A promising biotechnological approach or an innovative way of avoiding regulation? Large companies spend an average of €126M on the development of a genetically engineered crop (GMO), including €32M in regulatory costs. The Agriculture Department once takes two to five years to review applications, though it is trying to reduce that to 13 to 16 months. Targeted genome engineering (also known as genome editing) has emerged as an alternative to classical plant breeding and transgenic (GMO) methods to improve crop plants. Companies are now developing genetically modified crops using techniques that either are outside the jurisdiction of the Agriculture Department or use new methods — like “genome editing” — that were not envisioned when the regulations were created.
Until recently, available tools for introducing site-specific double strand DNA breaks were restricted to zinc finger nucleases (ZFNs) and TAL effector nucleases (TALENs). However, these technologies have not been widely adopted by the plant research community due to complicated design and laborious assembly of specific DNA binding proteins for each target gene. Recently, an easier method has emerged based on the bacterial CRISPR (clustered regularly interspaced short palindromic repeats)/Cas (CRISPR-associated) immune system.