Sections 3 and 4 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the primary federal law governing the regulation of pesticides, make clear that EPA shall require the submission of studies from pesticide applicants and registrants to support registration, registration review, and re-registration decisions. Congress placed this obligation on the pesticide registrant rather than requiring EPA to develop and fund such data.
Though people sometimes express concern that EPA scientists are not performing the actual laboratory work that provides the data used in support of pesticide registration, we believe the approach prescribed by FIFRA is effective and makes better use of scarce government resources. In addition, EPA has put in place practices and enforcement policies to help ensure that registrant-developed data represent sound science.
For example, EPA has developed an extensive set of guidelines and protocols that applicants and registrants use in developing required data. Further, to assure the quality and integrity of data submitted to the Agency, EPA regulations set forth good laboratory practices for those labs conducting studies that support or are intended to support applications for registration of pesticide products. EPA's Good Laboratory Practice Standards compliance monitoring program helps ensure the quality and integrity of test data submitted to the Agency in support of a pesticide product registration under FIFRA. EPA also conducts inspections of these laboratories and data audits to monitor compliance.
Once studies are submitted to the Agency, EPA scientists conduct extensive analysis of the data to ensure that the design of the study is appropriate and that the data are collected and analyzed accurately. In addition to registrant-submitted studies, EPA scientists also review pesticide studies from peer-reviewed scientific journals and data from a wide variety of sources when they are available. In so doing, the Agency scientists identify hazards and characterize risks using the best data available for their review.