Regulatory Science
Encyclopedia
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”
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)
There have been several attempts to define regulatory science. In many cases there are claims that there is a difference between regulatory science and “normal science”, “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.
s, regulation, and judicial decisions cover a large segment of human activities, regulatory science has a rather broad coverage including the following:
and regulatory pharmacology
covering air, drinking water, food, pesticides, drugs, and numerous other areas.
covers protection of various species, protection of wetlands
, and numerous other regulated areas including ecotoxicology
.
in the regulatory process including the economics
part of cost-benefit analysis
.
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.
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.
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 science
s 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, extrapolation
s, 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.
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.
, societal goals and decisions, or any other non-scientific objective is outside the purview of science.
the regulatory system”
Definition of regulatory science
Based on several decades of experience regulatory science is logically defined as a distinct scientific discipline constituting the 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
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(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)
There have been several attempts to define regulatory science. In many cases there are claims that there is a difference between regulatory science and “normal science”, “academic science”, or “research
Research
Research can be defined as the scientific search for knowledge, or as any systematic investigation, to establish novel facts, solve new or existing problems, prove new ideas, or develop new theories, usually using a scientific method...
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.
Regulatory Science Disciplines
As lawLaw
Law is a system of rules and guidelines which are enforced through social institutions to govern behavior, wherever possible. It shapes politics, economics and society in numerous ways and serves as a social mediator of relations between people. Contract law regulates everything from buying a bus...
s, regulation, and judicial decisions cover a large segment of human activities, regulatory science has a rather broad coverage including the following:
Human health
by far the most recognized segment of regulatory science covers a broad range of scientific areas including regulatory toxicologyToxicology
Toxicology is a branch of biology, chemistry, and medicine concerned with the study of the adverse effects of chemicals on living organisms...
and regulatory pharmacology
Pharmacology
Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
covering air, drinking water, food, pesticides, drugs, and numerous other areas.
Ecology
Regulatory ecologyEcology
Ecology is the scientific study of the relations that living organisms have with respect to each other and their natural environment. Variables of interest to ecologists include the composition, distribution, amount , number, and changing states of organisms within and among ecosystems...
covers protection of various species, protection of wetlands
Wetland conservation
Wetland conservation is aimed at protecting and preserving areas where water exists at or near the Earth's surface, such as swamps, marshes and bogs. Wetlands cover at least six per cent of the Earth and have become a focal issue for conservation due to the ecosystem services they provide...
, and numerous other regulated areas including ecotoxicology
Ecotoxicology
Ecotoxicology is the study of the effects of toxic chemicals on biological organisms, especially at the population, community, ecosystem level. Ecotoxicology is a multidisciplinary field, which integrates toxicology and ecology....
.
Regulatory engineering
Another large segment of regulatory science deal with regulatory engineering consisting of the application of engineering to numerous operations such as the safety of nuclear and other power plants, chemical production facilities, mining operations, and air transportation.Regulatory economics
There are numerous economic decisionsRegulatory economics
Regulatory economics is the economics of regulation, in the sense of the application of law by government that is used for various purposes, such as centrally-planning an economy, remedying market failure, enriching well-connected firms, or benefiting politicians...
in the regulatory process including the economics
Economics
Economics is the social science that analyzes the production, distribution, and consumption of goods and services. The term economics comes from the Ancient Greek from + , hence "rules of the house"...
part of cost-benefit analysis
Cost-benefit analysis
Cost–benefit analysis , sometimes called benefit–cost analysis , is a systematic process for calculating and comparing benefits and costs of a project for two purposes: to determine if it is a sound investment , to see how it compares with alternate projects...
.
Science in Legislation and in Courts
Although often less than fully recognized the scientific foundation of legislativeLegislation
Legislation is law which has been promulgated by a legislature or other governing body, or the process of making it...
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 theocraciesTheocracyTheocracy is a form of organization in which the official policy is to be governed by immediate divine guidance or by officials who are regarded as divinely guided, or simply pursuant to the doctrine of a particular religious sect or religion....
, individual scientists and others in rejecting scientifically valid ideas
Principle of skepticism
Skepticism
Skepticism has many definitions, but generally refers to any questioning attitude towards knowledge, facts, or opinions/beliefs stated as facts, or doubt regarding claims that are taken for granted elsewhere...
: 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
Reproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...
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.
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 reproducibilityClass 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 science
Applied science
Applied science is the application of scientific knowledge transferred into a physical environment. Examples include testing a theoretical model through the use of formal science or solving a practical problem through the use of natural science....
s 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, extrapolation
Extrapolation
In mathematics, extrapolation is the process of constructing new data points. It is similar to the process of interpolation, which constructs new points between known points, but the results of extrapolations are often less meaningful, and are subject to greater uncertainty. It may also mean...
s, 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
Predictive modelling
Predictive modelling is the process by which a model is created or chosen to try to best predict the probability of an outcome. In many cases the model is chosen on the basis of detection theory to try to guess the probability of an outcome given a set amount of input data, for example given an...
including much of risk assessment
Risk assessment
Risk assessment is a step in a risk management procedure. Risk assessment is the determination of quantitative or qualitative value of risk related to a concrete situation and a recognized threat...
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
Scientific community
The scientific community consists of the total body of scientists, its relationships and interactions. It is normally divided into "sub-communities" each working on a particular field within science. Objectivity is expected to be achieved by the scientific method...
and the general public are often provided fallacious information presented as science. Often called junk science
Junk science
Junk science is a term used in U.S. political and legal disputes that brands an advocate's claims about scientific data, research, or analyses as spurious. The term may convey a pejorative connotation that the advocate is driven by political, ideological, financial, or other unscientific...
, 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
Peer review
Peer review is a process of self-regulation by a profession or a process of evaluation involving qualified individuals within the relevant field. Peer review methods are employed to maintain standards, improve performance and provide credibility...
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, ideologyIdeology
An ideology is a set of ideas that constitutes one's goals, expectations, and actions. An ideology can be thought of as a comprehensive vision, as a way of looking at things , as in common sense and several philosophical tendencies , or a set of ideas proposed by the dominant class of a society to...
, societal goals and decisions, or any other non-scientific objective is outside the purview of science.