(3) 
2. All exemptions must be made on the basis of proven safety 
based on experimental data (ie. no significant risk.) 
3. The list of exchangers should be by species, not genus, 
and added only on the basis of safety as well as exchange. 
4. There should be full compliance with NEPA, and adequate 
opportunity for public comment. 
Exceptions 
The guidelines point out that weight must be given to both 
"scientific and societal benefits and potential risks," acknow- 
ledging that these decisions are not only technical, but are 
political. This situation demands much broader representation 
in the decision-making. Appropriate notice and comment is simply 
not adequate; the decision is already made. The decision makers 
can and do ignore public comment. 
Exceptions are easements of prohibitions. These experiments 
were not prohibited lightly; the ban should not be lifted without 
careful consideration of all possible consequences drawing on the 
full range of expertise, as well as the public. 
Recommendations ; 
1. All exceptions from the guidelines should be undertaken 
only after a full environmental impact statement to allow for 
assessment as well as better public input and awareness. In the 
case of a single risk assessment experiment where containment will 
not be breached,; an El A may;, be satisfactory. 
2. Waiver on large scale culture size should only be granted 
after full scale risk assessment studies on the organism, and an 
EIS on the large scale production process have been done. 
3. The guidelines presently state that prohibition of deliber- 
ate release into the environment should only be lifted only "if 
the requirements for a waiver are met, and if the requirements of 
NEPA are considered. " What are these requirements for a waiver? 
And aren't the requirements of NEPA going to be met, not only con- 
sidered? 
Certification of Host-Vector Systems 
New host-vector systems raise a whole new range of ecological 
and biological issues. The projections of safety being made from 
e. coli k-12 are no longer germane. These decisions must be made 
on the basis of as complete knowledge as possible. The NEPA 
process will help to inform the decisions. 
Recommendation: . 
1. Full compliance with NEPA must be required before approval 
of any host-vector system, as well as early public notice and 
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