Promote consistent and transparent risk assessment approaches, science methodologies and policies that broadly support industry’s commitment to the generation and the use of the best available and relevant science in chemical risk assessments.
The Center for Advancing Risk Assessment Science and Policy (ARASP) is a coalition of independent groups and associations that promotes the development and application of up-to-date, scientifically sound methods for conducting chemical assessments. ARASP is managed by the American Chemistry Council’s
Chemical Products and Technology Division.
Consumers, businesses, and the government all expect chemical research, testing and assessments to be firmly based on up-to-date scientific knowledge, meet the highest of standards of scientific inquiry and be evaluated in accordance with acceptable scientific approaches. As scientific methods and knowledge advance, approaches to evaluating the risks of chemicals and chemical products must evolve accordingly. Today, chemical risk assessment is on the verge of undergoing rapid and momentous change. Advances in molecular biology and genomics, the expanding spectrum of human biomonitoring, and recommendations from a series of recent reports from the
National Research Council (NRC) are converging to fundamentally transform the framework for conducting risk assessment of chemicals in commerce. Thus, it is essential to have the tools and resources to maintain up-to-date knowledge on risk assessment science and policy.
While extensive scientific research over the last 25 years has led to a considerable increase in knowledge of how chemicals act at the molecular, cellular, and organ levels, and the manner by which such effects are dependent upon the level of exposure, there are still many significant challenges to adopting policies and practices that put this knowledge into use in chemical-specific risk assessments. Such knowledge of modes of action would be ex-pected to cause a shift from default, conservative techniques to more science-based, biologically driven risk assessment methods. But this doesn’t appear to be happening in some key programs in regulatory agencies in the United States. This highlights the importance of industry engagement with the regulatory community.
The 2009 recommendations of a panel convened by the NRC could have an impact on the extent to which chemical-specific mode of action data is even considered, let alone accepted, in lieu of invoking a default, in chemical risk assessments. In the opinion of this NRC Panel, risk assessment for cancer and non-cancer effects should be harmonized by conducting both types of risk assessment the way cancer risk assessments are currently conducted for carcinogens with a mutagenic mode of action—using a default, low-dose, no-threshold approach. ARASP has shared its views concerning the NRC Panel’s opinion through different platforms.
If adopted and widely applied, such consequential changes in the manner by which systemic, non-cancer toxicity is evaluated could have a significant impact across many sectors. The chemical industry—and industrial sectors that rely on the products of chemistry—should proactively broaden and deepen the discussion within the scientific and risk assessment policy communities on mode of action and nonlinear modeling/thresholds, and advocate for the use of the best available scientific information for chemical risk assessments and regulatory policies. It is key to have collaboration in leading industry engagement on risk assessment science and policy issues.
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Dr. Neeraja Erraguntla