California Code of Regulations › Title 3 - Food and Agriculture › Division 6 - Pesticides and Pest Control Operations › Chapter 2 - Pesticides › Subchapter 1 - Pesticide Registration › Article 3 - Supplemental Data Requirements › Section 6194 - Required Submission of Data

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.