How EPA Receives Data for Pesticide Regulatory Decisions
Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), applicants for pesticide registration (i.e., applicants) must demonstrate whether using the pesticide according to label specifications will cause unreasonable adverse effects on the environment or human health. Registrants demonstrate this by submitting scientific studies and data to EPA. EPA generally reviews the studies and determines how the data should be considered for risk assessment. The applicant has the burden of supporting its registration through the submission and/or citation of studies or information that satisfy EPA’s data requirements.
EPA has established best practices to ensure the integrity of the data submitted by the applicant. These practices include but are not limited to:
- Standardized and peer-reviewed test guidelines that describe how to conduct the studies to generate data necessary to support the registration;
- Quality assurance and quality control measures to document data integrity;
- Consideration of whether generally accepted methods were used and sufficient numbers of measurements were made to achieve statistical reliability;
- Independent evaluation of each study including verification that each experiment was conducted in conformance with guideline requirements, an approved protocol, and good laboratory practices where applicable;
- Independent audits of laboratories by EPA to evaluate whether good laboratory practices are followed; and
- Submission of all raw data to EPA so the Agency can independently verify results.
EPA also reviews studies published in the scientific literature that are relevant to its regulatory decisions. Open literature studies provide important information, including information about some effects that may not be covered in the studies submitted by applicants.
However, many studies published in the scientific literature may lack sufficient information for a thorough independent evaluation of data quality. In cases where the information presented in the scientific literature conflicts with information submitted by the applicant, EPA determines if the discrepancies can be explained by differences in study design or environmental conditions or if one study is more reliable than the other. If not, then EPA may require the applicant to provide additional data.