food into a container other than packaging the food.
For farms and farm mixed-type facilities, packing also includes
activities traditionally performed by farms to prepare raw agricultural
commodities grown or raised on the same farm or another farm under the
same ownership for storage and transport, but does not include
activities that transform a raw agricultural commodity, as defined in
section 201(r) of the FD&C Act, into a processed food as defined in
section 201(gg) of the FD&C Act.
    Proposed Sec.  507.3 defines ``pest'' to mean any objectionable
animals or insects including, but not limited to, birds, rodents,
flies, and larvae. For example, mice would be objectionable animals in
the animal food manufacturing, processing, packing or holding
environment because they can cause contamination of food and food
contact surfaces with pathogens of animal or human health significance.
    Proposed Sec.  507.3 defines ``plant'' to mean the building or
establishment or parts thereof, used for or in connection with the
manufacturing, processing, packing, or holding of food.
    The Agency is proposing to define ``preventive controls'' to mean
those risk-based, reasonably appropriate procedures, practices, and
processes that a person knowledgeable about the safe manufacturing,
processing, packing, or holding of food would employ to significantly
minimize or prevent the hazards identified under the hazard analysis
that are consistent with the current scientific understanding of safe
food manufacturing, processing, packing, or holding at the time of the
analysis. The proposed definition would incorporate the definition in
section 418(o)(3) of the FD&C Act.
    Proposed Sec.  507.3 defines ``qualified end-user'' to mean, with
respect to an animal food, the consumer of the food (where the term
does not include a business); or a restaurant or retail food
establishment (as those terms are defined in Sec.  1.227 of this
chapter) that:
    a. Is located:
    [cir] In the same State as the qualified facility that sold the
food to such restaurant establishment; or
    [cir] Not more than 275 miles from such facility; and
    b. Is purchasing the food for sale directly to consumers at such
restaurant or retail food establishment.
    The proposed definition matches the definition in section
418(l)(4)(B) of the FD&C Act. As discussed previously in this section
of the document, for purposes of this proposed rule, the term
``consumer'' refers to the purchaser of the animal food to feed to an
animal(s), and the animal(s) consuming the food. With respect to animal
food, restaurants include pet shelters, kennels and veterinary
facilities in which animal food is provided to animals, as provided in
Sec.  1.227 of this chapter.
    Proposed Sec.  507.3 defines ``qualified facility'' to mean (when
including the sales by any subsidiary; affiliate; or subsidiaries or
affiliates, collectively, of any entity of which the facility is a
subsidiary or affiliate) a facility that is a very small business as
defined in this part, or a facility as to which both of the following
apply:
     During the 3-year period preceding the applicable calendar
year, the average annual monetary value of the animal food
manufactured, processed, packed, or held at such facility that is sold
directly to qualified end-users (as defined in this part) during such
period exceeded the average annual monetary value of the animal food
sold by such facility to all other purchasers; and
     The average annual monetary value of the animal food sold
during the 3-year period preceding the applicable calendar year was
less than $500,000, adjusted for inflation.
    This definition is based on the criteria in section 418(l)(1) of
the FD&C Act. The Agency is specifying ``animal food'' in this
definition as it intends to only include the sale of food for animals
and not the sale of human food in determining whether a facility meets
the requirements in those cases where a facility sells both. The Agency
requests comment on whether food for animals and humans should be
aggregated in determining whether a facility that sells both meets the
statutory criteria of a qualified facility.
    Proposed Sec.  507.3 defines ``qualified individual'' to mean a
person who has successfully completed training in the development and
application of risk-based preventive controls at least equivalent to
that received under a standardized curriculum recognized as adequate by
FDA or is otherwise qualified through job experience to develop and
apply a food safety system. The Agency is proposing to define the term
``qualified individual'' to have a concise term to use in proposed
provisions that would require that an activity be performed by such an
individual. The Agency is proposing to establish requirements for a
qualified individual in proposed section Sec.  507.50 (see section
X.J).
    Proposed Sec.  507.3 defines ``quality control operation'' to mean
a planned and systematic procedure for taking all actions necessary to
prevent food from being adulterated.
    Proposed Sec.  507.3 defines ``reasonably foreseeable hazard'' ``to
mean a potential biological, chemical, physical, or radiological hazard
that may be associated with the facility or the food. This term is used
in FSMA and the concept is grounded in the hazard evaluation process in
HACCP systems.
    Proposed Sec.  507.3 defines ``rework'' to mean clean,
unadulterated food that has been removed from processing for reasons
other than insanitary conditions or that has been successfully
reconditioned by reprocessing and that is suitable for use as animal
food.
    Proposed Sec.  507.3 defines ``safe moisture level'' as a level of
moisture low enough to prevent the growth of undesirable microorganisms
in the finished product under the intended conditions of manufacturing,
processing, packing, and holding. The safe moisture level for food is
related to its water activity (aw). An aw will be
considered safe for a food if adequate data are available that
demonstrate that the food at or below the given aw will not
support the growth of undesirable microorganisms.
    Proposed Sec.  507.3 defines ``sanitize'' to mean to adequately
treat cleaned food-contact surfaces by a process that is effective in
destroying vegetative cells of microorganisms of animal and human
health significance, and in substantially reducing numbers of other
undesirable microorganisms, but without adversely affecting the product
or its safety for animals or humans. For example, an appropriate
sanitizing process for a facility that manufactures, processes, packs
or holds animal food can be one that does not cause illness to the
person implementing it and does not make the food unsafe for the
intended animal species, person handling the food or humans consuming
human food derived from animals that consume the animal food. It is
well established that sanitizers can be inactivated by organic material
and, thus, are not effective unless used on clean surfaces (Ref. 35).
The Agency recognizes that in certain situations effective cleaning and
sanitizing of food-contact surfaces for animal food helps protect the
health of animals by controlling the transmission of animal diseases.
Effective cleaning and sanitizing of food-contact surfaces for animal
food can also protect human

health by preventing transmission of human diseases that occur through
handling of the contaminated food.
    Proposed Sec.  507.3 defines ``should,'' explaining that ``should''
is used to state recommended or advisory procedures or identify
recommended equipment. ``Should'' denotes non-binding guidance.
Consistent with the Agency's good guidance practices regulation (21 CFR
10.115), proposed provisions containing the word ``should'' are draft
guidance at this stage. They do not create or confer any rights for or
on any person and do not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
    The Agency is proposing to define ``significantly minimize'' to
mean to reduce to an acceptable level, including to eliminate.
``Significantly minimize'' and ``preventive control'' are terms used in
FSMA and are consistent with the definition of ``control measure'' in
the National Advisory Committee on Microbiological Criteria for Foods
(NACMCF) HACCP guidelines, the Codex HACCP Annex, and FDA's HACCP
regulation for juice. The NACMCF HACCP guidelines define ``control
measure'' as any action or activity that can be used to prevent,
eliminate or reduce a significant hazard (Ref. 29). The Codex HACCP
Annex defines ``control measure'' as any action and activity that can
be used to prevent or eliminate a food safety hazard or reduce it to an
acceptable level (Ref. 36). For further discussion on the definition of
``significantly minimize'' and its consistency with the term ``control
measure'' as used in HACCP, see section X.B.4 of the document for the
proposed rule for preventive controls for human food (78 FR 3646).
    The Agency is proposing to define the term ``small business'' to
mean a business employing fewer than 500 persons. See section VIII.B.2
for additional discussion of small business.
    The proposed limit of 500 employees would include all employees of
the business rather than be limited to the employees at a particular
facility. FDA conducted a study as required by section 418(l)(5) of the
FD&C Act that was used to help determine this definition. That study is
available in the docket established for this proposed rule (Ref. 16).
The Agency requests comment on that study, particularly in regards to
business size for animal food facilities. The Agency will consider
comments regarding the study, as well as comments regarding its
proposed definition for small business, in any final rule based on this
proposed rule.
    The Agency is proposing to define the term ``subsidiary,'' as it is
defined in section 418(l)(4)(D) of the FD&C Act, to mean any company
that is owned or controlled directly or indirectly by another company.
    The Agency is proposing to define the term ``validation'' to mean
that element of verification focused on collecting and evaluating
scientific and technical information to determine whether the food
safety plan, when properly implemented, will effectively control the
identified hazards.
    The Agency is proposing to define the term ``verification'' to mean
those activities, other than monitoring, that establish the validity of
the food safety plan and that the system is operating according to the
plan. For further discussion on the use of the terms ``validation'' and
``verification'' in HACCP, see section X.B.4 of the document for the
proposed rule for preventive controls for human food (78 FR 3646).
    The Agency is proposing to define the term ``very small business''
to mean, for purposes of this proposed part 507, a business that has
less than $500,000 in total annual sales of animal foods, adjusted for
inflation (Option 1 of co-proposal). As one co-proposal, the Agency is
proposing to define the term ``very small business'' to mean a business
that has less than $1,000,000 in total annual sales of animal foods,
adjusted for inflation (Option 2). As another co-proposal, the Agency
is proposing to define the term ``very small business'' to mean a
business that has less than $2,500,000 in total annual sales of animal
foods, adjusted for inflation (Option 3). See section VIII.B.2 for
additional discussion of the definition of very small business.
    The Agency is proposing to define the term ``water activity
(aw)'' to mean a measure of the free moisture in a food and
is the quotient of the water vapor pressure of the substance divided by
the vapor pressure of pure water at the same temperature.
2. Food Processing Sector Study and the Definitions of ``Small
Business'' and ``Very Small Business''
    FDA conducted a Food Processing Sector Study as required by section
418(l)(5) of the FD&C Act (Ref. 16). The purpose of that study was to
make determinations in five areas as required by section 418(l)(5)(A)
of the FD&C Act and to use the results of the study in defining the
terms ``small business'' and ``very small business.'' These areas
include, in part: (1) Distribution of food production by type and size
of operation, (2) the proportion of food produced by each type and size
of operation, (3) the number and types of food facilities co-located on
farms, (4) the incidence of foodborne illness originating from each
size and type of operation, and (5) the effect on foodborne illness
risk associated with certain activities regarding food. The Food
Processing Sector Study provides information on the number of
establishments and average sales per establishment by industry and size
of operation. FDA's proposed definitions are informed by that study.
The food processing sector study is available in the docket established
for this proposed rule (Ref. 16). The Agency requests comment on that
study. The Agency will consider comments regarding the study, as well
as comments regarding its proposed definitions ``small business'' and
``very small business,'' in any final rule based on this proposed rule.
    Section 418(l)(5)(B) of the FD&C Act required consideration of
harvestable acres, income, the number of employees, and the volume of
product in defining the terms ``small business'' and ``very small
business.'' The Food Processing Sector Study (Ref. 16) 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. ``Harvestable
acres,'' ``income,'' ``the number of employees,'' and ``the volume of
food harvested'' are all ways to measure the size of an operation.
Income does not appear to be the most relevant measure, since facility
income may be derived from multiple sources, many of which are not
food-related. ``Harvestable acres'' and ``volume of food harvested''
are similar measures that appear primarily relevant to the growing and
harvesting of crops, which are activities not subject to this
regulation. Harvestable acres and volume of food harvested do not
provide a meaningful measure with respect to the risk from pet food or
animal feed produced by a farm mixed-type facility (a pet food or
animal feed facility co-located on a farm subject to this regulation);
the Agency's qualitative risk assessment of manufacturing, processing,
packing, and holding activities conducted in a facility co-located on a
farm showed that risk was related to activity/animal food combinations;
these animal foods could be harvested from large or small farms (see
section VII.B for a discussion of that qualitative risk assessment). A
high risk activity/animal food combination (i.e., a not low-risk
activity/food combination) could be conducted on a farm with

