Environmentalists and politicians and federal regulators have added environmental estrogens or endocrine disrupters to the "concerns" or scares that dictate "environmental health policy." That policy, from its beginning, has been based on ideology, not on science. To provide some veneer to the ideology, its proponents have spawned bad science and junk science that claims chemicals in the environment are a major cause of human illness. There is no substance to the claims, but the current policies threaten to cost billions of dollars in wasted estrogen testing programs and to drive some substantial proportion of pesticides from the market.
Rachel Carson, conjuring up a cancer-free, pre-industrial Garden of Eden launched the biggest environmental scare of all in the 1960s. She charged that modern industrial chemicals in the environment caused human cancers. It mattered not at all to her or to her readers that cancers are found in every society, pre-industrial and modern. What mattered were opinions of people such as Umberto Safiotti of the National Cancer Institute, who wrote:
I consider cancer as a social disease, largely caused by external agents which are derived from our technology, conditioned by our societal lifestyle and whose control is dependent on societal actions and policies.(1)
When Saffioti said "societal actions and policies," he meant government regulations.
By 1968, environmental groups and individuals--including some scientists--appeared on TV and on the floors of the House and Senate to say, over and over again, "The environment causes 90 percent of cancers." They didn't have to say "environment" meant pollution from modern industry and chemicals--especially pesticides--everyone already knew that. Saffioti and others had told them.
In the 1970s, the National Cancer Institute released reports that blamed elevated rates for all kinds of cancers on chemicals in the workplace or in the environment. The institute did not have evidence to link those exposures to cancer. It didn't exist then, and it doesn't, except for a limited number of high exposures in the workplace, exist now. So what? The reports were gobbled up by the press, politicians, and the public.
In our ignorance of what causes most cancers, the "90 percent" misstatement provided great hope. If the carcinogenic agents in the environment could be identified and eliminated, cancer rates should drop. NCI scientists said so, and they said success was just around the corner if animal tests were used to identify carcinogens. Congress responded. It created the Environmental Protection Agency and the Occupational Safety and Health Administration. Both agencies have lots of tasks, but both place an emphasis on controlling exposures to carcinogens. Congress passed and amended law after law. The Clean Air Act, the Clean Water Act, the Safe Drinking Water Act, amendments to the Fungicide, Insecticide, and Rodenticide Act--the euphonious FIFRA--the Toxic Substances Control Act, and the Resource Recovery and Control Act poured forth from Capitol Hill.
And in return, EPA and OSHA, to justify their existence, generated scare after scare. They are aided by all kinds of people eager for explanations about their health problems or for government grants and contracts for research or other work or for money to compensate for health effects or other problems that could be blamed on chemicals.
In 1978, we had the occupational exposure scare. Astoundingly, according to a government report, six workplace substances caused 38 percent of all the cancers in the United States. It was nonsense, of course, and many scientists ridiculed the report, but the government never retracted it. The government scientists who contributed to it never repudiated it.
At about the same time, wastes disposed in Love Canal near Niagara Fall, NY, spewed liquids and gases into a residential community. The chemicals were blamed as the cause of cancers, birth defects, miscarriages, skin diseases, you name it. None of it was true, but waste sites around the country were routinely identified as "another Love Canal" or a "Love Canal in the making," and Congress gave the nation the Superfund Law. Since its passage, Superfund has enriched lawyers and provided secure employment to thousands who wear moon suits and dig up, burn, and rebury wastes, and done nothing for the nation's health. For those who doubt the importance of politics in the environmental health saga, it's worth recalling that every state had two waste sites on the first list of sites slated for priority cleanup under Superfund.
By the 1980s, EPA was chucking out the scares. We had the 2,4,5-T scare, the dioxin scare, the 2,4-D scare, the asbestos in schools scare, the radon in homes scare, the Alar scare, the EMF scare. I've left some out, but the common thread that linked the scares together was cancer. Each scare prompted investigations by affected industries and non-government scientists. Each scare fell apart, revealed as a house of cards jerry-rigged from bad science, worse interpretations of the science, and terrible policy.
