Apr. 12, 2001 (UPI) -- Food biotechnology giants Monsanto and Syngenta are applying to the U.S. Environmental Protection Agency for permission to continue to sell their genetically modified (GM) corn seed to farmers. The GM corn contains genes from bacteria that produce a pesticide fatal to the European corn borer pest but is believed to be harmless to humans. The Monsanto and Syngenta Bt corn registrations expire September 30, 2001. The EPA will issue a report on its review by July and invite public comment.

The debate can be lively. GM corn has caused concerns on a number of fronts amid increasing worry that genetically modified foods may cause human allergic reactions. This concern has intensified because of contamination of non-modified corn crops by modified corn pollen. Most corn-based foods in the United States have some GM corn in them, even though modified corn was only planted commercially for the first time about five years ago. Even corn grown as organic is often contaminated by GM corn in very minute amounts by corn pollen that travels on the wind.

Many foods that have been genetically modified to produce pesticides undergo extensive toxicity testing and must obtain EPA approval. About 50 crops have been approved by the Food and Drug Administration (FDA) through a currently voluntary process that does not involve toxicity testing.

Products that have been approved by the EPA include corn, cotton (some cooking oil is produced), potatoes, squash, watermelon, and papaya. No physically harmful effects have been demonstrated from GM corn grown for human use.

Ironically there is the possibility that the very genetic changes made to fight the European corn borer -- and causing anxiety -- may over time cause the corn borer to become resistant to the pesticide. If that were to happen, the amount of increased damage to crops could be substantial. GM corn contains genes from Bacillus thuringiensis or Bt, a bacterium that has been sprayed on crops for more than 30 years to discourage the corn borer.

In the moth stage, the European corn borer lays eggs between the early leaves and the stalk of the corn plant. The larval worms grow there, protected inside the stalk, interfering with water transport inside the corn and reducing crop yields, sometimes dramatically. When the developing larvae eat Bt corn, their digestive tract is paralyzed by a protein made by the Bt gene causing the death of the borer. Resistance occurs when only corn borers susceptible to the bioengineered pesticide in the plant die, allowing those corn borers who are inherently resistant to thrive and multiply.

In light of ongoing concerns, two scientific panels have called for a tightening of the EPA review and monitoring process. The National Academy of Science report on Genetically Modified Pest-Protected Plants noted that there was not "any evidence that foods on the market are unsafe to eat as a result of genetic modification."

However, the report called for the following: development of a general policy that would go beyond current efforts regarding the management of resistance in targeted pests; tighter review of effects of plant incorporated pesticides on nontarget species; better surveillance to detect genes escaping to other organisms; monitoring long-term impacts; and, heavily emphasized, developing improved methods for identifying potential allergens.

A separate government Scientific Advisory Panel convened by statute, said in its report Bt Plant Pesticides Benefits and Risks Assessment, that the EPA needed to do a more comprehensive assessment of allergenicity. The panel recommended specific improvements in the EPA pest resistance management strategy.

The comments from both scientific panels are in line with the criticisms levied by consumer groups and environmental organizations that biotechnology has outstripped the regulatory process.

Janet Andersen, director of biopesticides and pesticide pollution prevention at the EPA, addressed the issues of allergen testing and testing for possible teratogenicity (potential degree of harm to a fetus).

"The proteins that we have approved break down rapidly in the human digestive system and the proteins involved are searched carefully to see if they make any kind of allergen. The animal models are not there yet for allergen testing. . . . Teratogenic testing is not out of the question if the right kind of compound came along and raised a red flag," Andersen told UPI.

Andersen said the development of European corn borer resistance is monitored carefully. "The program goes heads and tails beyond any other insect resistance management program," she said. However, many individuals and food companies still reject the technology of bioengineered foods and the corn continues to be banned by a number of countries.

Charles Margulies, a bioengineering specialist for Greenpeace, told UPI: "The Bt crops and all of the biotech crops should never have been allowed into the environment or our food supply. We should have agricultural research and development into directions that really can provide us with sustainable food solutions."

"The biotechnology approach is unsustainable because it is inherently unpredictable. You're inserting genes into species that never could have been produced by traditional breeding and releasing these crops into the environment without regard for the potential side effects in the environment."

A spokesperson for Monsanto, Mark Buckingham, asked about the allergenicity issue, said: "We are very confident that the regulatory regime is very thorough. The testing is extremely thorough. All biotech products on the market have gone through extremely careful screening." Regarding the development of corn borer resistance to Bt pesticides, Buckingham said "there isn't a resistance issue. There is an insect resistance management plan in place. The industry, including Monsanto, completely supports that and has done so since Bt crops were introduced, and so do growers and that is unique to biotech. . . . We believe it will be effective."

Commenting on the contamination of non-Bt corn, Buckingham said "if particular purity is desired, then the techniques for growing those kinds of crops are well known."

Asked why some people reject GM foods, Buckingham said it was basically because of "a lack of understanding."

She said the Americans seemed more willing to eat GM food than Europeans because they had "more confidence in the (U.S.) regulatory system."

However, Jane Rissler, biotechnology expert for the Union of Concerned Scientists expressed concerns. "One of the major issues is how to do the testing. And I don't think either EPA or FDA has taken on the responsibility to figure that out. The FDA in particular has decided that for the most part food safety testing should not be required and so they have not developed any advice on how these tests should be done. . . . They talk about allergenicity testing where the methodology doesn't exist. One of the messages is that the technology has moved faster than the ability to do the safety testing. The products shouldn't be approved until they've developed appropriate methodology for testing," Rissler said.

Steve Johnson, an EPA official said scientific data supported the resistance management approach that the agency had in place. But biotech consultant Charles Benbrook said "the current resistance management plan . . . will probably delay the resistance by some number of years but I'm not convinced that (it is) satisfactory to prevent it." Novartis, all divisions, had sales of $21 billion in 2000, $4 billion in now spun-off Syngenta agribusiness and seeds, while Monsanto took in $5 billion.

Copyright 2001 by United Press International.