As previously discussed on this blog, the U.S. Food and Drug Administration (FDA) released a proposed rule on November 4, 2019 for recognizing accreditation bodies, which will, in turn, accredit laboratories to conduct food testing.  An FDA accreditation program for food testing laboratories is mandated by the FDA Food Safety Modernization Act (FSMA).  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.

FDA has thus far received comments from the American National Standards Institute (ANSI) National Accreditation Board (NAB) and two large food industry groups.  The Food and Beverage Issue Alliance and the American Frozen Food Institute have merely asked FDA to extend the comment period beyond the original March 3, 2020 due date.  The ANSI-NAB submitted substantive comments: asking FDA to clarify proposed nomenclature (e.g., “probationary,” probationary status,” and “accredited”), to use terms consistently, and to clearly document supplemental requirements for recognized accreditation bodies and qualified accredited laboratories beyond ISO/IEC 17011 and ISO/IEC 17025, respectively.

FDA recently announced a 30-day extension – until April 6, 2020 – for submitting comments on the proposed rule and associated information collection provisions for the proposed regulations on the laboratory accreditation program.