Products and substances listed in this section are excluded from FIFRA regulation if they meet the specified conditions or criteria.
(a) Liquid chemical sterilants. A liquid chemical sterilant product is not a pesticide under section 2(u) of FIFRA if it meets all of the following criteria. Excluded products are regulated by the Food and Drug Administration (FDA). Products excluded are those meeting all of the following criteria:
(1) Composition. The product must be in liquid form as sold or distributed. Pressurized gases or products in dry or semi-solid form are not excluded by this provision. Ethylene oxide products are not liquid products and are not excluded by this provision.
(2) Claims. The product must bear a sterilant claim, or a sterilant plus subordinate level disinfection claim. Products that bear antimicrobial claims solely at a level less than “sterilant” are not excluded and are jointly regulated by EPA and FDA.
(3) Use site.(i) The product must be intended and labeled only for use on “critical or semi-critical devices.” A “critical device” is 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. A semi-critical device is 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.
(ii) Liquid chemical sterilants that bear claims solely for use on non-critical medical devices are jointly regulated by EPA and FDA.
(iii) Liquid chemical sterilants that bear claims solely for use on sites that are not medical devices, such as veterinary equipment, are not excluded and are regulated solely by EPA.
(b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from regulation under FIFRA if it is a substance (or mixture of substances), meeting all of the following criteria:
(1) The substance prevents or hinders the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria and is distributed and sold solely for those purposes and no other pesticidal purposes. For purposes of this section, living organisms are not considered to be substances, and the actions of living organisms are not relevant to whether a substance is deemed to be a nitrogen stabilizer.
(2) The substance was in “commercial agronomic use” in the United States before January 1, 1992. EPA considers a substance to be in commercial agronomic use if it is available for sale or distribution to users for direct agronomic benefit, as opposed to limited research, experimental or demonstration use.
(3) The substance was not registered under FIFRA before January 1, 1992.
(4) Since January 1, 1992, the distributor or seller has made no claim that the product prevents or hinders the process of nitrification, denitrification, ammonia volatilization or urease production. EPA considers any of the following claims (or their equivalents) to be a claim that the product prevents or hinders nitrification, denitrification, ammonia volatilization or urease production:
(i) Improves crop utilization of applied nitrogen.
(ii) Reduces leaching of applied nitrogen or reduces groundwater nitrogen contamination.
(iii) Prevents nitrogen loss.
(iv) Prolongs availability of nitrogen.
(v) Increases nitrogen uptake, availability, usage, or efficiency.
(5) A product will be considered to have met the criterion of paragraph (b)(4) of this section that no nitrogen stabilization claim has been made if:
(i) The nitrogen stabilization claim, in whatever terms expressed, is made solely in compliance with a State requirement to include the claim in materials required to be submitted to a State legislative or regulatory authority, or in the labeling or other literature accompanying the product; and
(ii) The State requirement to include the claim was in effect both before the product bearing the claim was introduced into commercial agronomic use, and before the effective date of this rule.
(6) A product that meets all of the criteria of this paragraph with respect to one State is not thereby excluded from FIFRA regulation if distributed and sold in another State whose nitrogen stabilization statement requirement does not meet the requirements of paragraph (b)(5)(ii) of this section.
(c) Human drugs. Fungi, bacteria, viruses or other microorganisms in or on living man are not “pests” as defined in section 2(t) of FIFRA. Products intended and labeled for use against such organisms are human drugs subject to regulation by the FDA under the FFDCA.
(d) Animal drugs.(1) Fungi, viruses, bacteria or other microorganisms on or in living animals are not “pests” under section 2(t) of FIFRA. Products intended for use against such organisms are “animal drugs” regulated by the FDA under the FFDCA.
(2) A “new animal drug” as defined in section 201(w) of the FFDCA, or an animal drug that FDA has determined is not a “new animal drug” is not a pesticide under section 2(u) of FIFRA. Animal drugs are regulated by the FDA under the FFDCA.
(e) Animal feeds. An animal feed containing a new animal drug is not a pesticide under section 2(u) of FIFRA. An animal feed containing a new animal drug is subject to regulation by the FDA under the FFDCA.
(f) Vitamin hormone products. A product consisting of a mixture of plant hormones, plant nutrients, inoculants, or soil amendments is not a “plant regulator” under section 2(v) of FIFRA, provided it meets the following criteria:
(1) The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of § 156.62 of this chapter for Toxicity Category III or IV; and
(2) The product is not intended for use on food crop sites, and is labeled accordingly.
(g) Products intended to aid the growth of desirable plants. A product of any of the following types, intended only to aid the growth of desirable plants, is not a “plant regulator” under section 2(v) of FIFRA, and therefore is not a pesticide:
(1) A plant nutrient product, consisting of one or more macronutrients or micronutrient trace elements necessary to normal growth of plants and in a form readily usable by plants.
(2) A plant inoculant product consisting of microorganisms to be applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system.
(3) A soil amendment product containing a substance or substances intended for the purpose of improving soil characteristics favorable for plant growth.
[66 FR 64763, Dec. 14, 2001, as amended at 73 FR 75594, Dec. 12, 2008]
Title 40 published on 2012-07-01
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