Annex to CAC/RCP 1-1969 (Rev. 4-2003), '' 2003.
37. Anderson, J. E., R. R. Beelman, and S. Doores, ``Persistence of
Serological and Biological Activities of Staphylococcal Enterotoxin
A in Canned Mushrooms'', Journal of Food Protection, 59, 1292-1299,
1996.
38. Bennett, R. W. and M. R. Berry, ``Serological Reactivity and in
Vivo Toxicity of Staphylococcus aureus Enterotoxins A and D in
Selected Canned Foods'', Journal of Food Science, 52, 416-419, 1987.
39. FDA, ``Food Code 2009: Chapter 1-Purpose & Definitions'' (http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm186464.htm), 2009, Page Last Updated: August 19, 2013 (accessed
on August 27, 2013).
40. FDA, ``Food Code 2009: Annex 3--Public Health Reasons/
Administrative Guidelines--Chapter 1, Purpose and Definitions''
(http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm189170.htm), 2009, Page Last Updated: August 19, 2013
(accessed on August 27, 2013).
41. FDA, ``Food Code 2009: Annex 3--Public Health Reasons/
Administrative Guidelines-Chapter 3, Food'' (http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm189211.htm), 2009, Page Last Updated: August 19, 2013 (accessed
on August 27, 2013).
42. Association of American Feed Control Officials (AAFCO), ``Model
Good Manufacturing Practice Regulations for Feed and Feed
Ingredients'', In: AAFCO Official Publication, 210-215, 2010.
43. Food and Agriculture Organization of the United Nations (FAO)
and World Health Organization (WHO), ``Good practices for the feed
industry--Implementing the Codex Alimentarius Code of Practice on
Good Animal Feeding Section 3 Good Production Practices'' 2011.
44. British Standards Institute (BSI), ``Publicly Available
Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety
in the Manufacture of Food and Feed for Animals,'' 2011.
45. FDA, ``Salmonella Enteritidis Outbreak in Shell Eggs'' (http://www.fda.gov/Food/NewsEvents/NewsfromOtherFederalResources/ucm222684.htm), Last Update: November 30, 2010, Page Last Updated:
August 27, 2013, (Accessed on August 27, 2013).
46. Centers for Disease Control and Prevention (CDC),
``Investigation Update: Multistate Outbreak of Human Salmonella
Enteritidis Infections Associated with Shell Eggs'' (http://www.cdc.gov/salmonella/enteritidis/), Posted: December 2, 2010, Page
Last Updated: December 2, 2012 (accessed on August 23, 2013).
47. FDA, ``Quality Egg LLC (Wright County Egg), Galt, IA, 483,''
August, 2010.
48. FDA, ``FDA Foods Program, The Reportable Food Registry: A New
Approach to Targeting Inspection Resources and Identifying Patterns
of Adulteration. First Annual Report: September 8, 2009-September 7,
2010,'' January, 2011.
49. FDA, ``Food CGMP Modernization--A Focus on Food Safety'' (http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm207458.htm), November
2, 2005, Page Last Updated: June 17, 2013 (accessed on August 27,
2013).

50. FDA Memorandum, ``Food GMP Modernization Working Group: Summary
of Food Recalls, 1999-2003,'' 2004.
51. FDA Memorandum, ``Analysis of Food Recalls Initiated in 2008-
2009 by an FDA CGMP Working Group,'' 2012.
52. FDA, ``Preliminary Regulatory Impact Analysis,'' 2013.
53. Abbas, H. K., R. D. Cartwright, W. Xie, et al., ``Aflatoxin and
fumonisin contamination of corn (maize, Zea mays) hybrids in
Arkansas,'' Crop Protection, 25, 1-9, 2006.
54. European Food Safety Authority, ``Gossypol as undesirable
substance in animal feed: Scientific Opinion of the Panel on
Contaminants in the Food Chain,'' The EFSA Journal, 908, 1-55, 2008.
55. Rotter, B. A., D. B. Prelusky, and James J. Pestka, ``Invited
Review: Toxicology of Deoxynivalenol (Vomitoxin), '' Journal of
Toxicology and Environmental Health, Part A, 48, 1-34, 1996.
56. Johnson, W. D. and R. W. Storts, ``Peripheral Neuropathy
Associated with Dietary Riboflavin Deficiency in the Chicken I.
Light Microscopic Study,'' Veterinary Pathology, 25, 9-16, 1988.
57. Gries, C. L. and M. L. Scott, ``The Pathology of Thiamin,
Riboflavin, Pantothenic Acid and Niacin Deficiencies in the Chick,''
The Journal of Nutrition, 102, 1269-1286, 1971.
58. Phillips, P. H. and R. W. Engel, ``The Histopathology of
Neueomalacia and `Curled Toe' Paralysis in the Chick Fed Low
Riboflavin Diets,'' The Journal of Nutrition, 16, 451-463, 1938.
59. Wyatt, R. D., H. T. Tung, W. E. Donaldson, et al., ``A New
Description of Riboflavin Deficiency Syndrome in Chickens,'' Poultry
Science, 52, 237-244, 1973.
60. Cohen, R. D. H., ``Phosphorus in Rangeland Ruminant Nutrition: A
Review,'' Livestock Production Science, 7, 25-37, 1980.
61. National Research Council, ``Nutrient Requirements of Beef
Cattle: Seventh Revised Edition,'' 2000.
62. Traub-Dargatz, J. L., L. P. Garber,, P. J. Fedorka-Cray et al.,
``Fecal Shedding of Salmonella Spp by Horses in the United States
During 1998 and 1999 and Detection of Salmonella spp in Grain and
Concentrate Sources on Equine Operations,'' JAVMA, 217, 226-230,
2000.
63. Fedorka-Cray, P. J., A. Hogg, J. T. Gray, et al., ``Feed and
Feed Trucks as Sources of Salmonella Contamination in Swine,'' Swine
Health and Production, 5, 189-193, 1997.
64. D'Mello, J. P. F. and A. M. C. Macdonald, ``Mycotoxins,'' Animal
Feed Science Technology, 69, 155-166, 1997.
65. Caloni, F. and C. Cortinovis, ``Toxicological Effects of
Aflatoxins in Horses,'' The Veterinary Journal, 188, 270-273, 2011.
66. Creppy, E. E., ``Update of Survey, Regulation and Toxic Effects
of Mycotoxins in Europe,'' Toxicology Letters, 127, 19-28, 2002.
67. Braun, U., ``Traumatic Pericarditis in Cattle: Clinical,
Radiographic and Ultrasonographic Findings,'' The Veterinary
Journal, 182, 176-786, 2009.
68. FDA, ``Compliance Policy Guide Sec. 555.425 Foods, Adulteration
Involving hard or Sharp Foreign Objects'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074554.htm),
Update November 29, 2005, Page Last Updated: April 27, 2009
(accessed on August 27, 2013).
69. FDA, ``Accidental Radioactive Contamination of Human Food and
Animal Feeds: Recommendations for State and Local Agencies,''
August, 1998.
70. FDA, ``Compliance Policy Guide Sec. 560.750 Radionuclides in
Imported Foods--Levels of Concern'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074576.htm),
Updated November 29, 2005, Page Last Updated: December 9, 2009
(accessed on August 27, 2013).
71. Cavallarin, L., E. Tabacco, S. Antoniazzi, et al., ``Aflatoxin
Accumulation in Whole Cropmaize Silage as a Result of Aerobic
Exposure,'' Journal of the Science of Food and Agriculture, 91,
2419-2425, 2011.
72. Wojtala, G., ``Interstate Food Transportation Assessment
Project,'' 2007.
73. FDA, ``Industry Guidance: Information on Recalls of FDA
Regulated Products'' (http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm), December, 2011, Page Last Updated:
January 31, 2013 (accessed on August 27, 2013).
74. FDA, ``Recalls & Withdrawals'' (http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm), Page
Last Updated: August 15, 2013 (accessed on August 27, 2013).
75. FDA, ``Salmonella Model Press Release for Pet Food and Pet
Treats'' (http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129276.htm), Page Last Updated: June 27, 2011 (accessed on August
27, 2013).
76. FDA, ``Food Code 2009'' (http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM2019396.htm),
Page Last Updated: March 16, 2013 (accessed on August 27, 2013).
77. FDA, ``Grade ``A'' Pasteurized Milk Ordinance (2007 Revision)''
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk/ucm2007968.htm), Page
Last Updated: May 11, 2009 (accessed on August 27, 2013).
78. FDA, ``Fish and Fishery Products Hazards and Controls Guidance,
Fourth Edition'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm),
November 2011, Page Last Updated: July 5, 2013 (accessed on August
27, 2013).
79. Codex Alimentarius Commission, ``Guideline for the validation of
food safety control measures, CAC/GL 69-2008,'' 2008.
80. National Advisory Committee on Microbiological Criteria for
Foods, ``Parameters for Determining Inoculated Pack/Challenge Study
Protocols,'' Journal of Food Protection, 73, 140-202, 2010.
81. FDA, ``Guidance for Industry: Antimicrobial Food Additives''
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm077256.htm), July 1999, Page
Last Updated: August 16, 2013 (accessed on August 27, 2013).
82. Environmental Protection Agency (EPA), ``Pesticide Registration
Manual: Chapter 4-Additional Considerations for Antimicrobial
Products'' (http://www.epa.gov/pesticides/bluebook/chapter4.html),
December 28, 2011, Page Last Updated: May 2013 (accessed on August
21, 2013).
83. Centers for Disease Control and Prevention (CDC), ``Multistate
Outbreak of Salmonella Serotype Tennessee Infections Associated with
Peanut Butter--United States, 2006-2007'', In: Morbidity and
Mortality Weekly Report June 2007, (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5621a1.htm), 2007 (accessed on August 27, 2013).
84. Scott, V. N., C. Yuhuan, T. A. Freier, et al., ``Control of
Salmonella in Low-Moisture Foods I: Minimizing Entry of Salmonella
Into a Processing Facility,'' Food Protection Trends, 29, 342-353,
2009.
85. Chen, Y., V. N. Scott, T. A. Freier, et al., ``Control of
Salmonella in Low-Moisture Foods II: Hygiene Practices to Minimize
Salmonella Contamination and Growth,'' Food Protection Trends,
29:435-445, 2009.
86. Institute of Food Technologists, ``Evaluation & Definition of
Potentially Hazardous Foods'' (http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm094141.htm),
December 31, 2001, Page Last Updated: June 3, 2013 (accessed on
August 27, 2013).
87. FDA,''Fish and Fishery Products Hazards and Controls Guidance,
Fourth Edition. Appendix 4: Bacterial Pathogen Growth and
Inactivation'' April, 2011.
88. FDA, ``Food Code 2009: Chapter 3-Food'' (http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm186451.htm), August 19, 2013 (accessed on August 27, 2013).
89. International Commission on Microbiological Specifications for
Foods, ``Sampling Considerations and Statistical Aspects of Sampling
Plans,'' In: Microorganisms in Foods 8: Use of Data for Assessing
Process Control and Product Acceptance, edited by Springer355-364,
2011.
90. International Commission on Microbiological Specifications for
Foods, ``Selection of cases and attributes plans,'' In:
Microorganisms in Foods 7: Microbiological Testing in Food Safety

Management, edited by Tompkin, R. B., Gram, L., Roberts, T. A.,
Buchanan, R. L., van Schothorst, M., Dahms, S., and Cole, M. B.145-
172, 2002.
91. International Commission on Microbiological Specifications for
Foods, ``Sampling plans,'' In: Microorganisms in Foods 7:
Microbiological Testing in Food Safety Management, edited by
Tompkin, R. B., L. Gram, T. A. Roberts, R. L. Buchanan, et Al.,123-
143, 2002.
92. Codex Alimentarius Commission,''Guidelines on the Application of
General Principles of Food Hygiene to the Control of Listeria
monocytogenes in Ready-to-Eat Foods, CAC/GL 61-2007'' August, 2007.
93. Codex Alimentarius Commission,''Codex Standard for Natural
Mineral Waters, CODEX STAN 108-1981'' 1981.
94. Chen, Y., V.N. Scott, T.A. Freier, et al., ``Control of
Salmonella in Low-Moisture Foods III: Process Validation and
Environmental Monitoring,'' Food Protection Trends, 29:493-508,
2009.
95. Jarl, D. L. and E. A. Arnold, ``Influence of Drying Plant
Environment on Salmonellae Contamination of Dry Milk Products'',
Journal of Food Protection, 45, 16- 1982.
96. FDA,''Paperwork Reduction Act Analysis,'' 2013.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 225

    Animal drugs, Animal feeds, Labeling, Packaging and containers,
Reporting and recordkeeping requirements.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCB's).

