AN ACT Relating to the regulation of infectious waste; and creating a new chapter in Title 70 RCW.

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

NEW SECTION. Sec. 1. The legislature hereby finds and declares:

(1) The health and welfare of the people of the state depend on clean and pure environmental resources unaffected by infectious waste contamination.

(2) Safe and responsible management of infectious waste is necessary to prevent adverse effects on our environment and to protect public health and safety.

(3) Strong and effective enforcement of state and local infectious waste laws and regulations is essential to protect the public health and the environment and to meet the public's concerns regarding the encroachment of infectious waste into our daily lives.

NEW SECTION. Sec. 2. The purpose of this chapter is to establish a comprehensive framework for the regulation and management of infectious waste which will prevent land, air, and water pollution and conserve the natural, economic, and energy resources of the state. To this end it is the purpose of this chapter:

(1) To provide broad powers of regulation to the department of ecology, relating to the management of infectious waste;

(2) To provide the rules necessary to establish an infectious waste management plan;

(3) To designate those infectious wastes which are dangerous to the public health and environment;

(4) To establish the operation and monitoring requirements for infectious waste generators and infectious waste disposal sites; and

(5) To provide for the surveillance and monitoring of infectious wastes until they are rendered noninfectious and disposed of properly.

NEW SECTION. Sec. 3. Unless the context clearly requires otherwise, the definitions in this section apply throughout this chapter.

(1) "Contamination" means the degradation of naturally occurring water, air, or soil quality either directly or indirectly as a result of human activity; or the transfer of disease organisms from one material or object to another.

(2) "Department" means the department of ecology.

(3) "Director" means the director of the department of ecology or an authorized representative.

(4) "Facility" means any place where infectious waste activity occurs as defined in this chapter.

(5) "Infectious waste" means solid waste which is:

(a) Cultures and stocks of etiologic agents and associated biologicals, including, without limitation, specimen cultures, cultures and stocks of etiologic agents, wastes from production of biologicals and serums, and discarded live and attenuated vaccines.

(b) Laboratory waste which has come into contact with cultures and stocks of etiologic agents or blood specimens. Such waste includes but is not limited to culture dishes, blood specimen tubes, devices used to transfer, inoculate and mix cultures, paper and cloth which has come into contact with cultures and stocks of etiologic agents.

(c) Sharps, which means medical and laboratory equipment generated by an infectious waste generator that may cause punctures or cuts. Such waste includes, but is not limited to, needles, syringes, lancets, scalpel blades, broken or sharp laboratory glassware including slides, coverslips, and pasteur pipettes.

(d) Pathological waste, which means all human tissues and anatomical parts which emanate from surgery, obstetrical procedures, autopsy, and the laboratory.

(e) Human blood and blood products, including but not limited to serum and plasma, in fluid for exceeding fifty milliliters per container.

(f) Wastes that have come into contact with human body substances infected with anthrax, smallpox, rabies, plague and viral hemorrhagic fevers such as Lassa fever and Ebole-Marburg virus disease.

(g) As determined by and solely at the discretion of the infectious waste generator's infection control staff or committee, wastes that have come into contact with human body substances or other sources which may contain pathogenic microbial agents or other biologically active materials in sufficient concentrations that exposure to the waste directly or indirectly creates a significant risk of disease.

(h) Animal carcasses exposed to pathogens in research, their bedding, and other waste from such animals.

(i) Dialysis unit wastes which includes all wastes contaminated with the blood of patients undergoing hemodialysis, including home care treatment. Examples include but are not limited to disposable equipment and supplies such as tubing, filters, sheets, drapes, towels, gloves, aprons, and laboratory coats.

(6) "Infectious waste generator" means any producer of infectious waste to include without limitation the following categories: General acute care hospitals, skilled nursing facility or convalescent hospitals, intermediate care facilities, in-patient care facilities for the developmentally disabled, chronic dialysis clinics, community clinics, health maintenance organizations, surgical clinics, urgent care clinics, acute psychiatric hospitals, laboratories, medical buildings, physicians offices and clinics, veterinary offices and clinics, dental offices and clinics, funeral homes, long-term, home health care recipients, or other similar facilities.

(7) "Infectious waste storage/treatment operator" means a person who stores and/or treats infectious waste if required by this chapter, and is not an infectious waste generator.

(8) "Laboratory" means a room or building equipped for scientific experimentation, research, testing, or clinical studies of specimens, fluids, tissues, cultures or stocks of etiologic agents and associated biologicals or other biologically active agents.

(9) "Steam sterilization" means sterilizing infectious waste by use of saturated steam within a pressure vessel at temperatures sufficient to kill all microbiological agents in the waste as determined by the biological and chemical indicator monitoring requirements set forth in this chapter.

