My name is Rebecca Goldburg. I am a biologist by training (Ph.D.) and a Senior Scientist at the Environmental Defense Fund's (EDF's) New York City headquarters. I thank the Food and Drug Administration (FDA) for inviting me to speak today. Before I begin my remarks concerning FDA policy, I want to note that it is unfortunate that the FDA scheduled this public hearing during the World Trade Organization (WTO) Ministerial Meeting in Seattle, which is attracting enormous attention from nongovernment organizations (NGO's). As a result, a number of NGO representatives who might otherwise be at this hearing are now in Seattle.

In my brief remarks today I will comment both on the food safety and regulation of foods derived from genetically engineered crop plants, which I will refer to as genetically engineered foods. My comments are based on 13 years of involvement in environmental and food safety issues concerning the application of genetic engineering in agriculture. For example, in 1991, I coauthored a detailed proposal to FDA, entitled A Mutable Feast, in which the Environmental Defense Fund asked the agency to adopt regulations for genetically engineered foods. Currently, I serve in the National Research Council's "Committee on Genetically Modified Pest-Protected Plants."

Genetically engineered foods may pose risks to consumers

To consumers, most genetically engineered foods are essentially foods with added substances - usually proteins. This is because genes code for proteins, and when genetic engineers add a new gene to a crop plant they are in most cases adding a new protein to foods derived from the crop. For example, when a genetic engineer adds a bacterial gene to a tomato he or she is essentially adding a bacterial protein to that tomato. In most cases these added proteins will likely prove safe for human consumption. Nevertheless, just as with conventional food additives, substances added to foods via genetic engineering may in some instances prove hazardous.

A major concern about adding proteins to foods via genetic engineering is that they may cause susceptible individuals to become allergic to foods they previously could safely consume. Food allergies are a serious public health concern, affecting roughly 2.5 to 5 million Americans. Allergic reactions cause discomforts and in some cases can cause life-threatening anaphylactic shock. Since known food allergens are proteins, foods with new proteins added via genetic engineering could sometimes become newly allergenic.

This concern is real. One company has already dropped plans to commercialize soybeans with a Brazil nut gene after testing revealed the soybeans were likely to cause allergic reactions in Brazil nut allergic individuals.

Unfortunately, there is currently no predictive methodology for testing the allergenicity of most proteins introduced to foods via genetic engineering. Testing is only possible for proteins from commonly allergenic foods, such as nuts. Proteins from commonly allergenic foods can be screened for "antibody-antigen" reactions using blood serum available from individuals with common food allergies,. However, for most proteins, including those from foods that are not commonly allergenic and those from non-food sources such as bacteria, no such testing is possible. In other words, most proteins added to foods via genetic engineering cannot be tested for allergenicity. Instead, industry scientists simply screen the biochemical characteristics of proteins to see if they are consistent with the characteristics associated with allergens. It remains to be seen how effective such screening will be in protecting public health.

Extremely troubling, FDA regulators have failed to assume a leadership role in addressing the potentially serious food safety risks from allergens added to foods via genetic engineering.

Although FDA co-sponsored a scientific meeting on food allergy in 1994, the agency has not used its scientific resources to develop and publish guidance to industry on how to assess the allergenic potential of proteins. The Environmental Defense Fund urges that FDA develop such guidance. Given the existing uncertainties about assessment of potential allergens, guidance would be both helpful to industry and reassuring to consumers.

FDA's current policy concerning labeling of genetically engineered foods may not adequately protect public health. Food allergic consumers protect themselves from allergic reactions by avoiding those foods or substances to which they are allergic. Peanut allergic consumers, for example, do not eat whole peanuts and read food labels so that they do not ingest foods containing peanuts as an ingredient. In the case of genetically engineered foods, however, consumers may not be able to discriminate between genetically engineered foods that cause allergic reactions and other, non-allergenic foods. Most genetically engineered foods will look just like other foods, and FDA will only require labeling of genetically engineered foods under exceptional circumstances – for example, if there is evidence that a substance added to a food is allergenic. However, should an allergen added to a genetically engineered food not be detected by industry's current rudimentary screening procedures, allergic consumers would likely not be able to avoid foods containing the allergen. EDF urges that FDA reconsider its policy for labeling of genetically engineered foods not only as a matter of public information (as will be discussed by the next panel), but also to potentially help some consumers avoid exposure to allergens.

FDA does not appear to have taken significant steps to sufficiently improve the scientific understanding of food allergens to develop predictive tests for allergenicity. For example, I am not aware that FDA has pushed agencies within the Department of Health and Human Services to fund research on food allergy. EDF urges that FDA assume a leadership role in protecting consumers with food allergies by advocating support for scientific research that may result in a predict testing methodology for allergens.

FDA's policy for regulation of genetically engineered foods is inadequate to protect consumers

FDA’s current policy for genetically engineered foods, announced by former Vice President Dan Quayle in May 1992, as "regulatory relief," appears to do more to protect the biotechnology industry than to protect consumers. As stated above, most genetically engineered foods are essentially foods with added substances, usually proteins. FDA's policy gives manufacturers who use genetically engineering to add substances to food considerably more discretion than manufacturers who use other technologies to add substances to food.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA's current regulations, a food is "adulterated" if it contains an added substance, unless either:

a. FDA has approved the safety of the substance by issuing a specific food additive regulation, or
b. The substance is generally recognized as safe (GRAS).

The upshot is that FDA requires that manufacturers have scientific evidence to support the safety of substances traditionally added to foods during food processing – for example sweeteners or thickeners.

In contrast, under FDA's 1992 policy, the agency will only require food additive petitions for substances added to foods via genetic engineering "in cases where safety questions exist sufficient to warrant formal pre-market review." In other words, FDA will only require data substantiating the safety of genetically engineered foods when there is already reason to believe the foods might be hazardous. This sharp move away from consumer protection is elaborated in FDA’s policy by a series of "decision trees" for industry decision-making -- a series of yes-no questions, such as "Is there any reported toxicity?" or "Does the biological function raise any safety concern?" Food producers are supposed to work through the decision trees and decide for themselves whether they need to consult FDA before they market foods obtained from genetically engineered crops. Thus, FDA’s 1992 policy thus appears to significantly weaken the long-standing requirement under food safety law that food manufacturers must establish scientifically the safety of new substances added to food before selling them to the public, regardless of whether the manufacturers think they are safe. In other words, FDA's policy strongly favors food manufacturers at the expense of consumer protection.

In response to the considerable public outcry that followed the publication of FDA's policy in 1992, the agency now recommends that manufacturers voluntarily consult with the agency before bringing genetically engineered foods to market. However, because these consultations are outside the regulatory system, they are not subject to public scrutiny and are not a satisfactory substitute for a regulatory program.

The Environmental Defense Fund (EDF) urges that FDA revise its 1992 policy to be more protective of consumers. In particular, we urge that FDA draft a new policy that would:

1. Subject substances added to food via genetic engineering to the same regulatory requirements as substances added to foods via more traditional means. FDA should squarely place the burden on industry to substantiate scientifically the safety of substances added to foods via genetic engineering.

2. Require manufacturers to consult with FDA before bringing genetically engineered foods to market. FDA does not now require such mandatory consultations for foods altered by more traditional means. However, at least for the near future, while genetically engineered foods are new and their potential hazards are not fully understood, it behooves FDA to require consultations.