Federal Register / Vol. 48, No. 159 / Tuesday August 16, 1983 / Notices 
37199 
should be reviewed from their adequacy and 
clarity in dealing with human 
experimentation. 
We recognize that the issues which will be 
dealt with by RAC represent only some of the 
social and ethical issues associated with the 
applications of genetic and biomedical 
technologies. In addition, we believe that the 
general oversight function needed for these 
broader issues is not easily combined with 
the RAC's role in setting Guidelines and 
reviewing specific experiments. The expertise 
and experience of the RAC will be available 
to bodies which may exercise oversight of the 
broader issues. We expect continuing 
national discussion to lend new insight in 
dealing with the specific cases to be 
considered by RAC. 
II. Proposed Amendment of Procedures 
for Scale-Up of Exempt Organisms 
Dr. Irving S. Johnson of Lilly Research 
Laboratories, a division of Eli Lilly and 
Company, has proposed that procedures 
be modified for experiments involving 
more that 10 liters of culture of exempt 
organisms. Specifically, Dr. Johnson 
proposes the following two changes in 
the Guidelines: 
1. Delete statements in all sections of 
Appendix C that refer to large-scale 
experiments, viz: “Large-scale 
experiments [e.g., more that 10 liters of 
culture] require prior IBC review and 
approval. |See Section III-B-5.]” 
2. Modify Section III-B-5 to read as 
follows: 
III-B-5. Experiments With Non-Exempt 
Organisms Involving More Than 10 Liters of 
Culture. The appropriate containment will be 
decided by the IBC. Where appropriate, the 
large-scale containment recommendations of 
the NIH should be used (See Appendix K). 
III. Proposal To Include Streptococcus 
Mutans in Sublist F of Appendix A 
Dr. Francis Macrina of the Medical 
College of Virginia of the Virginia 
Commonwealth University requests that 
Streptococcus mutans be included in 
Sublist F and deleted from Sublist E of 
Appendix A of the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. Dr. Macrina argues that S. 
mutans should be included in Sublist F 
for the following reasons: 
(1) A broad host range streptococcal 
plasmid, pAM/3l (conferring 
erythromycin resistance), is 
conjugatively transmissible to S. 
mutans. Strains of S. mutans inheriting 
this plasmid are able to transmit it via 
conjugal transfer. 
(2) The report of non-plasmid 
associated conjugal transfer of 
tetracycline resistance from S. mutans to 
other strains of S. mutans and to S. 
faeca/is support the claim of natural 
genetic transfer from S. mutans to other 
streptococci. 
(3) A tetracycline resistance 
determinant from a naturally-resistant S. 
mutans clinical isolate shares sequence 
homology with the Tn916 (Tc r ) 
conjugative transposon originating in S. 
faecal is. 
(4) Naturally transformable strains of 
S. mutans are readily transformed with 
plasmid or chromosomal DNA from 
other mutans as well as sanguis strains. 
IV. Proposed Modification of Appendix 
L. 
Dr. Sue Tolin, in consultation with 
other members of the RAC Plant 
Working Group, has proposed 
amendments to Appendix L-ll-C. 
Appendix L-II-C currently reads: 
Appendix L-II-C. The vector consists of 
DNA: (i) from exempt host-vector systems 
(Appendix C): (ii) from plants of the same or 
closely related species: (iii) from 
nonpathogenic prokaryotes or nonpathogenic 
lower eukaryotic plants; (iv) from plant 
pathogens only if sequences causing disease 
have been deleted; of (v) chimeric vectors 
constructed from sequences defined in (i) to 
(iv) above. The DNA may be introduced by 
any suitable method. 
Dr. Tolin proposes that Appendix L- 
1 1— C be modified to read as follows: 
Appendix L-II-C. The vector consists of 
DNA: (i) From exempt hostvector systems 
(Appendix C); (ii) from plants of the same or 
closely related species: (iii) from 
nonpathogenic prokaryotes or nonpathogenic 
lower eukaryotic plants; (iv) from plant 
pathogens only if sequences resulting in 
production of disease symptoms have been 
deleted; or (v) chimeric vectors constructed 
from sequences defined in (i) to (iv) above. 
The DNA may be introduced by any suitable 
method. If sequences resulting in production 
of disease symptoms are retained for 
purposes of introducing the DNA into the 
plant, greenhouse-grown plants must be 
shown to be free of such sequences before 
such plants, derivatives, or seed from them 
can be used in field tests. 
Dr. Tolin notes that, under the present 
language, review by the Plant Working 
Group might have to be done in the 
strictest sense of the word “disease." If 
so, this may preclude the approval of 
some plasmid and virus-derived nucleic 
acid as vectors, since their replication 
might be construed as disease in ihe 
strict sense even though no symptoms 
develop in the plants. Dr. Tolin states 
that it is her belief that if all other 
stipulations of Appendix L a.v satisfied, 
this minor change will result in no 
greater probability of risk of introducing 
plants containing recombinant DNA into 
the environment. 
V. Request for Permission To Field Test 
Recombinant DNA Containing 
Rhizobium Meliloti 
BioTechnica International Inc., of 
Cambridge, Massachusetts, requests 
permission to field test recombinant 
strains of Rhizobium meliloti. This 
proposal will be reviewed in a portion of 
the RAC meeting closed to the public. 
VI. Request To Field Test Genetically 
Engineered Plants 
Cetus Madison Corporation requests 
permission to field test genetically 
engineered plants that have expressed 
disease resistance under greenhouse 
and growth chamber environments. This 
proposal will be reviewed in a portion of 
the RAC meeting closed to the public. 
Note. — 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 NIH lists in 
its announcements the number and title of 
affected individual programs for the guidance 
of the public. Because the guidance in this 
notice covers not only virtually every NIH 
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, NIH 
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, NIH invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: July 29, 1983. 
Richard M. Krause, 
Director. National Institute of Allergy and 
Infectious, Diseases National Institutes of 
Health. 
[FR Doc. S3- 22332 Filed B-1S-83; 6:45 «m| 
BILLING CODE 4140-01-M 
riR3] 
