SELECTION OF FIELD AND LABORATORY STUDIES FOR ENVIRONMENTAL ASSESSMENT

Selection and conduct of the proper field and/or laboratory studies fo r inclusion in an Environmental Assessment of EPA and FDA. regulated c hemicals are often poorly understood or appreciated. This may lead to performance of inappropriate, invalid, or insufficient studies resulti ng in increased regulatory review time or rejection of submissions. Th e focus of this presentation is on studies listed in FDA and EPA guide lines. A rationale for environmental fate and effects testing is prese nted together with a tabulated summary of suggested tests by FDA and E PA for regulated chemicals. A description of studies, their significan ce, and a logical, efficient approach to selecting appropriate studies is also presented.