[Federal Register Volume 66, Number 210 (Tuesday, October 30, 2001)]
[Notices]
[Pages 54768-54769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27285]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7094-9]


EPA Science Advisory Board Environmental Health Committee Review 
of the Trichloroethylene (TCE) Health Risk Assessment Synthesis and 
Characterization Draft Document; Request for Nominations

ACTION: Request for nominations to the Environmental Health Committee 
(EHC) of the Environmental Protection Agency's (EPA) Science Advisory 
Board (SAB) for its review of the Agency's draft Trichloroethylene 
(TCE) Health Risk Assessment.

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SUMMARY: The U.S. Environmental Protection Agency Science Advisory 
Board (SAB) is announcing the formation of a Panel to review the 
Agency's draft Trichloroethylene (TCE) Health Risk Assessment. The SAB 
is soliciting nominations to augment the existing EHC to form this 
Panel. The EPA Science Advisory Board was established to provide 
independent scientific and technical advice, consultation, and 
recommendations to the EPA Administrator on the technical bases for EPA 
regulations. In this sense, the Board functions as a technical peer 
review panel.
    Any interested person or organization may nominate qualified 
individuals for membership on the panel. Individuals should have 
expertise in one or more of the following areas: risk assessment and 
the application of the Agency's risk assessment guidelines; toxicology 
including carcinogenicity, with a focus on mechanisms of action and 
pharmacokinetic models; and molecular genetics. Nominees should be 
identified by name, occupation, position, address and telephone number. 
To be considered, all nominations must include a current resume 
providing the nominee's background, experience and qualifications.

Background

    EPA's Office of Research and Development (ORD) has completed an 
external review draft assessing the health risks of trichloroethylene. 
TCE is a major contaminant of concern in EPA's air, water, and waste 
programs. This draft was published for public comment on September 19, 
2001 at 66 FR 48257-48258. EPA's regulatory program and regional 
offices have identified TCE as among the highest priorities for a new 
assessment.
    This assessment was also shaped by several new developments in risk 
assessment. The practice of risk assessment is evolving from a focus on 
one toxic effect of one pollutant in one environmental medium toward 
integrated assessments covering multiple effects and multiple media and 
incorporating information about mode of action, uncertainty, human 
variation, and cumulative effects of multiple pollutants in different 
media. This evolution responds to recommendations of the National 
Research Council, which have been embraced in EPA's proposed cancer 
guidelines.
    This draft assessment takes on the new directions in risk 
assessment that EPA and others have advocated. The assessment discusses 
the possibility that children, infants, and the developing fetus may 
differ from adults with respect to susceptibility to TCE's toxic 
effects. The assessment addresses cumulative risks by discussing the 
implications of other chlorinated solvents and agents that have 
metabolic pathways, potential modes of action, and toxic effects 
similar to TCE. The assessment implements principles of the proposed 
cancer guidelines by emphasizing characterization discussions, using 
mode-of-action information, and identifying susceptible populations.
    The issues surrounding TCE are quite complex, with extensive 
information in some areas and relatively little information in others. 
The ORD initiated development of 16 peer-reviewed state-of-the-science 
papers that were published in Environmental Health Perspectives (vol. 
108, suppl. 2, May 2000). These papers, which provide the primary 
scientific support for the assessment, were written by well-recognized 
scientists carrying out research on TCE or its metabolites.
    To accomplish this review, the Science Advisory Board (SAB) will 
convene a Panel to address the following draft Charge:
    (a) Does the assessment adequately discuss the likelihood that 
trichloroethylene (TCE) acts through multiple metabolites and multiple 
modes of action?
    (b) Is the cancer weight-of-evidence characterization adequately 
supported?
    (c) A new feature of the cancer database is molecular information 
on the von Hippel-Lindau tumor suppressor gene. Is this information 
adequately discussed and are the conclusions appropriate?
    (d) Does the assessment adequately discuss the use of multiple 
critical effects in developing an oral reference dose (RfD) and 
inhalation reference concentration (RfC) for effects other than cancer? 
Are the uncertainty factors well discussed and well supported?
    (e) Does the assessment adequately discuss the derivation of a 
range of estimates for the cancer risk? Are there any studies that 
should/should not have been included?
    (f) Please comment on the use of calibrated models and uncertainty 
analysis to address the question of pharmacokinetic model uncertainty.
    (g) Is it appropriate to consider background exposures and other 
characteristics of an exposed population as modulating the risk of TCE 
exposure in that population?
    (h) Do the data support identifying risk factors that may be 
associated with increased risks from TCE exposure? Are there any risk 
factors that should/should not have been included?
    (i) Do the data support the possibility that TCE can affect 
children and adults differently? Should this be reflected in the 
quantitative assessment?
    The criteria for selecting Panel members are that these persons be 
recognized experts in their fields; that they be as impartial and 
objective as possible; that they represent an array of backgrounds and 
perspectives (within their disciplines); and that they be available to 
participate fully in the review, which will be conducted over a 
relatively short time frame (i.e., within approximately four months). 
Panel members will be asked to attend at least one public meeting 
followed by at least one public telephone conference meeting over the 
course of four months; they will be asked to participate in the 
discussion of key issues and assumptions at these meetings, and they 
will be asked to review and to help finalize the products and outputs 
of the panel. The panel will make recommendations to the Executive 
Committee (EC) of the SAB for approval of the Board's report and 
transmittal to the Administrator.

[[Page 54769]]

    Nominations should be submitted to Mr. Samuel Rondberg, Designated 
Federal Officer, EPA Science Advisory Board via e-mail to 
[email protected] followed by ``hard copy'' via U.S. mail 
addressed to Mr. Samuel Rondberg, Designated Federal Officer, EPA 
Science Advisory Board (1400A), U.S. Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460, telephone (301) 
812-2560, no later than November 9, 2001. The Agency will not formally 
acknowledge or respond to nominations.

General Information

    Additional information concerning the EPA Science Advisory Board, 
its structure, function, and composition, may be found on the SAB Web 
site (http://www.epa.gov/sab) and in the Science Advisory Board FY2000 
Annual Staff Report which is available from the SAB Publications Staff 
at (202) 564-4533 or via fax at (202) 501-0256.

    Dated: October 22, 2001.
Donald G. Barnes,
Staff Director, Science Advisory Board.
[FR Doc. 01-27285 Filed 10-29-01; 8:45 am]
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