13 November 2002

SECRET U.S. "BIOPHARMS" - MORE THAN AN ACCIDENT WAITING TO HAPPEN

Plants genetically engineered to produce pharmaceuticals are being grown at over 300 secret locations in the US.

Maize, soy, rice and tobacco are among the crops engineered to produce drugs. Interestingly the report below says that no one involved in today's scandal will identify the protein in question. The proteins involved in the secret trials are designed to act as vaccines, contraceptives, induce abortions, create blood clots, produce industrial enzymes and propagate allergenic enzymes.

The majority of engineered biopharmaceuticals are being incorporated into maize. ProdiGene, the company at the centre of the current scandal has the most biopharma plantings and projects that 10 percent of the U.S. maize crop will be devoted to biopharm products by 2010.

Far from supporting containment strategies such as buffer zones, ProdiGene has told its shareholders it is hoping to "gain regulatory approval to lessen or abandon these requirements altogether".

[See the report, "Manufacturing Drugs and Chemicals in Crops: Biopharming Poses New Threats to Consumers, Farmers, Food Companies and the Environment": http://www.gefoodalert.org]

Even corporate agribiz is scared. As the Washington Post reports, 'Karil L. Kochenderfer, director of biotechnology issues at the Grocery Manufacturers of America, said last night that she was relieved the soybeans had been intercepted, but added: "This is exactly the situation the food companies have been concerned about." '

In fact, this is not just an accident waiting to happen. Without testing of all grain from related plant species there is no way of knowing whether this is an accident that is already happening. The US could already have a pharma-contaminated food supply.

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Soybeans Mixed With Altered Corn

Suspect Crop Stopped From Getting Into Food
By Justin Gillis
Washington Post Staff Writer
Wednesday, November 13, 2002; Page E01

The government has quarantined and will probably destroy hundreds of thousands of bushels of soybeans in Nebraska after inspectors found evidence that the crops were mixed with a small amount of genetically altered corn.

Inspectors for the U.S. Department of Agriculture caught the problem within 24 hours of harvest last month and stopped movement of the beans and corn before they entered the food supply, two senior government administrators said last night. But a small plot of the soybeans had been mixed at a commercial grain elevator with many bushels from other local farms. That made the entire harvest unsuitable for human consumption under government regulations.

The soybeans are thought to have been mixed with grains of corn that include a pharmaceutical or industrial protein not approved for human consumption. No one involved in the case would identify the protein in question last night, so it was unclear how harmful it might be if someone inadvertently ate it. Most proteins are rapidly destroyed in the human digestive tract, but a few can survive long enough to cause health problems.

The soybeans are likely to be burned or turned into fuel, government administrators said, and an investigation being conducted could result in civil or criminal penalties for the company, ProdiGene Inc. of College Station, Tex.

ProdiGene executives, who were attempting to reach a settlement with the government last night, issued a statement acknowledging "compliance challenges" at an unspecified company site.

"As with any new industry and new regulatory program, we can always do better," president and chief executive Anthony G. Laos said in the statement. "Working together with USDA, we intend to, now and in the future."

A senior administrator at the USDA, Cindy Smith, and another at the Food and Drug Administration, Lester Crawford, said they were highly confident that the food supply had not been affected.

The soybean mishap is reminiscent of a debacle two years ago in which a gene-altered corn variety called StarLink, which is not approved for human consumption, was used in millions of dollars worth of food products that had to be recalled.

The food industry and environmental groups have grown increasingly worried about attempts to produce pharmaceutical and industrial compounds by genetically altering plants and animals.

Much discussion has focused on the theoretical possibility that such plants could spread altered genes to food crops in nearby fields. The ProdiGene mishap also revealed that the small biotechnology companies conducting the research can't be relied upon to carry out the most elementary requirements of their government research permits, critics said.

A plot of ProdiGene test corn, genetically altered to make a protein not proven safe for human consumption, was grown on a Nebraska field in 2001. Ordinary soybeans were planted in the same field this year. Corn seeds left over from the year before sprouted and grew a small number of corn plants containing the protein. The company was supposed to check and ensure that those plants were removed before setting seed, but it did not, Smith said, even after USDA inspectors issued a timely warning.  Crawford and Smith, while acknowledging that the mishap should not have happened, said the case demonstrated that the government can regulate the new technology. Smith noted that federal law includes potentially severe penalties, including millions in fines and jail time for executives, for companies that break the rules.

"I'm very confident we can prevent these things from getting into the food supply," said Smith, acting deputy administrator for biotechnology regulation at USDA. "I think the message for us is that the system is working."

Critics were less certain.

"This technology is moving so much faster than the government is," said Jane Rissler, deputy director of food and environment programs at the Union of Concerned Scientists, an advocacy group in Washington. "So much of this regulatory scheme depends on the industry's actions, and we cannot trust them."

Much about the case remained unclear last night, including the exact size and value of the soybean crop, the location of the grain elevator in Nebraska, and ProdiGene's potential liability.

Biotech companies have learned to move genes, which encode instructions for making proteins, from one species to another. One application of the technology is to turn plants and animals into factories for growing protein-based drugs and industrial enzymes that would otherwise be expensive or impossible to produce. Even many people who see the potential benefit of the technology have argued that it should be used only in plants that are not grown as food, or in plants that don't spread pollen too widely.

The Biotechnology Industry Organization, a Washington trade group, recently announced that its members would not grow corn altered in that way in the Midwestern corn belt, or altered canola in the Canadian canola belt, a nod to food-safety concerns. Environmental groups and food processors have argued that the moratorium is too weak and that stronger government regulation is needed. Farm interests in Iowa, seeing a potentially valuable crop slip away, have complained that the policy "redlines" their state and should be scrapped.

Karil L. Kochenderfer, director of biotechnology issues at the Grocery Manufacturers of America, said last night that she was relieved the soybeans had been intercepted, but added: "This is exactly the situation the food companies have been concerned about."