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1 process have been done. The guidelines presently state 
2 that prohibition of deliberate release into the environment 
3 should be lifted only if the requirements for a waiver are 
4 met and if the requirements of NEPA are considered. What 
5 are these requirements for a waiver, and are the requirements 
6 of NEPA going to be met, not only considered? 
7 Certification of Host-Vector Systems. New host- 
8 vector systems raise a whole new range of ecological and 
9 biological issues. The projections of safety being made 
10 from E. col i K 12 are no longer germane. These decisions 
11 must be made on the basis of as complete knowledge as 
12 possible. The NEPA process will help to inform the 
13 decisions. 
14 Responsibilities of the NIH. Due process 
15 considerations. The reference to shifting the burden of 
16 proof should be stricken from the guidelines. As discussed 
17 earlier, it is clearly premature. For an excellent discus- 
18 sion of where the burden of proof lies, I urge you to read 
19 Peter Hutt's March 3, 1978, letter to Dr. Fredrickson, 
20 P a g e 2 * I 
21 Appropriate notice and opportunity for public 
22 comment is an inadequate participation mechanism. By that 
23 point the important decisions have been made. Our comments j 
24 in the past have too often been ignored. The public 
25 perspective must be introduced at a much earlier point 
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