many harvestable acres or very few harvestable acres. For example, an
on-farm facility mixing and/or blending for the purpose of making a
complete animal food (which would not be considered a low-risk
activity/food combination) could be one that has very few acres, or the
mixing and/or blending for the purpose of making a complete animal food
could be a small component of a large farm operation. FDA has
previously used both number of employees and annual sales as criteria
for defining small and very small businesses, e.g., in Sec.
120.1(b)(1) and (b)(2) (21 CFR 120.1(b)(1) and (b)(2)) for human food.
However, FDA has not previously defined small or very small businesses
with regard to pet food or animal feed businesses. The Agency has
limited data on number of employees, income, and annual sales upon
which to base its definitions of small and very small business for
animal food, but no data for ``harvestable acres'' or ``the volume of
food harvested.''
    a. Definition of ``Small Business.'' FDA is proposing to define the
term ``small business'' to mean, for the purposes of part 507, a
business employing fewer than 500 persons. The proposed limit of 500
employees would include all employees of the business rather than be
limited to the employees at a particular facility. The Agency is
proposing to establish the same definition for small business as that
which has been established by the U.S. Small Business Administration
under 13 CFR part 121 for most food manufacturers. This is also the
same definition for small business the Agency used to define a small
business in its juice HACCP regulation (Sec.  120.1(b)(1)). The
definition of small business is relevant to two provisions in the
proposed rule. It would affect which facilities qualify for the
exemption in proposed Sec.  507.5(e) for on-farm packing or holding,
and the exemption in proposed Sec.  507.5(f) for on-farm manufacturing/
processing, of animal food by a small business if the only activities
subject to section 418 of the FD&C Act are the specific low-risk
activity/animal food combinations listed in those sections. It would
also affect what the compliance date is for facilities that meet the
definition.
Effect on Proposed Sec.  507.5(e) and (f)
    Under proposed Sec.  507.5(e) a farm mixed-type facility that meets
the definition of a small business and only conducts specific packing
or holding activity/animal food combinations would be eligible for an
exemption from subpart C. Similarly, under proposed Sec.  507.5(f) a
farm mixed-type facility that meets the definition of a small business
and only conducts specific manufacturing/processing activity/animal
food combinations would be eligible for an exemption from subpart C.
Based on the Food Processing Sector Study, the Agency estimates that
approximately 4,439 facilities would be part of a small business under
the proposed definition and thus satisfy the size requirement of the
exemption in proposed Sec.  507.5(e) and proposed Sec.  507.5(f). Of
those facilities, the Agency estimates that approximately 188 would be
co-located on farms. A subset of those facilities would qualify for the
exemption from subpart C based on their manufacturing/processing and
packing and holding activities.
Other Effects
    Based on the Food Processing Sector Study the Agency estimates that
businesses employing fewer than 500 employees produce approximately 18
percent (based on sales) of all manufactured food produced in the
United States and 86.9 percent of all manufactured pet food and animal
feed. As discussed in section VI, the compliance date for a small
business would be 2 years after the date of publication of the final
rule. Under this proposed definition, 4,439 facilities would be subject
to this compliance date.
    b. Definition of ``Very Small Business.'' In addition to defining
``small business,'' FDA is required to define ``very small business.''
FDA has not reached a tentative conclusion on how best to define ``very
small business'' for the purposes of this rule. Consequently, the
Agency is proposing three possible definitions based on annual sales of
animal food of $500,000, $1,000,000, or $2,500,000 and requesting
comment on which of these three options to include in a final rule. The
Food Processing Sector Study provided information for the development
of the three proposed definitions (Ref. 16). The Agency requests
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 dollar amounts it is
proposing would be appropriate. The Agency also requests comment on how
a particular dollar amount of sales would be in keeping with
Congressional intent, i.e., in light of the provisions in section
418(l) of the FD&C Act regarding qualified facilities, including the
statutory limitations on sales to qualified end-users.
    The definition of very small business is relevant to 3 provisions
of the proposed rule. It would affect which facilities qualify for the
exemption in Sec.  507.5(e) for on-farm packing or holding, and the
exemption in Sec.  507.5(f) for on-farm manufacturing/processing, of
animal food by a very small business if the only activities subject to
section 418 of the FD&C Act are the specific low-risk activity/animal
food combinations listed in those sections. It would also affect which
facilities are automatically ``qualified'' facilities subject to the
modified requirements in Sec.  507.7 and what the compliance date is
for such facilities.
Effect on Proposed Sec.  507.5(e) and (f)
    The definition of very small business affects which facilities
qualify for the exemption in Sec.  507.5(e) for on-farm packing or
holding, and the exemption in Sec.  507.5(f) for on-farm manufacturing/
processing, of animal food by a very small business if the only
activities subject to section 418 of the FD&C Act are the specific low-
risk activity/animal food combinations listed in those sections,
Other Effects
    The definition of very small business affects which facilities are
automatically ``qualified'' facilities subject to the modified
requirements in proposed Sec.  507.7, and the applicable compliance
dates for such facilities. There are two ways a facility may be
``qualified'' and thus subject to the modified requirements in proposed
Sec.  507.7. The first, limited annual monetary value of sales, is
based on fixed criteria set out in FSMA section 418(l)(1)(C). The
second, as provided by section 418(l)(1)(B), is to be a very small
business as defined by FDA. Therefore, the Agency discusses the effect
of the proposed definitions for very small business in relation to the
existing requirements for qualified facilities in section 418(l)(1)(C).
Less Than $500,000 in Total Annual Sales--Effect on Proposed Sec.
507.5(e) and (f)
    One possible definition of the term ``very small business,'' for
the purposes of proposed part 507, would be a business that has less
than $500,000 in total annual sales of animal food, adjusted for
inflation (Option 1 of the co-proposal). From the Food Processing
Sector Study it is apparent that the number of co-located facilities is
concentrated at the smaller end of the size spectrum. Using data from
Dun & Bradstreet, FDA estimates that 3 co-located facilities would meet
the size requirement for the exemptions in proposed Sec.  507.5(e) and
(f). A subset of those facilities might then qualify for

the exemption from subpart C based on their manufacturing/processing,
packing, or holding activities.
Less Than $500,000 in Total Annual Sales--Effect on Number of Qualified
Facilities
    The proposed definition of $500,000 uses a dollar amount for sales
that is, essentially, the same as the maximum dollar amount of sales by
a qualified facility to end-users other than those that would satisfy
the definition of ``qualified end-users,'' except unlike with section
418(l)(1)(C) of the FD&C Act, there would be no requirement that more
than half of sales must be to qualified end-users. The $500,000
definition of very small business would add approximately 3 domestic
facilities to the number of qualified facilities. FDA estimates that no
additional domestic animal food facilities beyond these 3 domestic
facilities would be qualified facilities under section 418(l)(1)(C) of
the FD&C Act, leading to a total of 3 domestic qualified facilities.
These 3 domestic qualified facilities would have a 3 year compliance
date. As a group, businesses with less than $500,000 in total annual
sales of animal food produce less than 0.003 percent of all animal food
produced in the United States when measured by dollar value.
Less Than $1,000,000 in Total Annual Sales--Effect on Proposed Sec.
507.5(e) and (f)
    One possible definition of the term ``very small business,'' for
the purposes of proposed part 507, would be a business that has less
than $1,000,000 in total annual sales of animal food, adjusted for
inflation (Option 2 of the co-proposal). Using data from Dun &
Bradstreet (in the Food Processing Sector Study), FDA estimates that
the same 3 facilities that met the $500,000 exemption would meet this
exemption level but no additional facilities would meet the size
requirement for the exemptions in proposed Sec.  507.5(e) and proposed
Sec.  507.5(f). A subset of those facilities might then qualify for the
exemption from subpart C based on their manufacturing/processing,
packing, or holding activities.
Less Than $1,000,000 in Total Annual Sales--Effect on Number of
Qualified Facilities
    Defining very small business to mean a business that has less than
$1,000,000 in total annual sales of animal food would add approximately
619 domestic facilities to the number of qualified facilities. FDA
estimates that no additional domestic pet food or animal feed
facilities beyond these 619 domestic facilities would be qualified
facilities under section 418(l)(1)(C) of the FD&C Act, leading to a
total of 619 domestic qualified facilities. These 619 domestic
qualified facilities would have a 3-year compliance date. As a group,
businesses with less than $1,000,000 in total annual sales of animal
food produce less than 1.71 percent of all pet food and animal feed
produced in the United States when measured by dollar value.
Less Than $2,500,000 in Total Annual Sales--Effect on Proposed Sec.
507.5(e) and (f)
    One possible definition of the term ``very small business,'' for
the purposes of proposed part 507, would be a business that has less
than $2,500,000 in total annual sales of animal food, adjusted for
inflation (Option 3 of the co-proposal). Using data from Dun &
Bradstreet, FDA estimates that the same 3 facilities that met the
$500,000 and $1,000,000 exemption would met this exemption level but no
additional facilities would meet the size requirement for the exemption
in proposed Sec.  507.5(e) and proposed Sec.  507.5(f). A subset of
those facilities might then qualify for the exemption from subpart C
based on their manufacturing/processing, packing, or holding
activities.
Less Than $2,500,000 in Total Annual Sales--Effect on Number of
Qualified Facilities
    As compared to Option 2, defining very small business to mean a
business that has less than $2,500,000 in total annual sales of animal
food would add another approximately 2,880 domestic facilities to the
number of qualified facilities. FDA estimates that no additional
domestic pet food or animal feed facilities beyond these 3,499 (the 619
facilities that qualify at the $1,000,000 exemption level plus the
2,880 facilities that qualify at the $2,500,000 exemption level)
domestic facilities would be qualified facilities under section
418(l)(1)(C) of the FD&C Act, leading to a total of 3,499 domestic
qualified facilities. These 3,499 domestic qualified facilities would
have 3 year compliance date. As a group, businesses with less than
$2,500,000 in 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.
Differences From the Proposed Preventive Control Rule for Human Food
    FDA is proposing different annual gross sales levels for the three
definition options of very small business for animal food facilities
than proposed for human food facilities. In the proposed rule for
preventive controls for human food (78 FR 3646), FDA proposed three
options for annual gross sales levels for very small business. Option 1
would be $250,000, Option 2 would be $500,000, and Option 3 would be $1
million. For the proposed rule for preventive controls for animal food,
FDA is proposing three different options for annual gross sales levels
for very small business. Option 1 would be $500,000, Option 2 would be
$1 million, and Option 3 would be $2.5 million. In general, the animal
food industry sector is more heavily weighted toward the medium and
larger facilities, when based on gross annual sales, than is the human
food industry sector. For example, facilities producing livestock or
poultry feed often buy and sell product measured in tons, resulting in
high annual gross sales. Though the annual gross sales levels would be
higher for each option in the proposed animal food rule, the percent of
facilities and percent of sales exempted would be comparable to the
annual gross sales levels for the three options for the proposed rule
for human food.

