HAR §4-66-47. Experimental use permits; exceptions

Upon written notification of the head, no experimental use permit is required for the intrastate shipment or use of a substance or mixture of substances being put through laboratory, enclosed space production, or limited field trials of less than one-fourth acre, in which the following three criteria have been met: (1) the purpose of the laboratory, enclosed space production, or limited field trials is to determine the value of a substance or mixture of substances as a pesticide or to determine its toxicity, or other properties; (2) the tests will be conducted by recognized research personnel; and (3) the research personnel conducting the tests do not expect to receive any benefit, other than the research, in pest 66-34 §4-66-48 control from the use of the substance or mixture of substances. If these three criteria are met, the substances or mixture of substances are not considered to be pesticides within the meaning of the Act or these rules. No State experimental use permit is required if an experimental use permit has been issued by the EPA for the proposed trial (s) . Written notification shall be submitted on forms prescribed by the head. [Eff 7/13/81; am and comp 12/16/06; am and comp ] (Auth: HRS §§149A-19, 149A-22, 149A-33; 7 USC §136v (a)) (Imp: HRS §§149A-19, 149A-22, 149A-33) §4-66-48 Experimental use permits; provisions for issuance. (a) A permit is required for a pesticide intended for experimental use that is not exempt under section 4-66-47. If a pesticide is to be tested for a use, which is likely to result in a residue on or in food or feed, a permit for experimental use may be issued provided: (1) A tolerance or exemption from the requirements of a tolerance has been established under section 408 of the Federal Food, Drug, and Cosmetic Act, codified at title 21 United States Code section 346a (2017); or a regulation established under section 409 of the Federal Food, Drug, and Cosmetic Act, codified at title 21 United States Code section 348 (2017); or (2) The food or feed product derived from the experimental use permit shall be destroyed or used as feed only for laboratory or experimental animals for testing purposes; or (3) Convincing evidence is submitted by the applicant that the proposed use shall not result in residues in or on food or feed that would be in excess of that authorized under section 408 of the Federal Food, Drug, and Cosmetic Act, codified at title 21 United States Code section 346a (2017), or a regulation established under section 409 of the Federal Food, Drug, and Cosmetic Act, 66-35 §4-66-48 section 348 of title 21, United States Code (2017), which would be hazardous to humans, other animals, or the environment. (b) A permit shall be issued only if it is clearly shown in the permit application that the applicant's instructions for use reasonably assure the protection of humans and the environment. (c) All applications for an experimental use permit shall be filed by a qualified person on a form prescribed by the head. Each application shall contain the following: (1) Name and address of the shipper, the consignee, and place or places from which the shipment shall be made; (2) Proposed date of shipment, or proposed shipping period that shall not exceed one year from the permit application date, and quantity to be shipped; (3) A statement of the composition of material to be covered by the permit, which shall apply to a single material or similar formulations of the material; (4) The name, address and telephone number and qualification of the person responsible for conducting the test; (5) Available data or reference to available data on the analytical method and toxicity of the pesticide; (6) The purpose or objective of the proposed tests; a description of the proposed testing program including test parameters; a designation of the pest organism or organisms involved; the amount of pesticide product proposed for use; the crops, fauna, flora, sites, modes, dosage rate, and situation of applications on or in which the pesticide is to be used; the number of acres, number of structure sites, or number of animals to be treated or included in the area of experimental use; the proposed dates, or period, or periods during which the testing program is to be conducted and the manner in which supervision of the program shall be accomplished; and the method of destruction or 66-36 §4-66-49 disposal of treated food or feed; (7) A statement that the pesticide is intended for experimental use only; (8) Proposed labeling that shall bear: (A) The prominent statement "For Distribution and Experimental Use Only Within Hawaii" in the container label and any accompanying circular or other labeling; (B) A warning or caution statement that may be necessary and if complied with is adequate for the protection of those who may handle or be exposed to the experimental formulations; (C) The name and address of the applicant for the permit; (D) The name or designation of the formulation; and (E) If the pesticide is to be sold to experimental use program participants, a statement of the names and percentages of the principal active ingredients in the product; provided that, if the shipper submits a copy of a valid experimental use permit issued under the provisions of FIFRA, and the accepted labeling related thereto, at the head's discretion, the head may exempt the shipper from the requirement of submitting a part of the application, the data, and information specified in this subsection; and (9) A statement as to the disposal of any unused portions of the experimental pesticide. [Eff 7/13./81~ am and comp 12/16/06; am and comp AUG L 3 2019 ] (Auth: HRS §§149A-19, 149A-22, 149A-33; 40 CFR §172.24) (Imp: HRS §§149A-19, 149A-22, 149A-33; 40 CFR §172.24)