Honorable Robert Bunda

President of the Senate

Twenty-Second State Legislature

Regular Session of 2003

State of Hawaii

Sir:

Your Committees on Water, Land, and Agriculture and Health, to which was referred S.B. No. 1260 entitled:

beg leave to report as follows:

The purpose of this measure is to authorize the Department of Health (DOH) and Tripler Army Medical Center to import microorganisms for laboratory diagnostics without review and permit approval from the Department of Agriculture (DOA) in order to prepare for and respond to bioterrorism acts and other public health emergencies in a timely manner.

The measure also authorizes laboratories that are federally certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA) and registered with DOH to import microorganisms for laboratory testing performed on humans, without prior review and permit approval from the DOA, in order to ensure accurate, reliable, and timely test results from federally certified laboratories.

The Department of Health and the Board of Agriculture submitted testimony in support of this measure.

Your Committees find that existing law provides a regulatory structure for microorganism import that involves a risk assessment review and permit process that, depending on risk level, requires action by the DOA or the Board of Agriculture (Board) prior to importation. Although the law also provides for the issuance of emergency import permits for state or federal agencies to address emergencies or disasters, that procedure is inadequate to meet the immediacy of an emergency situation.

Your Committees determine that authorizing an exemption from the review and permit approval process will allow the DOH and Tripler Army Medical Center the necessary access to import any species of microorganisms crucial for performing laboratory diagnostics for either bioterrorism preparedness or public health.

Your Committees also find that the CLIA established standards for all laboratory testing on human specimens for the purpose of diagnosis, prevention, treatment of disease, or impairment or assessment of health. Certified laboratories are required by federal law to import microorganisms to demonstrate laboratory proficiency in a timely manner. In order to maintain CLIA certification, the laboratory must submit extensive information to DOH regarding new or unidentified microorganisms and the laboratory which results in the further delay of receiving the microorganisms. Your Committees believe that CLIA laboratories should be exempt from the permit requirement if those laboratories register with the DOH pursuant to rule and import only microorganisms consistent with their federal certifications.

For purposes of clarity, your Committees have amended the measure as follows:

As affirmed by the records of votes of the members of your Committees on Water, Land, and Agriculture and Health that are attached to this report, your Committees are in accord with the intent and purpose of S.B. No. 1260, as amended herein, and recommends that it pass Second Reading in the form attached hereto as S.B. No. 1260, S.D. 1, and be placed on the calendar for Third Reading.