How FSMA’s Final Rule on Accredited Laboratories Will Impact the Food Industry

The Laboratory Accreditation for Analyses of Foods (LAAF) Final Rule is one of the last remaining major rules to be published as a requirement of the Food Safety Modernization Act (FSMA). FSMA directed FDA to establish a program for the testing of food in certain circumstances, to be performed by accredited laboratories as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Per FDA’s summary of the LAAF final rule:

Under the LAAF program, FDA will recognize accreditation bodies that will accredit laboratories to the standards ­established in this final rule. Laboratories accredited to the LAAF standard (“LAAF-accredited laboratories”) are authorized to conduct certain food testing as described in this rule. For purposes of this discussion, it applies to owners or consignees that must have certain food testing conducted by a laboratory accredited under this program. It’s important to note that lab accreditation is granted on ­individual analyses, not to the lab in general.

This rule applies when food testing is conducted in certain circumstances. “Food testing” and “testing of food” include the analysis of human or animal food, as well as testing of the food growing or manufacturing environment (i.e., “environmental testing”).

Direct receipt of food testing results in these circumstances is of particular importance to the Agency and to public health. This rule applies to food testing conducted under specific testing requirements in the FD&C Act and implementing regulations that “address an identified or suspected food safety problem,” and in directed food laboratory orders that we (FDA) will issue “as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem.”

If we [FDA] determine that the food testing results are valid and that they demonstrate the detained food product does not violate the FD&C Act, we [FDA] will release the food from detention and allow it to proceed into the United States. We [FDA] use the detention without physical examination (DWPE) procedure when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative.

Import alerts inform FDA field staff and the public that we [FDA] have enough evidence to allow for DWPE of products that appear to be in violation of FDA laws and regulations. Concerns periodically have arisen regarding importers’ manipulation or substitution of the samples a private laboratory tests, and practices such as “testing into compliance,” in which multiple samples from a shipment are tested, but only those results that would allow the shipment to enter the United States are submitted to us. See, e.g., “The Safety of Food Imports: Fraud & Deception in the Food Import Process; Hearings Before the Senate Committee on Governmental Affairs, Permanent Subcommittee on Investigations.”

Who Is Covered Under the Accredited Laboratories Rule?

The LAAF final rule applies to accreditation bodies (ABs) and food testing laboratories that wish to participate in the program. Their participation is voluntary for eligible entities. In certain circumstances, owners and consignees will be required to use LAAF-accredited laboratories to conduct food testing.

ISO 17025 is the international standard typically used to accredit laboratories and is a prerequisite of the FDA LAAF program, as is participation in a proficiency testing program for each analysis in the scope of accreditation requested. However, they are not equivalent, so it is important to understand the distinction between the two. Many labs are already accredited to ISO 17025, and that will certainly give them a head start in preparation for LAAF accreditation. However, FDA has not done an equivalency comparison, and will only recognize the LAAF accreditation for testing in the situations described in the final rule.