40 C.F.R. § 26.1301
To what does this subpart apply?
This subpart applies to any person who submits to EPA on or after April 15, 2013 either of the following:
(a) A report containing the results of any human research for consideration in connection with an action that may be performed by EPA under FIFRA (7 U.S.C. 136-136y) or section 408 of FFDCA (21 U.S.C. 346a).
(b) A report containing the results of any human research on or with a pesticide for consideration in connection with any action that may be performed by EPA under any regulatory statute administered by EPA.