Washington Post
August 16, 2004

'Data Quality' Law Is Nemesis Of Regulation

[RPR comment: When the burden of proof is on the public to prove harm
before an activity can be questioned (much less curbed), sowing doubt
is an easy way to maintain the status quo.  Doubt provides a green
light for just about anything.

This issue of RPR offers four ways of looking at the manufacture of
doubt.  A small industry has grown up to manufacture doubt and
uncertainty, as a way of preventing government regulation.

The Precautionary Principle reverses the burden of proof, so doubt and
uncertainty provide a yellow light or even a red light until more
information is made available.  Precaution puts the burden on industry
to provide information about its products and its processes.  As they
are fond of saying in Europe, "No data, no market."]

By Rick Weiss

Second of three articles

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 restrictions.

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 year.

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

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

** 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

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 science.

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

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 year.

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 dismiss. 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 professor.

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

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 said.
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

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 rare.

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

"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 regulation.

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

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 Institute. 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

"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 environment."

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 challenge.

'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 studies.

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 Syngenta." 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

"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

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 out."

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 surprising.

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

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