21 CFR Part 507

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

21 CFR Part 579

    Animal feeds, Animal foods, Radiation protection.

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

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

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

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

0
2. In Sec.  16.1, in paragraph (b)(2) add the following entry in
numerical order to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  507.60 through 507.83 (part 507, subpart D) relating to
withdrawal of exemption applicable to a qualified facility.
* * * * *

PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

0
3. The authority citation for 21 CFR part 225 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360b, 371, 374.

0
4. In Sec.  225.1, add paragraph (d) to read as follows:

Sec.  225.1  Current good manufacturing practice.

* * * * *
    (d) In addition, non-medicated feed is subject to part 507 of this
chapter.

PART 500--GENERAL

0
5. The authority citation for 21 CFR part 500 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.

0
6. Revise Sec.  500.23 to read as follows:

Sec.  500.23  Thermally processed low-acid foods packaged in
hermetically sealed containers.

    Except as provided in Sec.  507.5(b), the provisions of parts 507
and 113 of this chapter apply to the manufacturing, processing, or
packing of low-acid foods in hermetically sealed containers, and
intended for use as food for animals.
0
7. Add part 507 to read as follows:

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

Subpart A--General Provisions
Sec.
507.1 Applicability and status.
507.3 Definitions.
507.5 Exemptions.
507.7 Requirements that apply to a qualified facility.
507.10 Applicability of subpart C to a facility solely engaged in
the storage of packaged animal food that is not exposed to the
environment.
Subpart B--Current Good Manufacturing Practice
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitary operations.
507.20 Sanitary facilities and controls.
507.22 Equipment and utensils.
507.25 Processes and controls.
507.28 Warehousing and distribution.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
507.30 Requirement for a food safety plan.
507.33 Hazard analysis.
507.36 Preventive controls for hazards that are reasonably likely to
occur.
507.38 Recall plan for animal food with a hazard that is reasonably
likely to occur.
507.39 Monitoring.
507.42 Corrective actions.
507.45 Verification.
507.48 Modified requirements that apply to a facility solely engaged
in the storage of packaged animal food that is not exposed to the
environment.
507.50 Requirements applicable to a qualified individual.
507.55 Records required for this subpart C.
Subpart D--Withdrawal of an Exemption Applicable to a Qualified
Facility
507.60 Circumstances that may lead FDA to withdraw an exemption
applicable to a qualified facility.
507.62 Issuance of an order to withdraw an exemption applicable to a
qualified facility.
507.65 Contents of an order to withdraw an exemption applicable to a
qualified facility.
507.67 Compliance with, or appeal of, an order to withdraw an
exemption applicable to a qualified facility.
507.69 Procedure for submitting an appeal.
507.71 Procedure for requesting an informal hearing.
507.73 Requirements applicable to an informal hearing.
507.75 Presiding officer for an appeal and for an informal hearing.
507.77 Timeframe for issuing a decision on an appeal.
507.80 Revocation of an order to withdraw an exemption applicable to
a qualified facility.
507.83 Final agency action.
Subpart E--[Reserved]
Subpart F--Requirements Applying to Records That Must Be Established
and Maintained
507.100 Records subject to the requirements of this subpart F.
507.102 General requirements applying to records.
507.106 Additional requirements applying to the food safety plan.
507.108 Requirements for record retention.

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

Subpart A--General Provisions

Sec.  507.1  Applicability and status.

    (a) The criteria and definitions in this part will apply in
determining whether an animal food is adulterated:
    (1) Within the meaning of section 402(a)(3) of the Federal Food,
Drug, and

Cosmetic Act in that the food has been manufactured under such
conditions that it is unfit for food; or
    (2) Within the meaning of section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act in that the food has been prepared, packed, or
held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health. The criteria and definitions in this part also apply in
determining whether an animal food is in violation of section 361 of
the Public Health Service Act (42 U.S.C. 264).
    (b) The operation of a facility that manufactures, processes,
packs, or holds animal food for sale in the United States if the owner,
operator, or agent in charge of such facility is required to comply
with and is not in compliance with section 418 of the Federal Food,
Drug, and Cosmetic Act or subparts C, D, and F of this part and Sec.
507.7 is a prohibited act under section 301(uu) of the Federal Food,
Drug, and Cosmetic Act.
    (c) Animal food covered by specific current good manufacturing
practice regulations also is subject to the requirements of those
regulations.
    (d) Animal food for sale in the United States must be manufactured,
processed, packed, and held in accordance with the requirements in this
part, subject to the exemptions in Sec.  507.5. If a facility is
required to comply with subpart B of this part and is also required to
comply with subpart B of part 117 of this chapter because the facility
manufactures, processes, packs, or holds human food, then the facility
may choose to comply with the requirements in subpart B of part 117,
instead of subpart B of part 507, as to the manufacturing, processing,
packing, and holding of animal food at that facility. If a facility is
required to comply with subpart C of part 507 and is also required to
comply with subpart C of part 117 of this chapter, then the facility
may choose to comply with the requirements in subpart C of part 117 as
to the manufacturing, processing, packing, and holding of animal food
at the facility, instead of subpart C of part 507, so long as the food
safety plan also addresses all hazards that are reasonably likely to
occur in the animal food, including nutrient imbalances. In both
instances, when applying the requirements of part 117 of this chapter
to animal food, the term ``food'' in part 117 includes animal food.

Sec.  507.3  Definitions.

    The definitions and interpretations contained in section 201 of the
Federal Food, Drug, and Cosmetic Act apply to such terms when used in
this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
    Affiliate means any facility that controls, is controlled by, or is
under common control with another facility.
    Animal food means food for animals other than man and includes pet
food, animal feed, and raw materials and ingredients.
    Batter means a semifluid substance, usually composed of flour and
other ingredients, into which principal components of food are dipped
or with which they are coated, or which may be used directly to form
bakery foods.
    Blanching, except for tree nuts and peanuts, means a prepackaging
heat treatment of foodstuffs for a sufficient time and at a sufficient
temperature to partially or completely inactivate the naturally
occurring enzymes and to effect other physical or biochemical changes
in the food.
    Calendar day means every day shown on the calendar.
    Critical control point means a point, step, or procedure in a food
process at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce such hazard to an acceptable
level.
    Environmental pathogen means a microorganism that is of animal or
human health significance and is capable of surviving and persisting
within the manufacturing, processing, packing, or holding environment.
    Facility means a domestic facility or a foreign facility that is
required to register under section 415 of the Federal Food, Drug, and
Cosmetic Act, in accordance with the requirements of 21 CFR part 1,
subpart H.
    Farm means farm as defined in Sec.  1.227(b) of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food-contact surfaces are those surfaces that contact animal food
and those surfaces from which drainage, or other transfer, onto the
food or onto surfaces that contact the food ordinarily occurs during
the normal course of operations. ``Food-contact surfaces'' include
food-contact surfaces of utensils and equipment.
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed by farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities on the
farm on which they were grown or raised, or another farm under the same
ownership. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg). Gathering, washing, trimming of outer leaves of,
removing stems and husks from, sifting, filtering, threshing, shelling,
and cooling raw agricultural commodities grown on a farm or another
farm under the same ownership are examples of harvesting.
    Hazard means any biological, chemical, physical, or radiological
agent that is reasonably likely to cause illness or injury in animals
or humans in the absence of its control.
    Hazard reasonably likely to occur means a hazard for which a
prudent person who manufactures, processes, packs, or holds food would
establish controls because experience, illness data, scientific
reports, or other information provides a basis to conclude that there
is a reasonable possibility that the hazard will occur in the type of
food being manufactured, processed, packed, or held in the absence of
those controls.
    Holding means storage of food. Holding facilities include
warehouses, cold storage facilities, storage silos, grain elevators,
and liquid storage tanks. For farms and farm mixed-type facilities,
holding also includes activities traditionally performed by farms for
the safe or effective storage of raw agricultural commodities grown or
raised on the same farm or another farm under the same ownership, but
does not include activities that transform a raw agricultural
commodity, as defined in section 201(r) of the Federal Food, Drug, and
Cosmetic Act, into a processed food as defined in section 201(gg).
    Lot means the food produced during a period of time indicated by a
specific code.
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging. For farms and farm mixed-

