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Graphic of Scientists analyzing DNA helix and editing genome within organisms

In a 2018 Washington Post article, new GMO techniques were described in blushing terms: "the future of food" and "precise, fast and inexpensive." While new techniques including gene-editing, gene-silencing and synthetic biology proliferate across industries, there are serious concerns about their precision and efficiency. 

Read our recent blog post New GMOs and Where to Find Them

Before we look at what can go wrong, let us see what happens when gene-editing goes right. The most commonly used technique of the up-and-coming gene-editing lineup is undoubtedly CRISPR, which is relatively inexpensive and accessible (CRISPR kits are even available by mail order for the home geneticist).

In a theoretical nutshell, here's how CRISPR works: Scientists gather up their ingredients — an enzyme that will cut a strand of DNA as well as RNA that acts as a guide to exactly where the enzyme should cut. These ingredients are then injected into a living cell of the plant or animal that is being modified. The guide RNA finds the location in the DNA where the scientists want the cut to be made, and the enzyme does the cutting. The modification of the organism — the part of the process that brings about those new traits that the scientists are hoping for —  happens while the DNA is repairing itself from the cut. 

That is the theory. However, the devil is in the details, and a pattern of unexpected outcomes have led to questions about the precision of gene-editing techniques.

Gene-editing misses the mark

First up: Location, location, location. 

How effective is that guide RNA? Can it reliably locate the right spot, or will it go to another spot? Or, will it go to the right spot and another spot? When the guide RNA selects locations other than the intended target — which is quite common — the resulting cuts and repairs produce "off-target effects" that interfere with the normal functioning of genes. That can cause serious problems, such as mutations, disease, allergens or toxins. 

Off-target effects are a big deal, scuttling some of the most ambitious plans to "rewrite the code of life." Molecular geneticist Dr. Michael Antoniou took part in the Non-GMO Project's panel New Techniques, Same GMOs last October. Dr. Antoniou spoke about the conundrum of off-target effects:

"You hear people in an agricultural context say, 'If we can simply avoid these off-target cuts in the genome of the plant, then we'll only get what we want and therefore there's nothing to worry about.' But actually, what has been discovered in more recent years is that there are numerous types of unintended mutations, even at the intended gene-editing [site]. When you take these outcomes — both off-target and unintended on-target mutations — the claims of precision and predictability go out the window."

By modifying the pattern of gene function, Dr. Antoniou says, the plant biochemistry is inherently changed.

The unexpected results of new GMO techniques are of particular concern because the regulatory framework for traditional GMOs is ill-equipped for these new technologies. The products of new GMO techniques don't necessarily leave behind foreign DNA in the organism being modified, and many of them will not require disclosure under the new Bioengineered Foods labeling law.

And off-target effects aren't the only issue when it comes to gene-editing.

The confounding complexity of genes: Unknown ≠ Unimportant

Even when the cut is made at the correct spot, the outcome can still be unpredictable because of the complexity of gene functions. A single gene can be involved in several different and seemingly unrelated functions. Our understanding of how genes work is growing, but it's still limited. We see that play out in the narratives of some gene-editing experiments.

In early efforts to create the bull that is now called Cosmo  — the manliest of all manly bulls — scientists were looking for a section of DNA in the bovine genome where they could make a cut and insert genetic material without disrupting the necessary functions. They found what they thought was a promising section of "blank" DNA, but once edits were made to that spot, the embryos died. It's function was unknown, not unimportant. According to an article in Grist, "It was only blank because it was unexplored." In some as-yet-undiscovered way, that blank section of DNA was critical to the life of the growing organism. 

Another gene-edited bull, this one called Buri, was modified to produce offspring without horns. TALEN was the tool of choice in this work, and the company responsible for the work claimed success after ensuring no off-target effects had occurred during the editing process. Later, a researcher at the FDA was reviewing Buri's DNA records, and found that a section of non-bovine DNA — potentially antibiotic resistant — had attached itself to the bull's genome. In describing what had happened, one FDA official remarked, "Ideally, [the cell] will repair itself correctly. But it can also integrate any DNA that’s around. There’s that potential.”

