Toxic substances: Significant new uses— etc.,

[Federal Register: November 19, 1999 (Volume 64, Number 223)]

[Proposed Rules]

[Page 63275-63277]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19no99-32]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50637; FRL-6385-8]

RIN 2070-AB27

Proposed Revocation of Significant New Use Rules for Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke significant new use rules (SNURs) for 2 substances promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) based on new data. Based on the new data the Agency no longer finds that activities not described in the corresponding TSCA section 5(e) consent order for these chemical substances may result in significant changes in human or environmental exposure.

DATES: Comments, identified by docket control number OPPTS-50637, must be received on or before December 20, 1999. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50637 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: Joe Carra, Deputy Director, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e- mail address: TSCA-Hotline@epa.gov.

For technical information contact: James Alwood, Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (202) 260-1857; e-mail address: alwood.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this proposed rule. Potentially affected categories and entities may include, but are not limited to:

      Examples of Categories

      NAICS

      Potentially Affected Entities

      Chemical manufacturers

      325

      Manufacturers, importers, processors, and users of chemicals

      Petroleum and coal product

      324

      Manufacturers, industries

      importers, processors, and users of chemicals

      This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action applies to certain entities. To determine whether you or your business is affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under ``FOR FURTHER INFORMATION CONTACT.''

   2. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?

      1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations'' and then look up the entry for this document under the ``Federal Register-Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

      2. In person. The Agency has established an official record for this action under docket control number OPPTS-50637. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in

      [[Page 63276]]

      those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.

   3. How and to Whom Do I Submit Comments?

      You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-50637 in the subject line on the first page of your response.

      1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

      2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 260-7093.

      3. Electronically. You may submit your comments electronically by e-mail to: ``oppt.ncic@epa.gov,'' or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-50637. Electronic comments may also be filedonline at many Federal Depository Libraries.

   4. How Should I Handle CBI Information That I Want to Submit to the Agency?

      Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified under ``FOR FURTHER INFORMATION CONTACT.''

   5. What Should I Consider as I Prepare My Comments for EPA?

      We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments:

      1. Explain your views as clearly as possible.

      2. Describe any assumptions that you used.

      3. Provide copies of any technical information and/or data you used that support your views.

      4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

      5. Provide specific examples to illustrate your concerns.

      6. Offer alternative ways to improve the proposed rule.

      7. Make sure to submit your comments by the deadline in this document.

      8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

2. Background

   1. What Action is the Agency Taking?

      In the Federal Register referenced for each substance, OPPTS- 50591C, July 22, 1992, 57 FR 32441 and OPPTS-50615, May 27, 1994, 59 FR 27474 establishing significant new uses for the substances, EPA issued a SNUR. Because of additional data EPA has received for these substances, EPA is proposing to revoke the significant new use and recordkeeping requirements for the following chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides a brief description for the substances, including its premanufacture notice (PMN) number, chemical name (generic name if the specific name is claimed as CBI), CAS number (if assigned), basis for the revocation of the TSCA section 5(e) consent order for the substance, and the CFR citation removed in the regulatory text section of this proposed rule. Further background information for the substances is contained in Unit I.B.2 of this document.

      PMN Number P-88-1763

      Chemical name: Ethane, 2-chloro-1,1,1,2-tetrafluoro-. CAS number: 2837-89-0. Federal Register publication date and reference: July 22, 1992 (57 FR 32441). Docket number: OPPTS-50591C. Basis for revocation of SNUR: EPA received and evaluated the following toxicity testing. A chronic inhalation study in rats showed no significant effects at 2,000, 10,000 or 50,000 parts per million (ppm). For a 90-day inhalation study in mice, the No Observed Adverse Effect Level (NOAEL) was 15,000 ppm with reduced response to sound at 50,000 ppm. In a 90-day inhalation study in rats, the NOAEL was 5,000 ppm (3,200 mg/kg/day) for males based on lower serum triglyceride levels and decreased arousal at 15,000 ppm; the NOAEL for females was 15,000 ppm. In a 28-day inhalation study in rats, the PMN substance caused lethargy at 50,000 ppm. In a developmental toxicity study in rats by inhalation, the only effects were reduced maternal weight gain and reduced response to sound at 50,000 ppm. There were no fetal effects. In a rabbit development toxicity study (inhalation), there was reduced activity in maternal animals at 50,000 ppm. In addition, a cardiac sensitization study in dogs, showed effects at 25,000 ppm but not at 10,000 ppm. The substance was negative in the Ames assay and the mouse micronucleus assay. Based on the assessment of these test data, EPA determined that it could no longer support an unreasonable risk finding under section 5(e) of TSCA and has revoked the consent order. EPA can no longer make the finding that activities not described in the TSCA section 5(e) consent order may result in significant changes in human exposure. CFR citation: 40 CFR 721.3180.

