Rule2024-12027
Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation
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Published
June 3, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 107 (Monday, June 3, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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;
<a href="/cdn-cgi/l/email-protection#75260114161c105b3d14181814161e351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="67341306040e02492f060a0a06040c27010306490f0f1449000811">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
In the Federal Register of December 3, 2021 (86 FR 68728), we
issued the LAAF final rule (<a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf</a>), 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 (<a href="https://datadashboard.fda.gov/ora/fd/laaf.htm">https://datadashboard.fda.gov/ora/fd/laaf.htm</a>), 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 (<a href="https://fda.gov/food/cfsan-constituent-updates/fda-releases-public-registry-recognized-accreditation-bodies-under-laboratory-accreditation-analyses">https://fda.gov/food/cfsan-constituent-updates/fda-releases-public-registry-recognized-accreditation-bodies-under-laboratory-accreditation-analyses</a>). 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 (<a href="https://datadashboard.fda.gov/ora/fd/laaf.htm">https://datadashboard.fda.gov/ora/fd/laaf.htm</a>).
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
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