Notice2024-17791
Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 12, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled "Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food." This public meeting will assist in developing the post-market chemicals assessment program we will establish under the new FDA Human Foods Program. The purpose of the public meeting is to hear from interested parties about approaches to systematic post-market assessment of chemicals in food.
Full Text
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<title>Federal Register, Volume 89 Issue 155 (Monday, August 12, 2024)</title>
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[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65633-65635]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3609]
Development of an Enhanced Systematic Process for the Food and
Drug Administration's Post-Market Assessment of Chemicals in Food;
Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meeting entitled ``Development of an Enhanced
Systematic Process for FDA's Post-Market Assessment of Chemicals in
Food.'' This public meeting will assist in developing the post-market
chemicals assessment program we will establish under the new FDA Human
Foods Program. The purpose of the public meeting is to hear from
interested parties about approaches to systematic post-market
assessment of chemicals in food.
[[Page 65634]]
DATES: The public meeting will be held on September 25, 2024, from
12:30 p.m. to 4:30 p.m. Eastern Time. FDA is establishing a docket for
public comment on this meeting. The docket number is FDA-2024-N-3609.
The docket will close on December 6, 2024. Submit electronic or written
comments on this public meeting by December 6, 2024. See
``Participating in the Public Meeting'' in the SUPPLEMENTARY
INFORMATION section of this document for registration and other
information regarding meeting participation.
ADDRESSES: The public meeting will be held virtually and with limited
in-person attendance on the FDA White Oak campus. For more information
on the public meeting, see <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food">https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food</a>.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before December 6, 2024. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-3609 for ``Development of an Enhanced Systematic Process for
FDA's Post-Market Assessment of Chemicals in Food.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: For general questions about the public
meeting or for special accommodations due to disability: Jessica
Rowden, 240-461-0669, <a href="/cdn-cgi/l/email-protection#286b6e7b6966056b4745455b684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="d99a9f8a9897f49ab6b4b4aa99bfbdb8f7b1b1aaf7beb6af">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA endeavors to become more efficient, nimble, and prepared for
the ever-changing and complex industries we regulate. In May 2024, FDA
announced that we received approval for our reorganization proposal to
create a unified Human Foods Program. These changes will allow us to
more effectively realize the vision laid out in the FDA Food Safety
Modernization Act, elevate the importance of nutrition, strengthen
local, state, and international partnerships, and position FDA to
regulate innovative food and agricultural products more effectively as
we oversee the safety of the nation's food supply. One important goal
of this reorganization is to have a modernized FDA that optimizes
resources to help us meet our public health mission. FDA is planning to
implement the reorganization on October 1, 2024.
As part of this reorganization, we are developing a systematic
process for conducting post-market assessments of chemicals in food.
Such an assessment includes ingredients considered generally recognized
as safe, food additives, color additives, food contact substances, and
contaminants. We are holding a public meeting to discuss this
systematic process with interested parties to hear ideas and
perspectives to inform our thinking and help us further develop a
systematic process. The systematic process is intended to guide our
post-market assessment work in the new Human Foods Program and will
include a transparent process to help ensure post-market assessments
are conducted consistently across chemicals and are prioritized based
on the greatest public health needs, support confidence in the food
supply, and ensure that our food safety efforts continue to reflect the
most current and best available science.
[[Page 65635]]
II. Topics for Discussion at the Public Meeting
The public meeting will address a variety of topics related to
development of an enhanced systematic process for FDA's post-market
assessment of chemicals in food, including:
<bullet> Principles for the post-market assessment process,
<bullet> Steps in the post-market assessment process,
<bullet> Prioritizing chemicals for post-market assessment, and
<bullet> Engaging stakeholders throughout the post-market
assessment process.
III. Participating in the Public Meeting
Registration: This public meeting is a hybrid meeting offering both
online and in-person attendance. Registration is free and open for
virtual attendance. In-person attendance is free, but seating is
limited. Please note that in-person registration will be accepted in
the order of registration. We encourage organizations to consider
attendance numbers to help accommodate as many groups as possible for
in-person attendance. To register to attend the public meeting on the
``Development of an Enhanced Systematic Process for FDA's Post-Market
Assessment of Chemicals in Food,'' please register at <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food">https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food</a> for in-person attendance by
September 20, 2024, and for webcast attendance by September 24, 2024,
at 11:59 p.m. Eastern Time. Registrants will receive confirmation when
they have been accepted and will be provided the webcast link for those
who plan to attend virtually.
Request to Provide Open Public Comment: During online registration,
you may indicate if you wish to make open public comments during the
public meeting and which topic(s) you would like to address. All
requests to make public comments must be received by September 3, 2024,
at 11:59 p.m. Eastern Time. We will do our best to accommodate requests
to make public comments. We are seeking to have a broad representation
of ideas and issues presented at the meeting. Individuals and
organizations with common interests are urged to consolidate or
coordinate their comments. We will determine the amount of time for
each public comment and will notify all registrants who requested an
opportunity to make an open public comment.
Streaming Webcast of the Public Meeting: This public meeting will
be broadcast via Zoom.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
meeting website page at <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food">https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food</a>.
For more meeting specifics, please see <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food">https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food</a>. FDA will post an agenda and other meeting
materials on this web page in advance of the meeting.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17791 Filed 8-9-24; 8:45 am]
BILLING CODE 4164-01-P
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