The biotech industry has welcomed the decision by US regulators to simplify rules for certain gene-edited plants and seeds in the first major overhaul of the US Department of Agriculture (USDA) plant biotech regulations since 1987.
Under the USDA’s old system, pre-market reviews were required for all products that contained GMOs. The new rule, which comes into effect in April 2021, means an automatic approval of variations of established GM crops. No review will be required for a plant containing minor changes – such as a change to a pair of amino acid bases – that would create a trait that could have been achieved through traditional plant breeding. Other products will still require USDA review, for example, if they contain a gene that has been transferred between species.
Dana O’Brien, Executive Vice President of the Biotechnology Innovation Organization’s food & agriculture section, says the rule will accelerate innovation. ‘BIO is pleased that USDA’s updated regulatory approach builds on decades of scientific knowledge about biotechnology in food and agriculture. It holds great promise to enhance investment and product development by small and mid-sized companies in particular.’ BIO recognises that now government and industry must do more to improve dialogue about biotechnology innovation in food and agriculture. It notes the final rule does not contain a mechanism for mandatory notification by companies of exempt products.
Meanwhile, the American Seed Trade Association says it is important seed companies have a ‘clear, transparent, science-based process’ to obtain confirmation that a product meets one of the exemptions in the rule.
The Center for Science in the Public Interest is concerned that developers are not required to notify the agency of products they believe are exempt under the new regulations. ‘The result is that [we] will have no idea what products will enter the market and whether those products appropriately qualified for an exemption from oversight,’ comments CSPI biotechnology project director Gregory Jaffe.
At a time when consumers want greater transparency, Jaffe fears this approach could lead to potential consumer backlash and acceptance problems.
‘Consumers have a right to know how gene editing is being used to produce the foods they buy in the market,’ says Consumer Federation of America Director of food policy Thomas Gremillion. ‘This rule will undermine public confidence in the food supply, and ultimately set back beneficial uses of this technology.’
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