California Code of California Code of Regulations Regulations Title 3 Section 6710 Title 3 Section 6710 Pesticide Exposure Studies Involving Human Participants 2 Title 3 Section 6710 Title 3 Section 6710 ( a) No person shall conduct any pesticide exposure study in California, which involves human participants, unless the Director [ of CDPR] has given written authorization to the study director to conduct the pesticide exposure study according to an approved protocol. 3 Title 3 Section 6710 Title 3 Section 6710 ( b) The study director shall submit the protocol to the Director for review and provisionary determination of acceptability ( c) The Director shall forward a copy of the protocol and review documentation to the Office of Environmental Health Hazard Assessment for concurrent review.

( d) The Director shall provide comments to the study director on the basis of Department of Pesticide Regulation review and any comments from the Office of Environmental Health Hazard Assessment. The study director shall make any changes deemed necessary by the Director. Upon receipt of the Director's provisionary determination of acceptability, the study director shall obtain a review and approval from an Institutional Review Board ( IRB). The IRB must conduct its review in compliance with 40 CFR Part 26. 4 Title 3 Section 6710 Title 3 Section 6710 ( e) The study director shall submit to the Director the IRB's approval of the protocol and all documentation exchanged between the IRB and the study director related to the review.

( f) The Director shall make the final decision regarding approval or denial of the protocol based on the information required in subsection ( e), other relevant available information available to the Director. The Director shall notify the study director in writing of the decision and the basis for the decision. 5 Title 3 Section 6710 Title 3 Section 6710 ( g) The Director shall establish an expiration date for the approved protocol. In no instances shall the expiration date exceed that established by the IRB. If a pesticide exposure study is not completed by the expiration date established by the Director,

the study director shall not continue the pesticide exposure study until the Director has approved the renewal of the protocol in writing as required in subsection ( i). 6 Title 3 Section 6710 Title 3 Section 6710 ( h) Protocol Amendment.

° The study director shall not make an amendment to the approved protocol that may impact the health of the human participants without approval from the Director. For amendments where participant health is potentially impacted,

the study director shall make the request in writing. The proposed amendment, justification, potential impact on study participants, and any measures proposed to mitigate potential impacts shall accompany the request. . . .

° The Director shall provide comments to the study director. . . .

° The study director shall make any changes deemed necessary by the Director. Upon receipt of the Director's provisionary determination of acceptability, the study director shall obtain a review and approval of the proposed amendment from an IRB.

. . . 7 Title 3 Section 6710 Title 3 Section 6710 ( i) Renewal of Protocol. . . .

( j) In the event of any complications or adverse health effects identified during the conduct of the study, the study director shall take immediate action to ensure the health and safety of the human participants. The study director shall immediately notify the Director of such complications or adverse health effects and the immediate actions taken. 8 Title 3 Section 6710 Title 3 Section 6710 ( k) The study director shall submit the following information to the Director by the expiration date:

( 1) A statement regarding the status of the study including information as to whether the study was completed,

postponed, or cancelled.

( 2) A report and explanation of any complications or adverse health effects involving the human participants and what actions were taken.

( l) The Director or agricultural commissioner of the county where the study is taking place may inspect the pesticide exposure study activities to evaluate compliance with the protocol. . . .