Industry Plotted Bush Human Testing Policy
(Beyond Pesticides, June 5, 2006) One month before the Bush administration proposed rules authorizing experiments on humans with pesticides and other chemicals, Office of Management and Budget (OMB) and Environmental Protection Agency (EPA) staff met with pesticide industry lobbyists to map out its provisions, according to meeting notes posted May 30, 2006 by Public Employees for Environmental Responsibility (PEER). The industry requests for exemptions allowing some chemical testing on children and other provisions were incorporated into the human testing rule ultimately adopted in January 2006.
At the August 9, 2005 meeting held inside the President’s Office of Management and Budget, representatives of the pesticide trade association, Crop Life America, as well as Bayer Crop Life Science met with OMB and EPA officials. Also attending was a former top EPA official, James Aidala, who now acts a lobbyist at a law firm representing chemical companies.
The meeting notes
detail industry concerns about the text of a proposed rule that the
Bush administration first unveiled a month later on September 12th.
For example, the Crop Life America attendees urged:
• “Re kids—never say never” (emphasis in original);
• “Pesticides have benefits. Rule should say so. Testing, too, has benefits”; and
• “We want a rule quickly—[therefore] narrow [is] better. Don’t like being singled out but, speed is most imp.”
“These meeting notes make it clear that the pesticide industry’s top objective is access to children for experiments. After reading these ghoulish notes one has the urge to take a shower,” commented PEER Executive Director Jeff Ruch, whose organization works with EPA scientists who have been prevented from voicing ethical and scientific concerns about human subject testing. “For an administration which trumpets its concern for the ‘value and dignity of life,’ it is disconcerting that no ethicists, children advocates or scientists were invited to this meeting to counterbalance the pesticide pushers.”
The upcoming August 3rd deadline for EPA final approval for a controversial class of pesticides derived from nerve agents called organophosphates appeared to be a top industry priority. Mr. Aidala, the industry lobbyist, stated, “Won’t be able to meet the FQPA [Food Quality Protection Act] deadline. Wouldn’t anyway. Just do the rule first, then proceed ASAP.”
Mr. Aidala also
suggested how the rules could make subtle exceptions for chemicals testing
• “Distinguish testing kids from using data on kids who were tested”; and
• “Some workers may legally be children, albeit old enough for DOL” [Department of Labor coverage].
The human testing rule adopted by EPA earlier this year contains the loopholes advocated at the OMB meeting for exposing children to pesticides, such as testing on workers and exposures unconnected with the approval process for new pesticides or new uses for existing agents. In addition, the rule broadly allows dosing experiments on infants and pregnant women using non-pesticide chemicals.
Beyond Pesticides is opposed to testing pesticides on humans. Although EPA is assuring the highest levels of safeguards available, what continues to be an issue for environmental and public health advocates, is that pesticide “benefits” do not justify the intentional dosing of human subjects even on a voluntary basis. 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 or non-toxic approach to pest prevention or management. Therefore, EPA is not equipped to meet the 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 toxic chemicals.
Take Action: Let EPA know the public will not tolerate weak ethical standards, especially in a rule that allows people to be exposed to unnecessary and potentially detrimental health risks and that the proposal fails to comply with the Congressional mandate. Write to EPA Administrator Stephen Johnson, [email protected], and let him know how you feel about this important issue. Also, write to your Senators and Members of Congress. Much of the movement on this issue has been initiated in Congress and may continue as a result of Congress responding to public outrage. To determine your Senators and Member of Congress, visit www.congress.org or contact Beyond Pesticides.