Integrating any DNA that's around sounds less like an effective and precise method of genetic modification and more like a Spiderman villain's origin story.

Holistic solutions for systemic problems

At its core, there's a profound disconnect between the logic that underpins new GMO techniques like gene-editing and the types of problems they are aimed at. The problems of modern agriculture are systemic. They affect entire ecosystems, billions of organisms and millions of people. 

Soil loss across the corn belt, for example, is as bad as it is because of the cumulative effects of a century of extractive industrial agriculture. There is no GMO silver bullet that can produce meaningful change if synthetic fertilizers and pesticides continue to decimate biodiversity above and below the ground and genetically modified corn dominates the landscape. A commitment to regenerative farming practices can help rebuild soil, but these methods are neither genetically engineered nor patentable.

Or, consider genetically modified plants engineered to adapt to a changing climate. There are a variety of these crops in development and some already commercially available. But the most desirable traits for adaptability and stress tolerance are complex traits, involving multiple genes interacting in elaborate ways. True crop resilience depends on much more than a strategic snip of DNA.

The greatest problems are not with the plants or crops or livestock, but the systems that currently govern them. System-wide problems need system-wide solutions, and geneting engineering — even "targeted" gene-editing — isn't up to the task. 

Good science

There is amazing work being done by researchers, agroecologists, activists, environmental groups and concerned citizens all over the world to rebuild how food is produced in North America. There are committed regenerative farmers restoring land and indigenous peoples whose stewardship of the earth's biodiversity has never waivered. 

And there are farmers working on small plots the world over. These small-holder farms produce 70% of the world's food without GMOs — and do so with about a third of the resources used by industrial agriculture.

There is a world full of problems, yes, but there are also solutions. Another esteemed panel participant and friend of the Non-GMO Project, Dr. Vandana Shiva, sums up our concerns and our hopes beautifully:

"For 50 years, we were told repeatedly that only chemical agriculture is 'scientific agriculture.' They said they'd feed us with chemical fertilizers and pesticides. We put that aside. Then they came with GMOs. That's dead. Now, they're coming with the new GMOs. This will die, too, as long as people retain their thinking, as long as people make their choices with informed knowledge."

Close-up of DNA

It's been a big year for the biotech industry. You may have noticed the wealth of headlines reporting breakthroughs in gene editing and other new GMO techniques, news stories littered with acronyms like CRISPR, TALEN and RNAi. These are just some of the new techniques being used to create novel products in our food supply — some of which are even being marketed as "non-GMO"!

But you won't see the Butterfly on these products.

At the Non-GMO Project, we recognize that any process in which an organism’s genetic material is engineered in a laboratory is genetic engineering. The products of emerging techniques — including CRISPR, TALEN, RNAi and gene drives — are GMOs. The Non-GMO Project Standard adheres to the definition of GMOs laid out by the Codex Alimentarius, the internationally recognized set of standards addressing food issues, from production to labeling and everything in between.

Because the new federal bioengineered food labeling law does not recognize many products of emerging genetic engineering techniques as GMOs, tracking new techniques and their impact on the food supply is more important than ever. Rest assured, the products of gene editing are excluded from the Non-GMO Project Standard, and packaged goods that rely on gene-edited ingredients are not eligible to wear the Butterfly seal.

A GMO-producing trio: TALEN, CRISPR and RNAi

TALEN

In 2019, a GMO soybean became the first gene edited crop commercially available in the United States. The soybeans were engineered using a technique called TALEN, resulting in more oleic acid and fewer trans-fats. These soybeans do not require disclosure under the new bioengineered food labeling law, and oil or meal derived from the GMO soybeans could end up entering the food supply marketed as a "non-GMO product." 

