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Beyond Science and
Decisions: From Issue Identification to Dose-Response Assessment
Workshop I Date: March 16-18, 2010
Location: Texas Commission on Environmental Quality; Austin, Texas
Background & Purpose:
To continue the discussion
set forth by Science and Decisions: Advancement of Risk Assessment (NAS,
2008), and conducted under the aegis of the Alliance for Risk Assessment (ARA),
a series of three meetings is envisioned over the course of a year. The
ultimate goal is consensus among participants on guidance highlighting key
considerations for applying a variety of dose-response techniques to
different risk assessment settings, as characterized in early problem
formulation or issue identification. The workshops will focus on purpose-specific dose-response assessment, which
integrates relevant available data and is illustrated by case studies. The
workshop series will include brainstorming and selection of case studies
at the first meeting, evaluation of the case studies during the
second, and build consensus on purpose-specific dose-response assessment
methods during the third.
General Workshop Objectives:
- Build off of the NAS (2008) report on improving the risk assessment process
to develop practical guidance for use by risk managers at a variety of
levels (e.g., states, regional managers, people in a variety of agencies,
and in the private sector) for risk assessment techniques applicable to
specific problem formulations.
- Implement a multi-stakeholder approach to share information, ideas and
techniques in support of developing practical problem-driven risk assessment
guidance.
Specific Workshop Objectives:
- Identify useful dose-response techniques for specified problem
formulations, including characterization of assumptions, strengths and
limitations, and how the techniques address key considerations in the
dose-response.
- These techniques should appropriately reflect the relevant biology
(including the biology of thresholds), and mode of action information, at a
level of detail appropriate for the problem formulation.
- Provide methods to explicitly address human variability in cancer
assessment, and enhance the consideration of human variability in noncancer
assessment, including explicit consideration of underlying disease
processes.
- Identify methods for calculating the probability of response for noncancer
endpoints.
- Develop peer reviewed publications and/or a guidance document that will
serve as a resource for regulators and scientists to refer to for guidance
on key considerations for applying selected dose-response techniques for
various problem formulations, with suggested techniques and resources.
Roles
Steering Committee
The Alliance for Risk Assessment Steering Committee (SC) will provide
guidance and oversight of the workshop series and case study selection, and
serve as liaison between the Expert Panel and satellite meetings. The
Steering Committee will have the final decision on charge questions after
consultation with the DRAC, and will have the final decision on members of
the Expert Panel after a review of all nominations. The SC consists of 9
representatives of state, tribal, and federal government, academia, and
environmental NGOs. See
www.allianceforrisk.org/ARA_Steering_Committee.htm.
Expert Panel &
Nominations
The Panel will provide guidance and oversight during each of the second and
third
workshops. The Panel will consist of two co-chairs and 10 others with
extensive expertise in risk assessment methods and toxicology. They will
facilitate the brainstorming and selection of case studies during the first
workshop, lead evaluation of the case studies during the second workshop,
and build consensus on guidance for dose-response assessment methods during
the third workshop. PANEL NOMINATIONS CLOSED DECEMBER
31st 2009. Please contact Oliver Kroner
for more information.
Dose Response Advisory Committee (DRAC)
The Dose-Response Advisory Committee will be composed of state, federal,
industry, and NGO representatives. This group will represent the various
sponsors in the development of workshop structure, charge questions,
development of Panel nominations, and the recruitment of presenters. The DRAC will have the final decision on workshop structure, presenters, and
content, after consultation with the ARA Steering Committee.
Invited Experts
Workshop 1 will begin with several 20-30 minute presentations of recent work
that highlights relevant ongoing work and DR assessment methods. Presenters
will be selected by the DRAC after consultation with the Steering Committee.
Workshop 1
Workshop 1 will begin with several 20- or
30-minute presentations that highlight relevant, recent or ongoing work in
issue identification and assessment methods. Presenters will be selected by
the DRAC after consultation with the Steering Committee. A brief report will
be prepared from each meeting by TERA that summarizes presentations,
brainstorming, Panel discussions, and identified dose-response assessment
techniques and case studies. Final reports will be prepared based on
participant comments and
will be posted on TERA and the ARA websites.
For more information, please contact
Oliver Kroner.
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