Legal Toxins in Toys May Disrupt Male Sexual Development
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This article is adapted from Mark Schapiro's new book Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power (Chelsea Green).
Into the playrooms of children has come the unsettling news: those little red trains and other neat miniatures of the adult world may be coated in paint containing illegally high levels of lead, posing myriad risks to a child's neurological development. After that discovery prompted a mass recall this past summer, parents will never look at Thomas the Tank Engine the same way again. But the uproar over banned substances and rogue Chinese toy manufacturers has overshadowed an even more troubling issue: the toxins in toys that are perfectly legal. The United States remains one of the few developed countries to permit the import of plastic toys made with polyvinyl chloride additives called phthalates (pronounced tha-lates), which help make toys soft and pliable enough to be twisted or sucked yet durable enough to survive a 1-year-old's grip. A mounting body of scientific evidence suggests that phthalates impede the production of testosterone and disrupt the sexual development of infant boys.
That disturbing claim certainly caught my attention as I sat in a hearing room in the California Capitol January 10, 2006, and watched two of America's leading experts on the physiological effects of chemical exposure testify before the health committee of the State Assembly. Such hearings are normally dry affairs, but the scientists' allegations that children were gnawing and sucking on toy animals and other doodads that decrease production of the male sexual hormone gave the testimony a certain urgency. The experts had been called in by Democratic Assemblywoman Wilma Chan, author of a bill to ban phthalates from children's toys; the bill had been met by powerful opposition from the toy and plastics industries.
In the average home, phthalates are everywhere -- in shower curtains, shampoo bottles, raincoats and perfumes (to aid adherence to the skin). In hospitals, they're in medical tubing. A component of that distinct "new car smell" comes from phthalates in the plastic dashboard. The dash becomes more brittle as the car ages because phthalates are slowly migrating into the car's interior. As they sweat out of the plastic, residue enters the air or, through direct contact, the skin.
For infants, the most vulnerable population, exposure takes multiple routes: phthalates enter the womb through the umbilical cord or later through mother's breast milk. Exposure can come from dust in the air, from plasticized wall coverings or flooring and from decaying resins in plastic containers. It can also come from sucking on plastic toys. Plastic rubber duckies floating in many American bathtubs are squishy because of phthalates. Infants, according to the Intergovernmental Forum on Chemical Safety, an affiliate of the World Health Organization, have far less capacity for detoxifying chemicals than do adults, and with toys they face all three points of a "risk triangle": "increased vulnerability" to a chemical's "toxic effects" and plenty of possibilities for exposure through "intimate contact."
Chan's bill also proposed a toy ban on Bisphenol A, but most of the scientists' attention that day was focused on a phthalate called Di(2-ethylhexyl) Phthalate, or DEHP, which when ingested can impede the production of LH, a hormone responsible for triggering cells in the testes to produce testosterone. In a baby boy, testosterone plays a major role in determining everything from gender-based behavior to sex drive to what his sperm count will be twenty years later.
Dr. Earl Gray, who has been studying the effect of endocrine-disrupting chemicals on rodents for seventeen years at the EPA's research facility in Research Triangle Park, North Carolina, told the panel that sexual malformations may follow from below-normal LH and testosterone levels. Dr. Gray has found that rats fed phthalates during pregnancy gave birth to a high rate of male pups with incompletely descended testes and a rare condition known as hypospadias -- an opening in the penis elsewhere than on the tip. Both are symptoms of low testosterone. Scientists, Dr. Gray said, were calling these deformities "phthalate syndrome," and they are increasingly concerned about a parallel syndrome in human infants. Declining sperm counts among U.S. men and the rising incidence of conditions like hypospadias and testes cancer, Dr. Gray explained, are the possible outcome of early phthalate exposure. "The research," he said, "suggests more and more concern about phthalates."
