In the U.S., gene-editing technologies have already allowed more than 30 types of engineered crops to entirely bypass regulation by the USDA. One such crop is the CRISPR/Cas9-edited white button mushroom.
Genetically modified organisms, or GMOs as they are commonly known, have been a controversial topic since their inception, and pose unique challenges for governments to regulate effectively. Recently, both the U.S. and EU have evolved their thinking regarding GMOs, including whether or not modifications made with new breeding technologies (NBTs), specifically gene-editing technologies, should fall into the same category as that of organisms modified via previously known transgenic techniques. However, we observe that while regulation over these technologies is evolving, the debate may not be fully informed and/or is centered on only some of the relevant issues. Agricultural crops are some of the GMOs most visible to the general public, and will serve as the emphasis for this article. The first GMO crops were created via transgenesis—a process by which a plant genome is permanently altered by inserting foreign gene sequences from a different, non-sexually compatible plant or other organism, e.g., sequences that could not appear in the genome through non-genetic breeding techniques [see EMBO Rep. 7(8): 750–753 (2006)]. In contrast, gene-editing technologies allow for the modification of a plant genome to alter single or a few nucleotides, or targeting the insertion of genes to a specific location. They also allow for both intragenesis (the modification of portions of one or more genes) and cisgenesis (the insertion of one or more genes in the correct orientation and including natural expression signals). These technologies are capable of providing astounding improvements to crops, such as improving disease resistance or increasing metabolic efficiency; and this has led to a flurry of activity as many researchers and companies seek to expand and further develop gene-editing technologies in plants.