Section 4-66-34 - Applications for licensing pesticides and for approval of nonchemical pest control devicesThe 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.pdf 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 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 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 DEC 16 2006] (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)