• Jeffrey's Take: FDA says, \"Regulate gene edited animals\" - Jeffrey Smith
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On February 7th, the US Food and Drug Administration put out a strong statement in the publication Nature Biotechnology, which is one of the preeminent pro-GMO journals. And the statement basically endorsed the need for strict oversight of gene-editing in animals to protect public health.

It was the same time they published their research that Jeffrey has referred to previously with the hornless cattle. They were gene altered to have no horns and this was supposedly a very successful gene-editing by the company Recombinetics.

When they published their findings, there was an accompanying editorial or accompanying commentary saying, “This proves that animals that are gene-edited do not need any oversight because it was so clean and clear and predictable. We should essentially allow animals to go on the marketplace without any government oversight.”

But the FDA had developed a sequencing technology and they put the cows through this sequencing of the genome, and they found that there had been a mistake that was completely overlooked by the developers. There were bacterial genes in every cell of the cows’ genome and they contained antibiotic-resistant genes – bacterial genes that created antibiotic-resistant proteins.

This means that if bacteria inside the cow, for example, had touched the cells, and the cells with the antibiotic-resistant genes were to transfer to that bacteria, it could ultimately create diseases untreatable with antibiotics, which of course is already killing tens of thousands, possibly hundreds of thousands of people per year.

This was an alarming finding by the FDA, and this was published in Nature Biotechnology along with the statement by the FDA reminding, or explaining, that this demonstrates the need for regulatory oversight. If you look at what the USDA is doing, they say, “No regulatory oversight is needed.”

If you look at what the Australian government is doing, they said, “No regulatory oversight is needed for gene-edited plants, animals and microorganisms.” It’s one of the major biotech talking points and the major lobbying point in the world for years to try and get gene-edited GMOs essentially off the government regulation altogether so that companies can just do it and introduce it without anyone paying attention. We just saw with the hornless cattle, that could result in deaths – large scale deaths from antibiotic-resistant diseases and there are many other ways that gene editing could cause problems. That’s just one way.

The biotech industry claims that there’s no support for no government regulations. They claim that it’s so precise that oversight is unnecessary. There are more than a dozen peer-reviewed articles that came out in the last two years showing that there are all sorts of unpredicted changes that could result in serious problems.

The biotech industry also tries to claim that if it’s simply trying to make a change that occurs naturally in nature, then it should be considered natural and not touched by regulations. But with the hornless cattle – they were trying to create a mutation that was in fact natural. But the process itself – when you gene-edit – the molecular scissors cut the double-stranded DNA and then the cell recombines it, but it can grab other DNA material that’s in the Petri dish. That’s what happened here. So the process of genetic engineering accidentally pulled in these bacterial genes with the antibiotic-resistant genes and this was in an attempt to change gene expression to something else that occurs in nature.

One of the big statements that was issued in the Nature Biotechnology editorial (which tried to rebuff the FDA and tell them to rethink their proposal that all gene-edited animals be looked at) was the claim that we should be looking at product-based gene-editing, rather than process-based. That means that we should just look at what the product is supposed to be and see if it does what it’s supposed to be and if it does, it should be allowed to go on the market. Forget about the fact that it was gene-edited – we shouldn’t be looking at the process at all.

If you went by that logic, which Nature Biotechnology is trying to get people to do,  then you would allow these hornless cattle on the marketplace because you would never look at the genome sequencing. You’d never find the antibiotic-resistant genes, and you might imperil the lives of thousands of people, maybe more, for possibly centuries by creating this new type of cattle in the cattle gene pool.

It’s as if someone wrote this editorial for the Nature Biotechnology side who was completely unfamiliar with the articles that they themselves are publishing and completely unfamiliar and not referencing what the FDA statement was. This is what drives us crazy in the pro-science, anti-GMO world that we’re in.

The people who are part of the biotechnology lobbying team that develop these talking points are so unscientific and yet they just go on and on claiming things which we know are not true. Even in the same journal, the editorial by the journal completely ignores the problems that were brought up in other articles in the journal.

The process of gene-editing occurs when you take an egg from the animal and you remove the nucleus and replace the gene-edited adult cells into the egg. Then in that environment, those cells switch to become more like an embryo, they multiply, it’s transplanted into a fetus of an animal, and then there’s birth. So it’s similar to cloning, which has a high degree of birth defects and complications, and so it’s the same thing with gene editing. There are a lot of animal rights issues associated with gene editing.

It’s also interesting that the statement made by the FDA spokesperson in Nature Biotechnology specifically said his concerns relate to gene-editing animals, but not gene-edited plants. We think this is because of the political pressure. Companies like Monsanto, now Bayer, have been pushing their weight around in the regulatory agencies to try and get plants completely unregulated. However, all of the problems that were just described around the animals are the same as plants. You can create a gene-edited plant and it results in an allergen, a toxin, a carcinogen, or an anti-nutrient all from the same process that created this hornless cattle. Yet they’re distancing themselves from gene-edited plants. We think that that is an unscientific politically driven statement.

To summarize, gene editing is a new cheap form of GMOs and the biotech industry is dead set on allowing gene-edited plants, animals, and microorganisms to be introduced into the environment with no government oversight. They got that in place in Australia and they were hoping to get it in place here.

It’s interesting that the Trump administration – he signed an executive order on June 11th mandating that the five agencies in the government promote gene-edited products in the United States, eliminate barriers, and force the rest of the world to also accept the US-made gene-edited products.

It’s possible that the FDA is putting a flag in the dirt, so to speak, staking a claim saying it will not be bullied by the Trump administration to completely ignore all the gene-editing problems. Or if we think the FDA is still in the pocket of the biotech industry, then they’re making that statement so that the rest of the world, the rest of the regulatory agencies in the world come around and say, “Oh yes, we must now believe that the FDA is protecting us.” However, when they come out with their actual regulatory oversight protocols, it might be so weak as if to be non-existent, in which case they have all this fanfare in advancing “We need to protect the public with oversight.” But the oversight turns out to be a facade.

If you know anything about the FDA’s oversight of GMOs now, then you should know that the person in charge of creating that policy was Michael Taylor, Monsanto’s former attorney later Monsanto’s Vice President. That policy is that there are no required safety studies for GMOs and no required labeling.

A company can determine on its own whether their GMO is safe and put it on the market without even telling the FDA. Here it appears that the FDA wants to change that with respect to gene-edited animals. We’ll let you know how it turns out.