|Beyond Science and Decisions: From Problem Formulation to Dose-Response Assessment|
Date: June 9-10, 2015
The workshop seeks to advance the recommendations of the NAS (2009) and subsequent framework of ARA (Meek et al., 2013) on problem formulation and dose-response analysis, through review of illustrative case studies for further development of risk methods. This was the ninth workshop in an ongoing series hosted by the Alliance for Risk Assessment, engaging risk scientists from federal and state governments, industry, academia, consultative, and non-profit organizations. Several talks and case studies were presented and reviewed by a panel of risk scientists, with a focus on adverse outcome pathways and a framework for evaluating risk from exposures to flame retardants. Methods approved by the Science Panel will be integrated within the Dose-Response Framework, found at www.chemicalriskassessment.org.
Workshop Series General Information
Workshop VIII - May 21-22, 2014, Austin, TX, Webinar
Workshop VII - November 13, 2013, Webinar
Workshop VI - May 28-29, 2013, Arlington, VA, U.S. Environmental Protection Agency
Workshop IV - May 22-24, 2012, Austin, Texas, Texas Commission on Environmental Quality
Workshop II - October 11-13, 2010, Crystal City, Virginia (In tandem with the Federal & State Risk Assessment & Toxicology Committee)
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 was held at the Texas Commission on Environmental Quality (TCEQ), Austin, Texas, and 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, held in Crystal City, Virginia. 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 (http://chemicalriskassessment.org/methods/) 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 (held at the Noblis facilities in Falls Church, Virginia) 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. The framework has been revised since the initial development, and is currently available as a beta version of Framework 2.0. A manuscript describing the framework and workshop process was published in 2013 and is available via open access .
The workshop series has transitioned to an “evergreen” approach, including a standing panel that reviews methods and issues on a semi-annual basis, leading to updating of the framework. The standing panel was constituted in February 2012. Core panel members serve for 2-3 years; members may be added to the standing panel to ensure expertise on specific topics. Panel members were selected by the ARA Steering Committee to reflect a diversity of affiliations and areas of expertise, particularly biology/toxicology, risk assessment, and statistical/modeling. Under this evergreen approach, the workshop series is funded by organizations that desire technical feedback on the methods underlying case studies that might fit within the developing framework, from small grants to continue the development of the framework, and by donated time and in-kind resources. In addition, the funding is anticipated to cover a limited number of case studies and/or methods papers on broader topics chosen by the science panel. 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. Inclusion of a method or case study in the framework as an illustration of a useful technique does not imply panel acceptance of the chemical-specific outcome.
Meek, M.E., M. Bolger, J.S. Bus, J. Christopher, R.B. Conolly, R.J. Lewis, G. Paoli, R. Schoeny, L.T. Haber, A.B. Rosenstein, M.L. Dourson. 2013. A Framework for Fit-for-Purpose Dose Response Assessment. Regul. Toxicol. Pharmacol. 66(2):234-40. Doi: 10.1016/j.yrtph.2013.03.012 Available at http://www.sciencedirect.com/science/article/pii/S0273230013000500
General Workshop Objectives:
Specific Workshop Objectives:
Science Panel &
Dose Response Advisory Committee (DRAC)
The "Beyond Science and Decisions: From Problem Formulation to Dose Response" Alliance for Risk Assessment (ARA) project is funded through donations of money for travel, meeting expenses and contractor time, and by donated time. The distribution of donated money for the first 3 meetings in this series was 53%, 32%, and 14%, for industry, government and NGO groups, respectively; the distribution of donated time was roughly 33% for each sector. The distributions of time and money were different because many government and NGO groups were able to donate time, but not money.
The continuation of this project through the development of a standing science panel in meetings 4 and onward is envisioned to be based on donated money and time, as before. These resources are anticipated to come from different organizations that desire technical feedback on case studies that might fit within the developing framework, and from small grants to continue the development of the framework. In addition, this funding is anticipated to cover a limited number of case studies and/or methods papers on broader topics chosen by the science panel. In 2012, the distribution of grant money is anticipated to be 40%, 48%, and 13%, for industry, government and NGO groups, respectively. The distribution of donated time is anticipated to be similar across sectors.
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
Hegstad M. Alliance Plans Panel To Address Key Scientific Issues In Risk Assessment. Risk Policy Report 18, (29). July 19, 2011 link
Hegstad M. EPA Framework Emphasizes Risk Management Options In Assessments Risk Policy Report 18(22). May 31, 2011. link
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
RASS August 2011 link
RSESS Winter 2011 link
RSESS Winter 2012 link
International Programme for Chemical Safety
(2005) IPCS Framework for Analyzing the Relevance of a Cancer Mode of Action
United States (2005). Guidelines for Carcinogen Risk Assessment. link
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
Tox Forum 2012
Society of Toxicology 2012
Society for Risk Analysis - New England Chapter
Presentation at Society for Risk Analysis 2012
Presentation at Society for Risk Analysis 2014
*Fit for purpose: Consistent with the NRC (2009) report, this workshop defines “fit for purpose” as recognizing that the nature and extent of the assessment needs to be considered in the problem formulation stage, with level and complexity to be no greater than that needed to identify the best choice among risk management options. In practice, the workshop recognizes that this is accomplished by having a variety of available tools (e.g., tools for acute vs. chronic exposures) and using tiered approaches, proceeding down the tiering only as far as necessary to set an issue, exposure or chemical aside (as not of concern) or to target it for further assessment and/or management.
Adapted from: Meek, M.E., M. Bolger, J.S. Bus, J. Christopher, R.B. Conolly, R.J. Lewis, G. Paoli, R. Schoeny, L.T. Haber, A.B. Rosenstein, M.L. Dourson. 2013. A Framework for Fit-for-Purpose Dose Response Assessment. Manuscript in review
For more information, please contact Oliver Kroner.