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  Highlights of Calgene's Quest for FDA Approval of the Flavr Savr Tomato

  • 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.

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