FDA Would Require More Risk-Focused Verification of Foreign Food Suppliers

The FDA has released proposed changes to the requirements proposed in July 2013 concerning the requirement that importers verify the compliance of their foreign suppliers with U.S. food safety standards. The revised Proposed rule will be published in the Federal Register on September 29, 2014. In response to comments, the agency plans to change several requirements in order to provide for consistency with other requirements for preventive controls and avoid duplicative regulations.

Hazard Analysis

The agency’s original proposal (see U.S. food importers assigned responsibility of verifying that foreign suppliers meet U.S. standards, July 29, 2013) offered two options for importers to verify the compliance of their foreign suppliers. The revised proposal would require importers to perform a hazard analysis to determine the risks that are known and reasonably foreseeable and then determine whether they are significant rather than simply to analyze hazards that are reasonably likely to occur. A hazard would be known or reasonably foreseeable if a person knowledgeable about safe manufacturing, processing, holding or storage of food would take precautions to minimize significantly or prevent the hazard. The agency would require the importer to focus both on the hazards of the particular food and on any hazards concerning the particular supplier. The risk of intentional adulteration of the product for economic purposes must be considered.

Approved Suppliers

Rather than simply maintaining a list of approved suppliers, the importer would be required to consider the procedures, processes, and practices of the foreign supplier concerning the safety of the food and the entity that will be controlling the hazards. As in the original proposal, the importer would be primarily responsible for determining the risks posed by the particular supplier. Reliance on audits by government agencies with standards comparable to ours would be acceptable. The agency requests comments on the extent to which an importer should be permitted to substitute an unknown supplier if the previously approved supplier is unavailable.

SAHCODHA Hazards

With respect to hazards that could result in serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required either to conduct an onsite audit or to confirm that a reliable onsite audit has been conducted before importing the food for the first time and at least annually thereafter; the importer would be permitted to determine that some other or less frequent verification activity would address the risks adequately.

Compliance with Preventive Controls

The agency proposes that an importer who complies with the preventive controls for food for humans (or animals, if applicable) with respect to its suppliers would be considered to have complied with the foreign verification requirements as long as it confirms that the product came from the approved supplier when it entered the United States.

“Very Small” Importers and Suppliers

The FDA proposes to change the definition of “very small business” by raising the annual sales ceiling to $1 million from $500,000. The revised proposed rule states that the change is made to be consistent with the preventive controls regulations.

Related Documents

The FDA simultaneously released three other documents related to food safety, all of which will appear in the September 29, 2014, edition of the Federal Register, specifically: Good Manufacturing Practices (GMPs) and Preventive Controls for Food for Human Consumption, GMPs and Preventive Controls for Food for Animal Consumption, and Proposed Standards for Produce Safety.