What You Need to Know About the FSMA Laboratory Accreditation Rule

Food testing labs will soon see their regulatory environment change somewhat as part of the FDA’s Food Safety Modernization Act (FSMA), which seeks to implement its own laboratory accreditation program for food testing labs. The goal of this program is to ensure the safety of the U.S. food supply and protect U.S. consumers by helping ensure appropriate oversight of certain food testing that is relevant to public health. It will also ensure that the testing is done according to appropriate model standards which will help produce consistently reliable and valid test results. The FSMA final rule will be published in the next several months, after which point food testing laboratories affected by the rule will have a reasonable window of time to become accredited. The new accreditation program relies heavily on the requirements of ISO/IEC 17025: 2017, the recognized international standard for testing laboratories, but also includes requirements from the 2018 AOAC International Guidelines, as well as certain program-specific requirements. 

FSMA laboratory accreditation through this new program seeks to support the admissibility of imported food products entering the U.S., as well as 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. Its requirements have been developed with these goals in mind. The FSMA accreditation requirements are lengthy, but laboratories already accredited to ISO/IEC 17025:2017 will meet most of them by default, and will need to make only limited changes to meet the other requirements specified in the rule.  

The public comment period on the proposed rule to establish this FSMA accreditation program was extended due to process disruptions caused by COVID-19, but the comment period is now closed, which means that the new rule is nearing finalization. Although the exact date of the rule’s implementation has not yet been announced, it will most likely go into effect in early 2021, after which food testing laboratories subject to the rule will have a period of time to become accredited under the new program. Although there is not yet a finalized timeline for implementation, food testing laboratories have the opportunity to begin preemptively preparing for the new rule before it goes into effect. 

The FDA website has a detailed overview of the rule and how it will impact food testing laboratories, and although the comment period is closed, the full text of the proposed rule is still available electronically on regulations.gov. The FSMA final rule will be published in the Federal Register and will go into effect 60 days after publication. For labs who are uncertain about how this rule will affect them, or who are seeking more information to help them prepare for FSMA accreditation, AWPT has a team of expert consultants who can provide personalized hands-on guidance specific to FSMA accreditation. We also offer multiple courses, both self-directed and instructor-led, that provide detailed information on ISO/IEC 17025:2017, the standard from which most of the FSMA accreditation requirements are borrowed.