From: Robina Suwol
Date:
28 Feb 2006
Time: 19:48:37
Remote Name: 69.149.60.16
Mysterious Language Change Buried within Final Human Subject Testing Rule
By: Public Employees for Environmental Responsibility (PEER)
Published: Feb 28, 2006 at 06:54
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."
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.