REPORT TITLE: 
Microorganism importation


DESCRIPTION:
Establishes procedures to certify importers of microorganisms to
enable them to quickly take advantage of new biotechnology
advances.  Separates provisions for importation of
microorganisms from provisions for importation of plants and
animals.  Establishes the Microorganisms Import Certification
Fund funded by fees, fines, and appropriations.  (HB336 CD1)


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                        336
HOUSE OF REPRESENTATIVES                H.B. NO.           H.D. 1
TWENTIETH LEGISLATURE, 1999                                S.D. 1
STATE OF HAWAII                                            C.D. 1
                                                             
________________________________________________________________
________________________________________________________________


                     A BILL FOR AN ACT

RELATING TO PLANT AND NON-DOMESTIC ANIMAL QUARANTINE.



BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 1      SECTION 1.  Chapter 150A, Hawaii Revised Statutes, is
 
 2 amended by adding a new part to read as follows:
 
 3          "PART V.  CERTIFIED IMPORTERS OF MICROORGANISMS
 
 4      150A-A  Microorganism import.(a)  Notwithstanding the
 
 5 permit requirements of sections 150A-5 and 150A-6, the board may
 
 6 issue a certificate to an importer of microorganisms authorizing
 
 7 import and possession of microorganisms, other than
 
 8 microorganisms on the lists of nonrestricted microorganisms or
 
 9 prohibited microorganisms referenced in section 150A-6; provided
 
10 that:
 
11      (1)  The import and possession is for medical or scientific
 
12           purposes;
 
13      (2)  The microorganisms are contained in a laboratory or
 
14           other contained system approved by the department;
 
15      (3)  The microorganisms are used in a manner that will not
 
16           be detrimental to agriculture, horticulture, the
 
17           environment, animals, or humans; and
 
18      (4)  The importer is able to meet requirements established
 
19           by the board,
 
20 as further verified through site inspection by the department.
 

 
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 1      (b)  Import by a certified importer of microorganisms other
 
 2 than those listed in the importer's certificate or for uses other
 
 3 than specified for each type of microorganism listed in the
 
 4 certificate shall be pursuant to section 150A-6.
 
 5      (c)  A certified importer importing pursuant to certificate
 
 6 shall comply with the provisions of part II other than the permit
 
 7 requirement, as applicable, in particular, the notification,
 
 8 labeling, and inspection requirements of section 150A-5.
 
 9      150A-B  Certificate.(a)  An importer requesting a
 
10 certificate under this part shall complete and submit an
 
11 application to the department providing information as required
 
12 by rule.
 
13      (b)  Fees may be assessed for the processing and issuance of
 
14 a certificate and for inspections related to the certificate, as
 
15 established by rule.  Fees may vary according to the type of
 
16 certification issued and the costs incurred for inspections.
 
17      (c)  A certificate issued under this part shall be valid for
 
18 no more than two years from date of issuance.  A certified
 
19 importer may reapply for certification pursuant to subsection
 
20 (a).
 
21      150A-C  Suspension or revocation of certificate.  Any
 
22 certificate issued pursuant to this part may be suspended or
 
23 revoked by the department, after hearing, for violation of any
 

 
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 1 certificate requirement or condition or any provision of this
 
 2 chapter or rule adopted under this part.  Any order made by the
 
 3 department for the suspension or revocation of a certificate
 
 4 shall be in writing and shall set forth the reasons for the
 
 5 suspension or revocation.  The action of the department in
 
 6 suspending or revoking a certificate may be reviewed in the
 
 7 manner provided in chapter 91.
 
 8      150A-D  Summary suspension.  Notwithstanding any law to the
 
 9 contrary, the department may cause the immediate suspension of an
 
10 importer's certificate, subject to subsequent notice and hearing
 
11 or other adequate procedures, upon the department's determination
 
12 that there is an impending danger of escape or release of, or
 
13 contamination from or exposure to microorganisms imported
 
14 pursuant to certificate so as to present a threat to public
 
15 health or safety, animal health, agriculture, horticulture, or
 
16 the environment, or in the event of a medical emergency or
 
17 agricultural or ecological disaster resulting from escape or
 
18 release of, or contamination from or exposure to microorganisms
 
19 imported pursuant to certificate.
 
