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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 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.

 

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