Beyond Science and Decisions:
Problem Formulation to Dose Response
Stakeholder Process
ARA* Process
25 Groups: Led by
Texas Commission
on Environmental
Quality (TCEQ)
Steering
Committee
Risk Document
Development
Training and
Certification
Workshop 1 Report
Available
Non-profit
Collaborators
Workshop Reports
2 & 3 Expected January
& May 2011
Methods Text
Expected Summer 2011
All information
To be web posted
Risk
Communication
Risk Research
And Tools
Risk Information
Exchange (RiskIE)
Peer Review &
Consult
* Alliance for Risk Assessment (ARA):
www.allianceforrisk.org
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
Additionally develop content of the NAS (2008) report on
improving the risk assessment process to develop
practical guidance for:
◦ Risk assessment techniques applicable to specific
issue identification (e.g., prioritization, screening and
full assessment);
◦ 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
guidance.

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 and toxicology
◦ 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 underlying
diseases.


Identify methods for calculating the
probability of response for noncancer
endpoints.
Develop guidance for regulators and
scientists for applying selected doseresponse techniques.


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Workshop 1: Presentations that highlight relevant
work in issue identification and assessment methods,
followed by brainstorming on purpose-focused
methods and selection of case studies. [Talks from
March 16–18, 2010 meeting & report now available.]
Workshop 2 (October/November, 2010): Case study
presentations and evaluation by science panel
selected by ARA Steering Committee
Workshop 3 (April, 2011): Panel builds consensus on
purpose-specific dose-response methods
Why is this Approach Useful?

Multi-stakeholder approach, with input from
experts in risk assessment, biology/toxicology,
and mathematical analysis

Case-studies to test principles and methods
against real-world data & review by expert panel

Integration of risk management-driven problem
formulation with mode of action and biology

Methods covering a range of
◦ problem formulations,
◦ risk management needs, and
◦ informed by state-of-the science guidance and frameworks
Path Forward

Workshop 1 participants evaluated and
recommended case study proposals, including new
proposals. Case studies are listed at
www.allianceforrisk.org/workshop/selections.htm

Summaries of breakout group discussions and
suggestions for team members will be posted at
http://www.allianceforrisk.org/Workshop/Workshop1MeetingReport.doc

Case study leaders are currently assembling teams;
additional participants are welcome.

Additional case studies may also be brought
forward to the second workshop
How Can You Participate?


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Participate in a case study or bring forward a
new one
Participate in workshops 2 or 3, either in
person or via webcast
Be a sponsor of the workshop series

Please visit www.allianceforrisk.org

TCEQ Workshop series contact:
◦
◦
◦
◦
Michael Dourson, Dourson@tera.org
Roberta Grant, Rgrant@tceq.state.tx.us
Lynne Haber, Haber@tera.org
Michael Honeycutt, MHoneycu@tceq.state.tx.us