20      The department may order the summary suspension of the
 
21 certificate for a period not to exceed twenty days.  The order of
 
22 suspension shall be served upon the certified importer at the
 
23 same time as the notice of hearing for further suspension or
 

 
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 1 revocation and the hearing shall be scheduled prior to the
 
 2 expiration of the order of suspension.  The period of suspension
 
 3 prior to the hearing shall not be extended beyond twenty days
 
 4 except upon the request of the importer for a reasonable
 
 5 continuance to adequately prepare the importer's defense.  Any
 
 6 attempt by the importer to continue the certified activity while
 
 7 the certificate has been summarily suspended shall of itself be
 
 8 sufficient to warrant a permanent revocation of the certificate
 
 9 and shall subject the importer to all penalties prescribed by
 
10 this chapter or any rule or order of the department.
 
11      150A-E  Emergency remediation.  In conjunction with summary
 
12 suspension of an importer's certificate, upon the department's
 
13 determination that there is an impending danger of escape or
 
14 release of, or contamination from or exposure to microorganisms
 
15 imported pursuant to certificate so as to present a threat to
 
16 public health or safety, animal health, agriculture,
 
17 horticulture, or the environment, or in the event of a medical
 
18 emergency or agricultural or ecological disaster resulting from
 
19 escape or release of, or contamination from or exposure to
 
20 microorganisms imported pursuant to certificate, the department
 
21 may, at the expense of the importer, seize, quarantine,
 
22 remediate, condemn, or destroy the imported microorganisms, or
 
23 any contaminated material, containment equipment, and laboratory
 

 
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 1 or other contained system approved by the department, as the
 
 2 department in its discretion determines is necessary to address
 
 3 the threat, emergency, or disaster.
 
 4      150A-F  Conditions of importation under certification.(a)
 
 5 A certificate issued to an importer under this part is non-
 
 6 transferable.
 
 7      (b)  Every importer issued a certificate shall comply with
 
 8 the requirements of the certificate.
 
 9      (c)  Any department employee or authorized representative
 
10 may enter the premises under certification at any reasonable time
 
11 to examine and inspect any microorganism, records, laboratory or
 
12 other contained system approved by the department, equipment,
 
13 procedures, manuals, and other related materials pertaining to
 
14 the microorganism imported pursuant to certificate, and may
 
15 conduct tests, collect samples, or perform any other duty for the
 
16 purpose of carrying out and effectuating the purposes of this
 
17 chapter.
 
18      150A-G  Penalties.  In addition to penalties that may be
 
19 applicable under section 150A-14, certified importers are subject
 
20 to penalties as follows:
 
21      (1)  A certified importer who violates any of the foregoing
 
22           sections in this part shall be guilty of a petty
 
23           misdemeanor and, notwithstanding section 706-640, shall
 

 
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 1           be subject to a fine of not less than $1,000 and not
 
 2           more than $10,000; and
 
 3      (2)  A certified importer who intentionally imports a
 
 4           microorganism not allowed by the importer's
 
 5           certification with the intent to propagate, sell, or
 
 6           release the microorganism shall be guilty of a class C
 
 7           felony and, notwithstanding section 706-640, shall be
 
 8           subject to a fine of not less than $50,000 but not more
 
 9           than $500,000.
 
10      150A-H  Microorganism import certification revolving fund.
 
