Meeting on the Safety and Labeling of Genetically Modified Organisms

Statement of Michael F. Jacobson, Ph.D., Executive Director, Center for Science in the Public Interest to the Food and Drug Administration, Chicago, Illinois • November 18, 1999

“Monsanto should not have to vouchsafe the safety of biotech food.... Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job”

  • —Phil Angell, Director of Corporate Communications, Monsanto, quoted in New York Times Magazine, October 25, 1998

“Ultimately, it is the food producer who is responsible for assuring safety.”

  • — FDA, “Statement of Policy: Foods Derived from New Plant Varieties”
    (GMO Policy), Federal Register, Vol. 57, No. 104 (1992), p. 22991

    Thank you very much for the opportunity to participate in this meeting. CSPI is a nonprofit consumer-advocacy organization that has focused on food safety and nutrition. A decade ago we led efforts to win passage of the Nutrition Labeling and Education Act. More recently, we have worked hard to obtain greater funding and greater authority for the FDA and USDA to fight food poisoning. CSPI is funded largely by foundation grants and our almost one million members; we do not accept funding from industry or government.

   Genetic engineering is a powerful technology. Used properly, it could greatly benefit farmers, consumers, and the environment. It holds out the promise of increased yields, reduced use of pesticides, and greater nutrition. But, if misused, it could cause great harm. GM foods currently on the market do not appear to endanger (or benefit) consumers, though GM crops certainly raise ecological concerns. Most consumers know little about biotechnology. However, increasingly partisan propaganda on all sides rapidly may replace ignorance with confusion. In such an environment it behooves government — as well as industry — to build long-term public confidence by establishing rules that err on the side of caution in protecting the environment and ensuring safety and choice to consumers.


   No obvious health problems have resulted from consuming biotech foods, but it would be difficult to know if GM foods in fact have increased (or decreased) disease rates. Immunotoxic or neurotoxic problems due to newly introduced genes could be particularly difficult to identify. Still, there is no reason to doubt the safety of any biotech foods on the market.

   One obvious concern about GMOs is that they might cause allergic reactions. In one prominent case, a company added to soybeans a Brazil-nut gene for a known allergen. Thanks to appropriate testing, the problem was discovered and the company never marketed the product. The FDA strongly encourages, but does not require, companies to conduct studies when a gene is transferred from a plant that is known to be a common allergen. Importantly, the Brazil-nut allergen gene was identified only because the allergen was known and could be tested for. But what if a protein newly introduced into the food supply causes occasional allergic reactions? Or if a new gene did not encode an allergen, but turned on dormant genes that did code for allergens? Or if a protein led to a behavior disorder, interfered with a medicine, or had other subtle effects? It would be difficult to identify such problems before or after marketing.

   Another concern is that levels of naturally occurring toxins, such as solanine, might be increased in GM versions of plants. The FDA encourages companies to screen for such substances, but does not require them to do so and report to the FDA the results of their studies. It may be unlikely, but is not inconceivable, that a genetically engineered food would engender a novel toxicity, as suggested by the recent study, published in The Lancet, of biotech potatoes.

   Risks of allergic reactions may be small, but are real; other risks may be speculative, but are not non-existent. The possibility of requiring routine toxicity studies should be considered; at the very least more research in this area should be conducted.

   Currently, the FDA asks, but does not require, companies to submit data only when biotech crops contain gene products from plants that commonly cause allergies or contain genes that code for novel proteins, though apparently companies are consulting with the FDA about every GMO. That kind of voluntary system does not inspire maximum public confidence in the safety of a powerful new technology.

   We urge the FDA to review the safety of every GMO before it is marketed. The FDA could require differing amounts of information depending on the product. For instance:

  • For GMOs made from gene transfers between closely related species, or if the donor organism is a traditional food and does not cause allergies, only notification and provision of specified summary data would be required. The FDA, during a review period of specified duration (say, 60 to 90 days), could demand more information, if it wished.
  • For GMOs containing genes from an organism that causes allergic reactions, thorough testing for allergenicity would be required. GMOs containing a gene for a common allergen would not be allowed.
  • For GMOs in which gene products were different from traditional foods or were present in significant quantity, food-additive petitions and more extensive safety testing (possibly including animal feeding studies) would be required.

   In the 1970s, recombinant-DNA laboratory research was new and highly controversial. A rigorous safety system was implemented, allaying public concerns. The same approach should be taken with genetically modified foods. We recognize that it is impossible to prove absolute safety, but consumer confidence in genetically engineered foods would be maximized if the FDA implemented a mandatory pre-approval process.


   A second key issue is labeling. Labeling, of course, should not be a substitute for safety; every biotech food should be safe. Yet, even assuming that biotech foods are as safe as conventional foods, several considerations indicate the need for labeling:

   For people with multiple or severe allergies, or with general safety concerns, GMOs raise warning flags. Those people fear that foods they were always able to consume might harbor new substances to which they might be sensitive.

   Second, many people are troubled by potential ecological effects of GMO crops, such as harm to wildlife or promotion of pesticide-resistant insects or weeds.

   Vegetarians and people with certain religious beliefs may wish not to consume foods containing gene products derived from animals. Other people believe it is simply unethical to move genes between distant species, such as putting a gene from an animal into a plant.

   Regardless of what one thinks of the validity of those concerns, labeling would enable those consumers to avoid biotech foods. Labeling is supported by most Americans, according to public-opinion polls.

   The FDA should adopt a strict definition of the term “GMO-free” and allow marketers of foods that meet that definition to make a label claim. The FDA also should require foods containing significant amounts (say, more than 1%) of biotech ingredients to disclose that fact on labels. If such a food contains a possible allergen, the label should indicate the food from which the genes were obtained (for example, “contains [food] protein”). Furthermore, any significant reductions in nutritional value or significant changes in sensory characteristics should be indicated on labels.

   One concern that is raised by GMO labeling is that it might mislead some consumers into thinking that GM foods are significantly less safe, or that GMO-free foods are significantly more safe, than other foods. The FDA should conduct consumer research to assess whether additional explanatory language might be appropriate.

   In summary, biotechnology could offer real benefits. Whether those benefits are realized depends, in part, on whether the FDA establishes new approval and labeling requirements that maximize public confidence.

Thank you once again for the opportunity to present CSPI’s views.