NEW SECTION. Sec. 4. The department after notice and public hearing shall:

(1) Adopt regulations designating as infectious wastes subject to the provisions of this chapter those substances which exhibit characteristics consistent with the definition provided in section 3(5) of this act.

(2) Adopt and may revise when appropriate, minimum standards and regulations for the storage and disposal of infectious wastes to protect against hazards to the public, and to the environment. Before adoption of such standards and regulations, the department shall consult with appropriate agencies of interested local governments and secure technical assistance from the department of agriculture, the department of social and health services, the department of wildlife, the department of natural resources, the department of fisheries, the department of labor and industries, and the department of community development, through the director of fire protection.

NEW SECTION. Sec. 5. The department in performing its duties under this chapter may:

(1) Conduct studies and coordinate research programs pertaining to infectious waste management;

(2) Render technical assistance to generators of infectious wastes and to state and local agencies in the planning and operation of infectious waste programs; and

(3) Provide for appropriate surveillance and monitoring of infectious waste disposal practices in this state.

NEW SECTION. Sec. 6. Each county or combination of contiguous counties shall develop regulations for the management of infectious waste, which regulations shall be consistent with the standards and regulations set forth in this chapter and promulgated by the department.

NEW SECTION. Sec. 7. It shall be unlawful for any person to operate an infectious waste collection site without a valid permit issued by the director. Permits shall not be transferable and shall be valid only for the facility for which issued.

NEW SECTION. Sec. 8. Any person desiring to operate an infectious waste collection site shall submit an application to the director, on a form provided by the director. The application shall include the applicant's full name, post office address, and the signature of the applicant or an authorized representative of the applicant; shall disclose whether such applicant is an individual, firm, corporation, and, if a partnership, the names and mailing addresses of all of the partners; the address, legal description, and type of infectious waste disposal site; and shall be accompanied by the permit fee of one hundred fifty dollars.

NEW SECTION. Sec. 9. When inspection reveals that the applicable requirements of this chapter and the regulations established by the department have been met and the one hundred fifty dollar fee has been paid, a permit shall be issued to the applicant by the director. The director may deny the application if in his or her judgment the operation of the site is likely to result in a hazard to the public health and/or will not meet the requirements of this chapter or the regulations established by the department. The director may also suspend or revoke a permit during its term for noncompliance with conditions of the permit, the permittee's failure to disclose relevant facts at any time, or if the permittee's activity endangers or manifests irresponsibility concerning public health or the environment. The director shall consider any relevant health and safety factors in making this determination. If an application is denied or a permit is suspended or revoked, the director at the time of the denial, suspension, or revocation shall inform the applicant in writing of the reasons for the denial or revocation and of the applicant's or permittee's right to an appeal under the terms of this chapter.

NEW SECTION. Sec. 10. Whenever the director denies, suspends, or revokes a permit for an infectious waste disposal site, he or she shall, upon request of the applicant or holder of the permit, grant a hearing on such denial, suspension, or revocation within thirty days after the request is made. Notice of the hearing shall be given all interested parties including the county or city having jurisdiction over the site. Within thirty days after the hearing, the director shall notify the applicant or the holder of the permit in writing of the determination and the reasons therefor. Any party aggrieved by such determination may appeal to the pollution control hearings board by filing with the hearings board a notice of appeal within thirty days after receipt of notice of the determination of the director. The hearings board shall hold a hearing in accordance with the provisions of the administrative procedure act, chapter 34.05 RCW.

NEW SECTION. Sec. 11. All permits issued under this chapter shall expire on the December 31st next following the date of issuance.

NEW SECTION. Sec. 12. Fees for inspection service requested by the infectious disposal site to be performed outside regular departmental working hours will be charged at a rate equal to the cost of performing the service. When plans and specifications that have been examined are altered and resubmitted, an additional fee for the reexamination of such plans shall be assessed at the current cost of plan review.

NEW SECTION. Sec. 13. (1) The director is also authorized to charge such fees as he or she may deem necessary for the furnishing of special services or materials requested that are not ordinarily provided under permit or pursuant to statute. Such services and materials to be furnished may include but are not limited to the following:

(a) Reproduction and/or search of records and documents.

(b) Examination, testing, or inspection of particular products, materials, construction, equipment, or appliances to determine their compliance with the provisions of this chapter or department rules.

(2) The director shall have full authority to specify the terms and conditions upon which such services and materials shall be made available, except that any fees imposed pursuant to this authorization shall be reasonably equivalent to the department's cost for furnishing the services and materials.

NEW SECTION. Sec. 14. The owner, occupant of the premises or both, shall be responsible for the safe and sanitary storage of all infectious wastes accumulated at that premises until it is removed to a disposal site. The storage area and storage containers shall be maintained in a clean, safe, and nuisance free condition.

