NEWS
05/18/1994

<TITLE>FLAVR SAVR, a new tomato developed through biotechnology, is as safe as tomatoes bred by conventional means</TITLE>
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P94-10                        Food and Drug Administration
FOR IMMEDIATE RELEASE         Brad Stone (202) 205-4144

     The Food and Drug Administration today announced that FLAVR
SAVR, a new tomato developed through biotechnology, is as safe as
tomatoes bred by conventional means.  This is the first time FDA
has evaluated a whole food produced by biotechnology, a science
that can make plant improvements with more precision than
traditional cross-breeding.  
     The finding that FLAVR SAVR tomatoes are as safe as their
traditionally developed counterparts follows FDA approval in 1990
of the first biotechnology food product, chymosin, a milk-
clotting agent for making cheese. 
     "We have approached our review of this product with
scientific rigor and a commitment to full, public disclosure of
that science," said FDA Commissioner David A. Kessler, M.D. 
"Consumers can be confident that we remain committed to assuring
that foods produced by genetic engineering are as safe as food in
our grocery stores today."
     The finding was accompanied by a new food additive
regulation allowing the use of an enzyme encoded by a marker gene
called the kanamycin resistance or kan-r gene.  The kan-r gene
confers resistance to the antibiotic kanamycin, allowing early
identification of plant cells successfully modified with a new 
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                               Page 2, P94-10, Flavr Savr Tomato
trait.  FDA is publishing in the Federal Register a food additive
regulation allowing the use of the enzyme encoded by the kan-r
gene in new varieties of these plants.
     FDA's review of the FLAVR SAVR was requested by the tomato's
developer, Calgene Inc. of Davis, Calif., in August 1991.  The
company later submitted a food additive petition on the use of
the kan-r gene in the development of new varieties of tomato,
cotton and rapeseed.
     In 1992, the U.S. Department of Agriculture granted Calgene
permission to begin large-scale production of the new tomato.
     Last month, FDA's approach to evaluating the safety of FLAVR
SAVR was discussed in a public meeting by outside experts of the
agency's Food Advisory Committee.  Members of the panel concurred
with FDA's preliminary assessment that all relevant safety
questions about the new tomato had been resolved.
     FDA has not found it necessary to require special labeling
for FLAVR SAVR since it maintains the essential characteristics
of traditionally developed tomatoes.  However, the company has
notified the agency that it plans to provide point-of-sale
information for consumers about the development of the new
product through genetic engineering.
     FDA is one of eight Public Health Service agencies in the
Department of Health and Human Services.
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