      PMN Number P-93-1235

      Chemical name: 2-Propenoic acid 3-(trimethoxysilyl) propyl ester. CAS number: Not available. Federal Register publication date and reference: May 27, 1994 (59 FR 27474).

      [[Page 63277]]

      Docket number: OPPTS-50615. Basis for revocation of SNUR: Based on short term studies on a series of acrylate substances and long term dermal bioassays on triethylene glycol diacrylate and triethylene glycol dimethacrylate, EPA no longer supports a carcinogenicity concern for this substance. Based on that assessment, EPA can no longer make the finding that activities not described in the PMN may result in significant changes in human exposure. CFR citation: 40 CFR 721.8654.

   2. What is the Agency's Authority for Taking this Action?

      During review of the PMNs submitted for the chemical substances that are the subject of this proposed revocation, EPA concluded that regulation was warranted based on available information that indicated activities not described in the TSCA section 5(e) consent order or the PMN might result in significant changes in human or environmental exposure as described in section 5(a)(2) of TSCA. Based on these findings, SNURs were promulgated.

      EPA has revoked the TSCA section 5(e) consent order that is the basis for one of the SNURs and no longer finds that activities other than those described in the TSCA section 5(e) consent order or the PMN may result in significant changes in human or environmental exposure. The revocation of SNUR provisions for these substances is consistent with the findings set forth in the preamble to the proposed revocation of each individual SNUR.

      Therefore, EPA is proposing to revoke the SNUR provisions for these chemical substances. When this revocation becomes final, EPA will no longer require notice of intent to manufacture, import, or process these substances. In addition, export notification under section 12(b) of TSCA will no longer be required.

3. Regulatory Assessment Requirements

   This proposed rule revokes or eliminates an existing regulatory requirement and does not contain any new or amended requirements. As such, the Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).

   Since this proposed rule does not impose any requirements, it does not contain any information collections subject to approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or require any other action under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

   Nor does it require any prior consultation as specified by Executive Order 12875, entitled ``Enhancing the Intergovernmental Partnership'' (58 FR 58093, October 28, 1993), or special considerations as required by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994) or require OMB review in accordance with Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997).

   On August 4, 1999, President Clinton issued a new executive order on Federalism, Executive Order 13132 (64 FR 43255, August 10, 1999), which will take effect on November 2, 1999. In the interim, the current Executive Order 12612 (52 FR 41685, October 30, 1987) on Federalism still applies. This proposed rule will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 12612.

   In addition, pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined that SNUR revocations, which eliminate requirements without imposing any new ones, have no adverse economic impacts. The Agency's generic certification for SNUR revocations appears on June 2, 1997 (62 FR 29684) (FRL-5597-1) and was provided to the Chief Counsel for Advocacy of the Small Business Administration.

   List of Subjects in 40 CFR Part 721

   Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

   Dated: November 1, 1999.

   Ward Penberthy,

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

   Therefore, it is proposed that 40 CFR part 721 be amended as follows:

   PART 721--[AMENDED]

   1. The authority citation for part 721 would continue to read as follows:

      Authority: 15 U.S.C. 2604, 2607, and 2625 (c).

      Sec. Sec. 721.3180, 721.8654 [Removed]

   2. By removing Sec. Sec. 721.3180 and 721.8654.

      [FR Doc. 99-30241Filed11-18-99; 8:45 am]

      BILLING CODE 6560-50-F