U.S. Environmental Protection Agency (EPA) has issued a major new report about hormone-disrupting chemicals. The report concludes that no action is needed to protect public health or the environment from the dangers of such chemicals.[1] Instead, more study is needed, the report says.
In birds, fish, amphibians, reptiles, and mammals, including humans, the body regulates itself by sending hormones through the blood stream. Hormones are natural chemicals, present in very low concentrations (measured in parts per trillion), that carry messages to turn on and off many essential bodily processes. In recent years a large number of studies have shown that vertebrates (animals with a backbone) can mistake some common industrial chemicals for hormones, thus disrupting normal chemical messages.
As a result of hormone disruption, many bodily functions can be turned on or off at the wrong time, resulting in birth defects, cancers, deformed sex organs, sterility, reduced mental capacity, immune system damage and other serious health problems.[2]
How can scientists learn about these effects? Because of international laws developed during the WW II Nuremburg Trials, controlled experiments on humans are no longer permitted. Therefore, evidence of hormone disruption must be gathered by observing effects in wildlife, by experimenting on laboratory animals, and by observing "natural experiments," which occur when workers are exposed to chemicals on the job, or when large numbers of people are exposed to pharmaceuticals that are mistakenly thought to be safe.
To prepare its latest report, EPA reviewed 300 scientific studies of hormone disruption. Dr. Robert Huggett, EPA's assistant administrator for research, told the NEW YORK TIMES that these 300 studies "demonstrate that exposure to certain endocrine [hormone] disrupting chemicals can lead to disturbing health effects in animals, including cancer, sterility, and developmental problems."[3]
One might reasonably ask, if 300 studies show that exposure to certain hormone-disrupting chemicals can cause cancer, sterility and developmental problems in animals, shouldn't public health authorities take precautionary action to prevent further exposures while studies continue? With 300 studies indicating serious problems, wouldn't it be reasonable to limit further exposure to these chemicals?
Historical evidence indicates that this is not how the public health system operates in the U.S. The principle of precautionary action was rejected by U.S. political and public health authorities 70 years ago. The historical record is very clear on this point.
The issue 70 years ago was whether General Motors (GM), Standard Oil of New Jersey, and the DuPont corporation should begin putting tetraethyl lead into gasoline. At that time, the toxicity of lead had been well-established for 100 years,[4,pg.76] but a new gasoline additive was needed by the automobile and petroleum corporations and lead suited their purposes.[4,pg.6]
In 1923, the automobile industry was booming. In 1916, 3.6 million cars were registered; in 1920 the number was 9.2 million and by 1925 it would be 17.5 million.[5] Prior to 1920, Ford had grabbed the lion's share of the market by mass producing the standardized Model T but General Motors developed a successful strategy for overtaking Ford. In the words of GM chairman Alfred Sloan, GM created demand "not for basic transportation but for progress in new cars for comfort, convenience, power and style."[6,pg.344] In the search for greater horsepower, GM developed higher-compression engines. However, with ordinary gasoline, high-compression engines developed an annoying "knock" because the gasoline burned explosively. So GM chemists searched systematically for a gasoline additive that would make gasoline burn evenly in high-compression engines, eliminating "knock." On February 1, 1923, in Dayton, Ohio, leaded gasoline went on sale for the first time.[4,pg.90]
Leaded gasoline was produced by the Ethyl Corporation --a joint venture of GM, Standard Oil of New Jersey, and DuPont.[4,pg.105] Tetraethyl lead is at least as toxic as normal metallic lead, but with this difference: tetraethyl lead is a volatile liquid, readily absorbed through the lungs and skin. Almost immediately, workers began to be poisoned. At Standard Oil's Bayway, N.J., facility, 5 workers died and 35 suffered severe palsy, tremors, hallucinations and other serious symptoms of nerve damage. Several of these workers spent the rest of their lives confined in insane asylums. One of the supervisors at the Bayway facility told the NEW YORK TIMES that "these men probably went insane because they worked too hard."[6,pg.345] At DuPont's Deepwater, N.J., plant, more than 300 workers were poisoned by tetraethyl lead. DuPont workers dubbed the plant "The House of Butterflies" because so many workers had hallucinations of insects. The NEW YORK TIMES reported that 80% of the workers at DuPont's lead plant were poisoned.[6,pg.347]
These industrial poisonings created headlines nationwide and public health officials became apprehensive about the prospect of treating billions of gallons of gasoline with tons of tetraethyl lead, which would be released into the air along with the exhaust fumes.
