Genetically Modified Organisms Debate in Food Labeling

Humans have been altering the genes of our food supply for 10,000 years. The FDA defines “genetic modification” as the alteration of the genotype of a plant using any technique, new or traditional, to add, delete, or change its hereditary traits (either through a single mutation that affects one gene or a major alteration that affect many genes).^[1] The FDA explained: “Most, if not all, cultivated food crops have been genetically modified.” Earlier methods included planting seeds from the best crops and cross-pollination, and these produced the product we think of today as corn on the cob. More recently, methods have evolved to include grafting, forced pollination, and radiation, with the newest method— genetic engineering—creating significant debate.^[2]

Genetic engineering is also called biotechnology and foods produced through this method are referred to as genetically modified organisms (GMOs), genetically engineered, or bioengineered.^[3] The goal of genetic modification is to develop a new plant variety that carries valued characteristics (such as larger fruit) or enhanced agronomic characteristics (such as hardiness).^[1] Traditional modification techniques were time consuming and less exact; genetic engineering uses recombinant DNA techniques that offer more precise and efficient methods to achieve the same types of goals.^[1] The FDA subjects GMOs to the same safety evaluation as other food, with the added requirement that developers of GMOs consult and meet with FDA before marketing their products.^174,175

Debates about genetic modification can be traced back centuries. The process was early on discussed as being unnatural. More recently it has been criticized as posing risks for health, safety, agriculture, and the environment, and the manufacturers have been accused of fostering dependence on bioengineered seed for profit.^176,177,178 Proponents of GMOs argue that they are safe and can reduce reliance on synthetic insecticides and toxic herbicides, increase food production, and can be used to address hunger and malnutrition in developing countries.^179,180These debates have resulted in significant efforts to increase the labeling of GMOs. A 2013 New York Times poll found that 93% of respondents wanted foods containing GMO ingredients to be labeled as such.^[6] ^[1] ^[8] ^[9] ^[10] ^[8] ^[12] ^[13]

In response to requests for increased labeling of GMO foods, the FDA has issued several documents. In a 1992 policy document, the FDA first noted that according to its regulations, if a food derived from a new plant variety differs from its traditional counterpart so that the common or usual name does not reveal material information, labeling must reflect this fact.^[1] So, for example, if peanut proteins were added to tomatoes, an allergy alert label would have to be displayed on the tomato product. For the majority of foods developed with recombinant DNA techniques, however, the FDA would not require a label noting this fact.^[1] The FDA explained:

The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. For this reason, the agency does not believe that the method of development of a new plant variety ... is normally material information within the meaning of [its regulations] and would not usually be required to be disclosed in labeling for the food.^[1]

In 1993, the FDA requested information on a variety of labeling options.^[17] And in 1999, the agency held hearings on the topic.^[18] The FDA concluded that mandatory labeling was not necessary and issued guidance for voluntary labeling. The FDA determined that such labeling must be precise and not claim superiority for non-GMO foods, so it suggested the following as examples of statements it found permissible:

n “We do not use ingredients that were produced using biotechnology.” n “This oil is made from soybeans that were not genetically engineered.”

n “Our tomato growers do not plant seeds developed using biotechnology.”^[18]

The agency cautioned against making statements that likely could not be accurate, such as proclaiming products to be “GMO-free,” given that most plants have been genetically modified. Further, it noted that a statement would be misleading if it claimed that a food was not bioengineered when, in fact, there were no marketed bioengineered varieties in existence, such as is the case with green beans.^[18]

Anti-GMO advocates seek increased labeling requirements. Maine and Connecticut passed GMO labeling laws that only become effective when a certain number of states pass similar laws. In 2014, Vermont passed the nation’s first law that would require GMO-related labeling upon its effective date of July 1, 2016.^[21] Vermont’s law requires that foods sold in the state that are produced “entirely or partially” by genetic engineering must be labeled as such and the product’s package, signage, and advertising cannot state that it is “natural,” “naturally made,” “naturally grown,” “all natural,” or use words of similar import.^[21] The Grocery Manufacturers Association (GMA), along with the Snack

Food Association, International Dairy Foods Association, and the National Association of Manufacturers sued Vermont in federal district court to block enforcement of this law.^[23] The GMA argues that Vermont’s law “is a costly and misguided measure that will set the nation on a path toward a 50-state patchwork of GMO labeling policies that do nothing to advance the health and safety of consumers.”^[23] The case is being fought on First Amendment, Commerce Clause, and preemption grounds. In April 2015, the court issued an opinion denying both the state’s motion to dismiss the case and the plaintiffs’ request for an injunction; this permits both the lawsuit to proceed and the law to be enforced by its effective date of July 1, 2016.

