2 
In many recombinant DNA experiments, DNA segments are carried by vectors 
into E. . col i . This organism lacks a mechanism for removal of intervening 
sequences and therefore cannot make the correct gene product if such sequences 
are present in the genes. 
On the other hand it appears that a protein cannot be made in a 
eukaryotic host unless the inserted gene contains intervening sequences. 
Another discovery is that there are changes in DNA structure during 
the process of differentiation. Dr. Singer gave examples in yeast and 
Salmonella, where certain characteristics are determined by DNA segments that 
move around. A striking case is the genes for immunoglobins, which are 
rearranged from fetal DNA to mature DNA. 
Through recombinant DNA procedures, defects in globir. production are being 
analyzed and diagnosis can now be made much more readily. Another major 
development is in the production of pharmaceutically important proteins, 
such as human growth hormone, insulin, and interferon. A lot of attention is 
being given to the problem of how to boost the level of protein synthesis 
in the _E. col i used for such production. 
Revision of the NIH Guidelines . Dr. William J. Gartland, Jr., Director 
of the NIH Office of Recombinant DNA Activities (ORDA), briefly reviewed the 
revisions of the Guidelines in the past year. He reported that the Recombinant 
DNA Advisory Committee (RAC), in September 1979, recommended exempting from 
the Guidelines most recombinant DNA experiments using the E_. col i K-12 host- 
vector system. 
In reviewing the RAC recommendations. Dr. Fredrickson decided that these 
experiments should not be exempt, but should be conducted at the P1-EK1 level, 
be registered with the local institutional biosafety committee (IBC), and 
require IBC approval for experiments in which a deliberate attempt is made to 
efficiently express a eukaryotic protein. This decision was published in 
November 1979 in the Federal Register for public comment, and promulgated 
on January 29, 1980. The Guidelines now have a new Section III -0 , on 
containment for E_. col i K-12 host- vector systems. 
Dr. Fredrickson noted that the Guideline revisions have placed more 
responsibility on the local institutions. With these revisions, he sent a 
letter to the president or dean of all universities where such research 
is taking place, specifying the new responsibilities of the IBCs and enjoining 
strict containment at the PI level. 
Risk-Assessment Program . Dr. Richard Krause, Director of the National 
Institute of Allergy and Infectious Diseases, briefly reviewed the NIH risk- 
assessment program. He noted that most of the information relevant to 
risk-assessment is coming from basic science and not from specific risk- 
assessment studies. The latter have included looking at survival of organisms 
in such places as sewage or the GI tract of animals. The data have been 
presented to the RAC. 
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