National Journal [Printer-friendly version] November 15, 2008 TOXIC SUSPICIONS COULD FUEL REGULATORY OVERHAUL [Rachel's introduction: The Kid-Safe [Chemical Act] standard would require EPA to consider evidence submitted by manufacturers to prove that a new compound is safe. "It flips the burden of proof onto business and the chemical manufacturers" and off government agencies laboring under many layers of time-consuming rules, said Daryl Ditz, senior chemicals adviser at the D.C.-based Center for International Environmental Law.] By Neil Munro Ron Vigdor, the founder and CEO of BornFree, sells trust. More precisely, he sells baby bottles for about $5.50 that are guaranteed to contain no bisphenol A, a chemical that is widely used in $1 baby bottles. An increasing number of young parents are worried about the toxicity of BPA in bottles made with an older plastic, so they're putting their trust in Vigdor's BPA-free bottles as fast as he can make them. Vigdor began selling his bottles in Whole Foods grocery stores in 2006, and his production capacity has grown to 1 million a year. The established companies -- which sell about 60 million baby bottles annually -- are now marketing their own BPA-free bottles and cutting production of older models. Still, the demand for BornFree products is so high, Vigdor said, "the company has had to fly orders by FedEx next-day air" from its factory in Israel. He expects that a larger manufacturer will buy his firm at a premium someday. "Let the bidding begin," he said with a laugh. This shift in demand away from low-cost items toward "green" products is one element of the increasingly commonplace convergence of economic issues and social trends, of business and culture. To promote his bottles, Vigdor has formed a marketing partnership with a Los Angeles- based anti-BPA advocacy group, Healthy Child-Healthy World. He has also testified in favor of an anti-BPA bill in California and works with the Center for Health, Environment, and Justice, one of many Washington groups seeking to restrict the use of BPA. To boost press coverage, Vigdor hired Fenton Communications, which specializes in political advocacy and was already engaged with other anti-BPA outfits, such as the Environmental Working Group. Vigdor's market gets a boost every time the media publicize a report on BPA's possible hazards -- as happened last month when The Journal of the American Medical Association reported that people with high levels of BPA in their urine were more likely to have heart disease or diabetes. The JAMA article was inconclusive -- the higher BPA levels could be the result of the diseases rather than the cause -- but it bolstered previous studies that cited potential harm from exposure to BPA. These reports are providing data for lawsuits claiming BPA-related damages, even as reviews at government agencies are generating more publicity, and advocacy campaigns urge Congress to ban the chemical's use in baby products and food containers. The anti-BPA campaign doesn't target just one chemical, however. A network of environmental groups is using the plastics controversy to press for an overhaul of the nation's chemical-safety laws, now enshrined in the Toxic Substances Control Act of 1976. The coalition wants to turn the law inside out, so that new chemicals would remain off the market until laboratory tests show that they pose almost no risk to human health. "BPA is really a poster child for demonstrating that the government has failed to protect us from dangerous chemicals," said Mike Schade, who leads the work on BPA issues for the Center for Health, Environment, and Justice. Janet Nudelman, the Breast Cancer Fund's program director, says that it's time to stop fighting dangerous chemicals singly and to enact a new regime. "Honestly, that's our endgame, and that is what most of the environmental organizations are working toward," she said. Companies can sell novel chemicals to "downstream" manufacturers, at home or abroad, after describing the compounds to the Environmental Protection Agency. But the environmental groups say that EPA is so hamstrung by bureaucratic rules and court challenges that it can do little to curb dangerous chemicals. They're backing legislation called the Kid-Safe Chemicals Act, sponsored by Reps. Henry Waxman and Hilda Solis, both D-Calif., and Sens. Frank Lautenberg, D-N.J., and Barbara Boxer, D-Calif. It would emulate a 2007 European law that forbids companies to sell a new chemical until they demonstrate its safety. But a European-style law could cripple innovation in the chemical industry, its executives warn. Congress should wait to see how the European law affects the U.S. chemical industry, then "learn and adopt what is beneficial to develop far more effective and maybe cost- effective regulation," said Linda Fisher, vice president and chief sustainability officer at DuPont, a diverse chemicals firm. Because of Europe's