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Expert Opinion on Regulatory Risk Assessment: Survey Results Dr. Robert Lichter George Mason University Center for Media & Public Affairs and Center for.

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Presentation on theme: "Expert Opinion on Regulatory Risk Assessment: Survey Results Dr. Robert Lichter George Mason University Center for Media & Public Affairs and Center for."— Presentation transcript:

1 Expert Opinion on Regulatory Risk Assessment: Survey Results Dr. Robert Lichter George Mason University Center for Media & Public Affairs and Center for Health & Risk Communication

2 Objective: “Inform the discussion regarding the quality of risk assessments and their role in guiding regulatory decisions by tapping into the experience of the scientific community” Purpose of the Survey

3 GMU surveyed members of three professional organizations whose memberships represent repositories of knowledge and experience in regulatory risk assessment:  Risk Assessment Specialty Section of the Society of Toxicology (SOT-RASS)  Dose Response Specialty Group of the Society for Risk Analysis (SRA-DRS), and  International Society of Regulatory Toxicology and Pharmacology (ISRTP). Survey Procedures

4 68% agree it’s very important to complete a problem formulation evaluation prior to conducting an assessment ×However, only 30% say prior problem formulations were often or always conducted Problem Formulation & Analysis Plans

5 94% support the use of inclusion/exclusion criteria ×But, only 24% percent report that standardized protocols are often or always employed for collecting studies & data Data Acquisition

6 69 % believe it’s very important for assessors to be able to independently analyze results ×But, 31% say the information is often or always made available 59% also believe it’s very important for peer reviewers to have access to data ×However, only 16% say the information is often or always made available to peer reviewers Access to Underlying Data

7 82% stated that the same criteria should be used to evaluate all studies regardless of institutional affiliation ×But, only 24% indicated that consistent & transparent criteria for evaluating studies are often or always used ×And, less than half (44%) reported that all relevant & reliable studies are often or always used Data Evaluation

8 89% stated that WoE should be fully described, documented and used ×But, only 45% stated it is often or always used ×And, only 24% indicated that WoE is often or always consistent & transparent Weight of Evidence (WoE)

9 For a non-mutagenic MOA, 88% indicated a non- linear (threshold) model should be used 75-82% stated that non-linear low dose extrapolations are warranted when the WoE indicates a threshold is involved for cancer effects ×61% stated that currently MOA is being poorly applied to characterize risk to humans Weight of Evidence: Mode of Action (MOA)

10 73% agreed that external independent peer review is very important 78% indicated external peer review should be conducted independently of the office or program that develops a risk assessment ×However, 75% indicated there was sometimes, rarely or never sufficient opportunity for stakeholder input ×And, 79% stated that input from outside experts was sometimes, rarely or never considered Scientific Peer Review Process

11 How often do government agencies follow their own guidance?  Often or always - 51%  Sometimes, rarely, or never - 49% Following Established Guidance

12 Risk Management Factors Needed - Deal of Weight (%) Current - Deal of Weight (%) Science9847 Costs/Benefits6741 Legal4872 Industry2028 Precautionary1952 Environmentalists1649 Politics866 Media443

13 Next Steps Additional analysis of the data and development of a manuscript for publication Thank You Dr. Robert Lichter George Mason University Center for Media & Public Affairs and Center for Health & Risk Communication


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