WASHINGTON, Feb. 24, 2016 - Agricultural scientists are pushing gene editing to do everything from create pigs that can’t catch the flu to produce corn with increased yields, but government regulators are scrambling to update antiquated regulations that threaten to hamper the technology.

The science of gene editing will revolutionize the way we produce food, say scientists like Sonny Ramaswamy, who is also administrator of USDA’s National Institute of Food and Agriculture.

“Imagine you can figure out a way to genome-edit rice to be more like corn, making twice as much grain with the same amount of inputs,” he told Agri-Pulse in an interview. “These are the types of things that are happening.”

The ability to edit a plant or animal’s DNA – effectively removing molecules like the one in a pig that allows a virus to make it sick – holds the promise of reducing malnutrition, improving animal welfare and combating climate change, he said. Farmers will be able to harvest more starch from grains and ranchers will be able to produce more meat from livestock, all without using up more land and inputs.

Until gene editing became a reality, scientists like Randy Prather at the University of Missouri, Columbia, and Bob Rowland at Kansas State University, thought they might never find the cure to porcine reproductive and respiratory syndrome (PRRS), a deadly viral illness that causes as much as a billion dollars in losses to the pork industry every year, according to a University of Minnesota study.  

Scientists had known for years that a molecule named CD 163 in swine DNA allowed the PRRS virus to attach itself in the lungs of pigs, and researchers like Rowland said they expected it would take decades longer for a cure using cloning and other methods.

But with the gene editing technique called CRISPR/Cas 9, Rowland and others were able to delete the CD 163 molecule and repair the DNA, creating an immune pig capable of passing that trait to offspring.

It’s impossible to say how long it will be before their discovery can be used to start breeding commercial swine, Rowland said. “We’re looking for policy to catch up with the transformational aspect of this technology.” And so is NIFA’s Ramaswamy.

“The EPA, USDA and FDA have to come up with an actual definitive regulatory framework,” he said.  “Currently they don’t have one in regards to gene editing.”

But even without regulations in place, the USDA is still pouring millions of dollars into research using gene editing. Some of those projects are being led by Agricultural Research Service scientists Bhanu Prakash Telugu and David Donovan, who believe they can effectively stop swine flu, a virus that sickens pigs and people alike. By deleting microscopic portions of a pig’s DNA, the scientists said they will be able to not only protect pigs from the virus, but also prevent them and their progeny from infecting humans.

Despite the breakthroughs, the government regulation needed to shepherd new products to the market is dated and geared towards dealing with genetic engineering and cloning. The FDA, in charge of regulating genetically altered animals, has no system in place to regulate the development and commercialization of gene-edited animals and instead holds those animals to the same standards as transgenic animals.

Note that FDA approved the first commercial genetically engineered animal – AquaBounty salmon – in November, more than two decades after the developer first applied for approval.

“We don’t have a position yet on genome editing technologies to engineer animals,” said a spokeswoman for the FDA, which still regulates the altered animals the same as it does for animal drugs, under the Federal Food, Drug, and Cosmetic Act.

No organizations have obtained FDA approval of gene-edited animals, and that may be because the agency is only prepared to deal with animals that were genetically modified, most often to produce pharmaceuticals or industrial products. And that’s unfair and stifling, said Rowland.

“Unlike the transgenic technology that leaves something behind, this leaves nothing behind,” he said about gene editing. “We’re not making a Frankenstein pig. We’re making a pig that is healthier. I always say that (gene editing) mimics what might happen during a million years of evolution. We’re not asking the pig to do something that it would not normally do.”

The FDA declined to make any officials available for an interview, but a spokeswoman said: “At this time, the agency hasn’t approved any products resulting from gene deletion technology. The agency is still in the deliberative process and has not issued a position regarding use of genome editing technologies to engineer animals.”

But change is being called for and one of the loudest voices is coming from the White House.

On July 2 the Obama administration issued a sweeping memorandum, ordering the USDA, FDA and EPA to overhaul their regulations to address gene editing.

Beyond just ordering the agencies to “ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness,” the White House also instructed them to contract with the National Academy of Sciences, Engineering and Medicine to produce a report that answers the questions: “What will the likely future products of biotechnology be over the next five-10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?” The White House uses blanket terms like “biotechnology,” but it is clear to the National Academy that it’s being asked to address gene editing, a spokesman said.

Representatives of the USDA, FDA and EPA have already held their first meeting with NAS, but the USDA is not waiting until the report is complete.

