Plant pathologist Yinong Yang of Penn State waited more than four months for a USDA response to his letter about his genetic editing of a white button mushroom to resist browning. The answer arrived this week: USDA said the mushroom is not subject to its biotechnology regulations because it contains no added genetic material. It is the first organism produced with the gene-editing tool called CRISPR-Cas9 to get the green light for commercialization from the federal government, says the journal Nature. “I am confident we’ll see more gene-edited crops falling outside of regulatory authority,” Chinese plant biologist Caixia Gao told Nature.
“The mushroom is one of about 30 genetically modified organisms (GMOs) to sidestep the USDA regulatory system in the past five years,” said Nature. In each case, USDA’s plant regulatory agency decided the GMOs, mostly plants, do not qualify for its review, which is based on plant protection laws that focus on the introduction of viruses, bacteria or other pests that destroy the value of a crop. FDA and EPA also play a role in biotechnology regulation.
“But until now, it was not clear whether the USDA would give the same pass to organisms engineered with science’s hottest new tool, CRISPR–Cas9,” said Nature. Yang told the journal that he presented his crop to USDA regulators last October. He submitted an official inquiry on Oct. 15.
The government is in the early stages of updating its biotech rules known as the Coordinated Framework for Regulation of Biotechnology. The mushroom is an example of one of the advances in genetic engineering – the manipulation or editing of genes within a plant to improve its value, rather than introducing genetic material from another organism.
In the past 18 months, GE apples and potatoes that resist browning have received federal approval for commercial sale.