[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60420-60424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16394]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT- 2023-0601; FRL-11581-03-OCSPP]
Proposed High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Under the Toxic Substances Control Act (TSCA) and related
implementing regulations, the Environmental Protection Agency (EPA or
Agency) is proposing to designate acetaldehyde (CASRN 75-07-0),
acrylonitrile (CASRN 107-13-1), benzenamine (CASRN 62-53-3), vinyl
chloride (CASRN 75-01-4), and 4,4-methylene bis(2-chloroaniline)
(MBOCA) (CASRN 101-14-4) as High-Priority Substances for risk
evaluation. EPA is providing a 90-day comment period, during which
interested persons may submit comments on the proposed designations of
these chemicals as High-Priority Substances for risk evaluation.
DATES: Comments must be received on or before October 23, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number, through https://www.regulations.gov. Follow the online
[[Page 60421]]
instructions for submitting comments. For comments not related to a
specific chemical, including general comments on Unit IV.A., use docket
ID number EPA-HQ-OPPT-2023-0601; submit information on the candidates
for which EPA is initiating the prioritization process to the
applicable chemical-specific docket ID number identified in Unit V. Do
not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting or visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Sarah Au, Data Gathering, Management,
and Policy Division (7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-0398; email address:
[email protected].
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to entities that currently or may manufacture (including
import) a chemical substance regulated under TSCA (e.g., entities
identified under North American Industrial Classification System
(NAICS) codes 325 and 324110). The action may also be of interest to
chemical processors, distributors in commerce, users, non-profit
organizations in the environmental and public health sectors, state and
local government agencies, and members of the public. Since other
entities may also be interested, the Agency has not attempted to
describe all the specific entities and corresponding NAICS codes for
entities that may be interested in or affected by this action.
B. What action is the Agency taking?
EPA is proposing to designate five chemical substances as High-
Priority Substances for risk evaluation pursuant to TSCA section 6(b),
15 U.S.C. 2605(b): acetaldehyde (CASRN 75-07-0), acrylonitrile (CASRN
107-13-1), benzenamine (CASRN 62-53-3), vinyl chloride (CASRN 75-01-4),
and 4,4'-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4). This
document includes a summary of the approach EPA used to support the
proposed designation for each chemical substance and instructions on
how to access the chemical-specific information, analysis, and basis
EPA used to make the proposed designation for each chemical substance.
C. Why is the Agency taking this action?
TSCA section 6(b) and implementing regulations at 40 CFR part 702,
subpart A require EPA to carry out the prioritization process for
chemical substances that may be designated as High-Priority Substances
for risk evaluation. Because EPA generally expects to complete five
risk evaluations per year over the next several years, EPA is proposing
the designation of five chemical substances as High-Priority Substances
under TSCA section 6(b)(3)(C), which requires EPA to designate at least
one chemical substance as a High-Priority Substance upon completion of
each risk evaluation of a High-Priority Substance. By proposing the
designation of these five chemical substances as High-Priority
Substances, EPA continues to build a sustainable pipeline of existing
chemical risk evaluations under TSCA section 6(b). The request for
interested persons to submit comments on EPA's proposed designation of
chemical substances as High-Priority Substances is required by TSCA
section 6(b)(1)(C)(ii) and implementing regulations (40 CFR 702.9(g)).
D. What is the Agency's authority for taking this action?
This document is issued pursuant to authorities in TSCA section
6(b)(1) and TSCA section 6(b)(3)(C), and the EPA implementing
regulations in 40 CFR part 702.
E. What are the estimated incremental impacts of this action?
This document identifies five chemical substances for proposed
designation as High-Priority Substances for risk evaluation and
provides a 90-day comment period for interested persons to submit
comments on the proposed designations. This document does not establish
requirements on persons or entities outside of the Agency. No
incremental impacts are therefore anticipated, and consequently EPA did
not estimate potential incremental impacts for this action.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI.
Do not submit CBI to EPA through https://www.regulations.gov or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and 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 and/or 40 CFR part 703, as applicable.
2. Tips for preparing your comments.
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
As required by TSCA section 6(b) and as described in 40 CFR 702.7,
on December 18, 2023 (Ref. 1), EPA initiated the prioritization process
for five chemical substances identified as candidates for High-Priority
Substance designation. Under TSCA section 6(b)(1)(B) and its
implementing regulations (40 CFR 702.3), a High-Priority Substance is
defined as a chemical substance that EPA determines, without
consideration of costs or other non-risk factors, may present an
unreasonable risk of injury to health or the environment because of a
potential hazard and a potential route of exposure under the conditions
of use, including an unreasonable risk to potentially exposed or
susceptible subpopulations identified as relevant by EPA.
