Bioengineered wheat has yet to be commercialized.

DANA POINT, CALIF. — “Everything that my lab has produced is down in the basement.”

That is how Peggy G. Lemaux, Ph.D., described the decades of work on genetic engineering (G.M.O.s) and genetic editing she and her colleagues at the University of California’s Plant & Microbiology have produced.

Throughout her presentation to the attendees at the 2017 North American Millers’ Association’s Annual Meeting at the Monarch Beach Resort in Dana Point, she cited costs related to government regulation and intellectual property issues as contributing factors to why the commercialization of genetically modified wheat has languished.

Peggy G. Lemaux, Ph.D.

While the majority of the United States’ canola, soybean, corn and sugar beet acreage is bioengineered, the same cannot be said for bioengineered wheat, which has yet to be commercialized. Consumers’ concerns are part of the challenge, but several other issues have prohibited wheat’s progress in this area, Dr. Lemaux said.

In 2014, 16 U.S., Canadian and Australian agricultural organizations endorsed the development of biotech wheat, noting their belief that wheat was at a competitive disadvantage to the other major crops. Farmers have moved to use bioengineered crops because they see benefits. According to a 2014 poll, the primary reason farmers plant bioengineered crops is to increase yield, but they also do so to reduce the use of pesticide and to save time. Dr. Lemaux noted that 75% of processed food has bioengineered ingredients. While usage of bioengineered ingredients is prevalent in processed food there are only a few whole foods that are bioengineered. Sweet corn, papaya, three kinds of squash, the innate potato and arctic apple have been commercialized.

Scientists have been able to develop a number of promising wheat varieties using traditional genetic modification and gene editing. The scientists have been able to improve photosynthesis efficiency in wheat plants, nitrogen fixing wheat to reduce the use of fertilizers and even develop wheat bread for those with celiac disease.

Another issue that academic research has found a solution to is pre-harvest sprouting, which occurs when wheat close to harvest becomes moist. Once this happens the wheat is not usable.

“By down regulating a single gene you could prevent pre-emergent sprouting. Not only that, we get about 12% increase in yield so it’s like, that’s a no-brainer that you can get higher yield and you prevent pre-harvest sprouting,” Dr. Lemaux said.

In 2012, a Berkeley researcher discovered a way to relatively easily alter any organisms’ DNA, just as a computer user can edit a word in a document.  The Crispr-Cas 9 genome editing technology is being used by researchers, but until recently no companies had licensed it in part because of intellectual property concerns.

“The companies come to us and say, ‘Oh, can we use that in our little wheat plant that we want to do?’” Dr. Lemaux said. “They can’t be sure if we develop something in my lab through genome editing that they’re actually going to be able to get it out commercially in part because of licensing.”

Dr. Lemaux and her colleagues have made some breakthroughs in genome editing that are not regulated by the U.S. Department of Agriculture as bioengineered organisms. However, the U.S.D.A., the Food and Drug Administration and the Environmental Protection Agency all play roles in the regulation of bioengineered crops and foods.

Dr. Lemaux and her colleagues have made some breakthroughs in genome editing that are not regulated by the U.S. Department of Agriculture as bioengineered organisms.

The U.S.D.A. assesses whether the technology could be a plant pest, while the F.D.A. analyzes the potential danger to humans, and the E.P.A. assesses risks to the environment.

Dr. Lemaux noted that to answer these three agency’s questions takes an investment of $10 million to $20 million. The high cost puts the development and commercialization of bioengineered wheat outside of the means of most smaller companies and academics, she added.

“I went to my dean and said, ‘I have this hypoallergenic wheat variety, and I would really like to get it out there,’” Dr. Lemaux said. “He is an economist…he was like…’yeah right!’ It really left academic scientists like myself in a place where we can’t do anything. We can do something. And, we can show you it works, like we have with pre-harvest sprouting and hypoallergenic wheat, but we can’t take it anywhere unless a company wants to partner with us. And often times the company will not want to partner with us, because U.C. Berkeley has patent rights to that, and they have to negotiate with the university. And, they don’t want to do that. They’d rather just do it themselves.