ATTACHMENT B: 40 CFR part 700 - General
Title 40: Protection of Environment

PART 700 -- GENERAL

Contents
Subpart A -- Addresses
§700.17   Addresses for the Office of Pollution Prevention and Toxics.
Subpart B [Reserved]
Subpart C -- Fees
§700.40   Purpose and applicability.
§700.41   Radon user fees.
§700.43   Definitions.
§700.45   Fee payments.
§700.49   Failure to remit fees.

Authority: 15 U.S.C 2625 and 2665, 44 U.S.C. 3504.
Source: 53 FR 31252, Aug. 17, 1988, unless otherwise noted.
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Subpart A -- Addresses
Source: 77 FR 46292, Aug. 3, 2012, unless otherwise noted.
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§700.17   Addresses for the Office of Pollution Prevention and Toxics.
The official addresses, unless otherwise noted, are as follows:
(a) Correspondence and non-docket materials -- (1) United States Postal Service mailing address. Office of Pollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
(2) Hand/courier delivery address. Office of Pollution Prevention and Toxics, Environmental Protection Agency, EPA East Bldg., 1201 Constitution Ave. NW., Washington, DC 20004. This is not a mailing address. You must make arrangements with the person receiving your delivery.
(b) Office of Pollution Prevention and Toxics Docket (OPPT Docket) -- (1) Electronic docket address. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov. Although listed in the docket index at regulations.gov, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only at the OPPT Docket.
(2) Physical location. Environmental Protection Agency Docket Center (EPA/DC), Environmental Protection Agency, EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The telephone number for the OPPT Docket is<PHONE_NUMBER>. This is not a mailing address. For instructions on visiting the docket, go to http://www.epa.gov/dockets/contacts.htm.
(3) United States Postal Service mailing address. Document Control Office (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
(4) Hand/courier delivery address. Document Control Office, Office of Pollution Prevention and Toxics, Environmental Protection Agency, EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Deliveries are only accepted between 8:30 a.m. and 4 p.m., and special arrangements should be made for deliveries of boxed information. The telephone number for the Document Control Office is<PHONE_NUMBER>.
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Subpart B [Reserved]
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Subpart C -- Fees
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§700.40   Purpose and applicability.
(a) Purpose. The purpose of this subpart is to collect fees from manufacturers, importers, and processors who submit notices and applications to EPA under section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) to defray part of EPA's cost of administering the Act.
(b) Applicability. This subpart applies to all manufacturers, importers, and processors who submit certain notices and applications to EPA under section 5 of the Act.
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§700.41   Radon user fees.
User fees relating to radon proficiency programs authorized under the Toxic Substances Control Act appear at 40 CFR part 195.
[59 FR 13177, Mar. 18, 1994]
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§700.43   Definitions.
Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§704.3, 720.3, and 725.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:
Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism (each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.
Consolidated premanufacture notice or consolidated PMN means any PMN submitted to EPA that covers more than one chemical substance (each being assigned a separate PMN number by EPA) as a result of a prenotice agreement with EPA (See 48 FR 21734).
Exemption application means any application submitted to EPA under section 5(h)(2) of the Act.
Exemption notice means any notice submitted to EPA under §723.175 of this chapter.
Final product means a new chemical substance (as "new chemical substance" is defined in §720.3 of this chapter) that is manufactured by a person for distribution in commerce, or for use by the person other than as an intermediate.
Intermediate premanufacture notice or intermediate PMN means any PMN submitted to EPA for a chemical substance which is an intermediate (as "intermediate" is defined in §720.3 of this chapter) in the production of a final product, provided that the PMN for the intermediate is submitted to EPA at the same time as, and together with, the PMN for the final product and that the PMN for the intermediate identifies the final product and describes the chemical reactions leading from the intermediate to the final product. If PMNs are submitted to EPA at the same time for several intermediates used in the production of a final product, each of those is an intermediate PMN if they all identify the final product and every other associated intermediate PMN and are submitted to EPA at the same time as, and together with, the PMN for the final product.
Joint submitters means two or more persons who submit a section 5 notice together.
Microbial commercial activity notice or MCAN means any notice for microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with subpart D of part 725 of this chapter.
Person means a manufacturer, importer, or processor.
Premanufacture notice or PMN means any notice submitted to EPA pursuant to section 5(a)(1)(A) of the Act in accordance with part 720 of this chapter or §723.250 of this chapter.
Section 5 notice means any PMN, consolidated PMN, intermediate PMN, significant new use notice, exemption notice, exemption application, any MCAN or consolidated MCAN submitted under section 5 of the Act.
Significant new use notice means any notice submitted to EPA pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of this chapter.
Small business concern means any person whose total annual sales in the person's fiscal year preceding the date of the submission of the applicable section 5 notice, when combined with those of the parent company (if any), are less than $40 million.
[53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, Apr. 11, 1997]
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§700.45   Fee payments.
(a) Persons who must pay fees. Persons submitting a section 5 notice to EPA shall remit for each such notice the appropriate fee identified in paragraph (b) of this section in accordance with the procedures in paragraph (e) of this section.
(b) Fees. Persons shall remit fee payments to EPA as follows:
(1) Small business concerns. Small business concerns shall remit a fee of $100 for each section 5 notice submitted.
(2) Others. Persons other than small business concerns shall remit fees according to the type of section 5 notice as follows:
(i) Premanufacture notices and consolidated premanufacture notices. Persons shall remit a fee of $2,500 for each PMN or consolidated PMN submitted.
(ii) Intermediate premanufacture notices. Persons shall remit a fee of $1,000 for each intermediate PMN. However, for the PMN for the final product the person shall submit the fee in paragraph (b)(2)(i) of this section.
(iii) Significant new use notices. Persons shall remit a fee of $2,500 for each significant new use notice submitted.
(iv) Exemption applications. Persons shall remit a fee of $2,500 for each exemption application submitted under section 5(h)(2) of the Act.
(v) Exemption notices. Persons shall remit a fee of $2,500 for each exemption notice submitted under §723.175 of this chapter.
(vi) MCAN and consolidated MCAN. Persons shall remit a fee of $2,500 for each MCAN or consolidated MCAN submitted.
(c) No fee required. Persons are exempt from remitting any fee for submissions under §§720.38, 723.50, and subparts E, F, and G of part 725 of this chapter.
(d) Joint submitters. Joint submitters of a section 5 notice are required to remit the appropriate fee identified in paragraph (b) of this section for each section 5 notice regardless of the number of joint submitters for that notice. To qualify for the fee identified in paragraph (b)(1) of this section, each joint submitter of a section 5 notice must qualify as a small business concern under §700.43.
(e) Remittance procedure. (1) Each remittance under this section shall be in United States currency and shall be paid by money order, bank draft, wire transfer, Pay.gov service provided through the Department of the Treasury, or check drawn to the order of the Environmental Protection Agency.
(2) Each paper remittance shall be sent to the Environmental Protection Agency, Washington Finance Center, Toxic Substances Control Act User Fees, P.O. Box 979073, St. Louis, MO 63197-9000.
(3) Persons who submit a TSCA section 5 notice shall place an identifying number and a payment identity number on the front page of each TSCA section 5 notice submitted. The identifying number must include the letters "TS" followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a check number, a wire transfer number, or a "Pay.gov" transaction number used to transmit the user fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one TSCA section 5 notice, the person shall include the name of the submitter and a new TS number for each TSCA section 5 notice to which the remittance applies, and the amount of the remittance that applies to each notice. Any remittance not having the identifying name and numbers described in this paragraph will be returned to the remitter.
(4)(i) Each person who remits the fee identified in paragraph (b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall insert a check mark for the statement, "The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b)." under "CERTIFICATION" on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
(ii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption application under TSCA section 5(h)(2) shall insert a check mark for the statement, "The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b)." in the exemption application.
(iii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption notice under §723.175 of this chapter shall include the words, "Each company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b)." in the certification required in §723.175(i)(1)(x) of this chapter.
(iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN for a microorganism shall insert a check mark for the statement, "The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b)." in the certification required in §725.25(b) of this chapter.
(5)(i) Each person who remits a fee identified in paragraph (b)(2) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall insert a check mark for the statement, "The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45(b)." under "CERTIFICATION" on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
(ii) Each person who remits a fee identified in paragraph (b)(2) of this section for an exemption application under TSCA section 5(h)(2) shall insert a check mark for the statement, "The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45(b)." in the exemption application.
(iii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption notice under §723.175 of this chapter shall include the words, "Each company identified in this notice has remitted a fee of $2,500 in accordance with 40 CFR 700.45(b)." in the certification required in §723.175(i)(1)(x) of this chapter.
(iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN for a microorganism shall insert a check mark for the statement, "The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b)." in the certification required in §725.25(b) of this chapter.
(f) Fee refunds. EPA will refund any fee paid for a section 5 notice whenever the Agency determines:
(1) That the chemical substance that is the subject of a PMN, intermediate PMN, exemption application, or exemption notice is not a new chemical substance as of the date of submission of the notice.
(2) In the case of a significant new use notice, that the notice was not required.
(3) The notice is incomplete under either §720.65(c) or 725.33, of this chapter.
(4) That as of the date of submission of the notice: the microorganism that is the subject of a MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use.
[53 FR 31252, Aug. 17, 1988, as amended at 54 FR 21429, May 18, 1989; 58 FR 34204, June 23, 1993; 62 FR 17932, Apr. 11, 1997; 75 FR 784, Jan. 6, 2010]
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§700.49   Failure to remit fees.
EPA will not consider a section 5 notice to be complete unless the appropriate certification under §700.45(e) is included and until the appropriate remittance under §700.45(b) has been sent to EPA as provided in §700.45(e) and received by EPA. EPA will notify the submitter that the section 5 notice is incomplete in accordance with §§720.65(c) and 725.33 of this chapter.
[62 FR 17932, Apr. 11, 1997]


