Created: 11/13/96

COMMENT ON

"STRATEGY FOR EVALUATING DATA RELATED TO

THE HEALTH EFFECTS OF ELECTRIC AND MAGNETIC FIELDS"

 

Comment submitted on November 8, 1996 in reply to a request from Christopher J. Portier, Ph.D., Chief, Laboratory of Computational Biology and Risk Assessment, and Chair, Risk Assessment Research Committee, National Institute of Environmental Sciences (NIEHS). The subject of the comment is the strategy proposed by NIEHS for evaluating the health risks of powerline electromagnetic fields.

 

INTRODUCTION

THE NIEHS PROPOSAL

EVALUATION OF NIEHS PROPOSAL

ALTERNATIVE PROPOSAL

FOOTNOTES AND REFERENCES

 

INTRODUCTION

This comment is in reply to a request from Christopher J. Portier, Ph.D., Chief, Laboratory of Computational Biology and Risk Assessment and Chair, Risk Assessment Research Committee, NIEHS, dated October 8, 1996. The subject of the comment is the proposed strategy for evaluating the health risks of powerline electromagnetic fields described in the letter, and in a document obtained from the NIEHS web site (1). It is concluded here that the proposed strategy is seriously flawed and should be disregarded, and a new strategy is proposed.

 

THE NIEHS PROPOSAL

Scientific meetings and other activities have been proposed by the NIEHS to address the question of whether electromagnetic fields (EMFs) produced by powerlines pose a risk to human health, and if so, to determine the significance of the risk and to develop mitigation technologies. The process will begin with three sequential multi-day symposia to treat non-overlapping subject matter in which experts would discuss relevant information within a particular procedural framework, and attempt to reach a consensus regarding the health risks due to exposure to power-frequency electromagnetic fields. The participants in the first symposium will determine whether theoretical and in vitro research findings support a causal linkage between EMFs and health effects. Participants in Symposium II will address the same question after considering the epidemiological results. The question will be considered for a third time by the participants in Symposium III, who will be charged with reviewing in vivo experimental and clinical laboratory findings.

Participation in the review and evaluation process will be by invitation from NIEHS. Each symposium will be chaired by a facilitator, and a record of the proceedings will be maintained by a rapporteur. The cost of participation in the symposium will be borne by the invitee, except in special cases.

The work of the rapporteurs will be submitted to a Working Group consisting, in part, of Principal Authors, who will produce a preliminary decision based on the proceedings from the symposia and other relevant information. Thereafter, the Working Group will produce a more definitive written decision for submission to the NIEHS Director. The Director will consider the decision and other relevant information, and prepare a report to Congress regarding the potential for human health effects from exposure to powerline EMFs. The overall proposal is summarized below.

EVALUATION OF NIEHS PROPOSAL

For the reasons discussed below, the proposed strategy for ascertaining the health risks of powerline EMFs is fatally defective. The Proposal should therefore be withdrawn, and a new proposal that remedies the present defects should be circulated.

 

Resort to Blue-Ribbon Committees is an Historical Error

Essentially all previous attempts to resolve the issue of health risks due to powerline EMFs have included appointment of a blue-ribbon committee charged to form a consensus regarding the risks. Committees assembled by the National Research Council of the National Academy of Sciences, the World Health Organization, the American Institute for Biological Studies, The American National Standards Institute, and many state agencies have each reached a consensus tending to exonerate electromagnetic fields, but their efforts lacked credibility and were largely ignored. Thus, the blue-ribbon committees have failed to resolve the issue. The need for the NIEHS to undertake the present activity is good evidence of the fact that the previous efforts failed.

The blue-ribbon committees failed principally because the results of their efforts were predictable once the members of the committees were identified. It was possible to predict the nature of the reasoning that would be followed, and the conclusion that would be reached, independently of the existing evidence. Thus, those who chose the committee members also chose the result that the committee would reach.

There is no reason to expect that the blue-ribbon panel proposed by the NIEHS will succeed because previous committees chosen in the manner outlined in the Proposal have failed. That flawed format should not, therefore, be implemented again.

 

Seeking Consensus Among Scientists is an Unreasonable Strategy for Finding the Truth Regarding EMF Health Risks

Investigators concerned with the health effects of EMFs come from all areas of scientific endeavor, display all levels of competence, and all degrees of interest and focus on the study of EMFs within their particular scientific specialty. Their value systems vary widely, as do their opinions regarding the manner and conditions under which the results of scientific studies ought to be used and applied in society at large. They also exhibit personalities that range from the meek to the aggressive. The conclusions of a blue-ribbon committee chosen non-randomly from the ranks of this group, therefore, would consist of an admixture of the science, values, philosophy, and personality traits of the committee members, and would not be representative of the objective state of the science. Additionally, essentially every EMF investigator who, credibly, could be asked to participate in the symposia or the Working Group is already explicitly or implicitly identified with particular views regarding the main issues. It will not be possible to prevent the symposia from being dominated by individuals having strong views, and it is those views rather than the reasons underlying them that will be reported.

