Emerging Techniques in Biotechnology Pose New Risks to the Non-GMO Supply Chain

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.