On July 25, the European Court of Justice pointed out in the judgment in the case of “French Farmers’ Federation v. French Prime Minister and French Minister of Agriculture, Agriculture, Food and Forestry â€that organisms modified by genetic mutagenesis should in principle be regarded as genetically modified Organisms, and subject to the regulation of the European Union ’s GMO Directive; but if some organisms modified by genetic mutagenesis have been used for a long time and have a consistent safety record, then the EU does not require them to comply with the requirements of this directive.
The judgment and influence of the judgment in this case are worthy of reference and consideration as a country with a global cultivation and import of genetically modified crops.
Litigation initiated by the French Farmers ’Federation
Before reading this case, we first need to demystify the gene mutation technology. Yuan Longping's hybrid rice is particularly well-known among many human practices for understanding and modifying genes. However, although crosses between different rice varieties can increase yield, they cannot obtain the excellent characteristics that all rice varieties do not have, such as insect resistance. Assuming that this characteristic was discovered in a certain weed, and people want to introduce this ability into rice, so as to reduce the use of pesticides, it is necessary to use genetically modified technology.
Scientists first need to find out which part of the gene makes the weeds resistant to insect pests, and then cut this part of the gene fragment and embed it into the rice gene sequence that it wants to improve. Compared with the transgenic technology, the gene mutagenesis technology does not embed the genes of other species. It only achieves the purpose similar to the transgenic technology by changing the biological genome composition. The controversial focus of this jurisprudence is precisely related to the difference and connection between transgenic technology and gene mutagenesis technology.
The EU GMO Directive has imposed strict restrictions on the environmental release and market circulation of genetically modified organisms within the EU, but it also states that organisms modified using genetic mutagenesis can be exempted from their supervision.
In March 2015, the French Farmers ’Federation, together with eight other organizations, filed a complaint with the French Supreme Administrative Court. They believe that before the GM directive was adopted in 2001, the gene mutagenesis technology remained in the traditional way of using similar hybridization; however, with the rapid development of technology, this technology can now achieve biological genes in the laboratory. Precise mutagenesis. These organizations believe that the potential damage to the environment and human health of organisms modified by precise genetic mutagenesis is the same as that of genetically modified technology. Therefore, organisms modified using this gene mutagenesis technology should be included in the regulatory scope of the European Union's GMO Directive.
Faced with this prosecution, the French Supreme Administrative Court asked the European Court of Justice to interpret the GM Directive, especially the provisions on jurisdiction, legal basis and the effectiveness of genetic mutation technology exemptions. After trial, the European Court determined that the key to determining whether an organism is a genetically modified organism according to the EU GMO Directive is to determine whether it contains genetic material that has been altered by unnatural means. Gene mutation is obviously not a natural way. Therefore, the organisms modified by genetic mutagenesis are genetically modified organisms. The European Court of Justice further discussed whether such GMOs need to be regulated by the EU GMO Directive.
The European Court of Justice first pointed out that, according to the jurisprudence, when interpreting EU law, it should not only be based on its literal meaning, but also combined with legislative purposes. The court pointed out that when the transgenic instruction was passed, the gene mutagenesis technology was still at the stage of random mutagenesis; and with the advancement of science and technology, the current gene mutagenesis technology can already directly modify genes. This technology is different from the traditional Random mutagenesis is essentially different.
The court held that the direct gene mutagenesis technology is very close to the genetically modified technology in terms of the output speed, effects and possible risks of genetically modified organisms. If the organisms modified by this method are excluded from the supervision of the genetically modified instructions, then Obviously contrary to the "precautionary principle" stipulated in the directive. Therefore, the European Court of Justice ruled that organisms modified by genetic mutagenesis technology should in principle be subject to the supervision of the EU GMO Directive, but those products that have been used for a long time and have a consistent safety record are not required to comply with the GMO Directive Requirements.
Some people are dissatisfied
The important application of gene mutagenesis technology is not limited to crop improvement, it is also used in the medical field, especially for the treatment of cancer. As of now, it is still unclear whether the potential danger of genetic mutagenesis technology is quite the same as that of genetically modified technology, and there are cases in practice that are contrary to the opinion of the European Court of Justice. Earlier, the Federal Institute for Risk Assessment under the German Federal Ministry of Food and Agriculture determined under German law that a rape modified by direct genetic mutagenesis is not a GMO; it is under the Swedish Agricultural Commission of the Swedish Ministry of Rural Affairs It also ruled that according to EU regulations, any organism modified by genetic mutagenesis cannot be counted as a genetically modified organism.
