Description
The purpose of this document is to state the Food and Drug Administration’s (FDA’s or the Agency’s) intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA)-regulated establishments subject to USDA-administered hazard analysis and critical control point (HACCP) requirements (or at state-inspected establishments subject to requirements equivalent to the federal standards).
Scope & Applicability
Product Classes
2Animals imported for slaughter and processing
Animals imported for food use, including cattle, poultry, and swine
Stakeholders
1Person 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
Identified Hazards
Hazards
1Food safety hazards expected to arise in live animals; Hazards requiring supplier control in live animals
Related CFR Sections (8)
- 21CFR1.509§ 1.509 How must the importer be identified at entry?
(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entryRead full regulation →
- 21CFR123.12§ 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and fishery products.Read full regulation →
- 21CFR1.506§ 1.506 What foreign supplier verification and related activities must I conduct?
(a) Use of approved foreign suppliers.Read full regulation →
- 21CFR1.505§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
(a) Evaluation of a foreign supplier's performance and the risk posed by a food.Read full regulation →
- 21CFR1.504§ 1.504 What hazard analysis must I conduct?
(a) Requirement for a hazard analysis. Except as specified in paragraph (d) of this section, you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you imRead full regulation →
- 21CFR1.500§ 1.500 What definitions apply to this subpart?
The following definitions apply to words and phrases as they are used in this subpart. Other definitions of these terms may apply when they are used in other subparts of this part .Read full regulation →
- 21CFR1.502§ 1.502 What foreign supplier verification program (FSVP) must I have?
(a) General. Except as specified in paragraph (b) of this section, for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same leRead 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 →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 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: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (Status: Final)
- Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities (Status: Final)
- Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products (Status: Final)
- Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (Status: Final)
- FDA Oversight of Food Covered by Systems Recognition Arrangements (Status: Final)