(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. § 136 et seq.) pursuant to subdivision (u) of Section 2 of that act (7 U.S.C. § 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. § 306 (k)) if both of the following apply:

(1) The product does not include ethylene oxide as an active ingredient.

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Terms Used In California Food and Agricultural Code 12804

  • environment: means the aggregate of all factors that influence the conditions of life in or about the state or within any portion thereof, and which are affected by the use of pesticides or related materials within the state. See California Food and Agricultural Code 14101
  • Subdivision: means a subdivision of the section in which that term occurs unless some other section is expressly mentioned. See California Food and Agricultural Code 49

(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 § 11346.1 of the Government Code.

(Added by Stats. 1997, Ch. 530, Sec. 1. Effective January 1, 1998.)