C. Proposed Sec.  507.5--Exemptions

1. Proposed Sec.  507.5(a)--Exemption Applicable to Establishments Not
Required To Register Under Section 415 of the FD&C Act
    Proposed Sec.  507.5(a) would exempt establishments not required to
register under section 415 of the FD&C Act. According to section
415(c)(1) of the FD&C Act, establishments that are not required to
register include farms; restaurants; other retail food establishments;
nonprofit food establishments in which food is prepared for or served
directly to the consumer; or fishing vessels (except such vessels
engaged in processing as defined in 21 CFR 123.3(k)). The Agency has
interpreted these terms in Sec.  1.227. For example, in the animal food
context, a ``restaurant'' includes pet shelters, kennels, and
veterinary facilities in which food is provided to animals. A ``retail
food establishment'' is an establishment that sells food directly to
consumers as their primary business function, where the term
``consumer'' does not include a business. A grocery store, including
the pet food aisle, would be an example. In

addition, the Agency has interpreted ``nonprofit food establishment''
to include a charitable entity that provides food or meals for
consumption by animals in the United States. To be considered a
nonprofit food establishment, the establishment must meet the terms of
section 501(c)(3) of the U.S. Internal Revenue Code. Certain nonprofit
wildlife rehabilitation centers would likely fall into this category.
    In section VIII.B of the document for the proposed rule for
preventive controls for human food (78 FR 3646), FDA proposed to
further clarify the scope of the definition of ``farm'' for the
purposes of section 415 of the FD&C Act to mean a facility in one
general physical location devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both. The term
``farm'' would include: (1) Facilities that pack or hold food, provided
that all food used in such activities is grown, raised, or consumed on
that farm or another farm under the same ownership and (2) facilities
that manufacture/process food, provided that all food used in such
activities is consumed on that farm or another farm under the same
ownership. Because this definition of ``farm'' reflects the Agency's
interpretation of the term in section 415 of the FD&C Act,
establishments that meet this definition would not be required to
register under section 415 of the FD&C Act and would therefore be
excluded from the scope of this rulemaking under proposed Sec.
507.5(a). For example, a farm that manufactures/processes food, e.g.,
by using mobile equipment to mix grain and forage with a commercially
produced protein/mineral supplement into a total-mixed ration to feed
to dairy cattle on its farm, or another farm under the same ownership,
would be exempt from this proposed rule. As another example, a crop
farm that grows, harvests, and stores agronomic crops such as alfalfa
hay, corn, and other feed grains for distribution into commerce as
animal food would be exempt from the proposed rule.
    Similarly, the exemption in Sec.  507.5(a) would exempt activities
of farm mixed-type facilities that fall within the farm definition
previously mentioned. As discussed in section VIII.B of this document
and section VIII.E.1 of the document for the proposed rule for
preventive controls for human food (78 FR 3646), a ``mixed-type
facility'' would be an establishment that engages in both activities
that are exempt from registration under section 415 of the FD&C Act and
activities that require the establishment to be registered. An example
of such a facility would be a ``farm mixed-type facility,'' an
establishment that grows and harvests crops or raises animals and may
conduct other activities within the farm definition, but also conducts
activities that require the establishment to be registered. FDA
tentatively concludes that the portion of a farm mixed-type facility
that is within the farm definition--and therefore the portion that is
exempt from registration under section 415 of the FD&C Act--should be
treated the same way for the purposes of proposed Sec.  507.5(a) as the
same activities on farms that only conduct activities within the farm
definition.
    Section 418 of the FD&C Act sets forth requirements for the owner,
operator, or agent is in charge of a ``facility,'' defined in 418(o)(2)
as a domestic facility or foreign facility that is required to register
under section 415. Therefore section 418 of the FD&C Act only applies
to establishments that are required to register under section 415.
    The Agency tentatively concludes that these facilities should not
be subject to the CGMPs in proposed part 507 for several reasons.
Establishments that are not required to register under section 415 of
the FD&C Act are not commonly known to be sources of animal food
adulteration, they do not commonly stockpile large inventories of
animal food, and the rapid turnover of inventory further reduces the
risk that these establishments will adulterate animal food products
they use. In addition, most of the animals that are housed and cared
for by this sector are not food-producing animals, narrowing the scope
of the human health risk.
    Most of these establishments are already regulated by other
agencies, often multiple agencies, who already address animal food
safety to some degree. For example, many establishments that are not
required to register under section 415 of the FD&C Act fall under the
purview of the Animal Welfare Act (AWA), implemented by USDA. The AWA
and its implementing regulations provide for safe food and housing for
animals in indoor, outdoor and sheltered housing establishments, and
those under the control of dealers and exhibitors, among others.
Implementing regulations enforced by USDA specify that the food
provided to animals in these establishments must be uncontaminated and
wholesome (e.g., 9 CFR 3.9). In addition, veterinary clinics, among
others of these types of establishments, are regulated by State
governments.
    FDA also has other established regulations that incorporate feeding
practices and animal food storage. For example, Sec.  589.2000, Animal
Proteins Prohibited in Animal Feed, addresses, among other things, the
feeding of ruminant animals. The Agency does inspect ruminant feeders,
including farms and other establishments that may feed ruminant animals
to ensure compliance with this regulation. Although the focus of the
Agency's inspection work under this regulation is farms raising
ruminant animals such as cattle, sheep, goats, elk, and bison intended
to produce meat and milk for human consumption, the Agency also visits
a small number of other establishments to make sure those industry
sectors are aware of, and following, these regulations as they care for
their ruminant animals.
    Certain establishments that are not required to register under
section 415 of the FD&C Act conduct nonclinical laboratory studies in
animals to support applications for research or marketing permits for
products regulated by FDA, including food and color additives, animal
food additives, human and animal drugs, medical devices for human use,
biological products, and electronic products. These establishments must
comply with Good Laboratory Practice regulations already in place in
part 58 (21 CFR part 58), which include certain food safety measures.
For example, Sec.  58.45 states ``there shall be storage areas, as
needed, for feed, bedding, supplies, and equipment. Storage areas for
feed and bedding shall be separated from areas housing the test systems
and shall be protected against infestation or contamination. Perishable
supplies shall be preserved by appropriate means.'' In addition, Sec.
58.90(g) states ``feed and water used for the animals shall be analyzed
periodically to ensure that contaminants known to be capable of
interfering with the study and reasonably expected to be present in
such feed or water are not present at levels above those specified in
the protocol . . .''
    Finally, while establishments that are not required to register
under section 415 of the FD&C Act would not need to comply with the
proposed rule, they would still be subject to the adulteration
provisions of section 402 of the FD&C Act.
2. Proposed Sec.  507.5(b)--Exemption Applicable to Animal Food Subject
to Sec.  500.23 and Part 113-Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers
    Section 418(j)(1)(C) of the FD&C Act provides that section 418 of
the FD&C Act shall not apply to a facility if the owner, operator, or
agent in charge of such facility is required to comply with,

