FDA Publishes Proposed FSMA Laboratory Accreditation Rule

FDA Publishes Proposed FSMA Laboratory Accreditation Rule

FDA is proposing to establish a program for the testing of food by accredited laboratories as required by FSMA.

Subscribe
November 7, 2019

FDA is proposing to establish a program for the testing of food by accredited laboratories as required by FSMA as part of a proposed rule published in the Federal Register. The laboratory accreditation program, once established, will require testing of human and animal food in certain circumstances by accredited laboratories. Accredited laboratories would be required to follow model standards and would be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently reliable testing results.

Currently, FDA requires certain food testing, including environmental testing, to be conducted to help determine safety. The testing is largely completed by private laboratories that may conform to a variety of standards and be subject to various levels of oversight. Under the new proposed program, only laboratories accredited by an Accreditation Body (AB) recognized by the FDA will be able to conduct food testing in certain circumstances, which are outlined in the proposed rule. Further, the results will be required to be sent directly to the FDA by the accredited laboratories.

Circumstances that would require use of a laboratory accredited under this proposed rule are testing that is conducted 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);
  • Provide evidence to support the admissibility of imported food into U.S. commerce (e.g., testing conducted for a food that has been detained due to an appearance of adulteration);
  • Support the removal of a food from an import alert through successful consecutive testing;
  • Address an identified or suspected food safety problem and presented to FDA as part of 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;
  • Respond to a food testing order, a new procedure proposed by this rule to address an identified or suspected food safety problem.

Under the rule, when finalized, FDA will recognize ABs, which will, in turn, accredit laboratories to conduct food testing in these circumstances. The proposed rule outlines the procedures and standards that ABs and laboratories would need to follow to participate in the program, as well as procedures for how FDA would manage and oversee the program.

The proposed laboratory accreditation program would incorporate two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for ABs and laboratories, respectively. ABs and laboratories would also be required to meet certain additional requirements.

The proposed laboratory accreditation program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories.