USDA Classifies Gene-Edited Soybean As Non-RegulatedJune 10, 2020
The United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) declared Calyxt's high oleic low linolenic (HOLL) soybean as a non-regulated article. This means that the gene-edited soybean may be available in the US market in two years' time.
The HOLL soybean was developed using the TALEN® technology. TALEN® stands for Transcription Activator-Like Effector Nuclease, a breeding technology designed to specifically target genes in the plant to allow the selection of desired traits and accelerate breeding. The HOLL soybean is a second-generation product still in its developmental stage, with specific traits such as improved stability and production of heart-healthy oil.
In its letter to the developer, USDA APHIS' Biotechnology Regulatory Services (BRS) considered the gene-edited soybean a non-regulated article because it only contains the genetic material of the original soybean plant with deletions of five targeted genes. Though unregulated, BRS reminded the developer that accidental release of gene-edited soybean that does contain intentionally introduced genetic material may be a violation of the regulations and may merit reprimands.
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