How do regulatory challenges impact the commercialization of CRISPR-Cas9 technology in agricultural biotechnology, especially concerning the design of guide RNA?

Regulatory bodies require that any genome‑edited crop be proven safe, which forces companies to document every change, including the exact guide RNA sequence that directs Cas9. Because regulators scrutinize unintended edits, the guide RNA must be designed to minimize off‑target cuts, and every predicted off‑target site must be tested and reported. This extra documentation slows product approvals, as each new guide RNA design often needs a fresh safety dossier. For example, a soybean line edited for drought tolerance had to redo its regulatory submission when a new guide RNA was chosen that cut a nearby gene, illustrating how guide design directly affects commercialization timelines. Thus, stringent regulations make guide RNA design a critical, costly, and time‑consuming step in bringing CRISPR crops to market.