Federal Register / Vol. 52, No. 154 / Tuesday, August 11. 1987 / Notices 
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Section V, and that it be cited as 
indicated above in Section III— B— 5: 
50. “23. In accordance with accepted 
scientific and regulatory practices of the 
discipline of plant pathology, an exotic 
plant pathogen (e.g.. virus, bacterium, 
fungus) is one not known to occur within 
the United States [18). Recognition as to 
whether a pathogen has a potential 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. 
Examples of serious detrimental impacts 
are provided by plant pathogens that 
can significantly reduce the yield of a 
major crop plant and by pathogens of 
beneficial insects, such as pollinators. A 
listing of all possible cases is not 
appropriate for these Guidelines." 
51. To accommodate new Section III— 
B-5. renumber present Section III— B— 5 to 
III— B— G. It would read: 
52. “III-B-6, Experiments Involving 
More than 10 Liters of Culture. The 
appropriate containment will be decided 
by the EBC. Where appropriate. 
Appendix K, Physical Containment for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules, should be used.'* 
53. It is proposed to add at the end of 
this section: 
54. “Appendix K describes 
containment conditions BLl-LS through 
BL4-LS.” 
55. Section III— C. Experiments That 
Require IBC Notice Simultaneously with 
Initiation of Experiments, states that all 
experiments not included elsewhere in 
these NIH Guidelines can be conducted 
at BL1. 
50. It is proposed that the first two 
paragraphs of the current Section III— C 
be numbered as Section III-C-1. that the 
final paragraph of the current Section 
III— C be numbered III— C— 2. and that the 
following language be added as Section 
III— C— 3: 
57. "Section III— C— 3. Experiments 
Involving Whole Plants. Section III— C— 3 
covers experiments involving 
recombinant DNA-modified whole 
plants, and/or experiments involving 
recombinant DNA-modified organisms 
associated with whole plants, except 
those that fall under Section III— A. Ill— B. 
or III— D. It should be emphasized that 
knowledge of the organism(s) and 
judgment based on accepted scientific 
practices should be used in all cases in 
selecting the appropriate level of 
containment under the NIH Guidelines. 
For example, if the genetic 
modification has the objective of 
increasing pathogenicity or converting a 
non-pathogenic organism into a 
pathogen, then a higher level of 
containment may be appropriate, 
depending on the organism, its mode of 
dissemination , and its target organisms. 
By contrast, a lower level of 
containment may be appropriate for 
small animals associated with many 
types of recombinant DNA-modified 
plants." 
58. “Section III-C-3-a. BL1-P is 
recommended for all experiments with 
recombinant DNA-containing plants and 
plant associated microorganisms not 
covered below in Section III— 0—3— b or in 
other sections of the NIH Guidelines 
(see above). Such experiments include, 
for example, those involving 
recombinant DNA-modified plants that 
are not noxious weeds or cannot 
interbreed with noxious weeds. Also 
included are those involving whole 
plants and recombinant DNA-modified 
non-exotic (23) microorganisms that 
have no recognized potential for rapid 
and widespread dissemination and for 
serious detrimental impact on managed 
or natural ecosystems (e.g., Rhizobium 
spp.. Agrobacterium spp.) 
59. "Section III-C-3-b. BL2-P or BLl-P 
+ biological containment (BC) is 
recommended for the following 
experiments involving plants:" 
60. "Section III-C-3-b-(l). Plants 
modified by recombinant DNA that are 
noxious weeds or can interbreed with 
noxious weeds." 
61. "Section III-C-3-b-(2). Plants in 
which the introduced DNA represents 
the complete genome of a non-exotic 
infectious agent (23).” 
62. “Section III-C-3-b-(3). Plants 
associated with recombinant DNA- 
modified non-exotic microorganisms 
which have a recognized potential for 
serious detrimental impact on managed 
or natural ecosystems [23]." 
63. “Section III-C-3-b-(4). Plants 
associated with recombinant DNA- 
modified exotic microorganisms which 
have no recognized potential for serious 
detrimental impact on managed or 
natural ecosystems [23].” 
64. "Section III-C-3-b-{5). Experiments 
with recombinant DNA-modified insects 
or small animals associated with plants, 
or with insects or small animals with 
recombinant DNA-modified 
microorganisms associated with them if 
the recombinant DNA-modified 
organism has no recognized potential for 
serious detrimental impact on managed 
or natural ecosystems [23]." 
65. Under Section III-D-5 of Section 
III— D. Exempt Experiments, certain 
classes of recombinant DNA molecules 
are exempt from the NIH Guidelines and 
are listed in Appendix C. Appendix C-I 
specifies that most recombinant DNA 
molecules containing less than one half 
of a eukaryotic viral genome are exempt 
from the NIH Guidelines when 
propagated and maintained in cells in 
tissue culture. 
66. The following sentence is 
proposed as an addition to Appendix C- 
I for clarification of plant cell cultures 
which are induced to regenerate into 
whole plants. Without this sentence a 
strict interpretation of the NIH 
Guidelines would require IBC prior 
approval for the transition from a cell 
culture to a differentiated plant since it 
would be a whole plant and subject to 
Section III-B-5. 
67. It is proposed to add to Appendix 
C-I after the first paragraph the 
following: 
68. "Whole plants regenerated from 
plant cells and tissue cultures are 
covered by this exemption provided 
they remain axenic cultures even though 
they differentiate into embryonic tissue 
and regenerate into plantlets." 
69. Appendix C. Proposal to Modify 
Appendix G, Physical Containment. It is 
proposed that the following text be 
added at the very beginning of 
Appendix G: 
70. “Appendix G specifies physical 
containment for standard laboratory 
experiments and defines Biosafety Level 
1 to Biosafety Level 4 (BL1-BL4). For 
large scale (over 10 liters) research or 
production. Appendix K replaces 
Appendix G; it defines Biosafety Level 
1-Large Scale to Biosafety Level 4-Large 
Scale (BLl-LS to BL4-LS). For certain 
work with plants. Appendix P replaces 
Appendix G; it defines Biosafety Level 
1-Plants to Biosafety Level 3-Plants 
(BLl-P to BL3-P). For work animals. 
Appendix Q replaces Appendix G: it 
defines Biosafety Level 1-Animals to 
Biosafety Level 4-Animals (BL1-N to 
BL4-N)." 
.71. Appendix P. It is proposed that the 
following text be added to the NIH. 
Guidelines as Appendix-P: 
72. "Appendix P, Physical and 
Biological Containment for 
Recombinant DNA Research Involving 
Plants This appendix specifies physical 
and biological containment conditions 
and practices suitable to the greenhouse 
conduct of experiments involving 
recombinant DNA-containing plants, as 
well as plant-associated microorganisms 
and small animals. All provisions of the 
NIH Guidelines shall apply to plant 
research activities with the following 
modifications:" 
73. “Appendix P shall replace 
Appendix G when the research plants 
are of a size, number, or have growth 
requirements that preclude the use of 
containment described in Appendix G. 
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Recombinant DNA Research, Volume 13 
