FDA Facing Importer Outreach Challenge With FSVP Compliance Two Years Away

With deadlines for regulations implementing the Food Safety Modernization Act fast approaching and importer compliance with the Foreign Supplier Verification Program required in about two years, the Food and Drug Administration is faced with the increasingly imminent challenge of getting the word out to importers and foreign suppliers tasked with new responsibilities, said FDA officials at a meeting on FSMA implementation on April 23 in Washington, D.C.

Under deadlines agreed by the agency to settle a lawsuit (see 14022124), the first final FSMA regulations on preventative controls for human and animal food are due at the end of August. The final rule implementing FSVP is set to follow alongside the produce safety rule by Oct. 31. According to a presentation from the April 23 meeting (here), FDA has settled on the 18-month timetable for importer compliance with FSVP that was contemplated in the proposed FSVP regulations issued in 2013 (see 13072628). More specifically, importers will have to comply by the later of (1) 18 months after Oct. 31 or (2) six months after the date their supplier must comply with produce safety or preventative controls, which could be delayed if the supplier is a small business. That means importers will begin having to comply with FSVP by May 2017.

FDA has made progress in developing a protocol for inspections of importer FSVP plans, said Todd Cato, director of FDA’s Southwest import district office. The inspections will be “retrospective and records based,” checking to see that importers have a process for approving their foreign suppliers prior to purchase and confirming that importers have performed verification steps to ensure food from foreign suppliers meets “the same level of public health protection as food produced domestically.” Said Cato. FDA will also be reviewing importers’ records to make sure they have identified hazards related to the imported food and have documented and maintained records to support the verification steps they have taken for each food they import that is subject to FSVP.

However, in part because the definition of FSVP importer differs from the definition of importer of record, the agency does not “have a good grasp” on what importers are subject to FSVP, said Cato. The agency is going to have to develop an “inventory” of FSVP importers on the fly after the regulations take effect as they identify themselves. Many companies that will become FSVP importers have never had FDA show up at their door and ask to look at documents before, said Cato. “It’s going to be a unique and different experience for a lot of firms,” he said.

Not only does FDA need to reach those importers, but also foreign suppliers, third-party certification bodies, and other stakeholders that will form part of the international food safety system envisaged in FSMA. Meeting participants at an import-focused public comment session held later in the day suggested that trade associations and customs brokers could be key components to getting the word out to importers on the new requirements. However, some small importers may lack the knowledge to convey to their foreign suppliers what is necessary under the new rules, said commenters. FDA needs to leverage foreign governments to get the word out to suppliers, said an official in attendance from the Embassy of Denmark. And the agency needs to better overcome language barriers, as well as the difficulties of conveying the requirements of the produce safety rule to hard-to-reach small farmers in developing countries, said meeting participants.