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July 21, 2005

Gordon, Democrats Call on EPA Administrator to Clarify Legal Status of Human Pesticide Studies

(Washington, DC) Four Democratic Members of the House Science Committee questioned the legality of the human pesticide studies the Environmental Protection Agency (EPA) has decided to consider in setting safety standards for pesticide use. Democrats described the current process for evaluating studies involving human subjects "seriously deficient."

In a letter this week to EPA Administrator Stephen L. Johnson, Committee Democrats urged the Agency to move "expeditiously to establish a rigorous protocol for reviewing and overseeing any research that may be used in EPA regulatory decisions whether conducted, sponsored or submitted to the agency by a third party." They added, "However you proceed, it must be in compliance with standing law, and we seek your assurance that you have faithfully tended to your obligations under FIFRA."

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) prohibits the use of any pesticide "in a manner inconsistent with its labeling." FIFRA also deems it unlawful to use pesticides on tests with humans unless they are "fully informed of the nature and purposes of the test" and "freely volunteer to participate in the test."

"Research conducted, sponsored or accepted by EPA must conform to high ethical and scientific standards," said Science Committee Ranking Member Rep. Bart Gordon (D-TN), who has followed developments on this matter closely. "EPA's current policy is achieving neither. Administrator Johnson should reject any study that does not fully comply with EPA statutes and with government standards protecting human research subjects established through the Common Rule."

A report released last month by Rep. Henry Waxman (D-CA) and Sen. Barbara Boxer (D-CA) analyzed 22 human pesticide studies submitted to EPA. Their report revealed that many of these studies are ethically and scientifically flawed; in fact, five of the studies failed to provide even sample informed consent forms from "volunteers" and four studies did not indicate that informed consent was ever obtained.

At minimum, it appears that most - if not all - of the 22 intentional human dosing studies analyzed involve pesticide usage that is not in accordance with their labels.

Committee Member Rep. Mark Udall (D-CO) added, "No one should be asked to sacrifice their present or future health to perfect a risk assessment, especially in cases where the goal appears to be a weakening of health-based standards. EPA's failure to institute clear human protection policies and to fully enforce standards for human subject protection provides an open invitation for abuse."

"EPA's acceptance of unethical studies undermines public trust in the Agency. EPA should vigorously enforce existing law and move aggressively to discourage intentional dosing of humans with pesticides. EPA's lax enforcement of existing human research protection policy is indefensible. I hope our inquiry will encourage the Agency to reconsider their current dangerous, unethical and scientifically indefensible policy," stated Rep. Eddie Bernice Johnson (D-TX).

"In my view, the Agency has the authority to put a stop to these unethical experiments; they simply lack the will to do so. All studies EPA considers - whether in-house, government sponsored, or provided by third parties - should meet high ethical and scientific standards," said Rep. Brian Baird (D-WA). "The studies described in the report by Sen. Boxer and Rep. Waxman EPA are scientifically flawed and clearly negligent in their enforcement of human research protections. It should not take a moratorium enacted by Congress to force EPA to reject this research."

Both the House and Senate recently voted to include a provision in the FY2006 Interior Appropriations bill to reinstate EPA's moratorium on consideration of pesticide studies using human subjects, which the Administration lifted in 2001.

The leak on June 28, 2005 of EPA's long-delayed draft regulation on human testing received harsh criticism from inside and outside the Agency. The proposal contained few safeguards recommended by the three scientific panels that have examined this issue over the past five years. EPA is now expected to issue a proposed rule in August.

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