Democrats Denounce Bush's Human Pesticide Testing Plan

Alan · medicine forum Guru Joined: 09 Sep 2005 Posts: 1055

http://www.truthout.org/docs_2006/012306Q.shtml

Monday 23 January 2006

Washington, DC - Today, Senator Barbara Boxer, Rep. Henry A. Waxman, and
Rep. Hilda L. Solis criticized 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 US Senate. Representative Solis pushed the
moratorium through the US 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:

* 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.

* 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.

* 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.

http://www.truthout.org/docs_2006/012306Q.shtml

Lord Cerne Abbas

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