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The U.S. and Europe Rule on the Impossible Burger and CRISPR

The European Court of Justice ruled this week that genetic engineering methods - such as the use of certain applications of the gene cutter CRISPR - should be regulated as genetically engineered foods. (Gregor Fischer/Getty Images)

Last week was a momentous one for the future of genetically engineered foods, both in the U.S. and in Europe. On July 24, the U.S. Food and Drug Administration approved the Impossible Burger, an all-veggie burger that "bleeds" and sizzles just like meat. The burger's star ingredient - a protein called heme that renders blood red and helps make meat a carnivore's delight - was granted GRAS (generally recognized as safe) status. In 2015, the FDA had required that the $400 million Silicon Valley startup, Impossible Foods, demonstrate that their heme, made by genetically modified yeast, was safe.

But across the pond, two days later, Europe's highest court issued a very different decision: it ruled that in Europe, gene-edited crops should be subject to the same strict regulations the continent uses for genetically modified (GM) organisms. It was a major setback for advocates of genetically engineered crops.

Predictable reactions followed. While Impossible Foods celebrated its approval, an environmental advocacy organization Friends of the Earth (FOE) called the FDA ruling tremendously disappointing. Dana Perls, senior food and agriculture campaigner for FOE, says the ruling "is exactly why we need an overhaul of our regulations with the USDA [U.S. Department of Agriculture] and the FDA." Meanwhile, Nigel Halford, a crop geneticist at Rothamsted Research in Harpenden, UK, told Nature News that the European ruling was "a real hit to the head," noting that companies in Europe will not be willing to invest in a technology with no commercial application.

Gene editing can take many forms, in both medicine and agriculture. For Impossible Foods, the goal was to produce a lab-based vegetarian burger (it contains flecks of coconut fat, along with textured wheat and potato protein) that tasted and cooked just like meat, and help meet the global demand for beef without the carbon footprint. Company founder Patrick Brown, a biochemist at Stanford University, discovered that nodules on the roots of soy make small amounts of heme. He took the soybean gene that encodes the heme protein and inserted it in yeast. The modified yeast is able to produce huge quantities of the blood-like molecule, in vats of frothy red liquid. Each vat produces enough heme to make 20,000 quarter-pound burgers.

But even though heme itself is a molecule found in all mammals, including in abundant quantities in our own bodies, the genetic editing of yeast as well as the soybean root source caused a fierce backlash. Perls worries the heme and other proteins in the food could be an allergen. However, these proteins are likely already in yeast we consume elsewhere, or in other products where yeast fermentation is used.

Molecular biologist Layla Katiraee, one of six Science Moms, mothers who advocate for science-based decisions in regard to children's nutrition and health, tried the Impossible Burger and interviewed one of the firm's chief scientists. "I eat meat and love it, but last year our family made an effort to reduce our meat consumption. The Impossible Burger seemed like a really good option in terms of animal welfare and environmental sustainability."

Katiraee says she was "shocked at the 'frankenfood'-type backlash." Take the reaction of ETC Group, a nonprofit that looks at the socioeconomic and ecological issues surrounding new technologies. ETC was shrill in its condemnation of Impossible Burger last year: "The case of Impossible Burger raises concerns that surpass this one patty and implicates the extreme genetic engineering field of synthetic biology, particularly the new high-tech investor trend of "vat-itarian" foods (meat, dairy, and other animal proteins grown in a biotech vat instead of from an animal)," they wrote.

Yet the food industry already uses modified yeast and other microbes to produce key ingredients. Since the 1980s, rennet, the enzyme that turns milk into cheese, has been produced by genetically engineered microbes. Traditionally, rennet had been extracted from the stomach lining of unweaned calves. And in the world of medicine, diabetics around the world inject genetically modified insulin daily.

"I think these advocacy groups worry that if a product like Impossible Burger is very successful, acceptance of genetically engineered food will grow," says Katiraee.

"It has always baffled me that the backlash to genetic engineering is in food but not medicine," wrote food and farm consultant Emanuel Farrow last week on a facebook group called Food and Farm Discussion Lab. "Genentech...[was] engineering medications already in the late 80s for market ... Monsanto releases GE tomatoes in the early 90s and people lose their minds."

Meanwhile, the European decision to regulate gene-edited crops as genetically modified crops directly impacts the use of a gene editing technique known as CRISPR for plants. The technique is currently being investigated for its medical value, including potential treatments for cancer or heritable diseases. CRISPR has been embroiled in its own scientific controversy, with researchers claiming it might cause new mutations, but correcting that finding in a follow-up study noting that no such mutations were seen in mice experiments.

The European court's decision on CRISPR plants came in response to a lawsuit filed by FOE's branch in France. "People want real food grown by real farmers," says Perls.

Yet here, the USDA has no plans to regulate gene edited plants or crops. Their stance is that if no genetic material is added to a plant, it deserves no special regulation, and they have called the European ruling unfortunate.

Meanwhile, Impossible Burger is being served in several thousand restaurants around the U.S., and scientists like Katiraee approve: "I first tried it at a restaurant in Lansing, Michigan," she says. "It was prepared with white cheddar and crispy onions. Had I not been told that it was a plant based burger, I would never have known."

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