Washington, DC — Without any public notice, the U.S. Environmental Protection Agency has rewritten its proposed rule on human experiments to authorize chemical testing on fetal tissue, according to Public Employees for Environmental Responsibility (PEER). The change will allow pesticide and chemical companies to conduct experiments on aborted fetuses to buttress lobbying efforts for relaxation of federal regulation and increases in allowable dosage levels for its products.
EPA’s wording change came after the public comment period ended on its controversial plan to accept and conduct chemical experiments on humans. EPA’s proposed rule would have forbidden intentional exposure of a “pregnant woman, fetus, or newborn” but in its Final Rule announced on January 26, 2006, EPA altered the language to forbid intentional exposure of human subjects who are “pregnant women (and therefore their fetuses) or children.” [Emphasis added]
This wording change would appear to allow the use of a fetus or its tissue no longer within a pregnant woman for experiments. This rewrite came without any explanation by EPA. Moreover, at a February 13, 2006 “Stakeholders Meeting” to explain its new rule, EPA’s representatives were unable to answer questions about the origin or meaning of the new language.
Fetal tissue research has great potential for shedding light on the developmental effects of chemicals. Corporate access to fetal tissue experiments may better enable them to argue against extra strict regulations on chemical exposure of pregnant women and young children. But fetal research has been fraught with controversy. Since 1995, Congress has banned National Institutes of Health funding for human embryo research. In the current debate on stem cell research, the Bush administration has banned use of fetal tissue to harvest new stem cells.
“Under EPA’s rule, chemical companies could conduct experiments to justify pesticide exposures that biochemical companies could not perform to develop new lifesaving medicines,” stated PEER Executive Director Jeff Ruch. “Unfortunately, under the current administration, EPA has earned a reputation for blindly adopting language supplied by corporate lawyer-lobbyists.”
It was EPA’s sponsorship (in partnership with the American Chemistry Council) of an experiment called “CHEERS” in which Florida parents would have been paid to spray pesticides in the rooms of their infant children that sparked a renewed debate on human experiments for commercial purposes, such as setting pesticide exposure limits. Last summer, Congress banned human testing until EPA finally imposed strict ethics standards. After years of resisting any safeguards and propounding a “case-by-case” approach, EPA moved with alacrity to adopt rules so that it could resume consideration and funding of such research.
Environmental groups and congressional critics have served notice that they will challenge EPA’s new human testing rules, which become effective on April 7, 2006.
“Given the inherent controversy, EPA should have bent over backward to be aboveboard and transparent but, instead, the agency went behind closed doors to do something that flunks the smell test,” Ruch added.
###
Look at the language in the proposed rule (at §§ 26.220, 26.221, 26. 610 and 26.602)
Compare it with the final language that EPA adopted (at §§ 26.201, 26.203 and 26.1203)
Consider other ethical deficiencies, lapses and omissions in EPA’s human testing plan