July 18, 2005
The Honorable Stephen L. Johnson
Administrator
US Environmental Protection Agency
401 M Street, SW
Washington, DC 20460-0003
Dear Administrator Johnson:
More than a year after the completion of the study by the National Academy of Sciences and five years after the joint FIFRA Science Advisory Panel's (SAP) and the Science Advisory Board's (SAB) review of the ethical and scientific issues associated with intentional human dosing experiments testing toxic compounds, the Agency has failed to issue a binding rule to replace the current ad hoc, case-by-case review process. The Agency has done little more than solicit comments through two Federal Register notices. As a consequence, the Agency has permitted an ad hoc, unregulated process for evaluating third-party studies involving the intentional dosing of human subjects with toxic compounds to evolve without addressing the fundamental ethical issues raised by expert reviews undertaken at your direction....
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Letter to EPA Administrator on the Use of Human Exposure Data in Regulating Toxic Chemicals
July 18, 2005
The Honorable Stephen L. Johnson
Administrator
US Environmental Protection Agency
401 M Street, SW
Washington, DC 20460-0003
Dear Administrator Johnson:
More than a year after the completion of the study by the National Academy of Sciences and five years after the joint FIFRA Science Advisory Panel's (SAP) and the Science Advisory Board's (SAB) review of the ethical and scientific issues associated with intentional human dosing experiments testing toxic compounds, the Agency has failed to issue a binding rule to replace the current ad hoc, case-by-case review process. The Agency has done little more than solicit comments through two Federal Register notices. As a consequence, the Agency has permitted an ad hoc, unregulated process for evaluating third-party studies involving the intentional dosing of human subjects with toxic compounds to evolve without addressing the fundamental ethical issues raised by expert reviews undertaken at your direction....
Read the complete letterRelated Subcommittees
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