Description
The purpose of this guidance is to help a receiving facility comply with the requirements of 21 CFR part 507, subpart E of the preventive controls for animal food (PCAF) regulation for establishing and implementing a supply-chain program for its suppliers. See section III.B and the list of terms in Appendix A for the definition of a “receiving facility.” This guidance also is intended to help an entity other than the receiving facility conduct certain activities on behalf of a receiving facility, provided that the receiving facility complies with applicable requirements in subpart E to review and assess the entity’s applicable documentation, and document that review and assessment.
Scope & Applicability
Product Classes
4Food 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
Sprouts in their raw or natural state
Subject to specific exemptions based on hen count or treatment
RACs such as hops, wine grapes, pulse crops, and almonds
Stakeholders
10Entity responsible for supply-chain program requirements
entity that receives a product, raw material, or ingredient from a receiving facility
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
Person qualified to prepare translations
individual authorized to conduct audits under FSMA regulations; Individual performing the onsite audit
A facility subject to modified requirements based on size or sales; Status based on sales and market value thresholds; A facility that is a very small business or meets specific sales criteria to qualified end-users; Facility type eligible for modified requirements
Entity involved in investigational drug supply chain
An entity in the supply chain that may document that written procedures are being followed
Conducts audits of the supplier in accordance with subpart E
Preventive Controls Qualified Individual involved in corrections
Regulatory Context
Attributes
4A specific type of supplier with alternative verification activities
Recall designation for SAHCODHA hazards
Factor including procedures, compliance history, and food safety history
Condition for research or evaluation use exception
Identified Hazards
Hazards
10Known 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
Causative agent requiring inactivation controls
A pathogen capable of surviving and persisting with the manufacturing processing environment
Threshold for requiring an onsite audit of a supplier
hazard associated with animal food facilities
hazard identified in mineral premix
Hazard with reasonable probability of serious adverse health consequences; serious adverse health consequences or death to humans or animals; serious adverse health consequence or death to humans or animals; Serious Adverse Health Consequences or Death to Humans or Animals hazard
Reason for using an unapproved supplier on a temporary basis
Contamination in cereals and spices; approved suppliers control growth of mycotoxin-forming fungi; amount needed for a mycotoxin analysis; Identified as a potential chemical hazard in the hazard analysis tables.
SAHCODHA hazards requiring annual onsite audits.
Related CFR Sections (16)
- 21CFR507.175§ 507.175 Records documenting the supply-chain program.
(a) The records documenting the supply-chain program are subject to the requirements of subpart F of this part .Read full regulation →
- 21CFR507.49§ 507.49 Verification of implementation and effectiveness.
(a) You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards. To do so, you must conduct activities that include the following, as appropriate to the facility, the animal food, and the nature of the preventivRead full regulation →
- 21CFR507.135§ 507.135 Onsite audit.
(a) An onsite audit of a supplier must be performed by a qualified auditor.Read full regulation →
- 21CFR507.130§ 507.130 Conducting supplier verification activities for raw materials and other ingredients.
(a) Except as provided by paragraphs (c) , (d) , or (e) of this section, one or more of the supplier verification activities specified in § 507.110(b) , as determined under § 507.110(d) , must be conducted for each supplier before using the raw material or other ingredient from that supplier and perRead full regulation →
- 21CFR507.110§ 507.110 General requirements applicable to a supply-chain program.
(a) The supply-chain program must include:Read full regulation →
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
- 21CFR507.115§ 507.115 Responsibilities of the receiving facility.
- 21CFR507.42§ 507.42 Corrective actions and corrections.
(a) As appropriate to the nature of the hazard and the nature of the preventive control, except as provided by paragraph (c) of this section: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 →
- 21CFR500.23§ 500.23 Thermally processed low-acid foods packaged in hermetically sealed containers.
Except as provided in § 507.5(b) of this chapter , 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.Read full regulation →
- 21CFR507.105§ 507.105 Requirement to establish and implement a supply-chain program.
- 21CFR507.120§ 507.120 Using approved suppliers.
(a) The receiving facility must approve suppliers in accordance with the requirements of § 507.110(d) , and document that approval, before receiving raw materials and other ingredients received from those suppliers;Read full regulation →
- 21CFR507.125§ 507.125 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
Appropriate supplier verification activities (including the frequency of conducting the activity) must be determined in accordance with the requirements of § 507.110(d) .Read full regulation →
- 21CFR507.34§ 507.34 Preventive controls.
- 21CFR507.31§ 507.31 Food safety plan.
(a) You must prepare, or have prepared, and implement a written food safety plan.Read full regulation →
- 21CFR507.33§ 507.33 Hazard analysis.
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-12-16
PHS Act/Shell Egg Regulation/Adulterated
North Creek Farm
- 2025-11-25
PHS Act/Shell Egg Regulation/Adulterated
Robert G. Miller dba Granja Asomante
- 2025-11-18
Foreign Supplier Verification Program (FSVP)
Ocho Rios Atlanta Inc.
- 2025-11-04
Foreign Supplier Verification Program (FSVP)
East Bay Wholesale Corporation
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Adja Khady Food Distribution Inc
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Life Wholesale
- 2025-09-30
Foreign Supplier Verification Program (FSVP)
Delicias Del Country USA Inc
- 2025-09-30
Foreign Supplier Verification Program (FSVP)
Ever Rich Foods 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)
- 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)