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Papers Addressing Scientific Issues in the Risk Assessment of Metals

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Information about this document as published in the Federal Register.

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Environmental Protection Agency.


Notice of Availability and Public Comment Period.


The U.S. Environmental Protection Agency (EPA) is announcing a public comment period ending Start Printed Page 55052November 7, 2003 for the draft documents titled: Issue Paper on the Environmental Chemistry of Metals; Issue Paper on Metal Exposure Assessment; Issue Paper on the Ecological Effects of Metals; Issue Paper on the Human Health Effects of Metals; and Issue Paper on the Bioavailability and Bioaccumulation of Metals. These draft papers are being made available for public comment consistent with EPA's commitment to provide opportunities for external input. Scientific comments received on these papers will be made available to authors for final disposition. The material contained in these papers may be used in total, or in part, as source material for the Agency's framework for metals risk assessment and EPA's evaluation of this material will therefore include consideration of the Assessment Factors recently published by EPA for use in evaluating the quality of scientific and technical information. In addition to written comments, a public meeting will be held during the public comment period for stakeholders to provide additional input to EPA. Meeting logistics, to include registration information, will be announced in a subsequent Federal Register Notice. The meeting will be held in the Washington D.C. area.


The public comment period begins September 22, 2003, and ends November 7, 2003. Technical comments should be in writing and must be postmarked by November 7, 2003.


The draft issue papers are available primarily via the Internet on the Risk Assessment Forum's web page at​ncea/​raf/​recordisplay.cfm?​deid=​59052. A limited number of paper copies are available from EDOCKET. The EPA Office of Environmental Information (OEI) Docket (Docket I.D. No. OAR-2003-0192); telephone: (202) 566-1742; facsimile: (202) 566-1741; e-mail: 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.

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For information on the public comment period, contact the Office of Environmental Information Docket; telephone: (202) 566-1742; facsimile: (202) 566-1741; e-mail:

For technical information, contact Dr. William P. Wood, Executive Director, Risk Assessment Forum, National Center for Environmental Assessment, Office of Research and Development; telephone: (202) 564-3361; facsimile: (202) 565-0062; or e-mail:

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EPA has established an official public docket for this action under Docket ID No. OAR-2003-0192. 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) 566-1742.

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​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​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,” Start Printed Page 55053“Dockets,” and “EPA Dockets.” Once in the system, select “search,” and then key in Docket ID Number. 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, Attention Docket ID No. OAR-2003-0192. 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.


Many EPA programs are faced with deciding whether and how to regulate metals. These decisions range from site-specific assessments performed to determine, for example, whether a site needs remediation and, if so, to what degree; to national-scale assessments where, for example, national air and water quality standards are being developed; to national hazard or risk ranking conducted for purposes of setting priorities for future analysis, action, or information gathering. In recognition of the unique assessment issues raised by metals and the complexity of addressing these issues consistently across the Agency's various programs, an Agency workgroup, under the auspices of the Science Policy Council, is working to develop an integrated framework for metals risk assessment that will (1) foster consistent application of scientific principles for assessing the hazard and risk for metals, (2) reflect state-of-the-science application of methods and data, (3) incorporate a transparent process (i.e. articulating assumptions and uncertainties), and (4) provide the flexibility to address program-specific issues. Issues discussed in these papers are focused on the inorganic species of metals and metal compounds.

Role of the Issue Papers

In September 2002, EPA discussed plans for the development of the metals assessment framework and associated guidance with the Agency's Science Advisory Board (SAB). That discussion included the context and key issues the Agency believed should be addressed in a metals assessment guidance and also identified the anticipated process for development of such guidance. In their review, the SAB expanded and condensed key technical areas into those represented by the five issue papers identified above. The SAB also emphasized the importance of engaging the outside community so as to contribute to the knowledge base the Agency would draw from in developing the subsequent guidance. As part of the effort to engage stakeholders and the scientific community and to build on existing experience, the Agency has commissioned external experts to lead the development of scientific papers on issues and state-of-the-art approaches to metals risk assessment. (Some individual EPA experts contributed specific discussions on topic(s) for which he or she has scientific expertise or knowledge of current Agency practice). Although Agency technical staff, as well as representatives from other Federal agencies reviewed and commented on previous drafts, the comments were addressed at the discretion of each respective author or group of authors. Therefore, the views expressed are those of the authors and do not necessarily reflect the views or policies of the EPA and should not be construed as implying EPA consent or endorsement. Comments of a technical nature received during the public comment period will be provided to Eastern Research Group for disposition by the authors.

Organizing Questions

For the purpose of organizing comments on the issue papers, the Agency suggests that commenters address the following questions:

1. For the purpose of deriving general principles that can be applied in the assessment of metals, do the issue papers provide an appropriate level of detail?

2. Are there additional chemical, biological and physical processes that should be considered for metals assessment? If so, please describe and provide references.

3. Are you aware of any models, approaches or methods not considered in the reports that if implemented, would substantially reduce uncertainty in the Agency's metal assessments? If so, which ones are ready for application now (or in the next few years), and which types of assessments would benefit most from their application (e.g., hazard ranking/characterization, national, or site-specific assessments)?

4. What other suggestions do you have to improve the utility of these papers as the Agency develops a metals assessment framework?

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Dated: September 12, 2003.

Peter W. Preuss,

Director, National Center for Environmental Assessment.

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[FR Doc. 03-24006 Filed 9-18-03; 12:01 pm]