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KEYCODE BAYER #199

July 28, 2005

Bayer, Dow, Cheminova: Congress Blocks EPA on Pesticide Testing

WASHINGTON -- Congress is blocking the Environmental Protection Agency from relying on tests that expose pregnant women, infants and children to pesticides when the agency considers permits for pest killers.

Environmentalists and the pesticide industry claimed victory on the measure. It was a compromise from versions passed last month by the House and Senate that would have banned the EPA's use of all data from human pesticide testing for a year.

The language is attached to a final compromise bill funding the Interior Department and the EPA for the budget year beginning Oct. 1. The House passed the spending measure Thursday by a 410-10 vote.

The pesticide issue arose after a 2003 decision by a federal appeals court in Washington that sided with pesticide manufacturers. The decision forced the EPA to lift a freeze in place since 1998. The agency has accepted data, on a case-by-case basis, from tests on human subjects as it worked on regulations for future testing.

A draft of the rules envisions permitting the EPA to accept data from studies measuring the effects of pesticide exposure on children, pregnant women, newborns, infants and fetuses. In practice, these tests involve exposure to pesticides that occurs only as a matter of course. Even so, the proposed rules would permit additional exposure to these vulnerable groups, though not at levels that could prove toxic.

Environmentalists worry that deliberate pesticide exposure could lead to medical problems later on.

Over protests from the pesticide industry, Rep. Hilda Solis, D-Calif., and Sen. Barbara Boxer, D-Calif., succeeded in attaching to the spending bill a one-year freeze on testing.

The final language bans the EPA from using results from human testing -- including data from 22 older tests -- until the agency comes out with the new rules. That would happen no later than six months after Bush signs the bill.

"Congress shares our commitment to good science and supports our efforts to expedite the first-ever EPA rule addressing the scientific and ethical issues in ... human studies," EPA spokeswoman Eryn Witcher said.

In addition to the ban, Congress is instructing the EPA to set up an independent board to review testing on human subjects. Also, regulators are to follow the guidelines of the National Academy of Sciences and international standards adopted in the wake of the war crimes trials of Nazi doctors.

The early EPA draft rule rejected suggestions that an independent review board serve as a watchdog on human testing.

"I can't think of any recent examples where before EPA even puts out a rule, because something leaks out that's so bad that Congress adopts a statute that tells them what they can put in the rule," said Erik Olsen, an attorney with the Natural Resources Defense Council. The testing provision is a rare victory for liberal Democrats in the GOP-dominated Congress. Boxer and Solis had the backing of a coalition of religious groups that lobbied hard on the issue.

The top trade association representing the pesticide industry welcomed the developments. "We're relieved, clearly see it as an opportunity to move forward, resolve the issue by way of EPA being directed to issue the final rule and clearly see it as recognition by Congress that (human testing) is an important tool of science," said Jay Vroom, president and chief executive of CropLife America, the pesticide industry's trade association. He said that "none of the companies that we represent have done that kind of testing."

Boxer and Sen. Bill Nelson, D-Fla., had held up the confirmation of EPA Administrator Stephen Johnson until he promised to cancel a pesticide study on infants in Florida. Over the study's two years, the EPA had planned to give $970 plus a camcorder and children's clothes to each of the families of 60 children in Duval County, Fla., in what critics of the study noted was a low-income, minority neighborhood.
By ANDREW TAYLOR

Congress Curbs EPA Use of Pesticide-Experiment Data

By Juliet Eilperin, Washington Post

Lawmakers agreed late Tuesday to bar the Environmental Protection Agency from using data from experiments that expose human subjects to toxic chemicals until the agency establishes a new standard for evaluating pesticides based on such tests.

Environmentalists and industry officials both declared victory yesterday, saying the provision added to next year's Interior Department spending bill would encourage the Bush administration to devise a better policy for handling information culled from human testing.

The House and Senate earlier adopted language imposing a one-year moratorium on the use of human testing data, though the Senate also passed language allowing EPA to use the data as long as the studies met certain ethical standards and their benefits outweigh the risks to volunteers.

As a compromise, negotiators agreed to bar the agency from using the data until it establishes a comprehensive scientific and ethical standard for human pesticide testing. The provision directs EPA to finish the rule within 180 days and prohibits the use of pregnant women, infants or children as subjects. The agency will have to establish an independent scientific board to review the experiments, and the tests will have to conform with international standards.

Rep. Hilda L. Solis (D-Calif.), who had pushed for a one-year ban, said in an interview that the agreement represents "a small victory for us" and that "we'll certainly be watching to see what the EPA does." As for testing on pregnant women and infants, she added: "The moral of the story is that it's not acceptable."

Pesticide manufacturers said the provision would allow them to collect data they need when submitting federal applications to market their products.

"CropLife America believes the final agreement in the bill is a clear rejection of outright bans on using pesticide data from volunteer subjects," said Jay Vroom, president of the pesticide trade association. "Our industry is ethically bound to provide regulators the information they need to determine that our products are safe and beneficial."

