FDA Issues Final Rule for Laboratory Accreditation

December 2, 2021

  • In 2019, we reported on FDA’s proposed rule to Implement a Laboratory Accreditation Program for Food Testing.  On December 1, 2021, FDA published a final rule pursuant to the Food Safety Modernization Act (FSMA) on Laboratory Accreditation for Analyses of Foods (LAAF). LAAF will establish a laboratory accreditation program for testing of food in certain circumstances. Under the program, FDA will recognize accreditation bodies that will, in turn, accredit laboratories. The final rule provides eligibility requirements and procedures on how FDA will oversee the program.

  • The LAAF program is intended to improve the accuracy and reliability of certain food testing through uniform standards and enhanced FDA oversight. After the LAAF final rule is fully implemented, owners and consignees will be required to use LAAF-accredited laboratories for food testing under specific circumstances, such as to support removal of a food from an import alert or to support admission of an imported food detained at the border.

  • FDA plans to announce that accreditation bodies may apply for recognition in early 2022.  Eligibility requirements for accreditation bodies include complying with ISO/IEC 17011:2017(E), being a member of the International Laboratory Accreditation Cooperative (ILAC), and signing the ILAC Mutual Recognition Arrangement (MRA); the regulations also include conflict of interest provisions. Laboratories may apply for LAAF-accreditation after a sufficient amount of accreditation bodies have been recognized. Once enough laboratories are accredited, the agency will give owners and consignees 6 months’ notice that LAAF-accredited laboratories will be required for such food testing.

© 2022 Keller and Heckman LLP
National Law Review, Volume XI, Number 336
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