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'Data Quality' Law Is Nemesis Of Regulation

"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."

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_____
Government Printing Office provides the text of rules.
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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"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 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 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.

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