Foreign Supplier Verification Program (FSVP)
On November 16, 2015, FDA published the FSMA final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals and the first compliance dates began May 30. 2017.
The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
Who is covered by the rule?
The FSVP applies only to importers of food products in the United States. By federal definition, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.
For more information, see the Am I Subject to FSVP flow diagram.
Importers of the following categories of food products do not have to comply with the FSVP rule:
- Juice, fish, and fishery products subject to and in compliance with FDA's HACCP regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations;
- Food for research or evaluation;
- Food for personal consumption;
- Alcoholic beverages and certain ingredients for use in alcoholic beverages;
- Food that is imported for processing and future export;
- Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards);
- Certain meat, poultry, and egg products regulated by the U.S. Department of Agriculture (USDA) at the time of importation.
The date by which importers must comply with the FSVP regulations is the latest of the following dates:
- 18 months after publication of the final rule (which was May 30, 2017);
- For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations;
- For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions.
Read more on Compliance Dates for the FSVP Final Rule and Compliance Date Extensions and Clarifications for FSMA Final Rules.
FSVP is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
The specific responsibilities of importers with respect to food safety include:
- Determining known or reasonably foreseeable hazards with each food;
- Evaluating the risk posed by a food, based on the Hazard Analysis, and the foreign supplier’s performance;
- Approving suppliers and determining appropriate supplier verification activities based on the risks posed by an imported food and the supplier’s performance;
- Conducting supplier verification activities; and
- Conducting corrective actions for deviations and discrepancies. The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration, or misbranding has been adequately addressed.
Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
Importers are required to develop, maintain, and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. Similarly, if the importer obtains many different foods, from a single supplier, a separate FSVP would be required for each food.
Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if:
- They are in compliance with the supply-chain program requirements under the preventive controls rules;
- They implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or
- They are not required to implement preventive controls under those rules in certain specified circumstances. Examples of such circumstances include when the type of food (e.g., such as coffee beans) could not be consumed without application of a preventive control, or when the customer will be significantly minimizing or preventing identified hazards) and they comply with requirements for disclosures and written assurances.
Unique Facility Identifier
The FSVP rule requires importers to provide the name, email address, and unique facility identifier (UFI) for each line entry of food product offered for importation into the United States.
DUNS numbers, assigned and managed by DUN & Bradstreet, are available free of charge to importers by visiting FDAdunslookup.com.
Modified FSVP Requirements
In certain cases, importers need not comply with all the FSVP requirements. The criteria for modified FSVP requirements are listed below.
- Dietary supplement importers: Importers complying with the requirements of 21 C.F.R. Part 111 (Current Good Manufacturing Practices) regulation will be required to comply with the modified requirements. Importers of other dietary supplements would be required to comply with the standard FSVP requirements (except the Hazard Analysis requirement).
- Very small importers and importers of food from certain small suppliers: The definition of “very small importer” is annual sales of $1 million for human food and $2.5 million for animal food (averaged over a 3-year period) combined with the U.S. market value of food that is imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee). In this case, importers would not have to conduct Hazard Analyses and would be able to verify their foreign suppliers by obtaining written assurances from their suppliers.
- Importers of certain small foreign suppliers are subject to modified FSVP requirements: Those small suppliers are:
- Facilities subject to modified requirements under the Preventive Controls rules because they are qualified facilities;
- Farms that are not covered farms under the Produce Safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption;
- Shell egg producers with fewer than 3,000 laying hens;
- Products from countries whose food safety system has been recognized as comparable or determined to be the equivalent of the U.S. system (e.g., Canada, New Zealand, Australia).
Assistance to Industry
The FDA has developed and continues to develop several guidance documents on subjects that include:
More information about the final rule can be found on FDA website.