The U.S. Food and Drug Administration (FDA) has released two proposed rules, one governing foreign supplier verification and the other governing third-party audits and certification.  Comments are due by November 26, 2013.

Foreign food suppliers, foreign food producers and U.S. importers should be aware that the U.S. Food and Drug Administration (FDA) has released two new proposed rules as part of FDA’s implementation of the Food Safety Modernization Act (FSMA) that will directly affect their operations.  The new proposed rules, one governing foreign supplier verification and the other governing third-party audits and certification, are intended to enhance FDA oversight of all imported human and animal foods.  They supplement FDA’s proposed rules on human food safety and fresh produce safety standards released in January 2013.

The foreign supplier verification proposed rule requires importers to perform certain activities to mitigate risks associated with their imported food.  Food importers must confirm that the foods they import are produced consistent with U.S. standards.  To meet that requirement, they must identify and control food safety hazards, conduct verification activities and take appropriate corrective action if the hazards are not adequately controlled.  Importers that do not comply will be subject to enforcement action.

The accredited third-party audits and certification proposed rule establishes a system to recognize foreign government agencies and private companies that could accredit third-party auditors of foreign food facilities.  The auditors would conduct food safety audits and issue certifications, which U.S. importers could then use to verify compliance with U.S. food safety standards as required by the foreign supplier verification rule.  FDA also may use the audits to decide whether to admit certain imported food into the United States and to help accelerate import procedures for food under a new voluntary accreditation program. 

These new food safety requirements are expected to cost foreign food suppliers, foreign food producers and U.S. food importers about $500 million annually to implement.

The newly released proposed rules have been published in the Federal Register with a 120-day public-comment period that ends on November 26, 2013.  It is anticipated that the various rulemakings and final implementation of the FSMA will occur by the end of 2015.