June 2002

Panel Moves Slowly to Answer Human Testing Acceptance Question

By mid-May, five months after EPA Assistant Administrator Stephen Johnson requested assistance on human testing from the National Academies, the organization and the EPA were still in the process of completing negotiations for a contract to form a panel which would delve into the issue. The panel is expected to begin work on the question by early summer. Johnson's request asked the National Academies to help the EPA develop "appropriate factors" and criteria to be applied to "difficult decisions" on human tests. The EPA also stated that it would not rely on any human data until it had received advice from the National Academies. This decision by the Agency has alarmed many toxicologists, because although the activist organizations whose concern prompted EPA's action have focused on data generated from pesticide manufacturers, the results from many different types of research involving chemicals (including pesticides) that are conducted by university scientists could also be rejected.

Meanwhile, various organizations are providing their input into the question. According to a member of the advisory board for the Center of Regulatory Effectiveness, the EPA is required by federal data quality guidelines to accept human data generated by third parties. The Office of Management and Budget earlier this year released guidance to ensure that federally disseminated information is accurate, clear, useful, and unbiased. Agencies are to develop their own specific policies in response to that guidance by October 1. Accordingly, if the EPA continues to reject human data generated by non-EPA scientists, then it is violating OMB's guidance, which is binding on federal agencies. EPA may respond that the data quality guidance is not binding, or it could interpret the use of best-available science as excluding this type of data.

A member of a group that opposes the use of human data to make regulatory decisions stated that human data should not be used because it is obtained using only a small number of adults. However, an analysis of safety standards conducted by the director of Toxicology Excellence of Risk Assessment concluded that critical adverse effects would be missed in many risk assessments if human data were ignored. (Chemical Regulation Reporter, Vol. 26, No. 19 & No. 21).

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