A proposed designation of a chemical substance as a High-Priority
Substance is not a finding of unreasonable risk. Rather, when
prioritization is complete, for those chemical substances designated as
High-Priority Substances, the Agency will have evidence that each such
substance may present an unreasonable risk of injury to health or the
environment because of a potential hazard and a potential route of
exposure under the conditions of use. Final designation of a chemical
substance as a High-Priority Substance initiates the TSCA risk
evaluation process (40 CFR 702.17), which culminates in a finding of
whether the chemical substance presents an unreasonable risk under its
conditions of use.
This document is intended to fulfill the TSCA section
6(b)(1)(C)(ii) requirement that EPA propose the designation of a
chemical substance as
[[Page 60422]]
a High-Priority Substance for risk evaluation after conducting a
screening review as required by TSCA section 6(b)(1)(A) (see also 40
CFR 702.9(a)). This document is also intended to fulfill the
requirement in TSCA section 6(b)(1)(C)(ii) that EPA request public
comments on proposed priority designations (see 40 CFR 702.9(g)).
EPA generally used reasonably available information to screen each
of the five candidate chemical substances against the following
criteria and considerations (see also 40 CFR 702.9(a)):
The chemical substance's hazard and exposure potential;
The chemical substance's persistence and bioaccumulation;
Potentially exposed or susceptible subpopulations;
Storage of the chemical substance near significant sources
of drinking water;
The chemical substance's conditions of use or significant
changes in conditions of use;
The chemical substance's production volume or significant
changes in production volume; and
Other risk-based criteria that EPA determines to be
relevant to the designation of the chemical substance's priority.
As described in 40 CFR 702.9(b), in conducting the screening review
during the prioritization process, EPA considered sources of
information relevant to the screening review criteria as outlined in
the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40
CFR 702.9(a)) and consistent with the scientific standards of TSCA
section 26(h), including, as appropriate, sources for hazard and
exposure data listed in Appendices A and B of the TSCA Work Plan
Chemicals: Methods Document (February 2012) (Ref. 2). In addition, as
required by 40 CFR 702.9, EPA considered the hazard and exposure
potential of the chemical substances and did not consider costs or
other non-risk factors in making a proposed priority designation.
III. Information and Comments Received
The initiation of the prioritization process (Ref. 1) included a
90-day public comment period during which interested persons were able
to submit relevant information on the five chemical substances
identified as candidates for High-Priority Substance designation. EPA
received over 9,000 submissions from commenters, including private
citizens, potentially affected businesses, trade associations, Tribes,
environmental and public health advocacy groups, and academia. Comments
addressed the overall prioritization process (e.g., the collection and
consideration of relevant information); the review process (e.g., the
use of data and approaches in risk evaluation); information specific to
the candidate chemical substances (e.g., relevant studies, assessments,
and conditions of use); and topics not germane to this prioritization
process (e.g., scheduling future chemicals for prioritization and
concerns about risk evaluation fees). To the extent that comments
provided information on additional conditions of use for these
candidate High-Priority Substances, those conditions of use are
discussed in the proposed designation documents for each chemical
substance. EPA will respond to those and any additional comments on the
proposed designations when EPA issues the final priority designation of
these chemical substances.
IV. Screening Review Criteria and Chemical Substances for Which EPA Is
Proposing a High-Priority Designation
A. What information, analysis, and basis were used to support the
proposed High-Priority Substance designations?
EPA used reasonably available information, including public
comments received during the 90-day comment period following initiation
of the prioritization process (Ref. 1), to analyze the candidate
chemical substances against the criteria and considerations in TSCA
section 6(b)(1)(A) and 40 CFR 702.9 (see Unit IV.). EPA developed a
proposed designation document for each chemical substance that
identifies the information, analysis, and basis used to support the
proposed designation of each as a High-Priority Substance for risk
evaluation. Additionally, EPA developed a systematic review support
document titled ``Updated Search Strategies Used to Identify
Potentially Relevant Discipline-Specific Information'' (Ref. 3) to
further explain how potentially relevant data sources for various
disciplines (e.g., physical and chemical properties, occupational
exposure and environmental release, environmental and human health
hazard), are identified from the larger set of data sources identified
for each of the chemical substances currently being proposed as High-
Priority Substances for risk evaluation. These documents are available
in the docket for each chemical substance proposed for designation as a
High-Priority Substance for risk evaluation.
Also included in each document is an explanation of the approach
EPA used to conduct the review. Each document includes an overview of
the requirements in TSCA section 6(b)(1)(A) and the regulatory section
addressing the following review criteria and considerations (40 CFR
702.9):
1. Production volume or significant changes in production volume.
EPA considered the reasonably available information on the current
production volume or significant changes in production volume of the
chemical substance. EPA primarily used reported information from
manufacturers (including importers) under EPA's Chemical Data Reporting
(CDR) rule (40 CFR part 711). EPA assembled information reported to the
Agency from 1986 through 2020 on the production volume under the
Inventory Update Rule (IUR) and CDR. The most recent principal
reporting year for which CDR data are available is 2019, for which
information was reported in 2020.
