Feds ignore evidence that biotech corn could cause allergies

SAN DIEGO, California, November 16, 2004 (ENS): Evidence that food allergies may be caused by corn genetically modified to produce its own insecticides has been ignored by the U.S. Environmental Protection Agency (EPA), according to a peer-reviewed scientific paper published by two U.S. scientists today.

The paper, “Safety Testing and Regulation of Genetically Engineered Foods,” documents fundamental flaws in how biotech companies test and the U.S. government regulates genetically modified crops. The authors raise serious questions about whether biotech foods, which have been on the market since 1994, are in fact safe, as claimed by the biotech industry and U.S. regulators. It is published in "Biotechnology and Genetic Engineering Reviews."

Lead author Dr. David Schubert is on the faculty of the Salk Institute of Biological Studies in San Diego, where he is head of the Cellular Neurobiology Laboratory and specializes in molecular genetics, cell biology, and protein chemistry.

“One thing that surprised us," he said, "is that U.S. regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review."

Instead, the U.S. Food and Drug Administration (FDA) has a voluntary consultation process when deciding whether or not permit marketing of genetically modified (GM) foods.

Companies that voluntarily consult with the FDA sometimes fail to respond to FDA requests for additional information. The FDA reviews “summary data,” not full studies, making a critical review impossible, the authors say. The FDA does not approve genetically modified crops as safe. The crop developers are made responsible for the safety of their products.

In addition, the authors found, when testing does take place, researchers use "surrogate GM proteins" for testing rather than the genetically modified plant-produced proteins that people actually consume.

The paper includes a comprehensive case study of two types of insecticide-producing genetically modified corn - Monsanto's MON810 variety and Syngenta's Bt11 variety. The study demonstrates how flawed testing and regulation permitted these varieties onto world markets despite evidence that they could cause food allergies.

The European Union recently approved 17 corn hybrids derived from MON810 over the objections of several European countries.

Dr. Schubert collaborated with co-author William Freese, a research analyst with Friends of the Earth U.S. with a BA in chemistry. Freese was part of the team that discovered GM StarLink corn, unapproved for human consumption, in the food supply. Schubert and Freese base their paper on nearly 100 sources, including little known U.S. regulatory documents and unpublished studies by biotech companies.

They found that the EPA "often fails to collect data for review of potential human health impacts and accepts substandard testing by biotech companies." The EPA has ignored evidence from independent researchers that conflicts with information provided by biotech companies.

Schubert and Freese found that the EPA raises the maximum permissible levels of herbicide residues on crops to facilitate introduction of herbicide tolerant genetically modified crops.

“In one case," said Freese, "the U.S. Environmental Protection Agency ignored a published study by a Food and Drug Administration (FDA) scientist suggesting that GM corn could cause food allergies, and instead asked Monsanto and Syngenta to essentially re-do FDA’s analysis.”

The authors advocate required testing of genetically modified crops. They say a science based testing regime would include long term animal feeding trials with the whole genetically modified crop to test for carcinogenic, reproductive and other adverse effects.

There would be testing for the potential of genetically modified crop compounds to cause mutations.

There would be testing for a full range of unintended effects with metabolic profiling, most important to allergy sufferers, there would be testing for allergenic potential according to strict, internationally accepted protocol.

But that type of testing is not likely to happen any time soon in the United States, Dr. Schubert told ENS. "It's very politicized," he said, " and there's a lot of input from the biotech industry. They initially wrote the laws a long time ago, and they control a lot of what's going on."

It would take new legislation to get required tested, and that is not likely, given today's political climate, Dr. Schubert said.

For people who are prone to allergies, Dr. Schubert says it is possible that drinking a beverage sweetened with corn syrup from genetically modified corn could cause an allergic reaction.

"The possiblity is there," he said. "The problem with allegies is it takes such a minute amount of material, especially that MON810. People have looked at that and the possiblity is there that this is allergenic, but the FDA ignored the evidence."

“The picture that emerges from our study of U.S. regulation of GM foods is a rubber-stamp ‘approval process’ designed to increase public confidence in, but not ensure the safety of, genetically engineered foods,” said Schubert.

For organic farmers trying to maintain the purity of their crops, genetically modified fields are "a serious problem," Schubert said. He suggests that the goal of genetically modified crop producers might be to saturate the system by getting so much GM material out there, that it is difficult to keep anything pure.

"I don't know if you can protect organic crops," he said. "There are rules on distance that genetically modified crops must be from other fields, but it is very difficult."

Even in the case of conventional crops, it is difficult to keep them from becoming contaminated with pollen from genetically modfied plants.

The U.S. Dept. of Agriculture (USDA) has not established rigorous rules to prevent this contamination, even when the contamination could lead to creation of difficult to control “superweeds,” the authors say.

Dr. Schubert is most concerned about biopharmaceuticals as a major problem for the future. "Those things can be deadly if they get into food crops, and eventually they will," he told ENS.

Biopharmaceuticals are proteins produced by living organisms that have medical or diagnostic uses.

The USDA permits cultivation of biopharmaceutical crops, despite two contamination incidents necessitating destruction of large quantities of corn and soybeans, the authors point out. The USDA does not test neighboring fields for GM contamination or require companies to supply test kits.

Nobody knows where the biopharmaceutical test plots are planted, as the USDA has allowed the companies to keep that information secret, citing fears of espionage, vandalism and civil unrest. However, a judge in Hawaii, which has more biopharmaceutical plots than any other state, has ordered that the locations of these test plots be made public.

When other scientists have criticized the biotech industry and the way it is regulated, they have drawn intense criticism themselves. Dr. Schubert says he is in a situation that enables him to present evidence untainted by politics. His primary research is medical, and he is not dependent upon the biotech industry for research funding.

"I'm in a unique situation, an old, tenured, senior faculty in a prestigious institution," he said. "I have freedom that younger people would not have."

The United States is the world’s largest exporter of genetically modified crops and accounts for nearly two-thirds of all biotech crops planted globally.

While the National Corn Growers Association says it supports "the positive contributions" of biotechnology as it relates to "human health, the environment, grain quality and production benefits," the association is insisting on tests to detect the presence the protein Cry9C, a modification of StarLink corn.

This protein, intended to be toxic to insect pests of corn, is believed to pose what the EPA calls a “medium likelihood” of allergenic risk to humans. It was approved in 1998 for animal feed, but found its way into taco shells and other food products. The foods were recalled, and the crop producer Aventis is not longer permitted to plant Cry9C modified corn.