Notice2022-27707
Cumulative Risk Assessment; Science Advisory Committee on Chemicals (SACC); Request for Nominations of ad hoc Expert Reviewers and Notice of Public Meeting
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Published
December 21, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 244 (Wednesday, December 21, 2022)</title>
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[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78103-78105]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 ``<a href="http://Zoom.gov">Zoom.gov</a>'' 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: <a href="/cdn-cgi/l/email-protection#6c070d010900420d000d0d2c091c0d420b031a"><span class="__cf_email__" data-cfemail="6f040e020a03410e030e0e2f0a1f0e41080019">[email protected]</span></a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> (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: <a href="https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101</a>.
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:
<bullet> Draft Proposed Principles of Cumulative Risk Assessment
Under the Toxic Substances Control Act; and
<bullet> 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'' (<a href="https://cfpub.epa.gov/si/si_public_record_report.cfm?Lab=NCEA&dirEntryId=202508">https://cfpub.epa.gov/si/si_public_record_report.cfm?Lab=NCEA&dirEntryId=202508</a>). 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> (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 ``<a href="http://Zoom.gov">Zoom.gov</a>'' 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:
<a href="https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101</a>.
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]
BILLING CODE 6560-50-P
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