The NewStandard ceased publishing on April 27, 2007.

EPA Chemical Testing Rules to Allow Human Toxicity Studies

by Brendan Coyne

Dec. 14, 2005 – The Environmental Protection Agency is nearing approval of long fought-over changes in the rules governing the use and testing of pesticides and other potential toxins on human subjects. The EPA has been temporarily barred from relying on the results of human tests since this summer, when Congress ordered the Agency develop new standards.

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Offered in September, the proposed rule provides clearer guidelines for human testing and would bar any government money from going directly to human testing. But the proposal leaves open the possibility for so-called "third parties," oftentimes the manufacturer, to use data gathered through "intentional-dosing human studies."

Public-interest and consumer advocates have long attacked such studies because they are producer-controlled and sometimes dangerous to participants, who are often poor and are lured by the relatively small cash payments provided for taking part.

Public Employees for Environmental Responsibility (PEER) charged in a statement released yesterday that the EPA rule would allow children, the mentally disabled and prisoners to be used as fodder for pesticide and other chemical-industry testing.

"The good news is that EPA, for the first time, is pledging to abide by the Nuremberg Code, adopted after World War II to prevent a repetition of the horrific Nazi human experiments," PEER Executive Director Jeff Ruch said in the statement. "The bad news is that EPA’s proposal breaks this long-overdue pledge by offering a plan peppered with loopholes that encourage unethical conduct and omit key protections for infants, pregnant women and other vulnerable populations."

PEER and eight other environmental, public-health and children’s advocacy groups joined together in filing comments opposing the new regulations yesterday. The coalition’s fourteen-page letter charged that, in addition to provisions permitting third-party human testing, the EPA rules open the door to new projects that use economic incentives to induce low-income people into voluntarily exposing themselves to toxins.

In September, the Baltimore Sun reported that the proposed rules specifically contain language allowing tests on "abused and neglected" children to be accepted as part of applications for new or expanded pesticide uses. The Agency disputed the conclusions in a letter to the editor but has yet to fully account for the language in the Federal Register.

Last week, the union representing about 6,500 EPA employees sent EPA administrator Stephen L. Johnson a letter outlining concern over loopholes and toothless ethical standards set forth in the proposed rules.

As part of the bill authorizing funds for the EPA, the Agency was tasked with developing and implementing new guidelines for pesticide- and chemical-toxicity studies after a 90-day public-comment period. The period, which officially began at the start of the current fiscal year, on October 1, ends in December. The new rules are expected to be in place by the end of January 2006.

In statements accompanying the proposed rules, the EPA noted that these are the first to be enacted and said the regulations would comply with National Academy of Sciences recommendations.

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The NewStandard ceased publishing on April 27, 2007.


Brendan Coyne is a contributing journalist.

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