Certain New Chemicals or Significant New Uses; Statements of Findings for July 2021, 52459-52460 [2021-20356]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices
Frequency of response: Every four
years.
Estimated total average number of
responses for each respondent: 7.38.
Estimated total annual burden hours:
735,456 hours.
Estimated total annual costs:
$79,267,359. This includes an estimated
burden cost of $79,267,359 and an
estimated cost of $0 for capital
investment or maintenance and
operational costs.
lotter on DSK11XQN23PROD with NOTICES1
III. Are there changes in the estimates
from the last approval?
There is an increase in total annual
costs compared with that identified in
the ICR currently approved by OMB.
The primary reason for changes in
respondent burden and cost are a result
of changes from finalized regulatory
actions in 2020. In addition, the
increase in the respondent burden and
agency costs were caused by an increase
in the hourly wages and a change in the
methodology to calculate loaded wages
(wages plus fringe benefits and
overhead). Please refer to Handbook on
Valuing Changes in Time Use Induced
by Regulatory Requirements and Other
U.S. EPA Actions. This change is an
adjustment.
In addition, OMB has requested that
EPA move towards using the 18question format for ICR Supporting
Statements used by other federal
agencies and departments and is based
on the submission instructions
established by OMB in 1995, replacing
the alternate format developed by EPA
and OMB prior to 1995. The Agency
does not expect this change in format to
result in substantive changes to the
information collection activities or
related estimated burden and costs.
IV. What is the next step in the process
for this ICR?
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 pursuant to 5 CFR
1320.12. EPA will issue another Federal
Register document pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the
submission of the ICR to OMB and the
opportunity to submit additional
comments. If you have any questions
about this ICR or the approval process,
please contact the person listed under
FOR FURTHER INFORMATION CONTACT.
Authority: 15 U.S.C. 2601 et seq.
Dated: September 15, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2021–20355 Filed 9–20–21; 8:45 am]
BILLING CODE 6560–50–P
VerDate Sep<11>2014
21:03 Sep 20, 2021
Jkt 253001
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2021–0146; FRL–8682–04–
OCSPP]
Certain New Chemicals or Significant
New Uses; Statements of Findings for
July 2021
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Toxic Substances Control
Act (TSCA) requires EPA to publish in
the Federal Register a statement of its
findings after its review of certain TSCA
notices when EPA makes a finding that
a new chemical substance or significant
new use is not likely to present an
unreasonable risk of injury to health or
the environment. Such statements apply
to premanufacture notices (PMNs),
microbial commercial activity notices
(MCANs), and significant new use
notices (SNUNs) submitted to EPA
under TSCA. This document presents
statements of findings made by EPA on
such submissions during the period
from July 1, 2021 to July 31, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Rebecca Edelstein, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: 202–564–1667 email
address: Edelstein.rebecca@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.
SUMMARY:
52459
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?
This document lists the statements of
findings made by EPA after review of
notices submitted under TSCA section
5(a) that certain new chemical
substances or significant new uses are
not likely to present an unreasonable
risk of injury to health or the
environment. This document presents
statements of findings made by EPA
during the period from July 1, 2021 to
July 31, 2021.
III. What is the Agency’s authority for
taking this action?
TSCA section 5(a)(3) requires EPA to
review a TSCA section 5(a) notice and
make one of the following specific
findings:
• The chemical substance or
significant new use presents an
unreasonable risk of injury to health or
the environment;
• The information available to EPA is
insufficient to permit a reasoned
evaluation of the health and
environmental effects of the chemical
substance or significant new use;
• The information available to EPA is
insufficient to permit a reasoned
evaluation of the health and
environmental effects and the chemical
substance or significant new use may
present an unreasonable risk of injury to
health or the environment;
• The chemical substance is or will
be produced in substantial quantities,
and such substance either enters or may
reasonably be anticipated to enter the
environment in substantial quantities or
SUPPLEMENTARY INFORMATION:
there is or may be significant or
substantial human exposure to the
I. General Information
substance; or
A. Does this action apply to me?
• The chemical substance or
significant new use is not likely to
This action is directed to the public
present an unreasonable risk of injury to
in general. As such, the Agency has not
health or the environment.
attempted to describe the specific
Unreasonable risk findings must be
entities that this action may apply to.
made without consideration of costs or
Although others may be affected, this
action applies directly to the submitters other non-risk factors, including an
unreasonable risk to a potentially
of the PMNs addressed in this action.
exposed or susceptible subpopulation
B. How can I get copies of this document identified as relevant under the
and other related information?
conditions of use. The term ‘‘conditions
The docket for this action, identified
of use’’ is defined in TSCA section 3 to
by docket identification (ID) number
mean ‘‘the circumstances, as determined
EPA–HQ–OPPT–2021–0146, is available by the Administrator, under which a
at https://www.regulations.gov. Due to
chemical substance is intended, known,
the public health concerns related to
or reasonably foreseen to be
COVID–19, the EPA Docket Center
manufactured, processed, distributed in
(EPA/DC) and Reading Room is closed
commerce, used, or disposed of.’’
