48 
1 and the types of polypeptide toxins meant in the revised 
2 guidelines. That is to say, pathogenic and/or toxic to 
3 what life forms? 
4 Further, the investigator is hard pressed to 
5 analyze the biological containment requirements for such 
6 experiments . Can an organism that grows in an insect 
7 or is found as a common soil organism, but only affects 
3 specific insects, be developed for pest control use and 
9 be considered an HV 1 system for shotgun experiments using 
10 DN A from entomopathogenic bacteria? The revised 
11 guidelines apparently do not address such types of 
12 bacterial recombinant DNA experiments. 
13 We further would ask the NIH to consider that 
14 the entomopathogenic bacteria or the baculoviruses be only 
15 required to meet the criteria of EPA for an exemption 
16 from a requirement of tolerance, which verifies that the 
yj organism has been rigorously tested for safety to mammals 
13 and other nontarget organisms in the environment, rather 
19 than have EPA registration stipulated for placement in a 
2Q specific containment level. Registration of the organism 
21 is granted subsequent to the exemption from a requirement 
22 of tolerance, provided the organism is shown to be 
23 efficacious. 
24 Section III-C- 3 , "Plant Viral Host-Vector Systems," 
25 dealing with DNA plant viruses serving as vectors for cloning 
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