Thursday, January 12, 2017

2540. "Genetically Edited" Food Have No Regulations Whatsoever

By Kenneth Chang, The New York Times, January 9, 2017
These genetically edited mushrooms will have longer shelf-life before getting dark
In a few years, you could be eating the next generation of genetically altered foods — potatoes that do not turn brown or soybeans with a healthier mix of fatty acids.
And you may have no idea that something is different, because there may be no mention on the labeling even after a law passed by Congress last year to disclose genetically modified ingredients takes effect.

A new generation of crops known as gene-edited rather than genetically modified is coming to the market. Created through new tools that snip and tweak DNA at precise locations, they, at least for now, largely fall outside of current regulations.

Unlike older methods of engineering genes, these techniques, like Crispr, so far have generally not been used to add genes from other organisms into the plants.

The federal Agriculture Department has asked companies to advise it of their plans. But once the companies submit data to show the agency that the gene edits do not introduce foreign genes from plant pests into the crops, the agency is giving businesses the green light.

Hundreds of acres of gene-edited crops have already been grown in several states, unencumbered by oversight or regulations. And a few people have eaten them already. “This is not Frankenfood,” said AndrĂ© Choulika, chief executive of Cellectis, one of the companies developing gene-edited crops.

In October, Cellectis hosted a dinner at Benoit New York, the Alain Ducasse Manhattan restaurant, and served dishes made from its gene-edited soybeans and potatoes. Guests included professors, journalists and celebrities like Neil Patrick Harris, the actor.
“I don’t even know what gene editing is,” Mr. Harris said. “I thought we were supposed to wear jeans.”

Calyxt, a subsidiary of Cellectis doing the gene-edited food, is also developing new versions of wheat including one with greater resistance to fungal diseases, another lower in carbohydrates and higher in dietary fibers.

Other companies also developing gene-edited crops including DuPont Pioneer, which has used the technology for a new variety of waxy corn, used most commonly not for food but for starch in adhesives. Scientists at Pennsylvania State University have used Crispr to create mushrooms that do not turn brown as quickly.

The current regulations were written for the earlier generation of genetically modified organisms, where scientists used bacteria and viruses — typically from plant pests — to drop a payload of new genes into the nuclei of the plant cells where they merge with the plant’s DNA. That worked, but scientists could not control where the new genes would be inserted, and that led to worries of potentially dangerous genetic disruptions or crossbreeding with non-G.M.O. crops.

Companies like Calyxt have portrayed gene editing more like moving the cursor in a word processor to a particular location and making a small change to the text.

Federal agencies have not yet said how they intend to regulate gene-edited foods, and the incoming Trump administration, while criticizing overregulation in general, has not weighed in.

Other parts of the world are also considering whether to regulate gene-edited foods and how to do so. In Europe, where many countries have banned the cultivation of G.M.O.s, the European Commission has created a scientific panel to study the issue, with debate resuming this year.

Dr. Choulika said the inspiration for the October gathering was a dinner more than two centuries earlier, by Antoine-Augustin Parmentier, a French scientist who was enthralled with potatoes brought to Europe from South America. But many Europeans scorned the potato. France even outlawed the growing of potatoes in 1748. Largely because of Parmentier’s work, potatoes were declared to be safely edible in 1772, and the ban was lifted. Still, few wanted to eat them.

In 1778, Parmentier organized the first in a series of lavish dinners for the high society of Paris, serving dishes all made with potatoes. Potatoes became a fixture in French cuisine.

With farmers harvesting the first substantial plantings of the Cellectis gene-edited potatoes and soybeans last year, Dr. Choulika thought of throwing a modern version of Parmentier’s gathering.

“This is the first dinner on Earth with gene-edited foods,” Dr. Choulika said to the diners. “Things that you eat today, millions of people are going to eat during the 21st century, and this will not stop.”

