BILL REQ. #:  H-5923.1 

Read first time 03/05/08.   Referred to Committee on Health Care & Wellness.

     AN ACT Relating to biological research laboratory health and safety; adding a new chapter to Title 70 RCW; and prescribing penalties.

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

NEW SECTION.  Sec. 1   Biotechnology research promises advances in fields ranging from medicine and agriculture to combating bioterrorism. It is a well-funded and rapidly growing enterprise in research centers around the United States, including Seattle.
     As with other technologies such as nuclear energy, research in biotechnology also carries risks. Some materials used in biotechnology labs are dangerous and/or environmentally destructive. Improper handling of those materials could cause loss of life, personal injury, environmental destruction, and property damage.
     Although research in biotechnology is relatively new, exposures to dangerous substances from various biotechnology labs around the country, including exposures at a biotechnology lab operated in downtown Seattle, already have occurred. Nonetheless, biotechnology research in Seattle is largely unregulated. Indeed, human exposures have occurred without the public ever being informed.
     Safe and responsible biotechnology research requires that the research be transparent, subject to independent oversight and regulation, and that violations of those regulations be effectively sanctioned. These regulations are established in order to accomplish those ends.

NEW SECTION.  Sec. 2   The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
     (1) "Biological agent" means any naturally occurring, bioengineered, or genetically altered or synthesized microorganism including, but not limited to, bacteria, virus, fungus, and protozoa, or infectious substance or vector, or component of any such microorganism or infectious substance capable of causing death, disease, or other physiological change in a human, an animal, a plant, or other living organism; deterioration of food, water, equipment, supplies, or material of any kind; or having a deleterious effect on the environment.
     (2) "Biosafety level 2 laboratory" means a laboratory that is designed, equipped, or operated as a biosafety level 2 laboratory as defined by the United States national institutes of health guidelines for research involving recombinant DNA molecules.
     (3) "Biosafety level 3 laboratory" means a laboratory that is designed, equipped, or operated as a biosafety level 3 laboratory as defined by the United States national institutes of health guidelines for research involving recombinant DNA molecules.
     (4) "Biosafety level 4 laboratory" means a laboratory that is designed, equipped, or operated as a biosafety level 4 laboratory as defined by the United States national institutes of health guidelines for research involving recombinant DNA molecules.
     (5) "Commission" means the Washington state biosafety commission created in section 5 of this act.
     (6) "Department" means the department of health.
     (7) "Facility" means a building or combination of buildings under common control and ownership containing one or more laboratories subject to a common institutional biosafety committee.
     (8) "Laboratory" means a room or rooms used primarily for biological research, development, nonroutine testing, or experimentation activity, or any room or rooms where vertebrate animals are contained under animal biosafety levels described in national institutes of health guidelines including, but not limited to, 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.
     (9) "Principal investigator" means the individual designated by a research sponsor to direct the biological research project or program the research sponsor conducts at biosafety laboratory levels 2 or 3, who is responsible to the research sponsor for the scientific and technical direction of that project or program.
     (10) "Research sponsor" means any state, public or private corporation or authority, individual, trust, firm, joint stock company, limited liability company, partnership, research group, task force, university program, association, or entity or group thereof, group of persons, and agency or political subdivision of the state of Washington, the federal government, or other government, subdivision, agent or agency thereof, which operates or which proposes to operate a biosafety level 2 and/or biosafety level 3 laboratory in Washington state.
     (11) "Toxin" means any toxic material or product of plants, animals, microorganisms including, but not limited to, bacteria, virus, fungus, rickettsia, or protozoa, misfolded protein, infectious substance, or a recombinant or synthesized molecule, whatever its origin or method of production. "Toxin" includes any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such substance.

