Description
The FDA 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 regulation. On November 27, 2015, FDA published the final ruleForeign Supplier Verification Programs for Importers of Food for Humans and Animals(FSVP regulation) (80 FR 74225).
Scope & Applicability
Product Classes
9Food intended for human consumption subject to Part 117; Food manufactured, processed, packed, or held
Food that is in a form that is edible without additional preparation to achieve food safety
RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
A dietary supplement is deemed to be food under section 201(ff)
Subject to specific exemptions based on hen count or treatment
Food 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
Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Specific written assurance requirements for producers
environment supporting C. botulinum growth if inadequately processed; This chapter does not address heat treatments that lead to commercial sterility of low-acid canned foods.; commonly called LACF, subject to 21 CFR part 113; Thermally processed foods in hermetically sealed containers
Stakeholders
6Person 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
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
importer meeting specific financial thresholds for modified requirements; Importer meeting specific sales thresholds; importer subject to modified FSVP requirements
Suppliers for whom modified procedures may apply; Includes qualified facilities, certain farms, and shell egg producers
Person identified to perform FSVP activities on the importer's behalf; person performing FSVP activities; person with education, training, or experience to perform FSVP activities; Person with education, training, or experience to perform FSVP activities; Person required to conduct or oversee hazard analysis; Person with education, training, or experience to perform FSVP activities.; person required to conduct and document verification activities; person with expertise to review and assess verif
Establishment that manufactures/processes food exported to the US; Establishment that manufactures/processes food exported to the United States
Regulatory Context
Attributes
3Requirements for evaluation of foreign suppliers
Status of a foreign supplier with a food safety authority
Status for certain farms under produce safety regulation
Identified Hazards
Hazards
2Quantitative and predictive food microbiology; Topic of resources provided by FDA and USDA/ARS
Definition of a hazard likely to cause illness or injury
Related CFR Sections (15)
- 21CFR1.506§ 1.506 What foreign supplier verification and related activities must I conduct?
(a) Use of approved foreign suppliers.Read full regulation →
- 21CFR1.513§ 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?
(a) General.Read full regulation →
- 21CFR1.511§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?
(a) Importers subject to certain requirements in the dietary supplement current good manufacturing practice regulation. If you are required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you impRead full regulation →
- 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 →
- 21CFR1.503§ 1.503 Who must develop my FSVP and perform FSVP activities?
(a) Qualified individual. A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able tRead full regulation →
- 21CFR1.501§ 1.501 To what foods do the requirements in this subpart apply?
(a) General. Except as specified otherwise in this section, the requirements in this subpart apply to all food imported or offered for import into the United States and to the importers of such food.Read 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 →
- 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 →
- 21CFR1.505§ 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 →
- 21CFR1.508§ 1.508 What corrective actions must I take under my FSVP?
(a) You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of tRead full regulation →
- 21CFR1.510§ 1.510 How must I maintain records of my FSVP?
(a) General requirements for records.Read full regulation →
- 21CFR1.512§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?
(a) Eligibility. This section applies only if:Read full regulation →
- 21CFR117.3§ 117.3 Definitions.
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 →
- 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 →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 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.
- 2025-11-11
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
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)