FDA has, at long last, issued the Final Rule for Laboratory Accreditation for Analyses of Food (LAAF Rule), laying out the specifications for the requirement that an accredited lab be used for food testing. What is important to understand is that the rule does not require that facilities use the accredited labs for all testing (e.g., those being run for a COA, etc.), only for those circumstances defined in the final rule.
Issued on December 1, the rule outlines the eligibility requirements for accreditation bodies and LAAF-accredited labs and how FDA will manage and oversee the LAAF program. The rule was issued, as required by FSMA, to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories. Currently, private labs are used that follow a variety of standards and oversight levels.
Once the rule is implemented, testing must be conducted through an LAAF-accredited lab when required by FDA regulations to address an identified or suspected food safety issue that violates the FD&C Act. This would not include routine product testing and environmental monitoring requirements, as these are not conducted to address a suspected (or identified) food safety problem, rather to verify the implementation and effectiveness of preventive controls and not because a food safety problem is suspected or identified.
Additionally, LAAF-Accredited Lab testing would be required:
- To support removal of a food from an import alert through successful consecutive testing requirements.
- When an imported food is detained at the border because it is or appears to be a violation of the FD&C Act.
- To fulfill a directed food laboratory order from FDA to address an identified or suspected food safety problem in certain, rare circumstances.
- For certain administrative processes (such as testing submitted in connection with an appeal of an administrative detention order, as part of evidence for an informal hearing before a mandatory recall order, or as part of a corrective action plan submitted after an order suspending the registration of a food facility).
The rule is applicable to owners and consignees of food for humans or animals; specifically, “any person with an ownership or consignment interest in the food product or environment that is the subject of food testing conducted under § 1.1107(a).”
However, you don’t need to begin seeking a lab just yet. In fact, you can’t, as no labs have yet been accredited. And it may be a while before you have to deal with compliance, as FDA is taking a “stepwise approach” to implementation:
- Announcing accreditation body application availability in early 2022.
- Announcing laboratory application availability once “a sufficient number” of accreditation bodies are recognized.
- Publishing a document in the Federal Register once there is “sufficient LAAF-accredited laboratory capacity” on the requirements for LAAF-accredited laboratory testing – with six months for compliance.
- Potentially publishing separate documents for various types of food testing based on capacity for each.
While the rule is intended to instill more uniformity among food-testing labs, an important take-away is understanding that only specific testing is required to be conducted through the accredited labs as defined by FDA. Most routine and environmental testing can still be conducted at your lab of choice, with the general caveat that it is not testing that is required by FDA regulation to address an identified or suspected food safety issue. However, we certainly recommend that you use a lab that has good practices, and one way to assure that is to use accredited labs for routine testing.