Seeking consensus among non-EMF investigators would be even more futile because, in addition to the enumerated problems, there would exist the further difficulty that the non-EMF scientists would be ignorant of the large body of experimental data that exists regarding EMF-induced bioeffects, and it would be a hopeless task to expect such an individual to master that information within the time frame of a symposium (2).

A non-EMF biological scientist is likely to have only a rudimentary understanding of electromagnetic fields because they are not encountered in the classical biological education in the United States. With regard to the biologists on the faculty of my Institution, for example (which I think is representative of other faculties), Ohm's law is the limit of their working knowledge. It simply makes no sense to ask such individuals to make global judgments regarding EMF studies by biologists who have learned about electromagnetic fields and then proceeded to employ them in scientific studies that were ultimately published in peer-reviewed publications. A non-EMF physical scientist is also incompetent to make global judgments regarding health risks because such matters are as far from the area of expertise of the classically trained physicist as are electromagnetic fields from the expertise of the biologist.

These considerations indicate that a strategy for replying to Congress that was based on seeking consensus among EMF experts, non-EMF experts, or a combination of such experts would have a scant possibility of ascertaining the truth regarding EMF health risks.

 

A Tri-Partate Adjudicatory Process is Logically Defective

The question posed by Congress to the NIEHS Director can be answered only by individuals who have considered all the pertinent evidence. But the Proposal arbitrarily divides the scientific data, and forces participants in individual symposia to reach judgments regarding the ultimate issue based on only part of the evidence. It is not logical to pose the basic question to the participants in the individual symposia because whatever shortcomings might exist in the data within the jurisdiction of one symposium might be cured by the data within the jurisdiction of another symposium. Only if the evidence is considered altogether is it reasonable to make a final decision regarding the ultimate issue.

 

Symposium 1 is Unnecessary

The nature of EMF biological transduction mechanisms are of fundamental scientific importance, and great scientific accolades will be received by the individual who provides an explanation for the process. It is well to remember, however, that the question posed to NIEHS by Congress did not involve that issue, but rather the issue of whether present patterns of exposure to powerline EMFs create a health risk. The latter can be answered without answering the former, and it is my view that such was Congress' intent. On the other hand, linkage of the two issues has the effect of delaying indefinitely a substantive reply to Congress' question because, despite some promising leads, we are far from meeting the heavy burden imposed on anyone who proposes a deductive explanation of EMF bioeffects from physical theories. The first symposium, therefore, will create heat but no light because the only relevant question that could be posed to a physicist regarding the main issue is whether the laws of physics predict or preclude EMF transduction. Since the answer obviously is No, the symposium can serve no useful purpose (3).

 

The Proposal's Verbal Ambiguities Preclude Its Implementation

The Proposal speaks of "causal linkage", but nowhere are these and other fundamental and dispositive terms actually defined. A cause to a physical scientist is a force, like gravity, that constitutes a necessary and sufficient factor to bring about a result. In contrast, the biologist normally uses the term to indicate a factor that is sufficient in the circumstances. The issue of whose cause is to be employed is outcome determinative. EMFs may be a cause of physical changes, but can never be a cause of disease under the physicist's definition of the word.

Similarly, health risk to a physicist implies concepts such as dose-effect, linearity of response, robustness, rigorous reproducibility, and near certainty. Others, particularly biologists, disagree regarding the degree of the applicability of these criteria in making judgments regarding what constitutes scientific knowledge regarding the question of health risks due to EMFs. Again, the choice is outcome determinative.

The Proposal also contains implicit ambiguities, the most important of which involves the extent of the burden of proof in making a judgment concerning health risks. In most physical measurements, accuracy and precision are usually matters of choice because they are under the control of the investigator. In biological studies, however, chance and uncontrolled factors are always present, and protection at the 5% level against a type-1 error is generally considered sufficient to warrant an assertion of a cause-and-effect relationship in a particular study. Generalization of results of biological studies never occurs with such a high degree of confidence, and when scientific data is taken over into the public domain the law imposes a preponderance-of-the-evidence burden (4). In physics, in contrast, a measurement to within 5% is generally considered to be only a first approximation, and the generalization of the results of such measurements (the electrical resistance of copper, as opposed to the results of a particular measurement, for example) is expected to be better than the results of individual experiments. The choice as to which rule to follow, again, is outcome determinative.

