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Seeker Editor's Note: Rachel's Environment & Health News is named for the woman who became the linchpin for the beginning of the clean-up-the-environment movement, Rachel Carson. Carson's book Silent Spring (published in 1962) described the harms which our increasingly chemicalized society was causing to humans and other animals. The Environmental Research Foundation which publishes the newsletter continues her work. I have had a long-standing interest in protecting our environmental good health and wish to share this resource of information.

Pamphlet #824 Part 1 - August 18, 2005

Thirty years ago, scientists began reporting birth defects and unusual homosexual behavior in wildlife, which they couldn't explain. (See Rachel's #146, #263.) By the late 1980s, Theo Colborn -- an expert on the Great Lakes -- thought she saw a pattern, and she pulled together a scientific meeting in July 1991 to discuss it. The result was the "Wingspread Statement" on hormone-disrupting chemicals which began:

"We are certain of the following:

"A large number of man-made chemicals that have been released into the environment, as well as a few natural ones, have the potential to disrupt the endocrine [hormone] system of animals, including humans.... Many wildlife populations are already affected by these compounds." (Rachel's #263)

Five years later, Colborn, joined by biologist Pete Myers and journalist Dianne Dumanoski, popularized the idea that industrial chemicals at low levels can interfere with hormones in wildlife and quite possibly in humans. Their book, "Our Stolen Future," caused New York Times science writer Gina Kolata to go ballistic. Reviewing the book, Kolata scoffed at the main hypothesis, that industrial chemicals may be interfering with the hormones that control and regulate growth, health and behavior in wildlife and humans, leading to increases in birth defects, problems of sexual development, breast cancer, prostate cancer, and even mental problems like attention deficit disorder, reduced IQ, and violent behavior.

Kolata said "the factual basis of the book's alarms... have been refuted by careful studies," though she did not cite a single study as evidence. To be fair, Ms. Kolata was merely reflecting the views of the chemical industry on the question of hormone disruption. The industry had a great deal at stake. If the theory of hormone disruption were true, the chemical industry could only be viewed as a major menace to public health and the natural environment.

Now, almost 10 years later, the debate over hormone disruption seems to be over. The Wall Street Journal conceded this summer that low levels of industrial chemicals are linked to rising rates of childhood cancer and brain disorders, among other maladies.

Here's the opening paragraph of the Journal's front-page story July 25, 2005:

"For years, scientists have struggled to explain rising rates of some cancers and childhood brain disorders. Something about modern living has driven a steady rise of certain maladies, from breast and prostate cancer to autism and learning disabilities.

"One suspect now is drawing intense scrutiny: the prevalence in the environment of certain industrial chemicals at extremely low levels. A growing body of animal research suggests to some scientists that even minute traces of some chemicals, always assumed to be biologically insignificant, can affect such processes as gene activation and the brain development of newborns.

"An especially striking finding: It appears that some substances may have effects at the very lowest exposures that are absent at higher levels.... This challenges an axiom of toxicology stated by the Swiss chemist Paracelsus nearly 500 years ago: The dose makes the poison."[1] [See Rachel's #754, #755.]

The Journal went on to point out that many scientists are now convinced that insignificant levels of several individual chemicals can combine to produce significant effects.

The Journal explained: The harm from low-level exposure to a single hormone-disrupting chemical "will always be small," said Andreas Kortenkamp, who directs scientific research on hormone-disrupting chemicals for the European Union (EU). But exposure to low levels of many chemicals simultaneously will produce a cumulative effect on the human hormone system "that is likely to be very large," Kortenkamp told the Journal.

Given these facts, it seems safe to say that the chemical industry is now widely acknowledged as a major menace to public health and the natural environment. This presents the industry with an uncomfortable problem of financial liability.

Naturally, as a matter of self-preservation, the industry has developed a defensive response. Of course the industry has been studying these problems at least as long as Theo Colborn has been studying them. Industry scientists and lawyers knew the truth long before it made its way onto the front page of the Wall Street Journal -- just as the tobacco industry knew the truth about tobacco at least 50 years before they publicly acknowledged the problem of lung cancer.

The chemical industry response has been complex and exceedingly clever, intended to make it impossible for government to effectively regulate any industry. The strategy has succeeded in spades.

In the "old days" -- say, around 1975 -- a chemical like DDT could be banned because government scientists examined the scientific literature, balanced "the weight of the evidence," and concluded that DDT was probably causing serious harm to wildlife, such as the bald eagle, our national emblem.

Today it would be impossible to ban a chemical on such grounds because a series of laws and regulations passed during the past 20 years have changed the standards for scientific "proof" that government regulators must meet.

