You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

June 11, 2024

Genome Editing in Thai and Indonesian Agricultural Biotechnology

Subscribe to Updates

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.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Locations

RELATED INSIGHTS​ 

October 25, 2023
Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of
Read More
October 25, 2023
One significant development in the health sector in Indonesia is the use of information technology and communication in the implementation of health efforts—particularly digital health services such as telehealth and telemedicine integrated into the country’s National Health Information System. This development was addressed in a major new piece of legislation for the healthcare sector in Indonesia. Enacted in August 2023, Law No. 17 of 2023 concerning Health (the “Health Law”) provides the updates needed to support the development of healthcare services in Indonesia. Under the Health Law, health information system (HIS) providers must: Carry out processing of data and health information in the territory of Indonesia, except for certain limited and specific processing activities that may be conducted outside Indonesia when permitted by the relevant authorities and in compliance with relevant regulations. Ensure the reliability of its HIS, including availability, security, maintenance, and integration with Indonesia’s National Health Information System. Provide quality health data and information. Process data and health information, which includes planning, collection, storage, inspection, transfer, utilization, and destruction. Record its data- and information-processing history. Protect every person’s data and health information. Obtain approval from the relevant personal data subject or comply with relevant regulations if the processing of data and health information involves an individual’s health data. Inform the data owner if there is a failure to protect data and individual health information. The Health Law’s personal data protection requirements listed above appear to be aligned with the provisions in Law No. 27 of 2022 concerning Personal Data Protection (the “PDP Law”). Under this law, data and information relating to health are identified as “specific personal data,” the processing of which carries a high potential risk of impacting the relevant personal data subject. In the implementation of digital health services, patients’ personal data or medical records
Read More
October 19, 2023
Cambodia’s Law on Food Safety came into force on June 8, 2022. This law has been widely regarded as a major legal development of the food safety framework in Cambodia, providing new rules, clarifying existing rules, and setting a clear framework for its implementation and enforcement. In addressing some of the key features of this new law shortly after it was passed in 2022, we remarked that we eagerly await implementing regulations. Since then, various regulations have been adopted, such as two regulations (Sub-Decree No. 13 and Prakas No. 80) on food surveillance, recalls, and seizure. These implementing rules are essential in ensuring that enforcement officers can remove noncompliant and unsafe foods from the market. Another key aspect of the Law on Food Safety is that it requires Khmer-language labeling on prepackaged food products. There has been a notable increase in the inclusion of Khmer labeling on food products in the market since June 2022, but noncompliance is still considerable, especially for imported foods. Further interesting labeling rules set by the Law on Food Safety include a requirement to provide nutrition information. This requirement has not yet been widely adopted, with many in the industry highlighting that the details of this labeling requirement are not clear. Indeed, the relevant article of the Law on Food Safety itself only sets the requirement for food products to bear nutrition labeling and does not spell out what detailed information should be provided or in what manner. However, a prakas (ministerial regulation) adopted months prior to the Law on Food Safety does set out clear guidance on nutrition labeling. As long as this earlier regulation is not replaced or abrogated, and as far as it does not conflict with later laws or regulations, it can be relied upon for guidance. What are the
Read More
September 20, 2023
Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.
Read More