http://www.ems.org/nws/2005/02/07/epa_embraces_hum
From: Public
Employees for Environmental Responsibility (PEER)
Press Release
February
7, 2005
Contact: Chas
Offutt (202) 265-7337
EPA
EMBRACES HUMAN PESTICIDE DOSING WITHOUT SAFEGUARDS
Ethical
Rules “Non-Binding”— No Standards to Protect
Infants and Fetuses
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.
