34518 
Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
indicates the date and time of each entry 
and exit. Practical and effective 
protocols for emergency situations are 
established. 
Appendix G— II-D-2-d. Personnel 
enter and exit the facility only through 
the clothing change and shower rooms. 
Personnel shower each time they exit 
the facility. Personnel use the air locks 
to enter or exit the laboratory only in an 
emergency. 
Appendix G-II-D-2-e. Street clothing 
is removed in the outer clothing change 
room and kept there. Complete 
laboratory clothing (may ha disposable), 
including undergarments, pants and 
shirts or Jump suits, shoes, and gloves, 
is provided and used by all personnel 
entering the facility. Head covers are 
provided for personnel who do not 
wash their hair during the exit shower. 
When exiting the laboratory and before 
proceeding into the shower area, 
personnel remove their laboratory 
clothing and store it In a locker or 
hamper in the iimer change room. 
Protective clothing shall be 
decontaminated prior to laundering or 
disposal. 
Appendix G-II-D-2-f. When 
materials that contain organisms 
containing recombinant DNA molecules 
or experimental animals are present in 
the I^oratory or animal rooms, a hazard 
warning sign incorporating the 
universal biosafety symbol is posted on 
all access doors. The sign identifies the 
agent, lists the name of the Principal 
Investigator or other responsible 
personfs), and indicates any special 
requiremc^’s for entering the area (e.g., 
the need for immunizations or 
respirators). 
Appendix G-II-D-2-g. Supplies and 
materials needed in the facility are 
brought in by way of the double-doored 
autoclave, fi^gation chamber, or 
airlock which is appropriately 
decontaminated between each use. After 
securing the outer doors, personnel 
within the facility retrieve the materials 
by opening the interior doors or the 
autoclave, fumigation chamber, or 
airlock. These doors are secured after 
materials are brou^t into the facility. 
Appendix G-II-D-2-h. An Insect and 
rodent control progam is in efiect. 
Appendix G-II-5-2d. Materials (e.g., 
plants, animals, and clothing) not 
related to the experiment being 
conducted are not permitted in the 
facility. 
Appendi.x G-II-D-2-j. Hypodermic 
needles and syringes are used only for 
parenteral injection and aspiration of 
fluids from laboratory animals and 
diaphragm bottles. Gnly needle-loddng 
syringes or disposable sjrringe-needle 
xmits (i.e., needle is integral partoftinit) 
are used for the injection or aspiration 
of fluids containing organisms that 
contain recombinant DNA molecules. 
Needles should not be bent, sheared, 
replaced in the needle sheath or guard, 
or removed from the syringe following 
use. The needle and syringe should be 
placed in a puncture-resistant container 
and decontaminated, preferably by 
autoclaving before discard or reuse. 
Whenever possible, cannulas are used 
instead of sharp needles (e.g., gavage). 
Appendix G-II-D-2-k. A system is 
set up for reporting laboratory accidents, 
exposures, employee absenteeism, and 
for the medical surveillance of potential 
laboratory-associated illnesses. Spills 
and accidents which result in overt 
exposures to organisms containing 
recombinant DNA molecules are 
immediately reported to the Biological 
Seifety Officer, Institutional Biosafety 
Committee, and NlH/ORDA. Reports to 
the NIH/ORDA shall be sent to the 
Office of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, Room 4B11, Bethesda, Meuyland 
20892, (301) 496-9838. Written records 
are prepared and maintained. An 
essential adjimct to such a reporting- 
surveillance system is the availability of 
a facility for quarantine, isolation, and 
medical care of persoimel with potential 
or known laboratory associated 
illnesses. 
Appendix G-II-D-2-l. Laboratory 
animals involved in experiments 
requiring BL4 level physical 
containment shadl be housed either in 
cages contained in Class HI cabinets or 
in partial contaiiunent caging systems, 
such as Horsfall imits (see Appendix G- 
III-K), open cages placed in ventilated 
enclosures, or solid-wall and- bottom 
cages placed on holding racks equipped 
with ultraviolet irradiation lamps and 
reflectors that are located in a specially 
designed area in which all persoimel are 
required to wear one-piece positive 
pressure suits. 
Appendix G-II-D-2-m. Alternative 
Selection of Containment Equipment 
(BU) 
Experimental procedures involving a 
host-vector system that provides a one- 
step higher level of biological 
containment than that specified may be 
conducted in the BL4 facility using 
containment equipment requirements 
specified for the BL3 level of physical 
containment. Alternative conciliations 
of containment safeguards are shown in 
Appendix G — Table 1, 
Appendix G-II-D-3. Containment 
Equipment (BL4). Appendix G-II-IJ-3- 
a. All procedures within the facility 
with agents assigned to Biosafety Level 
4 are conducted in the Class in 
biological safety cabinet or in Class I or 
II biological safety cabinets used in 
conjunction with one-piece positive 
pressure personnel suits ventilated by a 
life-support system. 
Appendix G-ll-D-4. Laboratory 
Facilities (BL4). Appendix G-II-D—4-a. 
The maximum containment facility 
consists of either a separate building or 
a clearly demarcated and isolated zone 
within a building. Outer and irmer 
change rooms separated by a shower are 
provided for personnel entering and 
exiting the facility. A double-doored 
autoclave, fumigation chamber, or 
ventilated airlock is provided for 
passage of those materials, supplies, or 
equipment which are not brou^t into 
the facility through the change room. 
Appendix G-n-D-4-b. Walls, floors, 
and ceilings of the facility are 
constructed to form a sealed internal 
shell which facilitates fumigation and is 
animal and insect proof The internal 
surfaces of this shell are resistant to 
liquids and chemicals, thus facilitating 
cleaning and decontamination of the 
area. All penetrations in these structures 
and surfaces are sealed. Any drains in 
the floors contain traps filled with a 
chemical disinfectant of demonstrated 
efficacy against the target agent, and 
they are connected directly to the liquid 
waste decontamination system. Sewer 
and other ventilation lines contain high 
efficiency particulate air/HEPA filters. 
Appendix G-U-D— 4-c. Internal 
facility appurtenances, such as light 
fixtures, air ducts, and utility pipes, are 
arranged to minimize the horizontal 
surface area on which dust can settle. 
Appendix G-n-D-4-d. Bench tops 
have seamless surfaces which are 
impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate beat. 
Appendix G-II-D- 4 - e . Laboratory 
furniture is simple and of sturdy 
construction; and spaces between 
benches, cabinets, and equipment are 
accessible for cleaning. 
Appendix G-II-D-4-f A foot, elbow, 
or automatically operated hand washing 
sink is provided near the door of each 
laboratory room in the facility. 
Appendix G-II-D— 4-g. If there is a 
central vacuum system, it does not serve 
areas outside the facility. In-line high 
efficiency particulate air/HEFA filters 
are placed as near as practicable to each 
use point or service cock. Filters are 
installed to permit In-place 
decontamination and replacement. 
Other liquid and gas services to the 
facility are protected by devices that 
prevent back-flow. / 
Appendix G-U-D-4— h. If water 
fountains are provided, they are foot 
operated and are located in the facility 
Recombinant DNA Research, Volume 19 
[719] 
