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Section 13127.3 Of Article 14. Birth Defect Prevention From California Food And Agricultural Code >> Division 7. >> Chapter 2. >> Article 14.
13127.3
. (a) The director shall grant an extension of time for
submission of the required data if, and only if, the director, with
the concurrence of the Secretary for Environmental Protection, makes
a finding that both of the following conditions are satisfied:
(1) The registrant has submitted at least eight of the mandatory health effects studies, and has initiated the studies required to fill the remaining data gaps by January 15, 1992, unless the registrant can demonstrate to the satisfaction of the director that it failed to have eight studies submitted, and the remaining studies initiated, in accordance with this paragraph because not more than two studies were delayed due to specific, written direction of the department based upon a written evaluation by a department toxicologist.
(2) That the registrant has taken appropriate steps to meet the requirements of this article. To determine whether appropriate steps have been taken, the director shall consider the registrant's timely response to data call-ins on other active ingredients contained in products registered with the department pursuant to this article and pursuant to Article 15 (commencing with Section 13141), and whether the registrant has responded in a timely and appropriate manner to notices and correspondence from the department relating to data call-ins and has taken appropriate measures to address study deficiencies identified by the department.
(b) A registrant shall not be considered to have taken the appropriate steps, as provided in subdivision (a), if the registrant has failed to meet the deadlines established by this article due to efforts to coordinate compliance with federal data requirements.
(1) The registrant has submitted at least eight of the mandatory health effects studies, and has initiated the studies required to fill the remaining data gaps by January 15, 1992, unless the registrant can demonstrate to the satisfaction of the director that it failed to have eight studies submitted, and the remaining studies initiated, in accordance with this paragraph because not more than two studies were delayed due to specific, written direction of the department based upon a written evaluation by a department toxicologist.
(2) That the registrant has taken appropriate steps to meet the requirements of this article. To determine whether appropriate steps have been taken, the director shall consider the registrant's timely response to data call-ins on other active ingredients contained in products registered with the department pursuant to this article and pursuant to Article 15 (commencing with Section 13141), and whether the registrant has responded in a timely and appropriate manner to notices and correspondence from the department relating to data call-ins and has taken appropriate measures to address study deficiencies identified by the department.
(b) A registrant shall not be considered to have taken the appropriate steps, as provided in subdivision (a), if the registrant has failed to meet the deadlines established by this article due to efforts to coordinate compliance with federal data requirements.