2. Conditions of use or significant changes in conditions of use.
EPA considered the reasonably available information on conditions
of use or significant changes in conditions of use of the chemical
substances. TSCA section 3(4) defines the term ``conditions of use'' to
mean the circumstances, as determined by the Administrator, under which
a chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
EPA assembled information submitted by manufacturers (including
importers) during the 2016 and 2020 CDR reporting cycles. CDR requires
manufacturers (including importers) to report information on the
chemical substances they produce domestically or import into the United
States. The threshold for such reporting is generally production volume
of more than 25,000 lbs per site. Based on the manufacturing
information, industrial processing and use information, consumer and
commercial use information reported under CDR during the 2016 and 2020
reporting cycles, EPA developed a list of conditions of use. In
addition, EPA reviewed uses from other publicly available data sources
such as the Toxics Release Inventory (TRI), Discharge Monitoring
Reports (DMRs), National Emissions Inventory (NEI), Safety Data Sheets
(SDS), Chemical Exposure Knowledgebase (ChemExpo), High Priority
Chemicals Data System (HPCDS), chemical-specific information received
from public commenters, and chemical-specific information from EPA's
screening review of the
[[Page 60423]]
reasonably available information for each chemical substance. Should
EPA make a final decision to designate a chemical substance as a High-
Priority Substance for risk evaluation, further characterization of
relevant TSCA conditions of use will be identified during the risk
evaluation process as part of the Agency's scope document.
3. Potentially exposed or susceptible subpopulations.
In this review, EPA considered reasonably available information to
identify potentially exposed or susceptible subpopulations. At this
stage, EPA analyzed information about children, women of reproductive
age, consumers, workers, and overburdened communities for the following
scenarios:
For children, EPA screened for each chemical substance's
use in products and articles regulated under TSCA and intended for
children, using CDR information reported during the 2016 and 2020 CDR
cycles. EPA presented information regarding those commercial and
consumer uses when the chemical substance was identified as being used
in products intended for children and also indicated if use in
children's products was identified in the High Priority Chemicals Data
System (HPCDS). Additionally, EPA identified the potential for
developmental hazards resulting from exposure to the chemical substance
that may affect children.
For women of reproductive age, EPA screened against the
exposure and hazard information for the chemical substance that
characterized potential for reproductive and/or developmental effects
following exposure to the chemical substance.
For consumers, EPA characterized the potential for
consumer exposure based on consumer uses reported to CDR during the
2016 and 2020 reporting cycles, and reported consumer uses in the
Chemical and Products database (CPDat), HPCDS, and public comment.
For workers, EPA characterized the potential for
occupational exposures to workers based on the conditions of use of
each chemical.
For overburdened communities, EPA described the
considerations for overburdened communities that may experience
disproportionate environmental harms, risks, or multiple burdens from
chemical exposure.
4. Persistence and bioaccumulation.
EPA considered reasonably available information of the chemical
substance and assessed physical and chemical properties used to
determine persistence and bioaccumulation based on the best available
science. In the proposed designation documents, EPA presents a summary
of the physical, chemical, environmental fate, and transport properties
of each chemical substance.
5. Storage near significant sources of drinking water.
TSCA section 6(b)(1)(A) specifically requires the Agency to
consider the chemical substance's storage near significant sources of
drinking water. EPA reviewed reasonably available information,
including certain existing regulations or protections in place for the
proposed chemical substances, such as existing National Primary
Drinking Water Regulations (40 CFR part 141) and other regulations
under the Clean Water Act (CWA) (40 CFR 401.15). In addition, EPA
considered the consolidated list of chemicals subject to reporting
requirements under the Emergency Planning and Community Right-to-Know
Act (EPCRA) section 302 and section 313, Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA), and the Clean Air
Act (CAA) (section 112) (Regulated Chemicals for Accidental Release
Prevention). Regulation under one or more of these authorities is an
indication that a substance is a potential health or environmental
hazard, which, if released near a significant source of drinking water,
may present unreasonable risk to health or the environment. To identify
storage of chemical substances near significant sources of drinking
water, EPA also identified facilities reporting the chemical substances
to the TRI in 2022 near potential sources of drinking water using
public water systems data stored in EPA's Safe Drinking Water
Information System Federal Data Warehouse. EPA determined whether TRI
reporting facilities are located inside defined Source Water Protection
Areas or within 4 miles of wellheads to identify potential storage of
each chemical substance near sources of surface water and groundwater,
respectively.
