E9-18195. Product Stewardship Program for Six Siloxanes Conducted Under a Memorandum of Understanding (MOU) Signed by EPA and The Dow Corning Corporation; Notice of Receipt and Availability of the MOU Data

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This document announces the receipt of toxicity and exposure data and information that were developed through a Product Stewardship Program (PSP) agreed upon under a Memorandum of Understanding (MOU) signed by EPA and Dow Corning Corporation. The MOU covered six siloxanes deemed representative of a broad class of siloxanes that have widespread use in a variety of industrial and consumer applications. A docket has been established to make data and information developed through this MOU available to the public.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Robert Jones, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, and may be of particular interest to those persons who are or may be interested in the information developed on the six siloxane chemicals subject to the PSP MOU. If you have any questions regarding the completion of the MOU or the availability of the information from this effort, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2009-0180. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. Background

The 30th Report of the TSCA Interagency Testing Committee (ITC) to the EPA Administrator recommended 56 silicone chemicals for health effects testing to meet data needs expressed by the U.S. Food and Drug Administration (57 FR 30608, July 9, 1992). The six siloxanes covered by this MOU between EPA and the Dow Corning Corporation are included among the 56 silicone chemicals recommended by the ITC in its 30th Report to EPA. In response to that ITC recommendation, EPA issued a final TSCA section 8(d) information reporting rule (58 FR 28511, May 14, 1993) requiring manufacturers, importers, and processors of the 56 silicone chemicals to submit to EPA unpublished health and safety data on those chemicals; information concerning the uses of and exposure to the chemicals was submitted voluntarily by industry directly to the ITC. On review of the TSCA section 8(d) information materials received, the ITC considered the need for formal designations for testing under section 4 of TSCA. EPA issued a notice titled Testing Consent Agreement; Development for Octamethylcyclotetrasiloxane (OMCTS); Solicitation of Interested Parties (53 FR 11341, April 6, 1988) and a final rule titled Testing Consent Order for Octamethylcyclotetrasiloxane (54 FR 818, January 10, 1989) docket number OPTS-42071B.

These actions lead to the more broadly based discussion of an appropriate PSP based on the Responsible Care principles developed by the Chemical Manufacturers Association—now the American Chemistry Council. Dow Corning Corporation agreed to develop a specific PSP for six siloxane chemicals including: Octamethylcyclotetrasiloxane (D4) CAS No. 556-67-2; decamethylcyclopentasiloxane (D5) CAS No. 541-02-6; dodecamethylcyclohexasiloxane (D6) CAS No. 540-97-6; hexamethyldisiloxane (HMDS) CAS No. 107-46-0; polydimethylsiloxane (PDMS 10 cst) CAS No. 63148-62-9; and polydimethylsiloxane (PDMS 350 cst) CAS No. 63148-62-9. These were selected because they are representative of the broad class of siloxane materials that have widespread use in industrial and consumer applications. Dow Corning Corporation and EPA signed the formal PSP MOU on April 9, 1996. The MOU was initiated in 1996 with a baseline report, and a Project Plan for assessing exposure. The MOU was monitored through annual progress reports and regular scientific briefings with EPA.

This notice acknowledges that work agreed upon in the MOU has been received and announces that the data and information produced under the MOU is available in the public docket at http://www.regulations.gov at docket number EPA-HQ-OPPT-2009-0180. Materials include annual progress reports, over 88 reports assessing potential toxicity and exposures concerning the six siloxanes, and related TSCA section 8(e) notices and FYI submissions. The MOU and a baseline report describe the PSP based on “Implementing Product Stewardship: a Resource Guide,” Chemical Manufacturers Association (CMA), 1992. The program included a description of the PSP goals, plans for communicating health and safety information, toxicity testing, exposure assessment and monitoring, identifying any additional data needs for risk assessment, development and implementation of pollution prevention, waste minimization, and exposure reduction plans, and exercising its environmental responsibility through design of processes, products, packaging, etc. to minimize the consumption of natural resources and energy and eliminate, where feasible, generation of waste materials and releases to the environment.

List of Subjects

• Environmental protection
• Hazardous chemicals
• Siloxanes

Dated: July 21, 2009.

Jim Willis,

Director, Chemical Control Division, Office of Prevention, Pesticides and Toxic Substances.