[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Rules and Regulations]
[Pages 47463-47464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2019-N-3325]


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.

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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; 
[email protected].

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 (Sec. Sec.  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 
(Sec.  1.1102). At Sec.  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 (Sec.  1.1107(a)(4)); and to support 
removal from an import alert through successful consecutive testing 
(Sec.  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 Sec.  1.1152(b). FDA maintains on its website the LAAF 
Dashboard (https://datadashboard.fda.gov/ora/fd/laaf.htm), which 
identifies recognized

[[Page 47464]]

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 Sec.  1.1107(a).
    FDA has determined that the LAAF program has attained sufficient 
laboratory capacity for the food testing described in Sec.  
1.1107(a)(4) and (5) for the analyte group of mycotoxins and its 
specific analytes, including aflatoxin. In Sec.  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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  
1.1107(a)(1) through (3).

    Dated: May 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12027 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P