Washington Post
August 26, 2004


By Rick Weiss

Things were not looking good a few years ago for the makers of
atrazine, America's second-leading weedkiller. The company was
seeking approval from the Environmental Protection Agency to
keep the highly profitable product on the market. But
scientists were finding it was disrupting hormones in wildlife
-- in some cases turning frogs into bizarre creatures bearing
both male and female sex organs.

Last October, concerns about the herbicide led the European
Union to ban atrazine, starting in 2005. Yet that same month,
after 10 years of contentious scientific review, the EPA
decided to permit ongoing use in the United States with no new

Herbicide approvals are complicated, and there is no one reason
that atrazine passed regulatory muster in this country. But
close observers give significant credit to a single sentence
that was added to the EPA's final scientific assessment last

Hormone disruption, it read, cannot be considered a "legitimate
regulatory endpoint at this time" -- that is, it is not an
acceptable reason to restrict a chemical's use -- because the
government had not settled on an officially accepted test for
measuring such disruption.

Those words, which effectively rendered moot hundreds of pages
of scientific evidence, were adopted by the EPA as a result of
a petition filed by a Washington consultant working with
atrazine's primary manufacturer, Syngenta Crop Protection. The
petition was filed under the Data Quality Act, a little-known
piece of legislation that, under President Bush's Office of
Management and Budget, has become a potent tool for companies
seeking to beat back regulation.

The Data Quality Act -- written by an industry lobbyist and
slipped into a giant appropriations bill in 2000 without
congressional discussion or debate -- is just two sentences
directing the OMB to ensure that all information disseminated
by the federal government is reliable. But the Bush
administration's interpretation of those two sentences could
tip the balance in regulatory disputes that weigh the interests
of consumers and businesses.

John D. Graham, administrator of the OMB Office of Information
and Regulatory Affairs (OIRA), who has directed implementation
of the Data Quality Act, said the law will keep the federal
government hewing to "sound science." He said the act, which
allows people and companies to challenge government information
they believe is inaccurate, is equally accessible to "a wide
diversity of interests, both in the business community and in
the consumer, environmental and conservation communities."

But many consumers, conservationists and worker advocates say
the act is inherently biased in favor of industry. By demanding
that government use only data that have achieved a rare level
of certainty, these critics maintain, the act dismisses
scientific information that in the past would have triggered
tighter regulation.

A Washington Post analysis of government records indicates that
in the first 20 months since the act was fully implemented, it
has been used predominantly by industry. Setting aside the many
Data Quality Act petitions filed to correct narrow
typographical or factual errors in government publications or
Web sites, the analysis found 39 petitions with potentially
broad economic, policy or regulatory impact. Of those, 32 were
filed by regulated industries, business or trade organizations
or their lobbyists. Seven were filed by environmental or
citizen groups. Some environmental groups are boycotting the
act, adding to the imbalance in its use.

Among the petitions:

** The American Chemistry Council and others challenged data
used by the Consumer Product Safety Commission (CPSC) as it
sought to ban wood treated with heavy metals and arsenic in
playground equipment.

** Logging groups challenged Forest Service calculations used to
justify restrictions on timber harvests.

** Sugar interests challenged the Agriculture Department and the
Food and Drug Administration over dietary recommendations to
limit sugar intake.

** The Salt Institute and the U.S. Chamber of Commerce
challenged data that led the National Institutes of Health to
recommend that people cut back on salt.

** The Nickel Development Institute and other nickel interests
challenged a government report on the hazards of that metal.

** The Association of Home Appliance Manufacturers petitioned
the CPSC to retract data that ranked the risk of lint fires in
various clothes dryers.

Environmental and consumer groups say the Data Quality Act fits
into a larger Bush administration agenda. In the past six
months, more than 4,000 scientists, including dozens of Nobel
laureates and 11 winners of the National Medal of Science, have
signed statements accusing the administration of politicizing

The White House's heavy editing of a key global-warming report,
its efforts to emphasize abstinence rather than condoms in the
war against AIDS and its alleged stacking of scientific
advisory committees have drawn particular ire. But many
scientists and public advocates believe that far more is at
stake with the Data Quality Act.