NEW SECTION.  Sec. 3   There is established in the department, a high containment biological research laboratory health and safety program for biosafety level 2 and 3 laboratories located in Washington state.
     (1) The program shall provide standards for location, operation, and maintenance of high containment biological research laboratories and the oversight of such laboratories to protect the safety of laboratory workers, the public, and the environment from regulated agents and toxins.
     (2) The program shall provide standards for the transportation, relocation, shipment, delivery, conveyance, and receipt of regulated agents and toxins.
     (3) The program shall provide for procedures which would allow the department to order biosafety level 2 and 3 laboratories to immediately cease and desist work on a project and lock down and/or refrain from any activity that the department determines could cause immediate and irreparable injury, loss, or damage.
     (4) The program shall be administered by the commission.

NEW SECTION.  Sec. 4   The department shall adopt rules for the implementation of the program that establish the criteria for determining appropriate locations for siting a building or facility that contains a laboratory, including whether a laboratory may be created within an existing building. The criteria shall include, at a minimum, that:
     (1) Sites shall not be within a floodplain, within eight hundred yards of property whose regular use could endanger the site due to fire or explosion; or near an area of traffic congestion that might impede emergency access for evacuation or endanger motorists or pedestrians.      (2) Sites shall have sufficient land available to provide for a reasonable buffer around the buildings which shall be no less than one hundred fifty unobstructed feet in each direction.
     (3) Other criteria for consideration shall include proximity of wetlands, waterways, and water bodies; the relationship of the site to groundwater elevation; the nature and extent of residential areas and schools in proximity to the site; the availability and suitability of access roads to the site, including the ability of first responders to access the site in an emergency; the potential for adverse public health and safety impacts; potential impact of increased traffic volume on adjacent roads; and the potential threat of terrorist attack or infiltration of the building.
     (4) The department shall set forth procedures, consistent with this section, for the submission, review, and approval of permit and construction applications, and the issuance and renewal of permit and construction applications. Permits may be issued which contain conditions or restrictions that serve and protect public health and safety.
     (a) The application for a permit or renewal of a permit shall be acted upon within sixty days of submission of a completed application. The department is not 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 it establishes substantial compliance with this chapter. A provisional permit shall not exceed one hundred twenty days in duration, and shall not be renewed or extended.
     (b) To the extent that the permit application may require the submission or review of trade secret information under RCW 19.108.010, the research sponsor may submit such information under seal. Commission members and their staff shall be prohibited from disclosing trade secret information submitted under seal pursuant to this subsection to any third party, and such matter shall be used by the commission and its staff for no purpose other than the permitting process. Reckless or intentional disclosure of trade secret information submitted under seal is a misdemeanor.
     (c) The denial of a permit application may be appealed pursuant to the rules of practice and procedure of the King county board of appeals.
     (d) Prior to issuance of any permit for a biosafety level 3 laboratory under this chapter, the department must hold, with sixty days, notice to the public of the application and its contents, a public hearing on the application with opportunity for reasonable public comment on whether the application should be granted.

NEW SECTION.  Sec. 5   (1) The department shall appoint a Washington state biosafety commission composed of both scientific and community representatives drawn from lists submitted to it from community and neighborhood organizations, universities, colleges, and public interest organizations located within Washington state to assist in regulating biological laboratories and facilities operating under the auspices of this chapter. The commission shall include at least nine members and one salaried executive director who shall be selected by the department for a term of four years. Members will be appointed for a two-year term and may be removed only for cause. Members shall have no financial, professional, familial, close social, or business relationship in or with the regulated research sponsors, their affiliates, subsidiaries, employees, contractors, subcontractors, investors, or funders. Members appointed to fill vacancies shall serve for a full term. Any member of the commission is eligible for reappointment for up to three consecutive terms. Members of the commission shall serve without compensation, but their reasonable costs and expenses shall be reimbursed by the department.
     (2) The commission shall periodically report to the department and provide technical assistance, review of the effectiveness of this chapter and advise and/or deliberate as needed about technical issues arising out of permits and applications of this chapter.
     (3) The commission shall consider policy changes or possible amendments to this chapter, improve the system of laboratory and facility regulation, for the safe handling, relocation, shipment, delivery, conveyance, receipt, and transportation of biological agents or toxins and deliberate as needed.
     (4) The commission shall meet monthly or with sufficient frequency to assure its ability to carry out its duties and responsibilities.

