17 
Dr. Clowes said that wnen the NIH Guidelines were originally formulated it 
was not known that viral oncogenes, particularly retrovirus oncogenes, in 
certain circumstances can be as effective as the whole virus in causing 
tumors. Also, viruses causing human cancer had not been discovered. The 
issue of what is adequate containment might be reconsidered in light of 
this new information. 
Dr. Landy suggested that the questions raised by Dr. Bartels are answered 
in her cwn article. He quoted from Dr. Bartels' article: 
"The problem pointed out is not of an epidemiological nature, 
as was feared at the outset of the recombinant DNA debate; 
instead, the focus has shifted to the realm of occupational 
health. Hie number of persons potentially affected is thus 
limited." 
Dr. Landy stated his view that the RAC was established as the result of 
concerns of an epidemiological nature; i.e., that "new life forms" might 
spread and cause disease in the general population. He said that risk to 
investigators has been adequately dealt with in documents such as the 
CDC-NIH document "Biosafety in Microbiological and Biomedical Laboratories." 
Dr. Malcolm Martin attended this portion of the meeting and said Dr. Bartels 
argues that eukaryotic oncogenes may be potentially dangerous for laboratory 
workers. This is a nagging issue that has been discussed for many years. 
He said that he is not aware of any work that has shown that oral admini- 
stration of DNA has produced a tumor or infection in animals. 
Dr. Martin said that in his laboratory the cloned Harvey Sarcoma virus sarc 
gene, an oncogene, had been intraperitoneally inoculated into almost two 
dozen hamsters. The animals were observed for over 300 days and no tumors 
were detected. 
Dr. Martin said to date no case of oncogene activation by hypomethylation 
has been reported. He said that it is simplistic to think that transforma- 
tion in tissue culture extrapolates to some danger to animals or man. 
Dr. Levine moved that Ct. Martin put this information in a letter which 
would be sent to Dr. Bartels. Dr. Martin agreed to do this. Dr. Joklik 
seconded this motion. By a vote of thirteen in favor, none opposed, and 
no abstentions, the motion was carried. 
SHIPMENT OF RECOMBINANT ORGANISMS - APPENDIX H 
Dr. Tolin noted that Appendix H of the Guidelines describes the conditions 
under which organisms containing recombinant DNA are to be transported. 
These specifications essentially describe shipment conditions for etiolcgic 
agents and require organisms containing recombinant DNA to be packaged and 
labeled as etiologic agents. Questions concerning shipment conditions for 
plant materials have arisen with increasing frequency; should these materials 
[2011 
