We have been tinkering with our food’s DNA since the dawn of agriculture. By selectively breeding plants and animals with the most desirable traits, our predecessors transformed organisms’ genomes, turning a scraggly grass into plump‐​kernelled corn, for example. For the past 20 years Americans have been eating plants in which scientists have used modern tools to insert a gene here or tweak a gene there, helping the crops tolerate drought and resist herbicides.

Consumer and environmental groups and organic farm organizations have alleged safety concerns about GMO food products and the chemicals applied on GMO crops in the United States. The scientific evidence for GMO foods, however, has been globally evaluated by a wide range of governmental bodies and established private organizations, including the European Union, World Health Organization, American Medical Association, U.S. National Academy of Sciences, Health Canada, and British Royal Society. In its “Statement by the … Board of Directors On Labeling of Genetically Modified Foods,” released in 2012, the American Association for the Advancement of Science (AAAS), the world’s largest general scientific society, concluded from a review of the scientific evidence that consuming foods containing ingredients derived from genetically modified crops is no riskier than consuming the same foods containing ingredients from crop plants modified by conventional plant improvement techniques. Other organizations have reached similar conclusions.

One GMO‐​related public issue maturing in the U.S. public policy process concerns the mandatory labeling of foods containing GMO ingredients. According to the Center for Food Safety, a Washington, D.C.–based nonprofit organization, 64 countries now legally require some form of GMO retail food labeling, including the 28 member‐​nations of the European Union, but not (presently) the United States. If GMO retail food labeling is to become mandatory in the United States, its regulation would be the responsibility of the FDA.

Biotech regulation / Federal regulation of GMOs operates under a formal policy known as the “Coordinated Framework for Regulation of Biotechnology.” GMOs are nationally regulated pursuant to health, safety, and environmental legislation governing conventional products and premised on the assumption that regulation of GMOs should focus on the nature of the products rather than the process in which they are produced. Under the Coordinated Framework, published in the Federal Register in 1986, the federal regulatory jurisdiction over biotechnology products is allocated among three governing agencies—the U.S. Department of Agriculture (plant GMOs), the U.S. Environmental Protection Agency (chemical substances from genetically modified plants), and the FDA (GMO food)—in the same manner as conventional products, using existing laws and regulations governing conventional products.

The GMOs found in food, drugs, and biological products are regulated by the FDA under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Since 1992, the FDA has been guided in its administrative responsibilities by the “FDA Statement of Policy: Foods Derived from New Plant Varieties.” In the overwhelming majority of cases, the policy directs the agency to treat foods derived from GMOs in the same way as those derived from conventionally bred plants, presuming that most foods derived from GMO plants would be “generally recognized as safe.” Also since 1992, the FDA places explicit responsibility on the manufacturer—not an independent scientific review board—to assure the safety of GMO foods. Since 1997, however, there has been FDA guidance to industry involving voluntary “consultation procedures” concerning the food safety of new proteins in new plant varieties, including those developed through genetic engineering.

The FDA, the lead federal agency tasked with overseeing the labeling of processed retail food, has the legal authority to prevent false and misleading labeling of foods and drugs. Because the FDA does not view genetically engineered food as materially different from traditional food products, there is no need to specifically label those products as containing GMOs or change the name of the food product. The FDA reasons that such labeling would imply to consumers that GMO food is inferior or unsafe. A name change would, however, be in order if a food derived from a genetically engineered plant is significantly different from its traditional counterpart, that the usual name no longer sufficiently describes the new food product, or if there is a safety issue such as the presence of allergens in the GMO food product.

FDA Commissioner Margaret Hamburg recently announced that the agency plans on finalizing guidance on “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering,” which was initially released for comment in the Federal Register in January 2001. This industry guide evaluates specific food labeling statements, such as “GMO free,” and offers guidance on what the FDA would and would not consider misleading statements. The “Voluntary Labeling Guidelines” are considered the “best practices” on an issue, and the food industry will generally consider it to be a compliance document because of the potential liability associated with noncompliance. A recent consumer survey of 1,000 participants conducted between March 28 and April 7, 2014, by the International Food Council found that 63 percent of Americans support the FDA’s current voluntary policy for labeling GMO foods, a percentage that is consistent with survey findings in previous years.

