Section 6193.5 - Acute Effects Data for Dietary Risk Assessment(a) For the purposes of this section, "acute exposure" is defined as a single treatment or repeated treatments during a period normally not to exceed seven days. Signs of acute toxicity are physical, behavioral, or biochemical manifestations, resulting from acute exposure, which are relevant to assessing dietary risks resulting from acute exposures of humans. Relevant observations of acute toxicity are described in the United States Environmental Protection Agency Pesticide Assessment Guidelines, Subdivision F.(b) The following data, from studies using active ingredients, are required to assess dietary risk resulting from acute exposures:(1) Acute oral LD50 toxicity data as required pursuant to Title 40 Code of Federal Regulations, Part 158.340; and(2) Oral toxicity data demonstrating a No Observed Effect Level (NOEL) for signs of acute toxicity following acute exposure and oral toxicity data sufficient to produce a dose-response curve for active ingredients with known biological indicators (e.g., cholinesterase inhibition) when this response is relevant to the NOEL. For active ingredients with anticholinesterase activity, at a minimum, red blood cell cholinesterase activity must be reported.(c) The data listed in subsection (b) shall be submitted with each application for registration of: (1) A pesticide product intended for use on food or feed crops and containing an active ingredient not currently registered for food or feed use; or(2) Amended labeling which would add directions for use on food or feed crops to the label of a pesticide product containing an active ingredient not currently registered for food or feed use.(d) Pursuant to Section 13060 of the Food and Agricultural Code, when notified by the Department, registrants of pesticides labeled for use on food or feed crops must submit the acute effects data listed in subsection (b). Registrants shall have nine months from the date of the Department's notice to submit the data.(e) The Department will not require the data listed in subsections (b) for active ingredients for which the Department has made a written determination that existing data demonstrates that acute dietary exposure is not of toxicological concern.Cal. Code Regs. Tit. 3, § 6193.5
1. New section filed 2-27-92; operative 3-30-92 (Register 92, No. 12).
2. Change without regulatory effect amending subsections (c)(1)-(d) and NOTE filed 3-27-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 13). Note: Authority cited: Section 12781, Food and Agricultural Code. Reference: Sections 12824 and 13060, Food and Agricultural Code.
1. New section filed 2-27-92; operative 3-30-92 (Register 92, No. 12).
2. Change without regulatory effect amending subsections (c)(1)-(d) and Note filed 3-27-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 13).