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Court Rules that Gene Editing is the Same as GMO, FDA Believes it Should be Regulated

(How cows may have protected us from the dangers of gene editing)

Advocates for gene editing (aka GMO 2.0) have been embarking on a massive PR campaign to convince us that this technology is not only different than modern genetic engineering — which usually inserts foreign DNA into organisms — but that it is incredibly precise. So precise that it doesn’t even need government regulation.

Two recent events have completely undermined both of these arguments.

1) The Conseil d’Etat, France’s top administrative court, ruled that organisms obtained via gene editing or in-vitro mutagenesis techniques should be subject to GMO regulation.

In essence, the court has said that even though the technique is slightly different, it is still genetic engineering and must be regulated as such — a blow to the ag-biotech industry who is desperate to disassociate GMOs with gene-edited crops.

Despite this ruling, the organic industry remains under attack.

Some media outlets have published highly misleading and inaccurate articles which say that organic foods derived from mutagenesis must be regulated as a GMO.

“The narrative that certain organic foods must now be regulated as GMOs is incorrect. The court clearly said that in-vitro mutagenesis is subject to regulation. This is very different than conventional mutagenesis — a conventional breeding technique — which is presently allowed in organic,” said Michael Hansen, PhD, Senior Staff Scientist at Consumer Reports.

2) In 2016, a Minnesota-based animal biotechnology company called Recombinetics announced that it had created hornless cattle using gene editing.

As published in the journal Nature Biotechnology in that same year, Recombinetics researchers reported detecting no unexpected alterations, such as insertions or deletions of DNA, as a result of the gene-editing procedure. They concluded that “our animals are free of off-target events.” — i.e. everything went exactly as planned and there were no unintended or unexpected events.

Also in 2016, in a commentary titled ‘Regulate genome-edited products, not genome editing itself‘ academic researchers, some of whom were associated with Recombinetics, argued that “the effects of genome editing are largely identical to those of the natural processes that continually create variation in the genomes of food animals. From this point of view, it is hard to see why the process of genome editing to introduce defined genetic changes should be regulated.”

Fast-forward to August of 2019, and flaws in this “perfect” gene-editing technology began to appear.

Namely, scientists at the FDA — not researchers at Recombinetics — dropped a bombshell when they found foreign, non-bovine DNA inserted into the animal’s genome during the gene-editing process. This was completely unexpected and threw the entire hornless cow experiment into question, as well as the notion that gene editing is so precise.

Just two weeks ago, on February 7th, the FDA officially stated that “genome editing in animals can have unintended consequences.”

Furthermore, in a companion piece published in Nature Biotechnology called ‘Genome editing in animals: Why FDA regulation matters,” Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, defended the value of FDA oversight of gene editing in animals to protect animal and human health.


Despite the fact that gene editing is not currently allowed in organic, the USDA seems to want to insert this technology into our industry.

Last summer, USDA Undersecretary Greg Ibach testified at a House Agriculture Subcommittee meeting called “Assessing the Effectiveness of the National Organic Program”, where he said,

“There is the opportunity to open the discussion to consider whether it is appropriate for some of these new technologies, including gene editing, to be eligible to be used to enhance organic production.”

Not only is gene editing an advanced form of GMOs and should be treated as such, exactly what the French court ruled, but this technology is not as precise as many scientists would like us to believe. It can result in unintended consequences and should be regulated, two positions that are held by the FDA.

All stakeholders must remain vigilant because at some point the National Organic Standards Board — under pressure from the USDA — may want to discuss its possible inclusion in organic.

It goes without saying that gene editing has absolutely no business in the organic industry.

With gratitude,

Max Goldberg, Founder

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This Week's Quick Hits

Quick Hits

* Tomorrow through Saturday, the UAE will be hosting its first-ever Annual Organic Festival.

* Food & Water Watch’s 15th Anniversary Benefit will take place in NYC on Tuesday, March 24th.

* Long Island, NY restaurant chain Organic Krush is opening its fifth location.

* Clemson University’s regulatory arm has been recognized by the USDA’s National Organic Program as among the nation’s best organic certification programs. I wonder if Dabo Swinney is running this one as well.

* SÜPRMARKT is raising funds to open South Central LA’s first organic produce market at a historic space in Nipsey Square.

* In Paris, organic farming is taking over fallow parking lots.

* In Las Vegas, True Bar — a standalone bar concept from True Food Kitchen — has opened its first location, where it is serving organic vodka and gin from Prairie Organic Spirits. The featured Prairie drink at True Bar is called the “Causemo” because it is supporting organic farmers with the company’s “cause.”

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