The Court of Justice of the European Union on July 25 decided that organisms obtained by mutagenesis including CRISPR and other gene editing techniques are genetically modified organisms (GMOs) and are, in principle, subject to the same EU regulatory burdens as transgenic crops.
The effects of this EU court decision will likely not be limited to Europe, but may be felt by farmers and independent seed companies here in the United States. Independent seed companies have long searched for sources of genetics and traits beyond the few multinational companies that out-license today. The U.S. market has mainly been driven to this consolidated state because of the high regulatory costs and burdens for GMO approval around the world. These approvals are required to keep key export markets open for grain produced from GMO seed.
There’s a lot of promise with gene-edited products and technologies because they are non-GMO techniques. Gene editing does not incorporate foreign DNA into the final product, which means one can get to the same point with traditional plant breeding as one can with gene editing. The cost to develop traits and genetics with gene editing is also much less expensive than GMO techniques and thus more accessible to more companies.
There was a lot of hope that these products would be regulated the same way as traditionally bred plants and would lower the barriers to commercialization around the world. Unfortunately, the Court of Justice decision puts gene-edited products in the same regulatory bucket as their GMO counterparts.
The disappointment for independent companies is that this decision will continue to constrict the market of companies that can bring gene-edited technologies to a commercial state. Without those regulatory burdens, hundreds of seed companies around the world could continue the work they’re doing with gene editing crops and have a predictable path to commercialization. The way GMO products are approved for import approval around the world makes it very complicated and cumbersome. Smaller companies just don’t have the resources to overcome those obstacles. GMO traits, such as Enlist and Duracade, have been waiting commercialization for a number of years because of these regulations. Gene-edited products may face this same fate. In this case, a decision made in Europe affects not only European farmers’ access to technology but could limit the competitive licensing environment for independent U.S. seed companies.