By Sheldon Krimsky

from GeneWatch 29-1 | Jan-May 2016

The U.S. government established its labeling policy in the 1990s just as the first food products of biotechnology entered the market. Its policy was based on the principle of material equivalence, sometimes also referred to as "substantial equivalence." It is also based on the concept that labeling a food product should not be based on the process of breeding the crop (such as genetic engineering), but rather on the properties of the product resulting from any form of breeding. With respect to foods produced from GMOs, whose parental crops are already consumed as food, the FDA has asserted that foods containing such GMOs are the substantial equivalent of the unmodified and unlabeled foods. Therefore, FDA does not require labeling of such GMO foods.

U.S. policy on labeling is strikingly at odds with that of the European Union. The European Parliament adopted a regulation in 1997 requiring that foods derived from GMOs be labeled as such, and the following year added similar regulation targeting GM maize and soybeans. The European Parliament later strengthened the rules to require labeling whenever genetically modified organisms make up at least one percent of a product. Japan also went on to institute mandatory GMO labeling.[1]

The current debate over whether labeling of GMO foods should be legally mandated has generated a host of arguments, pro and con, based on scientific, legal, economic, commercial, religious, and policy considerations. The purpose of this article is to summarize the way this debate has played out.


Point: Under current U.S. policy, labeling of food can only be mandated for a crop or processed food derived from it if that crop is materially different from a parental variety in nutritional quality or food safety. In Alliance for Bio-Integrity et al. v. Shalala, the US District Court found that FDA had no basis under federal law for requiring labeling, because FDA had determined that crops produced with genetic engineering posed no different or greater food safety concerns than crops produced through traditional plant breeding methods.

Counterpoint: There are many labels on food that are based on factors other than nutrition or risk. We have labels for "dolphin-free tuna" or Kosher food, or trans fats. We even have a label for organic food that is not produced by genetic engineering, ionizing radiation, or use of sewage sludge, and which must be produced using allowable substances listed by USDA. To receive such a label we do not have to prove that the composition of the organic product is substantially different from the non-organic product.

Point: The labeling for "dolphin-free" and Kosher are not mandated labels but voluntary. In July 2003, the U.S. Food and Drug Administration (FDA) announced that it would require mandatory trans fat labeling effective January 2006. The reason justifying this was that trans fats are unhealthy and represent a risk to consumers. GMO labeling can be done by manufacturers on a voluntary basis, but it cannot be mandatory because the food product is not materially different from the non-GMO counterpart. The organic label is not required for food producers. Moreover, popular opinion for labeling does not change the legal authority of FDA to require labeling.

Counterpoint: Maize with a genetically engineered protein from the bacterium bacillus thuringiensis, which is toxic to some insects, makes the GMO maize materially different than the non-GMO variety.

Point: It is different by the criteria that it has a new protein, which the parental plant does not have. But it is nutritionally equivalent to the non-GMO and does not present any unacceptable risk to the consumer. Unless there are risks in the Bt corn product, such as possessing allergenic properties not found in the non-GMO counterpart, labels cannot be mandated.

Counterpoint: But the U.S. does not have required testing to evaluate whether there is nutritional equivalence or whether there are long term risks from consuming the GMOs. Without required comprehensive pre-market testing, how would the consumer know whether the criteria for material equivalence and safety are met?

Point: Many professional groups including the National Academy of Sciences do not believe there is prima facie evidence of material difference between GMOs and non-GMOs or that there are risks to consumers. Until such evidence can be presented, the U.S. policy will maintain that mandatory labeling by the federal government is not justified.

Counterpoint: GMOs are made with antibiotic resistant markers. These are proteins, which, if they entered our gut bacteria, could make them resistant to antibiotics. This is especially concerning if the bacteria in our gut happens to be pathogenic.

Point: Antibiotic resistant markers used in the molecular breeding of crops is considered a processing aid. FDA's labeling regulations exempt processing aids like the antibiotic resistance enzyme from the labeling requirements.

Counterpoint: What about states requiring labels on GMOs? Why shouldn't states adopt their own criteria on questions of material equivalence, risk and the precautionary principle? States, through their democratic processes, should be able to allow their citizenry to make their own choices on whether they prefer to buy GMOs. Based on public referenda, California requires labeling on products for toxic chemicals that are not required by the federal government or by other states.

Point: There are no federal laws preempting states from passing labeling statutes for GMOs, although there is still a labeling preemption bill pending in Congress. While states have enacted labeling for certain products that list toxic substances, which is not federally mandated, it often drives up the price of products. Companies often include the state-mandated labels for all their products regardless of where they are shipped rather than operating with a patchwork of labeling requirements.

Counterpoint: When states have attempted to create labeling laws for GMOs they are usually sued by the food industry. Some courts have ruled against some labeling requirements, based on claims that corporations have a First Amendment right not to be compelled to state things about what is in their food that is not justified by legally valid government interests.

Point: Every state GMO labeling initiative put to a popular vote has lost at the ballot box. This was likely due, at least in part, to voters' concerns that labeling would cause an increase in food prices. Anyway, just labeling a food "GMO" or "GMO ingredients" doesn't tell consumers what, if anything, is new about the food constituents.

Counterpoint: Many ballot initiatives have failed by the slimmest of margins, and only after the commercial interests opposing labeling have overwhelmed the voting public with millions of dollars in anti-labeling advertisements. The forecasted effects of labeling on food prices vary significantly depending on which economic analysis one reads. Meanwhile, in national polls, the majority of consumers believe they should have a right to know if the food was produced by genetic engineering. How food is produced is becoming increasingly important for consumers, such as whether the food is organically grown, whether food animals are grass fed, or whether chickens are "free range." Consumers should have a right to the information they consider relevant to such a highly personal decision as the purchase of the food they eat and serve their families.

Point: The USDA has developed a new government certification program for labeling foods that are free of GMOs. This should satisfy those consumers who wish to make choices based on GMO content in food.

Counterpoint: This certification program is not mandatory. If companies feel that putting a GMO label on their product will reduce sales, they will prefer no label of any kind. People may oppose GMOs for any number of reasons including sustainability, seed patents, corporate contracts restricting the use of seeds, religious principles, and unknown risks. Whatever their reason, it is their right as consumers to make a choice.                               


Sheldon Krimsky, PhD, is Director and a co-founder of the Council for Responsible Genetics.



1. Karen A. Goldman, Labeling of Genetically Modified Foods: Legal and Scientific Issues, Georgetown International Environmental Law Review 2:721 (2000).

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