Prompted by a series of deadly foodborne illness outbreaks, many tied to imported foods, in 2011 the U.S. Congress signed the FDA Food Safety Modernization Act (FSMA) into law. The goal was to develop food safety regulations focused on prevention across the entire supply chain. Although the FDA has used its discretion on what to enforce while the industry becomes more familiar with the new requirements, inspections and enforcement of certain rules have already begun.
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One FSMA rule, the Foreign Supplier Verification Programs (FSVP), requires companies to verify that their food has been produced in a manner that meets U.S. food safety standards. They must also develop, document, implement, validate, and keep records of a food safety plan. As part of an inspection, the FDA will review the importer’s records to determine compliance with the FSVP regulation.
In October, the FDA published the list of records required under FSVP.
“The FSVP Records Requirements List does not contain any new policies or procedures,” clarified Taryn Sjursen, a health communications specialist at FDA. “It is a tool importers may use, in conjunction with the FSVP regulation, to determine the FSVP records they should have — develop, implement, and maintain — as part of their FSVP for a specific imported food from a specific foreign supplier.”
The published list of records is organized based on the sections of the FSVP regulation. Required documents include everything from records of audit procedures, audit dates, conclusions, corrective actions to number of food samples tested, type of tests conducted, dates of tests, date of test report, results, and any corrective actions.
“Although there are still some future compliance dates relating to importers from certain foreign suppliers (i.e., July 27, 2020), the compliance date for these verification activities for most importers has already passed,” the FDA spokesperson says.
FSMA also permits foreign suppliers to enter the Voluntary Qualified Importer Program, which is a fee-based program that offers importers expedited review and entry of food into the U.S. when specific requirements are met.