Document

Certain New Chemicals or Significant New Uses; Statements of Findings for February 2017

Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices...

Environmental Protection Agency
  1. [EPA-HQ-OPPT-2017-0141; FRL-9960-36]

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) 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 section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from January 1, 2017 to February 28, 2017.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Greg Schweer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 202-564-8469; email address: .

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: .

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-2017-0141, is available at http://www.regulations.gov or 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. Please review the visitor instructions and additional information about the docket available at http://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 January 1, 2017 to February 28, 2017.

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:

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 ( printed page 19047) 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: J-17-0001-0005; Chemical identity: Saccharomyces cerevisiae modified (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-40.

EPA Case Number: J-17-0006; Chemical identity: Saccharomyces cerevisiae modified (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-42.

EPA Case Number: P-17-0144; Chemical identity: Amines, C36-alkylenedi-, polymers with octahydro-4,7-methano-1H-indenedimethanamine and pyromellitic dianhydride, maleated (CASRN: 2020378-57-6); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-41.

EPA Case Number: P-17-0158; Chemical identity: Perylene bisimide (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-43.

EPA Case Number: P-17-0160; Chemical identity: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide and alkyl 2-propenoate (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-44.

EPA Case Number: P-17-0161; Chemical identity: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide, ethenylbenzene and alkyl 2-propenoate (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-44.

EPA Case Number: P-17-0182; Chemical identity: Alkyldioic acid, polymer with 2,2-dimethyl-1,3-propanediol, heteropolycyclic carboxy acid anhydride and 1,3-propanediol (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-45.

EPA Case Number: P-17-0185; Chemical identity: Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with C18-unsatd. fatty acid trimers, alkylenediamine and hydroxyalkanoic acid (generic name); Web site link: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-46.

Authority: 15 U.S.C. 2601 et seq.

Dated: March 29, 2017.

Maria J. Doa,

Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

[FR Doc. 2017-08246 Filed 4-24-17; 8:45 am]

BILLING CODE 6560-50-P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

82 FR 19046

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Certain New Chemicals or Significant New Uses; Statements of Findings for February 2017,” thefederalregister.org (April 25, 2017), https://thefederalregister.org/documents/2017-08246/certain-new-chemicals-or-significant-new-uses-statements-of-findings-for-february-2017.