6. Hazard potential.
EPA considered reasonably available information to identify the
potential hazards for each chemical substance. EPA surveyed information
from previous assessments and databases and summarized the reasonably
available information for potential human health and environmental
hazards by endpoints of concern.
7. Exposure potential.
EPA considered reasonably available information to identify
potential environmental, worker/occupational, consumer, and general
population exposure for each chemical substances for the following
scenarios:
For environmental exposure, EPA considered the conditions
of use and activities associated with those conditions of use and
considered environmental monitoring data and fate properties of each
chemical substance to anticipate its presence in different
environmental media.
For worker/occupational exposure, EPA identified the
conditions of use likely to result in workers being exposed to the
chemical substance, such as manufacturing, processing, industrial and
commercial use, distribution in commerce, and disposal.
For consumer exposure, EPA considered consumer uses using
CDR information and information from CPDat. Additionally, EPA
considered the potential use in children's products from the High
Priority Chemicals Data System (HPCDS) and through public comments.
For general population exposure, EPA considered releases
from certain conditions of use as reported in TRI, such as
manufacturing, that may result in general population exposure via
pathways and routes such as drinking water ingestion and/or inhalation
from releases to the atmosphere.
8. Other risk-based criteria EPA determined to be relevant to the
designation of the chemical substance.
EPA did not identify other risk-based criteria relevant to the
proposed designations of the candidate chemical substances as High-
Priority Substances for risk evaluation.
EPA is including in the docket a technical support document titled
``Updated Search Strategies Used to Identify Potentially Relevant
Discipline-Specific Information'' (Ref 3.), which provides information
describing the Agency's search methods for publicly available peer-
reviewed and gray literature. The document also provides information
describing the processes and tools used to identify discipline-specific
pools of information from EPA's search for publicly available peer-
reviewed and gray literature.
B. What are the chemicals being proposed as High-Priority Substances
for risk evaluation?
EPA is proposing to designate acetaldehyde (CASRN 75-07-0),
acrylonitrile (CASRN 107-13-1), benzenamine (CASRN 62-53-3), vinyl
chloride (CASRN 75-01-4), and 4,4'-methylene bis(2-chloroaniline)
(MBOCA) (CASRN 101-14-4) as High-Priority Substances for risk
evaluation. The proposed designations are based on the preliminary
conclusion that each such chemical substance satisfies the definition
of High-Priority Substance in
[[Page 60424]]
TSCA section 6(b)(1)(B) and 40 CFR 702.3. As mentioned previously, a
proposed designation of a chemical substance as a High-Priority
Substance is not a finding of unreasonable risk. Rather, when
prioritization is complete, a final designation as a High-Priority
Substance will initiate the risk evaluation for the chemical substance,
which will culminate in a finding of whether the chemical substance
presents an unreasonable risk to health or the environment under the
conditions of use. Based on the information provided in the proposed
designation documents, the Agency is proposing these five chemical
substances as High-Priority Substances for risk evaluation. In each
chemical substance's docket, EPA has included the chemical-specific
designation document containing the information, analysis, and basis
used to support the proposed designation.
V. Request for Comment
EPA is interested in comments that would inform the exposure and
hazard assessments and the identification of conditions of use for the
following chemicals:
Acetaldehyde, CASRN 75-07-0, Docket ID number: EPA-HQ-
OPPT-2018-0497,
Acrylonitrile, CASRN 107-13-1, Docket ID number: EPA-HQ-
OPPT-2018-0449,
Benzenamine, CASRN 62-53-3, Docket ID number: EPA-HQ-OPPT-
2018-0474,
Vinyl chloride CASRN 75-01-4, Docket ID number: EPA-HQ-
OPPT-2018-0448, and
4,4'-Methylene bis(2-chloroaniline) (MBOCA), CASRN 101-14-
4, Docket ID number: EPA-HQ-OPPT-2018-0464.
VI. References
The following is a list of the documents specifically referenced in
this document. The docket includes these documents and other
information considered by EPA, including documents referenced within
the documents included in the docket, even if the referenced documents
are not physically located in the docket. For assistance in locating
these other documents, please consult the person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA. Initiation of Prioritization Under the Toxic Substances
Control Act (TSCA). Notice (88 FR 87423, December 18, 2023 (FRL
11581-01-OCSPP)).
2. EPA. TSCA Work Plan Chemicals; Methods Document. February
2012.
3. EPA. Updated Search Strategies Used to Identify Potentially
Relevant Discipline-Specific Information. 2024.
Authority: 15 U.S.C. 2601 et seq.
Dated: July 22, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-16394 Filed 7-24-24; 8:45 am]
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