We wish to note that the current criteria for this 
"GILSP-equivalent" class of microorganisms — cloning into 
"exempt" organisms, E. coli, B. subtilis, and Saccharomyces — 
have worked effectively for the hundreds of FDA-regulated 
production organisms currently in use; however, generic 
criteria would be a substantial improvement over the current 
approach, and would obviate the necessity of piecemeal 
additions, an organism at a time. The establishment of generic 
criteria would represent appropriate and desirable evolution; 
we endorse such a change. 
Sincerely yours 
Special Assistant to the 
Commissioner 
FDA 
5600 Fishers Lane 
Rockville, MD 20857 
Enclosure 
[ 368 ] 
Recombinant DNA Research, Volume 13 
