Labeling would be misleading, and review would be pointless and burdensome.
The gratuitous controversy continues over whether foods from plants and animals that have been genetically engineered should be labeled as such. The battle has been fought in the media, in state legislatures, through referendum issues, and in federal courts. Most labeling proposals have failed. Yet even though mandatory labeling fails every test for rationality — scientific, economic, and common-sense — and even though activists’ “successes” are likely to be reversed as unconstitutional when they are challenged in the federal courts, the true believers soldier on.
Tired of these endless activist brush fires, food, farm, and agribusiness interests have devised a sweeping legislative solution. Unfortunately, it is a flawed Faustian bargain. The bill, the Safe & Accurate Food Labeling Act, failed last year in the House, but Representatives Mike Pompeo (R., Kan.) and G. K. Butterfield (D., N.C.) reintroduced it as H.R. 1599 on March 25.
The bill has two principal goals: (1) Affirm that the U.S. Food and Drug Administration is the definitive national authority on the safety and labeling of genetically engineered food, thereby preempting regulation by states and localities and eliminating the prospect of a 50-state patchwork of laws; and (2) require the FDA to conduct a case-by-case review and approve “the use or application of the bioengineered organism in food.”
The first is very good; the second, very bad.
FDA preemption of state and local regulation will extinguish the brush fires. State and local safety and labeling laws for genetically engineered foods should be prohibited, because they are inherently misleading: They imply, wrongly, that genetically engineered ingredients are less safe or nutritious than “natural” substances, or at least that they are fundamentally different in some way. The newest techniques for genetic modification are part of a centuries-old continuum of technologies, and, as federal regulators have said repeatedly, labeling would erroneously imply a meaningful difference where none exists. Moreover, federal courts have said that such mandatory labeling violates First Amendment protections of commercial free speech.
The new law would leave the FDA’s policy, which was announced in 1992 (and most recently updated in 2013), as the sole determinant of labeling. The agency has said that requiring the labeling of “foods derived from new plant varieties,” however they are created, is appropriate only when it conveys “material” information that bears on safety or usage, such as the presence of a completely new substance in the food supply, an increase in the level of a natural food toxin, or the presence of a potent allergen where a consumer would not expect to encounter it. That makes scientific sense, and it does not transgress constitutional guarantees.
Mandatory FDA case-by-case review is a flawed solution to a non-problem. There is a longstanding consensus in the scientific community — which is reflected repeatedly in statements of federal-government policy — that the newest techniques of genetic modification are essentially an extension, or refinement, of older, less precise, and less predictable ones and that oversight should focus on the characteristics of products, not on the processes or technologies that produced them. The FDA currently requires consultation if a new product differs in a material way (as defined in the 1992 policy) from foods already in the food supply. Other than that, there is a voluntary consultation program for genetically engineered foods whereby the developer provides the agency with information about the product. To our knowledge, no genetically engineered product has been marketed without the FDA’s imprimatur.
For a quarter century, genetically engineered crops have been the most scrutinized food products in human history, without any scientific justification for such a burden. And after the consumption of more than 3 trillion servings of foods with genetically engineered ingredients, there hasn’t been so much as a single tummy-ache documented. It is noteworthy that similar foods made with older, less precise, and less predictable techniques are not routinely subject to review, voluntary or otherwise.
The mandatory-review provision of the legislation would be a major escalation of regulation without any justification — except perhaps as a bargaining chip for the creation of explicit prohibitions against state and local regulation. Trading mandatory review for explicit preemption of state and local regulation is a misguided bargain.
After the consumption of more than 3 trillion servings of foods with genetically engineered ingredients, there hasn’t been so much as a single tummy-ache documented.
The Pompeo-Butterfield bill further demonstrates its unscientific, illogical basis by singling out only foods from organisms modified with recombinant DNA technology, which is just one of many molecular techniques for genetic modification.
Finally, although making the voluntary consultation compulsory would not in any way enhance the safety of the food supply, it would complicate product development and further inhibit innovation. Required FDA approval of new genetically engineered foods would likely constitute a “major federal action,” triggering FDA procedural obligations under the National Environmental Policy Act (NEPA). In the past, activists acting in bad faith have frequently delayed approvals by bringing nuisance lawsuits that claimed purely procedural deficiencies under the act.
Another concern is the FDA’s unnecessarily, excruciatingly long review times. For example, regulators took two and four years, respectively, to review bruise-resistant, lower-carcinogen potatoes and non-browning apples, even though the genetic changes were well circumscribed and minimal. Complex new pharmaceuticals often are evaluated and approved in less time.
The Pompeo-Butterfield bill gets it half right, but the half that’s wrong is very wrong. Unfortunately, the Grocery Manufacturers Association doesn’t care about that, and by putting its muscle behind the creation of a new, totally superfluous layer of regulation, is willing at a stroke to sell out academic researchers, farmers, and agribusiness companies — and, ultimately, the best interests of consumers. Even if radical activists are the only ones who raise objections to a new product or technology, GMA would just as soon have it go away.
The Pompeo-Butterfield legislation should be amended to focus solely on confirming that FDA policies on genetically engineered foods preempt those of states and localities, lest it stumble over that most magisterial influence: the law of unintended consequences.
— Henry I. Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA. Drew L. Kershen is the Earl Sneed Centennial Professor of Law (Emeritus), University of Oklahoma College of Law.