Washington, DC — In a notice slated for publication in the Federal Register, the U.S. Environmental Protection Agency is announcing that it will accept experiments using human subjects submitted by pesticide companies and chemical manufacturers, according to a document released today by Public Employees for Environmental Responsibility (PEER). Under the new system, EPA imposes no rules to prevent unethical practices but will instead make decisions "concerning ethically problematic studies on a case-by-case basis."
In its notice, EPA defers developing enforceable ethical standards until an unspecified future time. The agency attributes this ad hoc policy to continuing "public debate" about ethical standards. Thus, under this interim policy, EPA will accept human experimental data "unless there is clear evidence" of "fundamentally unethical" conduct, such as harm to the participants or "some form of undue coercion."
"By this sleazy move, EPA abdicates its moral responsibility to ensure that the data submitted by industry does not use human beings as chemical guinea pigs," stated PEER Executive Director Jeff Ruch, noting that EPA will officially assume that all human dosing experiments are done ethically unless conclusively proven otherwise. "Under this plan, even if ‘ethical concerns' do surface, EPA's political appointees will act as the sole arbiters, guided only by their own moral compasses."
EPA has yet to adopt safeguards that are in place at other federal agencies, such as the FDA, providing special protections for experiments involving pregnant women, fetuses and children. In addition, EPA does not prohibit payments to induce subjects to volunteer, nor does it require independent review of study ethics.
This latest notice applies only to experiments conducted by industry without the participation of, or funding from, EPA. Recently, EPA itself proposed to 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 earlier this month, EPA announced further review even though it had already recruited families with half of the 60 children called for in the study design. CHEERS and similar studies with direct EPA involvement are outside the scope of this new notice and are also proceeding on a case-by-case basis, without any policy guidance.
Industry has been pressing the Bush Administration to liberalize rules on human testing of pesticides and other chemicals. This industry pressure follows the 1996 amendments to the Federal Food, Drug and Cosmetic Act setting ten-fold stricter exposure standards for children absent reliable data showing no harm. Industry needs actual human experimental data to justify higher chemical exposures for children.
"Can toddlers ever give informed consent for chemical experimentation? – EPA apparently thinks so," added Ruch. "No civilized country would encourage using infants as subjects for testing potentially harmful substances that have no medical or other countervailing benefit to the child."