NEW SECTION.  Sec. 6   (1) A research sponsor that holds a permit issued under this chapter shall have an institutional biosafety committee for each facility to ensure the public safety and conformance with this chapter. Composition of the committee shall include at least two community representatives who have no financial, professional, familial, close social, or business relationship in or with the regulated research sponsor, its affiliates or subsidiaries, employees, contractors, subcontractors, or investors. Community representatives shall be selected by joint approval of the department and neighborhood organizations representing the communities or community where the laboratory is located. Community representatives shall be individuals whose principal residence is within three miles of the laboratory, and whose principal residence has been within three miles of the laboratory for at least two years immediately preceding their selection as such.
     (2) Each committee shall report to the commission. The committee will meet at least four times a year and at such other times as may be specified by the commission, or guidelines issued under this chapter, or as requested by any member of the committee. Except for executive sessions, meetings of the committee and all of its subcommittees shall be open to the public. Notice of such public meetings and the conduct of public meetings shall be in accordance with the Washington state open public meetings act.
     (3) Each committee shall file an annual report with the commission. The report shall include, at a minimum, complete copies of all committee minutes for the preceding reporting period, certification that the laboratory and/or facility is in compliance with this chapter, a report on any quality assurance and quality improvement efforts made during the period, a complete roster of current committee members, and an update of any information relative to the permit application. To the extent committee minutes contain information that jeopardizes trade secret information as defined by RCW 19.108.010, the commission shall develop procedures for assuring confidentiality of said information. Committee minutes shall, at a minimum, conform to the national institutes of health office of biotechnology activities issued guidance concerning the preparation of, and public access to, minutes of committee meetings and department of health and human services guidance on the content of minutes of committee meetings, dated February 23, 2007.

NEW SECTION.  Sec. 7   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 and/or the commission for any issuance of permits, the inspection of laboratories, and any other costs associated with implementation of this chapter. Full payment of such fees shall be a condition for the granting or renewal of any permit.

NEW SECTION.  Sec. 8   (1) 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 biosafety level 2 or 3 laboratories, shall obtain a permit from the commission. The permittee shall ensure that all persons in such laboratories comply with the requirements set forth in this chapter and the rules adopted under this chapter.
     (2) Each permit application shall include the following:
     (a) Name and location of the research sponsor;
     (b) The location and biosafety level rating or ratings for each laboratory that will operate under the permit;
     (c) Roster, biographical information, and contact information of the institutional biosafety committee indicating the chair, and community members;
     (d) Name, title, and contact information of each of the following: (i) A health officer responsible for the health of the laboratory or facility, known as the "health officer"; (ii) an officer responsible for biological safety at the laboratory or facility, known as the "biological safety officer"; and (iii) an official responsible for the overall operation of the laboratory or facility, known as the "responsible official";
     (e) Project information including, but not limited to, the title and brief description of the project, grant identification number or other unique institutional identifier number, the principal investigator, and the agent or agents used in the project, including all biological agents and toxins for each project or program;
     (f) 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 and toxins, training of all employees, visitors, or students, and first responder plans including evacuation and emergency response;
     (g) Other information as required by the commission and guidelines issued under this chapter; and
     (h) Any incident in which the research sponsor, any of its officers, employees, or any other person who will work in the lab or exercise authority over activity in the lab was found to have violated, or was sanctioned for violating, any law, rule, or ordinance regulating the environment, health, safety, public disclosure, and/or the truthfulness of statements.

