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.
