Containment Practices 
(Macroorganisms) 
Appendix P-III-C-1 . Effective 
j dissemination of arthropods and other 
small animals can be prevented by using 
I onq or more of the following 
I procedures: fi) Use non-flying, flight- 
I imf>aired, or sterile arthropods; (ii) use 
' non-motile or sterile strains of small 
I animals; (iii) conduct experiments at a 
I time of year that precludes the -survival 
of escaping organisms; i(ivi) useanimals 
that have an obligate association with a 
plant ihatis not present within the 
dispersal range of the organism; or (v) 
prevent the escape of -organisms present 
in run-olf water hy ■ chemical .treatment 
I or evaporation oT run tolf water. 
I Appendix ^.Physical and iBialogicaJ 
I Containment forfecnrnhinani'DNA 
Research .involving .Anundls 
Appendix'Q specifies containment 
and confinement practices for researdi 
involving whole animals, both those in 
which the animal ’s genome hasheen 
, altered by stable introduction of 
recombinantXlNA. or J3NA derived 
jl therefrom, into the germ-line (transgenic 
; animals) and experiments involving 
viable recombinant DNA-modified 
microorganisms tested . on whole 
animals. The appendixapphes to 
animal research activities with the 
following modifications: 
Appendix'Q shall supersede 
Appendix"G when research animals are 
of a size or have growth requirements 
I that preclude the “use 6f containment for 
laboratory animals. Some animals may 
' require other type5 of containment (see 
[ Appendix Q-ifiI-53). The animals 
! covered in App>endixJQ -are those 
species normally categorized as animals 
including but ndt limited to cattle , 
swine, sheep, goats, horses, and poultry. 
The Instituticmal -Biosafety 'Ccnumittee 
shall include at least one .scientist with 
expertise in animal containment 
principles when experiments utilizing 
Appe^ix Qxequire .Institutional 
Biosafe^ Committee prior approval. 
The institution shall establish and 
maintain a -health siirveniflncftp rngram 
for personnel engaged in animal 
research involving viable recombinant 
DNA-contmiiingiriicroo^anisms that 
require Biosafety 'Level (BL) 3 or greater 
containment in the lahorata^. 
A ppen dix Q-J. -General Consi derations 
Appendix tJ-l-A. Containment Levels 
The containment levels required for 
research Involving recombinant "DNA 
associated -with or In animals is ba$ed 
on classification of experiments in 
Section III. For the purpose of animal 
research , -four le vels of containment are 
established. These are referred to as 
BLl-Ariimals (N), BL2-N, BLS-'N, and 
BL4-^ and are described in the 
following sections of Appendix Q. The 
descriptions include: (i) standard 
practicesfor physical and biological 
containment, and (ii) animal facilities. 
Appendix Q-I-B. Disposal of Animals 
(BLl-N through BL4-N) 
Appendix Q-^I-B-1. When an animal 
covered by Appendix Q containing 
recombinantDNA or a recombinant 
DNA-derived organism is euthanized or 
dies, the carcass shall be disposed of to 
avoid its use as food for human beings 
or animals unless food use is 
specifically authorized by an 
appropriate Federal agency. 
Appendix Q-J-B-2. A permanent 
record shall be maintained -of the 
experimental use and disposal of each 
animal orgroirp of animals. 
Appendix Q-II. Physical and Biological 
Containment Levels 
Appendix Q-II-A. Biosafety Level 1 — 
Animals (BLl-N) 
Appendix Q-H-A-l. Standard Practices 
(BLl-N) 
Appendix Q-II-A- 1-a. Animal Facility 
Access IBLl-N) 
Appendix Q-lI-A-l-a-(l). The 
containment area shallbe locked. 
Appendix Q-lI-A-l-a-(2). Access to 
the containment area shall be fimited or 
restricted when experimental animals 
are being held. 
Appendix Q-II-A-l-a-^3). The 
containment area shall be patrolled or 
monitored at ‘frequent i ntervals . 
Appendix Q-II— A— 1-b. Other (BLl-N) 
Appendix Q-II-A-l-h-Kl). All 
genetically engineered neonates shall be 
permanently marked within 72 hours 
after birth, Tf their size permits. If their 
size doesnot-permit marking, their 
containers should he mariced. In 
addition, transgenic animals should 
contain distinct and biochenncailly 
assayableDNA sequences that allow 
identification 'of transgenic animals 
from among non-transgehic animals. 
Appendix Q-II-A-l-b-(2). A double 
barrier shall be provided to separate 
male and female animals unless 
reproductive studies ere part of the 
experiment or either measures are lalcen 
to avoid reproductive transmission. 
Reproductive incapacitation may be 
used. 
Appendix Q-TI-A-l^>-i(3).The 
containment-area shall be innccordance 
with ^tate and Federal laws and animal 
care Teqtdrements. 
Appendix Q-^II-A-2. Animal Facilities 
(BLl-N) 
Appendix Q-TI-A-2— (a). Animals 
shall be confined to securely fenced 
areas or be lintenclosed structures 
(animal rooms) to minimize the 
possibility of theft or unintentional 
release. 
Appendix -Q-II-B. Biosafety Level 2— 
Animals (RL2-N) (see Appendix Q-HI- 
A) 
Appendix Q-3I-B-1. Standard Practices 
(BL2-N) 
Appendix Q-^H-B-l-a. Animal Facility 
Access (BL2-N) 
Appendix Q-iII-B—l—a-(l). The 
containment area shall be locked. 
Appendix Q-II-B- l-a-(2). The 
containment area shall be patrolled or 
monitored at frequent intervals. 
Appendix'Q^n-B-T^-(3).The 
containment building shall be 
controlled and have -a locking access. 
Appendix Q-lMB-l-a-(4). The 
Animal Facility’Directorshallestablish 
policies andprocedures 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. 
Appendix Q-II-B-1— a-(5). Animals of 
the same or different species, which are 
not inyolvnd in the woric being 
performed, shall not be permitted in the 
animal area. 
Appendix Q-JI-B-l-rb. 
Decontamination:and Inactivation (BL2- 
N) 
Appendix Q-TI— B-l-b-(l ) . 
Contaminated materials that are 
decontaminated at a she away from the 
laboratory shall be placed in a closed 
durable ledk-proof container prior to 
removal from the laboratory. 
Appendix Q-TI-B-l-b-K2). Needles 
and syringes shall be promptly placed 
in a puncture-resistant container and 
decontaminated, preferably by 
autoclaving, before discard or reuse. 
Appendix Q-rll-B-l-c. Signs (BL2-tN) 
Appendix Q-B-B— l-c-{l). When the 
animal research requires special 
provisions ?or«ntry {e.g., vaccination), a 
warning sign incxi^orating the 
uriiversahbic)safety symbol shall be 
posted'onsfll-aecessxloorsto the animal 
work area. The sign shaill1ndicate: '(i) 
the agent, >{ii) the animal ‘Species, {iii) 
the name and telephone number ctf the 
Animal Facility Director orother 
responsiblelndividual.and {iv) any 
special requirements for entering the 
laboratory. 
II 34540 
FederoQ Register / Vdl. 59, No. 127 / Tuesday, 'July 5, 1994 / Notices 
Appendix P—rn-C. Biological 
Recombinant DNA Research, Volume 19 
[741] 
