Some Food for FDA Regulation

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

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.


Monsanto also conducted a study of the effects of consuming its genetically modified beans, which was also presented to the FDA. Besides possible allergic reactions, what might be expected from consuming higher levels of trypsin-inhibitor and lectin? Slower, or lower, growth, for starters. That is what happened to male rats fed unprocessed meal from Roundup Ready soybeans. Compared with controls, cumulative body weight gains were significantly lower in male rats fed Roundup Ready soy. Although the growth of dairy cattle was not affected, higher levels of fat were measured in the milk of cows fed Roundup Ready soy meal.

These analyses did not reveal all the differences between Roundup Ready and conventional beans. In May 2000, Monsanto reported to the FDA the discovery of a genetic surprise package in its soybeans. When company scientists spliced the Roundup-tolerant gene into the bean, they accidentally threw in two extra gene fragments. Not to worry, according to Monsanto representatives: The gene fragments were contained in the Roundup Ready beans approved by the FDA in 1994 and have been consumed nearly worldwide ever since.

But this discovery further challenges the presumption of equivalence between genetically modified and conventional foods, while undermining the contention that genetic engineering is precise or predictable. Even so, the genetic hitchhikers, like the red flags in the 1994 study, were barely mentioned in the U.S. media and did not appear to raise FDA concern.

Do Monsanto’s own findings prove that Roundup Ready soy products will slow or stunt growth in animals and children, or change the fat content of milk in cows and breast-feeding mothers? Of course not. Do they prove that all Roundup Ready soy will always contain more allergens and less protein? No.

But the studies do confirm that transgenic foods need rigorous testing--by someone other than the affected industries and the researchers they fund--before they’re released into the food supply. They also suggest that consumers may not be adequately protected when the FDA leaves the question of biofood safety up to the companies selling the biofoods.

A promised and long-awaited revision of FDA biotech-food policy is expected to make some improvements in oversight, but as outlined in the agency’s press release, it is expected to fall far short of what is needed to ensure the safety of biotech foods. In drafting its 1992 policy, FDA representatives relied primarily on an opinion by FDA attorneys that food and drug law did not give the agency responsibility for labeling transgenic foods, and the relevant food and drug law has not changed.

Rep. Dennis J. Kucinich (D-Ohio) and Sen. Barbara Boxer (D-Calif.) have introduced legislation calling to alter this situation. The Genetically Engineered Food Safety Act, co-authored by Kucinich, provides for mandatory safety testing of genetically modified foods before they are released into the food supply.

Many food-safety activists target food manufacturers, food retailers and fast-food chains when demanding a recall of genetically modified foods. Given the pervasiveness of biofoods in the marketplace, and the challenges in detecting them, their time and energy would be better spent supporting legislation proposed to change regulatory policy that victimizes food manufacturers, retailers and consumers alike.