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"EPA To Hunt Dangers in Everyday Products," read the headline in the New York Times last summer. Soon, the story said, the Environmental Protection Agency would begin testing the first of about 62,000 chemicals for harmful hormonal effects.
"The action," it declared, "is in response to a growing body of research indicating that man-made industrial chemicals and pesticides may commit a kind of molecular sabotage within the body’s regulatory apparatus, possibly causing birth defects, low sperm counts, breast cancer, mental impairment and a range of other ailments."
Sounds scary - and it is scary, to the chemical industry, at least. To do a thorough testing of a suspect chemical costs an average $1.5 million. If the EPA does not call off the hunt at a preliminary stage, somebody has to cough up $23 billion to test just the most suspicious 24% of the lot.
But are everyday chemicals hidden causes of birth defects, mental impairment and other bad things? It turns out that there is no growing body of research to that effect. Indeed, the testing is in response to stunning findings reported two years ago in Science magazine. Last year the authors of that Science article officially withdrew the findings, after neither they nor anyone else could replicate their work. But the witch-hunt continues unabated.
And it could cost industry plenty. "Companies and ultimately consumers will be severely impacted by the campaigns and publicity alone, regardless of any ultimate scientific consensus," says Steven Usdin, publisher and editor of the Endocrine/Estrogen Letter. "Some of the individual products threatened with bans are billion-dollar businesses."
Some quick background: The body’s endocrine system comprises those organs that produce hormones, which are powerful molecules that transmit commands from one part of the body to another. Hormone-producing organs include the adrenal glands, ovaries, testes, hypothalamus and pituitary gland. Among other things, hormones affect mental states, sperm production, pregnancy and menstruation.
Chemicals that affect natural hormones in lab tests are widely called endocrine disrupters, though most have never been tested in animals, much less been shown to disrupt anything in human beings.
The environmentalist position on endocrine disrupters — or "modulators," as they are called by scientists looking for a more neutral term — is simple: Ban them.
But science gives us no precise definition of what kind of effect is great enough to be called a disruption.
Here are two things we do know. First, the suspected endocrine modulators that environmentalists want banned are, in effect, utterly swamped by other modulators not on their hit list — namely, natural modulators in plants we eat, hormones from our own bodies, synthetic hormones in contraceptives and postmenopausal hormone replacement pills. Second, if even a small part of the green wish list is granted, the plastics, farming and pharmaceutical industries will be devastated, and our way of life will be altered in ways nobody can even guess.
Putting a price on elimination or reduction of such chemicals is impossible because there is no agreement about which ones will be involved. But removal of just one class of chemicals that many environmentalists have branded endocrine disrupters — namely, organochlorines — could, according to a 1993 industry-sponsored study, cost the nation $100 billion yearly. These chemicals perform vital services in sanitizing drinking water and are necessary to produce most pesticides and many pharmaceuticals.
The Science article appeared just months after publication of Our Stolen Future, coauthored by Theo Colborn, Dianne Dumanoski and the director of the W. Alton Jones Foundation, John Peterson Myers. This foundation gives about $2 million yearly to organizations that spread endocrine disrupter fears, one of which is the Tulane/Xavier Center for Bioenvironmental Research, which produced the June 1996 Science study. The Science article claimed that four pesticides tested individually had virtually no hormonal effects, but when combined, their potency jumped up as much as a thousandfold. Then the media jumped, with headlines such as the Associated Press’ "Study Finds Combined Pesticides are Incredibly More Dangerous." Science retracted the study in July 1997.
In the meantime, faced with a tsunami of press coverage, the feds jumped. Lynn Goldman, assistant administrator of the Office of Prevention, Pesticides & Toxic Substances at the Environmental Protection Agency, ordered new studies. Congress, in part through legislation sponsored by New York Senator Al D’Amato, directed the EPA to begin screening chemicals for hormonal effects. By the time the study was retracted, the wheels were set in motion, and Dr. Goldman made clear the EPA wasn’t about to hit the brakes.
Our Stolen Future made the spectacular claim that human sperm counts were declining. "You’re half the man your father was," taunted a Greenpeace slogan. But then last November we heard we might actually be a third the man our fathers were.
Sharma H. Swan, a member of a National Academy of Sciences committee evaluating endocrine disrupters, and two of her California Health Services Department colleagues published a paper in Environmental Health Perspectives claiming sperm counts are dropping in the U.S., and faster yet in Europe. "Sperm Counts Continue to Plunge," cried the Calgary Herald. "Studies Point to a Fearsome Chemical Risk," shouted the Toronto Star.
Milk panic in England, 1996
There’s another side to this scare story. "The differences [in Swan’s study] represent geographic differences rather than data over time," explains Dr. Harry Fisch, director of the Male Reproductive Center at Columbia-Presbyterian Medical Center in New York. "Before 1970 nearly all the studies were from the New York region, which has higher sperm counts," while the later data represent areas of the country that for whatever reason have lower sperm counts. "If you just take out New York City from the analysis, there’s no decline."
As to Swan’s European findings, he notes: "If you evaluate the European data against previous European data, there actually appears to be a slight increase." Instead, she compared Europe to the U. S. Further, says Fisch, "if she had included later published data, even using her own statistical methodology she would have found no decline."
Yet another panic came in 1996, after the British government revealed it had found phthalates in several brands of baby milk. Phthalates are "plasticizers," meaning they make plastics soft and flexible. Newspaper scare stories followed.
The fear was prompted by a study in which phthalates appeared to have caused shrunken testicles and lowered sperm production in rats. Yet nobody was more disgusted at the media madness than its lead author, Richard Sharpe, a mate fertility specialist in Edinburgh, Scotland. In a newspaper commentary he blasted the media for "fuel[ing] the public panic."
