32 C.F.R. Subpart G—Facilities
Title 32 - National Defense
The design of the facility is important in providing a secondary barrier to protect individuals inside and outside the facility. Because the hazards presented by various organisms and materials vary, the requirements for the facility will vary accordingly. The minimum facility requirements for the various biosafety levels and toxins are described below. The biosafety levels correspond to those described in the HHS Publication Biosafety in Microbiological and Biomedical Laboratories (HHS No. (NIH) 88–8395), while the large-scale biosafety levels were adapted from those described in the NIH Guidelines for Research Involving Recombinant DNA Molecules. (a) Laboratories. Each laboratory used for this level will, as a minimum, have the following features: (1) A sink for handwashing. (2) Work surfaces that are impervious to water and resistant to acids, alkalis, organic solvents, and moderate heat. (3) Fly screens on any windows that can be opened. (4) Furnishings and surfaces that are sturdy and designed to be easily cleaned. (5) Spaces between furnishings and equipment that are accessible for cleaning. (b) Animal facilities. Each room will have the following features: (1) Design and construction to facilitate cleaning and housekeeping. (2) A sink for handwashing within the facility. (3) Fly screens on any windows that can be opened. (4) Ventilation designed so that the direction of airflow in the animal facility is inward, with the exhausted air discharged to the outside without being recirculated. (5) Self-closing doors that open inward. (a) Laboratories. Each laboratory used for this level of hazard will have, in addition to the requirements stated in §627.43(a), the following: (1) An autoclave available. (2) Containment equipment necessary for the operations unless the safety officer approves the use of a compensatory level of personal protective equipment. (3) An eyewash available near the laboratory. (b) Animal facilities. In addition to the requirements stated in §627.43(b), facilities will include— (1) A sink for handwashing in each room where animals are housed. (2) An autoclave available in the building. (3) Appropriate containment equipment unless the safety officer approves the use of a compensatory level of personal protective equipment. (a) General requirements. Each suite used as a laboratory or in which infected animals are housed will, as a minimum, have the following features: (1) Physical separation from areas which are open to unrestricted traffic. (2) All entrances to each laboratory or animal room from the nonlaboratory access corridors will be through two sets of doors. A change room or airlock may be incorporated between the doors. (3) The interior surfaces of walls, floors, and ceilings will be water resistant so that they may be easily cleaned. (4) All penetrations into the walls, floors, and ceilings should be sealed or capable of being sealed to facilitate decontamination. (5) A foot, elbow, or automatically operated sink will be located near the exit door to each laboratory or animal room. (6) An autoclave should be in each laboratory or animal room and will be available to the facility. (7) A ventilation system that will— (i) Create directional airflow that draws air into the laboratory through the entry areas. (ii) Not recirculate laboratory air. (iii) Discharge the exhaust air from the laboratory to the outside and disperse the exhaust air away from occupied areas and air intakes. (iv) Exhaust the HEPA-filtered air from Class I or II biological safety cabinets or other primary containment devices directly to the exterior of the laboratory or through the building exhaust system. Exhaust air from the cabinets may be recirculated within the laboratory if the cabinet is tested and certified at least every 12 months. If the filtered cabinet exhaust is discharged through the building exhaust system, it will be connected to this system in a manner (for example, thimble unit connection) that avoids any interference with the air balance of the cabinets or the building exhaust system. (8) All windows to the facility will be sealed shut. (9) Appropriate biological safety cabinets or other specialized containment equipment will be provided. (10) Any vacuum line in the facility will have a HEPA filter and liquid disinfectant trap. (11) Bench tops that are impervious to water and resistant to acids, alkalis, organic solvents, and moderate heat. (12) Furnishings that are sturdy and spaces between benches, cabinets, and equipment that are accessible for cleaning. (13) An eyewash available in or near the laboratory. (b) Additional animal facility requirements. In addition to the requirements given in §627.44(b) and 627.45(a), all doors to the animal rooms will open inward and be self-closing. The engineering controls within the facility must provide absolute biological containment. All procedures with etiologic agents requiring this biosafety level of facilities, equipment, and procedures must be conducted either in Class III biological safety cabinets, or in a facility that is designed for the use of a personal positive pressure suit as