[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76077-76078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26203]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0435; FRL-10017-14]
Di-isodecyl Phthalate (DIDP); Draft Scope of the Risk Evaluation
to be Conducted Under the Toxic Substances Control Act (TSCA); Notice
of Availability and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on the draft scope
document for the risk evaluation to be conducted for di-isodecyl
phthalate (DIDP) (1,2-benzenedicarboxylic acid, 1,2-diisodecyl ester
and 1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-
rich; Chemical Abstracts Service Registry Number (CASRN) 26761-40-0 and
CASRN 68515-49-1), a category of chemical substances for which EPA
received a manufacturer request for risk evaluation. The draft scope
document for this category of chemical substances includes the
conditions of use, hazards, exposures, and the potentially exposed or
susceptible subpopulations EPA plans to consider in conducting the risk
evaluation for this category of chemical substances. EPA is also asking
the public to provide additional data or information that could be
useful to the Agency in finalizing the scope of the risk evaluation.
DATES: Comments must be received on or before January 11, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0435, through the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. To make special
arrangements for hand delivery or delivery of boxed information, please
follow the instructions at http://www.epa.gov/dockets/contacts.html.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Collin Beachum, Existing
Chemical Risk Assessment Division (Mailcode E205-02), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 109
T.W. Alexander Drive, RTP, NC 27711; telephone number: (919) 541-7554;
email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to entities that 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, and users; non-governmental 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 is the Agency's authority for taking this action?
The draft scope document is issued pursuant to TSCA section 6(b)
and EPA's implementing regulations at 40 CFR 702.41(c)(7).
C. What action is the Agency taking?
EPA is publishing the draft scope of the risk evaluation for DIDP
under TSCA. Through the risk evaluation process, EPA will determine
whether the category of chemical substances presents an unreasonable
risk of injury to health or the environment under the conditions of
use, as determined by the Administrator, in accordance with TSCA
section 6(b)(4).
II. Background
TSCA allows chemical manufacturers to request an EPA-conducted risk
evaluation of a chemical under 40 CFR 702.37. On May 24, 2019, EPA
received a manufacturer request for a risk
[[Page 76078]]
evaluation of DIDP. On December 20, 2019, the Agency granted the
request, and subsequently initiated the scoping process for a risk
evaluation for this category of chemical substances. The purpose of a
risk evaluation is to determine whether a chemical substance, or group
of chemical substances, presents an unreasonable risk to health or the
environment, under the conditions of use, including an unreasonable
risk to a relevant potentially exposed or susceptible subpopulation (15
U.S.C. 2605(b)(4)(A)). As part of this process, EPA must evaluate both
hazards and exposures for the conditions of use; describe whether
aggregate or sentinel exposures were considered and the basis for
consideration; not consider costs or other nonrisk factors; take into
account where relevant, likely duration, intensity, frequency, and
number of exposures and describe the weight of the scientific evidence
for hazards and exposures (15 U.S.C. 2605(b)(4)(F)). This process will
culminate in a determination of whether or not the category of chemical
substances presents an unreasonable risk of injury to health or the
environment under the conditions of use (15 U.S.C. 2605(b)(4)(A); 40
CFR 702.47).
III. Draft Scope of the Risk Evaluation for Di-isodecyl phthalate
(DIDP)
The category of chemical substances for which EPA is publishing the
draft scope of the risk evaluation includes the following chemical
substances: 1,2-benzenedicarboxylic acid, 1,2-diisodecyl ester (CASRN
26761-40-0) and 1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl
esters, C10-rich; (CASRN 68515-49-1). The draft scope of the risk
evaluation for this category of chemical substances includes the
conditions of use, hazards, exposures, and the potentially exposed or
susceptible subpopulations EPA plans to consider in the risk evaluation
(15 U.S.C. 2605(b)(4)(D)).
Development of the scope is the first step of a risk evaluation.
The draft scope of the risk evaluation will include the following
components (40 CFR 702.41(c)):
The conditions of use, as determined by the Administrator,
that EPA plans to consider in the risk evaluation.
The potentially exposed populations that EPA plans to
evaluate; the ecological receptors that EPA plans to evaluate; and the
hazards to health and the environment that EPA plans to evaluate.
A description of the reasonably available information and
the science approaches that the Agency plans to use.
A conceptual model that will describe the actual or
predicted relationships between the chemical substance, the conditions
of use within the scope of the evaluation and the receptors, either
human or environmental, with consideration of the life cycle of the
chemical substance--from manufacturing, processing, distribution in
commerce, use, to release or disposal--and identification of human and
ecological health hazards EPA plans to evaluate for the exposure
scenarios EPA plans to evaluate.
An analysis plan, which will identify the approaches and
methods EPA plans to use to assess exposure, hazards, and risk,
including associated uncertainty and variability, as well as a strategy
for using reasonably available information and best available science
approaches.
A plan for peer review.
EPA encourages commenters to provide information they believe might
be missing or may further inform the risk evaluation. EPA will publish
a notice in the Federal Register announcing the availability of the
final scope within three months of publishing the draft scope.
IV. References
The following is a listing of the documents that are specifically
referenced in this Federal Register notice. The docket for this action
includes these documents and other information considered by EPA,
including documents that are referenced within the documents that are
included in the docket. For assistance in locating these referenced
documents, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. Di-isodecyl Phthalate (DIDP) (1,2-Benzene-dicarboxylic
acid, 1,2- diisodecyl ester); Manufacturer Request for Risk Evaluation
Under the Toxic Substances Control Act (TSCA); Notice of Availability
and Request for Comments. Federal Register. (84 FR 42914, August 30,
2019) (FRL-9998-26).
(Authority: 15 U.S.C. 2601 et seq.)
Andrew Wheeler,
Administrator.
[FR Doc. 2020-26203 Filed 11-25-20; 8:45 am]
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