Federal Register / Vol. 49, No. 22 7 / Friday. November 23, 1984 / Notices 
46283 
individual laboratory rooms is required 
for program or support purposes are 
authoiized to enter. The supervisor has 
the final responsibility for assessing 
each circumstance and determining who 
may enter or work in the laboratory. 
Access to the facility is limited by 
means of secure, locked doors; 
accessibility is managed by the 
laboratory director, biohazards control 
officer, or other person responsible for 
the physical security of the facility. 
Before entering, persons are advised of 
the potential biohazards and instructed 
as to appropriated safeguards for 
ensuring their safety. Authorized 
persons comply with the instructions 
and all other applicable entry and exit 
procedures. A logbook signed by all 
personnel 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 leave the facility only through 
the clothing change and shower rooms. 
Personnel shower each time they leave 
the facility. Personnel use the airlocks to 
enter or leave the laboratory only in an 
emergency. 
Appendix G-lI-D-2-e. Street clothing 
is removed in the outer clothing change 
room and kept there. Complete 
laboratory clothing, including 
undergarments, 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-II-D-2-h. An insect and 
rodent control program is in effect. 
Appendix G-ll-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-lI-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. 
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 
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-I. 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 ars 
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-1I-D-3. Containment 
Equipment. 
Appendix G-lI-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 double-doored 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 facilitate 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 scaled. Any drains in 
the floors contain traps filled with a 
chemisal 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-U-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. 
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