Federal Register / Vol. 53, No. 207 / Wednesday, October 26, 1988 / Notices 
43411 
Appendix C-IV — Experiments Involving 
Bacillus Subtilis or Bacillus Licheniformis 
Host-Vector Systems 
Any asporogenic Bccillus subtilis or 
Bacillus licheniformis strain * * * 
Data in support of the request were 
included in the submission. 
This proposal was published in the 
April 18, 1983. Federal Register (53 FR 
12752) for public comment. One letter of 
support for this proposal was received. 
The RAC considered this proposal at 
the June 3. 1938. meeting. Tne RAC 
recommended that "asporogenic" be 
added before "Bacillus licheniformis" 
for emphasis. By a vote of fourteen in 
favor, none opposed, and no 
abstentions. RAC recommended 
approval of the proposal. 
1 accept this recommendation and 
Appendix C-IV has been modified 
accordingly. 
II. Summary of Actions 
A. Revision of Appendix K-l 
Appendix K-I is modified to read as 
follows: 
Appendix K-I — Selection of Physical 
Containment Levels 
The selection of the physical containment 
level required for recombinant DNA research 
or production involving more than 10 liters of 
culture is based on the containment 
guidelines established in Part III of the 
Guidelines. For purposes of large-scale 
research or production, three physical 
containment levels are established. The*- 
referred to as BLl-LS. BL2-LS. and BL3- 
The BLl-LS level of physical coctair.mer.. is 
recommended for large-scale research or 
production of viable organisms containing 
recombinant DNA molecules which require 
BLl containment at the laboratory scale. For 
large-scale fermentation experiments 
involving non pathogenic and non-toxigenic 
recombinant strains of host organisms having 
an extended history of safe industrial use. the 
IBC may set large-scale containment 
conditions at those appropriate for the host 
organism unmodified by recombinant DNA 
techniques and consistent with good 
industrial large-scale practices. The BL2-LS 
level of physical containment is required for 
large-scale research or production of viable 
organisms containing recombinant DNA 
molecules which requires BL2 containment at 
the laboratory-scale. The BL3-LS level of 
physical containment is required for large- 
scale research or production of viable 
organisms containing recombinant DNA 
molecules which require BL3 containment at 
the laboratory scale No provisions are made 
for large-scale research or production of 
viable organisms containing recombinant 
DNA molecules which require BL4 
containment at the laboratory-scale. If 
necessary, these requirements will be 
established by NTH on an individual basis. 
B Revision of Appendix D 
The following section is added to 
Appendix D: 
Appendix D-XU 
"Eli Lilly and Company of Indianapolis. 
Indiana, may conduct large-scale 
experiments and production involving 
CephaJosporium acremonium strain LU4-79- 
6 under less thar. Biosafety Level 1-Large 
Scale (BLl-LS) conditions. 
C. Revision of Sublisl A of Appendix A 
Sublist A of Appendix A is modified 
by the addition of Pseudomonas 
mer.docina to the list of organisms. 
D. Revision of Appendix C-PV 
Appendix C-iV is modified to read as 
follows: 
•ndix C-IV — Experiments Involving 
■js subtilis or Bacillus licheniformis 
• ector Systems 
Any asporogenic Bacillus subtilis strain 
which does not revert to a sporeformer with a 
frequency greater than 10" ’ car. be used for 
cloning DNA with the exception of those 
experiments listed below. 
For these exempt laboratory experiments. 
BLl physical containment conditions are 
recommended. 
For large-scale fermentation experiments 
BLl-LS physical containment conditions are 
recommended. However, following review by 
the IBC of appropriate data for a particular 
host-vector system, some latitude in the 
application of BLl-LS requirements as 
outlined in Appendix K-1I-A through K— II— F 
is permitted. 
Exceptions. Experiments described in 
Section III— A which require specific RAC 
review and approval before initiation of the 
experiment. 
Experiments invok ing Class 3. 1. or 5 
organisms (1) or cells known to be infected 
with these agents may be conducted under 
containment conditions specified by Section 
III— B— 2 with prior IBC review and approval. 
Large-scale experiments (e g.. more than 10 
liters of culture) require prior IBC review and 
approval (see Section III— B— 51. 
Experiments involving the deliberate 
cloning of genes coding for the biosynthesis 
of molecules toxic for vertebrates (see 
Appendix F). 
OMB's “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Catalog of Federal Domestic 
Assistance. Normally NTH lists in its 
announcements the number and title of 
affected individual programs fo; the 
guidance of the public. Because the 
guidance in this notice covers not only 
virtually every NTH program but also 
essentially every Federal research 
program in which DNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition. NTH could 
not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NIH Guidelines. In lieu of the individual 
program listing. NTH invites readers to 
direct questions to the information 
address above about whether individual 
programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
|cmes B. Wyngaarden, 
Director. National Institutes of Health. 
(FR Doc. 88-24705 Filed 10-25-88: 8:45 am) 
BILLING CODE 4 1 40-0 1 -M 
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