A federal bill, Safe and Accurate Food Labeling Act of 2014, would establish premarket notification requirements for GMOs and would preempt any state or local requirements with respect to GMOs and GMO-labeling.^[25] It also would authorize the Secretary of HHS to permit GMO labeling only upon the determination that there is a material difference between a food produced from, containing, or consisting of a GMO and a comparable non-GMO food, and that such a disclosure is necessary to protect public health and prevent the food label from being false or misleading. The bill states that the use of bioengineering does not, by itself, constitute a material difference. Food industry companies have engaged in substantial lobbying related to this bill.^[26] At this point, there are no federal labeling requirements related to GMOs, although it remains to be seen whether this will change anytime soon.

[1] 57 FR 22984 (May 29, 1992).
[2] Pamela C. Ronald. Plant Engineers Sow Debate. Scientific American Classics. 2014.
[3] Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism. Berkeley and LosAngeles, CA::University of California Press; 2003, p. 139.
[4] 57 FR 22984 (May 29, 1992).
[5] 57 FR 22984 (May 29, 1992).
[6] Food and Drug Administration. Food. Questions & Answers on Food from GeneticallyEngineered Plants. July 22, 2014. http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/ucm346030.htm
[7] 57 FR 22984 (May 29, 1992).
[8] The Birth of the Great GMO Debate. Scientific American. Classics Agriculture. No. 22. May 2014.
[9] 9 V.S.A. § 3041 et seq. (2014).
[10] Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism. Berkeley and LosAngeles, CA: University of California Press. 2003, p. 139.
[11] The Birth of the Great GMO Debate. Scientific American. Classics Agriculture. No. 22. May 2014.
[12] Dan Charles. In A Grain OfGolden Rice, A World OfControversy Over GMO Foods. NationalPublic Radio. The Salt. March 7, 2013 http://www.npr.org/blogs/thesalt/2013/03/07/173611461/in-a-grain-of-golden-rice-a-world-of-controversy-over-gmo-foods
[13] Allison Kopicki. Strong Support for Labeling Modified Foods. The New York Times. July27, 2013. http://www.nytimes.com/2013/07/28/science/strong-support-for-labeling-modified-foods.html
[14] 57 FR 22984 (May 29, 1992).
[15] 57 FR 22984 (May 29, 1992).
[16] 57 FR 22984 (May 29, 1992).
[17] 58 FR 25837 (April 28, 1993).
[18] Food and Drug Administration. Food. DRAFT Guidance for Industry: Voluntary LabelingIndicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance.http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm
[19] Food and Drug Administration. Food. DRAFT Guidance for Industry: Voluntary LabelingIndicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance.http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm
[20] Food and Drug Administration. Food. DRAFT Guidance for Industry: Voluntary LabelingIndicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance.http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm
[21] 9 V.S.A. §§ 3041-3048 (2014).
[22] 9 V.S.A. §§ 3041-3048 (2014).
[23] Grocery Manufacturers Association. Newsroom. GMA Files Lawsuit to Overturn Vermont’sUnconstitutional Mandatory GMO Labeling Law. June 13, 2014. http://www.gmaonline.org/news-events/newsroom/gma-files-lawsuit-to-overturn-vermonts-unconstitutional-mandatory-gmo-label/
[24] Grocery Manufacturers Association. Newsroom. GMA Files Lawsuit to Overturn Vermont’sUnconstitutional Mandatory GMO Labeling Law. June 13, 2014. http://www.gmaonline.org/news-events/newsroom/gma-files-lawsuit-to-overturn-vermonts-unconstitutional-mandatory-gmo-label/
[25] HR 4432 - Safe and Accurate Food Labeling Act of 2014113 th Congress (2013-2014).
[26] Clients lobbying on HR 4432: Safe and Accurate Food Labeling Act of 2014. http://www.opensecrets.org/lobby/billsum.php?id=hr4432-113