[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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