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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Nolice.s 
Appendix Q-II-B-l-c. Signs (BL2-N) 
Appendix Q-II-B-l-c-(l)- When the 
animal research requires special 
provisions for entry (e.g., vaccination), a 
warning sign incorporating tlie 
universal biosafety symbol shall be 
posted on all access doors to the animal 
work area. The sign shall indicate: (i) 
The agent, (ii) the animal species, (iii) 
the name and telephone number of the 
Animal Facility Director or other 
responsible individual, and (iv) any 
special requirements for entering the 
laboratory. 
Appendix Q-II-B-l-d. Protective 
Clothing (BL2-N) 
Appendix Q-II-B-l-d-(l)- Laboratory 
coats, gowns, smocks, or uniforms shall 
be worn while in the animal area or 
attached laboratory. 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-II-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 shall 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) 49&-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-Il-B-l-f-(l). Biological 
materials removed from ihe animal 
containment area in a viable or intact 
state shall be transferred to a non- 
breakable sealed primary container and 
then enclosed in a non-bieakable sealed 
secondary container. All containers, 
primary and secondary, shall be 
disinfected before removal from the 
animal facility. Advance approval for 
transfer of material shall be obtained 
from the Animal Facility Director. 
Packages 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-II-B-l-g-(2). Needles and 
syringes shall be used only for 
parenteral injection and aspiration of 
fluids from laboratory animals and 
diaphragm bottles. O^ly 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. Needles 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, or anim.s) wastr 
etc ) should be prevented. 
Appendix Q-ll-B-l-g-(4). Ea'ing, 
dri;nkir!g, smoking, and applying 
cosmetics shall not be pemrilted in the 
work area. 
Appendix Q-II-B-l-g-(5). Indi viduals 
who handle materials and animals 
containing recombinant DNA molecules 
shall be required to wash their hands 
before exiting the containment area. 
Appendix Q-Il-B-l-g-(6). 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-B-l-g-(7). The 
containment area shall be in accordance 
with state and Federal laws and animal 
care requirements. 
Appendix Q-II-B-l-g-(8). 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. 
Appendix Q-lI-B-2, Animal Facilities 
(BL2-N) 
Appendix Q-ll-B-2-a. Animals shall 
be contained within an enclosed 
.structure (animal room or equivalent) to 
minimize the possibility of theft 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 arthr opods. 
Appendix Q-lI-B-2-b. Surfaces shall 
be impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate heal. 
Appendix Q-ll-B-2-c. The animal 
containment area shall be designed so 
that it can be easily cleaned. 
Appendix Q-II-^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 a.-e 
used in the experiment or the age.ol 
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 e^juivalent 
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