TALEN has also been used to modify alfalfa for animal feed, and even to modify the animals themselves. One infamous case of TALEN-gone-wrong can be found in the GMO cattle engineered to be hornless. The hornless bull was initially hailed as a success, but was later found to contain non-bovine DNA that could increase antibiotic resistance. This extra genetic information was picked up in the lab during the genetic engineering process. Critically, the company responsible for the creation of the GMO cattle did not find this error — it was detected purely by chance by an FDA researcher running tests on software. 

CRISPR

Another gene-editing tool used to create GMO livestock is CRISPR. Of all the emerging acronyms, this is likely the most familiar, as CRISPR has generated a lot of press — and controversy. Its creators won the Nobel Prize in Chemistry for their discovery, while a scientist in China "shocked the world" with the use of CRISPR to edit human embryos. 

There are many projects involving CRISPR in development, including some varieties of genetically modified livestock. Researchers are working to create animals that offer producers higher profit margins or can better withstand the harsh conditions of factory farming. Genetically modified animals include such creations as "double-muscled" pigs and poultry with enhanced immune systems

CRISPR is often described to layfolk as "operating like a pair of scissors." Or, in a much grander vision for the future, the Nobel Prize press release described CRISPR as "a tool for rewriting the code of life" — a jaw-dropping example of hubris considering how much we don't know about the function of genetic material

Whether it's kitchen chemistry or re-creating the world, the overall message is, "We've got this."

In truth, we very much don't have this. The gene-editing process can impact sections of DNA that weren't intended, creating so-called "off target effects." There are also the unforeseen consequences resulting from our limited knowledge of the complex and interrelated functions of genes.

One recent CRISPR story involves a bull named Cosmo, engineered to produce more male offspring — a beneficial trait in the beef industry. In the case of Cosmo, the Baker City Herald reported as much:

"A close look at Cosmo’s DNA after birth revealed Crispr’s unpredictability. Researchers said there was a piece of genetic code that didn’t belong, and Cosmo had more SRY, the gene that causes male traits, than intended." 

The Baker City Herald continues with a description of odd side effects in other CRISPR animals: “pigs with extra vertebrae, cattle that die prematurely, rabbits with huge tongues.”

This "rewrite" of the code of life is clearly not ready for publication.

RNAi

Short for RNA Interference, this new GMO technique uses RNA molecules to interfere with the expression of certain genes in order to modify an organism's attributes. For example, RNAi was used in the creation of the Arctic Apple to interfere with the apple's natural tendency to turn brown when it's cut open. 

Additional products of RNAi currently on the market include some varieties of Simplot Innate potatoes, engineered to reduce the appearance of bruising. The trouble with inhibiting a gene to hide damage is that the damage is still there, weakening tissues and providing an entrypoint for pathogens. It's only the visual indicators that have been eliminated. At the Non-GMO Project, we believe that's important information and we're better off recognizing it for what it is. 

Learn more about GMO potatoes

Syn(bio) City — GMO dairy, breast milk and "meat juices"

Short for synthetic biology, “synbio”refers to the merging of biology and engineering. Currently, the term largely refers to the genetic engineering of microorganisms such as yeast and is often used to produce flavorings or dairy proteins. 

Synbio dairy proteins are a hot item in the frozen foods aisle, providing the key ingredient to several GMO frozen dairy desserts, including Brave Robot, Smitten N’Ice Cream, Nick's and Graeter’s Perfect Indulgence. These brands all get their "dairy-identical" synbio dairy proteins from a single source: Perfect Day, who brought their own limited release ice cream to market for $20/pint a few years back. One of the co-founders at Perfect Day, Ryan Pandya, described their marketing strategy in enigmatic terms: "We want people to know it’s plant-based but not from plants, it’s an animal product but without animals." Which leaves one to wonder: What is it, then? Well, it's GMO. 

