In September, a group of non-governmental organizations, non-GMO food associations, and a food retailer announced that the first-ever public detection method for a gene-edited crop had been successfully developed and published. The gene-edited crop is an herbicide-tolerant canola, called SU Canola, developed by U.S. biotechnology company Cibus.
John Fagan, Ph.D., CEO and chief science officer of Health Research Institute, was an author of the paper that detailed the gene editing test method. The paper was published in the open access journal, Foods, in September.
Fagan was an early voice in the scientific debate on genetically engineered crops, and has worked globally for more than 25 years researching safety issues regarding GMOs and pesticides. He is also a successful entrepreneur, having founded the first GMO testing labs in North America and Japan and an early GMO lab in Europe.
Ken Roseboro, editor of The Organic & Non-GMO Report, interviewed Fagan about the new test.
What led to the development of the gene editing test?
John Fagan: I’ve been following what’s going on in Europe with gene editing and also becoming concerned about what’s happening in the U.S. where gene edited crops are essentially being de-regulated. I was approached by a coalition of advocacy organizations and organizations involved in non-GMO labeling, and that led to a research project where we looked into the possibility of testing for gene edited crops.
One of the big arguments that was being used in Europe was that gene editing is so precise that there aren’t going to be any problems with it. Another part of that argument is that the changes made in gene editing are so subtle, it’s just a tiny deletion or insertion of one or a few letters of the genetic code within a gene. The changes are so minor that they are “nature identical.” Proponents of gene editing are saying “There are no problems, no safety risks here, relax.”
That argument is followed by the claim that one can use tests to detect gene edited crops anyway, they are invisible, so don’t worry about them.
As a molecular biologist, I understood very clearly based on biological principles that if there was a change in the DNA it could be detected, even one small change. I knew that there are PCR (polymerase chain reaction) methods that could detect those changes.
On that basis, we decided to take one of the worst-case scenarios, which is a gene edited crop in which only a single letter of the genetic code had been edited, and develop a test for it. At least we would have debunked the argument that they weren’t detectable.
You chose that canola because it was the hardest thing to do?
JF: It was two things. First, it was the first gene edited crop in the marketplace. The second thing was that it was the difficult case that a number of “experts” said would be difficult or impossible to detect.
Is it more challenging to develop a test for a gene edited crop than a test for a genetically modified crop developed using “older” genetic engineering techniques?
JF: Regular GMOs are made by taking a gene and modifying it in a test tube and then inserting it into the DNA of another organism, expecting that it will confer on that organism the function that the gene had in its original organism.
For example, with Roundup Ready soybeans, scientists found a bacterium that had an enzyme that was resistant to glyphosate herbicide, and then they isolated the gene for that enzyme and put it into soy. This made the soybeans resistant to glyphosate. That’s how it works with regular recombinant-based GMOs.
But with gene editing, scientists will take a gene whose protein is sensitive to glyphosate. They will edit that gene to make that protein resistant to glyphosate.
So, you’re essentially editing a gene that’s already present in the plant. In a way it’s much more refined than recombinant DNA where you randomly slam a foreign gene into the DNA of a plant and hope it works.
Are there risks with gene editing technology as there are with “older” genetic engineering methods?
JF: Yes, the problems are still there. When gene editing first began to become prominent about five years ago, people were saying “This is so precise, we know exactly what we are doing. We are directing a specific change in the lettering of this gene in exactly the way we want.”
But we are discovering that it’s not precise. There are a lot of off-target effects. There was an article in Nature magazine in July of this year that described the use of one of the gene editing methods, CRISPR-Cas, on human embryonic cells. They described the effects of the gene-editing as causing chromosomal mayhem. They saw whole hunks of chromosomes blown away by this procedure. Chromosomal mayhem is not precise. Similar things have been seen in gene edited rice and other crops as well. So, it’s extremely important to test the safety of these things because the off-target effects could be anywhere in the plant.
In terms of safety we cannot be certain that any gene edited crop is safe until you test it for safety. And yet, the regulators in some countries are saying it is precise, that we don’t have to worry about any safety issues. The developers of gene editing technology have been very effective in painting a picture of the technology that is not justified. It’s a real problem.
Will you be able to develop other tests for gene edited crops based on this test?
JF: Every gene edited product has a different genetic sequence so every PCR test will be different. But the basic strategy that we used, PCR, is applicable to any GMO or gene edited GMO.
What we’ve showed—and is the key point of our paper—is that the same method used to test for every GMO for the past 20 years can be used for gene edited GMOs. It doesn’t need new fancy science to do it.
It would be a big deal for GMO testing labs around the world to develop a whole new methodology for gene editing. What we showed is that they don’t have to do that; this is something that can fit seamlessly into the routine these labs already have. That is very important in terms of the efficacy and efficiency of this method. It’s applied to a new class of GMOs, gene edited GMOs.
How will this test be made available?
JF: It’s open source. Any lab is welcome to use it. Information in the paper we published is sufficient to set up the test. That’s because we’ve done the sequencing, and we’ve tested our method with the exact genetic material of the gene edited canola. We put a sequence into the paper that labs can synthesize and use as the reference material to do the test. There are laboratories that have done that and are setting up the test.
Do you think the ability to detect a gene edited crop will influence regulations on gene editing in agriculture and food production?
JF: I think so. The regulators are going to figure it out though it may take a few years. The U.S. and a few other countries have essentially deregulated gene editing based on claims of the biotech industry that these gene edited crops are precise and safe. But what will become more and more clear is that chromosomal mayhem is happening.
Unfortunately, we are reliving what I call the DDT phenomenon. In the early 1960s, there were magazine ads with cows, chickens, and zucchinis holding hands and singing “DDT is good for me.” But 20 years later, humanity discovered that DDT wasn’t good for us.
We should be proactive about new technologies and assess them in a rigorous way before they go to market. Again, we have failed to do that with gene edited GMOs, and that’s why consumers don’t trust this technology.
What has been the response to development of the test?
JF: Among people who are concerned about GMOs and marketing non-GMO products, there has been a very positive response.
In the EU the regulators have reacted defensively. Cibus’s canola has been in the market in the U.S. and Canada for three years at least. It could easily be in canola exports to the EU from the U.S. or Canada, and it would be illegal in the EU because it hasn’t been through the authorization procedure for genetically modified crops.
What we have done has been a catalyst for moving the issue in Europe into a very active state. Before it was just sitting there, and now something is being done to sort the whole thing out. There are strong forces in Europe that are very intent on regulating gene edited crops, and development of this test will force the requirement that all gene edited crops have to be regulated, tested for safety, and labeled if they are present at more than 0.9%. I consider that a success.
What does this new test mean for the organic, non-GMO, and natural food sectors?
JF: It means that there are tools available to keep GMOs—including gene edited GMOs—under control in the organic, non-GMO, and natural food industries. All those industries need to do is apply those testing tools.
Consumers continue to be concerned about GMOs. To be able to provide clear cut verification of these new GMOs will ease their concerns. Having these tests also creates improved marketing opportunity for companies that are prepared to make sure their products are free of these gene edited crops. That’s an ongoing opportunity, and this just adds to it.