GOVERNMENT & POLICY E N V I R O N M E N T
PRECAUTIONARY PRINCIPLE DEBATE Despite growing conflict between U.S. and EU, history of precautionary action has been similar BETTE H I L E M A N , C&EN WASHINGTON
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environmental conflicts in recent years b e t w e e n 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. T h e U.S. responds that the levels of hormones found in U.S. beef will not harm human health, a stance validated by a World Tirade Organization tribunal. Europeans, similarly, argue that antibiotics should not be used routinely in livestock as growth p r o m o t e r s 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 p u t in place in the European Union (C&EN, Dec. 3 , 2 0 0 1 , 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 t h e utility of p r e c a u t i o n a r y a p proaches as a basis for regulatory policies, t h e E u r o p e a n Environm e n t Agency (EEA) asked European and U.S. experts to write 14 case studies of h o w governments have addressed or failed to address specific environmental or health problems. T h e 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. E E A is an analytical agency t h a t scrutinizes policy implementation in the E U by monitoring, evaluating, and detecting trends. In some cases, the report says, governments took a precautionary 24
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approach and acted almost as soon as credible evidence of damage became available. T h e actions taken to prevent chlorofluor o c a r b o n s ( C F C s ) from h a r m i n g t h e 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. T h e authors conclude from t h e case studies that failing to act on early warnings sometimes led to costly environmental and h e a l t h 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, w h e n 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 hum a n 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 t h e lining of t h e chest or abdomen—in the E U over the next 35 years. Because asbestos also initiates lung cancer, the total disease burden in the E U over that period could be as high as 4 0 0 , 0 0 0 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 fewyears later. In 1899, aphysician reported the first case of lung disease from a s b e s t o s . I n 1 9 0 6 , a French inspector noted 50 deaths a m o n g female a s b e s t o s 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" HTTP://PUBS.ACS.ORG/CEN
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precautionary principle that somehow tells you exactly what to he precautionary principle—acting on credible early warndo in any particular situation. That is the myth. Like a unicorn, ings even though the risk is not completely understood or everybody has a different view of it," says George M. Gray, acting proven scientifically—has become a key guide to policymaking in the European Union. director of the Harvard Center for Risk Analysis. (Before taking his position at OMB, Graham was the director of the center.) In 2000, the European Commission spelled out its concept of When it comes to precautionary action, however, there are not the principle in its "Communication on the Precautionary Princithat many broad differences between the U.S. and the EU. Both ple." Currently, it is applying the principle to the development of many regulations. the U.S. and the EU have long histories of taking precautionary action in the face of uncertainty. The principle as a guideline for decision-making At the meeting in Brussels, "it became clear that in the EU has four central components, says Joel A. the EU favors the precautionary principle, whereas Tickner of the Lowell Center for Sustainable Prothe U.S. does not talk about it in the same way," duction at the University of Massachusetts. These are taking preventive action in the face of uncersays Poul Harremoes, professor of environmental tainty, shifting the burden of proof to the propoengineering at the Technical University of Dennents of an activity, exploring a wide range of altermark. "But when you get to the history of precaunatives to possibly harmful actions, and increasing tionary action—what the EU has done and what the public participation in decision-making. U.S. has done—it is difficult to find that there has been such a significant difference," he explains. U.S. government officials criticize the principle in Some of the apparent conflicts involve semantics, many public forums, saying it is mythical or imprache says. tical. The mere mention of the principle often makes U.S. officials see red. Tickner points out that the U.S.-EU dispute is to Harremoes an extent motivated by trade barriers. The U.S. acJohn D. Graham, administrator of the White cuses the EU of making regulations to protect its markets rather House Office of Management & Budget's Office of Information & Regulatory Affairs, explained U.S. policy on the precautionary than health or the environment. principle at a conference in Brussels in January. "The U.S. govFurthermore, Tickner says, there may be another motivation. ernment supports precautionary approaches to risk manageIn the U.S., any law or regulation developed under uncertainty is ment, but we do not recognize any universal precautionary prinlikely to be challenged in court, whereas European society is not ciple. We consider it to be a mythical concept, perhaps like a so litigious. U.S. regulators believe they need some sort of quanunicorn," he said. titative tool, he says, and so insist on adhering to traditional approaches that rely primarily on quantitative risk assessments. "Graham's statement means that there is no such thing as a
