The fruit of Calgene Inc.'s labor is paying off for other companieswhose genetically engineered foods have made it through the FDA'sconsultation process.
Seven products from five companies have been given the go-aheadfrom the agency, although they still will need approval from the U.S.Department of Agriculture(USDA) and, in some cases, theEnvironmental Protection Agency. The FDA on Wednesday andThursday updated a joint meeting of the Food and VeterinaryMedicine advisory committees on the oversight process used toevaluate the products.
The FDA told the committees that there were no outstanding issuesfor the seven products, as far as it was concerned, said FDAspokesman Brad Stone. He told BioWorld that the issue was widelymisreported in the general press, many of which said or implied thatthe advisory committee or FDA approved the products formarketing.
The FDA actually already had completed its consultation process,but presented the information in a public forum to the committees.The committee found the FDA's review process satisfactory.
"We have notified each of the developers that at this point, we don'tsee anything that would cause us concern regarding these productsbeing marketed directly to the public," Stone said.
George Dahlman, an agribusiness analyst with Pipar Jaffrey Inc., ofMinneapolis, told BioWorld one of the significant points is thediversity of technologies involved: food for human ingestion,herbicide-resistant crops, insertion of a gene from the bacteriumBacillus thuringiensis.
"We think this is the beginning of what will become a fairly routineprocess for approval of genetically engineered products," he said.
Three tomato products made it through the FDA process: DNA PlantTechnology Corp., of Oakland, Calif., and Monsanto Co., of St.Louis, have products with altered genes slowing the ripeningprocess; and Zeneca Plant Sciences' tomato is designed to slow thefruit's tendency toward turning mushy.
Monsanto's potato, through insertion of the B. thuringiensis gene, isdesigned to be resistant to the Colorado potato beetle, the mostdamaging pest to potato growers, Stacey Soble, a Monsantocommunications consultant, told BioWorld. The company's soybeanplant is altered so it can be sprayed with the common weed killerRound-Up.
Calgene, of Davis, Calif., and partner Rhone-Poulenc AgriculturalCo., of Research Triangle Park, N.C., is producing a cotton tolerantto the herbicide bromoxynil.
And Asgrow Seed Co., a subsidiary of The Upjohn Co., ofKalamazoo, Mich., has cleared the FDA process with its squashengineered to resist viruses.All the companies have filed or will filefor non-regulated status with the USDA, allowing them to use theproducts without further approval.
Calgene Paved The Way
Calgene got the process going with approval last spring of its FlavrSavr tomato, marketed under the MacGregor's brand name. CarolynHayworth, Calgene's manager of public affairs, told BioWorld thecompany started rolling out its tomato three weeks ago, mostly inCalifornia and Midwest stores. "We're certainly not having aproblem selling the product," Hayworth said, adding that Calgeneintends to have its tomato in 750 to 1,000 stores by the end of theyear.
Sano Shimoda, president of Orinda, Calif.-based BioScienceSecurities Inc., told BioWorld the full impact of genetically alteredagriculture products has yet to be seen, and still isn't fully believed.But, he said, it will be.
"What biotechnology is going to do in agriculture is create asignificant number of specialty markets out of commodity markets,"Shimoda said. "It's going to create premium value-added products,and the technology has the potential to restructure many segments ofagriculture through increased vertical integration as well as majorconsolidation. That process is at hand.
"Wall Street does not understand many areas of agriculture," he said."Biotechnology is going to create premium-margin products andsubstantial growth potential based on leading-edge technologiescombined with execution of a commercialization strategy.Companies will be created that have access to proprietarytechnology. Those that don't have access will be non-competitive."
Richard Godown, senior vice president of the Washington-basedBiotechnology Industry Organization, praised the completion of theFDA consultation process for these food products.
"It will be an important broadening range of genetically modifiedproducts available," Godown told BioWorld. "Their use willsignificantly extend the reach of biotechnology's food andagricultural products, and ease the path for those following nextyear."
DNA Plant, which hopes for a full roll-out of its tomato next fall, hasa pipeline of engineered fruits and vegetables being altered with itsTranswitch technology. Among those expected by the end of thedecade are cherry tomatoes, sweet peppers, seedless mini-melons,bananas, pineapples and others.
Dahlman said Monsanto's use of B. thuringiensis will pave the wayfor its use in a number of products. Soble said Monsanto hasaffiliated with NTG Gargiulo, a shipper/p/packer/handler in Naples,Fla., on its tomato, which needs more work before being ready formarket. "We want to have a superior product to put the gene into,"she said.
Calgene's Hayworth said the years of working with the FDA,helping the agency pioneer the regulatory process, was worth it. "Itreally paid off," she said. "We laid down a road for a lot of people tofollow. We think we took all the right steps, and hope everyone elsethinks so, too." n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.