Haw. Code R. § 4-71A-4 - Request for importation

(a) Except as otherwise provided for microbial products, a request to import a microorganism species, regardless of whether listed for import or unlisted, shall be submitted to the chief with the following information:

(1) Importer's reason for importing the specific microorganism into the State;

(2) A request that the department inspect the microorganism upon arrival in the State;

(3) An agreement to be responsible for all costs, charges, or expenses incident to the inspection or treatment of the imported microorganisms;

(4) A waiver of all claims for damages incident to the inspection or the fumigation, disinfection, quarantine, or destruction of the microorganism, if any treatment is deemed necessary;

(5) Name, complete address, telephone, and facsimile numbers of the shipper and importer;

(6) Quantity, common and scientific names (genus and species names unless not yet classified) of each microorganism;

(7) Description of each species of microorganism including whether or not the microorganism is a recombinant DNA strain;

(8) Mode of transportation; and

(9) Approximate date of arrival.

(b) A request to import into Hawaii and possess a microorganism species on the restricted list, Part B, for the purposes described in section 4-71A-22(c)(1), (2) and (3), shall include, in addition to the information required in subsection (a), the following:

(1) Description of the proposed use of the microorganism, including whether or not inoculation studies will be done;

(2) Description and location of the facility, and description of the equipment and procedures that will be used to contain the microorganism, including a floor plan or blueprint of the facility or both that addresses:

(A) Design and construction;

(B) Work and storage areas;

(C) Equipment such as biosafety cabinets, autoclaves, freezers, incubators, holding tanks, generators;

(D) Plumbing system such as sinks, drains, effluent treatment and discharge systems;

(E) Air-handling system such as air conditioning, supply and exhaust air system, and types and placement of filters; and

(F) Biosafety procedures.

(3) Explanation of the method for destroying and disposing of the microorganism;

(4) Statement as to whether or not the use of the microorganism is subject to federal, county or state requirements other than the department's;

(5) The material safety data sheet, product label, and product information sheet;

(6) Importer's qualification and previous experience working with the requested microorganism, including documentation to confirm relevant education, employment, and previous experience; and

(7) Any other pertinent documented information required by the chief.

(c) A request to import an unlisted microorganism or a microorganism that requires board action shall include the information required in subsections (a) and (b), as well as the following additional information:

(1) Description of the microorganism including information on its taxonomic classification, natural habitat, geographic range or niche requirements, temperature requirements, host range, and dispersal capabilities; and

(2) Analysis of the microorganism's potential impact on Hawaii's environment, agricultural, horticultural and aquacultural industries, and animal and human health, in the event the microorganism escapes or is released into the environment.

(d) Failure to provide the information requested and to complete the application as required in this section shall be sufficient cause for denial of the request for import.

Notes

Haw. Code R. § 4-71A-4

[Eff. 11/30/01] (Auth: HRS §§ 150A-9, 150A-6.3) (Imp: HRS § 150A-6.3)