 

The Proposal Inextricably Commingles Science and Values

Over the past 30 years, I have attended numerous scientific meetings and spoken with many EMF scientists. I have encountered two extreme positions regarding the issue of health risks posed by environmental electromagnetic fields. Some scientists are strongly impressed by the critical role of electricity in modern civilization, and adversely disposed to any steps that might restrict its use except where warranted by clear, obvious, and certain scientific data. At the other pole are those who see EMFs as a principal factor in human disease, to be guarded against by government mandate, irrespective of the cost. Not surprisingly, individuals in the respective camps give different answers to the question posed by Congress while professing to reason from the same data base. The point is that for these scientists, and those with in-between views, personal values influence the answers that would be given to the question of EMF-induced health risks. Although this is a normal human reaction, it would be improper for the NIEHS to employ a strategy that encouraged commingling of scientific judgment and personal values because they are entirely separate factors, within the adjudicatory domain of entirely different groups. Scientists should judge the science, but society's representatives should judge the judgment of the scientists and utilize the values of society to determine the appropriate response to any risk posed by EMFs.

In the United States, decisions affecting the public that involve scientific issues must be made on the basis of "scientific knowledge" (5). In the Daubert case (5), the Supreme Court specifically rejected consensus and general acceptance as a basis for public policy decisions involving science. None of the parties or interveners in the case had the temerity to argue to the Court that such decisions ought to be made on the basis of the value system of particular scientists. Despite this, the Proposal envisions an adjudication process that will essentially guarantee a pivotal role for the personal values and beliefs of the symposia participants.

 

Extrinsic Validity of the Data is Not Assured

The source of funding of a scientific experiment is not a factor in the peer review of a manuscript because the review process is limited to scientific considerations. But suppose that an employee of a power company published a study that concluded that living near powerlines does not result in increased risk for disease. Even though the employee-employer relationship does not affect the peer evaluation, ordinary human experience suggests that such studies might be biased in some manner. The relationship could, therefore, properly serve as a basis to give less weight to the results of the study. Thus, depending on how a study was funded, a question concerning its extrinsic validity may arise. Similar concerns are also engendered when a study is funded via contract.

A contract is a method of funding research to provide knowledge that is desired by the funding party. Both the Electric Power Research Institute (EPRI) and individual electric utility companies have routinely employed the contract mechanism for funding research. Data obtained pursuant to these contracts is owned by EPRI or the individual utility company, and it is the industry itself that has the right in the first instance to determine disposition of the data and the extent of access that will be permitted. Investigators working under a contract may be permitted to submit some of their work for peer review, depending on the needs and desires of the sponsor. But the sponsor may have various concerns, including potential civil liability, that could encourage secrecy regarding some or all of the study results. The lack of academic freedom to publish whatever data one chooses is a well-understood aspect of contract research. In agreeing to perform contract research, an investigator acknowledges that the primary goal is the satisfaction of the contract, not contribution to the corpus of public knowledge in science.

In the case of EPRI, restricted access to scientific information is the rule from the beginning to the end of the contract process. The experimental design is not disclosed in advance, mid-stream changes in experimental strategies can be implemented with no need to rationalize the changes, only selected portions of the results need be disclosed, and when final reports are prepared they normally cannot be obtained by non-members of EPRI unless the requesting scientist is willing to pay $200 for a copy of the final report. There is no national registry of EMF research performed by the power industry; it is not possible, therefore, to establish what research is occurring or has occurred.

The nature of the privity between the author of a scientific study and the electric utility industry in whose favor the results are advanced can affect the weight accorded the study because directed research such as that performed by an employee or contractor of a party may be partisan in the sense that non-scientific considerations may affect what is done, what is released, and how it is interpreted (6).

In contrast, research funded by grants from the National Institutes of Health is performed pursuant to a specific plan, and the plan itself, as well as all data reported to the granting agency, is available under the federal Freedom-of-Information statute. Moreover, NIH has promulgated policies directing that the raw data obtained during the conduct of the research, as well as associated materials, should be made available to all interested parties.

Although the idea of dishonesty in science, in any form and to any degree is repugnant, various species of dishonesty do occur. The steps envisioned in the Proposal for assuring the reliability of data are inadequate because NIEHS cannot guarantee that the data volunteered by the industry is valid.

 

Work Product of Previous Blue-Ribbon Committees Not Excluded

Several factors indicate that the work product of the previous EMF blue-ribbon committees is not reliable. First, the primary goal of all the past committees was to arrive at a consensus, whereas the primary goal of the strategy implemented by NIEHS is to convey truthful and accurate knowledge to the Congress. Since there is no necessary connection between the consensus reached by any past EMF blue-ribbon committee and the accuracy of its work, there is no justification for allowing symposia participants to utilize the results of previous blue-ribbon committees.

