FDA Rules Tripping Up Food Importers

Companies have some flexibility in determining appropriate verification methods, depending upon the hazards needing to be controlled, the foreign supplier’s food safety record, and other factors. Verification methods could include onsite audits and inspections, sampling and testing, and review of the supplier’s safety records, says Hank Karayan, global FSMA program director at SGS, a multi-industry inspection, verification, testing, and certification company.

Importers must also designate a “qualified individual,” defined as someone possessing either appropriate training or job experience with developing a food safety system, to develop and perform FSVP activities for each imported food item. Importers that do not have a qualified individual on staff may outsource FSVP development to a third party, such as Registrar Corp, or outsource verification activities to companies such as SGS.

FDA has staggered FSVP compliance dates based on the size of the foreign supplier (not the size of the U.S. importer) and the dates of other FSMA regulations to which the foreign supplier would be subject. This was to give U.S. importers time to become familiar with their legal responsibilities and develop their FSVPs. It also aligns FSVP compliance dates with other FSMA regulations, particularly the produce safety and preventive controls rules for human and animal food.

“We linked the FSVP compliance dates to the other FSMA rules because we wanted to minimize the likelihood that an importer would be required to comply with the FSVP regulations before its supplier is required to comply with other FSMA safety regulations,” explained Sharon Mayl, senior advisor for policy in FDA’s Office of Foods and Veterinary Medicine.

The first FSVP compliance date was May 30, 2017 for U.S. companies that import food from large foreign suppliers or from suppliers not subject to the preventive controls or produce safety rules. For foreign suppliers that are subject only to the preventive controls rule, the next importer compliance dates are March 19, 2018 for “small businesses” (defined as foreign suppliers with fewer than 500 full-time employees), and March 18, 2019, for “qualified facilities” and “very small businesses” (foreign suppliers with less than $1 million in average annual sales).

For importers whose foreign suppliers are subject only to the produce safety rule, the compliance dates are July 29, 2019 for small business, and July 27, 2020 for very small businesses. All other businesses must comply starting July 26, 2018.

“Remember that, unlike traditional facility inspections, FSVP inspections are based on the review of records, rather than observations of food production,” FDA’s Mayl explained. Most FSVP inspections will occur at the importer’s place of business, where the investigator will ask to see the importer’s FSVP records. In most cases, if deficiencies are found, the importer will be provided an opportunity to correct them.

“Our focus right now is on supporting compliance, except for problems that pose a danger to health or reflect intentional disregard for legal responsibilities,” Mayl said.

But companies that receive a citation for not having a FSVP may find themselves on FDA’s radar. This is because the agency’s risk analysis algorithms may automatically assign companies with prior deficiencies a higher risk score, increasing scrutiny and the potential for enforcement actions, Registrar Corp’s Statman says. “The best way to stay out of trouble with FDA is to stay out of trouble with FDA,” he says. “But if an importer or processor develops a clean record early, later deficiencies may have less effect.”

Beginning this year, U.S. importers can apply to register in FDA’s Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry into the U.S. of food from foreign companies that have been certified by auditors under the Accredited Third-Party Certification rule. “Expedited shipment entry gives importers incentive to adopt robust management of the safety and security of their supply chain,” said Doriliz De Leon, a consumer safety officer in the Food Adulteration Assessment Branch in FDA’s Center for Food Safety and Applied Nutrition.