Europe’s Dangerous Over-Precaution

European Union (EU) officials are deliberating on whether to apply the “precautionary principle” to nearly all chemicals in commerce within the EU—a move that could stall scientific innovation and eventually ban many existing products.

Under the proposed EU Chemicals Policy, manufacturers would have to conduct studies showing that chemicals used in their products are safe before sale. Chemicals already in commerce would remain on the market while new health studies are underway. But once studies are complete, EU regulators will decide which to register for legal sale and which to ban. New products would not even enter markets at all until they are studied and approved.

In July, the EU collected about 6,000 comments on this policy from individuals and groups around the world, and they are slated to make a final decision by early 2004.

Theoretical risks

Supposedly, the EU Chemical Policy will prevent the introduction of new “dangerous” and allegedly cancer-causing chemicals and force the elimination of existing “dangerous” chemicals. The more likely result is delay and arbitrary bans based on theoretical risks and political considerations —— a policy that will promote stagnation over progress.

Advocates of the policy note that much data is lacking on specific chemicals, but there is enough information about the general sources of cancer-related disease to cast serious doubts on all of the EU policy’s alleged benefits. For instance, if trace levels of chemicals were a source of health problems, one might expect that along with increased chemical use, there would be some measurable adverse impact on life expectancy, cancer rates, or other illnesses. But in developed nations, where chemical use has greatly increased, people are living longer, healthier lives. According to the World Health Organization (WHO), the average worldwide human life span has increased from 45 years in 1950 to about 66 in 2000, and will most likely continue to increase to 77 years by 2050.

Meanwhile, cancer rates in developed nations actually show a decline when factors like smoking and the fact that the population is aging are considered. For example, a report of the National Cancer Institute notes: “Cancer incidence for all sites combined decreased from 1992 through 1998 among all persons in the United States.”

In addition, studies assessing whether cancers are a result of trace levels of chemicals in the environment have failed to find a direct link, such as the recent study among women in Long Island, New York — one of the largest breast cancer studies produced in the U.S. — which could not find any such link between elevated breast cancer rates and pesticides despite years of media hype that simply assumed there was a link.

Moreover, the WHO estimates that only 1 to 4 percent of cancers can be attributed to environmental pollution in developed countries. The WHO suggests that cancer prevention efforts should focus on three factors: tobacco use, diet, and infections which together account for 75 percent of cancer cases worldwide.

The real fear 

If there is anything to fear, it isn’t chemicals, but an overly precautionary chemicals policy. Because manufacturers can never demonstrate that anything is 100 percent safe, bans are likely to be arbitrary, and many valuable products may be eliminated or never reach markets.

“Precautionary” policies are already producing seriously adverse impacts around the world. A dramatic example is the ban of the pesticide DDT. DDT can be used in limited in amounts to control malaria in a way that has no adverse public or wildlife impacts. Yet developing nations have followed western advice to ban the product even though it was helping alleviate malaria in the developing world and eradicated malaria in the West. As a result, malaria cases have skyrocketed in poor nations that banned the use of DDT. Currently, about 2.1 billion people a year are at risk from mosquito-borne diseases, according to the WHO. In Africa, 1.5 to 2.7 million people, mostly children, die from malaria alone every year.

Even in the United States, where there is no official precautionary policy and where regulators are supposed to consider trade-offs and weigh the risks, regulators ban, preempt, or delay life saving products just to be “on the safe side.”

For years, the U.S. Food and Drug Administration (FDA) has been delaying the introduction of life-saving drugs into the market, sometimes for decades, with deadly results. For example, the FDA delayed approval of the Omnicarbon heart valve for 15 years, finally granting approval in 2001. Meanwhile, this device had been saving lives in Italy, Germany, France, Switzerland, and Japan since 1986, with nearly 30,000 of such devices implanted during the years of FDA delay.

The precautionary principle has a miserable record when applied to policy.

Yet its advocates continue pushing for it. We already are seeing cases in which misguided allegedly “precautionary” approaches are proving deadly, particularly to people in the developing world. The EU chemicals policy promises to expand such failed approaches, depriving consumers of access to beneficial and often life-saving products.