Jurris.COM
Section 13130.3 Of Article 14. Birth Defect Prevention From California Food And Agricultural Code >> Division 7. >> Chapter 2. >> Article 14.
13130.3
. (a) Notwithstanding subdivision (b) of Section 13127, the
time permitted by the director for submitting data to fill a data gap
shall be as follows:
(1) For oncogenicity studies and chronic feeding studies, 48 months.
(2) For reproduction studies, 48 months.
(3) For teratogenicity and neurotoxicity studies, 24 months.
(4) For mutagenicity studies, 12 months. The time permitted by the director for submitting data to fill a data gap shall commence upon the date the department notifies the registrant of the data gap.
(b) Notwithstanding the time limit established in subdivision (a) for submitting data to fill a data gap, the department may, with the concurrence of the Office of Environmental Health Hazard Assessment, grant an extension of time to complete the required studies, upon a written finding that events beyond the control of the persons responsible for submitting the data prevent submission of the data within the prescribed time, and that those persons have made a good faith effort to complete the studies within the prescribed time. Not more than one extension of time per data requirement may be granted to complete the required studies. The length of an extension granted pursuant to this subdivision shall be limited to the time necessary to complete the studies, not to exceed the length of time specified in subdivision (a) for conducting the studies.
(1) For oncogenicity studies and chronic feeding studies, 48 months.
(2) For reproduction studies, 48 months.
(3) For teratogenicity and neurotoxicity studies, 24 months.
(4) For mutagenicity studies, 12 months. The time permitted by the director for submitting data to fill a data gap shall commence upon the date the department notifies the registrant of the data gap.
(b) Notwithstanding the time limit established in subdivision (a) for submitting data to fill a data gap, the department may, with the concurrence of the Office of Environmental Health Hazard Assessment, grant an extension of time to complete the required studies, upon a written finding that events beyond the control of the persons responsible for submitting the data prevent submission of the data within the prescribed time, and that those persons have made a good faith effort to complete the studies within the prescribed time. Not more than one extension of time per data requirement may be granted to complete the required studies. The length of an extension granted pursuant to this subdivision shall be limited to the time necessary to complete the studies, not to exceed the length of time specified in subdivision (a) for conducting the studies.