Second, no consensus has any practical value unless it is formed by a representative group of individuals, because only in that case would it be reasonable to regard the committee's opinion as an accurate characterization of the state of the EMF science. If the committee members were chosen because of their opinions, as has frequently been the case, there would not be a basis for according the committee's opinion more weight than that due the members as individuals.

Third, blue-ribbon committees often have obvious conflict-of-interest problems that it would be excessively naive to ignore. It is not realistic to expect that employees of companies deriving profit from the manufacture or use of devices that emit electromagnetic fields will adequately represent the interests of those who are exposed to the emissions of these devices. Conflicts-of-interest occur even when a committee is appointed by a federal (7) or state (8) agency. Governmental involvement in committee selection therefore confers no advantage in this regard. Conflicts-of-interest should be suspected whenever the results of a blue-ribbon committee are colorably dispositive of an EMF bioeffects dispute because the disputes are incapable of resolution on a purely scientific basis (9).

Fourth, the credibility of the EMF bioeffects blue-ribbon committees has been seriously damaged by the manner in which the committees were chosen and tasked, and by the circumstances that characterized their activities. For example:

1. The persons responsible for selection of committee members and the mechanism by which they chose the members were usually not disclosed.

2. The committees frequently contained many, sometimes even a majority, of scientists having no previous professional experience with studies involving the biological effects of electromagnetic fields.

3. EMF biological scientists appointed to the committees generally identified with their own research as robust and well-established, and the results of other EMF investigators as problematical.

4. EMF biophysical scientists appointed to the committees were usually strident polemicists who derided the possibility of EMF-related health effects on the basis of their understanding of physical theory.

5. The final judgments of EMF blue-ribbon committees have nearly always supported the agency or industry whose EMF-emitting hardware gave rise to the concern that led to the formation of the committee, particularly in those cases where the agency or industry funded the committee (10).

6. The final reports of EMF blue-ribbon committees usually deprecated the EMF studies that were not performed by members of that committee, but accepted or even lauded the work of committee members (11).

Despite the shortcomings of previous EMF blue-ribbon committees, the Proposal fails to preclude or account for these problems, thereby guaranteeing that they will play a prominent part in the proposed symposia.

 

Failure to Consider Industry Arguments

The question posed by Congress to NIEHS has a long history in administrative and judicial forums in the United States, beginning with the Public Service Commission of New York, in 1974. A discernible pattern of industry arguments has evolved, and those arguments can be anticipated to also arise during the NIEHS review of the EMF bioeffects issue. Under the Proposal, these arguments will proceed in the absence of guidelines for assessing their relevance and materiality, and for determining the role that they will play in the process. Typical examples of industry arguments are as follows.

Role of Frequency. The issue posed by Congress involves the health and safety of electromagnetic fields from the electric power system, which operates at 60 Hz. Consequently, all theoretical and experimental data dealing with other frequencies is irrelevant and should not be considered.

Specificity of Response. In order for electromagnetic fields to be considered a health risk, they must cause specific human illness. For example, they must be capable of causing non-Hodgkin's lymphoma, or chronic lymphocytic leukemia, or other specific histological subtype of cancer. Studies linking electromagnetic fields to cancer in general or to other disease processes are therefore irrelevant.

In Vitro Studies. All in vitro studies are irrelevant because one cannot infer the likelihood of disease and the occurrence of any particular effect in an isolated cell. At best, in vitro studies are useful for understanding mechanisms, but it is universally conceded that mechanisms are not identified or even reasonably suspected.

These, and other similar arguments (12), have been well crafted by industry attorneys during the past 20 years. The industry has assembled a well-oiled machine consisting of an extensive database, private consulting companies, a seasoned group of expert witnesses and attorneys specializing in the defense of EMF claims, and a battle-tested sequence of arguments and positions that can be condensed or expanded and changed in complexity or detail to meet the constraints of any forum. The industry arguments can be mastered quickly by any reasonably competent scientist who chooses to do so. Does NIEHS intend to allow these arguments to be made during the course of its review of the evidence? If so, whom does NIEHS expect will argue the contrary position? If no one does, as will likely be the case for the reasons discussed above and in the next section of this comment, would it be fair to say that both sides of the issues were considered?

 

Financial and Personal Risks Not Adequately Considered

In 1975, Robert O. Becker, M.D., was the first investigator in the United States to seriously warn of health risks from powerlines. At that time he was an established investigator with an international reputation. He had received the highest award offered by the Veterans Administration (VA) for scientific research, was a fully funded medical investigator within the VA, and had several NIH grants. When he opined publicly (in a proper forum, at the request of the officers of that forum, and without remuneration) that powerline electromagnetic fields were health risks, the bottom simply dropped out of his scientific career. During the next 5 years Dr. Becker lost all his grants, and was forced into retirement at the age of 56. Dr. Becker's fate is well known within the EMF community, and stands as a strong deterrent to those who would speak publicly on the wrong side of the powerline EMF issue.

