alliance for risk assessment dose response framework- society for risk analysis 2014

ARA DOSE RESPONSE FRAMEWORK

Oliver Kroner, TERA 1

Beyond Science & Decisions Workshop Objectives

• Build off the NAS (2009) report – Develop practical guidance

for use by risk managers at a variety of levels

– Risk assessment techniques applicable to specific problem formulations.

• Implement a multi-stakeholder approach to share information, ideas, and techniques

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Collaborators

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55+ sponsors and collaborators:

• 12 government agencies • 19 industry groups • 7 scientific societies • 9 non-profit orgs/consortia • 8 consulting groups

Standing Panel• Annie Jarabek, U.S. EPA NCEA• Richard Beauchamp, Texas Dept State Health Services• James S. Bus, Exponent• Mike Dourson, TERA• R. Jeffrey Lewis, ExxonMobil Biomedical Sciences, Inc.• Bette Meek, McLaughlin Centre for Population Health Risk• Assessment, University of Ottawa (Chairperson)• Greg Paoli, Risk Sciences International (NAS 2009 Panel)• Alan Stern, New Jersey Dept of Environmental Protection• Ad hoc: Moiz Mumtaz, Agency for Toxic Substances and Disease

Registry (ATSDR)

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Beyond Science & Decisions

• 8 Workshops over 4 years• Over 40 Case Studies illustrating state-of-the-

science risk methods– Problem Formulation + Applications– Data Requirements– Strengths and Weaknesses

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Recognized Need• Panel requested a “map” of the case studies

– Chart what has been covered, where we have gaps• Share with the risk assessment community

– Identify target audience and purpose of the case studies, and format case studies to be useful for real world application

• Develop a library of methods

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Dose Response Framework (beta)

www.chemicalriskassessment.org• Audience:

Risk assessors seeking information on risk methods• Purpose:

One-stop-shop for risk methods To catalogue, organize, and highlight key aspects of

risk methods To demonstrate real world application of the

methods

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How often is the Framework updated?

• The Framework is an “evergreen” database, intended to grow and evolve over time to reflect the state of the science. It is envisioned that it will be updated twice each year following the Science Panel's review of submitted case studies.

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Accomplishments to Date• >40 case studies catalogued• Open access manuscript:

– Meek et al. 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

• On NLM’s Enviro-Health Links http://sis.nlm.nih.gov/enviro/toxweblinks.html (see Associations)

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Next Steps

• Beyond Science & Decisions Workshop 9 – Spring 2015http://allianceforrisk.org/ARA_Dose-Response.htm

• Additional methods being added • Seeking case studies for Panel review• Seeking user feedback

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Clarifying Questions?

Oliver KronerTERA

kroner@tera.org

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Acknowledgments:Dr. Lynne HaberTERA

Questions1. What features (e.g., advanced search methods) are

missing or could be enhanced? 2. Are additional changes needed to make it easier to

search for methods to address specific issues/problems? If so, what?

3. The site was designed without emphasis on the chemicals featured in the various case studies. Would it be useful to allow users to sort and filter methods by chemical for identifying chemical specific information?

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Panel Feedback

• Strengthening the emphasis on problem formulation/fit-for-purpose risk assessment, which could potentially be done using a “schematic,” or increasing the focus on problem formulation on the case study pages

• Panelists asked about the possibility of creating an instructional video demonstrating the purpose of the site and how to use it

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Panel Recommendations

• Possible rubrics may include: – Method’s level of acceptance (e.g., new

experimental method, well-established) – Human-relevance – Extrapolation assumptions

• Increased inclusion/emphasis on exposure methods

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Panel Recommendations

• Offering an inventory of tools available to risk assessors (e.g, Benchmark Dose Software), with links and tutorials as feasible.

• Offering abstracts of key references cited, or links to where the reference can be found, as done by U.S. EPA’s HERO Database.

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