Notice2022-04039
Toxic Substances Control Act (TSCA) Collaborative Research Program To Support New Chemical Reviews; Notice of Public Meeting and Request for Comments
Primary source
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Published
February 25, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is holding a virtual public meeting to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. This virtual meeting will be held over 2 half days. In addition, EPA is announcing the availability of and soliciting public comment on the draft document entitled "Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA." The Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. This effort will be performed in partnership with the Agency's Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. The results of the effort are expected to bring innovative science to new chemical reviews, modernize the approaches used, and increase the transparency of the information underpinning the human health and ecological risk assessment process.
Full Text
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<title>Federal Register, Volume 87 Issue 38 (Friday, February 25, 2022)</title>
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[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Pages 10784-10786]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04039]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0218; FRL-9593-01-OCSPP]
Toxic Substances Control Act (TSCA) Collaborative Research
Program To Support New Chemical Reviews; Notice of Public Meeting and
Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is holding a virtual
public meeting to seek individual input on the proposed Toxic
Substances Control Act (TSCA) New Chemicals Collaborative Research
Program. This virtual meeting will be held over 2 half days. In
addition, EPA is announcing the availability of and soliciting public
comment on the draft document entitled ``Modernizing the Process and
Bringing Innovative Science to Evaluate New Chemicals Under TSCA.'' The
Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing
to develop and implement a multi-year collaborative research program
focused on approaches for performing risk assessments on new chemical
substances under TSCA. This effort will be performed in partnership
with the Agency's Office of Research and Development (ORD) and other
federal entities to leverage their expertise and resources. The results
of the effort are expected to bring innovative science to new chemical
reviews, modernize the approaches used, and increase the transparency
of the information underpinning the human health and ecological risk
assessment process.
DATES:
Virtual Public Meeting: Will be held virtually on April 20 and 21,
2022, from 1:00 p.m. to approximately 5:00 p.m. (EDT) each day. See the
additional details and instructions for registration that appear in
Unit III.
Written Comments: Submit your written comments on or before April
26, 2022. As described in Unit III., you may also register to make oral
comments during the virtual public meeting.
Special accommodations: Requests for special accommodations should
be submitted on or before April 6th, 2022, to allow EPA time to process
these requests.
ADDRESSES:
Virtual Public Meeting: You must register online to receive the
webcast meeting link and audio teleconference information. Please
follow the registration instructions that will be announced on the New
Chemicals Collaborative Research Program website available at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative</a> by March 14, 2022. For additional
instructions related to this meeting, see Unit III.
Written Comments: Submit written comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2022-0218, through the Federal
eRulemaking Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online
instructions for submitting comments. Do not electronically submit any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Copyrighted material will not be posted without explicit permission of
the copyright holder. Members of the public should also be aware that
their personal contact information, if included in any written
comments, may be posted on the internet at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Additional information on commenting or visiting the docket, along with
more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
[[Page 10785]]
Due to public health concerns related to COVID-19, the EPA Docket
Center and Reading Room are open to the public by appointment only. For
further information on the EPA Docket Center (EPA/DC) services, docket
contact information and the current status of the EPA/DC and Reading
Room, please visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact Sarah Swenson, listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Sarah Swenson, Office of Chemical
Safety and Pollution Prevention (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 566-0279; email address: <a href="/cdn-cgi/l/email-protection#d6a5a1b3b8a5b9b8f8a5b7a4b7be96b3a6b7f8b1b9a0"><span class="__cf_email__" data-cfemail="8af9fdefe4f9e5e4a4f9ebf8ebe2caeffaeba4ede5fc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This notice is directed to the public in general. This notice may
be of specific interest to persons who are or may be interested in risk
assessments of new chemical substances under TSCA (e.g., submitters of
TSCA 5 notices, industry, non-governmental organizations (NGOs), and
academia). Since other entities may also be interested in this notice,
the EPA has not attempted to describe all the specific entities that
may be interested in this subject.
B. Where can I access information about this meeting?
Information about this meeting is available in the docket for this
meeting, identified by docket ID number EPA-HQ-OPPT-2022-0218, at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
C. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the
individual listed under FOR FURTHER INFORMATION CONTACT to obtain
special instructions before submitting your comments.
2. Tips for preparing your comments. When preparing and submitting
your comments, see Tips for Effective Comments at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background
A. What is the proposed TSCA New Chemicals Collaborative Research
Program?
OCSPP is proposing to develop and implement a multi-year
collaborative research program focused on approaches for performing
risk assessments on new chemical substances under TSCA. This effort
will be performed in partnership with ORD and other federal entities to
leverage their expertise and resources. The results of the effort are
expected to bring innovative science to new chemical reviews, modernize
the approaches used, and increase the transparency of the human health
and ecological risk assessment process.
This research program will refine existing approaches and develop
and implement new approach methodologies (NAMs) to ensure the best
available science is used in TSCA new chemical evaluations. Key areas
proposed in the TSCA New Chemicals Collaborative Research Program
include:
<bullet> Updating OCSPP's approach to using data from structurally-
similar chemicals to determine potential risks from new chemicals, also
known as read-across. This will increase the efficiency of new chemical
reviews promoting the use of the best available data to protect human
health and the environment.
