4 December 2002

BIO BACKTRACKS ON PHARMAGEDDON POLICY - BIOTECH COMPANIES CHANGE SELF-IMPOSED MORATORIUM

Even as ProdiGene moves to buy about half a million bushels of pharma-corn contaminated soybeans, BIO is already starting to backtrack on its commitment not to grow pharma crops in food producing areas like Iowa - the state where ProdiGene was ordered to destroy 155 acres of corn because windborn pollen from its drug producing corn may have contaminated nearby fields.

1. Biotech companies change self-imposed moratorium
2. UPDATE 2 - ProdiGene to buy back contaminated soybeans

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1. Biotech companies change self-imposed moratorium

Source - Associated Press (Eng)
Wednesday, December 04, 2002  09:44
1239 XENGLISH XFINSEC XFINMKT V%WIREI P%AP

By EMILY GERSEMA, The Associated Press

WASHINGTON (AP) - Biotechnology companies are softening a self-imposed moratorium on growing pharmaceutical crops in major corn-growing states after Iowa lawmakers complained that the policy unfairly discriminated against their state.

Lisa Dry, a spokeswoman for the Biotechnology Industry Organization, said Tuesday the companies changed the policy "because we did not want to appear to encourage discrimination against certain parts of the country."

Companies are producing enzymes and proteins used in pharmaceuticals by growing them in genetically modified corn. A dozen companies that are members of the biotech group agreed in October to stop growing such crops in corn-belt states in 2003, saying they wanted to build the public's trust that they could grow them without contaminating crops grown for food.

But the new policy said: "Detailed scientific and regulatory analyses confirm that plants that produce pharmaceutical and industrial products can be safely planted, grown and harvested in an agricultural region where all of the appropriate production, confinement, and handling practices are implemented."

Dry declined to elaborate on the change. But Andrew Baum, president of SemBioSys, a Canada-based biotech company that is a member of the group, said the revised policy is really a clarification of the moratorium.

"It's not a fundamental change in what any of the companies are going to do," Baum said. "I don't think any companies have backed away from their commitment to ensure that we don't create a problem for the food supply."

Environmental groups such as Friends of the Earth say pharmaceutical crops should not be grown at all.

"Not only is this brand of science for profit wildly ill-advised, it's sure to lead to a plate full of food rife with chemicals that ought to be on a druggist's shelf or in a chemical plant - not in a grocery store," said Mark Helm, a spokesman for Friends of the Earth.
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On the Net:
Biotechnology Industry Organization: http://www.bio.org
Friends of the Earth: http://www.foe.org

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2. UPDATE 2-ProdiGene to buy back contaminated soybeans

Source - Reuters Securities News (Eng)
Wednesday, November 20, 2002  04:57

(Adds USDA, ProdiGene reaction, new throughout)
    WASHINGTON, Nov 19 (Reuters) - The Food and Drug Administration said on Tuesday that ProdiGene Inc. agreed to buy back about half a million bushels of soybeans contaminated with bio-corn and to strengthen its controls on biotech crops grown to produce ingredients for drugs.     Despite the deal with the FDA, the U.S. Agriculture Department said it was continuing its investigation into whether privately-held ProdiGene violated federal regulations regarding biotech crops, which could lead to fines of up to $500,000 per incident.     The FDA said in a statement on Tuesday that the 500,000 bushels of Nebraska soybeans were accidentally tainted by a tiny amount of ProdiGene's bio-corn variety grown to produce pharmaceutical materials for clinical study.     "FDA is confident that the material from the corn would pose virtually no health risk, but even the minuscule amount of material in question should not have been present in the soybeans," the agency said.     "These products will not enter the human or animal food supply," the FDA said.     The soybeans in question have been under U.S. Agriculture Department control in a locked warehouse in Aurora, Nebraska, since they were harvested last month.     "ProdiGene looks forward to implementing the new compliance program as soon as possible," said Anthony Laos, the company's chief executive, in a statement. "We intend to continue to work closely with the government to set the standard for our industry."

    PRODIGENE AGREES TO BUY SOYBEANS
    With soybeans commanding more than $5.60 per bushel on the Chicago futures market, privately-held ProdiGene could pay more than $2 million to purchase the soybeans.     John Taylor, FDA's associate commissioner of regulatory affairs, said the agreement completes the agency's probe into the company's actions. He said no fines would be assessed.     Jim Rogers, spokesman for USDA's Animal and Plant Health Inspection Service, said the department was still investigating whether ProdiGene violated any federal regulations. The company could face fines of up to $500,000 for each violation.     FDA said the soybeans would be destroyed.

The company, based in College Station, Texas, had hoped to resell the grain for use as bio-diesel to salvage some of their value.     "My understanding is their going to be destroyed and not going to be made into any kind of fuel production," FDA Commissioner Mark McClellan told Reuters after speaking at an unrelated event.     Last week, the USDA said it was also investigating a separate incidents of suspected contamination by ProdiGene, a biotech company experimenting with corn engineered to make medicine for diabetes and diarrhea.     In Iowa, ProdiGene was ordered to destroy 155 acres (63 hectares) of corn because windborn pollen from its bio-corn may have contaminated nearby fields.     "Today's action will help ensure the proper handling of bioengineered materials being studied by ProdiGene for pharmaceutical uses, now and in the future," the FDA said.

American food makers and environmental groups this week continued to urge the Bush administration to temporarily ban the use of food crops for pharmaceutical purposes.     Environmentalists fear humans could suffer allergic reactions or other effects if they eat bioengineered food not approved for consumption. Europe has banned virtually all biotech foods because of consumer concerns.     Greenpeace activists on Tuesday protested outside the Nebraska silo that contained the contaminated soybeans. They urged the federal government to immediately ban drug production in food crops.     Only about 300 acres throughout the United States were planted with pharm-crops this year, according to the industry.     The ProdiGene incidents came to light less than a month after it and other biotech companies voluntarily agreed to stop growing pharmaceutical crops in the Midwest and Plains states to avoid accidental contamination.
 
additional reporting by Randy Fabi and Christopher Doering in Washington
(Julie Vorman, 202 898 8467 washington.commodsenergy.newsroom@reuters.com)