1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
7 l J 
Secretary Califano. I hope you will find these comments 
and recomendat ions useful. 
Scope and applicability. In general, we 
support efforts to further extend the guidelines to the 
private sector, such as those in the proposed revisions. 
It is unfortunate that no nore conprehens ive mechanism 
exists to transforn the guidelines into full-fledged 
regulations -- legal authority extending to industry and 
acadenia alike, and to both effectively. 
We would still urge that HEW use Section 361 
of the Public Health Service Act. Congressional inaction 
on this issue does not in any way diminish the need for 
meaningful regulation in this rapidly developing new 
field. It was hardball politics, not new data, that 
killed the House and Senate bills. 
The new data, discovered and/or developed in 
only one year's tine, offers assurance about one small 
part of the potential danger, E. col i K12. We are 
already considering approval of new host-vector systems, 
deliberate release into the environment, and exempting 
research with wild-type jE. col i . What little we know 
now will become even less as we continue to open nroad 
new biological and ecological vistas. 
We urge you to reconsider your decision 
regarding 361 in light of the inadequacy of the existing 
[ 171 ] 