NEW SECTION.  Sec. 9   If the secretary of the department becomes aware of credible evidence that activity at a facility licensed for, or seeking a license for, operation under this chapter is likely to pose a significant and imminent threat to human health or to the environment or to cause substantial property damage, the secretary may find that immediate closure of the facility is required to avert such danger and order all research and related activity at that facility suspended until such time as the secretary finds that threat to have been resolved. If the research sponsor believes the secretary's finding to have been unwarranted, it may seek reversal of the decision in a county superior court based on clear and convincing evidence.

NEW SECTION.  Sec. 10   (1) The licensed research sponsor must, within twenty-four hours, report to the commission any incident in which there was human exposure to a biological agent or toxin, and/or a reasonable likelihood of such exposure, including all incidents resulting in actual or recommended prophylactic quarantine or drug use.
     (2) A research sponsor shall report any release or spread of a biological agent or toxin, or the reasonable likelihood of a release or spread, outside the primary containment area of a biosafety level 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 commission.
     (3) 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 a threat to the public health, death, illness, or bodily injury to any person to report said incident not later than seventy-two hours after the incident. The report shall be a public record.
     (4) On an annual basis, the facility or laboratory shall provide the commission with third party certification for all biosafety cabinets, autoclaves, tissue digesters, incubators, centrifuges, and all other major laboratory equipment.

NEW SECTION.  Sec. 11   Each facility with a laboratory shall have and implement a plan to provide adequate training for the proper handling of biological agents and toxins that might be present therein. Such training shall include, but not be limited to, decontamination methods, personnel safety precautions and work habits, early warning disease surveillance, and accident response actions and notifications, access control and monitoring, personnel management, inventory and accountability, information security, and transport of biological agents. Each facility shall provide a training plan to its institutional biosafety committee and to the commission 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 level laboratory located within a facility without first completing the facility's training plan.

NEW SECTION.  Sec. 12   Each facility regulated by this chapter shall implement a waste management and decontamination plan submitted to and approved in advance as a condition of permitting by the commission.

NEW SECTION.  Sec. 13   A facility regulated by this chapter shall develop an emergency response plan, in conjunction with local and state officials, that addresses security threats and releases involving the spread of biological agents and toxins. The emergency response plan shall comply with local, state, and federal plans already in existence. The plan must address such events as severe weather, earthquakes, power outages, power line breaks, terrorism, and other natural, accidental, or intentional disasters or emergencies. The emergency response plan shall, at a minimum, address the following:
     (1) Particular hazards associated with specific biological agents 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 coordinated with Seattle public health and safety officials;
     (11) Critique of response and follow up subsequent to an incident; and
     (12) Communication to the public and the local news media.

NEW SECTION.  Sec. 14   The commission has the authority to 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 such inspection is conducted at a reasonable time under the circumstances and in a manner that maintains the health and safety systems of the laboratories involved. Failure to provide any requested documentation or access to a laboratory for the purpose of inspection will result in a fine and/or 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 such time as the failure has been rectified.

NEW SECTION.  Sec. 15   (1) Any biosafety level 2 or 3 laboratory research or project is forbidden in Washington state if it is reasonably likely to:
     (a) Be used to harm human health, human habitat, agriculture, or the breeding or raising of livestock;
     (b) Render an immunization ineffective or lessen immunity in humans, animals, or plants;
     (c) Confer to a biological agent or toxin resistance of clinically and/or agriculturally useful prophylaxes or therapeutics against that agent or toxin;
     (d) Enhance the virulence of a biological agent or render a nonpathogen virulent;
     (e) Enhance the ease of transmission of a biological agent from human to human, animal to animal, or animal to human;
     (f) Enable the evasion of diagnostic/detection modalities;
     (g) Alter the host range or vector of a biological agent or toxin;
     (h) Enhance the susceptibility of a host population; or
     (i) Create a novel biological agent or toxin, reconstitute or revitalize an eradicated, inactive, dormant, or extinct biological agent that is harmful to humans, human habitat, agriculture, or livestock.
     (2) A principal investigator may seek an exemption to the prohibitions listed in subsection (1) of this section for a specific research project by submitting to the commission, in advance, a written request which specifies in detail the precise research proposed 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 proposed for exemption, and any extraordinary safeguards and precautions which need to be implemented. The commission may permit exemptions to the prohibitions listed in subsection (1) of this section, only on a research project by project basis; it may not issue a blanket exemption to any particular principal investigator or research sponsor, nor may the commission issue a blanket exemption for a particular type of research project. Any exemption permitted under this section shall be updated and resubmitted to the commission annually for review and reconsideration. Research or projects that are subject to the prohibitions described in subsection (1) of this section 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 (1) of this section.
     (3) Biosafety level 4 laboratories and facilities that contain them are not permitted within Washington state.

