This is a proposal for research involving scripted exposure, and thus intentional exposure of human subjects, with the intent to submit the resulting data to EPA under FIFRA.
The following regulatory requirements apply:
- 40 CFR §26.1125 requires prior submission of the protocol and supporting documentation
- 40 CFR §26.1601 requires review of the protocol by EPA and the Human Subjects Review Board (HSRB)
- EPA Science Assessment of AEATF II Solid Pour Scenario and Protocol (PDF)(49 pp, 2 MB, April 8, 2014)