FDA Releases Final Rule For Lab Accreditation For Analysis Of Foods

The US Food and Drug Administration (FDA) on Wednesday issued a final rule establishing the Laboratory Accreditation for Analysis of Foods (LAAF) program, as required by the Food Safety Modernization Act (FSMA).

Under the LAAF program, FDA will recognize accreditation bodies (AB) that will accredit food testing laboratories to standards established in the final rule (referred to as LAAF-accredited laboratories). The final rule outlines eligibility requirements that ABs and laboratories will need to satisfy to participate in the program, as well as procedures for how FDA will manage and oversee the program.

FDA had published a proposed rule for “Laboratory Accreditation for Analyses of Foods” in the Federal Register on Nov. 4, 2019. Upon close of the comment period on July 6, 2020, the agency had received approximately 70 comment submissions that covered almost every aspect of the proposed rule.

The final rule contains model standards that laboratories must meet in order to participate and conduct certain food testing covered by the final rule. The rule will establish a publicly available registry listing accreditation bodies and laboratories that have been recognized or accredited.

Results of food testing conducted by laboratories under the program must be sent directly to FDA. LAAF-accredited laboratories are required to submit to FDA analytical reports as specified in this final rule.

The final rule contains eligibility requirements for accreditation bodies to qualify for FDA recognition and requirements that accreditation bodies must meet once recognized, such as requirements related to assessing and overseeing laboratories, conflicts of interest, reporting, and records.

Also, the final rule contains eligibility requirements for laboratories to qualify for LAAFaccreditation by a recognized accreditation body and requirements that laboratories must meet once LAAF-accredited, such as requirements related to conflicts of interest, analysis, reporting, and records. These requirements will help ensure the effectiveness of the recognized accreditation bodies and LAAF-accredited laboratories under this program, FDA stated.

The final rule contains procedures FDA will follow to recognize accreditation bodies under this program and procedures for accreditation bodies to follow to LAAF-accredit laboratories under this program. This rule contains regulatory procedures and requirements relating to FDA’s oversight of recognized accreditation bodies and LAAF-accredited laboratories.

Food testing, including environmental testing, is completed by private laboratories that may conform to a variety of standards and be subject to various levels of oversight, FDA noted. Once the LAAF program is fully implemented, only LAAF-accredited laboratories will be able to conduct food testing in certain circumstances that are defined in the final rule.

The LAAF program will ...

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