The U.S. Food and Drug Administration has published its proposed regulations to implement its Foreign Supplier Verification Program (FSVP) and third-party auditor accreditation under the Food Safety Modernization Act (FSMA).
Under the proposed rules, the importer or its U.S. agent must provide assurances that imported food meets FSMA standards or face entry and/or eligibility denials to participate in FDA’s voluntary qualified importer program (VQIP) for expedited review and entry of food, which is currently in development.
Law firm and trade consultancy Sandler, Travis Rosenberg said the agency’s “175-page tome on the FSVP
sets forth details of the importer’s obligations under the proposed rule, placing for the first time the responsibility for ensuring the safety of imported food squarely on the shoulders of the importer or, if foreign, the importer’s U.S. agent.”
FDA’s 217-page proposed rule on the accreditation of third-party auditors
further explains the requirements and circumstances guiding the agency's use of certifications from accredited auditors in determining whether to admit certain imported food into the United States. The rule includes requirements for accreditation bodies seeking FDA recognition as well as requirements for third-party auditors seeking accreditation, the firm explained.
The agency has relieved certain importers from the requirements, including those with dietary supplements, very small imports, and imports from food suppliers in good compliance standing with FDA. The proposed rule would exempt from FSVP requirements certain juice and seafood from facilities in compliance with federal safety regulations, food imported for research, food imported for personal consumption, alcoholic beverages, and food that is imported for further processing or transshipped.
United Fresh Produce Association “welcomed” the release of the two proposed FDA rules.
“The rules for imported foods and third-party auditor accreditation will have a critically important role in the safety of fresh produce,” said Tom Stenzel, United Fresh’s president and chief executive officer, in a statement. “United Fresh will immediately begin a comprehensive review of these new draft rules and work closely with FDA to ensure that they contribute to our mutual goal of continued food safety improvement.”
Since January, United Fresh has conducted a full review of FDA’s proposed Produce Safety and Preventive Controls rules, bringing together member company experts from each segment of the produce supply chain. United said it will use that same process in the review of FDA’s draft rules on imports and third-party auditors to provide comments to FDA.
“Initially, we don’t see any surprises in FDA’s draft rules on imported foods and third-party auditor accreditation,” said David Gombas, United Fresh's senior vice president for food safety and technology. “However, it’s important that we thoughtfully review them in a line-by-line fashion, including analysis of their interaction with other FSMA draft rules, to ensure they advance food safety and are workable for the industry.”
Comments on the proposed rules on foreign supplier verification and third-party auditor accreditation are due within 120 days of the July 29 publication in the Federal Register
. FDA has also indicated the comment period for the draft Preventive Controls and Produce Safety rules will be extended 60 days past the current Sept. 16 deadline.