Rachel's Democracy & Health News #839 January 26, 2006 IN 2005 THE WHEELS CAME OFF THE U.S. CHEMICAL-REGULATION SYSTEM Rachel's summary: In 2005 the Wall Street Journal blew the whistle on the U.S. system for regulating chemicals, showing that it is based on scientific assumptions that are simply wrong, and that the system is allowing all of the nation's babies and children to be exposed to combinations of industrial poisons that no one even knows how to evaluate for safety. By Peter Montague [In this series we are describing the important news of 2005. -- Editors] The wheels came off the U.S. chemical regulatory system in a very public way in 2005. The Wall Street Journal published a 4-part series showing that the system is scientifically bankrupt because it is based on assumptions that are simply wrong. Despite these revelations, bureaucratic inertia allowed the system to keep on trucking, but I suppose that's to be expected. Acknowledging the harsh truth would be too devastating, personally, for the well- intended, hard-working civil servants who have devoted their lives to the proposition that a chemical regulatory system like ours could somehow protect human health and the environment from the industrial poisons that are intentionally discharged in multi-billion-ton quantities year after year into the air, water, and soil that make life possible. Think of it -- 1800 brand-new chemicals gushing into commercial channels each year, without the responsible parties being required to provide any detailed health or safety testing data. Armed with minimal (or no) health and safety data, the government then has a scant few months in which to prove that one or another of these 1800 new chemicals poses an "unreasonable risk" to human health or the environment. If by some miracle the government feels is can meet that scientific and legal burden and it orders the responsible party to produce some safety-test results, the responsible party can go to court to dispute the government's order. In court, even a modest-sized corporation like Monsanto can field an army of junkyard-dog lawyers to oppose the government; the government, for its part, has been shredded and downsized by decades of tax cuts, so its legal staff is a gaggle of relative pipsqueaks compared to any major chemical corporation's. Given such a system, what are the chances that industrial poisons will NOT be released into the environment in harmful quantities? Zero. The system was designed to fail from the get-go in 1965. What's amazing is that all of us have been able to convince ourselves for 40 years that the U.S. chemical requlatory system is basically sound -- that if we all just keep pretending it is working, somehow it will work. "Oh, our emperor is a wearing a fine set of threads, isn't he? Yes, yes, look at that golden raiment glinting in the sunlight.... [40-year pause]... Oh my, isn't that his willy I'm seeing?" Today, I doubt you could find a single federal scientist who actually believes in his or her heart that the chemical regulatory system is presently protecting the public adequately from unwanted assault by industrial poisons. But of course they could never admit anything like that in public -- for one thing, they'd be fired or sent to Siberia (or Kansas) almost immediately. It may be years before the full extent of the system's essentially- total failure is acknowledged in Washington -- if ever -- but to anyone who reads the Wall Street Journal carefully, the U.S. chemical regulatory system now looks like a 40-year-old jalopy, rusted out, gussied up every four years with a fresh paint job of promises, its credibility sustained mainly by the "Ooohs and aaahs" of the chemical corporation flaks who designed and built the system 40 years ago and who are desperately hoping no one will notice that their baby is a tangled heap of legal junk that has NEVER protected workers, moms, or babies -- not to mention the fish, birds, beasts and vegetables that most of us eat, and the water we drink. What's odd is that the truth leaked out in 2005 not through the nation's "newspaper of record," the New York Times (which continues to oooh and aaah that the system will be ready to roll any day now -- all that's needed is more research) but through the Wall Street Journal (WSJ). This leads me to believe that the editors of the Journal must have seen clouds of liability lawsuits on the horizon for their main readers, the corporate elite, and they felt they simply had to raise a warning flag by revealing a modicum of the truth. The truth, it turns out, ain't pretty, when you get it in concentrated bites -- like four long stories by a powerful WSJ writer named Peter Waldman. In a series that began in July, the WSJ told its readers that, "For years... something about modern living has driven a steady rise of certain maladies, from breast and prostate cancer to autism and learning disabilities." In the very next paragraph the WSJ said "one suspect that is drawing intense scrutiny" from scientists is "the prevalence in the environment of certain industrial chemicals at extremely low levels -- minute levels previously thought to be biologically insignificant." The third paragraph contains this bomb shell: "An especially striking finding: It appears that some substances may have effects at the very lowest exposures that are absent at higher levels." Striking indeed. The WSJ goes on to explain that this "especially striking finding" runs contrary to the basic premise of the science of toxicology which was established 500 years ago by the Swiss physician (and alchemist and astrologer) Paracelsus: "The dose makes the poison." If the "dose makes the poison" then tiny doses should be assumed non- poisonous, shouldn't they? The entire chemical regulation system is built on that assumption (as is the science of toxicology) -- but it now turns out that this assumption doesn't necessarily hold true. A striking finding, indeed. More like a Richter-8 earthquake. As the WSJ said, "the new science of low-dose exposure is challenging centuries of accepted wisdom about toxic substances and rattling the foundation of environmental law" -- because U.S. environmental laws are ALL based on the assumption that tiny doses don't have any biological consequences. To its great credit, the WSJ doesn't flinch and doesn't stop there. It immediately asks the obvious question: "But what if it turned out that common substances have essentially no safe exposure levels at all?" And it immediately offers a hard-edged answer: "That was ultimately what the U.S. Environmental Protection Agency concluded about lead after studying its effects on children for decades." So there's no safe dose of lead for children, EPA acknowledges, yet U.S. industry is allowed to continue to use about 260,000 metric tons of lead each year all of which eventually enters the environment and gets into air, soil, water, and the food chain. That fact alone sums up the effectiveness of the U.S. regulatory system. But it gets worse. The WSJ immediately points out that "...scientists have found that with some chemicals, traces as minute as mere parts per trillion have biological effects. That's one-millionth of the smallest traces even