Debate Over Genetically Modified Organisms (GMOs): Mandatory Labeling For Biotech Foods May Develop, Despite FDA's Position

Date: Mar 10, 2000

The controversy over genetically modified organisms (GMOs) and biotech foods is gaining momentum. The primary issue seems to be one of labeling. The ultimate objective of some is to kill this technology completely, and they see mandatory labeling as a way of doing this. The Food and Drug Administration (FDA) and the food and packaging industries must confront this issue of labeling genetically modified food products.

The Benefits

Genetic modification or bioengineering refers to new methods of plant breeding that permit scientists to improve food crops by introducing a gene for a specific trait into a particular plant. Advocates point to the long history of conventional genetic modification to support modern methods. They assert that the process produces not only safe food, but also more abundant and nutritious varieties. For example:

    • Inserting a gene from a specific bacteria (known as BT) into corn provides protection against a lethal type of caterpillar, reducing the need for chemical pesticides.

    • Similarly, biotechnology-produced rice incorporates beta-carotene to help prevent severe Vitamin A deficiency, which is a substantial cause of blindness in third world countries.

    • Biotechnology also helps reduce some plants' dependence on certain tilling methods that cause extensive soil erosion.

    • Increasing shelf life for certain fruits and vegetables through biotechnology helps reduce food waste.

The Supposed Risks

Opponents claim that the use of such technology is risky because genetic modification can introduce (into the food supply) genes from unrelated species with no history of use as part of the human diet. Although all will readily agree that there has been no demonstration of risk to human health, they are effectively spreading the message that the food industry is failing to protect consumer interests by not conducting long-term studies on the effects of genetically modified foods before selling them.

These opponents are the same proponents of GMO labeling and they've gained a stronghold in the European Union (EU) by carefully fomenting consumer anxiety about such products.

That controversy is now being felt in the U.S. and several food processors have recently issued position statements. At Gerber Products, Sheldon Jones, vice president of communications, says that "wherever possible" the company will not use biotech ingredients in its products, not because there's proof of any danger but just to distance itself from the debate.

Frito-Lay Inc. has also announced that it will not use genetically modified corn in any of its corn snacks.

Other companies, including agricultural giant Archer Daniels Midland, are encouraging suppliers to begin separating genetically modified crops from conventional ones.

In The International Arena

Governmental action on the development, use and labeling of genetically modified foods is much farther along in Europe and other parts of the world than in the United States.

For example, the EU just recently announced two regulations that address labeling requirements for genetically modified ingredients and additives. Commission Regulation 49/2000 requires labeling of ingredients derived from particular varieties of genetically modified soy beans and corn. Commission Regulation 50/2000 extends the labeling requirements to any food that contains an additive or flavoring ingredient derived from a GMO.

An unanswered question about the latter regulation is whether it covers (as food additives) packaging materials and adjuvants that may be derived from genetically modified plants.

Even international bodies are giving serious consideration to these issues, including the World Trade Organization (WTO) and bodies which consider standards for food such as the Codex Alimentarius. (See Regulatory Update, July 1999.)

If labeling provisions have the effect desired by their proponents, U.S. food producers could be hit hard. According to conservative estimates, about 50% of the 1999 U.S. soybean crop and one third of the U.S. corn crop contain transplanted genes. Thus, decisions made at the international level to regulate GMO products, no more than at the national level, could have serious consequences for international food trade.

Back In The USA

Precipitous labeling requirements are not now being considered by the U.S. government, which so far stands four-square behind the safety of genetically modified products currently on the market.

In the U.S., bioengineered foods are regulated by three federal agencies:

    • The Food and Drug Administration (FDA) is responsible for the safety and labeling of all foods and animal feeds derived from the crops, including biotech plants.

    • The Environmental Protection Agency (EPA) regulates pesticides, so any genetic modifications that reduce a plant's susceptibility to insects and the like fall under its jurisdiction as well.

    • The U.S. Department of Agriculture's Animal and Health Inspection Service (APHIS) oversees the agricultural and environmental safety of field testing genetically engineered plants.

The primary law that ensures the safety of bioengineered foods is the Federal Food, Drug and Cosmetic Act, under which countries have a legal obligation to ensure that any food they sell meets the safety standards of the law. This applies equally to conventional and bioengineered food.

Because genetic engineering only involves the addition of DNA to a plant that directs the production of a specific protein, the DNA that is added to the plant is considered to be generally recognized as safe (GRAS).

Plus, the proteins which result from the addition of the DNA are generally digested and metabolized, or otherwise don't raise the kind of food safety questions typically encountered when food additives are added to the diet. If the proteins are pesticides, then they are regulated by EPA and go through a rather extensive review process before going on the market. If the proteins are enzymes, they are reviewed by FDA through a consultation process in which the Agency can determine whether they agree if the protein to be added to food is GRAS.

As part of this consultation process, FDA will request - and a bioengineering company will provide - data to compare the bioengineered food to a conventional food. FDA usually requests information about the characteristics of the proteins made by the genes, their biological function, their origin and the level at which they will be found in food. FDA will also seek information on the food product itself specifically with respect to nutrients and other characteristics pertaining to safety and use of a product.

FDA's position is that labeling requirements under the law apply equally to traditional and bioengineered foods - it must be truthful and not misleading. No additional information is necessary for a bioengineered food if it proves equivalent to its traditional counterpart in terms of nutrients and safety. If a bioengineered food is significantly different from its traditional counterpart, it must be labeled to indicate that difference.

In the words of FDA Commissioner Jane Henney: "We are not aware of any information that foods developed through genetic engineering differ as a class in quality, safety, or any other attribute for foods developed through conventional means. That's why there has been no requirement to add a special label saying that they are bioengineered. Companies are free to include in the labeling of a bioengineered product any statement as long as the labeling is truthful and not misleading. Obviously, a label that implies that a food is better than another because it was - or was not - bioengineered, would be misleading."

And this is the rub. In FDA's view - and in the view of the proponents of GMO labeling requirements - a label designating food as derived from GMOs would inherently imply that the product is not as "good" as its conventional counterpart. This is simply misleading in FDA's judgment.

To Label Or Not To Label

Misleading or not, it does look like requiring labeling for genetically modified food products is headed in our direction, whether required by governments here or abroad or a fait accompli because of public outcry.

Industry and the government must do a much better job educating the public about the techniques used to make genetically modified foods, how such foods are established to be safe and the benefits that consumers may reap from the use of GMOs both in terms of human health and environmental quality.

Used with permission. Copyright FOOD & DRUG PACKAGING, April, 2000.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.