There is extreme inconsistency and contradiction amongst global regulatory bodies that oversee biotechnologies, particularly around regulations pertaining to genetically modified organisms (GMO) and genetic engineering (GE). GE technologies like CRISPR-Cas9 and TALENs are gaining popularity, but fractured regulations are holding many of these technologies back from commercialization.

In the U.S., regulators have previously defined GMOs as transgenic organisms developed using the introduction of foreign DNA; this definition is now under review. Since GE technologies including CRISPR-Cas9 and TALENs do not introduce foreign DNA when used for site-specific cleavage, proponents argue that regulators should not treat these technologies the same as GMOs. In comparison, the deletions in plant genomes created using GE could be changes that occur naturally. However, CRISPR-Cas9 can also be used in combination with homology-directed repair (HDR), and in some cases insert foreign DNA. Conversely, the EU defines GMOs as organisms whose DNA is altered by the introduction of a modified gene or a gene from another variety or species; this definition would not include technologies like CRISPR-Cas9 (when used for gene silencing) under the same regulation as GMOs.

Lux Research dug into the minute differences between how regulatory agencies in a selected portion of major agricultural countries define GMO and GE. In the table below, we outline the regulatory bodies responsible for oversight of biotechnology and their respective definitions of GMO and GE for selected major agricultural regions/organizations.

We could argue the nuances between individual countries’ definitions and regulatory frameworks indefinitely. Regardless, agricultural commodity crops like corn and soy are such important global commodities, it is vital for the industry to have regulatory consensus. Regulators appear to be responding to this concern; the USDA recently overhauled their public website, changing the public-facing definition of GMO to be “An organism produced through genetic modification,” and further defining genetic modification as “The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods.” However, the USDA clarifies that this definition “is intended for general education only, and does not replace any definitions currently in use in any U.S. Government laws or regulations.” In the map below, we map out which countries’ definitions of GMO distinctly do not apply to GE technologies (when used for gene silencing).  The map answers the question, “Based on the country’s current definition of GMO, are GE crops different than GMOs?”.

As the figure shows, the EU is currently the only region whose definition of GMO distinctly does not apply to GE, with the U.S. regulation currently under review. However, the EU is one of the most restrictive geographies of biotechnology. Additionally, the U.S., Brazil, and India are three of the most receptive countries to biotechnology, each having more than 9 million hectares planted with GMO crops. However, Brazil and India’s current regulatory definitions of GMO would include GE crops. This map further emphasizes that regulatory loopholes should not be used to plan biotechnology strategies, because regulatory definitions often contradict regulatory activity.

Overall, the agricultural regulatory bodies worldwide are trending towards regulating GE crops in the same way that they regulate GMO crops. Readers in the health and life sciences industry should not build product strategies based on the hope that regulators will treat GE crops differently than GMOs. It is too risky to place bets on regulators allowing the selling or labeling of GE crops to be any different from that of GMOs. By closely examining how each country is defining GMO and GE, we see that regulators are trending towards classifying both technologies as the same, no matter the scientific differences between them.

By: Laura Lee