EPA's Latest Human Pesticide Testing Rule Called Illegal, Immoral

Monday, California legislators Senator Barbara Boxer, and Representatives Henry Waxman and Hilda Solis released details of the rule and called on EPA Administrator Stephen Johnson to withdraw the rule, calling it a "profound moral and ethical breach." "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. In August 2005, Congress enacted a moratorium upon the EPA using human pesticide experiments until strict ethical standards were established. Boxer championed the moratorium in the U.S. Senate. Solis pushed the moratorium through the U.S. House of Representatives. The law creating the moratorium passed overwhelmingly in the House and Senate with strong bipartisan support, which included conservative Republicans, who questioned the ethics of testing toxic chemicals on humans. But the leaked final draft rule would allow manufacturers to conduct testing of pesticides upon pregnant women and children so long as there is no "intent" at the outset of the study to submit the results to the EPA. Additionally, the plan would allow pesticides to be tested upon pregnant women and children in studies intended for submission to the EPA 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 regulation is an open invitation to test pesticides on humans, which is the exact opposite of what Congress intended," said 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." People with high levels of pesticides in their blood are far more likely to develop genetic mutations linked with cancers, birth defects, and neurological disorders peer-reviewed scientific studies across the world have documented. In its moratorium legislation, Congress required that the 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. But the final draft rule 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 Human Subjects Review Board would not have any authority to block or require modifications to unethical research. Full story: http://www.ens-newswire.com/ens/jan2006/2006-01-25-05.asp [Proofreader's note: this article was edited for spelling and typos on January 26, 2006]

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