The origin of the term “regulatory science” is unknown. It was probably coined in the 1970s 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 because “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: 1) science and 2) non-scientific areas that are typically outside the purview of science. Regulatory science is a scientific discipline consisting of the development and application of scientific methods, tools, approaches, and other relevant processes derived from various scientific disciplines used in regulatory and other policy 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. Regulatory science also includes assessing the validity of scientific claims in courts, and assists in numerous other policy decisions.
Regulatory Science Processes and Tools
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 Partially Reproducible Evolving Science, Evidence-Based Science, and Hypothesized Science. On occasion, it also uses Scientific Judgment and Speculation.
A major tool of regulatory science is risk analysis consisting of risk assessment, risk management, and risk communication. Whereas risk assessment is entirely the domain of the scientific community, risk management and risk communication are managed by decision makers with the support of scientists.
An increasingly recognized and important tool of regulatory science is independent peer review. Due to the nature of regulatory science, it is imperative that both the scientific foundation and non-scientific inputs that are evaluated by reviewers who are qualified and have no conflict of interest—based on review criteria that are responsive to the needs of stakeholders of regulatory science. Furthermore, transparency is a key factor in the acceptability of the peer-review process.
Regulatory Science Ethics
There are ethical principles that members of all professions must follow. In addition, certain professions have ethical requirements that are unique. The unique regulatory science ethical requirements include the following:
Finality Principle: The media, certain policy makers, many advocacy organizations, and others claim that an issue is settled; the science has spoken; the toxicity of agent is scientifically proven; science has established the benefit of a medical procedure; and numerous others. The regulatory science ethics finality principle is as follows:
A scientific issue is only then settled if any investigator who has the necessary skills and, depending upon the nature of the issue, relevant equipment and facilities is able to reproduce and confirm it.
Transparency Principle: It may be recalled that regulatory science relies upon assumptions, judgments, and default data. The authors of regulatory science must provide justification for using them and provide potential alternatives that were not used. The regulatory science ethics transparency principle is as follows:
Regulatory science information must include assumptions, judgments, and similar parts in a language understandable to a knowledgeable non-specialist.
Confirmation Principle: As previously stated, there is a consensus within the scientific community that independent peer review is a prerequisite for acceptability of scientific claims. The regulatory science ethics confirmation principle requires that:
Regulatory science information is only then acceptable if it has been subjected to independent peer review and the review criteria (questions provided to peer-reviewers) include compliance with the Transparency Principle of regulatory science ethics.
For a more comprehensive explanation of Regulatory Science, please refer to:
Peer Review and Scientific Assessment, A Handbook for Funding Organizations, Regulatory Agencies, and Editors, by A. Alan Moghissi, Betty R. Love, and Sorin R. Straja