Risk and Precaution — A U.S. Perspective
What is the role of government in protecting the public interest when regulating the field of science?
November 15, 2004
Public health historians have taught us that tragedies can occur from insufficient consideration of precaution in risk management. Prominent industry cases include tobacco, asbestos and lead.
Concerning the health risks of each of these substances, historians have argued that harm could have been mitigated, or prevented altogether, if policy makers had acted upon preliminary indications of danger to public health.
And yet, we should not overlook the scientific complexities that underpin each of these examples. Take the link between smoking and lung cancer. In the middle of the previous century, many thoughtful clinicians were skeptical of this link.
They treated lung cancer patients who never smoked. They also treated heavy smokers who never developed a lung ailment.
It ultimately took large-scale statistical studies — including a prominent one of British physicians — to buttress the medical case against smoking.
At the same time, there are many contemporary examples of postulated dangers that did not materialize.
In U.S. regulatory history, the most prominent illustration would be the Food and Drug Administration’s regulatory equivalent of war against the artificial sweetener saccharin. The FDA was alarmed when it was shown that rodents developed bladder cancer after consuming large, sustained doses of saccharin.
However, the U.S. Congress overturned the FDA’s attempted ban on saccharin — in this case an incriminated product was protected by popular opinion.
After 25 years of additional science, it now appears that Congress may have been on to something.
Experimental biologists have demonstrated that the rodent tumors occurred because of cell proliferation — and this response does not occur at the lower doses of saccharin that are typical of human consumption.
Epidemiologists have also learned, based on long-term studies of saccharin users, that no elevation in bladder risk can be detected. Recently, the U.S. Department of Health and Human Services quietly recognized the scientific realities by removing saccharin from the agency’s official list of carcinogens.
Next, consider the hypothesis that magnetic fields from electric power-lines are associated with the development of human cancers. Early published studies found that living near a power-line was associated with childhood leukemia and brain cancer in adults.
The U.S. Congress launched a multi-year $50 million research effort to verify this hypothesis. When the entire program was concluded several years ago, the U.S. government concluded that there was no consistent support for this hypothesis in biology or epidemiology.
I find it interesting that the World Health Organization continues to examine the hypothesis — and is holding international meetings about appropriate precautionary approaches to this concern.
While concern about magnetic fields from power-lines has diminished in the United States, lawsuits have been filed against cell-phone companies on the grounds that brain cancer may be related to use of cellular phones. It will be instructive to follow this hypothesis in the years ahead.
With these scientific case studies as background, I would like to lay out some of the reasons why U.S. government officials are reluctant to embrace what the EU refers to as “the” precautionary principle.
First, there is no such thing as “the” precautionary principle. The Swedish philosopher Sandin has documented 19 different versions of the principle. While certain themes are similar, crucial details vary — such as the degree of scientific evidence necessary to justify precaution and the role of economics in decisions made on grounds of precaution.
Even the European Community's 2000 “Communication” on precaution — though it provides constructive guidance to policymakers — does not provide an explicit definition of the principle.
Second, Americans recognize that sensible precautions are an important feature of wise decision-making. In fact, there are established approaches to precaution defined in both decision theory and economics. We do not see why a universal new principle is needed.
Third, if an extreme version of precaution were adopted, it could thwart the technological innovation that has supported rising living standards throughout the world.
Consider the following thought experiment. It is 1850 and the following strict version of the precautionary principle is being applied. No innovator may market a new technology unless it meets an evidentiary standard of absolute safety — including consideration of long-term effects.
What would have happened to electricity, the internal combustion engine, plastics, pharmaceuticals, the Internet, cell phones and so forth? Innovation is a process of trial, error and refinement — a critical process that could be disrupted by overly simplistic views of precaution.
Fourth, the proponents of the precautionary principle need to explain more clearly how the principle addresses the risks of precautionary action. For example, the United States has learned that when FDA regulation of new drugs became too stringent, it caused harmful delays in the introduction of effective therapies into medicine.
Should the precautionary principle apply only to the potential hazard of immediate concern? Or should it also apply to the potential risks of precautionary measures?
Finally, we see the precautionary principle as potential camouflage for protectionism, even though the principle is often advocated to advance such lofty objectives as protection, democracy and ethics.
As the EC Communication recognizes, it is important to make sure that the precautionary principle is not abused for illegitimate trade purposes. Yet one of the early decisions of the World Trade Organization — concerning the EC’s ban on hormone-treated beef — illustrated the dangers.
The European Community had attempted to justify a permanent ban on certain hormone-treated products, when the issue should have been handled under provisional authority that is receptive to scientific advances.
For years, the U.S. has also been making the case in Europe — with limited success — that genetically modified foods should be regulated based on science and risk assessment.
Our backs are now against the wall and we are doing what the Bush Administration does not like to do. We are litigating the GMO issue in the World Trade Organization — in order to uphold the future viability of this promising technology.
Although we have intense policy disagreements with our European colleagues, we have seen indications that the EU does recognize the need to subject the precautionary principle to reasoned checks and balances.
For example, the European Community’s 2000 Communication on precaution describes the principle within science-informed decision making that includes risk assessment, risk management and risk communication.
The Communication also describes a role for cost-benefit analysis — as well as other principles of risk management such as proportionality.
More recently, the European Commission has issued papers outlining a more rigorous process of “better regulation," where the tools of regulatory impact analysis recommended by the OECD will be used more consistently and transparently.
Even in the domain of specific regulatory decisions, there are some signs of light from a U.S. government perspective. In a number of recent cases where the European Commission was involved, a different approach was taken.
Officials in Upper Austria invoked the precautionary principle to preclude use of a commission-authorized genetically modified seed in Upper Austria. The European Counsel rejected that notion, stressing that an appeal to the precautionary principle must have some basis in science.
In summary, advocacy of the precautionary principle is here to stay. Precaution is a sensible concept — and is built into modern tools of economic and decision analysis.
However, in my view, the notion that a universal precautionary principle is necessary should not be endorsed until (a) it is defined, (b) it is shown to offer distinct advantages to the science-based approaches to risk management currently employed in the United States.
In other words, the U.S. government will continue to take a precautionary approach to universal adoption of “the” precautionary principle.
Adapted from remarks delivered at the Brookings-AEI Conference on
John D. Graham
Administrator, OMB’s Office of Information and Regulatory Affairs John D. Graham is the Administrator for the Office of Information and Regulatory Affairs at the U.S. Office of Management and Budget. His responsibilities include coordination of regulatory review, paperwork reduction, statistical policy and information policy in the U.S. Federal government. Prior to joining the Bush Administration, […]