Federal Register / Vol. 53, No. 251 / Friday, December 30, 1988 / Notices 
53263 
recommended for experiments for which 
there is convincing biological evidence 
that precludes the possibility of survival, 
transfer, or dissemination of the 
recombinant DNA molecules into the 
environment, or for which there is no 
recognizable and predictable risk to the 
environment in the event of accidental 
release.” 
5. The following words in the second 
sentence are deleted: 
“sexual and vegetative reproduction 
and minimizes.” 
37. The second sentence is revised to 
read as follows: 
"Animals containing sequences from 
viral vectors, if the sequences do not 
lead to transmissible infection either 
directly or indirectly as a result of 
complementation or recombination in 
animals, may be propagated under 
conditions of physical containment 
comparable to BLl or BLl-N and 
appropriate to the organism under 
study." 
46. Revise by adding “or BL2-P + BC" 
after “BL3-P." 
48a. This paragraph is revised to read 
as follows: 
“III— B— 5 — d. BL3-P containment is 
recommended for experiments involving 
sequences encoding potent vertebrate 
toxins introduced into plants or 
associated organisms. Recombinant 
DNAs containing genes for the 
biosynthesis of toxic molecules lethal 
for vertebrates at an LDso of less than 
100 nanograms per kilogram body 
weight fall under Section I1I-A-1 and 
require RAC review and NIH and IBC 
approval before initiation.” 
50. The second sentence of this 
paragraph is amended to read as 
follows: 
"Determination of whether or not a 
pathogen has a potenial for serious 
detrimental impact on managed 
(agricultural, forest, grassland) or 
natural ecosystems should be made by 
the PI and IBC, in consultation with 
scientists knowledgeable of plant 
diseases, crops and ecosystems in the 
geographic area of the research." 
70. The third sentence of this 
paragraph is amended as follows: 
“For certain work with plants, 
Appendix P replaces Appendix G; it 
defines Biosaftey Level 1-Plants to 
Biosafety Level 4-Plants (BLl-P to BL4- 
P}." 
75. Substitute the word "arthropods” 
for "insects.” 
87. This sentence is amended to 
correct a typographical error, as follows: 
"Personnel are required to read 
instructions on BLl-P greenhouse' 
practices and procedures and to follow 
them.” 
88. The second sentence of this 
paragraph is deleted. 
89. This sentence is revised to read as 
follows: 
"A record is kept of experiments in 
progress in the facility." 
91a. Substitute the word "arthropod” 
for "insect.” 
91b. Substitute the word “arthropods” 
for both occurrences of the word 
"insects.” 
91c. This sentence is deleted. 
93a. Delete the word “permanent" in 
the first sentence. 
93c. Substitute the word "arthropods" 
for "insects.” 
98. The third sentence of this 
paragraph is revised to read as follows: 
“It should advise personnel of 
potential consequences if practices are 
not followed and outline contingency 
plans in the event containment loss 
results in release of organisms." 
100. The second sentence is amended 
to read: 
"Decontamination of run-off water is 
not necessarily required.” 
101. Substitute the word "arthropods" 
for both occurrences of the word 
"insects." Change "microorganisms" to 
“macroorganisms” to correct a 
typographical error. 
103a. This paragraph is deleted. 
105. Delete the word "permanent” in 
the first sentence. 
106a. A new sentence is added at the 
end of this paragraph to read as follows: 
“Soil beds are also acceptable unless 
propagules of experimental organisms 
are readily disseminated through soil." 
106b. The following words are deleted 
from this paragraph: 
"No. 30 mesh (or finer).” The word 
“insects" is replaced with "arthropods." 
108. This sentence is revised to read 
as follows: 
"An autoclave for treatment of 
contaminated greenhouse materials is 
available." 
114. This first sentence of this 
paragraph is revised to read as follows: 
"All experimental materials, except 
those that are to remain in a viable or 
intact state for experimental purposes, 
are sterilized in an autoclave or 
rendered biologically inactive before 
disposal.”. 
115. The word "insect" is replaced 
with “arthropod." 
116. The word “insect” is replaced 
with “Artropods.” 
122. The word “permanent” is deleted 
from the first sentence. 
125. The word "permanent” is deleted 
from the first sentence. 
147. The word "Insects" is replaced 
with "Arthropods." 
153. The word "insect" is replaced 
with "arthropod.” 
160. The following sentence is deleted 
from this paragraph: 
"A backup source of electricity is 
provided to run the air handling 
equipment if the main power source 
should fail." 
171. This sentence is revised to read 
as follows: 
"Ensuring that no organism that can 
serve as a host promote the 
transmission of the virus or 
microorganism is present within a 
farthest distance that the airborne virus 
or microorganism may be expected to be 
effectively disseminated." 
173. Replace the word "insect" with 
“arthropod.” 
176. Replace the word “insects" with 
“arthropods." 
177. Replace the word "insects” with 
“arthropods" in both occurrences. 
184. The first sentence of this 
paragraph is amended to read as 
follows: 
‘This appendix of the NIH Guidelines 
specifies containment and confinement 
practices for research involving whole 
animals, both those in which the 
animal’s genome has been altered by 
rcombinant DNA techniques and 
experiments involving recombinant- 
DNA-modified nicroorganisms tested on 
whole animals." 
241. This paragraph is amended to 
read as follows: 
"Append, x Q-II-C-l-f. Animals 
holding areas shall be cleaned at least 
once a day and decontaminated 
immediately following any spill of 
viable materials." 
283. This paragraph is amended to 
read as follows: 
“Appendix Q-II-D-l-f. Animal 
holding areas shall be cleaned at least 
once a day and decontaminated 
immediately following any spill of 
viable materials.” 
285. Change “18" to "16" in this 
paragraph. 
301. The fourth sentence of this 
paragraph is amended to read as 
follows: 
"The air pressure within the suit area 
is to be less than that of any adjacent 
area." 
308. This paragraph is amended to 
read as follows: 
"Appendix Q-II-D-2-u. Respirators 
shall be worn in rooms containing 
experimental animals.” 
328. The third sentence of this 
paragraph is amended to read as 
follows: 
"It is universally accepted if bacterial 
spores are used to challenge and verify 
that the equipment is capable of killing 
spores then assurance is provided that 
all other known agents will also be 
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Recombinant DNA Research, Volume 13 
