From: Robina Suwol
Date: 29 Jan 2006
Time: 18:24:04
Remote Name: 69.149.51.251
FOR IMMEDIATE RELEASE - WASHINGTON, DC - January 23, 2006
Today, Senator Barbara Boxer, Rep. Henry A. Waxman, and Rep. Hilda L. Solis
criticize a Bush Administration plan to promote pesticide experimentation upon
humans. The plan, contained in a final draft rule, was leaked to the
legislators by a concerned Administration official who requested that the
original copy of the plan not be duplicated in its entirety and widely
distributed out of concern for anonymity. According to the EPA's communications
plan, the Administration will officially announce the pesticide experimentation
plan later this week as a final regulation.
In August 2005, Congress enacted a moratorium upon EPA using human pesticide
experiments until strict ethical standards were established. Senator Boxer
championed the moratorium in the U.S. Senate. Representative Solis pushed the
moratorium through the U.S. House of Representatives.
"The Administration plan is inconsistent with the law passed by Congress with
bipartisan support. The loopholes which allow continued testing on pregnant
women, infants and children are contrary to law and widely accepted ethical
guidelines, including the Nuremberg code. The fact that EPA allows pesticide
testing of any kind on the most vulnerable, including abused and neglected
children, is simply astonishing," said Senator Boxer.
"The regulation is an open invitation to test pesticides on humans, which is the
exact opposite of what Congress intended," said Rep. Waxman. "The
Administration predicts that over 30 pesticide experiments will be submitted to
EPA each year under the new rule. That's an enormous step in the wrong
direction."
"This is yet another example of the Bush Administration choosing to ignore the
letter of the law and going its own way. Congress passed legislation to curb
the practice of unethical pesticide testing on humans, but with this rule the
Bush Administration is authorizing systematic testing of pesticides on humans
which not only fails to meet its congressional mandate but which will increase
the number of unethical studies," said Congresswoman Solis. "Americans should be
concerned about just how far the Bush Administration will go to allow pesticide
testing on pregnant women and children and, the ease at which it chooses to
ignore the law. The Bush Administration must revise this rule to meet its
Congressional mandate and give Americans a policy which is moral, ethical, and
safe."
"This rule has not been signed by EPA Administrator Stephen Johnson yet. It's
within his power to fix this regulation, and we are calling on him to do so,"
said Senator Boxer.
If the rule is finalized as currently drafted, it would apply to studies in
which humans are intentionally dosed with pesticides, as well as "observational"
studies. Some of the serious flaws of the plan include the following:
a.. The Administration plan is inconsistent with federal law.Congress required
that EPA ensure that pesticides are never tested upon pregnant women and
children. But the final rule would allow manufacturers to conduct testing of
pesticides upon both pregnant women and children so long as there is no "intent"
at the outset of the study to submit the results to EPA. Additionally, the plan
would allow pesticides to be tested upon pregnant women and children in studies
intended for submission at exposure levels up to the current legal limits - even
though the National Academy of Sciences found that in some cases this level of
exposure could present acute risks to children.
b.. The Administration plan is inconsistent with the recommendations of the
National Academy of Sciences.Congress required that EPA establish a Human
Subjects Review Board (HSRB) as recommended by the National Academy of
Sciences. The Academy urged that this Board review research protocols prior to
consideration by an Independent Review Board (IRB). The Academy expected that
the HSRB would have ethical and pesticide expertise that IRBs typically lack.
This approach would allow an IRB to block unethical research or require
modifications suggested by the Human Subjects Review Board prior to the
initiation of a study. However, the Administration plan would establish a
powerless Human Subjects Review Board that would consider research protocols
after an IRB and EPA staff had already approved a study. Under the
Administration plan, the HSRB would not have any authority to block or require
modifications to unethical research.
c.. The Administration plan would establish loopholes that could legally allow
unethical experiments.The Administration plan introduces new loopholes that will
allow for ethical abuse. While the plan would require researchers to document
their ethical compliance in the United States when the plan applies to them, it
waives overseas researchers from having to prove a study was ethically conducted
- even when the researcher intends to submit the study to EPA. Also, the plan
would commendably subject EPA observational studies to the Common Rule. However,
observational studies conducted by the pesticide industry would be bound by no
specific ethical requirements. These loopholes were never suggested or even
contemplated by Congress.
For More Information, contact: David Sandretti (Boxer): (202) 224-3553 Karen Lightfoot (Waxman): (202) 225-5051 Sonia Melendez (Solis): (202) 225-5464
For this article: http://seattlepi.nwsource.com/national/1501AP_EPA_Human_Testing.html