Flickr / U.S. Food and Drug Administration
Previously, we discussed the Food and Drug Administration’s (“FDA”) seven major food safety rules mandated by the Food Safety Modernization Act (“FSMA”).  (See previous posts here, here, and here.)  Of the seven, the rule for Foreign Supplier Verification Programs (“FSVP”) for Importers of Food for Humans and Animals will have the biggest impact on importers of food into the United States.  The FSVP is a program that requires food importers to verify that their foreign suppliers are producing food that meets appropriate safety regulations and ensure the food is not adultered or misbranded with respect to allergen labeling.
May 30, 2017 marked the first major compliance date under FSVP where the FDA is now checking to ensure food importers are performing certain risk-based activities to verify imported food meets U.S. safety standards.

(Note: compliance dates are based on the size of the foreign supplier and the regulations that apply to the foreign supplier, not the size of the importer.)  With some exceptions, all U.S. owners or consignees of the food offered for import, or if there is no U.S. owner or consignee, U.S. agents or representatives of the foreign owner or consignee will need to comply with FSVP requirements.  The rule requires a qualified individual to develop, maintain and follow an FSVP for all food imported and for the foreign supplier for that food.  Separate FSVPs are required for each food and each foreign supplier.
Key requirements are:

  • A hazard analysis must be performed to identify potential biological (e.g. parasites and bacteria), chemical (e.g. pesticides, unapproved additives, or food allergens) or physical hazards (e.g. foreign objects like glass)that are typically associated with the type of food being imported, and a determination  on whether a control is required.
  • A risk evaluation must be performed prior to approving the food and foreign supplier.  The evaluation should consider the food’s hazard analysis and the foreign supplier’s food safety practices, compliance history with U.S. food safety regulations, and food safety performance history.  Evaluations must be performed at least every three years or when new information is available about a potential hazard.
  • A verification of the foreign supplier’s activities to provide assurance that any hazards requiring a control are significantly minimized or prevented.  Verification can be accomplished through annual audits, testing of food, or review of the foreign supplier’s records.
  • Corrective actions must follow every determination that a foreign supplier is producing food that is adultered, misbranded with respect to allergen labeling, or does not meet the same level of public health protection as required under applicable produce safety and preventative controls regulations.
  • The FSVP importer must be identified when filing for entry with the U.S. Customs and Border Protection by name, e-mail, and unique facility identifier accepted by the FDA (such as a DUNS number).

Importers that are also manufacturers or processors are deemed in compliance with most FSVP requirements if they are in compliance with the supply-chain program requirements under the preventive control rules, they implement preventive controls for the hazards, or they are importing food that would otherwise not be consumed without the application of a preventive control by a subsequent entity in the distribution chain (e.g. processing coffee beans) and written assurances and disclosures are provided.  The FDA has extended the compliance date for obtaining these written assurances for two years, however, for purposes of the May 30, 2017 compliance date, disclosure is still required.