December 2, 2021
Food Safety Update: FDA-FSMA Final Rule on Laboratory Accreditation for Analyses of Foods
ANAB Is a Recognized Accreditation Body Under the FDA FSMA
In an effort to enhance the U.S. Food and Drug Administration’s (FDA) capacity to protect U.S. consumers from unsafe food, the FDA this week issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). The ANSI National Accreditation Board (ANAB), a wholly owned subsidiary of the American National Standards Institute (ANSI), is a recognized accreditation body (AB) under the FDA FSMA. In accordance with the program, the FDA will recognize ANAB and other ABs that will accredit food testing laboratories to standards established in the final rule (referred to as LAAF-accredited laboratories).
The final rule also outlines eligibility requirements that ABs and laboratories will need to satisfy to participate in the program, as well as procedures for how the FDA will manage and oversee the program.
Ultimately, the establishment of the LAAF program will improve the FDA’s ability to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories.
The LAAF program will cover food testing:
- to support removal of a food from an import alert through successful consecutive testing requirements;
- to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
- required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
- required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
- conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.
Whereas current food testing (including environmental testing) is largely completed by private laboratories that may conform to a variety of standards and have various levels of oversight, under the fully implemented LAAF program, only LAAF-accredited laboratories will be able to conduct food testing in certain circumstances that are defined in the final rule.
About the FSMA
The FSMA empowers the FDA to take proactive steps to prevent the sale, distribution, and consumption of tainted food products by recognizing accreditation bodies such as ANAB to assess the competence of food safety product certification bodies according to ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services, or ISO/IEC 17021-1, Conformity Assessment — Requirements for bodies providing audit and certification of management systems, and FDA regulations.
ANAB is also recognized by the FDA, in the FSMA program, as an accreditor of management systems certification bodies under ISO/IEC 17021-1.
Access more information on accreditation about FSMA and ANAB’s accreditation process via ANAB.
The ANSI National Accreditation Board (ANAB), a wholly owned subsidiary of the American National Standards Institute (ANSI), is the largest multi-disciplinary ISO/IEC 17011 accreditation body in North America, with comprehensive signatory status across the multilateral recognition arrangements of the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). The ANAB accreditation portfolio includes management systems certification bodies, calibration and testing labs, product certification bodies, personnel credentialing organizations, forensic test and calibration service providers, inspection bodies, police crime units, greenhouse gas validation and verification bodies, reference material producers, and proficiency test providers.
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