In 1924, General Motors and DuPont paid the federal Bureau of Mines to investigate the hazards of lead from automobile exhausts.[4,pg.25] The Bureau of Mines agreed to investigate and accepted a stipulation by Charles Kettering, president of the Ethyl Corporation: "...the Bureau [shall] refrain from giving out the usual press and progress reports during the course of the work, as [Ethyl Corporation] feels that the newspapers are apt to give scare headlines and false impressions before we definitely know what the influence of the material will be."[6,pg.345] Further, the Bureau agreed never to mention the word "lead" in its reports but to use only the trade name "Ethyl." Further, Ethyl Corporation insisted that "all manuscripts, before publication, will be submitted to the Company for comment, criticism, and approval."[6,pg.345] The Bureau of Mines agreed. During an 8-month period, the Bureau exposed monkeys, dogs, rabbits, guinea pigs, and pigeons to automobile exhaust on 188 occasions, half for 3 hours at a time and half for 6.
The Bureau reported finding no evidence of lead poisoning, and no accumulation of lead, in any of the animals.[4,pg.27] The NEW YORK TIMES reported the Bureau's results November 1, 1924, with this headline: "No Peril to Public Seen in Ethyl Gas/ Bureau of Mines Reports After Long Experiments with Motor Exhausts/ More Deaths Unlikely."[6,pg.346] The TIMES also reported that "the investigation carried out indicates the danger of sufficient lead accumulation in the streets through the discharging of scale from automobile motors to be seemingly remote."[6,pg.346]
Despite this reassuring news, public health authorities remained concerned about the prospect of putting millions of pounds of toxic lead in the form of a fine dust into the streets of every American city and town.
Therefore, the U.S. Public Health Service convened a conference May 20, 1925 to discuss the issue. Just before the conference, Standard Oil announced it was temporarily suspending the sale of leaded gasoline.
Here in summary is what the conference revealed:
** Charles F. Kettering, president of the Ethyl Corporation, pointed to the unique properties of tetraethyl lead as an anti-knock additive. Other additives gummed up the engine, but the lead compounds passed out through the exhaust, leaving the engine clean, he said.[4,pg.8]
** Mr. Kettering said American automobiles would burn 15 billion gallons of gasoline in 1926.[4,pg.9]
** Lt. Col. E.B. Vedder, chief of the U.S. Chemical War Service, said lead is a cumulative poison.[4,pg.31]
** Robert Kehoe, a medical consultant to GM and to the Ethyl Corporation, confirmed that "in sublethal dose, lead is cumulative."[4,pg.50]
** Joseph C. Aub of Harvard University emphasized that "lead is an accumulative poison".[4,pg.72]
** Robert Kehoe established that lead passed through the placenta of a rabbit, contaminating unborn rabbits with lead if the pregnant mother were exposed.[4,pg.52]
** Robert Kehoe established that pregnant rabbits exposed to lead had abortions, miscarriages, and premature births.[4,pg.54]
** Robert Kehoe, the industry's consultant, acknowledged that poisoning by tetraethyl lead is the same as other lead poisoning: "In those cases in which absorption is present over a long period of time the symptoms do not differ strikingly from the symptoms in chronic lead poisoning....," Kehoe said.[4,pg.80]
** Alice Hamilton of Harvard University --one of the country's acknowledged experts on lead poisoning --said, "...lead is a slow and cumulative poison and... it does not usually produce striking symptoms that are easily recognized."[4,pg.98]
** E.R. Hayhurst from Ohio State University made the point that serious lead poisoning "is most apt to occur in cases using lead in the form of a dust."[4,pg.89]
** R.R. Sayers of the U.S. Bureau of Mines described experiments in which 5 times the normal amount of tetraethyl lead was added to gasoline and animals were forced to breathe the exhaust fumes. "The dust from the floor of the test chamber contained 10.5% of lead within six months without cleaning," Sayers said.[4,pg.27]
** Joseph Aub of Harvard calculated that 15 billion gallons of leaded gasoline would release 50 thousand tons of lead dust each year.[4,pg.72]
** David Edsall, dean of the Harvard School of Public Health, summarized as follows:
"The only conclusion that I can draw from the data presented here to-day is that in the question of the exhaust... I can not escape feeling that a hazard is perfectly clearly shown thus far by what has been reported here to-day, that it appears to be a hazard of considerable moment, and that the only way that it could be said that it is a safe thing to continue with that hazard would be after very careful and prolonged and devoted study as to how great the hazard is."[4,pg.77]
The conference resolved unanimously that the Surgeon General should appoint a seven-member panel to determine the dangers of leaded gasoline by January 1, 1926, and, until then, the sale of leaded gasoline should remain suspended. At the time, it seemed like a great victory for the principle of precautionary action. But it was not to be.
