Di-isononyl Phthalate (DINP); Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice of Availability, 48693-48695 [2021-18772]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
public visitors, with limited exceptions,
to reduce the risk of transmitting
COVID–19. Our Docket Center staff will
continue to provide remote customer
service via email, phone, and webform.
The EPA encourages the public to
submit comments via https://
www.regulations.gov/ as there may be a
delay in processing mail and faxes.
Hand deliveries or couriers will be
received by scheduled appointment
only. For further information and
updates on EPA Docket Center services,
please visit us online at https://
www.epa.gov/dockets.
The EPA continues to carefully and
continuously monitor information from
the Center of Disease Control, local area
health departments, and our federal
partners so that the Agency can respond
rapidly as conditions change regarding
COVID–19.
FOR FURTHER INFORMATION CONTACT:
Corey Sugerik, Air Quality Policy
Division, Office of Air Quality Planning
and Standards, C504–05, Environmental
Protection Agency, Research Triangle
Park, NC; telephone number: (919) 541–
3223; fax number: (919) 541–5509;
email address: sugerik.corey@epa.gov.
SUPPLEMENTARY INFORMATION:
Supporting documents which explain in
detail the information that the EPA will
be collecting are available in the public
docket for this ICR. The docket can be
viewed online at https://
www.regulations.gov or in person at the
EPA Docket Center, WJC West, Room
3334, 1301 Constitution Avenue NW,
Washington, DC. The telephone number
for the Docket Center is (202) 566–1744.
The EPA’s policy is that all comments
received will be included in the public
docket without change including any
personal information provided, unless
the comment includes profanity, threats,
information claimed to be Confidential
Business Information or other
information whose disclosure is
restricted by statute. For additional
information about EPA’s public docket,
visit https://www.epa.gov/dockets.
Pursuant to section 3506(c)(2)(A) of
the PRA, the EPA is soliciting comments
and information to enable it to: (i)
Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information will have
practical utility; (ii) evaluate the
accuracy of the Agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(iii) enhance the quality, utility, and
clarity of the information to be
collected; and (iv) minimize the burden
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of the collection of information on those
who are to respond, including through
the use of appropriate automated
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses. The EPA will consider the
comments received and amend the ICR
as appropriate. The final ICR package
will then be submitted to OMB for
review and approval. At that time, the
EPA will issue another Federal Register
notice to announce the submission of
the ICR to OMB and the opportunity to
submit additional comments to OMB.
Abstract: Title V of the Clean Air Act
(CAA or Act) requires states to develop
and implement a program for issuing
operating permits to all sources that fall
under any Act definition of ‘‘major’’ and
certain other non-major sources that are
subject to federal air quality regulations.
The Act further requires the EPA to
develop regulations that establish the
minimum requirements for those state
operating permits programs and to
oversee implementation of the state
programs. The EPA regulations setting
forth requirements for the state
operating permit program are found at
40 CFR part 70. The part 70 program is
designed to be implemented primarily
by state, local and tribal permitting
authorities in all areas where they have
jurisdiction.
In order to receive an operating
permit for a major or other source
subject to the permitting program, the
applicant must conduct the necessary
research, perform the appropriate
analyses and prepare the permit
application with documentation to
demonstrate that its facility meets all
applicable statutory and regulatory
requirements. Specific activities and
requirements are listed and described in
the Supporting Statement for the 40 CFR
part 70 ICR.
Under 40 CFR part 70, state, local and
tribal permitting authorities review
permit applications, provide for public
review of proposed permits, issue
permits based on consideration of all
technical factors and public input and
review information submittals required
of sources during the term of the permit.
Also, under 40 CFR part 70, the EPA
reviews certain actions of the permitting
authorities and provides oversight of the
programs to ensure that they are being
adequately implemented and enforced.
Consequently, information prepared and
submitted by sources is essential for
sources to receive permits, and for
federal, state, local and tribal permitting
authorities to adequately review the
permit applications and thereby
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48693
properly administer and manage the
program.
Information that is collected is
handled according to the EPA’s policies
set forth in title 40, chapter 1, part 2,
subpart B—Confidentiality of Business
Information (see 40 CFR part 2). See also
section 114(c) of the Act.
Form Numbers: None.
Respondents/affected entities:
Industrial plants (sources); state, local
and tribal permitting authorities.
Respondent’s obligation to respond:
mandatory (see 40 CFR part 70).
Estimated number of respondents:
14,201 sources and 117 state, local and
tribal permitting authorities.
