R 325.70012 HIV and HBV research laboratories and production facilities.

Rule 12. (1) This rule applies to research laboratories and production facilities that are engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. This rule applies to such laboratories and facilities in addition to the other requirements of these rules. This rule does not apply to clinical or diagnostic laboratories that are engaged solely in the analysis of blood, tissues, or organs. (2) Research laboratories and production facilities shall be in compliance with all of the following requirements: (a) All infectious liquid or solid waste shall be incinerated or decontaminated by a method known to effectively destroy bloodborne pathogens before being disposed of. (b) Laboratory doors shall be kept closed when work involving HIV or HBV is in progress. (c) Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before being removed from the work area. (d) Access to the work area shall be limited to authorized persons only.Written policies and procedures shall be established whereby only persons who have been advised of the biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms. (e) When other potentially infectious material or infected animals are present in the work area or containment module, a hazard warning sign that incorporates the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall be in compliance with the provisions of R 325.70014(1). (f) All activities that involve other potentially infectious material shall be conducted in biological safety cabinets or other physical containment devices within the containment module. Work with such material shall not be conducted on the open bench. (g) Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms.Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered. (h) Special care shall be taken to avoid skin contamination with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making contact with other potentially infectious materials is unavoidable. (i) All waste from work areas, including animal rooms, shall be incinerated or decontaminated by a method known to effectively destroy bloodborne pathogens before disposal. (j) Vacuum lines shall be protected with high-efficiency particulate air (HEPA) filters, or equivalent filters, and liquid disinfectant traps.Filters and traps shall be checked routinely and maintained or replaced as necessary. (k) Hypodermic needles, syringes, and other sharp instruments shall be used only when a safer alternate technique is not feasible. Only needle-locking syringes or disposable syringe with needle units that have a needle as an integral part of the syringe shall be used for the injection or aspiration of other potentially infectious material. Extreme caution shall be used when handling needles and syringes to avoid autoinoculation and the generation of aerosols during use and disposal. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe after being used. The needle and syringe shall be promptly placed in a puncture-resistant container and decontaminated, preferably by autoclaving, before being discarded or reused. (l) A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or another responsible person. Spills shall immediately be contained and cleaned up by appropriate professional staff who are trained and equipped to work with potentially concentrated infectious material. (m) A biosafety manual shall be prepared or adopted and reviewed and updated at least annually. Personnel shall be advised of potential hazards and shall be required to read and follow instructions on practices and procedures. (n) Both of the following containment equipment requirements shall be complied with: (i) Class I, II, or III certified biological safety cabinets or other appropriate combinations of personal protection or physical containment devices, such as any of the following, shall be used for all activities with other potentially infectious material that poses a threat of exposure to droplets, splashes, spills, or aerosols: (A) Special protective clothing. (B) Respirators. (C) Centrifuge safety cups. (D) Sealed centrifuge rotors. (E) Containment caging for animals. (ii) Biological safety cabinets shall be certified when installed, at least annually, and when they are relocated. (3) HIV and HBV research laboratories shall be in compliance with both of the following requirements: (a) Each laboratory shall contain a sink for washing hands and an eye wash station that are readily available in the work area. (b) An autoclave for the decontamination of regulated wastes shall be available. (4) HIV and HBV production facilities shall be in compliance with all of the following requirements: (a) The work areas shall be separated from areas that are open to an unrestricted traffic flow within the building. Passage through 2 sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doored room for changing clothes, an airlock, or other access facility that requires passing through 2 sets of doors before entering the work area. Showers may be included as part of the changing room. (b) The interior surfaces of walls, floors, and ceilings shall be water-resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination of the work area. (c) Each work area shall contain a sink for washing hands. The sink shall be foot-operated, elbow-operated, or automatically operated and shall be located near the exit door of the work area. (d) Access doors to the work area or containment module shall be self- closing. (e) An autoclave for the decontamination of infectious wastes shall be available within, or as near as possible to, the work area. (f) A ducted exhaust air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow into the work area shall be verified. (5) Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in R 325.70016(6).