SB2491

SECTION 1. The legislature finds that research in the fields of biotechnology, including biological agents, human pathogens, and toxins, have become more prevalent over the past decade because of widespread bioterrorism concerns. As a result of those concerns, biotechnology research is a well-funded field that is growing rapidly throughout the United States.

However, similar to other advanced technologies, biotechnology research comes with potential risks to people, property, and the environment. The substances that are used in biotechnology research laboratories are often very dangerous, hazardous, or environmentally destructive. Improper handling of those substances could potentially result in serious bodily injury or even the loss of life.

Unfortunately, the potential catastrophes associated with biotechnology research are closer to home than most people think for two reasons. One reason is that the field of biotechnology research is largely unregulated and there is no widespread use of uniform rules or safeguards. The second reason is that the biotechnological research is being conducted at major universities located in large urban centers.

In Hawaii, the University of Hawaii at Manoa and the department of agriculture have conducted research related to microorganisms and human pathogens, such as the avian, West Nile, and dengue flu viruses, for many years. Upon the receipt of grants to conduct biotechnological research from the National Institutes of Health, the University of Hawaii at Manoa established an institutional biosafety committee, as required by the grants, to oversee its research activities. Unfortunately, the institutional biosafety committee failed to maintain compliance with the reporting guidelines required by the National Institutes of Health and the department of agriculture. Furthermore, an ineffective recordkeeping system at the department of agriculture prevented the location and inventory of hundreds of microbes and viruses from being properly recorded after they were properly imported to Hawaii for research purposes by permit.

To reduce the risk of potential catastrophes, but still engage in biotechnology research that would benefit the people of Hawaii, a health and safety program needs to be established that would enable biotechnology research laboratories to operate in a safe and reasonable manner. A health and safety program, along with an accompanying oversight committee, would ensure that biotechnology research laboratories in Hawaii would use an approved set of uniform rules, policies, practices, and procedures when engaging in their research activities. The health and safety program and oversight committee would regulate and sanction, if necessary, any violations or unapproved practices by the research laboratories. The legislature believes that this Act will allow advanced biotechnology research to take place in Hawaii in a manner that provides for satisfactory safeguards, which will serve to protect the citizens and visitors of Hawaii from the potential dangers associated with biological agents, human pathogens, and toxins.

SECTION 2. Chapter 321, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"PART . BIOTECHNOLOGY RESEARCH

§321-A Definitions. For purposes of this part, the following terms shall have the following meanings:

"Biological agent" means any naturally occurring, bioengineered, or genetically altered or synthesized microorganism (including bacteria, virus, fungus, and protozoa), or infectious substance or vector, or component of any such microorganism or infectious substance capable of:

(1) Causing death, disease, or other physiological change in a human, an animal, a plant, or other living organism;

(2) Causing deterioration of food, water, equipment, supplies, or material of any kind; or

(3) Having a deleterious effect on the environment.

"Biosafety level two laboratory" means a laboratory that is designed, equipped, or operated as a level two biosafety laboratory as defined by the United States National Institutes of Health Guidelines for research involving recombinant deoxyribonucleic acid molecules.

"Biosafety level three laboratory" means a laboratory that is designed, equipped, or operated as a level three biosafety laboratory as defined by the United States National Institutes of Health Guidelines for research involving recombinant deoxyribonucleic acid molecules.

"Biosafety level four laboratory" means a laboratory that is designed, equipped, or operated as a biosafety level four laboratory as defined by the United States National Institutes of Health Guidelines for research involving recombinant deoxyribonucleic acid molecules.

"Department" means the department of health.

"Director" means the director of health.

"Facility" means a building or combination of buildings under common control and ownership containing one or more laboratories subject to this part.

"Human pathogen" means an infectious or biological agent that causes disease or illness to its human host.