regulations, "in the last 10 years they've had perhaps 2,000 new [chemical] molecules introduced," said Jim Cooper, a vice president at the National Petrochemical and Refiners Association, whose members help develop many novel chemicals. In contrast, "we have 1,200 to 1,500 [new chemicals] per year." About half of the chemicals developed in the United States eventually reach the market. Environmental advocates, however, say that an overhaul of the toxic substances law would greatly increase public health and spur marketplace innovations such as Vigdor's BPA-free bottles. "Enough with the science... we have enough information to act," Schade said. "We're really wasting time when we argue about these [scientific] details -- this chemical [BPA] causes harm, there are safer alternatives, [and] the only people that benefit are the chemical companies." How Harmful? The science surrounding chemicals such as BPA is so complex that legislators and their staff -- few of whom are biologists -- can be deterred by the complexity, or else cling to a few questionable studies. For a taste of that complexity, consider BPA's proper name: 4,4'-dihydroxy-2,2-diphenylpropane. BPA was invented in 1891, but it was largely ignored until the 1940s and'50s when the fast-growing plastics industry began using it to make hard polycarbonate plastics. Several companies, including Dow Chemical and BASF, manufacture BPA, which other companies use to make auto parts and other consumer goods, in addition to plastic bottles and liners for food cans. The problem is that BPA is an excellent impersonator of estrogen, a critical hormone in men and women. If BPA enters the body, a portion can escape the digestive system and drift through the bloodstream until it is mistakenly picked up by cells in place of real estrogen. Once absorbed into a cell, BPA disrupts vital, complex and subtle chemical processes and can eventually cause cancerous cell growth, even if BPA is present at the lowest level that high-tech machines can detect, say Frederick vom Saal, a biology professor at the University of Missouri and the leading scientific critic of BPA. According to the Food and Drug Administration, two industry-funded studies of rats established that adverse effects occur when the daily concentration of BPA in the body exceeds 5-thousandths of a gram of the compound for every kilogram (2.2 pounds) of body weight. This safety level is 2,000 times higher than the amount of BPA found by testing in infants and 27,000 times higher than the level found in adults, FDA documents say. Vom Saal and his allies argue that BPA is dangerous at levels far below the FDA's safety estimate, and they have produced hundreds of academic papers reporting on BPA's effects on rodents and rodent cells. The professor says, for example, that doses of BPA that were far below the level that the FDA deemed safe have harmed laboratory mice. The environmentalists' animal experiments don't translate well into human hazards, industry officials contend. Their experts say that very little BPA leaches from containers into food; the human digestive system quickly excretes most BPA molecules that enter the stomach; and the liver breaks down any BPA that gets into the bloodstream almost immediately. In contrast, they say, laboratory experiments on rodents usually involve injecting BPA into the bloodstream rather than having the subjects digest it over a long period, and rodents' metabolic systems are slower to break down BPA molecules than humans'. The government safety levels are far too high for infants and pregnant women, vom Saal counters. Until several months after birth, babies lack mature livers and can't break down BPA that gets into their bloodstream, giving each molecule more time to infiltrate and damage the critical stem cells that are rapidly building the infants' organs, he said. Moreover, some people carry genes that make them more vulnerable than others, he said. On September 16, vom Saal's cause got a boost when JAMA published a report by a British team that found higher levels of BPA in people with significant heart disease or diabetes. However, the study didn't show whether high levels of BPA caused the diseases or vice versa. Although the report did not provide a decisive demonstration of human harm, it validates predictions drawn from animal studies, vom Saal said. The environmental coalitions back up their anti-BPA case with criticism of industry-funded scientific papers, especially the two studies that the FDA relied upon. Both were flawed because they tested BPA on a particular type of laboratory rat -- dubbed Sprague-Dawley -- that is unusually resistant to estrogen-impersonating chemicals, said Robert H. Weiss, founder of Rights for America, a law firm based in New York City that has filed several suits against baby-bottle manufacturers for not warning parents that their products contained BPA. Industry officials respond that they