For purposes of this subchapter—
((a)) ** Active ingredient** The term “active ingredient” means—
((1)) in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which will prevent, destroy, repel, or mitigate any pest;
((2)) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;
((3)) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant;
((4)) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue; and
((5)) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria.
((b)) ** Administrator** The term “Administrator” means the Administrator of the Environmental Protection Agency.
((c)) ** Adulterated** The term “adulterated” applies to any pesticide if—
((1)) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold;
((2)) any substance has been substituted wholly or in part for the pesticide; or
((3)) any valuable constituent of the pesticide has been wholly or in part abstracted.
((d)) ** Animal** The term “animal” means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds, fish, and shellfish.
((e)) ** Certified applicator, etc.**
((1)) ** Certified applicator** The term “certified applicator” means any individual who is certified under as authorized to use or supervise the use of any pesticide which is classified for restricted use. Any applicator who holds or applies registered pesticides, or uses dilutions of registered pesticides consistent with subsection (ee), only to provide a service of controlling pests without delivering any unapplied pesticide to any person so served is not deemed to be a seller or distributor of pesticides under this subchapter.section 136i of this title
((2)) ** Private applicator** The term “private applicator” means a certified applicator who uses or supervises the use of any pesticide which is classified for restricted use for purposes of producing any agricultural commodity on property owned or rented by the applicator or the applicator’s employer or (if applied without compensation other than trading of personal services between producers of agricultural commodities) on the property of another person.
((3)) ** Commercial applicator** The term “commercial applicator” means an applicator (whether or not the applicator is a private applicator with respect to some uses) who uses or supervises the use of any pesticide which is classified for restricted use for any purpose or on any property other than as provided by paragraph (2).
((4)) ** Under the direct supervision of a certified applicator** Unless otherwise prescribed by its labeling, a pesticide shall be considered to be applied under the direct supervision of a certified applicator if it is applied by a competent person acting under the instructions and control of a certified applicator who is available if and when needed, even though such certified applicator is not physically present at the time and place the pesticide is applied.
((f)) ** Defoliant** The term “defoliant” means any substance or mixture of substances intended for causing the leaves or foliage to drop from a plant, with or without causing abscission.
((g)) ** Desiccant** The term “desiccant” means any substance or mixture of substances intended for artificially accelerating the drying of plant tissue.
((h)) ** Device** The term “device” means any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom.
((i)) ** District court** The term “district court” means a United States district court, the District Court of Guam, the District Court of the Virgin Islands, and the highest court of American Samoa.
((j)) ** Environment** The term “environment” includes water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these.
((k)) ** Fungus** The term “fungus” means any non-chlorophyll-bearing thallophyte (that is, any non-chlorophyll-bearing plant of a lower order than mosses and liverworts), as for example, rust, smut, mildew, mold, yeast, and bacteria, except those on or in living man or other animals and those on or in processed food, beverages, or pharmaceuticals.
((l)) ** Imminent hazard** The term “imminent hazard” means a situation which exists when the continued use of a pesticide during the time required for cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened by the Secretary pursuant to the Endangered Species Act of 1973 [ et seq.].16 U.S.C. 1531
((m)) ** Inert ingredient** The term “inert ingredient” means an ingredient which is not active.
((n)) ** Ingredient statement** The term “ingredient statement” means a statement which contains—
((1)) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and
((2)) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculated as elementary arsenic.
((o)) ** Insect** The term “insect” means any of the numerous small invertebrate animals generally having the body more or less obviously segmented, for the most part belonging to the class insecta, comprising six-legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than six legs, as for example, spiders, mites, ticks, centipedes, and wood lice.
((p)) ** Label and labeling**
((1)) ** Label** The term “label” means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.
((2)) ** Labeling** The term “labeling” means all labels and all other written, printed, or graphic matter—
((A)) accompanying the pesticide or device at any time; or
((B)) to which reference is made on the label or in literature accompanying the pesticide or device, except to current official publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the Department of Health and Human Services, State experiment stations, State agricultural colleges, and other similar Federal or State institutions or agencies authorized by law to conduct research in the field of pesticides.
