Plastic (16 page)

The ACC vigilantly tracks the research, publicizing studies that show no adverse effects and picking apart each finding that suggests a problem. It criticized Swan for using "unproven methods," such as the anogenital distance measurement and the play survey, and hammered on methodological errors, which she acknowledges but insists did not affect the statistical significance of her final results. In general, the ACC draws on a standing set of criticisms to point out flaws that may be accurate but not always meaningful. Among the oft-cited complaints: the sample sizes are too small; rats are poor models for human health hazards; the doses administered in animal studies are much higher than those experienced by humans; the demonstrated health effects are not necessarily adverse.
Almost invariably, when an epidemiological study reports a risk associated with phthalates, the group counters with a press release pointing out that the study shows a correlation only, not proof of a causal effect. Which is true—that's precisely what epidemiological studies do. Still, the correlations highlighted by epidemiological studies have long been the gold standard for assessing risks to public health.

The insistent focus on the flaws of each individual study ignores—and obscures—how each may be contributing to an increasingly disturbing body of evidence. The nitpicking zeroes in on and tries to amp up the uncertainty that is always inherent in science. It's a strategy taken straight from the tobacco industry, and one that, incredibly enough, was committed to paper in 1969 by an executive at the cigarette maker Brown and Williamson: "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the mind of the general public."

As Swan and others have pointed out, there was never a single study that "proved" smoking causes lung cancer. It took a combination of in vitro, animal, and human population studies to demonstrate the dangers of tobacco. A series of epidemiological studies pointed to the risk, prompting the surgeon general to issue his famous 1964 warning. Over the next forty-some years, researchers painstakingly pieced together, through cell and animal studies, the biological mechanisms that explained how tobacco smoke could induce tumors in the lungs. Meanwhile, the tobacco industry spent those decades denying there was any connection.

It's unlikely science will deliver neat, definitive answers about the risks of endocrine disrupters any time soon. So do we wait for children like Amy to grow up before we discover the dangers of DEHP exposure? Do we wait to see if she develops liver problems, launches into puberty at an early age, has trouble conceiving a child? Or have we reached the point where there is enough evidence to fairly act on the side of caution? I think we have. Yet our current system for regulating chemicals makes that difficult to do.

We have no coherent or comprehensive body of law for managing the chemicals we experience in daily life. Instead, there's a weak and uncoordinated patchwork of national and state laws. Federal regulation of chemicals is divided among various agencies, leading to fragmented and inconsistent policies. The EPA, for instance, recently announced it would take steps to limit use of phthalates, including DEHP.
The FDA, however, still judges that the chemical offers more benefit than risk and has thus far ignored calls to limit its use in medical devices and require labeling of medical products that contain it. The FDA's only action to date has been a 2002 advisory recommending that hospitals not use devices containing DEHP in women pregnant with boys, in male infants, and in young teenage boys.
U.S. regulators at both the FDA and the EPA have lagged behind the changing scientific understanding about chemical risks. For instance, both agencies still base their safety assessments of chemicals on studies of one chemical at a time, rather than looking at aggregate effects.

But there is a much bigger problem: U.S. law tends to treat chemicals as safe until proven otherwise. Regulators are required to find what author Mark Schapiro called "a scientifically improbable smoking gun"
before they can pull a suspect chemical off the market. Nowhere are the failings of that approach more clear than in the main federal law regulating synthetic chemicals, the Toxic Substance and Control Act. Enacted in 1976, the law gives the EPA the power to require testing of and restrict chemical substances. Yet it's had little opportunity to exercise that power. The sixty-two thousand chemicals in use when the law was passed were exempted from the testing requirements. And the law's provisions bind EPA regulators in a Catch-22: they need evidence of harm or exposure before they can require a manufacturer to provide more information about a chemical, but without the information, how do they establish evidence of harm? In the absence of that evidence, the regulators cannot act. So while twenty thousand chemicals have been introduced since 1976, the EPA has been able to require intensive reviews for only two hundred, and it has used its authority to restrict only five. The hurdles are so high, the agency could not even successfully ban asbestos, an undisputed carcinogen. "This means," wrote John Wargo, an expert on chemical policy, "that nearly all chemicals in commerce have been poorly tested to determine their environmental behavior or effects on human health."

