The Brave Old World of Genetic Engineering

The Brave Old World of Genetic Engineering

 “Genetic engineering” is not a meaningful “category,” and we must stop regulating it as though it were. 

Even after two decades of stunning scientific, humanitarian and financial successes and an admirable record of safety, the application of genetic engineering (GE) to agriculture is still beleaguered by activists and over-regulated by bureaucrats.  This opposition and obstruction can be traced back to a fundamental fallacy–namely, that the terms “genetic engineering” and the common shorthand “GMO” (for “genetically modified organism”) represent a meaningful grouping of things, a “category.”

Genetically engineered organisms and the foods derived from them do not in any way constitute genuine categories, which makes any choice of what to include in them wholly arbitrary and misleading.  Nor have they been shown to be less safe or, given the pedigree of the foods in our diet, in any way less “natural” than thousands of other common foods.  As FDA has stated in response to calls for mandatory labeling to identify foods produced with modern genetic engineering techniques, such labeling would erroneously imply a meaningful difference where none exists.  (And because it would be misleading, it would render the food “misbranded,” making its sale a violation of the Federal Food, Drug and Cosmetic Act.)  Although FDA has consistently rejected calls for either a mandatory safety review or labeling based on the use of certain techniques, legislation just proposed in the House of Representatives would require the former.

Top: Lesser cornstalk borer larvae extensively damaged the leaves of this unprotected peanut plant. (Image Number K8664-2)-Photo by Herb Pilcher. Bottom: After only a few bites of peanut leaves of this genetically engineered plant (containing the genes of the Bacillus thuringiensis (Bt) bacteria), this lesser cornstalk borer larva crawled off the leaf and died. (Image Number K8664-1)-Photo by Herb Pilcher. (Photo credit: Wikipedia)

Genetic modification by means of selection and hybridization has been with us for millennia, and the techniques employed along the way, up to today, are part of a seamless continuum.  Breeders routinely use radiation or chemical mutagens on seeds to scramble a plant’s DNA to generate new traits, and more than a half century of “wide cross” hybridizations, which involve the movement of genes from one species or one genus to another, has given rise to plants thatdo not exist in nature; they include the varieties of corn, oats, pumpkin, wheat, rice, tomatoes and potatoes we buy routinely.  (Yes, even “heirloom” varieties and the overpriced organic stuff at Whole Foods.)  On average, we consume dozens of servings of these genetically improved varieties of fruits, vegetables, and grains every day: With the exception of wild berries, wild game, wild mushrooms and fish and shellfish, virtually everything in North American and European diets has been genetically improved in some way.

The erroneous assumption that “genetic engineering” or “genetic modification” is a meaningful category has led to various kinds of mischief, including the vandalization of field trials and destruction of laboratories; state referendum issues and legislative proposals that would require pointless, expensive labeling of some GE foods; local bans or restrictions; and a spate of spurious lawsuits of various kinds.  Perhaps worst of all, it has also led to a quarter-century of unscientific regulatory approaches at the federal level that inhibit the kinds of agricultural innovations that can provide less impact on the natural environment, solutions to the problems of American farmers, and greater food security for many of the world’s poor.

Although laboratory research on plants has been robust since the advent of molecular genetic engineering techniques in the early 1970’s, the commercialization of products has been disappointing, largely because of unscientific, excessive government regulation that discriminates against modern, molecular GE techniques.  For a quarter century, GE crops have been the most scrutinized in human history, without any scientific justification for such a burden.  They are far more precisely and predictably crafted than their predecessors, and none has caused even a single instance of documented harm to humans or disruption of an ecosystem.  Yet, they are subjected to disproportionately extensive and expensive regulation.

Although hundreds of studies–both formal risk-assessments as well as observations of “real-world use”–have confirmed the safety of the technology, not only has there been no reduction or rationalization of the regulatory burden placed on plants made the newer techniques of genetic engineering, but in many cases regulatory stringency and burdens are actually increasing.

