Rachel's Democracy & Health News #841 [Printer-friendly version] February 9, 2006 TWIDDLING OUR THUMBS AS WE TURN OUR BOYS INTO GIRLS [Rachel's introduction: Chemicals widely used in toys, cosmetics and pharmaceutical drugs can interfere with the sexual development of male rodents. In recent years, studies have began to accumulate showing similar effects on the sexual development of baby boys. Spokeswomen for the chemical industry, supported by risk assessors within the U.S. Environmental Protection Agency, deny there's evidence of harm.] By Peter Montague [DHN introduction: One of the watershed events of 2005 was a four-part series on chemicals published in the Wall Street Journal (WSJ), written by Peter Waldman, a WSJ reporter. The series basically showed that the U.S. chemical regulation system is utterly broken and is not much more than a public relations scam. In Rachel's News #839 and #840 we discussed the first two parts of Mr. Waldman's WSJ series; here we discuss part 3. In some quotations from WSJ we have added explanatory links.--DHN Editors] In part 3 of his series, Peter Waldman begins by offering his mostly male audience a lesson in reproductive biology: "In the 12th week of a human pregnancy, the momentous event of gender formation begins, as X and Y chromosomes trigger biochemical reactions that shape male or female organs. Estrogens carry the process forward in girls, while in boys, male hormones called androgens do." "Phthalate syndrome" in rodents Mr. Waldman goes on: "Now scientists have indications the process may be influenced from beyond the womb, raising a fresh debate over industrial chemicals and safety. In rodent experiments, common chemicals called phthalates, used in a wide variety of products from toys to cosmetics to pills, can block the action of fetal androgens. The result is what scientists call demasculinized effects in male offspring, ranging from undescended testes at birth to low sperm counts and benign testicular tumors later in life. 'Phthalate syndrome," researchers call it." In other words, these common chemicals, phthalates -- found in toys, cosmetics, and pharmaceutical drugs -- can interfere with the development of male rodents so reliably that there's a name for the effect: "phthalate syndrome." Now I don't know about you, but it I were a scientist studying a group of chemicals commonly found in toys, cosmetics and drugs, and I discovered that my chemicals could reliably demasculinize male baby rodents, I'd be asking myself, "Wouldn't it be smart to keep these chemicals away from human babies?" That would be called a "precautionary approach" to phthalates -- but this is a noxious idea to U.S. chemical executives and regulators alike. In the U.S., you've got to prove harm to a scientific certainty before you are officially allowed to become concerned about a chemical. And even then the chemical corporations have the right to drag you into court for a decade or two while they continue to sell product (because the corporations are considered legal "persons" and they have arranged for the burden of proof of harm to rest on the public, not on the corporations). So what kind of evidence do we have about harm from phthalates? First WSJ tells us that "...last year, federal scientists found gene alterations in the fetuses of pregnant rats that had been exposed to extremely low levels of phthalates, levels no higher than the trace amounts detected in some humans." OK, so it isn't just high doses that causes problems in rodents. Next we learn that two studies in 2005 found "direct links" to humans: "First, a small study found that baby boys whose mothers had the greatest phthalate exposures while pregnant were much more likely than other baby boys to have certain demasculinized traits." And: "...another small study found that 3-month-old boys exposed to higher levels of phthalates through breast milk produced less testosterone than baby boys exposed to lower levels of the chemicals." Testosterone is male sex hormone and it is what turns boys into boys instead of girls during the 12th week of pregnancy. "Testicular dysgenesis syndrome" in humans WSJ goes on to explain that scientists in Europe "have identified what some see as a human counterpart to rodents' phthalate syndrome, one they call "testicular dysgenesis syndrome," which they think may be due in part to exposure to phthalates and other chemicals that interfere with male sex hormones. These problems begin while the baby is still in the womb. Richard Sharpe of the University of Edinburgh in Scotland, a researcher on male reproduction, told the WSJ, "We know abnormal development of the fetal testes underlies many of the reproductive disorders we're seeing in men. We do not know what's causing this, but we do know high doses of phthalates induce parallel disorders in rats." Now the chemists who make this stuff have known for a long time that it leaks into the environment and then gets into people. How could it not? Phthalates were measured in the Charles and Merrimack Rivers in Massachusetts in 1973. That same year, a study reported finding phthalates in environmental samples. That same year, 1973, researcher reported measuring phthalates in cosmetics. The following year, 1974, we find an article describing phthalates measured in food. So it's definitely no surprise that they're in our mothers' wombs. WSJ acknowledges all this: "It isn't surprising to find traces of phthalates in human blood and urine, because they are used so widely. Nearly five million metric tons [11 billion pounds] of phthalates are consumed by industry every year, 13% in the U.S. They are made from petroleum byproducts and chemically known as esters, or compounds of organic acid and alcohol. The common varieties with large molecules are used to plasticize, or make pliable, otherwise rigid plastics -- such as polyvinyl chloride, known as PVC -- in things like construction materials, clothing, toys and furnishings. Small-molecule phthalates are used as solvents and in