This past Friday, February 11, 2011, the U.S. Department of Agriculture issued its decision to grant full deregulation of Syngenta’s genetically engineered corn expressing a thermostable alpha-amylase for use in ethanol processing. This decision means that the company can now sell this new maize variety, trade named EnogenTM, to growers in the U.S. beginning with the 2011 growing season. This decision is noteworthy for several reasons, mostly because it is the first U.S. regulatory approval for commercial use of a genetically engineered plant designed and dedicated for use as an improved biofuel feedstock.
I’ve briefly described this product in an earlier entry in this blog. Originally known by the internal product name “Corn [Maize] event 3272”, this line was developed using recombinant DNA technology to introduce into corn the amy797E gene and the pmi marker gene. The amy797E gene is derived from alpha-amylase genes from three hyperthermophilic microorganisms of the archaeal order Thermococcales, and it encodes a thermostable AMY797E alpha-amylase enzyme which catalyses the hydrolysis of starch by cleaving the internal alpha-1,4-glucosidic bonds into dextrins, maltose and glucose. The pmi gene from Escherichia coli encodes the phosphomannose isomerase (PMI) enzyme, which allows the plant to utilize mannose as a carbon source. The company’s press release announcing the approval describes the product and its importance as follows:
By enabling expression of an optimized alpha-amylase enzyme directly in corn, dry grind ethanol production can be improved in a way that can be easily integrated into existing infrastructure. “Enogen corn seed offers growers an opportunity to cultivate a premium specialty crop. It is a breakthrough product that provides U.S. ethanol producers with a proven means to generate more gallons of ethanol from their existing facilities,” said Davor Pisk, Chief Operating Officer. “Enogen corn also reduces the energy and water consumed in the production process while substantially reducing carbon emissions.”
This action has important implications for several reasons. As mentioned above, it is the first U.S. approval for commercial use of a genetically engineered plant variety specifically designed for biofuel production (although in May 2010 USDA did grant the biotechnology company Arborgen a significant permit for expanded field testing of transgenic Eucalyptus varieties as improved energy crops, but that permit was only for experimental field testing, not commercial use and sale). Although, as noted in Syngenta’s press release, the corn amylase trait in Enogen had already been approved for import into Australia, Canada, Japan, Mexico, New Zealand, Philippines, Russia and Taiwan, and for cultivation in Canada, the U.S. regulatory approval had been pending since 2005, and followed multiple years of field testing at numerous plots around the country and the world. I’ve described this long history and USDA’s environmental assessment of Enogen corn in an earlier blog entry. The history of agricultural biotechnology regulation is replete with examples where pioneering applicants proposing the first of a new type of product have often been subjected to long regulatory review times and some amount of regulatory uncertainty, but where after the initial approval the path was cleared for subsequent applicants of similar products. As I’ve described in prior entries in the blog, there are a good number of companies developing transgenic plants as improved biofuel feedstocks, including several other efforts to develop energy crops expressing biodegradative enzymes in planta to improve the efficiency and economics of feedstock processing, and it is good to know that developers of such products can now see the roadmap to regulatory approval in the U.S.
USDA’s decision on the Syngenta decision comes hard on the heels of two other long-awaited biotechnology regulatory decisions, the January 27, 2011 decision to fully deregulate Roundup® Ready alfalfa and the February 4, 2011 decision to partially deregulate Roundup® Ready sugar beets, both of which had been the subject of protracted legal action. Over the past two or more years, it has seemed that the Biotechnology Regulatory Services (BRS) branch of USDA’s Animal and Plant Health Inspection Service (APHIS) has been (understandably) paralyzed by these ongoing legal challenges, and had seemed to put on hold deregulation petitions for numerous biotech crops as well as the agency’s effort first proposed in 2007 to rewrite the biotechnology regulations. Although each of these recent decisions may yet be subject to further legal challenge, it is good to see the logjam breaking somewhat with these three decisions being issued early enough in the year to apply to the 2011 growing season.
Finally, the Enogen approval is noteworthy for its several commercial implications. It will be the first transgenic plant variety to be sold in the U.S. as a dedicated energy crop, which will make its ultimate commercial success a bellwether for other companies developing similar products. Perhaps more importantly are the conditions that Syngenta will place on its use in 2011. According to the company’s press release, production of Enogen corn will be managed using a contracted, closed production system, through which the company plans to sell the seeds to only a small number of corn growers in close proximity to the ethanol production facilities that will process the corn, in preparation for larger scale commercial introduction in 2012. Such a “closed loop” system serves two purposes. It addresses the concern expressed by many biotech opponents as well as corn millers and others in the food industry over the disruption to food supplies that could arise if the amylase corn is inadvertently found in food supplies. As reported in the New York Times on February 11, 2011, Syngenta’s own data has apparently indicated that as little as one amylase corn kernel mixed with 10,000 conventional kernels could be enough to weaken the corn starch and disrupt food processing operations. Syngenta’s response is that the enzyme is not active when the kernel is intact and is most active at higher temperatures and at certain levels of acidity and moisture found in ethanol factories but rarely in factories that make corn starch, corn syrup or corn chips. Having a closed loop arrangement where growers are contracted to grow the corn and sell it to ethanol producers puts in place a system where the transgenic corn is segregated and kept separate from corn grain that will be used for animal feed or human food processing, to try to avoid as best as possible any inadvertent contamination of food corn with the amylase-expressing corn (although, as noted in the New York Times article, the alpha-amylase expressed in Enogen corn has already been approved for food use by the U.S. Food and Drug Administration, and this should to some extent lessen the concern over inadvertent contamination).
But the closed loop system is also important for other commercial reasons. Presumably, Enogen corn seed will be sold at a premium over other, traditional corn varieties, but the harvested corn should command a higher price than traditional corn when sold to ethanol producers. In order for growers to be sure of getting that higher price for their crop in return for paying the higher price for seed, some guaranteed form of segregation would be needed. In fact, such a model seems to be critical for the future success of all plant species (conventional or transgenic) that are being developed as dedicated energy crops – in most cases the developer will need to sell seed at a premium (e.g. to recoup R&D costs) and so the grower must be guaranteed of being able to sell the crop to the fuel producers at a higher cost. So, Syngenta’s experience with its closed loop system may be an indicator of the success that similar such models will face in the coming years.
Although it has been a long, hard path for Syngenta to win this approval, and although roadblocks may yet lie ahead, this can only be a positive development for the many other companies developing transgenic plants as improved biofuel feedstocks. I’ll be watching and commenting on future regulatory developments as they may arise.
D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production,” and will also complement Dr. Glass’s upcoming presentation on uses of biotechnology to improve the plant species used as feedstocks for biofuel production, at the “Energy Crops” session at the World Biofuels Market conference in Rotterdam, the Netherlands, on March 22, 2011. Slides from Dr. Glass’s presentations, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99 or at www.dglassassociates.com.
Bio-Based Chemicals and Fuels: Business, Policy and Regulation 