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John D. Graham, Ph.D., Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office of the President of the United States

Remarks Prepared for The International Society of Regulatory Toxicology and Pharmacology Precautionary Principle Workshop, Crystal City, VA, June 20, 2002.

It seems that each new year brings new concerns about risks to human welfare, quality of life, and environmental protection. Most public concern in the United States relates now to the war against terrorism and the economic hardship that many citizens continue to face. There are also continuing concerns about the health and safety risks that people face from the consumer products, production methods, and wastes that support the high standard of living we now enjoy. And there are some broader concerns about what economic development is doing to the global environment and the welfare of future generations. Given the explosion of information about possible risks in life, it is difficult for the public to know which of the many possible risks justify attention by policy makers.


The Bush Administration believes that science should have a strong role in setting risk-management priorities. Even in the relatively simple case of health risks, sound science is critical. First, there is the basic hazard question: What is the degree of certainty that any hazard exists? For example, how confident are we that the magnetic fields emitted from electric powerlines cause an elevation in cancer rates among people living near those powerlines? Second, if the hazard exists, a probability assessment is required to distinguish a significant risk from a negligible one. For example, if magnetic fields do cause cancer, how much is the probability of cancer increased by a lifetime of exposure to a nearby powerline? Third, the number of people exposed to a hazard needs to be considered because population exposures contribute to the public health significance of the hazard. Fourth, the severity of the health effect is relevant. Even in the case of a dreaded disease such as leukemia, we need to be sensitive to the distinctions between those forms of leukemia that are untreatable and rapidly fatal versus those forms that can be treated effectively by the tools of modern medicine. In other words, the number and quality of life years lost from disease need to be considered. Although these basic scientific questions have been framed for health risks, it is feasible to frame a related set of questions for other types of risks, such as threats to natural resources and global ecology.


Regardless of how much scientific knowledge there is, public officials need to consider the degree of public concern about possible risks and how that compares with expert assessments. The emerging science of risk perception and communication is exploring these issues. How much does the public understand and care about a hazard? How volatile is public opinion likely to be in the face of new evidence or dramatic portrayals of danger? Does the hazard have characteristics that elevate public concern, such as an unfair distribution of risks and benefits? These social science questions remind us that the challenge of risk management will not be resolved by hard science alone. We need to consider the type and degree of public participation that is appropriate for decisions about risks.


Given these sweeping questions about risk, what can we possibly hope to accomplish in this brief conference? I would frame our task as follows: There is a subset of possible risks in daily life that are subject to substantial scientific uncertainty - often on all four of the scientific questions that I mentioned - but that, for one reason or another, trigger significant public concern. Under these circumstances, what is the appropriate role for precaution in the responses of risk managers? I have in mind risk managers in both the public and private sectors.


What do I mean by precaution? I can assure you that I do not intend to define any universal precautionary principle. As you know, the US government supports precautionary approaches to risk management, but we do not recognize any universal precautionary principle. We consider it to be a mythical concept, perhaps like a unicorn.


I do believe that a dictionary definition of "precaution" is a useful starting point for the conference. WEBSTER'S Second College Edition of the NEW WORLD DICTIONARY defines precaution as "care taken beforehand", or more precisely, as "a measure taken beforehand against possible danger". I presume that the word "beforehand" means before science has resolved all the key technical questions about the hazard of interest or at least before the actual occurrence of the event. Precaution is a well-respected concept: people practice it regularly in the stock market and in hospitals to cope with the uncertain risks of life.


Indeed, Americans have experienced the pain and suffering that can result from insufficient precaution in risk management. The health risks of smoking, the neurotoxic effects of low doses of lead, once used as an additive to gasoline, and the respiratory diseases from exposure to asbestos in the workplace: each became major public health problems in the United States. Public health historians teach us that these problems could have been reduced or even prevented altogether if early signals of danger had stimulated precautionary measures by risk managers.


We should not belittle the scientific challenges in each of these examples. Consider tobacco. Although the causal link between smoking and lung cancer now seems obvious, in the middle of the previous century it did not seem obvious to many well-trained and thoughtful physicians. They argued that they had treated many smokers for a lifetime who never developed a significant lung ailment. Likewise, they had treated patients with lung cancer who were not smokers. The science of toxicology did not resolve this dilemma because it proved difficult to produce tumors in laboratory animals with tobacco exposures. The field of science that proved to be most decisive is the one that some people now trust the least: epidemiology. There was in fact a large statistical study of the health of British physicians that played an important role in building the medical consensus against smoking. Interestingly, epidemiology also played a pivotal role in uncovering the neurotoxic effects of lead at low doses and the diseases associated with exposure to asbestos on the job.


If we knew that scientific progress would always verify early signals of danger or show that hazards are worse than predicted, then the challenge of precaution would be much easier. A recent report from the European commission makes the point that uncertain environmental hazards often prove to be worse than anticipated. Yet the dynamics of science are not so easily predicted. There are in fact many cases of postulated or claimed hazards that have not been confirmed.