<bullet> Digitizing and consolidating information on chemicals to
include data and studies that currently only exist in hard copy or in
various disparate TSCA databases. The information will be combined with
publicly available sources to expand the amount of information
available, enhancing chemical reviews and enabling efficient sharing of
chemical information across EPA. Safeguards for confidential business
information will be maintained as appropriate in this process.
<bullet> Updating and augmenting the models used for predicting a
chemical's physical-chemical properties and environmental fate/
transport, hazard, exposure, and toxicokinetics, to provide a suite of
models to be used for new chemicals assessments. The goal of this
effort is to update the models to reflect the best available science,
increase transparency, and establish a process for updating these
models as science evolves.
<bullet> Exploring ways to integrate and apply NAMs in new
chemicals assessments, reducing the use of animal testing. As this
effort evolves, the goal is to develop a suite of accepted, fit-for-
purpose NAMs that could be used by external stakeholders for data
submissions under TSCA as well as informing and expanding new chemical
categories.
<bullet> Developing a decision support tool that integrates the
various information streams specifically used for new chemical risk
assessments. The decision support tool will more efficiently integrate
all the data streams (e.g., chemistry, fate, exposures, hazards) into a
final risk assessment and transparently document the decisions and
assumptions made. Simply put, this will facilitate the new chemicals
program tracking decisions over time and evaluating consistency within
and across chemistries.
Additional information on each of these key areas will be provided
in draft collaborative research plan that will be available in the
docket in by March 14, 2022.
B. How is EPA seeking public comments?
EPA is seeking public comments through several planned activities
including:
<bullet> Through this Federal Register Notice, EPA is announcing it
intends to have a virtual public meeting on April 20 and 21, 2022, to
seek individual input from the public on the proposed TSCA New
Chemicals Collaborative Research Program. The agenda and instructions
for registration for this meeting will be added to the EPA website and
public docket March 14, 2022.
<bullet> At the same time, EPA will launch the website for this
collaborative research program. EPA intends to make the collaborative
research program document and charge questions available during the
week of March 14, 2022 and will issue a listserv to alert the public
when these documents become available. The date the documents are added
to the docket will start the official 60 days public comment period.
<bullet> Following the virtual public meeting, EPA intends to
update the draft collaborative research program document as
appropriate, and will place the document in the relevant docket, ID
number EPA-HQ-OPPT-2022-0218.
<bullet> Later in 2022, the Agency is planning to engage the EPA's
Board of Scientific Counselors (BOSC), a federal advisory committee,
for peer review; EPA also intends to issue a Federal Register Notice
announcing the BOSC meeting and open a docket for public comments.
<bullet> EPA intends to solicit public comment at various points in
the development and implementation of the collaborative research
program, and
[[Page 10786]]
<bullet> Conduct additional outreach to external stakeholders
through a variety of mechanisms as appropriate, to receive input and
enhance transparency.
C. How can I access the documents?
EPA's background documents and the related supporting materials to
the draft are available in the docket established for this meeting at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>; docket ID number EPA-HQ-OPPT-2022-0218. In
addition, EPA will provide additional background documents as the
materials become available. You may obtain electronic copies of these
documents, and certain other related documents that might be available,
in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
After the virtual public meeting, the EPA will prepare meeting
minutes summarizing the individual comments received at the meeting.
The meeting minutes will be posted on the EPA website and in the
relevant docket.
III. Public Participation Instructions
To participate in the virtual public meeting, please follow the
instructions in this unit.
A. How can I provide comments?
To ensure proper receipt of comments it is imperative that you
identify docket ID number EPA-HQ-OPPT-2022-0218 in the subject line on
the first page of your request.
1. Written comments. The Agency encourages written comments for the
virtual public meeting. Comments should be submitted using the
instructions in ADDRESSES and Unit I.B. and C, on or before the date
set in the DATES section. Anyone submitting written comments after this
date should contact the individual listed under FOR FURTHER INFORMATION
CONTACT. If you submit comments after the date set in the DATES
section, those comments will be provided to the SACC members.
2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments during the virtual public meeting
to please follow the registration instructions that will be announced
on the EPA website available at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative</a> by March 14, 2022.
Oral comments during the virtual public meeting are limited to 5
minutes unless arrangements have been made prior to the date set in the
DATES section. In addition, each speaker should email a copy of his/her
comments to the individual listed under FOR FURTHER INFORMATION CONTACT
March 28, 2022 prior to the meeting.
B. How can I participate in the virtual public meeting?
This meeting is virtual and viewed via webcast. For information on
how to first register and then view the webcast, please refer to the
EPA website available at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative</a>.
EPA intends to announce registration instructions on the EPA website by
March 14, 2022.
Authority: 15 U.S.C. 2601 et seq.
Michal Freedhoff,
Assistant Administrator, Office of Chemicals Safety and Pollution
Prevention.
[FR Doc. 2022-04039 Filed 2-24-22; 8:45 am]
BILLING CODE 6560-50-P
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