[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 56712]]

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

[[Page 56713]]

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
----------------------------------------------------------------------------------------------------------------
             Activity                        Date              Electronic address          Other information
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

    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


