From Bio Journal - September 2023

Successive development of new genetic engineering techniques to evade regulations

In the August issue, we reported that NTT Green & Food Co., Ltd. is pushing forward with the farming of heat-tolerant flounder using epigenome-editing technology, and NARO is conducting research on a "super-rapid rice development method." Epigenome editing and ultra-rapid rice development methods are not subject to the Cartagena Act regulations because they are not genetic modification (GM) technologies. They are also not genome editing because they do not dissect DNA strands. Therefore, these developments are being carried out with the idea that there is no need even for notification, let alone regulation.

In the first place, GM technology was the first to develop new varieties by genetic manipulation. GM technology came to be regulated by the Convention on Biological Diversity and the Cartagena Protocol, but with the development of new genetic engineering technologies, development that evades regulations is gaining momentum. This has been aggressively pursued by researchers and companies in Europe, where the regulatory environment is harsh. New crop development is therefore being actively implemented in Europe using New Plant Breeding Techniques (NPBTs) that manipulate genes but are "not GM." At the heart of this movement were Dutch researchers who lobbied the European Commission to refrain from imposing regulations. A European Commission think tank, the Joint Research Center (JRC), defined NPBT in 2011. Eight kinds of NPBT were taken up. These are genome editing, oligonucleotide-directed mutagenesis technology (ODM), RNA-dependent DNA methylation (RdDM), cisgenesis and intragenesis, grafting, reverse breeding, agroinfiltration and synthetic genomics. Genome editing is included, but this was still before CRISPR-Cas9 appeared on the scene. The point is that there are no foreign genes remaining, as in GM technology.

In Japan, the Science Council of Japan published Current Status and Issues in New Plant Breeding Technology (NPBT) in 2014. Here, SPT (Speed Production Technology) was added to the eight technologies cited by the European Commission. This is rapid and efficient breeding. Fruit trees, for example, have a long period between flowering and fruit ripening. This is a technology that accelerates flowering or promotes the production of new generations. Such is the case with NARO's super-rapid rice development method. Subsequently, the promotion of NPBT was co-opted and a budget allotted in the Cross-Ministerial Strategic Innovation Promotion Program (SIP) launched by the government in fiscal 2014. SIP was then passed on to the Comprehensive Innovation Strategy from FY 2018, and the first issue that arose was how to respond to genome editing technology, for which applications were rapidly appearing with the advent of CRISPR-Cas9. The Japanese government decided not to regulate genome-editing technology because "unlike GMOs, no foreign genes remain," as with its original objective of not regulating NPBT.

Thus, the response to NPBT has changed significantly with the advent of CRISPR-Cas9, but this was not only in the case of genome editing. The flounder epigenome-editing modifications being developed by Regional Fish are modifications of RNA-dependent DNA methylation (RdDM). Using CRISPR-Cas9, DNA methylation (disrupting the function of genes), which used to be done using RNA, can now be easily carried out to disrupt the function of genes. In the future, there will likely be more biotechnologies that are not subject to regulation because no foreign genes remain and are not genome-edited because they do not dissect DNA.

Notification for Sanatech Seed's new genome-edited tomato accepted

The Research Committee on Genetically Modified Food, etc. of the Newly Developed Food Research Committee of the Food Sanitation Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labour and Welfare (MHLW) accepted a notification submitted by Sanatech Seed Co., Ltd. on July 27, for a high-GABA medium-sized tomato named "Esprosso." On the same day, the Ministry of Agriculture, Forestry and Fisheries (MAFF), also accepted the notification of an information document. Medium-sized tomatoes have thus been added to Sicilian Rouge, the cherry tomatoes currently produced and marketed.

MHLW holds hearing with cultured meat companies

On August 4, the Ministry of Health, Labour and Welfare (MHLW) held a meeting of the Research Committee on Newly Developed Foods under the Food Sanitation Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council to hear from businesses about foods made using cell culture technology (so-called cultured meat). To date, MHLW has invited the development side to attend council meetings, but has not held hearings with organizations or individuals who are opposed or cautious about the technology.

MHLW responds to consumer groups' open letter on cultured meat

On August 4, MHLW responded to an open letter on cultured meat submitted by consumer groups including the Consumers Union of Japan. As cultured meat differs from conventional meat, the ministry is involved in ensuring food safety. MHLW responded that they were in the process of collecting information on safety, the status of research and development, and other matters concerning cultured meat. Citing intellectual property rights, MHLW has not made public important sections of the council deliberations.

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