Section 6710 - Pesticide Exposure Studies Involving Human Participants(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.(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. The Director or commissioner may order the study director or human participants to cease immediately any human pesticide exposure activity conducted during the study to protect the safety of the human participants. The Director may cancel the authorization to conduct the pesticide exposure study whenever it is deemed necessary to protect participant safety, public safety, or the environment.Cal. Code Regs. Tit. 3, § 6710
1. Amendment filed 9-26-88; operative 10-26-88 (Register 88, No. 41).
2. Amendment of section and NOTE filed 5-26-95; operative 6-26-95 (Register 95, No. 21).
3. Repealer and new section heading and section filed 7-18-2002 as an emergency; operative 7-18-2002 (Register 2002, No. 29). A Certificate of Compliance must be transmitted to OAL by 11-15-2002 or emergency language will be repealed by operation of law on the following day.
4. Repealer and new section heading and section refiled 11-7-2002 as an emergency; operative 11-15-2002 (Register 2002, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-17-2003 or emergency language will be repealed by operation of law on the following day.
5. Certificate of Compliance as to 11-17-2002 order, including further amendment of section, transmitted to OAL 3-17-2003 and filed 4-24-2003 (Register 2003, No. 17). Note: Authority cited: Sections 12976 and 12981, Food and Agricultural Code. Reference: Sections 12980, 12981, 12987 and 12988, Food and Agricultural Code.
1. Amendment filed 9-26-88; operative 10-26-88 (Register 88, No. 41).
2. Amendment of section and Note filed 5-26-95; operative 6-26-95 (Register 95, No. 21).
3. Repealer and new section heading and section filed 7-18-2002 as an emergency; operative 7-18-2002 (Register 2002, No. 29). A Certificate of Compliance must be transmitted to OAL by 11-15-2002 or emergency language will be repealed by operation of law on the following day.
4. Repealer and new section heading and section refiled 11-7-2002 as an emergency; operative 11-15-2002 (Register 2002, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-17-2003 or emergency language will be repealed by operation of law on the following day.
5. Certificate of Compliance as to 11-17-2002 order, including further amendment of section, transmitted to OAL 3-17-2003 and filed 4-24-2003 (Register 2003, No. 17).