11 (a)  There is established in the state treasury the microorganism
 
12 import certification revolving fund which shall be administered
 
13 by the department for the purposes of this section.  The
 
14 microorganism import certification revolving fund shall consist
 
15 of:
 
16      (1)  Legislative appropriations to the microorganism import
 
17           certification revolving fund;  
 
18      (2)  Certification and inspection fees, as authorized by
 
19           rule;  
 
20      (3)  All fines collected pursuant to this part;  
 
21      (4)  Reimbursements for any costs paid by the department to
 
22           remediate any impending danger or actual emergencies
 
23           involving microorganisms imported pursuant to
 
24           certificate;  
 

 
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 1      (5)  All interest earned on or accrued to moneys deposited
 
 2           in the microorganism import certification revolving
 
 3           fund;  
 
 4      (6)  Grants and gifts to the microorganism import
 
 5           certification revolving fund; and
 
 6      (7)  Any other moneys made available to the microorganism
 
 7           import certification revolving fund from other sources;  
 
 8      (b)  The balance in the microorganism import certification
 
 9 revolving fund shall not exceed $500,000.  All amounts in excess
 
10 of $500,000 shall be deposited to the credit of the state general
 
11 fund.  
 
12      (c)  The department shall expend moneys in the microorganism
 
13 import certification revolving fund for the development,
 
14 administration, and operation of the microorganism import
 
15 certification program, including but not limited to personnel,
 
16 training, materials and equipment, compliance monitoring
 
17 activities, educational workshops for certified importers and
 
18 applicants for certification, evaluation and remediation of
 
19 impending threat or actual emergencies related to microorganisms
 
20 imported pursuant to certificate, and for any other purpose
 
21 deemed necessary to carry out the purposes of this part.  
 
22      (d)  The department may set fees, by rule, for educational
 
23 workshops for certified importers or applicants for
 
24 certification."
 

 
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 1      SECTION 2.  Section 150A-2, Hawaii Revised Statutes, is
 
 2 amended by amending the definitions of "algae", "bacteria",
 
 3 "fungus", "protozoa", and "virus" to read as follows:  
 
 4      ""Algae" means any plant containing chlorophyll, which lacks
 
 5 true roots, stems, and leaves, and typically inhabits moist
 
 6 habitats, except those algae on or in humans or animals in Hawaii
 
 7 and those in or on processed foods, beverages, or
 
 8 pharmaceuticals[, and those in certain microbial products or used
 
 9 as food or for food preparation as specified by rule].  
 
10      "Bacteria" means any prokaryotic or [archaebacterial]
 
11 archaeobacterial organism, except those bacteria on or in humans
 
12 or animals in Hawaii, and those in or on processed foods,
 
13 beverages, or pharmaceuticals[, and those in certain microbial
 
14 products or used as food or for food preparation as specified by
 
15 rule].  
 
16      "Fungus" means all nonchlorophyll-bearing thallophytes,
 
17 except those fungi on or in humans or animals in Hawaii, and
 
18 those on or in processed foods, beverages, or pharmaceuticals[,
 
19 and those in certain microbial products or used as food or for
 
20 food preparation as specified by rule].  
 
21      "Protozoa" means any nonphotosynthetic eukaryotic organisms,
 
22 either unicellular or composed of a group of more or less
 
23 identical cells, generally motile by means of appendages or
 

 
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 1 movements of the cell itself at some or all stages of their life
 
 2 cycle, except those protozoa on or in humans or animals in
 
 3 Hawaii, and those in or on processed foods, beverages, or
 
 4 pharmaceuticals[, and those in certain microbial products as
 
 5 specified by rule].  
 
 6      "Virus" means any or a class of noncellular submicroscopic
 
 7 obligate parasite, chiefly nucleoprotein in composition but often
 
 8 reducible to crystalline form, except those viruses on or in
 
 9 humans, or animals in Hawaii, and those on or in processed foods,
 
10 beverages, or pharmaceuticals[, and those in certain microbial
 
11 products as specified by rule]."  
 
