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Federal Register / Vol. 53, No. 207 / Wednesday, October 26, 1988 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
AGENCY; National Institutes of Health, 
PHS, DHHS. 
ACTION: Notice of Actions under NIH 
guidelines for research involving 
recombinant DNA molecules. 
summary: This notice sets forth four 
actions to be taken by the Director, 
National Institutes of Health (NIH), 
under the May 7, 1986, NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (51 FR 16958, May 7, 
1986). 
EFFECTIVE DATE: October 26, 1988. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Ms. Rachel Levinson, Office of 
Recombinant DNA Activities, National 
Institutes of Health, 12441 Parklawn 
Drive, Suite 58, Rockville, Maryland, 
(301) 770-0131. 
SUPPLEMENTARY INFORMATION: Today 
four actions are being promulgated 
under the NTH Guidelines for Research 
Involving Recombinant DNA Molecules. 
These four proposed actions were 
published for comment in the Federal 
Register of April 18, 1988 (53 FR 12752). 
and reviewed and recommended for 
approval by the NIH Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on June 3, 1988. A transcript and 
minutes of that meeting are available 
from the Office of Recombinant DNA 
Activities at the address given above. 
In accordance with section IV-C-l-b 
of the NTH Guidelines, these actions 
have been found to comply with the NIH 
Guidelines and to present no significant 
risk to health or to the environment. 
Part I of this announcement provides 
background information on the actions. 
Part II provides a summary of the 
actions of the Director. NTH. 
I. Decisions on Actions Under NTH 
Guidelines 
A. Proposed .Amendment Regcrding 
Certain Lorge-Scois Fermentation 
Experiments 
In a letter dated March 24. 1988. Dr. 
Joseph R. Fordham of Novo 
Laboratories. Inc., Danbury. 
Connecticut, requested that Section III— 
B-5. Experiments Involving More Than 
10 Liters of Culture, be amended by 
adding the following paragraph: 
"For large-scale (LS) fermentation 
experiments, involving ncn-pathogenic 
and non-toxicogenir. recombinant 
strains of host organisms having an 
extended history of safe industrial use 
the appropriate physical containment 
conditions need be no greater than those 
for the host organisms unmodified by 
recombinant DNA techniques; the IBC 
can specify higher containment if it 
deems it necessary.” 
Justification for the proposed change 
was included in the submission. 
This proposal was published for 
comment in the Federal Register of April 
18. 1988 (53 FR 12752). 
Three letters were received with 
comments on this proposal. All of the 
letters provided unqualified support for 
the proposal. 
The RAC considered this proposal at 
the June 3, 1988, meeting. The RAC 
supported the proposal but felt that it 
should be incorporated into Appendix K, 
"Physical Containment for Large-Scale 
Uses of Organisms Containing 
Recombinant DNA Molecules,” rather 
than in Section III— B— 5. Accordingly, the 
RAC recommended that Appendix K-I 
be 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. These are 
referred to as BL1-LS, BL2-LS, and BL3-LS. 
The BLl-LS level of physical containment 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-scaie research or production of viable 
organisms containing recombinant DNA 
molecules which require BL£ 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 NIH on an individual basis. 
The RAC then voted 17 in favor, none 
opposed, ar.d one abstention to 
recommend approval of the proposal as 
amended. 
I accept this recommendation and 
Appendix K-I has been modified 
accordingly. 
B. Large-Scale Production Involving 
Cephaiospotium Acremonlum Strain 
LU 4-79-6 
In a letter dated December 4, 1987, Dr. 
Mark A. Fogelsong of Eli Lilly and 
Company, Indianapolis, Indiana, 
requested approval to conduct large- 
scale experiments and production 
involving Cephalosporium acremonium 
strain LU4-79-6 under less than 
Biosafety Level 1-Large Scale (BLl-LS) 
conditions. Information on C. 
acremonium and construction of strain 
LU4-79-6 was provided in the 
submission. 
This proposal was published for 
comment in the Federal Register of April 
18, 1988 (53 FR 12752). 
Four letters were received with 
comments of support for the proposal. 
The RAC considered this proposal at 
the June 3, 1988, meeting. By a vote of 
twelve in favor, none opposed, and three 
abstentions, the RAC recommended 
approval of the proposal. 
I accept this recommendation and 
Appendix D has been modified 
accordingly. 
C. Proposed Amendment of Appendix A 
To Include Pseudomonas Mendocino 
In a letter dated March 23, 1988, Dr. 
Burt D. Ensley of AMGen, Thousand 
Oaks, California, requested that 
Pseudomonas mendocina be included in 
Sublist A of Appendix A of the NIH 
Guidelines. Data in support of the 
request were included in the submission. 
This proposal was published for 
comment in the Federal Register of April 
18, 1988 (53 FR 12752), for public 
comment. No comments on the proposal 
were received. 
The RAC considered this proposal at 
the June 3, 1988, meeting. By a vote of 
fourteen in favor, none opposed, and no 
abstentions, RAC recommended 
approval of the proposal. 
I accept this recommendation and 
Appendix A has been modified 
accordingly. 
D. Proposed Amendment of Appendix 
C--IV To include Bocilius Licheniformis 
In a letter dated March 30, 1988, Dr. 
Joseph R. Fordham of Novo 
Laboratories, Inc., Danbury, 
Connecticut, requested that Bacillus 
licheniformis be added to the title and 
to the first sentence of Appendix C-IV 
of the NTH Guidelines. This section 
would be amended tc read as follows: 
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Recombinant DNA Research, Volume 13 