Early indications that drinking coffee might cause bladder cancer were not confirmed. In the 1970's, the US Food and Drug Administration declared a virtual war against the artificial sweetener saccharin, after animal tests revealed bladder cancers following administration of huge doses to rodents. The American people resisted the FDA's conclusion and possibly for good reason. After thirty years of biological experiments and large-scale statistical studies of the consumers of saccharin, it now appears that the prediction of a human cancer risk may have been incorrect. Indeed, the US government recently took steps to remove saccharin from its official list of carcinogens. More recently, scientific findings were publicized claiming that low doses of chemicals now in widespread use may be doing harm to the endocrine systems of the human body. Yet further science has revealed that some of these early findings about so-called "endocrine disruptors" cannot be replicated by qualified scientists.


Global predictions of risk are also fallible. When I was a college student in the 1970's, there were scholarly predictions of a Malthusian global catastrophe, in part stimulated by reports of the Club of Rome. There were also economists predicting that the world price of oil would rise so high, due to limited petroleum reserves, that the price of gasoline at the pump in the United States would increase dramatically. Looking back, some of these predictions may have been erroneous. As an academic, I contributed to the erroneous predictions when I forecasted that front-seat airbags would save 9,000 lives per year in the United States. It now appears that the correct number will be somewhere around 3,000 lives saved per year.


As we contemplate the role of precaution in risk management, we must remember that sometimes possible risks prove far worse than expected; other times predictions of doom simply do not materialize.


It is therefore useful to draw a distinction between the role of precaution in the scientific assessment of risk and the role of precaution in risk management. When analysts assess risks, they may introduce conservative assumptions or safety factors into the analysis to account for unknowns. These protective practices may be intended to establish an upper bound on the true yet unknown risk. In the United States, the technical community is now trying to bring more valid data into the risk assessment process. When considering the role of precaution in risk management, it is appropriate for policy-makers and the public to inquire about the degree of precaution embedded in the risk assessment.


The use of precaution in risk management is sensible but susceptible to misuse. If precaution is taken to an extreme, it can be very harmful to technological innovation. Consider the following thought experiment: Imagine it is 1850 and a decision is made that any technological innovation cannot be adopted unless and until it is proven to be completely safe by the proponents of the innovation. Under this scenario, what would have happened to electricity, the internal combustion engine, plastics, pharmaceuticals, the computer, the Internet, the cellular phone and so forth?


In the United States we have also learned the hard way that the urge for precaution can lead to unfortunate outcomes. In energy policy, for example, some of us regret our historical decisions regarding nuclear energy. The possible risks of nuclear power generation, coupled with the desire for precaution and rising costs of construction, caused a virtual halt in the construction of new nuclear plants in the United States. Thirty years later, we now find ourselves even more deeply dependent on fossil fuels, which are a major source of environmental concerns and calls for precaution. Part of the answer lies in cleaner coal technologies, renewables and energy conservation, but it also may be very unwise to foreclose the advanced nuclear option.


Reasonable people can disagree about what is precautionary and what is dangerous. Consider whether the diesel engine should be used in passenger cars and light trucks. Regulators in the State of California have set the tailpipe emission standards for particles and nitrogen dioxide so stringently that it may not be feasible to offer diesel-powered cars for sale in the future. California's regulators see this rule as a measure to protect public health from the known or possible health risks of smog and soot in the air. Meanwhile, European regulators and finance authorities have facilitated the growth of the diesel-engine market in Europe to the point that a substantial share of new cars in Europe are equipped with diesel engines. From a global climate perspective, the pro-diesel policy in Europe looks precautionary since the diesel offers significant fuel efficiency advantages over gasoline-powered vehicles. Yet we should also not forget that the price of gasoline at the pump is three to four times larger in Europe than it is in the United States, reflecting European tax policies.


The diesel example reminds us that a zero-risk policy is rarely feasible. More often, policy makers are engaged in an exercise of risk selection and we should not permit any rhetoric about complete safety to obscure this truth.


In preparing for this conference, I re-read the European Commission's February 2000 Communication on precaution and related comments from committees in the European Parliament. I was encouraged by these documents, even though we have many differences of opinion about specific risk-management issues and even though the documents do not provide a definition of the precautionary "principle" while asserting its existence. Based on these documents, I detected the following points of possible conceptual agreement.


First, precaution is a necessary and useful concept but it is also subjective and susceptible to abuse by policy-makers for trade purposes and other reasons. I was encouraged by a recent decision from the European Court of Justice. The Court sided with the EC over France on a BSE matter, suggesting that France may have overinterpreted the precautionary principle. Second, scientific and procedural safeguards need to be built into risk management decisions that are based in part on precaution. Third, adoption of precautionary measures should be preceded by a scientific evaluation of the hazard and, where feasible, a formal analysis of the benefits, risks, and costs of alternative precautionary measures. Fourth, concerns for fairness, equity and public participation need to be reflected in risk management. Finally, the set of possible precautionary measures is large, ranging from bans or product restrictions to education or warnings to market-based reforms. Even the initiation of a targeted research program to better understand a possible risk is a precautionary measure. As we consider the case studies in this conference, we might consider what mix of measures are appropriate in various circumstances.


I conclude on notes of both optimism and caution. Precaution is a perfectly sensible concept that is built into many health, safety, and environmental laws in the United States. At the same time, it may be wise to apply a precautionary approach to any attempt to enact a universal precautionary principle into American law.


Thank you very much for the opportunity to deliver these opening remarks. I look forward to questions and comments.