2 
The essentials of the Baltimore/ Campbell proposals give 
the following signals to entrepreneurs in emerging 
industries: Outside of a very few proscribed experiments, any 
of a vast variety of modifications of organisms can be 
carried out without forethought, without special precautions, 
and without informing any agency of government of their 
nature ;that there will be no sanctions if in fact 
irresponsible and dangerous procedures are enagaged in; and 
that no long term epidemiological, monitoring, risk 
assessment program need be put in place in parallel with the 
developing new technology. That is, anything goes. 
The proposals now before the RAC 
1) Rest on a fundamental logical fallacy in their 
development of regulatory approach. 
2) Lack a meaningful scientific basis. 
3) Violate major tenets of responsible occupational and 
environmental health practice. 
4) Were developed without sufficient input from 
professionals in the area of public, occupational, and 
environmental health. 
5) Represent a violation of basic notions of conflict of 
interest, in that m«nbers of the committee, via equity 
positions in emerging biotechnology corporations, stand to 
gain directly from this major alteration in regulatory 
process. 
Below I expand briefly on each of these points: 
Logical Fallacy 
- The Baltimore/ Campbell position, that "the time for 
Guidelines with attached ovesight procedures and penalties 
has passed” is based on an assessment of the potential risk 
associated with development in recombinant DNA technology. 
All of the risk assessment programs, for example those 
considered at the Falmouth and Pasadena Conferences, were 
based on the assumption of stric t adherenc e to the existing 
guidelines. In particular, consideration of the risks 
associated with the introduction of foreign genes into 
micro-organiasms other than E. coli K12, or into wild type or 
disease causing strains of bacteria, were generally excluded. 
- The conclusions with respect to limited risk referred 
only to operations carried out within the scope of the strict 
guidelines then in place and depended on adherence to the 
guidelines. However, these outcomes were then presented as 
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