EPA Looking at Using Tests on People

WASHINGTON (AP) - In setting limits on chemicals in food and water, the Environmental Protection Agency may rely on industry tests that expose people to poisons and raise ethical questions.

The new policy, which the EPA is still developing, would allow Bush administration political appointees to referee any ethical disputes. Agency officials are putting the finishing touches on a plan to take a case-by-case approach.

"It says we're going to look at each study on its individual terms and accept studies unless they are fundamentally unethical or have significant deficiencies," said Bill Jordan, a senior policy adviser in EPA's Office of Pesticide Programs. "We're setting the stage for making decisions about these studies. No guarantees that we will accept the data, and no guarantees that we will reject the data, either."

He added: "The system is for each program office to look at a study, and if there's any reason for concern, to bring it to the highest levels in our agency. If we need to, we'll go to outside peer reviewers, bioethicists."

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EPA scientists and environmentalists said the two-year study, with $2 million in backing from a chemical makers' trade group, might encourage poor families to use more pesticides. Families that participated were to get $970 each plus a camcorder and children's clothes.

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E.P.A. to Bar Data From Pesticide Studies Involving Children and Pregnant Women

By MICHAEL JANOFSKY
Published: September 7, 2005

WASHINGTON, Sept. 6 - Researchers will no longer be allowed to include children and pregnant women in studies examining the effects of pesticides to help set federal standards, according to the first regulations for human testing of pesticides that the Environmental Protection Agency plans to propose.

The regulations, to be proposed on Wednesday, would also establish an independent oversight panel to ensure that all studies submitted to the agency were conducted ethically and followed internationally accepted protocols for human testing.

Agency officials discussed the new regulations with reporters on Tuesday. They declined to make copies of the proposal available, leading at least one major critic of the agency, Senator Barbara Boxer, Democrat of California, to suggest that a close examination of the regulations might reveal weaknesses identified in an earlier version...

The proposed regulations...came several months after Congress put restrictions on human pesticide tests as part of an appropriations bill. Congressional concern grew after reports that parents in Florida would be paid to participate in a program, known as Cheers, by allowing their children to be tested to measure household exposure to pesticides...

Researchers call for end to pharmaceutical industry's ‘cynical use’ of drug studies

Patients who volunteer for studies that help drug companies to develop new products are often misled into taking part, say research ethicists in the latest edition of the British Medical Journal.

The ethicists have called on drug companies to immediately end what they say is a “cynical use of these studies for marketing purposes”.

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Exceptions in new EPA rules would allow testing pesticides on children

WASHINGTON - The Environmental Protection Agency's new rules on human testing, which the agency said last week would "categorically" protect children and pregnant women from pesticide testing, include numerous exemptions - including one that specifically allows testing of children who have been "abused and neglected."

The new policy, which the EPA is still developing, would allow Bush administration political appointees to referee any ethical disputes. Agency officials are putting the finishing touches on a plan to take a case-by-case approach.