Description
This guidance is intended for domestic and foreign facilities that are required to register under section 415 the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and its implementing regulations because they manufacture, process, pack, or hold human food for consumption in the United States and their human food production also provides by-products for use as animal food in the US. This guidance contains information for these facilities to determine what requirements to follow for their human food by-products for use as animal food. The regulations applicable to human food by-product for use as animal food were 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 (the final rule). (80 FR 56170).
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4by-products for use as animal food
RACs such as hops, wine grapes, pulse crops, and almonds
This guidance covers human food by-products for use as animal food.
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
Stakeholders
5role responsible for evaluating food safety before release; PCQI role in food safety
Target audience for the compliance guide
A business averaging less than $1,000,000 in annual sales of human food; Definition based on average annual sales plus market value; Business averaging less than $2,500,000 in annual sales of animal food
Client or owner of the animal; Using medicated feed in an extralabel manner for a minor species; recipient of Warning Letters and responsible for tissue residue violations
Facilities distributing a by-product
Regulatory Context
Document Types
5for human food adulterated with rodent, roach, or bird excreta
for other adulterated food
Contains preventive controls and monitoring procedures for food safety.
Compliance Policy Guidance for diversion of adulterated food
Compliance Policy Guidance for diversion of contaminated food
Technical Details
Substances
1High-risk drug component subject to testing for DEG and EG.; Excipient identified as a high-risk drug component for DEG/EG contamination.
Processes
4Making food from ingredients or manipulating food
rework the batch of affected food for beef cattle
Drying the drug substance (e.g., changing from vacuum tray dryer to fluid bed dryer)
generally considered further manufacturing or processing
Identified Hazards
Hazards
2Microorganisms or particulate matter that could adversely affect the device.
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Related CFR Sections (7)
- 21CFR507.12§ 507.12 Applicability of this part to the holding and distribution of human food by-products for use as animal food.
(a) Except as provided by paragraph (b) of this section, the requirements of this part do not apply to by-products of human food production, or the off-farm packing and holding of raw agricultural commodities, that are packed or held by that human food facility for distribution as animal food if: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 →
- 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 →
- 21CFR184.1666§ 184.1666 Propylene glycol.
(a) Propylene glycol (C 3 H 8 O 2 , CAS Reg. No. 57-55-6) is known as 1,2-propanediol. It does not occur in nature. Propylene glycol is manufactured by treating propylene with chlorinated water to form the chlorohydrin which is converted to the glycol by treatment with sodium carbonate solution. It Read full regulation →
- 21CFR589.1001§ 589.1001 Propylene glycol in or on cat food.
The Food and Drug Administration has determined that propylene glycol in or on cat food has not been shown by adequate scientific data to be safe for use. Use of propylene glycol in or on cat food causes the feed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act (the actRead full regulation →
- 21CFR507.5§ 507.5 Exemptions.
(a) This part does not apply to establishments, including “farms” (as defined in § 1.227 of this chapter ), that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR1.226§ 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:Read full regulation →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Recent Cases
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 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
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 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.
See Also (8)
- Small Entity Compliance Guide: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules of the FDA Food Safety Modernization Act (Status: Final)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Status: Draft)
- CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507) (Status: Final)
- CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species (Status: Final)
- CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)
- Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Status: Draft)
- Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (Status: Final)