The pharmaceutical industry has a long, distinguished and 
safe record of experience with large scale bioprocessing 
utilizing a wide range of organisms, most notably Streptomyces , 
Actinomyces, Penicillium, and Cephalosporium. Industrial medical 
surveillance programs have monitored potential health risks 
associated with research, development and production processes 
for over thirty years. These surveillance programs have 
demonstrated that, with the exception of isolated cases of 
hypersensitivity reactions, there are no health risks associated 
with large-scale bioprocesses utilizing these low risk industrial 
organisms. This historical perspective clearly establishes the 
non-pathogenicity and non-toxicogenicity of these low risk 
microorganisms . 
Based on laboratory experiments, there is no evidence that 
unique hazards accompany the transfer of genes between organisms 
of these and other genera. Extensive laboratory experimentation 
with recombinant and non- recombinant organisms has established 
that pathogenicity is a multi-faceted trait, and there is no 
evidence that indicates that the transfer of a non- 
toxicogenic/non-pathogenic gene will render a non-pathogenic 
organism pathogenic. Therefore, the probability that a non- 
pathogenic organism could be inadvertently converted to a 
pathogenic organism by minor genetic modifications with rDNA 
techniques is highly unlikely. 
Recommendation : 
To continue to realize the potential benefits of genetic 
engineering with rDNA techniques we must continue to evaluate and 
modify, where appropriate, regulatory guidelines governing this 
technology. These changes in the guidelines are clearly 
appropriate and will enhance the competitive position of the U.S. 
biotechnology and pharmaceutical industries. Relaxation of the 
guidelines allowing for exemption from BL1-LS containment 
conditions for non-pathogenic and non-toxicogenic recombinant 
strains of host organisms having an extended history of safe 
industrial use represents a significant step leading toward 
commercialization of rDNA technologies in the traditional 
antibiotic and food bioprocessing industries. 
S J — 
John F. Beary III, M.D. 
Recombinant DNA Research, Volume 13 
[371] 
