FDA Releases Foreign Supplier Verification Requirements Final Rule, Other FSMA Rules

The Food and Drug Administration released final rules for several Food Safety Modernization Act regulations. The final rules on the foreign supplier verification programs (FSVP) (here), accredited third-party certification (here) and produce safety (here), are scheduled for publication in the Federal Register on Nov. 27. The compliance requirements of the FSVP will affect some importers 18 months after the rule's official publication, said the FDA fact sheet on FSVP (here).

The FDA included elements of both the original (see 13072628) and supplemental proposals (see 14091917) within the FSVP final rule, it said. The agency added "greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains," the FDA said. "For example, importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation."

The timing for compliance with the FSVP final rule is dependent on the type of company, said the FDA. "The date by which importers must comply with the FSVP regulations is the latest of" either 18 months after publication; six months after a foreign supplier subject to preventive controls or produce safety rules is required to meet the relevant regulations; or, for importers that are manufacturers or processors "subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions," the agency said.

Among other things, the FDA decided to go forward with its revised proposal to define a very small importer as having a "sales ceiling of $1 million for human food and $2.5 million for animal food," said the FDA. That definition is consistent with the definition of very small business in the preventive controls rules, it said. Also subject to modified FSVP requirements are importers from small foreign suppliers, said the agency. There are also modified requirements for "certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the" U.S. system, said the FDA.

The FDA also released a fact sheet on accredited third-party certification (here). FDA has said it hopes to launch the Voluntary Qualified Importer Program in 2017 (see 1503260014), following the implementation of a system of accreditation bodies for third-party auditors that will certify foreign food exporters as eligible sources of imports under the program. FDA also released a fact sheet on the produce safety rule (here) and a related environmental impact statement (here). The agency also scheduled webinars to discuss the final rules (here).