Hearings, Meetings, Proceedings, etc.: Development of an Enhanced Systematic Process for the Post-Market Assessment of Chemicals in Food

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

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.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.

• 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:

• 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.

• 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• 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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov 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.

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.

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:

• Principles for the post-market assessment process,
• Steps in the post-market assessment process,
• Prioritizing chemicals for post-market assessment, and
• 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 https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food 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 https://www.regulations.gov. 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 https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food.

For more meeting specifics, please see https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food. FDA will post an agenda and other meeting materials on this web page in advance of the meeting.

[FR Doc. 2024-17791 Filed 8-9-24; 8:45 am]

BILLING CODE 4164-01-P