Thirty years after researchers first discovered evidence that a breakdown product of the active ingredient in Scotchgard fabric protector was showing up in human blood, the manufacturer, 3M Corporation, voluntarily agreed to withdraw the product from the market. The long saga, from Scotchgard’s creation to its demise, illustrates much about what is wrong with the current regulatory system – a labyrinthine structure that ultimately allows nearly all chemicals in commerce to stay on the market until and unless the government can prove two very difficult points: that the chemical in question is a health hazard, and that people are exposed to significant amounts. The active ingredient in Scotchgard is an organofluorine. Chemists had toyed with these compounds since the 1930s, but their first important commercial use came about quite by accident in the 1950s, when a lab technician spilled an organofluorine on her tennis shoe and noticed that, as a result, her shoe resisted water and nearly everything else. Marketed under the trade name Scotchgard, the compound became a staple of the textile, furniture, carpet and clothing industries. In 1968, independent researchers at the University of Rochester published the results of blood tests showing that an organic fluorine breakdown product of Scotchgard – perfluorooctane sulfonate, or PFOS - was present in human blood. In the mid-1970s, 3M followed up, and found PFOS in every company worker tested. The company's review of worker death records followed this discovery, but reported no unusual illnesses or early deaths. High-dose studies in test animals did not show excessive toxicity. The problem was put aside for another twenty years. In 1997, Cornell University researchers hired by 3M began to find PFOS in samples from blood banks across the United States. In follow-up testing, scientists found PFOS in blood samples from as far away as the Baltics. Every bald eagle and every child in a Minnesota pilot study tested positive for PFOS. Another round of animal tests followed – and this time, the results were alarming. When adult rats were treated with high doses of PFOS, they survived but their offspring died within days of birth. At a reduced dose, death rates of newborn rats dropped, but remained abnormally high. Scientists theorized that PFOS may block the formation of cholesterol, which is essential to biological development. On May 16, 2000, 3M voluntarily agreed to phase out production of Scotchgard within three years. The organic fluorine in Scotchgard is one of approximately 75,000 chemicals registered with the EPA. Not all of these are actually produced, but the EPA has no idea exactly how many chemicals are used in consumer products sold in the U.S. Furthermore, the government has no health data on most of these chemicals, including many that are produced in enormous quantities. The Toxic Substances Control Act (TSCA) was aimed at addressing the enormous gap in regulation. But impediments written into the law, as well as decisions made in implementation, have frustrated efforts to accurately assess the toxicity of existing chemicals as well as new ones. The EPA rarely requests that testing be done on chemicals already on the market. In order to do so, the agency must prove first that the chemical may “present an unreasonable risk,” and second, that it enters the environment “in substantial quantities” or presents a likelihood of “substantial human exposure.” The challenge is nearly insurmountable. If no testing or use data on a chemical exists, it is all but impossible for the EPA to assemble proof of risk and exposure. Without that proof, the agency has no authority to mandate testing. The system is a classic Catch-22. In a perverse twist, the law actually rewards chemical makers who do not test their products. If a manufacturer discovers evidence that a chemical may pose substantial risk of injury to health or the environment, the law requires the company to immediately inform the EPA. But, if a company never tests to find out whether its products are dangerous or not, it will never have bad news and so is not required to report to the agency. Beginning in 1979, TSCA required pre-manufacture notifications (PMNs) for all new chemicals. As with existing chemicals, if a manufacturer has test data indicating potential toxic effects, the company must submit that information to EPA. But if the company has done no testing, there is nothing to report. TSCA does not require specific batteries of health tests before a chemical goes on the market. The pre-manufacture notices may alert the agency to compounds that could be toxic because of their chemical structures. If the very basic data on chemical composition submitted raises alarms, EPA has authority to require further testing. Between 1979 and 1993, manufacturers withdrew plans to produce 1,020 chemicals after EPA raised questions, and the agency restricted another 832. But 19,000 new chemicals went on the market during those years with no additional testing required. TSCA also gave EPA the authority to require testing of what are known as high production volume chemicals – or HPVs – produced in quantities of over one million pounds a year. Approximately 3,000 chemicals fall into this category – including benzene and DEHP phthalate. Exposures to HPV chemicals are presumed to be high. But when EPA analyzed its data banks, it found no toxicity information whatsoever for a whopping 43 percent of these high volume compounds. In fact, complete testing data existed for only about 210 chemicals. On the eve of Earth Day 1998, Vice President Al Gore challenged the chemical industry to begin testing these chemicals themselves. In an orchestrated response, the industry accepted the challenge. Gore was roundly praised for spurring the industry to act. But internal industry documents reveal that the Chemical Manufacturers Association had long been quietly developing the idea of voluntary testing as a strategy to avoid tougher regulations. A CMA memo from 1992 outlined that the voluntary development of health, safety and environmental information will “potentially avert restrictive regulatory actions and legislative initiatives.” It continues: “Burdensome changes to TSCA, such as a mandated list of chemicals for base set testing, may be averted because of industry support of these voluntary programs.” The plan took effect on October 9, 1998. As of February 2001 - 28 months later - industry had submitted only 17 testing work plans to EPA – and EPA had not received the results of any new tests. EPA now refers inquiries about the voluntary testing program to an industry website, www.hpvchallenge.com, which reports that companies so far have completed 63 tests. But of those 63 tests, only 21 are directly related to human health. In addition, companies that produce almost one-quarter of the high production volume chemicals – about 700 chemicals – have not agreed to cooperate at all. EPA can move to mandate tests, but as of December 2000, had only taken action on 37 of these chemicals. At that rate, mandatory testing requirements for all 700 chemicals will be in place by the year 2022 – and that does not mean the results of the tests, only how they are to proceed. If, like the Scotchgard metabolite PFOS, other high production volume chemicals turn out to be present in human and animals worldwide, and if some do produce toxic effects, it could be a very long time before we find out. In the meantime, these products will remain on the market.