Mike Firko, deputy administrator for the Animal and Plant Health Inspection Service’s Biotechnology Regulatory Services, acknowledged to Agri-Pulse that his agency is still operating under outdated regulations, but he said BRS is doing its best to allow researchers to do their work on gene-edited plants.

Often, BRS just lets the researchers proceed without government interference.

“We are doing things the way we’ve been doing them for 29 years,” Firko said. “There are certain things that fall under our regulatory authority… and other things that may not fall under our authority.”

The high-yield corn being developed by North Carolina-based Benson Hill Biosystems to increase photosynthetic efficiency got the all-clear from BRS to plant without going through years of supervised test planting in May 2015, and Minnesota-based Calyxt was cleared earlier this month to go forward with a wheat that will be resistant to mildew.

The BRS decision that Calyxt’s wheat is not a regulated product was a major win for the company, CEO Luc Mathis told Agri-Pulse. Calyxt plans to begin field testing the gene-edited wheat in the U.S. this year and the company expects to be able to begin selling seeds on the market in as little as three or four years.

Had BRS determined that the wheat was a regulated plant and subject to tight oversight by the government, the approval process could have taken up to 13 years, Mathis said.

For more than three decades most modified plants have come firmly under the regulatory authority of USDA because the regulations were written to make sure that they did. Most of the corn, soybeans, cotton and sugar beets produced in the U.S. come from genetically modified seeds born of a technology based on inserting foreign material into the plant – usually to make them resistant to pesticides. Gene-edited plants, however, often have no foreign material inserted. And if they don’t, the USDA decided it has no authority to hold them back.

For USDA to have regulatory authority, researchers must have used recombinant DNA technology and the resulting plant must contain a remnant of plant pest material in its genetic makeup, Firko said. “In cases where we find that there is no remnant of any plant pest material in the final product, it does not fall under our statutory authority,” he said.

That was the case for the corn being developed by Massachusetts-based Agrivida Inc., which is using gene editing to boost starch production from corn. The company is using bacteria considered a plant pest to alter the DNA of corn, Firko said in a Nov. 30 letter to the company, but that bacteria is not left behind in the finished product.

BRS is now applying its current regulations to a science it wasn’t designed to address, but that is changing. Earlier this month the USDA agency began the biggest overhaul of biotech regulations in more than 30 years and it includes how to deal with the emerging science of gene editing.
One option BRS is proposing would be to exempt the plants produced with gene editing from regulation. That would be the best course of action, say groups like the National Corn Growers Association.

“If the government does not step in and over-regulate it, it has the ability to permeate the whole seed industry,” said Rick Vierling, NCGA’s director of research. “Our mission is increased economic opportunity for farmers. This is an economic opportunity. There’s a potential to decrease seed costs, increase production.”

Also, because using gene editing technology is much cheaper and faster than the traditional transgenic method, Vierling said he expects to see the creation of corn plants that are geared to benefiting customers.

“We really have the opportunity to start with the output traits that are going to be beneficial to the consumers of corn and corn products,” he said. “You’re going to have corn that’s more nutritious than it is now. (Gene editing) is going to open that up like GMOs (genetically modified organisms) never did.”

Gene editing and techniques like CRISPR (the acronym stands for Clustered, Regularly-Interspaced Short Palindromic Repeats) should not raise any health concerns, Vierling said, although he expects many will argue the opposite. “It’s a naturally occurring system,” he said about CRISPR. “It was discovered. It wasn’t invented. With GMOs, we always hear, ‘It’s not natural.’ All that crap. This whole CRISPR is a naturally occurring system. I think that’s something we need to get across.”

But even government proponents like NIFA’s Ramaswamy say further study is needed on the relatively new science.

“We’re providing funding on the potential for unintended consequences,” he said. “What are the risks? How do you mitigate the risks? A number of projects have been funded.”

And the University of Missouri’s Rowland said there are still some answers needed after he and other researchers created a way to wipe out PRRS. They blocked the virus by removing a protein from a pig’s DNA, but more needs to be learned about potential secondary health effects on the animals.

Even if there were secondary effects, though, it’s unlikely the animals would live long enough to encounter them, he said. “The thing about pigs is, they only live to be about six months old. We eat them.” And the technology has unlimited potential, he said.

“Anybody who can think about doing something with this technology – they’re doing it,” Rowland said. “I think it really is transformational. I’ve been fighting [PRRS] for my whole career – for 20 years. And I always thought it would be a generational problem. It would be something the next generation would solve. But now my job is done.”


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