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Until recently, the prohibitive costs and questionable relevance of current methods of toxicity assessment have resulted in an exorbitant “control dilemma” for the >60,000 synthetic compounds used by industry and now for emerging advanced materials. Over 90% of all compounds have yet to be tested for adverse biological effects. Lawmakers in Europe have responded by legislating the need to assess the toxicity of all chemicals (required by industries from all nations selling products to EU consumers under the REACH legislation) and have broadened the types of scientific evidence useful for chemical regulation.  Likewise in the US, the National Research Council has recognized this costly data gap and provided guidance on the science needed to characterize the adverse effects of all chemicals with its vision for twenty first century toxicity testing.

Using current methods of chemical safety testing, the economic implication of this law in Europe alone is estimated at €9.5 billion over 10 years, which spurs science to provide a robust and cost-effective solution. HOWEVER, there are huge scientific constraints in determining the human health risks for an ever-increasing number and diversity of consumer products, while toxicity testing fails to keep pace with modern biology.

 

Lawmakers have also passed a legislation to achieve “good chemical status” for all ground and surface waters in Europe (Water Framework Directive, WFD). Like REACH, this has spurred science to provide the next-generation assays for effective environmental health management. HOWEVER, there are again huge scientific constraints in monitoring for the presence of chemical contaminants (especially in continental water resources) and determining the level of concern so policy makers and regulators can better balance economic priorities with the need to protect vital ecosystem services, while many contaminants are practically undetectable in environmental samples using conventional methods.

In order to effectively implement these two groundbreaking policy directives (which can form the basis for a global shift in policy and practice via OECD bodies) and fulfill the National Research Council recommendations whilst consolidating and increasing the competitiveness of industry, we require an equally novel, groundbreaking and coordinated scientific enterprise to meet these legislative and regulatory challenges.

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