For years, federal officials allowed manufacturers to conduct human experiments on the grounds they provided a clearer assessment of how pesticides could affect the environment and public health. Concerned that these tests were harming volunteers, President Bill Clinton imposed a moratorium in 1998, but President Bush lifted it in his first term. EPA officials now judge human pesticide studies on a case-by-case basis.

Last month, congressional Democrats released a report showing EPA was using data from tests that exposed volunteers to several poisons, including an insecticide used for chemical warfare in World War I and a pesticide closely related to the chemical that killed thousands in Bhopal, India.

Administration officials have resisted the idea of a one-year moratorium but said they could accept the new testing provision.

"This language makes it clear that Congress shares our commitment to good science and supports our efforts to expedite the first-ever EPA rule addressing the scientific and ethical issues in considering third-party human studies," agency spokeswoman Eryn Witcher said.

Washington Post, August 11, 2005

EPA Devises Rules on the Use of Data From Pesticide Tests on Humans

Standards Would Continue to Allow Some Studies Involving Children and Pregnant Women, Critics Say

The Environmental Protection Agency is set to release the first-ever federal standards governing use of data from tests that expose human subjects to toxic pesticides, but lawmakers and some medical experts said the rules fail to adequately protect children and pregnant women.

The proposal -- which was obtained yesterday from the advocacy group Public Employees for Environmental Responsibility and will become public within weeks -- would limit the instances in which pesticide manufacturers could expose children and pregnant women to toxic chemicals, and would establish an independent board to gauge whether such human experiments meet established ethical standards. But the new rules, which will be subject to public comment before taking effect in about six months, allow some tests on vulnerable subjects and do not apply to studies conducted before the guidelines become law.

Much of the controversy centers on whether it is acceptable to expose children and pregnant women to pesticides under any circumstances. One EPA official, who asked not to be identified because the agency has not published its proposal, said the EPA wanted to let manufacturers keep the option of testing on children such products as mosquito and tick repellents to ascertain their efficacy.

For months, lawmakers have been dueling with Bush administration officials over how drastically they should curb tests that expose humans to toxic chemicals, including an insecticide used in chemical warfare during World War I. Two weeks ago, Congress prohibited the EPA from considering data culled from such experiments until the government enacts stricter national standards.

For years, federal officials allowed manufacturers to conduct human studies on the grounds that they provided a clearer picture of how pesticides could affect the environment and public health. President Bill Clinton imposed a moratorium in 1998 out of concern that such tests harmed volunteers; although President Bush initially backed the moratorium, his administration abandoned it in 2003 to satisfy a court ruling in favor of pesticide makers, which argued that the federal government had not engaged the public fully enough before banning the information. EPA officials now consider data from human experiments on a case-by-case basis when judging whether to approve pesticides.

EPA spokeswoman Eryn Witcher said the new rule is "a landmark regulation that will extend very rigorous protections to the public. . . . Our proposal bans the intentional dosing of pregnant women and children with pesticides for toxicity studies, follows the recommendations set by the nation's highest science review panel, and adheres to the highest ethical standards set for federal agencies."

However, Sen. Barbara Boxer (D-Calif.), who led the fight in the Senate to restrict pesticide testing on human volunteers, wrote a letter yesterday to EPA Administrator Stephen L. Johnson saying the proposal "fails to adequately ensure that people, including the most vulnerable among us, are protected from unethical industry tests in which human subjects swallow, inhale, are sprayed with, or are otherwise exposed to toxic pesticides."

"I am writing to you so that you are personally aware that EPA appears to be heading on a course at variance with the dictates of Congress, as well as religious groups, public health and environmental groups that supported congressional action," Boxer added. "There is still an opportunity for EPA to change course. However, if you go forward with this approach, I am also putting you on notice that I will use every means available to ensure that EPA complies with congressional direction."

Witcher said the agency will be able to comment in greater detail once the new rules are finalized, and "there will be ample opportunity for public feedback" before they take effect.

Leo Trasande, assistant director of the Mount Sinai Center for Children's Health and the Environment, said after reviewing the proposal that the agency is on "a dangerous slippery slope" that could allow pesticide makers to conduct questionable studies as long as they said they were not aimed at gauging their products' toxicity. "EPA is again failing in its duty to protect children from pesticides and other toxic exposures," he said.
CropLife America spokesman George Clarke, whose group represents the country's biggest pesticide manufacturers, said yesterday he will not comment on the EPA's plan until it is formally unveiled. (By Juliet Eilperin)

Nature 437, 24-25 (1 September 2005)

US set to endorse human pesticide testing

by Meredith Wadman

Pesticide manufacturers are pushing hard to ensure that data from toxicity tests on people can be used in licence applications for their products.
The pesticide industry is keenly awaiting an imminent US ruling. Within days, the Environmental Protection Agency (EPA) is expected to publish its proposed policy on the use of human subjects in tests to assess the safety of pesticides.
The $10-billion industry has plenty riding on the details of this regulation. It wants to use human toxicity data to help it keep at least a dozen pesticides on the market. These products must pass new safety hurdles with the EPA by next August or face being banned or restricted.

