[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42914-42915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17790]



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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0435; FRL-9998-26]


Di-isodecyl Phthalate (DIDP); Manufacturer Request for Risk 
Evaluation 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: EPA is announcing the availability of and soliciting public 
comment on a manufacturer request for a risk evaluation of di-isodecyl 
phthalate (DIDP) under the Toxic Substances Control Act (TSCA). The 
request was made by ExxonMobil Chemical Company through the American 
Chemistry Council's High Phthalates Council. EPA conducts risk 
evaluations to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to potentially exposed or susceptible subpopulations, 
under the conditions of use. In the docket associated with this request 
is the manufacturer request for an EPA conducted risk evaluation and 
possible additional conditions of use EPA has identified for inclusion 
within the scope of a risk evaluation of DIDP. After considering 
comments received in response to this solicitation, EPA will make a 
decision whether to grant or deny the manufacturer request. All TSCA 
risk evaluations, whether EPA-initiated or manufacturer-requested, will 
be conducted in the same manner.

DATES: Comments must be received on or before October 3, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0435, by one of the following methods:
     Federal eRulemaking Portal: 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.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Eva Cappuccilli, National Program 
Chemicals Division, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, Mail Code 7404T, 1200 Pennsylvania 
Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4688; 
email address: cappuccilli.eva@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this apply to me?

    This notice is directed to the public in general, and may be of 
interest to persons who currently or may manufacture (including 
import), process, distribute, use, and/or dispose of DIDP. Since other 
entities may also be interested in these risk evaluations, the EPA has 
not attempted to describe all the specific entities that may be 
affected by this action.

B. What is EPA's authority for taking this action?

    TSCA section 6(b) requires that EPA conduct risk evaluations on 
existing chemicals and identifies the minimum components EPA must 
include in all chemical substance risk evaluations. 15 U.S.C. 2605(b). 
The risk evaluation must not consider costs or other non-risk factors. 
15 U.S.C. 2605(b)(4)(F)(iii). The specific risk evaluation process is 
set out in 40 CFR part 702 and summarized on EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
    TSCA section 6(b) also allows manufacturers of a chemical to 
request an EPA-conducted risk evaluation on the chemical. TSCA required 
EPA to develop the form and manner under which these requests must be 
made, and the criteria for which EPA will determine whether to grant a 
request. These requirements and criteria are set out in 40 CFR 702.37.
    Under 40 CFR 702.37(e)(3), EPA is required to assess whether the 
circumstances identified in a manufacturer request for a risk 
evaluation constitute conditions of use (as defined under TSCA section 
(3)(4) and implementing regulations (40 CFR 702.33)), and whether those 
conditions of use warrant inclusion within the scope of a risk 
evaluation for the chemical substance. EPA will also assess what, if 
any, additional conditions of use warrant inclusion within the scope of 
a risk evaluation for the chemical substance. EPA will conduct these 
assessments based on the same considerations applied in the same manner 
as it would for a risk evaluation in the EPA-initiated risk evaluation 
process.
    No later than 60 business days after receiving a manufacturer 
request for risk evaluation that EPA has determined to be facially 
complete (meeting the criteria set forth in 40 CFR 702.37(e)(1)), EPA 
is required to submit for publication the receipt of the request in the 
Federal Register, open a public docket for the request (which must 
contain the manufacturer request and EPA's possible additional 
conditions of use), and provide no less than 45 calendar days for 
public comment. This notice identifies the docket containing the 
manufacturer request, EPA's possible additional conditions of use, and 
the basis for including those possible additional conditions of use. 
During the public comment period, the public may submit comments and 
information relevant to the requested risk evaluation, as well as the 
additional possible conditions of use EPA is including in the docket.
    After the comment period closes, the Agency has up to 60 days to 
either grant or deny the request to conduct a risk evaluation under 40 
CFR 702.37(e)(6). EPA will review the request along with any additional 
information received during the comment period, and grant the request 
if it determines the request meets all of the following requirements 
listed under 40 CFR 702.37(e)(6)(ii):
     The circumstances identified in the request constitute 
conditions of use that warrant inclusion in a risk evaluation for the 
chemical substance;
     EPA has all the information needed to conduct such risk 
evaluation on the conditions of use that were the subject of the 
request; and
     All other criteria and requirements of 40 CFR 702.37 have 
been met.

C. What action is EPA taking?

    EPA is announcing the availability of and soliciting public comment 
on a manufacturer request for a risk evaluation of DIDP under TSCA that 
is described in detail in Unit II. Also available in the docket 
associated with this request are the manufacturer request and possible 
additional conditions of use EPA identified for inclusion in a risk 
evaluation of DIDP. This notice satisfies 40 CFR 702.37(e)(4).

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C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed 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.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Summary of This Manufacturer Request

    On May 24, 2019, EPA received a manufacturer request for a TSCA 
risk evaluation of DIDP that was made by ExxonMobil Chemical Company 
through the American Chemistry Council's High Phthalates Council. After 
determining the request was facially complete (i.e., EPA determined 
that the request appeared to be consistent with the requirements in 40 
CFR 702.37(b) through (d), such as including all the necessary 
information in those paragraphs), EPA notified the public of the 
receipt of the request on June 13, 2019 via a listserv announcement to 
stakeholders.

A. What is di-isononyl phthalate (DIDP)?

    DIDP is a phthalate used as a plasticizer to impart flexibility to 
polyvinyl chloride (PVC) in consumer, commercial and industrial 
adhesives, sealants, lubricants, greases, and paints and coatings. 
There are two commercial products that the manufacturer submitted for 
risk evaluation under the name DIDP. The commercial products for DIDP 
can be represented by the Chemical Abstracts Service Registry Numbers 
(CASRNs) 68515-49-1 and 26761-40-0.

B. What are the conditions of use?

    The manufacturer request for a risk evaluation of DIDP identifying 
conditions of use of interest to the manufacturer is included in docket 
EPA-HQ-OPPT-2018-0435. Subject to further analysis and public comment, 
EPA anticipates including activities identified in the request as 
conditions of use in the risk evaluation of DIDP.
    EPA has identified additional conditions of use pursuant to 40 CFR 
702.37(e)(3), which are also included in docket EPA-HQ-OPPT-2018-0435.

III. Request for Comment

    The docket associated with this request contains the manufacturer 
request (excluding information claimed as CBI) and EPA's possible 
additional conditions of use as described 40 CFR 702.37(e)(3), and the 
basis for these possible additions. During the comment period, the 
public may submit comments and information relevant to the requested 
risk evaluation; in particular, commenters are encouraged to identify 
any information not included in the request that the commenters believe 
would be needed to conduct a risk evaluation, and to provide any other 
information relevant to EPA's possible additional conditions of use, 
such as information on other conditions of use of the chemical than 
those included in the request or in EPA's additional conditions of use. 
40 CFR 702.37(e)(4). In addition, at any time prior to the end of the 
comment period, the requesting manufacturer(s) may supplement the 
original request with any new information it receives. 40 CFR 
702.37(e)(5).

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

    Dated: August 13, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-17790 Filed 8-16-19; 8:45 am]
BILLING CODE 6560-50-P


