Notice2021-18773
Di-isodecyl Phthalate (DIDP); Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice of Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 31, 2021
Issuing agencies
Environmental Protection Agency
Abstract
In accordance with the Toxic Substances Control Act (TSCA) and implementing regulations, EPA is announcing the availability of the final scope of 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 scope document includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this category of chemical substances.
Full Text
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<title>Federal Register, Volume 86 Issue 166 (Tuesday, August 31, 2021)</title>
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[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48695-48696]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18773]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0435; FRL-8807-01-OCSPP]
Di-isodecyl Phthalate (DIDP); Final Scope of the Risk Evaluation
To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice
of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In accordance with the Toxic Substances Control Act (TSCA) and
implementing regulations, EPA is announcing the availability of the
final scope of 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 scope document
includes the conditions of use, hazards, exposures, and the potentially
exposed or susceptible subpopulations that EPA plans to consider in
conducting the risk evaluation for this category of chemical
substances.
ADDRESSES: The docket, identified by docket identification (ID) number
EPA-HQ-OPPT-2018-0435, is available online at <a href="http://www.regulations.gov">http://www.regulations.gov</a> or in-person at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#9efcfbfffdf6ebf3b0fdf1f2f2f7f0defbeeffb0f9f1e8"><span class="__cf_email__" data-cfemail="57353236343f223a7934383b3b3e391732273679303821">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#7c282f3f3d51341308101512193c190c1d521b130a"><span class="__cf_email__" data-cfemail="41151202006c092e352d282f24012431206f262e37">[email protected]</span></a>.
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 final scope document is issued pursuant to TSCA section
6(b)(4)(D) and EPA's implementing regulations at 40 CFR 702.41(c)(8).
C. What action is the Agency taking?
EPA is publishing the final 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 substance under 40 CFR 702.37. On May 24,
2019, EPA received a manufacturer request for a risk evaluation of DIDP
(Ref. 1). On December 2, 2019, the Agency granted the request and
subsequently initiated the scoping process for a risk evaluation for
this category of chemical substances on January 2, 2020. Pursuant to 40
CFR 702.41(c)(7), EPA announced the availability of and sought public
comment on the draft scope document for the risk evaluation to be
conducted for DIDP under TSCA (85 FR 76077, November 27, 2020) (FRL-
10017-14) (Ref. 2).
The purpose of 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
[[Page 48696]]
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. Information and Comments Received
In the Federal Register of November 27, 2020 (Ref. 2), EPA
announced the availability of the draft scope document for the risk
evaluation to be conducted for DIDP under TSCA and invited public
comments on EPA's draft scope document, including additional data or
information relevant to the category of chemical substances or that
otherwise could be useful to the Agency in finalizing the scope of the
risk evaluation. To the extent that comments provided information on
conditions of use, as well as other elements of the draft scope
document, those comments and other submitted information (e.g.,
relevant studies and assessments) were used to inform revisions to the
draft scope document and may be considered in subsequent phases of the
risk evaluation process.
EPA received five unique submissions for DIDP, including comments
from potentially affected businesses or trade associations,
environmental and public health advocacy groups (some submissions were
signed by more than one group), and a group of state attorneys general.
Comments addressed the overall approach to the risk evaluation
process (e.g., collection, consideration, and systematic review of
relevant information), the specific elements of the scope document
(e.g., hazard, exposure, and potentially exposed or susceptible
subpopulations), information specific to the chemical substances (e.g.,
relevant studies, assessments, and conditions of use), and topics
beyond the draft scope document phase of the process (e.g., risk
management). EPA considered those comments, as applicable and
appropriate, in developing the final scope document. Concurrently with
the publication of the final scope document, EPA is publishing a
response to comments document that contains a comprehensive summary of
and response to public comments received on the DIDP draft scope
document. The comprehensive response to comments document is available
in the docket EPA-HQ-OPPT-2019-0435 (Ref. 3).
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 19,
2019) (FRL-9998-26).
2. EPA. 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. Federal
Register. (85 FR 76077, November 27, 2020) (FRL-10017-14).
3. EPA. EPA Response to Public Comments Received on the Draft
Scopes of the Risk Evaluations Under the Toxic Substances Control Act
(TSCA) 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) CASRN 26761-40-0 and 68515-49-1 and
Di-isononyl Phthalate (DINP) (1,2-Benzene-dicarboxylic acid, 1,2-
diisononyl ester, and 1,2-Benzenedicarboxylic acid, di-C8-10-branched
alkyl esters, C9-rich) CASRNs 28553-12-0 and 68515-48-0. (August 2021).
Authority: 15 U.S.C. 2601 et seq.
Michael S. Regan,
Administrator.
[FR Doc. 2021-18773 Filed 8-30-21; 8:45 am]
BILLING CODE 6560-50-P
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