Chemical Regulation

The following text will appear as an editorial in Integrated Environmental Assessment and Management in the April 2015 issue. As usual a button for a printer-friendly format is found at the bottom of the text.

Scientists in the fields of toxicology and ecotoxicology are expected to explain how chemicals act on organisms and ecosystems and to make predictions that help guide regulatory actions and policy-making. The role of academic science in this context is challenged time and again, often with the argument that its contributions are not sufficiently in line with regulatory approaches for chemical risk assessment and management. Here we argue that nonconformity in academic research should be welcomed because academia’s crucial role is that of examination and forecasting of science, policy, and social issues potentially looming on the horizon.

Academic scientists are motivated to explore unknown phenomena, new chemicals, and novel endpoints. They often engage in exploratory toxicological or ecotoxicological research that delivers a posteriori hypotheses about cause-effect relationships, modes and mechanisms of action, and susceptible biocenoses, species, organs, tissues or cells. This type of research searches for patterns, devises novel theoretical models, and develops new experimental techniques. It is useful for determining whether a condition or problem warrants further investigation and, if so, provides the information for appropriate research designs and data collection methods. Such work often embraces John Tukey’s (1962) philosophy that it is “far better to have an approximate answer to the right question, which is often vague, than an exact answer to the wrong question, which can always be made precise”. Exploratory research informs regulatory chemical risk assessment and management, but rarely are the results sufficient for final regulatory decision-making.

Confirmatory research, on the other hand, is inherently narrower in scope and starts with a well-defined a priori hypothesis. It confirms or refutes a pre-specified causal relationship or mechanism of toxic action, underpins the relevance of a phenomenon, and maximizes Society’s confidence in the work presented. Confirmatory research is often intended to provide the regulatory community with the data needed to derive robust quantitative conclusions on the toxicological or ecotoxicological consequences of chemical exposure.

A great deal of value of academic science lies in exploratory research and the ability to build critical, long-term perspectives on current practices and the consequences of human activity. Researchers in academia should therefore strive to be more than service providers for regulatory risk assessment. Rather, academics should contemplate how regulatory goals, for example the substitution of hazardous chemicals with less harmful alternatives, could be implemented, or how new methods and tools could strengthen regulatory practice. Academic research in toxicology and ecotoxicology should prepare the foundation for the next generation of regulatory guidelines, which are urgently needed in an increasingly interconnected world with limited natural resources and planetary boundaries that are becoming more and more obvious.

Consequently, education in academic research institutions should provide the platforms for training the next generation of critically thinking scientists that have the intelectual capacity to ask fundamental and challenging questions about chemical interactions with the environment and human health. Education should, of course, teach students both current and new or emerging analytical tools and techniques; but education should also emphasize the limitations of current knowledge and how different laboratory and field-based studies support or distract from scientifically sound chemical risk assessment and management.

Academic research, happily ignoring prescriptive regulatory practices, guidelines, and the (eco)toxicological ‘flavor of the month’, is absolutely vital for the continuous development of new ecotoxicological and toxicological knowledge needed to solve tomorrow’s problems. The tendency to pressure academia – via grants and continuous external and internal evaluations – to justify the immediate societal value of every activity therefore warrants more critical assessment.

Academic research is increasingly built on external funding, and public institutions providing the funding rarely agree to sponsor confirmatory studies. Herein lies a challenge facing the present day chemical management as a whole: the role of the impartial, confirmatory analyst in toxicology and ecotoxicology is largely vacant. Confirmatory research in business is largely focused on chemicals and human activities immediately relevant to a particular business, and therefore not always sufficiently systematic and publicly disseminated, as well as sometimes embued with conflict of interest. Regulatory authorities often lack the financial, laboratory capacity, and technical resources necessary to build upon or confirm the results of exploratory research. Consequently, the lack of systematically planned, well implemented, documented, and disseminated confirmatory research constitutes a critical gap in our ability to assess and manage chemical risks.

Regulatory guidelines serve specific purposes, but scientific discovery and the exploration of unknown phenomena are not amongst them. This, however, does not imply that results generated from non-standard, exploratory approaches should be readily dismissed. The two volumes of “Late Lessons from Early Warnings”, published by the European Environment Agency in 2001 and 2013 [1,2] should remind us that high quality academic research can properly motivate early regulatory actions. Regrettably, assessment approaches and decision criteria addressing when and how regulatory agencies should respond to academic research (exploratory or otherwise) remain largely lacking.

The body of toxicological and ecotoxicological knowledge must be safeguarded from incomplete knowledge and spurious results. In the long run, this obligation can only be met by supporting a collaborative combination of exploratory and confirmatory research that is published and discussed in the open scientific literature.

Academic institutions have enjoyed centuries of postulating and opining on all facets of science, often leaving the task of discerning the practicality, relevance, and usefulness of academic research to business, governments, and other institutions. This needs to change, particularly with the aim to improve chemical risk assessment and management. The academic community needs to find its voice and engage more actively in promoting the value of academic research for the long-term development of toxicology and ecotoxicology and its benefits to Society.

1. European Environmental Agency, Late lessons from early warnings: the precautionary principle 1896-2000. Environmental Issue Report 22, 2001. Available at the Agency’s website for direct download (PDF)
2. European Environmental Agency, Late lessons from early warnings: science, precaution, innovation, Report 2013/1, 2013. Available at the Agency’s website for direct download (PDF)

Prof. Thomas Backhaus
Senior Editor, Integrated Environmental Assessment and Management
University of Gothenburg, Sweden

Dr. Xenia Trier
Technical University of Denmark, Denmark