In fact, by the late 1970s, there was ample evidence that the much-talked about "cancer epidemic" and the 90 percent statement were simply wrong. Cancer rates were not increasing and rates for some cancers were higher in industrial countries and rates for others were higher in non-industrial countries. The U.S. fell in the middle of countries when ranked by cancer rates. Sure, there are some carcinogenic substances in the nation's workplaces, but the best estimates are that they cause four percent or less of all cancers, and the percentage is decreasing because the biggest occupational threat, asbestos, is gone. Environmental exposures might cause two or three percent of cancer--on the outside--and they might cause much less.
The research into causes of cancer--not stories designed to bolster the chemicals cause cancer myth--did reveal that there are preventable causes of cancer. Not smoking is a good idea, as is eating lots of fruits and vegetables, not gaining too much weight, restricting the number of sexual partners, and, for those who are fair-skinned, being careful about sun exposures. It's not a lot different from what your mother or grandmother told you.
The government can take a nanny role in urging us to behave, but that's not where the big bucks are. The big bucks are in regulation, and regulation doesn't seem to have much to do with cancer.
In any case, cancer death rates began to fall in 1990, they've fallen since, and the fall is growing steeper. Maybe that information is blunting the cancer scare. I somehow doubt it. I think that the public has become numb to the cancer scare or that it fatalistically accepts the notion that "everything causes cancer." In any case, the environmentalists and the regulators needed a new scare.
The collapse of the cancer scare wasn't good news to everyone. Government bureaucrats and scientists in the anti-carcinogen offices and programs at EPA and elsewhere have secure jobs. Congress easily finds the will to write laws establishing environmental protection activities, but it lacks the will or patience to examine those activities to see if they've accomplished anything. And, let's face it, Congress doesn't eliminate established programs. But the growth of programs slows, and money can become scarce, and that can squeeze researchers who depend on EPA grants and contracts to fund their often senseless surveys and testing programs. Moreover, the fading of scares doesn't benefit environmental organizations that utter shrill cries about scares and coming calamities in their campaigns for contributions.
Here's an example of just how disappointed some people can be that cancer isn't on the rise. Dr. Theo Colborn, a wildlife biologist working for the Conservation Foundation in the late 1980s, was convinced that the chemicals in the Great Lakes were causing human cancer. She set out to prove it by reviewing the available literature about cancer rates in that region She couldn't. In fact, she found that the rates for some cancers in the Great Lakes region were lower than the rates for the same cancers in other parts of the United States and Canada. Here's how she described the incident in a book she co-authored:
Colborn was puzzled. The high cancer rates she had heard so much about appeared to be more myth than reality. After months of chasing the specter of cancer, she found herself at a dead end.
Faced with this major setback...(2)That's what she wrote, "Faced with this major setback" It's hard to imagine that the person who wrote that failing to find high cancer rates was a setback has public health or the interest of people at the core of her being.
Failing to find cancer slowed her down but didn't stop her. She knew that those chemicals were causing something. All she had to do was find it.
And find it, she did. She collected every paper that described any abnormality in wildlife that live on or around the Great Lakes, and concluded that synthetic chemicals were mimicking the effects of hormones. They were causing every problem in the literature, whether it was homosexual behavior among gulls, crossed bills in other birds, cancer in fish, or increases or decreases in any wildlife population.
The chemicals that have those activities were called "environmental estrogens" or "endocrine disrupters." There was no more evidence to link them to every abnormality in wildlife than there had been in the 1960s to link every human cancer to chemicals. The absence of evidence wasn't much of a problem. Colborn and her colleagues believed that chemicals were the culprit, and the press and much of the public, nutured on the idea that chemicals were bad, didn't require evidence.
Even so, Colborn had a problem that EPA faced in its early days. Soon after EPA was established, the agency leaders realized that protecting wildlife and the environment might be a good thing, but that Congress might not decide to lavish funds on such activities. They were sure, however, that Congress would throw money at programs that were going to protect human health from environmental risks.(3) Whether Colborn knew that history or not, she apparently realized that any real splash for endocrine disrupters depended on tying them to human health effects.
Using the same techniques she'd used to catalogue the adverse effects of endocrine disrupters on wildlife, she reviewed the literature about human health effects that someway or another might be related to disruption of hormone activity. The list was long, including cancers, birth defects, and learning disabilities, but the big hitter on the list was decreased sperm counts. According to Colborn and other's analyses of sperm counts made in different parts of the world under different conditions of nutrition and stress and at different time periods, sperm counts had decreased by 50 percent in the post-World War II period.
