The document discusses challenges with accessing chemical data for regulatory purposes and proposes potential solutions. It notes that generating data is costly but necessary to gain market access, and that data sharing is difficult due to regional restrictions and ownership issues. It proposes creating a centralized global database where studies could be purchased via subscription. This would facilitate consistent data access and interpretation across regulatory agencies. Ensuring high quality, compliant data remains challenging due to subjectivity, but the goal of safety and a viable industry requires improved data sharing and alternative assessment methods.

1. Dow.com
The quality of and access to data
on chemicals
- Industry perspective
Nicholas Ball, Toxicology Consultant, Dow

2. Access to Data
Access to data = License to sell  No Data, No Market
Cost of data
How much to run a
study
Value of data
Value of the market
you gain access to
Difficulties!

3. Data Sharing
Time/Resource consuming to manage and maintain
Usage rights – often limited to a specific region/purpose
Fair pricing scheme
New studies run by multiple companies
• Who owns them?
• What can they do with it?
The REACH ‘12 year rule on data protection’ and its consequences
• Data freely available ‘For REACH purposes’ 12 yrs after submission
• Other regulations/jurisdictions
DOW RESTRICTED

4. A solution?
Can we build a portal to facilitate access to our data – like a subscription or
license?
E.g. ‘Amazon’ or ‘I-Tunes’ for data
Data stored in central database; Curated; Valued; Disseminated
• Purchase access to the studies you need for the region you need
Opportunity:
Managed ‘Globally’ - Accessible by regulatory agencies globally
Everyone using the same data – one dataset, one interpretation
DOW RESTRICTED

5. Mutual Acceptance of…
1. Data
2. ‘Alternative approaches’
• Read across
• In silico
• Weight of evidence
• waiving
3. Interpretation
• Hazard classification
• ‘Risk’

6. Quality and Compliance Conundrum
Quality
1) the quality of the studies cf. Reliability
2) the quality of the data reporting in the IUCLID dataset
3) the relevance of data for the endpoint to be addressed
4) The justification / support for any adaptations
Compliance
Does information submitted address the requirements?
Quality Compliance
• Expert judgement
• Subjectivity / Ambiguity
• Perspective - Registrants vs
Authority

7. WE ALL have a common goal
We want people and the environment to be safe when handling and using
chemicals
But we also need
An economically viable, functional and responsible industry
This can only be accomplished with
- Better access to reliable data
- Mutual acceptance of data and Alternative approaches
- Commitment to understand and meet Quality and Compliance needs