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2-Plants: Some news on pharma crop difficulties in the U.S.

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                                  PART I
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TITLE:  Farm groups still support genetic crop development
SOURCE: UPI Farming Today, USA, by Gregory Tejeda
DATE:   Nov 18, 2002

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Farm groups still support genetic crop development

Various farm-related groups are continuing to support the development of 
pharmaceutical and industrial crops, even though there have been two recent 
incidents where genetic elements of those crops became mixed with food 
intended for human consumption.

The Agriculture Department last week revealed the existence of a food crop 
in Iowa and a soybean crop in Nebraska both tainted by crops that were 
genetically altered to develop substances for use in drugs or industrial 

Federal officials would not say what chemical or drug was grown in either 
genetically modified crop, but activists with the Washington-based Center 
for Food Safety say their research indicates they could be AIDS vaccines, 
blood-clotting agents, digestive enzymes or industrial adhesives.

"With this latest contamination, the government should halt all 
experimental genetically engineered crops grown on farms," said Matt Rand 
of the National Environmental Trust.

"If the government continues to develop policies for the biotech industry 
instead of for the safety of the U.S. food supply, it is just a matter of 
time before one of these experimental crops ends up on our dinner plates," 
he said.

But the American Farm Bureau Federation, National Corn Growers Association 
and the American Soybean Association all disagree.

They said they still see the benefits of the genetically modified crops and 
believe existing safety measures by the Animal Plant and Health Inspection 
Service can prevent harmful contamination of the food supply.

"Plant-made pharmaceuticals offer tremendous benefits in preventing and 
treating diseases," farm bureau President Bob Stallman said.

Soybean association President Dwain Ford said he was encouraged by how 
quickly the Agriculture Department last week cracked down on the two 
situations, placing the possibly contaminated crops under quarantine.

"Their monitoring procedures prevented the affected soybeans from moving 
beyond the single elevator where they were first stored, and that all 
soybeans that may have been commingled with the ProdiGene corn product will 
be destroyed," Ford said, of the Nebraska soybean incident.

The corn growers group noted its input has been sought during the past two 
years to develop safety regulations and policies related to the testing and 
production of pharmaceutical proteins in corn.

                                  PART II
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TITLE:  ProdiGene nears deal on quarantined soybeans
SOURCE: Reuters, by Christopher Doering
DATE:   Nov 18, 2002

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ProdiGene nears deal on quarantined soybeans

WASHINGTON - ProdiGene Inc. said it was close to a deal with federal 
regulators on how to dispose of some 500,000 bushels of quarantined 
soybeans in Nebraska that were accidentally contaminated by an experimental 
corn variety the biotech firm engineered to produce medicine.

 "We are in active discussions with USDA," said Anthony Laos, chief 
executive of privately held ProdiGene.

"We hope to get that settled today or Monday. We want to get this behind 
us," Laos told reporters.

A spokeswoman for the U.S. Agriculture Department's Animal and Plant Health 
Inspection Service said the discussions were ongoing, but was uncertain 
when an agreement would be reached.

ProdiGene is suspected of contaminating corn fields in Iowa and soybeans in 
Nebraska with residue from an experimental corn variety engineered to 
produce pharmaceuticals. The bio-corn - which is grown to produce trypsin 
and another compound to treat diarrhea - has not been approved for human or 
livestock feed.

ProdiGene would like to channel the quarantined soybeans into bio-diesel to 
recover some of the costs of buying the 500,000 bushels - more than $2 
million, based on the $5.60 per bushel price of soybeans on the Chicago 
futures market. Cindy Smith, the USDA's acting head of biotech regulations, 
said last week ProdiGene was expected to buy the soybeans and destroy them.

Laos said that if Texas-based ProdiGene would sell the soybeans for non-
food use, ProdiGene would still lose "a couple hundred thousand dollars or 
more." ProdiGene also could face fines of up to $500,000 if it violated 
federal regulations for experimental field trials of new crops.

The USDA quarantined the soybeans in Nebraska after discovering the 
possible contamination during harvest last month. Investigators suspect the 
contamination occurred when a small amount of ProdiGene's corn plants mixed 
in with soybeans subsequently grown on the same field and adjacent fields.

In Iowa, the company was ordered to destroy 155 acres (63 hectares) of corn 
in September because windborne pollen from its bio-corn may have 
contaminated nearby fields.

Laos said ProdiGene will shift its plantings next year to areas farther 
from fields where food crops are grown. He did not specify the distance.

ProdiGene also will hire more of its own inspectors to ensure compliance 
with federal regulations, he said.

Laos said ProdiGene will continue its focus on developing bio-pharm 
products, and said that while any financial impact from the pending 
investigation may hurt the company, it will not have a long-term impact.

"How this will be handled will be a strain on ProdiGene," said Laos, who 
said he took full responsibility for the company's recent problems.

"But it will not put us out of business," he said.

                                  PART III
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TITLE:  CSPI on Possible Permit Violations by ProdiGene
SOURCE: Centre for Science in the Public Interest, USA, by Gregory Jaffe
DATE:   Nov 15, 2002

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CSPI on Possible Permit Violations by ProdiGene
Statement of CSPI Biotechnology Project Director Gregory Jaffe

The permit violations by ProdiGene, Inc., as well as the permit violations 
Environmental Protection Agency uncovered earlier this year for genetically 
engineered crops grown in Hawaii, provide ample evidence that the 
biotechnology industry cannot be trusted to meet its obligations of 
safeguarding the food supply and environment. The new infractions are 
especially troublesome because the unapproved crops made it so close to 
entering the food chain.

To prevent future violations, the federal government needs to put in place 
a robust inspection and enforcement program that ensures that permit 
conditions are adhered to. This time USDA’s inspection program was able to 
catch ProdiGene’s violations before unapproved corn entered the food 
supply, but it is unknown whether similar violations have gone undetected.

If the biotechnology industry continues on its path of producing 
pharmaceuticals and industrial chemicals in food crops such as corn and 
canola, the Food and Drug Administration should have a mandatory premarket 
food-safety approval process before those crops can be grown in the field. 
That would ensure that no person will be exposed, even inadvertently, to 
any harmful substances if permit conditions are violated or containment is 
less than 100 percent.

In addition, USDA needs to increase the transparency of its regulatory 
process and enforcement activities. The alleged violations occurred weeks 
ago, yet the public has still not been adequately informed about the nature 
of those violations or the actions taken by the government to contain 
problems resulting from those violations.

The enormous promise of agricultural biotechnology will not be realized 
unless robust and sensible regulatory systems ensure the safety of products 
in an open and transparent manner. The message to consumers from the 
ProdiGene problem is that the current regulatory system is far from 
achieving that goal.


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