Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification.

SUMMARY:

The Food and Drug Administration (FDA or we) has determined that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import-related food testing covered by the LAAF regulation for mycotoxins. As sufficient capacity is reached for additional analytes covered under the import-related food testing provisions of the LAAF regulation, those specific analytes and compliance dates will be posted on the LAAF Dashboard. Owners and consignees of imported food subject to the LAAF regulation must use a LAAF-accredited laboratory to conduct covered import-related food testing starting on the applicable compliance date, which is 6 months from the date a specific analyte is listed on a public registry, based on FDA's determination that sufficient laboratory capacity has been achieved for such analyte. FDA has not yet made a capacity determination for the other food testing circumstances covered by the LAAF regulation.

DATES:

Compliance Dates: A LAAF-accredited laboratory must conduct certain import-related food testing covered by the LAAF regulation (21 CFR 1.1107(a)(4), (5)) beginning 6 months from the date a specific analyte is posted on the LAAF Dashboard.

FOR FURTHER INFORMATION CONTACT:

Stacie Hammack, Chemist, Food and Feed Laboratory Operations, Office of Regulatory Affairs, Food and Drug Administration, 60 8th St. NE, Atlanta, GA 30309, 301-796-5817; Stacie.Hammack@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Background

In the Federal Register of December 3, 2021 (86 FR 68728), we issued the LAAF final rule ( https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf ), which establishes the LAAF program for the testing of human and animal food in certain circumstances by accredited laboratories, as required under section 422 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350k). The purpose of the LAAF program is to improve the safety of the U.S. food supply and protect U.S. consumers by helping to 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. Under the LAAF regulation, which is codified at part 1 (21 CFR part 1), subpart R (§§ 1.1101 through 1.1201), FDA has been recognizing, and will continue to recognize, accreditation bodies that then assess laboratories to the standards established in the regulation (referred to as LAAF-accredited laboratories). Participation in the LAAF program is voluntary for accreditation bodies and laboratories.

The LAAF regulation defines food testing and testing of food to mean the analysis of food product samples or environmental samples (§ 1.1102). At § 1.1107(a), the LAAF regulation details five food testing circumstances in which owners and consignees must use a LAAF-accredited laboratory. This document relates to a determination of sufficient laboratory capacity for two of those circumstances related to import testing: in support of admission of an article of food under section 801(a) of the FD&C Act (§ 1.1107(a)(4)); and to support removal from an import alert through successful consecutive testing (§ 1.1107(a)(5)), for specific analyte(s) as listed on the LAAF Dashboard. For example, aflatoxin is a specific analyte within the analyte group of mycotoxins for which we have determined sufficient laboratory capacity has been met for the testing circumstances in this document.

In those testing circumstances covered by the LAAF regulation for which FDA has determined sufficient laboratory capacity has been met, persons with an ownership or consignment interest in the food product or environment that is the subject of the testing (owners and consignees) must use a laboratory that is LAAF-accredited for an analytical method for the appropriate analyte to conduct such testing. LAAF-accredited laboratories must comply with all applicable LAAF requirements, including the submission of results directly to FDA, in accordance with § 1.1152(b). FDA maintains on its website the LAAF Dashboard ( https://datadashboard.fda.gov/ora/fd/laaf.htm ), which identifies recognized accreditation bodies and LAAF-accredited laboratories and includes information on each laboratory's location, scope of LAAF-accreditation, analytes, and methods. The LAAF Dashboard also identifies analyte groups and specific analyte(s) with sufficient laboratory capacity for testing under the LAAF program with compliance dates established 6 months after each such specific analyte is posted on the LAAF Dashboard.

We explained in the LAAF final rule that implementation of the LAAF program will necessarily occur in a stepwise fashion. The first step was recognizing a sufficient number of accreditation bodies; we announced the completion of that step on July 12, 2022 ( https://fda.gov/food/cfsan-constituent-updates/fda-releases-public-registry-recognized-accreditation-bodies-under-laboratory-accreditation-analyses ). Laboratories interested in participating in the LAAF program have since been applying to the recognized accreditation bodies, and those recognized accreditation bodies have been assessing those laboratories and providing them with LAAF-accreditation as appropriate. We explained in the LAAF final rule that when a sufficient number of laboratories became LAAF-accredited, we would publish a document in the Federal Register giving owners and consignees 6 months' notice that they will be required to use a LAAF-accredited laboratory for food testing covered by the LAAF regulation. We stated in the final rule that, given the breadth of analytes, matrices, and methods covered by the LAAF regulation, it may be necessary for us to separately consider whether sufficient laboratory capacity has been attained for the variety of testing circumstances described in § 1.1107(a).

FDA has determined that the LAAF program has attained sufficient laboratory capacity for the food testing described in § 1.1107(a)(4) and (5) for the analyte group of mycotoxins and its specific analytes, including aflatoxin. In § 1.1107(a)(4), the LAAF regulation covers food testing in support of admission of an article of food under section 801(a) of the FD&C Act (21 U.S.C. 381(a)). Section 801(a) of the FD&C Act authorizes FDA to detain food at the border because it is, or appears to be, in violation of the FD&C Act or its implementing regulations. If FDA detains a food product imported or offered for import under section 801(a) of the FD&C Act, but FDA has not yet refused admission, the owner or consignee may introduce testimonial evidence that the food is admissible. Owners and consignees often engage laboratories to test the food and submit to FDA the results of the testing, as testimony to support admission of the food. If FDA determines that the food testing results are valid and that they overcome the appearance of a violation of the FD&C Act, then FDA will release the food from detention and allow it to proceed for entry into the United States. The testing of detained product at the direction of such owners and consignees is covered by the LAAF regulation at § 1.1107(a)(4).

Section 1.1107(a)(5) of the LAAF regulation also relates to detained food offered for import; it states that testing to support removal from an import alert through successful consecutive testing is covered by the LAAF regulation. An import alert informs FDA staff and the public that we have enough evidence to detain, without first physically examining (sampling), products offered for import that appear to violate the FD&C Act. Often, individual import alerts include specific information regarding removal from the import alert. Many current import alerts indicate that it would be helpful for owners or consignees to present to FDA evidence of at least five consecutive shipments to the United States that have been found to not be in violation. Owners and consignees often engage laboratories and submit to FDA the results of the testing as testimony to support removal from import alert; such testing is covered by the LAAF regulation at § 1.1107(a)(5).

Owners and consignees will be required to use a LAAF-accredited laboratory starting 6 months from the date a specific analyte is posted on the LAAF Dashboard. LAAF-accredited laboratories must comply with all applicable LAAF requirements, including the submission of results directly to FDA, in accordance with § 1.1152(b). The LAAF Dashboard includes a table of analyte groups and specific analytes with sufficient capacity and the compliance date for those analyses, in addition to the list of LAAF-accredited laboratories, their location, contact details, and the list of LAAF-accredited analytes and methods. As capacity for additional analytes is reached, those will be added to the LAAF Dashboard with a compliance date of 6 months after posting to the LAAF Dashboard. The LAAF Dashboard may be viewed at ( https://datadashboard.fda.gov/ora/fd/laaf.htm ).

We will continue stepwise implementation of the LAAF program for other food testing circumstances in which owners and consignees are required to use a LAAF-accredited laboratory. FDA has not yet made a capacity determination for the other food testing circumstances covered by the LAAF regulation. We will publish one or more additional notices in the Federal Register when the LAAF program attains sufficient laboratory capacity to support the food testing described in § 1.1107(a)(1) through (3).