and is in compliance with, ``[t]he Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers standards of the [FDA] (or
any successor standards).'' (The Agency interprets ``Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
standards'' to mean the requirements of Sec.  500.23 and part 113.
Section 500.23 establishes that part 113 also applies to food for
animals.) Importantly, section 418(j)(2) of the FD&C Act limits the
express exemption associated with Sec.  500.23 and part 113 to
microbiological hazards that are regulated under Sec.  500.23 and part
113 (or any successor regulations). FDA considers the language of
section 418(j)(1)(C) of the FD&C Act to be ambiguous with regard to
application of the exemption. The language of section 418(j)(1)(C)
exempts a facility from section 418 of the FD&C Act if the owner,
operator, or agent in charge of the facility is required to comply
with, and is in compliance with, Sec.  500.23 and part 113 ``with
respect to such facility[.]'' However, Sec.  500.23 and part 113 do not
apply to ``facilities,'' establishments, or plants. Rather, they apply
to the specified foods (low-acid canned foods) and to persons defined
as ``commercial processors'' who conduct certain activities involving
those foods. See, e.g., Sec.  113.3(d) (definition of ``Commercial
processor''), and section 404 of the FD&C Act (21 U.S.C. 344), which
provides FDA with legal authority to issue Sec.  500.23 and part 113
(``[The Secretary] shall promulgate regulations providing for the
issuance, to manufacturers, processors, or packers of such class of
food [presenting specific risks defined in the section] in such
locality of permits to which shall be attached such conditions
governing the manufacture, processing, or packaging of such class of
food . . .''). Thus, it is unclear for purposes of section 418(j)(1)(C)
under what circumstances a low-acid canned food processor is required
to comply with Sec.  500.23 and part 113 ``with respect to [a]
facility,'' especially when such a person also conducts activities
involving other foods not subject to Sec.  500.23 and part 113 at the
same facility.
    The Agency tentatively concludes that it should interpret section
418(j)(1)(C) to exempt those activities of a facility that are subject
to Sec.  500.23 and part 113, and only those activities. Such an
interpretation would fulfill the apparent goal of the exemption without
being too narrow or too broad. The Agency also tentatively concludes
that it should include the exemption provided in section 418(j)(1)(C)
of the FD&C Act in the proposed rule to establish by regulation the
reach of the exemption as the Agency has interpreted it. Proposed Sec.
507.5(b) would provide that subpart C would not apply with respect to
activities that are subject to Sec.  500.23 and part 113 (Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at
a facility if the owner, operator, or agent in charge of the facility
is required to comply with, and is in compliance with, Sec.  500.23 and
part 113 with respect to such activities. Consistent with section
418(j)(2) of the FD&C Act, proposed Sec.  507.5(b) would establish that
the exemption would be applicable only with respect to the
microbiological hazards that are regulated under Sec.  500.23 and part
113. A facility that is required to comply with, and is in compliance
with, Sec.  500.23 and part 113 would be subject to the requirements in
proposed subpart C for hazards such as chemical hazards (e.g.,
pesticide residues), physical hazards (e.g., metal fragments that could
be introduced from equipment) and radiological hazards (e.g., high
concentrations of radium-226, radium-228 or uranium in well water used
in product). A facility that is required to comply with, and is in
compliance with, Sec.  500.23 and part 113 also would be subject to the
requirements in proposed subpart C for biological hazards not regulated
under Sec.  500.23 and part 113. For example, the heat-stable toxin
produced by the Staphylococcus aureus is a biological hazard that would
not be inactivated or destroyed by the processing required under Sec.
500.23 and part 113 (Ref. 37) (Ref. 38).
    The Agency requests comment on the criteria that should be used to
determine whether a facility is in compliance with Sec.  500.23 and
part 113.
3. Proposed Sec.  507.5(c)--Exemptions Applicable to Activities Subject
to Standards for Produce Safety in Section 419 of the FD&C Act
    Section 418(k) of the FD&C Act provides that section 418 of the
FD&C Act ``shall not apply to activities of a facility that are subject
to section 419 [of the FD&C Act].'' Section 419, ``Standards for
Produce Safety,'' requires FDA to establish by regulation ``science-
based minimum standards for the safe production and harvesting of those
types of fruits and vegetables, including specific mixes or categories
of fruits and vegetables, that are raw agricultural commodities for
which [FDA] has determined that such standards minimize the risk of
serious adverse health consequences or death.'' Section 419(h) of the
FD&C Act provides that section 419 of the FD&C Act ``shall not apply to
activities of a facility that are subject to section 418 [of the FD&C
Act.]'' FDA issued a proposed rule to implement section 419 on January
16, 2013 (78 FR 3504.) That proposed rule would apply section 419 to
``farms'' (as would be defined in proposed Sec. Sec.  1.227 and 1.328
of the proposed rule for preventive controls for human food (78 FR
3646) that are not required to register under section 415 of the FD&C
Act and to farms that conduct an activity (or activities) that triggers
the section 415 registration requirement (``farm mixed-type
facilities''), but only with respect to their activities that are
within the farm definition and therefore do not trigger the
registration requirement. The Agency tentatively concludes that it
should include a provision implementing section 418(k) of the FD&C Act
in the proposed rule for clarity and consistency, though section 419 of
the FD&C Act applies only to human food. Proposed Sec.  507.5(c) would
provide that subpart C would not apply to activities of a facility that
are subject to section 419 of the FD&C Act (Standards for Produce
Safety).
4. Proposed Sec.  507.5(d)--Exemption Applicable to a Qualified
Facility
    Section 418(l) of the FD&C Act establishes modified requirements
for ``qualified facilities.'' The Agency describes what a qualified
facility is in section VIII.D, where the Agency proposes the
requirements for such a facility (proposed Sec.  507.7). The Agency
also defines the term ``qualified facility'' in proposed Sec.  507.3
(see the discussion of definitions in section VIII.B). Section
418(l)(2)(A) of the FD&C Act provides that a qualified facility ``shall
not be subject to the requirements under [sections 418(a) through (i)
and (n) of the FD&C Act];'' as a practical matter with respect to the
provisions of this proposed rule, section 418(l)(2)(A) of the FD&C Act
provides that a qualified facility would be exempt from the
requirements of proposed subpart C. Importantly, section 418(l)(3) of
the FD&C Act provides that the Secretary of HHS may withdraw the
exemption provided in section 418(l)(2)(A) under certain circumstances.
The Agency discusses the withdrawal provisions of section 418(l)(3),
and its proposed provisions to implement section 418(l)(3) (proposed
subpart D), in section XI.
    The Agency tentatively concludes that it should include the
exemption provided in section 418(l)(2)(A) of the FD&C Act in the
proposed rule to establish by regulation the reach of the provision.
Proposed Sec.  507.5(d) would provide that subpart C would not apply

to a qualified facility, except as provided by subpart E (i.e., except
as provided by the proposed provisions for withdrawal), and that
qualified facilities are subject to the requirements in Sec.  507.7.
5. Proposed Sec.  507.2(e) and (f)--Exemption Applicable to Certain On-
farm Manufacturing, Processing, Packing or Holding Food by a Small or
Very Small Business
    a. Requirements of section 103 of FSMA. As discussed in section
VII.A.1, section 103(c)(1)(A) of FSMA requires that the Secretary
publish a proposed rule to issue regulations with respect to ``(i)
activities that constitute on-farm packing or holding of food that is
not grown, raised, or consumed on such farm or another farm under the
same ownership for purposes of section 415 of the [FD&C Act]; and (ii)
activities that constitute on-farm manufacturing or processing of food
that is not consumed on that farm or on another farm under common
ownership for purposes of section 415.'' Section 103(c)(1)(B) of FSMA
directs that the rulemaking ``shall enhance the implementation of such
section 415 [of the FD&C Act] and clarify the activities that are
included as part of the definition of the term ``facility'' under such
section 415.'' In section VII, the Agency discusses clarifications of
certain on-farm activities and whether they trigger the section 415
registration requirement in order to enhance the implementation of
section 415 by clarifying the treatment of various activities for
purposes of section 415, including activities conducted on farms.
    In the proposed rule for preventive controls for human food (78 FR
3646), FDA proposed adding a new definition of the term ``Mixed-type
facility'' to Sec.  1.227. The proposed definition would also state
that an example of such a facility is a ``farm mixed-type facility,''
which is an establishment that grows and harvests crops or raises
animals, and may conduct other activities within the farm definition,
but also conducts activities that require the establishment to be
registered. Mixed-type facility would mean an establishment that
engages in both activities that are exempt from registration under
section 415 of the FD&C Act and activities that require the
establishment to be registered. Because the specific classes of
activities mentioned in FSMA section 103(c) are, by definition, on-farm
activities that do not fall within the farm definition, Congress has
explicitly directed FDA to engage in rulemaking addressing
establishments that conduct activities that are outside the farm
definition on farms. Accordingly, FDA proposed to define the term
``farm mixed-type facility'' to refer to these establishments (78 FR
3646).
    As discussed in section VII.A.2, section 103(c)(1)(C) of FSMA
requires that the Secretary conduct a science-based risk analysis of
``(i) specific types of on-farm packing or holding of food that is not
grown, raised, or consumed on such farm or another farm under the same
ownership, as such packing and holding relates to specific animal
foods; and (ii) specific on-farm manufacturing and processing
activities as such activities relate to specific foods that are not
consumed on that farm or on another farm under common ownership.'' As
discussed in section VII.B, consistent with the requirements of section
103(c)(1)(C) of FSMA the Agency has conducted a qualitative risk
assessment related to activity/animal food combinations for the purpose
of determining which activity/animal food combinations would be
considered low risk.
    Section 103(c)(1)(D)(i) of FSMA requires that, in issuing the
regulations under section 103(c)(1)(A), ``the Secretary shall consider
the results of the science-based risk analysis conducted under [section
103(c)(1)(C) of FSMA], and shall exempt certain facilities from the
requirements in section 418 of the [FD&C Act] . . ., including hazard
analysis and preventive controls, and the mandatory inspection
frequency in section 421 of [the FD&C Act] . . . or modify the
requirements in [sections 418 or 421 of the FD&C Act], as the Secretary
determines appropriate, if such facilities are engaged only in specific
types of on-farm manufacturing, processing, packing, or holding
activities that the Secretary determines to be low risk involving
specific foods the Secretary determines to be low risk.'' Section
103(c)(1)(D)(ii) of FSMA provides that ``[t]he exemptions or
modifications under section 103(c)(1)(D)(i) of FSMA shall not include
an exemption from the requirement to register under section 415 of the
[FD&C Act] . . . if applicable, and shall apply only to small
businesses and very small businesses, as defined in the regulation
promulgated under section 418(n) of the [FD&C Act].''
    b. FDA's interpretation of section 103(c)(1)(D)(i) of FSMA. FDA
considers the language of section 103(c)(1)(D)(i) of FSMA to be
unambiguous with regard to the reach of the exemption. The language of
section 103(c)(1)(D)(i) includes the requirement ``if such facilities
are engaged only in specific types of on-farm manufacturing,
processing, packing, or holding activities that the Secretary
determines to be low risk involving specific foods the Secretary
determines to be low risk.'' FDA tentatively concludes that this
language is unambiguous and means that Congress intended us to exempt a
facility from, or modify the requirements of, section 418 of the FD&C
Act under this authority if the facility only conducts a limited set of
low-risk activity/animal food combinations that would otherwise be
subject to section 418, that is, to the extent the facility is subject
to section 418, it ``is engaged only in'' the identified activities
involving the identified foods. This interpretation seems both
protective of public health and consistent with the preventive purpose
of section 418 of the FD&C Act. This interpretation would mean that a
facility would be required to conduct a hazard analysis and establish
and implement risk-based preventive controls for all activities
conducted on all animal foods (including low-risk activity/animal food
combinations) if a facility conducts a single activity subject to
section 418 of the FD&C Act that is not a low-risk activity/animal food
combination, unless the facility qualifies for another exemption from
subpart C.
    c. Proposed Sec.  507.5(e)--Exemptions for on-farm low-risk packing
or holding activity/food combinations. Proposed Sec.  507.5(e) would
provide that subpart C would not apply to on-farm packing or holding of
animal food by a small or very small business if the only packing and
holding activities subject to section 418 of the FD&C Act that the
business conducts are the following low-risk packing or holding
activity/animal food combinations on animal food not grown, raised, or
consumed on that farm mixed-type facility or another farm or farm
mixed-type facility under the same ownership:
    1. Conveying, weighing, sorting, culling, or grading (incidental to
storing):
     Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
     Oilseed (e.g., cottonseed, linseed, rapeseed, soybean,
sunflower);
     Grain or oilseed byproducts;
     Forage (e.g., hay or ensiled material); or
     Other plants or plant byproducts (e.g., almond, peanut, or
soybean hulls, citrus, other fruit including culled fruit, potatoes, or
other vegetables including culled vegetables).
    2. Storing:
     Dried grain;
     Dried oilseed;
     Byproducts of dried grain or dried oilseed;

