Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities

Description

The purpose of this document is to state the Food and Drug Administration’s (FDA’s) intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of grains imported into the United States as raw agricultural commodities (RACs). For the reasons stated below, we intend to exercise enforcement discretion with respect to the FSVP regulation for importers of grain RACs that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing (such as certain commodity brokers with respect to the FSVP regulation).

Scope & Applicability

• 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 →

• 21CFR1.502§ 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 →

• 21CFR1.500§ 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 →

• 21CFR1.504§ 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 →

• 21CFR1.506§ 1.506 What foreign supplier verification and related activities must I conduct?

  (a) Use of approved foreign suppliers.Read full regulation →

• 21CFR1.507§ 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?

  (a) Circumstances. You are not required to conduct an evaluation of a food and foreign supplier under § 1.505 or supplier verification activities under § 1.506 when you identify a hazard requiring a control (identified hazard) in a food and any of the following circumstances apply:Read 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 →

• 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 →

• CGMP/Animal Food/Adulterated

  King Farm

  2025-12-23

• Foreign Supplier Verification Program (FSVP)

  Ocho Rios Atlanta Inc.

  2025-11-18

• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

  Compass Group USA

  2025-11-11

• Foreign Supplier Verification Program (FSVP)

  East Bay Wholesale Corporation

  2025-11-04

• Foreign Supplier Verification Program (FSVP)

  V & L Produce, Inc.

  2025-10-28

• Foreign Supplier Verification Program (FSVP)

  Adja Khady Food Distribution Inc

  2025-10-07

• Foreign Supplier Verification Program (FSVP)

  Life Wholesale

  2025-10-07

• 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

  2025-09-30

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