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Federal Register / Vol. 52. No. 154 / Tuesday. August 11. 1987 / Notices 
cross-fertile plant is flowering within the 
normal pollen dispersal range of the 
experimental plant." 
168. Ensuring that no cross-fertile 
plant is growing within the experimental 
plant's known pollen dispersal range." 
169. "Appendix P— III— B. 
Microorganisms. Effective 
dissemination of microorganisms 
beyond the confines of the greenhouse 
can be prevented by one or more of the 
following:" 
170. "Confining all operations to 
injections of microorganisms or other 
biological procedures, including genetic 
manipulation, that limit replication or 
reproduction of viruses and 
microorganisms, or sequences derived 
from microorganisms, to internal plant 
parts or adherent surfaces of plants." 
171. "Ensuring that no organism that 
can serve as a host or promote the 
transmission of the virus or 
microorganism is present within a 
distance that the airborne virus or 
microorganism may be expected to be 
disseminated." 
172. "Carrying out the experiment at a 
time of year when plants that can serve 
as a host are either not growing or are 
not susceptible to productive infection.” 
173. "Using viruses and other 
microorganism (or their genomes) with 
insect or animal vectors in the absence 
of the vectors." 
174. Using microorganisms that have 
an obligate association with the plant.” 
175. “Using microorganism that are 
genetically disabled to minimize 
survivial outside of the research facility, 
or whose natural mode of transmission 
requires injury of the target organism or 
in some other way assures that 
inadvertent release is unlikely to initiate 
a productive infection of organisms 
outside of the experimental facility." 
176. "Appendix P-UI-C. 
Microorganisms. Effective 
dissemination of insects and other small 
animals can be prevented in the 
following way:" 
177. "Insects: using non-flying, flight- 
impaired or sterile insects." 
178. "Other animals: using non-motile 
or sterile strains." 
179. "Conducting the experiment at a 
time of year that precludes the survival 
of escaping organisms." 
180 "Effluent treatment: collecting 
run-off water and allowing it to 
evaporate or treating it chemically to 
prevent escape of organisms with run- 
off water." 
181. "Using animals that have an 
obligate association with a plant that is 
not present within the organism’s 
dispersal range." 
182. "Appendix Q." 
183. "Appendix Q. Physical and 
Biological Containment for 
Recombinant DNA Research Involving 
Animals. " 
184. "This appendix of the NIH 
Guidelines specifies containment and 
confinement practices for research 
involving recombinant DNA molecules 
in animals or for microorganisms 
associated with animals. All provisions 
of the NIH Guidelines shall apply to 
animal research activities with the 
following modifications:" 
185. "Appendix Q shall replace 
Appendix G when the research animals 
are of a size or have growth 
requirements that preclude the use of 
containment for laboratory animals. 
Some animals may require other types 
of containment (4). The animals covered 
in Appendix Q are those species 
normally categorized as animals 
including but not limited to cattle, 
swine, sheep, goats, horses, and 
poultry." 
186. "The Institutional Biosafety 
Committee (IBC) shall include at least 
one scientist with expertise in animal 
containment principles when 
experiments utilizing Appendix Q 
require IBC prior approval." 
167. "The institution shall establish 
and maintain a health surveillance 
program for personnel engaged in 
animal research involving viable 
recombinant DNA-containing 
microorganisms which require BL3 or 
greater containment in the laboratory." 
188. "Appendix Q-l. General 
Consideration . " 
189. "Appendix Q-l-A. Containment 
Levels. The containment levels required 
for research involving recombinant DNA 
molecules in or associated with animals 
is based on classification of experiments 
in Section III of the NIH Guidelines. For 
the purpose of animal research, four 
levels of containment are established. 
These are referred to as BLl-N, BL2-N. 
BL3-N. and BL4-N and are described in 
the following sections of Appendix Q. 
The descriptions include: (1) standard 
practices. (2) special practices for 
physical and biological containment, 
and (3) special animal containment 
facilities.” 
190. "Appendix Q-I-B. Disposal of 
Animals . " 
191. "When an animal covered by 
Appendix Q containing recombinant 
DNA or a recombinant DNA-derived 
organism is euthanized or dies, the 
carcass must 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. A record must be maintained of 
the experimental use and disposal of 
each animal or group of animals for 
three years." 
192. "Appendix Q-II. Physical and 
Biological Containment Levels." 
193. "Appendix Q-II-A. Biosafety 
Level 1 for Animals — BLl-N." 
194. "Appendix Q-II-A-1. Standard 
Practices — BLl-N . " 
195. "Appendix Q-II-A-l-a. Access to 
the containment area shall be limited or 
restricted when experimental animals 
are being held." 
196. "Appendix Q-II-A-l-b. All 
genetically engineered neonates will 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 assayable DNA 
sequences which allow identification of 
transgenic animals from among non- 
transgenic animals." 
197. "Appendix (J-II-A-2. Special 
Practices — BLl-N. ” 
198. "Appendix Q-II-A-2-a. The 
containment areas will be locked." 
199. "Appendix Q-Il-A-2-b. The 
containment area will be patrolled or 
monitored at frequent intervals." 
200. "Appendix Q-II-A-2-c. A double 
barrier shall be provided to separate 
male(s) and female(s) animals, unless 
reproductive studies are part of the 
experiment or other measures are taken 
that avoid reproductive transmission." 
201. "Appendix Q-II-A-2-d. 
Reproductive incapacitation can be 
utilized if needed." 
202. "Appendix Q-II-A-2-e. The 
animal containment area shall be in 
accordance with Federal law and 
animal care requirements." 
203. "Appendix Q-II-A-3. Special 
Animal Facilities — BLl-N. Animals 
must be confined in securely fenced 
areas or otherwise confined but do not 
have to be in enclosed structures 
(animal rooms) to minimize the 
possibility of theft or unintentional 
release." 
204. "Appendix Q-II-B. Biosafety 
Level 2 for Animals — BL2-N. " 
205. "Appendix Q-II-B-1. Standard 
Practices — BL2-N. " 
206. "Appendix Q-II-B-l-a. All 
genetically engineered neonates will 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 which allow 
identification of transgenic animals from 
among non-transgenic animals. 
207. “Appendix Q-II-B-l-b. 
Appropriate steps should be taken to 
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