Also testifying that day was Dr. Shanna Swan, director of the Center for Reproductive Epidemiology at the University of Rochester School of Medicine, in New York. Dr. Swan conducted a study, published in the June 2005 Environmental Health Perspectives , that sent shock waves through the medical community. Swan took urine samples from 134 pregnant women in Los Angeles, Minneapolis and Columbia, Missouri, and tested them for phthalates. The results showed an apparent correlation between women who had higher phthalate levels in their urine and the fact that their male children, within thirteen months of birth, showed "reduced ano-genital distance (AGD)." That measurement of the distance between the anus and the scrotum is a means of distinguishing between male and female rodents and is a key indicator of testosterone levels. Dr. Gray has been seeing shorter AGDs in rats fed phthalates -- now Dr. Swan was seeing it in humans.
Dr. Swan summarized this in layman's terms for the committee: "Wherever we've looked," she said, "human studies are consistent with rodent studies. Phthalates are making the ano-genital distance shorter, in a more feminine direction."
That was pretty strong language from two of America's most eminent specialists on the developing endocrine system. But representatives of the chemical and toy industries were also invited to testify. Dr. James Lamb, a former EPA reproductive biologist now working for the Weinberg Group, a consulting firm that lobbies on behalf of the chemical industry, asserted that the effects seen in animals from phthalate exposure were from quantities placed in their feed that far exceeded the amounts children would absorb from playing with or sucking on toys. "Phthalate syndrome," he said, "is a rat syndrome, not a human syndrome."
Joan Lawrence, vice president for standards and regulatory affairs of the Toy Industry Association (TIA), assured the panel, "If there was solid scientific evidence that these products were harmful, the toy industry would be the first to remove them." Lawrence and Lamb asked, Had scientists established a link between phthalates and sexual malformation beyond a shadow of a doubt? The answer, Gray and Swan conceded, was no. The links between infant phthalate exposure and the symptoms of endocrine disruption are highly suggestive, they said, but have yet to be definitively proven.
None of the advocates of Chan's proposed ban argued that the amount of phthalates to which an infant would be exposed by toys alone would be enough to trigger the spiral of dysfunction prompted by lower levels of testosterone. Nor could they say absolutely that phthalates were the cause of the troubles they were seeing. But removing phthalates from toys, the scientists told the panel, would make for one less contaminant amid multiple exposures to phthalates and other chemicals that are possible contributors to rising endocrine-related troubles, and sexual dysfunction levels, in American men.
That logic, in fact, had led the European Union to ban phthalates eight years before. The very different ways the battle over phthalates has unfolded in Europe and America reflect the vastly different approaches taken by the EU and U.S. governments to protecting citizens from chemical hazards. Here, concern about a product's safety is not enough to justify regulation; irrefutable evidence of harmful effects -- a scientific standard that is elusive at best -- is required, as is a cost-benefit analysis weighing the "benefits" to society against the "costs" to industry of making the change. The EU, in marked contrast, operates according to the "precautionary principle." As Robert Donkers, who served as the EU's environment counselor in Washington until September, explained to me, "Unlike in the United States, we don't wait until we have 100 percent proof. Rather, if there's fear, scientific suspicions that [a chemical] could cause irreversible damage in the future, we don't want to wait. By the time it's proven, it could be much too late." This was the perspective of Assemblywoman Chan and the advocates of her bill; the risks of doing nothing, they argued, were far greater than the risks of doing something. But that argument would not immediately hold sway in Sacramento. After heavy lobbying by the industry, Chan's bill was defeated by one vote.
In the decade before the EU passed its ban in 1999, numerous studies on phthalates' effects on humans were published in European scientific journals. In the Netherlands, scientists asked men to chew on pieces of plastic children's toys, then tested their saliva and blood to see how easily phthalates pass into the human body; in Denmark scientists concluded that high levels of phthalates in breast milk contributed to lower levels of testosterone in male offspring in their first three months of life; and in Italy, doctors reported that phthalates could contribute to premature births. In 1998 the European Chemical Bureau, an arm of the European Commission that reviews research on chemical toxicity, affirmed that phthalates easily slough off products like plastic toys and recommended tighter exposure standards. Across Europe, parents expressed alarm: if these are really such powerful endocrine disrupters as scientists are suggesting, what are they doing in my son's crib? (Most concern, of course, has been focused on infant boys because of the concern about testosterone levels.)
