A statement issued by the U.S. Secretary of Agriculture Sonny Perdue last week has clarified that the U.S. Department of Agriculture (USDA) currently does not, and has no plans to, regulate gene edited plants or crops. As opposed to genetically modified organisms (GMOs) that involve adding genes from other organisms such as bacteria, the USDA considers gene-edited plants as being similar to plants developed through traditional breeding techniques and therefore require less regulatory oversight.
The USDA has been quietly approving CRISPR-edited products for some time now, with the unofficial stance being that unless other genetic material is being added to a plant then the crop deserves no special regulation. This new statement is the most official stance the regulatory body has released on the matter to date.
"With this approach, USDA seeks to allow innovation when there is no risk present," says Secretary Perdue. "At the same time, I want to be clear to consumers that we will not be stepping away from our regulatory responsibilities. While these crops do not require regulatory oversight, we do have an important role to play in protecting plant health by evaluating products developed using modern biotechnology."
The statement clarifies that this means the body will not regulate plants that undergo a variety of genetic changes, including genetic deletions, single base pair substitutions, or insertions from compatible plant relatives that could be generated through traditional plant breeding.
Recently, countries in Europe have also been grappling with this new conundrum, and while many have taken a hard line on GMOs, they are also drawing a big distinction between gene-editing and what is classically defined as a GMO. Both Germany and Sweden recently made individual rulings stating that gene-edited plants could not be classified the same as GMOs.
Due to a complicated regulatory framework in the United States, the USDA isn't the only agency to have a say in this matter. Both the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) also play roles in overseeing these regulations, and the FDA in particular has the final say over the safety of food for human beings.
Despite the FDA currently offering no specific guidelines on genetically edited foods, a spokesperson has stated that the agency is currently considering the issue. However, the FDA did release controversial guidelines last year regarding genetically altered animals. The agency stated any genomic editing whatsoever in animals should not only trigger governmental oversight but also result in the animal product being classified as an "animal drug."
Following on from the recent debate over whether or not lab-grown meat should be called meat, it seems we are undoubtedly moving into new waters regarding food classifications as biotechnology rapidly progresses. Will the general public see any difference between GMO corn and CRISPR-edited corn? That's yet to be determined but this certainly is only the beginning of a new world of regulatory challenges for determining what is safe and what isn't.