Over 20 plus years, I have worked both sides on substance regulation. There are some constant signals that have come up for those substances who walked away relatively unscathed.
Checklist
This checklist includes:
- 10 years of solid science to back up your case
- Up to date and realistic exposure/impact data and evidence
- A first-class independent Risk Assessment on hand
- A first-class independent Risk Management Options Assessment on hand
- A board of senior-level people making the decisions
- A constructive approach with the regulators
- A willingness to work with governments
- Have world-class scientific experts and regulatory scientific expert on hand
- A long term approach
- A long term and steady budget to support the work
On hand means you need the studies, evidence and science way before it is asked for.
Few do all 10. Those who do are those who walk away relatively unscathed.