The document discusses key elements for the success of new testing and assessment methods in the regulatory context, emphasizing the importance of mutual acceptance of data among OECD countries. It highlights the need for methods to be valid, reproducible, and complementary to traditional approaches, while advocating for collaboration in case studies to improve acceptance. Challenges include data sharing limitations, identifying reference chemicals, and ensuring effective validation without duplicating efforts.

1. KEY ELEMENTS OF SUCCESS
FOR NEW TESTING AND
ASSESSMENT APPROACHES
IN REGULATORY CONTEXT
Helsinki Chemicals Forum,
7-8 June 2017
Panel 4
Anne Gourmelon
ENV/EHS - OECD

2. New approaches discussed at OECD
• For OECD countries (regulators and industry), the
Mutual Acceptance of Data system is important:
– novel approaches have to find their place in that
system
– the MAD system will evolve to accommodate novel
approaches
• Regulators and industry want methods that are:
– relevant, reproducible
– broadly available
– recognised as usable for a defined regulatory purpose
– well characterised (incl. uncertainty and limitations)

3. Key elements of success for acceptance
• Having methods that are recognised as valid is a must
for their acceptance and use
• For novel approaches: demonstration of their
application in case studies greatly facilitate their uptake
– Learn and develop together the good practice
– Learn together what works and what does not
• Not oppose systematically the novel approaches to the
traditional ones, but see them initially as
complementary
– This will allow more data and better comparison over time

4. Key elements of success for acceptance
• Building a strategy of how these novel approaches
fit together
– Problem formulation/scope of use
– Define the approach: which methods, data
interpretation, combination of methods and
prediction models)
– Clarity on overall predictive capacity and uncertainty
• Accept that technology will develop faster, but that
your goal is to have good enough approaches that
stay applicable for some time, and get upgraded
– moving together is more important than moving
faster

5. Foreseeable challenges
• Mutualising data and knowledge of toxicity pathways impeded
by limited data sharing and issues of data ownership
– Slows the development of AOPs as tools to build chemicals
categories
• Identifying good sets of reference chemicals for hazard
endpoints where novel approaches are developed
– Gaining access to in vivo data, reviewing quality
• Evolving validation, while maintaining the basic principles of
relevance, availability, reproducibility
• Avoiding duplication of efforts, not loosing more time
– Convincing people to work together