     Forage; or
     Other plants or plant byproducts.
    3. Packing:
     Grain;
     Oilseed;
     Grain or oilseed byproducts;
     Forage; or
     Other plants or plant byproducts.
    4. Mixing (incidental to packing or storing):
     Grain, whole; or
     Forage.
    The low-risk on farm packing and holding activity/animal food
combinations on food not grown, raised, or consumed on that farm mixed-
type facility or another farm or farm mixed-type facility under the
same ownership reflect the findings of the analysis required by section
103(c)(1)(C) of FSMA, discussed in sections VII.B and VII.C.
    For purposes of proposed Sec.  507.5(e) and (f), ``other plant
byproducts'' includes such things as barley hulls, cottonseed hulls,
corn cobs, oat hulls, rice hulls, and straw. Grain and oilseed
byproducts can be considered part of ``grain and oilseed'' as a general
matter, but FDA has addressed those foods separately for the purpose of
the risk evaluation and the proposed Sec.  507.5(e) and (f) exemptions
in order to accurately reflect differences in activity/animal food
combinations likely to be performed on farm mixed-type facilities on
grain and oilseed byproducts as compared to other grains and oilseeds,
as well as differences in risk across those activity/animal food
combinations.
    d. Proposed Sec.  507.5(f)--Exemptions for on-farm low-risk
manufacturing/processing activity/animal food combinations. Proposed
Sec.  507.5(f) would provide that subpart C would not apply to on-farm
low-risk manufacturing/processing activities conducted by a small or
very small business if the only manufacturing/processing activities
subject to section 418 of the FD&C Act that the business conducts
consists of the following:
    1. When conducted on a farm/farm mixed-typed facility's own (those
grown or raised on that farm/farm mixed-type facility or another farm/
farm mixed-type facility under the same ownership) raw agricultural
commodities for distribution into commerce:
     Cracking, crimping, flaking:
    [cir] Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
    [cir] Oilseed (e.g., cotton seed, linseed, rapeseed, soybean,
sunflower); or
    [cir] Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
    [cir] Grain;
    [cir] Oilseed;
    [cir] Grain or oilseed byproducts;
    [cir] Forage (e.g., hay or ensiled material); or
    [cir] Other plants or plant byproducts (e.g., such as almond,
peanut, or soybean hulls, citrus, other fruit including culled fruit,
potatoes, or other vegetables including culled vegetables).
     Making silage.
     Chopping, or shredding hay.
     Extracting (mechanical) or wet rolling:
    [cir] Grain; or
    [cir] Oilseed.
    2. When conducted on animal food other than the farm mixed-typed
facility's own raw agriculture commodities for distribution into
commerce:
     Cracking, crimping, flaking, or shelling:
    [cir] Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
    [cir] Oilseed (e.g., cotton seed, linseed, rapeseed, soybean,
sunflower); or
    [cir] Grain or oilseed byproducts.
     Crushing, grinding, milling, pulverizing, or dry rolling:
    [cir] Grain;
    [cir] Oilseed;
    [cir] Grain or oilseed byproducts;
    [cir] Forage (e.g., hay or ensiled material); or
    [cir] Other plants or plant byproducts (e.g., such as almond,
peanut, or soybean hulls, citrus, other fruit including culled fruit,
potatoes, or other vegetables including culled vegetables).
     Making silage.
     Chopping or shredding hay.
     Extracting (mechanical) or wet rolling:
    [cir] Grain; or
    [cir] Oilseed.
     Labeling:
    [cir] Grain whole; or
    [cir] Oilseed whole.
     Sifting, separating, or sizing:
    [cir] Grain;
    [cir] Oilseed;
    [cir] Grain or oilseed byproducts; or
    [cir] Other plants or plant byproducts.
    The low-risk on-farm manufacturing/processing activity/animal food
combinations reflect the findings of the analysis required by section
103(c)(1)(C) of FSMA, discussed in sections VII.B and VII.C.
6. Proposed Sec.  507.5(g) and (h)--Exemptions Applicable to Raw
Agricultural Commodities (RACs)
    In Sec.  507.5(g), the Agency is proposing that subpart C would not
apply to facilities solely engaged in the storage of raw agricultural
commodities (other than fruits and vegetables) intended for further
distribution or processing. And in Sec.  507.5(h), the Agency is
proposing that subpart B would not apply to the holding or
transportation of one or more ``raw agricultural commodities,'' as
defined in section 201(r) of the FD&C Act.
    The current 21 CFR 110.19(a) for human food, provides that
establishments engaged solely in the harvesting, storage, or
distribution of one or more RACs, which are ordinarily cleaned,
prepared, treated, or otherwise processed before being marketed to the
consuming public, are exempt from the requirements of part 110 (21 CFR
part 110). In section VIII.D of the document for the proposed rule for
preventive controls for human food (78 FR 3646), the Agency discusses
the meaning of the term raw agricultural commodity. The Agency
tentatively concludes that the exemption for RACs from proposed part
507 subpart B for animal food is consistent with the treatment of RACs
for human food.
    Section 418(m) of the FD&C Act provides in relevant part that FDA
may by regulation ``exempt or modify the requirements for compliance
under [section 418 of the FD&C Act] with respect to facilities that are
solely engaged in . . . the storage of raw agricultural commodities
(other than fruits and vegetables) intended for further distribution or
processing''.
    This provision would exempt, for example, facilities that only
store whole grains (such as corn, wheat, barley, oats, and soybeans)
for animal food from subpart C. This would include facilities such as
grain elevators provided that such facilities do not conduct other
activities subject to section 418 of the FD&C Act. Outbreaks of illness
associated with feeding RACs to animals have not been traced back to
storage facilities solely engaged in the storage of RACs. In addition,
facilities that are solely engaged in the storage of RACs are exempt
from the current part 110 CGMP regulations for human food, and FDA
proposes to also exempt these facilities from the proposed CGMPs for
animal food. Such facilities would remain subject to the requirements
of the FD&C Act. For example, if animal food is stored under insanitary
conditions whereby the animal food may become contaminated with filth
or rendered injurious to health, the animal food would be adulterated
under section 402(a)(4) of the FD&C Act.
    While outbreaks of illness associated with feeding RACs to animals
have not been traced back to storage facilities solely engaged in the
storage of RACs, FDA is aware of changes in feeding practices which
might increase the risk associated with feeding RACs obtained

directly from storage facilities. FDA is aware that some farms function
as animal feeding operations, growing no crops for animal food use, but
simply purchasing animal food, raw agricultural commodities, or animal
food ingredients for further manufacturing into animal food for animals
held on that farm. In the animal food industry, raw agriculture
commodities such as corn, wheat, oats, barley, rye, milo, rice,
soybeans, peanuts, and canola are shipped directly from grain elevators
to farms that raise animals for human food production such as poultry
farms (broilers, layers), dairy farms, beef-feed lots, and swine farms.
At these farms, the raw agricultural commodity received from the grain
elevators is mixed (processed) into animal food rations.
    While the Agency tentatively concludes that animal food facilities
such as grain elevators that are solely engaged in the storage of
grains that are raw agricultural commodities should be exempt from
proposed subpart B and proposed subpart C, the Agency does have some
concerns. One of those concerns is the potential for mycotoxins, such
as aflatoxins, fumonisins, and DON, to be present in RACs obtained by
farms and fed to animals. This concern is largely mitigated for RACs
intended for human food because RACs for human food routinely undergo
further processing and are rarely consumed in the ``raw'' state.
    Mycotoxins are toxic by-products of mold that can develop in
certain agricultural commodities pre-harvest or post-harvest while in
storage. Mycotoxins can reduce animal productivity, cause sudden death
if fed in large quantities, and can become a component of milk and eggs
intended for human consumption.
    Mycotoxin contamination varies greatly from year to year and by
geographic region of the country, depending on weather conditions that
stress crops and predispose to mold growth. In regions of the country
where conditions tend to favor mold growth, grain elevators and other
buyers routinely monitor for this hazard and turn away producers whose
crops exceed FDA's action levels for the various mycotoxins. For
example, grain elevators will reject corn that tests higher than 20
parts per billion for aflatoxin, the action level established by FDA
for use in feed for animal species other than beef cattle, swine,
poultry, or when the intended species is not known. Grain elevators in
other regions of the country are familiar with the weather phenomena
that predispose to mycotoxin production and monitor incoming shipments
of grain accordingly. The grain industry is also familiar with proper
drying and storing procedures to prevent mold growth and mycotoxin
production. Therefore, due to controls already in place by the grain
industry, and due to regulatory oversight by USDA under the United
States Grain Standards Act, FDA has tentatively concluded to exempt
facilities solely holding grains from preventive controls.
    However, the Agency is seeking comment on whether animal food
facilities, such as grain elevators, that are solely engaged in the
storage of grains that are raw agricultural commodities should be
exempt from subpart B and subpart C of proposed part 507; how many of
these types of facilities and operations are in the United States; and
what is the best approach to ensure that the raw agricultural
commodities distributed by these facilities to animal feeding
operations are free of hazards that would be likely to cause illness or
injury to animals or humans.
7. Applicability of Part 507 to Alcoholic Beverages
    In the proposed rule for preventive controls for human food (78 FR
3646), the Agency is proposing that proposed subpart C, ``Hazard
Analysis and Risk-Based Preventive Controls,'' would not apply to
certain alcoholic beverages and a very narrow set of prepackaged other
food at alcoholic beverage facilities, based on the Agency's
interpretation of section 116 of FSMA. Under proposed Sec.  117.5(i),
subpart C of the human food rule would not apply with respect to food
that is not an alcoholic beverage at certain alcoholic beverage
facilities, provided that such food (1) is in prepackaged form that
prevents any direct human contact with such food, and (2) constitutes
not more than 5 percent of the overall sales of the facility, as
determined by the Secretary of the Treasury (see section X.C.7 of the
document for the proposed rule for preventive controls for human food
(78 FR 3646)). Section 116 of FSMA applies to animal food. However, the
Agency is not aware of any animal food at alcoholic beverage facilities
that would be exempt from section 418 of the FD&C Act under the
proposed interpretation, and therefore is not aware of any animal food
at alcoholic beverage facilities that would be exempt from proposed
subpart C, ``Hazard Analysis and Risk-Based Preventive Controls,'' for
animal food. For example, FDA understands that many breweries and
distilleries sell spent grains, such as brewers dried grains and
distillers dried grains, as animal food. Because those spent grains are
not alcoholic beverages themselves, and they are not in a prepackaged
form that prevents any direct human contact with the food, the Agency
tentatively concludes that subpart C of this proposed rule would apply
to them.

