- 2 - 
upon granting of an exemption from the 10 liter restriction. This system 
places an unnecessary burden of uncertainty upon those developing pro- 
cesses destined for large-scale production. Clarification is needed. 
We suggest that a schedule for assigning containment levels to exempted 
large scale activities be developed to provide more certainty for plan- 
ning research programs. 
Finally, due to increased involvement of the Research Advisory 
Committee in decisions affecting industries potentially involved in large 
scale production, we would propose adding to the Committee's membership 
individual (s) with knowledge and expertise in the area of industrial 
microbiology and large scale production of microbial products. 
We recognize that the NIH Guidelines do not apply to research con- 
ducted in private industrial laboratories; nevertheless, the spirit and 
intent of the guidelines has been, and should continue to be, followed 
by PMA member firms. If, at some time in the future, compliance with all 
provisions of the guidelines becomes mandatory for all laboratories in- 
volved in Recombinant DNA Research, certain procedures in the guidelines 
will pose a difficult problem in terms of patentability of new concepts 
and protection of proprietary interests. With the few exceptions discussed 
in our specific comments, compliance with other features of the guidelines 
appears reasonable. 
We are pleased to participate in your efforts to improve the 
revised guidelines, and you have our assurance of continued cooperation 
and assistance in your excellent endeavor. 
Sincerely yours 
BRUCE J. BRENNAN 
[A-361] 