"Laboratory" means a room or rooms used primarily for biological research, development, non-routine testing, or experimentation activity, or any room or rooms where vertebrate animals are contained under animal biosafety levels described in the National Institutes of Health Guidelines. The term "laboratory" also includes all enclosed areas with a laboratory containment area, including any rooms, closets, facilities, freezers, refrigerators, or incubators where biological agents are stored, fermented, grown, proliferated, or colonized.

"Principal investigator" means the individual who is designated by a research sponsor to direct a biological research project or program the research sponsor conducts at a level two or level three biosafety laboratory, and who is responsible to the research sponsor for the scientific and technical direction of that project or program.

"Research sponsor" means any state, corporation, authority, individual, trust, firm, joint stock company, limited liability company, partnership, research group, task force, university program, association, or entity or any group thereof, any group of persons, and any agency or political subdivision of the State of Hawaii, the federal government or any other government, subdivision, agent or agency thereof, which operates or proposes to operate a level two or level three biosafety laboratory in Hawaii.

"Toxin" means any toxic material or product of plants, animals, microorganisms (including bacteria, virus, fungus, rickettsia, or protozoa), protein, infectious substance, or a recombinant or synthesized molecule, whatever its origin or method of production. Toxin includes:

(1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or

(2) Any poisonous isomer or biological product, homolog, or derivative of such substance.

§321-B Establishment of a health and safety program for biological research laboratories. (a) There shall be established within the department, a health and safety program for level two and level three biological research laboratories in Hawaii.

(b) The health and safety program shall provide standards for the location, operation, and maintenance of biological research laboratories, including oversight, to protect the safety of laboratory workers, the public, and the environment from controlled biological agents, human pathogens, and toxins.

(c) The health and safety program shall provide standards for the transportation, relocation, shipment, delivery, conveyance, and receipt of biological agents, human pathogens, agents, and toxins.

(d) The health and safety program shall provide for procedures that would allow the department to order any level two or level three biosafety laboratory to immediately cease and desist work on a project and lock down or refrain from any activity that the department determines could cause immediate or irreparable injury or damage.

(e) The health and safety program shall be administered by the Hawaii biosafety committee, which shall be appointed by the director.

§321-C Criteria for laboratory location. (a) The department shall adopt rules in accordance with chapter 91 for the implementation of the health and safety program that establish the criteria for determining appropriate locations for the building or facility that contains a laboratory, including whether a laboratory may be created within an existing building. At a minimum, the criteria shall:

(1) Provide that sites shall not:

(A) Be within a flood plain;

(B) Be within eight hundred yards of property whose regular use could endanger the site due to fire or explosion;

(D) Endanger motorists or pedestrians.

(2) Provide that sites shall have sufficient land available to provide for a reasonable buffer around the buildings that shall be no less than one hundred and fifty unobstructed feet in each direction; and

(3) Address the:

(A) Proximity of wetlands, waterways, and water bodies;

(B) Relationship of the site to groundwater elevation;

(D) Availability and suitability of access roads to the site, including the ability of first responders to access the site in an emergency;

(E) Potential for adverse public health and safety impacts;

(F) Potential impact of increased traffic volume on adjacent roads; and

(G) Potential threat of terrorist attack or infiltration of the building.

(b) The department shall set forth procedures, consistent with this part, for the submission, review, and approval of permit and construction applications and the issuance and renewal of permit and construction applications; provided that:

permits may be issued that contain conditions or restrictions that serve and protect public health and safety; provided further that:

(1) Applications for a permit or renewal of a permit shall be acted upon within sixty-days of the submission of a completed application. The department shall not be obligated to review incomplete applications. If, at the conclusion of the sixty-day period, the review of the application is not complete, the department may issue to a research sponsor a provisional permit if the application is complete and the research sponsor has established substantial compliance with this part. A provisional permit shall not exceed one hundred and twenty days in duration and shall not be renewed or extended;

(2) To the extent that the permit application may require the submission or review of trade secret information, the research sponsor may submit the information under seal. Department officers and employees shall be prohibited from disclosing trade secret information submitted under seal pursuant to this part to any third party and the information shall be used by the department and its staff for no purpose other than the permitting process. Reckless or intentional disclosure of trade secret information submitted under seal shall be a misdemeanor;

(3) The denial of a permit application may be appealed; and

(4) Prior to issuance of any permit for a level three biosafety laboratory under this part, the department shall hold, with sixty-days notice to the public of the application and its contents, a public hearing on the application with a reasonable opportunity for public comment on whether the application should be granted.

