March 2004

Human Testing Addressed by
Academies Panel

The National Academies’ National Research Council recently presented the EPA with a report it had requested nearly two years ago regarding the use of human testing for pesticides and other compounds (CS, June 2002). Although it does not recommend banning human exposure outright, testing should only be considered by the agency if it addresses regulatory questions that cannot be answered with animal studies or other testing that does not involve humans.

The recommendations are expected to influence the agency’s draft of intentional dosing studies. EPA had attempted to institute a ban in a December 2001 press release that pledged to refrain from using human data until the academies’ study was completed, but the policy was challenged and struck down in June of 2003. Now that the report is out, the agency must decide how to handle such data.

The authors of the report urged EPA to add several procedures to ensure that such studies adhere to more rigorous ethical and scientific requirements. Equitable selection and recruitment of human subjects and obtaining informed consent from those volunteers were also recommended steps. They also recommended creation of a Human Studies Review Board to evaluate all human dosing studies that are undertaken under agency auspices, and it is hoped that private researchers would submit studies to the board prior to conducting them.

Many data submitters believe that current human data would fulfill the recommended requirements because it was conducted in accordance with the Common Rule, a set of federal regulations governing the protection of human subjects. The regulations were simultaneously adopted by 15 agencies and departments in 1991, including the EPA and the Departments of Agriculture, Defense, Energy, and Health and Human Services. (Chemical Regulation Reporter, 2/23/04).

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