Federal officials are seeking public comment on proposed regulations to better oversee next-generation food modification.
Meanwhile, the St. Louis-based seed giant Monsanto is making strides with gene-editing tools.
Photo by Robert Holly | Midwest Center for Investigative Reporting
In the United States, three federal agencies are in charge of overseeing biotechnology, such as GMOs derived from genetic engineering. A sample from a Monsanto research laboratory on July 20, 2015, is shown here.
Advanced gene-editing tools such as CRISPR-Cpf1, CRISPR-Cas and EXZACT are more precise than the older, slower, less accurate methods researchers previously used to make genetically modified organisms, or GMOs. Instead of modifying a plant’s genetic makeup by introducing DNA from a different plant, the cutting-edge tools allow researchers to edit or tweak DNA already in that one plant. Rather than modifying organisms, the tools allow them to be edited.
And that increased precision, researchers say, could soon lead to vegetables with boosted nutritional value or fruits that don’t spoil.
“The CRISPR technology has profound opportunity, not only in agriculture with crops and with animal improvement, but it’s also being used extensively in human health and healthcare and medicine,” Monsanto Chief Technology Officer Robb Fraley said during a Jan. 5 conference call with reporters. “It’s been an exciting breakthrough.”
Currently, the Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency regulate genetically engineered organisms using a three-pronged system known as the 1986 Coordinated Framework for the Regulation of Biotechnology.
The approval process for new GMOs can take anywhere from five to more than 10 years, records show.
Next-generation gene-editing techniques fall largely outside of government regulation, though agencies are trying to change that.
The USDA recently announced it is in the process of revising its rules “in response to advances in genetic engineering,” and the FDA recently established a docket in the Federal Register to gather public comments on using groundbreaking gene-editing tools to produce new plant varieties for human and animal food.
In January, Monsanto announced it signed a global licensing agreement with the Broad Institute of MIT and Harvard for the use of its CRISPR-Cpf1 gene-editing technology.
The announcement marked Monsanto’s second such licensing agreement with the Broad Institute — and third overall — in less than six months.
Monsanto licensed the institute’s CRISPR-Cas technology in September.
Then, in October, Monsanto announced it secured a non-exclusive global option and licensing deal with competitor Dow Chemical for the use of its EXZACT Precision Technology, which uses a process called the “zinc fingers” technique.
By pursuing licensing agreements, Monsanto has indicated its plans to shift its resources — and $1.5 billion research and development budget — toward more advanced genetic alteration tools, which Fraley described as the “next generation” of biotechnology.
But with that shift comes a very real marketing risk.
While consumers have typically welcomed next-generation technology when it comes to their phones, cars and computers, they have largely shunned it in their food.
Data from the Organic Trade Association shows that United States organic sales routinely top tens of billions of dollars. They reached more than $43 billion in 2015, partially because consumers mistrust GMOs, according to researchers.
A study conducted by the Pew Research Center found that more than half of U.S. adults believe it is generally unsafe to eat genetically modified foods.
Much of that sentiment is captured in the public comments filed online each time Monsanto seeks federal approval for a new variety of genetically modified corn or soybean. Often, its petitions are met with dozens or even hundreds of scathing remarks.
“I am opposed to Monsanto Co. being unregulated,” wrote Delonda Pushetonequa, during a public comment window in 2015, when Monsanto sought USDA deregulation on a variety of higher-yielding corn. “I am opposed to any Monsanto or GMO crops being planted anywhere near my community.”
Despite consumer doubts, several scientific studies have identified GMOs safe for human consumption. That includes an analysis published last year by the National Academies of Sciences, Engineering and Medicine.
It is unclear how consumers will react to “genetically edited” versus “genetically modified.”
Still, Fraley said that he sees the next generation of “exciting” gene-editing tools as “an opportunity to rethink communication.” Embracing discussion and fostering a sense of transparency will help Monsanto avoid some of the backlash it encountered with GMOs, he said.
“We clearly made a mistake in not reaching out to the public in having that dialogue [on GMOs] up front,” Fraley said.
Monsanto posted nearly $10 billion in net sales for its seeds and genomics segment for fiscal year 2016.
Monsanto did not disclose terms of its licensing agreements with the Broad Institute and Dow Chemical.
See related: "GMOs, Monsanto and the fight against climate change"
Twenty years ago, less than 10 percent of corn and soybean acres in the United States were planted with genetically engineered seeds, the type of biotechnology now commonly known as GMOs. Farmers have rushed to adopt the engineered seeds since then, in part because of climate change concerns.