described in §627.46(b) in conjunction with Class I or II biological safety cabinets. (a) General requirements. The facility will have the following features: (1) A separate building or a clearly demarcated and isolated area within a building which incorporates positive personnel control for access. (2) All entrances from access corridors incorporate an inner and outer change room. (3) Inner and outer change rooms separated by a shower facility. (4) A double-doored autoclave, fumigation chamber, or ventilated airlock for passage of all items which do not enter the facility through the change room. (5) Interior surfaces of walls, floors, and ceilings resistant to water and chemicals to facilitate cleaning and disinfecting. (6) Walls, floors, and ceilings of the facility constructed to form a sealed internal shell which facilitates fumigation and is animal and insect proof. (7) All penetrations into the walls, floors, and ceilings sealed. (8) All liquid drains in the facility connected directly to a liquid waste decontamination system. (i) Holding tanks collecting waste from sinks, biological safety cabinets, floors, and autoclave chambers provide decontamination by heat treatment. (ii) Holding tanks collecting waste from shower rooms and toilets provide decontamination by heat or chemical disinfectant methods. (9) Sewer and other ventilation vents contain in-line HEPA filters. (10) Internal facility appurtenances (for example, light fixtures, air ducts, and utility pipes) arranged to minimize the horizontal surface area on which dust can settle. (11) A foot, elbow, or automatically operated handwashing sink located near the exit door to each laboratory or animal room. (12) Self-closing and lockable access doors. (13) A ventilation system that— (i) Is dedicated to the facility and provides fresh air meeting American Society of Heating, Refrigerating, and Air Condition Engineers, Inc. (ASHRAE) Standard 62. (ii) Maintains a negative pressure differential and assures flow inward from areas outside of the facility toward areas of highest potential risk. (iii) Has manometers or magnehelic gauges to provide, sense, and display pressure differentials between adjacent areas maintained at different pressure levels. An alarm will sound when the pressures fall below acceptable levels. (iv) Has the air supply and exhaust interlocked to ensure that exhaust failure or reduction will not allow the air pressure in the area to become positive to the adjacent areas. (v) Does not recirculate exhaust air. (vi) Is HEPA-filtered and discharged to the outside, dispersing the exhaust air away from occupied areas and air intakes. (vii) Has the HEPA filters on the exhaust located as near to the rooms as is practicable. (viii) Has the filter chambers designed to allow in-place decontamination before the filters are removed and to facilitate certification testing. (ix) Contains prefilters and HEPA filters in the air supply system to protect the supply air system should air pressures become unbalanced. (x) Exhausts the HEPA-filtered air from Class I or II biological safety cabinets directly into the laboratory or to the exterior of the building. If the HEPA-filtered exhaust from these cabinets is recirculated, the cabinets are tested and certified every 6 months. If the filtered cabinet exhaust is discharged through the building exhaust system, it will be connected to this system in a manner (for example, thimble unit connection) that avoids any interference with the air balance of the cabinets or the building exhaust system. (xi) Passes the treated exhaust air from Class III biological safety cabinets through two sets of HEPA filters in series to the exterior of the facility through the laboratory exhaust air system. (14) Windows (if present) sealed shut and breakage resistant. (15) Has a double-doored autoclave for decontaminating materials passing out of the facility. The autoclave door that opens to the area external to the facility is sealed to the outer wall and automatically controlled so that it can only be opened after the autoclave sterilization cycle has been completed. (16) Has a pass-through dunk tank, fumigation chamber, or an equivalent decontamination method for materials and equipment that cannot be autoclaved. (17) Has central vacuum systems (if present) that— (i) Do not serve areas outside the facility. (ii) Have an in-line HEPA filter placed as near as practicable to each use point or service cock. (iii) Have filters designed to allow in-place decontamination and replacement. (18) Liquid and gas services to the facility provided with protective devices that prevent backflow. (b) Additional requirements for personal positive pressure suit areas. If personal positive pressure suits are worn in lieu of using Class III biological safety cabinets for containment, a special suit area will be provided. The suit area will provide the following, in addition to the requirements stated in §627.46(a): (1) An exhaust system dedicated to that area that provides filtration by two sets of HEPA filters installed in series. This system will be backed up by a duplicate filtration unit, exhaust fan, and an automatically starting emergency