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FDA Issues Proposed Rules for Foreign Suppliers, Third-Party Audits

Jul 31, 2013

The Food and Drug Administration released on Friday two proposed rules designed to ensure the safety of imported food under the Food Safety Modernization Act. Under the rules, importers would be responsible for verifying that their foreign suppliers are implementing prevention-oriented food safety practices and are reaching the same level of food safety as domestic growers and processors. FDA also proposed ways to strengthen the quality, objectivity and transparency of foreign food safety audits, which importers rely on to help manage the safety of their global supply chains.

According to FDA, imported food comes to the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply. The agency estimates that the new rules would cost between $400 million and $500 million a year to implement.

The proposed Foreign Supplier Verification Programs for Importers of Food for Humans and Animals would require importers to have verification programs that would identify hazards associated with each imported food that are reasonably likely to occur. Importers also would be responsible for providing assurances that these hazards are being adequately controlled.

Under the proposed rule on the Accreditation of Third-Party Auditors, FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-parties to audit and issue certifications for foreign food facilities and food, under certain circumstances.

Importers would not generally be required to obtain certifications, but FDA said it could use certifications to determine whether to admit certain imported food that poses a safety risk into the United States.

These proposals work in concert with the proposed rules released in January 2013 for produce safety and preventive controls in facilities that produce human food. Those proposed rules are currently open for comment until September 16, 2013, but FDA intends to grant a 60-day final extension of the comment period to allow commenters an opportunity to consider the relationships between the January proposals and the two proposals announced this week.  The comment period for all will end November 26, 2013.

IDFA is currently reviewing the proposed rules, each more than 50 pages, and will provide an in-depth review to members soon.

Members with questions may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at cdetlefsen@idfa.org.

 

 
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