Calgene Inc. announced Friday that the USDA has "deregulated"its genetically engineered Flavr Savr tomato, leaving thecompany free to grow and ship the fruit anywhere in the U.Swithout further permits or approvals.

This is the first biotech product for which USDA's Animal andPlant Health Inspection Service (APHIS) has granted apermanent exemption from the limitations imposed under itsfield test regulations. This means that the Flavr Savr tomatowill now be regulated entirely by the FDA on issues of foodsafety as it goes to market.

Tom Churchwell, chief executive officer of Calgene's subsidiary,Calgene Fresh, also in Davis, Calif., predicted the tomato willarrive in stores "in the late summer of 1993."

The decision by APHIS to deregulate the Flavr Savr tomato,which has been genetically engineered via antisense technologyto vine-ripen and delay softening, was "made based upon ananalysis of data submitted by Calgene, public comments,scientific literature and expert opinions from the scientificcommunity," said Terry Medley, director of APHIS' division ofbiotechnology, biologics and environmental protection.

"It's up to the company or university researcher to ask forderegulation," John Payne, the associate director of APHIS'sdivision of biotechnology, biologics and environmentalprotection, told BioWorld. "It usually takes from one to threeyears of field trials to get adequate data to answer theenvironmental safety questions and demonstrate that aproduct should no longer be regulated," Payne explained.

Payne said agency reviewers took about four months to processCalgene's deregulation request. He said the process will becomefaster as time goes on. "We expect three to five products in thenext four to five months," he said.

There is already a second product being reviewed forderegulation, said Payne. It's a squash produced by the AsgrowSeeds subsidiary of Upjohn of Kalamazoo, Mich., that containsthe coat protein genes for cauliflower mosaic virus andwatermelon mosaic virus: it's resistant to both.

"We published a proposal to no longer regulate this productabout a month ago in the Federal Register," said Payne. "Thecomment period closes today; we should be making a decisionfairly soon."

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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