[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76072-76073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26204]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0436; FRL-10017-15]


Di-isononyl Phthalate (DINP); 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-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; Chemical Abstracts Service Registry Number (CASRN) 28553-12-0 and 
CASRN 68515-48-0) 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 evaluations; 
comments may be submitted to this docket.

DATES: Comments must be received on or before January 11, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0436, 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,

[[Page 76073]]

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 DINP 
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 evaluation of DINP (Ref. 1). 
On December 20, 2019, the Agency granted the request, and subsequently 
initiated the scoping process for the 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-isononyl phthalate 
(DINP)

    The category of chemical substances for which EPA is publishing the 
draft scope of the risk evaluation includes the following chemical 
substances: 1,2-benzene-dicarboxylic acid, 1,2-diisononyl ester (CASRN 
28553-12-0), and 1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl 
esters, C9-rich; (CASRN 68515-48-0). 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-isononyl Phthalate (DINP) (1,2-Benzene- dicarboxylic 
acid, 1,2- diisononyl ester); Manufacturer Request for Risk Evaluation 
Under the Toxic Substances Control Act (TSCA); Notice of Availability 
and Request for Comments. Federal Register. (84 FR 42912, August 19, 
2019) (FRL-9998-25).

(Authority: 15 U.S.C. 2601 et seq.)

Andrew Wheeler,
Administrator.
[FR Doc. 2020-26204 Filed 11-25-20; 8:45 am]
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