power source. The ventilation system will maintain the suit area under negative pressure relative to the surrounding areas. (2) An entry area consisting of an airlock fitted with airtight doors. (3) A chemical shower to decontaminate the surface of the personal positive pressure suit upon exit. (4) An air supply and distribution system to support the life support system of the personal positive pressure suits. (5) Emergency lighting and communications systems. (6) Sealed penetrations into the internal shell of the area. (7) A double-doored autoclave to decontaminate waste materials to be removed from the suit area. (c) Additional laboratory requirements. In addition to those given in §627.45, if water fountains are provided, they will be foot operated and located in the facility corridors outside the laboratory. (d) Additional animal facility requirements. In addition to those requirements given in §627.45, all animal facility external doors will be self-locking. The following requirements apply to facilities in which an individual culture of viable etiologic agents exceed 10 liters: (a) BL–1 LS. In addition to the laboratory requirements stated §627.43(a), the exhaust gases removed from a closed system or other primary containment equipment shall be treated by filters which have efficiencies equivalent to HEPA filters or by other equivalent procedures (for example, incineration) to minimize the release of viable organisms. (b) BL–2 LS. In addition to the requirements stated in §§627.44(a) and 627.47(a), these facilities will have— (1) Rotating seals and other mechanical devices directly associated with a closed system used to contain viable organisms shall be designed to prevent leakage or shall be fully enclosed in ventilated housings that are exhausted through filters which have efficiencies equivalent to HEPA filters or through equivalent treatment devices. (2) A closed system used to propagate and grow viable organisms shall include monitoring or sensing devices that monitor the integrity of containment during operations. (3) Closed systems used for the propagation and growth of viable organisms shall be tested operationally for integrity of the containment features. The containment will be rechecked following modification or replacement of essential containment features. Procedures and methods used in the testing shall be appropriate for the equipment design and for recovery and demonstration of the test organism. Records of tests and results shall be maintained on file. (c) BL–3 LS. The requirements stated in §§627.45 and 627.57(b) apply, and all closed systems and other primary containment equipment used in handling cultures of viable organisms shall be located within a controlled area which meets the requirements of a BL–3 facility plus the following requirements: (1) All utilities and service or process piping or wiring entering the controlled area shall be protected against contamination. (2) A shower facility shall be provided. This facility shall be located near the controlled area. (3) The controlled area shall be designed to preclude release of culture fluids outside in the event of an accidental spill or release from the closed systems or other primary containment equipment. (4) The controlled area shall have a ventilation system capable of controlling air movement. The movement of air shall be from areas of lower contamination potential to areas of higher contamination potential. If the ventilation system provides positive pressure supply air, the system shall operate so as to prevent the reversal of air movement or shall be equipped with an alarm that would be actuated if reversal in the direction of air movement were to occur. The exhaust air from the controlled area shall not be recirculated to other areas of the facility. The exhaust air from the controlled area may be discharged to the outdoors after filtration or other means of effectively reducing an accidental aerosol burden, and dispersed clear of occupied buildings and air intakes. General requirements for all facilities in which toxins are used are as follows. Such facilities will— (a) Have a ventilation system that provides three to six air changes per hour, and that provides a directional airflow inward relative to the access halls. (b) Have a sink for handwashing. (c) Have an eyewash available. (d) Have bench tops that are impervious to water and resistant to acids, alkalis, organic solvents, and moderate heat. (e) Have furniture, furnishings, and surfaces that are sturdy and designed to be easily cleaned. (f) Be arranged so that items are accessible for cleaning. (g) Have a quick-drench shower available within the facility. (h) A fume hood, biological safety cabinet, glove box, or equivalent engineering control equipped with HEPA filters and with charcoal filters if volatile materials are being used.
Title 32: National Defense
PART 627—THE BIOLOGICAL DEFENSE SAFETY PROGRAM, TECHNICAL SAFETY REQUIREMENTS (DA PAMPHLET 385–69)
Subpart G—Facilities
§ 627.42 Introduction.
§ 627.43 Biosafety level 1.
§ 627.44 Biosafety level 2.
§ 627.45 Biosafety level 3.
§ 627.46 Biosafety level 4.
§ 627.47 Large-scale facilities.
§ 627.48 Toxins.
