[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78103-78105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27707]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0918; FRL-10490-01-OCSPP]


Cumulative Risk Assessment; Science Advisory Committee on 
Chemicals (SACC); Request for Nominations of ad hoc Expert Reviewers 
and Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is 
seeking public nominations of scientific and technical experts that EPA 
can consider for service as ad hoc reviewers assisting the Science 
Advisory Committee on Chemicals (SACC) with the peer review of two 
draft documents entitled: ``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 two draft documents will be submitted to 
the SACC and released for public review and comment in late February 
2023. EPA is also announcing the scheduling of a 4-day virtual public 
meeting for the SACC to consider and review the two draft documents.

DATES: The following is a chronological listing of the dates for the 
specific activities that are described in more detail under 
SUPPLEMENTARY INFORMATION.
    January 20, 2023--Deadline for submitting all nominations to EPA.
    April 24, 2023--Deadline for submitting a request for special 
accommodations to allow EPA time to process the request before the 
meeting.
    May 8 to 11, 2023, from 10:00 a.m. to approximately 5:30 p.m. 
(ET)--The public virtual meeting will be held via a webcast platform 
such as ``Zoom.gov'' and audio teleconference, and you must register to 
receive the links.

ADDRESSES: 
    Nominations: Submit your nominations to the Designated Federal 
Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
    Special accommodations: For information on meeting access or 
services for individuals with disabilities, and to request 
accommodation for a disability, please contact the DFO listed under FOR 
FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Contact the DFO, Dr. Alaa Kamel, 
Mission Support Division, Office of Program Support, Office of Chemical 
Safety and Pollution Prevention, Environmental Protection Agency; 
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. What action is the Agency taking?

    The Agency is seeking public nominations of scientific and 
technical experts that EPA can consider for service as ad hoc reviewers 
assisting the Science Advisory Committee on Chemicals (SACC) with the 
peer review of two draft documents entitled: ``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 is also 
announcing the scheduling of a 4-day virtual public meeting for the 
SACC to consider and review the two draft documents. EPA will be 
soliciting comments from the SACC on the two draft documents 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.
    This document provides instructions for submitting nominations for 
ad hoc reviewers, requesting special accommodations for the virtual 
public meeting, and accessing the materials provided to the SACC. EPA 
will publish a separate document in the Federal Register in late 
February 2023 to announce the availability of and solicit public 
comment on the two draft documents, and instructions for submitting 
comments, and registering to provide oral comments.

B. 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) section 26(o), 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. appendix 2 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.

[[Page 78104]]

C. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those involved in the manufacture, 
processing, distribution, and disposal of chemical substances and 
mixtures, and/or those interested in the assessment of risks involving 
chemical substances and mixtures regulated under TSCA. Since other 
entities may also be interested, the Agency has not attempted to 
describe all the specific entities that may be affected by this action.

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

    1. Submitting CBI. Do not submit CBI or other sensitive information 
to EPA through https://www.regulations.gov or email. If your nomination 
contains any information that you consider to be CBI or otherwise 
protected, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT to obtain special instructions before submitting that 
information. For inclusion in the public docket, please submit a copy 
of the nomination that does not contain the information you consider to 
be CBI or otherwise protected.
    2. Tips for preparing comments. When preparing and submitting your 
comments, see Tips for Effective Comments at https://www.epa.gov/dockets.

II. Nominations for ad hoc Reviewers

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 comprised of experts in 
toxicology; environmental risk assessment; exposure assessment; and 
related sciences (e.g., synthetic biology, pharmacology, biotechnology, 
nanotechnology, biochemistry, biostatistics, physiologically based 
pharmacokinetic modelling (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 reviewers with 
specific expertise in the topics under consideration.

B. Why is EPA seeking nominations for ad hoc reviewers?

    As part of a broader process for developing a pool of candidates 
for SACC peer reviews, EPA is asking the public and stakeholder 
communities for nominations of scientific and technical experts that 
EPA can consider as prospective candidates for service as ad hoc 
reviewers assisting the SACC with the peer reviews. Any interested 
person or organization may nominate qualified individuals for 
consideration as prospective candidates for this review by following 
the instructions provided in this document. Individuals may also self-
nominate.
    Those who are selected from the pool of prospective candidates will 
be invited to attend the public meeting and to participate in the 
discussion of key issues and assumptions at the meeting. In addition, 
they will be asked to review and to help finalize the meeting minutes.

C. What expertise is sought for this peer review?

    Individuals nominated for this SACC peer review, should have 
expertise in one or more of the following areas: Chemical mixtures risk 
assessment (especially with experience using dose additive component-
based mixtures approaches, including relative potency factors); mode of 
action (MOA); phthalate toxicology; male reproductive toxicology; 
exposure assessment (occupational, consumer, and general population 
exposure); biomonitoring data; and biostatistics. Nominees should be 
scientists who have sufficient professional qualifications, including 
training and experience, to be capable of providing expert comments on 
the scientific issues for this review.