adhesives, waxes, inks, cosmetics, insecticides and drugs." Let's see now. In the U.S. we use 1,430,000,000 (1.43 billion) pounds of this stuff each year in products that everyone knows will end up in our homes, then in our bodies, and we know it causes baby boy rats to start to turn into sickly baby girl rats -- and we don't have the sense to call a halt? I suppose the Bible had it right: "The love of money is the root of all evil" -- because the actions of chemists, corporate executives and risk assessors who allow this to continue surely qualify as evil by any normal definition. Marian Stanley of the American Chemistry Council (formerly the Chemical Manufacturer's Association) told the WSJ that phthalates are among the most widely studied chemicals and have proved safe for more than 50 years. So the chemical manufacturers admit they have been pumping this stuff into the public for 50 years while evidence of harm has accumulated. You have to appreciate their candor, and marvel at their gall. Government researcher L. Earl Gray told the WSJ that -- even today -- EPA is "moving cautiously" because, "All this work on the effects of phthalates on the male reproductive system is just five years old." But wait. Mr. Gray himself published his first studies of the ability of certain industrial chemicals to interfere with hormones and alter the development of rodent fetuses at least 25 years ago. If you go to the government's oldest database on chemicals and health, known as Pub Med, and type in "phthalates" your retrieve 467 scientific and medical articles going back to 1965. Back in 1987 -- almost 20 years ago -- U.S. EPA listed one phthalate (bis(2-ethylhexyl)phthalate) as among the 100 most toxic chemicals found at Superfund sites. In 1991, Mr. Gray signed the Wingspread Statement, which was titled, "Chemically Induced Alterations in Sexual Development: The Wildlife/Human Connection." Why were phthalates identified as a major problem in 1987 and then ignored for 15 years? Surely the EPA had knowledgable staff who must have suspected a problem. Were they ignored? Silenced? What? Last summer Mr. Gray told WSJ, "There appears to be clear disruption of the androgen pathway, but how? What are phthalates doing?" Who CARES exactly what phthalates are doing? Pregnant moms don't want the government to sit around while its scientists tease out the precise mechanism by which phthalates cause undescended testicles, hypospadias (a malformation of the penis, often requiring surgery), reduced sperm count, diminished sperm quality, and testicular cancer. They just want phthalates kept out of their babies. Is this too difficult for government scientists and corporate spokeswomen to grasp? But here's a breath of fresh air. At least one corporate scientist, Dr. Rochelle Tyl, a toxicologist, told the WSJ that the broader question is: "If we know something bad is happening, or we think we do, do we wait for the data or do we act now to protect people?" Exactly so. But U.S. EPA and the Chemical Manufacturers Association both give the same answer: "Definitely, let's wait for something bad to happen." Now I can understand why corporations would want to wait for something bad to happen -- most companies in the business of making harmful chemicals also have some fiduciary interest in medical technology, or in "environmental remediation." Many of them have figured out that they can get paid to create problems and then get paid again to fix them. It's that love of money thing again -- it keeps the wheels turning and the economy growing. But why would government not ask the same precautionary question that Dr. Tyl asked and answer it in a way that protects public health? Very mysterious. Perhaps the government is beholden to the corporations at election time and there is no longer any such thing as an independent moral agent making decisions inside the regulatory system. I'm speculating because I don't know. The Japanese have banned phthalates in certain food-handling equipment. The Europeans have banned phthalates from cosmetics and toys. Last summer the European Parliament asked the European Commission (the regulatory body of the European Union) to review products "made from plasticised material which may expose people to risks, especially those used in medical devices." Late last year, Unilever, Revlon Inc., and L'Oreal SA's American subsidiary -- hounded wonderfully by the safe cosmetics campaign -- agreed to go along with whatever the Europeans decide to ban from products. Procter & Gamble Co. said last year it would no longer use phthalates in nail polish. It's a start. Other firms are resisting. Exxon Mobil Corp. and BASF dominate the $7.3 billion phthalates market. According to WSJ, "An Exxon Mobil spokeswoman says risk assessments by government agencies in Europe and the U.S. confirm 'the safety of phthalates in their current applications."" Risk assessment is definitely the polluter's most useful pseudo-scientific tool. As first EPA administrator William Ruckelshaus said in 1984, "We should remember that risk assessment data can be like the captured spy: If you torture it long enough, it will tell you anything you want to know." Despite these assurances from the polluters' spokeswomen, the WSJ raises serious concerns about the safety of phthalates: "For instance, a 2003 study divided 168 male patients at a fertility clinic into three groups based on levels of phthalate metabolites in their urine. The study found that men in the highest third for one of the phthalates were three to five times as likely as those in the lowest third to have a low sperm count or low sperm activity. Men highest in a different phthalate also had more abnormally shaped sperm, according to the study, which was done by researchers at the Harvard School of Public Health and published in the journal Epidemiology," WSJ reports And "The latest human study, on 96 baby boys in Denmark and Finland, found that those fed breast milk containing higher levels of certain phthalates had less testosterone during their crucial