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1994.05.18 : New Tomato Developed thru Biotechnology

Contact:  PHS/Food and Drug Administration   Brad Stone (202) 205-4144
May 18, 1994                                 Home (703) 204-4497 


     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 
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..                         Page 2


     FDA is one of eight Public Health Service agencies in the
Department of Health and Human Services.


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