Description
This guidance describes FDA’s current thinking on considerations for determining whether a measure or procedure used in lieu of an FDA requirement in 21 CFR part 112, 117, or 507 provides the same level of public health protection (SLPHP) as the corresponding FDA requirement.
Scope & Applicability
Product Classes
2commodity subject to equivalence determinations
Commodity for which FDA has undertaken equivalence determinations
Stakeholders
4Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Industry association that may conduct an SLPHP evaluation
Entity being verified by the importer; The establishment that manufactures, processes, raises, or grows the food.; entity producing food outside the US; entity being verified by the importer; Entity being evaluated and verified by the importer.; The establishment that manufactures or processes food for export to the US.; entity supplying food from outside the United States; The entity producing the food outside the U.S.; entity being verified under FSVP; entity providing food to the importer; en
Entity involved in evaluating SLPHP measures; State, tribe, or foreign country regulatory body; Entity of a state, tribe, or foreign country conducting evaluations
Identified Hazards
Hazards
2Risks controlled by FDA requirements or alternative measures; Hazards addressed by FDA requirements or foreign country requirements
potential source of human pathogens on seed
Related CFR Sections (10)
- 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 →
- 21CFR112.176§ 112.176 What process applies to a petition requesting a variance?
(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a variance.Read full regulation →
- 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 →
- 21CFR112.44§ 112.44 What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
(a) Microbial quality criterion. When you use agricultural water for any one or more of the following purposes, you must ensure there is no detectable generic Escherichia coli ( E. coli ) in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purRead full regulation →
- 21CFR112.54§ 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?
Each of the following treatment processes are acceptable for a biological soil amendment of animal origin that you apply in the growing of covered produce, provided that the resulting biological soil amendments are applied in accordance with the applicable requirements of § 112.56 :Read full regulation →
- 21CFR117.410§ 117.410 General requirements applicable to a supply-chain program.
(a) The supply-chain program must include:Read full regulation →
- 21CFR112.177§ 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?
(a) A State, tribe, or a foreign country that believes that a variance requested by a petition submitted by another State, tribe, or foreign country should also apply to similarly situated persons in its jurisdiction may request that the variance be applied to its similarly situated persons by submiRead full regulation →
- 21CFR112.12§ 112.12 Are there any alternatives to the requirements established in this part?
(a) You may establish alternatives to certain specific requirements of subpart E of this part , as specified in § 112.45(b) , provided that you satisfy the requirements of paragraphs (b) and (c) of this section.Read full regulation →
- 21CFR112.173§ 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?
In addition to the requirements set forth in § 10.30 of this chapter , the Statement of Grounds in a petition requesting a variance must:Read full regulation →
- 21CFR117.475§ 117.475 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 →
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/Dietary Supplement/Adulterated/Misbranded
Valentine Enterprises, Inc.
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, Inc.
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Vidaslim Co.
- 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
- 2025-09-16
Unapproved New Drugs/Misbranded
Mericon Industries, Inc.
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- CVM GFI #239 Human Food By-Products For Use As Animal Food (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)
- Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Status: Final)
- 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 #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (Status: Draft)