( 2 ) 
We would still urge that HEW use Sec. 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 rapid- 
ly developing new field. It was "hard ball" politics, not new 
data that killed both the Senate and House bills. 
The new data discovered and/or developed in only one year's 
time offers assurance about one small part of the potential dan- 
ger — e. coli k-12. We are already considering approval of 
new host-vector systems, deliberate release into the environment, 
and exempting research with wild-type e. coli. What little we 
know now, will become even less as we continue to open broad 
new biological and ecological vistas. 
We urge you to reconsider your decision regarding Sec. 361 
in light of the inadequacy of the existing NIH proposals, and 
the need for legally enforceable regulations due to increasing 
interest in the private sector. Even if Congress acted next ses- 
sion, which is far from certain, it would be a minimum of two 
years before regulation would be in place. The drawbacks of that 
course of inaction far outweigh the use of Sec. 361. 
Recommendations : 
1. Promulgate the guidelines as regulations under existing 
authority . 
2. In the absence of full regulation under existing author- 
ity, NIH funded investigators should require an approved MUA with 
certification on file with the NIH, prior to shipment or transfer 
of recombinant DNA materials. 
3. The guidelines should apply to all recombinant DNA research 
at institutions receiving any NIH funding. 
Exemptions 
The requirement for the fourth class of exemptions is that they 
"exchange DNA by known physiological processes." "Known" is a 
much broader class of exemption. How does the NIH define it? 
More significantly, there is no requirement that that particular 
class of exemptions be "safe." 
The Decision of the Director (p 33044) says that "provision 
will be made for public input either by announcement of proposed 
exemptions prior to consideration by the Recombinant DNA Advisory 
Committee, or before a decision by the Director becomes effective." 
Obviously, the second alternative is totally inadequate. A 
procedure must be developed to allow for public notice and oppor- 
tunity for input before the decision is made (ie. before the RAC 
has considered it.) 
Recommendations : 
1. "Known" should be changed to "natural." 
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