From their perspective, the act is shifting the authority over
the nation's science into the politicized environment of the
OMB -- a change, they say, that will favor big business.

"It's a tool to clobber every effort to regulate," said Rena
Steinzor, a professor of law and director of the Environmental
Law Clinic at the University of Maryland. "In my view, it
amounts to censorship and harassment."

That's a view that Christopher C. Horner of the free-market
Competitive Enterprise Institute -- which has used the act
repeatedly to challenge scientific information -- brushed off
as "whiny."

"Hey, you're making me be accurate," he mocked. "I have no
sympathy for that."

Horner said the act, if anything, has proved less useful than
anticipated to groups such as his that seek to minimize
government regulation. And figures from the OMB confirm that
agencies have in many cases resisted challenges to their
scientific findings.

Of the 39 Data Quality Act petitions in The Post's analysis,
five have resulted in at least some of the changes sought --
all of them filed by industry interests. Five were denied, five
were diverted by the agencies to other bureaucratic avenues,
and 24 are pending.

Yet there are signs, Graham acknowledged, that petitioners are
becoming more innovative in their use of the act. And
petitioners are homing in on agencies whose mission is to
protect the environment and public health. The most heavily
petitioned are the Environmental Protection Agency, the Fish
and Wildlife Service, the National Institutes of Health, and
the Consumer Product Safety Commission.

Studying Atrazine

Nearly 80 million pounds of atrazine are sprayed on tens of
millions of U.S. acres every year, mostly on corn. It is,
according to the EPA, the most prevalent herbicide in ground
and surface water, remaining stable and toxic for decades in
some environments.

It is also a major source of revenue for Syngenta, a Swiss
company with U.S. headquarters in Greensboro, N.C., that sells
hundreds of millions of dollars' worth of the chemical every

It has been nearly five decades since atrazine was first
"registered" -- meaning it was approved for use under certain
conditions. Over the years, as more was learned about the
chemical's potential toxicity to wildlife and humans, it came
under increasing federal scrutiny and regulatory restriction.
The number of pounds that farmers can legally apply per acre
has progressively been reduced, and users have been required to
keep the chemical farther and farther away from wells, lakes
and reservoirs.

For decades, the main concern was cancer. The chemical clearly
causes cancer in rats, and male workers in Syngenta's
production facility in Louisiana have experienced much higher
rates of prostate cancer than other men statewide. But studies
supported by Syngenta recently convinced the EPA that the
mechanism by which atrazine causes cancer in rats probably does
not occur in people. (The company said the only reason for the
high rate of prostate cancer in its workers is that it has an
aggressive screening program that finds cases that would
otherwise go undetected.) Studies are ongoing, but the EPA has
for now backed off atrazine's cancer threat.

Hermaphrodite frogs, however, have been more difficult to

For years, evidence has accumulated suggesting that atrazine
may scramble hormones in frogs and other animals. The European
Union has officially declared the chemical an endocrine
disrupter. Given those concerns, Syngenta's predecessor company
-- Novartis Agribusiness -- decided early in the EPA's review
not to leave the question up to government scientists. In 1998,
it hired a private risk-assessment service, EcoRisk Inc. of
Ferndale, Wash., to arrange experiments on atrazine's
environmental impacts.

EcoRisk, whose past clients include the Chlorine Chemistry
Council, Dow Chemical and Ciba-Geigy Corp., in turn hired
Tyrone B. Hayes, a professor of integrative biology and an
expert in frog development at the University of California at
Berkeley. Hayes holds a biology degree from Harvard and a
doctorate in amphibian development from Berkeley, where he was
tenured at age 30 and became the university's youngest full

As part of a team of scientists assembled by EcoRisk, Hayes
tested the effects of atrazine on tadpoles of African clawed
frogs, a popular "lab rat" species for scientists. Male
tadpoles raised with no atrazine in the water developed
normally. But those exposed to atrazine were "demasculinized."
They had smaller larynxes (voice boxes), their testosterone
levels were one-tenth of normal levels, and many grew up as
hermaphrodites, with a mix of male and female traits. Moreover,
the effects appeared with very small exposures -- just 0.1
parts per billion, or the equivalent of one drop of atrazine in
5,000 40-gallon barrels of water. That's one-thirtieth the
level currently allowed in U.S. drinking water.

