Data disclosure for chemical evaluations

Abstract

Background: Public disclosure of scientific data used by the government to make regulatory decisions for chemicals is a practical step that can enhance public confdence in the scientifc basis of such decisions. oB je c t iv e s: We reviewed the U.S. Environmental Protection Agency's (EPA) current practices regarding disclosure of data under lying regulatory and policy decisions involving chemicals, including pesticides. We sought to identify additional opportunities for the U.S. EPA to disclose data and, more generally, to promote broad access to data it uses, regardless of origin. disc us sio n: We recommend that when the U.S. EPA proposes a regulatory determination or other policy decision that relies on scientifc research, it should provide sufcient under lying raw data and information about methods to enable reanalysis and attempts to independently reproduce the work, including the sensitivity of results to alternative analyses. Tis recommendation applies regardless of who conducted the work. If the U.S. EPA is unable to provide such transparency, it should state whether it had full access to all underlying data and methods. A timely version of submitted data cleared of information about confdential business matters and personal privacy should fully meet the standards of transparency described below, including public access sufcient for others to undertake an independent reanalysis. co n c l u sio n: Reliable chemical evaluation is essential for protecting public health and the environment and for ensuring availability of useful chemicals under appropriate conditions. Permitting qualifed researchers to endeavor to independently reproduce the analyses used in regulatory determinations of pesticides and other chemicals would increase confdence in the scientifc basis of such determinations.