Section 6194 - Required Submission of Data(a) Registrants required to submit data in support of registrations pursuant to Food and Agricultural Code sections 13060 (c) (1), 13127, 13143 or 13146 shall respond to the director's notices of the data and study requirements. Where the notice pertains to data required pursuant to Food and Agricultural Code section 13127, the data shall be one or more of the mandatory health effects studies specified in Food and Agricultural Code section 13123. Where the notice pertains to data required pursuant to Food and Agricultural Code sections 13143 or 13146, the data shall be all or some of the information specified in Food and Agricultural Code section 13143 (a) (1) through (6). Where the notice pertains to data required pursuant to Food and Agricultural Code section 13060 (c) (1), the data shall be that listed in section 6193.5 (b). Not later than 90 days after the date of such a notice, registrants shall inform the director in writing as to how they will comply with the data requirements by choosing one or more of the following options: (1) Submit the data with their response to the notice.(2) Develop and submit the data.(3) Agree to jointly develop and submit the data with one or more parties and provide a copy of the agreement signed by the participating parties.(4) Acquire authorization to use data being developed and submitted by another party and provide a copy of the authorization signed by that party.(5) For data required pursuant to sections 13127, 13143 or 13146 of the Food and Agricultural Code, offer to compensate the developer(s) of the data and provide a copy of the offer, together with evidence that the data developer(s) received the offer.(6) Claim the data requirements are not applicable to the registered use patterns of the registrant's pesticide products and provide information supporting the claim.(7) When applicable to the particular notice, claim an exemption from the mandatory health effects data requirements pursuant to Food and Agricultural Code section 13128, or claim an exemption from the acute effects data requirements pursuant to Food and Agricultural Code section 13060(c)(2), and provide the information specified in subsection (c). An option shall be chosen for each data requirement; however, different options may be chosen for different data requirements. When requested by the director, registrants who have chosen options (2) and/or (3) shall submit a written status report to the director regarding the development of the data which shall include, but is not limited to:
(1) The name and address of the person/organization conducting the study,(2) The initiation and expected completion dates, and(3) The scheduled date of submission of the data to the Department. The status report shall be submitted not later than 30 days after the date of the director's request, unless a later date is specified.(b) Pursuant to Food and Agricultural Code sections 13060(c)(2) and 13128, data requirements noticed pursuant to Food and Agricultural Code sections 13060(c)(1) and 13127, respectively, shall not apply to applicants or registrants of end use products that are formulated using another producer's pesticide product which is registered with the United States Environmental Protection Agency (EPA) provided, all pesticide active ingredients in the formulated product are derived solely from one or more EPA registered pesticide products and the producer(s) has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this section, and is/are in compliance with the requirements of sections 13060 (c) (1) or 13127, whichever applies, of the Food and Agricultural Code and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations.(c) The director shall grant an exemption as authorized by sections 13060 (c) (2) and 13128 of the Food and Agricultural Code to an applicant or registrant that meets the conditions specified in subsection (b). To apply for an exemption, the applicant or registrant shall submit the following: (1) The name and the EPA registration number of each pesticide product purchased to formulate the end use product, and(2) The name of the producer(s) from whom the applicant or registrant purchases the active ingredient(s) used to formulate the product(s), who has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this section, and is/are in compliance with the requirements of sections 13060(c)(1) or 13127, whichever applies, of the Food and Agricultural Code and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations. If the active ingredient(s) is/are not purchased directly from the producer(s), but through a supplier, include a statement identifying the producer(s) by name and certifying that the active ingredient(s) used to formulate the product(s) is/are purchased indirectly from a producer(s) who has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this section, and is/are in compliance with the requirements of sections 13060 (c) (1) or 13127, whichever applies, of the Food and Agricultural Code and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations.(d) If a registrant that has been granted an exemption pursuant to sections 13060 (c) (2) or 13128 of the Food and Agricultural Code purchases a pesticide product different from that reported in accordance with subsection (c), the registrant shall notify the director of the change. If the registrant still meets the conditions specified in subsection (b) and wishes to request an exemption, the registrant shall reapply for the exemption following the procedure described in subsection (c).(e) An applicant or registrant that has been granted an exemption pursuant to sections 13060(c)(2) or 13128 of the Food and Agricultural Code will be exempt as long as the producer(s) of the pesticide active ingredient(s) in its end use product has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this section, and is/are in compliance with the requirements of sections 13060(c)(1) or 13127, respectively, of the Food and Agricultural Code and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations. An applicant or registrant that no longer qualifies for such an exemption is subject to the requirements of sections 13060 (c) (1) or 13127, whichever applies, of the Food and Agricultural Code.Cal. Code Regs. Tit. 3, § 6194
1. New section filed 6-1-87; operative 6-1-87 pursuant to Government Code section 11346.2(d) (Register 87, No. 24).
2. Amendment filed 3-17-89; operative 4-16-89 (Register 89, No. 12).
3. Amendment of subsections (b) and (c), and new subsection (e) filed 11-6-89 as an emergency; operative 11-6-89 (Register 89, No. 45). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 3-6-90.
4. Certificate of Compliance including amendment of subsections (b), (c) and (e) transmitted to OAL 3-6-90 and filed 4-2-90 (Register 90, No. 16).
5. Amendment filed 2-27-92; operative 3-30-92 (Register 92, No. 12). Note: Authority cited: Sections 12781 and 13145, Food and Agricultural Code. Reference: Sections 13060, 13127, 13128, 13143 and 13146, Food and Agricultural Code.
1. New section filed 6-1-87; operative 6-1-87 pursuant to Government Code section 11346.2(d) (Register 87, No. 24).
2. Amendment filed 3-17-89; operative 4-16-89 (Register 89, No. 12).
3. Amendment of subsections (b) and (c), and new subsection (e) filed 11-6-89 as an emergency; operative 11-6-89 (Register 89, No. 45). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 3-6-90.
4. Certificate of Compliance including amendment of subsections (b), (c) and (e) transmitted to OAL 3-6-90 and filed 4-2-90 (Register 90, No. 16).
5. Amendment filed 2-27-92; operative 3-30-92 (Register 92, No. 12).