What is Regulatory Science?

The origin of the term “regulatory science” is unknown. It was probably coined in the 1970’s when the newly formed U.S. Environmental Protection Agency was forced to make decisions based on incomplete and sometimes non-existing scientific information. There were those who argued that there is no reason to coin a new phrase as “science is science” regardless of how it is applied. However, others argued that regulatory science is a scientific discipline much like many other applied scientific disciplines. The emergence of risk analysis including risk assessment and risk management was a key reason for the establishment of regulatory science as a scientific discipline. During that period, there was increasing controversy dealing with nuclear power, pesticides, waste disposal, mine safety, chemical emissions, and numerous other issues. In order to address these issues the need for a predictive process became apparent to evaluate options for new laws, development of implementing regulations, and dealing with numerous court cases. One of the primary instruments to respond to that need was and continues to be risk assessment and management of the assessed risk. Meanwhile regulatory science has expanded significantly beyond risk analysis.

Laws, regulations, and judicial decisions typically and often consist of two parts: science and non-scientific areas that are typically outside of purview of science. Regulatory science responds to the former and consists of the scientific foundation of laws, regulations and judicial decisions. It is both interdisciplinary and multidisciplinary and relies upon virtually all scientific disciplines. A key characteristic of much of regulatory science is an attempt to predict future events. Laws and regulations dealing with food, drugs, environment, safety, economy, and many other human activities attempt to predict potential events and ensure that adverse consequences are avoided or favorable conditions are promoted. To be sure, regulatory science also includes assessing the validity of scientific claims in courts.

One of the reasons for the development of the concept of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims (MESC) derived from BAS was to respond to the needs of regulatory science. Based on BAS/MESC, regulatory science overwhelmingly relies upon Evolving Science (Reproducible Evolving Science, Rationalized Science and Hypothesized Science) and Borderline Science (both Scientific Judgment and Speculation).

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