ARCHIVED - Information: Safety Assessment of the Flavr Savr™ Tomato

April 1997

The Canadian government has completed its review of the first genetically engineered tomato that will be sold in Canada. The Flavr Savr™ tomato, produced by the Calgene, Inc. has been genetically engineered to slow the rate at which it ripens. This means that the Flavr Savr™ tomato can ripen longer on the vine than other tomatoes in order to more fully develop its flavour. Health Canada indicated that as a result of its assessment, it has no objection to the sale of Flavr Savr™ tomatoes as food in Canada.

Three elements present in the Flavr Savr™ tomato distinguish it from other tomato varieties. There is a gene, or specific DNA sequence that has been reversed within the plant, that retards the softening process. There is also a second gene and its resulting product, a biological marker, that allow researchers to identify the modified plants.

Growers can harvest the tomato and ship it at a riper stage, but its end use will not differ from that of other tomato varieties.

The federal government has put the Flavr Savr™ tomato through a thorough assessment before giving the go-ahead to import and sell the tomato in Canada. The process began in June 1994 when Calgene, Inc. notified Health Canada of their intention to sell genetically modified, slower-ripening tomatoes in Canada. Calgene provided information required under Health Canada'sGuidelines for the Safety Assessment of Novel Foods (September 1994). These guidelines are based on internationally accepted principles for establishing the safety of foods derived from genetically modified organisms. Other government agencies, consumers and industry played a major part in developing the guidelines that were used to assess Calgene's data.

Health Canada compared the Flavr Savr™ to other commercial varieties and found no difference in composition or nutritional characteristics. Based on Calgene's information, the Department found the Flavr Savr™ to be as safe and nutritious as other tomato varieties.

Agriculture and Agri-food Canada sets policy on food labelling and is responsible for compliance and enforcement. The Department also monitors the labelling of imported foods at the wholesale level and inspects imported food at the border. Agriculture and Agri-food Canada has reviewed information that Calgene, Inc. submitted for an importation permit for Flavr Savr™ tomatoes. The Department has determined that the importation of the tomato fruit for food does not pose a potential plant pest problem in Canada.

The Canadian government is at the preliminary stages of developing an appropriate federal approach to labelling novel foods derived from genetic engineering. Once this policy has been developed using an extensive consultation process, the Calgene tomato and other such products will be subject to this policy. In the meantime, existing policy on labelling is adequate to prevent false or misleading information on labels.

Health Canada has determined that there are no health or safety concerns that would warrant special labelling of the Flavr Savr™ tomato. Calgene, Inc. plans to provide point-of-sale information about the Flavr Savr™ and to market it as a distinct brand -- MacGregor -- to give consumers information they can use to make informed purchasing decisions. Existing provisions under the Food and Drugs Act ensure that such labelling is truthful and not misleading.