Notice2022-17393
Certain New Chemicals or Significant New Uses; Statements of Findings for March 2022 and April 2022
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 12, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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 submissions 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 March 1, 2022 to April 30, 2022.
Full Text
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<title>Federal Register, Volume 87 Issue 155 (Friday, August 12, 2022)</title>
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[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49821-49822]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17393]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0116; FRL-9412-13-OCSPP]
Certain New Chemicals or Significant New Uses; Statements of
Findings for March 2022 and April 2022
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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 submissions 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 March
1, 2022 to April 30, 2022.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2022-0116, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. 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. For the latest status information on EPA/DC services
and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Rebecca Edelstein, New Chemical
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:
<a href="/cdn-cgi/l/email-protection#563332333a2522333f3878243334333535371633263778313920"><span class="__cf_email__" data-cfemail="d1b4b5b4bda2a5b4b8bfffa3b4b3b4b2b2b091b4a1b0ffb6bea7">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#bce8effffd91f4d3c8d0d5d2d9fcd9ccdd92dbd3ca"><span class="__cf_email__" data-cfemail="1541465654385d7a61797c7b70557065743b727a63">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information that is directed to the public in
general.
B. What action is the Agency taking?
This document lists the statements of findings made by EPA after
review of submissions 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 reporting
period.
C. What is the Agency's authority for taking this action?
TSCA section 5(a)(3) requires EPA to review a submission under TSCA
section 5(a) and make one of the following specific findings:
<bullet> The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
<bullet> 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;
<bullet> 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;
<bullet> 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
<bullet> The chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment.
Under TSCA, the 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.''
TSCA section 5(g) requires EPA to publish in the Federal Register a
statement of its findings after its review of a submission under TSCA
section 5(a) 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
[[Page 49822]]
notwithstanding any remaining portion of the applicable review period.
II. Statements of 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:
The following list provides the EPA case number assigned to the
TSCA section 5(a) submission and the chemical identity (generic name if
the specific name is claimed as CBI).
<bullet> J-21-0020, J-21-0021, J-21-0022, J-21-0023, J-21-0024, J-
21-0025, CinderBio-1 (Generic Name).
<bullet> J-22-0009, J-22-0010, Genetically modified microorganism
for the production of a chemical substance (Generic Name).
<bullet> P-21-0189, Fats and Glyceridic oils, algae; CASRN:
1353573-84-8.
<bullet> J-22-0011, Biofuel producing Saccharomyces cerevisiae
modified, genetically stable (Genetic Name).
<bullet> P-21-0176, Alkane dioic acid, bis (poly aromatic triazine)
alkanoic ether phenoxy ester (Genetic Name).
To access 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), look up the specific case number at <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: July 28, 2022.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2022-17393 Filed 8-11-22; 8:45 am]
BILLING CODE 6560-50-P
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