After a phase of years of reviews and meetings, the government has cleared the way for research to develop new crop varieties using genome-edited technology. On 4 October 2022, it notified Standard Operating Procedures (SOPs) for regulatory review of Site-Directed Nuclease (SDN)-1 and SDN-2 categories of genome-edited plants. It will be possible after this notification to implement the technology of genome-editing plants of the same family to reduce the duration of developing varieties that have better productivity and that are resistant to climate change and diseases.
Plants under the SDN-1 and SDN-2 categories are those in which genes from the same plant family are edited. They are not called Genetically Modified (GM) because foreign genes are not involved. Regarding this decision of the government, scientists say that this has started a new phase of developing improved crop species in the country that would bring huge benefits to the country as well as its farmers.
The Office Memorandum (OM) says that the SOPs for Regulatory Review of Genome Edited Plants under SDN-1 and SDN-2 categories have been prepared after extensive deliberations by the expert committee constituted for this purpose. The Review Committee on Genetic Manipulation (RCGM) in its 240th meeting held on 7 September 2022 approved and recommended notifying the same. Subsequently, the Department of Biotechnology (DBT) has notified it. The SOPs provide a regulatory road map and requirements for research, development and meeting the threshold for exemption of genome-edited plant(s) under the SDN-1 and SDN-2 categories as per the OM issued by the Ministry of Environment, Forests and Climate Change (MoEF&CC) on 30 March 2022.
These SOPs shall be applicable to all organizations involved in research, development and handling of the genome-edited plants under SDN-1 and SDN-2 categories. These categories have also been defined in the notification. Research and development on genome-edited plants must be conducted with authorization from the Institutional Biosafety Committees (IBSCs) and subsequent information to RCGM. The research and development of genome-edited plants is to be conducted under containment as per “Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017”. The SOPs include a host of rules including those for the import of plants of these categories, data regarding varieties developed through this process and the requisite approval process for research.
In an interview given to Rural Voice after the SOP notification, Prof KC Bansal, Secretary of the National Academy of Agricultural Sciences (NAAS) and former Director of the National Bureau of Plant Genetic Resources (NBPGR), ICAR, said that the SOPs notified to develop crop varieties through genome-edited plants would herald a better future for the farmers. “Technology has always played a significant role in boosting our food production. India has taken a giant leap forward by notifying these SOPs for the development of genome-edited crops for sustainably feeding the ever-increasing population, and for preparing our crops for adaptation to the fast-changing climate. This will enable the smallholder farmers to realize full benefits of this powerful technology, leading to their increased profitability through saving precious resources like land and water, and with less input.”
The genes from the same plant family are used in this technology and no foreign genes are involved. It is, therefore, different from GM technology. The Union Government had decided to exempt the plants under SDN1 and SDN2 categories from the application of the provisions of Biosafety Rules. An OM was issued in this regard by the MoEF&CC on 30 March 2022. According to the memorandum, the said ministries and departments had sought exemption in pursuance of Rule 20 of the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells Rules, 1989. The Union Government had, therefore, decided to exempt the plants under SDN1 and SDN2 categories from the application of the provisions of Rules 7 to 11 of these Rules. For such genome-edited plants to be released as a new variety, further development and evaluation would be as per other applicable laws/acts/rules. Subsequent to the memorandum regarding this Cabinet decision, the guidelines were issued in this regard on 17 May 2022. But scientists had raised some questions about these guidelines. This raised the significance of SOPs because the members of the committee formed for this purpose said that the issue would be resolved in SOPs.
South Asia Biotechnology Centre (SABC) Founder-Director Bhagirath Choudhary told Rural Voice about the SOPs notification that the SOPs clearly say that the government has kept the regulatory process with regard to biotechnology extremely efficient. This shows “our commitment to regulatory requirement, biosafety and scientific scrutiny of genome-edited plants, even for exempted SDN-1 and SDN-2 categories.” He added, “Having a regulatory system in place after a decade of deliberation on genome-edited plants would pave a way for our scientific community to advance such products relevant for India’s need to cope up with climate vagaries, drought and submergence, disease resistance, quality and biofortification.”
In fact, the genes from the same plant family are edited in this technique and it is possible to produce a new variety by selecting traits like better productivity, disease resistance and temperature resilience from plants of the same family. Besides, one may benefit from a better-targeted approach through this. The benefit of this technology is that it cuts short the process of developing new varieties. Scientists say the process gets accelerated. That is, any crop variety may be developed in a very short period. Biosafety regulations are not applicable to genome-edited technology in the US and UK either.
Exempting genome-edited technology from biosafety guidelines will lead to the faster development of new varieties. Another advantage is that the bio-resources available in the country can be utilized for public goods. The beauty of this technology lies in the fact that not only can higher-yield genes be introduced into the plants through it but it can also play a big role in food and nutrition security because the nutrients available in various varieties of a plant can be brought together in one plant. Besides, this technology can also make plants resistant to climate change and temperature variations. A banana species has been developed at the Mohali-based National Agri-Food Biotechnology Institute (NABI).
This technology has greatly shortened the process of developing new species. Besides, it is capable of producing accurate results. The new gene-editing technique is called Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas9. The 2020 Nobel Prize for Chemistry was awarded jointly to France’s Emmanuelle Charpentier and the US’s Jennifer Doudna for developing this gene-editing technique. The technique is being used to develop new species through gene editing. Several varieties have been released in the US and Japan using this technology.