Powerful organizations including EPRI, the law firms of Crowel & Moring and Watson & Ritter, the American Physical Society, the Department of Energy, and Florida Power & Light Company steadfastly maintain that powerline electromagnetic fields are not health risks. Why would anyone choose to oppose that view publicly, despite the evidence? How would that investigator be protected from reprisals?

Furthermore, participation in the symposia is largely self-funded. This will present no problem for the industry groups, which possess abundant resources, but it will largely preclude scientists with opposing views from participating for lack of funds because these scientists have no sponsor. What resources would be made available to someone who agrees to oppose the industry groups?

No procedure evolved by NIEHS can succeed unless it is appropriately funded and the participants are protected from reprisals. These considerations, however, are ignored in the Proposal.

 

ALTERNATIVE PROPOSAL

The United States is at an historically significant point in the development of the relationship between science and society, and the NIEHS has an opportunity to chart the course of this development. Congress has vested considerable responsibility in the NIEHS regarding resolution of the EMF health-risk issue. This action was, in my view, an indication of the confidence and respect that those on all sides of the dispute have in the independence and impartiality of the NIEHS, and the resources and competence that it can muster.

Brief reflection will establish that, as a society, we are quickly running out of possible mechanisms for dealing in a fair and expedient manner with the EMF issue. State and federal blue-ribbon committees have failed because they lacked the mechanisms needed for elaboration of decisions in the public interest. State and federal regulatory agencies have failed because political considerations and the concerns of special interests have dominated the processes. The courts have failed because the extraordinary costs of civil litigation cannot normally be borne by ordinary citizens. Only the National Institutes of Health has the requisite technical expertise, credibility, resources, freedom from political pressure, and respect for dealing fairly with complex issues.

The fundamental problem with the Proposal as a putative strategy for responding to Congress' charge is that the Proposal fails to recognize the extent to which the blue-ribbon committee approach is a rotted structural mechanism that is incapable of serving the public interest regardingEMFs. Beneath the patching, paint, and polish, the NIEHS has proposed the same rotted structure.

If the NIEHS found it desirable to seize the present opportunity, it could design and implement an entirely new process for decision-making in the public interest regarding the EMF issue. If successful, that process could serve as the model for decision-making in future similar debates.

Evolution of the needed decisional mechanism should begin with a recognition that the blue-ribbon-committee process has failed, but that this failure can serve as the point of departure for the creation of a new system of scientific decision-making in the public interest. This can be accomplished by analyzing the factors that led to the failure, and creating a new system that avoids them. Such a plan is no guarantee of success, but it is sufficient to avoid the guarantee of failure.

Prior to any symposia or meetings dealing with the substantive issues, the NIEHS should formulate a comprehensive plan regarding how it will discharge its responsibilities under the Energy Policy Act of 1992, and submit that plan for (New Proposal) comments. Following whatever modifications may be appropriate, a direct inquiry into the substantive issues could proceed. Some of the important issues that ought to be considered in the New Proposal are discussed below.

 

Important Unresolved Issues

The intent of the NIEHS is to "... address the question of whether the EMFs produced by the generation, transmission, and use of electric energy pose a risk to human health, and if so, to determine the significance of the risk and develop mitigation technologies." Each of these goals, however, is far too vague. What does it mean, for example, to identify a factor as "a risk to human health?" How would an objective investigator determine whether a particular agent is or is not a risk? What kinds of reasoning would or would not be acceptable? Some argue, for example, that if powerline electromagnetic fields were shown to affect the growth rate, brain electrical activity, or neuroendocrine system of animals, then it would follow that it would be reasonable to assume that similar effects could occur in similarly exposed human subjects, and that such a situation would reasonably indicate a risk to human health. Others argue that the human body could handle such changes and perturbations, and that evidence of risk to human health must be based on a showing that exposed animals developed diseases.

Are the results of in vitro studies capable of providing evidence regarding risks to human health? If so, how? If not, should they be excluded from consideration?

Some argue that the physical process by which EMFs are transduced by the body must be established as a condition precedent to accepting any EMF-induced biological effect as real. Those opposed to this view argue that the transduction mechanism is irrelevant to a consideration of the existence or non-existence of a human health risk. Should this question be decided by scientists at a symposium, or is it more properly a decision reserved to a more disinterested group, or a group with public-policy responsibility?

