The Foreign Supplier Verification Program (FSVP) final rule applies to most entities who import food into the United States from abroad, including domestic facilities and food brokers. For each food it imports, an importer would be required to develop, maintain, and follow a Foreign Supplier Verification Program that provides “adequate assurances” that its foreign supplier is producing the food in compliance with processes and procedures that provide “at least the same level of public health protection” as FDA’s standards for preventive controls and produce safety, if either is applicable. The foreign supplier must also demonstrate that it is producing the food in compliance with the adulteration and allergen-labeling requirements of the Food Drug and Cosmetic Act (Sections 402 and 403(w), respectively).
- The definition of an “importer” is specific to the FSVP regulation (21 CFR 1.500), “the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food.”, the FSVP importer has to be identified at entry;
- If there is no owner or consignee in the U.S., the foreign owner or consignee may designate a U.S. Agent or representative to carry out the FSVP responsibilities. Whoever is handling the U.S. Customs entry filing understands that the person identified as the FSVP “importer” is the person FDA will see as responsible for complying with the FSVP rule;
- FSVP “importer” definition from FDA is not the same as the definition of “importer of record” under U.S. Customs and Border Protection (CBP). The key difference is that the FSVP “importer” must be someone (Person or Company) in the U.S. The FSVP importer can be but doesn’t have to be the importer of record;
- There are many different existing arrangements for importing food into the United States and that there may be more than one entity that could fall under the FSVP “importer” definition. The rule does not necessarily foresee only one “correct” party as the FSVP importer; discussions and negotiations among several parties may precede a decision on who will take on this new FSVP responsibility, this decision making/negotiation process must take place long before a food shipment is ready to be imported.
Unless it is exempt or subject to modified requirements an FSVP importer may need to perform the following activities:
- use a qualified individual to develop an FSVP and perform FSVP activities
- perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each imported food or type of food (e.g., parasites, pesticide residues, natural toxins, food decomposition, food allergens, glass or other foreign materials)
- evaluate risks posed by the food and the performance of the foreign supplier, considering the hazard analysis for the food, the entity that will be applying hazard controls (e.g., the foreign supplier or its ingredient supplier), the foreign supplier’s food safety practices and procedures, applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations (e.g., whether the supplier is the subject of an FDA warning letter or import alert), and the foreign supplier’s food safety performance history
- conduct appropriate supplier verification activities (e.g., annual onsite audits by a qualified auditor, sampling and testing, review of food safety records) to provide assurance that the hazards requiring a control have been significantly minimized or prevented
- take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate)
- reevaluate the food and foreign supplier every three years or sooner if the importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance
- identify the FSVP importer when filing for entry with U.S. Customs and Border Protection using the FSVP importer’s name, email address and unique facility identifier
For the Foreign Supplier Verification Program, the earliest compliance date for most entities will be six (6) months after their foreign supplier’s must comply with FSMA regulations or 18 months after the final rule is published, whichever is later. For example, if an importer’s foreign supplier is a very small business that must comply with the Preventive Controls Rule, the foreign supplier would have three (3) years after the Preventive Controls Final Rule is published to comply, and the importer would have six (6) months from that date to comply with FSVP. For Compliance Periods see below.
|Entities with more than 500 full time employees and an average > 1 mil. $||PCHF Sept. 2016||FSVP 05/30/2017|
|Entities with Less than 500 full time employees and an average > 1 mil. $||PCHF Sept. 2017||FSVP 03/18/2018|
|Entities with more than 500 full time employees and an average < 1 mil. $||PCHF Sept. 2018||FSVP 03/18/2019|
* Only Cheese products under Milk Ordinace Grade A (Pastorized Milk) have a unique Compliance Date in September 2018;
** Food Grade Materials have a unique Compliance Date in September 2018.
- Foods complying with the FDA HACCP rules for juice (21 CFR Part 120) and seafood (21 CFR Part 123) are exempt from FSVP because they are already subject to preventive controls in the form of the HACCP requirements (21 CFR 1.501(b)). Importers of raw materials and ingredients for the manufacture of juice or seafood need not comply with the FSVP rule so long as they are in compliance with HACCP requirements under 21 CFR parts 120 or 123;
- FSMA also exempted alcoholic beverages;
- Food that is subject to USDA jurisdiction, such as certain meats and poultry and processed egg products are exempt from the FSVP rule;
- Low‐acid canned foods (LACFs) are not exempt from FSVP. An importer of low‐acid canned foods must verify and document that the food was produced in accordance with the LACF regulations (21 CFR Part 113) pertaining to microbiological hazards. For all hazards not controlled by Part 113, i.e., non‐microbiological hazards, the importer must have an FSVP.
ITA Corp’s Food Safety Specialists have a team of Qualified Individuals that can develop, review, or implement your FSVPs for compliance.
The FSVP rule requires U.S. importers to monitor their suppliers’ FDA compliance statuses. Learn how ITA Corp’s FDA Compliance Monitor makes supplier monitoring easy
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