PANNA's Comments on Human TestingDecember 12, 2005 William L. Jordan, Senior Policy Advisor
Dear Mr. Jordan : This letter is a public comment for submission to the docket on 40 CFR Part 26, Protections for Subjects in Human Research, Proposed Rule , Docket ID EPA-HQ-OPP-2003-0132. Pesticide Action Network North America (PANNA) has worked for more than 20 years educating pesticide users and the general public on the environmental and human health hazards of exposure to pesticides, and promoting the replacement of hazardous pesticides with safer pest control methods. PANNA has serious concerns about the proposed rule on human testing. A discussion of our concerns follows. The conclusions of this discussion are:
All of these conclusions follow easily from the application of well-accepted ethical principles to the specific issue of intentional dosing of human subjects with pesticides. In particular, they follow from the Nuremberg Code, [2] with which Congress has explicitly instructed EPA to comply. Please note that our conclusions and supporting discussion refer only to research involving intentional dosing of human subjects with pesticides. It is not our intention to comment here on the ethics of testing of non-pesticide chemicals, including drugs or vitamins being studied for therapeutic or dietetic benefit. Well-established regulations already govern the ethical scientific investigation of a chemical's therapeutic value, including cases involving pesticides studied for this reason. PANNA notes and is proud to contribute to the body of comments that this public process has elicited, which nearly unanimously oppose intentional dosing of human subjects with pesticides, including the comments submitted by the Natural Resources Defense Council (NRDC), [3], [4] Center for Children's Health and the Environment of Mt. Sinai School of Medicine, [5] Environmental Working Group, [6] Beyond Pesticides, [7] Farmworker Justice Fund, [8], [9] Physicians for Social Responsibility, [10] and others representing environmental health and social justice concerns.
Although our comments do not repeat all the conclusions and supporting arguments made by these groups in this docket, we certainly share their concerns. In particular, we strongly support the special attention they give to exposure of already disproportionately exposed populations; to individuals and groups that are highly vulnerable to pesticide exposure; to populations unable to give informed consent, including children and the unborn; and to populations under economic or other duress that makes truly voluntary informed consent impossible. 1. Science Involving Intentional Dosing of Human Subjects with Pesticides in Order to Determine Regulatory Limits Is UnethicalCongress has required the EPA's rule to be consistent with the Nuremberg Code. Among the ten points of the Nuremberg Code, point six states:
Since pesticides are by definition toxic to living organisms, intentional exposure of a human subject to a pesticide always involves some degree of risk. A problem of humanitarian importance by definition directly addresses issues that are “involved in or connected with improving people's lives and reducing suffering” [11] Determining acceptable levels of pesticide exposure for regulatory purposes does not address a humanitarian problem. This means that scientific research that involves intentional dosing of human subjects in order to determine regulatory limits is unethical according to the Nuremberg Code, and may not be used by the EPA by explicit instruction of Congress. The EPA's analysis of compliance of its proposed rule with the Nuremberg Code [12] does not adequately address this point, because it equates the phrase “humanitarian importance” with the broader phrase “good of society.” Let us be clear: industrial interest in these studies is to rationalize an increase in the allowable exposure to a pesticide so as to maximize producer welfare, not to relieve human suffering. While the phrase “good of society” might be construed to encompass commercial interest, the phrase “humanitarian importance” does not. Other widely accepted ethical codes including the Declaration of Helsinki [13] echo the Nuremberg Code:
Science done to determine a regulatory limit is neither diagnostic, therapeutic or prophylactic, nor is it fundamental science on the etiology or pathogenesis of disease as required by the Declaration of Helsinki. To comply with the Nuremberg Code, EPA's final version of this rule must clarify that risk to human subjects can only be offset by humanitarian benefits. It should also define “humanitarian importance,” the definition of which should not be broadened to encompass commercial interest. 2. Unethical Science is Irreproducible and Unsound, Regardless of the Ethical Standards Applicable when the Science was PerformedA key part of scientific inquiry is that results of scientific experimentation be independently verifiable. Consider as an example the previous human testing studies performed under conditions since determined as unethical by current standards. These experimental results could no longer be verified by reproducing the experiment, because the experiment itself would not be permitted under current standards. In general, if the verification of a scientific result would necessitate violation of current ethical standards, then that experiment cannot be reproduced and therefore does not qualify as sound science. This is true even in cases where the study in question was considered ethical under weaker (or non-existent) ethical standards applicable at the time they were performed. CropLife America argues that unethical studies should not be “retroactively” excluded by currently applicable ethical standards.