When Hayes sought to publish his work and have the data
considered by the EPA, the company told him to run the tests
again, said Hayes and Tim Pastoor, a Syngenta vice president.
When repeated studies confirmed the worrisome link, Hayes was
reminded that his contract forbade him to publish without
Syngenta's approval. He was told that his data ought to be
passed to a company-selected statistician for double-checking.

Hayes quit EcoRisk and repeated his experiments on his own,
expanding his work to include other frog species. In one
follow-up study of 200 leopard frogs caught in the wild, he
found that 100 percent of males in areas that had been treated
with atrazine had abnormal sex organs. No such problems were
seen in frogs from untreated regions. He published his results
in two prestigious journals, Nature in 2002 and the Proceedings
of the National Academy of Sciences in 2003. That ensured the
EPA would consider his findings.

"We showed that these animals are chemically castrated," Hayes

Ernest Smith, a developmental biologist at Texas Tech
University in Lubbock and a member of the EcoRisk team, denied
that EcoRisk or Syngenta tried to bury Hayes's results.

"I think there were some communications breakdowns," he said.

Smith noted that studies conducted by the other team members
had contradicted Hayes's data. Some showed health effects only
at higher atrazine doses, while others found no effect at all.

A special EPA science panel would eventually level stinging
criticisms at those studies for their poor design and sloppy
implementation. Still, the conflicting results left the
atrazine question at a standoff. That is when the company
turned to the Data Quality Act -- and Jim J. Tozzi.

'Working the Regulatory Process'

Syngenta could not have found a better advocate. Tozzi wrote
the Data Quality Act and arranged for its congressional passage
after the 2000 elections.

Today he is a Washington lobbyist and head of the Center for
Regulatory Effectiveness, a watchdog group that specializes in
data quality. Tozzi does not reveal his center's contributors,
and the atrazine petition he filed does not have Syngenta's
name on it. The petition names only the Kansas Corn Growers
Association and the Triazine Network, a coalition formed in
1995 to defend atrazine and related herbicides. But Pastoor,
Syngenta's head of human safety, said the company helped
finance the petition process through contributions to another
of Tozzi's businesses, a lobbying firm called Multinational
Business Services.

Tozzi is "the master craftsman when it comes to working the
regulatory process," said Ken Cook of the Washington-based
Environmental Working Group. "He knows where the sensitive
spots are and where to press and leave no fingerprints."

Once a self-described "bottom-tier" musician on the steamy New
Orleans jazz circuit, Tozzi earned a degree in economics and
rose to OMB deputy administrator under Ronald Reagan. Under his
directorship, the OMB's Office of Information and Regulatory
Affairs was the gatekeeper for virtually all proposed
regulations dealing with public health and safety. It quickly
became known as a bureaucratic "black hole," where proposed
regulations went in for review and never came out, said Joan
Claybrook, president of Public Citizen, a Washington-based
consumer advocacy group.

Tozzi was at the OMB when evidence arose in the 1980s that
giving aspirin to children with flu symptoms increased the risk
of Reye's syndrome, a potentially fatal complication. A federal
health agency recommended that aspirin containers bear
warnings, but Tozzi said he was not satisfied the evidence was
good enough. It took years for activists and Congress to force
the labeling issue -- years in which almost 200 children died
of Reye's. Today, with labeling, the syndrome is extremely

After leaving the government, Tozzi helped Philip Morris fight
mounting evidence of the dangers of secondhand cigarette smoke.
That is when he pioneered the tactic of attacking the science
behind proposed regulations.

"The argument that it costs too much to protect people does not
sell," said Thomas O. McGarity, a professor at the University
of Texas Law School in Austin and president of the
Washington-based Center for Progressive Regulation, a network
of academics that supports regulatory action to protect health,
safety and the environment. "But what does sell is this idea
that the science is not good."

