It took some time to establish the exact area where M³ would strive for success, but a new year and an imminent change of season has decided that path. M³ is now a consulting company working to support the future of chemical risk assessment through the advancement of modern non-animal methods of toxicity and exposure evaluation.
The sheer volume of chemicals in commerce with a paucity of safety information coupled with international legislative and societal pressure to reduce the use of animals in product safety testing have necessitated the adoption of modern "high-throughput" methods of assessing both the toxicity of chemicals as well as the potential exposure to the public from their use in consumer goods, pesticides, pharmaceuticals, etc. The desired commercialization of emerging and rapidly developing technologies (such as products enabled by nanotechnology, synthetic biology and genetic modification) and introduction of new molecules and product formulations (such as biologically-sourced molecules or "discovered" computationally) threatens to severely stress existing governmental regulatory approval systems. This could stifle product approvals and failure to act (or react) in an effective and efficient manner could undermine confidence in public trust.
Bold leadership as well as subject matter expertise in science and regulation is needed to transform existing legislative programs, inform and advise future "21st century" law and policy and influence and educate the private and public sectors on the "21st century" approach to risk science.
As such, the "three Ms" have taken on a new meaning: Mode, Margin and Management.
- Mode (of Action): A mechanism-based approach to the risk assessment of all chemicals is already happening. In the age of "Big Data," the shift from low-throughput data collection based on observation of phenotypic outcomes to high-throughput methods data collection relying more on in vitro, in silico, and in chemico measurements managed through expert systems and using integrated testing approaches was inevitable.
- Margin (of Exposure): Both the ability for regulatory programs to prioritize limited resources and the capacity for the public to understand and appreciate rests on accurate measurement and communication of the frequency and duration and exposure to environmental chemicals. Advancement of research supporting the development of high-throughput "exposure-to-activity" and Margin of Exposure estimates (for example) is critical to ensuring testing using animals is reserved for only high-risk chemicals.
- Management: Professional and competent management of risk, using modern probabilistic approaches supported by high-throughput approaches to toxicity and exposure evaluation, will require internationally-coordinated and -supported effort, not to mention database(s) of empirical and predictive "mode-of-action" data on chemicals. Professional management of information will be needed to develop more automated approaches to using and interpreting high-throughput data via expert systems, machine learning, data mining, and structure-based modeling. Professional management of policy and regulatory issues will be needed to organize existing information, establish evidence-based "best practices" and focus resources on information needs, not information gaps. The Adverse Outcome Pathway concept holds tremendous promise as this new informational framework.
In summary, the expertise and services now offered by M³ will help ensure these the future approach to toxicity and exposure evaluation (and ultimately, chemical risk assessment) is practical yet protective yet achieves the goal of reducing, refining and replacing the use of animals. Our consultative services offer a low-cost and flexible option for clients interested in supporting the future of chemical risk assessment through the advancement of modern non-animal methods of toxicity and exposure evaluation.