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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.