c. By revising the definitions for ``Environmental pathogen'';
``Harvesting''; ``Hazard;'' ``Holding''; ``Packing''; and ``Very small
business''.
    The additions and revisions read as follows:

Sec.  507.3  Definitions.

* * * * *
    Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food for animals may be contaminated and may
result in foodborne illness if that animal food is not treated to
significantly minimize or prevent the environmental pathogen.
Environmental pathogen does not include the spores of pathogenic
sporeformers.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on 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 a
farm. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and

Cosmetic Act. Gathering, field coring, washing, trimming of outer
leaves of, removing stems and husks from, sifting, filtering,
threshing, shelling, and cooling raw agricultural commodities grown on
a farm are examples of harvesting.
    Hazard means any biological, chemical (including radiological), or
physical agent that is reasonably likely to cause illness or injury in
humans or animals in the absence of its control.
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food and activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets)), but does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological, chemical
(including radiological), or physical hazard that has the potential to
be associated with the facility or the food.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)), but does not include
activities that transform a raw agricultural commodity, as defined in
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a
processed food as defined in section 201(gg).
    Pathogen means a microorganism of public (human or animal) health
significance.
* * * * *
    Qualified auditor means a person who is a qualified individual as
defined in this part and has technical expertise obtained by a
combination of training and experience appropriate to perform the
auditing function as required by Sec.  507.53(c)(2).
* * * * *
    Receiving facility means a facility that is subject to subpart C of
this part and that manufactures/processes a raw material or ingredient
that it receives from a supplier.
* * * * *
    Significant hazard means a known or reasonably foreseeable hazard
for which a person knowledgeable about the safe manufacturing/
processing, packing, or holding of animal food would, based on the
outcome of a hazard analysis, establish controls to significantly
minimize or prevent the hazard in an animal food and components to
manage those controls (such as monitoring, corrections or corrective
actions, verification, and records) as appropriate to the food, the
facility, and the control.
* * * * *
    Supplier means the establishment that manufactures/processes the
food, raises the animal, or harvests the food that is provided to a
receiving facility without further manufacturing/processing by another
establishment, except for further manufacturing/processing that
consists solely of the addition of labeling or similar activity of a de
minimis nature.
* * * * *
    Very small business means, for purposes of this part, a business
that has less than $2,500,000 in total annual sales of food for
animals, adjusted for inflation.
    You means, for purposes of this part, the owner, operator, or agent
in charge of a facility.
0
8. Amend Sec.  507.5, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (a) to read as follows:

Sec.  507.5  Exemptions.

    (a)(1) Except as provided by paragraph (a)(2) of this section, this
part does not apply to establishments (including ``farms'' as defined
in Sec.  1.227 of this chapter) that are not required to register under
section 415 of the Federal Food, Drug, and Cosmetic Act.
    (2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates
raw agricultural commodities to create a distinct commodity, subpart B
of this part applies to the packaging, packing, and holding of the
dried commodities. Compliance with this requirement may be achieved by
complying with subpart B of this part or with the applicable
requirements for packing and holding in part 112 of this chapter.
* * * * *
0
9. Subpart A, as proposed to be added on October 29, 2013 (78 FR
64736), is amended by adding Sec.  507.12 to read as follows:

Sec.  507.12  Applicability of this part to the holding and
distribution of human food by-products for use in animal food.

    (a) Except as provided by paragraph (b) of this section, the
requirements of this part do not apply to by-products of human food
production that are packed or held by that human food facility for
distribution as animal food if:
    (1) The human food processor is subject to and in compliance with
subpart B of part 117 of this chapter, and in compliance with all
applicable human food safety requirements of the Federal Food, Drug,
and Cosmetic Act and implementing regulations; and
    (2) The human food processor does not further manufacture/process
the by-products intended for animal food.
    (b) The animal food from by-products identified in paragraph (a) of
this section must be held and distributed by that facility in
accordance with Sec.  507.28 and Sec.  117.95 of this chapter.
0
10. Revise subpart B, as proposed to be added on October 29, 2013 (78
FR 64736), to read as follows:
Subpart B--Current Good Manufacturing Practice
Sec.
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitation.
507.20 Water supply and plumbing.
507.22 Equipment and utensils.
507.25 Plant operations.
507.27 Holding and distribution.
507.28 Holding and distribution of human food by-products for use in
animal food.

Subpart B--Current Good Manufacturing Practice

Sec.  507.14  Personnel.

    (a) Plant management must take all reasonable measures and
precautions to ensure that all persons working in direct contact with
animal food, animal food-contact surfaces, and animal food-packaging
materials conform to hygienic practices to the extent necessary to
protect against contamination of animal food. The methods for
maintaining cleanliness include:
    (1) Maintaining adequate personal cleanliness;
    (2) Washing hands thoroughly in an adequate hand-washing facility
as necessary and appropriate to prevent contamination;
    (3) Removing or securing jewelry and other objects that might fall
into animal food, equipment, or containers;
    (4) Storing clothing or other personal belongings in areas other
than where animal food is exposed or where equipment or utensils are
cleaned; and
    (5) Taking any other necessary precautions to protect against
contamination of animal food, animal

food-contact surfaces, or animal food-packaging materials.
    (b) Personnel responsible for identifying sanitation failures or
animal food contamination should have a background of education or
experience, or a combination thereof, to provide a level of competency
necessary for production of clean and safe animal food. Animal food
handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary
practices.
    (c) Responsibility for ensuring compliance by all personnel with
all requirements of this subpart must be clearly assigned to competent
supervisory personnel.

Sec.  507.17  Plant and grounds.

    (a) The grounds surrounding an animal food plant under the control
of the operator must be kept in a condition that will protect against
the contamination of animal food. Maintenance of grounds must include:
    (1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant that
may constitute an attractant, breeding place, or harborage for pests;
    (2) Maintaining driveways, yards, and parking areas so that they do
not constitute a source of contamination in areas where animal food is
exposed;
    (3) Adequately draining areas that may contribute to contamination
of animal food; and
    (4) Treating and disposing of waste so that it does not constitute
a source of contamination in areas where animal food is exposed.
    (b) Buildings, structures, fixtures, and other physical facilities
of the plant must be suitable in size, construction, and design to
facilitate cleaning, maintenance, and pest control to reduce the
potential for contamination of animal food, animal food-contact
surfaces, and animal food-packaging materials. This includes:
    (1) Providing adequate space between equipment, walls, and stored
materials to permit employees to perform their duties and to allow
cleaning and maintenance of equipment;
    (2) Being constructed in a manner such that drip or condensate from
fixtures, ducts, and pipes does not serve as a source of contamination;
    (3) Providing adequate ventilation or control equipment to minimize
vapors (for example, steam) and fumes in areas where they may
contaminate animal food; and locating and operating fans and other air-
blowing equipment in a manner that minimizes the potential for
contaminating animal food;
    (4) Providing adequate lighting in hand-washing areas, toilet
rooms, areas where animal food is received, manufactured/processed,
packed, or stored, and areas where equipment or utensils are cleaned;
    (5) Providing safety-type light bulbs, fixtures, and skylights, or
other glass items suspended over exposed animal food in any step of
preparation, to protect against animal food contamination in case of
glass breakage; and
    (6) Protecting animal food stored outdoors in bulk by any effective
means, including:
    (i) Using protective coverings;
    (ii) Controlling areas over and around the bulk animal food to
eliminate harborages for pests; and
    (iii) Checking on a regular basis for pests and pest infestation.

