The Food and Drug Administration (FDA) has recognized ANAB as an accreditation body (AB) for the Laboratory Accreditation for Analyses of Foods (LAAF) program. This program focuses on the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
About the LAAF Program
The FDA established the LAAF program as required by the Food Safety Modernization Act (FSMA) section 202(a), which added section 422 to the FD&C Act (21 U.S.C. 350k). The FSMA final rule on LAAF sets a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, the FDA recognizes ABs that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories). Establishing this program will help the FDA improve the safety of the U.S. food supply and protect U.S. consumers by adopting a modern, preventive, and risk-based approach to food safety regulation. This helps ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards to produce reliable and valid test results.
ANAB Accreditation for the FSMA LAAF Program
The rule went into effect February 1, 2022. Effective June 1, 2022, ANAB is accepted as a recognized AB for the FSMA LAAF program. While ANAB has been recognized, the rule requires sufficient Accreditation Body Capacity prior to Accreditation Bodies accrediting laboratories under the program. Once sufficient capacity has been established, FDA will publish a notice in the Federal Register. While the FDA approval process is two steps, laboratories wanting to participate in the program can submit their application to ANAB now.
What Is Included in the LAAF Program?
The LAAF program is applicable to food testing in certain circumstances by accredited laboratories. Foods included in the program are bottled water, shell eggs, sprouts, and import/export food products and foods suspected of adulteration.
Supplemental requirement (SR) 2440 was developed to document the additional requirements of the LAAF program, including but not limited to:
- Impartiality and confidentiality
- Analysis of samples
- Methods of analysis
- Notification and reporting
- Confidentiality and disclosure of information
Once a laboratory is accredited to the LAAF program requirements by a recognized AB, the laboratory applies for FDA recognition for publication on the FDA website. Laboratories participating in the voluntary LAAF program are also accredited to ISO/IEC 17025:2017 for test methods included in the LAAF program.
Laboratories participating in the program must demonstrate competence to applicable LAAF methods, as well as pass proficiency testing for LAAF methods within a 12-month period. Additionally, laboratories must be compliant to all requirements under the LAAF program. The FDA LAAF program will be listed on the laboratory’s scope of accreditation header under the ISO/IEC 17025:2017 designation. Scope methods under the LAAF program will be identified in the FDA LAAF program table with a footnote that states “Testing meets the requirements of ANAB SR 2440, FDA Laboratory Accreditation for Analysis of Foods (LAAF) Accreditation Program. Recognition by the FDA can be confirmed by visiting their website https://www.fda.gov.”