[Federal Register Volume 89, Number 232 (Tuesday, December 3, 2024)]
[Notices]
[Pages 95782-95785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28287]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0551; FRL-12418-01-OCSPP]
Benzyl Butyl Phthalate (BBP), Dibutyl Phthalate (DBP), Di(2-
ethylhexyl) Phthalate (DEHP), Diisobutyl Phthalate (DIBP), and
Dicyclohexyl Phthalate (DCHP); Technical Support Documents; Science
Advisory Committee on Chemicals (SACC) Peer Review; Request for
Nominations of Ad Hoc Reviewers
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 the Agency's
technical support documents for benzyl butyl phthalate (BBP), dibutyl
phthalate (DBP), di(2-ethylhexyl) phthalate (DEHP), diisobutyl
phthalate (DIBP), and dicyclohexyl phthalate (DCHP) and the cross-
phthalate technical support documents for human health benchmark dose
(BMD) analysis, cancer analysis, and cumulative risk analysis. To
facilitate nominations, this document provides information about the
SACC, the intended topic for the planned peer review, the expertise
sought for this peer review, instructions for submitting nominations to
EPA, and the Agency's plan for selecting the ad hoc reviewers for this
peer review. EPA is planning to convene a virtual public meeting of the
SACC in the spring of 2025 to review the technical support documents.
DATES: Submit your nominations on or before January 2, 2025.
ADDRESSES: Submit your nominations to [email protected].
FOR FURTHER INFORMATION CONTACT: The Designated Federal Official (DFO)
for the SACC is Dr. Alaa Kamel, Mission Support Division (7602M),
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 SACC with the peer review of the Agency's technical
support documents for the evaluation of the risks from BBP, DBP, DEHP,
DIBP and DCHP to inform risk management decisions under TSCA. EPA is
planning to hold a virtual public meeting in the spring of 2025 for the
SACC to consider and review technical support documents. At that time,
EPA will solicit comments from the SACC on the critical inputs and
novel approaches for a variety of charge questions related to
individual, draft chemical risk evaluations and the draft cumulative
risk analysis.
To facilitate nominations, this document provides information about
the SACC, the intended topic for the planned peer review, the expertise
sought for this peer review, instructions for submitting nominations to
EPA, and the Agency's plan for selecting the ad hoc reviewers for this
peer review.
B. What is the Agency's authority for taking this action?
TSCA section 6(b) requires that EPA conduct risk evaluations on
existing chemical substances and identifies the minimum components EPA
must include in all chemical substance risk evaluations (15 U.S.C.
2605(b)). The risk evaluation must not consider costs or other non-risk
factors (15 U.S.C. 2605(b)(4)(F)(iii)). The specific risk evaluation
process is addressed in 40 CFR part 702 and summarized on EPA's website
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
The SACC was established by EPA in 2016 in accordance with TSCA, 15
U.S.C. 2625(o), to provide independent advice and expert consultation
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, and supports
activities under TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention
Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes.
C. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of particular 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.
Members of at-risk communities, non-
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governmental organizations (NGOs) (particularly those with an interest
in protecting health for at-risk communities), and Federal, State and
local officials may also be interested. Since other entities may also
be interested, the Agency has not attempted to describe all the
specific entities to which this action may apply.
D. How can I stay informed about SACC activities?
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.
II. Background
A. What is the purpose of the SACC?
The SACC provides independent 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 (PBPK) modeling, computational toxicology,
epidemiology, environmental fate, environmental engineering and
sustainability). The SACC currently consists of 20 members. When
needed, the committee will be assisted by ad hoc reviewers with
specific expertise in the topics under consideration.
B. Why is EPA conducting these risk evaluations?
TSCA requires EPA to conduct risk evaluations on high-priority
chemical substances and identifies the minimum components EPA must
include in all chemical substance risk evaluations. The purpose of
conducting risk evaluations is to determine whether a chemical
substance presents an unreasonable risk to human health or the
environment under the Conditions of Use (COUs). These evaluations
include assessing unreasonable risks to relevant potentially exposed or
susceptible subpopulations. As part of this process, EPA: (1)
Integrates hazard and exposure assessments using the best available
science that is reasonably available to assure decisions are based on
the weight of the scientific evidence, and (2) Conducts peer review for
risk evaluation approaches that have not been previously peer reviewed.
For more information about the three stages of EPA's process for
ensuring the safety of existing chemicals (i.e., prioritization, risk
evaluation, and risk management), go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals.
