FDA Issues Proposed Rule to Implement a Laboratory Accreditation Program for Food Testing as Required by FSMA
The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories. Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet.
On November 1, 2019, FDA released a proposed rule under which FDA will recognize accreditation bodies, which will, in turn, accredit laboratories to conduct food testing. FDA’s proposed laboratory accreditation program partially incorporates two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for accreditation bodies and laboratories, respectively. Once the laboratory accreditation program is established, testing of human and animal food in certain circumstances must be conducted by an accredited laboratory and the results must be sent directly to FDA. A full test report is required unless the testing laboratory meets FDA’s proposed provisions for submitting an abridged report. Circumstances where testing by an accredited laboratory would be required include:
– To comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water, and sprouts);
– To provide evidence on the admissibility of imported food (e.g., for a food that has been detained due to an appearance of adulteration);
– To support the removal of a food from an import alert through successful consecutive testing;
– To address an identified or suspected food safety problem and provide evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;
– To respond to a “food testing order,” which is a new procedure proposed by this rule to address an identified or suspected food safety problem.
Laboratories run and operated by federal agencies, states, localities, and foreign government entities, as well as private laboratories, including in-house laboratories, will be eligible for accreditation under FDA’s proposed program. Laboratories could be accredited in one or more major disciplines (e.g., microbiology, chemistry, and physical testing). FDA will establish a publicly available list of recognized accreditation bodies and laboratories accredited. Both accrediting bodies and accredited laboratories will be subject to FDA oversight, although accrediting bodies will have primary oversight of accredited laboratories.
Comments on FDA’s proposed rule are due by March 3, 2020. The laboratory accreditation program would become effective 60 days after a final rule is published; however, FDA will allow itself an unspecified time period after that to get ready to accept applications for recognition from accrediting bodies. Then it will take more time for FDA to recognize a sufficient number of accrediting bodies so that laboratories may then apply for accreditation. In this regard, the compliance date for testing to be conducted by an accredited laboratory participating in FDA’s program would be no sooner than six months after FDA publishes notice of sufficient laboratory capacity. Thus, mandatory testing by an accredited laboratory appears to be a couple of years away at the earliest.