In a suburban Minneapolis lab, a small business that has never made a profit is ready to beat the largest agricultural firms in the market with the next potential breakthrough in genetic engineering, a "DNA-edited" crop.
Calyxt Inc., an eight-year firm co-founded by a professor of genetics, altered the genes of a soybean plant to produce a healthier oil using state-of-the-art editing technology instead of conventional genetic modification.
Seventy-eight farmers planted these soybeans this spring on 17,000 acres in South Dakota and Minnesota, a crop that is expected to be the first genetically-edited crop sold commercially, topping the Fortune 500 companies.
Seed development giants such as Monsanto, Syngenta AG and DowDuPont Inc have mastered the technology of genetically modified crops that emerged in the 1990s.
But they face a broader field of competition from new companies and smaller competitors because genetically modified crops have drastically reduced development costs and the US Department of Agriculture. UU (USDA) has decided not to regulate them.
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Gene editing could mean higher crop yields with a wide range of desirable characteristics: better-tasting tomatoes, low-gluten wheat, apples that do not turn brown, drought-resistant soybeans. A research scientist examines a soybean seedling in New Brighton, Minnesota
Relatively unknown companies such as Calyxt, Cibus and Benson Hill Biosystems are already moving forward on their own genetic modification projects in a race against Big Ag for the domain of potentially transformative technology.
"It's a very exciting time for such a young company," said Calyxt CEO Federico Tripodi, who oversees 45 people.
"The fact that such a small and agile company can achieve these things has sparked interest in the industry."
Genetic editing technology involves directing specific genes in a single organism and interrupting those linked to undesirable characteristics or altering them to make a positive change.
Traditional genetic modification, on the other hand, involves the transfer of a gene from one type of organism to another, a process that does not yet have full consumer acceptance.
Gene editing could mean higher crop yields with a wide range of desirable characteristics: better-tasting tomatoes, low-gluten wheat, apples that do not turn brown, drought-resistant soybeans or more suitable potatoes for storage in cold.
Advances could also double the 15-billion-dollar global biotech seed market in a decade, said analyst Nick Anderson of investment bank Berenberg.
The USDA has sent 23 queries on whether genetically modified crops need regulation and decided that none meet their monitoring criteria.
That saves its developers years of time and incalculable amounts of money compared to traditional genetically modified crops. Of those 23 agencies, only three were being developed by the main agricultural companies.
Genetic editing technology involves directing specific genes in a single organism and interrupting those linked to undesirable characteristics or altering them to make a positive change. Above, mature high-fiber wheat plants are grown in a Calyxt greenhouse
The new competitive landscape could encourage more licensing partnerships and agreements between large and small firms, along with universities or other public research institutions, said Monsanto spokeswoman Camille Lynne Scott.
Monsanto, which was recently acquired by Bayer AG, invested $ 100 million in Startwise Plants this year to accelerate the development of genetically modified plants.
Benson Hill, based in North Carolina, founded in 2012 and named after two scientists, licenses mainly crop technology to other companies.
But he decided to produce his own higher-yield corn plant because of the low development costs, said Chief Executive Matt Crisp.
Calyxt plans to sell his soybean oil edited by genes to food companies and has a dozen more genetically modified crops, including high-fiber wheat and potatoes that stay fresh longer.
Developing and marketing a traditional genetically modified crop could easily cost $ 150 million, which only a few large companies can afford, Crisp said.
With the edition of genes, that cost could fall up to 90 percent, he said.
WHAT ARE GENE-EDITED CROPS AND HOW ARE DIFFERENT FOR GM PLANTS?
The genetic edition promises to produce & # 39; super crops & # 39; altering or eliminating genes that occur naturally in plants.
Unlike genetically modified (GM) plants, genetically modified (GE) crops do not contain "foreign" DNA from other species.
GM crops are produced using CRISPR, a new tool to perform precise editions in DNA.
Scientists use a specialized protein to make small changes in plant DNA that could occur naturally or through selective breeding.
Genetically modified crops have added foreign genes to their DNA, a process that often can not occur naturally.
I know. The US, Brazil, Canada and Argentina have indicated that they will exempt GM crops that do not contain foreign DNA from GM regulations.
The European Commission is awaiting a ruling from the European court.
"We're seeing a lot of organizations interested in gene editing," Crisp said, referring to traditional crop-growing companies, along with technology companies and food companies.
"That speaks to the power of technology and how we are at a crucial moment to modernize the food system."
Advocates of gene editing say it allows a higher level of accuracy than the traditional modification.
