Advances in biotechnology have enabled the development of a range of new agricultural tools. From DNA sequencing to plant tissue culture and gene editing, these advances are facilitating the development of better crops.
Genetically modified organisms (GMOs) are one well-known example of agricultural biotechnology. GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA. This DNA may be synthetic in origin or sourced from other organisms.
Genome editing (also called gene editing or GEd) involves making precise changes to an organism’s genome without the integration of foreign DNA elements. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, in which scientists make precise “cuts” in the DNA to create a new genetic variation. Unlike with GMOs, this introduces only minor modifications that are indistinguishable from natural mutations, typically by transplanting genes that code desirable traits from one species into another.
GEd technology has been recognized and supported by the Food and Agriculture Organization of the United Nations (FAO). Thirteen FAO-member countries who are also members of the Organization for Economic Cooperation and Development (OECD) announced their support of the use of GEd technology for commercial uses and consumption at a recent WTO meeting. In addition, over 40 countries around the world, such as Argentina, Australia, Brazil, Canada, Chile, China, England, Japan, Kenya, the Philippines, Russia, the UK, and the US, have published policies emphasizing that foods free of transgenes (i.e., foods that do not contain genes transferred from external sources) are not GMOs, concluding that GEd plants are as safe as normal plants.
In February 2024, the European Parliament approved new genomic techniques (NGTs), or GEd. As a result, plants that are produced using GEd technology are not classified by the EU as GMOs, and the EU authorities consider them to be the same as conventional plants.
Thailand’s Stance toward GEd
In Thailand, the Department of Agriculture in the Ministry of Agriculture and Cooperatives (MOAC) views the results of the EU vote as providing timely support for Thailand’s own policy consideration of the issue. The European Parliament has agreed that genome editing technology is highly safe for human health and the environment, and its use can potentially reduce costs and increase the quality and productivity of agriculture. With this development, it is an opportune time for Thailand to accelerate the process of adopting GEd technology in the agricultural sector for food safety and security by drafting guidelines for the application of GEd technology.
Since the beginning of 2024, the MOAC has taken several actions targeting the development of GEd knowledge.
One event the Department of Agriculture organized was a seminar titled “Modern Biotechnology to Solve the Global Crisis and Emerging Pests.” This event was a brainstorming seminar for all stakeholders on how to take advantage of technology that is safe and on par with other countries, as well as creating guidelines for operating and driving GEd technology in Thailand, including communicating with the public and consumers for a better understanding of the safety of GEd technology and its difference from the production of GMOs. The seminar emphasized that Thailand must be able to take advantage of GEd technology in its future planning for addressing global crises and emerging pests that will impact its agricultural sector.
The Department of Agriculture also organized an academic seminar on GEd technology to set a clear national stance on the issue and accelerate communication with the public and consumers that plants produced with GEd technology are different from GMOs. Next, the Department of Agriculture will invite experts from the FAO, from various countries such as Australia, Japan, and the United States, and from the private and public sectors to join together in a push to build confidence in GEd technology and speed up the preparation of operational procedures. Doing so will assist Thailand in leveraging genome editing technology for the agricultural sector for food safety and security through modern biotechnology. The experts mentioned above recognize that NGTs, or GEd, are likely to continue playing an important role in the increasingly dire situations of global warming and global food crises.
Most professionals believe that using GEd technology to modify the genetics of groups of plants that can be naturally hybridized can produce high-yielding plant varieties that are resistant to disease and drought. In addition, they believe that GEd technology will increase nutritional value. Most countries in the world have invested in research into GEd and approved the use of GEd technology, accepting GEd technology for both commercial and consumption purposes, as with conventional crops, to increase national food security.
Early Support for GEd in Thailand
Though the Ministry of Agriculture and Cooperatives in Thailand has not yet issued any draft notifications or announced public hearings regarding the use of GEd, there is progress in the public sector. One project showing that Thailand is ready to support the use of GEd technology was launched when the National Center for Genetic Engineering and Biotechnology (BIOTEC) released a publication looking at the issue of genome editing and providing technical criteria for considering organisms developed with GEd technology.
Under the guidelines, genome-edited plants derived from the use of GEd techniques employing site-directed nucleases (SDNs) are generally classified into three categories:
- SDN-1 (deletion), site-directed mutagenesis without using a DNA sequence template.;
- SDN-2 (substitution), site-directed mutagenesis using a DNA sequence template.; and
- SDN-3 (insertion), site-directed insertion of a gene/large DNA sequence using a DNA sequence template.
