Democrats Denounce Bush's Human Pesticide Testing Plan

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

Democrats Denounce Bush's Human Pesticide Testing Plan

t r u t h o u t | Press Release

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 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.

Randi Airola

517-819-5926