Federal Register ^ Vol. '59, "No. 127 / Tuesday, July 5, 1994 / Notices 
34543 
Append ixQ-n-C-l-g-(6l. Animal 
holding areas shall be cleaned at least 
once a day and decontaminated 
immediately following any -^ill-ot 
viable materials. 
Appendix Q-Il^C-l-g-{7). All 
procedures shall be perfonned carefully 
to minimize the creation of aerosols. 
Appendix Q-TI-C-l-g-{8j. A double 
barrier shall be pro\ided to separate 
male and female animals unless 
reproductr\‘e studies are part of the 
experiment or other measures are taben 
to Bvard reproductive transmission. 
Reproductive mcapacitation may be 
used. 
Appendix Q-II-G-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-flO). All 
animals shall be euthanized et the end 
of their experimental tisefulness and the 
carcasses decontaminated before 
disposal man approved manner. 
Appendix Q-lI^C-l-g-{llJ. 
Personnel shall be required to shower 
before exiting the BL3-N area and 
wearing personal clothing. 
Appermix Q-n-Ol-g^l2j. 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-H-C-l-g-{13). Needles 
and syringes shall be used only for 
parenteral injection and a^iration of 
fluids from laboratoiy animals and 
diaphragm bottles. Only needle-locking 
syringes or disposable syriixge-needle 
units (i.e.. needle is integral to the 
syringe) shall be used for the injection 
or aspiration of fluids containing 
organisms that contain recombinaitt 
DNA. Extreme caittion shall he used 
when handPing needles and syringes to 
avoid antoinoculadoD 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 .fringes 
shall be promptly placed in a puncture- 
resistant container and decontaminated, 
preferably by autodaving.beTore 
discard or reuse. 
Append ^ 
biosafety manual shah be prepared or 
adapted. Personnel shall he advised of 
special hazards and required to read and 
follow instructions on practices and 
procedures 
Appendix Q-4J-C-2 Animal Facilities 
(BL3-N) 
Appendix Q-II-02-a. Animals shall 
lie contained with'm an enclosed 
struct ore fan fraal room or equivalent) to 
minimize the possilj^ity of thrdt or 
unintentional release and avoid 
arthropod access. The special prosision 
to avoid the entry or escape of 
arthropods from the animal areas may 
be waived if the agent in tise is not 
known to be transmitted by arthropods. 
Appendix Q-Il-Cl-2-b. The interior 
walls, floors, and ceilings shall be 
impervaous to water end resistant to 
acids, alkalis, organic solvents, and 
moderate heat, to facilitate cleaning. 
Penetrations in these structures and 
surfaces Je.gv, plumbing and utilities) 
shall be sealed. 
Appendix'Q-n-C-2— c. Windows in 
the animal facility shall be dosed, 
sealed, and bredcage resistant (e.g., 
double-pane tempered glass or 
equivalent). The need to maintain 
negative pressure diould be considered 
when constructing or renovating the 
animal facility. 
Appendix -Q-Il-C-2—d. An autoclave, 
incinerator, tir ether 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-n-C-2-e. ff arthropods 
are used in the experiment or the agent 
under study can be transmitted by an 
arthropod, die interior woilc area shall 
be appropriately screened (52 mesh). All 
perimeter joints and openings shall be 
sealed, and additional arthropod control 
meohanisms used lo minimize 
arthropod entry and propagation, 
including appropriate screening, or the 
equivalent of access doors. 
Appendix Q-H-C-2-f. Access doors 
lo the containment area shall be self- 
closing. 
Appendix Q—H-G-2-g. The animal 
area Aa'll be separated from all other 
areas. 
Fassage through two sets of doors 
shall be the basic requirement forentry 
into the animal area from access 
corridors or other contiguous areas. The 
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. 
AppendiK‘Q-lI-C-2-h. Liquid 
effluent from containment equipment, 
sinks, biological safety cabinets, animal 
rooms, primary barriers, floor drains, 
and sterilizers shall be decontaminated 
•by heat treatment before being released 
irtlo the sanitary system. The procedure 
used for heat decontamination cf liquid 
wastes shall be monitored with a 
Tecordrng'diermometeT. The 
effectiveness dffhe boat 
decontamination process system shall 
bo revalidated every 30 days with an 
indicator organism. 
Appendix Q-Il-C-2-i. An exhaust air 
ventilation sj^stem ■shall be provided. 
This system shall create directional 
airflow that xlraws 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 and 
air intakes. Personnel shall verify that 
the direction of the airflow (into the 
animal room) is proper. 
Appendix Q-lI-C-2-j. If the .agent is 
transmitted by aerosol, then the exhaust 
air shall pass through a high efficiency 
particulate air/HEPA filter. 
Appendix Q-4I-C-2-k. Vacuum lines 
shall be protected with high efficiency 
particulate air/HEPA {filters and liquid 
disinfectant traps. 
Appendix Q-H-C-2-1. In lieu of open 
housing in the special animal room, 
animals held in a BL3-N area may be 
housed in partial-containment caging 
systems Horsfall units or 
gnotobiotic systems., or other special 
containment primary barriers). Prudent 
judgment must -be exercised to 
implement -this ventilation system (e.g.. 
animal species) and its discharge 
location. 
Appendix Q-ll-C-2-m. Each animal 
area shall contain a foot, elbow, or 
automatically operated sink for hand 
washing. The sink shall be located near 
the exit door. 
Appendix Q-B-C-2-n. Restraining 
devices for animals may be required lo 
avoid damage to Xhe integrity of the 
animal containment facility. 
Appendix 'Q-Il-D. Biosafety Level 4 — 
Animals (BL4-N) (see Appendix Q--1II- 
C) 
Appendix Q-U-D-1. Standard Practices 
(BL4-N) 
Appendix Q-ill— I>-1— a. Animal Facility 
Access (BLft-4vJ) 
Appendix 'Q-n-D-l-a-(l). 
Individuals under 16 years of age shall 
not be permitted to enter the animal 
area. 
Appendix Q— H-I>-l-a-(2).''nic 
containment area -shall be locked. 
Appendix Q-Il-D-l-a-(3). The 
containment area shall be patrolled or 
monitored frequent intervals. 
Appendix 'Q-fl-O-l-e-l'y . The 
containment building -shall be 
controlled and have a locking access. 
Appendix Q-Il-4>-l-fi-(5). The 
Animal Facility Director shall establish 
policies and prooedures -whereby only 
persons who have been advised of the 
potential hazard and who meet any 
[ 744 ] 
Recombinant DNA Research, Volume 19 
