Clinical Studies Debate
In 1998, the EPA placed a moratorium on clinical studies, or human studies, citing both ethical and scientific concerns. While the use of clinical studies for pesticide tolerances had been in decline since the 1980s, the passing of the FQPA re-generated interest in the practice. By testing on humans, pesticide manufacturers could eliminate the additional safety margins required when using data collected from animal testing. Following their moratorium the EPA had the National Academy of Sciences convene a panel of experts to determine the ethical solution to the human studies debate. While the National Academy of sciences established the panel, both pesticide manufactures and environmentalists established their own opinions. The Environmental Working Group and the Natural Resources Defense Council argued that clinical studies were both inaccurate and ethically wrong; pesticide manufacturers argued that not only were clinical studies crucial but that they must be allowed to conduct the tests to determine "No observable adverse effects level", meaning they administer the drug until an effect is observed.
The National Academy of Sciences released a report in 2004 supporting the use of clinical studies under strict regulations; the regulations mandated that the study's benefit to society outweigh the risk to the individual, that the study be conducted under a strict ethical code, that there be reasonable certainty that no harm will come to participants and that it has been shown that no other study will work. In 2005, adhering to a congressional directive, the EPA adopted the Human Studies Regulation; the regulations permit human studies, do not allow the use of pregnant women or children in human studies, mandate that a strict ethical code be followed and establish a Human Studies Review Board to oversee the use of human studies. The EPA considers the regulations as a major accomplishment in public policy.
Read more about this topic: Food Quality Protection Act
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