Frequency of response: On occasion.
Total estimated burden: 4,756,110
hours (per year). Burden is defined at 5
CFR 1320.03(b).
Total estimated cost: $325,175,507
(per year). There are no annualized
capital or operation & maintenance
costs.
Changes in Estimates: There is an
increase of 17,185 hours in the total
estimated respondent burden compared
with the ICR currently approved by
OMB. This increase is due to updated
estimates of the number of sources and
permits subject to the part 70 program,
rather than any change in federal
mandates.
Dated: August 26, 2021.
Scott Mathias,
Director, Air Quality Policy Division, OAQPS.
[FR Doc. 2021–18762 Filed 8–30–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0436; FRL–8806–01–
OCSPP]
Di-isononyl Phthalate (DINP); Final
Scope of the Risk Evaluation To Be
Conducted Under the Toxic
Substances Control Act (TSCA); Notice
of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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-isononyl phthalate
(DINP) (1,2-benzene-dicarboxylic acid,
1,2-diisononyl ester, and 1,2benzenedicarboxylic acid, di-C8-10branched alkyl esters, C9-rich; Chemical
Abstracts Service Registry Number
(CASRN) 28553–12–0 and CASRN
SUMMARY:
E:\FR\FM\31AUN1.SGM
31AUN1
48694
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
68515–48–0), 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–2018–0436, is available
online at https://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
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
20:08 Aug 30, 2021
Jkt 253001
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 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 substance
under 40 CFR 702.37. On May 24, 2019,
EPA received a manufacturer request for
a risk evaluation of DINP (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 DINP under TSCA (85 FR 76072,
November 27, 2020) (FRL–10017–15)
(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
category of chemical substances
presents an unreasonable risk of injury
to health or the environment under the
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
conditions of use (15 U.S.C.
2605(b)(4)(A); 40 CFR 702.47).
III. Information and Comments
Received on the Draft Scope
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 DINP 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 six unique submissions
for DINP, including comments from
potentially affected businesses or trade
associations, environmental and public
health advocacy groups (some
submissions were signed by more than
one group), a group of state attorneys
general, and one anonymous comment.
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 DINP draft scope document. The
comprehensive response to comments
document is available in the docket
EPA–HQ–OPPT–2019–0436 (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
E:\FR\FM\31AUN1.SGM
31AUN1
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
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, 1,2diisononyl 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).
2. EPA. 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.
Federal Register. (85 FR 76072,
November 27, 2020) (FRL–10017–15).
3. EPA. EPA Response to Public
Comments Received on the Draft Scopes
of the Risk Evaluations Under the Toxic
Substances Control Act (TSCA) for: Diisodecyl Phthalate (DIDP) (1,2Benzenedicarboxylic acid, 1,2diisodecyl ester and 1,2Benzenedicarboxylic acid, di-C9-11branched alkyl esters, C10-rich) CASRN
26761–40–0 and 68515–49–1 and Diisononyl Phthalate (DINP) (1,2-Benzenedicarboxylic acid, 1,2-diisononyl ester,
and 1,2-Benzenedicarboxylic acid, diC8-10-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. 2021–18772 Filed 8–30–21; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 1,2benzenedicarboxylic acid, di-C9-11-
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:08 Aug 30, 2021
Jkt 253001
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 https://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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
48695
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
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48693-48695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18772]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0436; FRL-8806-01-OCSPP]
Di-isononyl Phthalate (DINP); 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.
-----------------------------------------------------------------------
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-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
[[Page 48694]]
68515-48-0), 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-2018-0436, is available online at https://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: [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 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 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 substance under 40 CFR 702.37. On May 24,
2019, EPA received a manufacturer request for a risk evaluation of DINP
(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 DINP under TSCA (85 FR 76072, November 27, 2020) (FRL-
10017-15) (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 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 on the Draft Scope
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 DINP 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 six unique submissions for DINP, including comments
from potentially affected businesses or trade associations,
environmental and public health advocacy groups (some submissions were
signed by more than one group), a group of state attorneys general, and
one anonymous comment.
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 DINP draft scope
document. The comprehensive response to comments document is available
in the docket EPA-HQ-OPPT-2019-0436 (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
[[Page 48695]]
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).
2. EPA. 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. Federal
Register. (85 FR 76072, November 27, 2020) (FRL-10017-15).
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. 2021-18772 Filed 8-30-21; 8:45 am]
BILLING CODE 6560-50-P