Federal Register / Vol. 49, No. 227 / Friday. November 23, 1984 / Notices 
46261 
the facility. Personnel use the airlocks to 
enter or leave 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, including under 
garments, pants and shirts or jumpsuits, 
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 leaving the 
laboratory and before proceeding into 
the shower area, personnel remove their 
laboratory clothing and store it in a 
locker or hamper in the inner change 
room. 
"Appendix G-II-D-2-f. When 
materials that contain organisms 
containing recombinant DNA molecules 
or experimental animals are present in 
the laboratory or animal rooms, a 
hazard warning sign incorporating the 
' universal biohazard symbol is posted on 
all access doors. The sign identifies the 
agent, lists the name of the laboratory 
director or other responsible person(s), 
and indicates any special requirements 
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, fumigation 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 brought into the facility. 
“Appendix G-Il-D-2-h. An insect and 
rodent control program is in effect. 
“Appendix G-II-D-2-i. Materials (e.g., 
plants, animals, and clothing) not 
related to the experiment being 
conducted are not permitted in the 
facility. 
"Appendix 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. Only needle-locking 
syringes or disposable syringe-needle 
units (i.e., needle is integral part of unit) 
are used for the injection or aspiration 
of fluids containing organisms that 
contain recombinant DNA molecules. 
Needless 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 
and exposures and employee 
absenteeism and for the medical 
surveillance of potential laboratory- 
associated illnesses. Written records are 
prepared and maintained. An essential 
adjunct to such a reporting surveillance 
system is the availability of a facility for 
quarantine, isolation, and medical care 
of personnel with potential or known 
laboratory associated illnesses. 
“Appendix G-II-D-2-1. Laboratory 
animals involved in experiments 
requiring BL4 level physical containment 
shall be housed either in cages 
contained in Class III cabinets or in 
partial containment caging systems 
(such as Horsfall units [11]), 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 personnel are required to wear 
one-piece positive pressure suits. 
"Appendix G-II-D-2-m. Alternative 
Selection of Containment Equipment. 
Experimental procedures involving a 
host-vector system that provides a one- 
step higher level of biological 
containment than that specified can be 
conducted in the BL4 facility using 
containment equipment requirements 
specified for the BL3 level of physical 
containment. Alternative combinations 
of containment safeguards are shown in 
Table I. 
"Appendix G-II-D-3. Containment 
Equipment. 
"Appendix G-II-D-3-a. All 
procedures within the facility with 
agents assigned to Biosafety Level 4 are 
conducted in the Class III 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-II-D-4. Laboratory 
Facilities. 
"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 inner change rooms 
separated by a shower are provided for 
personnel entering and leaving the 
facility. A doubledoored autoclave, 
fumigation chamber, or ventilated 
airlock is provided for passage of those 
materials, supplies, or equipment which 
are not brought into the facility through 
the change room. 
"Appendix G-II-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 
HEPA filters. 
"Appendix G-II-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-II-D-4-d. Bench tops 
have seamless surfaces which are 
impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate heat. 
"Appendix G-II-D- 4 -e. Laboratory 
furniture is of simple and 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 HEPA 
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 backflow. 
"Appendix G-II-D-4-h. If water 
fountains are provided, they are foot 
operated and are located in the facility 
corridors outside the laboratory. The 
water service to the fountain is not 
connected to the backflow-protected 
distribution system supplying water to 
the laboratory areas. 
"Appendix G-II-D-4-i. Access doors 
to the laboratory are self-closing and 
lockable. 
“Appendix G— II— D— 4— j. Any windows 
are breakage resistant. 
"Appendix G-II-D—4-k. A double- 
doored autoclave is provided for 
decontaminating materials passing out 
of the facility. The autoclave door which 
opens to the area external to the facility 
is sealed to the outer wall and 
automatically controlled so that the 
outside door can only be opened after 
the autoclave "sterilization" cycle has 
been completed. 
"Appendix G-II-D-4-1. A pass- 
through dunk tank, fumigation chamber, 
or an equivalent decontamination 
method is provided so that materials 
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