March 7, 1975
Page 5750
SETTING ENVIRONMENTAL STANDARDS
Mr. MUSKIE. Mr. President, two recent decisions of the U.S. courts of appeals have serious ramifications for the establishment of standards to protect the public health from environmental pollutants currently regulated.
The first decision overturned a court order shutting down the Reserve Mining Co. The second decision set aside a health-based regulation which required phase out of lead in gasoline. Both rulings were based on the absence of proof of a specific cause-effect relationship between a particular pollutant and a precise human health result.
This reversal of the burden of proof requirement in environmental law fails to recognize the unique characteristics of environmental health hazards. It is the total body exposure to environmental insult, not the single pollutant level which ultimately determines the extent of adverse public health impacts.
Is it possible, or even desirable to establish definitive proof of causal relationships between single pollutant levels and increased death and illness as the recent appeals court decisions would require?
Gershon Fishbein, publisher of the Environmental Health Letter has written a thoughtful analysis of the burden of proof dilemma presented by the recent court decisions. He poses the questions we must all consider, if our environmental regulations are to remain protective of public health. I ask unanimous consent that his article be printed in the RECORD.
There being no objection, the article was ordered to be printed in the RECORD, as follows:
[From the Washington Post, Feb. 23, 1975]
SETTING ENVIRONMENTAL STANDARDS
(By Gershon Fishbein)
Two recent appeals court decisions have restricted the authority of the Environmental Protection Agency to establish standards to protect the public health from environmental contaminants under present laws.
The first ruling overturned a lower court order closing down Reserve Mining Co. in Silver Bay, Minn., because of the alleged presence of asbestos in the drinking water, which some scientists said could lead to cancer. More recently, the court in Washington set aside EPA's regulations phasing out the lead content of gasoline.
In each case, the court based its ruling on the same premise: that EPA had not furnished definite proof that the asbestos or the lead had caused demonstrable illness in a substantial part of the population. And in each case, the court cited the absence of a cause-and-effect relationship between statistics on deaths and illnesses and exposure to the environmental contaminants.
To EPA administrator Russell Train and his subordinates, it was clear that the combined effect of the two decisions was to impose a near-impossible burden on the agency's ability to enforce the Clean Air Act, in which the primary standards are based solely on protection of public health, and the water pollution laws related to health.
Train's concern, shared by many authorities and researchers, is based on the widely held view that the health hazards of environmental exposures cannot be pinned down in the same way that communicable diseases in one individual can be traced to one virus or bacteria. Yet that is the sort of proof which the courts appear to want before they uphold EPA's health regulations and, presumably, the standards of other agencies as well.
The concept of "one germ, one disease," or Koch's Postulate (named for Robert Koch, the 19th century German bacteriologist who discovered the cause of tuberculosis) is one of clinical medicine's most cherished maxims. It holds that a single organism causes a single disease.
This principle holds especially true in communicable diseases such as tuberculosis or common cold when an infected individual can threaten the community. In environmental health, however, the cycle of disease transmission is reversed. It is the community which threatens man – through air pollution from many sources, or radiation, or pesticides. Thus, multiple causation is one distinctive characteristic of environmental health.
Another is the long period – sometimes 20 years or more – between exposure to a contaminant and the clinical evidence of cancer or other disease. This is in contrast to viral diseases, when symptoms frequently appear in 24 to 48 hours.
Still another characteristic is the accumulation of cellular and other damages in the body from many sources over a long period of time, adding up to what is referred to by environmental physiologists as "total body burden."
MAJOR OBSTACLES
Train and his deputy, John R. Quarles, Jr., believe that the courts ignored all of these distinctive characteristics of environmental disease in insisting on specific cause-and-effect proof – body counts, as Train put it. Such proof is, of course, available in clinical medicine but almost never in environmental medicine; there is, however, a fairly strong consensus among researchers that air pollution will, as a minimum, aggravate the condition of those with heart disease and asthma as well as the very old and very young (collectively, a substantial percentage of the population).
Faced with such scientific uncertainties, regulatory agencies charged with establishing standards of public health protection from environmental sources run headlong into major obstacles in trying to be as specific as possible in selecting standards. Dr. John F. Finklea, director of the National Environmental Research Center in North Carolina – the principal EPA health laboratory – and his colleagues ticked off some of the problems in a recent paper which sought to predict the health benefits and risks of equipping automobiles with catalysts:
There is usually insufficient information regarding the magnitude and frequency of exposure to environmental agents because health-related environmental monitoring has been an "underdeveloped activity" and because of wide variations in human reaction to the same agent.
