The U.S. Department of Agriculture (USDA) has approvedCalgene Inc.'s petition for non-regulated status of its BXNbromoxynil-resistant cotton varieties, the Davis, Calif., companyannounced Wednesday. But before the company can engage inthe unrestricted commercialization of the herbicide-resistantcottons it must get permission from the U.S. EnvironmentalProtection Agency (EPA) and the FDA.

Under regulations issued by USDA on March 31, 1993,researchers are required to give 30 days notice to USDA'sAnimal, Plant Health Inspection Service (APHIS) beforeplanting any genetically altered corn, cotton, potatoes,tomatoes, soybeans or tobacco. The approval of Calgene'spetition exempts the company from this requirement, allowingfor regular, unreported planting of BXN cotton from thecompany's current seed lines or subsequent progeny.

Calgene spokeswoman Carolyn Hayworth said the company iscurrently in consultation with FDA and hopes to have theagency's permission to commercialize the BXN cotton before the1994 planting season (that begins in March). Calgene requiresFDA approval for its BXN cotton because cotton oils from theplants may be used in foods.

EPA is also currently reviewing the herbicide bromoxynil,marketed by Rhone-Poulenc Ag Co. under the trade nameBuctril. Although Buctril has been used as a broad-leafherbicide for many years with other farm plants such as corn,wheat and barley, the agency must decide if the chemical issafe for use on cotton. Normally, Buctril would kill cotton,which is also a broad-leaf plant. Calgene's BXN cotton, however,has been engineered with a gene from a soil organismdiscovered in Oregon that breaks down bromoxynil, causing theresulting plant to resist the effects of the chemical.

Hayworth said that Calgene will most likely be allowed to plantits cotton in the 1994 season under an experimental use permitfrom EPA. The company is hoping for final approval by the endof 1994 or early 1995.

BXN cotton will be marketed in the U.S. by Stoneville PedigreedSeed Co., a wholly owned subsidiary of Calgene that wasacquired in 1986. Calgene (NASDAQ:CGNE) has estimated that15 percent of cotton crops are lost each year because of theineffectiveness of currently used broad-leaf weed-controlpractices. At present, herbicides used to combat the weeds incotton farming must be used at a higher dose and morefrequently than bromoxynil would be, Hayworth said. Thecompany estimated that if its cotton completely replacedunaltered strains of the plant in U.S. agriculture, 9 millionfewer pounds of herbicide would be used each year.

Calgene's stock gained 75 cents on Wednesday, closing at$12.50 per share.

-- Karl A. Thiel Associate Editor

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