39 
which are admittedly a hazard, but which, in the opinion of the 
Secretary alone, do not pose a “significant” risk. 
We respectfully suggest that H.R. 11192 delegates unfettered dis- 
cretion to the Secretary of H.E.W. without adequate standards to 
protect public health and the environment. Specifically, we think the 
broad exemption power is not sensible public policy for the following 
reasons : 
1. Conflict of interest may result in a biased judgment on what 
constitutes a “significant risk' 1 ' 1 
Decisions involving recombinant DNA are made by the National 
Institutes of Health, which is the primary funding agency for re- 
combinant DNA research. NIH awards grants and contracts in this 
field with the expectation that the United States will advance com- 
petitively with other nations in this rapidly developing field. There 
is an inherent conflict of interest when one involves the same agency 
in both financial subsidies and regulatory decisions. NIH, we think, 
will have a tendency to advise the Secretary of H.E.W. that research 
proposals seeking exemption from the NIH guidelines do not pose a 
“significant” risk. 
2. The Secretary ’s broad exemption power will encourage requests 
for exemptions 
Because H.R. 11192 provides no specific standards qualifying an 
experiment for an exemption, the Secretary of HEW may be inun- 
dated with requests for relief from the NIH guidelines. Indeed, ap- 
plying for an exemption may become routine whenever a facility 
begins a new recombinant DNA experiment, or a new stage of an on- 
going experiment. The result will be case by case decisions by the 
Secretary of HEW allowing exemptions. We do not think that such 
close involvement of the Secretary was ever intended by the Inter- 
state and Foreign Commerce Committee. Nor do we think the scientific 
community wants the HEW Secretary a participant in day to day 
research decisions. 
3. The Secretary's broad exemption power invites litigation by citizen 
groups 
In debate by the full Interstate and Foreign Commerce Committee, 
it was said that the Secretary of H.E.W. should be able to exempt 
experiments by order from the NIH guidelines to save time. It is 
true that issuing an order is an expedited procedure less time con- 
suming than the issuance of regulations, which require publication 
and comment. However, the exercise of the Secretary’s exemption 
power without any limits in the law to restrain its arbitrary use will 
invite time-consuming litigation. Since all public representation is 
eliminated by H.R. 11192, the only way citizens can “participate” in 
regulation of recombinant DNA activities is through litigation. It is 
quite likely that concerned citizens who have not been allowed to 
comment on the appropriateness of an exemption will test the Secre- 
tary’s order in court. They may seek temporary restraining orders or 
other forms of injunctive relief. Courts of equity, which can grant 
such relief, traditionally refuse to take jurisdiction of cases involving 
them in remedies requiring continuous and detailed court supervision. 
The courts will be reluctant to involve themselves in case by case de- 
cisions on recombinant DNA experiments. 
[Appendix B — 169] 
