2011 California Code
Food and Agricultural Code
DIVISION 7. AGRICULTURAL CHEMICALS, LIVESTOCK REMEDIES, AND COMMERCIAL FEEDS [12500 - 15340]
ARTICLE 14. Birth Defect Prevention
Section 13123

For purposes of this chapter, the following terms mean:

(a) Adverse reproductive effect 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) Data gap means that the department does not have on file a full set of valid mandatory health effects studies.

(c) Mandatory health effects study 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) Teratogenic 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) Mutagenic effect 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) Chronic toxicity 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) Oncogenic means the property of a substance or a mixture of substances to produce or induce benign or malignant tumor formations in living animals.

(h) Neurotoxic effect 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) Initiation means that the mandatory health effects study or any necessary preliminary studies, such as pilot studies or range finding studies, have been commenced.

(j) Data generator means a person who has completed and filed with the director a data commitment status report.

(k) Completion 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) Submitted 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) Suspend 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.

(Amended by Stats. 1992, Ch. 706, Sec. 13. Effective September 15, 1992.)