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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 r...
Collaborators
3
55+ sponsors and collaborators:
• 12 government agencies
• 19 industry groups
• 7 scientific societies
• 9...
Standing Panel
• Annie Jarabek, U.S. EPA NCEA
• Richard Beauchamp, Texas Dept State Health Services
• James S. Bus, Expone...
Beyond Science & Decisions
• 8 Workshops over 4 years
• Over 40 Case Studies illustrating state-of-the-
science risk metho...
Recognized Need
• Panel requested a “map” of the case studies
– Chart what has been covered, where we have
gaps
• Share wi...
Dose Response Framework (beta)
www.chemicalriskassessment.org
• Audience:
 Risk assessors seeking information on risk met...
8
ARA Workshop IV 9
ARA Workshop IV 10
ARA Workshop IV 11
ARA Workshop IV 12
ARA Workshop IV 13
ARA Workshop IV 14
ARA Workshop IV 15
ARA Workshop IV 16
ARA Workshop IV 17
ARA Workshop IV 18
How often is the Framework
updated?
• The Framework is an “evergreen” database,
intended to grow and evolve over time to
r...
Accomplishments to Date
• >40 case studies catalogued
• Open access manuscript:
– Meek et al. 2013. A Framework for Fit-fo...
Next Steps
• Beyond Science & Decisions Workshop 9 –
Spring 2015
http://allianceforrisk.org/ARA_Dose-Response.htm
• Additi...
Clarifying Questions?
Oliver Kroner
TERA
kroner@tera.org
24
ARA Dose Response Framework
Acknowledgments:
Dr. Lynne Haber
T...
Questions
1. What features (e.g., advanced search methods)
are missing or could be enhanced?
2. Are additional changes nee...
Panel Feedback
• Strengthening the emphasis on problem
formulation/fit-for-purpose risk assessment,
which could potentiall...
Panel Recommendations
• Possible rubrics may include:
– Method’s level of acceptance (e.g., new
experimental method, well-...
Panel Recommendations
• Offering an inventory of tools available to risk
assessors (e.g, Benchmark Dose Software),
with li...
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Alliance for Risk Assessment Dose Response Framework- Society for Risk Analysis 2014

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With improvements in our biological understating, computational power, and an ever-changing regulatory landscape, new methods for evaluating human health impact and risk are emerging. Since 2010, the Beyond Science & Decisions workshop series has provided a venue for testing, vetting, and improving novel risk assessment methods. With the collaboration of over 55 organizations representing government, industry, scientific societies, consultancies, and environmental NGOs, the series has now reviewed over 30 case studies illustrating such methods. The ARA Dose Response Framework includes these case studies and links to key guidance documents on a range of risk assessment issues. It was developed by panel members and workshop participants as a way to categorize and identify gaps in available methods, and to aid risk assessors in identifying useful tools for different problem formulations. It is intended as a tool to help guide the risk assessor in selecting an appropriate method(s) for addressing different issues related to hazard characterization and dose-response assessment, and to help the field of risk assessment identify gaps in methodology. This symposium will highlight several methods that have been presented as part of the workshop series, and then provide an interactive demonstration of the Dose Response Framework and how these methods fit within the framework. The session will then open for audience discussion on enhancements to the Framework.

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Alliance for Risk Assessment Dose Response Framework- Society for Risk Analysis 2014

  1. 1. ARA DOSE RESPONSE FRAMEWORK Oliver Kroner, TERA 1
  2. 2. 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 2 ARA Dose Response Framework
  3. 3. Collaborators 3 55+ sponsors and collaborators: • 12 government agencies • 19 industry groups • 7 scientific societies • 9 non-profit orgs/consortia • 8 consulting groups
  4. 4. 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) 4 ARA Dose Response Framework
  5. 5. 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 5 ARA Dose Response Framework
  6. 6. 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 6 ARA Dose Response Framework
  7. 7. 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 7 ARA Dose Response Framework
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  9. 9. ARA Workshop IV 9
  10. 10. ARA Workshop IV 10
  11. 11. ARA Workshop IV 11
  12. 12. ARA Workshop IV 12
  13. 13. ARA Workshop IV 13
  14. 14. ARA Workshop IV 14
  15. 15. ARA Workshop IV 15
  16. 16. ARA Workshop IV 16
  17. 17. ARA Workshop IV 17
  18. 18. ARA Workshop IV 18
  19. 19. 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. 21 ARA Dose Response Framework
  20. 20. 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) 22 ARA Dose Response Framework
  21. 21. Next Steps • Beyond Science & Decisions Workshop 9 – Spring 2015 http://allianceforrisk.org/ARA_Dose-Response.htm • Additional methods being added • Seeking case studies for Panel review • Seeking user feedback 23 ARA Dose Response Framework
  22. 22. Clarifying Questions? Oliver Kroner TERA kroner@tera.org 24 ARA Dose Response Framework Acknowledgments: Dr. Lynne Haber TERA
  23. 23. Questions 1. 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? 25 ARA Dose Response Framework
  24. 24. 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 26 ARA Dose Response Framework
  25. 25. 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 27 ARA Dose Response Framework
  26. 26. 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. 28 ARA Dose Response Framework

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