Are
all
those chemicals dangerous? It's hard to tell, but the EPA has said that at least sixteen thousand were potentially causes for concern owing to their high production volume and chemical properties. Meanwhile, European regulators have estimated that an astounding 70 percent of new chemicals have some hazardous property, ranging from carcinogenicity to flammability.

Everyone concerned with chemical policy—the head of the EPA, environmental activists, even the American Chemistry Council—agrees the law is a poor vehicle for navigating our current chemical landscape. Yet agreeing on some alternative approach is another matter (as has been evident in debate over a reform bill winding its way through Congress as of mid-2010). A major point of contention is that American policymakers are starting to look to Europe as a model for regulating the chemical industry.

In Europe, the burden of proof is on safety rather than danger. European regulators "act on the principle of preventing harm before it happens, even in the face of scientific uncertainty."
Guided by that precautionary principle, Europeans began limiting DEHP and other phthalates while American regulators continued debating the risks.
(The EU, for instance, barred the use of DEHP in children's toys in 1999, nine years before the U.S. Congress passed similar legislation.) A new directive known as REACH (for Registration, Evaluation, and Authorization of Chemicals), adopted in 2007, requires testing of both newly introduced chemicals and those already in use, with the burden on manufacturers to demonstrate that they can be used safely. The agency charged with implementing REACH targeted DEHP as one of the first fifteen "substances of very high concern" to be regulated. In essence, European regulators are treating chemicals the way U.S. regulators treat drugs: they're presumed to be dangerous unless shown to be otherwise.
American manufacturers are already selling products in European markets that have been reformulated to comply with the precautionary principle. Shouldn't American citizens demand the same on this side of the Atlantic?

Some states have already taken the initiative. In 2008, California passed landmark safer chemicals legislation that requires the state to collect data on chemical toxicity, restrict some of the most hazardous substances, and promote research into safer substitutes. The law expands on the approach taken by Massachusetts, which since 1989 has required companies using large quantities of toxic materials to disclose that use and explore alternatives to dangerous chemicals and has promoted programs to help companies either switch to safer alternatives or use smaller quantities of the hazardous substances.

Still, state efforts are no substitute for across-the-board federal protections. John Wargo, a professor at Yale University, argued convincingly that what we need is a national "plastics control law." Congress, he pointed out, has passed laws to regulate other health or environmental risks, such as pesticides, pharmaceuticals, and tobacco. Why not the same for plastics—materials that touch the life of every single American? He proposed a comprehensive policy that, among other things, would include tough premarket testing of chemicals used in plastics, mandatory labeling of ingredients, and strict prohibitions of chemicals and compounds that pose a threat to human health or that don't quickly degrade into harmless substances.

Of course, it's possible to set the safety bar too high as well as too low. Plastics have proven benefits in medicine and other fields. Proposing unachievable standards—demanding that substances be proven absolutely benign—could produce the same regulatory "paralysis by analysis" we're now experiencing. But when adequately funded research indicates significant evidence of harm, we are betraying our children if we fail to take action against a potentially dangerous chemical, especially when alternatives are available.

Who's responsible for taking action? Often the first step is made by an ordinary person paying attention. A person like Paula Safreed. In the early 1990s, Safreed was a nurse in the NICU at the Brigham and Women's Hospital in Boston. In addition to caring for babies, she was in charge of ordering supplies for the unit, which put her in regular conversation with the vendors of medical equipment. She began hearing rumblings about the chemical in the plastic IV bags and tubing she used to treat her tiny patients. What caught her attention wasn't anything to do with DEHP's potential reproductive effects. Rather, it was a comment by a vendor that DEHP had been linked with damage to the liver. It reminded her of a baby she had cared for years earlier, one of a set of twins born prematurely. One twin died, but this boy survived and spent months in the Brigham NICU, receiving blood transfusions, proteins, and lipids, as well as intravenous nutrients, via vinyl IV bags and tubing. Safreed was thrilled to see him get strong enough to go home and utterly devastated when he later developed liver cancer and died at the age of three. She knew he had liver troubles, a common complication in preemies who spend a long time taking artificial nutrients. Still, Safreed was haunted by the possibility that the very things the NICU staff did to save his life had contributed to ending it.

