COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Ten 
but to take appropriate action. In short, it is imperative 
that the Department of HEW continue to exercise some initia- 
tive in pursuing adequate regulation (but not over- regulation) 
of all research on recombinant DNA molecules in the United 
States, either through existing or pending legislation, in 
order to reassure the American public that its interests are 
fully protected and to forestall other regulatory controls 
that could seriously hinder the future of reasonable scien- 
tific progress in this highly important experimental area. 
VI 
During the course of the two days of discussion 
at the December 1977 meeting, a number of substantive and 
procedural provisions of the Guidelines were discussed which 
appear to deserve further consideration. 
A. Substantive issues . 
At the outset, I should point out that I do 
not concur with those who objected to the wording of the 
Guidelines as "vague." Having spent 4 years in the govern- 
ment attempting to fashion detailed regulations governing 
complex and sensitive scientific issues, I understand quite 
fully the limitations of the process. Vagueness is an in- 
herent problem in any regulation. My review of the Guide- 
lines does not indicate that they are "vaguer" than 
comparable regulations in other equally complex areas. Thus, 
my comments relate to specific aspects of the Guidelines and 
not to any general deficiency. 
1. As published in the Federal Register of Sep- 
tember 27, 1977, it was proposed that present Appendix D 
(which sets forth supplementary information on physical con- 
tainment) would be deleted. Apparently, anticipating concern 
about this proposed deletion, it was stated during the 
December 1977 meeting that NIH is reconsidering that pro- 
posed deletion. 
I would strongly urge that Appendix D be retained. 
To the extent that questions have been raised about specific 
aspects of that Appendix, they should be resolved by further 
modification of those provisions. But it is extremely im- 
portant, in my opinion, to retain an appendix that provides 
at least general guidance about adequate provisions for 
physical containment. 
[Appendix A — 248] 
