The Proposed FSMA Rule - An Accreditation Body Perspective and the Impact on Laboratories and Stakeholders
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. ANAB has utilized our experience with third party certification bodies to provide our experience and perspective to the FDA on the proposed rule for the accreditation of laboratories.
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. An 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. The Proposed Rule provides the framework to use the current trusted model but needs clarity and structure to work effectively.
This presentation will address the impact of the new proposed laboratory rule from the Accreditation Body perspective providing the participants the implications on the laboratory, data users and stakeholders.