The specifics of regulatory decision making differ among government agencies across the world, yet they generally overlap in the types of data they rely upon to estimate risk. These data are generally expensive to generate, have limited throughput and are generally inadequate for addressing issues of complexity inherent in most exposure contexts. The various omics technologies have the potential to greatly enhance risk estimation as it applies in diverse regulatory contexts. We will work towards making OMICs technologies relevant to the policy makers and regulatory bodies that manage environmental and human health risks of chemical substances and other risk factors.
One area that is particularly advanced in terms of research, forward thinking and stakeholder support and that can also serve as an example of the long range vision of the OMICs IG is the regulation of chemicals. Significant legislations such as REACH and the Water Framework Directive in Europe are already enforced. These legislations require safety assessment and risk management for all chemicals used by industry and actions that will ensure that ecosystems are in “good health”.
While these and other legislations in Europe and North America are revolutionary steps toward maintaining a healthier environment, there are substantial scientific constraints on our ability to measure ecological and human health risks and adverse effects for an ever increasing number and diversity of products and production processes which may pose several types or risk. Standard procedures for toxicity testing are too expensive to keep pace with industry and require the extensive use of mammalian animal models. This has created an enormous backlog of chemicals that have yet to be assessed for potential health hazards. Hence, there exists a data gap that needs to be filled to enable policy makers and regulators to balance economic priorities with the need to protect vital ecosystems and human health.
To fully implement these policy directives, we require equally novel, revolutionary and coordinated scientific approaches that are rapid, cost effective, and consistent with global ethical standards for the treatment of animals. A proposed solution, and the one of the focus points of our discussion, is to apply ultra-high-throughput toxicity testing with data-rich OMICS approaches (e.g. genomics, transcriptomics, metabolomics) in non-mammalian or non-vertebrate model organisms (when feasible), and/or in vitro models, and using non-lethal sampling methods for studies involving wildlife (if possible). Key questions that arise include the reliability and expense of these technologies, and the extent to which OMICs measurements can be tied to mechanisms of toxicity and adverse outcome pathways for humans, wildlife, and the ecosystems on which we depend. Furthermore, to answer these questions, a shared understanding of “tolerable risk” must be generated between scientists, industry and regulators.
We believe that a close dialogue and shared understanding of OMICS among environmental risk assessors, academia, industry, regulators and legislators in the long term will help us to achieve the IG objectives.
The strategy for engaging stakeholders may draw upon other extensive and existing global networks such as the Consortium for Environmental Omics and Toxicology (CEOT), which has grown by grass roots meetings and has the vision to “transform environment and health protection by the application of OMICS technologies for (eco)toxicology by creating comprehensive knowledge on effects of chemicals and environmental change on biological systems, thereby dramatically reducing uncertainty”. Groups such as CEOT are natural allies to the OMICs IG since they include members of SETAC and other scientists, advisors and technology specialists from industries, government and NGOs around the globe including BGI China National GeneBank (CNGB), CSIRO (in Australia), CNRS (in France), Helmholtz Centre for Environmental Research (UFZ) and Karlsruhe Institute of Technology (KIT in Germany), National Institute of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), Lawrence Berkeley National Laboratory (LBNL), U.S. EPA, Institute for Genomic Biology (USA), Okazaki National Research Institute for Basic Biology (Japan), Spanish National Research Council (CSIC), Institute for Genome Regulation (in Spain), Karolinska Institute (in Sweden), ELIXIR UK, TGAC (in UK), NIVA (Norway), plus a growing number of University research groups and SMEs, to name a few. The contacts and relationships that flow from such a collective can enable effective, efficient and imaginative engagement with stakeholders having vested interests in OMICS.
Delivering Impact for policy makers. To ensure that the scientific research reaches the decision makers, our group plans to engage with organizations such as the European Commission’s Joint Research Centre (JRC), the US Environmental Protection Agency (EPA) and Environment Canada, among other institutions from all over the world, which are tasked to conduct science and advise policy makers at a global scale. Our aim is to encourage collaboration in research that meets governments’ needs to set standards for safety governance based on robust scientific knowledge. OMICs IG could/should play an interfacing role at engaging stakeholder groups (such as ESTAF, PARERE, EuropaBio, etc.), with the international community (via the Organisation for the Economic Co-operation and Development (OECD) – notably through its task force for Hazard Assessment with links to regulatory agencies around the world, and its task force for Molecular Screening for Toxicogenomics responsible for the Adverse Outcome Pathway (AOP) programme – and with other scientific committees. These include the three independent Scientific Committees that provide the European Commission with the scientific advice it needs when preparing policy and proposals relating to chemical safety and the environment. They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), which are made up of external experts.
Delivering Impact for regulators and industry. Knowledge exchange between the SETAC OMICS Global Advisory Group and regulators on our topic of Omics-informed hazard assessment has already begun at recent Society of Ecotoxicology and Chemistry (SETAC) annual meetings and will grow to involve a broad stakeholders community including: industry sectors via their trade organizations (i.e., International Council of Chemical Associations, Cosmetics Europe, American Chemistry Council, CEFIC, CONCAWE, etc.); the ECVAM Stakeholder Forum (ESTAF) that brings together 15 European stakeholder organizations from academia, industry and civil society / animal welfare; ILSI Health and Environmental Sciences Institute (HESI, USA) and ECETOC (Europe) for advancing translational science to create science-based solutions for a sustainable environment that bring together an even larger tri-partite association of industry, regulators and academics; ECHA in Europe, Defra in the UK, US EPA which are the national regulators; plus the OECD Task Force on Hazard Assessment, OECD Advisory Group on Molecular Screening and Toxicogenomics, US and National Toxicology Program. A focus for this IG will be to enhance the uptake of OMICS research findings by regulators and industry risk assessors, now and far into the future. Regulation-focussed executive summary papers may also be written and submitted to a combination of popular and/or relevant professional publications.
A wider tier of impact will nevertheless be delivered through workshops, training opportunities, special sessions at meetings and publications that will engage businesses, local policy actors and academics, while being accessible to the civil society and its representatives.