http://www.peer.org/press/539.html
Press Release
- Public
Employees for Environmental Responsibility (PEER)
November
30, 2004
Contact: Chas
Offutt (202) 265-7337
EPA SET TO
ACCEPT HUMAN PESTICIDE DOSING STUDIES
“Senior
Agency Officials” to Decide Ethical Concerns on “Case-By-Case
Basis”
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.”
###
See
the draft EPA notice on “Human Testing: Proposed Plan and
Description of Review Process”
Read about
questionable human dosing studies that EPA is accepting now. Article
by Dr. Alan Lockwood (American Journal of Public Health, vol.
94 [ 2004] 1908)
Find
out about EPA’s plan to pay poor parents to dose their infants
with pesticides
Public
Employees for Environmental Responsibility (PEER) is a national
alliance of local, state and federal resource professionals, working
to protect the environment.