Rachel's Environment & Health News

August 18, 2005

ENDING REGULATION BY MANUFACTURING DOUBT, PT. 1

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 #654, #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]

[To be continued.]

======================

[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.