Office of Recombinant DNA Activities 
January 15, 1987 
prepare a baker's yeast that can be grown on lactose which Is available In 
cheese whey, a byproduct of cheese manufacturing. There Is nothing unsafe 
about either yeast strain Involved In this product of recombinant DNA work, 
and the new properties of the recombinant DNA baker's yeast strain are 
entirely Innocous. There Is no conceivable reason why this new, 
genetically engineered baker's yeast should not be considered to be as safe 
as any baker's yeast that Is unmodified by recombinant DNA techniques. 
We are also working with a strain of the yeast Saccharomyces 
cerevi siae that has been modified by recombinant DNA techniques to produce 
the human protein "alpha-l-antltrypsln. " In this case. It Is Inconceivable 
that a health hazard exists from contact with this yeast, and It Is 
virtually Impossible for this yeast to compete In open environments because 
of the useless metabolic load Imposed by the "alpha-l-antltrypsln" gene. 
Again, there Is no reason not to handle this recombinant yeast strain In 
the same way that one handles strains of the yeast Saccharomyces cerevi siae 
that are not modified by recombinant DNA techniques. 
Above are two examples of the yeast Saccharomyces cerevi siae modified 
by recombinant DNA techniques that are certainly as safe as strains of the 
yeast Saccharomyces cerevi siae that are not modified by recombinant DNA 
techniques. It should certainly be concluded that these new genetically 
engineered strains of yeast should be allowed to be handled by the same 
methods used for strains of Saccharomyces cerevisiae that are not 
genetically modified by recombinant DNA techniques. And this conclusion 
should be generalized as Dr. Frank E. Young, Commissioner of Food and 
Drugs, has recommended. 
In conclusion, I would like to point out that there has not been even 
one unpredicted product of genetic modification of organisms by recombinant 
DNA techniques In the entire world. This record stands even after more 
than a decade of thousands of experiments In hundreds of laboratories 
around the world. Certainly, thousands of people have been exposed to such 
genetically modified organisms for hundreds of hours as a result of all 
this work, and surprising adverse results have never been recorded. It is 
time to acknowledge that modification of organisms by recombinant DNA 
techniques produces organisms that are no more dangerous, nor more safe, 
than the organisms from which the genetically modified organism was 
derived. And this fact should be reflected in the Guidelines, and the 
Regulations, that pertain to any aspect of recombinant DNA work with 
organisms . 
I do hope that the recommendations proposed in the referenced Notice 
are accepted and that the NIH Recombinant Advisory Committee Guidelines are 
amended accordingly. 
Vice President, Research 
GWS/slb 
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