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SAVE THE DATE FOR NEXT MEETING! MAY 21-24 2012, AUSTIN, TX
 Workshop Series General Information
Workshop I - March 16-18, 2010, Texas Commission on Environmental Quality; Austin, Texas
Workshop II - October 11-13, 2010, Crystal City, Virginia (In
tandem with the Federal & State Risk Assessment & Toxicology
Committee)
Workshop III - May 4, 5, & 6,
2011, Noblis; 3150 Fairview Park Drive South, Falls Church,
Virginia
Background & Purpose:
The workshop series is continuing and expanding upon the discussion set forth by Science and Decisions: Advancement of Risk Assessment (NAS, 2009); these meetings are conducted under the aegis of the Alliance for Risk Assessment (ARA), a broad-based non-profit, government and NGO coalition. The first phase of the workshop series was three workshops over the course of about a year. The first workshop focused on brainstorming and selection of case studies illustrating various dose-response methods for different problem formulations. A broad range of case studies proposed at the first workshop was then developed by workshop participants and discussed by the Science Panel at the second workshop. In considering the case studies, the Science Panel members provided input on the utility of the case study methods to address specific problem formulations, and identified areas for additional development. The Science Panel and interested workshop participants developed an interactive framework for organizing case study methods, and the Panel used the framework to identify additional case studies that address important gaps in methodology; the third workshop focused on these case studies and associated issues. The framework references specific risk assessment methods, illustrated by case studies, and is intended for use by risk assessors and managers in a variety of settings (e.g., federal, state, and local agencies, industry). It is based on the fundamental premise that the appropriate methodology for dose-response assessment is necessarily based on objectives specific to that application, including varying levels of analysis. A manuscript describing the framework and workshop process is in preparation.
The workshop series is transitioning to an “evergreen” approach, including a standing panel that reviews methods and issues on a semi-annual basis, leading to updating of the framework.
General Workshop Objectives:
- Additionally develop the content of the NAS (2009) report on improving the risk assessment process to develop a compendium of practical, problem-driven approaches for “fit for purpose” risk assessments, linking methods with specific problem formulations (e.g., prioritization, screening, and in-depth assessment) 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).
- Implement a multi-stakeholder approach to share information, ideas and techniques in support of developing practical problem-driven risk assessment methods compendium.
Specific Workshop Objectives:
- Identify useful dose-response techniques for specific issues, including consideration of
relevant data, 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 identified issue.
- 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, as appropriate for the relevant risk assessment context.
- Identify methods for calculating the probability of response for noncancer endpoints, as appropriate for the relevant risk assessment context.
- Develop a risk methods compendium that will serve as a resource for regulators and scientists 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 (ARA SC) provides oversight of the workshop series. The Steering Committee advises the DRAC on charge questions and has the final decision on members of the Expert Panel after a review of all nominations. The ARA SC consists of a broad range of representatives from state, tribal, and federal government, academia, and environmental NGOs. See http://www.allianceforrisk.org/ARA_Steering_Committee.htm.
Expert Panel &
Nominations
The Panel provides input on case study methods being proposed to enhance the risk framework. Panel members provide input on the utility of the case study methods to address specific problem formulations, and identify areas for additional development of the case study and/or method. Core panel members will serve for 2-3 years; members may be added to the standing panel to ensure expertise on specific topics. NOW ACCEPTING SCIENCE PANEL NOMINATIONS. Please confirm interest with nominee and submit a CV to Oliver Kroner at Kroner@tera.org by January 26, 2012. Panel members are sought from a diversity of affiliations and areas of expertise, particularly biology/toxicology, risk assessment, and statistical/modeling.
Dose Response Advisory Committee (DRAC)
The workshop sponsors include state, federal, industry, and NGO representatives. The Dose-Response Advisory Committee represents the various sponsors and has final decision in the development of workshop structure and charge questions, and the recruitment of presenters, after consultation with the ARA Steering Committee.
References
Ginsberg et al. The NRC Silver Book: The Case for Improving Non-Cancer Risk Assessment. Guest Perspective. Risk Policy Report 17 (37) Sept. 14, 2010 link
Hegstad M. Two Years On, Assessors Urge NAS to Clarify Advice on Linear Risk Method. Guest Perspective. Risk Policy Report 17(43). October 26, 2010. link
International Programme for Chemical Safety
(2005) IPCS Framework for Analyzing the Relevance of a Cancer Mode of Action
for Humans.
http://www.informaworld.com/smpp/content~db=all~content=a769411607
Meek B, Dourson M. Integrating Cancer and Non-Cancer Dose Response Assessment Approaches to Risk Assessment: The Role of Mode of Action. Risk Policy Report 17(39) September, 28, 2010 link
National Academy of Sciences (2009). Science
and Decisions: Advancing Risk Assessment (NAS Final Report).
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=202175
United States (2005). Guidelines for
Carcinogen Risk Assessment. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=116283
Scientific Society Presentations
Society for Risk Analysis 2010 Annual Meeting Presentations from the symposium on “Beyond Science and Decisions
2011 Society for Risk Analysis Symposium: Improving Problem
Formulation and Dose-Response Beyond Science
and Decisions
Sponsored by: Dose-Response Specialty Group
Co-Chairs: Julie Fitzpatrick,
Rick Becker
For more information, please contact
Oliver Kroner.
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Workshop Collaborators
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