Some argue that the question of risk cannot be considered in isolation, and must be considered in relation to other factors such as cost of potential mitigation strategies. In this view, the methodology usually followed in relating scientific knowledge to society at large in non-EMF areas is not applicable to the powerline issue (4). In other words, the process ordinarily used to decide whether a particular drug is effective for treating disease, or whether the drug has side effects of a particular kind, or for deciding whether a particular pesticide residue will be a risk to human health, should not be followed in determining whether EMFs are health risks because economic dislocation could result. Economic consequences should be accepted by society, in this view, only if the quantum of the risk to human health is sufficiently great. Is this an acceptable argument? Is it an argument that ought to be permitted to be considered or decided by scientists? If so, should scientists making the argument be required to document these economic considerations?

The point of these and many other comparable examples is that one cannot pose a question regarding whether "risk" to human health exists unless one first indicates the type of evidence and reasoning by which an affirmative or negative answer to the question will be judged.

Similar comments can be made regarding the vagueness of the goal of determining the "... significance of the risk." "Significance" is a relative concept and therefore requires a frame of reference for rational discussion. It seems obvious that the risk posed by EMFs will be insignificant compared with some risks and significant when compared with others.

Other questions arise. For example: Is the question of "significance" related in any way to the involuntary aspect of present-day patterns of powerline EMF exposure? That is, would the significance of a risk properly be considered to differ in the case where a power company builds a powerline beside an already existing home, compared with the situation in which the home is purchased after construction of the line, with the new owner fully aware of the controversy and willing to accept whatever risks might exist?

Imprecise use of language and the implicit incorporation of inapplicable standards is pervasive in the EMF bioeffects literature, particularly in the literature that colorably exonerates electromagnetic fields as a health risk. For example, a recent press release from the National Research Council EMF Committee asserted that "no clear, convincing evidence exists to show that residential exposure to electric and magnetic fields (EMFs) are a threat to human health ...". The press release also says that "research has not shown in any convincing way that electromagnetic fields common in homes can cause health problems...". But what is "clear and convincing evidence" in the context of the EMF health issue? What agent or factor has been identified in the environment with respect to which, in the opinion of the Committee, there is clear and convincing evidence that the agent poses a risk to health? If none are identified, then perhaps it is the case that no amount of evidence could meet the "clear and convincing" standard. Statements that evidence was not "convincing" should therefore be accompanied by a definition or suitable examples of the kind of evidence that would be convincing. Only then can the judgment be adequately evaluated, and determined to have been made in accordance with the applicable evidentiary burden.

Where did the Committee get the idea that "clear and convincing" was the applicable standard? That is simply not the rule in the United States, yet it was apparently the rule imposed by the Committee.

In summary, the goals of the fact-finding effort must be precisely characterized so that the evidence obtained is relevant, and reasonable rules and procedures must be formulated in advance of the fact-finding phase. Otherwise, the resulting vacuum will be filled by the individual participants according to their own ideas.

 

Stipulated Questions

The answers to the ultimate questions to be addressed in the fact-finding effort should be decided by a proper group of judges, applying a defined procedure to the scientific facts as determined by the scientists. This is so because questions affecting the general public must be decided by disinterested representatives of the public, not by participants in the dispute, according to a pre-established set of rules. It is the NIEHS' responsibility, not that of the scientists, to create an appropriate procedure to implement the scientific fact-finding.

The most desirable strategy would consist of propounding stipulated questions to the scientists in the context of a reasonable procedure, and asking the judges to resolve the ultimate issue, depending on the answers to the stipulated questions. Thus, the scientists would determine the facts, and the judges would assess whether the opinions of the scientists were adequately based on scientific knowledge and were formed according to the proper rules and guidelines, and the judges would then determine what (and to what extent) values would be incorporated in addressing the question posed by Congress.

The stipulated questions could, for example, include the following:

1. Do the animal studies show that powerline electromagnetic fields can cause biological effects in similarly exposed human subjects?

2. Are the animal studies showing putative cause-and-effect relationships between electromagnetic fields and biological effects different in quantity or quality from similar types of studies that involve agents other than electromagnetic fields?

3. In considering the laboratory studies purporting to show a relationship between electromagnetic fields and biological effects, what frequencies, waveforms, and field strengths should be considered in answering the question?

4. Was scientific information from research projects performed under contract to the Electric Power Research Institute or individual power companies withheld?

5. Do the epidemiological studies purporting to show an association between EMF exposure and human disease, particularly cancer, differ in quantity or quality compared with epidemiological reports purporting to link other factors with human disease?

A record pertinent to the charge from Congress will be created only if questions are posed that are reasonably related to that charge. Otherwise, the symposia participants will simply formulate questions that they consider important.