type facilities, manufacturing/processing does not include activities
that are part of harvesting, packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa,
and microscopic parasites and includes species having animal or human
health significance. The term ``undesirable microorganisms'' includes
those microorganisms that are of animal or human health significance,
that subject food to decomposition, that indicate that food is
contaminated with filth, or that otherwise may cause food to be
adulterated.
    Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that grows and
harvests crops or raises animals and may conduct other activities
within the farm definition, but also conducts activities that require
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or
measurements to assess whether a process, point, or procedure is under
control and to produce an accurate record for use in verification.
    Packaging (when used as a verb) means placing food into a container
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging
the food. For farms and farm mixed-type facilities, packing also
includes activities traditionally performed by farms to prepare raw
agricultural commodities grown or raised on the same farm or another
farm under the same ownership for storage and transport, but does not
include activities that transform a raw agricultural commodity, as
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act,
into a processed food as defined in section 201(gg).
    Pest refers to any objectionable animals or insects including
birds, rodents, flies, and larvae.
    Plant means the building or establishment, or parts thereof, used
for or in connection with the manufacturing, processing, packing, or
holding of animal food.
    Preventive controls means those risk-based, reasonably appropriate
procedures, practices, and processes that a person knowledgeable about
the safe manufacturing, processing, packing, or holding of food would
employ to significantly minimize or prevent the hazards identified
under the hazard analysis that are consistent with the current
scientific understanding of safe food manufacturing, processing,
packing, or holding at the time of the analysis.
    Qualified end-user, with respect to an animal food, means the
consumer of the food (where the term does not include a business); or a
restaurant or retail food establishment (as those terms are defined in
Sec.  1.227(b) of this chapter) that:
    (1) Is located:
    (i) In the same State as the qualified facility that sold the food
to such restaurant or retail food establishment; or
    (ii) Not more than 275 miles from such facility; and
    (2) Is purchasing the food for sale directly to consumers at such
restaurant or retail food establishment.
    Qualified facility means (when including the sales by any
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of
any entity of which the facility is a subsidiary or affiliate) a
facility that is a very small business as defined in this part, or a
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar
year, the average annual monetary value of the animal food
manufactured, processed, packed, or held at such facility that is sold
directly to qualified end-users (as defined in this part) during such
period exceeded the average annual monetary value of the animal food
sold by such facility to all other purchasers; and
    (2) The average annual monetary value of all animal food sold
during the 3-year period preceding the applicable calendar year was
less than $500,000, adjusted for inflation.
    Qualified individual means a person who has successfully completed
training in the development and application of risk-based preventive
controls at least equivalent to that received under a standardized
curriculum recognized as adequate by FDA, or is otherwise qualified
through job experience to develop and apply a food safety system.
    Quality control operation means a planned and systematic procedure
for taking all actions necessary to prevent food from being
adulterated.
    Reasonably foreseeable hazard means a potential biological,
chemical, physical, or radiological hazard that may be associated with
the facility, or the food.
    Rework means clean, unadulterated food that has been removed from
processing for reasons other than insanitary conditions or that has
been successfully reconditioned by reprocessing and that is suitable
for use as food.
    Safe moisture level is a level of moisture low enough to prevent
the growth of undesirable microorganisms in the finished product under
the intended conditions of manufacturing, processing, packing, and
holding. The safe moisture level for a food is related to its water
activity (aw). An aw will be considered safe for
a food if adequate data are available that demonstrate that the food at
or below the given aw will not support the growth of
undesirable microorganisms.
    Sanitize means to adequately treat cleaned food-contact surfaces by
a process that is effective in destroying vegetative cells of
microorganisms of animal or human health significance, and in
substantially reducing numbers of other undesirable microorganisms, but
without adversely affecting the product or its safety for animals or
humans.
    Should is used to state recommended or advisory procedures or
identify recommended equipment. Should denotes non-binding guidance.
    Significantly minimize means to reduce to an acceptable level,
including to eliminate.
    Small business means, for purposes of this part, a business
employing fewer than 500 persons.
    Subsidiary means any company that is owned or controlled directly
or indirectly by another company.
    Validation means that element of verification focused on collecting
and evaluating scientific and technical information to determine
whether the food safety plan, when properly implemented, will
effectively control the identified hazards.
    Verification means those activities, other than monitoring, that
establish the validity of the food safety plan and that the system is
operating according to the plan.

Option 1 for Definition of ``Very Small Business''

    Very small business means, for purposes of this part, a business
that has less than $500,000 in total annual sales of animal food,
adjusted for inflation.

Option 2 for Definition of ``Very Small Business''

    Very small business means, for purposes of this part, a business
that has less than $1,000,000 in total annual sales of animal food,
adjusted for inflation.

Option 3 for Definition of ``Very Small Business''

    Very small business means, for purposes of this part, a business
that has less than $2,500,000 in total annual sales of animal food,
adjusted for inflation.
    Water activity (aw) means a measure of the free moisture
in a food and is the quotient of the water vapor pressure of the
substance divided by the vapor pressure of pure water at the same
temperature.

Sec.  507.5  Exemptions.

    (a) This part does not apply to establishments (including ``farms''
as defined in Sec.  1.227(b) of this chapter) that are not required to
register under section 415 of the Federal Food, Drug, and Cosmetic Act.
    (b) Activities in animal food facilities that are regulated under,
and are in compliance with, Sec.  500.23 and part 113 of this chapter
(Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers) are exempt from subpart C of part 507 only with respect to
those microbiological hazards regulated under part 113. The facilities
must comply with subparts C and F of this part regarding all other
potential hazards and must comply with subparts A and B of this part.
    (c) Subpart C of this part does not apply to activities of a
facility that are subject to section 419 of the Federal Food, Drug, and
Cosmetic Act (Standards for Produce Safety).
    (d) Except as provided in subpart D of this part, qualified
facilities are exempt from subpart C of this part if they comply with
the requirements in Sec.  507.7.
    (e) Subpart C of this part does not apply to on-farm packing or
holding of animal food by a small or very small business if the only
packing and holding activities subject to section 418 of the Federal
Food, Drug, and Cosmetic Act that the business conducts are the
following low-risk packing or holding activity/animal food combinations
on animal food not grown, raised, or consumed on that farm mixed-type
facility or another farm or farm mixed-type facility under the same
ownership:
    (1) Conveying, weighing, sorting, culling, or grading (incidental
to storing):
    (i) Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
    (ii) Oilseed (e.g., cottonseed, linseed, rapeseed, soybean,
sunflower);
    (iii) Grain or oilseed byproducts;
    (iv) Forage (e.g., hay or ensiled material); or
    (v) Other plants or plant byproducts (e.g., almond, peanut, or
soybean hulls, citrus, other fruit including culled fruit, potatoes, or
other vegetables including culled vegetables).
    (2) Storing:
    (i) Dried grain;
    (ii) Dried oilseed;
    (iii) Byproducts of dried grain or dried oilseed;
    (iv) Forage; or
    (v) Other plants or plant byproducts.
    (3) Packing:
    (i) Grain;
    (ii) Oilseed;
    (iii) Grain or oilseed byproducts;
    (iv) Forage; or
    (v) Other plants or plant byproducts.
    (4) Mixing (incidental to packing or storing):
    (i) Grain, whole; or
    (ii) Forage.
    (f) Subpart C does not apply to on-farm low-risk manufacturing/
processing activities conducted by a small or very small business if
the only manufacturing/processing activities subject to section 418 of
the Federal Food, Drug, and Cosmetic Act that the business conducts
consists of the following:
    (1) When conducted on a farm mixed-typed facility's own raw
agriculture commodities as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, (those grown or raised on that farm
mixed-type facility or another farm/farm mixed-typed facility under the
same ownership) for distribution into commerce:
    (i) Cracking, crimping, or flaking:
    (A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
    (B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean,
sunflower); or
    (C) Grain or oilseed byproducts.
    (ii) Crushing, grinding, milling, pulverizing, or dry rolling:
    (A) Grain;
    (B) Oilseed;
    (C) Grain or oilseed byproducts;
    (D) Forage (e.g., hay or ensiled material); or
    (E) Other plants or plant byproducts (e.g., such as almond, peanut,
or soybean hulls, citrus, other fruit including culled fruit, potatoes,
or other vegetables including culled vegetables).
    (iii) Making silage.
    (iv) Chopping or shredding hay.
    (v) Extracting (mechanical) or wet rolling:
    (A) Grain; or
    (B) Oilseed.
    (2) When conducted on animal food other than the farm mixed-typed
facility's own raw agriculture commodities for distribution into
commerce:
    (i) Cracking, crimping, flaking, or shelling:
    (A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale,
wheat);
    (B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean,
sunflower); or
    (C) Grain or oilseed byproducts.
    (ii) Crushing, grinding, milling, pulverizing, or dry rolling:
    (A) Grain;
    (B) Oilseed;
    (C) Grain or oilseed byproducts;
    (D) Forage (e.g., hay or ensiled material); or
    (E) Other plants or plant byproducts (e.g., such as almond, peanut,
or soybean hulls, citrus, other fruit including culled fruit, potatoes,
or other vegetables including culled vegetables).
    (iii) Making silage.
    (iv) Chopping or shredding hay.
    (v) Extracting (mechanical) or wet rolling:
    (A) Grain; or
    (B) Oilseed.
    (vi) Labeling:
    (A) Grain whole; or
    (B) Oilseed whole.
    (vii) Sifting, separating, or sizing:
    (A) Grain;
    (B) Oilseed;
    (C) Grain or oilseed byproducts; or
    (D) Other plants or plant byproducts.
    (g) Subpart C of this part does not apply to facilities that are
solely engaged in the storage of raw agricultural commodities (other
than fruits and vegetables) intended for further distribution or
processing.
    (h) Subpart B of this part does not apply to the holding or
transportation of one or more raw agricultural commodities as defined
in section 201(r) of the Federal Food, Drug, and Cosmetic Act.

Sec.  507.7  Requirements that apply to a qualified facility.

    (a) A qualified facility is exempt from subpart C of this part
provided that for the calendar year in which it is to be considered a
qualified facility, the facility has submitted to FDA documentation
that:
    (1) Demonstrates the facility is a qualified facility as defined in
Sec.  507.3. For the purpose of determining whether a facility
satisfies the definition of qualified facility, the baseline year for
calculating the adjustment for inflation is 2011; and
    (2)(i) Demonstrates the owner, operator, or agent in charge of the
facility has identified the potential hazards associated with the
animal food being manufactured, processed, packed, or held at the
facility, is implementing preventive controls to address the hazards,
and is monitoring the performance of the preventive controls to ensure
that such controls are effective; or

    (ii) Demonstrates the facility is in compliance with state, local,
county, or other applicable non-Federal food safety law. This
documentation may include inspection reports, certification by an
appropriate agency (such as a State department of agriculture), or
other documentation deemed appropriate by FDA.
    (b) The documentation required by paragraph (a) of this section
must be submitted to FDA by any one of the following means:
    (1) To submit electronically, go to http://www.access.fda.gov and
follow the instructions. This Web site is available from wherever the
Internet is accessible, including libraries, copy centers, schools, and
Internet cafes. FDA encourages electronic submission.
    (2) To submit documents in a paper format or in an electronic
format on a CD-ROM, mail these to the U.S. Food and Drug
Administration, ATTN: Qualified Facility Coordinator, 10903 New
Hampshire Ave., Silver Spring, MD 20993. We recommend that an owner,
operator, or agent in charge of a facility submit by mail only if the
facility does not have reasonable access to the Internet.
    (c) The documentation required by paragraph (a) of this section
must be:
    (1) Submitted to FDA initially within 90 days of the applicable
compliance date of this part; and
    (2) Resubmitted at least every 2 years, or whenever there is a
material change to the information described in paragraph (a) of this
section. For the purpose of this section, a material change is one that
changes whether or not a facility is a ``qualified facility''.
    (d) A qualified facility that does not submit documentation under
paragraph (a)(2)(i) of this section must provide notification to
consumers as to the name and complete business address (the street
address, city, state, and ZIP code for domestic facilities, and
comparable full address information for foreign facilities) of the
facility where the animal food was manufactured or processed as
follows:
    (1) Such notification must appear in a prominent and conspicuous
location on the label for animal food required to bear a package label
under any other provision of the Federal Food, Drug, and Cosmetic Act.
    (2) For animal food that is not required to bear a food packaging
label, the notification must appear prominently and conspicuously, at
the point of purchase, on a label, poster, sign, placard, or documents
delivered contemporaneously with the food in the normal course of
business, or in an electronic notice, in the case of Internet sales.
    (e) A qualified facility must maintain those records relied upon to
support the documentation required by Sec.  507.7(a)(2). These records
are subject to the requirements of subpart F of this part.

Sec.  507.10  Applicability of subpart C to a facility solely engaged
in the storage of packaged animal food that is not exposed to the
environment.

    (a) Subpart C of this part does not apply to a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment and does not require time/temperature control to ensure
the safety of the animal food.
    (b) A facility solely engaged in the storage of packaged animal
food that is not exposed to the environment but requires time/
temperature control is subject to the modified requirements in Sec.
507.48.

Subpart B--Current Good Manufacturing Practice

Sec.  507.14  Personnel.

