Federal Register / Vol. 59, No. .127 . / Tuesday, July 5, . 1994 / Notices 
34541 
Appendix Q-lI-B-l-d. Protective 
Clothing (BL2-N) 
Appendix Q-II-B-l-d-(l). Laboratory 
coats, gowTis, smocks, or uniforms shall 
be worn while in the animal area or 
attached laboratoiy'. Before entering 
non-laboratory areas (e.g., cafeteria, 
library, administrative offices), 
protective clothing shall be removed 
and kept in the work entrance area. 
Appendix Q-Il-B-l-d-{2). Special 
care shall be taken to avoid skin 
contamination with microorganisms 
containing recombinant DNA. 
Impervious and/or protective gloves 
shall be worn when handling 
experimental animals and when skin 
contact with an infectious agent is 
unavoidable. 
Appendix Q-II-B-l-e. Records (BL2-N) 
Appendix Q-II-B-l-e-{l). Any 
incident involving spills and accidents 
that result in environmental release or 
exposures of animals or laboratory 
workers to organisms containing 
recombinant DNA molecules shcdl be 
reported immediately to the Animal 
Facility Director, Institutional Biosafety 
Committee, NIH/ORDA, and other 
appropriate authorities (if applicable). 
Reports to the NIH/ORDA shall be sent 
to the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Building 31, Room 4B11, Bethesda, 
Maryland 20892, (301) 496-9838. 
Medical evaluation, surveillance, and 
treatment shall be provided as 
appropriate and written records 
maintained. If necessary, the area shall 
be appropriately decontaminated. 
Appendix Q-II-B-l-e-(2). When 
appropriate and giving consideration to 
the agent 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 
agent handled and the function of the 
animal facility. 
Appendix Q-Il-B-l-f. Transfer of 
Materials (BL2-N) 
Appendix Q-II-B-l-f-(l). Biological 
materials removed from the animal 
containment area in a viable or intact 
slate shall be transferred to a non- 
brcakable sealed primary container and 
then enclosed in a non-breakable sealed 
secondary container. All containers, 
primary and secondary, shall be 
disinfer.ted before removal from the 
animal facility. Advance approval for 
transfer of material shall be obtained 
from the Animal Facility Director, 
f'ackages containing viable agents may 
only be opened in a facility having an 
equivalent or higher level of physical 
containment unless the agent is 
biologically inactivated or incapable of 
reproduction. 
Appendix Q-lI-B-l-g. Other (BL2-N) 
Appendix Q-II-B-l-g-(l). All 
genetically engineered neonates shall 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 that allow 
identification of transgenic animals 
from among non-transgenic animals. 
Appendix Q-U-B-l-g-(2). 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. NeecUes and syringes shall 
be promptly placed in a puncture- 
resistant container and decontaminated, 
preferably by autoclaving, before 
discard or reuse. 
Appendix Q-II-B^l-g-{3). 
Appropriate steps should be taken to 
prevent horizontal transmission or 
exposure of laboratory personnel. If the 
agent used as a vector is known to be 
transmitted by a particular route (e.g., 
arthropods), 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 (e.g., arthropods, 
contaminated bedding, oir animal waste, 
etc.) should be prevented. 
Appendix Q-Il-B-l-g-(4). Eating, 
drinking, smoking, and applying 
cosmetics shall not be permitted in the 
work area. 
Appendix Q-II-B-l-g-(5). 
Individuals who handle materials and 
animals containing recombinant DNA 
molecules shall be required to wash 
their hands before exiting the 
containment area. 
Appendix Q-II-Ik-l-g-{6). A double 
barrier shall bo 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-Il-B-l-g-<7). The 
containment area shall be in accordance 
with state and Federal laws and animal 
care requirements. 
Appendix Q-Il-B-l-g-(8). A 
biosafety manual shall be prepared or 
adopted. Persormel shall be advised of 
special hazards and required to read and 
follow instructions on practices and 
procedures. 
Appendix Q-lI-B-2. Animal Facilities 
(BL2-N) 
Appendix Q-lI-B-2-a. Animals shall 
be contained within an enclosed 
structure (animal room or equivalent) to 
minimize the possibility of Aeft or 
unintentional release and to 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 
known to be transmitted by arthropods. 
Appendix Q-II-B-2-b. Surfaces shall 
be impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate beat. 
Appendix Q-lI-B-2-c. The animal 
containment area shall be designed so 
that it can be easily cleaned. 
Appendix Q-II-B-2-d. Windows that 
open shall be fitted with fly screens. 
Appendix Q-II-B-2-e. An autoclave 
shall be available for decontamination 
of laboratory wastes. 
Appendix Q-II-B-2-f. If arthropods 
are used in the experiment or the agent 
under study can be transmitted by an 
arthropod, interior work areas 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 of 
access doors or the equivalent. 
Appendix Q-II-C. Biosafety Level 3 — 
Animals (BL3-N) (see Appendix Q-IIl- 
B) 
Apjjendix Q-Il-C-1. Standard Practices 
(BL3-N) 
Appendix Q-II-C-l-a. Animal Facility 
Access (BL3-N) 
Appendix Q-II-C-l-a-(l). The 
containment area shall be locked. 
Appendix Q-II-C-l-a-(2). The 
containment area shall be patrolled or 
monitored at frequent intervals. 
Appendix Q—U— C— 1 — a — (3). The 
containment building shall be 
controlled and have a locking access. 
Appendix ^II-C-l-a-(4), The 
Animal Facility Director shall establish 
policies and procedures whereby only 
persons who nave been advised of the 
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Recombinant DNA Research, Volume 19 