The guidelines have not set out criteria for considering organisms developed with genome-editing technology that do not qualify as living beings genetically modified.
In the view of BIOTEC, SDN-1 plants are not considered to be GMOs, while SDN-2 and SDN-3 plants may be considered as such. If a party wishes to use GEd in conjunction with food, a safety assessment by BIOTEC will be required. The required safety assessment for SDN-1 is lower than for SDN-2 and SDN-3.
This is a positive sign showing that Thailand is ready to move forward with GEd technology development. We may see wider discussions, acceptance, and regulations regarding GEd technology in the future.
Indonesia’s Stance toward GEd
In recent discussions on GEd technology, Indonesian authorities agreed that the determination of whether or not genome-edited products are considered genetically modified will be based on the mechanism of genetic repair, in accordance with the definitions set forth in the Cartagena Protocol and Government Regulation No. 21 of 2005 regarding Biosafety of Genetically Modified Products. If the repair mechanism is carried out by involving donors or genes that do not have a taxonomic relationship with the organism that is the subject of the GEd, the genome-edited product is considered genetically modified. However, if it does not involve a donor or genes outside the individual, it can be considered non-genetically modified.
Despite the discussions surrounding genome editing, there are not yet any specific regulations on genome editing in Indonesia. Therefore, based on Government Regulation No. 21 of 2005 regarding Biosafety of Genetically Modified Products, GEd is still considered genetic modification, and genome-edited products must undergo a safety assessment in order to obtain approval from the Biosafety Commission.
The safety assessment procedure for genetically modified food products is overseen by Indonesia’s National Agency of Drug and Food Control, or BPOM, and involves the following steps:
- Application submission. Applications are submitted through BPOM’s e-filing system. Applicants must also submit supporting documents in accordance with the relevant BPOM regulations regarding genetically modified food products, accompanied by an integrity pact.
- Data verification process. If the application is not complete, the applicant must supply the required materials within 14 days of receiving notification from the head of BPOM.
- Biosafety commission assignment. The head of BPOM assigns the Biosafety Commission to conduct a food safety assessment. The Biosafety Commission has the task of providing recommendations to the authorized minister and the head of the authorized non-ministerial government institution (LPNK) in formulating and establishing policies and issuing biosafety certificates for genetically modified products.
- Assessment by Biosafety Commission. The Biosafety Commission conducts the food safety assessment within 14 days.
- Assessment by Biosafety Technical Team. The Biosafety Commission may assign the Biosafety Technical Team, which assists the Biosafety Commission in conducting evaluations and technical assessments of biosafety, to conduct a technical document review and perform further testing if necessary. This will be completed within 56 days of receiving the assignment letter from the Biosafety Commission.
- Technical assessment results. The Biosafety Technical Team submits the results of the technical assessment to the Biosafety Commission within 7 days.
- Assessment submission to Biosafety Clearing House. The Biosafety Commission submits the technical assessment of the Biosafety Technical Team to the Biosafety Clearing House, a Biosafety Commission tool that serves as a means of communication between the Biosafety Commission and stakeholders, within 15 days.
- Publication by Biosafety Clearing House. The Biosafety Clearing House publishes a summary of the Biosafety Technical Team’s technical assessment for 60 days to allow the public to comment.
- Report submission to Biosafety Commission. The Biosafety Clearing House then submits a public response report to the Biosafety Commission.
- Biosafety Commission recommendation. The Biosafety Commission submits a food safety recommendation to the head of BPOM within 14 days. In submitting recommendations on food safety of Genetically Modified Products to the Head BPOM, taking into account the results of the assessment of the Biosafety Commission Technical Team and input from the public.
- Issuance of approval by Head of BPOM. The head of BPOM issues a safety certificate and permit for the distribution of the genetically modified food.
Conclusion
As the regulatory landscapes continue to evolve around genome editing technologies in Thailand, Indonesia, and across the globe, businesses operating in the agricultural biotechnology sector must stay vigilant. Navigating the emerging regulations and approval processes will be crucial for companies looking to commercialize new genome-edited crops and food products. Companies must also carefully manage public perception around genome editing, clearly communicating the science and safety assessments behind these innovations. With strategic foresight and regulatory attentiveness, the agricultural biotech industry can capitalize on the promise of genome editing to enhance food security and drive sustainable productivity gains. Businesses primed to leverage genome editing technologies while mitigating regulatory risks will be positioned for leadership in this new age of agricultural biotechnology.
For further information, please contact:
Siradapat Ratanakorn, Tilleke & Gibbins
siradapat.r@tilleke.com
