Institute For Regulatory

Description

Introduction There is a consensus within a large segment of the scientific community that many societal decisions—legislative, regulatory, and judicial—are based on scientific information that is less than adequate and often poor. The consequences of reliance upon poor science in societal decisions are significant. They result in mis-diagnosis of a problem and mis-application of solutions to perceived or real problems. Experience has shown that mis-diagnosis of environmental problems results in expenditures of enormous sums of public funds for activities that have marginal impact on human or ecological health. In a society with limited public funds, the ultimate consequence of such a mis-diagnosis is a waste of national resources and a lack of funds for actions that address real social problems. The situation is analogous to medical mis-diagnosis. The patient may receive treatment that treats a non-existing disease; or worse yet, does not treat the true disease. The concept of best available science (BAS) was developed to respond to this crucial societal need. It requires an understanding of three independent and yet interrelated systems. The first deals with the status of knowledge of a specific scientific issue. The second system describes the selection process to ensure that the best scientific information is selected and the selection is commensurate with the status of science. Finally, the BAS concept requires a clear and unambiguous separation of science from all other non-scientific issues. Classification of scientific Information There appears to be a misconception in the public that “science is science”, therefore, all scientific assertions are alike. In fact, whereas some areas of science have advanced to the level of certainty, there are other areas that are highly uncertain. Thus, an assessment of BAS requires an appreciation of the status of the science under consideration. The following classification of scientific information is an update and expansion of a system that has been practiced by the scientific community for more than a century. Class I - Confirmed science: This class is equivalent to scientific law. It is scientific information that has been unequivocally confirmed and generally accepted. There is a great deal of misconception about Class I science. Although it can be assumed that the information in this class is absolute, there is no reason why this class of information may not have limitations. For example, the speed of light is known with a given accuracy. Many independent investigators have measured the speed of light and reported their results, which are not identical to those measured by others but are all within the generally‑accepted accuracy. Similarly, until the appearance of relativistic physics, certain laws were assumed to have universal applicability. Meanwhile, there is a consensus on the limitations of these laws in the classical physics without changing their status as Class I science. Simply stated, they do not apply to relativistic conditions. Class II - Applied science: This class consists of application of scientific laws to various branches of commerce and industry. It also includes facts from one branch of science applied to other branches. Engineering and other applied sciences fall into this class. Class III - Extrapolation: Scientific information obtained by extrapolation from observations beyond scientific limits falls into this category. Included also are models that use scientific information which has not been validated by experimental data or other convincing evidence. A large segment of contested scientific information falls into this class. An example of this class is the currently-used carcinogen assessment program by regulatory agencies. The process consists of exposing rodents to high levels of chemicals, occasionally so high that a fraction of animals die of acute poisoning. Subsequently, the results of these experiments are extrapolated to humans at exposure levels that are sometimes a million-fold lower. Class IV - Pseudo-science: Sometimes called junk science, or politically processed science, this information has the sole purpose of promoting someone’s ideology. The champion of this class of science was Lysenko, a Soviet geneticist who claimed a new form of genetics. This subsequently led to the effective destruction of genetics research in the Soviet Union and resulted in disastrous agricultural production in that country. Pseudo‑science is by no means limited to the past or the Soviet Union. A large segment of information disseminated by certain advocacy groups can be classified into this category. Often the dissemination of pseudo‑science is justified on the basis that it is necessary to exaggerate or scare people in order to move the democratic system. What is being overlooked is the long‑term damage that misinformation causes. Selection Process The scientific information was divided into the following four distinct categories: Personal Opinions: Expression of views by individuals regardless of their training, experience, and social agenda, are included in this group. Personal opinions are seldom—if ever—BAS. At best, this category can be used to initiate the study of a scientific issue. Unfortunately, the media relies largely on this category in its reporting of scientific issues. 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. This is the favorite category of government agencies, advocacy groups, and individuals who want to promote an idea or are reporting on a subject. In fact, this category is the more organized and written form of personal opinions. Again here, at best, this category should be used to initiate a study. Experience shows that in the overwhelming majority of cases this category does not meet the requirements of scientific acceptability. Peer-Reviewed Science: Information subjected to an independent peer review constitutes this category. Peer review is the foundation of scientific acceptability. There are numerous requirements for acceptability of peer review. Briefly, the individual who is chosen as a reviewer must be a “peer” to the author of the study and must have no conflict of interest. In addition, the author of the study must respond to the criticism by the peer to the satisfaction of an uninvolved person or organization. Consensus-Processed Science: This category consists of information resulting from a process used to resolve scientific disputes. The prerequisite for this process is the formation of a group of peers under the auspices of an organization that is uniquely qualified to do so. Professional societies are primary candidates for this activity. There are, however, certain limitations to such an approach as follows: 1. Professional societies are qualified to manage the consensus process in their disciplines. For example, engineers cannot authoritatively speak on medical practice, similarly, chemists cannot judge the validity of issues related to electrical engineering. 2. Professional societies are no more qualified to speak on societal implications of science than are members of the general public. Scientists, including engineers, probably have more information than the general public, and thus start from a stronger base. However, their obligation consists of providing the public with the best and most accurate scientific information rather than making societal decisions. 3. Management of the consensus process must exclude parochial interests of the profession represented by the professional society. Many professional societies represent their parochial interests and should disregard these interests during the consensus process. 4. Organizations established for the purpose of reaching a scientific consensus must meet certain requirements. For example, the National Research Council (the research arm of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine) is uniquely qualified to evaluate interdisciplinary issues. In contrast, organizations such as the National Council on Radiation Protection and Measurements are qualified to evaluate issues related to their areas of specialty, such as radiation. Separation of Science from Ideology The third and final requirement of BAS is based on the notion that no other criteria or parameters may be used to judge the validity of science. In effect, the BAS requires that peer reviewers would come to the same conclusion on a scientific issue regardless of the view on any other social issue. A similar situation exists for the consensus process. Accordingly, the selection of peer reviewers or those chosen for the consensus process must rely solely on criteria that are entirely scientific and exclude political, ideological, or any other non-scientific consideration.

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