    (a) Plant management must take all reasonable measures and
precautions to ensure that:
    (1) Any person who, by his own acknowledgement, by medical
examination, or by supervisory observation, is shown to have, or
appears to have any illness, open skin lesion, or other source of
abnormal microbial contamination by which there is a reasonable
possibility of animal food, animal food-contact surfaces, or animal
food-packaging materials becoming contaminated, is excluded from any
operations which may be expected to result in such contamination until
the condition is resolved;
    (2) Personnel have been instructed to report such health conditions
to their supervisors;
    (3) All persons working in direct contact with animal food, animal
food-contact surfaces, and animal food-packaging materials conform to
hygienic practices while on duty to the extent necessary to protect
against contamination of animal food. The methods for maintaining
cleanliness include:
    (i) Maintaining adequate personal cleanliness;
    (ii) Washing hands thoroughly (and sanitizing if necessary to
protect against contamination with undesirable microorganisms) in an
adequate hand-washing facility before starting work and at any other
time when the hands may have become soiled or contaminated;
    (iii) Removing all unsecured jewelry and other objects that might
fall into animal food, equipment, or containers;
    (iv) Storing clothing or other personal belongings in areas other
than where animal food is exposed or where equipment or utensils are
washed; and
    (v) Taking any other necessary precautions to protect against
contamination of animal food, animal food-contact surfaces, or animal
food-packaging materials with microorganisms or foreign substances.
    (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 unsanitary
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 about 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. The methods for adequate 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 roads, yards, and parking lots 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 by seepage, foot-borne filth, or providing a breeding
place for pests; and
    (4) Treating and disposing of waste so that it does not constitute
a source of contamination in areas where animal food is exposed. If the
plant grounds are bordered by grounds not under the operator's control
and not maintained in the manner described in paragraph (a)(1) through
(a)(3) of this section, care must be exercised in the plant by
inspection, extermination, or other means to exclude pests, dirt, and
filth that may be a source of animal food contamination.

    (b) The plant's buildings and structures must be suitable in size,
construction, and design to facilitate maintenance and sanitary
operations for animal food-production purposes (i.e., manufacturing,
processing, packing, and holding). The plant must:
    (1) Provide sufficient space for such placement of equipment and
storage of materials as is necessary for the maintenance of sanitary
operations and the production of safe animal food.
    (2) Permit the taking of proper precautions to reduce the potential
for contamination of animal food, animal food-contact surfaces, or
animal food-packaging materials with microorganisms, chemicals, filth,
and other extraneous material. The potential for contamination may be
reduced by adequate food safety controls and operating practices or
effective design, including the separation of operations in which
contamination is likely to occur, by one or more of the following
means: Location, time, partition, air flow, enclosed systems, or other
effective means.
    (3) Permit the taking of proper precautions to protect animal food
in outdoor bulk vessels by any effective means, including:
    (i) Using protective coverings;
    (ii) Controlling areas over and around the vessels to eliminate
harborages for pests;
    (iii) Checking on a regular basis for pests and pest infestation;
and
    (iv) Skimming fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and
ceilings may be adequately cleaned and kept clean and kept in good
repair; that drip or condensate from fixtures, ducts, and pipes does
not contaminate animal food, animal food-contact surfaces, or animal
food-packaging materials; and that aisles or working spaces are
provided between equipment and walls and are adequately unobstructed
and of adequate width to permit employees to perform their duties and
to protect against contaminating animal food, animal food-contact
surfaces, or animal food-packaging materials.
    (5) Provide adequate lighting in hand-washing areas, toilet rooms,
areas where animal food is examined, processed, or stored, and areas
where equipment or utensils are cleaned; and provide safety-type light
bulbs, fixtures, and skylights, or other glass items suspended over
exposed animal food in any step of preparation, or otherwise protect
against animal food contamination in case of glass breakage.
    (6) Provide adequate ventilation or control equipment to minimize
odors and vapors (including steam and noxious fumes) in areas where
they may contaminate animal food; and locate and operate fans and other
air-blowing equipment in a manner that minimizes the potential for
contaminating animal food, animal food-packaging materials, and animal
food-contact surfaces.
    (7) Provide, where necessary, adequate screening or other
protection against pests.

Sec.  507.19  Sanitary operations.

    (a) Buildings, fixtures, and other physical facilities of the plant
must be maintained in a sanitary condition and must be kept in repair
sufficient to prevent animal food from becoming adulterated. Cleaning
and sanitizing of utensils and equipment must be conducted in a manner
that protects against contamination of animal food, animal food-contact
surfaces, or animal food-packaging materials.
    (b) Cleaning compounds and sanitizing agents must be free from
undesirable microorganisms and must be safe and adequate under the
conditions of use. Compliance with this requirement may be verified by
any effective means, including purchase of these substances under a
supplier's guarantee or certification or examination of these
substances for contamination.
    (c) The following applies to toxic materials:
    (1) Only the following toxic materials may be used or stored in a
plant where animal food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide
chemicals must be identified, held, and stored in a manner that
protects against contamination of animal food, animal food-contact
surfaces, or animal food-packaging materials.
    (d) 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 on the premises 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.
    (e) All animal food-contact surfaces, including utensils and animal
food-contact surfaces of equipment, must be cleaned as frequently as
necessary to protect against contamination of animal food.
    (1) Animal food-contact surfaces used for manufacturing, processing
or holding low-moisture animal food must be in a clean, dry, sanitary
condition at the time of use. When the surfaces are wet-cleaned, they
must, when necessary, be sanitized and thoroughly dried before
subsequent use.
    (2) In wet processing, when cleaning is necessary to protect
against the introduction of 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. Where equipment and utensils are used in
a continuous production operation, the utensils and animal food-contact
surfaces of the equipment must be cleaned and sanitized as necessary.
    (3) Single-service articles (such as utensils intended for one-time
use, paper cups, and paper towels) should be stored in appropriate
containers and must be handled, dispensed, used, and disposed of in a
manner that protects against contamination of animal food, animal food-
contact surfaces, or animal food-packaging materials.
    (f) Non-animal food-contact surfaces of equipment used in the
operation of an animal food plant should be cleaned in a manner and as
frequently as necessary to protect against contamination of animal
food, animal food-contact surfaces, and animal food-packaging
materials.
    (g) Cleaned and sanitized portable equipment with animal food-
contact surfaces and utensils should be stored in a location and manner
that protects animal food-contact surfaces from contamination.

Sec.  507.20  Sanitary facilities and controls.

    (a) The water supply must be sufficient for the operations intended
and must be derived from an adequate source. Any water that contacts
animal food, animal food-contact surfaces, or animal food-packaging
materials must be safe and of adequate sanitary quality. Running water
at a suitable temperature, and under pressure as needed, must be
provided in all areas where required for the processing of animal food,
for the cleaning of equipment, utensils, and animal food-packaging
materials, or for employee sanitary facilities.

    (b) Plumbing must be of adequate size and design and adequately
installed and maintained to:
    (1) Carry sufficient quantities of water to required locations
throughout the plant;
    (2) Properly convey sewage and liquid disposable waste from the
plant;
    (3) Avoid constituting a source of contamination to animal food,
water supplies, equipment, or utensils or 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) Provide that there is not 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.
    (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, by providing facilities that are adequate, convenient, and
furnish running water at a suitable temperature.
    (f) Rubbish must be conveyed, stored, and disposed of in a way to
minimize the development of odor, minimize the potential for the waste
becoming an attractant and harborage or breeding place for pests, and
protect against contamination of animal food, animal food-contact
surfaces, animal food-packaging materials, water supplies, and ground
surfaces.

Sec.  507.22  Equipment and utensils.

    (a)(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 adulteration of animal food with lubricants, fuel,
metal fragments, contaminated water, or any other contaminants;
    (3) All equipment should be installed and maintained in such a way
to facilitate the cleaning of the equipment and all adjacent spaces;
    (4) Animal food-contact surfaces must be made of materials that
resist corrosion when in contact with animal food;
    (5) Animal food-contact surfaces must be made of nontoxic materials
and designed to withstand the environment of their intended use and the
action of animal food, and, if applicable, the action of cleaning
compounds and sanitizing agents; and
    (6) Animal food-contact surfaces must be maintained to protect
animal food from being contaminated.
    (b) Seams on animal food-contact surfaces must be maintained so as
to minimize accumulation of food particles, dirt, and organic matter,
and thus minimize the opportunity for growth of microorganisms.
    (c) Equipment in the animal food manufacturing or handling area
that does not come into contact with animal food must be constructed in
such a way that it can be kept in a clean condition.
    (d) Holding, conveying, and manufacturing systems, including
gravimetric, pneumatic, closed, and automated systems, must be of a
design and construction that enables them to be maintained in an
appropriate sanitary condition.
    (e) Each freezer and cold storage compartment used to store and
hold animal food capable of supporting growth of microorganisms must be
fitted with an indicating thermometer, temperature-measuring device, or
temperature-recording device installed to show the temperature
accurately within the compartment.
    (f) 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 and precise and adequately maintained, and
adequate in number for their designated uses.
    (g) Compressed air or other gases mechanically introduced into
animal food or used to clean animal food-contact surfaces or equipment
must be treated in such a way that animal food is not contaminated.

Sec.  507.25  Processes and controls.

    (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 adequate sanitation principles;
    (2) Containers holding animal food, raw materials, or ingredients
are labeled to accurately identify the contents;
    (3) The labeling for the finished animal food product contains the
specific information and instructions needed so the food can be safely
used for the intended animal species;
    (4) Appropriate quality control operations are employed so that
animal food-packaging materials are safe and suitable;
    (5) The overall sanitation of the plant is under the supervision of
one or more competent individuals assigned responsibility for this
function;
    (6) All reasonable precautions are taken so that production
procedures do not contribute to contamination from any source;
    (7) Chemical, microbial, or extraneous-material testing procedures
are used where necessary to identify sanitation failures or possible
animal food contamination; and
    (8) All animal food that has become contaminated to the extent that
it is adulterated is rejected, or if permissible, treated or processed
to eliminate the contamination.
    (b) Raw materials and ingredients:
    (1) Must be inspected and segregated or otherwise handled as
necessary to ensure that they are clean and suitable for processing
into animal food and must be stored under conditions that will protect
against contamination and minimize deterioration. In addition:
    (i) Raw materials must be washed or cleaned as necessary to remove
soil or other contamination;
    (ii) Water used for washing, rinsing, or conveying animal food must
be safe and of adequate sanitary quality;
    (iii) Water may be reused for washing, rinsing, or conveying animal
food if it does not increase the level of contamination of the animal
food; and
    (iv) Containers and carriers of raw materials should be inspected
on receipt to ensure that their condition has not contributed to
contamination or deterioration of animal food.
    (2) Must not contain levels of microorganisms that may render the
food injurious to the health of animals or humans, or they must be
treated (e.g., heat) during manufacturing operations so that they no
longer contain levels that would cause the product to be adulterated;
    (3) Susceptible to contamination with aflatoxin or other natural
toxins must comply with current FDA regulations for poisonous or
deleterious substances before these materials or ingredients are
incorporated into finished animal food;

