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House of Representatives Passes Bill to Ban Human Studies of Pesticides
The bill puts lawmakers at odds with a controversial proposed policy of the Bush Administration that currently allows on a case-by-case basis data from pesticide tests on humans to be used to support the registration of pesticide products. This is a reversal of the Clinton Administration. The Bush Administration in December 2001 had backed off plans to reverse the Clinton ban on human testing and then did an about face. See industry position. Representing the pesticide industry, CropLife sued EPA on February 12, 2002 (U.S. Court of Appeals D.C. Circuit Petition for Review (February 12, 2002) -- CropLife America, et al. v. EPA), arguing that the agency could not ban human testing. In that case, the Court of Appeals ruled on June 3, 2003 (CropLife America v. EPA) that EPA could not issue a ban without notice or the opportunity for public comment. EPA contracted with the National Academy of Sciences, which released the report, Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues, on the subject outlining protocol for human testing. See Daily News on the subject.
Instead of moving ahead with its position to ban human testing, on February 8, 2005 the Bush Administration published in the Federal Register (70 FR 6661) its proposal to allow human testing. Prior to this, on May 7, 2003, EPA issued an advance notice of proposed rulemaking (ANPR) on human testing (68 FR 24410) in which EPA announced its intention to undertake notice-and-comment rulemaking on its consideration of or reliance on research involving human participants. The ANPR also invited public comment on a broad range of issues related to this subject. EPA received over 600 submissions in response to the ANPR. Approximately 15 were from pesticide companies, pesticide users, and associated trade associations and groups. These comments mostly favored the agency's use of data from scientifically sound, ethically appropriate studies conducted with human participants. Several of these groups urged EPA to apply the Common Rule to human research conducted for EPA by third parties. About 60 submissions came from religious groups, farm-workers' and children's advocacy groups, and environmental and public health advocacy organizations. Most of these groups generally opposed EPA's consideration of results from human testing, especially those involving intentional dosing of test participants with pesticides, on ethical grounds.
Currently, EPA considers third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and, according to the agency “high ethical standards as a guide.” In its consideration and review of human studies submitted to the Agency, EPA generally accepts “scientifically valid studies unless there is clear evidence that the conduct of those studies was fundamentally unethical (e.g., the studies were intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted.”
In January 8, 2003 remarks to the Committee on the Use of Third Party Toxicity Research with Human Research Participants, Vera Hassner Sharav, the president of the Alliance for Human Research Protection (AHRP), testified that, "Pesticide experiments in human beings are morally unconscionable and scientifically dubious-they fail to meet fundamental standards of permissible research-as they offer no potential therapeutic benefit to the subjects or society." See Beyond Pesticides’ concerns about human testing with pesticides and comments submitted to EPA. EPA received comments until May 8, 2005 on its human testing proposal, but it will receive public comments (although it is not required to consider them) after the due date. See EPA’s website for EPA’s background and to submit comments.