 

The Science Court

The mechanism of the blue-ribbon committee is quite useless for resolving the EMF powerline dispute. The only reasonable alternative proposed thus far is the science court (13). The time has come to implement this concept.

How might a science court work? After the issues to be decided are identified and framed, case managers for each side could readily be chosen. Each side would then present the evidence in favor of its view, and have the opportunity to directly test the evidence presented by the opposing side. The great strength of the science court approach, is the ability it allows to force each side to directly confront the affirmative evidence advanced by the other side (14).

The judges would then decide which side presented the more persuasive case based on the scientific evidence, and they would determine whether one side carried its burden by a preponderance of the evidence. The judges would then formulate a final decision of the science phase of the inquiry which would be considered by the NIEHS Director, together with other relevant information, in making his report to Congress. The proposed procedure is illustrated below.

The Judges Should Be Laymen

The choice of judges is a pivotal question. There are several reasons why the judges should be laymen, not scientists. First, each EMF investigator can reasonably be expected to have a predisposition toward one side or the other in the dispute. This is an appropriate and desirable state of affairs with regard to intra-science considerations because the goal of scientific expertise involves ascertaining the superior data within one's specialty. On the other hand, such individuals, almost by definition, lack judicial temperament. Ideally, a judge should be a knowledgeable person with a scholarly intellect, no preconceived attitudes toward the issue in question, and the determination to make a decision based on the entirity of the evidence presented under the rules.

Scientists who possess EMF bioeffects knowledge are particularly valuable as participants in the science court, where the strength of the data and the power of their reasoning can be displayed. It is at this level of the process that all first-rank EMF investigators should be employed because they are uniquely qualified to relate and discuss the available evidence.

Second, non-EMF scientists should not function as judges because the advantages that would be conferred by having judges who were familiar, generally, with the methodology of science would be outweighed by the disadvantage of the effect of the respective scientific traditions of the judges in the decisional process. For example, obviously, judges selected from the Board of Councillors of the American Physical Society would be more likely to acquit EMFs than would be more biologically-oriented judges. The reason is that the scientific tradition of the physical scientist differs fundamentally from that of a biological scientist, and all evidence presented in a science court would be seen through the prism of the judges' prior conditioning (15). The same comment generally applies to any group of non-EMF scientists who might be chosen: In each case, even given objective procedural guidelines and procedures, the tendency will be to see the evidence in terms of the scientific traditions of the respective fields of the judges (16).

Third, the questions posed by Congress are not scientific questions, but rather are non-scientific questions the resolution of which requires evaluation of scientific data. Congress did not call on the NIEHS to evaluate the scientific sufficiency of the ion paramagnetic resonance model, the role of melatonin or ornithine decarboxylase, the utility of the use of wire codes as a surrogate for exposure to magnetic fields, or the role of the neuroendocrine system. These are scientific questions that must be answered by scientists. On the contrary, Congress asked whether exposure to electromagnetic fields from powerlines pose a significant risk to human health. The question cannot be answered purely within the scientific domain because it incorporates values and concepts that are themselves defined and given meaning only in the context of society at large, the larger community of which science is only a part. It is desirable that the particular step in the adjudicatory process at which the transition from science to society occurs should be precisely identifiable, and should be taken only by those competent to do so.

 

The Lay Judges Should be Judges

Judges are routinely charged with the responsibility for deciding issues based in the relatively narrow world of science, but having an impact in the more general world of society. They are therefore uniquely qualified to make judgements in the general public interest. There can be no serious question regarding the integrity and independence of judges, generally, and their freedom from undue influence. Thus, professional, competent scientists would judge the science, and professional, competent judges would judge the scientists, exactly as occurs in every other area in the United States in which scientific knowledge has a role or an impact (4).

To minimize possible conflicts and insure that only the best persons would be involved, it would be desirable to choose the judges from among senior federal judges who have a documented history of scholarship in matters involving science and science policy.

 

Procedures in the Science Court

The procedures to be followed in the science court must be specified by NIEHS, but they could include the following.

(1) The adversary proceeding will consist of affirmative cases put forth by case managers on each side of the debate, followed by a thorough cross-examination of the positions taken by representatives of the other side. This is the key aspect of the science court, and it is of profound importance in ascertaining the public interest. Events of the past 25 years have amply demonstrated that any view regarding EMF bioeffects, regardless of how extreme it may be, can be made to appear plausible if the proponent of that view is not required to directly confront the opposing evidence and arguments.

(2) The rules of evidence will be the scientific rules, not the legal rules of evidence. Consequently, personal attacks on the participants will not be allowed, and the expertise of participants will not be challengable. At the outset, the managers of the issue in the science court will agree upon a formulation of the rules ofscientific evidence which, after any appropriate modification will be approved by the NIEHS and will then govern the proceedings.

