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The EPA Opens a New Review of Handsoap, But Government Study Goes on for Decades

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In Washington, the wheels of government grind slowly -- when they grind at all.

One area of government habitually plagued by bureaucracy is the regulatory agencies, among them the Environmental Protection Agency and the Food and Drug Administration. Reviews of substances regulated by these agencies can take years, sometimes many years. Few reviews have lasted longer than the one afforded a chemical compound called triclosan, a widely used substance contained in products in the vast majority of American homes today. Primarily utilized in antibacterial hand soaps, it is also found in many other places like knives and cutting boards, essentially anywhere germs can congregate and be harmful.

Just Thursday, the Associated Press reported that FDA spokeswoman Stephanie Yao said evaluating triclosan is "one of the highest priorities" for the agency. Maybe, but a look at the history of the way the FDA and EPA have studied the substance suggests otherwise.

On March 27, 2013, the EPA initiated a comprehensive review of triclosan by opening a public docket for comment. "Though registration review schedules vary by chemical," the EPA says in a prepared statement issued to this author, "the process generally takes 6 to 7 years to complete once a docket is established. At this time, the EPA anticipates issuing a final registration review decision for triclosan in 2020." In the meantime, the EPA says "exposure to triclosan [does] not cause unreasonable adverse effects on human health or the environment." In other words, it is safe.

If that review sounds lengthy, consider this. The new examination is merely the latest step in a review process that has gone on for four decades. Not four years, four decades. Why so long? "At the regulatory agencies, it's not a conclusion that they are after," says Mattie Duppler of the Center for Fiscal Accountability, a government watchdog group. "It's a fact-finding mission. The focus is on process, not wrapping things up. Inertia is a powerful force in Washington. It really does dictate how a lot of business gets done."

In the case of triclosan, that business stretches all the way back to the days of Richard Nixon. In the late 1960s, hexachlorophene, a synthetic compound contained in over-the-counter products, was taken off the market after researchers determined that it caused brain damage when bath washes containing it were used on newborn babies. To replace it, industry developed triclosan, a chlorinated aromatic compound that was initially added to soap to increase its ability to kill germs and control the spread of contamination. It was so effective at eradicating bacteria that companies began adding it to an array of products ranging from hand soaps to merchandise like kitchen utensils.

In 1969, triclosan was registered with the EPA. At the EPA, because of an arcane nomenclature procedure, a bacterium is considered a "pest," implying (wrongly, some argue) that bacteria, which causes disease in humans and animals, should be viewed in the same way as actual pests like rodents and boll weevils. Regardless, since triclosan kills bacteria, the EPA categorized it as a "pesticide," though it has nothing to do with chemicals like Chlordane and DDT, which the public generally thinks of as pesticides. With that classification made in the early 1970s, the EPA started a review process.

For a product to remain on the market, the relevant regulatory agency, or agencies, must give it the designation "Safe and Effective." The EPA found that triclosan was effective -- it clearly killed bacteria -- but the agency needed additional information to determine if it was safe. An initial request for research was issued; periodically over the years the agency received extensive material from the public and industry. Even so, the EPA would never change its original opinion. This latest review announced in late March may lead to a final decision in 2020. Or, based on past history, it may not.

Meanwhile, back when triclosan was first created, it was determined that the substance also fell under the jurisdiction of the FDA, which began its own investigation. In 1974, because of the hexachlorophene debacle, the FDA instituted a review process of all over-the-counter products. At that time, an investigation of triclosan commenced; four years later, the substance was placed in the antimicrobial category. Soon, the FDA found that triclosan was safe, but the agency needed additional information to determine if it is effective -- just the opposite of what the EPA found. By 1978, public and industry sources submitted relevant research. Sixteen years passed. Finally, in 1994, the FDA issued a decision -- sort of. The agency needed additional information to make a final determination. Two decades later, still no decision. One was promised in 2012. But that deadline came and went too.

The FDA's inability to reach a final decision is the subject of ongoing litigation in the Southern District Court in Manhattan, as a public advocacy group is suing the FDA over its inability to conclude its examination of triclosan. But the litigation has developed its own complicated history, with a lower court throwing out the case only to have that move overruled by a higher court. Any decision will be subject to years of appeals.

When a process goes on this long, a kind of de facto acceptance of the substance sets in. "If the concern is public safety," Mattie Duppler says, "expediency is vital." Once it was apparent that hexachlorophene was a danger to newborns, for example, it was yanked from the market at once. "For the government to say they want to study something doesn't mean the substance is problematic."

Indeed, in its prepared statement, the EPA seems to be saying just that. "The most recent comprehensive risk assessment performed by the EPA on triclosan was conducted in support of the 2008 Registration Eligibility Decision.... Based on data available at the time, the EPA concluded that exposure to triclosan did not cause unreasonable adverse effects on human health or the environment."

Should the public be worried? No, the EPA appears to be saying. If there were the chance of danger, triclosan would have been pulled from the market, just as hexachlorophene was years ago. In the meantime, another review, another six years, and the wheels of government grind on.

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