D. Proposed Sec.  507.7--Requirements That Apply to a Qualified
Facility

1. Requirements of Section 418(l) of the FD&C Act
    Section 418(l) of the FD&C Act establishes modified requirements
for ``qualified facilities.'' As discussed in section II.C, section
418(l)(1) of the FD&C Act establishes the conditions for a facility to
be a ``qualified facility'' based on either business size (section
418(l)(1)(B) of the FD&C Act) or a combination of the average monetary
value of the food sold and the value of food sold to qualified end
users as compared to all other purchasers (section 418(l)(1)(C) of the
FD&C Act), and proposed Sec.  507.3 would establish a definition for
``qualified facility'' based on section 418(l)(1).
    Sections 418(l)(2)(A) and (B) of the FD&C Act provide that a
qualified facility is exempt from the requirements of sections 418(a)
through (i) and (n) of the FD&C Act (i.e., the requirements for hazard
analysis and risk-based preventive controls), but must instead submit
two types of documentation to the Secretary of HHS. The first type of
required documentation relates to food safety practices at the
facility, and section 418(l)(2)(B)(i) of the FD&C Act provides two
options for satisfying this documentation requirement. Under section
418(l)(2)(B)(i)(I) of the FD&C Act, the qualified facility may choose
to submit documentation that demonstrates that the owner, operator, or
agent in charge of the facility has identified potential hazards
associated with the food being produced, is implementing preventive
controls to address the hazards, and is monitoring the preventive
controls to ensure that such controls are effective. Alternatively,
under section 418(l)(2)(B)(i)(II) of the FD&C Act, the qualified
facility may choose to submit documentation (which may include
licenses, inspection reports, certificates, permits, credentials,
certification by an appropriate agency (such as a State department of
agriculture), or other evidence of oversight), as specified by the
Secretary, that the facility is in compliance with State, local,
county, or other applicable non-Federal food safety law.

    The second type of required documentation relates to whether the
facility satisfies the definition of a qualified facility. Under
section 418(l)(2)(B)(ii) of the FD&C Act, the facility must submit
documentation, as specified by the Secretary in a guidance document,
that the facility is a qualified facility under section 418(l)(1)(B) of
the FD&C Act or section 418(l)(1)(C) of the FD&C Act.
    Section 418(l)(7)(A) of the FD&C Act requires that a qualified
facility that is exempt from the requirements under sections 418 (a)
through (i) and subsection (n), and that does not prepare documentation
under section 418(l)(2)(B)(i)(I)of the FD&C Act, provide notification
to consumers by one of two procedures, depending on whether a food
packaging label is required on the food. With respect to an animal food
for which an animal food packaging label is required by the Secretary
of HHS under any other provision of the FD&C Act, section
418(l)(7)(A)(i) of the FD&C Act requires that a qualified facility
include prominently and conspicuously on such label the name and
business address of the facility where the food was manufactured or
processed. With respect to an animal food for which an animal food
packaging label is not required by the Secretary of HHS under any other
provisions of the FD&C Act, section 418(l)(7)(A)(ii) of the FD&C Act
requires that a qualified facility prominently and conspicuously
display, at the point of purchase, the name and business address of the
facility where the food was manufactured or processed, on a label,
poster, sign, placard, or documents delivered contemporaneously with
the food in the normal course of business, or, in the case of Internet
sales, in an electronic notice.
2. Proposed Sec.  507.7(a)--Documentation To Be Submitted
a. Proposed Sec.  507.7(a)(1)--Documentation That the Facility Is a
Qualified Facility
    Proposed Sec.  507.7(a)(1) would require that a qualified facility
submit to FDA documentation that the facility is a qualified facility.
Consistent with the conditions in section 418(l)(1) of the FD&C Act for
a facility to be a qualified facility, and the Agency's proposed
definition (proposed Sec.  507.3) of ``qualified facility,'' the
documentation would be directed to either the status of the facility as
a very small business (as would be defined in proposed Sec.  507.3) or
the applicability of conditions for average annual monetary value and
the value of food sold to qualified end users as compared to other
purchasers (as would be included in the definition of qualified
facility in proposed Sec.  507.3). As discussed further in section
VIII.D.5, FDA tentatively concludes that a statement from the owner,
operator, or agent in charge of a qualified facility certifying that
the facility is a very small business, otherwise meets the definition
of a qualified facility under proposed Sec.  507.3, or both, would be
acceptable for the purposes of satisfying the requirements that would
be established in proposed Sec.  507.7(a)(1). The Agency would not, for
example, require that a facility submit financial information to FDA
demonstrating its total sales or to the proportion of sales to
qualified end users.
    Proposed Sec.  507.7(a)(1) also would establish that, for the
purpose of determining whether a facility satisfies the definition of
qualified facility, the baseline year for calculating the adjustment
for inflation is 2011. The conditions related to average annual
monetary value established in section 418(l)(1)(C) of the FD&C Act, and
the definition of very small business in proposed Sec.  507.3, allow
adjustment for inflation. To establish a level playing field for all
facilities that may satisfy definition of a qualified facility, the
Agency is proposing to establish the baseline year for the calculation
in proposed Sec.  507.7(a)(1). The Agency is proposing to establish
2011 as the baseline year for inflation because 2011 is the year that
FSMA was enacted into law. The Agency tentatively concludes that
because Congress provided a specific dollar amount in section
418(l)(1)(C)(ii)(II) of the FD&C Act, i.e., $500,000, and it provided
that the dollar amount should be adjusted for inflation, it is
reasonable to establish the baseline year as the year that the law was
enacted.
b. Proposed Sec.  507.7(a)(2)--Documentation Related to Food Safety
Practices at a Facility
    Proposed Sec.  507.7(a)(2) would provide two options for satisfying
the documentation requirement in section 418(l)(2)(B)(i) of the FD&C
Act related to food safety practices at the facility. Proposed Sec.
507.7(a)(2)(i) would allow qualified facilities to submit documentation
to demonstrate that the owner, operator, or agent in charge of the
facility has identified the potential hazards associated with the food
being produced, is implementing preventive controls to address the
hazards, and is monitoring the performance of the preventive controls
to ensure that such controls are effective to satisfy this requirement.
    Proposed Sec.  507.7(a)(2)(i) would implement the provisions of
section 418(l)(2)(B)(i)(I) of the FD&C Act, except that proposed Sec.
507.7(a)(2)(i) would specify monitoring the performance of the
preventive controls to ensure that such controls are effective
(emphasis added). As discussed in section II.C, under the overall
framework of the proposed requirements that would be established in
subpart C, monitoring is directed to performance of preventive
controls. Thus, proposed Sec.  507.7(a)(2)(i) is consistent with the
statute and the overall framework of this proposed rule.
    Proposed Sec.  507.7(a)(2)(ii) would provide another option for
satisfying the documentation requirement in section 418(l)(2)(B)(i) of
the FD&C Act related to food safety practices at the facility by
allowing qualified facilities to submit documentation (which may
include licenses, inspection reports, certificates, permits,
credentials, certification by an appropriate agency (such as a State
department of agriculture), or other evidence of oversight), that the
facility is in compliance with State, local, county, or other
applicable non-Federal food safety law, including relevant laws and
regulations of foreign countries. Proposed Sec.  507.7(a)(2)(ii) would
implement the provisions of section 418(l)(2)(B)(i)(II) of the FD&C
Act.
    FDA tentatively concludes that a statement from the owner,
operator, or agent in charge of a qualified facility certifying that
the facility: (1) Has identified the potential hazards associated with
the animal food being produced, is implementing preventive controls to
address the hazards, and is monitoring the implementation of the
preventive controls to ensure that such controls are effective or (2)
that the facility is in compliance with State, local, county, or other
applicable non-Federal food safety law, including relevant laws and
regulations of foreign countries, would be acceptable for the purposes
of satisfying the requirements that would be established in proposed
Sec.  507.7(a)(2). The Agency would not, for example, require that a
facility submit documentation to FDA demonstrating the content of their
hazard identification, preventive controls, or monitoring of the
implementation of preventive controls; or copies of their non-Federal
licenses, inspection reports, certificates, permits, credentials, or
certifications.
3. Proposed Sec.  507.7(b)--Procedure for Submission
    Proposed Sec.  507.7(b) would require that qualified facilities
submit the