Sec.  507.19  Sanitation.

    (a) Buildings, structures, fixtures, and other physical facilities
of the plant must be kept clean and in good repair to prevent animal
food from becoming contaminated.
    (b) Animal food-contact and non-contact surfaces of utensils and
equipment must be cleaned and maintained and utensils and equipment
stored as necessary and appropriate to protect against contamination of
animal food, animal food-contact surfaces, or animal food-packaging
materials. When necessary, equipment must be disassembled for thorough
cleaning.
    In addition:
    (1) When it is necessary to wet-clean animal food-contact surfaces
used for manufacturing/processing, or holding low-moisture animal food,
the surfaces must be thoroughly dried before subsequent use.
    (2) In wet processing, when cleaning and sanitizing is necessary to
protect against the introduction of undesirable microorganisms into
animal food, all animal food-contact surfaces must be cleaned and
sanitized before use and after any interruption during which the animal
food-contact surfaces may have become contaminated.
    (c) Cleaning compounds and sanitizing agents must be safe and
adequate under the conditions of use.
    (d) The following applies to toxic materials:
    (1) Only the following toxic materials may be used or stored in a
plant where animal food is manufactured/processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in the plant's operations;
    (iii) Those necessary for plant and equipment maintenance and
operation; and
    (iv) Those necessary for use in laboratory testing procedures.
    (2) Toxic materials described in paragraph (d)(1) of this section
(for example cleaning compounds, sanitizing agents, and pesticide
chemicals) must be identified, used, and stored in a manner that
protects against contamination of animal food, animal food-contact
surfaces, or animal food-packaging materials.
    (e) Effective measures must be taken to exclude pests from the
manufacturing/processing, packing, and holding areas and to protect
against the contamination of animal food by pests. The use of
insecticides or rodenticides is permitted only under precautions and
restrictions that will protect against the contamination of animal
food, animal food-contact surfaces, and animal food-packaging
materials.
    (f) Trash and garbage must be conveyed, stored, and disposed of in
a way that protects against contamination of animal food, animal food-
contact surfaces, animal food-packaging materials, water supplies, and
ground surfaces, and minimizes the potential for the trash and garbage
to become an attractant and harborage or breeding place for pests.

Sec.  507.20  Water supply and plumbing.

    (a) The water supply must be adequate for the operations and must
be derived from a suitable source. Running water at a suitable
temperature, and under suitable pressure as needed, must be provided in
all areas where required for the manufacturing/processing of animal
food, for the cleaning of equipment, utensils, and animal food-
packaging materials, or for employee hand-washing facilities. Water
that contacts animal food, animal food-contact surfaces, or animal
food-packaging materials must be safe for its intended use. Water may
be reused for washing, rinsing, or conveying animal food if it does not
increase the level of contamination of the animal food.
    (b) Plumbing must be designed, installed, and maintained to:
    (1) Carry adequate quantities of water to required locations
throughout the plant;
    (2) Properly convey sewage and liquid disposable waste from the
plant;
    (3) Avoid being a source of contamination to animal food, animal
food-contact surfaces, or animal food-packaging materials, water
supplies,

equipment, or utensils, and avoid creating an unsanitary condition;
    (4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and
    (5) Ensure that there is no backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for animal food or animal food manufacturing/
processing.
    (c) Sewage must be disposed of through an adequate sewerage system
or through other adequate means.
    (d) Each plant must provide its employees with adequate, readily
accessible toilet facilities. Toilet facilities must be kept clean and
must not be a potential source of contamination of animal food, animal
food-contact surfaces, or animal food-packaging materials.
    (e) Each plant must provide hand-washing facilities designed to
ensure that an employee's hands are not a source of contamination of
animal food, animal food-contact surfaces, or animal food-packaging
materials.

Sec.  507.22  Equipment and utensils.

    (a) The following apply to plant equipment and utensils:
    (1) All plant equipment and utensils must be designed and of such
material and workmanship to be adequately cleanable, and must be
properly maintained;
    (2) The design, construction, and use of equipment and utensils
must preclude the contamination of animal food with lubricants, fuel,
metal fragments, contaminated water, or any other contaminants;
    (3) Equipment should be installed and maintained in such a way as
to facilitate the cleaning of the equipment and adjacent spaces;
    (4) Animal food-contact surfaces must be:
    (i) Made of materials that withstand the environment of their use
and the action of animal food, and, if applicable, the action of
cleaning compounds and sanitizing agents;
    (ii) Made of nontoxic materials; and
    (iii) Maintained to protect animal food from being contaminated.
    (5) Equipment in the animal food manufacturing/processing area that
does not come into contact with animal food must be designed and
constructed in such a way that it can be kept in a clean condition.
    (b) Holding, conveying, and manufacturing/processing systems,
including gravimetric, pneumatic, closed, and automated systems, must
be designed, constructed, and maintained in a way that does not
contaminate animal food.
    (c) Each freezer and cold storage compartment used to hold animal
food must be fitted with an accurate temperature monitoring device.
    (d) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, aw, or other conditions that control or
prevent the growth of undesirable microorganisms in animal food must be
accurate, precise, adequately maintained, and adequate in number for
their designated uses.
    (e) Compressed air or other gases mechanically introduced into
animal food or used to clean animal food-contact surfaces or equipment
must be used in such a way that animal food is not contaminated.

Sec.  507.25  Plant operations.

    (a) Plant management must ensure that:
    (1) All operations in the manufacturing/processing, packing, and
holding of animal food (including operations directed to receiving,
inspecting, transporting, and segregating) are conducted in accordance
with the current good manufacturing practice requirements of this
subpart;
    (2) Containers holding animal food, including raw materials,
ingredients, or rework, accurately identify the contents;
    (3) The labeling for the finished animal food product contains
information and instructions for safely using the product for the
intended animal species;
    (4) Animal food-packaging materials are safe and suitable;
    (5) The overall cleanliness of the plant is under the supervision
of one or more competent individuals assigned responsibility for this
function;
    (6) Reasonable precautions are taken so that plant operations do
not contribute to contamination of animal food, animal food-contact
surfaces, and animal food packaging materials;
    (7) Chemical, microbial, or extraneous-material testing procedures
are used where necessary to identify sanitation failures or possible
animal food contamination; and
    (8) Animal food that has become contaminated to the extent that it
is adulterated is rejected, disposed of, or if permissible, treated or
processed to eliminate the adulteration. If disposed of, it must be
done in a manner that protects against the contamination of other
animal food; and
    (9) All animal food manufacturing/processing, packing, and holding
is conducted under such conditions and controls as are necessary to
minimize the potential for the growth of undesirable microorganisms or
for the contamination of animal food.
    (b) Raw materials and ingredients:
    (1) Must be inspected to ensure that they are suitable for
manufacturing/processing into animal food and must be handled under
conditions that will protect against contamination and minimize
deterioration. In addition:
    (i) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles holding raw materials and ingredients must be inspected
upon receipt to determine whether contamination or deterioration of
animal food has occurred;
    (ii) Raw materials must be cleaned as necessary to minimize soil or
other contamination; and
    (iii) Raw materials and ingredients must be stored under conditions
that will protect against contamination and deterioration.
    (2) Susceptible to contamination with mycotoxins or other natural
toxins must be evaluated and used in a manner that does not result in
animal food that can cause injury or illness to animals or humans;
    (3) And all rework, must be held in containers designed and
constructed in a way that protects against contamination, and must be
held under conditions, e.g., appropriate temperature and relative
humidity, that will minimize the potential for growth of undesirable
microorganisms and in a manner that prevents the animal food from
becoming adulterated; and
    (4) If frozen, must be kept frozen. If thawing is required prior to
use, it must be done in a manner that minimizes the potential for the
growth of undesirable microorganisms.
    (c) For the purposes of manufacturing/processing operations, the
following apply:
    (1) Animal food must be maintained under conditions, e.g.,
appropriate temperature and relative humidity, that will minimize the
potential for growth of undesirable microorganisms and prevent the
animal food from becoming adulterated during manufacturing/processing,
packing, and holding;
    (2) Measures taken during manufacturing/processing, packing, and
holding of animal food to significantly minimize or prevent the growth
of undesirable microorganisms (for example, heat treating, freezing,
refrigerating, irradiating, controlling pH, or controlling aw) must be
adequate to prevent adulteration of animal food;
    (3) Work-in-process and rework must be handled in such a way that
it is

