in 1976 on safety standards for this research. Final regulations may be 
implemented in October 1978. In addition, the European Economic Community 
(EEC) is currently considering a directive that would require each 
member state to establish its own administrative mechanism to ensure 
that all recombinant DNA research is subject to national guidelines. 
5. How do the guidelines of the major scientifically advanced nations 
in Western Europe, Eastern Europe, and Asia compare with those of the 
United States? Are there less or greater restrictions on the research? 
A. In large part, the physical and biological containment standards are 
comparable, but there are differences among the various countries in the 
assignment and interpretation and application of those standards to 
individual experiments. The guidelines of the United Kingdom in large 
part are implemented on a case-by-case basis by a national committee. 
This model is used in several of the Western European countries. Thus, 
each national committee can apply standards for an individual experiment 
that may vary from the standards of the others and particularly from the 
NIH Guidelines where little flexibility is offered to deviate from the 
explicit standards. 
Variations in the application of certain standards involve, for example, 
the use of DNA from primates in recombinant DNA experiments. For example, 
the NIH Guidelines stipulate such work must generally be done at the 
P4+EK2 or P3+EK3 levels. (Under certain well defined and circumscribed 
conditions, these containment levels may be lowered.) Work could proceed 
only with great difficulty because there are no certified EK3 host- 
vector systems at present, and the only P4 facility in the U.S. for 
recombinant DNA research is at the NIH’s Frederick Cancer Research 
Center that has only now begun operation. In France, for this work, the 
standards are P3+EK1 or P2+EK2 (P3 is defined slightly differently than 
in the NIH Guidelines), and such experiments have been able to be performed. 
Thus, variation in application has resulted in some research proceeding 
in Europe that could not be done in the U.S. It should be noted that 
such variation only rests on estimates of potential hazard and not on a 
demonstrable risk. 
6. Is it correct that non-El. coli organisms are being used at present 
in other nations for recombinant DNA experiments aimed at the develop- 
ment of new antibiotics, the design of plants that can grow without 
fertilizer, and the construction of microbes capable of providing new 
sources of energy from the biomass — whereas the United States guidelines 
have prevented similar experiments from being carried out in this country? 
A. U.S. scientists who returned from the Workshop on "Plasmids and 
Other Extrachromosomal Genetic Elements" sponsored by the European 
Molecular Biology Organization, held April 1-5, 1978, at the Max Planck 
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