These dairy-without-the-animals desserts put a lot of weight on their non-animal status, appealing to the vegan market. But here we hit a snag: Producing the non-animal dairy protein relies on a digitized copy of a cow gene. While that information is part of an open source database, the genetic material originally came from an animal. According to Perfect Day, it came from a cow named L1 Dominette 01449. Depending on how strictly one defines and practices veganism, the origin of the genetic material becomes vitally important. A product that originated with blood drawn from a cow may not satisfy some vegans.

Other synbio products include human collagen for the skin care market, as well as "heme," a synbio compound that is used to create meat-like juices in the Impossible Burger. The Impossible Burger is also a tricky proposition for vegans: While the heme is derived from GMO soybeans, Impossible Foods conducted animal testing during its development. 

Developers are also using new techniques to synthesize proteins found in human breast milk, with a potential use in GMO infant formula.

The Butterfly is more important than ever!

With novel products made with new GMO techniques entering the market, it's more important than ever to look for the Butterfly. Many of these products won't require a "bioengineered food" disclosure under the new BE labeling law — a law which focuses on foods with detectable modified genetic material in the final product. 

Learn more about the bioengineered (BE) labeling law

The biotech industry knows all too well that the majority of Americans want GMOs to be clearly labeled. So, as they bring new products to market, they are bending over backwards to distance themselves from the simplest and most powerful acronym of all: G-M-O.

At the Non-GMO Project, we believe that everyone has the right to know what's in their food. That is only more critical in light of emerging technologies and new techniques, creating organisms that humans haven't eaten before. 

 

Last week’s blog, The CRISPR Revolution, closed with the enticing statement: Join us next week to find out where CRISPR technology can show up in your house! Spoiler alert: it’s unlikely to be hiding under your bed, or to jump out at you from a darkened corner. So far, the most common place to find CRISPR-Cas9 technology is in your mailbox.

CRISPR to the People

Neither snow nor rain nor gloom of night stays these intrepid citizens from conducting genetic engineering experiments in their kitchens. 

Since 2016, bio-hacker and general mischief-maker Josiah Zayner has made it his mission to sell CRISPR kits through the mail, allowing a curious public to tinker with strains of E. Coli bacteria in the comfort of their own home. The kits themselves contain a nonpathogenic form of the bacteria, though the real-world implications of mail-order E. Coli aren’t without complications. In 2017, German customs officials halted the import of CRISPR kits that were contaminated with a more dangerous strain of bacteria. To be fair, the hazard level in the contaminated kits was roughly equal to eating an egg salad sandwich from a vending machine. However, the German government weighed the egg salad argument against the potential of a product that is marketed towards novices, and ultimately landed on a firm policy of “Let’s not.”  

Is the mailbox the only way that CRISPR tech can find its way into your house? So far, yes. The United States holds an industry-friendly view of gene editing, considering it closer to conventional breeding than genetic modification. This allows the products of gene editing to avoid costly safety testing and other red tape. By contrast, the European Union views gene editing as closer to genetic modification: “As long as DNA manipulation exists, the outcome brings higher risks and uncertainties.” 

The products in development that could bring CRISPR to a grocery store near you include soy that is tolerant to drought and salt; cacao with increased pathogen resistance; and — the dream of carnival barkers everywhere — the double-muscled pig.

Organic Panic

We might think of organic agriculture as a set of technical requirements, but did you know that all organic farming is based on the four guiding Principles of health, ecology, fairness and care? Which is why it came as quite a shock when the USDA “opened the discussion" on gene editing in organic agriculture. The response from the organic community was swift and excoriating. Beyond Pesticides sums up the basic incompatibility of gene editing and organic: “Organic systems are modeled on natural ecosystems. GE organisms belong in neither [organic nor natural systems].” Also, gene editing relies on the outdated assumption of “one gene—one effect,” ignoring the fact that one gene can influence two or more seemingly unrelated traits. The statement from Beyond Pesticides continues: 

“Traditional breeding, like evolution itself, depends on forces acting on the whole organism. Exposure over time to different environments exposes unexpected traits. GE plants are created by manipulation of DNA that may create unanticipated results—results that may not be apparent until, for example, the plant is grown under unforeseen conditions.” 

