U.S. Regulators Monitor Safety of Bioengineered Food Products

By Michael S. Schechter
Washington File Staff Writer

Washington -- In the United States, the consumption of foods developed through advances in agricultural biotechnology has become exceedingly common in most households, though these genetically modified products have increasingly become a target of public interest groups and others questioning their safety and government regulatory procedures.

These foods reach consumers after rigorous self-examination from companies utilizing biotechnology in food production and from the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Together, they evaluate food supplies to determine if they are free of toxins and allergens.

Nearly all of the agricultural products common to the U.S. diet have been genetically modified through cross-breeding over the last few centuries. For example, botanists believe modern corn (maize) was developed from teosinte, a plant native to Central and South America. The "ears" of the teosinte plant are about two inches long and nearly flat, far different from the product eaten today. Without genetic enhancements, corn, a basic staple of millions of diets, would not exist.

Developments in genetic engineering now allow scientists to go beyond hybridization and to move genes with a level of precision never before known. Using the old methods, a farmer crossed two plants with desirable characteristics and hoped for the best. After waiting a decade or more to develop the new breed, the farmer probably discovered some unwanted traits in the new crop. The new laboratory techniques allow scientists to identify a part of an organism's genetic code, it's DNA, which produces a trait that may be valuable. This genetic sequence can be isolated and inserted into the genetic code of another organism, producing only the desired quality in the resulting product.

Monsanto Corporation, based in Missouri, has been a leader in agricultural biotechnology research and product development. It has developed, among others, Round-Up Ready Soybeans and Yieldgard Corn, which require less damaging farming techniques. Typically these products use less chemical pesticides and allow U.S. farmers to take advantage of environmentally sound agricultural practices, like no-till farming that requires very little cultivation while increasing yields per acre (2.47 acres are equal to one hectare).

At Monsanto, development of genetically enhanced foods begins with voluminous research. Scientists work to identify problems that plague food crops and create solutions to the viruses, weeds, and pests that destroy crops and ruin hundreds of millions of dollars of food each year. The research to produce a potential product and the extensive laboratory and field testing needed to ensure product safety mean that Monsanto has many years invested in each of its biotech products.

Russ Schneider, director of regulatory affairs at Monsanto, outlined the work that goes on at Monsanto to produce safe genetically engineered foods. In his Washington office pointing at a two-meter long bookshelf, filled end-to-end, Schneider identified the texts as all the lab data for just one biotechnology product.

"None of us would introduce a crop if we didn't think it was safe. We do eat here too," Schneider said. "I hate to be so blunt, but I'm a whole lot more concerned about my kids than anyone else."

Schneider estimated that it takes 40 to 50 scientists from four to five years to compile all the information necessary to demonstrate that one genetically engineered crop variety is safe. A central component of this examination is demonstrating that a new genetically engineered crop variety is essentially the same as the traditional variety, he said.

According to Schneider, proving a new crop, for example Round-Up Ready Soybeans, is the same as the traditional variety involves more than just examining the plant and doing laboratory tests for nutritional values. The new crops are fed to animals, such as cows, to determine not only if they are getting the same nutritional value, but also if it is digested and reacts with the animals' body in the same way.

Schneider, addressing the issue of new food allergies developing from genetically modified foods, said foods that cause allergic reactions usually fit a standard biochemical profile. Substances with high allergenicity are not easily digested in the stomach and will persist in a person's digestive tract for some time, he said.

Testing on the proteins used to genetically enhance foods shows that they do not have similar gene sequences to known allergens and they are digested almost as soon as they enter the stomach, he said. Foods that break down so easily are unlikely to cause allergic reactions.

Monsanto is responsible for all of the testing of these genetically-modified foods. Their data is given to either the EPA and the FDA, and in some cases, both agencies may review the material. The agencies have staffs of skilled scientists who review the testing data to determine whether the products might have any adverse impacts on humans . The reviews these government scientists conduct are peer-reviewed by at least two other, but often more, government scientists.

Plants Protect Themselves and the Environment

Janet Andersen, director of the EPA's Biopesticides and Pollution Prevention Division, says her division evaluates genetically modified plants that produce their own pesticides. Bacillus thuringiensis (Bt) Corn and Bt Cotton are examples of two such plants requiring EPA approval because they have been engineered to produce their own pesticide, reducing the need to spray fields with other pesticides, reducing costs and protecting the environment, according to industry and government experts.

Bt sprays were first introduced in 1961. Unlike chemical sprays, Bt is a microbial agent containing a living organism that kills certain insects that damage crops when eaten. Throughout the nearly 40 years of its use, Bt has been shown to have no ill effect on humans, even at concentrations thousands of times more potent than would typically be used in agricultural applications.

But with Bt corn and cotton, the plants produce their own control agent, eliminating the need for spraying. The success of these products has led to an effort to develop new products using new genetically engineered Bt protein; each must be tested to meet EPA standards for human health and environmental impact.

Critics have complained about FDA and EPA use of company-produced studies. Both FDA and EPA are quick to respond, pointing out that they thoroughly evaluate these studies.

EPA's Anderson is adamant about the validity of studies done by the companies themselves. "We have a strong belief in them. It's not like looking at a scientific journal... we look at every single piece of data and check it all out," she said. "We're looking at these studies in great detail. If we're not comfortable with a study, we won't accept it."

Food Safety and Principles of Freedom

James Maryanski, biotechnology coordinator at the FDA's Center for Food Safety and Applied Nutrition, heads up the group involved in the final analysis before genetically-engineered food is sold in food stores. While federal law does not require FDA review of every genetically modified plant, companies which produce any genetically-modified plant have all chosen to consult with the FDA..

U.S. law requires that additives placed in foods must be approved by the FDA before they are allowed to be sold. Most of the current breed of genetic modifications are not classified as additives by the FDA because they are among the thousands of proteins that are a normal part of the human diet. Others are Generally Regarded as Safe (GRAS) due to certain scientific characteristics. The companies engaged in food production make these determinations, but the FDA will intervene if presented with evidence that a particular product may be unsafe.

According to Maryanski, in 1994 the FDA had drawn up plans for a mandatory consultation process for GMO foods. The agency shelved the idea because companies involved in producing these new foods were choosing to err on the side of caution and conferred with the FDA voluntarily.

"We have operated on this voluntary basis, because companies are coming to us, because it's in their benefit to do so," Maryanski said. "And that could change if we find some reason why it would be more appropriate to have a mandatory requirement."

FDA's voluntary consultative process relies, in part, on market forces to ensure the food people eat is safe. Companies that put poorly tested and possibly unsafe products on the market will feel immediate consumer, non-governmental organization (NGO), and governmental pressure to reverse their actions. Maryanski said similar consequences would probably result from a company not participating in the FDA's consultation. The ultimate defense lies in the courts where consumers who believe they have suffered may bring lawsuits against the companies.

"The industry has the legal responsibility for the safety of the product," he said. "We provide guidance to the industry, so they know what kind of safety questions should be resolved."

Many of the critics of bioengineering and the entry of these foodstuffs into the marketplace focus their opposition on the process by which these products are created. But the FDA chooses to focus on the results, on the premise that bioengineering is scientifically sound. Relying on scientific fact and avoiding conjecture is what allows the FDA to have confidence in the safety of the U.S. food supply, according to Maryanski.

"We haven't found anything scientifically about the use of genetic engineering [that would cause us to think differently]," Maryanski said. "We treat them like other foods in the grocery store."

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