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, and several made by EPA during earlier time periods that were inadvertently omitted from notices for those time periods that were identified during a quality control review.

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. ( printed page 14838)

II. Statements of Findings Under TSCA Section 5(a)(3)(C)

In this unit, EPA identifies the PMNs, MCANs and SNUNs for which 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.

For the findings made during this period, 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 Confidential Business Information (CBI)), and the date the findings were made:

• P-24-0124, Alkyl alkenoic acid, alkyl ester, polymer with substituted carbomonocycle, substituted alkyl alkyl alkenoate phosphate, substituted alkyl alkyl alkenoate, alkyl alkenoate, heteromonocycle polymer, substitutes alkenyl substituted alkyl ester, alkyl substituted alkyl alkanoate initiated (Generic Name); Decision date: 01/29/2025.

In addition, the following list provides the same information for those cases where EPA made the findings during earlier time periods that were inadvertently omitted from notices for those time periods as identified during a quality control review:

• J-19-0026-0027, Biofuel-producing modified microorganism(s), with chromosomally-borne modifications (Generic Name). Decision date: 01/23/2020.
• J-23-0005-0006, Microorganisms genetically transformed to express an enzyme (Generic Name). Decision date: 11/27/2023.
• P-23-0028, Gelatin and maltodextrin crosslinked with linear and cyclic aliphatic polyisocyanates (Generic Name). Decision date: 12/14/2023.
• P-23-0101, Glycerides from fermentation of genetically modified microorganism, epoxidized (Generic Name). Decision date: 11/13/2024.
• P-23-0102, Glycerides from fermentation of genetically modified microorganism (Generic Name). Decision date: 06/07/2024.
• P-23-0103, Glycerides from fermentation of genetically modified microorganism, epoxidized, reaction products with ethanol (Generic Name). Decision date: 11/13/2024.
• P-23-0143, L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., sodium salts; CASRN 1917323-94-4. Decision date: 08/22/2024.
• P-24-0005, [1,1′-Biphenyl]-4,4′-diol, reaction products with 4-cyclohexylphenol and 2,4,6-trichloro-1,3,5-triazine; CASRN 2561414-35-3. Decision date: 07/16/2024.
• P-24-0106-0107, Glycerides, alkyl, epoxidized, alkyl esters (Generic Name). Decision date: 12/19/2024.

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 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.

90 FR 14837