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PRECAUTIONARY PRINCIPLE DEBATE
Despite growing conflict between U.S. and EU, history of precautionary action has been similar
BETTE HILEMAN, C&EN WASHINGTON
Some of the most intense environmental conflicts in recent years between U.S. and European regulators are disputes over when and how to apply the precautionary principle.
European officials argue that they have banned the use of hormones in beef as a precautionary measure to prevent health effects in humans. The U.S. responds that the levels of hormones found in U.S. beef will not harm human health, a stance validated by a World Trade Organization tribunal.
Europeans, similarly, argue that antibiotics should not be used routinely in livestock as growth promoters because the drugs may cause antibiotic-resistant bacteria to proliferate in the animals and lead to resistant infections in humans. The U.S. says such broad bans are unnecessary.
Disputes have also arisen over a precautionary approach to chemical regulation being put in place in the European Union (C&EN, Dec. 3, 2001, page 17) and over its refusal to approve new varieties of genetically modified food for growing or importing for precautionary reasons.
In an attempt to further transatlantic dialogue and to understand the utility of precautionary approaches as a basis for regulatory policies, the European Environment Agency (EEA) asked European and U.S. experts to write 14 case studies of how governments have addressed or failed to address specific environmental or health problems. The case studies were compiled in a 210-page report that was published in Europe in January and discussed at a press conference in Washington, D.C., on April 11. EEA is an analytical agency that scrutinizes policy implementation in the EU by monitoring, evaluating, and detecting trends.
In some cases, the report says, governments took a precautionary approach and acted almost as soon as credible evidence of damage became available. The actions taken to prevent chlorofluorocarbons (CFCs) from harming the stratospheric ozone layer exemplify early preventive action. In many other cases, asbestos and benzene, for example, adequate information on hazards was available before effective regulatory action was taken.
The authors conclude from the case studies that failing to act on early warnings sometimes led to costly environmental and health damage and to severe financial repercussions for industry. "The case studies provide many examples where regulatory inaction led to costly consequences that were not--and sometimes could not have been--foreseen," the report says. It also provides many examples where "early warnings" were ignored.
From the case studies, the authors draw 12 lessons about how to more effectively implement a precautionary approach. One of their most important recommendations is that regulators should clearly describe uncertainties and unknowns, as well as risks, when evaluating technologies and formulating public policies. Another lesson is that governments should perform long-term health monitoring if there are early indications that a chemical or practice could cause a problem. A third important lesson is that when regulators and scientists are evaluating whether a chemical should be used or manufactured, they should consider a range of alternatives.
HOWEVER, SOME critics say the report oversimplifies the regulatory histories and concentrates too much on what might have been done. They contend that the report ignores the huge complications involved in deciding how and when to take action.
"There are a lot of subtleties involved in making decisions that the precautionary principle doesn't help you address," says George M. Gray, acting director of the Harvard Center for Risk Analysis. "A blanket principle can't be used as a decision-making tool," he adds. Traditional risk assessment--which uses animal studies and human health effects and exposure data to make quantitative estimates of risk--Gray says, is still the best approach as a trigger for action in deciding how and when to regulate chemicals, substances, or practices.
According to the report, asbestos is an example of a substance whose hazards were ignored for so long that it caused many unnecessary deaths and financial costs. It is now estimated that past exposure to asbestos will lead to some 250,000 deaths from mesothelioma--cancer of the lining of the chest or abdomen--in the EU over the next 35 years. Because asbestos also initiates lung cancer, the total disease burden in the EU over that period could be as high as 400,000 deaths, writes David Gee, scientific liaison at EEA.
Asbestos mining started in Canada in 1879 and in Australia, Russia, South Africa, and other countries a few years later. In 1899, a physician reported the first case of lung disease from asbestos. In 1906, a French inspector noted 50 deaths among female asbestos textile workers that he attributed to asbestos. All of these reports were ignored. However, by 1918, U.S. and Canadian insurance companies had seen enough evidence of asbestos disease to decline insurance coverage for asbestos "due to assumed injurious conditions in the industry."
In the U.K. in 1930, a study of asbestos workers found that 66% of those employed for 20 years or more suffered from asbestosis. This led to dust control regulations in 1931 that were largely unenforced.
It wasn't until the 1960s that Europe took strong action to protect asbestos workers. In 1969, after more evidence of health effects from asbestos came to light, a workplace level of 2 million fibers per m3 of air was set in the U.K. This level was later found to cause asbestosis in one out of 10 workers. In 1984, the levels were lowered to 0.5 million fibers per m3 for white asbestos and 0.2 million fibers per m3 for brown. In 1998 and 1999, the U.K. and France banned all forms of asbestos, and the remaining EU states will phase it out by 2005. When Canada appealed the French ban to the World Trade Organization as a trade barrier, WTO upheld the ban and decided there is no known threshold of safety for asbestos.
