More on the EPA Human Pesticide Dosing Studies

**A* <g*@earthlink.net>**

Hi, Folks!

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

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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 
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 
<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: 
<http://www.peer.org/EPA/LockwoodHumanPesticideTests_article.pdf>Article by 
Dr. Alan Lockwood (American Journal of Public Health, vol. 94 [2004] 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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