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Federal Register / Vol. 45, No. 164 / Thursday, August 21, 1980 / Notices 
containment for experiments not 
covered by the Guidelines.” 
P. Amendment of Section IV-D-5-c- 
(3). Section IV-D-5-c-(3) would be 
amended to read as follows: 
”IV-D-5-c-(3). Submit the initial 
research protocol (and also subsequent 
changes — e.g., changes in the source of 
DNA or host-vector system] to the IBC 
for review and approval or 
disapproval:" 
Q. Amendment of Section IV-D-5-d. 
The heading of Section IV-D-5-d would 
be amended to read: 
“IV-D-5-d. PI Responsibilites Prior to 
Initiating the Research. ” 
R. Amendment of Section IV-DS-e. 
The heading of Section IV-D-5-e would 
be amended to read: 
"IV-D-5-e. PI Responsibilities During 
the Conduct of the Research. " 
. S. Section IV-D-5-e-(6). A new 
Section, IV-D-5-e-(6), would be added 
to read as follows: 
”IV-D-5-e-(6). Initiating no 
recombinant DNA research for which 
containment is not specified by the 
Guidelines until approval is received 
from the IBC.” 
T. Deletion of Section FV-E-l-b(3)- 
(e). Section IV-E-l-b(3)-(e) would be 
deleted. This section currently reads as 
follows: 
“IV-E-l-b-(3)-(e). Lowering 
containment levels for characterized 
clones or purified DNA (See Sections 
III- A-3-a and -b, and Footnotes 3 and 
41);" 
U. Deletion of Sections IV-E-3-b, IV- 
E-3-c, and IV-E-3-c-(l) through IV -E- 
3-c-(3). Sections IV-E-3-b, IV-E-3-c, 
IV- E-3-c-(l), IV-E-3-c-(2), and IV-E-3- 
c-(3) would be deleted. These sections 
currently read as follows: 
"IV-E-3-b. Registration of 
recombinant DNA projects; and 
IV-E-3-c. Review of Memoranda of 
Understanding and Agreement (MUAs), 
and approval of those that conform to 
the Guidelines. In so doing, ORDA shall: 
IV-E-3-c-(l). Conduct an independent 
evaluation of the containment levels 
required for the research covered by 
these Guidelines; 
IV-E-3-c-(2). Determine whether the 
physical and biological containment 
levels approved by the IBC are in 
accordance with the requirement of the 
Guidelines; 
IV-E-3-c-(3). Notify Institutions and 
the IBC chairperson in a timely fashion 
when MUAs (including changes in 
ongoing projects) do not conform to the 
Guidelines, and inform them of 
corrective measures to be taken;" 
V. Deletion of Section IV-E-4-a. 
Section IV-E-4-a would be deleted. This 
Section currently reads as follows: 
‘TV-E-4-a. Awarding no grant or 
contract involving recombinant DNA 
techniques unless a properly executed 
MUA has been received;" 
W. Deletion of Sections IV-F-1 and 
IV-F-2. Sections IV-F-1 and IV-F-2 
would be deleted. These sections 
currently read as follows: 
"IV-F-1. Required Registration. 
Institutions receiving NIH funds for 
recombinant DNA projects shall inform 
NIH of all recombinant DNA projects at 
the Institution. A non-NIH project, after 
approval by the Institutional Biosafety 
Committee, shall be registered with NIH 
within 30 days of initiation. Applications 
for NIH projects must be accompanied 
by a Memorandum of Understanding 
and Agreement (MUA).” 
“For information on MUAs or 
equivalent documents that must be 
submitted for registration of 
recombinant DNA projects, see the 
Administrative Practices Supplement 
(APS).” 
‘TV-F-2. Federal Agency Registration. 
Institutions at which recombinant DNA 
research projects funded by other 
Federal agencies are conducted need 
not register such projects with NIH 
when'the Federal agency maintains a 
registry and provides such information 
to NIH. Registration of non-NIH-funded 
research with the NIH Office of 
Recombinant DNA Activities (ORDA) is 
described in the APS. (The information 
required is similar to that in an MUA for 
NIH-supported research.)” 
X. Amendment of Section IV-F-3. 
Section IV-F-3 could be amended to 
read as follows: 
“IV-F-3. Voluntary Registration and 
Certification. Any institution that it not 
require to comply with the Guidelines 
may nevertheless register its intent to 
comply by submitting the appropriate 
information to ORDA. NIH will accept 
requests for certification of host-vector 
systems proposed by the institution. The 
submitter must agree to abide by the 
physical and biological containment 
standards of the NIH Guidelines." 
9. Proposed amendment of appendix E 
of the guidelines. Dr. Fritz Reusser of the 
Upjohn Company, has requested that 
two sections of Appendix E be amended 
in order to include additional 
Streptomyces species. The proposed 
revised sections would read as follows: 
“Bacillus subtilis strains that do not 
carry an asporogenic mutation can be 
used as hosts specifically for the cloning 
of DNA derived from E. coli K-12 and 
Streptomyces coelicolor, S. 
aureofaciens, S. rimosus, S. griseus, S. 
cyaneus and S. venezuelae using NIH- 
approved Staphylococcus aureus 
plasmids as vectors under P2 
conditions.” 
“Streptomyces coelicolor, S. 
Aureofaciens, S. rimosus, S. griseus, S. 
cyaneus and S. Venezuelae can be used 
as hosts for the cloning of DNA derived 
from B. Subtilis, E. Coli, K-12, or from S. 
Aureus vectors that have been approved 
for use in B. subtilis, under P2 
conditions, using as vectors any 
plasmids indignous to these 
Streptomyces species or able to 
replicate in these hosts by natural 
biological mechanisms.” 
10. Request for exemption under 
Section l-E-4. Dr. Walter R. Guild of 
Duke University, has proposed that 
Streptococcus sanguis and 
Streptococcus pneumoniae be included 
under the exemption category of Section 
I-E-4, and added to Appendix A of the 
Guidelines on the basis that these 
bacteria exchange chromosomal genes 
in both directions by known 
physiological processes. 
11. Proposed amendments of Section 
IV-E-2. Dr. Irving Johnson of Eli Lilly 
and Company, submitted a number of 
proposals for changes in the Guidelines 
for consideration at the June 5-6, 1980 
RAC meeting. Some were deferred. He 
has now resubmitted two proposed 
revisions of the Guidelines. 
A. Following the first sentence of the 
second paragraph of IV-E-2, the 
following sentence would be inserted: 
“Appropriate representatives of 
industry shall also be chosen to provide 
expertise in fermentation technology, 
engineering, and other aspects of large- 
scale production." 
[When this proposal was discussed at 
the June 1980 meeting, objections were 
raised to inclusion of the words “of 
industry." A motion passed to include a 
modification of this sentence in the 
Guidelines as follows: 
"Members should be chosen to provide 
expertise in fermentation technology, 
engineering, and other aspects of large-scale 
production." 
This was followed, however, by 
passage of a motion to reconsider, and 
then passage of a motion to defer 
consideration until the September RAC 
meeting], 
B. A new Section IV-E-2-b would i>e 
added to read as follows: 
"A permanent subcommittee of the 
RAC shall be responsible for advising 
the Director, NIH, on the actions, listed 
in Section IV-E-l-b-[3]-[d] pertaining 
to large-scale applications. Submissions 
that are in compliance with the 
Guidelines may be recommended by the 
subcommittee to the Director of NIH for 
approval. The subcommittee shall also 
be authorized to consider preliminary 
plans for large-scale operations and to 
recommend approval contingent upon 
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