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the retreat from precaution:
REGULATING
DIETHYLSTILBESTROL (DES), ENDOCRINE DISRUPTORS, AND ENVIRONMENTAL HEALTH
NANCY LANGSTON
ABSTRACT
Rates of intersexuality, reproductive cancers, and infertility appear to be increasing. Many researchers suspect that a key role is played by endocrine disruptors—the industrial pollutants that mimic hormones and disrupt the endocrine systems that shape sexual development. Yet, for all the concern raised by a flood of experimental research showing endocrine disruption in animals and epidemiological studies suggesting effects on human reproduction, the U.S. government has essentially failed to regulate these chemicals, retreating from a precautionary principle that would require caution in the use of potentially toxic chemicals. Debates in the 1930s and 1940s over the regulation of diethylstilbestrol (DES), the first synthetic estrogen and the first chemical known to act as an endocrine disruptor, show how political pressures, scientific uncertainty, and changing conceptual models of gender and health led to this retreat from precaution.
| RATES OF INTERSEXUALITY, reproductive cancers, and infertility appear to be increasing across a broad range of animals, from polar bears to people. Many researchers suspect that a key role is played by endocrine disruptors—industrial pollutants that mimic hormones and alter sexual development, with potentially irreversible effects. In the past decade, hundreds of experimental studies have shown that endocrine disruptors can lead to reproductive problems in laboratory animals and wildlife, while epidemiological studies have found correlations between human exposure to industrial chemicals and reproductive problems in humans. Yet the U.S. government has failed to regulate these chemicals, arguing that because scientists have not proven low-level exposure is the cause of reproductive problems in humans, too much scientific uncertainty remains for regulators to act. |
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Environmentalists counter that, even in the absence of certainty, the precautionary principle should apply in the regulation of endocrine disruptors. The precautionary principle states that if an action might cause severe or irreversible harm to complex systems where consequences are unpredictable, the burden of proof should fall on industry to show that potentially toxic chemicals are safe before releasing them into the environment. As Ted Schettler of Greater Boston Physicians for Social Responsibility writes: "The limits of science and rigorous requirements for establishing causal proof often conspire with a perverse requirement for proving harm, rather than safety, to shape public policies which fail to ensure protection of public health and the environment."1 Industry advocates argue, on the other hand, that application of the precautionary principle would put an end to innovation and potentially life-saving advances.2 |
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These are not new debates. The concept of precaution came into widespread American use in the 1990s, yet industries, regulators, and citizens have been arguing over the same principles since the 1930s.3 This essay examines American debates over precaution and regulation in the 1930s and 1940s, focusing on diethylstilbestrol (DES), the first synthetic estrogen and the first chemical known to act as an endocrine disruptor. Even before the Food and Drug Administration approved the drug in 1941, researchers knew that DES caused cancer and problems with sexual development in laboratory animals. These concerns initially led FDA Commissioner Walter Campbell to reject the drug, arguing that regulators must follow what he called the "conservative principle."4 FDA regulators essentially adopted the precautionary principle sixty years before that term came into common usage. Yet by 1947, the FDA had abandoned its position of precaution, telling critics of DES that it was up to them to prove that DES had caused harm, rather than up to the drug companies to show that DES was safe.5 This paper argues that a constellation of political, scientific, and conceptual factors led to this retreat from the precautionary principle in the 1940s. That retreat was at the heart of the DES tragedy and is key to understanding the roots of our current problems with endocrine disruptors. |
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