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For Immediate Release: Sep 22, 2008
Contact: Kirsten Stade (202) 265-7337

EPA DELAYS EXPERIMENTS EXPOSING CHILDREN TO CHEMICALS

Studies Modeled on Infamous CHEERS Underline Enduring Ethical Uncertainties


Washington, DC — 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.

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.”

 

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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

View the EPA notice of cancellation