protected against contamination and the growth of undesirable
microorganisms;
    (4) Steps such as cutting, drying, defatting, grinding, mixing,
extruding, pelleting, and cooling, must be performed in a way that
protects animal food against contamination;
    (5) Filling, assembling, packaging, and other operations must be
performed in such a way that the animal food is protected against
contamination and growth of undesirable microorganisms;
    (6) Animal food that relies on the control of aw for preventing the
growth of undesirable microorganisms must be processed to and
maintained at a safe moisture level;
    (7) Animal food that relies principally on the control of pH for
preventing the growth of undesirable microorganisms must be monitored
and maintained at the appropriate pH; and
    (8) When ice is used in contact with animal food, it must be made
from water that is safe and must be used only if it has been
manufactured in accordance with current good manufacturing practice as
outlined in this subpart.

Sec.  507.27  Holding and distribution.

    (a) Animal food held for distribution must be held under conditions
that will protect against contamination and minimize deterioration,
including the following:
    (1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned, and maintained
to prevent the contamination of animal food;
    (2) Animal food held for distribution must be held in a way that
prevents contamination from sources such as trash and garbage; and
    (3) Labeling identifying the product by the common and usual name
must be affixed to or accompany the animal food.
    (b) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food.
    (c) Animal food returned from distribution must be assessed for
animal food safety to determine the appropriate disposition. Returned
animal food must be identified as such and segregated until assessed.
    (d) Unpackaged or bulk animal food must be held in a manner that
does not result in cross contamination with other animal food.

Sec.  507.28  Holding and distribution of human food by-products for
use as animal food.

    (a) Human food by-products held for distribution as animal food
must be held under conditions that will protect against contamination,
including the following:
    (1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned, and maintained
to prevent the contamination of animal food;
    (2) Animal food held for distribution must be held in a way to
prevent contamination from sources such as trash and garbage; and
    (3) Labeling identifying the product by the common and usual name
must be affixed to or accompany animal food.
    (b) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food.
0
11. Revise subpart C, as proposed to be added on October 29, 2013 (78
FR 64736), to read as follows:
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
Sec.
507.31 Food safety plan.
507.33 Hazard analysis.
507.36 Preventive controls.
507.37 Supplier program.
507.38 Recall plan.
507.39 Preventive control management components.
507.40 Monitoring.
507.42 Corrective actions and corrections.
507.45 Verification.
507.47 Validation.
507.49 Verification of implementation and effectiveness.
507.50 Reanalysis.
507.51 Modified requirements that apply to a facility solely engaged
in the storage of packaged animal food that is not exposed to the
environment.
507.53 Requirements applicable to a qualified individual and a
qualified auditor.
507.55 Implementation records.

Subpart C--Hazard Analysis and Risk-Based Preventive Controls

Sec.  507.31  Food safety plan.

    (a) You must prepare, or have prepared, and implement a written
food safety plan.
    (b) One or more qualified individuals must prepare, or oversee the
preparation of, the food safety plan.
    (c) The written food safety plan must include:
    (1) The written hazard analysis as required by Sec.  507.33(a)(2);
    (2) The written preventive controls as required by Sec.  507.36(b);
    (3) The written supplier program as required by Sec.  507.37(a)(2).
    (4) The written recall plan as required by Sec.  507.38(a)(1);
    (5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec.  507.40(a)(1);
    (6) The written corrective action procedures as required by Sec.
507.42(a)(1); and
    (7) The written verification procedures as required by Sec.
507.49(b).
    (d) The food safety plan required by this section is a record that
is subject to the requirements of subpart F of this part.

Sec.  507.33  Hazard analysis.

    (a) You must:
    (1) Identify and evaluate, based on experience, illness data,
scientific reports, and other information, known or reasonably
foreseeable hazards for each type of animal food manufactured/
processed, packed, or held at your facility to determine whether there
are significant hazards; and
    (2) Develop a written hazard analysis.
    (b) The hazard identification must consider:
    (1) Hazards that include:
    (i) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances
such as pesticide and drug residues, natural toxins, decomposition,
unapproved food or color additives, and nutrient imbalances; and
    (iii) Physical hazards; and
    (2) Hazards that may be present in the animal food for any of the
following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of
economic gain.
    (c)(1) The hazard analysis must include an evaluation of the
hazards identified in paragraph (b) of this section to assess the
severity of the illness or injury if the hazard were to occur and the
probability that the hazard will occur in the absence of preventive
controls.
    (2) The hazard evaluation required by paragraph (c)(1) of this
section must include an evaluation of environmental pathogens whenever
an animal food is exposed to the environment prior to packaging and the
packaged animal food does not receive a treatment that would
significantly minimize the pathogen.
    (d) The hazard evaluation must consider the effect of the following
on

the safety of the finished animal food for the intended animal:
    (1) The formulation of the animal food;
    (2) The condition, function, and design of the facility and
equipment;
    (3) Raw materials and ingredients;
    (4) Transportation practices;
    (5) Manufacturing/processing procedures;
    (6) Packaging activities and labeling activities;
    (7) Storage and distribution;
    (8) Intended or reasonably foreseeable use;
    (9) Sanitation, including employee hygiene; and
    (10) Any other relevant factors.

Sec.  507.36  Preventive controls.

    (a)(1) You must identify and implement preventive controls to
provide assurances that significant hazards will be significantly
minimized or prevented and the animal food manufactured, processed,
packed, or held by your facility will not be adulterated under section
402 of the Federal Food, Drug, and Cosmetic Act; and
    (2) Preventive controls required by paragraph (a)(1) of this
section include, as appropriate to the facility and animal food:
    (i) Controls at critical control points (CCPs), if there are any
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate
for animal food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and
animal food:
    (1) Process controls include procedures, practices, and processes
to ensure the control of parameters during operations such as heat
processing, irradiating, and refrigerating animal food. Process
controls must include, as appropriate to the applicable control:
    (i) Parameters associated with the control of the hazard; and
    (ii) The maximum or minimum value, or combination of values, to
which any biological, chemical, or physical parameter must be
controlled to significantly minimize or prevent a significant hazard.
    (2) Sanitation controls include procedures, practices, and
processes to ensure that the facility is maintained in a sanitary
condition adequate to significantly minimize or prevent hazards such as
environmental pathogens and biological hazards due to employee
handling. Sanitation controls must include as appropriate to the
facility and the animal food, procedures, practices, and processes for
the:
    (i) Cleanliness of animal food-contact surfaces, including animal
food-contact surfaces of utensils and equipment; and
    (ii) Prevention of cross-contamination from insanitary objects and
from personnel to animal food, animal food packaging material, and
other animal food-contact surfaces and from raw product to processed
product.
    (3) Supplier controls that include the supplier program as required
by Sec.  507.37;
    (4) A recall plan as required by Sec.  507.38; and
    (5) Other preventive controls that include any procedures,
practices, and processes necessary to satisfy the requirements of
paragraph (a) of this section. Examples of other controls include
hygiene training and other current good manufacturing practices.

Sec.  507.37  Supplier program.

