Viewpoint: Genetic engineering produces a genuine monstrosity

This article originally ran at Forbes and has been republished here with permission of the author.

Activists have warned for decades that genetic engineering would create some sort of monstrosity like Dr. Frankenstein’s creature. It turns out they were right: Government regulation has run amok and threatens advances in agriculture. USDA’s existing regulatory policy harms researchers, farmers and consumers alike, but there is little interest in taking up sticks and pitchforks (metaphorically speaking) to resist the bureaucrats.

USDA’s unscientific, overly complex regulation of genetically engineered crops is a historical fluke – an anomaly that originated more than a quarter century ago. In 1986 the White House Office of Science and Technology Policy published a policy statement on the regulation of biotechnology that focused oversight and regulatory triggers on the risk-related characteristics of products, such as plants’ weediness or toxicity. OSTP specifically rejected regulation based on the particular process used for genetic modification. (Genetic modification had been performed by a continuum of techniques for centuries.)

In 1992, in a second policy statement the federal government reaffirmed the overarching principle for biotechnology regulation: The degree and intrusiveness of oversight “should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique.” Thus, dating from the 1980′s, there has been a broad consensus in the scientific community (which has been reflected in statements of federal government policy) that the newest techniques of genetic modification are essentially an extension, or refinement, of older, less precise and less predictable ones, and that oversight should focus on the characteristics of products, not on process.

However, intent on building a regulatory empire, USDA heeded neither the consensus of the scientific community nor the directives from the White House. The resulting unscientific, stultifying regulation has inhibited research and development, particularly in public institutions, ever since, and has provided an endless source of all manner of mischief, including superfluous, obstructive government bureaucracies; wasteful spending on poorly-conceived risk-assessment research; vandalism of field trials; bad-faith legal harassment; and endless nattering by the ill-informed and the ideological.

A manifestation of the mischief spawned by flawed regulation is USDA’s recent decision to perform unnecessary, expensive, time-consuming Environmental Impact Statements (EISs) on two applications for crops genetically engineered to be resistant to 2,4-D and dicamba, herbicides that have been safely and widely used in the U.S. since the 1960′s.

In what way is USDA’s biotechnology regulation mischievous? USDA’s Animal and Plant Health Inspection Service (APHIS) had long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are “plant pests,” defined by means of an inclusive list – essentially a “thumbs up or thumbs down” approach. A plant that an investigator might wish to introduce into the field is either on the inclusive, prohibited list of plants pests – and therefore requires a permit – or it’s exempt.

This straightforward approach is risk-based, in that the organisms required to undergo case-by-case governmental review are an enhanced-risk group – organisms that can injure or damage plants – compared to organisms not considered to be plant pests. But for a quarter century, this risk-based USDA regulation has had a kind of evil twin – a regime focused exclusively on plants altered or produced with the most precise genetic engineering techniques. USDA tortured the original concept of a plant pest as something known to be harmful and crafted a new, jury-rigged category: a “regulated article,” defined in a way that captures virtually every genetically engineered plant for case by-case review, regardless of its potential risk.

In order to perform a field trial with a regulated article, a researcher must apply to USDA and submit extensive paperwork before, during and after the field trial. After conducting field trials for a number of years at many sites, the developer then submits a vast dossier of data and requests “deregulation” by USDA, which is equivalent to approval for unconditional release. These requirements make genetically engineered plants extraordinarily expensive to develop and test – which is the reason that up to now, commercialization has been limited primarily to huge-scale commodity crops.

USDA’s discriminatory treatment of genetically engineered plants – most of which have been modified for enhanced pest-, disease-, or herbicide-resistance – makes no sense. Plants have long been selected by nature and bred by humans or irradiated to create mutants with enhanced resistance or tolerance to external threats – insects, disease organisms, herbicides and environmental stresses – to their survival and productivity. Plants have also been modified by farmers and plant breeders for other qualities, such as yield and attractiveness to consumers. Corn has undergone gradual but drastic modification that has seen it evolve from the original grass-like plant, teosinte, with primitive, meager kernels into modern varieties with regularly arranged kernels bulging with carbohydrates, oils, and protein. Primitive wheat breeders crafted durum (hard) wheat for pasta and softer varieties for cakes, often by crossing wheat varieties with remotely related species of wild grasses.

