WASHINGTON, DC, September
9, 2005 (ENS): Under fire from citizens' groups and some
legislators for allowing human dose pesticide studies that could
harm children, the U.S. Environmental Protection Agency (EPA) this
week proposed a rule that will establish stringent enforceable ethical
safeguards governing the conduct of third-party intentional dosing
research with human subjects.
Among other new ethical protections, EPA proposes to prohibit all
new third-party intentional dosing research on pesticides with children
and pregnant women.
The agency announced a "categorical ban" on such studies
saying that EPA "will neither conduct nor support any intentional
dosing studies that involve pregnant women or children."
"We are pursuing a rigorous set of protections for human research
participants," said Susan Hazen, principal deputy assistant
administrator in EPA's Office of Prevention, Pesticides, and Toxic
"EPA believes that regulatory decisions should be supported
by the best scientific information," said Hazen. "We should
consider human data only if that information has been developed
with the foremost goal of providing protections for research participants.
We want to send a clear signal to the public that unethical research
should never be conducted and will not be accepted by EPA."
This rule is intended to ensure that people who volunteer for third-party
pesticide studies involving exposure to humans are treated ethically,
with full disclosure as to potential risks.
For any new, intentional dosing studies with pesticides, this proposal
would require researchers to comply with the requirements of the
Common Rule - current ethical standards for research conducted or
supported by the federal government.
Hazen says that EPA sponsored or supported research now meets current
federal ethical standards set forth in the Common Rule, and the
agency's new proposal would extend those and other safeguards to
third party research involving pesticides.
Researchers would have to submit detailed study protocols to EPA
prior to initiation so that EPA can review them to ensure the study
meets the new ethical protections and is scientifically sound. Then,
once the study is conducted, researchers would have to provide detailed
information to EPA describing how the study met the necessary ethical
This rule would also put in place standards that EPA would follow
in determining whether to rely on human studies. The agency is proposing
to establish a Human Studies Review Board to review study protocols
and selected available studies. The new protections would apply
to pesticide intentional dosing studies conducted by EPA, those
supported or sponsored by EPA, and those conducted by a pesticide
manufacturer or other researchers.
This rule focuses largely on pesticide studies because such studies
have elicited a strong expression of public concern, and because
the risks they potentially present to people who volunteer to participate.
Today's proposal is the first in a series of potential actions that
will address the full spectrum of human studies issues at EPA.
The agency says it has been conducting "a comprehensive review"
of older pesticides to ensure that they meet current health and
safety standards so that the public, especially infants, children
and other sensitive people, are protected from pesticide risks.
EPA welcomes public input, and the proposal includes a 90-day public
comment period. For more information on the rulemaking, visit: http://www.epa.gov/oppfead1/guidance/human-test.htm
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