When technology is developed in a controlled environment, it is not always reflective of how that tech will behave in nature. The unforeseen elements of the natural world are too great. And in many labs, those “unforeseens” are exactly the kind of noise that researchers try to eliminate in their experiments.

Gut Feelings

An adorable study on how to communicate with the public about emerging science and tech concluded that more studies need to be done on how people feel about science and tech (while somewhere, a snake consumes its own tail). This line of research illustrates a crucial cognitive divide, pitting the presentation of complex information in an analytic and reductive way against the innate human capacity to be intuitive and surprising.

In the 1980s, my dad flipped houses. There were entire pages of my address book (it was the eighties) filled with crossed-out and re-written coordinates for him. In my mind, he has never ceased to be a nomad, and there is a gap between us in how we think of “home.” My dad is a hermit crab, one eye always on the lookout for a new and better shell, whereas I’m just a regular hermit. I treat home like a sanctuary. My point being: People feel differently about things, particularly things that are important to them. So when the much-studied layperson rejects GMOs, they might do so for valid and deeply personal reasons. Because of crops that hold traditional and cultural significance, because “breaking bread” together is what community is based on, or because food is one of the things that bind us to the people we love. To the layperson, the prospect of transferring that inheritance to a distant corporation doesn’t sit well in the belly.

It might not be scientific, but it’s perfectly natural. 

Please review Understanding Biotechnology: What is a GMO? for GMO basics.

THE EMERGENCE OF NEW GMOS
For the past 25 years, genetically modified organisms have been largely limited to transgenic crops and animals: organisms that have been genetically modified by combining the DNA from two or more different species. This is beginning to change. GMOs are now being created with newer genetic engineering techniques, some of which do not involve transgenic technologies. The Non-GMO Project is committed to preventing these new GMOs from entering the non-GMO supply chain. At present, several factors are making this difficult:

Testing for GMOs depends on the commercial availability of such tests. There currently are no tests commercially available for new GMOs or their derivatives. This means that tracking them relies heavily on affidavits and other documentation rather than tests.

Additionally, GMO regulations have not caught up with new GMOs. GMOs are regulated under the Coordinated Framework for Regulation of Biotechnology in the United States. This law has not been effectively updated since 1986 and does not reflect the current state of biotechnology. The more recent National Bioengineered Food Disclosure Standard, a labeling law, does not address these new techniques.

There is also some degree of confusion about whether products of new genetic engineering techniques are GMOs. Some of these new GMOs have been marketed as non-GMO. To be clear, all products of new genetic engineering techniques are GMOs.

NEW TECHNIQUES
Many techniques are being used to genetically modify living organisms. Some of the more prevalent or noteworthy techniques include:

ODM – Oligonucleotide-directed mutagenesis involves the insertion of new DNA that mimics a portion of the plant’s genome and is incorporated via the cell’s own repair function.

RNAi – RNA interference is a process whereby RNA molecules inhibit gene expression via translation blocking or degradation. This prevents a specific portion of DNA from being read or degrades it so that it does not function.

ZFN – Zinc finger nucleases create double-strand breaks or cuts in DNA using DNA binding proteins. ZFN is older and more expensive than TALEN and CRISPR.

TALEN – Transcription activator-like effector nucleases create double-strand breaks or cuts in DNA using engineered restriction enzymes.

CRISPR – Clustered regularly interspaced short palindromic repeats create double-strand breaks or cuts in DNA using an endonuclease (Cas9) and synthetic guide RNA.

NEW PRODUCTS
New genetic engineering techniques are being used to develop novel products and ingredients. While many of these products are still in the research and development stages, some are commercially available now. As the Non-GMO Project understands it, these commercially available new GMOs include non-browning potatoes, non-browning apples, high-oleic acid soybeans, herbicide-tolerant canola, and many products of genetically engineered microbes.

As products of new genetic engineering techniques continue to enter the marketplace, the Non-GMO Project remains committed to keeping these new GMOs out of the non-GMO food supply.


