Certain New Chemicals or Significant New Uses; Statements of Findings for May 2021
| Published date | 15 July 2021 |
| Citation | 86 FR 37325 |
| Record Number | 2021-15086 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 86 Issue 133 (Thursday, July 15, 2021)
[Federal Register Volume 86, Number 133 (Thursday, July 15, 2021)]
[Notices]
[Pages 37325-37326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15086]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2021-0146; FRL-8682-01-OCSPP]
Certain New Chemicals or Significant New Uses; Statements of
Findings for May 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 May 1,
2021 to May 31, 2021.
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].
[[Page 37326]]
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 online at http://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.
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 May 1, 2021 to May 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 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-21-0010....................... Genetically https://
modified www.epa.gov/
microorganism for reviewing-new-
the production of chemicals-under-
a chemical toxic-substances-
substance control-act-tsca/
(Generic Name). tsca-section-5a3c-
determination-
509.
------------------------------------------------------------------------
Authority: 15 U.S.C. 2601 et seq.
Dated: July 7, 2021.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2021-15086 Filed 7-14-21; 8:45 am]
BILLING CODE 6560-50-P
