16 
II-(4) Vhat mechanisms will there be for general public discussion of issues of 
safety and benefit? Who will determine how safe is safe enough? Will the 
burden of proof be on the researcher to prove no harm or on the agency 
to prove harm? 
Mr. Mitchell asked if a consensus existed in the working group to accept the 
concepts contained in the language offered by Dr. Gottesman. The working 
group could then proceed to modify the language. By a vote of nine in favor, 
one opposed, and no abstentions, the working group accepted this consensus. 
Dr. McGarrity said the third sentence of point I-(4) is a juxtaposition of two 
separate thoughts , and the clause referring to the necessity of reviewing releases 
of genetically engineered organisms suggests a bias. 
Dr. Mitchell suggested the working group delete that clause. Dr. Gottesman 
agreed . 
Dr. McKinney suggested the first sentence of point I-(4) should include the idea 
that during the ten years since its inception RAC has exempted sane classes 
of experiments frcm special review. The working group could recommend the 
exempt classes of experiments be carefully considered as examples of possible 
categories of experiments requiring less stringent review. Dr. Walters suggested 
the word "activities" be substituted for the word "experiments" in the first 
sentence of point I-(4). 
By a vote of eight in favor, none opposed, and no abstentions, the working 
group accepted the following language for point I- (4) item of the response: 
"Cn the basis of information acquired ever the past ten years, the RAC has 
exempted sane classes of experiments from all special review and assigned 
to Institutional Biosafety Committees the responsibilities for cversight 
of other experiments. This has permitted the RAC to concentrate on the 
cases which are of major concern. We recommend that the exempt classes of 
experiments be considered carefully as examples of possible categories of 
experiments which might be appropriate for expedited review. Not all 
applications should need to be seen by the full review structure." 
Mr. Mitchell drew the attention of the working group to point II-(l). That 
item questions where the line between research and commercial application will 
be drawn and indicates particular concern about the fate of basic agricultural 
research . 
Dr. Gottesman expressed hope that all research activities including testing in 
the greenhouse would be covered by the NIH Guidelines. Dr. Walters supported 
the concept that the NIH Guidelines should provide safety standards for labora- 
tory research. 
Dr. Lardy did not think the working group should simply state reservations with- 
out offering solutions. If the working group position is that research should 
be covered under the NIH Guidelines, this position should be explicitly stated. 
[346] 