§321-D Hawaii biosafety committee; established. (a) There is established the Hawaii biosafety committee to assist in administering or overseeing biological laboratories and facilities operating under this part. The Hawaii biosafety committee shall be composed of scientific and community representatives appointed by the director from lists of potential members submitted to the department by community and neighborhood organizations, universities, colleges, and public interest organizations located within Hawaii. The biosafety committee shall consist of ten members, including one salaried executive director who shall be selected by the director for a term of four years.

(b) Members shall be appointed for a term of two years and may only be removed for cause. Members shall have no financial, professional, familial, or business relationship with the regulated research sponsors, their affiliates, subsidiaries, employees, contractors, subcontractors, investors, or founders. Members appointed to fill vacancies shall serve for a full term. Each member of the biosafety committee shall be eligible for reappointment for up to three consecutive terms. Members of the biosafety committee shall serve without compensation but their reasonable costs and expenses, including travel expenses, shall be reimbursed by the department.

(c) The biosafety committee shall periodically report to the department and provide technical assistance, review of the effectiveness of applicable statutes and rules, and advise or deliberate as needed about technical issues arising out of permits and applications derived from this part.

(d) The biosafety committee shall consider policy changes and possible amendments to applicable statutes and rules. The committee shall also seek to improve how the laboratories and facilities operate, how the laboratories and facilities handle biological agents, human pathogens, and toxins, and the delivery or transportation of biological agents, human pathogens, and toxins.

(e) The biosafety committee shall meet monthly or with sufficient frequency to assure its ability to carry out its duties and responsibilities.

§321-E Institutional biosafety committees; established. (a) A research sponsor that holds a permit issued pursuant to this part, shall have an institutional biosafety committee for each laboratory or facility to ensure the safety of the public and conformance with this part.

(b) Composition of an institutional biosafety committee shall include at least two community representatives who have no financial, professional, familial, or business relationship in or with the regulated research sponsor, its affiliates or subsidiaries, employees, contractors, sub-contractors, or investors. Community representatives shall be selected by joint approval of the department and neighborhood organizations representing the communities or community where the laboratory or facility is located. Community representatives shall be individuals whose principal residence is within three miles of the laboratory or facility, and whose principal residence has been within three miles of the laboratory or facility for at least the immediately preceding two years before their selection to an institutional biosafety committee.

(c) Each institutional biosafety committee shall report to the Hawaii biosafety committee. An institutional biosafety committee shall meet at least four times a year and at other times as specified by the Hawaii biosafety committee, or as requested by a member of an institutional biosafety committee. Except for executive sessions, meetings of an institutional biosafety committee and all of its subcommittees shall be open to the public.

(d) Each institutional biosafety committee shall file an annual report with the Hawaii biosafety committee. The report shall include, at a minimum, complete copies of all institutional biosafety committee minutes for the preceding reporting period, certification that the laboratory or facility is in compliance with this part, a report on any quality assurance and quality improvement efforts made during the period, a complete roster of current institutional biosafety committee members, and an update of any information relative to the permit application. To the extent institutional biosafety committee minutes contain information that jeopardizes trade secret information, the Hawaii biosafety committee shall develop procedures for assuring confidentiality of that information. Institutional biosafety committee minutes shall, at a minimum, conform to National Institutes of Health, Office of Biotechnology Activities-issued guidance concerning the preparation of, and public access to, minutes of institutional biosafety committee meetings.

