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.

The definitions in § 26.1102 apply to this subpart as well.

Any person who submits to EPA data derived from human research covered by this subpart shall provide at the time of submission information concerning the ethical conduct of such research. To the extent available to the submitter and not previously provided to EPA, such information should include:

(a) Copies of all of the records relevant to the research specified by § 26.1115(a) to be prepared and maintained by an IRB.

(b) Copies of all of the records relevant to the information identified in § 26.1125(a) through (f).

(c) Copies of sample records used to document informed consent as specified by § 26.1117, but not identifying any subjects of the research.

(d) If any of the information listed in paragraphs (a) through (c) of this section is not provided, the person shall describe the efforts made to obtain the information.