[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51412-51413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18011]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0116; FRL-9412-16-OCSPP]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for May, June, and July 2022

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 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 May 1, 
2022 to July 31, 2022.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2022-0116, 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. 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 https://www.epa.gov/dockets.

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: [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. 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:
     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.
    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 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).
     J-22-0012, J-22-0013, Genetically modified microorganism 
for the production of a chemical substance (Generic Name).
    To access EPA's decision document describing the basis of the ``not 
likely to present an unreasonable risk'' finding

[[Page 51413]]

made by EPA under TSCA section 5(a)(3)(C), look up the specific case 
number at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: August 15, 2022.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2022-18011 Filed 8-19-22; 8:45 am]
BILLING CODE 6560-50-P


