Washington, DC — The U.S. Environmental Protection Agency is in the final stage of welcoming industry experiments using human subjects to test the effects of pesticides and other commercial toxins, according to comments filed today by Public Employees for Environmental Responsibility (PEER) and a coalition of public health organizations. The proposed EPA rule, strongly supported by the chemical industry, allows experiments on humans to replace reliance on animal studies.
“The good news is that EPA, for the first time, is pledging to abide by the Nuremberg Code, adopted after World War II to prevent a repetition of the horrific Nazi human experiments,” stated PEER Executive Director Jeff Ruch, whose organization became involved after EPA gagged its own scientists from voicing objections. “The bad news is that EPA’s proposal breaks this long overdue pledge by offering a plan peppered with loopholes that encourage unethical conduct and omit key protections for infants, pregnant women and other vulnerable populations.”
The agency’s latest plan is the product of a Congressional ultimatum this summer to ban all future human tests until EPA finally adopted ethical safeguards. Congress acted after mushrooming controversy concerning an EPA study called “CHEERS” in which Florida parents would have been paid to spray pesticides in the rooms of their infant children. EPA Administrator Stephen Johnson, who sponsored the CHEERS experiment (in partnership with the American Chemistry Council), reluctantly cancelled the study only when it became clear that his confirmation to the agency’s top job would otherwise be blocked.
In order to dissolve the Congressional human subject ban, this September EPA offered a grudging plan that imposes few absolute safeguards. For example, EPA’s plan would allow –
- Dosing experiments involving infants and pregnant women using any chemical (except pesticides). Thus, companies will be free to test toxic agents, such as perchlorate, on nursing mothers;
- A repeat of the infamous (now canceled) CHEERS study because EPA pointedly omits any check against undue economic inducement, i.e., paying poor people enough to lure them into signing informed consent papers; and
- Studies on orphans, mentally ill children and prisoners without informed consent.
During the past decade, human testing has become central to the regulatory plans of the chemical industry. These companies are challenging the utility of animal studies and demanding that EPA use human subject tests as the new safety benchmark. Because human tests cannot use the same high concentrations used in animal tests, companies can argue that there is no definitive proof of harm from the introduction of chemicals based upon small-scale human studies of dubious probative value.
“Any plan for human subject protections supported by the chemical industry should give pause,” Ruch added. “The irony is that tests to develop medicines to benefit people have far more safeguards than EPA wants in experiments to see how chemicals harm people.”
Today marks the deadline for submission of public comments. After EPA reviews public comments, the agency will adopt final rules, a process that is expected to take a month.
The following groups have signed on to PEER’s comments