You
already know about herbicide-tolerant crops, Bt crops, and other types of transgenic GMOs such as the AquAdvantage salmon—we’ve been talking about them for years. If you have been paying attention to the news, you have probably heard a little about CRISPR and the newest wave of GMOs. These technologies, which may be referred to as gene editing, gene silencing, GMOs 2.0, or just “new GMOs,” have been making headlines recently.

When the Non-GMO Project talks about “new GMOs” or “products of new genetic engineering techniques,” we generally mean all the emerging GMOs that aren’t covered by the U.S. Department of Agriculture’s (USDA’s) Plant Protection Act (PPA). The PPA is a law that is meant to fight the spread of pests that can harm valuable crops. It essentially says that people cannot import plant pests, bring them across state lines, or otherwise spread them around. This law is important because many GMO plants are (loosely) regulated under this act because they include DNA from Agrobacterium tumefaciens; a plant pest

The newest types of GMOs do not include DNA from that bacteria, so they are not regulated under the PPA. This leads some people to mistakenly believe that they are not the products of genetic engineering. Some companies are even marketing these crops as non-GMO. The Non-GMO Project is working hard to correct these misconceptions. We all know that there is no way to start with biotechnology and end up with something that is not the product of genetic modification. New GMOs are still GMOs—and they’re not allowed in Non-GMO Project Verified products. 

So What are New Genetic Engineering Techniques?

It’s important to understand that all of the following techniques are forms of biotechnology, and they all produce GMOs.

This is not an exhaustive list; there are many techniques being used to create new GMOs and there may be more on the horizon. The Non-GMO Project is committed to staying ahead of these technologies in order to protect our supply chain. 

Fermentation: More than Just Kombucha and Sauerkraut

You may also have heard of synthetic biology. Synthetic biology is generally used to genetically modify microorganisms in order to exploit their natural function and make them produce compounds they would not typically produce. For example, yeast is sometimes genetically modified so that it creates vanillin instead of what it would normally excrete. In addition, that yeast produces vanillin by consuming sugar (often from genetically modified sugar beets or corn) in a fermentation tank. Companies sometimes call this process “brewing” or “fermenting,” so be aware that those words are often used to disguise synthetic biology in this context.

Like all GMOs, products of synthetic biology have the potential to disrupt traditional economies. If it’s cheaper to make vanilla flavor using GM yeast than it is to make it with real vanilla beans, that hurts the farmers in places like Madagascar who depend on harvesting vanilla beans for their income. Do we really want to buy into a food system that would take their livelihood and export it to American corporations? At the Non-GMO Project, our answer is a resounding “no.” We want to help create a future that supports a diverse genetic inheritance, ecological harmony, and farmers everywhere. 

You can help create a future we can all be proud of by choosing Non-GMO Project Verified products at the grocery store. By voting with our dollars every time we shop, collectively we have the power to change the way our food is grown and made. As products of synthetic biology and other types of new GMOs become more commonplace, we all need to work together to protect our non-GMO food supply.

Want to learn more about new GMOs? Check out this article by Non-GMO Project Executive Director Megan Westgate.

From CRISPR Babies to Regulatory Loopholes: The New GMO Landscape
Thursday, March 7 from 4:00-5:30 PM
Marriott Platinum Ballroom 3


Join us for a conversation about the state of the non-GMO landscape, including:

Featuring:

Moderated by:
Rebecca Spector, West Coast Director, Center for Food Safety

Is it possible to create a non-GMO product using genetic engineering? While that might seem ludicrous to most of us, biotechnology companies have mounted an aggressive campaign to convince the world that the products of new genetic engineering techniques such as CRISPR are, in fact, non-GMO. Although this is completely unsupported by the scientific reality (more on that in a moment), developers of these products are so determined to distance themselves from the consumer rejection of GMOs that they are willing to ignore facts and hope no one catches on. Unfortunately for them, that attempt is failing.