    (a)(1)(i) Except as provided in paragraph (a)(1)(ii) of this
section, the receiving facility must establish and implement a risk-
based supplier program for those raw materials and ingredients for
which the receiving facility has identified a significant hazard when
the hazard is controlled before receipt of the raw material or
ingredient.
    (ii) The receiving facility is not required to establish and
implement a supplier program for raw materials and ingredients for
which:
    (A) There are no significant hazards;
    (B) The preventive controls at the receiving facility are adequate
to significantly minimize or prevent each of the significant hazards;
or
    (C) The receiving facility relies on its customer to control the
hazard and annually obtains from its customer written assurance that
the customer has established and is following procedures (identified in
the written assurance) that will significantly minimize or prevent the
hazard.
    (2) The supplier program must be written.
    (3) The supplier program must include:
    (i) Verification activities, as appropriate to the hazard, and
documentation of these activities, to ensure raw materials and
ingredients are received only from suppliers approved for control of
the hazard(s) in that raw material or ingredient (or, when necessary
and appropriate, on a temporary basis from unapproved suppliers whose
raw materials or ingredients the receiving facility subjects to
adequate verification activities before acceptance for use); and
    (ii) Verification activities, as appropriate to the hazard, and
documentation of these activities, as required by paragraph (b) of this
section, to verify that:
    (A) The hazard is significantly minimized or prevented;
    (B) The incoming raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act; and
    (C) The incoming raw material or ingredient is produced in
compliance with the requirements of applicable FDA food safety
regulations.
    (4) When supplier verification activities are required under
paragraph (c) of this section for more than one type of hazard in an
animal food, the receiving facility must conduct the verification
activity or activities appropriate for each of those hazards.
    (5) For some hazards, in some situations under paragraph (b) it
will be necessary to conduct more than one verification activity and/or
to increase the frequency of one or more verification activities to
provide adequate assurances that the hazard is significantly minimized
or prevented.
    (b) In determining and documenting the appropriate verification
activities, the receiving facility must consider the following:
    (1) The hazard analysis, including the nature of the hazard,
applicable to the raw material and ingredients;
    (2) Where the preventive controls for those hazards are applied for
the raw material and ingredients such as at the supplier or the
supplier's supplier;
    (3) The supplier's procedures, processes, and practices related to
the safety of the raw material and ingredients;
    (4) Applicable FDA food safety regulations and information relevant
to the supplier's compliance with those regulations, including an FDA
warning letter or import alert relating to the safety of the animal
food;
    (5) The supplier's food safety performance history relevant to the
raw materials or ingredients that the receiving facility receives from
the supplier, including available information about results from
testing raw materials or ingredients for hazards, audit results
relating to the safety of the animal food, and responsiveness of the
supplier in correcting problems; and
    (6) Any other factors as appropriate and necessary. Examples of
factors that a receiving facility may determine are appropriate and
necessary are storage and transportation practices.
    (c)(1) Except as provided in paragraph (c)(2) or (3) of this
section, the receiving facility must conduct and document one or more
of the following supplier verification activities determined by the

receiving facility under paragraph (b) of this section, for each
supplier before using the raw material or ingredient and periodically
thereafter:
    (i) Onsite audits;
    (ii) Sampling and testing of the raw material or ingredient, which
may be conducted by either the supplier or receiving facility;
    (iii) Review by the receiving facility of the supplier's relevant
food safety records; or
    (iv) Other appropriate supplier verification activities based on
the risk associated with the ingredient and the supplier.
    (2)(i) Except as provided by paragraph (c)(2)(ii) of this section,
when a hazard in a raw material or ingredient will be controlled by the
supplier and is one for which there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals, the receiving facility must
have documentation of an onsite audit of the supplier before using the
raw material or ingredient from the supplier and at least annually
thereafter.
    (ii) The requirements of paragraph (c)(2)(i) of this section do not
apply if the receiving facility documents its determination that other
verification activities and/or less frequent onsite auditing of the
supplier provide adequate assurance that the hazards are controlled.
    (3) If a supplier is a qualified facility as defined by Sec.
507.3, the receiving facility need not comply with paragraphs (c)(1)
and (2) of this section if the receiving facility:
    (i) Documents, at the end of each calendar year, that the supplier
is a qualified facility as defined by Sec.  507.3; and
    (ii) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act. The written assurance must include a brief
description of the processes and procedures that the supplier is
following to ensure the safety of the animal food.
    (4) If a supplier is a farm that is not subject to the requirements
established in part 112 of this chapter in accordance with Sec.  112.4
regarding the raw material or ingredient that the receiving facility
receives from the farm, the receiving facility does not need to comply
with paragraphs (c)(1) and (2) of this section if the receiving
facility:
    (i) Documents, at the end of each calendar year, that the raw
material or ingredient provided by the supplier is not subject to part
112 of this chapter; and
    (ii) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act.
    (d)(1) An onsite audit of a supplier must be performed by a
qualified auditor;
    (2) If the raw material or ingredient at the supplier is subject to
one or more FDA food safety regulations, an onsite audit must consider
such regulations and include a review of the supplier's written plan
(e.g., HACCP plan or other food safety plan), if any, including its
implementation, for the hazard being audited.
    (e)(1) Instead of an onsite audit, a receiving facility may rely on
the results of an inspection of the supplier by FDA or, for a foreign
supplier, by FDA or the food safety authority of a country whose food
safety system FDA has recognized as comparable or has determined to be
equivalent to that of the United States, provided that the inspection
was conducted within 1 year of the date that the onsite audit would
have been required to be conducted; and
    (2) For inspections conducted by the food safety authority of a
country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent, the animal food that is the
subject of the onsite audit must be within the scope of the official
recognition or equivalence determination, and the foreign supplier must
be in, and under the regulatory oversight of, such country.
    (f) If the owner, operator, or agent in charge of a receiving
facility determines through auditing, verification testing, relevant
consumer, customer, or other complaints, or otherwise that the supplier
is not controlling hazards that the receiving facility has identified
as significant, the receiving facility must take and document prompt
action in accordance with Sec.  507.42 to ensure that raw materials or
ingredients from the supplier do not cause animal food that is
manufactured or processed by the receiving facility to be adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
    (g) The receiving facility must document the following in records
and review such records in accordance with Sec.  507.49(a)(4):
    (1) The written supplier program;
    (2) Documentation of the appropriate verification activities;
    (3) The annual written assurance that a receiving facility's
customer who is controlling a significant hazard has established and is
following procedures (identified in the written assurance) that will
significantly minimize or prevent the hazard;
    (4) Documentation demonstrating that products are received only
from approved suppliers;
    (5) Documentation of an onsite audit. This documentation must
include:
    (i) Documentation of audit procedures;
    (ii) The dates the audit was conducted;
    (iii) The conclusions of the audit;
    (iv) Corrective actions taken in response to significant
deficiencies identified during the audit; and
    (v) Documentation that the audit was conducted by a qualified
auditor.
    (6) Records of sampling and testing. These records must include:
    (i) Identification of the raw material or ingredient tested
(including lot number, as appropriate) and the number of samples
tested;
    (ii) Identification of test(s) conducted, including the analytical
method(s) used;
    (iii) The date(s) on which the test(s) were conducted;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards;
and
    (vi) Information identifying the laboratory conducting the testing.
    (7) Records of the review by the receiving facility of the
supplier's relevant food safety records. These records must include:
    (i) The date(s) of review;
    (ii) Corrective actions taken in response to significant
deficiencies identified during the review; and
    (iii) Documentation that the review was conducted by a qualified
individual.
    (8) Records of other appropriate supplier verification activities
based on the risk associated with the ingredient.
    (9) Documentation of any determination that verification activities
other than an onsite audit, and/or less frequent onsite auditing of a
supplier, provide adequate assurance that the hazards are controlled;
    (10) Documentation of an alternative verification activity for a
supplier that is a qualified facility, including:
    (i) The documentation that the supplier is a qualified facility as
defined by Sec.  507.3; and
    (ii) The written assurance that the supplier is producing the raw
material or ingredient in compliance with

applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act.
    (11) Documentation of an alternative verification activity for a
supplier that is a farm that supplies a raw material or ingredient that
is not subject to part 112 of this chapter, including:
    (i) The documentation that the raw material or ingredient provided
by the supplier is not subject to part 112 of this chapter; and
    (ii) The written assurance that the supplier is producing the raw
material or ingredient in compliance with applicable FDA food safety
regulations and that the raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
    (12) Evidence of an inspection of the supplier by FDA or the food
safety authority of another country.
    (13) Documentation of actions taken with respect to supplier non-
conformance.

Sec.  507.38  Recall plan.

