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HomeFood and Agricultural CodeDiv. 7Ch. 2Art. 3§ 12804 Sterilant Product Exemptions

§ 12804 Sterilant Product Exemptions

Food and Agricultural Code·California
AI Summary·Official Text·Key Terms·Related Statutes·References
AI SummaryVerified

§ 12804 Sterilant Product Exemptions

This law lets the director skip some of the usual rules for certain liquid chemical sterilants used on medical devices, but only if the product isn’t made with ethylene oxide and has FDA clearance.

Key Takeaways

  • •The director can exempt a sterilant from many rules if it’s exempt from the federal pesticide law and has FDA clearance.
  • •The product must NOT contain ethylene oxide as an active ingredient.
  • •Even after exemption, the director can still regulate the product if needed.
  • •Emergency rules could be adopted before July 1, 1998 without a special finding.

Example

A hospital wants to use a new liquid sterilant on its surgical tools. The product is exempt from the federal pesticide law and has been cleared by the FDA, and it does not contain ethylene oxide.

Because the product meets those conditions, the director can write a rule that lets the hospital use it without having to report pesticide‑related illnesses or follow some other usual requirements.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source
View on CA.gov

§ 12804 Sterilant Product Exemptions

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

Last verified: January 10, 2026

Key Terms

liquid chemical sterilant productethylene oxideemergency regulationsfederal Insecticide, Fungicide, and Rodenticide Actfederal Food and Drug Administration

Related Statutes

  • § 12803 Federal Pesticide Exemption Authority
  • § 40761 Tomato Processing Standards
  • § 10951 Swine Garbage Feeding Regulation
  • § 10952 Swine Feed Heating Requirements
  • § 11261 Coyote Control Donations

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Food and Agricultural Code. Section 12804.
View Official Source