HAR §4-66-33. Pesticide licensing; exceptions

(a) Any manufacturer, packer, seller, distributor, or shipper of a pesticide may apply to license a pesticide. (b) No person may distribute in the State, any pesticide that is not licensed with the department, except for the following: (1) Pesticides transferred between EPA registered establishments operated by the same producer for packaging or for use in producing another pesticide, provided the pesticides are labeled to clearly show the identity and purpose for which the pesticides are being transferred; (2) Pesticides distributed under an experimental use permit issued by the head; (3) Pesticides transferred for purpose of disposal when marked to show the pesticides are for disposal only, and accompanied by sufficient information to identify products and to ensure that product can be handled with minimum hazard to humans or the environment; (4) Pesticides intended solely for export when prepared or packed according to specifications of foreign purchaser; (5) Pesticides being distributed under a FIFRA, section 18 emergency exemption; and (6) Upon written notice to the head, pesticides distributed to research laboratories for the purpose of laboratory or enclosed space production tests, or limited replicated field trials of less than one-fourth acre, to determine toxicity or other properties, and 66-21 §4-66-33 from which the producer, researcher, or applicator or any other person conducting the laboratory or enclosed space production tests or field trial, does not expect to receive any benefit in pest control from its use. Notice shall be provided on forms prescribed by the head. [Eff 7 /13/81; comp 12/16/06; am and comp AUG232019 ] (Auth: 40CFR§152.30; HRS §§149A-13, 149A-19, 149A-33) (Imp: HRS §§149A-13, 149A-19, 149A-33) §4-66-34 Applications for licensing pesticides and for approval of nonchemical pest control devices. The procedures for licensing pesticides, or approval of nonchemical pest control devices as defined in chapter 460J, Hawaii Revised Statutes, are as follows: (1) Applications shall be filed by the applicant or by an agent whom the applicant has designated as such by a notarized letter. (2) Applications shall be made on forms prescribed by the department and shall contain the following information: name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use, name of the pesticide or nonchemical pest control device as shown on the label, the EPA registration number (for pesticides), the EPA establishment number, and the signature of the applicant or applicant's designated agent. (3) Applications shall be submitted no less than thirty calendar days prior to the date licensing is desired to take effect. (4) Applications shall be accompanied by one copy of the final printed label in text.pd£ or similar format, the EPA stamped "ACCEPTED" label, if applicable, and any other printed or graphic matter that is required to accompany the pesticide or nonchemical pest control device when offered for sale or distribution, including all claims, directions for use, and any other materials specified by the head. ( 5) If requested by the head, the applicant for a pesticide license shall provide the complete 66-22 13 345 §4-66-34 formula of the pesticide, including active and inert ingredients, and a description of tests and test results thereof on which claims are based, including efficacy, residue, safety, and other supporting data that shows the pesticide shall perform its intended function without causing unreasonable adverse effects on humans or the environment. (6) If requested by the head, the applicant for nonchemical pest control device approval shall provide a description of the principles fundamental to the efficacy of the nonchemical pest control device, a description of the tests conducted according to the procedures described below and test results thereof on which claims are based, including efficacy, reliability, safety, and other supporting data that shows the nonchemical pest control device will perform its intended function without causing unreasonable adverse effects on humans or the environment. (7) Each test submitted pursuant to this section shall be based on a written protocol that clearly indicates the objectives and all the methods for the conduct of the test. The protocol shall contain, but not be limited to, the following information: (A) A descriptive title and statement of the purpose of the study; (B) The name and address of the sponsor and address of the testing facility at which the study was conducted; (C) Justification for the selection of the test organism; (D) Where applicable, the number, body weight range, sex, source of supply, species, strain, substrain and age of the organisms tested; (E) A description of the experimental design, including methods for the control of bias; (F) Where applicable, a description or identification of the diet for the test animals or fertilization and irrigation 66-23 §4-66-34 schedules for plants used in the test; (G) Treatments, such as the test frequency and volume for nonchemical pest control devices, and the method and frequency of administration; (H) The type and frequency of data collection, and measurements to be made; (I) The records to be maintained; (J) The date of approval by the sponsor and the signature of the test director; and (K) A statement of the proposed statistical analyses to be used. (8) The department may test nonchemical pest control devices to determine the reliability, efficacy and safety of the nonchemical pest control device. The applicant shall provide any nonchemical pest control devices to the department for testing upon request. (9) The department shall provide the applicant with a description of the tests to be conducted, and estimated schedule to complete the tests. (10) The applicant may initiate tests required pursuant to (8) above, using qualified testing facilities, with the concurrence of the department. [Eff 7/13/81; am and comp 12/16/06; am and comp AUG 2 3 lUl9 ] (Auth: HRS §§149A-13, 149A-15, 149A-19, 149A-33, 460J-24.5) (Imp: HRS §§149A-13, 149A-15, 149A-19, 149A-33, 460J-24.5) §4- 6 6-35 Pesticide licensing; effective date. (a) Licenses shall become effective on the date issued and, unless canceled by the head, shall continue in effect through the date of expiration. (b) Pesticide products are to be licensed for a period of three years. All licenses shall expire on December 31 of each third year after license issuance. (c) Provisional licenses may be issued for experimental use permits to cover the duration of the permit. (d) Any pesticide product licensed under the Act shall not require any further licensing by other persons 66-24 34 I ' provided: ( 1) (2) ( 3) §4-66-36 The pesticide product is in the manufacturer's or registrant's original unbroken container; The claims made in the pesticide product's directions for use, use classification, and other information contained in the labeling, do not differ from those made in conjunction with the license currently in effect; and Any change in the labeling or formula of a licensed pesticide shall be submitted in advance to the head provided: (A) The licensee shall describe the exact change and upon request, shall submit test results to support any change in labeling claims; and (B) After the effective date of any change in labeling or formulas, the pesticide shall be marketed only under the new label or formula. The head may permit a reasonable time for disposition of stocks, if in the opinion of the head, such disposition does not result in any unreasonable adverse effects on humans or the environment. [Eff 7/13/81; am and comp 12/16/06; am and comp AUG 2 3 2019 ] (Auth: HRS §§149A-13, 149A-19, 149A-33) (Imp: HRS §§149A-13, 149A-19, 149A-33)