Beyond Science and Decisions: From Problem Formulation to Dose-Response Assessment

February 24, 2021

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.

Organized by: Alliance for Risk Assessment

James Bus, Exponent
Michael Dourson, TERA
Neeraja Erraguntla, ACC
Suzanne Fitzpatrick, FDA
Mark S. Johnson, USARMY
Sabine Lange, TCEQ
Pamela Williams, E Risk Sciences, LLP

View and register for the event here.
Time: Held on February 24 and 25 of 2021
Location: Virtual Meeting

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.