D. How do I make a nomination?

    By the deadline indicated under DATES, submit your nomination to 
the DFO listed under FOR FURTHER INFORMATION CONTACT. Each nomination 
should include the following information: Contact information for the 
person making the nomination; name, affiliation, and contact 
information for the nominee; and the disciplinary and specific areas of 
expertise of the nominee.

E. Will ad hoc reviewers be subjected to an ethics review?

    SACC members and ad hoc reviewers are subject to the provisions of 
the Standards of Ethical Conduct for Employees of the Executive Branch 
at 5 CFR part 2635, conflict of interest statutes in title 18 of the 
United States Code and related regulations. In anticipation of this 
requirement, prospective candidates for service on the SACC will be 
asked to submit confidential financial information which shall fully 
disclose, among other financial interests, the candidate's employment, 
stocks and bonds, and where applicable, sources of research support. 
EPA will evaluate the candidates' financial disclosure forms to assess 
whether there are financial conflicts of interest, appearance of a loss 
of impartiality, or any prior involvement with the development of the 
documents under consideration (including previous scientific peer 
review) before the candidate is considered further for service on the 
SACC.

F. How will EPA select the ad hoc reviewers?

    The selection of scientists to serve as ad hoc reviewers for the 
SACC is based on the function of the Committee and the expertise needed 
to address the Agency's charge to the Committee. No interested 
scientists shall be ineligible to serve by reason of their membership 
on any other advisory committee to a federal department or agency or 
their employment by a federal department or agency, except EPA. Other 
factors considered during the selection process include availability of 
the prospective candidate to fully participate in the Committee's 
reviews, absence of any conflicts of interest or appearance of loss of 
impartiality, independence with respect to the matters under review, 
and lack of bias. Although financial conflicts of interest, the 
appearance of loss of impartiality, lack of independence, and bias may 
result in non-selection, the absence of such concerns does not assure 
that a candidate will be selected to serve on the SACC.
    Numerous qualified candidates are often identified for SACC 
reviews. Therefore, selection decisions involve carefully weighing a 
number of factors including the candidates' areas of expertise and 
professional qualifications and achieving an overall balance of 
different scientific perspectives across reviewers. The Agency will 
consider all nominations of prospective candidates for service as ad 
hoc reviewers for the SACC that are received on or before the date 
listed in the DATES section of this document. However, final selection 
of ad hoc reviewers is a discretionary function of the Agency. At this 
time, EPA anticipates selecting approximately 8-12 ad hoc reviewers to 
assist the SACC in their review of the designated topic.
    EPA plans to make a list of candidates under consideration as 
prospective ad hoc reviewers for this review available for public 
comment by mid to late February 2023. The list will be available in the 
docket at http://www.regulations.gov (docket ID number EPA-HQ-OPPT-
2022-0918) and on the

[[Page 78105]]

SACC website. 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.

III. Virtual Public Meeting of the SACC

A. What is the purpose of this public meeting?

    The focus of the 4-day virtual public meeting is the SACC peer 
review of the following two draft documents:
     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 be soliciting comments from the SACC on issues related to 
chemical grouping for purposes of Cumulative Risk Assessment (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. In 
addition, EPA intends to publish a separate document in the Federal 
Register to announce the availability of and solicit public comment on 
the two draft documents, at which time EPA will provide instructions 
for submitting comments and registering to provide oral comments at the 
meeting. EPA also intends to 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. Why did EPA develop these documents?

    Between 2020 and 2022 EPA published final scoping documents for 
twenty 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.
    1. Proposed principles of CRAs under TSCA. EPA's document entitled 
``Draft Proposed Principles of Cumulative Risk Assessment Under the 
Toxic Substances Control Act'' will describe 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 is not intended to be a framework nor a guidance 
document on conducting CRAs of chemical substances under TSCA, and it 
will not address cumulative impacts.
    2. Proposed approach for a CRA of phthalates under TSCA. 
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 
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'' (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'' will describe 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 will follow many of the recommendations made by the 
NRC in 2008. This draft document is not a CRA, and no risk estimates 
are presented. Instead, this draft document will outline several 
options EPA is considering for conducting a phthalate CRA under TSCA.

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

    EPA is planning to release the two draft documents mentioned above 
and all background documents, related supporting materials, and draft 
charge questions provided to the SACC by late February 2023. At that 
time, EPA will publish a separate document in the Federal Register to 
announce the availability of and solicit public comment on the two 
draft documents and provide instructions for submitting comments and 
registering to provide oral comments. These materials will also be 
available in the docket through https://www.regulations.gov (docket ID 
number EPA-HQ-OPPT-2022-0918) and the SACC website. In addition, as 
additional background materials become available and are provided to 
the SACC, EPA will include those additional background documents (e.g., 
SACC members and consultants participating in this meeting and the 
meeting agenda) in the docket and on the SACC website.

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

    The public virtual 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 February. You may 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.
    Authority: 15 U.S.C. 2625(o); 5 U.S.C. appendix 2 et. seq.

    Dated: December 16, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-27707 Filed 12-20-22; 8:45 am]
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