HAR §4-71A-27
HAR §4-71A-27. Standard permit conditions
Cite as Haw. Code R. § 4-71A-27
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-
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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
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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
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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. [Eff. 11/30/01] (Auth: HRS
§§150A-5.9, 150A-6.3) (Imp: HRS §150A-6.3)