Regulatory Data Gaps and Research Needs Sample Clauses

Regulatory Data Gaps and Research Needs. In deliverable D1.2, the NANoREG project produced an internal report on the knowledge gaps and research needs concerning the health and environmental safety of MNMs. This gap analysis involved reviewing the body of available work on EHS of MNMs and assessing where further work was required to address the regulatory questions identified in D1.1. This gap analysis revealed three key broad categories of knowledge gaps: a) characteristics that influence the risk posed by nanomaterials for human health and the environment, b) standardized methods able to determine these characteristics, and c) nano-specific risk assessment strategies and approaches. Analysing the regulatory questions in light of the research gaps and needs, the report highlighted needs for both the short and long term. In the short term, it was stated that to be able to answer the prioritised regulatory questions, it was important to better understand the implications of operationalising and implementing the EC definition within regulatory frameworks, and to predict and understand the transformation of MNMs under different conditions and processes. For the long term, it was highlighted as relevant to continue working to a) develop standardised test methods for characterisation and toxicity testing, b) improve our understanding of characteristics influencing both the hazard and exposure potential of MNMs, c) further develop and verify nano-specific assessment approaches and d) implement all of this in regulatory frameworks. Until standardised test methods and better information becomes available on the characteristics of MNMs, as well as their fate, behaviour, transformation and toxicity under various real world conditions, the deliverable argues that the implementation of governance approaches will have to accept and work with a significant amount of uncertainty. In this deliverable 6.2, we specifically aim to follow up on this conclusion by providing a detailed typology of relevant forms of uncertainty in science for policy on MNMs and elaborate on some of the factors that making filling these knowledge gaps particularly challenging. We also examine two particular governance approaches (namely Safe-by-Design and Responsible Research and Innovation) for the potential they offer for moving forward with risk management and innovation in the face of significant uncertainties.
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