[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Notices]
[Pages 10784-10786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative 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 https://www.regulations.gov. 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 https://www.regulations.gov. 
Additional information on commenting or visiting the docket, along with 
more information about dockets generally, is available at https://www.epa.gov/dockets.

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    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 https://www.epa.gov/dockets.
    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: [email protected].

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 
https://www.regulations.gov.

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov 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 https://www.epa.gov/dockets.

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:
     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.
     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.
     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.
     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.
     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:
     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.
     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.
     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.
     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.
     EPA intends to solicit public comment at various points in 
the development and implementation of the collaborative research 
program, and

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     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 
https://www.regulations.gov; 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 https://www.regulations.gov.
    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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-collaborative. 
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