Responding to mounting public fears, the EU issued a temporary ban in 1999 on the inclusion of six phthalates in children's "toys and teethers intended to be mouthed by children under three years of age." The ban was renewed yearly as scientists were encouraged to get to the heart of these concerns. The World Wildlife Fund took blood samples from members of the European Parliament in 2004 and detected DEHP in all thirty-nine of the MEPs tested. A year later the Parliament voted overwhelmingly to make the temporary ban permanent.
As of January three phthalates determined to be toxic to the reproductive system -- DEHP and two others, DBP and BBP -- were banned from "all toys and childcare articles." Three others deemed less dangerous -- DINP, DIDP, and DNOP -- are banned from toys, "if those articles can be put into the mouth by children." The bans are in place until 2010, when they will be put up for review or renewal depending on the results of research. Some EU countries, like Austria and Germany, imposed even tighter restrictions on phthalates, limiting their use in plastic food wrapping.
Many other countries are following the Europeans' lead -- including Japan, Norway, Argentina and Mexico, which have banned DEHP and other phthalates from most infant toys, and others, like Canada, which have banned them in teethers and rattles. That leaves the United States as one of the few developed countries with no government limits on phthalates in toys aimed at young children.
What has been the effect of removing toys with phthalates from European playrooms? The shift in production practices failed to trigger the dire economic consequences the toy industry predicted during its annual negotiations with the EU. From 2002 to '04, European toy-industry sales grew by 5 percent, to nearly $20 billion annually, according to the trade group Toy Industries of Europe. Responding to the ban, European industry began developing alternatives.
A Danish company, Danisco, one of the world's largest manufacturers of food additives, introduced a phthalate alternative for toys and other products that has been approved for use in Europe and the United States. In January 2006, the European Council for Plasticisers and Intermediates participated in a conference, "Plasticisers 2006," tailored to encourage the industry to develop phthalate alternatives in response to "increasingly stringent" legislative demands and "environmental awareness among the general population." On the other side of the Atlantic, however, the U.S. plastics industry, represented by the Vinyl Institute and the American Chemical Council, is continuing to fight legislative measures like the one proposed in California.
German chemical giant BASF shut down its European DEHP production after the EU ban in 2005. The company was formerly responsible for half the phthalate produced in Europe but "discontinued production of DEHP [in Europe] because the market has changed considerably over the last years," according to William Pagano, a BASF communications officer who responded to my questions via e-mail. Instead, BASF has a new and profitable plasticizer line called DINCH. Pagano said the company has spent "five million euros...for rigorous and extensive" safety testing of DINCH and that it has an "outstanding toxicological profile" for "sensitive applications...such as toys, food-contact materials, and medical applications." In the United States, however, the company continues to manufacture DEHP at two facilities, in Pittsburgh and Texas City, for many industrial and consumer uses on the U.S. market. Likewise, in China, where most toy manufacturing takes place, toys are produced with phthalates for the U.S. market but without them for the European market. Unlike in the recent scandals about lead paint in Thomas the Tank Engine toys, when Chinese companies ship phthalate-laden toys to America, they are simply abiding by U.S. rules.
In Brussels several months before the California debate, I interviewed David Cadogan, a chemist who works as the senior scientist for the Confederation of European Chemical Industries, Europe's chemical-industry trade group. Before coming to the group, Cadogan spent two decades in the private sector, specializing in the manufacture of plastics, including many phthalates. Now, as a representative of his industry, he'd lobbied the EP against the phthalate ban. He's no fan of the precautionary principle. The EU's decision, Dr. Cadogan told me, was prompted by "politicians' desire to appear to be protecting their constituents from scientifically unproven risks." But he conceded that since the ban had taken effect, it's had little impact on European toy makers. "I suppose," he shrugged, "we've learned to live without [phthalates]."
