Federal Register / V«ji. oa. No. 127 / Tuesday. July 5. 1994 / Notices 
34489 
Appendix Q-II-C. Biosafety Level 3 — 
Animals (BL3-N) (See Appendix Q-IIl- 
B) 
Appendix Q-II-C-1. Standard Practices 
(BL3-N) 
Appendix Q-II-C-l-a. Animal Facility 
Access (BL3-N) 
Appendix Q-Il-C-l-a-(l)- The 
containment area shall lie lo<Ted. 
Appendix Q-II-C-l-a-(2). The 
containment area shall be patrolled or 
monitored at frequent intervals. 
Appendix Q-II-C-1 -a-(3). The 
containment building shall be 
controlled and have a locking access. 
Appendix Q-Il-C-l-a-(4). The Animal 
Facility Director shall establish policies 
and procedures whereby only persons 
who have been advised of the potential 
hazard and who meet any specific entry 
mquirements (e.g.. vaccination] shall 
enter the laboratory or animal rooms. 
Appendix Q-II-C-1 -a-(5). Animal 
room doors, gates, or other closures 
shall be kept closed when experiments 
are in progress. 
Appendix Q-Il-C-l-b. Decontamination 
and Inactivation (BL3-N) 
Appendix Q-II-C-1 -b-(l). The work 
surfaces of containment equipment shall 
he decontaminated when work with 
organisms containing recombinant DNA 
molecules is finished. Where feasible, 
plastic-backed paper tow'eling shall be 
used on nonporous work surfaces to 
facilitate clean-up. 
Appendix Q-Il-C-l-b-(2). All animals 
shall be euthanized at the end of their 
experimental usefulness and the 
c;arca.sses decontaminated before 
disposal in aniipproved manner. 
Appendix Q-Il-C-l-b-(3). Needles and 
syringes shall be promptly placed in a 
puncture-resistant container and 
decontaminated, preferably by 
autoclaving, before discard or reuse. 
Appendix Q-ll-C-l-b-(4). Special 
safety testing, decontamination 
procedures, and Institutional Biosafety 
Coniniiltce approval shall be required to 
transfer agents or tissue/organ 
specimens from a BL3-N animal facility 
to 0 facility with a lower containment 
classification. 
Appendix Q-Jl-C-l-b-(5). 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 
into the sanitary system. The procedure 
usr?d for heat decontamination of liquid 
wastes shall fx) monitored with a 
rewjrding thermometer. The 
effediveness of the heat 
dix.ontarnination prrx;ess system shall 
be revalidated every 30 days with an 
indicator organism. 
Appendix Q-lI-C-l-c. Signs (BL3-N) 
.Appendix Q-Il-C-l-c-(l). When the 
animal research requires special 
provisions for entry (e.g., vaccination), a 
warning sign incorporating the 
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-Il-C-l-d. Protective 
Clothing (BL3-N) 
Appendix Q-Il-C-l-d-(l). Full 
protective clothing that protects the 
individual (e.g., scrub suits, coveralls, 
uniforms) shall be worn in the animal 
area. Clothing shall not be worn outside 
the animal containment area and shall 
be decontaminated before laundering or 
disposal. Personnel shall be required to 
shower before exiting the BL3-N area 
and wearing of personal clothing. 
Appendix Q-II-C-l-d-(2). Special care 
shalFbe taken to avoid skin 
contamination w'ith microorganisms 
containing recombinant DNA. 
Impervious and/or protective gloves 
shall be worn when handling 
experimental animals and when skin 
contact w'ith an infectious agent is 
unavoidable. 
Appendix Q-lI-C-l-d-(3). Appropriate 
respiratory protection shall be worn in 
rooms containing experimental animals. 
Appendix Q-Il-C-l-e. Records (BL3-N) 
Appendix Q-lI-C-l-e-(l). Documents 
regarding experimental animal use and 
disposal shall be maintained in a 
permanent record book. 
Appendix Q-II-C-l-e-(2). Any 
incident involving spills and accidents 
that result in envircmmental release or 
exposure of animals or laboratory 
workers to organisms containing 
recombinant DNA shall be reported 
immediately to the Biological Safety 
Office, 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, Bethe.sda, Maryland 20892, (301) 
400-9838. Medical evaluation, 
surveillance, and treatment shall bo 
provided as appropriate and written 
records maintained. If necessary, the 
area shall bo appropriately 
decontaminated. 
Appendix Q-Il-C-l-e-(3). 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 or the function of the 
facility. 
Appendix Q-Il-C-l-f. Transfer of 
Materials (BL3-N) 
Appendix Q-II-C-l-f-(l). Biological 
materials removed from the animal 
containment laboratory in a viable or 
intact state shall be transferred to a non- 
breakable sealed primary container and 
then enclosed in a non-breakable 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 
be opened only in a facility having an 
equivalent or higher level of physical 
containment unless the agent is 
biologically inactivated or incapable of 
reproduction. 
Appendix Q-II-C-l-f-(2). Special 
safety testing, decontamination 
procedures, and Institutional Biosafety 
Committee approval shall be required to 
transfer agents or tissue/organ 
specimens from a BL3-N animal facility 
to a facility with a lower containment 
classification. 
Appendix Q-Il-C-l-g. Other (BL3-N) 
Appendix Q-lI-C-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 nontransgenic animals. 
Appendix Q-II-C-l-g-(2). Appropriate 
steps should be taken to prevent 
horizontal transmission or exposure of 
laboratory personnel. If the agent used 
as the 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 
partit:ular route of transmission, all 
potential means of horizontal 
transmission (e.g., arthropods, 
contaminated bedding, or animal waste) 
should be prevented. 
Appendix Q-Il-C-l-g-(3). Eating, 
drinking, smoking, and applying 
cosmetic.s shall not Ixi permitted in the 
work area. 
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Recombinant DNA Research, Volume 19 
