Di-isodecyl Phthalate (DIDP); Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice of Availability, 48695-48696 [2021-18773]
Download as PDF
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
48696
Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
20:08 Aug 30, 2021
Jkt 253001
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, 1,2diisodecyl 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: 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. 2021–18773 Filed 8–30–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2003–0004; FRL–8829–01–
OCSPP]
Access to Confidential Business
Information by Eastern Research
Group and PG Environmental
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA has authorized its
contractors, Eastern Research Group
(ERG) of Lexington, MA, to access
information which has been submitted
to EPA under all sections of the Toxic
Substances Control Act (TSCA). Some of
the information may be claimed or
determined to be Confidential Business
Information (CBI).
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Access to the confidential data
will occur no sooner than September 7,
2021.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Colby
Lintner, Project Management and
Operations Division (7407M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–8182; fax number: (202) 564–8251;
email address: lintner.colby@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:
DATES:
I. General Information
A. Does this Action apply to me?
This action is directed to the public
in general. This action may, however, be
of interest to all who manufacture,
process, or distribute industrial
chemicals. Since other entities may also
be interested, the Agency has not
attempted to describe all the specific
entities that may be affected by this
action.
B. How can I get copies of this document
and other related information?
The docket for this action, identified
by docket identification (ID) number
EPA–HQ–OPPT–2003–0004 is available
at https://www.regulations.gov or 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.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280.
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.
II. What action is the Agency taking?
Under EPA contract number
68HERD20A0002/68HERH21F0196,
contractor ERG of 110 Hartwell Ave,
Suite 1, Lexington, MA will assist the
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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 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]
BILLING CODE 6560-50-P