The Ministry of Science and Technology has notified the “Standard Operating Procedures (SOPs) for regulatory review of Genome Edited Plants under SDN (site directed nuclease)-1 and SDN-2 categories, 2022”.
Key points
- These SOPs shall be applicable for all organizations involved in research, development and handling of the Genome Edited Plants under SDN-1 and SDN-2 categories from the date of notification.
- The SOPs provide regulatory road map, requirements for research and development and meet the threshold for exemption of Genome Edited Plant(s) under the SDN-1 or SDN-2 categories.
- These Guidelines & SOPs are expected to speed up development of plant varieties and to reduce the time of approval.
- New plant varieties with improved traits would contribute towards increasing Farmer’s income.
- Earlier, the Ministry of Environment, Forest and Climate Change had issued an Office Memorandum on 30th March 2022 for exemption of SDN-1 and SDN-2 categories of Genome Edited Plants which are free of exogenous introduced DNA from the provisions of Rules 7 to 11 (both inclusive) of the Rules 1989 of Environment Protect Act, 1986.
About SDN 1, SDN 2 and SDN 3
- Depending on the nature of the edit that is carried out, the process is divided into three categories — SDN 1, SDN 2 and SDN 3.
- SDN1 introduces changes in the host genome’s DNA through small insertions/deletions.
- In the case of SDN 2, the edit involves using a small DNA template to generate specific changes.
- Both the processes do not involve alien genetic material and the end result is indistinguishable from conventionally bred crop varieties.
- SDN3 process involves larger DNA elements or full length genes of foreign origin which makes it similar to Genetically modified organisms (GMO) development.