documentation that would be required by proposed Sec.  507.7(a) by one
of two procedures. Proposed Sec.  507.7(b)(1) would provide an option
to submit documentation electronically at http://www.access.fda.gov by
following the instructions to be provided on that Web page. Proposed
Sec.  507.7(b)(1) would inform facilities that this Web site is
available from wherever the Internet is accessible, including
libraries, copy centers, schools, and Internet cafes. Although
electronic submission is not required, proposed Sec.  507.7(b)(1) would
encourage electronic submission, which is efficient for FDA and should
also be efficient for facilities. Electronic submission generally would
be available 24 hours a day, 7 days a week, unless the Web site is
experiencing technical difficulties or is undergoing maintenance.
    Proposed Sec.  507.7(b)(2) would provide an option to submit
documentation by mail. A qualified facility would have the option to
submit documents in a paper format or in an electronic format on a CD-
ROM, by mail to the U.S. Food and Drug Administration, ATTN: Qualified
Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD
20993. ``Mail'' would include the U.S. mail and businesses that can
deliver documents to the address provided. The Agency would recommend
that an owner, operator or agent in charge of a qualified facility
submit by mail only if the qualified facility does not have reasonable
access to the Internet. It is not efficient for FDA to receive such
documents by mail.
    The Agency is not proposing to provide for submission by fax. The
Agency expects that there may be technical difficulties or loss or mix-
up of some submitted information if the Agency were to allow for
submission by fax.
4. Proposed Sec.  507.7(c)--Frequency of Submission
    Proposed Sec.  507.7(c)(1) would require that the documentation
that would be required by section Sec.  507.7(a) be submitted to FDA
initially within 90 days of the applicable compliance date of the rule.
As discussed in section VI, the compliance date for a small business
would be 2 years after the date of publication of the final rule and
the compliance date for a very small business would be 3 years after
the date of publication of the final rule.
    Proposed Sec.  507.7(c)(2) would require that the documentation
that would be required by proposed Sec.  507.7(a) also must be
resubmitted to FDA at least every 2 years, or whenever there is a
material change to the information that would be described in proposed
Sec.  507.7(a). For the purposes of proposed Sec.  507.7, a material
change would be one that changes whether or not a facility is a
``qualified facility.'' The status of a facility as a qualified
facility has the potential to change materially on an annual basis. For
example, if a facility reports that it is a very small business (i.e.,
under one option identified in proposed Sec.  507.3, has less than
$500,000 in total annual sales of animal food, adjusted for inflation),
its total annual sales of animal food likely would change on an annual
basis, and could change so as to exceed $ 500,000. Likewise, if a
facility reports that it otherwise satisfies the definition of a
qualified facility, its total annual sales of animal food and value of
animal food sold to qualified end users as compared to other purchasers
likely would change on an annual basis, and could change so as to no
longer satisfy the definition of a qualified facility.
5. Information That Would Be Submitted
    Consistent with section 418(l)(2)(B)(ii) of the FD&C Act, the
Agency intends to issue guidance regarding documentation that would be
submitted under proposed Sec.  507.7(a)(1) to demonstrate that a
facility is a qualified facility. As discussed in sections VIII.D.2.a
and VIII.D.2.b, the Agency tentatively concludes that certified
statements from the owner, operator, or agent in charge of a qualified
facility would be acceptable for the purposes of satisfying the
requirements that would be established in proposed Sec.  507.7(a)(1)
and (a)(2).
    To inform the guidance required under section 418(l)(2)(B)(ii) of
the FD&C Act and any other guidance that may be useful in addressing
questions regarding submission of documentation under this subpart, in
this document the Agency requests comment on an option it is
considering regarding the submission of documentation. Specifically,
the Agency requests comment on the efficiency and practicality of
submitting the required documentation using the existing mechanism for
registration of food facilities, with added features to enable a
facility to identify whether or not the facility is a qualified
facility. A facility that does not identify itself as a qualified
facility would not be prompted to provide additional information under
proposed Sec.  507.7(a).
    A facility that identifies itself as a qualified facility would be
prompted to provide the following information by checking items that
apply. Such items could include:
     Whether the facility satisfies the conditions for a
qualified facility:
    [cir] As a very small business as that term would be defined in
proposed Sec.  507.3;
    [cir] As a facility that otherwise satisfies the definition of
qualified facility in proposed Sec.  507.3 based on average monetary
value of sales and value of animal food sold to qualified end users as
compared to other purchasers; or
    [cir] Both of the conditions.
     Whether the facility:
    [cir] Has identified the potential hazards associated with the
animal food being produced, is implementing preventive controls to
address the hazards, and is monitoring the implementation of the
preventive controls to ensure that such controls are effective;
    [cir] Is in compliance with State, local, county, or other
applicable non-Federal food safety law, including relevant laws and
regulations of foreign countries; or
    [cir] Both of the conditions.
    In essence, such a system would provide for self-certification that
the facility has appropriate information demonstrating that the
facility is a qualified facility and either has identified the
potential hazards associated with the food being produced, is
implementing preventive controls to address the hazards, and is
monitoring the implementation of the preventive controls to ensure that
such controls are effective; or is in compliance with State, local,
county, or other applicable non-Federal food safety law, including
relevant laws and regulations of foreign countries. Such a system may
include a statement reminding submitters that anyone who makes a
materially false, fictitious, or fraudulent statement to the U.S.
Government is subject to criminal penalties under 18 U.S.C. 1001. Using
such a system, a qualified facility could update the documentation
required by proposed Sec.  507.7(a) during the biennial registration
required by section 415(a)(3) of the FD&C Act.
6. Proposed Sec.  507.7(d)--Notification to Consumers
    Proposed Sec.  507.7(d) would require that a qualified facility
that does submit the type of documentation directed to food safety
practices described in Sec.  507.7(a)(2)(i) provide notification to
consumers as to the name and complete business address of the facility
where the animal food was manufactured or processed (including the
street address or P.O. box, city, State, and zip code for domestic
facilities, and comparable full address information for foreign
facilities) consistent with section 418(l)(7) of the FD&C Act. If an
animal

food packaging label is required, proposed Sec.  507.7(d)(1) would
require that the required notification appear prominently and
conspicuously on the label of the animal food. If an animal food
packaging label is not required, proposed Sec.  507.7(d)(2) would
require that the required notification appear prominently and
conspicuously, at the point of purchase, on a label, poster, sign,
placard, or documents delivered contemporaneously with the animal food
in the normal course of business, or in an electronic notice, in the
case of Internet sales.
    Proposed Sec.  507.7(d) would enable consumers to contact the
facility where an animal food was manufactured or processed (e.g., if
the consumer identifies or suspects a food safety problem with a
product) irrespective of whether the animal food product bears a label.
The use of the term ``business address'' in section 418(l)(7) of the
FD&C Act contrasts with Congress' use of a different term, ``place of
business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)).
Section 403(e) provides that foods in package form are misbranded
unless the product label bears the name and place of business of the
manufacturer, packer, or distributor of the food. The Agency's
regulations interpret ``place of business'' as requiring only the
firm's city, state, and zip code to appear on the product label, as
long as the firm's street address is listed in a current telephone
directory or other city directory (21 CFR 501.5(d)). The Agency
tentatively concludes that the use of the term ``business address'' in
section 418(l)(7) demonstrates Congress' intent to require the
facility's full address, including the street address or P.O. box, to
appear on labels or other required notifications when the facility has
opted to not submit documentation directed to food safety practices
under section 418(l)(2)(B)(i)(I) of the FD&C Act. If Congress had
considered the less complete address already required under section
403(e)(1) of the FD&C Act and the ``place of business'' labeling
regulation (Sec.  501.5(d)) to be adequate for notification to
consumers for animal foods required to bear labels, there would have
been no need to impose a new, more specific requirement in section
418(l)(7) for the facility's ``business address'' to appear on the food
label. When proposed Sec.  507.7(d) would apply to an animal food for
which a food packaging label is required under any other provision of
the FD&C Act, the complete business address would substitute for the
``place of business'' required under section 403(e)(1) of the FD&C Act
and Sec.  501.5(d) and would not impose any requirement for a label
that would be in addition to any label required under any other
provision of the FD&C Act. The Agency asks for comment on this
interpretation.
7. Records
    Proposed Sec.  507.7(e) would require that a qualified facility
maintain records relied upon to support the documentation that would be
required by Sec.  507.7(a). Proposed Sec.  507.7(a) would not require
that a qualified facility establish any new records, but merely retain
those that the facility relied upon to support the documentation that
would be required by proposed Sec.  507.7(a). Proposed Sec.  507.7(e)
would establish that the records that a qualified facility must
maintain are subject to the requirements of subpart F of part 507. As
discussed in section XII, proposed subpart F would provide the general
requirements that apply to all records required to be established and
maintained by proposed part 507, including provisions for retention of
records and for making records available for official review. Together,
proposed Sec.  507.7(a) and (b) would make the underlying records
qualified facilities would rely on to support their self-certifications
available to FDA upon request. The Agency tentatively concludes that it
is appropriate to require that the records relied upon to support a
self-certified statement be retained and made available to FDA upon
request.