Last December, the European Food Safety Authority published a “Scientific Opinion” which concluded that a variety of soybean genetically engineered to have higher than usual levels of oleic acid (which yields a healthier cooking oil) “is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment; that “bioinformatic analyses and genetic stability studies did not raise safety issues”; and that the variety “is agronomically equivalent to non-[engineered] reference soybeans.”  Moreover, the EFSA safety assessment “identified no concerns regarding potential toxicity and allergenicity” and the nutritional assessment of the soybean variety’s oil and “derived food products did not identify concerns on human health and nutrition.”

Such conclusions following the evaluation of new genetically engineered crops are typical – and yet the panel recommended for high-oleic acid soybeans a “post-market monitoring plan, focusing on the collection of consumption data for the European population, for the marketed foods and feed.”  This recommendation is inconsistent, baseless, wasteful, and just plain asinine.

Pursuing what seems to be an official policy of wastefulness and cluelessness, on January 16 EFSA held its seventh meeting with representatives from consumer and NGOs to “discuss scientific issues regarding environmental risk assessment (ERA) and risk assessment considerations for plants” in the non-category of “new biotechnology-based breeding techniques.” Yet again that begs the question that those considerations are somehow different from those for older, conventional biotechnology-based breeding techniques.  It makes one wonder why European regulators don’t convene meetings to discuss new designs for perpetual-motion machines or methods for estimating the number of angels that can dance on the head of a pin.

The regulatory obstacles that discriminate against genetic engineering impede the development of crops with both commercial and humanitarian potential, and many of the GE crops foreseen in the early days of the technology have literally withered on the vine as regulatory costs have made testing and commercial development economically unfeasible.

The degree of regulation should be commensurate with the level of risk.  Given both theoretical considerations and the vast experience accumulated during the past two decades, none of the regulatory regimes for the field trials and commercialization of GE crops around the world are scientifically defensible or justifiable.  USDA’s Animal and Plant Health Inspection Service is no betterthan EFSA.

Legislation introduced in April in the U.S. House of Representatives by Reps. Mike Pompeo (R-Kansas) and G.K. Butterfield (D-NC) would mandate yet another escalation of regulation, without any justification for it.

At present, the FDA operates a voluntary consultation program for genetically engineered foods during which the developer provides the FDA various kinds of information about the product. Without any known exceptions developers have engaged in this voluntary consultation, which is more than adequate to protect American consumers. As discussed above, there is a broad consensus that there is no scientific reason to view food made with modern molecular techniques as fundamentally different from other food, so even the “voluntary” consultation–which no food producer dares to flout–is gratuitous and excessive. (Virtually identical foods made with older, less precise and less predictable techniques would not routinely be subject to review, voluntary or otherwise.)

Another concern is that a mandatory FDA review of new genetically engineered foods could constitute a “major federal action” that would trigger FDA procedural obligations under NEPA, the federal National Environmental Policy Act.  In the past, activists acting in bad faith have delayed approvals by bringing numerous nuisance lawsuits that claimed purely procedural deficiencies under the Act.

Other concerns include gratuitous delays and political interference in the review of applications.

To be clear, the Pompeo-Butterfield bill would do absolutely nothing to enhance the safety of the food supply, which even its congressional supporters acknowledge.  On the contrary, by creating even more burdensome regulation and uncertainty about the path to the marketing of superior new products, it would do exactly the opposite.

What, then, is the rationale for more regulation?  Simple–political horse-trading.  It’s a tradeoff for another positive provision of the bill which would explicitly preempt state and local labeling laws, by affirming that the FDA is the sole authority for labeling requirements.  (FDA’s policy, which was promulgated in 1992 and 2001 policy statements, is that labeling should convey “material” information that bears on safety or usage, and that the use of a certain process or technique, is not material.  The bottom line is that labeling must not be “false or misleading in any particular.”)

Regulatory changes are in order–in fact, they’re long overdue–but they should be in the direction of making regulation more scientific and risk-based—rather than creating even more regulatory oversight focused on a bogus pseudo-category.

The opportunity costs of unnecessary regulatory delays and inflated development expenses are formidable.  As University of California agricultural economist David Zilberman and his colleagues have 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.”

We have already foregone significant benefits, and genetic engineering will fail to realize its full potential as long as it is regarded by activists, regulators and legislators as a distinct and unique category.