[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12354-12356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03974]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0918; FRL-10490-02-OCSPP]


Cumulative Risk Assessment; Science Advisory Committee on 
Chemicals (SACC) Virtual Public Meeting; Notice of Availability and 
Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting public comment on two draft documents 
that are being submitted to the Science Advisory Committee on Chemicals 
(SACC) for peer review: ``Draft Proposed Principles of Cumulative Risk 
Assessment under the Toxic Substances Control Act'' and ``Draft 
Proposed Approach for Cumulative Risk Assessment of High-Priority 
Phthalates and a Manufacturer-Requested Phthalate under the Toxic 
Substance Control Act.'' The SACC will consider and review these 
documents at a 4-day virtual public meeting on May 8 to 11, 2023, that 
was previously announced in the Federal Register of December 21, 2022.

DATES: The following is a chronological listing of the dates for the 
specific activities that are described in more detail under 
SUPPLEMENTARY INFORMATION.
    April 24, 2023--Deadline for submitting a request for special 
accommodations for participating in the virtual public meeting in order 
to allow EPA time to process the request before the meeting.
    April 28, 2023--Deadline for providing comments for distribution to 
the SACC before the meeting.
    May 1, 2023--Deadline for registering to be listed on the meeting 
agenda to make oral comments during the virtual meeting. Those not 
making oral comments may continue to register through May 11, 2023 in 
order to receive the links to observe the meeting.

ADDRESSES: Submit written comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2022-0918, through the Federal eRulemaking 
Portal

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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 from the 
copyright holder. Members of the public should also be aware that 
personal information 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.
    For information on how to register and access the virtual public 
meeting, please refer to the SACC website at https://www.epa.gov/tsca-peer-review. EPA intends to announce registration instructions on the 
SACC website by early April 2023. You may also subscribe to the 
following listserv for alerts regarding this and other SACC-related 
activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.
    For information on special accommodations, meeting access or 
services for individuals with disabilities, and to request 
accommodation for a disability, please contact the Designated Federal 
Officer (DFO) listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Contact the DFO, Dr. Alaa Kamel, 
Mission Support Division (7602M), Office of Program Support, Office of 
Chemical Safety and Pollution Prevention, EPA, telephone number: (202) 
564-5336 or call the SACC main office at (202) 564-8450; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general.

B. What action is the Agency taking?

    EPA is announcing the availability of and soliciting public comment 
on the following two draft documents that are being submitted to the 
Science Advisory Committee on Chemicals (SACC) for peer review: ``Draft 
Proposed Principles of Cumulative Risk Assessment under the Toxic 
Substances Control Act'' and ``Draft Proposed Approach for Cumulative 
Risk Assessment of High-Priority Phthalates and a Manufacturer-
Requested Phthalate under the Toxic Substance Control Act.'' The SACC 
will consider and review these documents at a 4-day virtual public 
meeting on May 8 to 11, 2023, which was previously announced in the 
Federal Register of December 21, 2022 (87 FR 78103 (FRL-10490-01-
OCSPP)).
    This document provides instructions for accessing the materials 
provided to the SACC, submitting comments, and registering to provide 
oral comments at the meeting.

C. What is the Agency's authority for taking this action?

    The SACC was established by EPA in 2016 in accordance with the 
Toxic Substances Control Act (TSCA), 15 U.S.C. 2625(o), as amended by 
the Frank R. Lautenberg Chemical Safety for the 21st Century Act, 
Public Law 114-182, June 22, 2016, to provide independent advice and 
expert consultation, at the request of the Administrator, with respect 
to the scientific and technical aspects of issues relating to the 
implementation of TSCA. The SACC operates in accordance with the 
Federal Advisory Committee Act (FACA), 5 U.S.C. 10 et seq., and 
supports activities under the TSCA, 15 U.S.C. 2601 et seq., the 
Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other 
applicable statutes.

D. What should I consider as I submit my comments to EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email (contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT for instructions). Clearly mark the part or all of 
the information that you claim to be CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing comments. When preparing and submitting your 
comments, see Tips for Effective Comments at https://www.epa.gov/dockets.

II. Background

A. What is the purpose of the SACC?

    The SACC provides independent scientific advice and recommendations 
to the EPA on the scientific and technical aspects of risk assessments, 
methodologies, and pollution prevention measures and approaches for 
chemicals regulated under TSCA. The SACC is composed of experts in 
toxicology; environmental risk assessment; exposure assessment; and 
related sciences (e.g., synthetic biology, pharmacology, biotechnology, 
nanotechnology, biochemistry, biostatistics, physiologically based 
pharmacokinetic modeling (PBPK), computational toxicology, 
epidemiology, environmental fate, and environmental engineering and 
sustainability). The SACC currently consists of 17 members. When 
needed, the committee will be assisted by ad hoc peer reviewers with 
specific expertise in the topics under consideration.

