A few see opportunity, but nearly all biopesticide developersagreed Thursday that turmoil could be the first result of afederal appeals court decision that would effectively halt theuse of chemical pesticides with any link to cancer on foodcrops.

"Biopesticides can't just step in and replace chemicalpesticides," said Joe Panetta, director of regulatory affairs forMycogen Corp. of San Diego, which markets a line of geneticallyengineered bioinsecticides. Mycogen officials, he said, weresurprised that even pesticides remotely associated with cancer,could be removed from the market.

On Wednesday, the U.S. Court of Appeals for the Ninth Circuit inSan Francisco ruled that pesticides are covered by a 1958amendment to the Food, Drug and Cosmetics Act banning foodswith even trace amounts of potentially carcinogenic additives.The probable effect is that the Environmental ProtectionAgency must ban all chemical pesticides with componentslinked to causing cancer. The ruling could apply to 67 of theroughly 300 chemical pesticides used on food crops that havebeen found to cause cancer in laboratory animals.

"The EPA has been reluctant to ban a chemical until areplacement is available," said Bruce G. Fielding Jr., vicepresident of Biosys of Palo Alto, Calif., which is marketing eightbiopesticide products based on naturally occurring strains ofnematode.

"If tomorrow, 67 products got the boot, you'd createconsiderable turmoil," said Neal Briggi, who heads the U.S. PlantProtection division of Novo Nordisk in Danbury, Conn.Consumers have come to rely on reasonably priced food of goodquality in which dangers are minimal, he said. "Now they wantto modify that, and that's fine. But you've got to let the systemcatch up."

Biopesticides, which use versions of natural factors instead ofchemicals to control insects, weeds and funguses, is an infantbyproduct of biotechnology. Although there are several strainsof natural organisms to control pests, all but a few geneticallyengineered biopesticides are still in development, testing orregulatory review before the EPA.

Just the fact that the EPA has been told to change regulationsrelated to chemical pesticides worries some biopesticidedevelopers, who think it may distract EPA staff from allpending pesticide applications. "Any tidal wave that hits theEPA has a fallout effect on anyone who deals with the agency,"Briggi said.

The biggest impact of the ruling on the $5.7 billion chemicalpesticide industry -- and the largest potential opportunity forbiopesticides -- would likely be in fungicides, which rely moreon the chemicals that have been associated with causing cancerin laboratory studies.

"Many of these fungicides are highly toxic," said James A.Wylie, president of EcoScience Inc. of Worcester, Mass. "Thecourt has reconfirmed the intent of the law, and what it will dois push people to seek alternatives."

Like many biopesticide developers, Wylie does not expectbiopesticides to supplant chemical pesticides.

"Our objective is not that we can remove the need forchemicals," concurs Novo Nordisk's Briggi. "Nobody sees a paththat any one (biopesticide) will swamp any particular(pesticide) category."

However, the ruling could present an opportunity forEcoScience, which is developing biofungicides to attack blueand gray molds that damage stored apples and pears, and theblue and green molds that affect citrus fruit.

Another potential beneficiary of the ruling is Ecogen Inc. ofLanghorne, Pa., which is developing products to attack powderymildew and fungal or post-harvest rot. Biopesticides shouldexpand their tiny fraction of the U.S. pesticide market "as theruling is implemented," Jack Davies, chairman and chiefexecutive, said.

Others doubt the ruling will be implemented. The decisioncould be appealed or Congress might take up the issue.Congress could either set allowable limits on pesticide residuesor specifically empower the regulatory agencies to handle thatjob, said Dick Herrett with Envirag Associates, a public policyconsulting group in Bethesda, Md.

"This debate (over setting a tolerable pesticide residues infood) has been going on for a long time," Herrett said. Thecourt's decisions will "mean considerable rethinking aboutlegislation."

"I think it'll come back to a more modified approach," saidBraggi.

-- Steve Payne and Ray Potter BioWorld Staff

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

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