DEPARTMENT OF HEALTH fli HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda. Maryland 20205 
Bldg. 7, Rm. 304 
January 29, 1982 
Or. Willlaa J. Gartland, Jr. 
Director, Office of Recoaibinaot 
D)IA Activities 
Building 31, Rooa 4A52 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Bill: 
This ia to give ay coaaents on the proposed changes in the NIH Guidelines 
presented in the Federal Register of Deceaber 4 and Deceaber 7, 1981. 
First, I enthusiastically endorse the concept of reducing both the con- 
tainaent requireaents and the adainistrative review. However, as to the 
aeans of achieving the reductions, I don't find either proposal to be 
fully satisfactory. 
Vith regard to the Baltiaore-Casq>bell proposal, I agree with making the 
great bulk of the guidelines a voluntary code of practice, but I would 
like to see retention of NIH's control over four categories of research 
that carry a clear potential of risk. These are 1) the drug resistance 
traits, 2) the highly potent polypeptide toxins, 3) deliberate release 
into the environment, and 4) virus-virus recombinants that could gener- 
ate a nondefective vims with an expanded host range or tissue specific- 
ity. Numbers 1, 2, and 3 are the old prohibitions; they should not be 
prohibited (as would follow from the admonition in section III of the 
Baltimo re-Campbell proposal) but should be done only after careful 
scrutiny. 
Vith regard to nondefective virus-virus recombinants, I think there 
will be intensive investigation of the molecular basis of the exquisite 
species and tissue specificities of viral infections, using ^ vitro 
generated recombinants. This will be an exciting and important field, 
vith implications not only for virus infections but also for cell regu- 
lation and control mechanisms. These experistents will by design gener- 
ate novel viruses with expanded host ranges and increased ability to 
replicate in various cells or organs. I would like to be assured that 
such experiments are done with care, awareness, and external expert 
review. 
I agree with the Gottesmann proposal to the extent that it maintains a 
residuum of NIH control and oversight, but I feel that the classifica- 
tion of experiments is still overly complex and that the use of the old 
CDC classification for deciding on containment conditions does not have 
a solid scientific basis. 
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