WASHINGTON – Manufacturers would be allowed to test some pesticides on human volunteers when seeking government approval without applying all the ethical safeguards recommended last year by an expert panel under proposed rules soon to be issued by the Environmental Protection Agency.
The regulations represent the latest step in an ongoing battle over whether the EPA should use data from human tests of toxic chemicals when deciding whether to approve new pesticide products. The rules would omit some provisions urged by the National Academy of Sciences last year that would have imposed more stringent limits on such studies.
Policy-makers have grappled for nearly a decade over whether to rely on human testing when considering pesticide applications. Manufacturers say these studies help gauge how their products affect consumers and the environment, while critics counter they unnecessarily expose vulnerable subjects to dangerous chemicals.
President Bill Clinton issued a moratorium on using such tests in 1998, but the Bush administration has revived the practice on a case-by-case basis while crafting the new standards.
Under the draft rule, the EPA could still accept some studies involving children, pregnant women and newborns, and it would not establish an independent ethics review board to scrutinize human studies on the grounds that this would “unnecessarily confine EPA’s discretion.”
The agency would allow testing pesticides on humans to determine at what level they become toxic. This could include tests on prisoners, even though they might be “vulnerable to coercion or undue influence,” the draft rule states.
The National Academy had urged creation of a “Human Studies Review Board to address in an integrated way the scientific and ethical issues raised by such studies.”
It identified children as “a special case” because they can be swayed by adults and are often more vulnerable to toxic exposures, and proposed a national panel of scientists to judge whether they could be included in the tests. The Academy’s report said prisoners should not be used as subjects if alternative volunteers could be found because inmates are less free to offer informed consent.
EPA spokeswoman Eryn Witcher said the rule will be offered for public comment before it is finalized.
The draft rules come at a time when lawmakers are preparing to vote on whether to bar the EPA from considering such tests altogether. The House approved a ban last month, and Sen. Barbara Boxer, D-Calif., plans to offer a similar amendment today to the EPA’s annual spending bill.
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