California Code of Regulations › Title 3 - Food and Agriculture › Division 6 - Pesticides and Pest Control Operations › Chapter 3 - Pest Control Operations › Subchapter 3 - Pesticide Worker Safety › Article 1 - General Scope and Purpose › Section 6710 - Pesticide Exposure Studies Involving Human Participants

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No
					 person shall conduct any pesticide exposure study in California, which involves
					 human participants, unless the Director has given written authorization to the
					 study director to conduct the pesticide exposure study according to an approved
					 protocol.
(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 Title 40 Code of Federal Regulations (Protection of Environment), Part 26
					 (Protection of Human Subjects).
(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.
(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).
(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 forward a copy of the proposed amendment and any
					 accompanying documentation to the Office of Environmental Health Hazard
					 Assessment for concurrent review. 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 of the proposed amendment
					 from an IRB as required in subsection (d). The study director shall submit to
					 the Director the protocol and all documentation exchanged between the IRB and
					 the study director. The Director shall notify the study director of the
					 decision and the basis for the decision. If approved by the Director, the
					 pesticide exposure study shall be conducted in accordance with the approved
					 amended protocol. In the event that the potential impact on human participants
					 is uncertain, the study director shall consult with the Director.
(i) Renewal of Protocol. The study director
					 shall obtain approval of renewal from an IRB as described in subsection (d)
					 prior to requesting the Director's approval to renew the protocol. The study
					 director shall submit, to the Director, the protocol and all documentation
					 exchanged between the IRB and the study director regarding the renewal. After
					 reviewing the documentation, if the Director approves the request for protocol
					 renewal, the Director shall establish a revised expiration date. The revised
					 expiration shall not exceed that date established in the IRB's renewal
					 recommendation.
(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.
(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.