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'Data Quality' Law Is Nemesis Of Regulation

"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.

Scientist Tyrone B. Hayes found that even very small amounts of atrazine had a "demasculinizing" effect on tadpoles. (University Of California At Berkeley)

_____Assailing EPA Science_____
Timeline: Recommended study of effects on humans of weedkiller atrazine -- which is thought to scramble hormones in frogs and cause cancer in rats -- is held up by regulatory process.
Data Quality Act
_____More From Series_____
Bush Forces a Shift In Regulatory Thrust (The Washington Post, Aug 15, 2004)
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About This Series


An Agency Takes a Turn

Under President Bush, the Occupational Safety and Health Administration has made sometimes subtle changes in regulations that carry large consequences for workers and employers. Across the government, the Bush administration has started fewer regulations and killed more of the proposals Bush inherited than two predecessors.


A Policy Puts Science on Trial

A last-minute addition to an unrelated piece of legislation has created a tool for attacking the science used by federal agencies as a basis for new regulations. Industry has embraced the Data Quality Act to challenge 32 major proposals, including a successful assault on efforts to restrict the use of the herbicide atrazine.


A Word Accelerates Mountaintop Mining

By changing the word "waste" to "fill" in a regulation covering coal mining, Bush appointees have allowed an increase in the destruction of mountaintops in Appalachia.

_____Regulations on the Web_____
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The Federal Register lists new rules and proposals daily.
The General Accounting Office offers cost-benefit analyses of major rules.
OMB Watch is a public interest group that monitors the Office of Management and Budget.
The Mercatus Center at George Mason University provides conservative analysis of rules.
Regulation.org is the conservative Heritage Foundation's rules site.
The AEI-Brookings Joint Center for Regulatory Studies offers scholary rules analysis, including its $100 Million Club.
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"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 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 report.

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