WASHINGTON, April 14, 2016 – A gene-edited mushroom won’t be regulated by the Animal and Plant Health Inspection Service (APHIS), making it the first crop edited with CRISPR-Cas9 to go unregulated by USDA.

In Wednesday letter to the mushroom developer, Yinong Yang, an associate professor of plant pathology at Penn State University, APHIS said it had determined the fungus did not contain any introduced genetic material or pose a threat as a plant pest, and as such, would not be regulated by USDA as a genetically-engineered (GE) organism.

The edited white button mushroom won’t brown as quickly as its conventional counterpart – which will improve its appearance and shelf life – and will be easier to harvest with automation, Yang says.

About 30 gene-edited organisms have sidestepped APHIS regulation in the past five years, but none of them have been produced using the CRISPR-Cas9 tool until now. Other gene-editing techniques used by researchers include the zinc-finger nuclease (ZFN) and the transcription activator-like effector nuclease (TALEN) tools.

In comments published by the Genetic Expert News Service (GENeS), Alan Bennett, a professor of plant sciences at the University of California, Davis, said APHIS’ decision to not regulate Yang’s mushroom doesn’t mean “any genome-edited crop plant” will be automatically given the same determination.

“The USDA regulatory framework for genetically modified crops is obsolete and is currently under review,” Bennett continued. “A regulatory framework that is science-based may well conclude that certain types of genome edited crop plants should not require regulatory oversight – but the floodgates are not opening yet.”

Rodolphe Barrangou, a professor of food science at North Carolina State University, said the mushroom was just the “first of an ongoing pipeline” of CRISPR-Cas9-edited food products.

“Everyone I talk to who is doing any genetics research is using CRISPR… In six months, the number (of CRISPR-Cas9-edited food products in development) will be much higher,” he said. “If USDA decide a CRISPR-edited food does not fall under their purview it will surely accelerate development.”


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