NEW SECTION.  Sec. 16   (1) A copy of this chapter 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 chapter. All entities permitted under this chapter shall have a system for reporting health and safety violations, including a method to report in an anonymous manner to the health and safety officer and a method to report in an anonymous manner to the institutional biosafety committee.
     (2) A person is not required to conduct scientific research, experimentation, study, or take other action in a laboratory that violates any provision of this chapter or permits issued under this chapter or has reasonable potential to adversely affect public or employee health and safety. A person or employer shall not discharge, refuse to hire, discipline, or in any manner retaliate or take any adverse action against any employee, applicant, or other person because such employee, applicant, or person discloses or threatens to disclose to a supervisor or a governmental agency an activity, policy, or practice that the person reasonably believes is in violation of this chapter; or objects to or refuses to participate in any activity, policy, or practice that the person reasonably believes is in violation of this chapter. 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, in proper circumstances, bring an action in the name of the state against the facility alleged to have violated this section. 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 may, within one year after said notice, institute a civil action in court of jurisdiction where the facility is located. Any party to said 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 may, in addition to issuing temporary restraining orders or preliminary or permanent injunctions, order the reinstatement of an employee's, researcher's, or student's position, the restatement of salary and fringe benefits and rights, compensation of three times lost wages and benefits or other remuneration, interest for liquidated damages, and/or repayment by the facility of employee's, researcher's, or student's reasonable costs and attorneys' fees.

NEW SECTION.  Sec. 17   (1) The intentional or reckless violation of any conditional restriction of a permit or any provision of this chapter subjects the violator to conviction of a gross misdemeanor. Each violation constitutes a separate and distinct offense. Any false statement contained in an application for a permit under this chapter or in any report or disclosure required under this chapter, including a false statement that matter is a trade secret, constitutes a violation subject to the sanctions listed in section 17 of this act.
     (2) Any violation of this chapter at the laboratory or pertaining to the laboratory or any violation of any condition or restriction on a laboratory permit, regardless of the identity or affiliation of the violator, 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, and may result in more serious sanctions including permanent revocation of the permit and assessment of a civil penalty against the research sponsor of up to three hundred thousand dollars. Where the violation was caused by the reckless or intentional conduct of research sponsor or agent thereof, suspension of the research sponsor's permit to operate the laboratory at which the violation occurred for a period of not less than one year and assessment of three hundred thousand dollars against the research sponsor shall be the minimum sanction. Each violation constitutes a separate and distinct ground for sanction under this section.
     (3) Any violation of this chapter at the laboratory or pertaining to the laboratory or any violation of a condition or restriction on a laboratory permit, regardless of the identity or affiliation of the violator, which is preceded by two prior violations will result in revocation of all the research sponsor's permits to operate any biosafety level 2 or 3 laboratory for a period of two years, and in the preclusion of the research sponsor's obtaining any additional permits to operate any biosafety level 2 or 3 laboratory for a period of two years.

NEW SECTION.  Sec. 18   If any provision of this act or its application to any person or circumstance is held invalid, the remainder of the act or the application of the provision to other persons or circumstances is not affected.

NEW SECTION.  Sec. 19   Part headings used in this act are not any part of the law.

NEW SECTION.  Sec. 20   Sections 1 through 19 of this act constitute a new chapter in Title 70 RCW.