In the U.S., the Occupational Safety & Health Administration started regulating asbestos exposure in the workplace in 1970, setting a level of 0.2 million fibers per m3. In 1994, the standard was lowered to 0.1 million fibers per m3.
"The case studies provide many examples where regulatory inaction led to costly consequences that were not--and sometimes could not have been--foreseen."
EARLY WARNINGS about benzene were also ignored for almost 100 years in some countries, writes one of the report's authors, Peter F. Infante, an epidemiologist at OSHA. Benzene has been known as a powerful bone marrow poison since 1897, when a doctor observed aplastic anemia among young women manufacturing bicycle tires in Sweden where benzene was used as a solvent, and a physician in France observed hemorrhaging in a young man who used benzene for dry cleaning.
Between 1910 and 1914, the industrial uses of benzene expanded greatly, and reports of aplastic anemia, called benzene poisoning at the time, increased sharply. As more and more reports of aplastic anemia among benzene workers came to light, workplace standards were set at 100 ppm in 1946, 50 ppm in 1947, 35 ppm in 1948, and 25 ppm in 1957. In 1977, the U.S. Department of Labor attempted to set the level at 1 ppm, but the American Petroleum Institute blocked it with court action.
By 1978, benzene had been voluntarily withdrawn from most consumer products. Studies published in 1996 show that exposure levels close to 1 ppm in the workplace cause leukemia. Even today, consumers are exposed to benzene, which is present at a level of 1.5% in gasoline.
In contrast, when science revealed the ozone layer was being rapidly depleted, relatively prompt action was taken to reduce the use of chlorofluorocarbons and other ozone-depleting substances, writes a report author, Joe Farman, consultant to the European Ozone Research Coordinating Unit in Cambridge, England. In the early 1970s, it was discovered that virtually all the CFCs that had ever been released remained in the atmosphere. In 1974, Mario J. Molina, F. Sherwood Rowland, and Ralph J. Cicerone published articles pointing out that CFCs would eventually reach the stratosphere, that chlorine would be released there by photolysis, and that this would initiate an ozone-destroying chain reaction. However, most scientists believed that this would happen very gradually.
Ozone depletion over Antarctica--much more severe than any of the predictions--was reported in Nature in May 1985. Experiments confirmed that the depletion was chemically driven, and in September 1987, the Montreal protocol was signed, initiating a series of cutbacks and phaseouts of ozone-depleting substances in both developing and developed countries.
The lesson from the ozone hole saga is that governments can find the will to act when presented with strong evidence of severe damage, Farman writes.
The new chemical policies in Sweden and the EU are not evaluated in the report because the details of the policies are still under discussion. However, some critics say that these policies exemplify a precautionary approach carried to extremes, while others consider them sensible.
"What the Swedish government said is: 'We can't do quantitative risk assessments on every chemical, but what we can do is identify characteristics in chemicals, like persistence and bioaccumulation, that seem to be associated with harmful effects. We can work on those,'" explains Joel A. Tickner of the Lowell Center for Sustainable Production at the University of Massachusetts.
Chemicals with those characteristics, especially those found in breast milk, have been restricted in Sweden without undergoing formal risk assessments. "It is a very scientifically informed position," he claims.
Chemical policies similar in some respects to Sweden's have now been adopted by the entire EU. The EU has banned all phthalates in children's polyvinyl chloride toys on the basis of their being presumed endocrine disrupters, says David Stanners, head of strategic development and international cooperation at EEA. The U.S., which has access to the same scientific studies of phthalates as the EU, has decided not to place an overall ban on phthalates in toys. However, in 1998 the Consumer Product Safety Commission asked manufacturers not to use diisononyl phthalate (DINP) in toys intended to be mouthed by young children.
Another feature of the European chemical policy is that producers must now perform risk assessments on all "new chemicals"--those placed on the market after 1981--or they will be removed from the market, Stanners says. And "old chemicals" will be required to have risk assessments performed over the next 10 to 20 years.
SOME SAY this policy exemplifies a more precautionary approach than that taken by the U.S. First, the producers must pay for all the risk assessments, in contrast to the situation in many countries where the burden of proof is on the public authorities to show that chemicals are safe or unsafe, Stanners says. In placing the burden of proof on the producers, the EU is trying to incorporate the costs of testing the chemicals into the market prices of the chemicals and "at the same time to promote the search for alternatives," he says. Because risk assessments are very expensive, companies may decide not to do risk assessments on quite a few chemicals, and instead substitute other chemicals already known to be safe, he explains. So the "EU is trying to encourage innovation and the search for alternatives," he claims.
