Politics & Policy

What’s in a Name? Plenty, if It’s a ‘GMO.’

‘Genetically modified organism’ is a meaningless category.

‘GMOs” get a lot of attention. Devotees of organic and “natural” food want to avoid them, on principle. Anti-technology activists prattle about their imaginary dangers. Pandering to special interests, confused members of Congress have been trying to find a way to require labels on them, which they finally accomplished with legislation last week. But that effort, like others, became fatally tangled up in terminology.

The problem is that there’s no such thing as a GMO, except in the fevered imagination of bureaucrats, legislators, and activists. The bipartisan “compromise” on GMO labeling passed last week includes a weird, unscientific, politically motivated hodge-podge of products that makes absolutely no sense. For example, corn or soybeans modified with recombinant-DNA (“gene-splicing”) techniques would need to be labeled, while oils from them would not.

That’s not the only flaw. Genetic engineering is a seamless continuum of techniques that have been used over millennia, including (among others) hybridization, mutagenesis, wide-cross hybridization (movement of genes across “natural breeding barriers”), recombinant DNA, and now gene-editing. But, inexplicably, the new legislation covers labeling only if a food “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques” and “for which the modification could not otherwise be obtained through conventional breeding or found in nature.” Older techniques and also anything modified with the newest gene-editing techniques would be exempt.

This is the proverbial legislative sausage-making at its worst.

The new law does accomplish one important thing — the preemption of individual states’ ability to impose other labeling requirements — which was the primary motivation for legislation in the first place. But that could easily have been accomplished without instituting mandatory labeling.

This confusion about terminology is not new. Three decades ago, on January 13, 1987, when I was special assistant to Food and Drug Administration head Frank Young, he and I co-authored a Wall Street Journal op-ed, “Biotechnology: A ‘Scientific’ Term in Name Only,” that began this way:

Defining the terms “biotechnology” and “genetic engineering” isn’t an easy task, since the terms don’t represent natural groupings of processes or prod­ucts. . . . The terms are ambiguous, the source of much confusion and little advantage, and we would do well to return to more specific and descriptive terms.

What was then called “biotechnology” or “genetic engineering” has now become “genetic modification” — and the outcomes dubbed “genetically modified organisms,” or “GMOs” — but our observations remain equally valid. Imprecise, confusing terminology still leads to fuzzy thinking about laboratory alterations of the genomes of organisms, and over the years, arbitrary, unwarranted, and draconian regulation has been costly in terms of lost advances in many sectors of U.S. research and development.

Imprecise, confusing terminology still leads to fuzzy thinking about laboratory alterations of the genomes of organisms.

Some legislators and activists might reply that the use of “conventional” or pre-molecular, techniques is somehow different — more “natural” — because no “foreign” genes are added to the genome of the resulting plant. They’re wrong.

Since at least the 1930s, plant breeders have performed “wide cross” hybridizations, in which large numbers of “foreign,” or “alien,” genes have been moved across what used to be thought of as “natural breeding boundaries” to create plant varieties that cannot and do not exist in nature. Most of these hybridizations, which are performed between organisms of different species or genera, produce a non-viable zygote, so laboratory scientists devised mechanical and biochemical ways to “rescue” the embryos and enable them to develop. Common commercial crops derived from wide crosses include tomato, potato, sweet potato, oat, rice, wheat, corn, and pumpkin, among others.

Wide-cross hybridizations and radiation-induced mutagenesis represent far more drastic tinkering with nature — and lead to far less predictable results — than the modern molecular techniques used to alter genes, but neither legislators nor anti-genetic-engineering activists have shown any concern about creating new plant varieties with those older techniques. Even though the outcomes would by any reasonable definition be “genetically modified” or “bioengineered,” they are not subject to mandatory testing or review before entering the food chain, nor would the new law require them to be labeled. In contrast, if a gene is moved by recombinant DNA techniques, the resulting variety is subject to lengthy, hugely expensive, and increasingly politicized regulation.

To be clear, it’s not the source of genetic material or whether DNAs from different organisms are mixed that confers risk; what is important is the function of the genetic alteration — for example, whether it could cause the organism to express a new toxin or allergen or become more weed-like.

All the hoopla over the labeling legislation is likely to be for naught. Its arbitrary, unscientific scope makes it extremely unlikely that the new legislation is constitutional. In a 2015 decision, the U.S. Supreme Court ruled that labeling mandates are “compelled commercial speech” and subject to “strict scrutiny” to ensure they don’t run afoul of the free-speech guarantees of the First Amendment. So without some compelling state interest, such as ensuring consumer safety or proper usage, a requirement to label foods that contain “genetically engineered” ingredients, as defined, is unlikely to survive the strict-scrutiny standard. A Vermont genetic-engineering-labeling law already has been challenged by a variety of food-industry groups, and a decision from the U.S. 2nd Circuit Court of Appeals could come at any time.

In our 1987 op-ed, FDA commissioner Young and I called for the use of more precise, meaningful terms in order to convey “meaning more clearly, whether the intent is to laud progress, or to call for oversight, or to seek additional funding.” We concluded by asking, “Is that degree of verbal and literary discipline too much to ask?” Three decades later, I guess we know the answer.

— 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.

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