For Immediate Release

EPA Delays Experiments Exposing Children to Chemicals

Studies Modeled on Infamous CHEERS Underline Enduring Ethical Uncertainties

WASHINGTON - The U.S. Environmental Protection Agency is temporarily shelving two
studies which involve exposing infants and schoolchildren to pesticides
and other hazardous chemicals. EPA cited ethical and perception
concerns (the need "to ensure the utmost confidence in the approaches
used") as the basis for suspending applications for funding, according
to agency documents posted by Public Employees for Environmental
Responsibility (PEER).

The two studies, entitled "Observational Studies to
Characterize the Determinants of Exposure to Chemicals in the
Environment for Early-Lifestage Age Groups" (involving infants under
age 3 in the Las Vegas area) and "Novel Approaches for Assessing
Exposure for School-Aged Children in Longitudinal Studies" have been
"cancelled until further notice." They are reminiscent of a notorious
experiment called the Children's Environmental Exposure Research Study
(with the anomalous acronym CHEERS) in which Florida parents would have
been paid to spray pesticides in the rooms of their infant children.
The ensuing furor forced EPA to grudgingly end CHEERS in April 2005 in
order to secure the confirmation of EPA Administrator Stephen Johnson.

EPA formally legalized human subject experimentation in February
2007, but prior to that, the Bush administration conducted and
encouraged human subject studies on a case-by-case basis. Its 2007
rules, however, still allowed experiments such as CHEERS and left many
other ethical questions unaddressed.

In late 2007, EPA commissioned a new effort to allay public unease
about using humans as subjects for pesticide and chemical experiments.
This latest product, called Scientific and Ethical Approaches for
Observational Exposure Studies (SAEOES), was written by EPA's principal
investigator for CHEERS but fails to mention that study. In fact, it
does not provide any concrete guidance on an array of ethical
quandaries, such as vulnerable populations, payments to participants
and conflicts-of-interest by scientists.


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The September 8th EPA
announcement states that "Administrator Johnson is taking action to
identify [SEAOES] as an Agency Guidance Document, setting its
procedures and protocols as official EPA policy" prior to restarting
the two suspended studies.

"This is a smokescreen to prevent a new controversy prior to the
election about the government using babies as guinea pigs," said PEER
Executive Director Jeff Ruch. "Nothing in SEAOES will prevent ethically
questionable studies from continuing, even if the document does become
official EPA policy. This document does not have any hard and fast
rules to protect children used as experimental subjects."

"Observational" studies are controversial because they often involve
payments to parents to participate under the fig leaf of the parent
attesting the child would be exposed to the chemicals anyway. Moreover,
truly observational studies preclude medical, safety or other
assistance to prevent damage to the child.

"These EPA experiments, in essence, legitimize vastly more numerous
human subject experiments by industry and corporate consultants, often
in Third World countries," Ruch added. "Corporate sponsored experiments
are usually designed to justify higher human exposures to pesticides or
other noxious chemicals, particularly for children, while serving no
discernible public health purpose."


See EPA study on "Exposure to Chemicals in the Environment for Early-Lifestage Age Groups"

Look at "Novel Approaches for Assessing Exposure for School-Aged Children"
(Note, EPA removed the protocol)

Compare these studies to the infamous CHEERS study

Examine the weaknesses and loopholes in EPA ethical standards for human subject studies


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