With CRISPR, a popular type of gene-editing technology used by Syngenta, scientists transfer an RNA molecule and an enzyme to a culture cell.
When the RNA finds a specific strand of DNA inside the cell, it binds to it and the enzyme creates a break in the cell's DNA.
Then, the cell repairs the broken DNA in a way that interrupts or improves the gene.
Biotechnology companies hope technology can avoid the label "Frankenfood & # 39; that critics have put on traditional genetically modified crops.
But acceptance by regulators and the public worldwide remains uncertain.
The USDA has received 23 queries on whether genetically modified crops need regulation and decided that none meet their monitoring criteria.
The Court of Justice of the European Union ruled on July 25 that gene-editing techniques are subject to the regulations that regulate genetically modified crops.
The decision will limit the edition of genes in Europe to investigate and make it illegal to grow cash crops.
The German chemical industry association called the decision "hostile to progress".
The Secretary of Agriculture of EE. US, Sonny Perdue criticized the decision to enact unnecessary barriers to innovation and stigmatize genetic editing technology by subjecting it to the "regressive and obsolete" regulations of the EU governing genetically modified crops.
The USDA also has no current plans to regulate gene editing in animal products, according to a document provided by the agency.
However, the US Food and Drug Administration. UU It plans to regulate the editing of genes in plants and animals, wrote FDA Commissioner Scott Gottlieb in a June publication.
The agency is developing an "innovative and agile" approach to regulate gene editing, he wrote, which will aim to ensure its safety for both humans and animals, while allowing companies to bring beneficial products to the market.
The USDA, on the other hand, chose not to regulate genetically modified crops because the process typically introduces characteristics that are "indistinguishable" from those created through traditional plant breeding, which takes much longer, said USDA Secretary Perdue in a statement. March statement.
Biotechnology companies hope technology can avoid the label "Frankenfood & # 39; that critics have put on traditional genetically modified crops. But acceptance by regulators and the general public remains uncertain
Although there has been no widespread consumer resistance to gene editing, activists who have long opposed genetically modified crops are still suspecting some kind of DNA retouching.
The new technique increases the risks of creating unwanted changes in the food supply and ensures greater regulation, said Lucy Sharratt, coordinator of the Canadian Biotechnology Action Network.
That kind of opposition is the reason why the agribusiness giant, Cargill Inc, is following genetically modified technology with caution, said Randal Giroux, vice president of food safety, quality and regulatory affairs at the firm.
Cargill announced in February it would collaborate with Precision BioSciences to develop healthier canola oil, but is making slow progress in agreements to store and transport crops modified by genes from other companies pending clarity from regulators, Giroux said.
"We really want to see the evolution of gene editing in the market," said Giroux. "We are observing how consumers adopt these products and react to these products."
Other major agricultural biotechnology companies are moving more aggressively, hoping to take advantage of lighter regulations to accelerate development.
WHAT IS CRISPR-CAS9?
CRISPR-Cas9 is a tool for making precise editions in DNA, discovered in bacteria.
The acronym stands for "Continuously Grouped Palindromic Intercalated Repetitions".
The technique involves a DNA-cutting enzyme and a small label that tells the enzyme where to cut.
The CRISPR / Cas9 technique uses labels that identify the location of the mutation, and an enzyme, which acts as small scissors, to cut the DNA in a precise place, which allows to eliminate small portions of a gene.
By editing this label, scientists can direct the enzyme to specific regions of DNA and make precise cuts, wherever they want.
It has been used to "silence" genes, effectively shutting them down.
When the cellular machinery repairs the DNA break, it removes a small fragment of DNA.
In this way, researchers can deactivate specific genes in the genome.
The approach has previously been used to edit the HBB gene responsible for a condition called β-thalassemia.
A gene-engineered crop can take five years to go from development to commercialization in the United States, compared to a genetically modified crop that could take 12 years, said Dan Dyer, head of seed development at Syngenta.
The firm is working on better tasting tomatoes that take longer to break down and hopes to launch a genetically modified crop in the mid-2020s, said Jeff Rowe, president of global seeds at Syngenta.
DowDuPont, in a secret location in the Midwest of the USA. UU., It is conducting field tests of waxy corn, a variety grown for industrial purposes that has been edited to obtain higher yields.
The company plans a commercial launch next spring.
Small companies will be on the heels of these massive companies in the race to bring the next generation of genetically modified foods to the market, said Robert Wager, a faculty member in biology at Vancouver Island University.
"The lack of status regulated by the USDA is a big game changer," he said, "for universities and small emerging companies to enter the market."