((q)) ** Misbranded**
((1)) A pesticide is misbranded if—
((A)) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular;
((B)) it is contained in a package or other container or wrapping which does not conform to the standards established by the Administrator pursuant to ;
((C)) it is an imitation of, or is offered for sale under the name of, another pesticide;
((D)) its label does not bear the registration number assigned under to each establishment in which it was produced;
((E)) any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
((F)) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under , are adequate to protect health and the environment;
((G)) the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under , is adequate to protect health and the environment; or
((H)) in the case of a pesticide not registered in accordance with and intended for export, the label does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under customary conditions of purchase and use, the following: “Not Registered for Use in the United States of America”.
((2)) A pesticide is misbranded if—
((A)) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot be clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is not misbranded under this subparagraph if—
((i)) the size or form of the immediate container, or the outside container or wrapper of the retail package, makes it impracticable to place the ingredient statement on the part which is presented or displayed under customary conditions of purchase; and
((ii)) the ingredient statement appears prominently on another part of the immediate container, or outside container or wrapper, permitted by the Administrator;
((B)) the labeling does not contain a statement of the use classification under which the product is registered;
((C)) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing—
((i)) the name and address of the producer, registrant, or person for whom produced;
((ii)) the name, brand, or trademark under which the pesticide is sold;
((iii)) the net weight or measure of the content, except that the Administrator may permit reasonable variations; and
((iv)) when required by regulation of the Administrator to effectuate the purposes of this subchapter, the registration number assigned to the pesticide under this subchapter, and the use classification; and
((D)) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in addition to any other matter required by this subchapter—
((i)) the skull and crossbones;
((ii)) the word “poison” prominently in red on a background of distinctly contrasting color; and
((iii)) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.
((r)) ** Nematode** The term “nematode” means invertebrate animals of the phylum nemathelminthes and class nematoda, that is, unsegmented round worms with elongated, fusiform, or saclike bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts; may also be called nemas or eelworms.
((s)) ** Person** The term “person” means any individual, partnership, association, corporation, or any organized group of persons whether incorporated or not.
((t)) ** Pest** The term “pest” means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest under .section 136w(c)(1) of this title
((u)) ** Pesticide** The term “pesticide” means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer, except that the term “pesticide” shall not include any article that is a “new animal drug” within the meaning of section 321(w) of title 21, that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 321(x) of title 21 bearing or containing a new animal drug. 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 . 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.11section 321 of title 21
((v)) ** Plant regulator** The term “plant regulator” means any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but shall not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, and soil amendments. Also, the term “plant regulator” shall not be required to include any of such of those nutrient mixtures or soil amendments as are commonly known as vitamin-hormone horticultural products, intended for improvement, maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are nontoxic, nonpoisonous in the undiluted packaged concentration.
((w)) ** Producer and produce** The term “producer” means the person who manufactures, prepares, compounds, propagates, or processes any pesticide or device or active ingredient used in producing a pesticide. The term “produce” means to manufacture, prepare, compound, propagate, or process any pesticide or device or active ingredient used in producing a pesticide. The dilution by individuals of formulated pesticides for their own use and according to the directions on registered labels shall not of itself result in such individuals being included in the definition of “producer” for the purposes of this subchapter.
((x)) ** Protect health and the environment** The terms “protect health and the environment” and “protection of health and the environment” mean protection against any unreasonable adverse effects on the environment.
((y)) ** Registrant** The term “registrant” means a person who has registered any pesticide pursuant to the provisions of this subchapter.
((z)) ** Registration** The term “registration” includes reregistration.
((aa)) ** State** The term “State” means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa.
((bb)) ** Unreasonable adverse effects on the environment** The term “unreasonable adverse effects on the environment” means (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under . The Administrator shall consider the risks and benefits of public health pesticides separate from the risks and benefits of other pesticides. In weighing any regulatory action concerning a public health pesticide under this subchapter, the Administrator shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.section 346a of title 21
((cc)) ** Weed** The term “weed” means any plant which grows where not wanted.
((dd)) ** Establishment** The term “establishment” means any place where a pesticide or device or active ingredient used in producing a pesticide is produced, or held, for distribution or sale.
