DEFINITIONS.

SEC. 221. DEFINITIONS. Section 2 (7 U.S.C. 136), as amended by section 210(a) is further amended— (1) in subsection (u), by adding at the end the following: “The term ‘pesticide’ does not include liquid chemical sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). For purposes of the preceding sentence, the term ‘critical device’ includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body and the term ‘semi-critical device’ includes any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.”; and (2) by adding at the end the following: “(mm) Antimicrobial Pesticide.— “(1) In general.— The term ‘antimicrobial pesticide’ means a pesticide that— “(A) is intended to— “(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or “(ii) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and “(B) in the intended use is exempt from, or otherwise not subject to, a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a food additive regulation under section 409 of such Act. “(2) Excluded products.— The term ‘antimicrobial pesticide’ does not include— “(A) a wood preservative or antifouling paint product for which a claim of pesticidal activity other than or in addition to an activity described in paragraph (1) is made; “(B) an agricultural fungicide product; or 110 STAT. 1503 “(C) an aquatic herbicide product. “(3) Included products.— The term ‘antimicrobial pesticide’ does include any other chemical sterilant product (other than liquid chemical sterilant products exempt under subsection (u)), any other disinfectant product, any other industrial microbiocide product, and any other preservative product that is not excluded by paragraph (2).”.