[Federal Register: October 30, 2001 (Volume 66, Number 210)]
[Notices]
[Page 54768-54769]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc01-61]
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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
Rondberg.Sam@epamail.epa.gov 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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