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Plant breeders have learned from experience about the need for risk analysis, assessment and management. New varieties of plants (whatever the technique used to craft them) that normally harbor relatively high levels of toxins – such as celery, squash and potatoes – are analyzed carefully to make sure that levels of potentially harmful substances remain in the safe range.
The degree of regulatory oversight should be proportionate to the perceived risk of the genetically engineered plant, which is a function of certain characteristics of the host plant (weediness, toxicity, ability to outcross, etc.) and the introduced gene. What is important is not the source of the new genetic material or the method used to introduce a gene; it is its function. But for a quarter century, plants made with the newest, most precise techniques have been subjected to the most regulation, independent of risk.

Moreover, the fact that USDA’s regulatory policy makes “deregulation” a “major action” triggers certain required assessments under the National Environmental Policy Act, which has provided an opportunity for activists to enlist the courts in obstructing the deregulation of various genetically engineered plant varieties.

There are no outstanding, unresolved issues of environmental or human safety concerning the crops (corn and soybeans) resistant to 2,4-D and dicamba for which EISs will be performed. There is no need for USDA to perform EISs prior to their “deregulation” (that is, approval for unlimited, unconditional release). After Dow AgroSciences and Monsanto filed a petition to deregulate their 2,4-D- and dicamba-resistant crops, respectively, several years ago, USDA’s Animal and Plant Health Inspection Service (APHIS) initiated the process required by the Plant Protection Act to determine whether these seeds and plants could be plant pests. APHIS should complete that determination; and if these seeds and plants are not plant pests (as seems self-evident), APHIS should deregulate without further delay, in accordance with a recent Ninth Circuit Court of Appeals decision, Center for Food Safety v. Vilsack, which held that once APHIS has determined that a genetically engineered agricultural commodity is not a “plant pest,” the agency lacks jurisdiction to consult further under the Endangered Species Act (ESA) or to conduct an EIS. The wording of the decision is definitive: “[O]nce APHIS concluded that [the genetically engineered plant] was not a plant pest because it did not cause plant pest injury to plants, the agency had no jurisdiction to continue regulating the crop. The agency’s deregulation of [the plant] was thus a non-discretionary act that did not trigger the agency’s duty to consult under the ESA.”

That ruling of the Ninth Circuit makes NEPA and ESA relevant only when APHIS determines that a genetically engineered agricultural commodity is a “plant pest” under the Plant Protection Act.

In the published announcements that EISs would be undertaken for the evaluation of the crops resistant to 2,4-D and dicamba, APHIS indicated that the decision was driven by concerns about weed resistance related to herbicide usage. However, EPA – not USDA – has the authority to regulate herbicides (under FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act), taking into account the environmental impact of weed resistance issues. EPA had already exercised its authority under FIFRA in authorizing dicamba and 2,4-D as herbicides – and EPA’s environmental reviews under FIFRA are considered to be “functionally equivalent” to an EIS under NEPA. Therefore, given that EPA had performed the functional equivalent of an EIS, APHIS is limited to determining plant pest status but lacks the statutory authority to consider weed resistance. APHIS’ NEPA obligations can be fulfilled with a simple Environmental Assessment (EA) that relies upon EPA’s herbicide approvals under FIFRA.

The performance of unnecessary EISs is a huge waste of government officials’ time, labor and resources. The delay in deregulation harms farmers, who need improved corn and soybean varieties for easier weed-control; unduly burdens industry; and creates a disincentive to innovative R&D.

The fundamental problem with USDA’s regulation of genetically engineered plants lies not at the end of the process – that is, the determination whether an EA suffices or an EIS is required; rather it resides in what comes under regulators’ purview in the first place. What we need is a more rational approach to the scope of the new plant varieties that are subject to governmental review – an approach that is based on the risk-related characteristics of plants and conforms to announcements of policy published by OSTP in 1986 and 1992. Until then, plant genetic engineering will fail to realize anything approaching its full potential.


Henry I. Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy & Public Policy at Stanford University’s Hoover Institution.  He was the founding director of the FDA’s Office of Biotechnology. Follow him on Twitter @henryimiller.

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