§321-F Permit fees. The department is authorized to establish fees for the issuance and renewal of permits, which may vary according to the type of use and scale of activity being conducted. All fees shall be directly related to the costs incurred by the department or the Hawaii biosafety committee for any issuance of permits, the inspection of laboratories, and any other costs associated with implementation of this part. Full payment of the fees shall be a condition for the granting or renewal of any permit.

§321-G Research pre-approval requirement. (a) Any research sponsor operating or proposing to operate a biological laboratory or laboratories, or any research sponsor conducting or proposing to conduct any biological research at level two or level three biosafety laboratories, shall obtain a permit from the Hawaii biosafety committee. The permittee shall ensure that all persons in the laboratories comply with the requirements set forth in this part and the rules issued pursuant to this part.

(b) Each permit application shall include the following:

(1) Name and location of the research sponsor;

(2) The location and biosafety level rating or ratings for each laboratory that will operate under the permit;

(3) Roster, biographical information, and contact information of the institutional biosafety committee indicating the chair and community members;

(4) Name, title, and contact information of each of the following:

(A) A health officer responsible for the health of the laboratory or facility, known as the health officer;

(B) An officer responsible for biological safety at the laboratory or facility, known as the biological safety officer; and

(5) Project information including, but not limited to, the title and a description of the project, the grant identification number or other unique institutional identifier number, the principal investigator, and all biological agents, human pathogens, and toxins used for each project or program;

(6) Procedures and policies relating to laboratory safety including, but not limited to, research, training, security, laboratory inspections, transportation, waste disposal, commissioning, decommissioning, decontamination, termination of work with biological agents, human pathogens, and toxins, training of all employees, visitors, or students, and first responder plans with evacuation and emergency response;

(7) Other information as required by the Hawaii biosafety committee and rules under this part; and

(8) Any incident in which the research sponsor, any of its officers, employees, or any other person who will work in the laboratory was found to have violated, or was sanctioned for violating, any law, rule, or ordinance regulating the environment, health, safety, public disclosure, or the truthfulness of statements.

§321-H Suspension of permit. If the director becomes aware of credible evidence that an activity at a facility licensed for, or seeking a license for, operation under this part is likely to pose a significant and imminent threat to human health or to the environment or cause substantial property damage, the director may find that immediate closure of the facility is required to avert the danger and may order all research and related activity at that facility be suspended until the director finds that the threat is resolved. If the research sponsor believes the director's finding to have been unwarranted, the research sponsor may seek reversal of the decision by a clear and convincing standard.

§321-I Reporting requirements. (a) The licensed research sponsor shall, within twenty-four hours, report to the Hawaii biosafety committee any incident in which there was human exposure to a biological agent, human pathogen, or toxin, and a reasonable likelihood of exposure, including all incidents resulting in actual or recommended prophylactic quarantine or drug use.

(b) A research sponsor shall report any release or spread of a biological agent, human pathogen, or toxin, and the reasonable likelihood of a release or spread, outside the primary containment area of a biosafety laboratory to the department as soon as possible and in no case more than twenty-four hours after the event. The report shall also be provided to the Hawaii biosafety committee.

(c) The facility or laboratory shall also provide the institutional biosafety committee with a detailed report of all incidents, accidents, and other events that cause, or are suspected to have caused, an illness, bodily injury, or death to the public within seventy-two hours of the incident, accident, or event.

(d) On an annual basis, the facility or laboratory shall provide the Hawaii biosafety committee with an independent certification from a third party for all biosafety cabinets, autoclaves, tissue digesters, incubators, centrifuges, and all other major laboratory equipment.

§321-J Laboratory employee training. Each facility with a laboratory defined under this part shall have and implement a plan to provide adequate training for the proper handling of biological agents, human pathogens, and toxins that might be present therein. Employee training shall include, but not be limited to, decontamination methods, personnel safety precautions and work habits, early warning disease surveillance, accident response actions and notifications, access control and monitoring, personnel management, inventory and accountability, information security, and the transport of biological agents, human pathogens, and toxins. Each facility shall provide a training plan to its institutional biosafety committee and to the Hawaii biosafety committee for approval and shall update the plan annually, or as necessary. The training plan shall ensure that all laboratory staff, facility workers, and researchers, including the principal investigator for each facility, are trained adequately. The principal investigator shall participate in the creation and implementation of the training plan. No individual other than a local, state, or federal government representative with authorized access for regulatory compliance for investigative purposes may enter the biosafety laboratory located within a facility without first completing the facility's training plan.