What are traditional GMOs?

When most people think of GMOs, they think of transgenic crops—fruits, vegetables, and grains that have been engineered with combinations of plant, animal, bacteria, and virus genes that cannot occur in nature or in traditional breeding. For example, one of the first GMOs (which was never commercialized) was a tomato that had been engineered with an arctic flounder gene to increase its frost tolerance.

Globally, most GMO crops now being grown have been engineered with a gene from a soil bacterium (Agrobacterium tumefaciens) that makes them herbicide tolerant (HT). In other words, DNA from bacteria has been inserted into the DNA of crops such as corn and soybeans so that they can be sprayed with certain chemical pesticides without dying. This type of GMO has been highly profitable for the chemical companies that develop them, patent them, and sell the herbicides to be used with them, but the technology is starting to fail. In recent years, there has been a “superweed” epidemic as a result of increased glyphosate use on HT crops. The biotech industry has responded by developing crops that are tolerant to increasingly toxic chemicals, such as dicamba and 2,4-D, a strategy that so far has met with disastrous results.

The other common trait in traditional GMOs is insect resistance. With this type of transgenic crop, genes from a different type of soil bacterium (Bacillus thuringiensis [Bt]) is engineered into the plant, effectively turning the entire plant into an insecticide factory. If an insect eats any part of a Bt crop, it will die—unless that insect has developed a Bt tolerance. As is the case with HT crops, pest resistance to Bt crops is seriously threatening the long-term viability of the technology.

Finally, in addition to crops, genetically engineered microbes have been used for decades to produce enzymes, yeast products, acids, vitamins, and other processed inputs. These GMOs are not necessarily transgenic (i.e., containing genes from other species), but they are still GMOs because they have been created using genetic engineering.

What is genetic engineering?

Genetic engineering, also called biotechnology, bioengineering, or genetic modification, is a technology that encompasses a variety of techniques. The most authoritative international definition of genetic engineering comes from Codex Alimentarius, a collection of global food standards developed by the United Nations to address safety, quality, and international trade. This is also the definition used in the Non-GMO Project Standard, and it reads as follows:

Biotechnology – the application of:

  1. in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and the direct injection of nucleic acid into cells or organelles; or
  2. fusion of cells beyond the taxonomic family, that overcame natural physiological, reproductive, or recombination barriers and that are not techniques used in traditional breeding and selection.

A key phrase in the definition above is “in vitro nucleic acid techniques.” Understanding this term illuminates the fundamental criterion that qualifies a given technique as genetic engineering.

Translated from Latin, in vitro literally means “in glass” (e.g., in a test tube or petri dish). “Nucleic Acid” is the “NA” in DNA and RNA. So basically, any time nucleic acids are tinkered with in glass, the process being used is genetic engineering.

All genetic engineering is inherently reductionist and relies on unproven and unreliable assumptions about the predictability of a given gene’s function in isolation from its original DNA sequence. DNA and RNA are the building blocks of life, and their scope and complexity are vast. For example, as a human being, your genome is made up of approximately 20,000 genes, which are in turn composed of approximately 3 billion base pairs of DNA. This genome that codes for everything that makes you biologically unique (20,000 genes made up of 3 billion base pairs!) is copied into virtually every single cell of your body.

The complexity and sophistication with which these gene sequences interact are far beyond the capacity of our current scientific understanding, which is why manipulating genes in isolation, in the ways allowed by genetic engineering, is so problematic. Whether a GMO is created by combining genes from multiple species (as in traditional transgenics) or by rearranging or silencing genes within a species, the fundamental premise remains the same—the flawed idea that genes can be reduced to isolated functions, without regard for the complex interplay of the entire genome.  

What are new GMOs?

