Over-regulation at USDA is holding back American agriculture

Over-regulation at USDA is holding back American agriculture
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The Foundation for Food and Agriculture Research (FFAR) will tackle “key problems” in the industry at its October 6 annual board meeting including optimizing agricultural water usage and improving soil health. And while those issues are important, FFAR is ignoring the most pressing issue in the industry — excessive and wrong-headed government regulation.

That omission was predictable, given that four ex officio members of FFAR’s board are senior USDA officials.

Excessively burdensome regulation blunts technological innovation, as explained in a 2013 policy memo by Progressive Policy Institute economists Michael Mandel and Diana Carew: "For each new regulation added to the existing pile, there is a greater possibility for…inefficient company resource allocation, and for reduced ability to invest in innovation.” The result? "The negative effect on U.S. industry of regulatory accumulation actually compounds on itself for every additional regulation added to the pile."


As the regulator of the critical agricultural sector of genetically engineered plants, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) is in dire need of reform to make its regulation more science-based and less burdensome. Some background is necessary. 

Before the advent of molecular techniques for genetic modification in the 1970s, APHIS had long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are plant pests, which were defined by means of an inclusive list — essentially a binary “thumbs up or down” approach. A plant that an investigator might wish to introduce into the field is either on the prohibited list of plant pests, and therefore requires a permit, or it is 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 are known to injure or damage plants), unlike organisms not considered to be plant pests.

But for 30 years, APHIS has applied a parallel regime (in addition to its basic risk-based regulation) that focuses exclusively on plants altered or produced with the most precise genetic engineering techniques. APHIS reworked the original concept of a plant pest (something known to be harmful) to craft a new category — a “regulated article” — defined in a way that captures virtually every recombinant DNA-modified plant for case-by-case review, regardless of its potential risk, because it might be a plant pest. (Recombinant DNA technology is the prototypic “gene-splicing” technology, invented in the 1970s.) 

In order to perform a field trial with a regulated article, a researcher must apply to APHIS and submit extensive paperwork before, during and after the field trial. After conducting field trials for a number of years at many sites, the researcher must then submit copious data to APHIS and request “deregulation,” which is equivalent to approval for unconditional release and sale. These requirements make genetically engineered plants extraordinarily expensive to develop and test.

The cost of discovery, development, and regulatory authorization of a new trait introduced between 2008 and 2012 averaged $136 million, according to Wendelyn Jones of DuPont Pioneer, a major corporation involved in crop genetics. That huge price-tag is the primary reason that more than 99 percent of the genetically engineered crop acreage currently cultivated is huge-scale commodity crops, while so-called “specialty crops” — fruits, nuts and vegetables — are underrepresented. 

APHIS’s approach to recombinant DNA-modified plants is impossible to justify. Plants have long been selected by nature, as well as bred or otherwise manipulated by humans, for enhanced resistance or tolerance to external threats to their survival and productivity, such as insects, disease organisms, weeds, herbicides and environmental stresses. Plants have also been modified for qualities attractive to consumers, such as seedless watermelons and the tangerine-grapefruit hybrid called a tangelo.

Along the way, plant breeders have learned from experience about the need for risk analysis, assessment and management. New varieties of plants (whichever techniques are used to craft them) that normally harbor relatively high levels of various toxins are analyzed carefully to make sure that levels of those substances remain in the safe range. Celery, squash and potatoes are among the crops in need of such scrutiny. 

The basic tenets of government regulation are that similar things should be regulated similarly, and the degree of oversight should be proportionate to the risk of the product or activity. For new varieties of plants, risk is a function of certain characteristics of the parental plant (such as weediness, toxicity or ability to “outcross” with other plants) and of the introduced gene or genes. In other words, it is not the source or the method used to introduce a gene but its function that determines how it contributes to risk. 

Under APHIS’s “regulated article” regime, however, only plants made with the newest, most precise techniques have been subjected to more extensive and burdensome regulation, independent of the risk of the product. 

Under its discriminatory and unscientific regulatory regime, APHIS has approved 196 varieties of genetically engineered crops, and farmers have widely and rapidly adopted many of them. After the cultivation worldwide of more than 5 billion acres of genetically engineered crops (by more than 18 million farmers in 26 countries) and the consumption of more than 4 trillion servings of food containing genetically engineered ingredients in North America alone, there has not been a single documented ecosystem disruption or a single confirmed tummy ache.

The regulatory excesses to which genetic engineering applied to agriculture has been subjected — not only by USDA but also by EPA and FDA — have diminished investment in research and development and make it less likely that the field will yield the “next big thing.” 

The reform of regulation of genetically engineered plants could yield tremendous humanitarian and economic benefits in the near-term and for generations to come. Regulators won’t do it without significant prodding, however, so it should be part of the agenda of FFAR and major health-related philanthropies. 

Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University's Hoover Institution. He was the founding director of the FDA’s Office of Biotechnology.