((ee)) ** To use any registered pesticide in a manner inconsistent with its labeling** The term “to use any registered pesticide in a manner inconsistent with its labeling” means to use any registered pesticide in a manner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage, concentration, or frequency, (2) applying a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment, (3) employing any method of application not prohibited by the labeling unless the labeling specifically states that the product may be applied only by the methods specified on the labeling, (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibited by the labeling, (5) any use of a pesticide in conformance with section 136c, 136p, or 136v of this title, or (6) any use of a pesticide in a manner that the Administrator determines to be consistent with the purposes of this subchapter. After , the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use of definite amounts of dilution.March 31, 19791979-03-31
((ff)) ** Outstanding data requirement**
((1)) ** In general** The term “outstanding data requirement” means a requirement for any study, information, or data that is necessary to make a determination under and which study, information, or data—
((A)) has not been submitted to the Administrator; or
((B)) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid, complete, or adequate to make a determination under and the regulations and guidelines issued under such section.
((2)) ** Factors** In making a determination under paragraph (1)(B) respecting a study, the Administrator shall examine, at a minimum, relevant protocols, documentation of the conduct and analysis of the study, and the results of the study to determine whether the study and the results of the study fulfill the data requirement for which the study was submitted to the Administrator.
((gg)) ** To distribute or sell** The term “to distribute or sell” means to distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment, ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver. The term does not include the holding or application of registered pesticides or use dilutions thereof by any applicator who provides a service of controlling pests without delivering any unapplied pesticide to any person so served.
((hh)) ** Nitrogen stabilizer** The term “nitrogen stabilizer” means any substance or mixture of substances intended for preventing or hindering the process of nitrification, denitrification, ammonia volatilization, or urease production through action upon soil bacteria. Such term shall not include—
((1)) dicyandiamide;
((2)) ammonium thiosulfate; or
((3)) ** any substance or mixture of substances.—**
((A)) that was not registered pursuant to prior to ; and
((B)) that was in commercial agronomic use prior to , with respect to which after , the distributor or seller of the substance or mixture has made no specific claim of prevention or hindering of the process of nitrification, denitrification, ammonia volatilization urease production regardless of the actual use or purpose for, or future use or purpose for, the substance or mixture.
((jj)) ** Maintenance applicator** The term “maintenance applicator” means any individual who, in the principal course of such individual’s employment, uses, or supervises the use of, a pesticide not classified for restricted use (other than a ready to use consumer products pesticide); for the purpose of providing structural pest control or lawn pest control including janitors, general maintenance personnel, sanitation personnel, and grounds maintenance personnel. The term “maintenance applicator” does not include private applicators as defined in subsection (e)(2); individuals who use antimicrobial pesticides, sanitizers or disinfectants; individuals employed by Federal, State, and local governments or any political subdivisions thereof, or individuals who use pesticides not classified for restricted use in or around their homes, boats, sod farms, nurseries, greenhouses, or other noncommercial property.
((kk)) ** Service technician** The term “service technician” means any individual who uses or supervises the use of pesticides (other than a ready to use consumer products pesticide) for the purpose of providing structural pest control or lawn pest control on the property of another for a fee. The term “service technician” does not include individuals who use antimicrobial pesticides, sanitizers or disinfectants; or who otherwise apply ready to use consumer products pesticides.
((ll)) ** Minor use** The term “minor use” means the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where—
((1)) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or
((2)) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and—
((A)) there are insufficient efficacious alternative registered pesticides available for the use;
((B)) the alternatives to the pesticide use pose greater risks to the environment or human health;
((C)) the minor use pesticide plays or will play a significant part in managing pest resistance; or
((D)) the minor use pesticide plays or will play a significant part in an integrated pest management program.
((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 or a food additive regulation under .
((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
((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).
((nn)) ** Public health pesticide** The term “public health pesticide” means any minor use pesticide product registered for use and used predominantly in public health programs for vector control or for other recognized health protection uses, including the prevention or mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public health.
((oo)) ** Vector** The term “vector” means any organism capable of transmitting the causative agent of human disease or capable of producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats.