Perhaps the changes will make life better for farmers and other rural residents in some ways. But if the USDA really wants to promote prosperity in rural America, it should pare back the excessive regulations that have been constraining agricultural innovation for the last three decades.
Consider the USDA’s questionable certification of “organic” products, which has been discussed in these pages previously. (See “The USDA’s Meaningless Organic Label,” Spring 2016.) Because the “organic” designation doesn’t reflect any difference in food safety or healthfulness, and because the requirements for earning the “USDA Organic” label are wholly arbitrary—not to mention the USDA’s questionable effectiveness in correctly identifying which products meet those requirements—consumers and producers of organic products would likely be better served by private certification regimes that would respond to market demands rather than political whims.
Another example, also previously discussed in these pages, would be a drastic relaxation—if not an outright repeal—of USDA and Food and Drug Administration regulations that inhibit the development and use of genetically modified organisms (GMOs). (See “The USDA’s Anti-Science Activism,” Summer 2011.) The longstanding scientific consensus is that GMOs pose no more (and often less) risk to human health and the rest of the planet than organisms created through largely unregulated traditional techniques. Permitting broader use of genetic modification would open the way for developing both animals and plants that require fewer inputs, are more healthful and environmentally friendly, and would make land that would have been needed for agriculture available for other uses.
Likewise, the once-promising sector of “biopharming,” which uses genetic engineering techniques to induce crops such as corn, rice, and tobacco to produce high concentrations of high-value pharmaceuticals, is moribund as a result of USDA regulation. Not surprisingly, few companies or other potential sponsors are willing to invest in the development of badly needed genetically improved varieties of the subsistence crops grown in the developing world. Unwise excessive regulation has a wide ripple effect.
Needed regulatory reform at APHIS / The USDA, through the Biotechnology Regulatory Services organization within its Animal and Plant Health Inspection Service (APHIS), is responsible for the regulation of genetically engineered plants. APHIS had long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are plant pests, which are 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. But for more than a quarter-century, in addition to its basic risk-based regulation, APHIS has applied a parallel regime that focuses exclusively on plants altered or produced with the most precise genetic engineering techniques. Thus, APHIS distorts the original concept of a plant pest (something known to be harmful) because it has crafted 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.
Permitting broader use of genetic modification would open the way for developing both animals and plants that are more environmentally friendly.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 a vast amount of data to APHIS and request “deregulation” of the organism, 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.
APHIS’s approach to recombinant DNA-modified plants is difficult 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. These threats include insects, disease organisms, weeds, herbicides, and environmental stresses. Plants have also been modified for qualities attractive to consumers, such as seedless watermelons and grapes and the tangerine–grapefruit hybrid called a tangelo.
APHIS has not shown any willingness to rationalize its regulatory approach, so the regulatory obstacles that discriminate against genetic engineering continue to impede the development of crops with both commercial and humanitarian potential. Many innovative genetically engineered 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 opportunity costs of unnecessary regulatory delays and inflated development expenses are formidable. As agricultural economists Gregory Graff, Gal Hochman, and David Zilberman observed in a 2009 paper in the journal AgBioForum, “The forgone 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.”
Conclusion / If the USDA wants to undertake meaningful, long-overdue, and obviously needed reform, it should worry less about its organizational chart and more about the restraints it places on agricultural innovation. Department officials have acknowledged that plants modified with the new gene editing techniques will not be considered “regulated articles” because they don’t meet the definition in the regulations. But there’s nothing in its current reform plans that indicates a more appropriate, scientific approach to regulating recombinant DNA-modified plants or for removing the USDA’s involvement in the organics market.