After some collaborations with big companies like Monsanto and DuPont Pioneer, Cellectis started Calyxt, to explore opportunities for using gene editing for foods.
Dr. Choulika said he considered G.M.O.s safe, but that the gene-editing techniques like those used by Calyxt would be more acceptable to consumers. Often in G.M.O.s, the inserted genes came from unrelated species, like the bacterial genes that were added to cotton so that it would exude a toxin to repel bollworms, a mixing of species known as transgenesis.

“There’s not this blockage of transgenesis that freaks out people for no reason,” he said. “I think it is a question of perception.”

Instead of using bacteria and viruses to burrow into a cell, gene-editing techniques — Calyxt uses one called Talen — create molecules that act as a template to match a specific segment of DNA and then make a cut there.

For the Calyxt soybeans, for example, the only change was to turn off two genes. “There is nothing taken out or added to the plant,” Dr. Choulika said. “It’s what nature would have produced.”

Those edits change the mix of fatty acids and perhaps make for a better cooking oil. “Better than olive oil,” Dr. Choulika said.

At the dinner, the soybeans were transformed into a several dishes including soy blinis, mini tofu and soy burgers, and soybean hummus. Carole Pourchet, director of the Lab, the research and development arm of Mr. Ducasse’s food enterprise, said the gene-edited soy cooked like normal soy, but that the potatoes were a little drier, leading to the idea to confit them to retain moisture.

The potatoes showed up in mashed potatoes, potato pie and blinis.

“The dinner was maybe potatoes cooked 10 ways,” said Richard C. Mulligan, a professor of genetics at Harvard Medical School who was one of the guests. Dr. Choulika worked as a postdoctoral researcher in Dr. Mulligan’s laboratory two decades ago.
Federico Tripodi, chief executive of the Calyxt subsidiary, said the company hoped the soybeans would be used in cooking oil for commercial and industrial use by 2018.

The potatoes, edited to remain fresher longer and not produce carcinogens when fried, could be grown and sold in 2019. A second potato that is slower to turn brown just got word from the U.S.D.A. that it, too, is not subject to regulation.

Gene editing is not being used only with plants. A Minnesota company, Recombinetics, is editing the genes of farm animals — for example, creating cattle without horns.

Critics warned that the industry was repeating the same mistakes of G.M.O.s.

“We’ve never been against any of this technology,” said Michael K. Hansen, a senior staff scientist at Consumers Union. “We don’t say it’s inherently bad or these crops are inherently dangers. It’s just they raise safety issues, and there should be required safety assessments.”

While the gene-editing templates match a specific sequence, it is possible that the same sequence occurs elsewhere in the genome or they will match similar sequences, and the DNA will be sliced in those places, too, with unknown consequences. “They make it sound very exact,” Dr. Hansen said. “It will have off-target effects.”

Dr. Hansen said unregulated gene-edited crops could also create trade havoc if traces of them accidentally mixed into exports to countries that prohibited them.

Daniel Voytas, chief science officer of Calyxt who was one of the inventors of the Talen gene-editing technology, said the company had not checked the entire genomes of their plants, but did look for unintended changes within sections that were similar to the parts they were editing. “We didn’t find any,” he said.

Dr. Voytas said it would not be “a huge amount of work” to sequence the entire genome and that all of the data they presented was available on the U.S.D.A.’s website.

A U.S.D.A. advisory board in November unanimously recommended that standards for organic foods exclude gene-edited crops even if they were grown without chemical fertilizers and abided by the other strictures of organic farming.

Dr. Mulligan of Harvard said he was not sure that people would see much difference between gene-edited and genetically modified. “The objection that people have is a more visceral and vague objection to messing with DNA,” he said. “It’s hard to see that the public would see the difference.”

He admitted that he was more excited by the chef.

“The good thing with this is Ducasse is such a culinary artist,” Dr. Mulligan said. “He is really well known for being able to take anything and make it taste good.”

For Mr. Harris, the dinner provided a whirlwind introduction to biotechnology — “realities that I thought were theoreticals,” he said.

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