In a brightly-lit lab at the University of Nebraska Lincoln, workers with tweezers hunch over petri dishes scattered with sprouted sorghum seeds. Sorghum produces grain and also a sugary stalk.
But this sorghum has a genetic tweak, explains plant scientist Tom Clemente. Instead of sugar, it’s engineered to make oil, which could be used to make fuel or chemicals.
“You know if we can get oil in a stock of sorghum anywhere greater than 5 percent, that’s a winner,” Clemente says. “That’s a grand slam.”
The genetically engineered sorghum could be a new source of biofuel and a new drought-resistant crop for farmers. But if the technology is going to ever reach the field, Clemente says it won’t come from a lab on campus. It will take a big seed company to carry it across the finish line, a company like Monsanto or Syngenta.
Getting a new genetically modified plant to farms takes years of field trials and repetitive studies. The process is often too time-consuming and expensive for the public sector or for small startups. If seed companies don’t see dollar signs, Clemente says, new technology can wither away.
“We push forward with the innovations,” Clemente says. “But the frustrating part is there’s a lot of technology sitting on the shelf in Nebraska, and Illinois, and Missouri that’ll never see the light of day because of these regulations.”
That’s one complaint about existing federal oversight of biotechnology: the time and money it takes to bring new products to the public are stifling innovation.
But there are other problems. Three government agencies share the job of regulating biotechnology: the Food and Drug Administration, the Environmental Protection Agency and the Department of Agriculture. The last time they updated their regulations was 1992, but today a wave of new discoveries is breaking out of that old regulatory framework. Inventions like gene editing and programmable cells could transform everything from agriculture and medicine to energy and manufacturing.
“How we make things is going to change in an absolutely fundamental way,” says biotech investor Juan Enriquez, speaking earlier this year to a scientific panel reporting to the government about trends in industry. “And it’s going to make the Industrial Revolution and the Digital Revolution maybe look a little unsophisticated.”
Last year the White House told the three federal agencies to update the regulatory system and open a simpler path for new biotechnology. A joint proposal is expected by this fall. Enriquez says regulators have a tough challenge.
“You have to have what is almost impossible to have in today’s political climate which is a nuanced debate,” he says.
New technologies can be difficult to categorize. For instance, scientists in Minnesota have edited a milk cow’s DNA so it doesn’t grow horns. Right now, horns are often cut off on the farm.
The cows are genetically modified. But the only difference from the original DNA is simply that the gene controlling horn growth has been turned off. A rash of new genetically modified crops and animals is putting old regulations to the test. Should the government put all engineered crops and animals under the same microscope, or should some low-risk technologies just get a once-over?
The Minnesota researchers say their engineered cow is just as safe as a cow variety created through conventional breeding and does not deserve extra federal oversight, but others want regulators to remain skeptical.
“It’s like pulling a string on a cloth,” says Doug Gurian-Sherman, a scientist with the Center for Food Safety. “Maybe that thread will break and the garment stays intact. Maybe it won’t.”
Gurian-Sherman agrees that hornless milk cows are probably harmless to humans. Still, he argues regulators should monitor all altered organisms to catch unforeseen side effects. He thinks regulators should be able to weigh biotechnology against cheaper, low-tech alternatives.
And he says there’s another reason to keep track of what’s engineered. How else would you know whether a product needs a special label?
“We could have products entering our food supply and the marketplace that the public is completely unaware of,” Gurian-Sherman says.
Casting a wide regulatory net, Gurian-Sherman says, provides the most transparency to the public. But researchers like Tom Clemente in Nebraska say that’s not a good scientific rationale.
“The debate is around [regulating] based on science,” Clemente says. “The way we introduce these traits through the tools of biotechnology are as safe, or safer, than what we have done through conventional crossing.”
Clemente says regulators ought to focus the most attention and resources where the greatest risks are, such as traits that could impact health or the environment, rather than types of engineering that have already been shown to be safe.
