Dr. Donald Fredrickson 
January 3, 1978 
Page Two 
committee representing only academic and primarily scientific 
interests. The committee membership must be broadened to include 
representatives of the public interest, including labor and 
environmental groups, elected or appointed governmental offi- 
cials, and the non-scientif ic professions. Ideally the committee 
should be composed of a majority of non-scientists, with the 
scientific minority made up of people with experience in the 
disciplines relevant to setting biological and physical contain- 
ment requirements and no financial ties to recombinant DNA 
research. A broad based committee will greatly enhance public 
confidence in NIH recombinant DNA policy. The need for a broad 
committee is further strengthened by the blatantly societal 
nature of decisions to allow deliberate release into the 
environment of recombinant organisms and industry involvement 
in recombinant DNA activities. 
3. Beefed up enforcement procedures. 
a. Mandatory worker and citizen representation on 
biohazard committees, to make it easier for individuals to 
report alleged violations. 
b. Mandatory periodic inspections by biohazard com- 
mittees of all ongoing projects. Copies of the inspection 
reports should be forwarded to NIH. 
c. Open biohazard committee meetings. 
d. Mid- level penalties for violations of the guidelines. 
It is obvious that a person's grant will not be cut off because 
of a single violation of the laboratory practices requirements. 
But some incentive is needed to deter these violations. The 
monetary penalties in the Cambridge DNA regulations may serve 
as a guide. Of course, the authority of NIH to levy such fines 
must be investigated. In addition, penalties should also be 
applicable to biohazard committee members who do not report 
violations to NIH. 
e. Increased NIH staff. 
4. Revision of the guidelines into language appropriate for 
regulations . The present guidelines are so vague as to make them 
unenforceable. Obviously written by people with little or no 
experience in regulation, they need to be completely rewritten 
to eliminate vagueness and loopholes. Moreover, required training 
and laboratory techniques must be specified. I urge you to study 
[Appendix A — 173] 
