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Section 12804 Of Article 3. Exemptions From California Food And Agricultural Code >> Division 7. >> Chapter 2. >> Article 3.
12804
. (a) The director, by regulation, may exempt from all or part
of the requirements of this division a liquid chemical sterilant
product for use on a critical or semi-critical medical device that is
exempt from the federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. Sec. 136 et seq.) pursuant to subdivision (u) of Section 2
of that act (7 U.S.C. Sec. 136 (u)), and that has obtained clearance
from the federal Food and Drug Administration under subdivision (k)
of Section 510 of the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 306 (k)) if both of the following apply:
(1) The product does not include ethylene oxide as an active ingredient.
(2) The director excludes from the exempting regulation requirements to report pesticide-related illnesses, to collect information and data concerning pesticide-related illnesses, and to transmit that information and data to the appropriate agency or entity for inspection or followup, and other specific requirements of this division that may otherwise be applicable and that are necessary to protect the public health or the environment. Notwithstanding any other provision of law, the director shall retain the authority to regulate any substance exempted pursuant to this section whether registered or not.
(b) On or before July 1, 1998, the director may adopt the regulations authorized under subdivision (a) as emergency regulations. In adopting those regulations as emergency regulations, the director is not required to make the finding required by subdivision (b) of Section 11346.1 of the Government Code.
(1) The product does not include ethylene oxide as an active ingredient.
(2) The director excludes from the exempting regulation requirements to report pesticide-related illnesses, to collect information and data concerning pesticide-related illnesses, and to transmit that information and data to the appropriate agency or entity for inspection or followup, and other specific requirements of this division that may otherwise be applicable and that are necessary to protect the public health or the environment. Notwithstanding any other provision of law, the director shall retain the authority to regulate any substance exempted pursuant to this section whether registered or not.
(b) On or before July 1, 1998, the director may adopt the regulations authorized under subdivision (a) as emergency regulations. In adopting those regulations as emergency regulations, the director is not required to make the finding required by subdivision (b) of Section 11346.1 of the Government Code.