    (4) Including rework, must be held in bulk, or in containers
designed and constructed in a way that protects against contamination,
and must be held at a temperature and relative humidity and in a manner
that prevents the animal food from becoming adulterated. Material
scheduled for rework must be identified as such;
    (5) If frozen, must be kept frozen. If thawing is required prior to
use, it must be done in a manner that prevents the raw materials and
ingredients from becoming adulterated; and
    (6) Whether liquid or dry, received and stored in bulk form must be
held in a manner that protects against contamination.
    (c) For the purposes of manufacturing operations, the following
apply:
    (1) Equipment, utensils, and finished animal food containers must
be maintained in an acceptable condition through appropriate cleaning
and sanitizing, as necessary. When necessary, equipment must be taken
apart for thorough cleaning;
    (2) All animal food manufacturing, processing, packing, and holding
must be conducted under such conditions and controls as are necessary
to minimize the potential for the growth of microorganisms or for the
contamination of animal food;
    (3) Animal food that can support the rapid growth of undesirable
microorganisms must be held at temperatures that will prevent the
animal food from becoming adulterated during manufacturing, processing,
packing, and holding;
    (4) Measures taken to destroy or prevent the growth of undesirable
microorganisms, such as sterilizing, irradiating, pasteurizing,
cooking, freezing, refrigerating, controlling pH, or controlling
aw, must be adequate under the conditions of manufacture,
handling, and distribution to prevent animal food from being
adulterated;
    (5) Work-in-process and rework must be handled in a manner that
protects against contamination and the growth of undesirable
microorganisms;
    (6) Effective measures must be taken to protect finished animal
food from contamination by raw materials, ingredients, or refuse. When
raw materials, ingredients, or refuse are unprotected, they must not be
handled simultaneously in a receiving, loading, or shipping area if
that handling could result in contaminated animal food. Animal food
transported by conveyor must be protected against contamination as
necessary;
    (7) Equipment, containers, and utensils used to convey, hold, or
store raw materials, work-in-process, rework, or animal food must be
constructed, handled, and maintained during manufacturing, processing,
packing, or holding in a manner that protects against contamination of
animal food;
    (8) Effective measures must be taken to protect against the
inclusion of metal or other extraneous material in animal food;
    (9) Adulterated animal food, raw materials, and ingredients must be
disposed of in a manner that protects against the contamination of
other animal food or, if the adulterated animal food, raw materials, or
ingredients are capable of being reconditioned, they must be
reconditioned using a method that has been proven to be effective;
    (10) Steps such as washing, peeling, trimming, cutting, sorting and
inspecting, mashing, dewatering, cooling, shredding, extruding, drying,
defatting, and forming must be performed in a way that protects animal
food against contamination. Animal food should be protected from
contaminants that may drip, drain, or be drawn into the animal food;
    (11) Heat blanching, when required in the preparation of animal
food, should be effected by heating the animal food to the required
temperature, holding it at this temperature for the required time, and
then either rapidly cooling the animal food or passing it to subsequent
manufacturing without delay. Thermophilic growth and contamination in
blanchers should be minimized by the use of adequate operating
temperatures and by periodic cleaning;
    (12) Batters, breading, sauces, gravies, dressings, and other
similar preparations must be treated or maintained in such a manner
that they are protected against contamination;
    (13) 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;
    (14) Animal food, including dry mixes, nuts, intermediate moisture
animal food, and dehydrated 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;
    (15) 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
    (16) When ice is used in contact with animal food, it must be made
from water that is safe and of adequate sanitary quality, and must be
used only if it has been manufactured in accordance with current good
manufacturing practice as outlined in this part.

Sec.  507.28  Warehousing and distribution.

    Storage and transportation of animal food must be conducted under
conditions that will protect against biological, chemical, physical,
and radiological contamination of animal food as well as against
deterioration of the animal food and the container.

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

Sec.  507.30  Requirement for a food safety plan.

    (a) The owner, operator, or agent in charge of a facility must
prepare, or have prepared, and implement a written food safety plan.
    (b) The written food safety plan must be prepared by (or its
preparation overseen by) a qualified individual.
    (c) The written food safety plan must include:
    (1) The hazard analysis as required by Sec.  507.33;
    (2) The preventive controls as required by Sec.  507.36;
    (3) The recall plan as required by Sec.  507.38;
    (4) The procedures and the frequency with which these procedures
will be conducted for monitoring the performance of the preventive
controls as required by Sec.  507.39;
    (5) The corrective action procedures as required by Sec.  507.42;
and
    (6) The verification procedures and the frequency with which they
will be performed as required by Sec.  507.45.

Sec.  507.33  Hazard analysis.

    (a) The owner, operator, or agent in charge of a facility must
identify and evaluate known or reasonably foreseeable hazards for each
type of animal food manufactured, processed, packed, or held at the
facility to determine whether there are hazards that are reasonably
likely to occur and develop a written hazard analysis.
    (b) The hazard analysis must consider hazards that may occur
naturally or may be unintentionally introduced including:
    (1) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other microorganisms of animal
or human health significance;
    (2) Chemical hazards, including substances such as pesticide and
drug residues, natural toxins, decomposition, unapproved food or color
additives, and nutrient imbalances;
    (3) Physical hazards; and
    (4) Radiological hazards.

    (c) The hazard analysis must contain an evaluation of the hazards
identified in paragraph (b) of this section to determine whether the
hazards are reasonably likely to occur, including an assessment of the
severity of the illness or injury if the hazard were to occur.
    (d) The hazard analysis must consider the effect of the following
on the safety of the finished animal food:
    (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 for hazards that are reasonably
likely to occur.

    For hazards identified in the hazard analysis as reasonably likely
to occur:
    (a) The owner, operator, or agent in charge of a facility must
identify and implement preventive controls, including at critical
control points, if any, to provide assurances that hazards identified
in the hazard analysis as reasonably likely to occur will be
significantly minimized or prevented and the animal food manufactured,
processed, packed, or held by such facility will not be adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
    (b) Preventive controls must be written.
    (c) Preventive controls must include, as appropriate to the
facility and animal food:
    (1) Parameters associated with the control of the hazard, such as
parameters associated with heat processing, irradiating, and
refrigerating animal foods; and
    (2) The maximum or minimum value, or combination of values, to
which any biological, chemical, physical, or radiological parameter
must be controlled to significantly minimize or prevent a hazard that
is reasonably likely to occur.
    (d) Preventive controls must include, as appropriate:
    (1) Process controls that include those procedures, practices, and
processes performed on an animal food during manufacturing/processing
that are employed to significantly minimize or prevent hazards that are
reasonably likely to occur;
    (2) Sanitation controls:
    (i) Where necessary to significantly minimize or prevent hazards
that are reasonably likely to occur, procedures for the:
    (A) Cleanliness of animal food-contact surfaces, including animal
food-contact surfaces of utensils and equipment; and
    (B) 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.
    (ii) The owner, operator, or agent in charge must take action to
correct, in a timely manner, conditions and practices that are not
consistent with the procedures in paragraph (d)(2)(i)(A) or
(d)(2)(i)(B) of this section.
    (iii) The owner, operator, or agent in charge of the facility is
not required to follow the corrective actions described in Sec.
507.42(a) and (b) when the owner, operator, or agent in charge of a
facility takes action, in accordance with paragraph (d)(2)(ii) of this
section, to correct conditions and practices that are not consistent
with the procedures in paragraph (d)(2)(i)(A) or (d)(2)(i)(B) of this
section.
    (iv) All corrective actions taken in accordance with paragraph
(d)(2)(ii) of this section must be documented in records that are
subject to verification in accordance with Sec.  507.45(b)(2) and
records review in accordance with Sec.  507.45(c)(1)(i) and (c)(2).
    (3) A recall plan as required by Sec.  507.38; and
    (4) Any other controls necessary to satisfy the requirements of
paragraph (a) of this section.
    (e)(1) Except as provided by paragraph (e)(2) of this section, the
preventive controls required under this section are subject to:
    (i) Monitoring as required by Sec.  507.39;
    (ii) Corrective actions as required by Sec.  507.42; and
    (iii) Verification as required by Sec.  507.45.
    (2) The recall plan established in Sec.  507.38 is not subject to
the requirements of paragraph (e)(1) of this section.

Sec.  507.38  Recall plan for animal food with a hazard that is
reasonably likely to occur.

    (a) The owner, operator, or agent in charge of a facility must
develop a written recall plan for animal food with a hazard that is
reasonably likely to occur and assign responsibility for performing all
actions in the plan.
    (b) The written recall plan must include procedures for:
    (1) Directly notifying direct consignees about the animal food
being recalled, including how to return or dispose of the affected
animal food;
    (2) Notifying the public about any hazard presented by the animal
food when appropriate to protect animal and human health;
    (3) Conducting effectiveness checks (as described in part 7 of this
chapter) to verify the recall has been carried out; and
    (4) The proper disposition (e.g., destroying, reprocessing, or
diverting to another use that would not present a safety concern) of
the recalled animal food.

Sec.  507.39  Monitoring.

    (a) The owner, operator, or agent in charge of a facility must
establish and implement written procedures for monitoring the
preventive controls. These procedures must include:
    (1) What preventive controls will be monitored;
    (2) Who will perform the monitoring;
    (3) How the monitoring will be performed;
    (4) What parameter will be measured, if applicable;
    (5) Frequency with which the monitoring will be performed; and
    (6) Any additional information needed to ensure appropriate
monitoring of the preventive controls.
    (b) The owner, operator, or agent in charge of a facility must
monitor the preventive controls with sufficient frequency to provide
assurance that the preventive controls are consistently performed.
    (c) 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(b)(1) and records review in accordance
with Sec.  507.45(c)(1)(i) and (c)(2).

Sec.  507.42  Corrective actions.

    (a) The owner, operator, or agent in charge of a facility must
establish and implement written corrective action procedures that must
be taken if preventive controls are not properly implemented. The
corrective active procedures must describe the steps to be taken to
ensure:
    (1) Appropriate action is taken to identify and correct a problem
with implementation of a preventive control to reduce the likelihood
that the problem will recur;
    (2) All affected animal food is evaluated for safety; and
    (3) All affected animal food is prevented from entering into
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.
    (b) If a preventive control is not properly implemented and a
specific corrective action procedure has not been established, or a
preventive control is found to be ineffective, the owner, operator, or
agent in charge of a facility must:
    (1) Take corrective action to identify and correct the problem to
reduce the likelihood that the problem will recur;
    (2) Evaluate all affected animal food for safety;
    (3) As necessary, prevent affected animal food from entering
commerce as would be done following the corrective action procedure
under paragraph (a)(3) of this section; and
    (4) Reanalyze the food safety plan in accordance with Sec.
507.45(e) to determine whether modification of the food safety plan is
required.
    (c) When corrective actions are taken, they must be documented in
written records. These records are subject to verification in
accordance with Sec.  507.45(b)(2) and records review in accordance
with Sec.  507.45(c)(1)(i) and (c)(2).

Sec.  507.45  Verification.

