03-32056. Neurotoxicity of Tetrachloroethylene (Perchloroethylene): Discussion Paper

AGENCY:

Environmental Protection Agency.

ACTION:

Notice of availability of discussion document and plans for conducting a consultation workshop on the Neurotoxicity of Tetrachloroethylene.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing the availability of an External Review Draft entitled, “Neurotoxicity of Tetrachloroethylene (Perchloroethylene): Discussion Paper” (EPA/600//P-03/005A). EPA will accept public comments on the paper within 60 days of the date of this notice. The document was prepared by the EPA's National Center for Environmental Assessment (NCEA) within the Office of Research and Development.

This document serves as background material for an EPA-sponsored workshop designed to consult with neurotoxicologists about the potential adverse effects of perchloroethylene. Versar, Inc., an EPA contractor, will convene a panel of experts and conduct a one-day meeting to discuss the available information and related issues in evaluating the neurotoxic potential of perchloroethylene to humans under environmental exposure conditions. Details of the expert consultation meeting will be announced at a later date.

NCEA will consider the opinions of the individual consultants as well as the submitted written public comments in preparing an Integrated Risk Information System (IRIS) Toxicological Review of Tetrachloroethylene. The IRIS document, which will evaluate all health effects and will estimate population risks, will be peer-reviewed at a subsequent time.

DATES:

The sixty-day public comment period begins December 30, 2003, and ends March 1, 2004. Technical comments must be postmarked by March 1, 2004. An announcement of the date of the consultation meeting will be made in a forthcoming Federal Register (FR) notice.

ADDRESSES:

The draft document is available primarily via the Internet on the National Center for Environmental Assessment's home page at http://www.epa.gov/​ncea under the What's New and Publications menus. A limited number of paper copies are available from the Technical Information Staff, NCEA; telephone: [phone]; facsimile: 202-565-0050. If you are requesting a paper copy, please provide your name, mailing address, and the document title. Copies are not available from the contractor.

Comments may be submitted electronically, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

For information on the public comment period, contact the Technical Information Staff, National Center for Environmental Assessment; telephone: [phone]; facsimile: 202-565-0050.

SUPPLEMENTARY INFORMATION:

I. How To Get a Copy of the Document and Submit Technical Comments

EPA has established an official public docket for this action under Docket ID No. ORD-2003-0014. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Office of Environmental Information (OEI) Docket in the Headquarters EPA Docket Center, (EPA/DC) EPA West Building, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 [phone], and the telephone number for the OEI Docket is [phone].

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, by facsimile, or by hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” Late comments may be considered if time permits.

If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/​edocket,, and follow the online instructions for submitting comments. To access EPA's electronic public docket from the EPA Internet Home Page, select “Information Sources,” “Dockets,” and “EPA Dockets.” Once in the system, select “search,” and then key in Docket ID No. ORD-2003-0014. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

Comments may be sent by electronic mail (e-mail) to [e-mail], Attention: Docket ID No. ORD-2003-0014. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

You may submit comments on a disk or CD ROM that you mail to the OEI Docket mailing address. These electronic submissions will be accepted in WordPerfect, Word, or ASCII file format. Avoid the use of special characters and any form of encryption.

If you provide comments in writing, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.

In addition to submitting written comments on the discussion paper, you will also have an opportunity at the consultation workshop to ask the experts their opinions and/or clarification of each issue to be discussed at the workshop. Details of the workshop will be announced in a forthcoming Federal Register Notice.

II. Information on the Document

This discussion document and the consultation workshop of neurotoxicology experts are part of the preparation of an IRIS Toxicological Review of Tetrachloroethylene (Perchloroethylene, or perc) by NCEA. In a review of the published literature, NCEA has found that impairment of visual information processing and other adverse neurobehavioral effects have been observed in several studies of employees working in dry cleaning and metal degreasing facilities using perc. Two studies of people living near dry cleaning facilities have also shown neurological effects, and their exposures have been at lower concentrations than the occupationally exposed workers. The discussion document reviews the published reports of neurotoxic effects of perc in humans and animals and discusses the strengths and limitations of the evidence of neurotoxicity. NCEA decided to seek consultation of experts in neurotoxicology to get their opinions about whether these findings for perc and similar findings for other agents imply that perc exposure to the general population results in an appreciable risk of deleterious neurological effects.

Dated: December 22, 2003.

Peter W. Preuss,

Director, National Center for Environmental Assessment.