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Some Food for FDA Regulation

THE NATION | BIOTECH

January 07, 2001|Barbara Keeler and Marc Lappe | Barbara Keeler is a medical writer. Marc Lappe, former head of California's Hazard Evaluation System, is the author of "Against the Grain" and director of the Center for Ethics and Toxics

WASHINGTON — Despite consumer pleas, the Food and Drug Administration has declined since 1992 to require that genetically modified food seeds be proved safe for consumption before their release into the food supply. Nor does the FDA require ingredient labels for genetically modified foods. Instead, the agency encourages producers to voluntarily submit safety data. Its rationale is that genetically modified foods are substantially equivalent to their conventionally grown counterparts. In other words, food is food, and according to food and drug law, foods are presumed safe.

The flaw in this policy is that the presumption of equivalence does not rest on a substantial body of research comparing genetically modified and conventional foods. Far from being confirmed by extensive research, this presumption is challenged even by the producers themselves, notably in a study that Monsanto conducted on one of its biotech foods. Rather than prove safety, this study raised red flags that should have prompted researchers and the FDA to call for more testing. Instead of requiring further testing, the FDA allowed the most commonly consumed genetically modified soybeans, which are produced by Monsanto, to flood the market and rapidly pervade the food supply.

To create its soy, Monsanto scientists spliced a gene from a bacteria into a soybean seed that instructed it to grow even when sprayed with Monsanto's potent weed killer, Roundup. Accordingly, when Roundup is sprayed on soy fields, Monsanto's Roundup Ready soy plants are left standing while nearly everything else is smoked. This strategy is not exclusive to Monsanto. The most common genetically modified foods that the FDA regulates tolerate a specific herbicide manufactured by the company engineering the seed. Consumers don't benefit, but sales of the companies' herbicides soar.

Herbicide-tolerant plants survive weed killers, but what about the health of consumers who eat genetically modified beans? According to the FDA's 1992 policy, Monsanto was not required by law to prove the safety of its beans to the FDA before marketing Roundup Ready soybeans. This regulatory effect must be corrected. Toward that end, legislation compelling the FDA to require premarket proof of safety for all genetically modified food seeds should be passed.

Monsanto did turn over a study to the FDA in 1994. Eventually published by the Journal of Nutrition in March 1996, the study claimed to prove that Roundup-tolerant soybean seeds are equivalent to con- ventional ones. But combined data from the study's three experiments showed significant differences in fat, carbohydrates, ash and some fatty acids. Also, the brain-boosting vitamin choline was 29% lower in Roundup Ready lecithin, which is commonly used as a source of choline.

Monsanto's researchers decided in advance to test Roundup Ready soybeans that would differ in important respects from the beans people would eventually eat. While both the tested beans and those on the market carried the Roundup-tolerant gene, the Roundup Ready beans now common in food products were actually treated with Roundup; the ones Monsanto tested and fed to animals were not.

Beyond differences in nutrient content, the findings also raised questions about allergens. Allergic reactions are most commonly triggered by undigested proteins. One table in Monsanto's study shows that, relative to conventional soy meal, raw Roundup Ready soy meal contained 27% more trypsin inhibitor, a potential allergen that interferes with protein digestion and has been associated with enlarged cells in rat pancreases. This important measurement was camouflaged in a table on unrelated information.

Because its policy does not require premarket proof of safety or equivalence for genetically modified food, the FDA had little basis for rejecting the study's results. Perhaps more important, the FDA did not see all the data, specifically, that from Experiment 1, the first of the study's three experiments. According to FDA representatives, the agency did not ask to see the data.

What did the omitted data show? Significantly lower levels of protein and one fatty acid in Roundup Ready soybeans. Significantly lower levels of phenylalanine, an essential amino acid that can potentially affect levels of key estrogen-boosting phytoestrogens, for which soy products are often prescribed and consumed. And higher levels of the allergen trypsin inhibitor in toasted Roundup Ready soy meal than in the control group of soy. Even more unsettling was one measurement of trypsin inhibitor in toasted Roundup Ready soy meal that exceeded what the authors reported as the highest levels measured for soybeans by other researchers. After a second toasting, the levels of another allergen, called lectin, in Roundup Ready soy meal, were nearly double those in conventional beans.

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