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."

Pesticide Industry Plotted Bush Human Testing Policy Meeting with OMB Staff Laid Out Exemptions for Experiments on Children

One month before the Bush administration proposed rules authorizing experiments on humans with pesticides and other chemicals, its key operatives met with pesticide industry lobbyists to map out its provisions, according to meeting notes posted today by Public Employees for Environmental Responsibility (PEER). The industry requests for exemptions allowing some chemical testing on children and other provisions were incorporated into the human testing rule ultimately adopted this January 26th.

At the August 9, 2005 meeting held inside the President's Office of Management and Budget, representatives of the pesticide trade association, Crop Life America, as well as Bayer Crop Life Science met with OMB and U.S. Environmental Protection Agency officials. Also attending was a former top EPA official, James Aidala, who now acts a lobbyist at a law firm representing chemical companies.

The meeting notes detail industry concerns about the text of a proposed rule that the Bush administration first unveiled a month later on September 12th. For example, the Crop Life America attendees urged:

"Re kids-never say never" (emphasis in original);

"Pesticides have benefits. Rule should say so. Testing, too, has benefits"; and

"We want a rule quickly-[therefore] narrow [is] better. Don't like being singled out but, speed is most imp."

"These meeting notes make it clear that the pesticide industry's top objective is access to children for experiments. After reading these ghoulish notes one has the urge to take a shower," commented PEER Executive Director Jeff Ruch, whose organization works with EPA scientists who have been prevented from voicing ethical and scientific concerns about human subject testing. "For an administration which trumpets its concern for the 'value and dignity of life,' it is disconcerting that no ethicists, children advocates or scientists were invited to this meeting to counterbalance the pesticide pushers."

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Human Experimentation: A Rule Gone Awry?

The U.S. EPA’s new Protections for Subjects in Human Research rule, which came into force on 7 April 2006, was born of a need to tighten the ethical guidelines controlling nonmedical human experimentation. The rule was ostensibly designed to offer people greater protection in pesticide toxicity experiments. But just two weeks after its coming into force, a coalition of labor and environmental interest groups filed suit against the EPA, challenging the rule’s legality and ethics. Against a backdrop of claims of industry influence, financial interests, and bipartisan rhetoric, the Second Circuit Court of Appeals in New York City must now determine whether this rule safeguards Americans against unethical experimentation or sells them out to big business.

The plaintiffs—the Natural Resources Defense Council (NRDC), Pesticide Action Network North America, San Francisco Bay Area Physicians for Social Responsibility, and Northwest Treeplanters and Farmworkers United, Oregon’s union of farm, nursery, and reforestation workers—filed their suit on 23 February 2006. They claim the new rule does not meet the demands of Congress to afford the fullest protection to human subjects—especially pregnant women and children—in pesticide experiments, and charge that the rule is undercut by numerous loopholes that ultimately encourage, rather than deter, human testing.

“EPA is giving its official blessing for pesticide companies to use pregnant women, infants, and children as lab rats in flagrant violation of [the EPA Appropriations Act of August 2005] cracking down on this repugnant practice,” said Erik Olson, senior attorney for the NRDC, in a 23 January 2006 press release from that organization. “There is simply no legal or moral justification for the agency to allow human testing of these dangerous chemicals. None.”

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