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Federal Register / Vol. 44. No. 148 / Tuesday. July 31. 1979 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Pub. L 92-463. notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health. 
Conference Room 10, Building 31 C. 
Bethesda. Maryland 20205, on 
September 6-7, 1979. from 9:00 a.m. to 
5:00 p.m. This meeting will be open to 
the public on September 6 from 9 a.m. to 
5 pm.. and September 7. from 9 ?.m. to 3 
p.m., to discuss: 
Proposed procedures for the 
Recombinant DNA Advisory 
Committee 
Proposed procedures for approval of 
large-scale experiments 
Prokaryote host-vectors other than £ 
coli K-12 
Large-scale experiments 
Amendment of Guidelines 
Proposed exemption under I-E-5 for £ 
coli K-12 host-vector systems 
Exemptions for organisms that exchange 
genetic information (I-E-4) 
£ coli host-vector Systems 
NIH'risk-assessment plan 
Reports of Plasmid and Phage 
Subcommittees 
Review of protocols for required 
containment levels 
Other matters requiring necessary 
action by the Committee. 
Attendance by the public will be 
limited to space available. 
In accordance with the provisions set 
forth in section 552b(c)(4). Title 5. U.S. 
Code and Section 10(d) of Pub. L 92-463, 
the meeting will be closed to the public 
on September 7 from 3 p.m. to 5 p.m. for 
the review, discussion and evaluation of 
a proposal from a commercial concern 
for scale-up of recombinant DNA 
experiments. This proposal and the 
discussions could reveal confidential 
trade secrets or commercial property 
such as patentable material 
Dr. William J. Gartland, Jr.. Executive 
Secretary, Recombinant DNA Advisory 
Committee. National Insitutes of Health. 
Building 31. Room 4A52, telephone 301- 
496-6051, will provide materials to be 
discussed at the meeting, rosters of 
committee members and substantive 
program information. A summary of the 
meeting will be available at a later date. 
Dated: July 25. 1979. 
Suzanne L Fremeau. 
Committee Management Officer. NJH. 
|F* Doc. Filed --30--V *45 *a) 
BILLING COO€ 4110-0*-* 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health. 
PHS. DHEW. 
action: Notice of proposed actions 
under NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth the 
proposals for actions to be taken under 
the 1978 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
[Federal Register of December 22. 1978 
(43 FR 60108)). Interested parties are 
invited to submit comments concerning 
these proposals. After consideration of 
these proposals and comments by the 
NIH Recombinant DNA Advisory 
Committee (RAC) at its September 6-7, 
1979. meeting, the Director of the 
National Institutes of Health will issue 
decisions on these proposals in accord 
with the Guidelines. 
date: Comments must be receiveu by 
August 30, 1979. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director. Office of Recombinant 
DNA Activities. Building 31. Room 4A5Z 
National Institutes of Health. Bethesda. 
Maryland 20205. All comments received 
in timely responses to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Drs. Michael Resnick or Stanley 
Barban. Office of Recombinant DNA 
Activities. National Institutes of Health. 
Bethesda, Mary land 20205. (301) 496- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following changes and 
amendments under the Guidelines for 
Research Involving Recombinant DNA 
Molecules (43 FR 60108). as well as 
actions under these Guidelines. 
1. Proposed Exemption for £ coli K- 
12 Host- Vector Systems. The RCA 
Working Group on £ coli K-12 host- 
vector systems will report to the full 
committee for discussion/action 
documentation for a proposed 
exemption under I-E-5 of the Guidelines 
for experiments involving EKl and EK2 
host-vector systems. This proposed 
action would exempt certain categories 
of recombinant DNA molecules in 
addition to those already stated in 
Sections 1-E-l to -4. The proposed 
exemption is as follows: 
Those recombinant DNA molecules 
that are propagated in £ coli K-12 hosts 
not containing conjugation-proficient 
plasmids or generalized transducing 
phages, when lambda or lambdoid 
bacteriophages or non-conjugative 
plasmids are used as vectors, can be 
handled at Pi and are exempted from 
the Guidelines. 
2. Use of Agrobacterium tumefaciens 
as a Host-Vector System. At its May 21- 
23. 1979 meeting, the RAC recommended 
approval at the P3 level of physical 
containment, of specific experiments 
involving introduction of well- 
characterized fragments of eukary otic 
DNA into Agrobacterium tumefaciens 
carrying a Ti plasmid, using an EK2 
plasmid vector coupled to a gragment of 
the Ti plasmid and/or the origin of 
replication of a cryptic A. tumefaciens. 
plasmid, and introduction of these 
bacteria into plant parts or cells in 
culture under P3 conditions. Approval is 
now requested by Dr. M. D. Chilton for 
modification of the experimental 
procedure as follows: 
Cloned desired fragments from any 
non-prohibited source may be 
transferred into Agrobacterium 
tumefaciens containing a Ti plasmid (or 
directives thereof), using a 
nonconjugative £ coZ; plasmid vector 
coupled to a fragment of the Ti plasmid 
and/or the origin of replication of an 
Agrobacterium plasmid, under 
containment conditions one step higher 
than would be required for the desired 
DNA in EKl or HVl systems. Transfer 
into plant parts or cells in culture would 
be permitted at the same containment 
level (one step higher). 
The modification inv’olves two 
changes: (1) it would extend the range of 
desired DNA fragments to be studied, 
including prokaryotic DNA, synthetic 
DNA. and eukaryotic DNA. that are not 
yet judged to be "well-characterized"; 
(2) it would make the containment level 
variable, depending upon the nature of 
the desired DNA to be studied. The 
requirement of P3 containment 
conditions for all experiments in this 
category seems inconsistent and 
arbitrary. 
3. Proposed Exemption for 
Pseudomonas putida and Pseudomonas 
fluorescens under Section /-£—#. Dr. N. 
Omston of Yale University has 
proposed, in accord with Section I-E-4 
of the Guidelines, that Pseudomonas 
putida and Pseudomonas fluorescens be 
added to the exempt list in Appendix A 
of gram-negative organisms that 
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