THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Gene-edited Crops in the USA Slipping through the Regulatory Net
An article in Nature Biotechnology states that the US Department of Agriculture (USDA) has informed the developers of the first commercial CRISPR-edited crops – an anti-browning mushroom and a waxy corn genetically modified with the gene editing tool CRISPR-Cas9 – that they can be cultivated and sold without oversight by the agency (see http://www.nature.com/nbt/journal/v34/n6/full/nbt0616-582.html). The USDA has ruled similarly on plants transformed with other gene-editing techniques.
DuPont Pioneer engineered the waxy corn to contain starch composed exclusively of the branched polysaccharide amylopectin, a commodity in processed foods, adhesives and high-gloss paper. It used CRISPR-Cas9 to shut down an endogenous waxy gene that encodes the endosperm’s granule-bound starch synthase responsible for making amylose. Meanwhile, Yinong Yang, a plant pathologist at Pennsylvania State University, used CRISPR-Cas9 to engineer a common white button mushroom (Agaricus bisporus) to have anti-browning properties by knocking out one of the six genes that encode an enzyme that causes browning in many fruits and vegetables.
Plant pests have served as the basis for the USDA’s oversight of biotechnology products since the 1980s. Newer genetic engineering techniques that do not involve plant pests are, however, quickly replacing the old ones, and the USDA appears to be saying it does not have the authority to regulate products made with these techniques because they do not contain genetic material from plant pests, such as viruses or bacteria.
However, numerous concerns have been raised about these new technologies, including off-target effects with unpredictable consequences. These effects include new environmental and health concerns beyond those associated with older GM techniques. Therefore, there is a strong argument for ensuring that case-specific risk assessment and regulation are still required for such gene-edited crops.
With best wishes,
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