Laboratory Requirements for the FDA LAAF Accreditation Program

Researcher examining sprouts in greenhouse to attain LAAF accreditation.

What Is the FDA LAAF-Accreditation Program?

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) has established the Laboratory Accreditation for Analysis of Foods (LAAF) program, which is now final rule.  The LAAF program tests food and food storage environments under certain circumstances to expedite review of analytical data and release products to the marketplace. Product testing under the LAAF program may include but is not limited to Bottled Water, Shell Eggs, Sprouts, imported products or food suspected of adulteration.

Who Is Recognized to Accredit Laboratories Under the LAAF Program?

The FDA recognizes participating accreditation bodies, like ANAB, who accredit laboratories under the LAAF-accreditation program requirements. LAAF-accredited laboratories are then listed on the FDA’s website. When the FDA has determined enough LAAF-accredited laboratories are available to meet industry demands, the FDA will provide 6-months’ notice requiring owners and consignees to have testing performed by LAAF-accredited laboratories to support removal of a food product from an import alert.

What Are the LAAF Laboratory Requirements?

To participate in the LAAF-accreditation program, laboratories must be accredited to ISO/IEC 17025:2017 and ANAB’s FDA LAAF-accreditation program supplemental requirements, AR 2440. Participating laboratories must pass proficiency testing for each method to be recognized under the LAAF-accreditation program within the past 12 months and submit the PT reports to their accreditation body.

LAAF-accreditation requires an on-site assessment every two years. Laboratories may use any FDA or standard methods which are validated, verified, and fit for purpose.  Laboratory analysts must be qualified by education, training and/or experience, have demonstrated capability to perform the method and compliant to LAAF program conflict-of-interest requirements. The laboratory must be compliant to the LAAF reporting requirements for either full or abridged analytical reports submitted to the FDA be compliant to LAAF document retention requirements and confidentiality requirements.

The LAAF-accreditation program is available for U.S. laboratories and foreign laboratories.

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