Report Title:

Microorganism Import

Description:

Establishes conditions under which the import of microorganisms under an award for laboratory research is exempt from microorganism import requirements. Repeals provisions for microorganism import certification for medical or scientific purposes. (HB563 HD1)

HOUSE OF REPRESENTATIVES

H.B. NO.

563

TWENTY-THIRD LEGISLATURE, 2005

H.D. 1

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

RELATING TO MICROORGANISM IMPORT.

 

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

SECTION 1. Section 150A-6.3, Hawaii Revised Statutes, is amended by amending subsection (f) to read as follows:

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

(1) The state department of health or Tripler Army Medical Center for their laboratories; provided that the department of health shall develop and implement within its laboratories a mechanism for coordinated oversight and inventory control of microorganisms imported for its laboratories and implement internal procedures to assure proper biosafety containment and laboratory practices commensurate with microorganism risk levels; [and]

(2) A laboratory certified under the Clinical Laboratories Improvement Amendments of 1988 (42 U.S.C. 263 et seq.); provided that the certified laboratory is registered with the department pursuant to rules and imports microorganisms that are applicable to the category of examinations or procedures for which the foregoing certification was approved[.]; and

(3) A laboratory that has received a federal grant award or an award from a non-federal funding agency approved by the board, for laboratory research that requires the use of microorganisms; provided that the laboratory research:

(A) Is under the oversight of an institutional biosafety committee to:

(i) Coordinate oversight and inventory control of microorganisms imported for the grantee's laboratory;

(ii) Implement internal procedures to assure proper biosafety containment and laboratory practices commensurate with microorganism risk levels; and

(iii) When warranted, suspend or terminate research that fails to comply with the institutional biosafety committee's policies and procedures;

provided further that the institutional biosafety committee satisfies criteria specified by rules and is approved by the department; and

(B) Does not involve certain microorganisms of heightened concern relative to agriculture and the environment, as specified by rules.

A laboratory importing microorganisms under this paragraph shall provide the department, in advance of shipment, a photocopy of the official award approval and the scientific name of any microorganism to be imported under the award or, if the scientific name has not yet been determined, a detailed description of the microorganism.

The department of health and Tripler Army Medical Center may transfer any such imported microorganisms between their respective laboratories without approval from the department of agriculture, but with notification to the department of agriculture prior to the transfer; provided that transfer of such imported microorganisms from the department of health, Tripler Army Medical Center, [or] a laboratory certified and registered as described in paragraph (2), or a laboratory that has received an award for research as described in paragraph (3) to other entities in the State shall require prior approval from the department of agriculture in the form of a letter of authorization or a permit for possession."

SECTION 2. Part V of chapter 150A, Hawaii Revised Statutes, is repealed.

SECTION 3. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 4. This Act shall take effect on July 1, 2020.