12      SECTION 3.  Section 150A-6, Hawaii Revised Statutes, is
 
13 amended to read as follows:  
 
14      "150A-6  Soil, plants, animals, etc., importation or
 
15 possession prohibited.(a)  No person shall transport, receive
 
16 for transport, or cause to be transported to the State, for the
 
17 purpose of debarkation or entry thereinto, any of the following:  
 
18      (1)  Soil; provided that limited quantifies of soil may be
 
19           imported into the State for experimental or other
 
20           scientific purposes under permit with conditions
 
21           prescribed by the department;  
 
22      (2)  Rocks, plants, plant products, or any article with soil
 
23           adhering thereto;  
 

 
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 1      (3)  Any live snake, flying fox, fruit bat, Gila monster,
 
 2           injurious insect, or eels of the order Anguilliformes,
 
 3           or any other animal, plant, or microorganism in any
 
 4           stage of development that is detrimental or potentially
 
 5           harmful to agriculture, horticulture, animal or public
 
 6           health, or natural resources, including native biota,
 
 7           or has an adverse effect on the environment as
 
 8           determined by the board, except that, notwithstanding
 
 9           the list of animals prohibited entry into the State,
 
10           the department may bring into and maintain in the State
 
11           one live, sterile brown tree snake of the male sex for
 
12           the purpose of research or training of snake detector
 
13           dogs, and, further, that a government agency may bring
 
14           into and maintain in the State not more than two live,
 
15           nonvenomous snakes of the male sex solely for the
 
16           purpose of exhibition in a government zoo, but only
 
17           after:  
 
18           (A)  The board is presented with satisfactory evidence
 
19                that the sex of the snakes was established to be
 
20                male prior to the shipment; and 
 
21           (B)  The gives written approval conditioned upon such
 
22                terms as the board may deem necessary, which terms
 
23                shall include measures to assure the prevention of
 

 
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 1                escape, continuing supervision and control by the
 
 2                board with respect to any department import under
 
 3                this paragraph, and the manner in which the snakes
 
 4                shall be disposed of or destroyed.  
 
 5           In case of the death of one or more snakes, the
 
 6           department or government agency may import and maintain
 
 7           replacements subject to the conditions described in
 
 8           this paragraph; and 
 
 9      (4)  Any live or dead honey bees, or used bee equipment that
 
10           is not certified by the department to be free of pests;
 
11           provided that nothing in this paragraph shall be
 
12           construed to prohibit the importation of bee semen.
 
13      (b)  The board shall maintain:
 
14      (1)  A list of [conditionally-approved] conditionally
 
15           approved animals [and microorganisms]that require a
 
16           permit for import into the State;
 
17      (2)  A list of restricted animals [and microorganisms] that
 
18           require a permit for both import into the State and
 
19           possession; and
 
20      (3)  A list of animals [and microorganisms]that are
 
21           prohibited entry into the State;
 
22 provided that the board shall adopt rules, pursuant to chapter
 
23 91, to establish an ad hoc panel of no fewer than three members
 

 
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 1 with applicable expertise in vertebrate biology to identify
 
 2 whether an animal is a prohibited hybrid animal when the
 
 3 department suspects that the lineage of the animal is not as
 
 4 stated by the owner or on other official documents.
 
 5      Animals [and microorganisms] on the lists of [conditionally-
 
 6 approved] conditionally approved and restricted animals [and
 
 7 microorganisms] shall be imported only by permit.  Any animal [or
 
 8 microorganism] that is not on the lists of [conditionally-
 
 9 approved] conditionally approved, restricted, or prohibited
 
10 animals [and microorganisms] shall be prohibited until the
 
11 board's review and determination for placement on one of these
 
12 lists; provided that the department may issue a special permit on
 
13 a case-by-case basis for the importation and possession of an
 
14 animal [or a microorganism] that is not on the lists of
 
15 prohibited, restricted, or [conditionally-approved] conditionally
 
16 approved animals [or microorganisms], for the purpose of
 
17 remediating medical emergencies or agricultural or ecological
 
18 disasters, or conducting medical or scientific research in a
 
19 manner that the animal [or microorganism] will not be detrimental
 
20 to agriculture, the environment, or humans if the importer of the
 
21 animal [or microorganism] can meet permit requirements
 
22 [consistent with Centers for Disease Control and National
 
23 Institute of Health guidelines or other guidelines] as determined
 

 
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 1 by the board; and provided further that the department may issue
 