If there's anything that catches the attention of Congress, it's risks to males. Congress banned leaded gasoline after EPA released a report that said atmospheric lead was a cause of heart attacks in middle-aged men. The reported decrease in sperm counts leaped up for attention, and attention it got. Congressional hearings were held, magazine articles were written, experts opined about endocrine disrupters and sexual dysfunctions.
And then it fell apart. Scientists found large geographical variations in sperm counts that have not changed over time. Those geographical variations and poor study designs accounted for the reported decrease. That scare went away, but endocrine disrupters were here to stay.
Well-organized and affluent women's groups are convinced that breast cancer is unusually common on Long Island. That may be true, and rumor has it that a very large NCI study will confirm a breast cancer excess. We know that obesity, estrogen replacement therapy, and late child-bearing or no child-bearing, all of which are more common in affluent women, are associated with breast cancer. Nevertheless, from the very beginning, environmental chemicals have been singled out as the cause of the breast cancer excess. The insecticide aldicarb, which is very resistant to degradation was blamed, but subsequent studies failed to confirm the link. A well-publicized study found a link between DDT and breast cancer, but larger, follow-up studies failed to confirm it. But there're lots of environmental chemicals, and no evidence is required to justify a suggestion of a link between the chemicals and cancer.
Senator Al D'Amato is from Long Island, and he shares his constituents concerns. During hearing about the Clean Water Act, Senator D'Amato heard testimony by Dr. Anna Soto from Tufts University about her "E-Screen."(4) According to Dr. Soto, her quick laboratory test could identify chemicals that behave as environmental estrogens or endocrine disrupters for $500 a chemical. Since environmental estrogens seem to some people to be a likely cause of breast cancer, Soto's test appeared to be a real bargain.
Senator D'Amato pushed for an amendment to require E-Screen testing of chemicals that are regulated under the Clean Water Act, but he was unsuccessful. Later in 1995, a senior Senate staffer, Jimmy Powell, took the E-Screen amendment to a very junior Senate staffer and told her to incorporate it into the Safe Drinking Water Act as an "administrative amendment." She did, it passed the Senate, and, for the first time, there was a legislative requirement for endocrine testing.
In the spring of 1996, House Committees were considering legislation to amend the Safe Drinking Water Act and new legislation related to pesticides in food. Aware of the Senate's action, some members of the House committees were eager to include endocrine testing in their legislation, but there was resistance as well. Chemical companies viewed the imposition of yet another test as certain to be an expense, unlikely to cost as little as $500 a chemical, and bound to raise new concerns about chemicals that would require far more extensive tests and research to understand or discount.
Furthermore, so far as food was concerned, there was a general conviction that all the safety factors built into the testing of pesticides and other chemicals that might end up in food provided adequate margins of protection. That conviction was shattered by rumors that reached the House in May 1996.(5) According to the rumors, Dr. John McLachlan and his colleagues at Tulane University had shown that mixtures of pesticides and other environmental chemicals such as PCBs were far more potent in activating estrogen receptors, the first step in estrogen modulation of biochemical pathways than were single chemicals. In the most extreme case, two chemicals at concentrations considered safe by all conventional toxicity tests were 1600 times as potent as estrogen receptor activators as either chemical by itself. The powerful synergy raised new alarms.
In May, everyone concerned about pesticides knew that EPA had a draft of the Tulane paper, and EPA staff were drifting around House offices, but they refused to answer questions about the Tulane results. The silence signaled the expected significance of the paper. A month later, in June, the paper appeared in Science. It was a big deal. Science ran a news article about the research with a picture of the Tulane researchers. It also ran an editorial by a scientist from the National Institutes of Health who offered some theoretical explanations for how combinations of pesticides at very low levels could affect cells and activate the estrogen receptors. The New York Times, The Washington Post, other major newspapers, and newsmagazines and TV reported the news. If there was ever any doubt that FQPA would require tests for endocrine activity, the flurry of news about the Tulane results erased them.
While the House was drafting the FQPA, Dr. Lynn Goldman, an assistant administrator at EPA, established a committee called the "Endocrine Disrupter Screening and Testing Advisory Committee" (EDSTAC) to advise her. Oddly enough, she appointed herself chairperson of the committee. In effect, Dr. Goldman's committee will advise Dr. Goldman. The committee is big; there're more than 50 members and assorted experts, and it meets in nice cities around the country--Miami next month. The committee is costing taxpayers about $20 million in travel, meeting rooms, reports, support staff, and so forth, but that is a bargain compared to what EDSTAC will recommend.
