FSMA Accreditation Program Nearing Finalization

As part of ongoing policy developments under the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) is working to establish its own accreditation program for food testing laboratories. This program will be carried out by accreditation bodies (ABs), such as A2LA, that are recognized by the FDA based on criteria established in the FSMA Proposed Rule on Laboratory Accreditation. The same rule establishes the requirements that food testing laboratories must meet to gain accreditation. Although this new rule has been posted for comment since November of 2019, the FDA has recently extended the comment period until July 6th, 2020 to give interested parties additional opportunities to weigh in. 

This FSMA accreditation program is being developed with a few specific goals in mind. In particular, it seeks to support the admissibility of imported food products entering the U.S., to address potential food safety concerns, and to provide evidence for preventative action, corrective action, or legal penalty as appropriate in the event of food safety problems. The program incorporates the requirements of ISO/IEC 17025:2017, as well as some of the requirements from the 2018 AOAC International Guidelines and will affect many of A2LA’s currently accredited food testing laboratories. It will also create an impetus for other laboratories to seek accreditation to the FSMA accreditation program. 

Currently, A2LA meets all the FDA requirements listed for ABs, which specify that recognized ABs be signatories of the International Laboratory Accreditation Cooperation Mutual Recognition Agreement (ILAC-MRA) and adhere to requirements that include avoiding conflicts of interest, submitting reports, and maintaining records. In anticipation of the rule going into effect – which is expected in early 2021 – A2LA has an FSMA-specific program developed and ready to implement for labs seeking FSMA accreditation. Exactly how long laboratories will have to be come accredited once the program is published by the FDA remains unclear, but A2LA has been proactive through the rule’s review process and is well-equipped to guide current and future customers through FSMA accreditation. Detailed information on A2LA’s FSMA accreditation program for food testing laboratories will become available once the rule is finalized and published. 

For more information on the FSMA Proposed Rule on laboratory Accreditation, visit the FSMA detail page on FDA.gov. To provide a comment on the rule, which remains open until July 6th, 2020, visit the relevant page on regulations.gov. To learn more about current A2LA food testing accreditation programs, visit the Food and Pharmaceutical program page.