Haw. Code R. § 4-71A-27

Current through April, 2024
Section 4-71A-27 - Standard permit conditions

All microorganisms allowed import through permit issued by the chief are subject to the standard permit conditions set forth below, provided that, for each permit, the identity of the microorganism or microorganisms or, alternatively, reference to an attached list of identified microorganisms to be imported, the purpose or purposes for import, permittee's name and address, site including address, and name and title of the person responsible for the particular import shall be inserted, as appropriate, in conditions (1),(2),(4) and (5), respectively:

(1) The microorganisms, _________________, shall be used for_________________, a purpose approved by the chief, and shall not be sold, given, transferred or released in Hawaii, unless approved by the chief in writing;
(2) The permittee, _________________, shall be responsible and accountable for all microorganisms imported, from the time of their arrival to their final disposition;
(3) The microorganisms are subject to the pre-entry requirements of section 4-71A-8 and the inspection requirements of section 4- 71A-9;
(4) The microorganisms shall be safeguarded at

_________________, a site inspected and approved by the branch prior to importation. Removal of the microorganisms to another site shall require site inspection and prior approval by the chief;

(5) The microorganisms shall be maintained by

_________________ as the responsible person or by trained or certified personnel designated by the responsible person;

(6) The permittee shall adhere to the use, facility, equipment, procedures, and safeguards proposed and described in the permit application, as approved;
(7) The approved site, microorganisms, and records pertaining to the microorganisms under permit shall be subject to post-entry inspections pursuant to section 4-71A-16;
(8) The permittee shall immediately report to the chief any theft, accidental release, exposure, or disease outbreaks involving the microorganisms;
(9) Upon completion or termination of the use of the microorganisms, the microorganisms shall be destroyed by autoclaving. In the event autoclaving is not possible, the permittee shall obtain written authorization from the chief for an appropriate alternate method of destruction;
(10) The permittee shall submit an annual report of all the microorganisms imported for the calendar year by January 31st of the following year. The report shall include the permit number, scientific name and quantity of each microorganism species imported, and status of use of the microorganisms;
(11) The permittee shall submit a final report on the method of destruction of the microorganism species to the chief within 30 days of completion or termination of the use of the microorganisms;
(12) The permittee shall have available a procedural or safety manual at the time of inspection which identifies the hazards that will or may be encountered, and which specifies practices and procedures designed to minimize or eliminate risks of exposure or contamination;
(13) It is the responsibility of the permittee to comply with any applicable requirements of municipal, state, or federal law pertaining to the microorganisms;
(14) The permittee shall submit to the chief a copy of all valid licenses, permits, certificates or their equivalent required for the operation of the facility where the microorganisms are safeguarded. The permit issued by the chief may be cancelled upon revocation, suspension, or termination of any of the aforementioned documents required for operation of the facility;
(15) Any violation of the permit conditions may result in citation or in cancellation of the permit, or both;
(16) A cancelled permit is invalid and upon written notification from the chief, all microorganisms listed on the permit shall not be imported. In the event of permit cancellation, any microorganism species imported may be moved, seized, treated, quarantined, destroyed, or sent out of state at the discretion of the chief. Any expense or loss in connection therewith shall be borne by the permittee;
(17) The permit conditions are subject to cancellation or amendment at any time due to changes in statute or administrative rules restricting or disallowing import of the microorganisms or due to Board of Agriculture action disallowing a previously permitted use of the microorganisms; and
(18) The permittee shall agree in advance to defend and indemnify the State of Hawaii, its officers, agents, and employees for any and all claims against the State of Hawaii, its officers, agents, or employees that may arise from or be attributable to any of the microorganisms that are introduced under this permit. This permit condition shall not apply to a permittee that is a federal or State of Hawaii entity or employee, provided that the state employee is a permittee in the employee's official capacity.

Haw. Code R. § 4-71A-27

[Eff. 11/30/01] (Auth: HRS §§ 150A-5.9, 150A-6.3) (Imp: HRS § 150A-6.3)