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1 NIH proposals, as pointed out in today's testimony, and 
2 the need for legally enforceable regulations due to 
3 increasing interest in the private sector. Even if 
4 Congress acted next session, which is highly uncertain, 
5 it would be a minimum of two years before regulation 
5 would be in place. I hope you will agree with us that 
7 the drawbacks of that course of inaction far outweigh 
8 the use of Section 361 . 
9 We would recommend, one, that you promulgate 
10 the guidelines as regulations under an existing authority. 
11 In the absence of full regulation under existing authority, 
12 could NIH-funded investigators require an approved MU A 
13 with certification on file with the NIH prior to shipment 
1 4 or transfer of recombinant DNA materials? 
1 5 Exemptions. The requirement for the fourth 
15 class of exemptions is that they "exchange DNA by known 
17 physiological processes." There is no longer a requirement 
18 that they must be "natural" physiological processes. "Known 
19 is a much broader class of exemption. How does the NIH 
20 define it? 
21 More significantly, there is no requirement that 
22 that particular class of exemptions be "safe." 
23 We would recommend that, one, all exemptions be 
24 made on the basis of proven safety based on experimental 
25 data — i.e., no significant risk. The list of exchangers 
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