Description
The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF or the rule) (80 FR 56173).
Scope & Applicability
Product Classes
3Food 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
by-products for use as animal food
RACs such as hops, wine grapes, pulse crops, and almonds
Stakeholders
10role responsible for evaluating food safety before release; PCQI role in food safety
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Consumer, restaurant, or retail food establishment meeting specific distance or location criteria
A person with technical expertise to perform auditing functions.; Person performing onsite audits of suppliers; person who has technical expertise to perform the auditing function; Individual conducting onsite audits
Person qualified to prepare translations
Authorized representative conducting the inspection
Entity from which raw materials are received
Manufacturer/processor covered by preventive controls requirements; Manufacturer/processor receiving ingredients from a supplier
Assigned responsibility for plant cleanliness
Persons to whom the PCHF requirements apply; Responsible for determining hazards requiring preventive controls; Person responsible for determining hazards requiring preventive control
Regulatory Context
Attributes
5Averaging less than $2,500,000 in annual sales/market value
Metric used to determine small business status based on 2,080 hours per year
Identifier required in documentation
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
Lack of change to water activity
Identified Hazards
Hazards
10Hazards requiring preventive controls or supply-chain-applied controls
Objectionable animals or insects including birds, rodents, flies, and larvae
Adulteration link that triggers DWPE.
Pathogen capable of surviving in the manufacturing environment
Presence in food products leading to detention; Management in spices; Contaminants found in spices and herbs; Physical and chemical separation of mycotoxins from agricultural products; Ingredient-related chemical hazards; toxic metabolites produced by certain fungi; Chemical hazard requiring process controls like storage and sorting.; Hazard produced by mold during storage; Toxic metabolites produced by certain fungi; chemical hazard narrowly applying to a subset of foods; Potential food-related
Biological hazards found in the processing environment; Pathogens present in the facility environment; Pathogens like Listeria or Salmonella exposed to the facility environment; Pathogens that can contaminate animal food from the facility environment; Biological hazards addressed by sanitation controls.; Hazards requiring environmental monitoring; Pathogens capable of surviving in the manufacturing environment
Hazards that may cause illness or injury to humans or animals; Hazards associated with animal food and facilities.; Foreign objects like metal or plastic fragments; sharp hazards, choking hazards, and conditions of animal food
Includes radiological hazards in animal food; Includes radiological hazards to be evaluated.; Chemical substances including radiological hazards; Category of hazards including industrial contaminants
Known or reasonably foreseeable hazards requiring preventive control; Types of hazards analyzed in the food safety plan.; Pathogens or biological agents that can cause illness; Pathogens and microbial forms in animal food
Risks associated with fresh fruits and vegetables
Related CFR Sections (20)
- 21CFR1.227§ 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
- 21CFR507.50§ 507.50 Reanalysis.
(a) You must conduct a reanalysis of the food safety plan as a whole at least once every 3 years.Read full regulation →
- 21CFR507.4§ 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
- 21CFR507.53§ 507.53 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
(a) One or more preventive controls qualified individuals must do or oversee the following:Read full regulation →
- 21CFR507.105§ 507.105 Requirement to establish and implement a supply-chain program.
- 21CFR507.202§ 507.202 General requirements applying to records.
(a) Records must:Read full regulation →
- 21CFR507.45§ 507.45 Verification.
(a) Verification activities must include, as appropriate to the nature of the preventive control and its role in the facility's food safety system:Read full regulation →
- 21CFR507.39§ 507.39 Preventive control management components.
(a) Except as provided by paragraphs (b) and (c) of this section, the preventive controls required under § 507.34 are subject to the following preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventRead full regulation →
- 21CFR507.38§ 507.38 Recall plan.
(a) For animal food with a hazard requiring a preventive control you must:Read full regulation →
- 21CFR507.34§ 507.34 Preventive controls.
- 21CFR507.33§ 507.33 Hazard analysis.
- 21CFR507.25§ 507.25 Plant operations.
(a) Management of the establishment must ensure that: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 →
- 21CFR507.5§ 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 →
- 21CFR507.31§ 507.31 Food safety plan.
(a) You must prepare, or have prepared, and implement a written food safety plan.Read full regulation →
- 21CFR507.7§ 507.7 Requirements that apply to a qualified facility.
(a) A qualified facility must submit the following attestations to FDA:Read full regulation →
- 21CFR507.60§ 507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption.
(a) FDA may withdraw a qualified facility exemption under § 507.5(d) :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 →
- 21CFR507.17§ 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 →
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
- 2025-10-28
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.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
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)
- CVM GFI #239 Human Food By-Products For Use As Animal Food (Status: Draft)
- 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)
- 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)