"That was when I started to get interested in plastics," she said.
She began quizzing vendors about the contents of their products and pushing the hospital administrators to buy bags and tubing and other equipment made without DEHP. At the time, alternatives were few and far between and significantly more expensive. Still, Safreed kept pushing.

She was not alone. During that same period, a coalition of environmental groups started a new organization, Health Care Without Harm, aimed at getting hospitals to phase out their use of vinyl IV bags, tubing, and other equipment that contained the plasticizing chemical DEHP. The drive was an outgrowth of a broader campaign to get hospitals to stop using PVC in general, because incineration of medical waste containing PVC had made hospitals a leading source of dioxin emissions. Discovery of that fact was "an incredible irony and a teachable moment," according to Health Care Without Harm founder Gary Cohen. "Because if you want to detoxify the economy, you start with the sector of people who have taken an oath to do no harm."

Organizers from the group began talking about the risks of DEHP with hospitals around the country, quickly winning the support of influential university-affiliated hospitals such as the Brigham, as well as powerful chains like Kaiser Permanente and Catholic Healthcare West, both of which made far-reaching pledges to completely eliminate PVC and its additive DEHP from their facilities. (Kaiser has even replaced its vinyl carpet and flooring with alternative materials.) As of 2010, about 120 of the more than 5,000 hospitals in the United States had publicly signed on to Health Care Without Harm's campaign.

The Brigham NICU was one of the nation's first to start adopting alternatives to PVC, and nurses there give the credit to Safreed, who has since retired. "All our products are DEHP-free," the NICU's assistant manager Julianne Mazzawi said proudly while showing me a package containing a slender coil of IV tubing that had a prominent label to that effect. The FDA may not require labeling yet, but some manufacturers are going ahead and doing it on their own.

But what's really driven change in the medical marketplace has been Health Care Without Harm's success in reaching the half dozen or so organizations that negotiate bulk purchases on behalf of most of the nation's hospitals.
These group-purchasing organizations hold enormous sway over the market; when they began asking about alternatives to PVC and DEHP, medical manufacturers sat up and listened.

Most major medical suppliers now offer products, particularly many types of IV bags, tubing, and neonatal care equipment, that are free of DEHP and PVC. Some suppliers, such as Baxter, have introduced alternatives while continuing to defend the safety of PVC and DEHP, which lends a certain schizophrenic quality to their promotional brochures. Other suppliers embraced new approaches early and with gusto. Starting in the 1970s, leaders of the company B. Braun (now B. Braun McGaw) saw the opportunity to carve out a new market niche by developing alternatives to PVC and DEHP. It mainly uses the common plastic polypropylene (the stuff of bottle caps, disposable diapers, and monobloc chairs). "Polypropylene is a cleaner material than vinyl because it doesn't contain chloride. And it doesn't contain plasticizers" so there's nothing to leach out, said David Schuck, vice president of pharmaceutical testing for the company. He said safety testing has shown the resin has no hormonal effects. (Still the company uses glass containers only for its intravenous nutritional supplements for infants.) Other companies are using other types of plastics—such as polyurethane, polyethylene-like polymers, and silicone—that they say are safer and don't require the use of chemical additives.

Meanwhile, the makers of additives are coming out with alternative, ostensibly safer plasticizers that can be used to soften PVC. At least four are already used in children's products, including citrates, compounds based on citric acid. These have been available for years but were rarely used because they cost more than phthalates. Another alternative softener is a chemical called Hexamoll DINCH, introduced by BASF, one of the world's leading makers of phthalates. BASF spokesman Patrick Harmon said the company spent seven million dollars on safety testing and is "very confident" it is safe.
Though American manufacturers have not yet adopted it, he said it is being used in Europe for toys, food packaging, and medical devices, including the IV tubing and bags used to deliver nutritional supplements to preemies.