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In August 2005, Congress passed a law requiring EPA to establish stronger ethical guidelines on pesticide studies involving human subjects. The August legislation sponsored by Senator Barbara Boxer and Representative Henry Waxman specifies that EPA practices "shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation...." EPA responded on September 12th by opening a 90-day public comment period on a proposed new rule titled "Protections for Subjects in Human Research."
One of the key tenants of the Nuremberg code states, "The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment." Analyses of EPA's proposed rule by Pesticide Action Network North America, Natural Resources Defense Council and other organizations reveal provisions in the proposed rule that would allow EPA to use studies based on intentionally testing pesticides on humans as an acceptable source of data in determining pesticide exposure regulations - a practice that contradicts the Nuremburg Code, and that PANNA and many organizations denounce as unethical.
Pesticide industry registrants frequently challenge EPA's pesticide exposure limits as too conservative and submit studies supporting increases in allowable exposure levels. Yet pesticides are by definition chemicals that are toxic to organisms, and the intentional exposure of human subjects to a pesticide necessarily involves some risk of harm. No humanitarian need justifies the risk of exposing humans to pesticides in order to allow chemical companies to preserve or increase their markets or sales. Such studies risks are unethical, and must not be used by EPA by explicit instruction from Congress.
EPA is also considering "grandfathering" the use of unethical studies into its regulatory process. But unethical science is not reproducible science, and is therefore unreliable. It is a fundamental hallmark of the scientific method that experiments should be reproducible by other scientists, whose work then confirms or refutes the experimental results. Unethical experiments by definition must not be reproduced, and therefore are neither reliable nor acceptable as a basis for safety regulations, especially when conducted by corporations that claim them as "confidential business information" and refuse to make public their results. EPA must reject past studies based on intentional human dosing in its decision making process.
PAN's position is that scientific questions involving human pesticide exposure should be addressed to the fullest extent possible through studies that pose no additional risk to subjects. Such methods include biomonitoring and epidemiological studies. Every person alive today has been exposed to pesticides already, and EPA should apply its limited resources to evaluating the impacts of existing exposures, particularly amongst highly vulnerable populations. This means more resources should be dedicated to biomonitoring of the existing pesticide body burdens of workers who are exposed to pesticides in their jobs; pregnant women, children, and elders; and persons with potentially suppressed immune systems. Furthermore, while it is appropriate that the chemical industry be required to finance ethical research, all industry-supported studies should be overseen by appropriate public institutions, with mechanisms in place to assure no conflicts of interest or undue industry influence.
Congress has instructed EPA to follow clear international ethical guidelines that rule against human dosing for corporate profit. But EPA's proposed rule on human testing contains deep ethical flaws. It must be changed to avoid additional human pesticide exposures for the purpose of undermining health protections.
To take action on this issue by contacting EPA during the comment period through December 12th, subscribe to Pesticide Action Network North America's alert service.
Sources: Oleskey, Christopher; A. Fleischman; L. Goldman; K. Hirschhorn; P. J. Landrigan; M. Lappe; M. F. Marshall; H. Needleman; R. Rhodes; and M. McCally. 2005. "Pesticide Testing in Humans: Ethics and Public Policy" in Environmental Health Perspectives 113: 11. http://ehp.niehs.nih.gov/members/2004/6522/6522.html
"Permissible Medical Experiments." Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg October 1946 - April 1949, Washington. U.S. Government Printing Office (n.d.), vol. 2., pp. 181-182. http://www.hhs.gov/ohrp/references/nurcode.htm
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Contact: PAN North America