Report Title:

Microorganism Importation; Bioterrorism and Health Emergencies

Description:

Authorizes the Department of Health and Tripler Army Medical Center to import microorganisms for laboratory diagnostics without review and permit approval by the Department of Agriculture (DOA), but with notification to DOA prior to transfer, to prepare for bioterrorism acts and other public health emergencies in a timely manner. (SD1)

THE SENATE

S.B. NO.

1260

TWENTY-SECOND LEGISLATURE, 2003

S.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) [Permits issued under rules adopted prior to Act 211, Session Laws of Hawaii 2000, are valid until the expiration date shown on the permit with no entitlement to renewal on the original import terms and conditions. Upon expiration of those permits, continued import is subject to reapplication and satisfaction of requirements under rules adopted to implement this section.]The 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.

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 Statutory material to be repealed is bracketed and stricken.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

SECTION 3. This Act shall take effect upon its approval.