THE LABELING LOGIC

No Labels, No Tests, No Problem Says FDA

Charles Margulis is a Genetic Engineering Specialist with Greenpeace.

In January 2001, the Food and Drug Administration (FDA) issued two new proposals for genetically engineered food. Neither proposal makes any significant change from the agency's 1992 position. In 1992, FDA's policy allowed unlabeled, untested gene-altered foods into our diets and environment for the first time. Even before then, scientists, doctors and the American people criticized FDA for allowing this mass food experiment.

The first of the new FDA proposals is an agency rule that still fails to require any pre-market safety testing of genetically engineered (GE) food. The rule only requires that companies notify the agency before bringing a new engineered food to market. Instead of mandatory testing and review, FDA will allow GE foods on the market with no comprehensive scientific review.

The second proposal outlines agency guidelines for food companies who wish to "voluntarily" label their products. While agency guidelines do not have the force of law that an FDA rule would have, the net effect of the guidelines will be the same: responsible food companies who avoid GE food will have a difficult time labeling their non-GE products, while thousands of unlabeled GE foods will remain on our supermarket shelves.

Guidelines for No Labeling: Don't Ask, Can't Tell

In just the past few years, the food and biotech industry's refusal to keep GE soy, corn and other crops separate throughout the food chain has brought us thousands of foods in our supermarkets made with ingredients from these gene-altered crops. Despite massive public support for labeling, FDA has refused to require labels on any of these GE foods. Since genetic engineering first appeared in our food, any company could have "voluntarily" labeled their GE foods. Yet there is not a single GE food that has been voluntarily labeled, since food-makers are aware that consumers don't want GE food.

Now the FDA proposes guidelines for "voluntary" labeling. But if no food company has yet instituted voluntary labels on GE foods, what good are these new guidelines? FDA's guidelines are not intended to encourage food companies to label their GE foods, but to threaten responsible food companies who avoid GE food and who wish to label their non-GE products.

This is not the first time FDA has used this strategy to favor the biotech industry over consumer protection. In 1993, when Monsanto brought its genetically engineered cow drug, bovine growth hormone (BGH) to market, FDA published guidelines (written by an agency official who formerly worked as a lawyer for Monsanto) that warned milk and dairy producers that "No BGH" labels would be misleading. Several dairies and food companies, including Ben & Jerry's and Stonyfield Farms yogurt were sued for informing their consumers with "No BGH" labels.

The agency's new guidelines on GE food suggest that food producers who label non-GE products could be misleading consumers about their foods, since FDA claims that GE foods are equivalent to non-GE foods. FDA says food producers should not label products as "non-GE," since that could be misleading. But FDA does not find it misleading if GE foods are unlabeled. The agency says that there is no "material" reason that GE foods should be labeled.

Material Information for Consumers' Right to Know

FDA claims that since genetically engineered foods are equivalent to their natural counterparts, there is no "material" justification for requiring labels. A change in the nutrition or the use of one of the most common allergens by genetic engineers would trigger labeling, says the agency. To date, FDA has found no such cases, so no engineered foods are required to be labeled.

What is a "material" change to FDA? Any "performance changes" in food, such as changes in the foods' physical properties, flavor characteristics, functional properties or shelf life have been categorized as "material" information that must be communicated to consumers via labeling. Almost all of the engineered crops in the U.S. have been altered for insect resistance (plant foods that contain a built-in pesticide that remains in the food after harvest) or for tolerance to toxic herbicides. In both cases, the GE foods are altered for specific functional changes, yet FDA refuses to acknowledge that these are material changes about which consumers have a right to know.

The agency has stated that selling irradiated food without labels would mislead consumers, since that would falsely represent to consumers that the food was not so processed. To be consistent, one would expect that FDA would also rule that unlabeled GE foods would mislead consumers, since this would lead them to believe that the food was not so altered.

Yet FDA holds a completely opposite view on genetically engineered food. In an Alice-in-Wonderland twist, the agency maintains that no labels are needed on foods made with gene-altered ingredients, but natural foods labeled as "not genetically engineered" could be misleading. In FDA's Wonderland, a consumer who buys an unlabeled tomato has a right to expect that the tomato is not irradiated, but no right to expect that the tomato is not genetically engineered.

Also, when it required labels on irradiated food, FDA noted that labeling could be required even if there were no significant changes in the food. FDA said that the fact that the food had been irradiated could be "material information" to consumers who desire such information. Clearly the vast majority of Americans desire labeling of genetically engineered food. Even a biotech industry poll found that 93 percent of Americans want labels on engineered food, and FDA's own focus groups found that "Virtually all participants said that bioengineered foods should be labeled as such. ..."