In addition, the United States Department of Agriculture also issued a statement, arguing that genetic mutagenesis technology, including direct gene mutagenesis technology, is closer to traditional hybrid breeding than transgenic technology. Therefore, the agency has no plan to include organisms that have been modified by genetic mutagenesis technology as they do with genetically modified organisms.
Regarding the judgment of the European Court of Justice, Kay Puenhagen, associate professor of the Law School of Wageningen University in the Netherlands, pointed out: "This is a very important judgment and a very strict one. Foods that have been improved by technology must go through the EU ’s lengthy approval process before they are available on the market. "
Stefan Janssen, a professor in the Department of Plant Physiology at Umeå University in Sweden, is concerned that European gene technology research will be in trouble. The German Chemical Industry Association even more directly pointed to the judgment as "reversing history."
Steven Salzberg, a professor at Johns Hopkins University in the United States, pointed out that the decision of the European Court of Justice is confusing. On the one hand, "organisms modified by genetic mutagenesis technology should in principle be subject to the supervision of the EU's GMO Directive". In fact, almost all foods are included in the supervision of the GMO Directive, because whether it is wheat, corn or pigs, cattle, They are the products of long-term genetic modification of human beings, and they are far from their wild forms; on the other hand, "the products of genetic mutagenesis technology that have been used for a long time and have a consistent safety record are not required to comply with the GM directive. "Requirement" has exempted the supervision of almost all products of genetic mutagenesis technology.
In contrast, environmentalists, farmers who reverse genetic organization and some farmers who are worried that GM may pose a danger to the environment and health have welcomed the verdict. They pointed out that if new genetic mutagenesis technology is not included in the GM directive The scope of supervision, then there will be more and more companies "drill this loophole." In a statement, a member of the environmental group Friends of the Earth, Mute Shenfu, said: "We welcome this important ruling, which breaks the current biotech industry's attempt to force genetically modified products to our farms and tables."
Gene technology law requires systematic legal regulation
Transgenic technology has achieved significant results in increasing world crop yields and reducing the use of chemical fertilizers and pesticides. Research in this area is of great significance to solve the problems of food shortage, hunger and malnutrition, and its possible potential dangers Inconclusive. Therefore, although many countries use legal means to control genetically modified organisms due to prudent considerations, the degree of rigor varies greatly from country to country.
The decision of the European Court of Justice once again shows that the European Union is the most strictly regulated GMO in the world. This judgment sounded the alarm for countries with large planted GM crops and large imports of GM crops. These countries should pay close attention to the latest developments in GM regulation in various countries in the world in order to continuously improve the reasonable and effective regulation of GM organisms.
First, the legal regulation of genetically modified organisms should avoid hindering the corresponding scientific research activities. As an emerging discipline, genetic engineering has broad prospects for its research. However, as mentioned above, if the legal supervision of genetically modified organisms is too cautious and strict, it is likely to hinder scientific research in this field. In response to this problem, the correct measures should be: on the one hand, it should increase its investment in scientific research in this field, on the one hand, it should provide a flexible legal regulatory environment for scientific research on genetically modified technologies.
Secondly, granting legal exemptions for scientific research activities does not mean relaxing supervision in other fields. On the contrary, a country ’s supervision of genetically modified organisms should not be limited to the agricultural sector, but should fully integrate the existing laws and regulations of agricultural genetically modified organisms safety management as the core. Regulatory Law, as soon as possible to formulate a gene technology law as a systemic law, comprehensive legal regulation of the entire field of gene technology, a special chapter provides legal prevention of genetically modified biological environmental risks. Through comprehensive legislation to clarify the powers and responsibilities of various regulatory departments, coordinate and coordinate the relationship between the law and other departmental laws, to achieve full-field, full-process, comprehensive and comprehensive risk control of the application of genetically modified technology.
Finally, the general public has little knowledge about genetically modified technology, but is generally concerned about the potential risks to human health and the ecological environment. Therefore, governments of all countries must focus on establishing adequate risk communication and public participation mechanisms. Both the Convention on Biological Diversity and the Cartagena Protocol on Biosafety, to which China has acceded, require parties to enable the public to obtain relevant information and materials and solicit public opinions in the decision-making process. The Nagoya-Kuala Lumpur Supplementary Protocol, an important supplement to the Convention on the Protection of Biological Diversity, also requires the establishment of a clearing house.
The future genetic technology law should implement the spirit and rules of these international conventions, provide adequate risk communication and public participation due process and material and technical guarantees, in order to effectively bridge the gap between the technical rationality and social perception of the risk of genetically modified organisms and rebuild Social trust system.
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