Taxpayers in the United States have invested heavily in public-sector research in agricultural biotechnology to provide more-sustainable and productive crops and safe and nutritious foods. Since the mid-1980s, scientists at the USDA and in university and small private laboratories have developed a broad range of genetically engineered (GE) varieties of specialty crops with useful traits including enhanced tolerances of biotic and abiotic stresses and improved nutrition1. Almost a thousand different GE lines of small-market and specialty crops1 were among the almost 17,000 regulated field trials approved by USDA since 1987.
In spite of this large public investment—as well as early technical successes and promising results in field trials—only a few GE specialty crops developed in public institutions have been released to date:
A now defunct flax intended to be used for bioremediation
These are very sparse returns considering substantial public investment over a quarter century. In fact, the majority of scientists at public institutions do not even consider further development of GE crops for commercial utility, even for traits that could advance agricultural systems, improve human health and help feed the increasing global population. On the other hand, there are signs that this trend is changing. Several transgenic events in specialty crops, are now moving towards commercialization as a result of collaborative efforts involving universities, industry, and regulatory agencies. Furthermore, the Farm Bill—passed in February 2014—has restored the Specialty Crop Research Initiative funding, to about $80 million per crop.
Scientists from seven universities on the North Carolina Research Campus are focused on specialty crops that provide bioactive compounds, which interface with human therapeutic targets to counteract chronic disease or bolster metabolism to increase endurance. We are going beyond anecdotal evidence to try to elucidate biomarkers: what are the mechanisms of action of compounds in specialty crops that help them to interact with human therapeutic targets and counteract disease? What are these bioactive phytochemicals or “phytoactives”?
There is cutting-edge science underway and it is applied within Synthetic Genomics, not specifically on specialty crops as defined, but on low-acreage or potential crops of the future. Many of these concepts will apply to specialty crops.
The commercialization of genetically engineered traits in specialty crops is a complicated process. University researchers are more accustomed to thinking about innovation as an event rather than as a process. Within Texas A&M AgriLife Research we are taking on the challenge of how to look at innovation as a process and how to steward innovation beyond simply publishing, to create opportunities for our industry partners. In so doing, we are addressing a fundamental problem: the weakness of the pipeline.
The chief obstacle to getting GM fruits and vegetables onto the market, is the regulatory system. Hundreds of millions of dollars of taxpayers’ money have supported the development of genetically modified specialty crops. Where are the results of that effort? Did all of those projects fail? Was it a waste of money? At a meeting in Washington it emerged that there was a great deal of interest in joining forces to develop products that big companies probably wouldn’t be interested in: public-good, high-value items, that don’t necessarily have sufficient dollar value to generate industry interest in terms of profit but would be good for the environment, for society and for human health.
Biotech specialty crops face a number of potential barriers. Regulatory uncertainty over new plant-breeding methods and costly overseas approvals could complicate plans for commercialization. Stacking a generic crop aids innovators in the marketplace, but generic crops may need the regulatory data held by patent holders to achieve regulatory approval. Sustainability standards may arbitrarily deny use of biotechnology. Any innovator heading into this sector will need to be aware of all the potential threats awaiting these exciting opportunities in genetic engineering of biotech crops.
The intellectual-property landscape for transformation has shifted. Sponsors of translational research are increasingly interested in clearing IP barriers in advance of making grant awards. And plant-gene patents may become moot, if the Supreme Court rules similarly to their opinion on human genes.