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children with pesticides – known as CHEERS – was withdrawn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,"
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
"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,"
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
"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
"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."
Copyright Environment News Service (ENS) 2005. All Rights Reserved.