At their headquarters in Santa Clara, researchers at Coherent Inc., the world's largest laser manufacturer, are wrestling with an environmental law that is transforming their entire product line.
Soon, everything produced at the Bay Area company -- even the tiniest microchip inside its high-powered lasers that fly on NASA satellites and bleach jeans sold at boutiques -- must be free of lead, mercury and four other hazardous substances.
The mandate that has Coherent and other American electronics companies scrambling doesn't come from lawmakers in Washington, or even Sacramento.
Instead, it was crafted 5,000 miles away, in Brussels, the capital of the European Union.
Europe's law, governing any product with a battery or a cord, has spawned a multibillion-dollar effort by the electronics industry to wean itself from toxic compounds.
"This is the first time we've encountered something like this on such a global scale," said Gerry Barker, a vice president of Coherent, whose lasers are used to create master copies of Hollywood films, test the safety of car tires, imprint expiration dates on soda cans and more.
And the electronics rule is only the beginning.
Already, Europe is setting environmental standards for international commerce, forcing changes in how industries around the world make plastic, electronics, toys, cosmetics and furniture. Now, the EU is on the verge of going further -- overhauling how all toxic compounds are regulated. A proposal about to be debated by Europe's Parliament would require testing thousands of chemicals, cost industries several billion dollars, and could lead to many more compounds and products being pulled off the market.
Years ago, when rivers oozed poisons, eagle chicks were dying from DDT in their eggs and aerosol sprays were eating a hole in the Earth's ozone layer, the United States was the world's trailblazer when it came to regulating toxic substances. Regardless of whether Republicans or Democrats controlled the White House, the United States was the acknowledged global pioneer of tough new laws that aimed to safeguard the public from chemicals considered risky.
Today, the United States is no longer the vanguard. Instead, the planet's most stringent chemical policies, with far-reaching impacts on global trade, are often born in Stockholm and codified in Brussels.
"In the environment, generally, we were the ones who were always out in front," said Kal Raustiala, a professor of international law at UCLA. "Now we have tended to back off while the Europeans have become more aggressive regulators."
Europe has imposed many pioneering and aggressive -- some say foolish and extreme -- bans meant to protect people from exposure to hundreds of industrial compounds that have been linked to cancer, reproductive harm and other health effects. Recent measures adopted by the European Union have taken aim at chemicals called phthalates, which make nail polishes chip-resistant, and compounds added to foam cushions that slow the spread of fires in furniture.
EU's Big Market
Many companies, even those based in America, follow the European rules because the EU, with 25 countries and 460 million people, surpasses even the United States as a market. Rather than lose access to it, many companies redesign their products to meet European standards. For example, Revlon, L'Oreal and Estee Lauder have said that all their products meet European directives that control the ingredients of cosmetics. And U.S. computer companies say they are trying to remove lead and other substances banned in the EU from everything they sell.
As the EU emerges as the world's toughest environmental cop, its policies increasingly are at odds with Washington.
Among the compounds now phased out or restricted in Europe but still used in high volumes in the United States are the pesticides atrazine, lindane and methyl bromide; some phthalates, found in beauty products, plastic toys and other products; and nonylphenol in detergents and plastic packaging. In animal tests, those compounds have altered hormones, caused cancer, triggered neurological changes in fetuses or damaged a newborn's reproductive development.
The "biggest single difference" between EU and U.S. policy is in the regulation of cosmetics, said Alastair Iles, a postdoctoral fellow at UC Berkeley's Energy and Resources Group. Cosmetics sold in Europe cannot contain about 600 substances that are allowed in U.S. products, including, as of last September, any compound linked to cancer, genetic mutations and reproductive effects.
Driving EU policy is a "better safe than sorry" philosophy called the precautionary principle. Following that guideline, which is codified into EU law, European regulators have taken action against chemicals even when their dangers remain largely uncertain.
Across the Atlantic, by contrast, U.S. regulators are reluctant to move against a product already in use unless a clear danger can be shown. A chemical, they say, is innocent until proven guilty.
Critics say the U.S. Environmental Protection Agency's search for scientific clarity takes so long that the public often goes unprotected. Paralysis by analysis, the critics call it.
U.S. risk assessments can last years, sometimes longer than a decade, and in some cases, the EPA still reaches no conclusions and relies upon industries to act voluntarily. For instance, despite research that showed by 2002 that polybrominated flame retardants were doubling in concentration in Americans' breast milk every few years, the EPA has still not completed its risk review. Meanwhile, the U.S. manufacturer of two of the flame retardants agreed voluntarily to stop making them last year after they were banned in Europe and in California.
In the 1970s and '80s, all the major chemical and pollution laws in the United States had a precautionary slant, said Frank Ackerman, an economist at Tufts University's Global Development and Environment Institute.
Lengthy reviews of chemicals, which now dominate U.S. policy, began to evolve under President Reagan and grew in the 1990s. Carl Cranor, an environmental philosophy professor at UC Riverside, said that a conservative groundswell in American politics and a backlash by industries set off "an ideological sea change."
Part of the change stems from the much more vocal role of U.S. companies in battling chemical regulations, said Sheila Jasanoff, a professor of science and technology studies at Harvard University's John F. Kennedy School of Government. American attitudes toward averting environmental risks haven't changed since the 1970s, Jasanoff said. "What has changed is politics and political culture," she said.
EPA's Limited Role
The Toxic Substances Control Act, adopted by Congress in 1976, grants the EPA authority to restrict industrial chemicals that "present an unreasonable risk of injury to health or the environment." The law, however, also tells EPA to use "the least burdensome" approach to do so and compare the costs and benefits.
