Regulatory science refers broadly to the scientific and technical foundations upon which regulations are based in various industries - particularly those involving health or safety. Regulatory bodies employing such principles in the US include for example the FDA for food and medical products, the EPA for the environment, and OSHA for work safety. "Regulatory Science" is contrasted from regulatory affairs and regulatory law, which refer to the administrative or legal aspects of regulation, in that the former is focused on the regulations' scientific (natural, not social) underpinnings and concerns - rather than the regulations' promulgation, implementation, compliance, or enforcement.
- 1 History
- 2 Definition
- 3 Areas of Focus
- 4 Regulatory Economics
- 5 Science in Legislation and in Courts
- 6 Scientific Foundation of Regulatory Science
- 7 Distinctives of Regulatory Science
- 8 References
The origin of the term regulatory science is unknown. It was probably coined sometimes in the late 1970s in an undated memorandum prepared by A. Alan Moghissi who was describing scientific issues that the newly formed US Environmental Protection Agency (EPA) was facing. During that period the EPA was forced to meet legally mandated deadlines to make decisions that would require reliance upon science that was not meeting conventional scientific requirements. At that time the prevailing view was that there was no need to establish a new scientific discipline because “science is science” regardless of how its application. In the spring of 1985 Moghissi established the Institute for Regulatory Science in the Commonwealth of Virginia as a non-profit organization with the objective to perform scientific studies “at the interface between science and the regulatory system”
Based on several decades of experience regulatory science is logically defined as a distinct scientific discipline constituting the (natural, not social) scientific foundation of regulatory, legislative, and judicial decisions. Much like many scientific disciplines that have evolved within the last several decades, regulatory science is both interdisciplinary and multidisciplinary and relies upon a large number of basic and applied scientific disciplines.
Consistent with its mission, the Food and Drug Administration (FDA) suggests that “Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.”(1) To the extent that goes beyond discovery and into development, the term "Regulatory Science & Engineering" is sometimes employed (see also "Regulatory Engineering" below).
There have been several attempts to define regulatory science. In many cases there are claims that there is a difference between regulatory science and “academic science” or “research science” (2). The primary problem is the lack of appreciation that many branches of science are evolving and much of the evolving science includes inherent uncertainties.
Engineering is the development of new products and processes, hence regulatory engineering encompasses principally the development of products and processes to facilitate or better examine regulations or their scientific foundations. Another related segment of regulatory science deal with the application of engineering design or analysis to operations such as the safety of nuclear and other power plants, chemical production facilities, mining operations, and air transportation.
Sometimes the term "regulatory engineer(ing)" is misused to refer to essentially administrative or regulatory roles dealing with organizing or coordinating regulatory matters for an organization; however, "engineering" refers only to functional design of products and processes, and in many jurisdictions this definition is legally enforced (see Regulation and licensure in engineering).
Areas of Focus
By far the predominant foci of Regulatory Science pertains to human health and well-being. This realm covers a broad range of scientific areas - including pollution and toxicology, work safety, food, drugs, and numerous others.
Though secondary to human interest, regulations targeting animals and the environment can also be included. (For example, the US Clean Water Act is based upon an interest in protecting water quality for its own sake, in contrast with the Clean Air Act which is premised upon protecting air quality only for the sake of human health; however, these are ideological policy premises rather than scientific matters themselves.)
The US Department of Agriculture regulates animal care, and the FDA regulates humaneness for animal studies. Regulatory ecology covers protection of various species, protection of wetlands, and numerous other regulated areas including ecotoxicology.
Science in Legislation and in Courts
Although often less than fully recognized the scientific foundation of legislative decisions are included in regulatory science and should be based on reliable science. Similarly courts have recognized the need to rely upon information that meets scientific requirements.
