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.