[14] However, CropLife America 's argument did not consider the opposing argument that evolving ethical standards may render a scientific result unverifiable because reproducing the experiment would violate current ethical standards. Additionally, PANNA is concerned that acceptance of studies judged unethical under current standards—using the argument that the risk to human subjects has already been taken—will encourage unethical studies to be conducted in the future, because the same argument would be just as applicable to future unethical studies. Unethical, and hence irreproducible, experiments should not inform EPA regulatory decisions, and the proposed rule should reflect this. 3. Science that Involves Intentional Risk to Human Subjects is Unethical if Results are not Made PublicPANNA acknowledges that in principle there may be science involving intentional risk to human subjects that is ethical due to its humanitarian importance. Although identification of such cases is among the tasks of well-constituted independent human studies review boards, and provision of specific examples is beyond the scope of these comments, we do note that to satisfy the standard of maximizing humanitarian benefits in relation to risks, ethical science must be subjected to the highest standards of review and made available to the scientific community and to the public. At a minimum this involves presentation and/or publication in appropriate venues and peer-reviewed journals, although other means are possible as well. This requirement holds true whether or not the scientific results confirm or fail to support the experimenter's hypotheses, or the expectations of the institution(s) sponsoring the study. Maximizing humanitarian benefit in relation to risk is implicit in the Nuremberg Code. To deprive society of the benefit of any knowledge gained from science involving intentionally exposing human subjects to risk is unethical, even in studies conducted in pursuit of legitimate humanitarian purposes, because this fails to maximize the benefits in relation to the risks. In particular, science that involves intentional exposure of human subjects to risk is unethical if the results and other knowledge generated by this science are kept from the public for commercial purposes, including designating them as “confidential business information.” The human subjects rule should make specific demands requiring the maximization of humanitarian benefit, including making results readily available to the public. 4. Ethical Considerations Require that Least-Risk and Least-Harm Science, including Biomonitoring and Epidemiological Studies, be Pursued More VigorouslyAlso following from maximizing humanitarian benefit in relation to risk, scientific questions involving human pesticide exposure should be addressed to the fullest extent possible through science that does not involve intentional risk to human subjects. Such science includes, but is not limited to, biomonitoring and epidemiological studies. EPA should apply its limited resources to more vigorous evaluation of current and past exposures, particularly among populations with the greatest likelihood of exposure or vulnerability. Furthermore, pesticide manufacturers, formulators, distributors, retailers, or other industry representatives should have no role in the design or execution of research on human health effects of pesticides. While both the fairness of the “Polluter Pays” principle and the economic wisdom of internalizing external costs of products and processes require that the chemical industry pay a greater proportion for such research, it is absolutely essential that this be done with mechanisms that preclude either the appearance, or more importantly the reality, of any industry influence on the design, execution or outcomes of the research. Finally, given the history of studies of existing exposures, the human subjects rule should require that studies involving existing pesticide exposures have safety measures in place so that if and when dangerous exposures are found by the study, researchers are required to inform their subjects about the possible risks of these exposures and ways that they can reduce or eliminate those risks. In such cases, researchers must not in any way induce the subjects to perpetuate existing exposures in order to continue collecting information. SummaryWe hope these comments clearly present our conclusions, the basis upon which they are made, and their firm grounding in principles embodied in the Nuremberg Code and other well-accepted ethical standards. PANNA urges EPA to address these concerns by revising the proposed human testing rule to ensure that it is both fully health-protective for all human subjects, and fully compliant with the Nuremberg Code. To do so, EPA must ensure that the final rule provides no opportunity, however slight or exceptional, for the pesticide industry to risk people's health or well being for the purpose of establishing permissible pesticide exposure levels. Sincerely yours, Brian R. Hill, PhD, Staff Scientist Margaret Reeves, PhD, Senior Scientist and Program Coordinator
[1] This is the converse of the more commonly found conclusion, also supported by PANNA, that unsound science involving risk to human subjects is unethical. [2]Nuremberg Code, Directives for Human Experimentation, Office of Human Subjects Research, National Institute of Health, http://ohsr.od.nih.gov/guidelines/nuremberg.html , Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182, Washington , DC , US Government Printing Office, 1949. [3]Comments of the Natural Resources Defense Council on EPA's Proposed Plan and Description of Review Process for Human Testing, EPA-HQ-OPP-2003-0132-0230. [4] These comments were submitted on behalf of NRDC and PANNA, they are incorporated by reference herein. [5] C Oleskey, et al, Pesticide Testing in Humans: Ethics and Public Policy, EPA-HQ-OPP-2003-0132-0015. [6] The English Patients: Human Experiments and Pesticide Policy, Environmental Working Group, EPA-HQ-OPP-2003-132-0006. [7] Comments of Beyond Pesticides, EPA-HQ-OPP-2003-0132-0121. [8] Comments of Farmworker Justice Fund, California Rural Legal Assistance Foundation, Michigan Migrant Legal Assistance Project, Inc, and Migrant Farmworker Justice Project. EPA-HQ-OPP-2003-0132-0120. [9] Farmworker Justice Fund Action Alert, 12/5/2005, containing comments to be submitted to this docket. [10] Comments on behalf of Physicians for Social Responsibility, EPA-HQ-OPP-2003-0132-0223. [11] Cambridge Dictionary of American English, Cambridge University Press, Cambridge , UK ; New York , 2000, definition reprinted on-line at http://dictionary.cambridge.org/define.asp?key=humanitarian*1+0 . [12] Consistency of EPA's Proposed Human Studies Rule with the Nuremberg Code, EPA-HQ-OPP-2003-0132-0247. [13] World Medical Association Declaration of Helsinki : Ethical Principles for Medical Research Involving Human Subjects, EPA-HQ-OPP-0132-0239. [14]CropLife America Comments: OPP-2003-0132; FRL-7695-4, EPA-HQ-OPP-2003-0132-0227, p 5. |
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