More on the EPA Human Pesticide Dosing Studies
- Subject: [cg] More on the EPA Human Pesticide Dosing Studies
- From: Alliums <firstname.lastname@example.org>
- Date: Fri, 03 Dec 2004 14:47:28 -0500
Here is some of the most complete information on the EPA pesticide studies
to commence on children in poverty in the US. This information comes from
the Women, Food & Agriculture network, which has been dealing with the
issue for the last 10 days. It's been a VERY hot topic on the US/PA
agricultural lists I subscribe to.
Dorene Pasekoff, Coordinator
St. John's United Church of Christ Organic Community Garden and Labyrinth
A mission of
St. John's United Church of Christ, 315 Gay Street, Phoenixville, PA 19460
EPA Set to Accept Human Pesticide Dosing Studies
Public Employees for Environmental Responsibility
Tuesday 30 November 2004
"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
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
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
<http://www.peer.org/EPA/EPAhumanstudiesdraft.htm>"Human Testing: Proposed
Plan and Description of Review Process."
Read about questionable human dosing studies the EPA is accepting now:
Dr. Alan Lockwood (American Journal of Public Health, vol. 94  1908).
Find out about the <http://www.peer.org/press/530.html>EPA's plan to
pay poor parents to dose their infants with pesticides.
<http://www.peer.org/index.html>Click here: Public Employees for
Environmental's Home Page
Protecting Employees Who Protect the Environment
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