Science is ever evolving and often hobbled by uncertainty, but
policymakers have long recognized this and relied on
weight-of-evidence arguments in making regulations, according
to McGarity, other activists and Clinton administration
officials. They point out that DDT was banned despite lingering
doubts about its role in the decline of birds. Many other
substances, including vinyl chloride and asbestos, also were
regulated before their full effects were known.

Tozzi, believing that the regulatory bar was too low, tried
repeatedly to get Congress to pass legislation that would make
it easier to challenge the science used to underpin
regulations. Then, unable to receive broad congressional
support, he crafted legislative language himself and gave it to
Rep. Jo Ann Emerson (R-Mo.), a former lobbyist and onetime
deputy director of communications for the National Republican
Congressional Committee. The wording -- two sentences of 32
short lines -- directed the OMB to issue guidelines "ensuring
and maximizing the quality, objectivity, utility, and integrity
of information... disseminated by Federal agencies."

Emerson slipped the sentences into the 712-page Treasury and
General Government Appropriations Act, which became the coming
year's omnibus spending bill. Under pressure to wrap up the
long-delayed budget, President Bill Clinton signed the huge
bill on Dec. 21, 2000, nine days after the Supreme Court ruled
that George W. Bush was to be the next president. It is not
clear whether anyone in Congress other than Emerson and Sen.
Richard C. Shelby (R-Ala.) knew about the buried language.

"We sandwiched this in between Jerry Ford's library and
something else," Tozzi said. "Was it something that did not
have hearings? Yes. Is it something that keeps me awake at
night? No. Is it something that I would do again, exactly? Yes,
you bet your ass I would. I would not even think about it,
okay? Sometimes you get the monkey, and sometimes the monkey
gets you."

Tozzi found even more reason to rejoice as Bush made a pivotal
appointment to head the OIRA, Tozzi's old domain within OMB
that would now handle data quality: John Graham, a
risk-assessment specialist with a history of close ties to
regulated industries.

"John Graham came in, and he did an unbelievable job," Tozzi
said. "Better than I could have done had I been there myself."

Politicizing the Process

Graham had been the head of Harvard's Center for Risk Analysis,
an institution funded primarily by contributions from more than
100 industry and trade association donors. While there, he had
amassed a reputation as a skilled critic of the cost of

In one analysis, conducted with funding from the auto industry,
he concluded that it would be a mistake to require side air
bags in cars because they would cost $400,000 for every year of
life saved. Independent experts reviewing his work found that
the figure was actually about $60,000, and Graham had to
rewrite his article -- and change his conclusion -- before it
could be published in a prestigious medical journal.

When Bush nominated Graham to head the OIRA, many citizen and
environmental groups vehemently objected and more than
one-third of the Senate voted no. In his first few months,
Graham sent many near-final regulations back to the agencies
that had proposed them, often saying he was not convinced they
were worth the cost.

Then he turned to the job of implementing the Data Quality Act.

By the fall of 2001, Graham's office had published detailed
guidelines for implementing the act. A year later, federal
agencies started accepting petitions requesting that they
withdraw information that allegedly did not meet OMB standards
for "quality, objectivity, utility, and integrity."

Individual agencies are responsible for reviewing the
challenged data and deciding whether they are indeed reliable.
But the OMB, a part of the White House, oversees the process
closely -- through involvement in the agencies' deliberations
and by demanding annual reports describing how agencies dealt
with each petition.

OMB staff members have been providing "extensive assistance to
agencies in preparing responses to correction requests," Graham
acknowledged. "OMB oversight is critical to make sure that
agencies handle these requests in a diligent and consistent
manner," he said.

Graham said the OMB's unprecedented foray into science is
justified in part because the data in question often serve as a
foundation for costly regulation, which the OMB oversees. To
fulfill the new role, Graham hired the OMB's first nine career
scientists, including six with PhDs.

