§150A-6.3  Microorganism import.  (a) The board shall maintain:

(1)  A list of nonrestricted microorganisms allowedentry into the State without a permit;

(2)  A list of restricted microorganisms that requirea permit for import into the State and possession; and

(3)  A list of microorganisms that are select humanpathogens allowed entry into the State without a permit but that require thedepartment to notify the department of health of entry for the purpose ofpossible department of health inspection and monitoring.

Import of a microorganism on these lists, as well asimport of any unlisted microorganism, shall be subject to the notification,labeling, and inspection requirements of section 150A-5, and is allowed only asprovided herein.

(b)  Import of a microorganism on therestricted list of microorganisms shall be by permit issued pursuant to rulesand subject to conditions established by rules; provided that, if thedepartment in its discretion determines that import of a microorganism on therestricted list or the microorganism's proposed use presents a high risk toagriculture, horticulture, the environment, or animal or public health, theimport request shall be subject to advisory committee review and boardapproval, including a determination that the importer is able to comply withconditions established by the board, before a permit may be issued.

(c)  Import and possession of an unlistedmicroorganism may be allowed based on the department's determination of thelevel of risk presented by the import, including its proposed use, toagriculture, horticulture, the environment, or animal or public health.  Importshall be either by letter of authorization or special permit issued by thedepartment, without advisory committee review or board approval, or,alternatively, by special permit issued by the department subsequent toadvisory committee review and board approval, according to risk level asprovided by rule; provided that in the latter instance the importer is able tocomply with conditions established by the board.

(d)  The department may issue an emergencypermit on a case-by-case basis to a state or federal agency or state universityto allow import and possession of a microorganism on the list of restrictedmicroorganisms or an unlisted microorganism for the purpose of remediating anyemergency or disaster affecting agriculture, horticulture, the environment,animal or public health, or for emergency preparedness; provided that:

(1)  The board, without advisory committee review,first obtains advice from qualified persons with relevant expertise;

(2)  The board determines that import in less timethan is required for issuance of a special permit under subsections (b) and (c)as applicable, is necessary to remediate the emergency or disaster; and

(3)  The importer is able to meet conditionsestablished by the board.

(e)  Microbial products may be imported asfollows:

(1)  Microbial products containing certain strains ofmicroorganisms on the nonrestricted list of microorganisms, as identified byrule, may enter the State without a permit but shall not be imported without aregistration issued pursuant to rules.  Import of an unregistered microbialproduct required to be registered with the department is a violation of thissection; and

(2)  Import of microbial products other than thoseproducts required to be registered pursuant to paragraph (1) shall be by permitor letter of authorization, as provided in subsections (b) and (c) asapplicable.

(f)  The requirements of this section otherthan the notification, labeling, and inspection requirements of section 150A-5shall not apply to import of microorganisms by the following:

(1)  The state department of health orTripler Army Medical Center for their laboratories; provided that thedepartment of health shall develop and implement within its laboratories amechanism for coordinated oversight and inventory control of microorganismsimported for its laboratories and implement internal procedures to assureproper biosafety containment and laboratory practices commensurate withmicroorganism risk levels; and

(2)  A laboratory certified under theClinical Laboratories Improvement Amendments of 1988 (42 U.S.C. 263 et seq.);provided that the certified laboratory is registered with the departmentpursuant to rules and imports microorganisms that are applicable to thecategory of examinations or procedures for which the foregoing certificationwas approved.

The department of health and Tripler Army MedicalCenter may transfer any such imported microorganisms between their respectivelaboratories without approval from the department of agriculture, but withnotification to the department of agriculture prior to the transfer; providedthat transfer of such imported microorganisms from the department of health,Tripler Army Medical Center, or a laboratory certified and registered asdescribed in paragraph (2) to other entities in the State shall require priorapproval from the department of agriculture in the form of a letter ofauthorization or a permit for possession.

(g)  The board may amend conditions in permits,letters of authorization, and registrations, or cancel permits, letters ofauthorization, and registrations, as necessary, if the board determines thatthe classification of the microorganism being imported or the conditionsattendant to the microorganism's import and use must be changed due to newlydiscovered risks to agriculture, horticulture, the environment, or animal orpublic health. [L 2000, c 211, pt of §1; am L 2002, c 61, §2; am L 2003, c 12,§1]