Section 13123 Of Article 14. Birth Defect Prevention From California Food And Agricultural Code >> Division 7. >> Chapter 2. >> Article 14.
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.