The Data Quality Act, or at least something like it, "was
absolutely needed," said Horner of the Competitive Enterprise

Yet Steinzor, the Maryland environmental lawyer, and other
critics complain that the OMB's involvement politicizes the
process. The expertise of the handful of scientists hired by
Graham, they say, cannot match that of the thousands of experts
on agency staffs.

And while Graham said the OMB still supports
weight-of-the-evidence analyses, Steinzor and others contend
that the Data Quality Act inherently focuses on individual
snippets of data -- each of which is inevitably open to
criticism -- instead of on overarching bodies of evidence.

"You can get lost in the minutiae, and that's exactly where
they want you to go," Steinzor said. "They just pick, pick,
pick, until you're so addled you can't protect people or the

A Tool for Decreasing Regulation

A few environmental and public interest groups have tried to
use the Data Quality Act. Public Employees for Environmental
Responsibility, a Washington-based group that helps federal
scientists who believe their data are being suppressed, has
filed three petitions under the act.

One challenged the credibility of a Defense Department document
supporting a proposed Army Corps of Engineers project; one
contended that the Fish and Wildlife Service had made selective
use of data to conclude that hunters should be allowed to shoot
rare trumpeter swans; and one charged that Fish and Wildlife
had used unsound science to develop "an inadequate recovery
plan" for the Florida panther.

"I'm not sure it is the sharpest tool in the environmental
toolbox, but at least it is a tool," said executive director
Jeff Ruch, adding that the swan petition lost and the other two
are still under review.

Many citizen groups and environmental activists believe the
Data Quality Act will always be more useful to those seeking to
decrease government regulation. Newly proposed regulations must
be justified with evidence, they note, and the act is designed
specifically to challenge such evidence.

"What it really can do best is slow the regulatory process,"
said Sean Moulton, a senior policy analyst with OMB Watch, a
government watchdog group. "And even a simple delay of a rule
can mean a huge financial windfall for an industry."

In the first 20 months, a handful of petitions -- all from
industry -- have been at least partly successful. In one, the
Competitive Enterprise Institute had wording added to a
multi-agency federal climate change report stating that the
report's findings did not meet Data Quality Act standards.

In another, a law firm with corporate clients in asbestos
litigation got the EPA to agree to make changes in its booklet
that offers warnings and safety advice to brake mechanics.

Yet another, filed by a group that receives funding from the
conservative Scaife Foundation, succeeded in getting the
National Institutes of Health to downgrade warnings about the
effects of smokeless tobacco. And then there was the atrazine

'Manufacturing Uncertainty'

That petition, filed by Tozzi, made a two-pronged attack on the
effort to regulate atrazine more stringently. The first was to
claim that the evidence for atrazine's gender-bending effects
in frogs was not fully reproduced by other Syngenta-funded
EcoRisk scientists. The second was to claim that the EPA did
not have the proper test to prove atrazine had ill effects.

Tozzi said reliance on irreproducible results would violate the
Data Quality Act because information that is not reproducible
is "not accurate, reliable or useful."

As evidence of irreproducibility, he pointed to the dozen or so
studies sponsored by Syngenta in addition to Hayes's study. An
independent panel of experts convened by the EPA had already
expressed exasperation over the conflicting results and
mistakes they found in the design and implementation of those

In at least two of the studies the "control" frogs that were
supposed to be atrazine-free were later found to have been in
water contaminated with atrazine, an error the scientists said
was unintentional. Another set of Syngenta studies was found to
be unreliable because 80 to 90 percent of the animals died,
apparently as a result of inadequate care.

Essentially what Syngenta-funded scientists did "was produce a
number of studies that were purposefully flawed and misleading,
and that changed the weight of the evidence," Hayes said.

While the EPA review also found some flaws in Hayes's studies,
his conclusions have been echoed by at least four other
independent research teams in three countries.

"What a coincidence that everybody can find an effect of
atrazine on gonads," Hayes said, "except [those] funded by

David Michaels, a professor of occupational and environmental
health at George Washington University School of Public Health
and Health Services, said even a good study will appear "not
reproducible" if enough bad studies are thrown into the mix.