 2 a short-term special permit on a case-by-case basis not to exceed
 
 3 ninety days for the importation and possession of an animal that
 
 4 is not on the list of prohibited, restricted, or [conditionally-
 
 5 approved] conditionally approved animals for the purpose of
 
 6 filming, performance, or exhibition if the importer of the animal
 
 7 can meet permit and bonding requirements as determined by the
 
 8 board.  [All]
 
 9      (c)  The board shall maintain:
 
10      (1)  A list of nonrestricted microorganisms allowed entry
 
11           into the State without a permit but which are subject
 
12           to the notification, labeling, and inspection
 
13           requirements of section 150A-5;
 
14      (2)  A list of restricted microorganisms that require a
 
15           permit for import into the State and possession, except
 
16           as otherwise provided in part V; and
 
17      (3)  A list of microorganisms that are prohibited entry into
 
18           the State, except that the department may issue an
 
19           emergency permit on a case-by-case basis to a state or
 
20           federal agency or state university for the import and
 
21           possession of a microorganism on the list of prohibited
 
22           microorganisms for the purpose of remediating medical
 
23           emergencies or agricultural or ecological disasters
 
24           pursuant to the board's determination that:
 

 
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 1           (A)  An emergency or disaster exists; and
 
 2           (B)  The importer is able to meet permit requirements
 
 3                consistent with Centers for Disease Control and
 
 4                Prevention and National Institutes of Health
 
 5                guidelines or other guidelines as determined by
 
 6                the board.
 
 7 No emergency permit may be issued until the board, without regard
 
 8 to rule requirements for advisory review, obtains advice from
 
 9 qualified persons with relevant expertise.
 
10      Except as otherwise provided in part V, any microorganism
 
11 that is not on the lists of nonrestricted, restricted, or
 
12 prohibited microorganisms may not enter the State until the
 
13 board's review and determination for placement on one of those
 
14 lists; provided that pending the listing by rule of an unlisted
 
15 microorganism determined by the board to be allowed for import,
 
16 the department may issue a special permit on a case-by-case basis
 
17 for the import and possession of the microorganism for purposes
 
18 approved by the board if the microorganism is to be used in a
 
19 manner that will not be detrimental to agriculture, horticulture,
 
20 the environment, animals, and humans, and if the importer is able
 
21 to meet conditions established by the board.
 
22      (d)  Except as otherwise provided herein, all permits
 
23 referenced in this section shall be issued pursuant to rules.
 

 
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 1 Any violation of the conditions listed on the permits shall be a
 
 2 violation of this section.
 
 3      [(c)] (e)  The board shall maintain a list of restricted
 
 4 plants and a list of prohibited plants.  Restricted plants shall
 
 5 not be imported into the State without a permit issued pursuant
 
 6 to rules, and any violation of the conditions listed on the
 
 7 permit shall be a violation of this section.
 
 8      [(d)] (f)  No person shall possess, propagate, sell,
 
 9 transfer, or harbor any plant, animal, or microorganism included
 
10 on the list or lists of prohibited plants, animals, and
 
11 microorganisms maintained by the board under this section, except
 
12 as allowed by the board upon a determination that the species:
 
13      (1)  Was initially permitted entry and later prohibited
 
14           entry into the State; or
 
15      (2)  Was continually prohibited but unlawfully introduced
 
16           and is currently established in the State; and
 
17      (3)  Is not significantly harmful to agriculture,
 
18           horticulture, animal or public health, and the
 
19           environment.
 
