Landmark Decision Should Inform New US Biotechnology Regulations
Statement by Global Justice Ecology Project Executive Director
New York- On July 25th, the European Court of Justice (ECJ) ruled that products resulting from Talens and CRISPR, which are new gene editing tools are, in fact, genetically modified organisms (GMOs). This decision means that because these organisms could not occur naturally, they will be kept under regulatory purview.
This landmark decision has important implications for biotechnology regulations currently being revised by the US government.
“The decision by the ECJ which recognizes that new genetic technologies such as Talens or CRISPR are still GMOs is groundbreaking,” said Anne Petermann, Executive Director of Global Justice Ecology Project and the Coordinator of the Campaign to STOP GE Trees, some of whose members were involved in this important case. “It recognizes that just because a technology makes genetic engineering easier or more accessible it does not reduce the inherent risk of such endeavors.
“GJEP is encouraged by the ECJ’s willingness to reign in corporations involved in altering the genetic make up of the natural world.
“The United States must also recognize the vast potential for harm that is inherent in genetically engineering our food and forests, whether transgenic or not. This is especially urgent as researchers in the US consider plans to genetically engineer forest trees using these new and unproven technologies.”
HOW CRISPR WORKS:
Researchers create a small piece of RNA with a short”guide” sequence that attaches (binds) to a specific target sequence of DNA in a genome. The RNA also binds to the Cas9 enzyme. As in bacteria, the modified RNA is used to recognize the DNA sequence, and the Cas9 enzyme cuts the DNA at the targeted location. Although Cas9 is the enzyme that is used most often, other enzymes (for example Cpf1) can also be used. Once the DNA is cut, researchers use the cell’s own DNA repair machinery to add or delete pieces of genetic material, or to make changes to the DNA by replacing an existing segment with a customized DNA sequence.
The court’s decision explicitly states, “In today’s judgment, the Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally. It follows that those organisms come, in principle, within the scope of the GMO Directive and are subject to the obligations laid down by that directive.”