With A Free Pass, CRISPR-Edited Plants Reach Market In Record Time | agriculture bioptechnology | Scoop.it

CRISPR–Cas9-edited plants can be culti- vated and sold free from regulation, the US Department of Agriculture (USDA) is mak- ing increasingly clear. The agency gave a free pass to Camelina sativa , or false flax, with enhanced omega-3 oil. And more recently, in October, said that a drought-tolerant soybean variety developed with CRISPR falls outside of its regulatory purview. This laissez faire attitude from the agency shaves years and tens of millions of dollars off the cost of bringing a biotech plant to market. “It eliminates that huge barrier to entry for agbiotech companies,” says Oliver Peoples, CEO of Woburn, Massachusetts– based Yield10 Bioscience (formerly Metabolix) which developed the camelina. 

It would have taken Yield10 at least six years and $30–50 million to test and col- lect the data necessary to bring genetically engineered camelina through the full USDA regulatory process, says Peoples. “We did this in two years and [USDA’s decision] took two months, and I assure you we didn’t spend $30 million on it,” he says. The company will present its technology to the US Food and Drug Administration’s voluntary review process, he says.

The USDA’s change in attitude toward genetic engineering came with the arrival of new technologies to modify plants. Unlike transgenic plants modified using older technologies, plants modified with CRISPR–Cas9 and other new gene editing techniques do not require USDA oversight because the resulting plants don’t contain DNA from “plant pests” such as viruses or bacteria. Such organisms were a necessary component in early plant modification tools, such as Agrobacterium -mediated transfor - mation, and triggered regulatory oversight when the US government in the 1980s and 1990s wrote its framework for regulating biotech crops. Although the USDA recently reviewed the old biotech framework, so far, the agency has not broadened the regulatory net to catch organisms made with the newer techniques.

Via Loïc Lepiniec, Jonathan Lapleau