[Federal Register Volume 68, Number 183 (Monday, September 22, 2003)]
[Notices]
[Pages 55051-55053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24006]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7562-4; OAR-2003-0192]


Papers Addressing Scientific Issues in the Risk Assessment of 
Metals

AGENCY: Environmental Protection Agency.

ACTION: Notice of Availability and Public Comment Period.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a 
public comment period ending

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November 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.

DATES: 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.

ADDRESSES: The draft issue papers are available primarily via the 
Internet on the Risk Assessment Forum's web page at http://cfpub.epa.gov/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: [email protected]. 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 Office of Environmental Information Docket; 
telephone: (202) 566-1742; facsimile: (202) 566-1741; e-mail: [email protected].
    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: [email protected]@epa.gov.

SUPPLEMENTARY INFORMATION: 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 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,''

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``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 [email protected], 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.

Background

    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?

    Dated: September 12, 2003.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 03-24006 Filed 9-18-03; 12:01 pm]
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