§321-K Waste management plan. Each facility operating under this part shall implement a waste management and decontamination plan submitted to and approved in advance as a condition of permitting by the Hawaii biosafety committee.

§321-L Emergency response plan. A facility operating under this part shall develop an emergency response plan, in conjunction with local and state officials that address security threats and releases involving the spread of biological agents, human pathogens, and toxins. The emergency response plan shall comply with local, state, and federal plans already in existence. The plan shall address events such as severe weather, earthquakes, power outages, power line breaks, terrorism, and other natural, accidental, or intentional emergencies. The emergency response plan, at a minimum, shall address the following:

(1) Particular hazards associated with specific biological agents, human pathogens, and toxins located at the facility or its laboratories;

(2) Personnel roles, lines of authority, training, and communication;

(3) Emergency assessment and prevention;

(4) Site security and control;

(5) Evacuation routes and procedures;

(6) Decontamination;

(7) Emergency medical treatment and first-aid;

(8) Emergency alerting and response procedures;

(9) Personal protective and emergency equipment;

(10) Regulatory scheduled preparedness exercises;

(11) Critique of response and follow-up subsequent to an incident; and

(12) Communication to the public and the local news media.

§321-M Inspections. The Hawaii biosafety committee may review all documentation relating to the operations of the facility and any laboratories therein, and to conduct a physical inspection of any facility or laboratory, with or without prior notice, so long as the inspection is conducted at a reasonable time under the circumstances and in a manner that maintains the protection of the laboratories involved. Failure to provide any requested documentation or access to a laboratory for the purpose of inspection shall result in a fine and the immediate suspension or restriction of a research sponsor's permit to operate. A failure to provide requested documentation or access to a laboratory for the purpose of inspection for a period exceeding seven days shall result in suspension of the facility or laboratory permit to operate at least until the failure has been rectified.

§321-N Prohibited research projects. (a) Every level two, level three, and level four biosafety laboratory or facility in the State of Hawaii is prohibited from conducting research or research projects that are reasonably likely to result in the following:

(1) Harm to human health, human habitat, agriculture, or the breeding or raising of livestock;

(2) Render an immunization ineffective or lessen immunity in humans, animals, or plants;

(3) Confer to a biological agent, human pathogen, or toxin resistance of clinically or agriculturally useful prophylaxes or therapeutics against that biological agent, human pathogen, or toxin;

(4) Enhance the virulence of a biological agent, human pathogen, or toxin, or render a nonpathogen virulent;

(5) Enhance the ease of transmission of a biological agent, human pathogen, or toxin from human to human, animal to animal, or animal to human;

(6) Enable the evasion of diagnostic or detection modalities;

(7) Alter the host range or vector of a biological agent, human pathogen, or toxin;

(8) Enhance the susceptibility of a host population; or

(9) Create a novel biological agent, human pathogen, or toxin, or revitalize an eradicated, inactive, dormant, or extinct biological agent, human pathogen, or toxin that is harmful to humans, human habitat, agriculture, or livestock.

