[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56711-56713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0966]
Closer to Zero Action Plan: Impacts of Toxic Element Exposure and
Nutrition at Different Crucial Developmental Stages; 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 virtual public meeting entitled ``Closer to Zero Action Plan:
Impacts of Toxic Element Exposure and Nutrition at Different Crucial
Developmental Stages.'' The purpose of the public meeting is to discuss
the scope of the Closer to Zero action plan as it relates to the
impacts of toxic element exposure and nutrition at different crucial
developmental stages, including discussion of the key nutrients in food
for growth and development, foods commonly consumed by babies and young
children, and exposure risks of toxic elements.
DATES: The public meeting will be held on November 18, 2021, from 10
a.m. to 4 p.m. Eastern Time. FDA is
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establishing a docket for public comment on this meeting. The docket
number is FDA-2021-N-0966. The docket will close on December 20, 2021.
Submit electronic or written comments on this public meeting by
December 20, 2021. See ``Participating in the Public Meeting'' in the
SUPPLEMENTARY INFORMATION section of this document for closing dates
for advanced registration and other information regarding meeting
participation.
ADDRESSES: Due to the impact of the COVID-19 pandemic, this meeting
will be held virtually to help protect the public and limit the spread
of the virus.
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 20, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 20, 2021. 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:
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-2021-N-0966 for ``Closer to Zero Action Plan: Impacts of Toxic
Element Exposure and Nutrition at Different Crucial Developmental
Stages.'' 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.
FOR FURTHER INFORMATION CONTACT: For general questions about the public
meeting or for special accommodations due to disability: Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On April 8, 2021, FDA announced the Closer to Zero (C2Z) action
plan (available at: https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods#Introduction) for reducing exposure
to toxic elements from foods for babies and young children (see ``FDA
Releases Action Plan for Reducing Exposure to Toxic Elements from Foods
for Babies, Young Children,'' available at: https://www.fda.gov/news-events/press-announcements/fda-releases-action-plan-reducing-exposure-toxic-elements-foods-babies-young-children). We have prioritized
reducing exposure to toxic elements from foods for babies and young
children because their smaller body sizes and rapid development make
them more vulnerable to the harmful effects of these toxic elements.
Exposure to toxic elements, including arsenic, lead, cadmium, and
mercury, from foods depends on the levels of the elements in the food
and the amount of the food consumed. Nutrient exposures can interact
with the uptake of these elements and the nutrient status of children
can modulate the effects of these elements. The levels of toxic
elements in foods depend on many factors, including:
The levels of these elements in the air, water, and soil
used to grow the crops, which vary depending on factors such as
geographical differences and past or current contamination,
The type of food crop and how much ``uptake'' there is of
specific elements from the environment, and
Industrial, manufacturing, and agricultural processes.
The C2Z action plan sets forth our approach to reducing exposure to
toxic elements in foods commonly eaten by babies and young children to
the lowest possible levels. FDA's goal is to reduce the levels of
arsenic, lead, cadmium, and mercury in these foods to the greatest
extent possible without setting levels that are not currently feasible
and without reducing the availability of nutritious, affordable foods
on which
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many families rely. The C2Z action plan outlines a multi-phase,
science-based iterative approach to achieving our goal of getting
levels of toxic elements in food closer to zero over time.
Closer to Zero includes research and evaluation of changes in
dietary exposures to toxic elements, setting action levels (recommended
limits of toxic elements in foods that can be achieved by industry and
progressively lowered as appropriate), encouraging adoption of best
practices by industry, and monitoring progress.
II. Purpose and Format of the Public Meeting
We are holding our first C2Z action plan meeting to get stakeholder
input regarding the plan's scope. We will discuss foods commonly
consumed by babies and young children, the impacts of toxic element
exposures at different crucial developmental stages, and the
interaction of nutrients and nutrient status as co-exposures to lead,
arsenic, cadmium, and mercury on growth and development.
We will outline the C2Z plan including FDA's four-stage approach
for continual improvement and additional work related to levels of
toxic elements in food. Stakeholder panels will provide perspectives on
the various issues needed to fulfill the C2Z plan. We will provide an
opportunity for questions as well as an opportunity for open public
comment. We expect this meeting to be the first of several regarding
the C2Z action plan.
III. Participating in the Public Meeting
Registration: Registration is free and early registration is
recommended. To register to attend the public meeting on ``Closer to
Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at
Different Crucial Developmental Stages,'' by webcast, please register
at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops by November 12, 2021 at 11:59 p.m. Eastern Time. Registrants
will receive confirmation when they have been accepted and will be
provided the webcast link.
Table 1 provides information on participation in the public
meetings.
Table 1--Information on Participating in the Public Meeting and on Submitting Comments to Closer to Zero Action
Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages for Babies and
Young Children
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Activity Date Electronic address Other information
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Public Meeting.................... November 18, 2021.... Webcast information will Webcast will have closed
be provided prior to the captioning.
meeting.
Advance Registration.............. By November 12, 2021. https://www.fda.gov/news- There is no registration
events/fda-meetings- fee for the public
conferences-and-workshops. meeting. Early
registration is
recommended.
Request to make oral presentation. By November 1, 2021.. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops.
Notice confirming opportunity to By November 4, 2021.. .......................... An FDA representative
make oral presentation. will confirm the
opportunity to make an
oral presentation and
will provide the
approximate time on the
public meeting agenda to
do so.
Submitting either electronic or Submit comments by https:// See ADDRESSES for
written comments. December 20, 2021. www.regulations.gov. addition information on
submitting comments.
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Requests for Oral Presentations: During online registration, you
may indicate if you wish to present oral comments during the public
comment session, and you may indicate which topic(s) you would like to
address. FDA will do its best to accommodate requests to make public
comments. We seek a broad representation of ideas and issues presented
at the meeting.
All requests to make oral presentations must be received by
November 1, 2021, 11:59 p.m. Eastern time. We urge individuals and
organizations with common interests to consolidate or coordinate their
presentations and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each presentation is to begin,
and we will select and notify participants by November 4, 2021.
Typically, presentations are between 3 and 5 minutes. No commercial or
promotional material will be permitted to be presented at the public
meeting. Actual presentation times may vary based on how the meeting
progresses in real time.
An agenda for the public meeting and any other background materials
will be made available at least 5 days before the meeting at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops. Those
without internet or email access can register and/or request to
participate by contacting Juanita Yates (see FOR FURTHER INFORMATION
CONTACT) no later than November 1, 2021.
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 and https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops. You may also view the transcript at the
Dockets Management Staff (see ADDRESSES).
Dated: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22109 Filed 10-8-21; 8:45 am]
BILLING CODE 4164-01-P