Pros and cons / Advocates of mandatory GMO retail food labeling argue that American consumers have a right to know what specific ingredients are in their processed foods, as well as an accurate quantity of those GMO ingredients. This transparency issue has particular saliency as to GMO food products for which serious personal health or environmental concerns have been raised by consumers or special interest groups. Furthermore, proponents of mandatory GMO food labeling emphasize “choice,” by which consumers should have the right to decide what food ingredients they should be ingesting in the processed foods they eat—whether those foods contain GMOs or not.

Yet, according to the AAAS, critics of legally mandating GMO labeling of processed foods argue that it could “mislead and falsely alarm consumers” as “genetically modified crops pose no greater risk than the same foods made from crops modified by conventional plant breeding techniques.” The AAAS also reports that “each new crop must be subjected to rigorous analysis in order to receive [FDA] approval … and if a new protein trial has been added, the protein must be shown to be neither toxic nor allergenic.”

Labeling requirements (including specific individual state‐​mandated GMO percentage thresholds) of GMO processed foods would impose a cost on all consumers—including those not desiring such information. The existing U.S. food system infrastructure—i.e., involving separate planting, storage, processing and packaging, and transportation—is inadequate to accommodate this segregation of GMO and non‐​GMO products and meet the legislative requirements of high non‐​GMO purity standards. Thus, the implementation of such requirements necessitates significant capital investment on the part of the GMO food processing industry and increases costs to the consumer. A 2014 Cornell University study, conducted by William Lesser of the Dyson School of Applied Economics and Management, concludes that New York state’s proposed mandatory GMO labeling bill would cost New York families an average of $500 per year, echoing similar increases in the cost of food for consumers found in earlier studies undertaken in both Washington state and California.

With diminished economic prospects and high non‐​GMO purity thresholds, many food processors may decide to abandon genetically engineered food production. Previous experiences with mandatory GMO retail food labeling in the European Union, Japan, and New Zealand have resulted in grocery retailers eliminating GMO food products from their shelves, largely because of consumer aversion to those products after mandatory labeling requirements were implemented.

Mandatory labeling successes / Over the last few years, anti‐​GMO advocacy groups have altered their political lobbying and advocacy advertising campaigns. They have shifted from focusing on the safety issues they allege are inherent to genetically engineered crops, to emphasizing the American consumer’s right of “choice” in product selection and “right to know” what ingredients are in the processed food they eat. The political battleground between pro‐ and anti‐​GMO food interests regarding mandatory GMO retail food labeling has shifted from the federal government arena, where anti‐​GMO interest groups have had little legislative or administrative success since 2000, to the state government arena, where three states have recently passed GMO retail food labeling legislation.

On June 4, 2013, Connecticut passed legislation requiring that infant formula or baby food that is produced from GMOs be labeled as “produced with generic engineering” on the product. The GMO labeling of infant formula is to start July 1, 2015, and the compliance enforcement date is July 1, 2019. There is a provision that the labeling requirement is not to be effective until four additional states enact similar legislation, one of which must border Connecticut, and the total population of those states exceeds 20 million people.

On June 12, 2013, Maine passed legislation requiring that food and feed produced from GMOs and having a content of at least 0.9 percent GMOs is to have a disclosure statement of “Produced with Genetic Engineering.” This law does not apply to alcoholic beverages, restaurants, unintentionally commingled products, and some other situations. The law also contains a provision that it will be repealed if a similar law is not adopted in at least five states or states with a combined population of at least 20 million people.

On May 9, 2014, Vermont became the first state to implement mandatory labeling of food that has been genetically engineered. Unlike the other two New England states, the Vermont legislature did not include a “trigger” provision restricting the effective date of implementation of the law contingent upon the legislative actions of other state governments addressing the issue of consumer labeling of GMO food.

Anti‐​GMO food interest groups have become actively involved in introducing state ballot initiatives on mandatory GMO retail food labeling west of the Mississippi River. In November 2012, California’s Proposition 37 (requiring the mandatory labeling of GMO foods) was defeated by California voters by a narrow margin of 51.4 to 48.6 percent. Similarly, in a closely contested vote, the state of Washington’s Initiative 522, also requiring mandatory GMO retail food labeling, was defeated in November 2013. This past November, Colorado’s citizenry resoundingly voted down Proposition 105, with 66 percent of voters in opposition. The measure would have required the labeling of GMO retail food sold in the state with text reading “produced with genetic engineering.” Oregon likewise voted down Measure 92, by a narrow margin of 1.2 percent of voters. The measure would have required GMO retail food labeling reading “produced with genetic engineering” on food and products sold in the state.

