Pesticide anyone? Testing on People again!

Democrats Denounce Bush's Human Pesticide Testing Plan
t r u t h o u t | Press Release
Monday 23 January 2006

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

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.