EPA is required under TSCA section
to visitors with limited exceptions. The
5(g) to publish in the Federal Register
staff continues to provide remote
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
E:\FR\FM\21SEN1.SGM
21SEN1
52460
Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices
a statement of its findings after its
review of a TSCA section 5(a) notice
when EPA makes a finding that a new
chemical substance or significant new
use is not likely to present an
unreasonable risk of injury to health or
the environment. Such statements apply
to PMNs, MCANs, and SNUNs
submitted to EPA under TSCA section
5.
Anyone who plans to manufacture
(which includes import) a new chemical
substance for a non-exempt commercial
purpose and any manufacturer or
processor wishing to engage in a use of
a chemical substance designated by EPA
as a significant new use must submit a
notice to EPA at least 90 days before
commencing manufacture of the new
chemical substance or before engaging
in the significant new use.
The submitter of a notice to EPA for
which EPA has made a finding of ‘‘not
likely to present an unreasonable risk of
injury to health or the environment’’
may commence manufacture of the
chemical substance or manufacture or
processing for the significant new use
notwithstanding any remaining portion
of the applicable review period.
IV. Statements of Administrator
Findings Under TSCA Section 5(a)(3)(C)
In this unit, EPA provides the
following information (to the extent that
such information is not claimed as
EPA case No.
Chemical identity
Website link
J–21–0014, J–21–0015, J–21–
0016, J–21–0017, J–21–0018.
Chromosomally modified Saccharomyces cerevisiae
(Generic Name).
J–21–0019 ....................................
Strain of Escherichia coli modified with genetically-stable, plasmid-borne DNA for the production of
plasmid-borne DNA (Generic Name).
Alkanedioic acid, dialkyl ester, polymer with dialkylalkanediol, alkyl (substituted alkyl)-alkanediol and
heteropolycycle (Generic Name).
P–21–0037: [1,1’-Biphenyl]-3,3’,4,4’-tetracarboxamide,
N3,N3’,N4,N4’-tetraoctyl; CASRN: 2169674–18–2
(Specific)..
P–21–0038: [1,1’-Biphenyl]-3,3’,4,4’-tetracarboxamide,
N3, N3’, N4, N4’-tetradodecyl; CASRN: 2413095–68–
6 (Specific).
1-Propanethiol, 3-(triethoxysilyl)-, reaction products with
polybutadiene; CASRN: 2109699–92–3 (Specific).
P–21–0020 ....................................
P–21–0037, ...................................
P–21–0038 ....................................
P–21–0085 ....................................
lotter on DSK11XQN23PROD with NOTICES1
https://www.epa.gov/system/files/documents/202107/j-21-0014-0018_determination_noncbi_final.pdf.
https://www.epa.gov/system/files/documents/202107/j-21-0019_determination_non-cbi_final.pdf.
https://www.epa.gov/system/files/documents/202107/p-21-0020_determination_non-cbi_final.pdf.
https://www.epa.gov/system/files/documents/202107/p-21-0037-0038_determination_noncbi_final.pdf.
https://www.epa.gov/system/files/documents/202108/p-21-0085_determination_noncbi_final_1.pdf.
of receipt and opportunity to comment
on these applications.
Dated: September 13, 2021.
DATES: Comments must be received on
Madison Le,
or before October 21, 2021.
Director, New Chemicals Division, Office of
ADDRESSES: Submit your comments,
Pollution Prevention and Toxics.
identified by docket identification (ID)
[FR Doc. 2021–20356 Filed 9–20–21; 8:45 am]
number and the File Symbol of interest
BILLING CODE 6560–50–P
as shown in the body of this document,
online at https://www.regulations.gov.
Follow the online instructions for
ENVIRONMENTAL PROTECTION
submitting comments. Do not submit
AGENCY
electronically any information you
[EPA–HQ–OPP–2021–0083; FRL–8793–02–
consider to be Confidential Business
OCSPP]
Information (CBI) or other information
whose disclosure is restricted by statute.
Pesticide Product Registration;
Additional instructions on commenting
Receipt of Applications for New Active
or visiting the docket, along with more
Ingredients (September 2021)
information about dockets generally, is
available at https://www.epa.gov/
AGENCY: Environmental Protection
dockets/about-epa-dockets.
Agency (EPA).
Due to the public health concerns
ACTION: Notice.
related to COVID–19, the EPA/DC and
SUMMARY: EPA has received applications Reading Room is closed to visitors with
to register pesticide products containing limited exceptions. The staff continues
to provide remote customer service via
active ingredients not included in any
email, phone, and webform. For the
currently registered pesticide products.
latest status information on the EPA/DC
Pursuant to the Federal Insecticide,
and docket access, visit https://
Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice www.epa.gov/dockets.
Authority: 15 U.S.C. 2601 et seq.
VerDate Sep<11>2014
22:10 Sep 20, 2021
Confidential Business Information
(CBI)) on the PMNs, MCANs and
SNUNs for which, during this period,
EPA has made findings under TSCA
section 5(a)(3)(C) that the new chemical
substances or significant new uses are
not likely to present an unreasonable
risk of injury to health or the
environment:
• EPA case number assigned to the
TSCA section 5(a) notice.
