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
Purpose of the Survey
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”
Survey Procedures
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).
Problem Formulation &
Analysis Plans
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
Data Acquisition
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
Access to Underlying Data
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
Data Evaluation
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
Weight of Evidence (WoE)
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:
Mode of Action (MOA)
 For a non-mutagenic MOA, 88% indicated a nonlinear (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
Scientific Peer Review Process
 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
Following Established Guidance
How often do government agencies follow their
own guidance?
Often or always - 51%
Sometimes, rarely, or never - 49%
Risk Management Factors
Risk Management
Factors
Needed - Deal of
Weight (%)
Current - Deal of
Weight (%)
Science
98
47
Costs/Benefits
67
41
Legal
48
72
Industry
20
28
Precautionary
19
52
Environmentalists
16
49
Politics
8
66
Media
4
43
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
slichter@gmu.edu