    (a) Except as provided by paragraph (a)(3) of this section, the
owner, operator, or agent in charge of a facility must validate that
the preventive controls identified and implemented in accordance with
Sec.  507.36 to control the hazards identified in the hazard analysis
as reasonably likely to occur are adequate to do so. 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
insufficient, conducting studies) to determine whether the preventive
controls, when properly implemented, will effectively control the
hazards that are reasonably likely to occur; and
    (3) Need not address:
    (i) The sanitation controls in Sec.  507.36(d)(2); and
    (ii) The recall plan in Sec.  507.38.
    (b) The owner, operator, or agent in charge of a facility must
verify that:
    (1) Monitoring is conducted as required by Sec.  507.39;
    (2) Appropriate decisions about corrective actions are being made
as required by Sec.  507.42;
    (3) The preventive controls are consistently implemented and are
effectively and significantly minimizing or preventing the hazards that
are reasonably likely to occur; and
    (4) The activities conducted must include, as appropriate to the
facility and the animal food, calibration of process monitoring and
verification instruments.
    (c) The owner, operator, or agent in charge of a facility must
verify that the preventive controls are consistently implemented and
are effectively and significantly minimizing or preventing the hazards
that are reasonably likely to occur by ensuring that a qualified
individual is conducting (or overseeing):
    (1) A review of the following records in the timeframe specified:
    (i) Monitoring and corrective action records within 1 week after
the records are made; and
    (ii) Records of calibration of instruments within a reasonable time
after the records are created.
    (2) A review of the records in paragraphs (c)(1)(i) and (c)(1)(ii)
of this section to ensure:
    (i) The records are complete;
    (ii) The activities reflected in the records occurred in accordance
with the food safety plan;
    (iii) The preventive controls are effective; and
    (iv) Appropriate decisions were made about corrective actions.
    (d) The owner, operator, or agent in charge of a facility must
establish and implement written procedures, as appropriate to the
facility and the animal food, for the frequency of calibrating process
monitoring and verification instruments.
    (e) The owner, operator, or agent in charge of a facility must:
    (1) Conduct a reanalysis of the food safety plan:
    (i) At least once every 3 years;
    (ii) Whenever a significant change is made in the activities
conducted at the facility operated by such owner, operator, or agent in
charge if the change creates a reasonable potential for a new hazard or
creates a significant increase in a previously identified hazard;
    (iii) Whenever the owner, operator, or agent in charge becomes
aware of new information about potential hazards associated with the
animal food;
    (iv) Whenever a preventive control is not properly implemented and
a specific corrective action procedure has not been established;
    (v) Whenever a preventive control is found to be ineffective; and
    (vi) Whenever FDA requires a reanalysis in response to newly
identified hazards and developments in scientific understanding.
    (2) Complete the reanalysis and implement any additional preventive
controls needed to address the hazard identified before the change in
activities at the facility is operative or, when necessary, during the
first 6 weeks of production;
    (3) Revise the written food safety plan if a significant change is
made, or document the basis for the conclusion that no additional or
revised preventive controls are needed; and
    (4) Ensure the reanalysis is performed (or overseen) by a qualified
individual.
    (f) All verification activities taken in accordance with this
section must be documented in records.

Sec.  507.48  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.  507.50  Requirements applicable to a qualified individual.

    (a) One or more qualified individuals must do or oversee the
following:
    (1) Prepare the food safety plan (Sec.  507.30));
    (2) Validate the preventive controls (Sec.  507.45(a));
    (3) Conduct a review of records for implementation and
effectiveness of preventive controls and appropriateness of corrective
actions (Sec.  507.45(c));
    (4) Perform a reanalysis of the food safety plan (Sec.  507.45(e)).
    (b) To be qualified, an 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.
    (c) 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  Records required for this subpart C.

    (a) The owner, operator, or agent in charge of a facility must
establish and maintain the following records:
    (1) The written food safety plan, including the written hazard
analysis, preventive controls, monitoring procedures, corrective action
procedures, verification procedures, and recall plan;
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable,
those related to:
    (i) Validation;
    (ii) Monitoring;
    (iii) Corrective actions;
    (iv) Calibration of process monitoring and verification
instruments;
    (v) Records review; and
    (vi) Reanalysis; and
    (5) Records that document applicable training for the qualified
individual.
    (b) The records that the owner, operator, or agent in charge of a
facility must establish and maintain are subject to the requirements of
subpart F of this part.

Subpart D--Withdrawal of an Exemption Applicable to a Qualified
Facility

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

    FDA may withdraw the exemption applicable to a qualified facility
under Sec.  507.5(d):
    (a) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
    (b) If FDA determines that it is necessary to protect the animal or
human health and prevent or mitigate a foodborne illness outbreak based
on conduct or conditions associated with the qualified facility that
are material to the safety of the animal food manufactured, processed,
packed, or held at such facility.

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

    (a) If FDA determines that an exemption applicable to a qualified
facility under Sec.  507.5(d) should be withdrawn, any officer or
qualified employee of FDA may issue an order to withdraw the exemption.
    (b) 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.
    (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.

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

    An order to withdraw an exemption applicable to a qualified
facility under Sec.  507.5(d) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order,
including information relevant to:
    (1) An active investigation of a foodborne illness outbreak that is
directly linked to the facility; or
    (2) Conduct or conditions associated with a qualified facility that
are material to the safety of the animal food manufactured, processed,
packed, or held at such facility.
    (d) A statement that the facility must comply with subpart C of
this part on the date that is 60 calendar days after the date of the
order;
    (e) The text of section 418(l) of the Federal Food, Drug, and
Cosmetic Act and of this subpart D;
    (f) A statement that any informal hearing on an appeal of the order
must be conducted as a regulatory hearing under part 16 of this
chapter, with certain exceptions described in Sec.  507.73;
    (g) The mailing address, telephone number, email address, and
facsimile number of the FDA district office and the name of the FDA
District Director in whose district the facility is located (or, in the
case of a foreign facility, the same information for the Director of
the Division of Compliance in the Center for Veterinary Medicine); and
    (h) The name and the title of the FDA representative who approved
the order.

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

    (a) The owner, operator, or agent in charge of a qualified facility
that receives an order under Sec.  507.60 to withdraw an exemption
applicable to that facility under Sec.  507.5(d) must either:
    (1) Comply with applicable requirements of this part within 60
calendar days of the date of the order; or
    (2) Appeal the order within 10 calendar days of the date of the
order in accordance with the requirements of Sec.  507.69.
    (b) Submission of an appeal, including submission of a request for
an informal hearing, will not operate to delay or stay any
administrative action, including enforcement action by FDA, unless the
Commissioner, as a matter of discretion, determines that delay or a
stay is in the public interest.

    (c) If the owner, operator, or agent in charge of the qualified
facility appeals the order, and FDA confirms the order, the owner,
operator, or agent in charge of the facility must comply with
applicable requirements of this part within 60 calendar days of the
date of the order.

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), the owner, operator, or agent
in charge of the facility 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 the order;
    (2) Respond with particularity to the facts and issues contained in
the order, including any supporting documentation upon which the owner,
operator, or agent in charge of the facility relies.
    (b) In a written appeal of the order withdrawing an exemption
provided under Sec.  507.5(d), the owner, operator, or agent in charge
of the facility may include a written request for an informal hearing
as provided in Sec.  507.71.

Sec.  507.71  Procedure for requesting an informal hearing.

    (a) If the owner, operator, or agent in charge of the facility
appeals the order, the owner, operator, or agent in charge of the
facility:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with
its written appeal submitted in accordance with Sec.  507.69 within 10
calendar days of the date of the order.
    (b) A request for an informal hearing may be denied, in whole or in
part, if the presiding officer determines that no genuine and
substantial issue of material fact has been raised by the material
submitted. If the presiding officer determines that a hearing is not
justified, written notice of the determination will be given to the
owner, operator, or agent in charge of the facility explaining the
reason for the denial.

Sec.  507.73  Requirements applicable to an informal hearing.

    If the owner, operator, or agent in charge of the facility requests
an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 10 calendar days after the date
the appeal is filed or, if applicable, within a timeframe agreed upon
in writing by the owner, operator, or agent in charge of the facility
and FDA.
    (b) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec.  507.62 and
507.65, rather than the notice under Sec.  16.22(a) of this chapter,
provides notice of opportunity for a hearing under this section and is
part of the administrative record of the regulatory hearing under Sec.
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to
the FDA District Director (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) as provided in the order withdrawing an exemption.
    (3) Section 507.75, rather than Sec.  16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 2 calendar days of
issuance of the report. The presiding officer will then issue the final
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under Sec.  507.73(c)(4) are part of the administrative
record.
    (6) No party shall have the right, under Sec.  16.119 of this
chapter to petition the Commissioner for reconsideration or a stay of
the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of
an order withdrawing an exemption, the hearing must be conducted as a
regulatory hearing under part 16 of this chapter, except that Sec.
16.95(b) does not apply to a hearing under this subpart. With respect
to a regulatory hearing under this subpart, the administrative record
of the hearing specified in Sec. Sec.  16.80(a)(1), (a)(2), (a)(3), and
(a)(5), and 507.73(c)(5) constitutes the exclusive record for the
presiding officer's final decision. For purposes of judicial review
under Sec.  10.45 of this chapter, the record of the administrative
proceeding consists of the record of the hearing and the presiding
officer's final decision.

Sec.  507.75  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing,
must be an FDA Regional Food and Drug Director or another FDA official
senior to an FDA District Director.

Sec.  507.77  Timeframe for issuing a decision on an appeal.

    (a) If the owner, operator, or agent in charge of a facility
appeals the order without requesting a hearing, the presiding officer
must issue a written report that includes a final decision confirming
or revoking the withdrawal by the 10th calendar day after the appeal is
filed.
    (b) If the owner, operator, or agent in charge of a facility
appeals the order and requests an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is
held, the presiding officer must provide a 2 calendar day opportunity
for the hearing participants to review and submit comments on the
report of the hearing under Sec.  507.73(c)(4), and must issue a final
decision within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer
must issue a final decision on the appeal confirming or revoking the
withdrawal within 10 calendar days after the date the appeal is filed.

Sec.  507.80  Revocation of an order to withdraw an exemption
applicable to a qualified facility.

    An order to withdraw an exemption applicable to a qualified
facility under Sec.  507.5(d) is revoked if:
    (a) The owner, operator, or agent in charge of the facility appeals
the order and requests an informal hearing, FDA grants the request for
an informal hearing, and the presiding officer does not confirm the
order within the 10 calendar days after the hearing, or issues a
decision revoking the order within that time; or
    (b) The owner, operator, or agent in charge of the facility appeals
the order and requests an informal hearing, FDA

denies the request for an informal hearing, and FDA does not confirm
the order within the 10 calendar days after the appeal is filed, or
issues a decision revoking the order within that time; or
    (c) The owner, operator, or agent in charge of the facility appeals
the order without requesting an informal hearing, and FDA does not
confirm the order within the 10 calendar days after the appeal is
filed, or issues a decision revoking the order within that time.

Sec.  507.83  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is
considered a final agency action for purposes of 5 U.S.C. 702.

Subpart E--[Reserved]

Subpart F--Requirements Applying to Records That Must Be
Established and Maintained

Sec.  507.100  Records subject to the requirements of this subpart F.

    (a) Except as provided by paragraphs (d) and (e) of this section,
all records required by this part are subject to all requirements of
this subpart F.
    (b) Records required by this part are subject to the disclosure
requirements under part 20 of this chapter.
    (c) All records required by this part must be made promptly
available to a duly authorized representative of the Secretary of
Health and Human Services upon oral or written request.
    (d) The requirements of Sec.  507.106 apply only to the written
food safety plan.
    (e) The requirements of Sec.  507.102(a)(2), (a)(4), and (a)(5) and
(b) do not apply to the records required by Sec.  507.7(e) pertaining
to qualified facilities.

Sec.  507.102  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;
    (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.  507.106  Additional requirements applying to the food safety
plan.