    (a) For animal food with a significant hazard you must:
    (1) Establish a written recall plan for the animal food; and
    (2) Assign responsibility for performing all procedures in the
recall plan.
    (b) The written recall plan must include procedures that describe
the steps to perform the following actions as appropriate to the
facility:
    (1) Directly notify direct consignees about the animal food being
recalled, including how to return or dispose of the affected animal
food;
    (2) Notify the public about any hazard presented by the animal food
when appropriate to protect animal and human health;
    (3) Conduct effectiveness checks (as described in part 7 of this
chapter) to verify the recall has been carried out; and
    (4) Appropriately dispose of recalled animal food (e.g.,
reprocessing, reworking, diverting to another use that would not
present a safety concern, or destroying).

Sec.  507.39  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section,
the preventive controls required under Sec.  507.36 are subject to the
following preventive control management components as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control:
    (1) Monitoring in accordance with Sec.  507.40;
    (2) Corrective actions and corrections in accordance with Sec.
507.42; and
    (3) Verification in accordance with Sec.  507.45.
    (b) The supplier program established in Sec.  507.37 is subject to
the following preventive control management components as appropriate
to ensure the effectiveness of the supplier program, taking into
account the nature of the hazard controlled before receipt of the raw
material or ingredient:
    (1) Corrective actions and corrections in accordance with Sec.
507.42, taking into account the nature of any supplier non-conformance;
    (2) Review of records in accordance with Sec.  507.49(a)(4)(ii);
and
    (3) Reanalysis in accordance with Sec.  507.50.
    (c) The recall plan established in Sec.  507.38 is not subject to
the requirements of paragraph (a) of this section.

Sec.  507.40  Monitoring.

    (a) As appropriate to the preventive control you must:
    (1) Establish and implement written procedures, including the
frequency with which they are to be performed, for monitoring the
preventive controls; and
    (2) Monitor the preventive controls with adequate frequency to
provide assurance that they are consistently performed.
    (b) You must monitor the preventive controls with adequate
frequency to provide assurance that the preventive controls are
consistently performed.
    (c) All monitoring of preventive controls in accordance with this
section must be documented in records that are subject to verification
in accordance with Sec.  507.45(a)(2) and records review in accordance
with Sec.  507.49(a)(4)(i).

Sec.  507.42  Corrective actions and corrections.

    (a) As appropriate to the preventive control, except as provided by
paragraph (c) of this section:
    (1)(i) You must establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented.
    (ii) The corrective action procedures required by paragraph
(a)(1)(i) of this section must include procedures to address, as
appropriate:
    (A) The presence of a pathogen or appropriate indicator organism in
animal food detected as a result of product testing conducted in
accordance with Sec.  507.49(a)(2); and
    (B) The presence of an environmental pathogen or appropriate
indicator organism detected through the environmental monitoring
conducted in accordance with Sec.  507.49(a)(3).
    (2) The corrective action procedures must describe the steps to be
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken when necessary, to reduce the
likelihood that the problem will recur;
    (iii) All affected animal food is evaluated for safety; and
    (iv) All affected animal food is prevented from entering into
commerce if you cannot ensure the affected animal food is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act.
    (b)(1) Except as provided by paragraph (c) of this section, you are
subject to the requirements of paragraph (b)(2) of this section if any
of the following circumstances apply:
    (i) A preventive control is not properly implemented and a specific
corrective action procedure has not been established;
    (ii) A preventive control is found to be ineffective; or
    (iii) A review of records in accordance with Sec.  507.49(a)(4)
finds that the records are not complete, the activities conducted did
not occur in accordance with the food safety plan, or appropriate
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this
section apply, you must:
    (i) Take corrective action to identify and correct the problem;
    (ii) Reduce the likelihood that the problem will recur;
    (iii) Evaluate all affected animal food for safety;
    (iv) As necessary, prevent affected animal food from entering
commerce as would be done following the corrective action procedure
under paragraph (a)(2) of this section; and
    (v) When appropriate, reanalyze the food safety plan in accordance
with Sec.  507.50 to determine whether modification of the food safety
plan is required.
    (c) You do not need to comply with the requirements of paragraphs
(a) and (b) of this section for conditions and practices that are not
consistent with the sanitation controls in Sec.  507.36(c)(2)(i) or
(ii) if you take action, in a timely manner, to correct such conditions
and practices.
    (d) All corrective actions (and, when appropriate, corrections)
taken in accordance with this section must be

documented in records. These records are subject to verification in
accordance with Sec.  507.45(a)(3) and records review in accordance
with Sec.  507.49(a)(4)(i).

Sec.  507.45  Verification.

    (a) Verification activities must include, as appropriate to the
preventive control:
    (1) Validation in accordance with Sec.  507.47;
    (2) Verification that monitoring is being conducted as required by
Sec.  507.39 (and in accordance with Sec.  507.40);
    (3) Verification that appropriate decisions about corrective
actions are being made as required by Sec.  507.39 (and in accordance
with Sec.  507.42);
    (4) Verification of implementation and effectiveness in accordance
with Sec.  507.49; and
    (5) Reanalysis in accordance with Sec.  507.50.
    (b) All verification activities conducted in accordance with this
section must be documented in records.

Sec.  507.47  Validation.

    (a) Except as provided by paragraph (b)(3) of this section, you
must validate that the preventive controls identified and implemented
in accordance with Sec.  507.36 to control the significant hazards are
adequate to do so as appropriate to the nature of the preventive
control.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a qualified individual:
    (i) Prior to implementation of the food safety plan or, when
necessary, during the first 6 weeks of production; and
    (ii) Whenever a reanalysis of the food safety plan reveals the need
to do so;
    (2) Must include collecting and evaluating scientific and technical
information (or, when such information is not available or is
inadequate, conducting studies) to determine whether the preventive
controls, when properly implemented, will effectively control
significant hazards; and
    (3) Need not address:
    (i) The sanitation controls in Sec.  507.36(c)(2);
    (ii) The supplier program in Sec.  507.37; and
    (iii) The recall plan in Sec.  507.38.

Sec.  507.49  Verification of implementation and effectiveness.

    (a) You must verify that the preventive controls are consistently
implemented and are effectively and significantly minimizing or
preventing the significant hazards. To do so, you must conduct
activities that include the following, as appropriate to the facility,
the animal food, and the nature of the preventive control:
    (1) Calibration of process monitoring and verification instruments;
    (2) Product testing for a pathogen (or appropriate indicator
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for
an appropriate indicator organism, if contamination of an animal food
with an environmental pathogen is a significant hazard, by collecting
and testing environmental samples; and
    (4) Review of the following records within the specified
timeframes, by (or under the oversight of) a qualified individual, to
ensure the records are complete, the activities reflected in the
records occurred in accordance with the food safety plan, the
preventive controls are effective, and appropriate decisions were made
about corrective actions:
    (i) Monitoring and corrective action records within a week after
the records are created; and
    (ii) Records of calibration, product testing, environmental
monitoring, and supplier verification activities within a reasonable
time after the records are created.
    (b) As appropriate to the facility, the food, and the nature of the
preventive control, you must establish and implement written procedures
for the following activities:
    (1) The method and frequency of calibrating process monitoring
instruments and verification instruments as required by paragraph
(a)(1) of this section.
    (2) Product testing as required by paragraph (a)(2) of this
section. Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
507.42(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of
this section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected
and the number of sites to be tested during routine environmental
monitoring. The number and location of sampling sites must be adequate
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing
samples. The timing and frequency for collecting and testing samples
must be adequate to determine whether preventive controls are
effective;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
507.42(a)(1)(ii).

Sec.  507.50  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan:
    (1) At least once every 3 years;
    (2) Whenever a significant change is made in the activities
conducted at your facility if the change creates a reasonable potential
for a new hazard or creates a significant increase in a previously
identified hazard;
    (3) Whenever you become aware of new information about potential
hazards associated with the animal food;
    (4) Whenever appropriate after an unanticipated animal food safety
problem in accordance with Sec.  507.42(b); and
    (5) Whenever you find that a preventive control is ineffective.
    (b) You must complete the reanalysis required by paragraph (a) of
this section and implement any additional preventive controls needed to
address the hazard identified, if any, before the change in activities
at the facility is operative or, when necessary, during the first 6
weeks of production.
    (c) You must revise the written food safety plan if a significant
change is made or document the basis for the conclusion that no
revisions are needed.
    (d) A qualified individual must perform (or oversee) the
reanalysis.
    (e) You must conduct a reanalysis of the food safety plan when FDA
determines it is necessary to respond to new hazards and developments
in scientific understanding.

Sec.  507.51  Modified requirements that apply to a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment.

