Dr. William J. Gartland, Jr. 
May 23, 1988 
The pharmaceutical industry has experience with large-scale 
bioprocessing utilizing a wide range of organisms, most 
notably Streptcmyces , Actinomyces , Penicillium , and 
Cephalospor ium , which has clearly established the non- 
pathogenecity and non-toxicogenicity of these industrial 
organisms. Extensive laboratory experimentation with reccmbinant 
and non-reccmbinant organisms has failed to establish that 
any unique hazards result from the transfer of genes between 
the organisms and other genera or that the transfer of a gene 
will convert a non-pathogenic organism to a pathogenic one. 
The available data, therefore, supports acceptance of the 
amendment . 
Very truly yours, 
Antibiotic Fermentation Technology 
and Culture Development 
tlf 
[376] 
Recombinant DNA Research, Volume 13 