20 Under the circumstances described in this subsection, the board
 
21 may permit possession of the individual plant, animal, or
 
22 microorganism through its registration with the department while
 
23 still prohibiting the same species of plant, animal, or
 
24 microorganism from importation, propagation, transfer, and sale.
 

 
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 1      [(e)]  (g)  Without regard to the notice and public hearing
 
 2 requirements of chapter 91, the board may adopt rules to make
 
 3 additions to or deletions from the lists required to be
 
 4 maintained in subsections (b), [and] (c)[;], and (e); provided
 
 5 that the board shall adopt rules pursuant to chapter 91 to
 
 6 establish methods to obtain public input and to notify the public
 
 7 as to any additions to or deletions from the lists required under
 
 8 subsections (b), [and] (c)[.], and (e)."
 
 9      SECTION 4.  Section 150A-7, Hawaii Revised Statutes, is
 
10 amended by amending subsection (b) to read as follows:
 
11      "(b)  It is a violation of section 150A-6 to bring to or
 
12 possess in the State any living creature that is prohibited, or
 
13 restricted and without a permit issued by the department, except
 
14 as expressly provided in that section or in part V, and such a
 
15 creature shall constitute contraband and shall be seized
 
16 immediately upon discovery whenever found, and be destroyed,
 
17 donated to a government zoo, or sent out of the State, at the
 
18 discretion of the department.  Any expense or loss in connection
 
19 therewith shall be borne by the owner or the owner's agent.  [The
 
20 foregoing shall not apply to any snake which is brought into the
 
21 State by the department for the purpose of research or training
 
22 of snake detector dogs, or by a government agency solely for the
 
23 purpose of exhibition in a government zoo pursuant to section
 
24 150A-6(a)(3).]"
 

 
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 1      SECTION 5.  Section 150A-7.5, Hawaii Revised Statutes, is
 
 2 amended to read as follows:
 
 3      "[[]150A-7.5[]]  User fees.  Fees may be assessed for the
 
 4 processing and issuance of [import] permits issued by the
 
 5 department under this part and for inspections related to
 
 6 [import] permit conditions, as established by rule."
 
 7      SECTION 6.  Section 150A-9.5, Hawaii Revised Statutes, is
 
 8 amended by amending subsection (c) to read as follows:
 
 9      "(c)  Interim rules adopted by the department pursuant to
 
10 this section shall be effective as stated by such rules; provided
 
11 that any interim rule shall be published at least once [in each
 
12 newspaper of general circulation in the State] statewide within
 
13 [five] ten days of issuance; and provided further that no interim
 
14 rule shall be effective for more than one hundred eighty days."
 
15      SECTION 7.  There is appropriated out of the general
 
16 revenues of the State of Hawaii the sum of $0 or so much thereof
 
17 as may be necessary for fiscal year 1999-2000 and the same sum or
 
18 so much thereof as may be necessary for fiscal year 2000-2001 to
 
19 be deposited into the Microorganism Import Certification
 
20 Revolving Fund for the development, administration, and operation
 
21 of the microorganism import certification program.
 
22      SECTION 8.  There is appropriated out of the Microorganism
 
23 Import Certification Revolving Fund the sum of $100,000 or so
 

 
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 1 much thereof as may be necessary for fiscal year 1999-2000 and
 
 2 the same sum or so much thereof as be necessary for fiscal year
 
 3 2000-2001 for the development, administration, and operation of
 
 4 the microorganism import certification program.
 
 5      SECTION 9.  The sums appropriated shall be expended by the
 
 6 department of agriculture for the purposes of the Microorganism
 
 7 Import Certification Revolving Fund.
 
 8      SECTION 10.  In codifying the new sections added by this
 
 9 Act, the revisor of statutes shall substitute the appropriate
 
10 section numbers for the letters used in designating the new
 
11 sections in this Act.
 
12      SECTION 11.  Statutory material to be repealed is bracketed.
 
13 New statutory material is underscored.
 
14      SECTION 12.  This Act shall take effect on July 1, 1999.