The U.S. Food and Drug Administration has 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.

On July 26, the FDA issued proposed regulations that it says would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP) regulations, importers would be required to perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act.

The proposed regulations vary based on the type of food product (such as processed foods, produce and dietary supplements), the category of importer, the nature of the hazard in the food and who is to control the hazard. All importers must establish and follow an FSVP, unless otherwise exempted. An importer of food under the proposed FSVP regulations is the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. Under the proposed FSVP regulations, an importer would be required to develop, maintain and follow an FSVP for each food it imports.


Also on July 26, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. The proposed rule would implement Section 307 of the Food Safety Modernization Act.

Importers will not generally be required to obtain certifications, but in certain circumstances the FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the U.S. that the FDA has determined poses a food safety risk or in determining whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.

The proposal contains requirements for accreditation bodies seeking recognition by the FDA as well as requirements for third-party auditors seeking accreditation. The requirements will help ensure the competence and independence of the accreditation bodies and third-party auditors participating in the program. In addition, it contains FDA procedures for recognition and accreditation as well as requirements relating to monitoring and oversight of participating accreditation bodies and auditors. These include procedures that the FDA will follow when removing an auditor or an accreditation body from the program.