Jim Solyst, who leads science policy efforts at the American Chemistry Council, says it is impossible to predict whether the EU's new chemical policy will be practical. "It is difficult to say [how it will work out] until we see how it is being implemented," he explains. "The European chemical policy is in the discussion phase. We need to know what will happen on a case-by-case basis," he adds.
Solyst does not consider a precautionary approach embodied in the European chemical policies more protective than the traditional risk assessment approaches that have been used for years. "If you understand risk assessment, you realize that the process is very precautionary. There are times when you just don't have the toxicological data or more likely the exposure data, so you rely on default assumptions," he says. "The use of default assumptions is an example of a precautionary approach, and it's one that we understand. It's proven to be a pretty effective way of regulating," he adds. "That's why we in the industry are committed to research and testing, like high-production-volume testing."
Nicholas A. Ashford, professor of technology and policy at Massachusetts Institute of Technology, however, claims that the status quo is not good enough and that the U.S. has actually regressed recently in terms of taking precautionary action. "Across the board, our resolve to protect people to the extent we used to protect them has greatly waned," he notes. The U.S. is "ignoring very important early warnings of problems, specifically neurological and reproductive effects from chemicals in the occupational, environmental, and food areas," he adds.
For example, "we are not regulating silica exposures for workers in the glass wool industries," Ashford explains. "We are inadequately regulating a variety of neurotoxic chemicals, and we have ignored the relatively strong suggestion that ergonomic hazards lead to real disease. We still do not have an ergonomic standard, only the voluntary plan recently released."
Ashford and Tickner note that when the U.S. has taken action to regulate a substance or a process, it has seldom been wrong. In fact, the substance usually turns out to be more dangerous than scientists initially thought it was.
Harvard's Gray, however, notes an exception to the U.S. record--saccharin. The Food & Drug Administration considered banning it as a carcinogen in 1977, but Congress placed a moratorium on this ban. Eventually, studies showed that saccharin is harmless.
It is hard to say how the U.S.-EU disputes over the precautionary principle will play out over time. But if the arguments from each side continue to diverge, they will lead to increasing discord, unless the U.S. and EU realize that their previous actions have been very similar.
The precautionary principle--acting on credible early warnings even though the risk is not completely understood or proven scientifically--has become a key guide to policy-making in the European Union.
PHOTO BY BETTE HILEMAN
In 2000, the European Commission spelled out its concept of the principle in its "Communication on the Precautionary Principle." Currently, it is applying the principle to the development of many regulations.
The principle as a guideline for decision-making in the EU has four central components, says Joel A. Tickner of the Lowell Center for Sustainable Production at the University of Massachusetts. These are taking preventive action in the face of uncertainty, shifting the burden of proof to the proponents of an activity, exploring a wide range of alternatives to possibly harmful actions, and increasing public participation in decision-making.
U.S. government officials criticize the principle in many public forums, saying it is mythical or impractical. The mere mention of the principle often makes U.S. officials see red.
John D. Graham, administrator of the White House Office of Management & Budget's Office of Information & Regulatory Affairs, explained U.S. policy on the precautionary principle at a conference in Brussels in January. "The U.S. 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," he said.
"Graham's statement means that there is no such thing as a precautionary principle that somehow tells you exactly what to do in any particular situation. That is the myth. Like a unicorn, everybody has a different view of it," says George M. Gray, acting director of the Harvard Center for Risk Analysis. (Before taking his position at OMB, Graham was the director of the center.)
When it comes to precautionary action, however, there are not that many broad differences between the U.S. and the EU. Both the U.S. and the EU have long histories of taking precautionary action in the face of uncertainty.
At the meeting in Brussels, "it became clear that the EU favors the precautionary principle, whereas the U.S. does not talk about it in the same way," says Poul Harremoës, professor of environmental engineering at the Technical University of Denmark. "But when you get to the history of precautionary action--what the EU has done and what the U.S. has done--it is difficult to find that there has been such a significant difference," he explains. Some of the apparent conflicts involve semantics, he says.
Tickner points out that the U.S.-EU dispute is to an extent motivated by trade barriers. The U.S. accuses the EU of making regulations to protect its markets rather than health or the environment.
Furthermore, Tickner says, there may be another motivation. In the U.S., any law or regulation developed under uncertainty is likely to be challenged in court, whereas European society is not so litigious. U.S. regulators believe they need some sort of quantitative tool, he says, and so insist on adhering to traditional approaches that rely primarily on quantitative risk assessments.
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