(b) A principal investigator may seek an exemption to the prohibitions listed in subsection (a) for a specific research project by submitting to the Hawaii biosafety committee, in advance, a written request that specifies in detail the precise research to be carried out, the purpose and need for the exemption, the names of all research sponsors for the research that will be subject to the exemption, the unavailability of alternative means of conducting the research, a clear explanation of any special risks involved in the research or project, and any extraordinary safeguards and precautions that would need to be implemented. The Hawaii biosafety committee may only permit an exemption to the prohibitions listed in subsection (a) on a case by case basis. The Hawaii biosafety committee may not issue a blanket exemption to any particular principal investigator or research sponsor, nor may the Hawaii biosafety committee issue a blanket exemption for a particular type of research project. Any exemption permitted under this part shall be updated and resubmitted to the Hawaii biosafety committee annually for review and reconsideration. Research or projects that are subject to the prohibitions described in subsection (a) shall not be exempted solely on the basis that the research or project has dual purposes or uses, some of which may not violate subsection (a).

§321-O Notice to employees of biosafety laboratories or facilities. (a) A copy of this part and the rules adopted pursuant to this part shall be distributed to all employees, students, and any other person who has regular access to any portion of a facility or laboratory permitted under this part. All entities permitted pursuant to this part shall have a system for reporting health and safety violations, including a method to report in an anonymous manner to the department and a method to report in an anonymous manner to the institutional biosafety committee.

(b) No person shall be required to conduct scientific research, experimentation, study, or take other action in a laboratory that violates any provision of this part or permits issued hereunder or has reasonable potential to adversely affect public or employee health and safety. No person or employer shall discharge, refuse to hire, discipline, retaliate, or take any adverse action against any employee, applicant, or other person because the employee, applicant, or other person discloses, or threatens to disclose, an activity, policy, or practice that the person reasonably believes is in violation of this part. In addition to any other remedy provided by law, an employee, researcher, or student aggrieved by a violation of this subsection, within two years, may file a complaint with the attorney general, who, after a proper investigation, may bring an action in the name of the State of Hawaii against the facility alleged to have violated this part. If the attorney general declines to bring an action based on the complaint filed, the attorney general shall expeditiously provide notice of decline to the grievant. The aggrieved employee, researcher, or student, within one year after the notice, may institute a civil action. Any party to the action shall be entitled to trial by jury. Remedies available in common law tort actions shall be available to prevailing parties, in addition to any legal or equitable relief. The court, in addition to issuing a restraining order or injunction, may order the reinstatement of an employee's, researcher's, or student's position. In addition, compensation of three times the lost wages, or other remuneration, and interest for liquidated damages shall be paid by the facility to the employee, researcher, or student, plus reasonable costs and attorneys' fees.

§321-P Fines, civil penalties, and revocation of permits. (a) The intentional or reckless violation of any conditional restriction of a permit or any provision of this part shall subject the violator to conviction of a misdemeanor with a fine not to exceed $5,000. Each violation shall constitute a separate and distinct offense. Any false statement contained in an application for a permit under this part, or in any report required under this part, shall constitute a violation.

(b) Any violation of this part at the laboratory or of any condition or restriction on a laboratory permit, may result in the suspension of the research sponsor's permit to operate one or more laboratories for a period of not less than one year, permanent revocation of the permit, and assessment of a civil penalty against the research sponsor not to exceed $300,000. Where the violation was caused by the reckless or intentional conduct of the research sponsor, or agent thereof, the suspension of the research sponsor's permit to operate the laboratory where the violation occurred for a period of not less than one year and assessment of a $300,000 civil penalty shall be the minimum sanction. Each violation shall constitute a separate and distinct ground for sanction under this part.

(c) Any violation of this part at the laboratory or of a condition or restriction on a laboratory permit, that is preceded by two prior violations, shall result in revocation of all the research sponsor's permits to operate any level two or level three biosafety laboratory for a period of two years. The research sponsor shall also be precluded from obtaining any additional permits to operate any level two or level three biosafety laboratory for a period of two years thereafter."

SECTION 3. In codifying the new sections added by section 2 of this Act, the revisor of statutes shall substitute appropriate section numbers for the letters used in designating the new sections in this Act.

SECTION 4. This Act shall take effect on July 1, 2008.

INTRODUCED BY:	_____________________________

THE SENATE	S.B. NO.	2491
TWENTY-FOURTH LEGISLATURE, 2008
STATE OF HAWAII