"I call this 'manufacturing uncertainty," and there is a whole
industry to do this," said Michaels, who was the Energy
Department's assistant secretary for environment, safety and
health under Clinton. "They reanalyze the data to make
[previously firm] conclusions disappear -- poof. Then they say
one study says yes and the other says no, so we're nowhere."

Pastoor of Syngenta said there was no conspiracy to create
conflicting data.

"I don't think it's extending things too far to say atrazine
may be one of the best studied chemicals on the face of the
earth," he said. "Unfortunately -- or fortunately, depending on
how you look at it," other EcoRisk team members "could not
replicate what Tyrone had done."

But Hayes was not the only team member who at least privately
agreed that atrazine was having some effect on frogs. Team
member James Carr of Texas Tech told Hayes in an e-mail in
February 2003: "I agree with you that the important issue is
for everyone involved to come to grips with (and stop
minimizing) the fact that independent laboratories have
demonstrated an effect of atrazine on gonadal differentiation
in frogs. There is no denying this."

The second prong of Tozzi's attack was that the EPA had not
designated tests that would serve as the gold standard of proof
of hormone disruption in frogs.

The EPA does have certain "guideline tests" that can
automatically trigger regulation, including some that measure
certain health effects of chemicals on wildlife. But not for
hormone disruption.

Jennifer Sass, a scientist with the Natural Resources Defense
Council, said Tozzi's position flies in the face of decades of
regulatory science. She said the evidence on atrazine's effects
was more than convincing by traditional standards. The act, she
said, has "hamstrung EPA's ability to express anything that it
couldn't back up with a mountain of data. It basically blocked
EPA scientists from expressing an expert opinion."

Hayes said he supports efforts at the EPA to create a gold
standard test. However, he said, "when we discover a pattern
like this, we know we have a problem. Yes, we should work to
validate it perfectly. But in the meantime, let's not keep
using 80 million pounds of atrazine per year while we figure it

Avoiding Tighter Restrictions

The EPA ultimately agreed with Tozzi that the lack of such a
test prevented it from regulating atrazine as a hormone
disruptor -- a concession many environmentalists found

No one claims that Syngenta's Data Quality Act petition was
single-handedly responsible for giving atrazine's renewed
approval the green light. But coming at the end of an arduous
10-year review, the data quality challenge was "the final
one-two-three punch," said Sass of the NRDC, which has sued the
EPA repeatedly on atrazine.

She and others said that once the EPA conceded that it could
not regulate atrazine as a hormone disrupter, Syngenta was free
to reach the regulatory finish line.

In closed meetings -- details of which the EPA has declined to
release -- company representatives and EPA officials worked out
a plan to avoid tighter restrictions. Instead, the plan calls
for Syngenta to track atrazine levels in 40 U.S. watersheds
over the next three years to see how farmers are doing in their
efforts to minimize contamination. If concentrations rise above
a level that the company agrees is "of concern," then the
company will work with the farmers to try to reduce the levels.

The company will also fund more studies on frogs and reanalyze
its data on employee cancers.

The resolution, Sass said, was "basically negotiated instead of
going with a scientific rationale."

Asked why other stakeholders, such as environmental groups or
outside scientists, were not allowed to be part of the
negotiations as they were in earlier stages of atrazine's
review, James Jones, director of the EPA's office of pesticide
programs, said opening the meetings "would be incredibly
complicated and would create a disincentive for the company to
come to the table."

Exempting Atrazine

In June, Tozzi filed his latest Data Quality Act petition.

This time it was directed at the National Toxicology Program.
That is a part of the National Institutes of Health that
reviews chemicals to see if they cause cancer.

The program had announced in the Federal Register that atrazine
was among a long list of chemicals that it was considering for
examination. In his petition, Tozzi seized on a few sentences
from the program's description of its chemical review
procedures. He claimed that those sentences contained
discrepancies that violated the Data Quality Act.

Therefore, he wrote, the program should be barred from
reviewing the cancer-causing potential of any chemicals. In
particular, the petition noted, atrazine.

Researchers Lucy Shackelford and Julie Tate contributed to this

2004 The Washington Post Company