38 
of research through support of two amendments to Section 106 of 
H.R. 1192. The first of these amendments, offered by Representative 
Mikulski, would have placed the burden on the Secretary to show that 
the local or State regulation was not necessary to protect public health 
or the environment. 
The second amendment, offered by Representative Marks, would 
have changed the burden in section 106 (b) (2) from a showing by local 
governments that their regulation is “necessary” to a more easily met 
showing that local regulation was “reasonable” to protect public health 
and the environment. Although the supporters of the H.R. 11192 sub- 
stitute argued that this bill does allow for local regulation if such 
regulation is “reasonable,” they steadfastly refused to support an 
amendment to say what they claimed they meant. 
While we are greatly concerned that the protections afforded our 
people in this bill will in future years prove to have been insufficient 
for their protection, our fundamental concern as to the preemption 
issue is with the notion that a scientific elite and an insular Federal 
bureaucracy know what is best for the people — and that they, and not 
the people, directly or through their representatives, must be allowed 
to govern. That is the premise on which the preemption section in 
H.R. 11192 was drafted. 
This attitude, which characterized much of the debate on this section, 
is contrary to the principles of Jeffersonian democracy, to our populist 
tradition, to our view of this nation as one of self-governing people. 
III. DISCRETION IN THE HEW SECRETARY TO EXEMPT BY ORDER 
RECOMBINANT DNA ACTIVITIES 
Sec. 102(b) of H.R. 11192 allows the Secretary of Health, Educa- 
tion, and Welfare to exempt by order any recombinant DNA activity 
which the Secretary finds does not present “a significant risk” if ex- 
cused from the safety requirements of the NIH guidelines. This con- 
stitutes a significant change from the bill reported out of the House 
Subcommittee on Health and the Environment H.R. 7897. The sub- 
committee, after hearing testimony, researching this subject and de- 
liberating for months, concluded such an exemption should be permit- 
ted only by regulation. 
Debate by the full Interstate and Foreign Commerce Committee on 
H.R. 11192 disclosed that this sweeping exemption power was sought 
so that the Secretary of HEW could exempt risk assessment studies, 
among others, from the NIH guidelines. We think this poses serious 
potential risks for public health and the environment. 
Permitting exemptions by order, instead of administrative regula- 
tion, eliminates any public comment. Thus, the last vestige of public 
participation in regulation of recombinant DNA is stricken from the 
legislation reported to full committee by the House Subcommittee on 
Health and the Environment. The Subcommittee bill. H.R. 7897, man- 
dated that persons not involved in recombinant DNA activities and 
persons representing the public interest be members of the Recom- 
binant DNA Advisory Committee and the Local Biohazards Commit- 
tee. H.R. 11192 eliminates both these committees, as well as adminis- 
trative hearings on exemptions from the NIH guidelines. 
The authority conferred on the H.E.W. Secretary by H.R. 11192, 
by use of the word “significant”, allows him to exempt activities 
[Appendix B — 168] 
