[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: [email protected].
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]
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