On November 13, 2015, the FDA finalized its rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

The rule is scheduled to be published in the Federal Register on November 27, 2015. The pre-publication version of the rule is available here. The linchpin of the rule is the requirement that importers implement a FSVP to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

Importers covered by the rule will need to:

  • Determine known or reasonably foreseeable hazards with each food. These can include biological hazards such as parasites, chemical hazards such a pesticide residue, and/or physical hazards such as glass. The importer’s analysis must assess the probability of these hazards and that the severity of the illness or injury that could potentially occur by evaluating factors such as how the food is harvested or manufactured, how the food is packaged, how it is transported, etc. The importer can also rely on another entity to conduct this hazard analysis as long as the importer reviews and assesses all relevant documentation related to the analysis.
  • Evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance. Factors that importer’s must consider in the evaluation can include the foreign supplier’s procedures, processes, and practices related to food safety, and any information that FDA may have regarding the foreign supplier’s compliance. The importer can also rely on another entity to perform the risk evaluation under certain circumstances.
  • Use that evaluation to approve suppliers and determine appropriate supplier verification activities. Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure that it only imports from approved foreign suppliers. Appropriate supplier verification activities may include annual on-site audits of the supplier’s facility, sampling and testing, or a review of the supplier’s relevant food safety records. The importer can also rely on another entity to determine and perform appropriate supplier verification activities under certain circumstances.
  • Conduct corrective actions. If something goes wrong and an importer determines that its foreign supplier has not used safe processes and procedures, the importer must take immediate corrective action. The appropriate action will depend on the circumstances, but can include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.

Some key points about the FSVP rule are:

  • Very small importers are subject to modified requirements. The definition of very small importer is an importer with a sales ceiling of $1 million for human food and $2.5 million for animal food.
  • Importers of certain small foreign suppliers are also subject to modified requirements, e.g. farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales.
  • Certain foods are not covered by FSVP, including (1) juice and fish that complies with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations; (2) food for research or evaluation; (3) food for personal consumption; (4) alcoholic beverages; (5) food that is imported for processes and future export; (6) low-acid canned foods; and (7) certain meat, poultry, and egg products that are regulated by the U.S. Department of Agriculture at the time of import.
  • If an importer is subject to FSVP rules, the general compliance deadline will be within 18 months of the anticipated November 27, 2015 publication date.

In light of this new rule, it is important for companies to determine whether they are subject to FSVP requirements, and, if so, to begin taking steps to ensure compliance.