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For Immediate Release: Monday, December 12, 2005
Contact: Chas Offutt (202) 265-7337
EPA TO EXPAND USE OF HUMAN CHEMICAL EXPERIMENTS
Public Comment Period Closes Today on EPA Plan
Washington, DC — The U.S. Environmental Protection Agency is in the
final stage of welcoming industry experiments using human subjects to
test the effects of pesticides and other commercial toxins, according
to comments filed today by Public Employees for Environmental
Responsibility (PEER) and a coalition of public health organizations.
The proposed EPA rule, strongly supported by the chemical industry,
allows experiments on humans to replace reliance on animal studies.
“The good news is that EPA, for the first time, is pledging to abide
by the Nuremberg Code, adopted after World War II to prevent a
repetition of the horrific Nazi human experiments,” stated PEER
Executive Director Jeff Ruch, whose organization became involved after
EPA gagged its own scientists from voicing objections. “The bad news is
that EPA’s proposal breaks this long overdue pledge by offering a plan
peppered with loopholes that encourage unethical conduct and omit key
protections for infants, pregnant women and other vulnerable
populations.”
The agency’s latest plan is the product of a Congressional ultimatum
this summer to ban all future human tests until EPA finally adopted
ethical safeguards. Congress acted after mushrooming controversy
concerning an EPA study called “CHEERS” in which Florida parents would
have been paid to spray pesticides in the rooms of their infant
children. EPA Administrator Stephen Johnson, who sponsored the CHEERS
experiment (in partnership with the American Chemistry Council),
reluctantly cancelled the study only when it became clear that his
confirmation to the agency’s top job would otherwise be blocked.
In order to dissolve the Congressional human subject ban, this
September EPA offered a grudging plan that imposes few absolute
safeguards. For example, EPA’s plan would allow –
• Dosing experiments involving infants and pregnant
women using any chemical (except pesticides). Thus, companies will be
free to test toxic agents, such as perchlorate, on nursing mothers;
•
A repeat of the infamous (now canceled) CHEERS study because EPA
pointedly omits any check against undue economic inducement, i.e.,
paying poor people enough to lure them into signing informed consent
papers; and
• Studies on orphans, mentally ill children and prisoners without informed consent.
During the past decade, human testing has become
central to the regulatory plans of the chemical industry. These
companies are challenging the utility of animal studies and demanding
that EPA use human subject tests as the new safety benchmark. Because
human tests cannot use the same high concentrations used in animal
tests, companies can argue that there is no definitive proof of harm
from the introduction of chemicals based upon small-scale human studies
of dubious probative value.
“Any plan for human subject protections supported by the chemical
industry should give pause,” Ruch added. “The irony is that tests to
develop medicines to benefit people have far more safeguards than EPA
wants in experiments to see how chemicals harm people.”
Today marks the deadline for submission of public comments. After
EPA reviews public comments, the agency will adopt final rules, a
process that is expected to take a month.
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Read the PEER comments on EPA’s proposed human testing rule
View the EPA proposal
Visit PEER’s human testing center to get more information
The following groups have signed on to PEER’s comments
Alliance for Human Research Protection (AHRP)
Center for Environmental Health
Citizens Campaign for the Environment (CCE)
Environmental Research Foundation
Health Care Without Harm
Organic Consumers Association
Protect All Children's Environment (PACE)
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