Scientific Foundation of Regulatory Science
Based on the unique needs of regulatory science Moghissi et al. developed the concept of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims” (MESC) derived from BAS. The BAS/MESC system is rather complex, but its basic requirements are as follows:
Principles of the BAS/MESC
- Open-mindedness principle: This principle implies the willingness to accept new knowledge and careful evaluation of the claim. Historical evidence suggests numerous misdeeds by theocracies, individual scientists and others in rejecting scientifically valid ideas
Principle of skepticism: This principle requires that those who make a scientific claim are obligated to provide sufficient evidence supporting their claim. The skepticism principle makes sure that the open-mindedness principle is not misused. Universal scientific principles: All scientific disciplines use certain methods, processes, and techniques in pursuit of their professional activities. The universal scientific principles (USP) imply that there are certain principles applicable to virtually all scientific disciplines and is valid regardless of the nature of the discipline. Reproducibility principle: Reproducibility is the true proof of the validity of a scientific claim and separates undisputed areas of science form those that include assumptions, interpretations, and in some cases, the inclusion of ideological and societal objectives in a scientific assertion.
Pillars of BAS/MESC
I: Classification of scientific information
As virtually every scientist has observed, science evolves. Therefore, it is necessary to classify scientific information in terms of the level of maturity and reproducibility
Class I: Proven science: This class consists of scientific laws (or principles) and their application. A fey characteristic of the class is its compliance with Reproducibility Principle implying that any investigator who has the necessary skills, and if necessary, proper equipment can reproduce it. This class includes not only basic sciences but also applied sciences such as engineering.
Class II: Evolving science: It is likely that there are many groups in this class. However, currently there are only three groups.
Class IIA: reliable and reproducible information dealing with a subject that is not completely understood constitutes the core of this class. An example of this class includes a large part of medical science.
Class IIB: Rationalized science: The scientific foundation of information placed in this class is derived from proven or reproducible evolving science. However, it uses assumptions, extrapolations, and similar processes in deriving its results and conclusions. A characteristic of this class is its level of reproducibility requiring that the investigator who tries to reproduce the information must have not only proper skills and the necessary equipment, but must also accept the asserted scientific foundation; assumptions; choice of mathematical processes; default data; and numerous other prerequisites. Many predictive models including much of risk assessment fall into this class.
Class IIC: Hypothesized science: This class consists of an organized response to an observation, an idea, or any other initiating thought process. For obvious reasons this class does not comply with Reproducibility Principle.
Class III: Borderline science: Often a decision maker must make a decision without information covered in classes I and II. Information included in this class includes Scientific Judgment and Speculation.
Fallacious Information: Most unfortunately the scientific community and the general public are often provided fallacious information presented as science. Often called junk science, as we will see later in this paper, some of the science provided to the regulators by special interest groups qualifies as fallacious information.
II: Reliability of scientific information
The reliability of scientific information can be logically categorized into several distinct categories in ascending level of reliability.
I: Personal opinions: This category consists of expression of views by individuals. However, regardless of their training, experience, and social agenda personal opinions are seldom reliable.
II: Gray literature: Written information prepared by government agencies, advocacy groups, and others that has not been subjected to an independent peer review is included in this category.
III: Peer-reviewed science: This category consists of information that has been subjected to an independent peer review.
IV: Consensus-processed science: Contested areas of science often require the establishment of a panel to reach a consensus on a specific scientific subject.
III: Outside the purview of science
Most religious and related beliefs are outside the purview of science as science cannot prove or disprove the existence of a god and habits that are derived from that belief. Similarly, ideology, societal goals and decisions, or any other non-scientific objective is outside the purview of science.
Distinctives of Regulatory Science
A closer look at many legislative, regulatory and judicial decisions indicates that in the majority of cases their scientific foundation is rationalized science (Class IIB), and sometimes hypothesized science (Class IIC) and even borderline science (Class III). Independent peer review is mandatory for the establishment of scientific validity of regulatory science and its separation from fallacious information. Consensus process increases the likelihood that scientific research will confirm information placed classes IIB, IIC, and III)
1. FDA (Food and Drug Administration) The Promise of regulatory science FDA 2010 www.fda.gov/scienceResearch/specialtopics/RegulatoryScience/ucm2282002.htm
2. Jasanoff S. The fifth branch: science advisors as policy makers. Cambridge, MA Harvard University Press 1990
3. Moghissi AA, Swentnam M, Love BR, Straja SR. Best Available Science; its evolution, taxonomy, and application, second edition. Arlington, VA: Potomac Institute Press; 2010
- 3. Moghissi AA, Swentnam M, Love BR, Straja SR. Best Available Science; its evolution, taxonomy, and application, second edition. Arlington, VA: Potomac Institute Press; 2010