"The law is an ass" is an observation made popular by Charles Dickens in "Oliver Twist" (1838). Never was it more true 180 years later, when, on July 25, 2018, the Court of Justice of the European Union (CJEU) ruled that the modern techniques of genetic breeding of crops and animals are subject to the EU regulations that govern so-called "GMOs," genetically modified organisms.
This court decision — and even the need for such a decision — is ridiculous, not unlike debating whether taping a plastic cone to the head of a horse makes it fit the definition of a unicorn.
The reality is that there's no such thing as a GMO, except in the fevered imagination of bureaucrats, legislators, and activists — and now, a few jurists.
However, that fact hasn't stopped many regulatory agencies worldwide from imposing unreasonable and debilitating regulatory burdens on variously arbitrarily defined categories of "GMOs."
Genetic engineering encompasses a seamless continuum of techniques that have been used over millennia, including (among others) selective breeding, hybridization, mutagenesis, and wide-cross hybridization (movement of genes across supposed "natural breeding barriers").
With the exception of wild mushrooms, wild berries, wild game and most fish and shellfish, virtually all the fruits, vegetables, grains and animals in our diet have been purposefully genetically modified.
Where do the newer techniques fit in? For at least thirty years, analyses by the scientific community have concluded repeatedly that, compared to older breeding methods, modern molecular techniques for genetic modification pose no unique or incremental risks to human or animal health or to the natural environment.
In the most comprehensive and unequivocal analysis, the 1989 U.S. National Research Council report on the risks of genetically engineered plants and microorganisms, "Field Testing of Genetically Modified Organisms," concluded that "the same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods."
That analysis went further, emphasizing that the modern molecular techniques are more precise, circumscribed, and predictable than other methods:
With classical techniques of gene transfer, a variable number of genes can be transferred, the number depending on the mechanism of transfer; but predicting the precise number or the traits that have been transferred is difficult, and we cannot always predict the phenotypic expression that will result.
With organisms modified by molecular methods; we are in a better, if not perfect, position to predict the phenotypic expression.
That analysis was three decades ago.
The more recent, even more precise "new breeding techniques," or "NBTs," such as gene-editing methods CRISPR-cas9 and CRISPR-cas13, offer even greater possibilities for helping to address the challenges to providing sufficient amounts of safe and nutritious food in the face of world population growth and changing climates.
What are some consequences of the CJEU ruling? European scientists in plant and animal molecular biology are deeply discouraged because, at least in Europe, their research is henceforth unlikely to progress beyond their laboratories.
Only enterprises with very deep pockets can contemplate the time and costs that will be required to gain regulatory approval for products of modern breeding techniques.
Given that the EU regulators have only approved two "GMOs" for European commercial cultivation, of the hundreds worldwide, it is unlikely that even these very large enterprises would try to obtain European approvals. (Unlike new pharmaceuticals, new crop varieties seldom yield the kinds of high profit-margins that make huge R&D expenditures worthwhile.)
Thus, European farmers have lost access to crops and animals with desirable traits that can promote higher yields, greater sustainability, enhanced food security, and environmental advantages.
Other nations and their farmers might hesitate to adopt crops or animals made with NBTs, fearing regulatory delays and market disruptions simply because they used techniques that are superior but disfavored by European regulators.
Developing countries and their farmers, where these NBTs offer great hope for agricultural development, will hesitate to adopt them and, without access to agricultural innovation, their public health and economic well-being will suffer.
Aside from the disheartening consequences of public policy that discriminates against superior technologies, as Ottoline Leyser, Director of the Sainsbury Laboratory at the University of Cambridge, has said, "the main problem illustrated by this (CJEU) ruling is the deep logical flaw in the whole regulatory approach."
More specifically, that flaw is that the term "genetically modified organism," or "GMO," is a legal, not scientific, construct that creates an arbitrary and meaningless process-based category for regulatory purposes.
Again quoting Professor Leyser:
We should assess new crop varieties on the traits they are supposed to deliver, not on how those traits were introduced. The system needs to be proportional and risk-based.
This should of course include consideration of the unintended effects of whatever genetic improvement process was used. Instead we spend years debating whether or not a new technique counts as genetic modification or not. That this is even a relevant question lays bare the flaws in our current approach.
Therein lies the unwisdom in the CEJU decision, and in the need to bring the issue to the courts in the first place.
We note a bitter irony in this public policy quagmire: Assuming for the sake of argument it was reasonable to regulate the products of genetic engineering according to which technique(s) was used, regulators have turned the paradigm on its head, regulating the most precise and predictable techniques most stringently, the opposite of what logic would dictate.
Putting it another way, echoing Professor Leyser, regulation has not been proportional to the identified or perceived risks.
Instead, legislators and regulators have focused on hypothetical risks, grossly over-regulating plants and animals bred with modern genetic techniques, while paying scant attention to risks that can arise (infrequently) from plants and animals crafted with conventional, non-molecular breeding techniques.
What underlies this public policy imbecility? Regulations have reflected fears and myths rather than the scientific consensus about molecular biology and genetic modification.
Legislators and courts, including the CJEU, have given excessive credence to these fears and myths — and the public concerns they have evoked — by invoking the "precautionary principle," interpreted in a way that is antagonistic to science and technology and stifles progress.
Legislators, regulators and the courts have contributed to a "post-truth" era of pseudo-science and eco-fundamentalism, in which there is suspicion of scientific expertise and of modern technology.
This topic is treated eloquently and at length by Dick Taverne (aka Baron Taverne, QC) in his book, "The March of Unreason." He identifies ominous trends that are contrary to the principles of the Enlightenment, returning us to an era in which inherited dogma and superstition took precedence over experimental data.
Not only do the practices of eco-fundamentalism retard technologies and the availability of products which, used responsibly, could dramatically improve and extend many lives and protect the environment, but they strangle scientific creativity and technological innovation.
Until policy makers, including de facto policy makers in the judiciary, correct the fundamental flaws in the regulation of agricultural biotechnology, the CJEU decision will stand as a landmark of both bad jurisprudence and the strangulation of European agricultural innovation.
- Miller, an M.D., is also 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.
- Kershen is the Earl Sneed Centennial Professor of Law (Emeritus), University of Oklahoma College of Law, in Norman, Oklahoma. He has taught, lectured, and published about agricultural biotechnology for more than 20 years.