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 UK. and France banned all forms of asbestos, and the remaining EU states will phase it out by 2005. W h e n Canada appealed the
French ban to the World Trade Organization as a trade barrier, W T O 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. 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 bi-
cycle 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 US. 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 ex-
The case studies provide many examples where regulatory inaction led to costly consequences that were not—and sometimes could not have been—foreseen," HTTP: / / P U B S . ACS.ORG/CEN
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GOVERNMENT & POLICY posure levels close to 1 p p m in the work- basis of their being presumed endocrine displace cause leukemia. Even today, conrupters, says David Stanners, head of stratesumers are exposed to benzene, which is gic development and international cooperpresent at a level of 1.5% in gasoline. ation at E E A T h e U.S., which has access to the same scientific studies of phthalates as In contrast, when science revealed the the EU, has decided not to place an overall ozone layer was being rapidly depleted, relban on phthalates in toys. However, in 1998 atively prompt action was taken to reduce the Consumer Product Safety Commission the use of chlorofluorocarbons and other asked manufacturers not to use diisononyl ozone-depleting substances, writes a rephthalate ( D I N P ) in toys intended to be port author, Joe Farman, consultant to the mouthed by young children. European Ozone Research Coordinating Unit in Cambridge, England. In the early Another feature of the European chem1970s, it was discovered that virtually all ical policy is that producers must now perthe CFCs that had ever been released reform risk assessments on all "new chemimained in the atmosphere. In 1974, Mario cals"—those placed on the market after 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 t h a t 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 Ashford Solyst September 1987, the Montreal protocol was signed, initiating a series of cutbacks 1981—or they will be removed from the and phaseouts of ozone-depleting submarket, Stanners says. And "old chemicals" stances in both developing and developed will be required to have risk assessments countries. performed over the next 10 to 2 0 years. T h e lesson from the ozone hole saga is that governments can find the will to act SOME SAY this policy exemplifies a more when presented with strong evidence of precautionary approach than that taken severe damage, Farman writes. by the U.S. First, the producers must pay T h e new chemical policies in Sweden for all the risk assessments, in contrast to and the E U are not evaluated in the report the situation in many countries where the because the details of the policies are still burden of proof is on the public authoriunder discussion. However, some critics ties to show that chemicals are safe or unsay that these policies exemplify a precausafe, Stanners says. In placing the burden t i o n a r y a p p r o a c h carried to e x t r e m e s , of proof on the producers, the E U is trywhile others consider t h e m sensible. ing to incorporate the costs of testing the chemicals into the market prices of the "What the Swedish government said is: chemicals and "at the same time to pro'We can't do quantitative risk assessments on mote the search for alternatives," he says. every chemical, but what we can do is idenBecause risk assessments are very expentify characteristics in chemicals, like persive, companies may decide not to do risk sistence and bioaccumulation, that seem to assessments on quite a few chemicals, and be associated with hairnful effects. "We can instead substitute other chemicals already work on those,'" explains Joel A. Tickner of known to be safe, he explains. So the "EU the Lowell Center for Sustainable Producis trying to encourage innovation and the tion at the University of Massachusetts. search for alternatives," he claims. Chemicals with those characteristics, especially those found in breast milk, have Jim Solyst, who leads science policy efbeen restricted in Sweden without underforts at the American Chemistry Council, going formal risk assessments. "It is a very says it is impossible to predict whether the scientifically informed position," he claims. EU's new chemical policy will be practiChemical policies similar in some respects cal. "It is difficult to say {how it will work to Sweden's have now been adopted by the out] until we see h o w it is being impleentire EU. T h e E U has banned all phthalates m e n t e d , " h e explains. " T h e E u r o p e a n in children's polyvinyl chloride toys on the chemical policy is in the discussion phase. 26
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W e 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 T h e r e 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 I n s t i t u t e 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 t h e m has greatly waned," he notes. T h e U.S. is "ignoring v e r y i m p o r t a n t early w a r n i n g s 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 andTickner 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 m o r e dangerous t h a n 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, b u t Congress placed a moratorium on this ban. Eventually studies showed that saccharin is harmless. It is hard to say how the US.-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 E U realize that their previous actions have been very similar. • HTTP://PUBS.ACS.ORG/CEN
