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FSMA: Foreign Supplier and Third-Party Audit Rules Now Final

Nov 18, 2015

The Food and Drug Administration released on Friday three new final rules under the Food Safety Modernization Act, and two are intended to formalize industry accountability and best practices for food importers. The Foreign Supplier Verification Programs rule makes importers accountable for verifying that imported food meets U.S. safety standards, and the Accredited Third-Party Certification rule establishes a program for the accreditation of third-party certification organizations to conduct food safety audits of foreign food facilities.

The third, the Produce Safety rule, establishes enforceable safety standards for produce farms. 

The Foreign Supplier Verification Programs rule requires food importers to verify that their non-U.S. suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities. The final rule requires importers to conduct verification activities, such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records, that are based on risks linked to the imported food and the performance of the supplier.

The rule on Accredited Third-Party Certification establishes a program for the accreditation of third-party certification organizations to conduct food safety audits and to certify that foreign food facilities and the food they produce meet applicable FDA food safety requirements. Such certifications would be used to qualify foreign companies for participation in FDA’s Voluntary Qualified Importer Program providing expedited review and entry of products into the U.S.  In specific circumstances, FDA can require a food that is offered for import to be accompanied by a certification from an accredited third-party auditor.

IDFA Webinar Scheduled for Dec. 1

IDFA is reviewing the text of the final rules and will hold a webinar on Dec. 1, 3:00-5:00 p.m., to help dairy companies prepare for implementation of these newly released final rules. The webinar will include presentations by Joseph Levitt and Elizabeth Fawell, who are legal and regulatory experts on the Food Safety Modernization Act at Hogan Lovells US, LLP, IDFA’s outside legal counsel. Online registration for the webinar, “Focus on Imports: FDA’s New Foreign Supplier Verification and Third-Party Certification Rules,” is available here.

FDA has finalized five of the seven major rules that will guide implementation of FSMA. The rules issued last week build on the two preventive controls rules the agency finalized in September, which mandate preventive practices in food processing and storage facilities.

Members with questions may contact Allan at

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