measurable three decades ago, when many of today's environmental laws were written." No wonder our laws have failed us -- they were based on false assumptions about the biological effects of low doses of chemicals. Having completely discredited the basis of the nation's environmental protection laws, the WSJ goes on to lob another grenade into the crowd: "Some chemical traces appear to have greater effects in combination than singly, another challenge to traditional toxicology, which tests things individually." Whatever remained of traditional toxicology has now been blown to smithereens (more on this below). Now the WSJ starts blasting away with some evidence to back up its frontal assault on toxicology and the nation's failed structure of environmental protection laws: ** "Tiny doses of bisphenol A, which is used in polycarbonate plastic baby bottles and in resins that line food cans, have been found to alter brain structure, neurochemistry, behavior, reproduction and immune response in animals.... ** "Minute levels of phthalates, which are used in toys, building materials, drug capsules, cosmetics and perfumes, have been statistically linked to sperm damage in men and genital changes, asthma and allergies in children. The U.S. Centers for Disease Control and Prevention has detected comparable levels in Americans' urine.... ** "A chemical used in munitions, called perchlorate, is known to inhibit production of thyroid hormone, which children need for brain development. The chemical has been detected in drinking-water supplies in 35 states, as well as in fruits, vegetables and breast milk.... ** "The weed killer atrazine has been linked to sexual malformations in frogs that were exposed to water containing just 1/30th as much atrazine as the EPA regards as safe in human drinking water.... ** "Since the review panel met in 2000, scientists have published more than 100 peer-reviewed articles reporting further low-dose effects in living animals and in human cells. The WSJ then goes on to give examples of chemicals that cause biological effects at low doses but no such effects at high doses -- thus standing Paracelsus and the science of toxicology on their heads. The mechanism seems to be that some hormone-disrupting chemicals at low doses latch onto the "hormone receptor sites" on cells and trigger unnatural biological responses, such as brain and reproductive system abnormalities. At higher doses the same chemical overwhelms the hormone-receptor system and the whole system shuts down, producing no biological response at all. The WSJ then gives an example of chemicals that, taken alone, produce no biological response, but taken together add up to produce a response: "Environmental chemicals don't exist in isolation. People are exposed to many different ones in trace amounts. So scientists at the University of London checked a mixture. They tested the hormonal strength of a blend of 11 common chemicals that can mimic estrogen [female sex hormone]. "Alone, each was very weak. But when scientists mixed low doses of all 11 in a solution with natural estrogen -- thus simulating the chemical cocktail that's inside the human body today -- they found the hormonal strength of natural estrogen was doubled. Such an effect inside the body could disrupt hormonal action." WSJ goes on to describe the response of U.S. Environmental Protection Agency (EPA): "In 2000, a separate EPA-organized panel, after reviewing 49 studies, said some hormonally active chemicals affect animals at doses as low as the 'background levels' to which the general human population is subject. The panel said the health implications weren't clear but urged the EPA to revisit its regulatory procedures to make sure such chemicals are tested in animals at appropriately small doses. "The EPA hesitated. It responded in 2002 that 'until there is an improved scientific understanding of the low-dose hypothesis, EPA believes that it would be premature to require routine testing of substances for low-dose effects.'... In other words, EPA's position is, "We don't even know enough to test for these effects." It must be obvious that as time has passed, our ignorance of chemicals has grown, not diminished. We know that combinations of chemicals are important. Each year, we add 1800 new chemicals into the mix and so we know less and less about what's going on, year after year, because the environment becomes ever so much more complicated. We are not making scientific progress -- we are losing ground in the struggle to understand what we are doing to ourselves and to all the other creatures with whom we share the planet. To summarize: ** Chemicals at low doses sometimes cause biological effects that are not present when the same chemicals are present in high doses. Obvious implication: Almost all chemical-safety testing done during the past 40 years has been with high doses, on the erroneous assumption that "the dose makes the poison." Therefore -- as a panel of experts told the EPA -- testing needs to be done with low doses as well as high doses. But EPA says we don't even know enough to begin testing. In other words, much of the chemical testing completed during the past 40 years needs to be re-done but the government hasn't a clue about how to begin. ** Chemicals at levels that are biologically insignificant can combine with other chemicals at levels that are biologically insignificant -- and, in so doing, can create biologically-significant combinations. Obvious implication: Chemicals need to be tested in combinations, not merely one at a time. But there aren't enough laboratories on earth to test all the possibly-relevant combinations. There are 80,000 chemicals in current commercial use. Suppose we wanted to test only 1000 of them, and we wanted to test all possible combinations of 11 chemicals out of the 1000, How many test would be required? The answer is 23,706,860,441,577,319,154,916,000 experiments. That's 23 million million million million safety tests. According to WSJ, EPA is hoping to develop new techniques that would allow them to do 15,000 safety tests in a year -- and at that rate they could test all 11-chemical combinations of 1000 chemicals in only 1,580,457,400,000,000,000,000,000 years (1.5 million million million million years). OK, this is ridiculous. But suppose EPA wanted to test something more realistic, like all 3-chemical combinations of only 1000 chemicals. It's still impossible -- it would require testing 166 million combinations and, at 15,000 tests per year, it would take 11,000 years to complete. So we're never going to be able to test chemicals in combinations in any thorough way -- even though the scientific literature is full of statements saying "We need to test chemicals in combination and we're working on it." Such statements are just eye wash, perhaps intended to keep us believing that the current chemical regulatory system can work if we just keep pretending that it can. [To be continued] ===========  The formula for combinations like these is n!/(r!*(n-r)!) where n is the total number of chemicals, r is the number of chemicals in each subcollection and n! means "n factorial" -- see any basic introduction to statistics or probability.