    The food safety plan must be signed and dated by the owner,
operator, or agent in charge of the facility upon initial completion
and upon any modification.

Sec.  507.108  Requirements for record retention.

    (a) All records required by this part must be retained at the plant
or facility for at least 2 years after the date they were prepared.
    (b) Records that relate to the general adequacy of the equipment or
processes being used by a facility, including the results of scientific
studies and evaluations, must be retained at the facility for at least
2 years after their use is discontinued (e.g., because the facility has
updated the written food safety plan (Sec.  507.30) or records that
document validation of the written food safety plan (Sec.  507.45(a)).
    (c) Except for the food safety plan, offsite storage of records is
permitted after 6 months following the date that the record was made if
such records can be retrieved and provided onsite within 24 hours of
request for official review. The food safety plan must remain onsite.
Electronic records are considered to be onsite if they are accessible
from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the
records may be transferred to some other reasonably accessible
location, but must be returned to the plant or facility within 24 hours
for official review upon request.

PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING
OF ANIMAL FEED AND PET FOOD

0
8. The authority citation for 21 CFR part 579 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 343, 348, 371.

0
9. In Sec.  579.12, add the following sentence to the end of the
paragraph to read as follows:

Sec.  579.12  Incorporation of regulations in part 179.

    * * * Any facility that treats animal feed and pet food with
ionizing radiation must comply with the requirements of part 507 of
this chapter and other applicable regulations.

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

Appendix

    Although the proposed rule that is the subject of this document
does not include provisions for environmental monitoring or finished
product testing, the Agency believes that these regimes can play a
critical role in a modern food safety system. In sections XI.K and
XI.L, the Agency requests comment on when and how these types of
testing are an appropriate means of implementing the statutory
directives set out in section 418 of the FD&C Act. In this Appendix,
the Agency provides background material on these testing measures.

I. The Role of Testing as a Verification Measure in a Modern Food
Safety System

A. Verification of Preventive Controls

    In some respects, animal food safety is a more complex subject
than human food safety in that the feeding of multiple and diverse
animal species is involved, many of which are associated with human
food in the form of meat, milk and eggs. However, the core
principles and approaches used to assess and prevent hazards that
are reasonably likely to occur in animal food are similar to those
used during the manufacture of food for humans, despite differences
in production practices and levels of sanitation involved (Ref. 1).
    The safety of food is principally ensured by the effective
implementation of scientifically valid preventive control measures
throughout the food chain (Ref. 2) (Ref. 3). Prevention of hazards
in animal food is much more effective than trying to differentiate
safe from unsafe animal food using testing. Although testing is
rarely considered a control measure, it plays a very important role
in ensuring the safety of animal food. An important purpose of
testing is to verify that control measures, including those related
to suppliers and those verified through environmental monitoring,
are controlling the hazard (Ref. 4) (Ref. 5). Testing is used in
conjunction with other verification measures in the food safety
system, such as audits of suppliers, observations of whether
activities are being conducted according to the food safety plan,
and reviewing records to determine whether process controls are
meeting specified limits for parameters established in the food
safety plan. Although testing may be conducted for biological,
chemical, physical, or radiological hazards, the most common testing
is for microbiological hazards. Thus, much of the testing described
below focuses on microbial testing, but many of the issues discussed
apply to testing for other hazards as well. The Agency focuses more
of its discussion below on verification testing of the environment
because of the increasing recognition of the benefits of such
testing in identifying conditions that could result in environmental
pathogens contaminating animal food; thus such verification testing
is important in preventing contamination in animal food, whereas
verification testing of raw materials,

ingredients, and finished products is used to detect contamination
that has already occurred.
    As discussed in sections I.C, I.E, and I.F of this Appendix,
microbial testing may include:
     Testing raw materials and ingredients to verify that
suppliers have significantly minimized or prevented hazards
reasonably likely to occur in the raw materials and ingredients;
     Testing the environment to verify that sanitation
controls have significantly minimized or prevented the potential for
environmental pathogens to contaminate animal food; and
     Testing finished product to verify that preventive
controls have significantly minimized or prevented hazards
reasonably likely to occur in the animal food.
    Further discussion of verification of preventive controls can be
found in section I.A of the Appendix of the document for the
proposed rule for preventive controls for human food (78 FR 3646).

B. Scientifically Valid Sampling and Testing

    Consistent with the Agency's discussion of the term
``scientifically valid'' in the proposed rule to establish CGMP
requirements for dietary ingredients and dietary supplements for
humans (68 FR 12158 at 12198), the Agency uses the term
``scientifically valid'' with respect to testing to mean using an
approach to both sampling and testing that is based on scientific
information, data, or results published in, for example, scientific
journals, references, text books, or proprietary research. A
scientifically valid analytical method is one that is based on
scientific data or results published in, for example, scientific
journals, references, text books, or proprietary research (68 FR
12158 at 12198). Sampling and testing used for verification in a
food safety system must be scientifically valid if they are to
provide assurance that preventive controls are effective.

C. Verification Testing of Raw Materials and Ingredients

    Raw materials and ingredients are often tested as part of a
supplier approval and verification program, as one of the
verification activities when a preventive control that is adequate
to significantly minimize or prevent the hazard is not applied at
the receiving facility. The utility and frequency of raw material
and ingredient testing for verification of supplier controls depend
on many factors, including:
     The hazard and its association with the raw material or
ingredient;
     The likelihood that the animal, or person handling the
animal food, would become ill if the hazard were present in the raw
material or ingredient;
     How that raw material or ingredient will be used by the
receiving facility (e.g., the effect of processing on the hazard);
and
     The potential for contamination of the facility's
environment with the hazard in the raw material or ingredient.
    Further discussion of verification testing of raw materials and
ingredients can be found in section I.C of the Appendix of the
document for the proposed rule for preventive controls for human
food (78 FR 3646).

D. Verification of Sanitation Controls to Significantly Minimize or
Prevent the Potential for an Environmental Pathogen To Contaminate
Animal Food

1. Environmental Pathogens in Animal Food

    Animal food can become contaminated with pathogenic
microorganisms at many different steps: on the farm; in packing,
manufacturing/processing, or distribution facilities; during storage
or transit; at retail establishments; and at the location of the
animal. Any time animal food is exposed to the environment during a
manufacturing, processing, packing, or holding activity, there is
the potential for the food to be contaminated with pathogenic
microorganisms. As discussed in section VIII.B of the preamble,
proposed Sec.  507.3 would define the term ``environmental
pathogen'' to mean a microorganism that is of animal or human health
significance and is capable of surviving and persisting within the
manufacturing, processing, packing, or holding environment. The
environmental pathogens most frequently involved in the
contamination of animal food leading to foodborne illness are
Salmonella spp.

2. Salmonella spp. as an Environmental Pathogen

    The Agency discusses Salmonella spp. in section II.E of the
preamble of this document and in section I.D.2 of the Appendix of
the document for the proposed rule for preventive controls for human
food (78 FR 3646). Salmonella has been isolated from a variety of
foods and it can get into food by a variety of mechanisms. The focus
here is on Salmonella contamination from the environment,
particularly as a hazard associated with low-moisture animal food
such as protein meals and dry animal food (Ref. 6). In the first RFR
Annual Report, 86 of the primary RFR entries reported for human and
animal food were a result of Salmonella contaminations. Almost half
of these were from low-moisture foods and 13 of these were animal
food (Ref. 7).

3. Environmental Pathogens in the Plant Environment

    Environmental pathogens may be introduced into a facility
through raw materials or ingredients, people, or objects. Once in
the facility, environmental pathogens can be a source of
contamination of animal food. Further discussion of ``Environmental
pathogens in the plant environment'' can be found in section I.D.4
of the Appendix of the document for the proposed rule for preventive
controls for human food (78 FR 3646).

4. Contamination of Animal Food With Salmonella spp. From the Plant
Environment

    The available data and information associate insanitary
conditions in animal and human food facilities with contamination of
a number of foods with the environmental pathogen Salmonella spp.
Such contamination has led to recalls and to outbreaks of foodborne
illness.
    In 2007, FDA identified S. Schwarzengrund, a rare serotype of
Salmonella associated with human illness, in a pet food. The Center
for Disease Control and Prevention (CDC) traced this rare strain of
Salmonella to a pet food manufacturing facility located in
Pennsylvania. Analytical tests conducted by the FDA confirmed S.
Schwarzengrund at the Pennsylvania facility. A recall was issued for
two brands of dry dog food and the manufacturing facility ceased
operations for 5 months for cleaning and disinfecting. Despite the
facility's efforts, additional S. Schwarzengrund illnesses in humans
were reported to CDC. After further investigations by FDA, the pet
food manufacturing facility issued a nationwide voluntary recall of
all dry dog and cat food products produced at the facility over a 5
month period. This recall involved approximately 23,109 tons of dry
pet foods, representing 105 brands. While no pets were reported
sick, 79 people in 21 states were reported as becoming ill due to
the handling of pet food contaminated with this Salmonella strain
(Ref. 8).
    In 2008-2009, an outbreak was linked to Salmonella Typhimurium
in peanut butter and peanut paste (Ref. 9) (Ref. 10). This outbreak
resulted in an estimated 714 illnesses, 166 hospitalizations, and 9
deaths (Ref. 10). Inspections conducted by FDA at the two implicated
ingredient manufacturing facilities (which shared ingredients)
revealed lack of controls to prevent product contamination from
pests, from an insanitary air-circulation system, from insanitary
food-contact surfaces, and from the processing environment (Ref. 11)
(Ref. 12). Several strains of Salmonella spp. were found in multiple
products and in the plant environment (Ref. 12). This outbreak led
to the recall of more than 3900 animal (including pet food) and
human food products containing peanut-derived ingredients (Ref. 11).

E. Role of Environmental Monitoring in Verifying the Implementation and
Effectiveness of Sanitation Controls in Significantly Minimizing or
Preventing the Potential for an Environmental Pathogen To Contaminate
Animal Food

1. Purpose of Environmental Monitoring

    The purpose of monitoring for environmental pathogens in
facilities where animal food is manufactured, processed, packed, or
held is to verify the implementation and effectiveness of sanitation
controls intended to significantly minimize or prevent the potential
for an environmental pathogen to contaminate animal food. In so
doing, environmental monitoring can find sources of environmental
pathogens that remain in the facility after routine cleaning and
sanitizing so that the environmental pathogens can be eliminated by
appropriate corrective actions (e.g., intensified cleaning and
sanitizing, sometimes involving equipment disassembly). For further
discussion, see section I.E. of the Appendix of the document for the
proposed rule for preventive controls for human food (78 FR 3646).

2. Indicator Organisms

    The term ``indicator organism'' can have different meanings,
depending on the

purpose of using an indicator organism. As discussed in the
scientific literature, the term ``indicator organism'' means a
microorganism or group of microorganisms that is indicative that (1)
a food has been exposed to conditions that pose an increased risk
for contamination of the food with a pathogen or (2) a food has been
exposed to conditions under which a pathogen can increase in numbers
(Ref. 13). This definition in the scientific literature is
consistent with a definition of indicator organism established by
NACMCF as one that indicates a state or condition and an index
organism as one for which the concentration or frequency correlates
with the concentration or frequency of another microorganism of
concern (Ref. 14). FDA considers the NACMCF definition of an
indicator organism to be an appropriate working definition for the
purpose of this document.
    Listeria spp. is an appropriate indicator organism for L.
monocytogenes. The Agency is aware that listeriosis occurs in a
number of animal species, especially ruminant animals, and is asking
for comment on whether L. monocytogenes is an environmental pathogen
of concern for animal food facilities. FDA's current thinking is
that there is no currently available indicator organism for
Salmonella spp. The Agency requests data, information, and other
comment bearing on whether there is a currently available indicator
organism for Salmonella spp. that could be used for environmental
monitoring.
    For additional discussion on indicator organisms, monitoring
procedures, and corrective actions, see section I.E.2 through 5 of
the Appendix for the proposed rule for preventive controls for human
food (78 FR 3646).