The links between exposure and disease are complex. For example, the effects of infrequent short-term peak exposures may well differ markedly from the effects of long-term exposures or frequently repeated short-term exposures over a long time. Furthermore, a single environmental agent may contribute to a number of different disorders and a single disorder may result from a combination of agents.
Environmental health studies are limited by deficiencies in vital records and imperfections in assessment of deaths and illnesses. A research data base which draws on the results of studies in occupational as well as clinical settings is usually lacking. But that sort of information might not be available for years. Meanwhile, the air and water pollution laws demand numerical standards and deadlines. So the environmental scientists dig in with animal investigations, develop computerized models, plot weather characteristics, study hospital admissions during air pollution episodes and measure them against national illness and health data – and generally come up with a series of projections, inferences and presumptions.
It is possible to determine from death certificates how many people in a community with excessive air pollution levels died of lung conditions. But death certificates don't indicate whether the victims were smokers or where they lived in relation to a polluting factory, for example.
LOOKING AT OPTIONS
Health standards based on presumptions usually give the public a greater margin of safety than otherwise. But is it fair to expect industry to spend the money necessary to comply with health standards based on little more than presumptions? Perhaps more relevant to the current dilemma, is it legal?
In the leaded gasoline and asbestos cases, EPA relied on what it believed to be the preponderance of scientific data suggesting adverse health effects in establishing standards or taking other corrective action. But the affected industries produced their own scientific studies to indicate the opposite. The court agreed with the industries.
This pattern, projected into the future, illustrates why EPA cannot rely entirely on the preponderance of scientific opinion indefinitely in trying to find a way to develop health standards which not only satisfy the research community but also survive the sterner tests imposed by the courts.
If not, what options are open to EPA in attempting to cope with the problem?
As a short-term step, EPA may consider asking Congress to amend the Clean Air Act to give the administrator greater discretionary authority in determining what constitutes "endangerment to public health." The objective would be to avoid any requirement of proving cause-and-effect relationships. EPA has made no decision on this, but the problem seems certain to surface when the Senate Public Works Committee begins consideration of Clean Air Act amendments March 19.
Other legislation includes the omnibus toxic substances control bill, which would require companies to put their chemical products through detailed and extensive tests for health effects and other environmental safeguards before being put on the market. EPA might push for precise review of health data here.
Then there is the bill by Sens. Philip Hart (D-Mich.) and Gaylord Nelson (DWis.) which would shift the burden of proof from government to industry in environmental suits. The bill, introduced just before adjournment in the last Congress and scheduled for reintroduction shortly, would require that industrial defendants prove the absence of environmental and human health damage in lawsuits rather than require the government to prove the existence of the hazard.
Alan O. Kirk II, who recently resigned as assistant EPA administrator for enforcement and general counsel to become general counsel of Pepco, had testified that the agency supported the general purpose of the legislation, which was introduced in the wake of the Reserve Mining case decision. Sen. Hart explained the objective this way:
"It would provide that once a `reasonable risk' of a threat to public health was established by parties requesting relief, the burden would then be on the defendant to prove that the relief requested was not justified. Thus, in situations where crucial evidence as to the extent of an acknowledged public health risk was lacking, defendants would be required to come forward and demonstrate the need for its activity outweighed the risks inherent in allowing the activity to continue. Most significantly, plaintiff's failure to prove actual harm would not, in and of itself, amount to a bar to relief."
EPA is also in the process of establishing standards of safety and purity in public drinking water supplies as a result of legislation passed in the final days of the 93d Congress. It seems certain that, forewarned by the lead and asbestos decisions, it will try to make such health standards court proof.
High officials of EPA express their view privately that the two judges who wrote the majority opinion in the leaded gasoline ruling took into consideration the energy and economic crisis in coming to their conclusions on health effects. Their view supports the dissent of Judge J. Skelly Wright, who contended:
"I suspect that the rigor of the majority's review and hostility to these regulations are related to the energy crisis and a reluctance to 'waste' a single gallon of gasoline for reasons of health when extra gallons might prove to be in short supply. . . It is the anguish of the children and urban adults who must continue to breathe our lead-polluted air that moves me."
If the court decision was in fact formulated with an eye on the energy crisis, it would, of course, not be the first time judicial rulings took into consideration the social and economic consequences of their actions. In past years, at the height of the environmental era, such decisions often favored the ecological cause. Now that the pendulum may be swinging a bit the other way, the courts may do the same.