2 . 
scientific communities here and abroad. We believe that in 
issuing the guidelines, NIH has probably gone as far as it 
could go — short of refusing to fund such research -- in 
protecting the public safety. 
We agree that both the benefits and risks of recombinant DNA 
research are uncertain and highly speculative at this time. 
We are concerned about the potential for release of micro- 
organisms or their toxic products that might adversely 
affect the environment. We believe that prudence dictates 
that research proceed with extreme caution. 
EPA's principal concerns and reservations about recombinant 
DNA research are: 
° ' Insufficient knowledge seems to exist now to assure 
that normally harmless strains of E. Coli or other 
host organisms will not be transformed into virulent 
pathogens which could find a niche for multiplication if 
accidentally released to the environment. Therefore, we 
recommend that very high priority be given to search 
for the knowledge or evidence needed to demonstrate 
safety of the biological containment concept. 
® The guidelines do not yet apply to all laboratories 
and researchers engaged in recombinant DNA research. 
° Even if the guidelines were made universally 
applicable it would be very difficult for any regulatory 
agency to enforce them. Observance of the guidelines 
depends primarily upon peer pressure without the force 
of law. Observance also depends on voluntary actions 
of individuals within laboratories to which the guidelines 
apply. No truly reliable means seem to exist for 
detecting or giving early warning of accidental release 
to the environment of potentially hazardous material. 
Furthermore, no penalities — other than loss of 
Federal financial support — seems to exist to deter 
individuals who deliberately do not honor the guidelines. 
® We are concerned about the apparent uncertainties in 
the ability to assess the probability or degree of 
hazards resulting from experiments carried out under 
less than the most stringent containment conditions. 
Appendix K — 159 
