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June 8-11, 2008 Guadalajara, Mexico.
Offered in conjunction with the 2008 World Congress
on Risk
In cooperation with the International Programme on
Chemical Safety (IPCS)
World
Congress Registration site:
http://www.sra.org/events_2008_world_congress.php
The
date for this course is June 8, 2008. The pre-registration
deadline is May 1, 2008.
Abstract:
Modern approaches to the evaluation of the chemical
toxicity have moved beyond the use of defaults and heavy reliance on
assumptions. Instead, the
state of the science emphasizes early and systematic consideration of
how the chemical causes its effects (potential modes of action), and to
use that information in interpreting toxicological data in hazard
characterization and in conducting on dose-response analysis.
Mode of action is a series of key biological events leading to an
observed toxicological effect supported by experimental observations and
related mechanistic data.
Mode of action is different from with mechanism of action, which
involves understanding of the molecular basis for an effect.
Building on earlier work of
the International Life Sciences Institute Risk Sciences Institute, the
World Health Organization, through the International Programme on
Chemical Safety (IPCS), has established a framework for considering the
weight of evidence of mode of action and human relevance.
This framework, which has been widely adopted and applied by
government agencies and international organizations, sets the scene for
considering the adequacy of
mechanistic data for application in the subsequent dose-response
analysis along a continuum of increasingly data informed approaches
which range from the use of traditional defaults, to group-specific
approaches, to chemical-specific approaches.
Additional guidance
developed by IPCS informs the choice and application of data that can be
used to replace defaults in dose-response with chemical specific
adjustment factors (CSAFs), based on consideration of relevant data on
mode of action.
This
full-day workshop will provide a brief review of basic concepts of risk
assessment, including hazard characterization and dose-response
analysis, with an emphasis on how recent developments affect the
approaches used. The focus
will be on the IPCS methodology for consideration of weight of evidence
of mode of action and chemical specific adjustment factors, including
examples.
Course Overview and Goals:
Introduction to
the Risk Assessment Paradigm
Hazard Characterization
Assessing Weight of Evidence
Considering Mechanistic Data in Hazard Characterization
The IPCS Mode of Action/Human
Relevance (MOA/HR) Framework
Examples
Dose-Response Analysis
Cancer/Non-Cancer
Considering Mechanistic Data in Dose Response Analysis
The IPCS CSAF Guidance
Examples
Where can you learn more?
Instructors
Dr. Lynne Haber
has 14 years of experience in developing human health risk values
for a variety of government agencies and private sponsors, and in
research related to risk assessment methods. She is the Research
Program Manager at Toxicology Excellence for Risk Assessment (TERA).
Her interests include the improved use of mechanistic data in risk
assessment, including incorporation of mode of action data in cancer
risk assessment, and use of data to replace default uncertainty
factors. She has been the lead author, coauthor, or reviewer of dozens
of detailed assessment documents. She has served as a panel chairperson
or panel member for scientific peer reviews organized by TERA,
EPA, and other U.S. and foreign government agencies. She has also
served on two panels for the NAS/NRC. Lynne is active in communicating
her findings to the broader scientific community through participation
in professional societies, teaching courses in risk assessment methods,
routine publication of her work, service as an editorial reviewer for
scientific journals, and through presentation of invited lecturers. Her
published work includes lead authorship of the chapter on noncancer risk
assessment (including dose-response modeling methods) for Pattys
Toxicology, and an invited review on the use of mechanistic data in risk
assessment. She was also the coauthor for an analysis of the effect of
genetic polymorphisms on human variability in dose, using PBPK and Monte
Carlo modeling. She has published on methods for deriving occupational
exposure limits, and on incorporating toxicokinetic data into risk
assessment. She served as vice president and councilor of the SRA
Dose-Response specialty group and as an officer of the SOT Risk
Assessment Specialty Section (RASS), is a Diplomate of the American
Board of Toxicology.
Ms. Bette Meek
has a background in toxicology and extensive
experience in assessment and the management of chemical assessment
programs within the Government of Canada. She is currently on
interchange from Health Canada to the University of Ottawa for a two
year period, where she has been appointed the Associate Director of
Chemical Risk Assessment in the McLaughlin Institute of Population
Health. Bettes most recent experience involved developing and
implementing process and methodology for the health assessment of
Existing Substances under the Canadian Environmental Protection Act (CEPA)
including the precedent setting mandate to
categorize and screen priorities from among the 23,000 substances
included on the Domestic Substances List.
Prior to managing the Existing Substances
program, Ms. Meek managed assessment programs for contaminants in
drinking water and air. With colleagues within Canada and
internationally, she has contributed to or led initiatives to increase
transparency, defensibility and efficiency in health risk assessment
having convened and participated in
initiatives in this area for numerous organizations including the
International Programme on Chemical Safety, the World Health
Organization, the International Life Sciences Institute, the U.S.
Environmental Protection Agency, the U.S. National Academy of Sciences
and the U.S. National Institute for Environmental Health Sciences.
Specific areas of focus have included development of analytical
frameworks for weight of evidence for mode of action, increasing
incorporation of biological data in dose-response analysis and refining
models of peer input, consultation and review.
She has also authored over 150 publications
in the area of chemical risk assessment and received several awards for
contribution in this domain.
Dr. Jay Zhao
had formal training in medicine,
public health, and toxicology, with more than 18 years of working and
teaching experience in environmental toxicology.
During the past
10 years, he has been
developing human health risk values for various government
agencies and private sponsors. Prior to his current position with
the U.S. EPA, he was the risk assessment program manager with Toxicology
Excellence for Risk Assessment (TERA). His primary
interests include improving the use of the latest technology in dose
response assessment, such as application of advanced mathematical
modeling in dose response analysis, incorporation of toxicokinetics and
toxicodynamics in quantitative estimation of interspecies and
intraspecies variations, and promoting the application of these new
methodologies in chemical risk assessment through providing training to
the public. Together with colleagues at
TERA, he has developed a series of risk assessment courses focused
on dose response assessment, including dose response in noncancer risk
assessment, dosimetric adjustment in risk assessment, benchmark dose
modeling, chemical specific adjustment factor, and case studies on
conducing dose response assessment in cancer and noncancer risk
assessment. He has had
numerous invitations from international, national, and local government
agencies, organizations and universities to provide trainings on
chemical risk assessment. In
addition to his active role in risk assessment training, he has been the
lead author, coauthor, or reviewer of various comprehensive chemical
assessment documents and manuscripts. Dr. Zhao served as president
and councilor of the Ohio SRA, and is also a Diplomate of the American
Board of Toxicology.
Registration
More information can be obtained from Dr. Lynne Haber
haber@tera.org, telephone 513-542-7475 ext. 17, fax 513-542-7487.
Related Links
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