Description
This guidance is intended for domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug and Cosmetic Act (the FD&C Act) because they manufacture, process, pack, or hold animal food for consumption in the U.S. This guidance contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food established in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015 (80 FR 56170) (the final rule). This guidance also provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping. The CGMP requirements are codified in 21 CFR part 507, subpart B (subpart B), and some related requirements are codified in 21 CFR part 507, subparts A and F (subparts A and F).
Scope & Applicability
Product Classes
7Includes food for animals that is imported
by-products for use as animal food
Finished pet food requires registration.
Food intended for animal consumption subject to Part 507; Food for animal consumption manufactured, processed, packed, or held; Subject of the preventive controls regulation; Product manufactured by contract feed mills
Manufacture involves use of drugs and specific laboratory controls
manufactured using Type A medicated article
RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
Stakeholders
9Facilities required to register under the FD&C Act
Business averaging less than $1,000,000 in annual sales
Entity type with specific compliance dates
responsible for taking additional precautions against contamination; Responsible for ensuring CGMP requirements are followed; Entity responsible for ensuring plant cleanliness and compliance.; Responsible for assessing returned animal food and implementing practices; Responsible for ensuring individuals are qualified and CGMPs are followed; Responsible for ensuring animal food is accurately identified and plant operations are controlled; Responsible for ensuring packaging materials are safe; Gro
Responsible for ensuring individuals comply with Part 507 requirements; Assigned responsibility for ensuring compliance and plant cleanliness
Person qualified to prepare translations
Facilities manufacturing animal food for U.S. consumption
An operation devoted to the growing of crops, harvesting of crops, or raising of animals; An operation devoted to the growing of crops, the raising of animals, or both.; Considered a business, not a consumer, for registration purposes.; Classification of activities for Farms and Facilities
restaurants, grocery stores, and hospitals subject to Food Code
Regulatory Context
Attributes
6Records must be retained for at least 2 years
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Surfaces that contact animal food or from which drainage occurs
Monitoring acidity to prevent microbial growth.
Factor affecting pathogen growth
Measure of free moisture in food; Control of water activity in food preservation; Factors that influence microbial growth in foods; Factor in food formulation affecting microbial growth; Controls such as reduced pH or water activity; formulation parameter used to inhibit pathogen growth; A factor influencing microbial growth and a barrier for C. botulinum.; A formulation parameter used as a process control.; factors associated with foods (such as water activity, pH, salt content, fat, and protei
Identified Hazards
Hazards
9Food safety concern for certain types of animal food; pathogens that must be controlled in pet food facilities; Pathogens or filth that cause decomposition or illness.; Growth must be minimized during manufacturing and holding
Objectionable animals or insects including birds, rodents, flies, and larvae
Adulteration link that triggers DWPE.
Metal fragments, wood splinters, or plastic pieces in food
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Includes rodents and birds that can contaminate equipment and produce.; Attracted by trash, litter, and waste.
Failure to perform duties in a competent manner may lead to this
Microorganisms or particulate matter that could adversely affect the device.
Facilities designed to prevent cross-contamination
Related CFR Sections (13)
- 21CFR507.17§ 507.17 Plant and grounds.
(a) The grounds around an animal food plant under the control of the management of the establishment must be kept in a condition that will protect against the contamination of animal food. Maintenance of grounds must include:Read full regulation →
- 21CFR507.19§ 507.19 Sanitation.
(a) Buildings, structures, fixtures, and other physical facilities of the plant must be kept clean and in good repair to prevent animal food from becoming adulterated.Read full regulation →
- 21CFR507.22§ 507.22 Equipment and utensils.
(a) The following apply to plant equipment and utensils used in manufacturing, processing, packing, and holding animal food:Read full regulation →
- 21CFR507.25§ 507.25 Plant operations.
(a) Management of the establishment must ensure that:Read full regulation →
- 21CFR507.28§ 507.28 Holding and distribution of human food by-products for use as animal food.
(a) Human food by-products held for distribution as animal food must be held under conditions that will protect against contamination, including the following:Read full regulation →
- 21CFR507.27§ 507.27 Holding and distribution.
(a) Animal food held for distribution must be held under conditions that will protect against contamination and minimize deterioration, including the following:Read full regulation →
- 21CFR507.4§ 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
- 21CFR507.20§ 507.20 Water supply and plumbing.
(a) The following apply to the water supply:Read full regulation →
- 21CFR507.14§ 507.14 Personnel.
(a) The management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices to the extent necessary to protect against the Read full regulation →
- 21CFR507.3§ 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:Read full regulation →
- 21CFR507.33§ 507.33 Hazard analysis.
- 21CFR117.95§ 117.95 Holding and distribution of human food by-products for use as animal food.
(a) Human food by-products held for distribution as animal food without additional manufacturing or processing by the human food processor, as identified in § 507.12 of this chapter , must be held under conditions that will protect against contamination, including the following:Read full regulation →
- 21CFR507.1§ 507.1 Applicability and status.
(a) The criteria and definitions in this part apply in determining whether an animal food is:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Lystn LLC dba Answers Pet Food
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
See Also (8)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Chapter 1 - General (Status: Final)
- Using Electronic Means to Distribute Certain Product Information: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003) (Status: Final)
- Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)