C. Why did EPA develop these documents?
EPA designated the following chemicals as High-Priority Substances
for risk evaluation under TSCA in December 2019: BBP (Butyl Benzyl
Phthalate, CASRN 85-68-7), DBP (Dibutyl Phthalate, CASRN 84-74-2), DEHP
(Di(2-ethylhexyl) Phthalate, CASRN 117-81-7), DIBP (Diisobutyl
Phthalate, CASRN 84-69-5), and DCHP (Dicyclohexyl Phthalate, CASRN 84-
61-7). For these chemicals, EPA published draft and final scope
documents in April and August 2020, respectively and, is currently in
the risk evaluation process. The scope documents outlined the hazards,
exposures, conditions of use, and the potentially exposed or
susceptible subpopulations the Agency expected to consider in its risk
evaluations. Although there are some differences in conditions of use
and exposures, these chemical substances are primarily used as
plasticizers in polyvinyl chloride (PVC) products and in adhesives,
sealants, paints, coatings, rubbers, and other applications. Because of
the significant similarities in exposure and physical chemical
properties of these phthalates, EPA is developing these risk
evaluations and the cumulative risk assessment in parallel. DIDP and
DINP were reviewed previously by the SACC (July 30-August 1, 2024); the
draft risk evaluations for BBP, DBP, DEHP, DIBP and DCHP are
incorporating many of the SACC recommendations from this previous peer
review.
EPA is soliciting comments from the SACC on a variety of charge
questions related to the data, methods, models, approaches for these
draft chemical risk evaluations, including the supporting draft
cumulative risk assessment analysis. Many of the methods and analyses
used in these evaluations are not novel and have been reviewed in the
development of the tools used in various agency work products or in
previous TSCA assessments. EPA is focusing peer review on the critical
inputs and novel approaches.
The draft risk evaluations for BBP, DBP, DEHP, DIBP and DCHP
include analyses of physical chemical properties, fate and transport in
the environment, exposure to workers, consumers and general population
including potentially exposed susceptible subpopulations, releases to
the environment, environmental hazard and risk characterization for
terrestrial and aquatic species, and human health hazard and risk
characterization for workers, consumers, and the general population.
The draft cumulative risk assessment analysis was developed based on
the Proposed Approach for Cumulative Risk Assessment under TSCA
including recommendations from the May 2023 SACC review. Specifically,
the cumulative risk assessment analysis technical support document
calculates relative potency factors for phthalate syndrome for each of
the six chemical substances based on a pooled dataset for assessing
fetal testicular testosterone health endpoint and estimates cumulative
non-attributable exposures from NHANES urinary biomonitoring data.
D. What is the topic of the planned SACC peer review?
EPA anticipates soliciting peer review from the SACC on the
following draft documents:
Physical and chemical and environmental fate technical
support documents for BBP, DBP, DEHP, DIBP and DCHP.
Ecological hazard technical support documents for BBP,
DBP, DEHP, DIBP and DCHP.
Non-cancer human health hazard technical support documents
for BBP, DBP, DEHP, DIBP and DCHP.
Cancer technical support document (a single document that
includes BBP, DBP, DEHP, DIBP and DCHP).
Environmental Releases and Occupational Exposure technical
support documents for BBP, DBP, DEHP, DIBP and DCHP.
Environmental and General Population Exposures to
Environmental Releases technical support documents for BBP, DBP, DEHP,
DIBP and DCHP.
Consumer and Indoor Air Exposure technical support
documents for BBP, DBP, DEHP, DIBP and DCHP.
Meta-analysis and benchmark dose technical support
document developed for the draft cumulative risk assessment.
Technical support document for the Cumulative Risk
Analysis of Di(2-ethylhexyl) Phthalate (DEHP), Dibutyl Phthalate (DBP),
Butyl Benzyl Phthalate (BBP), Diisobutyl Phthalate (DIBP), Dicyclohexyl
Phthalate (DCHP), and Diisononyl Phthalate (DINP) under TSCA.
Aspects of the risk evaluation for DCHP, including risk
characterization and application of the cumulative risk analysis.
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EPA expects to solicit feedback on the following scientific issues:
Physical-chemical properties and environmental fate
technical support documents. EPA expects to solicit feedback on the
data and methods used to characterize physical-chemical properties and
environmental fate of BBP, DBP, DEHP, DIBP and DCHP. Of particular
importance are the n-octanol/water partition coefficients
(Kow), organic carbon-water partition coefficients
(Koc), n-octanol/air partition coefficients
(Koa), bioaccumulation factors (BAF), and bioconcentration
factors (BCF). For DCHP specifically, EPA expects to solicit specific
feedback on the weight of the scientific evidence approach to describe
the water solubility range for DCHP and the use of a single value as
input to exposure models.
Ecological hazard technical support documents. EPA expects
to solicit feedback on the data and methods used to characterize
ecological hazards of BBP, DBP, DEHP, DIBP and DCHP.
Non-cancer human health hazard technical support
documents. EPA expects to solicit feedback on multiple scientific areas
including the selection of non-cancer points of departure used to
characterize non-cancer risks from acute, intermediate, and chronic
durations for BBP, DBP, DEHP, DIBP and DCHP. For DEHP there are
additional hazards for which EPA will solicit input; specifically,
female reproductive tract, inhalation, and glucose homeostasis/lipid
metabolism.