must depend on the government's science-based safety estimates when making business decisions. "The industry needs to rely on the regulatory agencies," not on the claims of advocates, said Cal Dooley, president and CEO of the industry's trade group, the American Chemistry Council. Dooley represented a House district in central California as a Democrat from 1991 to 2005. BPA's defenders skewered a February report by the Center for Health, Environment, and Justice, "Baby's Toxic Bottle," which said that heated bottles leached unsafe amounts of BPA into milk. Aided by Fenton's public-relations effort, the report got much media coverage, even though the test involved heating the bottles well above the temperature that parents would use to warm up refrigerated milk. The high heating, however, was intended to simulate the effects of washing a bottle 60 to 100 times, Schade said. "That was why we did it, not to show that parents will boil [babies'] milk." Asked for a comment, vom Saal said that his career, his funding, and the respect he gets from his peers all depend on whether his science is correct, not on praise from allies. Conflicting Interests So far, the evidence of harm from BPA hasn't been strong enough to persuade U.S. and foreign governments to bar the chemical. Japan pushed companies to reduce the use of BPA in food containers in the late 1990s, and this year the Canadian government forbade the sale of plastics containing BPA in the food sector. The European safety agency said recently that its BPA rules are adequate to protect newborns. In the U.S., however, official advice is more diverse. A 2007 panel selected by the National Institutes of Health, which included vom Saal and his scientific allies, concluded that the evidence warranted "great concern" about such health hazards as cancer, diabetes, autism, attention deficit disorder, and early puberty. A second NIH panel of outside experts reported in November that the evidence justified "some concern" about neurological effects on infants but only "minimal concern" about possible cancer or early puberty. Environmentalists criticized the second panel's report because its members used a reading list prepared by a company that provides similar research services for industry, including two BPA manufacturers. In August, an FDA panel said that the amount of BPA that leaches into food meets safety levels; on September 3, the National Toxicology Program at the Health and Human Services Department said it had "some concern" that BPA causes cancer and diabetes in adults, and developmental problems before and after birth. Under government rules, "some concern" is midway between the lowest level of concern -- "negligible concern" -- and the highest, "great concern." Dispassionate science can identify many risky chemicals, said David Michaels, author of Doubt Is Their Product, a book that describes how companies have used skewed scientific reports to hide the risk of chemicals for several decades. But in many cases, including that of BPA, the possible harm is just too subtle and gradual to demonstrate without illegal experiments on living, breathing -- and protesting -- people. If BPA causes health problems, "it would be difficult to identify them," said Michaels, an epidemiologist and former top safety official at the Energy Department, who now directs the Project on Scientific Knowledge and Public Policy at George Washington University. The project urges new courtroom rules regarding scientific evidence, and its work is funded, in part, by money from a lawsuit. Michaels says that there's enough evidence of risk to show that BPA "shouldn't be used in food products." The industry's strategy in defending current safety levels, Michaels said, is to cast doubt on reliable scientific evidence by burying it in a blizzard of complex and confusing scientific reports. Schade added, "It's right out of the playbook of the tobacco industry." That conflict-of-interest charge goes both ways, however. The class- action lawyers and environmental groups have an obvious incentive to develop studies that demonstrate problems with BPA -- they need to attract the attention of donors, subscribers, journalists, and politicians if they want to beat out competing groups. "There's certainly an underground economy of environmental advocates competing for a limited pie of foundation dollars, and the more apocalyptic your vision is, the more likely you are to reap the millions," said Dave Martosko, director of research at the Center for Consumer Freedom, which is financed by numerous companies. Burden Of Proof The scientific data on BPA's danger hasn't risen to the level that will force the FDA to reassess its standards or spur Congress to ban it, but environmentalists are keeping their eye on the main prize -- the Kid-Safe Chemicals Act. The bill hasn't received a hearing yet, but advocates and their backers on congressional staffs hope to take it