29802 
Federal Register / Vol. 52, No. 154 / Tuesday, August 11. 1987 / Notices 
ri.combinant-DNA containing pathogens 
which involves whole animals. 
14. Section III— B— 1— a currently reads: 
15. "Experiments involving the 
introduction of recombinant DNA into 
Class 2 agents can be carried out at DL2 
containment" 
18. It is proposed that the following 
text be added to the end of Section III— 
B-1-a: 
17. “Experiments with such agents 
shall be carried out with whole animals 
at BL2 or BL2-N containment." 
18. Section III— B— I— b currently reads: 
19. "Experiments involving the 
introduction of recombinant DNA into 
Class 3 agents can be carried out at BL3 
containment." 
20. It is proposed that the following 
text be added at the end of Section III— 
B— 1— b: 
21. "Experiments with such agents can 
be carried out with whole animals at 
BL3 or BL3-N containment." 
22. Section III— B— I — c currently reads: 
23. "Experiments involving the 
introduction of recombinant DNA into 
Class 4 agents can be carried out at BL4 
containment." 
24. It is proposed that the following 
text be added at the end of Section III— 
B-l-c 
25. "Experiments with such agents 
shall be carried out with whole animals 
at BL4 or BL4-N containment." 
28. Section UI-B-l-d currently reads: 
27. "Containment conditions for 
experiments involving the introduction 
of recombinant DNA into Class 5 agents 
will be set on a case-by-case basis 
following ORDA review. A U.S. 
Department of Agriculture (USDAJ 
permit is required for work with Class 5 
agents [18. 20]." 
28. It is proposed that the following 
text be added at the end of Section III— 
B-l-d: 
29. "Experiments with such agents 
shall be carried out with whole animals 
at BL4 or BI/4-N containment." 
30. Proposed changes in Section Ill-B- 
4. Recombinant DNA Experiments 
Involving Whole Animals or Plants. 
These changes clarify the organisms to 
which this section applies and the 
containment recommended for research. 
31. It is proposed that the title of 
Section III— B— 4 be changed to read: 
32. "Recombinant DNA Experiment 
Involving Whole Animals" since Item 
=43 proposes a new Section III— B— 5 
entitled: " Recombinant DNA 
Experiments Involving Whole Plants.'' 
33. It is proposed that the following 
text be inserted into Section III-B — 4 
prior to Section III— B— 4— d: 
34. ‘This section covers experiments 
involving whole animals, both those in 
which thp animal's genome has been 
altered by recombinant DNA techniques 
and experiments involving viable 
recombinant-DNA-modified 
microorganisms tested on whole 
animals. For the latter, other than 
viruses which are only vertically 
transmitted, the experiments may not be 
carried out at BLl-N containment; a 
minimum containment of BL1 or BI.2-N 
is required." 
35. Section III-B— 4— a currently reads: 
"Recombinant DNA, or RNA molecules 
derived therefrom, from any source 
except for greater than two-thirds of a 
eukaryotic viral genome may be 
transferred to any non-human 
vertebrate organism and propagated 
under conditions of physical 
containment comparable to BL1 and 
appropriate to the organism under study 
|2j. It is important that the investigator 
demonstrate that the fraction of the viral 
genome being utilized does not lead to 
productive infection. A USDA permit is 
required for work with Class 5 agents 
1 18 . 20 ]." 
36. It is proposed that Section III— B — 4— 
a be revised to read as follows: 
37. "Recombinant DNA. or RNA 
molecules derived therefrom, from any 
source except for a eukaryotic viral 
genome may be transferred to any non- 
human vertebrate or any invertebrate 
organism and propagated under 
conditions of physical containment 
comparable to BL1 or BLJ-N and 
appropriate to the organism under study 
|2]. Animals containing sequences from 
viral vectors are exempt if the 
sequences do not lead to transmissible 
infection either directly or indirectly as 
a result of complementation or 
recombination in animals. For 
experiments involving recombinant 
DNA modified Class 2. 3. 4. or 5 
organisms (1) using whole animals, see 
Section II1-B-1." 
38. Section III— B — 4— b currently reads: 
39. "For all experiments involving 
whole animals and plants and not 
covered by Section III— B — 4— a . the 
appropriate containment will be 
determined by the 1BC (22)." 
40. It is proposed that Section III— B — 4— 
b be changed to read: 
41. "For experiments involving whole 
Gnimals and not covered by Section III— 
B-l or Section III— B — 4— a. the appropriate 
containment will be determined by the 
1BC (22.23)." 
42. It is proposed that a new Section 
1 II-B— 5 be added for experiments with 
whole plants. This proposed new section 
would read as follows: 
43. "Section III-B— 5, Recombinant 
DNA Experiments Involving Whole 
Plants. 
"Experiments to genetically engineer 
plants by recombinant DNA methods, to 
utilize such plants for other 
experimental purposes (e.g.. response to 
stress), to propagate such plants, or to 
use plants together with microorganisms 
or insects containing recombinant DNA. 
can be conducted under the following 
containment conditions. If experiments 
involving whole plants are not described 
in III-I3-5 and do not fall under Section 
III— A or Section III— D. they are included 
in Section 111-C." 
44. Note . — For recombinant DNA 
experiments falling under IIl-B-5-a. Ill— 
B-5-b. III-B- 5-c. and III-B— 5— d. physical 
containment requirements can be 
reduced to the next lower level by 
appropriate biological containment 
practices, such as conducting 
experiments on a virus with an obligate 
insect vector in the absence of the 
vector or using a genetically attenuated 
strain. 
45. “Section III-B— 5— a. BL3-P or BL2-P 
i- BC containment is recommended for 
experiments involving most exotic (23) 
infectious agents with recognized 
potential for serious detrimental impact 
on managed or natural ecosystems when 
the exotic agent is modified by 
recombinant DNA techniques and is 
associated with whole plants. 
46. "III-B— 5— b. BL3-P containment is 
recommended for experiments involving 
plants containing cloned genomes of 
readily transmissible exotic (23) 
infectious agents with recognized 
potential for serious detrimental effects 
on managed or natural ecosystems in 
which there exists the possibility of 
reconstituting the complete and 
functional genome of the infectious 
agent by genomic complementation in 
planto." 
47. "III-B— 5— c- BL4-P containment is 
recommended for experiments with a 
small number of readily transmissible 
exotic (23) infectious agents, such as the 
soybean rust fungus (Phakopsora 
pachyrhizi) and maize streak or other 
viruses in the presence of their specific 
arthropod vectors, that have the 
potential of being serious pathogens of 
major U.S. crops." 
48a. "HI-B-5-d. BL3-P containment is 
recommended for experiments involving 
sequences encoding potent vertebrate 
toxins introduced into plants or 
associated organisms." 
48b. BI-3-P or BL2-P + BC is 
recommended for experiments with 
microbial pathogens of insects or small 
animals associated with plants if the 
recombinant DN'A-modified organism 
has a recognized potential for serious 
detrimental impact on managed or 
natural ecosystems. 
49. It is proposed that the following 
new footnote, number 23, be added to 
Recombinant DNA Research, Volume 13 
[23] 