Back in the States, Dr. Swan told me that what disturbs her most about the ongoing debate over phthalates in America is that substitutes are working. "We can switch. It's doable. Why put this into kids' bodies if we don't have to?"
Ironically, the EU's decision on phthalates was largely based on evidence generated by U.S. scientists, much of it funded by their government. Dr. Gray, for example, works for the EPA. The EPA has also funded many other U.S. scientists' research on phthalates, including that of Dr. Swan at the University of Rochester. The work of Swan, Gray and several other scientists at public research institutions across the country contributed to the EU's risk assessments of phthalates. Gray's and Swan's findings, along with those of European scientists, were an important part of the evidence used to support the EU's decision to limit infants' phthalate exposure.
The same data, however, have had an entirely different reception in the United States. The California hearing was the first of its kind in the country. Dr. Gray and Dr. Swan told me they had never presented their findings on phthalates to any U.S. legislative body, on either the federal or state level. "Nobody's ever asked," said Dr. Swan.
Jurisdiction over phthalates in the United States is scattered: the EPA has responsibility for phthalates released into the environment; the FDA, for medical devices like IV tubes; the National Institutes of Occupational Safety and Health, for workplace exposure (there appear to be higher pancreatic cancer rates among phthalate workers). In each, U.S. policy-makers are confronted with a powerful industry lobby that has largely succeeded in shaping a regulatory culture that imposes an obstacle course of cost-benefit analyses before acting.
"If you're a U.S. regulator, it's hard to resist the culture of analysis paralysis," says Joel Tickner, a toxicologist at the Lowell Center for Sustainable Production at UMass. "The more we think we don't know, the less the imperative to act."
The one body with jurisdiction over toys is the Consumer Products Safety Commission (CPSC). That government agency has been cut to 100 inspectors to monitor some 15,000 products -- including those lead-painted toys from China.
In 1998 a petition was submitted to the commission by a coalition of environmental health groups -- including National Environmental Trust, the Science and Environmental Health Network and Greenpeace -- demanding a ban on polyvinyl chloride, which contains phthalates, in children's toys. The CPSC went on to review toxicity studies of DINP, a phthalate that's similar to DEHP, and then in 2003 conducted a study of children's interactions with plastic toys. The CPSC's Human Relevance Working Group, the team charged with assessing people's interactions with potentially dangerous products, installed cameras to monitor the "mouthing behavior" of 169 children in Houston and Chicago for two days. Another 491 children were observed by their parents, who took notes on their behavior. The frequency with which the children (55 percent boys, 45 percent girls) mouthed soft plastic toys spread liberally around them was registered and timed. This research, commonly called the Kids Suck study, showed that the average 1-year-old or younger spends seventy minutes a day sucking on plastic; forty-eight minutes for children between 1 and 2; thirty-seven minutes for children between 2 and 3 -- not enough time sucking, CPSC concluded, to deliver a "designated health risk" to children under 5.
"The dose makes the poison," CPSC spokesman Scott Wolfson explained to me. "There were not enough phthalates released in those toys to pose any danger." Wolfson's comment revealed another key difference between European and American approaches to regulating chemical exposure. For phthalates, the United States looked at the time children may be exposed and determined it was not long enough for concern. The Europeans looked at phthalates' toxicity and decided to limit a potential route of exposure: toys.
Industry giants Mattel and Hasbro lobbied strenuously against EU regulation of phthalates. But when their campaign failed, both companies, which have significant European sales, announced they would abide by the European standards and remove phthalates from their worldwide production of young children's toys. Company members of the TIA, Joan Lawrence told me, agreed "voluntarily" to take DEHP and other phthalates out of rattles, pacifiers and teethers, products "intended to be used in the mouth." That agreement was announced in the 1980s, after concerns surfaced over phthalates' potential carcinogenicity. It did not, however, cover toys. The result can be seen in the playrooms of American children.
