Notice of Peer-Review Workshop

AGENCY:

Environmental Protection Agency.

ACTION:

Notice.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing that Versar, Inc., an EPA contractor for external scientific peer review, will convene a panel of experts and organize and conduct a peer consultation workshop to discuss neurotoxicity issues using the external review draft document titled, Neurotoxicity of Tetrachloroethylene (Perchloroethylene): Discussion Paper (EPA/600/P-03/005A) as background material. On December 30, 2003 (68 FR 75241), the EPA announced, via a Federal Register notice, a sixty-day public comment period for the draft paper. The paper was prepared by the EPA's National Center for Environmental Assessment-Washington Office (NCEA-W) within the Office of Research and Development. NCEA will consider both the peer consultation advice from this meeting and public comment submissions in the preparation of an IRIS Toxicological Review document on tetrachloroethylene.

DATES:

The one-day peer-review workshop will be held on February 25, 2004, from 8:30 a.m. to 4:30 p.m.

ADDRESSES:

The peer consultation workshop will be held at the Marriott Crystal City Hotel, 1999 Jefferson Davis Highway, Arlington, VA, 22202. Versar, Inc., an EPA contractor, is organizing, convening, and conducting the peer consultation workshop. To attend the workshop as an observer, register by February 23, 2004, by sending an e-mail to Ms. Traci Brody of Versar at tbrody@versar.com. You can also call Ms. Brody at (703) 750-3000 extension 449, or send a facsimile to (703) 642-6954.

The availability of the draft discussion paper and the procedures for submitting comments on the paper were announced in the December 30, 2003 Federal Register notice.

FOR FURTHER INFORMATION CONTACT:

The purpose of the workshop is to elicit comments from the expert panelists on the charge to the peer consultation panel, which is reproduced below. There will be limited time on the agenda for observers to make comments.

For workshop information, registration, and logistics, contact Ms. Traci Brody of Versar, Inc., at tbrody@versar.com. You can also call (703) 750-3000 extension 449, or send a facsimile to (703) 642-6954.

For information on the public comment period, contact Dr. Robert McGaughy; telephone: (202) 564-3244; facsimile: (202) 565-0079; or e-mail: mcgaughy.robert@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Workshop Information

The purpose of the workshop is to elicit comments from the expert panelists on the charge to the peer consultation panel, which is reproduced below.

(a) What are the relative strengths and limitations of the existing human studies of the neurological effects of perc (e.g. sample size, statistical power, potential biases, biological or clinical relevance of the findings, degree of consistency)? Do the EPA materials adequately evaluate these issues?

(b) How consistent are the visual contrast sensitivity effects seen in one residential study (with two exposed groups) with findings of other visual effects seen in other occupational and residential studies (where visual contrast sensitivity was not tested)?

(c) Table 1 of the EPA materials provides a summary of types of neurological tests that have been conducted measuring different effects with different populations exposed to perc. What is the biological and or clinical significance of the measured endpoints in these different studies?

(d) What weight should be attached to reported findings of neurological effects in residential populations at exposure levels below those seen in the occupational studies?

(e) Do the epidemiology studies identify susceptible populations, and in particular do the residential data indicate that children and elderly people may be more susceptible to the effects of perc?

(f) Do the studies reporting decrements in neurological function (including vision) in people exposed to organic solvents add support to conclusions about the hazards of perc?

(g) Can an association be made in the separate studies and in all studies collectively between perc exposure and observed neurotoxicity? Does the set of studies as a whole indicate that perc exposure to the general population presents a potential health hazard?

(h) Are there any published studies or data relevant to the neurotoxic risk which are not included in the discussion paper?

As part of your review, please comment on the use of secondary data in the document. The term “secondary data” for the purpose of this review refers to the use of published or unpublished data in the development of the Agency's assessment of the neurotoxic effects of tetrachloroethylene (perchloroethylene) in humans. Please comment on the Agency's use of secondary data in the discussion paper, relative to the data validity in the context of the use in this assessment.

Members of the public may attend the workshop as observers, and there will be a limited time for comments from the public in the afternoon. If you wish to make comments during the workshop, contact Versar, Inc. at least one week in advance of the meeting. Space is limited, and reservations will be accepted on a first-come, first-served basis.

II. 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 (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752; facsimile: (202) 566-1753; or e-mail: ORD.Docket@epa.gov.

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. ORD2003-0014. 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 ORD.Docket@epa.gov, Attention Docket ID No. ORD2003-0014. 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.