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November 22, 2005 Public Information and Records "Integrity" Branch (PIRIB) Office of Pesticide Programs U.S. Environmental Protection Agency Mail Code: 7502C 1200 Pennsylvania Ave., NW Washington, DC, 20460-0001 Attention: Docket ID Number OPP-2003-0132 Re: Comments on Docket ID Number OPP-2003-0132 Don't Waste Arizona, Inc. (DWA) is a non-profit environmental organization dedicated to the protection and preservation of the Arizona environment. DWAZ is especially concerned about environmental justice issues, pesticide, and toxics issues. DWAZ is headquartered at 6205 South 12th Street, Phoenix, AZ 85042, and may be reached at (602) 268-6110. DWA has members that would be potentially affected by this proposed rule. On behalf of itself and its potentially affected members, Don't Waste Arizona, Inc. (DWAZ) makes the following comments: The proposed rule is a civil and human rights violation in the making, as well as being an illegal action subverting and countering the will of the U.S. Congress. The EPA proposed rule was drafted in response to a Congressional mandate to establish enforceable and ethical guidance regarding intentional pesticide exposure human studies conducted by the EPA and third parties. The Congressional mandate, signed into law on August 2, 2005 as an attachment to the Department of Interior, Environment, and Related Agencies Appropriations Act for 2006, states, in part: "Such rule shall not permit the use of pregnant women, infants or children as subjects; 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; and shall establish an independent Human Subjects Review Board." The proposed rule explicitly ignores the congressional mandate on every point, does not explicitly prohibit testing on pregnant women and children with no exceptions, and raises dramatic ethical concerns regarding human testing pesticide experiments. The Rule Permits Testing on Pregnant Women and Children EPA will accept human studies on pregnant women or children if the study is "crucial to the protection of public health." The term protection of public health is not defined. Industries could make the case that increased crop yield, or control of diseases such as West Nile Virus can be categorized as a public health issue, although the potential benefit to society from the experiment may not outweigh the risk to the health of the participant. Pregnant women or children can be experimented on if they consume food sprayed with pesticides up to the legal exposure limit, instead of being directly sprayed with the same amount of the pesticide. Limits for pesticide exposures on food crops are set at standards for healthy adults, not for small children and their growing bodies, therefore a "legal exposure limit" is not safe for vulnerable populations. This makes EPA the equivalent of a type of child molester. Human Experiments Conducted Overseas Are Not Held to the Standards of the Rule EPA can waive the entire regulation when conducting or funding chemical tests on children outside the United States. This makes EPA the equivalent of a type of international child molesting ring. The Rule Allows "Neglected Or Abused Children" to Be Tested Without Parental Consent EPA waives the standard parental consent requirement for "neglected or abused children", but allows them to be recruited as participants in pesticide studies. This makes EPA the equivalent of a type of child molester. The Rule Allows Testing on Children of "Limited Capability" Without Their Consent If a child's capability is "so limited" that he or she "cannot reasonably be consulted," such as orphaned newborns, severely mentally disabled children, and other highly vulnerable populations, they can be experimented on with the permission of the institution or other guardian. This makes EPA the equivalent of a type of child molester. The Proposed Rule Is Not Consistent with the Nuremberg Code The Nuremberg Code, passed after the war atrocities of World War II, requires that voluntary consent of test subjects is "absolutely essential," and in particular that the test subject must have "legal capacity to give consent" and must be "so situated as to exercise free power of choice." The rule does not abide by this international treaty, which makes the intent of the EPA rule a criminal act. The Proposed Human Studies Review Board Has No Authority The required creation of a Human Studies Review Board to evaluate proposed tests, as established in this rule, has no authority beyond "review[ing] and comment[ing] on" proposed human tests. EPA is not bound by the review board's recommendations. Studies completed and submitted before the creation of the Human Studies Review Board are eligible to be relied upon under the proposed rule, even if conducted unethically. The Rule Has No Teeth EPA lists a number of potential consequences for entities that conduct or submit unethical human tests, including termination of ongoing studies, disqualification of the entity, and refusal to rely on the data. However, EPA gives itself the discretion not to impose any of these sanctions, and reserves the right to rely on data from unethical studies, or those "conducted at a disqualified institution." The Proposed Rule Allows Pesticide Testing on Prison Inmates EPA currently relies on some "third-party research with prisoner subjects." EPA deferred adopting any rules to protect prisoners, however, because such rules could "create as many problems as they solve." Despite the obvious problems of informed consent posed by testing chemicals on prison inmates, EPA dodges the issue in its proposed rule. EPA will therefore continue to rely on inmate experiments under this rule. The EPA is allowing or planning to allow a type of torture, and should be brought before the World Court regarding this proposed rule, as well as the people within the agency who have crafted it. Sincerely, Stephen M. Brittle President Don't Waste Arizona, Inc. 6205 South 12th Street Phoenix, AZ 85042