NEW SECTION. Sec. 15. (1) The owner, operator, or occupant of any premises, business establishment, or industry shall store containerized infectious wastes in containers that meet the following requirements:

(a) Disposable containers shall be sufficiently strong to allow lifting without breakage and shall be thirty-two gallons in capacity or less where manual handling is practiced;

(b) Reusable containers, except for detachable containers, shall be:

(i) Rigid and durable;

(ii) Corrosion resistant;

(iii) Nonabsorbent and water tight;

(iv) Rodent-proof and easily cleanable;

(v) Equipped with a close fitting cover;

(vi) Suitable for handling with no sharp edges or other hazardous conditions; and

(vii) Equal to or less than thirty-two gallons in volume where manual handling is practiced.

(c) Detachable containers shall be durable, corrosion-resistant, nonabsorbent, nonleaking and having either a solid cover or screen cover to prevent littering.

(2) The director may require disinfection of any container. Containers shall be cleaned frequently to prevent rodent/vector nuisances. All wastewater from container cleaning shall be disposed of in a sanitary sewer system unless otherwise authorized by the director.

NEW SECTION. Sec. 16. Each infectious waste generator and infectious waste disposal site operator must write an infectious waste management plan with an internal annual review. The plan shall include all aspects of applicable infectious waste management practice. The plan must be followed. The plan must include a listing of the generator's or disposal site's infection control staff or committee member, phone numbers of responsible individuals, definition of wastes handled by the system, department and individual responsibilities, procedures for waste identification, segregation, containment, transport, treatment, treatment monitoring, disposal, contingency planning, staff and housekeeping training for infectious waste identification, when applicable, and compliance with infectious waste regulations. The plan must include owner's or chief executive officer's endorsement letter. The plan shall be available for inspection at the request of the director.

NEW SECTION. Sec. 17. (1) Storage of infectious waste shall be in a manner and location which affords protection from animals, rain, and wind; does not provide a breeding place or a food source for insects or rodents; and is accessible only to personnel authorized in the infectious waste generator's infectious waste management plan.

(2) Infectious waste shall be segregated by separate containment from other waste at the point of origin.

(3) Infectious waste, except for sharps, shall be contained in disposable leakproof plastic bags with a minimum thickness of two mils, and have a strength to preclude ripping, tearing, or bursting under normal conditions of use. The bags shall be appropriately marked by the generator as containing infectious waste. The bags shall be secured to prevent leakage or expulsion of solid or liquid waste during storage, handling, or transport.

(4) Sharps shall be contained in leakproof, rigid, puncture resistant, break resistant containers which are tightly lidded during storage, handling, and transport.

(5) Infectious waste contained in disposable bags as described in subsection (3) of this section, shall be placed for storage, handling or transport in containers such as disposable or reusable pails, cartons, boxes, drums, or portable bins. The containers shall be of any color and shall be conspicuously labeled with the international biohazard symbol, and the words "Biochemical Waste" or words that clearly denote the presence of infectious waste.

(6) Operations involving reusable containers must comply with the following:

(a) Reusable containers for infectious waste storage, handling or transport shall be thoroughly washed and decontaminated by an approved method each time they are emptied unless the surfaces of the containers have been protected from contamination by disposable liners, bags or other devices removed with the waste, other than those required in subsection (3) of this section.

(b) Approved methods of decontamination are agitation to remove visible solid residue combined with one of the following procedures:

(i) Chemical disinfectants should be used in accordance with the manufacturer's recommendations for tuberculicidal and viracidal (Polio type 1 or 2, SA Rotovirus) killing capacities or by disinfectant concentration/contact times approved in writing by the director.

(ii) Other method approved in writing by the director.

(c) Reusable pails, drums, or bins used for containment of infectious waste shall not be used for any other purpose except after being disinfected by procedures as described in this section and after the international biohazard symbol and words biomedical waste are removed.

(7) Trash chutes shall not be used to transfer infectious waste.

(8) Unless approved in writing by the health officer, infectious waste other than sharps shall be treated in accordance with section 18 of this act within eight days, if said waste is stored at temperatures exceeding thirty-two degrees Fahrenheit or zero degrees centigrade, or within ninety days if said waste is stored at temperatures at or below thirty-two degrees Fahrenheit or zero degrees centigrade commencing from the time of generation. Treated sharps waste, except incinerated sharps, shall be transported within ninety days commencing from the time of generation. Sharps waste treated by incineration shall be treated within ninety days commencing from the time of generation.

(9) Infectious waste shall not be subject to compaction prior to treatment.

(10) Infectious waste shall not be placed into the general solid waste stream prior to treatment.

(11) At no time shall treated sharps waste, except incinerated sharps waste, be disposed into the general solid waste stream, unless approved in writing by the director.

(a) Treated sharps waste, except incinerated sharps waste, shall be transported separately from the general solid waste stream in approved sharps containers for disposal at a sanitary landfill approved in writing by the director.

