FDA Announces Proposed Rules on Safety of Imported Food

Please note that these rules were published in the Federal Register on July 29, 2013 at 78 FR 45730 and 78 FR 45782

The FDA announced that it was to issue two proposed rules to help ensure that imported food meets the same safety standards as food produced in the U.S. These proposals, one on the accreditation of third-party auditors and another on verifying foreign suppliers, are, according to the FDA, one step toward the implementation of the Food Safety Modernization Act (FSMA) (P.L. 111-353). Both proposed rules were published in the Federal Register on July 29, 2013.

Imported food in the U.S. comes from about 150 countries and accounts for 15 percent of the U.S. food supply—including 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans. FDA Commissioner Margaret Hamburg stated, “These rules would make importers more accountable for food safety, and would enhance our ability to monitor conditions and standards in foreign facilities that produce and process food.” While the FDA will continue to rely on inspections at U.S. ports of entry to keep contaminated foods from entering the U.S., under the proposed rules, “we will significantly enhance our ability to identify issues before food gets to our shores.”

Food Safety Modernization Act

According to the FDA, the FSMA aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. The law provides the FDA with new enforcement authority designed to achieve higher rates of compliance with prevention- and risk-based food safety standards.

Accreditation of Third-Party Auditors

The FDA proposed to amend its regulations to provide for the accreditation of third-party auditors and certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications. According to the FDA, the use of such auditors, certification bodies, and food and facility certifications will improve the safety of the U.S. food supply by preventing potentially harmful food from reaching U.S. consumers. The FDA stated that these regulations will also increase efficiency by reducing the number of redundant food safety audits.

Verifying Foreign Suppliers

Under the proposed rule for foreign supplier verification programs, American importers would have the responsibility of verifying that their suppliers produce foods that meet U.S. safety requirements. Importers would be required to have a plan for imported food, which includes identifying hazards associated with each food that are reasonably likely to occur, and provide adequate assurances that these identified hazards are being adequately controlled.