No Safety Testing: Don't Look, Don't See

To defend its failure to require pre-market testing, FDA claims that none of the gene-altered foods currently on the market are different than their natural counterparts in any nutritional or other meaningful way. But FDA refuses to acknowledge scientific differences between genetic engineering and traditional food production, and so by failing to look for changes, it falsely claims there are none.

FDA's failure to require safety testing of genetically engineered food is premised on two fundamental elements that contradict science and/or federal law. They are:

• That genetically engineered foods are "generally recognized as safe" (GRAS); and
  
  
• That genetically engineered foods are no different from foods produced through traditional breeding.

... endanger the health of millions by using an untested additive for as long a time as it may take for the government to suspect the deleteriousness of this additive, schedule research into its properties and effects, and, finally -- perhaps years later -- to begin the years-long experiments needed to prove the particular additive safe or unsafe.

Clearly the intent of the law is to require the developer of a new food ingredient to provide evidence of the safety of that food before it is allowed on the market. Yet FDA has allowed genetically engineered ingredients into the diet of millions of consumers without testing, despite the fact that these foods contain genetic material never before seen in the human diet.

An exception to the rule of food additive testing is for substances that are "generally recognized as safe." GRAS substances are defined as "... having been adequately shown through scientific procedures to be safe under the conditions of its intended use." GRAS can also apply to substances used safely in foods prior to 1958. Clearly, genetically engineered foods were not in use prior to 1958, so FDA must be relying on "scientific procedures" demonstrating their safety if it believes GE foods are GRAS.

However, the opposite is true. FDA's own scientists have warned that there is not enough scientific evidence to conclude that genetically engineered foods are GRAS. A general consensus among scientific experts is supposed to be the basis for finding a substance to be GRAS. But even FDA's lead Biotechnology Coordinator acknowledged in 1991 that "... there are a number of specific issues addressed in the [FDA policy] document for which a scientific consensus does not exist currently." He went on to note that allergies in gene-altered foods and the need for toxicity tests were among the issues of scientific concern.

Similarly, other scientists have warned of the lack of safety data on genetically engineered foods. Writing in Science magazine, one researcher noted that a survey of all available peer-reviewed literature on the subject found just seven studies on the health effects of gene-altered foods. A report from an expert panel commissioned by the Royal Society, Canada's most eminent scientific body, found recently that there are no "... validated study protocols currently available to assess the safety of GM [genetically modified] foods in their entirety (as opposed to food constituents) in a biologically and statistically meaningful manner."

Genetic Engineering Versus Traditional Breeding

Another pillar of FDA's policy is the assumption that the process of genetic engineering is merely an extension of traditional breeding, and that gene-altered foods have been shown to be "substantially equivalent" to their natural counterparts.

But again, FDA's policy contradicts the findings of its own scientists. Writing a summary of the agency's experts' opinions, a senior FDA scientist found: "The [draft policy] document is trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices ... [but] the processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." Another FDA scientist wrote: "We should also keep in mind that plant genetic engineering is an entirely new adventure with potentially new effects."

Because genetic engineering uses genes that breeders never have used, in ways that breeders never have used, to create organisms that breeders could never create, FDA scientists found that the potential of the technology "... is beyond the realm of possibility of standard breeding practice. The food safety of organisms derived from recombinant DNA technologies do not have the history of the safe use that has come to be associated with organisms derived by standard breeding practices." While FDA continues to falsely assert that the genes used in GE crops are well-characterized and common in food, in fact the technology allows the use of novel genetic material in cross-species combinations to produce foods that have never before been part of our diet or our environment.

Still, FDA says that biotech companies have shown that their products are "substantially equivalent " to natural foods. Since gene-altered foods are equivalent, the agency says, it would be an unfair burden to require more testing or labeling than would be required for the traditional counterpart.

But there is no scientifically agreed upon procedure to measure "substantial equivalence." FDA found that Monsanto's gene-altered soybeans were equivalent to natural soy. Yet tests showed the genetically engineered beans had significantly lower levels of protein and one fatty acid, significantly lower levels of phenylalanine, an essential amino acid, and 27 percent more trypsin inhibitor, a potential allergen that interferes with protein digestion and has been associated with enlarged cells in rat pancreases. Since "substantial equivalence" is not a scientific concept, FDA overlooks these and other statistically significant differences between natural and gene-altered foods.

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