up in the next Congress. The legislation follows the European Union's Registration, Evaluation, Authorization, and Restriction of Chemical Substances law, often called REACH, which was approved in December after years of debate. It requires chemical companies to demonstrate the safety of new compounds before selling them. European regulators have begun to assess numerous widely used chemicals but have yet to order the withdrawal of any from the market. The Kid-Safe standard would require EPA to consider evidence submitted by manufacturers to prove that a new compound is safe. "It flips the burden of proof onto business and the chemical manufacturers" and off government agencies laboring under many layers of time-consuming rules, said Daryl Ditz, senior chemicals adviser at the D.C.-based Center for International Environmental Law. The draft sets a very high standard: No approved chemical could cause more than one cancer per million people, and additional safety rules would be tightened tenfold for chemicals that might reach young people between conception and adulthood. The measure would regulate every chemical outside the drug and pesticide industries, which already have rules, said Andy Igrejas, manager of the Pew Charitable Trusts' environmental advocacy campaign, who helped draft the bill in cooperation with the Environmental Working Group. If enacted, it would control the dye used in carpets, the plastic in computers, the paint in offices, the seats in autos, the pipes in plumbing, and much, much else. It's an ambitious goal, yet Igrejas and other proponents contend that they are making progress because the public is growing more concerned about stories of lead paint on toys and other environmental controversies. Manufacturers say that the Kid-Safe act would stifle development of new products, but Ditz argues that the measure would help the nation by spurring innovation in the chemical industry. "It would shake things up in a dramatic way," he said, adding that European environmental groups have identified 270 "substances of very high concern" that they believe should be investigated for likely harm. The safety regime could be very stringent, yet new chemicals could still win approval after tests on animals, on human cells, and in computer models, Ditz said. Slowing Down The possibility that a Kid-Safe law would slow chemical-industry innovation doesn't trouble some advocates. "It's true," said Diana Zuckerman, president of the National Research Center for Women & Families. "The companies would be creating fewer new chemicals, and that would limit new products. But you know, we already have a lot of perfectly good products." Americans, she said, "care more about health than about a thousand different choices for fabric on a couch." The chemical industry doesn't think all would be lost if manufacturers had to prove the safety of their products, but they urge caution and further study. "We live with that [one-in-a-million standard] in the pesticide world," said DuPont's Fisher, who was EPA's deputy administrator from 2001 to '03. Already, she says, the European law, brand-conscious retailers, and wary consumers are "forcing us to look a lot differently at the materials we put in commerce, to look for substitutes, and sometimes it will lead to innovation and new products -- and sometimes it means we're getting out of products." Industry officials say that Congress should delay an overhaul of the toxic substances law until experts can determine the impact of the European law on the chemical industry and downstream companies, such as food and toy manufacturers. "We'll be very active with Congress if it takes up Kid-Safe," Fisher said. "We'll have a lot of very constructive ideas to bring to that table based on our experience with REACH." Overall, Dooley said, "What the industry will want is risk-based science and fact-based processes that provide us with a great deal of certainty." For now, he said, the industry is spending $45 million over three years on a public-relations campaign dubbed "Essential2." The campaign website recently offered this pitch: "Essential2living... We make the products that help keep you safe and healthy and create a brighter future for you and your family.... Find out more about how American Chemistry is helping you live longer and get more out of life." Chemical manufacturers are also lobbying hard against state-level restrictions, and they recently helped defeat a California ban on BPA in baby products. Dooley said that the industry is trying to talk with the various advocacy groups on the other side of the issue. "Can we find common ground? I'm confident we can." But the environmental organizations are confident that they're on track to revamp the nation's huge and diverse chemical industry. "It's a big fight," Ditz said. "I do this for a living, so obviously I've got a bias, [but] this is as profound as tackling the climate challenge."