Remember Senator D'Amato? He heard that Dr. Soto's test cost about $500 per chemical, and he also heard that the myriad pesticides on the market are based on no more than 400 chemicals. All of those chemicals could be run through the E-Screen for $200,000. Granted there are a lot of costs that aren't captured in the $500--often simply getting a chemical into solution so that the test can be run costs more than the test, and there are bound to be follow-on costs. Even so, getting the 400 active ingredients tested for a few hundred thousand dollars isn't necessarily a bad deal.
EDSTAC isn't content with testing only active ingredients in pesticides, and it isn't going to be limited to the E-Screen. The committee is considering tests for all of the 70,000 chemicals that it estimates are present in commerce, and it's not limiting its recommendations to tests for estrogenic activity. It's adding tests for testosterone and thyroid hormone activity as well as for anti-estrogenic, anti-testosterone, and anti-thyroid activity. The relatively simple E-Screen, which is run on cultured cells, is to be supplemented by some whole animal tests. Tests on single compounds will have to be complemented by tests of mixtures of compounds. The FQPA requires that "valid" tests be used. None of the tests being considered by EDSTAC has been validated; many of them have never been done.
EDSTAC's estimate of 70,000 chemicals in commerce is on the high side--some of those chemicals are used in such small amounts and under such controlled conditions that there's no exposure to them. Dr. Dan Byrd has estimated that 50,000 is a more realistic number. He's also looked at the price lists from commercial testing laboratories to see how much they would charge for a battery of tests something like EDSTAC is considering. Some of the tests haven't been developed, but assuming they can be, Dr. Byrd estimates testing each chemical will cost between $100,000 and 200,000. The total cost would be between $5 and $10 billion.
Since most of the 50,000 chemicals are commodity chemicals or chemicals that are no longer manufactured, the testing costs will have to be paid by the taxpayer. The FQPA requires that the estrogenic testing be completed in the third year after passage of the act in 1996. There's no way the testing will be complete by summer of 1999at will happen, not even if the tests were limited to running 400 chemicals through the E-Screen. The failure to meet the deadline means that disgruntled citizens groups, upset because the testing is going too slow will sue the government. More taxpayer expense.
At some time, the tests will get done and results will be released. Groups of citizens, newly informed that they have been exposed to estrogenic or anti-estrogenic compounds, will sue manufacturers, distributors, and sellers of the compounds. Class actions will proliferate, and the $5 or $10 billion may seem to be a bargain in the blizzard of legal fees.
When I first heard these projections, I thought EDSTAC and EPA will never go through with it. It costs too much and there're too many uncertainties involved with the tests. In fact, I don't think that EPA will launch a program to test all 50,000 chemicals. Instead, I expect EPA will launch a program to test a number of chemicals, and the program will never end. Government programs seldom do. Each year, EPA will add additional chemicals or additional tests.
The Tulane results played some major role in the passage of FQPA, the focus on endocrine disrupters, and Dr. Goldman's establishment of EDSTAC. The Tulane results are wrong. Several groups of scientists tried to replicate the Tulane results. None could. At first, Dr. McLachlan insisted his results were correct. He said that the experiments he reported required expertise and finesse and suggested that the scientists who couldn't repeat his findings were at fault, essentially incompetent. That changed. In July 1997, just 13 months after he published his report, he threw in the towel,(6) acknowledging that neither his laboratory nor anyone else had been able to produce the results that had created such a stir.
Whether the initial results were caused by a series of mistakes or a willful desire to show, once and for all, that environmental chemicals, especially pesticides are bad, bad, bad, we don't know. We do know that the results were wrong.
No matter, EPA now assumes as a matter of policy that synergy occurs. Good science, repeatable science that showed the reported synergy didn't occur has been brushed aside. In its place, we have bad science or junk science. If the Tulane results were the products of honest mistakes, they're bad science; if they flowed from ideology, they're junk science. The effect is the same, but the reasons are different.
The estrogenic disrupter testing under FQPA is going to cost a lot of money and cause a lot of mischief. But the effects of that testing are off somewhere in the future. More immediately, a combination of ideology-driven science and congressional misreading of that science threatens to drive between 50 and 80 percent of all pesticides from the market.
