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Section 13131.2 Of Article 14. Birth Defect Prevention From California Food And Agricultural Code >> Division 7. >> Chapter 2. >> Article 14.
13131.2
. (a) Prior to March 1, 1992, or in response to a written
objection filed pursuant to paragraph (2) of subdivision (b) of
Section 13131.1, the department may determine, with the concurrence
of the Office of Environmental Health Hazard Assessment, that one or
more of the mandatory health effects studies are not required in
order to evaluate pesticide active ingredients other than those
identified pursuant to subdivision (a) of Section 13127. This
determination may be made only in accordance with one or more of the
following criteria:
(1) The ingredient has been classified as "Generally Recognized as Safe" by the United States Food and Drug Administration.
(2) The study is not physically possible due to the nature of the ingredient.
(3) The department has on file toxicological data that is adequate for the assessment of the potential adverse health effects of the ingredient, and the studies relied upon for that purpose are of the same study type, are scientifically valid, and, when taken together, are of a power and sensitivity equivalent to the studies that would be waived pursuant to this subdivision.
(b) The director may, in conjunction with the Office of Environmental Health Hazard Assessment, develop regulations for modification of mandatory health effects studies.
(1) The ingredient has been classified as "Generally Recognized as Safe" by the United States Food and Drug Administration.
(2) The study is not physically possible due to the nature of the ingredient.
(3) The department has on file toxicological data that is adequate for the assessment of the potential adverse health effects of the ingredient, and the studies relied upon for that purpose are of the same study type, are scientifically valid, and, when taken together, are of a power and sensitivity equivalent to the studies that would be waived pursuant to this subdivision.
(b) The director may, in conjunction with the Office of Environmental Health Hazard Assessment, develop regulations for modification of mandatory health effects studies.
