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Federal Register / Vol. 49, No. 80 / Tuesday. April 24, 1984 / Notices 
Appendix G—ll-C^f-b. The interior 
surfaces of walls, floors, and ceilings are 
water resistant so that they can be easily 
cleaned. Penetrations in these surfaces are 
sealed or capable of being sealed to facilitate 
decontaminating the area. 
Appendix G-ll-C-4-c. Bench tops are 
impervious to water and resistant to acids, 
alkalis, organic solvents, and moderate heat. 
Appendix G-Il-C-4-d. Laboratory furniture 
is sturdy and spaces beteen benches, 
cabinets, and equipment are accessible for 
cleaning. 
Appendix G-H— C 4 -e Each laboratory 
contains fc sink for handwashing. The sink is 
foot, elbow, or automatically operated and is 
located near the laboratory exit door. 
Appendix G-U-C-4-f. Windows in the 
laboratory are closed and sealed. 
Appendix G-lI-C-4-g. Access doors to the 
laboratory or containment module are self- 
closing. 
Appendix G-II-C-4-b. An autoclave for 
decontaminating laboratory wastes Is 
available preferably within the laboratory. 
Appendix G-ll-C-4-i. A ducted exhaust air 
ventilation system is provided. This system 
creates directional airflow that draws air intq 
the laboratory through the entry area. The 
exhaust air is not recirculated to any other 
area of the building, is discharged to the 
outside, and is dispersed away from the 
occupied areas and air intakes. Personnel 
must verify that the direction of the airflow 
(into the laboratory) is proper. The exhaust 
air from the laboratory room can be 
discharged to the outside without being 
filtered or otherwise treated. 
Appendix C-II-C-4-j. The HEPA-filtered 
exhaust air from Class 1 or Class II biological 
safely cabinets is discharged directly to the 
outside or through the building exhaust 
system. Exhaust air from Class I or II 
biological safety cabinets may be 
recirculated within the laboratory if the 
cabinet is tested and certified at least every 
twelve months. If the HEPA-filtered exhaust 
air from Class 1 or II biological safety 
cabinets is to be discharged to the outside 
through the building exhaust air system, it is 
connected to this system in a manner (e.g., 
thimble unit connection [12]) that avoids any 
interference with the air balance of the 
cabinets or building exhaust system. 
i. The following language would be 
substituted for Appendix G-II-D, P4 
Level: 
Appendix G-II-D. Biosafety Level 4 (BL4). 
Appendix C-Il-D-1. Standard 
Microbiological Practices. 
Appendix G-ll-D~l-a. Work surfaces are 
decontaminated at least once a day and 
immediately after any spill of viable material. 
Appendix G-II-D-l-b. Only mechanical 
pipefitting devices are used. 
Appendix G-II-D-l-c. Eating, drinking, 
smoking, storing food, and applying 
cosmetics are not permitted in the laboratory. 
Appendix C-IJ-D-l-d. All procedures are 
performed carefully to minimize the creation 
of aerosols. 
Appendix G-ll-D-2. Special Practices. 
Appendix C-ll-D-2-a. Biological materials 
to be removed from the Class III cabinets or 
from the maximum containment laboratory in 
a viable or intact stale are transferred to a 
nonbreakable, sealed primary container and 
then enclosed in a nonbreakable, sealed 
secondary container which is removed from 
the facility through a disinfectant dunk tank, 
fumigation chamber, or an airlock designed 
for this purpose. 
Appendix C-ll-D-2-b. No materials, 
except for biological materials that are to 
remain in a viable or intact state, are 
removed from the maximum containment 
laboratory unless they have been autoclaved 
or decontaminated before they leave the 
facility. Equipment or material which might 
be damaged by high temperatures or steam is 
decontaminated by gaseous or vapor 
methods in an airlock or chamber designed 
for this purpose. 
Appendix G-II-D-2-c. Only persons whose 
presence in the facility or individual 
laboratory rooms is required for program or 
support purposes are authorized 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 appropriate safeguards for insuring 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-IJ~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-II-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 C-II-D-2-g. Supplies and 
materials needed in the facility are brought in 
by way of the double-doored autoclave, 
fumigation chamber, or airlopk which is 
appropriately decontaminated between each 
use. After securing the outer doors, personnel 
within the facility retrieve the materials by 
opening the interior doors of the autoclave, 
fumigation chamber, or airlock. These doors 
are secured after materials are brought into 
the facility. 
Appendix G-H-D-2-h. An insect and 
rodent control program is in effect. 
Appendix G-Il-D-2-i. Materials (e.g., 
plants, animals, and clothing) not related to 
(he experiment being conducted are not 
permitted in the facility. 
Appendix G-Jl-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 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 ajunct 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 C-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-ll-D-2-m. Alternative 
Selection of Containment Equipment. 
Experimental procedures involving a host- 
vector system that provides a one-step 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 1. 
Appendix G-ll-D-3. Containment 
Equipment 
Appendix G^Il-D-3-a. All procedures 
within the facility with agents assigned to 
Biosafety Level 4 are conducted in the Class 
HI biological safety cabinet or in Class I or 11 
biological safety cabinets used in conjunction 
with one-piece positive pressure personnel 
suits ventilated by a life support system. 
Appendix C-1I-D-4. Laboratory Facility. 
Appendix G-II-D-4-a. The maximum 
containment facility consists of either a 
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