The debate over labeling foods as "bioengineered" has raged for decades, in spite of longstanding consensus in the scientific community that mandatory labeling fails every test—scientific, economic, legal, and common-sense. In order to preempt state-by-state initiatives that were creating a patchwork of labeling requirements, in July 2016 Congress enacted, and President Obama signed, the National Bioengineered Food Disclosure Standard (NBFDS) law, which mandates labeling for bioengineered food, delegating power to the Secretary of Agriculture to "establish such requirements and procedures as the Secretary determines necessary to carry out the standard." But Congress could have—and should have—simply preempted states from promulgating labeling requirements beyond those of federal regulatory agencies. The secretary, in any event, assigned the task to the Agriculture Department's Agricultural Marketing Service (AMS).
AMS has said that it intends to issue a final regulation by the end of 2018, after review of public comments; that would be fast work. AMS has broad rulemaking power to decide numerous issues left unresolved by the statutory language—including determinations about which foods and food manufacturers should be included, the content thresholds beyond which labels would be required, and decisions about the language and design of authorized labels. In exercising its delegated power on such an open-ended and challenging task, AMS needs guiding perspectives to inform its choices, and it can find them in the NBFDS itself, past Food and Drug Administration regulations, the federal Coordinated Framework for Regulation of Biotechnology, and case law about constitutional limits on government-mandated labels.
Congress made clear in Section 293 of the NBFDS that bioengineered food "shall not be treated as safer than, or not as safe as, a non-bioengineered counterpart of the food," thereby expressing agreement with the FDA that bioengineered foods are, in general, "substantially equivalent" to non-bioengineered foods in regard to health and safety attributes. Consequently, AMS should not resolve any uncertainty in a manner that places bioengineered foods at a disadvantage in consumers' perceptions, and labels should not state or imply any disparagement of bioengineered foods.
In the 1990s, when activists opposed to bioengineered foods pressured the FDA to impose mandatory labeling under the aegis of the Food, Drug and Cosmetic Act, the FDA pushed back, responding that its statutory authority over labeling required that mandatory information be "material" to the food's health or safety attributes. Because bioengineering in itself does not confer differences regarding health or safety qualities, the FDA refused to impose a mandatory, across-the-board label, saying that a label was appropriate only if it was necessary to alert consumers about issues of safety or usage. A Wisconsin federal court agreed, rejecting the activists' demands.
AMS must strive for labels that are truthful and not misleading, but the law's mandate for labeling makes that difficult. And given that the definitions of terms like "bioengineered," "genetically modified," and "GMO" are mostly arbitrary, one possible approach for AMS would be to incorporate the FDA's understanding of labeling, and to mandate labels on as narrow a set of food products as possible. Neither the misperceptions of some consumers nor the demands of activists opposed to bioengineering can be permitted to mislead American consumers en masse, or to transgress the requirements of the Food, Drug and Cosmetic Act that food labeling not be inaccurate or misleading in any respect.
Two decades ago, Vermont passed a mandatory-label statute for a bioengineered food—milk from cows treated with bovine growth hormone. Dairy manufacturers sued to block it based on the argument, among others, that the statute violated the First Amendment. In the Amestoy case of 1996, the United States Court for the Second Circuit agreed, finding that "absent, however, some indication that the information bears on a reasonable concern for human health or safety or some other sufficiently substantial governmental concern, the manufacturers cannot be compelled to disclose it. Instead, those consumers interested in such information should exercise the power of their purse by buying products from manufacturers who voluntarily reveal it." Based on the First Amendment argument, the Second Circuit granted an injunction against the Vermont statute.
In fact, the entire premise of the NBFDS is in constitutional peril. A 2015 Supreme Court case, Reed v. Town of Gilbert, changed the legal landscape dramatically, further calling into question the constitutionality of special labeling to identify foods produced by a particular process, if unrelated to the healthfulness or safety of the protected product. Information required on labels is considered "commercial speech" and must therefore conform to the speech requirements of the First Amendment. The essence of Reed is the expansion of the range of regulations subject to "strict scrutiny"—the most rigorous standard of review for constitutionality—to include special labeling laws. As lawyer and New York Times Supreme Court correspondent Adam Liptak observed, Reed "marks an important shift toward treating countless laws that regulate speech with exceptional skepticism." He quotes First Amendment expert Floyd Abrams: "When a court applies strict scrutiny in determining whether a law is consistent with the First Amendment, only the rarest statute survives the examination." Therefore, a law that regulates a product label containing specific information about a food-production process unrelated to a health or environmental outcome would be highly unlikely to survive such scrutiny, and is probably unconstitutional.
While labeling is still enforceable, AMS must prevent it from unduly denigrating science and technology or from communicating misinformation to consumers about agricultural biotechnology. To accomplish that, we propose an outside-the-box remedy. Given that the techniques of bioengineering constitute a seamless continuum from selection and hybridization to mutagenesis, "wide crosses" (in which hybridization is forced, across species or genus lines), and molecular methods, AMS could reduce confusion, and meet the letter and spirit of the new law, by requiring the label on virtually all foods, conventional and organic, except those that have not been subjected to human intervention to accomplish genetic modification: wild berries, wild mushrooms, wild game, and currently commercially-available fish and shellfish, which would be the only exemptions from the "bioengineered" logo.
In order both to conform to the law and to avoid misleading and confusing consumers, USDA's labeling requirements should reflect the reality of the pedigree of the foods we consume, rather than trying to tread a fine line between the blandishments of activists and the presumed intent of legislators.
Drew Kershen is the Earl Sneed Centennial Professor of Law Emeritus, University of Oklahoma, and a Member of the Board of Directors of the Genetic Literacy Project. Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University's Hoover Institution. He was the founding director of the FDA's Office of Biotechnology.