Washington, DC —In a notice slated for publication in the Federal Register, the U.S. Environmental Protection Agency will formally adopt an open door policy of accepting experiments conducted by pesticide companies and chemical manufacturers using human subjects, according to a draft posted by EPA late last Friday. At the same time, the agency is indefinitely delaying development of ethical rules to protect test subjects, instead relying on its political appointees to flag immoral or unsafe practices on a “case-by-case” basis.
“At the request of chemical companies seeking to justify higher exposure limits, EPA will sanction dosing of infants, pregnant women and other vulnerable persons with commercial poisons,” stated Public Employees for Environmental Responsibility (PEER) Executive Director Jeff Ruch, whose organization has highlighted the agency’s lack of ethical or safety guidelines. “EPA’s stance is appallingly amoral.”
According to the new notice, EPA will –
- Defer adopting protections for infants, neonates, pregnant women, and prisoners that apply to all medical and drug testing overseen by the Department of Health and Human Services. Instead, EPA announces its “intent to publish a proposed rule” at some unspecified time in the future;
- Refuse to require that companies demonstrate that they have abided by informed consent, appropriate inducement and other basic ethical standards. Instead, EPA promises “to publish non-binding guidance reflecting its plans” to possibly apply these elemental safeguards sometime in the future; and
- Avoid any requirement of an independent safety or ethical review, as is required for all other government human subject studies. Instead, EPA has assigned one of its own staff members to act as a “Human Subjects Research Review Official” with powers yet to be determined. In practice, however, it will be up to the top political appointees to flag unethical corporate experiments on a case-by-case” basis.
In its notice that is purported to clarify its policy, EPA provides scant description as to what constitutes an “ethically problematic” study that it will not accept:
EPA “will continue to generally accept scientifically valid [human dosing] studies unless there is clear evidence that the conduct of these studies was fundamentally unethical (e.g., the studies were intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted.”
“Since there are no public notice requirements, the outside world will never learn of ethically dubious corporate experiments,” Ruch added, noting that many of the corporate studies will be done in developing countries. “EPA’s policy invites chemical companies to push the outside of the moral envelope.”
This latest draft notice represents EPA’s second recent attempt at codifying its pro-human testing policy; an earlier draft that was withdrawn after PEER publicly released it in late November. This latest draft is identical in effect to the earlier draft but specifies possible standards that EPA may consider in the future.
EPA itself has also proposed to directly conduct a controversial study that would pay parents to spray pesticides and other chemicals in the rooms occupied by infants under age 3. When that study (with the acronym CHEERS) drew unfavorable publicity late last year, EPA announced further review even though it had already recruited families with half of the 60 children called for in the study design.