New genetic engineering techniques such as CRISPR, RNAi, ODM, gene drives and other types of so-called “gene editing” generally do not contain foreign DNA in the finished product. Interestingly, though, that doesn’t always mean that the genetic engineering process itself is not transgenic. For example, current CRISPR products are created by using the same soil bacterium used in HT crops (Agrobacterium tumefaciens) to carry another foreign bacterial or archaebacterial gene inside the cell nucleus of a plant. Through this process, the DNA of the host plant is modified with the capacity to produce a new enzyme that makes changes to the plant’s DNA. Although the finished CRISPR product doesn’t contain the transgenes from the bacteria, it does retain the changes that were made to the DNA, and the process still relies on transgenic techniques.

Regardless of whether foreign DNA is used, though, any process where nucleic acid is engineered in a laboratory is genetic engineering, and the resulting products are GMOs. This also includes what is sometimes referred to as “synthetic biology” or “synbio.” Synthetic biology generally refers to the use of genetically engineered microbes to produce novel compounds that taste or smell like familiar substances but don’t actually come from the natural source. For example, genetically engineered yeasts (fed a growth medium based on GMO corn or sugar beet) are now being used to create experimental products and proteins that developers claim are molecularly identical to vanilla, stevia, cow’s milk, and even human breast milk.  

Regulation and oversight of new GMOs

In a landmark decision last week, the European Court of Justice ruled that GMOs created through new genetic engineering techniques such as CRISPR and ODM are still GMOs and are subject to regulation under the EU’s GMO Directive. The decision reflected a prioritization of scientific facts over industry pressure and was a decisive blow to biotech company efforts to claim that new GMOs are not GMOs simply because they don’t always contain transgenic DNA. Although most countries have not yet taken a position on the new techniques, the EU has long set trends when it comes to regulation and oversight of GMOs, and its ruling on new genetic engineering techniques is expected to be influential in much of the world.

The United States, however, continues to lag behind other countries when it comes to regulating GMOs of all types. Currently, there is no established regulatory framework within which we can expect any oversight of new GMOs. Even when it comes to simple labeling, the USDA’s National Bioengineered Food Disclosure Standard, still in draft form but scheduled to take effect in 2020, appears likely to leave new genetic engineering techniques out of its scope, meaning that products produced with CRISPR, RNAi, ODM, synthetic biology, etc. would not have to be labeled as GMOs.

Non-GMO Project Leadership

The Non-GMO Project has always held a firm position that anything produced with genetic engineering is a GMO. Our research team continually monitors not only how the techniques are evolving, but also what specific products are being created and how they are impacting the supply chain. When a product becomes commercially widespread, we add it to the Standard’s “High-Risk List” (Appendix B of the Non-GMO Project Standard). This High-Risk list is organized into Testable and Non-Testable GMOs, with corresponding requirements for proving non-GMO status for use in a Non-GMO Project Verified product.

While our Standard is uniquely rigorous in requiring ongoing testing for all Major High-Risk Ingredients that are testable, new GMOs pose a problem because they are not yet testable. Commercial tests for GMOs currently rely on the detection of foreign DNA or protein, so new GMOs that don’t contain transgenes cannot be tested in this way. When there is no point in the supply chain where a product can be tested using current methods (which also applies to synbio and all other products of GM microbes), the Standard requires an affidavit.    

Currently, besides products of synbio (which have been prohibited by the Non-GMO Project Standard since 2014), the only type of new GMO that has become commercially widespread is ODM canola. Since there are also widespread varieties of canola produced with traditional genetic engineering (which can be tested for), the Non-GMO Project Standard requires a Verified canola product to maintain ongoing testing as well as an affidavit declaring that ODM was not used in its production. We are closely monitoring a variety of other crops and products, including RNAi apples and potatoes, to determine at what point they should be added to the High-Risk List.

The Non-GMO Project is the only certification that is taking such a proactive and comprehensive approach to prohibiting products of new forms of genetic engineering. As the gold standard for shoppers looking to avoid GMOs, we will continue to monitor biotechnology developments and rapidly evolve our Standard as needed. Consumers can trust that regardless of which form of genetic engineering has been used, they can look for the Butterfly to avoid all types of GMOs.

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