Cancer hazard technical support document. EPA has
developed a single document evaluating cancer hazard potential for
these phthalates. EPA expects to solicit feedback on the following:
draft cancer classifications for DEHP, BBP, and DBP; tumor triad
(liver, pancreatic, and testicular tumors) and PPAR[alpha] mode of
action information relevant to DEHP; and the application of Rethinking
Carcinogenicity Assessment for Agrochemicals Project (ReCAAP) weight of
evidence framework for DCHP and DIBP.
Meta-analysis and benchmark dose modeling technical
support document and the cumulative risk assessment technical support
documents. EPA expects to solicit input on the methods and data used to
calculate background exposure levels from the NHANES data set, derive
relative potency factors, index chemical selection, and methods and
application of background exposures. The draft risk evaluation of DCHP
will contain an example of the application of cumulative risk
assessment analysis for an individual chemical. EPA anticipates
requesting input on the integration of the cumulative approaches within
the individual chemical risk characterization.
Technical support documents for environmental and general
population, consumer and indoor air, and occupational exposures. EPA
expects to request feedback and guidance on the data and methods used
in the draft exposure assessments. Included in this request for input
will be issues related to dermal absorption, such as the interpretation
of in vitro and in vivo studies and the use of flux-based calculations
for occupational exposures. Of specific importance are the data and
methods used to calculate dermal absorption and exposures in the
occupational exposure and the consumer and indoor air exposure
technical support documents.
Given the large volume of material across the five HPS phthalates,
EPA will be releasing chemical-specific technical support documents in
batches ahead of the draft risk evaluations. The formal 60-day public
comment period for each chemical risk evaluation will begin when the
Agency publishes a notice of availability in the Federal Register and
the chemical's full risk evaluation, including the risk
characterization and risk determination, are posted to the chemical
specific docket. Most immediately, the Agency anticipates that the DCHP
risk evaluation, and its associated supporting documents, is expected
to be released to the public at the end of December, and a notice of
availability will begin the public comment period for the DCHP draft
risk evaluation. Over the next several months, EPA expects to release
all the technical support documents for BBP, DBP, DEHP, and DIBP into
their respective chemical specific dockets as they are available, and
their dockets will be open for submission of comments. Nonetheless,
these TSDs will be formally available for a 60-day public comment
period with the release of each chemical risk evaluation to follow.
In the first quarter of 2025, OPPT will publish a notice of
availability in the Federal Register for the draft charge questions and
to begin an additional public comment period in this docket (EPA-HQ-
OPPT-2024-0551) specifically for the peer review by the SACC. At that
time, all of the risk evaluation documents (e.g., technical support
documents, supplemental files, etc.) relevant to peer review will also
be made available in this docket for a targeted peer review. EPA
anticipates requesting SACC peer review of the questions pertaining to
critical inputs and novel approaches contained in these documents to
constitute full peer review of the phthalate risk evaluations. The SACC
peer review will be focused on the DCHP risk evaluation and associated
supporting documents, and the technical support documents that describe
the data and analyses of physical chemistry and fate, hazards,
exposures, and releases for BBP, DBP, DEHP, and DIBP.
In total, EPA anticipates six opportunities for public comment;
five dockets and comment periods associated with each chemical (BBP,
DBP, DEHP, DIBP and DCHP) and one docket focused on the SACC peer
review.
III. Nominations for ad hoc Reviewers
A. 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 stakeholders 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
and final report.
B. 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: Physical and chemical
properties of phthalates including water solubility, bioconcentration
and bioaccumulation, analytical chemistry, modeling and field derived
data; Ecological hazard identification including general ecological
hazard identification and use of read-across and new alternative
methods; Environmental releases including methods for modeling and
considerations for use of monitoring data; General population exposure
including use of screening methods and refinements; Occupational
exposure including dermal exposure modeling with consideration of
empirical absorption data; Consumer exposure and indoor air exposure
including
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modeling data selection and interpretation and use of monitoring data;
Human health toxicology including inhalation hazard, glucose
metabolism, liver toxicity, phthalate syndrome, mode of action for
cancer and non-cancer, benchmark dose modeling and dose response
analysis; Cumulative and mixtures risk assessment for human health
including index chemical selection and relative potency factor
derivations; Biostatistics including analysis of NHANES biomonitoring
data and derivation of occupational exposure limits; Epidemiology
related to individual chemicals and phthalate mixtures for use in risk
assessments.
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.
C. How do I make a nomination?
Submit your nomination as directed under ADDRESSES by the deadline
indicated under DATES. 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.
Do not submit confidential business information (CBI) or other
sensitive information to EPA through 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.
D. 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. Selected candidates are required to complete an ethics training
prior to conducting their reviews.
E. 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, ability to be hired as an EPA Special Government Employee
(SGE), 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
several 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 by the deadline listed
under DATES. However, the final selection of ad hoc reviewers is a
discretionary function of the Agency.
EPA anticipates selecting approximately ten (10) 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 the winter of
2025. The list will be available in the docket at https://www.regulations.gov (docket ID No. EPA-HQ-OPPT-2024-0551) and through
the SACC website at https://www.epa.gov/tsca-peer-review.
Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.
Dated: November 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-28287 Filed 12-2-24; 8:45 am]
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