For purposes of this chapter, the following terms mean: (a) âAdverse reproductive effectâ means a statistically significant adverse effect on parental reproductive performance and the growth and development of offspring, including gonadal function, conception, and parturition; abortions; birth defects; stillbirths; and resorptions. (b) âData gapâ means that the department does not have on file a full set of valid mandatory health effects studies. (c) âMandatory health effects studyâ means adverse reproductive effect, chronic toxicity, mutagenicity, neurotoxicity, oncogenicity, and teratogenicity studies required for full registration or licensing of pesticides in California, as of July 1, 1983. (d) âTeratogenicâ means the property of a substance or mixture of substances to produce or induce functional deviations or developmental anomalies, not heritable, in or on an animal embryo or fetus. (e) âMutagenic effectâ means the property of a substance or mixture of substances to induce changes in the genetic complement of either somatic or germinal tissue in subsequent generations. (f) âChronic toxicityâ means the property of a substance or mixture of substances to cause adverse effects in an organism upon repeated or continuous exposure over a period of at least one-half the lifetime of that organism. (g) âOncogenicâ means the property of a substance or a mixture of substances to produce or induce benign or malignant tumor formations in living animals. (h) âNeurotoxic effectâ means any adverse effect on the nervous system such as delayed-onset locomotor ataxia resulting from single administration of the test substance, repeated once if necessary. (i) âInitiationâ means that the mandatory health effects study or any necessary preliminary studies, such as pilot studies or range finding studies, have been commenced. (j) âData generatorâ means a person who has completed and filed with the director a data commitment status report. (k) âCompletionâ means that the study has been finished, the data has been analyzed, and the final report of the results, including all exhibits, has been prepared and submitted to the department. ( l ) âSubmittedâ means deliverance of a completed study to the department. A study shall be deemed to be submitted until it has been determined by the department to be unacceptable and not capable of being upgraded. (m) âSuspendâ means the director has issued a notice of intent to suspend the registration of a pesticide product. The director shall issue a suspension order at the earliest possible time.
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