7 
by jurisdictional considerations. Some Members of the committee be- 
lieve that the case for need is not persuasive ; some would prefer to see 
very different legislation, or none at all. 
In its explanation of the need for this legislation the Committee on 
Interstate and Foreign Commerce states that: 
It is to be borne in mind, however, that legislation is not a 
direct response to perceived possible hazards but to the fact 
that the NIH Guidelines only apply to a fraction of the 
recombinant DNA activities being conducted. The NIH 
Guidelines are the primary response to potential hazards 
and, therefore, legislation is justified only to the extent that 
safety guidelines are necessary. 
The co mm ittee highlights this statement to raise several important 
points. First of all, although referred to as “Guidelines,” the NIH 
standards which govern the conduct of recombinant DNA research 
funded by the NIH and other Federal agencies have the force of regu- 
lations over federally funded researchers. Special conditions for the 
conduct of experiments are required, and it is asserted that noncompli- 
ance will result in the termination of funding of research grants and 
contracts. 
The question then can be asked, is it sensible or fair to require com- 
pliance with a set of standards by some researchers in this area and not 
bv all? It is the considered belief of most persons who have studied 
the matter that all should proceed under the same rules or the “guide- 
lines” will be little more than a charade. The desire to assure that 
recombinant DNA research be carried on under uniform ground rules 
throughout the country also has to be balanced with the desire to give 
assurance to the American people that every effort and caution is being 
taken to protect the public health. 
The question of “how best do you enforce a common set of standards 
in this rapidly moving area?” remains to be answered. It may be that 
the simplest and best way to assure, at least for some period of time, 
that all will follow the same guidelines is for the Congress to pass 
legislation. 
If these assumptions are correct, then the committee concludes that 
the bill H.R. 11192 establishes a reasonable basis for temporary regu- 
lation of all recombinant DNA research. It must be kept in mind, how- 
ever, Secretary of Health, Education, and Welfare Joseph A. Cali- 
fano, Jr., stated in releasing an Interim Report of the Interagency 
Committee on Recombinant DNA Research on March 16, 1977, that : 
“legislation in this area would represent an unusual regulation of 
activities affecting basic science.” 
For these reasons the committee intends that this legislation be 
viewed as an “experiment.” It is important that the experiment be 
conducted wisely, and that it be considered a learning experience. The 
two-year regulation period should.be an empirical one to determine 
which of the legislative and regulatory provisions work well and which 
don’t — and, importantly, if a need for continuation of the legislation 
exists. This view is implicit in several of the committee’s amendments 
to the bill. 
H. Kept 95-1005—78 2 
[Appendix B — 195] 