F. The Role of Finished Product Testing in Verifying the Implementation
and Effectiveness of Preventive Controls

    Although FDA is not including a provision for finished product
testing in this proposed rule, here the Agency sets out some
considerations regarding the appropriate use of such testing. The
utility of finished product testing for verification depends on many
factors that industry currently considers in determining whether
finished product testing is an appropriate approach to reducing the
risk of: animals consuming contaminated food, humans handling
contaminated food, and humans consuming food derived from animals
that consumed contaminated food. The first such consideration is the
nature of the hazard and whether there is evidence of adverse health
consequences from that hazard in the animal food being produced or
in a similar animal food. If the hazard were to be present in the
animal food, how likely is it that illness will occur and how
serious would the consequences be? The more likely and severe the
illness, the greater the frequency of conducting verification
testing should be. For example, Salmonella spp. is a hazard that
could cause serious illness, particularly in children and the
elderly who might get exposed to it through handling pet food
products contaminated with the organism. In contrast, in situations
where unlawful pesticide residues are considered reasonably likely
to occur, the presence of a pesticide residue that is not approved
for a specific commodity, but that is within the tolerance approved
for other commodities, while deemed unsafe as a matter of law, may
not actually result in illness. Thus, a firm is more likely to
conduct finished product testing to verify Salmonella spp. control
than to verify control of pesticides.
    Another consideration in determining whether finished product
testing is appropriate is the intended ``consumer'' of the animal
food and whether indirect exposure of a susceptible population may
occur. The greater the sensitivity of the intended ``consumer'' (as
would be the case, for example, for dioxin contamination), the
greater the likelihood that finished product testing would be used
as a verification activity.
    Another consideration in determining whether finished product
testing is appropriate is the impact of the animal food on the
contaminant. For example, depending on the animal food, pathogens
may survive in the food, increase in number, or die off. Finished
product testing generally is not conducted if pathogens that may be
in an animal food would die off in a relatively short period of time
(e.g., before the food reaches the ``consumer'').
    Additional considerations in determining whether finished
product testing is appropriate are the intended use of the animal
food; the types of controls the supplier has implemented to minimize
the potential for the hazard to be present (e.g., whether the
supplier has a kill step for a pathogen); the effect of processing
on the hazard; and whether a hazard can be reintroduced into a food
that has been treated to significantly minimize the hazard (e.g.,
Salmonella in dry or low-moisture pet food when a flavoring is
applied after heat treatment).
    For an extensive discussion on finished product testing and
metrics for microbiological risk management, see sections I.F and
I.G of the Appendix for the proposed rule for human food (78 FR
3646).

II. The Role of Supplier Approval and Verification Programs in a
Food Safety System

    An animal food can become contaminated through the use of
contaminated raw materials or ingredients as evident by the large
recall of pet food as a result of contamination of wheat gluten with
melamine (see discussion in section II.E.1of the preamble).
    The development of a supplier approval and verification program
is part of a preventive approach. Because many facilities acting as
suppliers procure their raw materials and ingredients from other
suppliers, there is often a chain of suppliers before a raw material
or other ingredient reaches the manufacturer/processor. To ensure
safe animal food and minimize the potential for contaminated animal
food to reach the consumer, each supplier in the chain must
implement preventive controls appropriate to the animal food and
operation for hazards reasonably likely to occur in the raw material
or other ingredient. A facility receiving raw materials or
ingredients from a supplier must ensure that the supplier (or a
supplier to the supplier) has implemented preventive controls to
significantly minimize or prevent hazards that the receiving
facility has identified as reasonably likely to occur in that raw
material or other ingredient unless the receiving facility will
itself control the identified hazard.
    A supplier approval and verification program is a means of
ensuring that raw materials and ingredients are procured from those
suppliers that can meet company specifications and have appropriate
programs in place, including those related to the safety of the raw
materials and ingredients. A supplier approval program can ensure a
methodical approach to identifying such suppliers. A supplier
verification program provides initial and ongoing assurance that
suppliers are complying with practices to achieve adequate control
of hazards in raw materials or ingredients.
    Supplier approval and verification is widely accepted in the
domestic and international food safety community. The NACMCF HACCP
guidelines describe Supplier Control as one of the common
prerequisite programs for the safe production of food products and
recommend that each facility should ensure that its suppliers have
in place effective GMP and food safety programs (Ref. 14). Codex
specifies that no raw material or ingredient should be accepted by
an establishment if it is known to contain parasites, undesirable
microorganisms, pesticides, veterinary drugs or toxic, decomposed or
extraneous substances which would not be reduced to an acceptable
level by normal sorting and/or processing (Ref. 15). Codex also
specifies that, where appropriate, specifications for raw materials
should be identified and applied and that, where necessary,
laboratory tests should be made to establish fitness for use (Ref.
15).
    Supplier verification activities include auditing a supplier to
ensure the supplier is complying with applicable food safety
requirements, such as requirements under proposed part 507. Audit
activities may include a range of activities, such as on-site
examinations of establishments, review of records, review of quality
assurance systems, and examination or laboratory testing of product
samples (Ref. 16). Other supplier verification activities include
conducting testing or requiring supplier certificates of analysis
(COAs), review of food safety plans and records, or combinations of
activities such as audits and periodic testing.
    An increasing number of establishments that sell food are
independently requiring, as a condition of doing business, that
their suppliers, both foreign and domestic, become certified as
meeting safety (as well as other) standards. In addition, domestic
and foreign suppliers (such as producers, co-manufacturers, or re-
packers) are increasingly looking to third-party certification
programs to assist them in meeting U.S. regulatory requirements
(Ref. 16). There are many established third-party certification
programs designed for various reasons that are currently being used
by industry. Many third party audit schemes used to assess the

industry's food safety management systems incorporate requirements
for manufacturers and processors to establish supplier approval
programs. An example of a food safety standard that was specifically
developed for the animal food industry is Publicly Available
Specification (PAS) 222:2011 (Ref. 1). This standard was developed
for the animal food industry by the British Standards Institution
(BSI) to specify requirements for prerequisite programs (PRPs) to
assist in controlling hazards in animal food. The PAS 222:2011
requirements can be used either in conjunction with ISO 22000, food
safety management systems, or as a stand-alone document.
    To ensure confidence in the delivery of safe food for animals
and humans worldwide, the Global Food Safety Initiative (GFSI), a
benchmarking organization, was established in 2000 to drive
continuous improvement in food safety management systems. Their
objectives include reducing risk by delivering equivalence and
convergence between effective food safety management systems and
managing cost in the global food system by eliminating redundancy
and improving operational efficiency (Ref. 17). GFSI has developed a
guidance document as a tool that fulfills the GFSI objectives of
determining equivalency between food safety management systems (Ref.
17). The document is not a food safety standard, but rather
specifies a process by which food safety schemes may gain
recognition, the requirements to be put in place for a food safety
scheme seeking recognition by GFSI, and the key elements for
production of safe food or feed, or for service provision (e.g.,
contract sanitation services or food transportation) in relation to
food safety (Ref. 17). This benchmark document has provisions
relevant to supplier approval and verification programs. For
example, it specifies that a food safety standard must require that
the organization control purchasing processes to ensure that all
externally sourced materials and services that have an effect on
food safety conform to requirements. It also specifies that a food
safety standard must require that the organization establish,
implement, and maintain procedures for the evaluation, approval and
continued monitoring of suppliers that have an effect on food
safety. Thus, all current GFSI-recognized schemes require supplier
controls to ensure that the raw materials and ingredients that have
an impact on food safety conform to specified requirements. The GFSI
guidance document also requires audit scheme owners to have a
clearly defined and documented audit frequency program, which must
ensure a minimum audit frequency of one audit per year of an
organization's facility (Ref. 17).
    Because GFSI is a document that outlines elements of a food
safety management system for benchmarking a variety of standards, it
does not have details about how facilities should comply with the
elements. This type of information is found in the food safety
schemes that are the basis for certification programs. For example,
the Safe Quality Food (SQF) 2000 Code, a HACCP-based supplier
assurance code for the food industry, specifies that raw materials
and services that impact on finished product safety be supplied by
an Approved Supplier. SQF 2000 specifies that the responsibility and
methods for selecting, evaluating, approving and monitoring an
Approved Supplier be documented and implemented, and that a register
of Approved Suppliers and records of inspections and audits of
Approved Suppliers be maintained. SQF 2000 requires that the
Approved Supplier Program contain, among other items, agreed
specifications; methods for granting Approved Supplier status;
methods and frequency of monitoring Approved Suppliers; and details
of certificates of analysis if required.
    According to SQF, the monitoring of Approved Suppliers is to be
based on the prior good performance of a supplier and the risk level
of the raw materials supplied. The monitoring and assessment of
Approved Suppliers can include:
     The inspection of raw materials received;
     The provision of certificates of analysis;
     Third party certification of an Approved Supplier; or
     The completion of 2nd party supplier audits.

III. References

1. British Standards Institute (BSI), ``Publicly Available
Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety
in the Manufacture of Food and Feed for Animals,'' 2011.
2. National Advisory Committee on Microbiological Criteria for
Foods, ``Hazard Analysis and Critical Control Point Principles and
Application Guidelines,'' Journal of Food Protection, 61, 1246-1259,
1998.
3. Codex Alimentarius Commission, ``Principles for the Establishment
and Application of Microbiological Criteria for Foods, CAC/GL 21-
1997,'' 1997.
4. International Commission on Microbiological Specifications for
Foods, ``Microbiological Hazards and Their Control,'' In:
Microorganisms in Foods 7: Microbiological Testing in Food Safety
Management, edited by Tompkin, R. B., L. Gram, T. A. Roberts, R. L.
Buchanan, et al.,1-21, 2002.
5. International Commission on Microbiological Specifications for
Foods, ``Selection and Use of Acceptance Criteria,'' In:
Microorganisms in Foods 7: Microbiological Testing in Food Safety
Management, edited by Tompkin, R. B., L. Gram, T. A. Roberts, R. L.
Buchanan, et al., 79-97, 2002.
6. Scott, V. N., C. Yuhuan, T. A. Freier, et al., ``Control of
Salmonella in low-moisture foods I: Minimizing entry of Salmonella
into a processing facility,'' Food Protection Trends, 29, 342-353,
2009.
7. FDA, ``FDA Foods Program, The Reportable Food Registry: A New
Approach to Targeting Inspection Resources and Identifying Patterns
of Adulteration. First Annual Report: September 8, 2009-September 7,
2010,'' January, 2011.
8. Centers for Disease Control and Prevention (CDC), ``Update:
Recall of Dry Dog and Cat Food Products Associated with Human
Salmonella Schwarzengrund Infections--United States, 2008,'' In: