Tuesday, July 30, 2013

FDA Releases Two Proposed Rules Under the Food Safety Modernization Act

On July 26, 2013, the U.S. Food and Drug Administration released two proposed rules under the Food Safety Modernization Act (FSMA). Enacted in 2011 by Congress, FSMA requires the FDA to create and enforce a number of rules dealing with prevention of contamination of the U.S. food supply in the United States.

The proposed rule for Foreign Supplier Verification Programs for importers of food for humans and animals deals with the strengthening of oversight of foods imported for U.S. consumers. Importers will be required to perform risk-based activities to verify that imported foods have been produced in a manner that provides the same level of public health protection as is required of domestic food producers. Proposed regulations vary based on the type of food product and several other factors.

The proposed rule on Accreditation of Third-party Auditors will establish a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. According to the FDA, generally importers will not be required to obtain certifications, but in certain situations, the FDA may use certifications from accredited auditors in determining whether to admit certain imported foods that may pose a safety risk. The FDA may also use these certifications in determining whether an importer is eligible to participate in a voluntary program under development for expedited review and entry of food.

Both rules are open for comment until November 26, 2013. For more information, please see the FDA website on FSMA.
Written by Sarah L. Doyle - Research Assistant
The Agricultural Law Resource and Reference Center
July 30, 2013

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