Institute for Molecular Genetics, reported that recombinant DNA experi- 
ments are proceeding in a number of European countries, approved by 
responsible national bodies, using bacterial organisms other than 
E. coli K-12. Many of these experiments are prevented by the current 
NTH Guidelines, but would be permitted under the Revised NTH Guidelines 
currently being prepared. 
7. Is the development of vaccines to fight viruses that are responsible 
for serious medical problems being prevented by the current NIH guidelines? 
Are such experiments permissible elsewhere? 
A. Possible vaccine development by means of recombinant DNA research 
techniques has been restricted by the NTH Guidelines. For example, work 
with the influenza virus under the NIH Guidelines largely must be done 
in a P4 containment facility. As noted in my response to question 6, 
the only P4 facility in the U.S. for recombinant DNA research that has 
recently become operational is that of the NTH. Under proposed revisions 
to the Guidelines, lower containment levels would be assigned for this 
work that would permit research to proceed. 
8. It has been claimed that recombinant DNA methods provide a way of 
reducing the risk of working with a number of medically important, 
disease-producing microbes. What is your view of this claim? If true, 
can work on such diseases be carried out more safely abroad by using 
recombinant DNA than in the United States by using the disease-producing 
microbes themselves? 
A. Employing recombinant DNA techniques for work with disease-producing 
microbes will significantly reduce the hazard because it is generally 
agreed that working, for example, with small segments of genes from such 
microbes inserted in E, coli K-12 is much safer than- working with the 
microbe itself. This applies equally to work with disease-producing 
viruses as reported in a joint U. S . /European Molecular Biology Organiza- 
tion Workshop that was convened in England in January to assess risks 
for recombinant DNA experiments involving the genes of animal, plant, 
and insect viruses. Presumably some such work can be done more easily 
in Europe than in the United States. 
9. To what extent does the NIH review process utilize a "case law" 
approach for upgrading or downgrading the initial judgmental' appraisals 
of the level of containment required for particular experiments? 
A. Under the current NIH Guidelines, the "case law" approach is only 
used when interpretations of the Guidelines are requested for individual 
experiments. Guidelines were developed to set standards for general 
classes of experiments rather than determining standards for each 
experiment on a case-bv-case basis. 
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