[To be continued] --Peter Montague
---March 20, 1997---
HEADLINES:
ON REGULATION
We often hear that regulation of toxic chemicals in the U.S. is the best in the world. That may be true, but it is also irrelevant. The question to ask about chemical regulation is, "Is it adequate to protect public health and the environment?" If it is adequate, then why would we care whether or not it is the best in the world? If it is adequate, then it is good enough. And if it is INADEQUATE and it is the best in the world, that only tells us something dismal about ourselves and about the rest of the world.
The U.S. regulatory system for toxic chemicals is now 21 years old. This seems long enough to reveal whether or not the system is adequate to protect public health and the environment.
The Toxic Substances Control Act (TSCA) was passed by Congress in 1976. It is a complicated law and many excellent books have been written to tell people how to comply with it.[1]
The basic idea of the law is that government should decide which chemicals, among the 70,000-or-so now in use, are dangerous, and then government should decide how to protect workers and the general public from the dangers (how to "manage the risks," to use today's buzz words).
It may come as a surprise to some people, but even a huge bureaucracy like our federal government has a very limited capacity to conduct studies of chemical safety. For example, the National Toxicology Program (NTP) --a consortium of eight federal agencies --studies ONLY the cancer effects of chemicals, and manages to test ONLY a couple of dozen new chemicals each year. (Effects on the nervous system, the reproductive system, the immune system, the endocrine system, and major organs such as kidney, liver, heart and brain are simply not considered by the NTP.) During a typical year, while the NTP is studying the cancer effects of one or two dozen chemicals, about 1000 new chemicals enter commercial markets. Our federal government is simply swamped by new chemicals and cannot keep up. Furthermore, it is highly unlikely that this situation will change. No one believes that our government --or anyone else --will ever have the capacity to fully evaluate the dangers of 1000 new chemicals each year, especially not in combination with the 70,000 chemicals already in use.
Congress understood this situation in 1976 and wrote provisions into TSCA to compensate for the government's intrinsic shortcomings. Under Section 8(e) of TSCA, any chemical manufacturer, processor, or distributor who becomes aware of "any information which indicates that their chemicals present a substantial risk of injury to human health or the environment" must report the information to EPA [U.S. Environmental Protection Agency]. To be reportable, such information does not need to establish conclusively that a substantial risk exists. Instead, information must be reported if it "reasonably supports the conclusion" that a chemical presents such a risk. The law says such information must be reported to EPA within 15 days and provides a penalty of $6,000 for each day that the reporting is late.
A recent book on TSCA describes the importance of Section 8(e): "In some respects, Section 8(e) is the most critical of the TSCA reporting requirements. EPA views its information-gathering under this section as an early-warning mechanism for keeping the Agency and citizens apprised of newly discovered chemical hazards."[1,pg.57]
For 14 years, EPA relied upon the TSCA 8(e) early-warning system. However, in 1990, EPA had to admit that the system has not been working.
From 1986 to 1990, EPA engaged in a 4-year legal battle with Monsanto Corporation over Monsanto's pesticide Santogard PVI. In 1990, Monsanto agreed to pay a fine for failing to report scientific data that the company had acquired in 1981 showing that Santogard PVI causes tumors in rats. Because the law provides fines of $6000 per day for failure to report under Section 8(e), in 1990 Monsanto should have paid a fine of 9 years x 365 days x $6000 = $19.7 million. EPA settled for $198,000 which, to a company the size of Monsanto, is pocket change. (Even a fine of $19.7 million would not have slowed Monsanto, which had 1996 sales of $9.2 billion.[2])
This event revealed (once again) the government's feebleness. It can't even collect fines from scofflaws, as provided by statute. This incident also gave the agency a hint that Section 8(e) wasn't producing the data needed to protect public health and safety.[3] EPA then sent a letter to all chemical manufacturers urging them to submit any data they had failed to report under Section 8(e). Six months later, the Chemical Manufacturers Association asked for a meeting with EPA officials and together they hammered out an "amnesty" program whereby companies that had violated 8(e) reporting requirements year after year would send EPA all the data they had withheld. In return, EPA would limit its fines to $15,000 for any human study and $6,000 for any animal study or other type of health study. In addition any one corporation's total liability would be capped at $1 million.
