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CSMS # 64697447 - Foreign Supplier Verification Programs (FSVP) Entry Declarations

The Foreign Supplier Verification Programs for Food Importers (FSVP) regulation applies to importers of human and animal food and the food they offer for importation into the United States, unless an exemption in 21 CFR 1.501 applies. When electronically filing entry via CBP’s Automated Commercial Environment (ACE), the entity role code “FSV” and identification information in 21 CFR 1.509(a) should be transmitted for each entry line of food subject to the FSVP regulation.

If the human or animal foods being offered for import are not subject to or are exempt from the FSVP regulation, the applicable Affirmation of Compliance (AofC) code, “FSX” or “RNE,” should be transmitted when electronically filing entry via ACE, depending on the nature of the exemption. See below for details:  For a listing of exemption codes visit the affirmation of compliance code quick reference guide.

• The AofC code “RNE” should be transmitted if the human or animal food offered for import is exempt from the regulation requirements because the imported food is intended to be used for research or evaluation. This exemption applies if:
  • the food is not intended for retail sale and is not sold or distributed to the public;
  • the food is labeled with the statement, “Food for research or evaluation use;”
  • AND the food is imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of.
• The AofC code “FSX” should be transmitted for all other exemptions indicated in 21 CFR 1.501, foods under enforcement discretion, and foods imported for use in non-food products.

It is the FSVP importer’s responsibility to comply with the FSVP regulation and to ensure that their Customs Broker/Filer transmits accurate entry declarations. The FDA will monitor future entries of foods to ensure appropriate entry data declarations are made. Transmission of inaccurate entry data declarations may result in an increase of FDA inspections. Furthermore, the FDA will place greater scrutiny on future shipments. 

Please submit questions related to the Food Safety Modernization Act (FSMA) rules through the FSMA Technical Assistance Network (TAN) on fda.gov. FDA Information Specialists or Subject Matter Experts will respond to inquiries received as soon as possible. Based on the complexity of the question, response times may vary.

To access detailed instruction related to CBP’s ACE system and entry data requirements, please visit cbp.gov to view the FDA Supplemental Guide for the Automated Commercial Environment.

For more information relating to the FSVP regulation, please see FDA’s webpage: FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.