Haw. Code R. § 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.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.
Notes
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