DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20205 
April 17, 1981 
Dr. William Gartland 
Office of Recombinant DNA 
National Institute of General 
Medical Sciences 
Building 31, 4A52 
Dear Dr. Gartland: 
I would like to comment on the proposed modifications of the "NIH Guide- 
lines for Research Involving Recombinant DNA Molecules" as suggested by David 
Baltimore and Allan Campbell and published In the Federal Register of Friday, 
March 20, 1981, on pages 17994-17997. Inevitably, the Baltimore-Campbell 
proposal must also be considered In the light of the alternative suggestions 
that emerged from the meeting of the Chairpersons of Institutional Biosafety 
Committees In November of 1980. Both of these proposals Involve an attempt 
to bring the Guidelines Into a state of consistency with present evaluations 
of the potential for hazard In recombinant DNA experiments. As I see that 
evaluation, there Is widespread agreement that experiments Involving E. coll 
K12 or cerevlslae host-vector systems will not generate harmful organisms. 
For other experimental systems the data are less firm, but there are no good 
scientific reasons to presume that significant problems are likely. For 
these reasons, continued surveillance of recombinant DNA experiments through 
complex registration and review requirements Is unwarranted. Nevertheless, 
exemption of experiments from the Guidelines seems to me less desirable than 
Inclusion In a set of standards as suggested by Baltimore and Campbell. The 
latter approach. If we can take adherence to the CDC Guidelines as an example, 
means that Investigators will still consider new protocols from the point of 
view of possible difficulties and will have the pressure of peers and common 
standards to enforce caution. Therefore I conclude that the Baltimore- 
Campbell approach Is more appropriate than option A or C. Option B Is essen- 
tially similar to the Baltimore-Campbell proposal. I do not see any valid 
reason for requiring prior review or registration. Including the special case 
of Class 3 agents and deliberate attempts to obtain expression of a eukaryote 
gene. 
The above refers to that part of the Baltimore-Campbell proposal relevant 
to the administrative aspects of the Guidelines. The second part of their 
proposal constitutes a major change In the actual containment levels for a 
variety of experiments. In some Instances a lowering of containment levels 
Is clearly called for. However there are some experiments which I know too 
little about to comment upon. I urge that the RAC carefully consider the 
experimental classifications at this time and proceed to lower containment 
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