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HCF 2019 Panel 5: Nicolas Ball

Panel 5: The quality of and access to data on chemicals

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HCF 2019 Panel 5: Nicolas Ball

  1. 1. Dow.com The quality of and access to data on chemicals - Industry perspective Nicholas Ball, Toxicology Consultant, Dow
  2. 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. 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. 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. 5. Mutual Acceptance of… 1. Data 2. ‘Alternative approaches’ • Read across • In silico • Weight of evidence • waiving 3. Interpretation • Hazard classification • ‘Risk’
  6. 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. 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