FDA Issues Two Proposed Rules under FSMA to Strengthen the Oversight of Imported Foods
July 26, 2013
Today, FDA issued two proposed rules under the Food Safety Modernization Act (FSMA) aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. These new measures respond to the challenges of food safety in today’s global food system, in which imported food comes into the U.S. from about 150 different countries and accounts for about 15 percent of the U.S. food supply. They are part of the effort mandated by Congress to modernize the food safety system and focus on preventing food safety problems, rather than relying primarily on responding to problems after they have occurred.
Under the proposed rule for Foreign Supplier Verification Programs (FSVP), importers would need to verify that their suppliers are meeting the same U.S. safety standards required of domestic producers. Requirements for verification activities would be primarily based on the type of food, nature of the hazard identified and on who—such as the foreign supplier, the importer, or the importer’s customer—is best able to control the hazard.
Under the proposed rule for 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 party auditors to audit and issue certifications for foreign food facilities.
The two proposed rules work together with the standards proposed in January 2013 for produce safetyand preventive controls in facilities that produce food for humans. The two proposed rules publish in the Federal Register on July 29, 2013. Comments on the two new proposed rules on the safety of imported food are due by 120 days from the publication date.
For more information:
Relevant section for small foreign suppliers (Under $500,000 in annual food sales, view full document):
Second, as shown in Diagram 4 below, the proposed rule would establish modified FSVP requirements for very small food importers and importers of food from very small foreign suppliers (i.e., entities with annual food sales of no more than $500,000). Because of the relatively small volume of food imported by and from these entities, which should reduce consumers’ exposure to, and therefore potential risk from, the imported food, we are proposing that in these situations the importer would not be required to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurance that describes the processes and procedures the suppliers use to ensure the safety of the food.
There is also another section for “food from a foreign supplier in a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States”. We will be doing more research on whether Japan qualifies for the below.
Third, as shown in Diagram 5 below, the proposed rule would exclude from most of the standard FSVP requirements (including hazard analysis and verification that identified hazards are adequately controlled) food from a foreign supplier in a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, provided that:
- The food is within the scope of FDA’s official recognition or equivalency determination regarding the food safety authority of the country in which the foreign supplier is located; and
- The importer determines that the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.