12 
with regard to the classification of the viral agents used in recombinant 
DNA research (viruses in general are “lumped together'’ rather than 
being classed as are bacteria in categories ranging from harmless to 
very dangerous) ; more work needs to be done in evaluating the 
methods of conducting certain types of research with plants; and 
there is still concerh that the legal processes for implementing the 
guidelines are inadequately described within the guidelines. 
A final decision on revision of the guidelines had not been made 
at the time of submittal of this report. 
C. INTERNATIONAL ACTIVITIES 
A “Report of the Federal Interagency Committee on Recombinant 
DNA Research: International Activities” was submitted to the Secre- 
tary of HEW in November 1977. This report summarizes the status of 
international activities and suggests a series of actions which should 
be taken to insure continuing coordination of efforts to regulate this 
research. Copies of the report are available from the NIH Office of 
Recombinant DNA Activities. 
D. Procedural Violations of the NIH Guidelines 
Two events have occurred which support the criticisms which have 
been leveled at the ability of the scientific community to regulate 
itself as well as the ability of the NIH to regulate laboratories conduct- 
ing such research. At the Department of Biochemistry and Biophysics, 
.tjniversity of California, San Francisco, investigators completed re- 
search which led to tfie successful isolation of the gene coding for rat 
insulin in a recombinant DNA experiment. This team used a plasmid 
vector for the experiment which, while it had been tentatively ap- 
proved by the Recombinant DNA Program Advisory Committee to 
the Director of NIH, had not been certified for use by the Director. 
The investigators apparently chose not to make public this incorrect 
application but instead destroyed the vector and experiments and 
then later repeated the experiment with approved procedures. The 
violation, whether technical because of ambiguous wording in the 
guidelines or for other reasons, created no health problem. It was not 
clear, however, that NIH had been fully aware of the violation until 
it was made public in an article in Science (Wade, Nicholas. Recombi- 
nant DNA: NIH Rules Broken in Insulin Gene Project, v. 197, 
September 30, 1977, Appendix). In another incident, queries by the 
Environmental Defense Fund led to an investigation by an NIH team 
which revealed that an investigator at Harvard University Medical 
School was conducting recombinant DNA experiments without the 
necessary memorandum of understanding and agreement having been 
filed with NIH (see New York Times, December 16, 1977 Appendix). 
Again, this event illustrates some difficulty that NIH has had in 
enforcing compliance with the guidelines and identifies at least two 
instances where scientists were conducting experiments with Federal 
funds. but not in conformance with the NIH procedures. In the latter 
case, the investigator was denied any further use of his grant to con- 
duct any recombinant DNA research pending the completion of an 
investigation into the incident. 
[Appendix B — 63] 
