Federal Register / Vol. 52, No. 154 / Tuesday, August 11. 1937 / Notices 
29611 
solvents, and moderate heat, so that 
they can be easily cleaned. Penetrations 
in these surfaces shall be sealed to 
facilitate decontaminating the area.” 
265. “Appendix Q-II-C-3-c. Windows 
in the laboratory shall be closed, scaled, 
and breakage resistant." 
266. "Appendix Q-II-C-3-d. An 
autoclave for sterilizing animals and 
wastes 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 zone," 
267. "Appendix Q-U-C-3-e. The 
animal area shall be separated from all 
other ureas. Passage through two sets of 
doors is the basic requirement for entry 
into the animal area from access 
corridors or other contiguous areas. 
Physical separation of the animal 
containment area from access corridors 
or other laboratories or activities will be 
provided by a double-doored clothes 
change room, equipped with integral 
showers and airlock." 
268. "Appendix Q-II-C-3-f. Liquid 
effluent from containment equipment, 
sinks, biological safety cabinets, animal 
rooms, primary barriers, floor drains, 
and sterilizers are decontaminated by 
heat treatment before being released 
into sanitary system(s). The procedure 
used for heat decontamination of liquid 
wastes is to be monitored with a 
recording thermometer. The waste is to 
be monitored for biological activity by 
introducing an appropriate indicator 
microorganism with a defined heat 
susceptibility pattern, and culturing 
samples of treated waste for presence of 
the organism." 
269. "Appendix Q-II-C-3-g. All 
perimeter joints and opening must be 
sealed to form an insect-proof 
structure." 
270. "Appendix Q-Il-C-3-h. Access 
doors to the containment area shall be 
self-closing." 
271. "Appendix Q-II-C-3-i. An 
exhaust air ventilation system is 
provided. This system creates 
directional airflow that draws air into 
the animal room through the entry area. 
The building exhaust can be used for 
this purpose if the exhaust air is not 
recirculated to any other area of the 
building, is discharged to the outside, 
and is dispersed away from occupied 
areas and air intakes. Personnel must 
verify that direction of the airflow (into 
the animal room) is proper. The exhaust 
air from the animal room that does not 
pass through biological safety cabinets 
or other primary containment equipment 
can be discharged to the outside without 
being filtered or otherwise treated. If the 
agent is transmitted by aerosol, then the 
exhaust air must pass through a HEPA 
filter. Heating, Ventilation, Air 
Conditioning (HVAC) supply and 
exhaust ducts should comply with the 
NIH Laboratory Safety Monograph or 
superseding volumes.” 
272. "Appendix Q-II-C-3-j. Vacuum 
lines shall be protected with high 
efficiency particulate air (HEPA) filters 
and liquid disinfectant traps." 
273. "Appendix Q-lI-C-3-k. 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, such as Horsfall units or 
gnotobiotic systems, or other special 
containment primary barriers. Prudent 
judgment must be exercised to 
implement this ventilation system and 
its discharge location and the animal 
species." 
274. “Appendix Q-II-C-3-1. Each 
animal area shall contain a sink for 
handwashing. The sink shall be foot, 
elbow, or automatically operated and 
shall be located near the exit door." 
275. “Appendix Q-II-C-3-m. 
Restraining devices for animals may be 
required to avoid damage to the 
integrity of the containment facility." 
276. "Appendix Q-II-D. Biosafety 
Level 4 for Animals — BL4-N. " 
277. “Appendix Q-II-D-1, Standard 
Practices — BL4-N. " 
278. "Appendix Q-U-D-l-a. All 
genetically engineered neonates will be 
permanently marked within 72 hours 
after birth if their size permits. If their 
size does not permit marking, their 
containers should be marked. In 
addition, transgenic animals should 
contain distinct and biochemically 
ussayable DNA sequences which allow 
identification of transgenic animals from 
among nontransgenic animats." 
279. "Appendix Q-II-D-l-b. All 
contaminated liquid or solid wastes 
shall be decontaminated before 
disposal.” 
280. “Appendix Q-II-D-l-c. Eating, 
drinking, smoking, and applying 
cosmetics are not permitted in the work 
area." 
281. "Appendix Q-IJ-D-l-d. If 
experiments involving other organisms 
which require lower levels of 
containment are to be conducted in the 
same area concurrently with 
experiments requiring BL4-N 
containment, they shall be conducted in 
accordance with BL4-N practices." 
282. "Appendix Q-Il-D-l-e. Persons 
shall wash their hands after handling 
materials involving organisms 
containing recombinant DNA molecules 
and animals, and when they leave the 
animal area." 
283. "Appendix Q-II-D-l-f. Animal 
holding areas shall be decontaminated 
at least once a day and after any spill of 
viable material." 
284. "Appendix Q-II-D-l-g. All 
procedures shall be performed carefully 
so as to minimize the creation of 
aerosols." 
285. "Appendix Q-II-D-l-h. Persons 
under 18 years of age shall not be 
permitted to enter the animal area.” 
236. "Appendix Q— II— D— 1— i. The work 
surfaces of containment equipment shall 
be decontaminated when work with 
organisms containing recombinant DNA 
molecules is finished. Where feasible, 
plastic-backed paper toweling shall be 
used on nonporous work surfaces to 
facilitate clean-up." 
287. "Appendix Q-II-D-2, Special 
Practices — BL4-N. ” 
288. "Appendix Q-II-D-2-a. The 
containment areas will be locked." 
289. "Appendix Q-II-D-2-b. The area 
will be patrolled or monitored at 
frequent intervals.” 
290. "Appendix Q-IMD-2-c. A double 
barrier shall be provided to separate 
male and female animals. Animal 
isolation barriers shall be sturdy and be 
accessible for cleaning.” 
291. “Appendix Q-II-D-2-d. 
Reproductive incapacitation can be 
utilized if needed.” 
292. "Appendix Q-II-D-2-e. The 
animal containment area shall be in 
accordance with Federal law and 
animal care requirements." 
293. "Appendix Q-II-D-2-f. The 
containment building will be controlled 
and have a lockable access." 
294. "Appendix Q-lI-D-2-g. All 
wastes from animal rooms and 
laboratories shall be appropriately 
decontaminated before disposal." 
295. “Appendix Q-II-D-2-h. No 
materials, except for biological 
materials that are to remain in a viable 
or intact state, shall be removed from 
the maximum containment laboratory 
unless they have been autoclaved or 
decontaminated. Equipment or material 
which might be damaged by high 
temperatures or steam shall be 
decontaminated by gaseous or vapor 
methods in an airlock or chamber 
designed for this purpose." 
296. "Appendix Q— II— D— 2— i. The 
director shall establish policies and 
procedures whereby only persons who 
huve been advised of the potential 
hazard and who meet any specific entry 
requirements (e.g., vaccination) may 
enter the laboratory or animal room." 
297. "Appendix Q— II— D— 2— j. When the 
animal research requires special 
provisions for entry (e.g., vaccination), a 
hazard warning sign incorporating. the 
universal biohazard symbol shall be 
posted on all access doors to the animal 
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Recombinant DNA Research, Volume 13 
