Proposed EPA rules on human testing come under attack

Document aims to protect subjects used in studies

August 11, 2005|By Andrew Schneider | Andrew Schneider,SUN NATIONAL STAFF

WASHINGTON - New rules drafted by the Environmental Protection Agency to protect human subjects of scientific tests came under harsh criticism yesterday from environmental groups, government scientists and members of Congress, who called the proposal misleading, dangerous and industry-friendly.

The 76-page draft, obtained by The Sun, was hurried to completion this month after Congress denounced this summer standards for EPA-related tests and noted health risks and ethical lapses in tests performed by the pesticide industry.

An introduction to the document promises more stringent rules, including tighter controls on human studies, the creation of an independent panel to evaluate the ethics of proposed studies, and protections preventing pregnant women and children from being used as test subjects.

EPA press secretary Eryn Witcher said she could not comment on specific criticism of the proposed rules because they are being reviewed. But she called the proposal "landmark regulation that will extend very rigorous protections."

The language of the rules falls short of those promises, according to EPA toxicologists, health experts and lawyers at the agency's headquarters and at its regional offices.

"This is a very important ethical, scientific and clinical issue, and they are going to try to fool the American public about its intent," said an EPA toxicologist who requested anonymity for fear of retribution. "It's a magician's trick."

Richard Wiles, senior vice president of the Environmental Working Group, which for decades has fought for better pesticide controls, said the rules "will give the pesticide industry essentially all the power."

The proposed rules are "so full of loopholes that almost any conceivable study would be allowed, and this may lead to an increase in pesticide levels in our food and concomitant damage to health and environment," said Dr. Alan Lockwood, a neurologist who serves with Physicians for Social Responsibility.

`Slap in the face'

The proposals were described by an environmentalist as a "slap in the face" to Congress, which had faulted the agency for moving forward on an earlier draft that legislators considered seriously flawed.

"Then EPA goes ahead and submits the same thing to the White House for approval," said Eric Olson, senior attorney for the National Resources Defense Council, which has worked closely with Congress on human testing issues. "It's clearly a violation of Congress' direct prohibition on all testing of pregnant women, infants and children."

Congress reviewed 22 EPA-related human studies conducted by the pesticide companies and found that test subjects didn't know what they were being exposed to and, in many cases, had no idea why the testing was being done.

They also found no evidence in many of those cases that the testing followed accepted international ethical standards.

Florida study

Congress' concern over EPA's pesticide program was piqued this year when it learned about an agency project that, using $2 million from the chemical industry, would have measured the pesticide consumption of infants in low-income households in Florida.

EPA would have paid the parents every time they sprayed pesticides. Children in the program were to be given teething rings and slices of cheese because researchers knew the youngsters would drop them, then place them in their mouths. In addition, the project was to have given parents about $1,000 and video equipment to monitor and record their children's activities.

The program was canceled after it surfaced during the confirmation hearings of EPA Administrator Stephen L. Johnson.

Concerns about human testing standards for EPA-related projects forged unusual agreement recently among Democrats and Republicans. Last month, the Senate approved legislation, 60-37, halting the agency's human testing projects and demanding that it issue detailed rules within 180 days.

`Flawed approach'

Late yesterday, Sen. Barbara Boxer, a California Democrat, wrote EPA Administrator Johnson, demanding changes, saying the proposal failed to address congressional concerns.

She urged Johnson to "abandon its flawed approach prior to proposing the rule.

"This 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," said the senator, who, with members of the House, have been fighting EPA on the issue.

California Rep. Henry Waxman yesterday called the proposal "deeply flawed" and said it "would allow unethical pesticide experiments on humans.

"Some of the industry experiments violate our most basic values, and EPA should stop looking to exploit loopholes and spend its time complying with the important ethical principles that govern human research," he said.

Review process

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