Industry's main strategy for ending government regulation is the manufacture of uncertainty and doubt. "If, for example, studies show that a company is exposing its workers to dangerous levels of a certain chemical, the business typically responds by hiring its own researchers to cast doubt on the studies," writes David Michaels in Scientific American.[2]

Increasingly, the U.S. regulatory system can be paralyzed by doubt. The system assumes that anyone can do anything they want to do (so long as it is legal), until harm can be proven. Until harm can be proven, anything goes. If I move into your town and set up a small shop and start belching bright blue smoke into the sky, it is up to you to prove that blue smoke causes harm before anyone can question my operation.

Once suspicion of harm is raised, the burden is still on the government and the public to prove harm. If one study shows that blue smoke causes asthma in children, the government may begin to examine all studies of blue smoke and eventually act on the weight of the evidence. (If government ever takes action to control blue smoke, we blue smoke producers can demand our day in court, but that's a later chapter in this story.)

Given the way the system works, as a blue smoke producer, it pays me to discredit previous blue smoke studies, to change "the weight of the evidence." With blue smoke studies in doubt, regulators will be paralyzed. "On the one hand we have studies showing harm from blue smoke, on the other hand those studies have been questioned by the Blue Smoke Association. Until this scientific dispute is resolved, we can't take action." This is how the regulatory system works.

"Doubt is our product."

It was the tobacco industry that discovered the power of doubt in a regulatory system that can be paralyzed by uncertainty. In 1969, an executive of Brown & Williamson (now owned by R.J. Reynolds) actually described the strategy in a memo: "Doubt is our product since it is the best means for competing with the 'body of fact' that exists in the mind of the general public."[2]

It turns out that creating doubt is remarkably easy to do. Take the example of atrazine, the potent weed killer that has been used for nearly 50 years. An estimated 80 million pounds of atrazine are spread into the environment each year in the U.S. In some environments, it persists and retains its toxicity for decades.

The initial concern about atrazine was cancer. Atrazine clearly causes cancer in laboratory rats. And the workers in a Louisiana atrazine factory have unusually high rates of prostate cancer. But Syngenta -- the Swiss firm that makes hundreds of millions of dollars each year selling atrazine in the U.S. -- has successfully cast doubt on these facts, paralyzing regulators. Syngenta argues that atrazine affects rats via biological mechanisms that do not exist in humans, and they say their workers have high rates of prostate cancer only because the company is extra vigilant looking for cancers among its workers.

Meanwhile, for years evidence has been accumulating, showing that atrazine scrambles the sex hormones of frogs, turning males into hermaphrodites. A hermaphrodite has sex organs of both genders. To prove otherwise, Syngenta hired a biologist named Tyrone B. Hayes, a biology professor at University of California, Berkeley. But Professor Hayes's experiments came out wrong and showed unmistakably that atrazine "demasculinizes" male frogs. Compared to unexposed frogs, males frogs exposed to atrazine have smaller larynxes (voice boxes), male hormone (testosterone) levels that are one-tenth of normal, and a mix of male and female traits -- they are hermaphrodites. Syngenta would not give Professor Hayes permission to publish his studies, so he ran a series of his own experiments on a wider variety of frogs, and published his results in prestigious journals (Nature, and the Proceedings of the National Academy of Sciences). "We showed that these animals are chemically castrated," Professor Hayes said. Four other groups of independent researchers in three countries reached similar conclusions.[3]

Syngenta solved this problem by creating doubt about Professor Hayes's studies. They hired scientists to reproduce the studies, but those scientists did sloppy work and were not able to reach the same conclusions that Hayes reached. An EPA panel of outside experts found numerous flaws and mistakes in the Syngenta studies. In at least two of the studies, the "unexposed" group of frogs had actually been exposed to atrazine. Not surprisingly, those studies did not find a significant difference between the "exposed" and "unexposed" frogs. In another of the studies, no conclusion could be reached because 80-90% of the frogs died, apparently as a result of inadequate care. As Professor Hayes summarized the situation, what Syngenta scientists did "was produce a number of studies that were purposefully flawed and misleading, and that changed the weight of the evidence."[3]

So it is rather easy to cast doubt on a scientific study -- simply try to reproduce the study using methods that are sloppy enough to assure that the results will not be reproduced. "On the one hand we have a study showing harm, on the other hand some scientists have been unable to reproduce these results." So regulators are paralyzed.

As David Michaels told a Texas reporter, "corporations and others who manufacture dangerous products and pollutants have realized that by adding manufactured uncertainty to the equation, they can essentially stop the regulatory process from moving forward."[4]

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[1] Peter Waldman, "Common Industrial Chemicals in Tiny Doses Raise Health Issue," Wall Street Journal July 25, 2005, pg. 1.