Perhaps as important, a formal EPA policy governing company-sponsored human tests would give an unprecedented government seal of approval to the controversial practice. Critics predict that this will encourage companies to conduct human toxicity tests on a wide range of some 1,200 active pesticide ingredients now on the market, with the aim of loosening their regulation.
Pesticide manufacturers say that human data are vital for fair, science-based regulation of their products. Tests on humans "provide very valuable insights into exactly what happens when humans are exposed to low levels of a compound", argues Ray McAllister, an agronomist and policy analyst at CropLife America, a Washington-based lobby group that represents the US pesticide industry. This, he says, reduces the uncertainty inherent in relying only on animal tests.
Independent scientists have backed the industry, with careful caveats. Most notably, the National Research Council in a 2004 report concluded that human test data could be used by the EPA, if strict ethical and scientific standards were met (see Nature 427, 770; 2004).

But environmental groups such as the Natural Resources Defense Council (NRDC) are scathing in their criticism of human experiments. They say that the industry wants to conduct them not for the public good, but to keep threatened products on the market. They point out that the use of human data could allow the industry to neutralize additional requirements dating from 1996 that govern the allowable levels of pesticide residues on food. Those rules set the levels ten times lower than their previous value — the human data could reverse that change for many products, experts say.

Some scientists also argue that there are few circumstances in which such studies can be ethical, and that the EPA should not accept data from them.
"Human dosing studies have failed to meet widely accepted ethical standards for the conduct of research," says Alan Lockwood, a neurologist at the University at Buffalo, New York, who has closely examined six of the company-conducted studies. "There is no assurance that any such study can be completely free of risk."

The human factor
The new EPA rule — which will remain provisional during a 90-day period of public comment — will mark a key moment in a decade-long political battle between pesticide makers and their critics. Congress joined the fray this year, when two Democrat senators blocked the nomination of Stephen Johnson as EPA administrator until he agreed to cancel a study on children.

Last month, a law came into effect that commands the EPA to finalize the rule within six months, and forbids it from considering human data in the interim. That bill was seen as something of a victory for pesticide makers, as they managed to head off a one-year moratorium sought by critics.

The current debate stems from a 1996 law that made it much harder for companies to meet EPA safety standards using animal tests alone. The Food Quality Protection Act was intended to tighten standards to protect vulnerable people such as children and babies from pesticide residues on food. But it encouraged pesticide makers to resume some human tests — which they had largely abandoned — and to resurrect data from studies dating as far back as the 1960s.

Concerned by this turn of events, the EPA launched a de facto moratorium on the use of human test data in 1998, which was formalized in 2001. The pesticide makers sued the agency and won, and since 2003, the EPA has considered human data on a case-by-case basis.

As of June this year, 24 human studies had been presented to the EPA by pesticide companies. Most have not been published, but opponents have criticized their ethics after the EPA produced them in response to demands from Congress. Some bioethicists have also criticized what they see as deficient informed-consent procedures, inadequate statistical power and financial conflicts of interest.

Several of the studies, for example, were done in Britain by Bayer, the world's largest pesticide manufacturer. In 1998 and 1999, it paid contractors to conduct three human dosing experiments using its pesticide azinphos methyl, an organophosphate that is used on 73% of US apples and more than half of US pears, cherries and blueberries. In high doses, it can lead to convulsions and death.
In a letter to one potential study participant, the pesticide was described as a "drug" that would be "administered orally". In a volunteer information sheet for another of the studies, nausea, vomiting and stomach cramps were listed as possible side effects, but weakness, respiratory failure and death were not.
Bayer declined to comment on the particulars of its studies, but in the past it has defended them as meeting international ethics requirements.

The studies have formed an important part of Bayer's pitch to save azinphos methyl from the axe under the tighter safety rules of 1996. In 2001, the EPA banned dozens of uses of the pesticide, but allowed its application to 15 crops to continue. It is those applications that the company is now fighting to retain.

Last November, in a key battle in this struggle, a dozen Bayer officials met with 15 EPA regulators at the company's request. Bayer's officials used the British studies to argue that the allowable levels for people's exposure to the pesticides' residues should be 17 times higher than they are at present. The EPA's decision is due by next August. In the meantime, anti-testing activists say that the imminent EPA rule accepting human data would make such meetings commonplace.

A leaked draft of the regulations circulated in Washington last month. It would allow the EPA to consider human data from the industry provided the tests meet current ethical standards. Earlier studies would also be admissible as long as they met the ethical standards of their day.

"If the rule stays as this draft has proposed, the floodgates will open for human testing," warns Erik Olson, a lawyer for the NRDC.

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