Two Views of the Flavr Savr
"NBIAP News Report." U.S. Department of Agriculture (July 1994)
The New Tomato: An Inside View
An enlightening talk by an elated Roger Salquist, CEO of Calgene,
Inc., was presented to the annual PaineWebber Conference on May 20,
less than 48 hours after the Flavr
Savr tomato received the FDA nod. Mr. Salquist, sporting tomato
sneakers, presented an interesting and unique view of the regulatory
process for genetically engineered foods and some thoughts on the
future of the foods.
From the first conversation with the FDA in February 1989 to the end
of the saga in May 1994, Calgene's quest for approval has broken new
ground, which will ultimately benefit others in the industry. Some
highlights of this story include:
- With its first submittal in November 1990 for approval of the
nptII selectable marker, Calgene did not want the confidentiality
usually maintained by the FDA. Instead, the company requested that
all findings and issues be made public.
- In May 1991, the FDA published its findings and called for
comments on the marker gene (note that the first filing was for the
marker, not the whole product, sort of a "straw man" for things to
come). Only 43 public comments were received.
- In August 1991, Calgene submitted a second filing for the whole
- In May 1992, the FDA published a policy on genetically
engineered foods and concluded that the technology did not make a
difference. However, rather than coming directly from the FDA, this
policy came via Dan Quayle's Council on Competitiveness, possibly not
the most appropriate medium for such an important message.
- In January 1993, the advisory opinion was converted to a food
additive petition, which requires more rigorous scrutiny but leads to
the highest level of formal FDA approval for this type of product. At
that time, an approval was expected in August 1993.
- In March 1993, Calgene submitted its final data package,
including a toxicity test. The FDA informed Calgene that its
submission was complete.
- In June 1993, Calgene resubmitted its environmental assessment.
Twenty days later, the FDA's opinion was published in the Federal
Register, calling for comments within 30 days. No comments were
- In November 1993, bovine somatotropin (BST) was approved by the
FDA. It is likely that this approval created a controversy that would
not have existed if Calgene's tomato was approved first: tomato
growers will sell an estimated $1 billion more tomatoes and thus
support the genetically engineered product, whereas many milk
producers are in fear of BST.
- In February 1994, a Food Advisory Committee Hearing to approve
the tomato was scheduled. This hearing was called off and rescheduled.
Calgene had to fire a number of its staff due to the delays.
- Subsequently, the FDA held a 3-day hearing, and the Center for
Food Safety published their opinion that the tomato was safe.
- Final approval came May 18, 1994 by fax. This was the first
time that the FDA approved a whole food made by biotechnology, a
process that is likely better, safer, and more precise than plant
breeding. This approval reaffirmed the FDA's May 1992 policy.
The future looks strong for Calgene, which has other key products in
the works. In March 1994, the company filed with the USDA a petition
for deregulation of its laurate canola; approval is expected late in
1994. Calgene is creating the first chocolate with genetically
engineered oils. With recent information possibly linking trans fatty
acids in margarine and other foods with health problems, the ability
to create specific oils is increasingly important, and Calgene is one
of the leaders in this field. Calgene has paved the way, and we will
likely hear more from this groundbreaking company.
Forum - Another Kind of Inside View
This writer has eaten a genetically engineered Flavr Savr tomato, and while the
taste can't compare with a summer garden grown tomato (what can?), it
was pretty darn good. The Flavr
Savr wasn't intended to compete with summer produce, but in the
winter when the grocery stores only sell the hard, green bullets that
bear no resemblance to a real tomato, the Flavr Savr should be appealing.
NBIAP Program Director Dr. David MacKenzie brought a crate of Flavr Savrs back to Washington,
D.C. from Calgene, Inc. headquarters in Davis, CA. Despite a long
coast to coast trip in the overhead bin of the airplane and a couple
of hot days in the trunk of a car, the tomato was red, firm, and
tasty. The skin seems a bit tough, but the fruity parts were solid and
had a tangy tomato flavor. Two chefs in the Washington, D.C. area who
have eaten and used Flavr Savrs
in sauces felt that they tasted better cooked.
All in all, Calgene seems to have produced a good but hardly
outstanding tomato using antisense technology. In California, the
tomatoes sell for $1.99 per pound. Whether consumers will pay a
premium price for shelf life extension for a fairly ordinary tomato
remains to be seen. A Boston supermarket in January will provide a
better site to test market the Flavr
Savr than California.
Calgene Fresh, Calgene's marketing organization, sells the Flavr Savr under the MacGregor's
trade name. The tomato-shaped, open-out brochure that accompanies the
tomato states that they are grown from Flavr Savr seeds and provide
summertime taste year round. Consumers are asked not to store the
tomatoes in the refrigerator to preserve flavor. On the back of the
brochure, there is an explanation of how the Flavr Savr was developed.
It says, "First, we made a copy of a gene which causes softening of
tomatoes. Then we put this copy into the plant backwards to slow down
the softening gene. Simple enough. But we have to know if this step
was successful. So we attach a gene which makes a naturally occurring
protein. This protein makes Flavr
Savr seeds resistant to the kanamycin contained in our test
medium. Now, the results become very easy to read. Those seeds
unaffected by the kanamycin carry the reversed gene and will be
planted for tomato production. No kanamycin is present in tomatoes
grown from Flavr Savr seeds."
The brochure also contains a nutrients content label.
The brochure is well done and bravos for the lesson in molecular
biology. However, the point isn't made up front that the tomatoes are
genetically engineered for summertime taste year-round. The question
is: How many people will read the description of the genetic
modification techniques used to produce the tomato? Or, will they
Calgene's Flavr Savr has some
heavyweight competition in the marketplace. Pioneer Hi-Bred
International Inc., the world's largest seed corn company, has
produced a long-lived tomato through hybridization which is called
Super Life. Pioneer doesn't plan to sell tomatoes, just seed to
commercial growers. DNA Plant Technology Corp. of New Jersey also has
developed a similar long shelf life tomato, which is marketed in
mid-Atlantic supermarkets. No matter who wins, the consumer should
enjoy better tomatoes throughout the year as a result of the tomato