U.S. FDA LAAF Program

U.S. FDA LAAF

ISO/IEC Standard 17025

Overview

Important Documents

Overview

The U.S. Food and Drug Administration (FDA) has recognized IAS under its Laboratory Accreditation for Analyses of Foods (LAAF) program to accredit certain types of food-testing labs to standards established in the FDA LAAF Final Rule. In this program, IAS will accredit food testing laboratories using the standard ISO/IEC 17025 and the LAAF program specifications. Food Testing labs from all around the world are eligible to apply (including US labs).

The establishment of the LAAF program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories. The LAAF final rule applies to accreditation bodies and food testing laboratories that wish to participate in the program. Their participation is entirely voluntary. In certain circumstances owners and consignees will be required to use LAAF-accredited laboratories to conduct food testing.

What testing is covered under the LAAF final rule?

After the LAAF final rule is fully implemented, owners and consignees will be required to use a LAAF-accredited laboratory for food testing:

to support removal from an import alert through successful consecutive testing (e.g., to get a food product or firm removed from the red list);
to support admission of an imported food (e.g., articles of human or animal food, and U.S. goods returned that are articles of food) detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act (e.g., products that contain or appear to contain unapproved food additives, including unauthorized food contact substances);
required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests related to 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 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 (e.g., testing submitted in connection with an appeal of an administrative detention order).

FDA LAAF Process

The first step in the process is to obtain accreditation from an LAAF-recognized accreditation body (i.e. IAS), which includes an assessment to ISO/IEC 17025 and the LAAF program specifications. For laboratories already accredited by IAS to ISO/IEC 17025, the process involves a scope expansion by IAS to include the LAAF program specifications. The next step involves the laboratory conducting food testing and submitting the results and supporting information to the FDA.

FDA LAAF Links

LAAF Fact Sheet: https://www.fda.gov/media/155663/download

FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods: https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-final-rule-laboratory-accreditation-analyses-foods

FSMA Final Rule on Laboratory Accreditation for Analyses of Foods (LAAF): https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf

Federal Register Notice announcing the Final Rule: https://www.federalregister.gov/documents/2021/12/03/2021-25716/laboratory-accreditation-for-analyses-of-foods