Washington, DC — In the wake of the recent cancellation of the CHEERS study in which parents were to be paid to expose their infant children to pesticides, the U.S. Environmental Protection Agency is finalizing a new policy that encourages the same type of human dosing studies by industry. Today EPA closes public comment on its “no safeguards” policy of accepting all human subject experiments submitted by industry, according to a filing today by Public Employees for Environmental Responsibility (PEER).
Under its new policy, EPA would accept all human chemical dosing studies “unless there is clear evidence that the conduct of these studies was fundamentally unethical… or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted.” Since industry is not required to disclose the conditions under which experiments were conducted, it is not clear how EPA will ever learn of “fundamentally unethical” practices. Moreover, EPA is unwilling to define what ethical lapses would disqualify an industry submission from being used for regulatory purposes.
“The Bush Administration is setting the ethical bar so low that only the most sleazy cannot limbo under it,” stated PEER Program Director Rebecca Roose. “The basic problem is this: the safeguards that apply to experiments involving development of drugs to help people are far more stringent than EPA’s standards for experiments to determine how much commercial poisons harm people.”
EPA’s refusal to adopt basic safeguards requiring proof of informed consent, independent review or protections for children is part of a Bush Administration drive to liberalize rules on human testing of pesticides and other chemicals. Without actual human experimental data to justify higher chemical exposures for children, industry must abide by the 1996 amendments to the Federal Food, Drug and Cosmetic Act setting ten-fold stricter exposure standards for children.
At the same time it is encouraging industry to expose human subjects, EPA itself is conducting similar experiments that serve to provide a template for industry. Last month to avoid a hold on his confirmation, EPA Administrator Stephen Johnson reluctantly cancelled a controversial study financed jointly by EPA and industry called CHEERS (Children’s Environmental Exposure Research Study) that would have paid Florida parents to apply pesticides and other chemicals in the rooms primarily occupied by their infant children. During his confirmation, Johnson disclosed that EPA is also conducting more than 250 other human experiments, several of which involve chemical testing on children, including –
- Exposing children (ages 3 to 12) to a powerful agricultural insecticide (chlorpyrifos) to test absorption in their systems through “urinary biomarker measurements”;
- Paying “young male volunteers” to inhale methanol vapors at levels described as “a worst case scenario”; and
- Having asthma sufferers inhale potentially harmful ultrafine carbon particles.
“The need for safeguards is particularly acute because EPA is giving industry an economic incentive to push the edge of the ethical envelope,” Roose added. “It is distressing that a federal agency is using tax dollars to write a primer for commercial exploitation of human subjects.”
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Read the PEER comments on lack of safeguards in EPA policy
See EPA’s “No Safeguards” Human Testing Policy Notice