The Food Safety Modernization Act (FSMA) empowers the Food and Drug Administration (FDA) to take proactive steps to prevent the sale, distribution, and consumption of tainted food products. The goal of FSMA is to create a food safety system that supports the prevention of contamination—rather than reacting to contagions that have already occurred. In November 2019, the FDA released the long-awaited laboratory portion of FSMA. This is the proposed rule under which the FDA will recognize accreditation bodies which will in turn accredit laboratories.
The ANSI National Accreditation Board (ANAB) was the first accreditation body (AB) recognized by the FDA to assess the competence of food safety certification bodies according to ISO/IEC 17021 Part – 1 and ISO/IEC 17065 in accordance with the FDA Third Party Program – 21 CFR Part 1, 11 and 16: Sub Part M regulations.
Many laboratories have sought accreditation as the means to improve their internal quality of test results. Accreditation refers to a recognized AB’s determination that a laboratory meets the applicable requirements of the specific program. While the FDA does not treat accredited test results differently than other results, accreditation by a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) attests to the competence of the laboratory and furthers confidence in testing results.
This presentation will address the impact of the new proposed laboratory rule not only on laboratories, but on the users of laboratories and those affected by the overall FSMA regulation.
During the presentation, we will review the FSMA requirements for certification bodies defined in Sub Part M, in relation to ISO/IEC 17065 and other accreditation requirements. We will also provide an overview of the accreditation process and benefits of accreditation for the certification bodies that participate in this program.
We will present lessons learned during the implementation of this accreditation program since March 2018, as well as the main findings raised during more than 12 assessments conducted in the last two years. Finally, we will discuss the impact of accreditation and the FMSA requirements on laboratory data users.