Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects

The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). As revised in 2006 and 2013, EPA regulations at 40 CFR Part 26 protect subjects of “third-party” human research (i.e., research that is not conducted or supported by EPA). In addition to other protections, the regulations require affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to EPA upon the completion of, certain studies that involve human research participants. The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional dosing of human subjects, these individuals (respondents) are required to submit study protocols to EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to EPA. This renewal ICR estimates the third party response burden from complying with the requirements in 40 CFR Part 26, as amended in 2006 and 2013.