(b) The sharps waste shall be covered with at least six inches of compacted waste material within twenty-four hours of disposal.

NEW SECTION. Sec. 18. Infectious waste shall be treated prior to disposal by one or more of the following methods:

(1) Cultures and stocks of etiologic agents and associated biologicals: Stream sterilization, incineration, or other treatment method approved in writing by the director.

(2) Laboratory waste: Stream sterilization, incineration, or other treatment method approved in writing by the director.

(3) Sharps: Incineration, containment, or other treatment method approved in writing by the director.

(4) Pathological waste: Incineration, interment, or other treatment method approved in writing by the director.

(5) Human blood and blood products: Direct pour via a utility sink drain or toilet to an approved sewage disposal system, incineration, or other treatment method approved in writing by the director, except as prohibited by section 19(3) of this act.

(6) Wastes that have come into contact with human body substances from patients diagnosed with anthrax, smallpox, rabies, plague and viral hemorrhagic fevers such as Lassa fever and Ebole-Marburg virus disease: Steam sterilization, incineration, or other treatment method approved in writing by the director.

(7) As determination by the infectious waste generator's infection control staff person or committee, wastes that have come into contact with human body substances which may create a significant risk of disease: Steam sterilization, incineration, or other treatment method approved in writing by the director.

(8) Animal carcasses exposed to pathogens in research: Incineration or other treatment method approved in writing by the director.

NEW SECTION. Sec. 19. (1) Infectious waste treatment and disposal shall be conducted as follows:

(a) Steam sterilization by heating in a steam sterilizer so as to kill all microbiological agents as determined by chemical and biological indicator monitoring requirements set forth in this section. Operating procedures for steam sterilizers shall include, but not be limited to, the following:

(i) Adoption of standard written operating procedures for each steam sterilizer, including time, temperature, pressure, type of waste, type of containers, closure on containers, pattern of loading, water content, and maximum load quantity.

(ii) Check of recording and/or indicating thermometers during each complete cycle to ensure the attainment of a minimum temperature of two hundred fifty degrees Fahrenheit or one hundred twenty-one degrees centigrade for one-half hour or longer, depending on quantity and compaction of the load, in order to achieve sterilization of the entire load. Thermometers shall be checked for calibration at least annually.

(iii) Use of heat sensitive tape or other device for each load that is processed to indicate that the load has undergone the steam sterilization process.

(iv) Use of the chemical migrating integrator Thermalog-S, or other chemical integrator meeting equivalent time, temperature and steam indicator specifications, based upon Bacillus stearothermophilus spore kill steam sterilization parameters, approved in writing by the director. The chemical integrator shall be placed at the center load of each cycle to confirm attainment of adequate sterilization conditions for each infectious waste treatment cycle run.

(v) Use of the biological indicator, Bacillus stearothermophilus, or other biological indicator approved in writing by the health officer, placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

(vi) Maintenance of records and procedures specified in (i), (ii), (iv) and (v) for a period of not less than one year.

(vii) Development and implementation of a written steam sterilization training program for steam sterilizer operators.

Infectious waste so treated shall be disposable into the general solid waste stream provided it is not otherwise hazardous waste or nonincinerated sharps waste.

(b) Incineration shall be conducted at a sufficient temperature and for sufficient duration that all combustible material is reduced to ash and that no unburned combustible material is evident in the ash. Operating procedures for incinerators shall include, but not be limited to, the following:

(i) Adoption of a standard written operating procedure for each incinerator that takes into account: Variation in waste composition, waste feed rate, and combustion temperature.

(ii) Development and implementation of a written incinerator operator training program for incinerator operators.

(c) Interment of pathological waste shall be conducted in such a manner so as to meet all federal, state, and local regulations.

(2) Each infectious waste generator and infectious waste disposal site operator must develop a contingency plan for the treatment of infectious waste. Provisions must be made for an alternate treatment plan in the event of equipment breakdown with an incinerator, steam sterilizer, or other method approved in writing by the director, as required by this section, for treating the waste prior to disposal.

(3) Each infectious waste generator and infectious waste disposal site operator is strictly forbidden, under any and all circumstances, from ever placing into the public sewer system, by any means through an act or an omission, untreated blood, untreated blood products, or blood-contaminated items, regardless of the size of the item, physical characteristics of the item, or the extent of the contamination.

NEW SECTION. Sec. 20. The director shall have the authority to inspect any infectious waste generator or infectious waste disposal site operator, at any reasonable time, for the purpose of evaluating the written infectious waste management plan and to determine if the infectious waste is being handled, stored, treated, and disposed in accordance with this chapter.

NEW SECTION. Sec. 21. 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. 22. Sections 1 through 20 of this act shall constitute a new chapter in Title 70 RCW.