Defining the terms "biotechnology" and "genetic engineering" isn't an easy task, since the terms don't represent natural groupings of processes or products. They connote something different to individual commentators, journalists, organizations, congressional staffers and members of the public. 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.
Those vague, problematic terms have now morphed into "genetic modification" and "genetically modified organisms," or "GMOs," but our observations remain equally valid. Imprecise, confusing terminology still leads to fuzzy thinking about alterations of the genomes of plants, animals and microorganisms. And that has given rise to unwarranted, draconian regulation of this non-category that has been costly in terms of foregone advances in many sectors of R&D worldwide.
Intentional genetic modification of organisms is hardly new. Farmers and plant breeders have been selecting and hybridizing plants to enhance their desirable characteristics for millennia. Modern varieties of innumerable crop plants such as corn, tomatoes and wheat bear little resemblance to their ancestors. A common technique for creating new plant varieties, which originated about a century ago, is subjecting seeds to radiation to scramble their DNA and create mutants, some of which may (and often do) exhibit desirable traits. Thousands of plant varieties that we consume routinely--including lettuces, wheat, rice, oats and the popular Rio-Sweet and Rio Star pink grapefruit varieties -– were derived this way.
There is a seamless continuum of techniques for the genetic improvement of organisms that both predates and includes the advent of molecular techniques, which were invented during the 1970's and have been significantly improved since then. A gene-editing technique called CRISPR-Cas9 has been revolutionary, and an even more precise technology called "base editing" is the most recent refinement.
Some of the skeptics about modern genetic engineering would remonstrate that using "conventional," or pre-molecular, techniques somehow is different -- more "natural" -- because they add no "foreign" genes to the genome of the resulting plant.
Since the 1930′s 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. In these hybridizations, which are performed between organisms of different species or genera, the parental plants may be sufficiently compatible to produce a zygote, but it does not survive and develop into a mature plant. To overcome this obstacle, 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.
Useful and generally safe, wide-cross hybridizations and radiation-induced mutagenesis represent far more drastic tinkering with nature -- and lead to far less precise and predictable results -- than the modern molecular techniques used to alter genes, but paradoxically neither federal regulators nor anti-genetic engineering activists have evinced any concern about creating new plant varieties with those older techniques. Even though the outcomes are by any reasonable definition "genetically modified," they are not subject to expensive mandatory testing or review before entering the food chain, or labeling when they are sold. In contrast, when a single gene is moved by molecular techniques, the resulting variety is subject to lengthy, hugely expensive -- and often politicized --regulation.
To be clear, it's not the source of genetic material, or whether DNAs from different organisms are mixed, that confers incremental 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 in the field.
In other words, "GMO" is an utterly meaningless term -- which is remarkable considering that if you Google it, you get about 21,000,000 hits. The issue is not merely semantic, with legislators and regulators deliberating over whether organisms made with the new "gene editing" techniques, such as CRISPR-Cas9, are "GMOs" – which is rather like discussing whether taping a plastic cone to the forehead of a horse makes it a "unicorn." Moreover, the term has, in effect, been monetized, with companies charging hefty fees for certifying that foods are "Non-GMO."
Generations of legislators, regulators and anti-technology activists worldwide fail to grasp that "genetic modification" is a continuum and that plants and microorganisms modified with molecular techniques are likely to pose lower environmental and health risks than conventional plants because of the high degree of precision with which they're developed. Nevertheless, regulation of the products of the newest technologies has been, literally, extraordinary. Those products are singled out for discriminatory sui generis regulation, and their reviews often drag on for years. In the European Union, there is a virtual ban on their cultivation.
We hasten to add that FDA was an exception to unscientific, technique-focused oversight of products made with molecular genetic engineering. During our tenure at the Agency, it was the only federal agency regulating these products that adopted scientifically defensible policies, regulating products according to their risk, not because certain techniques were used. FDA's policies would later change, for the worse.
In our 1987 op-ed, we called for the use of more precise, meaningful terms such as recombinant DNA technology, live vaccines and monoclonal antibodies, because "by using terms such as these, we would convey our meaning more clearly, whether the intent is to laud progress, to call for oversight, or to seek additional funding." (If we were writing the article today, we would add, "or to require labeling.")
We concluded by asking, "Is that degree of verbal and literary discipline too much to ask?" Apparently, it was. More than three decades later, it is past time to correct not only misleading terminology but also flawed public policy based on mistaken assumptions.
Henry I. Miller, a physician, molecular biologist and former flu virus researcher, is the Robert Wesson fellow in scientific philosophy and public policy at Stanford University's Hoover Institution. He was the founding director of the Food and Drug Administration's Office of Biotechnology. Twitter: @henryimiller. Frank E. Young, a physician and molecular biologist, has held a number of senior academic and government positions;. He headed the U.S. FDA from 1984 to 1989.