Description
The purpose of this document is to state the intent of the Food and Drug Administration (FDA, we, or the Agency) not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities.
Scope & Applicability
Product Classes
4Sprouts in their raw or natural state
Food transformed from its RAC state, not subject to the rule
Substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food; referred to as FCS throughout the guidance; The potential for genetic toxicity is an important consideration in the safety evaluation of FCSs.; toxicological recommendations for FCS
by-products for use as animal food
Stakeholders
6Facilities that would qualify as secondary activities farms except for ownership
Entities subject to verification programs; Entity producing food in compliance with US regulations
Must comply with registration if meeting facility/responsible person definitions
Establishment that is a farm but also conducts activities requiring registration; establishments that engage in both farm and non-farm activities
operation devoted to harvesting, packing, and/or holding of RACs; An operation not located on a primary production farm devoted to harvesting, packing, and/or holding RACs
Establishments that conduct activities within and outside the farm definition
Identified Hazards
Hazards
1Pathogens that the guidance aims to reduce or eliminate through commercial processing.; Pathogens that can cause human illness; Target of commercial processing to qualify for exemption; pathogens that can contaminate produce; Biological hazards that can contaminate produce.; visitors must be prevented from contaminating produce with these; Pathogens that can contaminate produce from ill persons; Pathogens that treatment processes are designed to reduce; Pathogens that instruments are intended to
Related CFR Sections (5)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 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 →
- 21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .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 →
- 21CFR112.3§ 112.3 What definitions apply to this part?
The definitions and interpretations of terms 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 →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-11-18
Foreign Supplier Verification Program (FSVP)
Ocho Rios Atlanta Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 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
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
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (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)
- Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Status: Final)
- 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)
- 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)