3 
evidence for minimal intrinsic risk, and as argunents that 
guidelines were not necessary. Each stage of the successive 
weakenings of the NIH guidelines have rested on the 
repetition of this fallacy. 
- In summary the logic has been; 
a) If the Guidelines are strictly followed, hazards 
are minimized. 
b) Since the hazards are minimal, 
c) There is no need for guidlines. 
The above syllogism is false. 
Risk Assessment 
- The Federal Register of December 1981 presents an 
"Evaluation of the Risks Associated ith Recombinant DNA 
Research" which attempts to provide scientific basis for the 
Baltimore/ Campbell proposals. This docunent is somewhat 
unusual when compared with analogous Federal Register 
documentation providing background for the lead, cotton dust, 
carcinogen and other standards; rather than presenting 
clearly the biological and public health bases for concern, 
it reads more like an adversarial brief attempting to argue 
that the risks are minimal, rather than providing the 
scientific basis for identifying them when they do arise. 
- For example, little emphasis or docunentmentation is 
provided with respect to the profound and widespread role of 
plasmids in bacterial pathogenesis; the major problems in the 
control of hospital acquired infections; the fact that the 
plasmid transfer referred to in the text is in fact a major 
public health problem, due to transfers of plasmids coding 
for both antibiotic resistance and toxins. These fundamental 
factual bases for concern, though touched on, are not given 
appropriate prominence. 
- The Document lays out three criteria requireds for 
generation of hazard by genetically modified micro-organisms: 
1) uniqueness 2) establishment in some niche; 3) deleterious 
effects on htnans or other hosts. It then points out that if 
any one were proved totally false, the basis for concern 
would be minimized. However, careful reading of the document 
makes clear that none of them have been proven false. In 
fact a much stronger case exists for likelihood of these 
three concerns than is made in the document. In fact with 
respect to the first, the technical arguments for the 
uniqueness and novelty of genetically modified organisms has 
been given enshrined in law through the Supreme Courts 
decision that genetically modified organisms can be patented. 
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