[2] David Michaels, "Doubt is Their Product," Scientific American Vol. 292, No. 6 (June 1, 2005), pgs. 96-101.

[3] Rick Weiss, "'Data Quality' Law is Nemesis of Regulation," Washington Post August 26, 2004.

[4] Jeff Nesmith, "New product for U.S. industry: 'manufactured doubt'," Austin (Tex.) Statesman June 26, 2005.

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Pamphlet #825 -- Part 2: Ending Government Regulation by Manufacturing Doubt, Sept. 01, 2005

Continued from Rachel's #824:

Smokers started calling cigarettes "coffin nails" in the 1920s. Almost 40 years later, science caught up to popular knowledge: In 1956, the U.S. Surgeon General concluded cigarettes cause lung cancer. To prevent regulation of cigarettes, tobacco corporations adopted a strategy of casting doubt on the scientific studies showing harm. Today it is no secret that many industrial chemicals are killing tens of thousands of workers and ordinary citizens each year, making many more sick, altering the sexual behavior of wildlife, and generally wreaking havoc with human health and the natural environment. In response, the chemical industry has honed and sharpened the "manufacture doubt" strategy, essentially paralyzing the U.S. regulatory system.

The Data Quality Act

In December, 2000, a two-sentence law called the "Data Quality Act" was slipped into the 712-page government spending bill, without benefit of public hearings or Congressional debate. The law was written by James J. Tozzi, a consultant to the tobacco and chemical industries,[1] and he says it was intended to "regulate the regulators."[2] President Clinton signed it into law, and it took effect in October 2002. On its face, the Data Quality Act appears to serve a worthy purpose: it requires government to set standards for the quality of scientific information and statistics used and disseminated by government. It requires government to create procedures "ensuring and maximizing the quality, objectivity, utility and integrity" of scientific information and data. Surely, good data is a goal everyone can support.

However the business community recognizes the real importance of the Data Quality Act, which is to give industry an unlimited license to cast doubt on the integrity of government data, and thereby paralyze regulation indefinitely. "This is the biggest sleeper there is in the regulatory area and will have an impact so far beyond anything people can imagine," says William L. Kovacs, vice president for environment, technology, and regulatory affairs of the United States Chamber of Commerce.[3]

The Data Quality Act is overseen by the Office of Management and Budget (OMB), a political agency whose directors are appointed by the White House. As the law has evolved, it has increasingly politicized science within the federal government because every agency of government must now develop procedures and definitions of science that satisfy OMB guidelines. OMB now has a powerful role in distinguishing "sound science" from "junk science."

In the case of atrazine, the second-most popular weed-killer in the U.S., the industry argued that, under the Data Quality Act, EPA (U.S. Environmental Protection Agency) had no right to regulate atrazine as a hormone-disrupting chemical because EPA had not defined a single procedure for determining hormone disruption, and therefore studies of hormone disruption are not "reproducible," and therefore not "reliable," as required by the Data Quality Act.

In the old days scientists knew what "reproducible" meant -- it meant that an experiment's design and methods had to be described in sufficient detail to allow another scientist to reproduce the experiment. It never meant that everyone had to agree that there was only one way to study a problem. But the Data Quality Act seems to have changed that because EPA accepted the atrazine industry's argument and concluded that endocrine [hormone] disruption cannot be considered "a legitimate regulatory endpoint at this time" -- meaning chemicals cannot be regulated in the U.S. just because they turn boys into girls. After a ten-year regulatory battle, atrazine was allowed to remain on the market, and industry had gained a powerful new way of undercutting all future regulations.

But the power of the Data Quality Act does not stop there. Using the Data Quality Act, OMB has now established an unprecedented government-wide "peer review" system for all data that might be used to support a regulation. The fact that a study has appeared in a peer-reviewed journal is no longer sufficient for it to be used for regulatory purposes.[4,5] Additional scrutiny is now required, thus expanding the reach of the Data Quality Act and the authority of OMB to influence government use of scientific information.

But the power of the Data Quality Act does not stop there. Recently, Jim Tozzi's industry group, the Center for Regulatory Effectiveness, wrote letters to every member of the American Association of University Professors, and to the World Health Organization, warning them that the industry group intended to challenge any research sent to the U.S. government that does not meet the standards defined under the Data Quality Act. To an individual researcher, the prospect of a lengthy scientific dispute with a combative and well-heeled industry group might seem daunting, to say the least. Could such a threat have a chilling effect on what scientific studies get considered by federal regulators? You bet it could.

