"Data Quality" Law Is Nemesis Of Regulation
 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 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 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 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 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 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 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 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