Updates on Regulatory Landscape for Gene-Edited Crops in Asia and Oceania
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Recent advancements in molecular biology, particularly gene/genome editing, have revolutionized genetic modification techniques. While these new methods do not inherently produce different outcomes compared to the current techniques used by scientists, they significantly enhance efficiency, speed, and precision. Consequently, there is a growing global interest in gene-edited crops and their regulation.
A key question is whether existing genetically modified (GM) product regulations should also apply to gene-edited ones. Many countries have established regulatory frameworks for these novel breeding innovations. ISAAA Brief 56, published in December 2021, provides a comprehensive overview of these guidelines.
Recently, countries in Asia and Oceania issued guidelines and regulations for new breeding innovations. Some of these countries have even approved their first gene-edited products. This article provides updates on the regulatory landscape for the regulation of gene-edited crops in Asia and Oceania.
Japan
In 2020, the Ministry of Health, Labour, and Welfare of Japan published its final guidelines, which state that gene-edited plants and food can be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria, a process similar to what is adopted in the United States, but developers must send a notification to the government. On September 15, 2021, Sanatech Seed Co., Ltd., together with its partner for sales Pioneer EcoScience Co, Ltd., started selling their genome-edited tomatoes with increased gamma-aminobutyric acid (GABA) called Sicilian Rouge High GABA. The tomato was edited using CRISPR-Cas9 to contain high levels of GABA, an amino acid believed to aid relaxation and help lower blood pressure. Developed in collaboration with the University of Tsukuba, the Sicilian Rouge High GABA is the world's first gene-edited tomato.
On March 20, 2023, the Ministry of Health, Labour, and Welfare and the Ministry of Agriculture, Forestry, and Fisheries in Japan gave their green light to a high-starch maize variety, the fourth genome-edited food product that Japan did not subject to regulations for genetically engineered crops. Aside from gene-edited high GABA tomato and high-starch maize, Japan has approved the sale of two gene-edited fishes, a Madai red sea bream and the 22-seiki fugu tiger puffer in October and November 2021.
India
On March 30, 2022, India's Ministry of Environment, Forest, and Climate Change announced the exemption of genome-edited plants without foreign genes from being treated as transgenic products. The Memorandum released by the Ministry states, “SDN1 and SDN2 genome-edited products free from exogenous introduced DNA be exempted from biosafety assessment in pursuance of rule 20 of the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically engineered Organisms or Cells Rules 1989.” The final guidelines for the safety assessment of genome-edited plants were released on May 17, 2022. The guidelines serve as a road map for the development and sustainable application of genome editing, including the regulatory pathways to be taken for the release of genome-edited plants.
Philippines
On May 19, 2022, the Philippine Department of Agriculture (DA) published the rules and procedures for the evaluation of products of plant breeding innovations (PBI). The regulation, marked as Memorandum Circular No. 8, Series of 2022 (MC8), provides a science-based and efficient process for the assessment and determination of whether gene-edited plants are to be considered genetically engineered (GE) or not.
In April 2023, the DA Bureau of Plant Industry (DA-BPI) determined that Tropic's reduced-browning banana is not a GMO. It was the first gene-edited product to pass the country's gene editing regulatory process.
In May 2024, the DA-BPI released a Certificate of Non-coverage from JDC No. 01 s.2021 for gene-edited high GABA Silician Rouge Tomato developed by Sanatech Seed Co. and released in Japan in 2021.
On June 21, 2024, new banana varieties with improved reduced-browning characteristics were determined as non-GMOs in the Philippines. The Certificates of Non-Coverage from JDC No. 01 s. 2021 was granted by the DA-BPI.
Thailand
Thailand's Minister of Agriculture and Cooperatives Captain Thamanat Prompow signed the country’s groundbreaking legislation for genome-edited organisms on July 11, 2024. The new regulation, titled “Certification of Organisms Developed from Genome Editing Technology for Agricultural Use, B.E. 2567 (2024),” aims to position Thailand as a global leader in agricultural innovation, in line with countries such as the United States, Japan, and Australia.
The announcement was made by Mr. Rapibhat Chandarasrivongs, Director-General of the Department of Agriculture on July 11, 2024. Mr. Chandarasrivongs emphasized that this development is aligned with Prime Minister Settha Thavisin's "Ignite Agriculture Hub" initiative and will help triple Thai farmers' income in four years.
New Zealand Revises Gene Technology Rule
In August 2024, New Zealand, through the Ministry of Business, Innovation, and Employment, announced that the country's gene technology rules will be revised to keep up with the advancements in science and technology, particularly gene editing. Similar to Australia, a regulator will be established to ensure the health and safety of people and the environment. The New Zealand government targets to implement the new legislation and the regulator in operation by the end of 2025.
As the world faces many challenges to feed its increasing population, scientists and researchers are always looking for new tools to help them develop crops with enhanced traits. Gene editing has the potential to revolutionize agriculture by addressing the challenges faced by farmers and consumers today. By creating more productive, resilient, and sustainable crops, gene editing can contribute to food security, environmental protection, and improved human health.
In September, ISAAA Inc., the Malaysian Biotechnology Information Center, and partners will hold the 7th Asian Short Course on Agribiotechnology, Biosafety Regulation, and Communication (ASCA7). This intensive 5-day program, to be held on September 2-6, 2024 at Maruay Garden Hotel in Bangkok, Thailand, is co-hosted by Thailand's Department of Agriculture and Biotechnology Alliance Association. A full session will tackle gene editing, including the commercial applications of genomics, gene editing, and bioinformatics in Japan, regulatory considerations of gene editing in the Philippines, and the status of gene-edited crop regulation in Asia and Australasia.
For more information, download and read ISAAA Brief 56 and the new infographic from the ISAAA website. For the latest gene editing guidelines and products, subscribe to the Biotech Updates.
For further reading:
- Updates on Global Regulatory Landscape for Gene-Edited Crops
- Japan Starts Sale of Genome-Edited High-GABA Tomato
- Japan Gives Nod to Genome-Edited Waxy Maize
- India Exempts Genome-Edited Plants from Biosafety Assessment
- Tropic's Gene-Edited Banana Determined as Non-GMO in the Philippines
- High GABA Tomato Determined as Non-GM in the Philippines
- Philippines Clears Gene-Edited Bananas Developed to Reduce Food Waste
- Thailand Approves Genome Editing Regulation
- New Zealand Updates Gene Technology Regulation
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