Notice2023-05680
Certain New Chemicals or Significant New Uses; Statements of Findings for December 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
March 21, 2023
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 December 1, 2022, to December 31, 2022.
Full Text
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<title>Federal Register, Volume 88 Issue 54 (Tuesday, March 21, 2023)</title>
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[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16976-16977]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05680]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0116; FRL-9412-15-OCSPP]
Certain New Chemicals or Significant New Uses; Statements of
Findings for December 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
December 1, 2022, to December 31, 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#93f6f7f6ffe0e7f6fafdbde1f6f1f6f0f0f2d3f6e3f2bdf4fce5"><span class="__cf_email__" data-cfemail="0f6a6b6a637c7b6a6661217d6a6d6a6c6c6e4f6a7f6e21686079">[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#aafef9e9eb87e2c5dec6c3c4cfeacfdacb84cdc5dc"><span class="__cf_email__" data-cfemail="cf9b9c8c8ee287a0bba3a6a1aa8faabfaee1a8a0b9">[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 several specific findings pertaining to
whether the substance may present unreasonable risk of injury to health
or the environment. Among those potential findings is that the chemical
substance or significant new use is not likely to present an
unreasonable risk of injury to health or the environment per TSCA
Section 5(a)(3)(C).
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 notwithstanding
any remaining portion of the applicable review period.
[[Page 16977]]
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
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-22-0019-0020, Saccharomyces cerevisiae, chromosomal
integration modification (Generic Name).
<bullet> J-22-0022-0025, Microorganisms stably transformed to
manufacture PHA (Generic Name).
<bullet> J-23-0002, Microorganism stably transformed to express a
recombinant protein (Generic Name).
<bullet> P-22-0017, 1-Eicosanol, manuf. of, distn., residues;
CASRN: 2682937-26-2 (Specific 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: March 14, 2023.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2023-05680 Filed 3-20-23; 8:45 am]
BILLING CODE 6560-50-P
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