34430 
Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
Appendix Q-lI-C-l-g-(4). Individuals 
who handle materials and animals 
containing recombinant DNA molecules 
shall be required to wash their hands 
before exiting the containment area. 
Appendix Q-ll-C-l-g-(5). Experiments 
involving other organisms that require 
containment levels lower than BL3-N 
may be conducted in the same area 
concurrently with experiments 
requiring BL3-N containment provided 
that they are conducted in accordance 
with BL3-N practices. 
Appendix Q-lI-C-l-g-(6). Animal 
holding areas shall be cleaned at least 
once a day and decontaminated 
immediately following any spill of 
viable materials. 
Appendix Q-II-C-]-g-(7). All 
procedures shall be performed carefully 
to minimize the creation of aerosols. 
Appendix Q-Il-C-l-g-(8). A double 
barrier shall be provided to separate 
male and female animals unless 
reproductive studies are part of the 
experiment or other measures are taken 
to avoid reproductive transmission. 
Reproductive incapacitation may be 
used. 
Appendix Q-II-C-l-g-(9). The 
containment area shall be in accordance 
with state and Federal laws and animal 
care requirements. 
Appendix Q-II-C-l-g-(lO) All animals 
shall be euthanized at the end of their 
experimental usefulness and the 
carcasses decontaminated before 
disposal in an approved manner. 
Appendix Q-Il-C-l-g-(ll). Personnel 
shall be required to shower before 
exiting tbe BL3-N area and wearing 
personal clothing. 
Appendix QTI-C-l-g-(12). Animals of 
the same or different species, which are 
not involved in the work being 
performed, shall not be permitted in the 
animal area. 
Appendix Q-II-C-l-g-(13). Needles 
and syringes shall be 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 to the 
syringe) shall be used for the injection 
or aspiration of fluids containing 
organisms that contain recombinant 
DNA. Extreme caution shall be used 
when handling needles and syringes to 
avoid autoinoculation and the 
generation of aerosols during use and 
disposal. Following use, needles shall 
not be bent, sheared, replaced in the 
needle sheath or guard or removed from 
the syringe. The needles and syringes 
shall be promptly placed in a puncture- 
resistant container and decontaminated, 
preferably by autoclaving, before 
discard or reuse. 
Appendix Q-II-C-l-g-(14), A biosafety 
manual shall be prepared or adopted. 
Personnel shall be advised of special 
hazards and required to read and follow 
instructions on practices and 
procedures- 
Append'x Q-n C-2. An(ma) Facdities 
IBL3-N) 
Appendix Q-ll-C-2.-a. Animals shall 
be contained within an enclosed 
structure (animal room or equivalent) to 
minimize the possibility of theft or 
unintentional release and avoid 
arthropod access. The special provision 
to avoid the entry or escape of 
arthropods from the animal areas may 
be waived if the agent in use is not 
knov,/n to be transmitted by arthropods. 
Appendix Q-lI-C-2-b. The interior 
w-alls, floors, and ceilings shall be 
imperv'ious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate heat, to facilitate cleaning. 
Penetrations in these structures and 
surfaces (e.g., plumbing and utilities) 
shall be sealed. 
Appendix Q-lI-C-2-c. Windows in 
the animal facility shall be closed, 
sealed, and breakage resistant (e g., 
double-pane tempered glass or 
equivalent) The need to maintain 
negative pressure should be considered 
when constructing cr renovating the 
animal facility. 
Appendix Q-ll-C-2-d. An autoclave, 
incinerator, or other effective means to 
decontaminate animals and waste shall 
be available, preferably within the 
containment area. If feasible, a double- 
door autoclave is preferred and should 
be positioned to allow removal of 
material from the containment area. 
Appendix Q-lI-C-2-e. If arthropods 
are used in the experiment or the agent 
under study can be transmitted by an 
arthropod, the interior work area shall 
be appropriately screened (52 mesh). All 
perimeter joints and openings shall be 
sealed, and additional arthropod control 
mechanisms used to minimize 
arthropod entry and propagation, 
including appropriate screening, or tbe 
equivalent of access doors. 
Appendix Q-II-C-2-f. Access doors 
to the containment area shall be self- 
closing. 
Appendix Q-lI-C-2-g. The animal 
area shall be separated from all other 
areas. Pa.ssage through two sets of doors 
shall be the basic requirement for entry 
into the animal area from access 
corridors or other contiguous areas. Tbe 
animal containment area shall be 
physically separated from access 
corridors and other laboratories or areas 
by a double-door clothes change room, 
equipped with integral showers and 
airlock. 
Appendix Q-lI-C-2-h Liquid 
effluent from containment equipment, 
sinks, biological safety cabinets, animal 
rooms, primary barriers, floor drains, 
a.nd sterilizers shall be decontaminated 
by heat treatment before being released 
into the sanitary system. The procedure 
-ised for heat decontamination of liquid 
wastes shall be monitored with a 
recording thermometer. The 
effectiveness of the heal 
decontamination process system shall 
be revalidated every 30 days wiih .an 
indicator organism. 
Appendix Q-H-C-2-i, An exhaust air 
ventilation system shall be provided. 
This system shall create directional 
airflow that draws air into the animal 
room through the entry area. The 
building exhaust, or the exhaust from 
primary containment units, may be used 
for this purpose if the exhaust air is 
discharged to the outside and shall be 
dispersed away from occupied areas ar.d 
air intakes. Personnel shall verify that 
the direction of the airflow (into the 
animal room) is proper. 
Appendix Q— lI-C-2-j. It the agent is 
transmitted by aerosol, then the exhaust 
air shall pass through a high eifK. iency 
particulate air/HEPA niter. 
Appendix Q-Il-C— 2-k. Vacuum lines 
shall be protected with high efficienty 
particulate air/HEPA Lh-rrs and liquid 
disinfectant traps. 
Appendix Q-lI-C-2-1 hi lieu of ope:/ 
housing in the special animal room, 
animals held in a BL3-N area may be 
housed in partial-containment raging 
systems (e.g., Horsfall units or 
gnotobiotic systems, or other special 
containment primary barriers). Prudent 
judgment must be exercised to 
implement this ventilation syslem (e.g., 
animal species) and its discharge 
location. 
Appendix Q-lI-C-2-n'j. Each ar. imai 
area shall contain a foot, elbow, or 
automatically operated sink for hand 
ivashing. The sink shall be loc.ated near 
the exit door. 
Appendix Q-lI-C-2-n. Restraining 
devices for animals may be required to 
avoid damage to the integrity of the 
animal containment facility. 
.Appendix Q-Il— D. Biosafety Level 4 — 
Animals (BL4-N) (See Appendix Q-!)l- 
C) 
Appendix Q— II— Ek-1. Standard Practices 
(BL4-N) 
Appendix Q-Il-D-)-a. .Animal Facility 
Access (BL4-N) 
Appendix Q— II— D-1— a— (1 ). 
Individuals under 16 years of age s.i.al.' 
not be permitted to enter the animal 
area. 
Recombinant DNA Research, Volume 19 
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