But the power of the Data Quality Act does not stop there. Jim Tozzi says he believes the Data Quality Act will give industry a potent new weapon in court against government regulators: "'With a government-set yardstick for quality,' Mr. Tozzi said, 'critics of regulations can now build more convincing cases showing that an agency was arbitrary and capricious in its choice of data.' Until now, such suits have generally failed."[3]

Industry is now developing a new legal tactic based on the Data Quality Act. They are challenging government use of particular scientific studies under the law, and if their challenge is rejected, they are suing in court. Chris Mooney, author of the new book, "The Republican War on Science" (ISBN 0465046754) wrote recently, "Whether companies can sue agencies that reject their 'data quality' complaints, thereby dragging individual studies into the courtroom, is the legal question at the core of the Salt Institute and Chamber of Commerce lawsuit. If the judge in the case writes a precedent-setting opinion, and if higher courts agree, a brand-new body of law could emerge, consisting largely of corporate lawsuits against scientific analyses."[5]

Ultimately the purpose of all these tactics is to paralyze government regulators by manufacturing uncertainty and doubt. Writing recently in Scientific American, David Michaels observes that, "Emphasizing uncertainty on behalf of big business has become a big business in itself."[6] Michaels told a Texas reporter, "corporations and others who manufacture dangerous products and pollutants have realized that by adding manufactured uncertainty to the equation, they can essentially stop the regulatory process from moving forward."[7]

Michaels was assistant secretary for environment, safety and health in the U.S. Department of Energy (DOE) during the Clinton Administration. In his Scientific American article, titled, "Doubt is Their Product," Michaels describes how the DOE tightened regulations 10-fold to protect federal nuclear workers from exposure to the highly toxic metal, beryllium. And he describes how, in 1998, the Occupational Safety and Health Administration (OSHA) -- the agency charged with protecting the health and safety of private-sector workers -- declared its intention to adopt the new, stricter standard. But three years later OSHA abandoned its effort to enact stricter beryllium regulations

Michaels describes the OSHA problem this way:

"Out of the almost 3,000 chemicals produced in large quantities (more than one million pounds annually), OSHA enforces exposure limits for fewer than 500. In the past 10 years the agency has issued new standards for a grand total of two chemicals; the vast majority of the others are still 'regulated' by voluntary standards set before 1971, when the newly created agency adopted them uncritically and unchanged. New science has had no impact on them. I conclude that successive OSHA administrators have simply recognized that establishing new standards is so time- and labor-intensive, and will inevitably call forth such orchestrated opposition from industry, that it is not worth expending the agency's limited resources on the effort."[6]

In other words, corporations have now succeeded in getting themselves "regulated" by a set of laws and rules that effectively paralyze government regulators. Regulation of chemicals has effectively ended. The regulatory system now regulates not industry but environmentalists, in the sense that it narrowly defines and restricts the responses that they can make to corporate harms. By channeling environmentalist responses into industry-defined activities, the regulatory system makes environmentalists entirely predictable and therefore manageable.

But all is not lost. Industry's strategy for ending government regulation has an Achilles' heel. The whole strategy rests on the assumption that, when the science is uncertain, we should proceed with "business as usual" until harm can be proven to a scientific certainty. The precautionary principle turns this assumption on its head, saying, "When the science is uncertain, but there is evidence of harm, we have a duty to take precautionary action to prevent harm." If the precautionary principle were adopted, industry's elaborate strategy for paralyzing government would crumble.

Could this be why the chemical industry and the Bush administration have mounted a coordinated campaign to discredit, demonize, and derail the precautionary principle? You think?

Writing the precautionary principle into local laws -- and perhaps more importantly into corporate charters -- would fundamentally change the balance of power between people and money. What a worthy fight this is!

[To keep abreast of developments with the precautionary principle, start your own free subscription to our new Rachel's Precaution Reporter by sending a blank E-mail to join-rpr-html@gselist.org. In response, you will receive an E-mail asking you to confirm that you want to subscribe.]

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[1] Andrew Schneider, "EPA warning on asbestos is under attack," St. Louis (Mo.) Post Dispatch Oct. 26, 2003. [CHECK DATE]

[2] Adrianne Appel, "Federal 'Junk Science' Rule Draws Fire," Boston Globe Dec. 23, 2003, pg. C4.

[3] Andrew C. Revkin, "Law Revises Standards for Scientific Study," New York Times March 21, 2002.

[4] Jocelyn Kaiser, "How Much Are Human Lives and Health Worth?" Science Vol. 299 (March 21, 2003), pgs. 1836-1837.

[5] Chris Mooney, "Op-Ed: Interrogations," New York Times August 31, 2005.

[6] David Michaels, "Doubt is Their Product," Scientific American Vol. 292, No. 6 (June 1, 2005), pgs. 96-101.

[7] Jeff Nesmith, "New product for U.S. industry: 'manufactured doubt'," Austin (Tex.) Statesman June 26, 2005.

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