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Federal Rej^ster / Vol. 59, 127 / Tuesday, July 5, 1994 / Notices 
potential hazard and who meet any 
specific entry requirements (e.g., 
vaccination) ahall enter the laboratory or 
animal roorns. 
Appendix Q-II-C-l-a-{5). Animal 
room doors, gates, or other closures 
shall be kept closed when experiments 
are :in (progress. 
Appendix Q-II-C—l-b. 
Decontamination and Inactivation (BL3- 
N) 
Appendix Q-n-C-l-b-(l). The work 
surfaces of containment equipment shall 
be decontaminated when work .with 
organisms containing recombinant DNA 
moleculesiis finished. Where feasible, 
plastic-backed paper toweling shall be 
used on nonporous work surfaces to 
facilitate clean-up.- 
Appendix'Q-n-G-l-b-(2). All 
animals sh^ll be euthanized at the end 
of their expeiiment^ usefulness and the 
carcasses decontaminated before 
disposal in an approved manner. 
Appendix Q-n-C-l-4>-{3). Needles 
and syringed shall be promptly placed 
in a puncture-resistant container and 
decontaminated, preferably by 
autoclaving, before discard or reuse. 
Appendix Q-n-C-l-b-j4). Special 
safety testing, decontamination 
procedures, and Institutional Biosafety 
CommiUee 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-H-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 prooedure 
used for heat decontamination of liquid 
wastes shall.be monitored with a 
recording thermometer. The 
effectiveness of the heat 
decontamination process system shall 
be revalidated revery 30 days with an 
indicator organism. 
App>endixQ-4I-C-l— c. Signs (BL3-T4) 
Appendix C^II-C-l-c-(l). When the 
animal researtb requires special 
provisions for entry (eg., vaccination), a 
warning sign Incorporating the 
universal biosafe^ syrribol 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 numiber of the 
Animal Facility Director or other 
responsible in^vidual, and '(iv) ariy 
special requirements for entering the 
laboratory. 
AppendixQ-4I^C-l-d. Protective 
Clothing (BL3-N) 
Appendix Q-II-C-l-d-(l). Full 
protective -clothing that protects the 
individual ((eg., 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-4I-G--l-d-(2). Special 
care shalLbe taken to avoid skin 
contamination with microorganisms 
containmg/recomhinant.DNA. 
Impervious and/ or protective gloves 
shall be worn when handling 
experimental animals and when skin 
contact with an infectious agent is 
unavbidable. 
Appendix Q-4I-C-l—d-(3). 
Appropriate respiratory .protection shall 
be worn in rooms containing 
experimental animals. 
Appendix Q-II-C-l-e. Records (BL3-N) 
Appendix .Q-U-C-l-e-rfl). 
Documents r^arding 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 environmental release or 
exposme 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 apphcable). Reports to the 
NIH/ORDA shall be sent to the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31, Room 
4B11, Bethesda,.M^land 20692, (301) 
496-!9838. Medical evaluation, 
surveillance, andfreatment shall be 
provided as appropriate and written 
records maintained. If necessary, the 
area shall be appropriately 
decontaminate. 
Appendix Q-rII-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 ihe fiinction of the 
facility. 
Appendix. Q-3I-C-l-f. Transfer of 
Materials (BL3-44) 
Appendix Q-Br4>-l-f-(l). Biological 
materials removed from the animd 
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 hi^er 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-4I~C-l-g. Other (BL3-N) 
Appendix Q-4I-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 non-transgenic animals. 
Appendix Q-H-C-l-g-(2). 
Appropriate steps should be taken to 
prevent horizontal transmission or 
exposure of laboratory persoimel. 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 ab^iKre of specific knowledge of 
a particular route of transmission, all 
potential means of horizontal 
transmission (e.g., arthropods, 
contaminated biding, or animal waste) 
should be prevented. 
Appendix Q-H-C-l-g-(3). Eating, 
drinking, smoking.nnd applying 
cosmetics shall not be permitted in the 
work area. 
Appendix Q-TI-C-l^-(4). 
Individuals who handle materials and 
animals containing recombinant DNA 
molecules shall be required to wash 
their handsbefore exiting the 
contmnment area. 
Appendix Q-3I-C-l-g-f5). 
Experiments involving other organisms 
that require containment levels lower 
thanBL3-N may.be conductedin the 
same area concurrently .with 
experiments requiring BL3-N 
containment provided that they are 
conducted in accordance with BL3-’N 
practices. 
Recombinant DNA Research, Volume 19 
[743] 