(3) The affirmative case for each side will be written and pre-filed, prior to oral proceedings conducted in an open fashion.

(4) At the open proceedings, each scientist who has agreed to participate will briefly summarize the position he has taken, after which that position will be challenged by scientists on the opposite side. It will be the responsibility of the case managers on either side to present an orderly and logical succession of scientists capable of explaining and defending the overall position advocated by each side. The record created, on which the decision will be made, will thus consist of the pre-filed direct positions of the scientists advocating each side of the issue, and the verbatim transcript of the cross-examination.

(5) The entire proceeding will be open to the public, but the deliberations of the judges will be in private.

(6) If participants rely on the results of contract research, the NIEHS should make an effort to convince the sponsoring company to make all the data gathered pursuant to that research available to the science court.

(7) The decision of the judges will consist of an enumeration of the specific findings made by the judges, and the relationship of those findings to the answers given to the stipulated questions. The judges will then make an overall decision indicating which side, if any, has carried its burden by a preponderance of the evidence. If the judges conclude that the evidence is in equipoise, they shall so state. This decision should serve as the answer to Congress regarding the question posed, and should not be substantially modified by the NIEHS Director.

(8) No appeals will be permitted in any judicial or administrative forum.

The NIEHS should invite top scientists on both sides of the dispute. If, however, the NIEHS is unable to secure the cooperation of a sufficient number of qualified scientists on one or the other side of the dispute, the judges and the NIEHS Director will be entitled to appropriate presumptions regarding the main issue. When an attempt was made almost 20 years ago to implement a science court procedure regarding the issue of health risks from powerline electromagnetic fields (17), scientists who spoke on behalf of the industry refused to take part because they felt that the science court would simply provide publicity for those on the other side of the dispute. If the same result were to occur today, then it may be reasonable to draw some obvious presumptions from the failure of individuals who might strongly oppose the notion that the EMFs were health risks when testifying, for example, in various court proceedings, but who then refused to take part in an NIEHS proceedings. On the other hand, if the NIEHS secured complete cooperation from the industry side, but none whatever from the opposite side, it would similarly be possible to draw reasonable presumptions and incorporate them into a decision or recommendation to Congress (18).

 

Bioethical Considerations

The question of exposure to powerline EMFs has serious bioethical implications that should be considered concomitantly with the question of health risks. Some would argue that the scientific evidence indicating that EMFs are a health risk is strong and becoming progressively stronger, and that the quantum and quality of the scientific knowledge tending to establish the existence of the risk exceed those for any other environmental factor. In this view, if the results of the NIEHS effort failed to establish the existence of the risk, it would follow that the process simply did not provide adequate resources, opportunity, an appropriate procedure, and a fair forum for an adjudication of the issue. Others would entirely disagree with the opinion. The point is that there exists a bona fide dispute among competent scientists regarding the health-risk issue. That being the case, is it ethically permissible for any result of the adjudication process to be presented to the Congress and the people in terms of a black-or-white answer?

In distinction to smoking which is a voluntary act, exposure to the electromagnetic fields of powerlines and other electrical appliances is usually involuntary. The bioethical ramifications of this distinction have been ignored by the EMF blue-ribbon committee, but they should be addressed by the NIEHS. Added urgency is provided by the asymmetry that presently exists between the parties that gain the benefit of public exposure to powerline EMFs and those who bear the risk of the exposure. If the power industry is correct in its assertion that environmental power-frequency EMFs do not constitute a health risk, the proper response would be to take no steps that would limit or interfere with the delivery of electric power because such steps would amount to an unjustified economic burden on the industry. On the other hand, if the industry is wrong, then disease rates among the exposed subjects would be increased. Thus, the benefit flows to the industry stockholders whereas the risks accrue to the exposed members of the public. Again, no such fundamental dichotomy exists with regard to smoking because the individual who enjoys the benefits and pleasures of smoking also runs any risks associated with smoking. Further, smokers are generally aware of the controversy regarding smoking's link to disease. However, most people are unaware of the existence of electromagnetic fields, and of the controversy surrounding exposure to fields.

When these various facets are considered, the situation seems reasonably akin to an experiment - collecting data with the intention of assessing whether the facts support a favored hypothesis. Indeed, if bioethicists and other similar experts determine that the situation does not amount to involuntary human experimentation, it would be important to delineate the aspects of the present exposure patterns that warrant the distinction. Identification of these distinctions and their acceptance by Congress might forestall development of future controversies. Failure to evaluate the bioethical dimensions of the question posed by Congress would be a serious error.


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Last updated: 11/15/96


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