A pivotal year for the EPA was 1991, when a federal appeals court nullified its ban on asbestos. The court ruled that the agency, despite 10 years of research, had failed to prove that asbestos posed an unreasonable risk and had not proved that the public would be inadequately protected by steps short of a ban.
Since then, the EPA has not banned or restricted any existing industrial chemical under the toxics law, except in a few instances where manufacturers acted voluntarily. New chemicals entering the market are more easily regulated, and so are pesticides, under a separate law.
Some states, including California, are filling what they see as a void by adopting their own rules. California and Maine banned some polybrominated flame retardants, for example.
Iles said that restricting a chemical under federal law now requires a "very tough burden of proof."
"Americans tend to think that products are safe because they are in the market and must somehow have passed government regulation," he said. "But there is no real regulation. Cosmetics, for example, are almost unregulated."
Since the asbestos rule was thrown out by the court, EPA officials perform more complicated calculations to quantify how much risk an industrial chemical poses, assigning a numeric value, for example, to the odds of contracting cancer or figuring out what dose might harm a fetus or child. They also do more research to predict the costs and the expected benefits to public health.
But making these precise judgments is difficult with today's industrial compounds. In most cases, the dangers are subtle, not overtly life-threatening.
Studies of laboratory animals suggest that low doses of dozens of chemicals can contribute to learning problems in children, skew sex hormones, suppress immune systems and heighten the risk of cancer. Some chemicals build up in the bodies of humans and wildlife, and spread globally via the air and oceans. But while harm is well-documented in some wild animals and lab tests, the risks to human beings are largely unknown.
In the face of that scientific uncertainty, Europeans say, their precautionary principle is simply common sense. If you smell smoke, you don't wait until your house is burning down to eliminate the cause, they say. Their standard of evidence for chemicals is similar to the creed of doctors: First, do no harm.
"In the EU, if there is a risk with potentially irreversible impact, we don't wait until the last piece of information," said Rob Donkers, the EU's environmental counselor in Washington, D.C.
"You can study things until you turn purple, but we do not work from the concept that you really need to prove a risk 100,000 times," he said. "In the face of potentially very dangerous situations, we start taking temporary risk management measures on the basis of the science that is available."
Europe's policy is, in part, a reaction to a series of disturbing revelations about dioxins in chicken, mad cow disease, toxic substances in diapers and baby toys, all of which have made many Europeans more averse to taking risks with chemicals.
Under Europe's rules, "there are chemicals that are going to be taken off the market, and there probably should be," said Joel Tickner, an assistant professor at the University of Massachusetts' School of Health and the Environment.
Conservative critics and some officials in the Bush administration criticize Europe's precautionary approach as extreme, vague, protectionist and driven by emotions, not science.
EPA officials would not go on the record comparing their policies with the EU's. But they asserted that their approach, while different, is also precautionary.
Instead of banning compounds, the EPA teams with industry to ensure there are safe alternatives. In the last five years, 3M Corp. voluntarily eliminated a perfluorinated chemical in Scotchgard that has been found in human blood and animals around the world, and Great Lakes Chemical Corp. ended manufacture of polybrominated flame retardants used in foam furniture. In those cases, EPA officials said, forming partnerships with industry was quicker than trying to impose regulations and facing court challenges as they did with asbestos.
More than any other environmental policy in Europe, the proposal known as REACH, or Registration, Evaluation and Authorization of Chemicals, worries U.S. officials and industries.
Under REACH, which was approved by the EU's executive arm and is scheduled to go before the European Parliament this fall, companies would have to register basic scientific data for about 30,000 compounds. More extensive testing would be required of 1,500 compounds that are known to cause cancer or birth defects, to build up in bodies or to persist in the environment, as well as several thousand others used in large volumes. Those chemicals would be subject to bans unless there is proof that they can be used safely or that the benefits outweigh the risks. The testing would cost industries $3.7 billion to $6.8 billion, the EU says.
Some company executives contend that Europe is blocking products that pose little or no danger. In Santa Clara, Barker of Coherent said that the EU's precautionary approach sounds good in principle but it forces businesses to do things that are "unnecessary and probably very expensive."
In some cases, U.S. officials say, Europeans are using the precautionary principle as an excuse to create trade barriers, such as their bans on hormones in beef and genetically modified corn and other foods.
Not on the Same Page
"There is a protectionist element to this, but it goes beyond Europe trying to protect its own industries or even the health of its public," said Mike Walls, managing director at the American Chemistry Council, which represents chemical manufacturers, the nation's largest exporter. "It's a drive to force everyone to conform to their standards -- standards that the rest of the world hasn't weighed in on."
John Graham, an economist and senior official of Bush's Office of Management and Budget, which reviews new regulations, has called the notion of a universal precautionary principle "a mythical concept, kind of like a unicorn."
"Reasonable people can disagree about what is precautionary and what is dangerous," he said at a 2002 conference.
It is ironic, says Richard Jensen, chairman of the University of Notre Dame's economics department, that Europeans "who embrace the precautionary principle should have such a high tolerance for risk from smoking and secondhand smoke."
Americans are more fearful of cigarettes, nuclear power and car exhaust -- and it shows in their laws. They also pasteurize foods to kill bacteria, while European children grow up drinking and eating raw milk and cheese.
Said UCLA's Raustiala, "The United States is quite schizophrenic, as are Europeans, about when we decide" to be cautious.