While this amnesty was in effect, during the period 1991-1994, more than 120 companies sent EPA 11,000 studies or reports of adverse health effects from chemicals on the market that had never been reported in scientific literature. The DuPont corporation alone submitted 1380 studies; the Ciba-Geigy corporation submitted 580; Shell Oil corporation submitted 351; Hoechst Celanese corporation submitted 200.
Some studies had been on company shelves since 1960 and had not been submitted when TSCA was passed in 1976. Under the law, any such study submitted in 1991 should have drawn a fine of 15 years x 365 days x $6000 = $32.9 million dollars. Thus the "amnesty" saved these chemical corporations hundreds of millions of dollars if not billions (and impoverished the taxpaying public by an equal amount).
(A skeletal description of each of the 11,000 studies is available from EPA on 3 IBM-compatible computer diskettes, free for the asking. It is called the "Triage" database. Phone [202] 554-1404.)[4]
Clearly, any taxpayer, or any member of the public hoping their government is going to protect them from toxic chemicals, will be greatly disheartened by these revelations. Anyone who examines this situation dispassionately can see that these corporations have been bamboozling the government for years, thumbing their noses at the most important toxic-chemical-control law on the books, and dancing away from major liability. Meanwhile, EPA is carrying their water for them. How many thousands of people have been poisoned because these corporations withheld crucial information from EPA's "early-warning" system? After these corporate scofflaws and poisoners are caught red handed, the government bends over backward to minimize any pain they might feel from their crimes.
EPA considers this program a great success. The NATIONAL LAW JOURNAL reports, "EPA views the program as an important success, and it has already attempted to duplicate it."[3] For example, to induce the natural gas industry to comply with another chemical-reporting law, EPA has waived $25,000-per-day fines and has agreed to cap liability at $3,000 per chemical, while capping any single company's liability at $90,000. Last year EPA began applying this same principal to "enforcement" of the nation's Right to Know law. EPA sent letters to thousands of food processors that have ignored the Right to Know law for years, waiving the $25,000-per-day fines and capping each corporation's liability at $2,000. This is called enforcement.[3]
How could EPA consider such programs a success? Because EPA has realized that it is powerless against the chemical corporations, who have bigger staffs, MUCH bigger budgets, and many, MANY more lawyers than EPA will ever have.
The NATIONAL LAW JOURNAL summarizes it this way:
"EPA policy makers have themselves concluded that they cannot count on the traditional techniques of deterrence to prevent crime on this beat. Not with thousands of factories, hundreds of thousands of products and a complex set of laws--the meaning of which are subject to perpetual debate."[3] What better summary of our situation could we ask for? Any large corporation can tie up EPA in legal snarls for years or decades.
The idea of "regulating" corporate behavior to prevent the poisoning of the environment is a joke. It never has worked, and it never will work. It cannot work. The entire result of 21 years of steady effort under TSCA has been to remove 9 chemicals from the market. We could multiply the size of our federal government by ten (a truly frightening thought) and it would still be no match for the Fortune 500.
Yet these corporate behemoths have a gaping vulnerability. They are amazingly weak. If you stop to think about it, they are nothing more than the wizard of Oz. Behind their enormous displays of green smoke and thunder, all of their power boils down to this: they were given a single piece of paper, as a matter of privilege (not a matter of right), by a state legislature. That paper could be withdrawn or modified at any time. Their power endures only so long we, the people, fail to develop strategies focused on this huge vulnerability.
Any time we decide that the situation needs changing, we have the legal power under the Constitution to change it. Most of us sit idly by, watching the planet's ecosystems being shredded by unnecessary "developments" and unneeded products, its species genetically engineered and poisoned and displaced, the vast majority of the world's peoples deracinated, impoverished, and enslaved. Most of us sit idly by, dreaming of new regulations to replace the old regulations that never worked and never COULD work. Instead, we should be thinking long and deeply about the corporate form. Thomas Hobbes, the 17th century British philosopher, called corporations "worms in the body politic." Obviously, the body politic needs to develop a modern immune system to protect itself against these particular worms and any similar ones that might come along.
But this task will require us to remove our rose-colored glasses and stop pretending that regulation can control the behavior of these worms. Regulation is a ruse, a foil, a ploy invented and created by corporate brigands in the period 1885-1915. The environmental community needs to stop playing their game.
And, unpleasant as it may seem, we need to point our fingers and demand of those who DO play such games, Which side are you on?
--Peter Montague