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September 7, 2005 - Pregnant Women and Children Protected from Human Testing

September 7, 2005 - Pregnant Women and Children Protected from Human Testing

Children and pregnant women will be exempt from inclusion in human testing studies meant to review pesticide standards, according to a planned proposal by the Environmental Protection Agency.

The upcoming proposal would also include appointment of an independent oversigh panel that will have responsibility for ensuring ethics and international protocols for human testing are strictly observed in each study submitted to the EPA.

In a statement, Senator Boxer said of the proposal: "One thing is clear. It must be changed dramatically from the version E.P.A. forwarded to O.M.B. just a few weeks ago. If not, it will be a direct attack on our most vulnerable citizens."

Agency officials discussed the new regulations with reporters on Tuesday. They declined to make copies of the proposal available, leading at least one major critic of the agency, Senator Barbara Boxer, Democrat of California, to suggest that a close examination of the regulations might reveal weaknesses identified in an earlier version. Agency officials said those weaknesses were removed from a draft sent to the Office of Management and Budget last month.

The proposed regulations, which would take effect in January after a public comment period, came several months after Congress put restrictions on human pesticide tests as part of an appropriations bill. Congressional concern grew after reports that parents in Florida would be paid to participate in a program, known as Cheers, by allowing their children to be tested to measure household exposure to pesticides.

"This proposed rule contains some of the strongest protections for human subjects ever proposed by the federal government," Jim Jones, director of pesticide programs for the agency, said Tuesday in a conference call with reporters.

Mr. Jones said an oversight panel to review tests involving pesticides would include medical ethicists and experts in chemical tests and would exclude anyone with connections to the agency or chemical companies.

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