Two Views of the Flavr Savr

The New Tomato: An Inside View

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 tomato.

• 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 received.

• 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

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 care?

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 competition.

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