E. Proposed Sec.  507.10--Applicability of Subpart C to a Facility
Solely Engaged in the Storage of Packaged Animal Food That Is Not
Exposed to the Environment

1. Requirements of Section 418 of the FD&C Act
    Section 418(m) of the FD&C Act provides, in relevant part, that
``[t]he Secretary may, by regulation, exempt or modify the requirements
for compliance under [section 418 of the FD&C Act] with respect to
facilities that are solely engaged in . . . the storage of packaged
foods that are not exposed to the environment.''
2. Petition Relevant to Section 418(m) of the FD&C Act
    In a letter dated July 22, 2011, an industry coalition of the
American Bakers Association, the American Frozen Food Institute, the
Grocery Manufacturers Association, the International Bottled Water
Association, the International Dairy Foods Association, the
International Warehouse Logistics Association, the Peanut and Tree Nut
Processors Association, and the Snack Food Association (the section
418(m) petitioners) submitted a citizen petition (Docket No. FDA-2011-
P-0561). The petition requests that FDA issue regulations under section
418(m) of the FD&C Act ``to exempt from compliance or modify the
requirements for compliance under section 418 [of the FD&C Act] for
facilities that are solely engaged in the storage of packaged foods
that are not exposed to the environment, by allowing such facilities to
satisfy the requirements of that section through compliance with the
[CGMPs] mandated for such facilities by [current] Sec.  110.93.'' For
full discussion of this petition, please see the discussion in section
X.D of the document for the proposed rule for preventive controls for
human food (78 FR 3646).
3. FDA's Tentative Response to the Petition
    The Agency tentatively agrees in part, and disagrees in part, with
the section 418(m) petitioners. As discussed more fully in the
paragraphs that follow, FDA agrees that it is appropriate for
facilities solely engaged in the storage of unexposed packaged animal
food to be exempt from the requirements that would be established in
proposed subpart C, provided that the animal food does not require
time/temperature control for safety. For unexposed packaged animal food
that requires time/temperature control for safety, FDA disagrees that
such an exemption is warranted, but tentatively concludes that
unexposed packaged animal food that requires time/temperature control
for safety could be subject to modified requirements rather than to the
full requirements that would be established in proposed subpart C.
    The Agency disagrees that warehouse operators do not have access to
information relevant to conducting a hazard analysis and establishing
risk-based preventive controls. The principal hazard that would be
identified in any hazard analysis for unexposed packaged animal food is
the potential for the growth of, or toxin formation by, microorganisms
of animal or human health significance when an unexposed refrigerated
packaged animal food requires time/temperature control for safety.
Information about this hazard and appropriate preventive controls for
this hazard is widely available (Refs. 39, 40, and 41). For example,
the 2009 Edition of FDA's Food Code defines ``Potentially Hazardous
Food (Time/Temperature Control for Safety Food)'' as a food that
requires time/temperature control for safety to limit pathogenic
microorganism growth or toxin

formation (Ref. 39). Earlier editions (e.g., the 2001 Food Code)
included a similar definition for ``potentially hazardous food''; since
2005, the definition jointly refers to ``potentially hazardous food''
and ``time/temperature control for safety food'' (commonly referred to
as TCS food) to emphasize the importance of temperature control in
keeping food safe. Although FDA disagrees that warehouse operators do
not have access to information relevant to conducting a hazard analysis
and establishing risk-based preventive controls, the Agency agrees that
it is not necessary for each facility solely engaged in the storage of
unexposed packaged animal food to conduct its own hazard analysis to
identify this hazard for unexposed refrigerated packaged animal food as
reasonably likely to occur and for each such facility to determine that
time/temperature control is the appropriate preventive control.
    FDA also disagrees that proposed Sec.  507.28 alone would be
adequate for addressing environmental problems such as a flood in the
facility and pest control problems, even though the animal food in
question is not exposed to the environment and pest control problems
with the container would likely be visible to the warehouse operator.
However, FDA tentatively concludes that proposed Sec.  507.28, along
with other applicable provisions of proposed part 507, subpart B, such
as pest control in proposed Sec.  507.19, do adequately address most
safety-related issues that may arise in facilities solely engaged in
the storage of unexposed packaged animal food. FDA disagrees that
proposed Sec.  507.28, or other provisions in proposed part 507,
subpart B, justifies the exemption from all preventive control
requirements sought by the petitioners in the specific case of
unexposed refrigerated packaged animal food that requires time/
temperature control for safety (later in this document stated as
unexposed refrigerated packaged TCS animal food). As discussed more
fully in section X.I, such animal food requires the implementation of
an appropriate preventive control (temperature), monitoring that
control, taking corrective actions when there is a problem with that
control, verifying that the control is consistently implemented, and
establishing and maintaining records documenting the monitoring,
corrective actions, and verification. FDA tentatively concludes that it
is appropriate to distinguish between packaged animal food that
requires such time/temperature control and packaged animal food that
does not.
    FDA also disagrees that an exemption provided under section 418(m)
of the FD&C Act should be established in a manner that has the
potential to be interpreted more broadly than section 418(m) provides.
The section 418(m) petitioners request that FDA establish a provision
that ``A facility that is engaged solely in the storage, holding,
warehousing, or distribution of packaged foods that are not exposed to
the environment shall be exempt from the requirements of section 418
[of the FD&C Act]'', whereas section 418(m) provides discretion for an
exemption ``with respect to facilities that are solely engaged in . . .
the storage of packaged foods that are not exposed to the
environment.'' Under proposed Sec.  507.3, ``holding'' would mean
storage of animal food, and holding facilities would include, relevant
to unexposed packaged animal food, warehouses and cold storage
facilities. To the extent that a facility that is engaged solely in
``warehousing'' or ``distribution'' of unexposed packaged animal food
is merely ``storing'' or ``holding'' the animal food, an exemption
established using the language provided by section 418(m) would apply
to that facility. However, to the extent that a facility that is
engaged solely in ``warehousing'' or ``distribution'' of unexposed
packaged animal food is not merely ``storing'' or ``holding'' the
animal food, an exemption established using the language provided by
section 418(m) would not apply to that facility.
    In response to the petition, FDA is proposing to establish an
exemption from subpart C for facilities solely engaged in the storage
of unexposed packaged animal food (proposed Sec.  507.10). FDA also is
proposing to establish modified requirements at such facilities to
require that the owner, operator, or agent in charge of such a facility
comply with modified requirements for any unexposed refrigerated
packaged TCS animal food (proposed Sec.  507.48). See the discussion of
proposed Sec.  507.10 in the next section and the discussion of
proposed Sec.  507.48 in section X.I.
4. Proposed Sec.  507.10--Applicability of Part 507 to a Facility
Solely Engaged in the Storage of Packaged Animal Food That Is Not
Exposed to the Environment
    Proposed Sec.  507.10(a) would provide that subpart C does not
apply to a facility solely engaged in the storage of packaged animal
food that is not exposed to the environment. Proposed Sec.  507.10(b)
would establish that unexposed packaged animal food at such facilities
is subject to modified requirements that would be established in
proposed Sec.  507.48. As discussed more fully in section X.I, the
modified requirements would mandate that such a facility establish and
implement appropriate temperature controls, monitor the temperature
controls, take corrective actions, verify that the temperature controls
are consistently implemented, and establish and maintain records
documenting the monitoring, corrective actions, and verification
activities for unexposed refrigerated packaged TCS animal food. These
modified requirements would be a subset of the proposed requirements
that would be established in subpart C.
    There are limited routes of contamination for unexposed packaged
animal food in a facility that solely stores unexposed packaged animal
food (e.g., packaged animal food in containers in a warehouse).
Contamination can occur, for example, if rodents gnaw through packages
or if human waste from an improperly maintained toilet facility spills
and seeps into paper-based packaging. However, with one exception, the
CGMP requirements in proposed subpart B (e.g., proposed Sec. Sec.
507.17, 507.19, 507.20, and 507.28) would apply to the storage of
unexposed packaged animal food and be adequate to prevent such
contamination so that it would not be necessary for the owner,
operator, or agent in charge of a facility to address these routes of
contamination by applying the hazard analysis and risk-based preventive
controls that would be established in proposed subpart C. The exception
would be for the rare circumstances in which RACs are packaged in a
manner in which the RACs are not exposed to the environment. An
establishment solely engaged in storing RACs would be exempt from CGMPs
in proposed subpart B. Such an establishment would continue to be
subject to section 402(a)(4) of the FD&C Act. An establishment that is
solely engaged in the storage of packaged RACs that are not exposed to
the environment may find the provisions of proposed subpart B helpful
in ensuring compliance with section 402(a)(4) of the FD&C Act.
    Many of the requirements that would be established in proposed
subpart C would be directed to manufacturing, processing, and packing
animal food and would not apply to the storage of unexposed packaged
animal food that does not require time/temperature control for safety.
This is the case for:
     Process controls (proposed Sec.  507.36(d)(1));
     Sanitation controls (proposed Sec.  507.36(d)(2));

     Monitoring of process controls and sanitation controls
(proposed Sec.  507.39);
     Corrective actions (proposed Sec.  507.42);
     Verification (including initial validation) of process
controls (proposed Sec.  507.45); and
     A recall plan (proposed Sec.  507.38) (recalls generally
are initiated by the manufacturer, processor, or packer of the animal
food).
    FDA tentatively concludes that the outcome of a hazard analysis for
storage of unexposed packaged animal food that does not require time/
temperature control for safety is that there are no hazards reasonably
likely to occur. FDA also tentatively concludes that there would be
little animal and human health benefit to requiring the owner,
operator, or agent in charge of each facility solely engaged in the
storage of such animal food to conduct its own hazard analysis and
document that outcome in its own animal food safety plan. Likewise, FDA
tentatively concludes that there would be no need for the facility to
establish and implement preventive controls, with corresponding
monitoring, corrective actions, or verification (including validation),
because there would be no hazards reasonably likely to occur to trigger
such activities. FDA also tentatively concludes that there would be no
need for a qualified individual to conduct activities such as preparing
the animal food safety plan (proposed Sec.  507.30(c)); validating the
preventive controls (proposed Sec.  507.45(a)); reviewing records for
implementation and effectiveness of preventive controls and
appropriateness of corrective actions (proposed Sec.  507.45(c)); or
performing reanalysis of the animal food safety plan (proposed Sec.
507.45(e)(4)), because the facility would not need to conduct these
activities. Thus, with the exception of the unexposed refrigerated
packaged TCS animal food, FDA tentatively concludes that the animal
food safety system that would be established in proposed subpart C is
not needed to significantly minimize or prevent the occurrence of
hazards that could affect unexposed packaged animal food at a facility
solely engaged in the storage of such animal food.
    The purpose of proposed Sec.  507.10(b) is to make clear that
although a facility solely engaged in the storage of unexposed packaged
animal food is exempt from subpart C, such a facility is subject to
modified requirements that would be established in proposed Sec.
507.48. These requirements would apply to the storage of unexposed
refrigerated packaged TCS animal food. The Agency explains the basis
for those proposed requirements in section X.I.

IX. Proposed Subpart B--Current Good Manufacturing Practice