Environment California and the Public Interest Research Group teamed up to conduct chemical analyses of infant playthings, an exercise never performed by the U.S. government. They bought teethers, bath books and toys and sent them to an EPA-certified chemical lab in Chicago for a breakdown. Fifteen of the eighteen products tested contained one or another of the six phthalates banned in the EU. A dozen infant products -- including waterproof books and bath toys -- contained measurable levels of DEHP. Nine of those contained multiple phthalates that toy makers have in the past decade said they would voluntarily remove. One teether -- the Teething Ring, which induces infants to suck on it to get an oral-pain-relief gel -- contained DEHP. Another, the Baby Gund Jungle Collection Teether, contained DBP, a phthalate classified by the EU as a reproductive toxin and carcinogen. Today, an American who wants phthalate-free toys can find them in the brands manufactured by multinationals. Those companies, according to Lawrence, account for about 40 percent of the U.S. market. But for those who buy at discount stores or buy generic brands online -- outlets that sell millions of baby products a year -- if they're plastic and soft there's a good chance they contain phthalates.
Chan's bill in California was modeled explicitly on Europe's law; it was, commented Peter Price, a lobbyist for the bill, "the EU directive coming to Sacramento." The arguments were the same as had been pushed in Europe, and the key players were the same, too: Hasbro and Mattel had acceded to the demands of the EU in Europe, but as the largest members of the trade group were a part of the lobbying campaign launched to kill the effort to impose those same restrictions in California. The same held for the Weinberg Group -- whose Brussels-based representatives had been the leading voice of U.S. industry opposition to the EU's phthalate initiatives and which would now send James Lamb to represent them in Sacramento.
After Chan's bill went down, San Francisco took up her idea; it passed an ordinance prohibiting the sale of toys and childcare articles containing phthalates likely to go into children's mouths from being sold within the city limits. That made San Francisco the first government in the country to limit children's exposure to phthalates. The sellers of toys containing the same six phthalates singled out by the EU would be subject to fines that could go to thousands of dollars. Shortly before the bill took effect, the San Francisco Chronicle tested samples of randomly purchased toys and discovered that at least three out of sixteen exceeded the city's new phthalate limits. Those included a teether, a doll and a rubber ducky sold at the drugstore chain Walgreens; the toys had thirteen times the allowable level of DEHP. The response of industry was not to remove toys from the market but to file a lawsuit: the TIA, along with the American Chemistry Council, the Juvenile Products Manufacturers Association, retail industry groups and local toy stores, sued to block the implementation of the ordinance on the grounds that on such matters city law is pre-empted by state law. That challenge is pending.
Wilma Chan was ultimately termed out, but her idea had better luck this year. In September the Assembly passed a similar bill, sponsored by Assemblywoman Fiona Ma of San Francisco, banning the use of phthalates in toys aimed at children under 3. Advocates mounted a poignant public campaign, featuring the distribution of 1,000 phthalate-free rubber duckies on the day of the vote; a rally in Los Angeles featuring Harvey Karp, a well-regarded pediatrician; and a novel initiative led by teenage girls, affiliated with Teens for Safe Cosmetics, who called friends around the state to pressure their legislators by telling them that within a year they would be voters. "It was one of those rare examples of 17-year-old girls being charitable to the generations behind them," commented Rachel Gibson, staff attorney at Environment California. On October 14, Governor Schwarzenegger signed Ma's bill. When it goes into effect next year, Californians will be the only Americans who can shop knowing their toys contain no phthalates.
Meanwhile, phthalates in toys continues to be an issue in Europe. Since the EU's ban two years ago, there have been almost monthly confiscations of toys that violate the phthalate restrictions. Last July customs authorities in Lithuania ordered an immediate withdrawal from the market of plastic hippopotamuses and dolphins from China because of their DEHP levels; the month before, they had confiscated a shipment of soft plastic toy snakes. There is nothing, of course, to prevent those toxic toy animals from coming into the United States.
Mark Schapiro is the editorial director of the Center for Investigative Reporting in San Francisco.