FDA rolls out more FSMA rules

Produce Safety rule, the Foreign Supplier Verification Programs (FSVP) rule, and the Accredited Third-Party Certification rule released Nov. 13.

The U.S. Food and Drug Administration finalized three more rules for the Food Safety and Modernization Act. The latest rules establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The agency also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities.

The final rules, which implement the FDA Food Safety Modernization Act, will help produce farmers and food importers take steps to prevent problems before they occur. They build on the preventive controls rules the FDA finalized in September 2015, which mandate modern preventive practices in food processing and storage facilities. These rules work together to systematically strengthen the food safety system and better protect public health.

The new rules released today are the Produce Safety rule, the Foreign Supplier Verification Programs (FSVP) rule, and the Accredited Third-Party Certification rule.

The Produce Safety rule establishes science-based standards for growing, harvesting, packing, and holding produce that are designed to work effectively for food safety across the wide diversity of produce farms.

The FSVP rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards. In 2013, the U.S. Department of Agriculture estimated that imported food accounted for about 19% of the U.S. food supply, including about 52% of the fresh fruits and 22% of the fresh vegetables consumed by Americans.

The final rule has elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. 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 Accredited Third-Party Certification rule establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  

The FDA has finalized five of the seven major rules that implement the core of FSMA. The remaining two rules on Sanitary Transportation and Intentional Adulteration are scheduled for release in spring 2016.

FDA will be hosting two webinars in the next few weeks on the FSMA final rules on produce safety, FSVP and third party auditors. These rules establish enforceable safety standards for the production and harvesting of produce on farms and make importers accountable for the safety of the food they bring into the U.S.

The first will be held on Nov. 17 from 2:00 to 3:00 PM ET featuring the final rule for produce safety. A webinar on the FSVP and third-party auditor will be held Nov. 23 from 10-11:30 AM EST.

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