Indeed not. A couple of months ago Sharpe conceded that his study could not be duplicated by the two other teams of researchers who tried. No matter. In October Sweden became the third European country to ban phthalates in toys.
"We’re being held hostage by ten mice," said a BASF executive.
Any positive finding is immediately exploited by environmentalists and trumpeted by reporters. Frederick vom Saal, a toxicologist at the University of Missouri-Columbia and also a member of the National Academy of Science endocrine disrupter panel, has gotten tremendous play from a study that tested a mere seven mice for each of various doses of two chemicals. One is bisphenol A, of which 1.8 billion pounds is sold in the U.S. each year to line food and drink cans and to make plastics. "We’re being held hostage by ten mice," was the apt description of the situation by a BASF executive at a March meeting of an EPA review panel.
October saw the release of a much bigger study financed by U.S. and European industry and conducted by an independent laboratory in Michigan. Instead of vom Saal’s seven mice per dose, it used 100. It also checked for more abnormalities. The results: Mice that were ready to try out for the Olympics. Zero abnormalities.
A skeptical scientist instinctively assumes that the more sensational the claim, the less true it’s likely to be. The media, though, reverse the formula. Thus the University of Florida’s Louis Guillette is world famous for asserting that alligator phalluses in Lake Apopka, Fla. have shrunk as a result of chemical spillage. He also won a spot on the National Academy of Sciences endocrine disrupter panel.
Guillette’s former coresearcher Timothy Gross is far more restrained in his interpretation of the data. He says Guillette’s celebrated work is based on "weak data," because Guillette didn’t know the age of the alligators and thus had no idea if their organs were still growing. (Guillette’s response: Phallus size is a function of body size, not age; also, he has confirmed his early conclusions with expanded studies.)
Gross is no apologist for chemical manufacturers. "I think it’s very clear that endocrine-active chemicals are indeed affecting wildlife," he says fish, alligators and freshwater turtles. But are these animals "canaries in the coal mine," as environmentalists put it? Gross thinks not. These are generally animals exposed to massive levels of contaminants, most of which were either banned or greatly restricted decades ago. They also eat the same things every day from the same source, rather than getting the varied diets humans do. Gross doesn’t completely dismiss possible human health effects from synthetic endocrine disrupters. But he says the country would be making a big mistake to enact wholesale bans on suspected endocrine disrupters.
The Statistical Assessment Services is a nonprofit organization in Washington, D.C. that exposes the misuse of statistics, skewering exaggerated claims from both ends of the political spectrum. When the organization looked at news stories about endocrine disruption that involved opinions attributed to scientists, they found 62% of the scientists saying they were a definite cause of harm and an additional 29% characterizing the threat as suspected. Statistical Assessment then compared this with a survey of 300 scientists in the endocrine disrupter field. This time it was 62% who said the threat was "minor" or "none."
Stephen Safe, a toxicologist at Texas A&M University, is one who thinks the dangers are overblown. He points out that the total hormonal activity of the synthetic modulators we receive from industrial activity is 40 million times lower than that from the natural components of foods we eat. The list of plants that appear to contain natural hormone modulators includes soybeans, barley, cabbage and corn. Researchers at King’s College in the United Kingdom recently reported that in test animals, one natural estrogen found in plants is 10 to 100 times as potent as bisphenol A. They also found that three different phthalates — the chemicals that caused the British dairy panic — produced no hormonal effects whatsoever.
Ironically, the chemical most often cited to show how great a threat endocrine modulators are may be the best evidence that the threat is overstated. From the late 1930s to the early 1970s, pregnant women at risk of miscarrying were prescribed the powerful endocrine modulator diethylstilbestrol. The drug didn’t protect against miscarriages. Instead, to the mothers’ horror, it devastated some of their children’s reproductive systems, causing a rare form of vaginal cancer and often infertility.
"Four to five million women were dosed with this stuff," says Robert Golden, a Ph.D. toxicologist in Potomac, Md., who has consulted for both the chemical industry and the U.S. Army, "so you have an experiment that was already done, and not on rodents but people."
This unfortunate experiment shed light on the chemical’s effects because of a wide variation in dosages. Doctors at the Mayo Clinic in Rochester, Minn. used lower doses; those at the University of Chicago, high ones. Side effects were almost unknown among the children of Mayo patients.
Nonetheless, even the doses recommended at the Mayo Clinic were massively higher than the exposure people get from environmental contaminants. Extrapolate from the diethylstdbestrol record, Golden says, and you can conclude that one endocrine modulator environmentalists most love to hate, the pesticide DDT, would cause no endocrine effect in a fetus exposed to more than a pound of DDT over the course of a pregnancy.
The National Academy of Sciences report is due to be released soon. Panel members can’t reveal its contents, but several hint strongly it will conclude that endocrine disrupter fears are overblown. Alas, such a conclusion coming from even this august body won’t necessarily stop the momentum in favor of extensive testing. Step one will be a screen using test tube and petri dish results. It is designed to be overly sensitive, so there’ll be lots of false positives.
Says Sandra Tirey, assistant vice president for regulatory affairs at the Chemical Manufacturers’ Association in Arlington, Va.: "I could see a company going through the first round of testing and having positive results and deciding to stop developing, making or selling the chemical because the costs of the subsequent tests" are greater than the profit from the chemical. Don’t forget legal costs. The electric power industry spent a lot of money defending itself from suits claiming that power lines cause cancer.
It is likely that the public’s fears about endocrine disrupters will subside someday, as they have subsided over power lines. But they will probably have occasioned a fair amount of economic disruption in the meantime.