FDA Sets Lab Requirements for Testing to Show Admissibility of Imports, Removal From Import Alert

FDA is finalizing its Laboratory Accreditation for Analyses of Foods (LAAF) framework for accreditation of laboratories for testing of food in certain circumstances, including tests to demonstrate admissibility of food detained by FDA at the border and tests used as evidence by importers seeking removal from import alert, it said in a final rule released Dec. 2.

The final rule, which takes effect Feb. 1, sets standards that laboratories must meet to conduct food testing covered by the new regulations. That includes testing to address an identified or suspected food safety problem, both in response to a specific testing requirement under FDA’s laws and regulations or as required by the secretary of health and human services. It also applies to testing used as evidence that an imported food detained at the border is not adulterated and misbranded and is admissible, as well as testing to support removal from an import alert through successful consecutive testing.

Testing required under FDA’s Foreign Supplier Verification Program is not covered by the new food testing accreditation scheme, FDA said.

The final rule establishes a publicly available registry listing LAAF accreditation bodies and laboratories that have been recognized or accredited by FDA under the new food testing program, and requires that results of food testing by these labs be sent directly to the agency. It also specifies the analytical reports LAAF labs must send under the final rule, and sets eligibility requirements for LAAF accreditation bodies to qualify for FDA recognition and requirements they must meet once recognized.

While the importer of record is responsible for compliance with FDA laws and regulations, including testing requirements set by FDA’s final rule, the agency said it will allow the importer of record to contract with other parties so that the other party agrees to engage an accredited LAAF laboratory to test the product. “Such arrangements are purely between the parties to the shipment; at the end of the day the importer of record remains the party ultimately responsible for the compliance of that entry and therefore is ultimately responsible for amassing any testimonial evidence (e.g., test results and associated analytical documentation) in support of admission of the food,” FDA said.

Foreign laboratories may seek LAAF accreditation as well, and there is no requirement that testing of imports subject to LAAF testing must be conducted in the U.S. However, FDA will generally require sampling after arrival in the U.S., unless it grants a written, case-by-case exception based on the specific circumstances of the shipment, such as product characteristics and the specifics of packaging and transportation.