In 1993, a committee of the National Research Council(7) spun together the facts that childhood developmental takes place at specific times as an infant matures into a toddler and then a child, that infants, toddlers, and children eat, proportionally, far larger amounts of foods such as apple juice and apple sauce and orange juice than do adults, and that pesticides can be present in those processed foods. From those three observations, the committee concluded that an additional safety factor should be included in setting acceptable levels for pesticides in those foods. Left out from the analysis was any evidence that current exposures cause any harm to any infants, toddlers, or children. No matter.
Most people who worry about pesticides expected EPA and the Food and Drug Administration to react to the NRC recommendation by reducing the allowable levels of pesticides on foods that are destined for consumption by children. Maybe they would have. We'll never know. In the FQPA, Congress directed that a new ten-fold safety factor be incorporated into the evaluation of the risks from pesticides.
Safety factors are a fundamental part in the evaluation of pesticide risks. Pesticides are tested in laboratory animals to determine what concentrations to cause effects on the nervous, digestive, endocrine, and other systems. At some, sufficiently low dose that varies from pesticide to pesticide, the chemical does not cause those adverse effects. That dose, called the "No Observed Adverse Effect Level" (or NOAEL), is then divided by 100 to set the acceptable daily limit for human ingestion of the chemical. The FQPA requires division by another factor of 10, so the acceptable daily limit will be the NOAEL divided by 1000 instead of 100. Acceptable limits will be ten-fold less.
Dr. Byrd(8) has estimated that up to 80 percent of all currently permitted uses of pesticides would be eliminated by an across the board application of the 1000-fold safety factor. He cites another toxicologist who estimates that 50 percent of all pesticides would be eliminated from the market. The extent to which these draconian reductions will be forced remains to be seen, but pesticide manufacturers and users can look forward to a period of even-greater limbo as EPA sorts through it new responsibilities and decides how to implement FQPA.
There's no convincing evidence that pesticides in food contribute to cancer causation(9) and none that they cause other adverse health effects. Restrictions on pesticides in food will not have a demonstrable effect on human health. On the other hand, the estrogen testing program and the new safety factor will drive pesticide costs up and pesticide availability down.
Some manufacturers may lose profitable product lines; some may even lose their businesses. Farmers will pay more. They will pass those costs onto middlemen and processors, who, in turn, will pass them onto consumers. Increases in the costs of fruits and vegetables won't change the food purchasing habits of the middle class, but they may and probably will affect the purchases of the poor. The poor are already at greater risks because of poor diets, and the increased costs can be expected to further decrease their consumption of fresh fruits and vegetables.
The National Cancer Institute urges everyone to eat five fresh fruits and vegetables daily. Those foods bestow some protection against cancer, and they take the place of the infamous "empty calories." Everyone agrees fruits and vegetables are good for one and all. At the same time, environmentalists pressure Congress to impose additional restrictions on pesticides. Congress obliges, passes the responsibility to EPA, and EPA, in some fashion, will act. As the agency acts, food prices can be expected to increase. The irony in the name of the Food Quality Protection Act may come back to haunt us. Protected or not, quality food will become more costly.
1. Umberto Saffiotti quoted in Edith Efron, The Apocalyptics (Touchstone: New York, 1984), p. 84.
2. Theo Colborn, Dianne Dumanoski, and John Peterson Myers, Our Stolen Future, (Dutton: New York, 1996), p. 19.
3. Marc K. Landy, Marc J. Roberts, and Stephen R. Thomas, The Environmental Protection Agency: Asking the Wrong Questions from Nixon to Clinton, (Oxford University Press: New York, 1994).
4. The source for the information about Senator D'Amato and the E-Screen is a personal communication from Daniel M. Byrd, III, of Consultants in Toxicology, Risk Assessment, and Product Safety, Washington, D.C.
5. Daniel M. Byrd, III, "Goodbye, Pesticides? The Food Quality Protection Act of 1996," Regulation (in press).
6. Michael Gough and Steven J. Milloy, "Junk Science: It's the Law," Investors Business Daily, August 25, 1997.
7. National Research Council, Pesticides in the Diets of Infants and Children, (National Academy Press: Washington, D.C., 1993).
8. Byrd, Regulation.
9. National Research Council, Carcinogens and Anti-Carcinogens in the Human Diet (National Academy Press: Washington, D.C., 1996).