• Chemical identity (generic name if
the specific name is claimed as CBI).
• Website link to EPA’s decision
document describing the basis of the
‘‘not likely to present an unreasonable
risk’’ finding made by EPA under TSCA
section 5(a)(3)(C).
Jkt 253001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Biopesticides and
Pollution Prevention Division (7511P),
main telephone number: (703) 305–
7090, email address: BPPDFRNotices@
epa.gov; The mailing address for each
contact person is: Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001. As part of
the mailing address, include the contact
person’s name, division, and mail code.
The division to contact is listed at the
end of each pesticide petition summary.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52459-52460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20356]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2021-0146; FRL-8682-04-OCSPP]
Certain New Chemicals or Significant New Uses; Statements of
Findings for July 2021
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Toxic Substances Control Act (TSCA) requires EPA to
publish in the Federal Register a statement of its findings after its
review of certain TSCA notices when EPA makes a finding that a new
chemical substance or significant new use is not likely to present an
unreasonable risk of injury to health or the environment. Such
statements apply to premanufacture notices (PMNs), microbial commercial
activity notices (MCANs), and significant new use notices (SNUNs)
submitted to EPA under TSCA. This document presents statements of
findings made by EPA on such submissions during the period from July 1,
2021 to July 31, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Rebecca Edelstein, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: 202-564-1667 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. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the PMNs addressed in 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-2021-0146, is available at https://www.regulations.gov. 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?
This document lists the statements of findings made by EPA after
review of notices submitted under TSCA section 5(a) that certain new
chemical substances or significant new uses are not likely to present
an unreasonable risk of injury to health or the environment. This
document presents statements of findings made by EPA during the period
from July 1, 2021 to July 31, 2021.
III. What is the Agency's authority for taking this action?
TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a)
notice and make one of the following specific findings:
The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
Unreasonable risk findings must be made without consideration of
costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
under the conditions of use. The term ``conditions of use'' is defined
in TSCA section 3 to mean ``the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.''
EPA is required under TSCA section 5(g) to publish in the Federal
Register
[[Page 52460]]
a statement of its findings after its review of a TSCA section 5(a)
notice when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to PMNs,
MCANs, and SNUNs submitted to EPA under TSCA section 5.
Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA as a significant new use must submit a
notice to EPA at least 90 days before commencing manufacture of the new
chemical substance or before engaging in the significant new use.
The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.
IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)
In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
EPA case number assigned to the TSCA section 5(a) notice.
Chemical identity (generic name if the specific name is
claimed as CBI).
Website link to EPA's decision document describing the
basis of the ``not likely to present an unreasonable risk'' finding
made by EPA under TSCA section 5(a)(3)(C).
------------------------------------------------------------------------
EPA case No. Chemical identity Website link
------------------------------------------------------------------------
J-21-0014, J-21-0015, J-21- Chromosomally https://
0016, J-21-0017, J-21-0018. modified www.epa.gov/
Saccharomyces system/files/
cerevisiae (Generic documents/2021-07/
Name). j-21-0014-
0018_determinatio
n_non-
cbi_final.pdf.
J-21-0019.................... Strain of Escherichia https://
coli modified with www.epa.gov/
genetically-stable, system/files/
plasmid-borne DNA documents/2021-07/
for the production j-21-
of plasmid-borne DNA 0019_determinatio
(Generic Name). n_non-
cbi_final.pdf.
P-21-0020.................... Alkanedioic acid, https://
dialkyl ester, www.epa.gov/
polymer with dialkyl- system/files/
alkanediol, alkyl documents/2021-07/
(substituted alkyl)- p-21-
alkanediol and 0020_determinatio
heteropolycycle n_non-
(Generic Name). cbi_final.pdf.
P-21-0037,................... P-21-0037: [1,1'- https://
P-21-0038.................... Biphenyl]-3,3',4,4'- www.epa.gov/
tetracarboxamide, system/files/
N3,N3',N4,N4'- documents/2021-07/
tetraoctyl; CASRN: p-21-0037-
2169674-18-2 0038_determinatio
(Specific).. n_non-
P-21-0038: [1,1'- cbi_final.pdf.
Biphenyl]-3,3',4,4'-
tetracarboxamide,
N3, N3', N4, N4'-
tetradodecyl; CASRN:
2413095-68-6
(Specific).
P-21-0085.................... 1-Propanethiol, 3- https://
(triethoxysilyl)-, www.epa.gov/
reaction products system/files/
with polybutadiene; documents/2021-08/
CASRN: 2109699-92-3 p-21-
(Specific). 0085_determinatio
n_non-
cbi_final_1.pdf.
------------------------------------------------------------------------
Authority: 15 U.S.C. 2601 et seq.
Dated: September 13, 2021.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2021-20356 Filed 9-20-21; 8:45 am]
BILLING CODE 6560-50-P
