HAR §4-71A-2. Definitions

As used in the chapter: “Advisory subcommittee” means one of the advisory subcommittees on entomology, invertebrate and aquatic biota, land vertebrates, plants, algae, bacteria, fungi, protozoa, or viruses appointed by the chairperson pursuant to section 150A-10, HRS; “Applicant” means a person who has submitted an application for import or possession of a microorganism or both through permit or other official document authorizing import under this chapter and has paid the applicable fee; “Board” means the board of agriculture of the department of agriculture; “Branch” means the plant quarantine branch; “Chief” means the chief or manager of the plant quarantine branch or a department employee designated by the chief or chairperson; “Completed permit application” means a permit application submitted by an applicant on the form 71A-3 §4-71A-2 provided by the department and which contains the required information adequate, in the chief’s judgment, for review by the department, and if appropriate, by the advisory subcommittee(s), advisory committee, and board of agriculture; “Department” means the department of agriculture; “High risk microorganism” means a microorganism the import of which has been determined to be highly likely to cause significant harm to agriculture, horticulture, the environment, or animal or public health, in the absence of appropriate restrictions or safeguards; “Importer” means a person who receives for transport or brings or causes to be brought to the State in any manner, any microorganism for the purpose of debarkation or entry; “Label” means the written, printed, or graphic matter on or attached to the outside of the container of microorganisms with the required markings to cause inspection of the microorganism contained in the shipment; “Letter of authorization” means an official document in lieu of an import permit or microbial product registration issued by the branch authorizing a specific unlisted microorganism species determined to be a low risk microorganism to enter the State; “Low risk microorganism” means a microorganism species that is most likely already present in Hawaii, the import of which is not likely to cause additional harm to agriculture, horticulture, the environment, or animal or public health in the absence of restrictions or safeguards, or for which department-imposed restrictions other than the notification, labeling, and inspection requirements of this chapter are not likely to reduce any risks that may be associated with import of the microorganism; “Microbial product” means a manufactured product containing known cultures of microorganisms for the purpose of bioremediation or bioaugmentation, including a product such as a microbial pesticide; “Microorganism” means any unicellular microscopic organism including but not limited to algae, bacteria, 71A-4 §4-71A-2 fungi, protozoa, and viruses; “Moderate risk microorganism” means a microorganism the import of which has been determined to potentially cause harm to agriculture, horticulture, the environment, or animal or public health, in the absence of appropriate restrictions or safeguards; “Nonrestricted microorganisms” means any microorganism on the list of nonrestricted microorganisms required to be maintained pursuant to section 150A-6.3 HRS; “Permit” means a written document issued by the branch to allow the introduction and possession of a microorganism subject to permit conditions established by rule or the board; “Permittee” means any person that has applied for and been granted a permit for the introduction and possession of a microorganism under this chapter; “Person” means any individual, agency, firm, corporation, association, institution, or partnership or any organized group of persons whether incorporated or not; “Recombinant DNA” means molecules that are constructed outside living cells by joining natural or synthetic deoxyribonucleic acid (DNA) segments to DNA molecules that can replicate in a living cell, or molecules that result from the replication of those described herein; “Restricted microorganism” means any microorganism on the list of restricted microorganisms required to be maintained pursuant to section 150A-6.3 HRS; “Registration” means the process required for import of microbial products containing certain strains of nonrestricted microorganisms; “Select human pathogens” means species of microorganisms that present high risk to public health and which have oversight by the Centers for Disease Control and Prevention under 42 United States Code of Federal Regulations, section 72.6; “Site inspection” means department inspection of the facility, equipment, records pertaining to the 71A-5 §4-71A-2 microorganisms imported under permit, as well as procedures to contain the microorganism; “Unlisted microorganism” means any microorganism not on the lists of nonrestricted or restricted microorganisms or on the list of select human pathogen microorganisms required to be maintained pursuant to section 150A-6.3, HRS. [Eff. 11/30/01] (Auth: HRS §§150A-9, 150A-6.3) (Imp: HRS §150A-6.3) §4-71A-3 Importation of microorganisms, generally. (a) The introduction into Hawaii of any microorganism shall require, at a minimum, a request for import, approval for the import in advance of shipment, and compliance with the notification, labeling, and inspection requirements of sections 4- 71A-4, 4-71A-8, and 4-71A-9. Failure to comply with these requirements is sufficient cause for refusal to allow entry of the microorganism into the State. (b) In addition to the requirements of subsection (a), import into Hawaii and possession of a microorganism is allowed only as provided below for each respective category and requires: (1) A written request for import pursuant to section 4-71A-4 and as provided in section 4-71A-24, for a microorganism species on the list of nonrestricted microorganisms; (2) A permit, for a microorganism species on the list of restricted microorganisms, Part A or Part B, as provided in sections 4-71A-4, 4- 71A-7 and, as applicable, sections 4-71A-21 and 4-71A-22; (3) A special permit or letter of authorization, according to risk level, for an unlisted microorganism species, as provided in section 4-71A-4 and 4-71A-25; (4) An emergency permit, for an unlisted microorganism species or a microorganism species on the list of restricted microorganisms in an emergency or disaster situation, as provided in section 4-71A-12; and 71A-6 §4-71A-4 (5) Notification to the department of health of entry for possible department of health inspection and monitoring, for a microorganism species on the list of select human pathogens, as provided in section 4- 71A-23. (c) Importation of microbial products shall be subject to the requirements of subsection (a) and subchapter 4. [Eff. 11/30/01] (Auth: HRS §§150A-9, 150A-6.3) (Imp: HRS §150A-6.3)