Laboratory Accreditation for Analyses of Foods (LAAF) FAQ
1. What is LAAF?
The FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF) establishes a laboratory accreditation program for testing food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies (ABs) that will accredit laboratories to the standards established in the final rule (LAAF-accredited laboratories).
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.
2. Who Is Affected by This Rule?
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 must use LAAF-accredited laboratories to conduct food testing.
3. What Testing Is Covered?
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 the admission of 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 violate 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 the FDA to require the 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 with an appeal of an administrative detention order).
4. What Is the LAAF Program Implementation Timeline?
When there is sufficient LAAF-accredited laboratory capacity for the food testing covered by the final rule, the agency will publish a document in the Federal Register giving owners and consignees six months’ notice that they will be required to use a LAAF-accredited laboratory for such food testing.
The agency may issue more than one Federal Register document as LAAF-accredited laboratory capacity is attained for various types of food testing described in the final rule.
5. What Is the Scope of Accreditation?
You may find our FDA LAAF scope of accreditation for our Gainesville facility at the A2LA website by clicking here.
6. How To Submit a Sample?
FDA LAAF program has specific guidelines that must be followed to submit an acceptable private laboratory analytical packet, including sampling plans, analytical methodology, photo reports, and entry documents.
To begin the FDA detention resolution process with Merieux, please contact us at gainesville.fda@mxns.com, and our expert team will guide you through the process to quickly resolve the detention.