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From November 30, 2005                                                                                                           

Tell EPA To Stop Pesticide Experimentation on Human Subjects
(Beyond Pesticides, November 30, 2005)
While EPA is characterizing its proposed rule on intentional dosing of human subjects with pesticides, Protections for Subjects in Human Research (70 Federal Register 53838), as protective of test subjects, it is basically flawed, unethical and out of step with international code. This proposal advances industry interests, not the public interest. Let EPA know that its proposal to allow human testing of pesticides, or intentional dosing with pesticides, does not provide adequate protection.

Please submit your comments by December 12, 2005 to opp-docket@epa.gov. Note docket ID number: OPP-2003-0132. Or mail to: EPA, Public Information and Records Integrity Branch, 7502C, Office of Pesticide Programs, 1200 Pennsylvania Avenue, NW, Washington DC 20460.

The thematic problems with the rule are as follows (For more information, see “EPA To Allow Human Testing with Pesticides” from the upcoming issue of Pesticides and You):

I. Pesticide “benefits” do not justify the intentional dosing of human subjects. It is simply unethical to test toxic chemicals on human subjects when there is not documented and fully determined societal benefit. EPA does not evaluate pesticides for their societal benefits in light of alternative approaches, practices and products. EPA does not by practice or rule, under the “unreasonable adverse effects” standard of the federal pesticide registration law (Federal Insecticide, Fungicide and Rodenticide Act - FIFRA), generally evaluate the actual need for a pesticide to determine whether the pest is adequately defined and, if so, whether there is a less toxic approach to pest prevention or management. Therefore, EPA is not equipped to meet the proposed rule’s requirement that human studies are approved “only if risks to subjects . . . are reasonable in relation to anticipated benefits.” This is a threshold issue when discussing the ethics of intentionally dosing human subjects with pesticides.

II. Disproportionately higher risk is allowed to vulnerable population groups. The exceptions and contradictions throughout the EPA proposed rule leaves children especially vulnerable to studies that intentionally dose them with pesticides. The proposed rule contradicts itself, saying that testing on women and infants is prohibited, then stating that it may utilize such studies “when such research is deemed scientifically sound and crucial to the protection of public health.” The protections for those with special disabilities or limited capacity are virtually none existent. The agency may even waive the consent requirement for neglected or abused children.

III. Observational studies that encourage pesticide use with incentives remain unaffected by the rule. Studies such as the highly controversial, and at least temporarily derailed Children’s Environmental Exposure Research Study (CHEERS), would not be outlawed or restricted by the proposed rule.

IV. Ethics are undermined by exceptions. The rule allows for circumstances that will enable EPA to utilize prohibited studies because of the use of words (such as fundamentally, seriously, significantly, and crucial) that are subject to interpretation. This language will allow the use of old studies, foreign experiments, prisoner studies, and others.

Thanks for speaking out!