Federal Register / Vol. 52, No. 154 / Tuesday. August 11, 1987 / Notices 
29809 
prevent horizontal transmission or 
exposure of laboratory personnel. If the 
agent used as vector is known to be 
transmitted by a particular route, such 
as an arthropod, special attention 
should be given to preventing spread by 
that route. In the absence of specific 
knowledge of a particular route of 
transmission, all potential means of 
horizontal transmission, such as 
arthropods, contaminated bedding, or 
animal waste, etc., should be 
prevented." 
208. "Appendix Q-Il-B-l-c. Eating, 
drinking, smoking, and applying 
cosmetics are not permitted in the work 
area." 
209. "Appendix Q-II-B-l-d. Persons 
shall wash their hands after handling 
materials involving organisms 
containing recombinant DNA molecules 
and animals, and when they leave the 
containment area." 
210. "Appendix Q-II-B-2, Special 
Practices — BL2-N. ” 
211. “Appendix Q-II-B-2-a. The 
containment areas will be locked." 
212. "Appendix Q-lI-B-2-b. The 
containment area will be patrolled or 
monitored at frequent intervals." 
213. “Appendix Q-II-B-2-c. A double 
barrier shall be provided to separate 
male(s) and female(s) animals, unless 
reproductive studies are part of the 
experiment or other measures are taken 
that avoid reproductive transmission." 
214. “Appendix Q-Il-B-2-<i. 
Reproductive incapacitation can be 
utilized if needed." 
215. "Appendix Q-II-B-2— e. The 
containment building will be controlled 
and have a lockable access." 
216. "Appendix Q-II-B-2-f. 
Contaminated materials that are to be 
decontaminated at a site away from the 
laboratory shall be placed in a durable 
leakproof container which shall be 
closed before being removed from the 
laboratory." 
217. “Appendix Q-II-B-2-g. The 
director shall establish policies and 
procedures whereby only persons who 
have been advised of the potential 
hazard and who meet any specific entry 
requirements (e.g., vaccination) may 
enter the laboratory or animal rooms." 
218. "Appendix Q-II-B-2-h. 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 
work area.” 
219. “The hazard warning sign shall 
identify the agent, animal species, list 
the name and telephone number of the 
director or other responsible pcrson(s), 
and indicate the special requirement(s) 
for entering the laboratory." 
220. "Appendix Q-II-B-2-i. 
Laboratory coats, gowns, smocks, or 
uniforms shall be worn while in the 
animal area or attached laboratory. 
Before leaving for nonlaboratory areas 
(e.g., cafeteria, library, administrative 
offices), this protective clothing shall be 
removed and left in the work entrance 
area. 
221. "Appendix Q— II— B— 2— j . Animals 
of the same or different species not 
involved in the work being performed 
shall not be permitted in the animal 
area." 
222. "Appendix Q-II-B-2-k. Special 
care shall be taken to avoid skin 
contamination with microorganisms 
containing recombinant DNA. 
Impervious and/or protective gloves 
shall be worn handling experimental 
animals and when skin contact with the 
infectious agent is unavoidable." 
223. “Appendix Q— II— B— 2— 1 . 
Hypodermic 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. Needles shall not be 
bent, sheared, replaced in the needle 
sheath or guard or removed from the 
syringe following use. The needles and 
syringe shall be promptly placed in a 
puncture-resistant container and 
docontaminated, preferably by 
autoclaving, before discard or reuse.” 
224. “Appendix Q-II-B-2-m. All 
incidences involving spills and 
accidents which result in environmental 
release or exposures of animals or 
laboratory workers to organisms 
containing recombinant DNA molecules 
shall be immediately reported to the 
director. Medical evaluation, 
surveillance, and treatment shall be 
provided as appropriate and written 
records shall be maintained. If 
necessary, the area will be 
appropriately decontaminated." 
225. "Appendix Q-Il-B-2-n. When 
appropriate and giving consideration to 
the agent(s) handled, baseline serum 
samples shall be collected and stored 
for animal care and other at-risk 
personnel. Additional serum specimens 
may be collected periodically depending 
on the agents handled or the function of 
the facility.” 
226. “Appendix Q-II-B-2-o. A 
biosafety manual shall be prepared or 
adopted. Personnel shall be advised of 
special hazards and shall be required to 
read instructions on practices and 
procedures and to follow them.” 
227. “Appendix Q-U-B-2-p. Biological 
materials to be removed from the animal 
containment area in a viable or intact 
state shall be transferred to a 
nonbreakable, sealed primary container 
and then enclosed in a nonbreakable, 
sealed secondary container. All 
containers, primary and secondary, shall 
be disinfected before removal from the 
facility. Advance approval for transfer 
of material must be obtained from the 
director. Such packages containing 
viable agents can only be opened in a 
facility having equivalent or higher 
physical containment unless the agent is 
biologically inactivated or is 
nonreproductive." 
228. “Appendix Q-II-B-3, Special 
Animal Facilities — BL2-N. " 
229. "Appendix Q-D-B-3-a. All 
animals shall be contained within an 
enclosed structure (animal room or 
equivalent) to avoid the possibility of 
theft or unintentional release and avoid 
access of arthropods. The special 
provision to avoid the entry or escape of 
arthropods from the animal areas may 
be wuived if the agent in use is known 
not to be transmitted by arthropods.” 
230. “Appendix Q-II-B-3-b. The 
animal laboratory area shall be 
designed so that is can be easily 
cleaned.” 
231. "Appendix Q-D-B-3-c. Surfaces 
shall be impervious to water and 
resistant to acids, alkalis, organic 
solvents, and moderate heat" 
232. “Appendix Q-II-B-3-d. If the 
building has windows that open, they 
shall be fitted with fly screens." 
233. "Appendix Q-II-B-3-e. An 
autoclave for decontaminating 
laboratory wastes shall be available." 
234. "Appendix Q-D-C Biosafety 
Level 3 for Animals — BL3-N." 
235. “Appendix Q-II-C-1, Standard 
Practices — BL3-N." 
236. “Appendix Q-II-C-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 
assayable DNA sequences which allow 
identification of transgenic animals 
among non-tronsgenic animals." 
237. "Appendix Q-II-C-l-b. 
Appropriate steps should be taken to 
prevent horizontal transmission or 
exposure of laboratory personnel. If the 
agent used as vector is known to be 
transmitted by a particular, route, such 
as an arthropod, special attention 
[ 30 ] 
Recombinant DNA Research, Volume 13 