    (a) The owner, operator, or agent in charge of a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment must conduct the following activities for any such
refrigerated packaged animal food that requires time/temperature
control to significantly minimize or prevent the

growth of, or toxin formation by, microorganisms of animal or human
health significance:
    (1) Establish and implement temperature controls adequate to
significantly minimize or prevent the growth of, or toxin formation by,
microorganisms of animal or human health significance;
    (2) Monitor the temperature controls with sufficient frequency to
provide assurance they are consistently performed;
    (3) Take appropriate corrective actions if there is a problem with
the temperature controls for such refrigerated packaged animal food to:
    (i) Correct the problem and reduce the likelihood that the problem
will recur;
    (ii) Evaluate all affected animal food for safety; and
    (iii) Prevent the animal food from entering commerce, if the owner,
operator, or agent in charge of the facility cannot ensure the affected
animal food is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented
by:
    (i) Calibrating temperature monitoring and recording devices;
    (ii) Reviewing records of calibration within a reasonable time
after the records are made; and
    (iii) Reviewing records of monitoring and corrective actions taken
to correct a problem with the control of temperature within a week
after the records are made;
    (5) Establish and maintain the following records:
    (i) Records documenting the monitoring of temperature controls for
any such refrigerated packaged animal food;
    (ii) Records of corrective actions taken when there is a problem
with the control of temperature for any such refrigerated packaged
animal food; and
    (iii) Records documenting the verification activities.
    (b) The records that a facility must establish and maintain under
paragraph (a)(5) of this section are subject to the requirements of
subpart F of this part.

Sec.  507.53  Requirements applicable to a qualified individual and a
qualified auditor.

    (a) One or more qualified individuals must do or oversee the
following:
    (1) Preparation of the food safety plan (Sec.  507.31(b));
    (2) Validation of the preventive controls (Sec.  507.47(b)(1));
    (3) Review of records (Sec.  507.49(a)(4)); and
    (4) Reanalysis of the food safety plan (Sec.  507.50(d)).
    (b) A qualified auditor must conduct an onsite audit (Sec.
507.37(d)).
    (c)(1) To be a qualified individual, the individual must have
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 be
otherwise qualified through job experience to develop and apply a food
safety system. Job experience may qualify an individual to perform
these functions if such experience has provided an individual with
knowledge at least equivalent to that provided through the standardized
curriculum. This individual may be, but is not required to be, an
employee of the facility.
    (2) To be a qualified auditor, a qualified individual must have
technical expertise obtained by a combination of training and
experience appropriate to perform the auditing function.
    (d) All applicable training must be documented in records,
including the date of the training, the type of training, and the
person(s) trained.

Sec.  507.55  Implementation records.

    (a) You must establish and maintain the following records
documenting implementation of the food safety plan:
    (1) Records that document the monitoring of preventive controls;
    (2) Records that document corrective actions;
    (3) Records that document verification, including, as applicable,
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification
instruments;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (4) Records that document the supplier program; and
    (5) Records that document applicable training for the qualified
individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to
the requirements of subpart F of this part.
0
12. Section 507.60, as proposed to be added on October 29, 2013 (78 FR
64736), is revised to read as follows:

Sec.  507.60  Circumstances that may lead FDA to withdraw an exemption
applicable to a qualified facility.

    (a) FDA may withdraw the exemption applicable to a qualified
facility under Sec.  507.5(d):
    (1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public
(human or animal) health and prevent or mitigate a foodborne illness
outbreak based on conditions or conduct associated with the qualified
facility that are material to the safety of the animal food
manufactured, processed, packed, or held at such facility.
    (b) Before FDA issues an order to withdraw an exemption applicable
to a qualified facility, FDA:
    (1) May consider one or more other actions to protect the public
(human or animal) health or mitigate a foodborne illness outbreak,
including, a warning letter, recall, administrative detention,
suspension of registration, import alert, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the
facility, in writing of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the facility to respond in writing, within 10 calendar
days of the date of receipt of the notification, to FDA's notification;
and
    (3) Must consider the actions taken by the facility to address the
circumstances that may lead FDA to withdraw the exemption.
0
13. Section 507.62, as proposed to be added on October 29, 2013 (78 FR
64736), is revised to read as follows:

Sec.  507.62  Issuance of an order to withdraw an exemption applicable
to a qualified facility.

    (a) An FDA District Director in whose district the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine), or an FDA official senior to such Director, must approve an
order to withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.
0
14. Amend Sec.  507.65, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (d) to read as follows:

Sec.  507.65  Contents of an order to withdraw an exemption applicable
to a qualified facility.

* * * * *
    (d) A statement that the facility must either:
    (1) Comply with subpart C of this part on the date that is 120
calendar days after the date of receipt of the order; or
    (2) Appeal the order within 10 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  507.69.
* * * * *
0
15. Amend Sec.  507.67, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraphs (a) and (c) to read as follows

Sec.  507.67  Compliance with, or appeal of, an order to withdraw an
exemption applicable to a qualified facility.

    (a) If you receive an order under Sec.  507.65 to withdraw an
exemption applicable to that facility under Sec.  507.5(d), you must
either:
    (1) Comply with applicable requirements of this part within 120
calendar days of the date of receipt of the order; or
    (2) Appeal the order within 10 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  507.69.
* * * * *
    (c) If you appeal the order, and FDA confirms the order, you must
comply with applicable requirements of this part within 120 calendar
days of the date of receipt of confirmation of the order.
0
16. Amend Sec.  507.69, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (a) introductory text and paragraph
(a)(1) to read as follows:

Sec.  507.69  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw an exemption applicable to a
qualified facility under Sec.  507.5(d), you must:
    (1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine), at the mailing address, email address, or
facsimile number identified in the order within 10 calendar days of the
date of receipt of the order;
* * * * *
0
17. Amend Sec.  507.71, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (a) to read as follows:

Sec.  507.71  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with
your written appeal submitted in accordance with Sec.  507.69 within 10
calendar days of the date of receipt of the order.
* * * * *
0
18. Subpart D, as proposed to be added on October 29, 2013 (78 FR
64736), is amended by adding Sec.  507.85 to read as follows:

Sec.  507.85  Reinstatement of an exemption that was withdrawn.

    (a) If the FDA District Director in whose district your facility is
located (or, in the case of a foreign facility, the Director of the
Division of Compliance in the Center for Veterinary Medicine)
determines that a facility has adequately resolved problems with the
conditions and conduct that are material to the safety of the animal
food manufactured, processed, packed, or held at the facility and that
continued withdrawal of the exemption is not necessary to protect
public (human and animal) health and prevent or mitigate a foodborne
illness outbreak, the FDA District Director in whose district your
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) will, on his own initiative or on the request of a facility,
reinstate the exemption.
    (b) You may ask FDA to reinstate an exemption that has been
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in
whose district your facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine); and
    (2) Present data and information to demonstrate that you have
adequately resolved the problems with the conditions or conduct that
are material to the safety of the animal food manufactured/processed,
packed, or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public (human and animal) health
and prevent or mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  507.60(a)(1) and
FDA later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will reinstate your exemption under Sec.  507.5(d),
and FDA will notify you in writing that your exempt status has been
reinstated.
    (d) If your exemption was withdrawn under both Sec. Sec.
507.60(a)(1) and 507.60(2) and FDA later determines, after finishing
the active investigation of a foodborne illness outbreak, that the
outbreak is not directly linked to your facility, FDA will inform you
of this finding and you may ask FDA to reinstate your exemption under
Sec.  507.5(d) in accordance with the requirements of paragraph (b) of
this section.

Sec.  507.100  [Redesignated as Sec.  507.200]

0
19. Redesignate Sec.  507.100, as proposed to be added on October 29,
2013 (78 FR 64736), as Sec.  507.200.
0
20. Revise Sec.  507.102, as proposed to be added on October 29, 2013
(78 FR 64736), to read as follows:

Sec.  507.202  General requirements applying to records.

    (a) Records must:
    (1) Be kept as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records, which
must be kept in accordance with part 11 of this chapter;
    (2) Contain the actual values and observations obtained during
monitoring and as appropriate, during verification activities;
    (3) Be accurate, indelible, and legible;
    (4) Be created concurrently with performance of the activity
documented; and
    (5) Be as detailed as necessary to provide history of work
performed.
    (b) All records must include:
    (1) The name and location of the plant or facility;
    (2) The date and time of the activity documented;
    (3) The signature or initials of the person performing the
activity; and
    (4) Where appropriate, the identity of the product and the
production code, if any.