B. Why did EPA develop these documents?

    Between 2020 and 2022, EPA published final scoping documents for 20 
High-Priority and three Manufacturer-Requested chemical substances for 
risk evaluation under TSCA. During the scoping process, EPA received 
comments from stakeholders urging the Agency to consider evaluating 
several chemical substances undergoing risk evaluation for cumulative 
risk to human health. TSCA does not explicitly require EPA to conduct 
cumulative risk assessments (CRAs). However, TSCA does require EPA to 
consider the reasonably available information and to use the best 
available science and to make decisions based on the weight of 
scientific evidence [15 U.S.C. 2625(h), (i), (k)]. EPA recognizes that 
for some chemical substances, the best available science may indicate 
that the development of a CRA is appropriate to ensure that any risks 
to human health and the environment are adequately characterized.
    EPA's document entitled ``Draft Proposed Principles of Cumulative 
Risk Assessment under the Toxic Substances Control Act'' describes the 
fundamental principles of CRA of chemical substances and how they may 
be applied within the regulatory requirements of TSCA to ensure TSCA 
risk evaluations are based on the best available science and are 
protective of human health. This draft document, a copy of which is 
being submitted to the SACC for review and is available in the docket 
for public review, is not a framework nor a guidance document on 
conducting CRAs of chemical substances, and it does not address 
cumulative impacts.
    Recognizing that human exposure to phthalates is widespread and 
that multiple phthalates can disrupt development of the male 
reproductive system in laboratory animals at potentially human relevant 
doses, EPA

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asked the National Research Council (NRC) of the National Academies of 
Science to review the health effects of phthalates and determine 
whether a cumulative risk assessment of phthalates should be conducted, 
and if so, what approaches could be used for the assessment. In 2008, 
NRC published their findings to EPA in a final report entitled 
``Phthalates and Cumulative Risk Assessment: The Task Ahead'' (a copy 
can be accessed at https://cfpub.epa.gov/si/si_public_record_report.cfm?Lab=NCEA&dirEntryId=202508. In that report, 
the NRC recommended that a cumulative risk assessment should be 
conducted for phthalates. EPA's document entitled ``Draft Proposed 
Approach for Cumulative Risk Assessment of High-Priority Phthalates and 
a Manufacturer-Requested Phthalate under the Toxic Substance Control 
Act'' describes EPA's proposed approach for evaluating a subset of 
High-Priority and Manufacturer-Requested phthalates for cumulative risk 
to human health under TSCA based on the principles of CRA described in 
EPA's draft principles document referenced previously. EPA's draft 
proposed approach follows many of the recommendations made by the NRC 
in 2008. This draft document, a copy of which is being submitted to the 
SACC for review and is available in the docket for public review, is 
not a CRA, and no risk estimates are presented. Instead, this draft 
document outlines several options EPA is considering for conducting a 
phthalate CRA under TSCA.
    In submitting these two draft documents to the SACC for peer 
review, EPA is soliciting comments from the SACC on issues related to 
chemical grouping for purposes of CRA, health outcomes related to 
phthalate syndrome, and possible approaches to developing the 
cumulative hazard and exposure assessment for High-Priority phthalates 
and a Manufacturer-Requested phthalate.

III. Virtual Public Meeting

A. What is the purpose of this public meeting of the SACC?

    The focus of the 4-day virtual public meeting is the SACC peer 
review of the following two draft documents and related public comments 
received by the deadlines listed under the DATES section:
     Draft Proposed Principles of Cumulative Risk Assessment 
under the Toxic Substances Control Act; and
     Draft Proposed Approach for Cumulative Risk Assessment of 
High-Priority Phthalates and a Manufacturer-Requested Phthalate under 
the Toxic Substance Control Act.
    EPA will provide a meeting agenda for each day of the meeting, and, 
as needed, may provide updated times for each day in the meeting agenda 
that will be posted in docket and on the SACC website.

B. How can I access the documents submitted for review to the SACC?

    These documents, including background documents, related supporting 
materials, and draft charge questions provided to the SACC, are 
available in the docket. As additional background materials become 
available and are provided to the SACC, EPA will include those 
additional background documents in the docket. All of these documents 
will be available through https://www.regulations.gov in Docket ID No. 
EPA-HQ-OPPT-2022-0918 and links on the SACC website at https://www.epa.gov/tsca-peer-review.
    After the public meeting, the SACC will prepare a meeting minutes 
and final report document summarizing its recommendations to the EPA. 
This document will also be added to the docket and available through 
the SACC website.

C. How can I provide comments for the SACC's consideration?

    To ensure proper receipt of comments by EPA, it is imperative that 
you identify Docket ID No. EPA-HQ-OPPT-2022-0918 in the subject line on 
the first page of your comments and follow the instructions in this 
unit.
    1. Written comments. Written comments must be submitted by the 
deadlines set in the DATES section and following the instructions in 
this document.
    2. Oral comments. Each individual or group wishing to make brief 
oral comments to the SACC during the peer review virtual public meeting 
must register to do so by the deadline set in the DATES section and 
following the registration instructions that will be announced on the 
SACC website by early April 2023. Oral comments will be limited to 5 
minutes. In addition, each speaker should submit a copy of their 
comments to the DFO prior to the meeting for distribution to the SACC 
by the DFO and inclusion in the docket.

D. How can I participate in the virtual public meeting?

    The virtual public meeting will be held via a webcast platform such 
as ``Zoom.gov'' and audio teleconference. 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 SACC website in April.
    Authority: 15 U.S.C. 2625(o); 5 U.S.C 10 et. seq.

    Dated: February 22, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2023-03974 Filed 2-24-23; 8:45 am]
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