The Center for Food Safety, a Washington, D.C.–based anti‐​GMO group, reports that through last June, there were 35 new mandatory GMO retail food labeling bills introduced in 20 states, while during the two‐​year period of 2013–14, there have been over 70 bills and ballot initiatives introduced in 30 states.

Consumer perceptions / If we look at the overall picture of American consumer surveys over the last quarter century, most studies show that consumers are

• favorable to the concept of GMO food,
• do not know much about GMO food,
• respond positively to safety perceptions of GMO food when provided more information about it,
• resort to emotional biases to inaccurately process information when they see GMO labels, and
• desperately want GMO labels to be mandatory, oftentimes with consumer support exceeding 90 percent.

How this information is conveyed can affect how American consumers perceive it. If information is provided as objective and verifiable, such as “more than half of our groceries are genetically modified today,” they have more of a learning and informative effect on the consumer. However, if presented with more alarming or vague language or labeling, they have a stronger likelihood of evoking stereotypes, risk perceptions, emotional schemas, and stigmatizing the label with negative perceptions, rather than adding any knowledge value for the consumer.

According to William Hallman, director of the Food Policy Institute at Rutgers University, the institute undertook a major survey of American consumer attitudes toward GMO foods in November 2013. Consumers were asked what information should be included on food labels that is not already there. Only 7 percent of survey respondents wanted GMO ingredients noted on retail food labels. But when presented with a list of possible information to include on retail food labels, 59 percent of survey respondents included GMO ingredients. When asked if GMO ingredients should be labeled, 73 percent said yes. “So which is it?” said Halman. “Is it 7 percent or 59 percent or 73 percent? It depends on how you ask the question.”

Politics and labeling / The recent interest group lobbying efforts at enacting mandatory GMO retail food labeling legislation at the state level has had success, albeit limited, with Vermont being a “breakthrough” for anti‐​GMO advocates. Yet, state‐​level mandatory GMO retail food labeling legislation is problematic, entailing potential nightmarish industry regulatory compliance by the food and agricultural industries. As diverse regulatory requirements of state legislation are enacted, the food industry will need to constantly readjust its labeling and business operating practices. For example, “non‐​purity” thresholds for GMO “contamination” of so‐​called non‐​GMO retail foods could differ from state to state, requiring multiple labeling requirements, improved crop separation operations, and different certification standards.

This limited anti‐​GMO state level success has, however, elicited a legislative response supported by the pro‐​GMO food lobby (known as the Coalition for Safe Affordable Food). Rep. Mike Pompeo (R‑Kansas) has introduced H.R. 4432, the Safe and Accurate Food Labeling Act, with 36 co‐​sponsors. The bill would amend the Food, Drug, and Cosmetic Act to preempt any state or local government requirement concerning GMO retail food labeling and set forth standards for any food label that contains claims that bioengineering was or was not used in the production of the food. Also under this bill, the FDA requires a mandated review (in lieu of the present voluntary review) of new biotechnology traits before they are introduced to the American consumer.

On June 12, 2014, a coalition of industry associations (including the Grocery Manufacturers Association, Snack Foods Association, International Dairy Foods Association, and the National Association of Manufacturers) filed a complaint in the District of Vermont court challenging the legality of the state’s new GMO retail food labeling law. Plaintiffs cite constitutional issues, including alleged violations of the First and Fourteenth Amendments, the Commerce Clause, and the Supremacy Clause, all pertaining to Vermont’s regulating national distribution and retail food labeling practices. They are requesting injunctive relief and a declaratory judgment invalidating the act.

While H.R. 4432 is sequestered in the U.S. House of Representative’s Subcommittee on Health and not likely to emerge in the 113th Congress, the 114th Congress will likely see a re‐​introduction of this or similar legislation and greater likelihood of its passage, courtesy of Republicans gaining majority control of both houses of Congress this past November. For GMO advocates, either the passage of this bill or a declaratory federal judgment against the Vermont mandatory GMO retail food labeling law would prevent what they believe is an effort by anti‐​GMO activists to “balkanize” this issue through a state‐​level solution. From the perspective of pro‐​GMO participants in the U.S. food and agricultural industries, if mandatory GMO food labeling is enacted into law at the state or federal level, it would have long‐​term, costly consequences for both American consumers and the food industry.