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 Substances.
"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
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
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
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 protections.
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
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
Copyright Environment News Service (ENS) 2005. All