Dr. John Spizizen and 
Dr. Donald Hel inski 
July 18, 1978 
Page Three 
Consistency Issues 
Independent of whether one adopts either the conservative or liberal position in 
arriving at groupings of organisms where cloning would be outside the Guidelines, 
one should be consistent in using genus and species names or only genus names. 
The present list in Appendix A is inconsistent. Thus it would appear that all 
species of Pseudomonas are included based on data from studies with only several 
species whereas in the genus Agrobacterium which only contains 4 or 5 species only 
cloning with A. tumefaciens is excluded. 
If the basis for the groupings in Appendixes data on genetic exchange, then the 
pathogencity and/or virulence should not be' a factor. It now appears that the 
vast majority of plant pathogens which are species of Pseudomonas and Erwinia can 
be used in cloning experiments outside the Guidelines (and even when data to verify 
that exchange does occur is generally lacking) whereas cloning with species of 
Vibrio , Pasteurella and Yersinia will still be under the Guidelines (even though 
data are available to demonstrate exchange - at least with E_. col i ) . I should 
also point out that the economic costs in the U. S. associated with diseases 
caused by Erwinia and Pseudomonas species are far in excess of those associated 
with diseases caused by Vibrio , Pasteurella and Yersinia species. If pathogenicity 
is to be an issue, I suggest that NIH consult some expert plant pathologists, as 
well as veterinarians and infectious diseases experts. 
In terms of other points for your consideration, I think it should be clear (and 
maybe it is elsewhere in the Guidelines) that one could use recombinant technology 
for cloning DNA from an organism into itself as though it were equivalent to any 
other genetic tool of analysis. In this regard, it should be possible to use 
recombinant technology to study the genetics of a class 3 etiologic agent using 
derivatives of that same class 3 etiologic agent. 
There should be a list of Bacillus species that can be cloned one into another, 
etc. outside of the Guidelines and similarly a list of Streptococcus species 
that exchange chromosomal DNA. I might add in terms of Streptococcus that al- 
though S.. mutans chromosomal DNA can be transformed into S^. s anguis , that S^. 
mutans subspecies have DNA going from 34 to 46% guanine + cytosine. I surmise that 
other absurdities are also p,_.- rated by Bergy's Manual. 
You have an unenviable task and I commiserate with you. Nevertheless, I implore 
that you be consistent. In this instance trying to be a middle roader will result 
in nothing but chaos. I will be present at the Advisory Committee Meeting at the 
beginning of August and so will be pleased to discuss this matters with you at 
that time. 
Other Points 
RCIII/pp 
[A-321] 
