PANEL 3: Priority setting of chemicals – potential for harmonisation and synergies Presentation: Michael Walls, Vice President – Regulatory and Technical Affairs, American Chemistry Council, US​

1. EFFECTIVE SCREENING OF
CHEMICALS FOR PRIORITY
REVIEW
Mike Walls
June 14, 2018

2. Why Align Prioritization?
Effective chemical regulation must be informed by risk
Efficient data collection requirements – tiered systems
Exposure must be accounted for in priority screening
Leveraging more developed systems globally
Appropriate decisions can be made in absence of full data set
Resource efficiencies; cost & burden sharing

3. 3
• INPUTS
• Readily Available Data
• Conservative assumptions
• TOOLS
• Simple models
• RESULTS
• Conservative exposure
estimates
• Uncertainty, variability
• Not a risk assessment
Prioritization
Screening

4. Use of Threshold of Toxicological Concern (TTC)
with High Throughput Exposure Predictions (HTE)
as a Risk-Based Screening Approach to Prioritize
More Than Seven Thousand Chemicals
Richard A. Becker, John F. Wambaugh, Susan P. Felter, Ted W. Simon and Grace Patlewicz

5. Priority Screening Challenges
Degree to which existing tools are implemented
Uncertainty over ability to deliver routine, acceptable
decisions
Leveraging value in speed and costs; resource demands
Aligning prioritization screening methods and tools with
regulatory objectives
Transparency for public, industry and government

6. Early Conclusions
Tools are available (e.g., ECETOC TRA, high throughput)
Must be comprehensive, understandable, pragmatic,
implementable
Engaging industry and stakeholders essential
Key objective = developing high quality, reliable
exposure modeling and data to inform process