Genetic engineering applied to agriculture has a long row to hoe.

In spite of the lack of scientific justification for skepticism about crops modified with molecular techniques of genetic engineering, they have been the most scrutinized agricultural products in human history. The assumption that "genetically engineered" or "genetically modified" is a meaningful - and dangerous - classification has led to excessive and dilatory regulation. The modern molecular techniques are an extension, or refinement, of older, less precise, less predictable methods of genetic modification, but as long as today's activists and regulators remain convinced that so called "GMOs" represent a distinct and dangerous category of research and products, genetic engineering will fall short of its potential.

At this year's annual meeting of the International Consortium on Applied Bioeconomy Research (ICABR) there were many presentations about the regulatory requirements in various countries for so-called “GMOs,” or genetically modified organisms. Because that term circumscribes an arbitrary, bureaucratically-determined, non-category devised by government officials and activists, the criteria for what should be included and require case by case review by regulators were extremely heterogenous. Some focused on the mixing of DNAs from different sources, or in combinations that are unlikely to exist in nature, while many were more concerned with the technique(s) used. Largely ignored was the most important factor: the function of the genetic modification, or its effect on the traits of the plant, animal or microorganism.

The focus on the technique(s) has caused no end of mischief. It has turned on its head the fundamental principle of regulation—proportionality–which dictates that the degree of scrutiny should be proportional to the perceived degree of risk. Ignoring this principle has led virtually everywhere to systematic over-regulation of the newest, most precise and predictable techniques of genetic engineering; astronomical R&D costs; blunted innovation; superfluous labeling of products; endless dithering about concepts like “coexistence” of organisms crafted with different genetic techniques; and widespread confusion among non-experts. Countless conferences have discussed the equivalent of whether a Lexus radio installed in a Toyota creates a new “category” for regulatory purposes.

The focus on genetic technique for regulatory purposes dates back to a historic 1975 meeting of scientists, ethicists, and members of the press held in Asilomar, California, which resulted in a temporary moratorium on research using the prototypic technique of molecular genetic engineering–recombinant DNA technology–and, ultimately, in the creation of highly restrictive, unnecessary regulation.

The 1974 article in the journal Science that led to the Asilomar meeting urged that “scientists throughout the world join with the members of this committee,” which was comprised of a handful of eminent biologists, to halt recombinant DNA experiments – even in laboratories – “until attempts have been made to evaluate the hazards and some resolution of the outstanding questions has been achieved.” And the official “Summary Statement of the Asilomar Conference on Recombinant DNA Molecules” concluded: “Even in the present, more limited conduct of research in this field, the evaluation of potential biohazards has proved to be extremely difficult,” because “[t]he new techniques, which permit combination of genetic information from very different organisms, place us in an area of biology with many unknowns.”

It is remarkable how similar these portentous sentiments were to those of plant breeder pioneer Luther Burbank: “We have recently advanced our knowledge of genetics to the point where we can manipulate life in a way never intended by nature. We must proceed with the utmost caution in the application of this new found knowledge.” That was in 1906.

Stanford University biochemistry professor Paul Berg was a prime mover in the Asilomar meeting and remains one of the staunchest defenders of its outcome. In a 2008 essay in the journal Nature modestly titled, “Meetings that changed the world: Asilomar 1975: DNA modification secured,” he recalled that at the time the greatest concerns were “that introduced genes could change normally innocuous microbes into cancer-causing agents or into human pathogens, resistant to antibiotics or able to produce dangerous toxins.” But what many have forgotten is that the research community was far from a consensus on the question of whether a moratorium was necessary at the time; indeed, many in the scientific community did not regard the hiatus as a success, either scientific or intellectual.

In fact, the Asilomar cabal misunderstood and exaggerated the potential risks of recombinant DNA technology, modern biotechnology's core technique; gave rise to a lengthy, damaging research moratorium; and induced the U.S. National Institutes of Health (NIH) to draft and promulgate overly restrictive “biosafety” guidelines which have survived to the present day.

If the presentations at the ICABR meeting are any indication, regulators worldwide appear to be en route to repeating or at least perpetuating that seminal blunder.

During the Asilomar conference, Stanley Cohen, James D. Watson, and Joshua Lederberg–all Nobel Laureates, as is Berg–argued publicly (and others privately) “against the forming of any official guidelines that spelled out how we should work with recombinant DNA.” In the words of science historian José Van Dijck, “In the politicized mood of the 1970s, genetics got annexed as an environmental issue; this new configuration manifested itself in changed images of genetics, genes, and geneticists,” which were no longer altogether altruistic, or even benign.

By 1978, the regulatory obstacles slowing research in many fields and labs induced Watson to dismiss the handwringing as “senseless hysteria” and to observe that “everyone I know who works with DNA now feels the same and the mere mention of ‘DNA Guidelines’ or ‘Memorandums of Understanding’ makes our mouths froth.” (As a laboratory scientist at NIH at the time, I shared that sentiment.)

Those technique-based NIH guidelines, which were focused on the use of a single technique instead of on the actual risks of experiments, have plagued genetic engineering research and development ever since. By assuming (incorrectly) from the beginning that recombinant DNA-modified organisms—which, as mentioned above, have come to be commonly known as “genetically modified organisms” or GMOs—were a high-risk category that needed to have sui generis regulation, the NIH guidelines created significant duplication of oversight for many products that were already sufficiently regulated if they posed unreasonable risk.

Worst of all, they reinforced the misconception that recombinant, or “genetically modified,” organisms are a meaningful “category.” Although NIH gradually pared back the scope and stringency of its guidelines, stultifying process-based, technique-focused approaches to regulation of this non-category (defined in different ways) have remained intact there and at other federal agencies, including the Environmental Protection Agency, the Food and Drug Administration, the Department of Agriculture, and in many foreign countries. And excessive government regulation perpetuates the misapprehension on the part of many non-experts that products or activities that are stringently regulated must, ipso facto, be high-risk.

Overregulation's toll on innovation is incalculable. As University of California Berkeley agricultural economist David Zilberman and his colleagues observed, “The foregone benefits from these otherwise feasible production technologies are irreversible, both in the sense that past harvests have been lower than they would have been if the technology had been introduced and in the sense that yield growth is a cumulative process of which the onset has been delayed.”

What does the future hold for genetic engineering? Will regulation be rationalized at long last? Will public skepticism abate?

“A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it,” physics Nobel Laureate Max Planck observed in 1936. But this does not seem to be happening in the case of the molecular techniques for genetic engineering: In spite of an extraordinary record of safety and benefits, both economic and humanitarian, new generations are being indoctrinated by activists and self-interested competitors with the idea that there is something fundamentally different, and deserving of concern, about the newer techniques, and over-regulation only reinforces those misapprehensions. We are not moving along the learning curve, and there no happy resolution is in sight.