Food Safety Magazine

News | July 26, 2013

FDA Issues Proposed Rules to Verify Safety of Imported Food

By Staff


Taking two steps forward in the implementation of the Food Safety Modernization Act (FSMA), on July 26 the U.S. Food and Drug Administration (FDA) released new proposed rules for verifying foreign suppliers and accrediting third-party auditors.

FDA officials said that under the proposed rules, "importers would be accountable for verifying that their foreign suppliers are implementing modern, prevention-oriented food safety practices, and achieving the same level of food safety as domestic growers and processors." The new regulations also seek to "strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains."

In announcing the new regulations, FDA Commissioner Margaret A. Hamburg said, "Today’s announcement of these two new proposed rules will help to meet the challenges of our complex global food supply system. Our success will depend in large part on partnerships across nations, industries, and business sectors." An FDA news release affirmed that imported food comes into the United States from about 150 different countries and accounts for roughly 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables that Americans consume.

Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importers would, for the first time, have a clearly defined responsibility to verify that their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.

"FSMA provides the FDA with a modern tool kit that shifts the paradigm for imports, as well as domestic foods, from a strategy of reaction to one of systematic prevention," said Michael R. Taylor, deputy commissioner for foods and veterinary medicine. "Rather than relying primarily on FDA investigators at the ports to detect and respond to food safety problems, importers would, for the first time, be held accountable for verifying, in a manner transparent to the FDA, that the food they import is safe."

FSMA also directs the FDA to establish a program for the Accreditation of Third-Party Auditors for imported food. Under this proposed rule, the 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-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.

Importers will not generally be required to obtain certifications, but certifications may be used by the FDA to determine whether to admit certain imported food that poses a safety risk into the United States. The FSVP proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days. The two proposed rules aim to help the FDA create an integrated import oversight system that works efficiently to improve food safety and protect public health.

The July 26 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 open for comment until September 16, 2013, but the FDA plans to grant a 60-day extension of the comment period to give commenters an opportunity to consider the interrelationships between the proposals announced in January and those issued on July 26.