hormonal surge at three months of age than baby boys exposed to lower levels." Of course, as you would expect, not all studies of phthalates show health effects in humans, so industry clings to these "negative" studies and keeps pumping out the pollutants. Studies that create doubt about the science allow polluters to continue polluting for decades -- so there's now a large and growing industrial enterprise devoted simply to ginning up faulty studies that don't find anything because they were designed not to, thus creating doubt. No one could ever accuse the Chemical Manufacturers of missing a trick. But -- to its credit -- the WSJ keeps offering new evidence: "A human study of 85 subjects published in June linked fetal exposure to phthalates to structural differences in the genitalia of baby boys. "Researchers measured phthalate levels in pregnant women and later examined their infant and toddler sons. For pregnant women who had the highest phthalate exposure -- a level equivalent to the top 25% of such exposure in American women -- baby sons had smaller genitalia, on average. And their sons were more likely to have incompletely descended testicles. "Most striking was a difference in the length of the perineum, the space between the genitalia and anus, which scientists call AGD, for anogenital distance. In rodents, a shortened perineum in males is closely correlated with phthalate exposure. A shortened AGD also is one of the most sensitive markers of demasculinization in animal studies," WSJ reported. And: "Males' perineums at birth are usually about twice as long as those of females, in both humans and laboratory rodents. In this study, the baby boys of women with the highest phthalate exposures were 10 times as likely to have a shortened AGD, adjusted for baby weight, as the sons of women who had the lowest phthalate exposures." WSJ continued to explore the meaning of this study: "Some endocrinologists call this the first study to link an industrial chemical measured in pregnant women to altered reproductive systems in offspring. 'It is really noteworthy that shortened AGD was seen," says Niels Skakkebaek, a reproductive-disorder expert at the University of Copenhagen, who wasn't an author of the study. 'If it is proven the environment changed the [physical characteristics] of these babies in such an anti-androgenic manner, it is very serious." Then the WSJ drops a bombshell from the Chemical Manufacturers: "Ms. Stanley of the American Chemistry Council doubts that any study can 'tease out' the cause of a human health condition, given the wide variety of chemical exposures in people's lives." In other words, the Chemical Manufacturers are pumping out 1.43 billion pounds of a chemical that is increasingly linked to sexual dysfunction, including genital cancer in boys, and they don't believe there is any way to definitively learn the truth about that chemical -- or any other chemical -- because the Chemical Manufacturers are pumping out so many other chemicals! Think about that. The U.S. regulatory system requires a very high level of proof of harm before action can be taken to curtail production of a chemical. And the chemical manufacturers don't believe science can EVER "tease out the cause of a human health condition" because we're all exposed to too many industrial poisons simultaneously. So the Chemical Manufacturers must think they're home free -- no amount of scientific study can ever trip them up. And of course the Chemical Manufacturers are right. Science cannot definitively "tease out" the effects of a single chemical when we are all exposed to a toxic soup of industrial poisons from the moment of conception onward. Scientists who insist otherwise are either fooling themselves, or trying to fool us. No matter how many studies are done, some uncertainty will always remain -- some variable that wasn't studied could always confound the results. The only way to pull back from the edge of this cliff is to alter our standards of proof, shift the burden onto the polluter to show that each of his or her products is the least-harmful one available to do the job -- and take precautionary action by insisting on safer substitutes for chemicals that seem harmful based on the weight of the evidence, not waiting for scientific certainty. Insist that every chemical on the market be accompanied by rigorous and thorough data. No data? No market. But of course different people will weigh the evidence differently. WSJ quotes Dr. Tyl, the chemical-industry toxicologist, saying "her own rat studies confirm that AGD is very sensitive to phthalates. She says that in rats that had very high phthalate exposures, a shortened AGD at birth was closely associated with a number of serious reproductive disorders later in life. However, in rats exposed to much lower doses of phthalates, a shortened AGD at birth did not always lead to later troubles. Many of these rats grew up to breed normally, she says, despite their slightly altered anatomy." And, says WSJ, "Dr. Tyl suggests that the same may be true of humans.... Dr. Tyl theorizes, that the boys with shortened AGD will grow up normally. 'At what point do changes like this cross the line' to become dangerous, she asks." And she answers her own question: "We don't know yet." OK, we don't know. We may never know. But we can ask 1000 pregnant moms one question: "Is it OK with you if I pump teensy amounts of a few dozen industrial poisons into your womb and alter the anatomy of your baby?" How many women out of a thousand would say, "Yes?" Maybe a few. Perhaps the wives of chemical company executives would answer, "Of course!. I love having those industrial chemicals in my baby. I'm tickled with the idea of Exxon-Mobil and BASF altering my child's anatomy before birth!" Maybe Marian Stanley (the flak for the Chemical Manufacturers) and the anyonymous spokeswoman for Exxon Mobil would say they are happy to have their babies' anatomy altered so their bosses can continue to consummate their love of money. But somehow I doubt it.