Author: David Harry
Introducing any new product into the marketplace—agricultural or otherwise—is nothing to be taken lightly. Our corporate mission is to introduce a new tree crop into the agricultural markets in the US and beyond, so it makes sense to be on the lookout for “teachable moments”—learning opportunities external to our primary business interests from which we can glean insights to help us prepare for contingencies that, one day, we may face ourselves .
Two areas we follow concern advances related to biofuels and genetically engineered crops. Being in the biofuels market ourselves, following developments in related biofuels crops simply makes good business sense. But what about genetic engineering? Genetic engineering, otherwise known as the process of genetic modification (GM), is common in agronomic commodities such as corn and soybeans, but still relatively rare in other agricultural crops. Why? Before any new GM crop is brought to market, it must first pass a series of stringent hurdles from US regulatory agencies including the Environmental Protection Agency (EPA), USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food and Drug Administration (FDA).
Over the past several years, Syngenta’s new bioengineered (GM) corn crop has slowly worked its way through this regulatory process towards commercialization. This particular crop, marketed under the name of Enogen corn (i.e. Event 3272), contains a gene encoding a heat-stable amylase enzyme from a thermophillic (heat loving) bacterium. Enogen grain containing this novel amylase is a more efficient feedstock for conversion to ethanol. Amylase breaks down complex carbohydrates such as starch into simple sugars that are then available for fermentation into ethanol. For non-Enogen corn, supplemental amylase is added during the milling and fermentation process. The end result of using Enogen grain, particularly for dry milling, is a higher ethanol yield per unit of grain, all the while using less energy.
From the standpoint of ethanol production, this sounds pretty good, right? Well perhaps so, but what about other indirect consequences, perhaps related broader environmental impacts or human health? To what extent have factors such as these been considered during product testing and regulatory approvals?
Some critics have drawn parallels between the release of Enogen corn and the “Taco-Gate” incident of over a decade ago involving Starlink corn. That incident involved the inadvertent mixing of Starlink with other grain destined for human foodstuffs. Starlink corn contained a type of insecticidal Bt protein that had yet to be approved for human consumption. This inadvertent mixing, once discovered, caused considerable uproar associated with possible health concerns and lead to a costly clean up process. In the end, no claims of adverse health effects were ever conclusively tied to the Starlink incident, but it did cause the industry to re-evaluate its ability to manage corn grain as a differentiated (i.e. non-commodity) product.
There are certainly lessons to be drawn from the Starlink incident, but to what extent have things changed since then? Should an earlier incident, such as Starlink, forever block attempts to try again? As a broader question, to what extent does developing novel agricultural products represent either a reasoned move forward, or a leap of faith? Perhaps it’s worthwhile to examine the Enogen situation more closely to better understand some of the factors that must be considered in introducing a new agricultural product.
First, because Enogen corn was developed using GE technology, regulatory approvals are required before being sold in the marketplace. In the US, several agencies manage different aspects of this process. APHIS approval is required to ensure that the GE product will not become a plant pest. EPA approval is required if the GE product involves a pesticide, and the FDA evaluates matters related to food and feed safety. In addition, the National Environmental Policy Act (NEPA) mandates that both direct and indirect environmental and health consequences be considered. Fulfilling NEPA’s requirements has generally been administered by APHIS. While these steps had been followed for Starlink corn, at the time of the incident, Starlink had been approved only as animal feed, not for human consumption. For Enogen corn, however, Syngenta took the additional step of obtaining FDA regulatory approval for human consumption—just in case.
Relative to other varieties, Enogen corn offers additional value only for ethanol production, hence Syngenta is appropriately targeting Enogen corn only to a specialized market segment. Syngenta’s ability to capture additional value from this market segment critically depends on the production system’s ability to distinguish and sequester specialty corn from it’s commodity counterpart. Syngenta reasons that since Starlink, markets and production systems for specialty corn have matured, pointing to examples including white and blue colored corn, non-GE and organic corn that, together, comprise about 8% of all US corn production. Critics point out that US agricultural production is leaky, meaning that small levels of inadvertent mixing of corn varieties is inevitable. This is bound to be true to some degree, but given the apparent economic viability of other specialty corn varieties, the system seems to be working. Moreover, given FDA’s approval of Enogen corn for human consumption, low-level leakage represents a potentially minor economic loss, but does not threaten the human food supply.
So to my way of thinking, Enogen’s potential health and environmental consequences have been adequately addressed, at least for those impacts related to the genes of Event 3272. Does this mean that with respect to broader questions such as overall impacts on food prices, or life-cycle contributions to greenhouse gases, it still makes sense to cultivate Enogen corn for ethanol production? That’s a very different question and is outside the scope of this blog post.
Let me conclude by bringing us back to my original thinking regarding the introduction of a new agricultural crop. It behooves a crop’s developers to think critically and carefully about many factors—environmental and climatic factors, potential pests and diseases, risk of invasiveness, consumer acceptance, production methods, near-term and downstream markets, the list goes on. Developing a GE pongamia variety could happen at some point a long way down the road, but it is certainly not something we are considering in the near-term. Yet following the development and regulatory approval of a GE crop offers important insights because of the close scrutiny received at each step of the process. These steps are characterized by critical evaluation and scientific testing, coupled with assessments of broader environmental, health, and economic impacts. While differing in both scope and detail, the steps we are following with pongamia follow an analogous logical and stepwise progression. With luck, a leap of faith can lead to a success, but more often than not, it falls flat. We don’t see that as an effective business strategy.
–David Harry is Director of Research and Development for TerViva. His background encompasses research and management positions in the public, private, and academic sectors, working primarily to integrate novel genetic applications with applied breeding in plants and animals. David has a B.S. and M.S. in forestry, and a Ph.D. in Genetics from UC Berkeley.