Document ID: EPA-HQ-OPPT-2018-0435-0035
Agency: epa
Document Type: Notice
Title: Di-isodecyl Phthalate (DIDP); Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice of Availability
Posted Date: 2021-08-31T04:00Z

[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48695-48696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 http://www.regulations.gov 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 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: beachum.collin@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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]
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