Sec. Sec.  507.106 and 507.108 [Redesignated as Sec. Sec.  507.206 and
507.208]
0
21. Redesignate Sec. Sec.  507.106 and 507.108, as proposed to be added
on October 29, 2013 (78 FR 64736), as Sec. Sec.  507.206 and 507.208,
respectively.
0
22. Subpart F, as proposed to be added on October 29, 2013 (78 FR
64736), is amended by adding Sec.  507.212 to read as follows:

Sec.  507.212  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with
other Federal, State, or local regulations, or for any other reason) do
not need to be

duplicated if they contain all of the required information and satisfy
the requirements of this subpart F. Existing records may be
supplemented as necessary to include all of the required information
and satisfy the requirements of this subpart F.
    (b) The information required by this part does not need to be kept
in one set of records. If existing records contain some of the required
information, any new information required by this part may be kept
either separately or combined with the existing records.

    Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.

    Note: The following appendix will not appear in the Code of
Federal Regulations.

Appendix

    The supplemental notice of proposed rulemaking that is the
subject of this document includes a discussion of our
reconsideration of the classification of specific activities as
harvesting, packing, holding, or manufacturing/processing, when
conducted on farms or on farm mixed-type facilities (see the
discussion and Table 5 in section VII.C). Table 1 in this Appendix
compares the classification of on-farm activities as harvesting,
packing, holding, or manufacturing/processing in the 2013 proposed
rule for preventive controls to our current thinking on the
classification of these on-farm activities as a result of the
proposed revisions to the ``farm'' definition.

Table 1--Classification of Activities Conducted On-Farms and Farm Mixed-
                             Type Facilities
------------------------------------------------------------------------
                                                          Examples using
                               Examples using the 2013     the proposed
       Classification             proposed ``farm''        revisions to
                                     definition*           the ``farm''
                                                            definition
------------------------------------------------------------------------
Harvesting Activities          Cooling RACs***
 traditionally performed by    (activity deleted          Gathering RACs
 farms for the purpose of      because is not done on
 removing RACs from growing    RACs for animal food)      Removing stems
 areas and preparing them      Filtering          and husks from
 for use as animal food.       RACs*** (activity          RACs
 Harvesting does not include   deleted because is not
 activities that change a      done on RACs for animal    Shelling RACs
 RAC into processed animal     food)
 food.                         Gathering RACs     Sifting RACs
                               Removing stems
                               and husks from RACs        Threshing RACs
                               Shelling RACs
                               Sifting RACs       Trimming outer
                               Threshing RACs     leaves from
                               Trimming of        RACs
                               outer leaves from RACs
                               Washing RACs***
                               (activity deleted
                               because is not done on
                               RACs for animal food)
Packing: Placing animal food   Coating RACs
 in a container other than     with wax/oil/resin for     Labeling RACs
 packaging the animal food     the purpose of storage
 and activities performed      or transport ***           Blending RACs
 incidental to packing an      (deleted because is not    (e.g.,
 animal food (e.g.,            done on RACs for animal    blending
 activities performed for      food)                      different lots
 the safe or effective         Drying RACs for    of the same
 packing of that animal food   the purpose of storage     RAC such as
 (such as sorting, culling     or transport ** (would     whole grains
 and grading)), but does not   change to only be          that does not
 include activities that       classified as              result in a
 transform a RAC into a        ``holding'')               new commodity)
 processed animal food.        Labeling RACs
                               Mixing RACs        Packaging RACs
                               Packaging a        regardless of
                               farm's or farm mixed-      ownership **
                               type facility's own RACs   (expanded to
                               ** (would no longer be     include
                               limited to ``own RACs'')   others' RACs)
                               Putting RACs or
                               individual unit cartons    Putting RACs
                               into non-consumer          or individual
                               containers                 unit cartons
                               Sorting/grading/   into non-
                               culling RACs               consumer
                               Stickering RACs    containers

                                                          Removing stems
                                                          and husks from
                                                          RACs ** (add'l
                                                          classification
                                                          )

                                                          Sifting RACS
                                                          ** (add'l
                                                          classification
                                                          )****

                                                          Sorting/
                                                          culling/
                                                          grading RACs

                                                          Stickering
                                                          RACs
                                                          Using
                                                          pesticides on
                                                          RACs ** (add'l
                                                          classification
                                                          )
Holding: Storage of animal     Drying/            Drying/
 food and activities           dehydrating RACs during    dehydrating
 performed incidental to       storage (incidental to     RACs
 storage of an animal food     packing or storing when    (incidental to
 (e.g., activities performed   the drying/dehydrating     storing when
 for the safe or effective     does not create a          the drying/
 storage of that food, and     distinct commodity)**      dehydrating
 activities performed as a     (would no longer be        does not
 practical necessity for the   incidental to packing,     create a
 distribution of that animal   would only be incidental   distinct
 food (such as blending of     to holding)                commodity)
 the same commodity and        Fumigating RACs
 breaking down pallets)).      during storage             Fumigating
 Holding does not include      Sorting/culling/   RACs during
 activities that change a      grading RACs               storage to
 RAC into a processed animal   Storing food       control pests
 food.
                                                          Sorting/
                                                          culling/
                                                          grading RACs

                                                          Storing animal
                                                          food

Manufacturing/Processing:      Artificial
 Making animal food from one   ripening *** (this         Canning
 or more ingredients, or       activity deleted because
 synthesizing, preparing,      is not done on animal      Chopping
 treating, modifying, or       food)
 manipulating animal food,     Canning            Cooking
 including food crops or       Chopping
 ingredients. Examples of      Coating RACs for   Cooling
 manufacturing/processing      purposes other than        Coring
 activities are cutting,       storage/transport ***      (except field
 peeling, trimming, washing,   (this activity deleted     coring)**
 eviscerating, rendering,      because is not done on     (because field
 cooking, baking, freezing,    animal food)               coring would
 cooling, pasteurizing,        Cooking            be newly
 homogenizing, mixing,         Cooling            classified as
 formulating, milling,         Coring             harvesting)
 grinding, extracting,         Cracking
 distilling, labeling, or      Crushing           Cracking
 packaging. For farms and      Cutting
 farm mixed-type facilities,   Distilling         Crushing
 manufacturing/processing      Drying/
 does not include activities   dehydrating RACS to        Cutting
 that are part of              create a distinct
 harvesting, packing, or       commodity                  Distilling
 holding.                      Extracting         Drying/
                               Formulating        dehydrating
                               Freezing           RACs to create
                               Grinding           a distinct
                               Homogenizing       commodity
                               Infusing
                               Irradiating        Extracting
                               Labeling (other
                               than RACs)                 Formulating
                               Milling
                               Mixing             Freezing
                               Packaging (other
                               than RACs)                 Grinding
                               Pasteurizing
                               Peeling            Homogenizing
                               Rendering
                               Roasting           Infusing
                               Salting
                               Slaughtering and   Irradiating
                               post-slaughter
                               operations                 Labeling
                               Slicing            (other than
                               Smoking            RACs)
                               Sorting,
                               culling, grading (not      Milling
                               incidental to packing or   Mixing
                               holding)
                               Trimming           Packaging
                               Washing            (other than
                                                          RACs)

                                                          Pasteurizing

                                                          Peeling

                                                          Rendering

                                                          Roasting

                                                          Salting

                                                          Slaughtering
                                                          and post-
                                                          slaughter
                                                          operations

                                                          Slicing

                                                          Smoking

                                                          Sorting,
                                                          culling,
                                                          grading (not
                                                          incidental to
                                                          packing or
                                                          holding)

                                                          Trimming

                                                          Washing
------------------------------------------------------------------------
* Examples were included in Table 4, Table 5, and/or proposed Sec.  Sec.
    507.3 and 507.5(e) and (f) in the 2013 proposed rule for preventive
  controls and/or in the Draft Risk Assessment (Ref. 1).
** Activities listed in italics represent a change between the 2013
  ``farm'' definition and our current thinking in light of the proposed
  revisions to the ``farm'' definition.
*** Activities deleted because they are not typically performed in
  animal food.
**** add'l = additional.

    The following reference has been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
This reference is also available electronically at http://www.regulatons.gov.

1. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/Animal
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm,'' 2013.

[FR Doc. 2014-22445 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P