The U.S. Food and Drug Administration proposed two new rules last week that would impact imported food, including by establishing a program to accredit third-party auditors to certify foreign food facilities.  The rules were called for by the Food Safety Modernization Act of 2011, which revised the regulatory system to deal with risks of food-borne illness. We have posted before about the litigation that can arise from such situations. 

Under the proposed rules, which follow on regulations proposed earlier this year, 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 FDA is also proposing rules 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. Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.

Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importers would 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.

The 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.