Senate approves ban on human pesticide testing

By J.R. Pegg

WASHINGTON, DC, June 30, 2005 (ENS): The Senate on Wednesday approved a one year moratorium prohibiting the U.S. Environmental Protection Agency (EPA) from funding or accepting studies that intentionally expose humans to hazardous chemicals used in pesticides.

But the Senate also passed a measure expediting an EPA regulation that could permit the agency to further use and fund human pesticide testing, leaving the prospects for either proposal uncertain.

Both measures were approved as amendments to the appropriations bill that funds the EPA and other agencies. The appropriations bill passed late Wednesday by a vote of 60-37.

The House of Representatives approved the moratorium last month by a unanimous voice vote, but it is unclear if it will be retained in the final House-Senate conference report.

Senator Barbara Boxer, a California Democrat and lead sponsor of the provision, said the EPA needs "a timeout" before it moves ahead with regulations to permit the federal agency from using data from studies that tested the effect of pesticides on humans – including children.

A recent report by Boxer and Congressman Henry Waxman, a California Democrat, found that the EPA is reviewing more than 20 human pesticide studies that violated ethical standards.

EPA funding of a Florida study that involved intentionally dosing children with pesticides – known as CHEERS – was withdrawn in April after Boxer and Florida Democratic Senator Bill Nelson threatened to block confirmation of EPA Administrator Stephen Johnson.

Boxer said, "The moral and ethical issues surrounding these pesticide experiments are overwhelming – EPA should never have been considering them to begin with. I hope they will use this next year to do the right thing and put in place the strictest standards on these pesticide experiments as recommended by the National Academy of Sciences and other widely accepted ethical guidelines."

The Clinton administration banned the EPA from considering or approving pesticide testing on humans but the Bush administration allowed the moratorium to lapse in 2003.

The EPA is currently developing new standards and permitting testing on a case-by-case basis.

A draft rule of the new standards is "rife with industry-friendly loopholes, ethical lapses and questionable scientific method," Boxer said.

Critics of the ban say it is unnecessary and premature.

In response to criticism of the draft rule, EPA officials said the regulation is far from final and has not been reviewed by EPA Administrator Stephen Johnson. The official proposal is expected to be released for public comment next month.

Senator Conrad Burns, a Montana Republican, reminded fellow senators of a 2004 report by the National Academies on intentional human dosing with pesticides which found "that in certain cases the societal benefits of such studies outweigh the risks."

Burns, the lead author of the Interior and EPA appropriations bill, proposed a rival amendment - one that calls on the EPA to further review and complete new standards on human pesticide studies.

The amendment passed by a vote of 57-40.

Burns said it would be foolish to disregard studies that have already been completed.

"We cannot just say stop," Burns said. "That is not fair to the American people, that is not fair to the American consumer and it is not fair to the folks that are involved in producing food, fiber and shelter for this country."

"I understand, nobody likes the idea of human dosing," Burns said. "If we could get around it, if there was any sure way we could get around it, we would. I don't like it either. But nonetheless, as we talk about this, we are holding up testing on the world around us. We cannot afford to lose any time or information."

Boxer said the Burns amendment, which calls on the EPA to issue its final rule 180 days after the bill is enacted into law, is "a step back from what is happening currently."

"It would push through a new regulation that has already been condemned by every major religious organization in the country," Boxer said.

New York Senator Hillary Rodham Clinton, a Democrat and cosponsor of the Boxer amendment, said the debate "is not about whether pesticides can be useful."

Clinton said the draft EPA rule sets a "dangerous course" and does not ensure that researchers follow strict ethical and medical guidelines.

"The Environmental Protection Agency must conduct and rely on safe, ethical tests to protect both the subjects of the tests and the integrity of the pesticide safety standards that protect our children," Clinton said.

Both the Boxer and the Burns amendments are part of a $26.3 billion bill that includes funding for the EPA, Interior Department, Forest Service and other land and cultural programs.

The spending bill passed Wednesday night by a vote of 94-0 - it is $752 million less than last year’s appropriations.

In recent Federal Register notices, the EPA has proposed that pesticide companies submit human exposure experiments when seeking to market new chemicals or broaden the application of existing ones.

EPA is not, however, requiring the industry to observe any ethical safeguards, such as informed consent, no undue risk to participants and exclusion of infants or other vulnerable populations, according to Public Employees for Environmental Responsibility (PEER), a national organization representing workers in natural resources agencies.

"The issue here is not the march of science but whether standards of basic decency will be applied to experiments conducted for commercial gain," said PEER Executive Director Jeff Ruch, whose organization has been publicizing ethical concerns raised by the EPA’s own scientists.

"It is beyond ironic," said Ruch, "that EPA claims these studies are required to protect human health while turning its back on the health risks posed to the troops of human guinea pigs it is creating."