Govt begins developing draft guidelines for assessing safety of genome-edited plants
Oct 27, 2022
New Delhi [India] October 27 : The department of biotechnology under the ministry of science and technology on Thursday said it proactively initiated the development of draft guidelines for the safety assessment of genome-edited plants through extensive deliberations.
In the official statement of the ministry of environment, forest and climate change, it said the draft guidelines were revised, considered and approved by Review Committee on Genetic Manipulation (RCGM) in its 231st meeting on April 28, 2022.
It said the ministry issued an office memorandum on March 30, 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 EPA, 1986.
The draft was accordingly revised, considered and approved by RCGM on April 18.
SDN1 introduces changes in the host genome's DNA through small insertions/deletions without introduction of foreign genetic material. In the case of SDN 2, the edit involves using a small DNA template to generate specific changes.
Thereupon, the "Guidelines for the Safety Assessment of Genome Edited Plants, 2022" were notified on May 17, 2022. The guidelines determine regulatory requirement for appropriate category of experiments and provide the regulatory framework and scientific guidance on data requirement in context of research and development of genome-edited plants.
The ministry said towards enabling biosafety regulation by institutional biosafety committees (IBSCs), the SOPs and checklist were drafted to bring clarity to all the stakeholders.
Based on RCGM recommendations, the ministry said the "standard operating procedures (SOPs) for regulatory review of genome-edited plants under SDN-1 and SDN-2 categories, 2022", were notified on October 4, 2022. 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.
Considering huge growth and advancement in genome-editing research and applications in the field of agriculture, the ministry said guidelines and SOPs would be very valuable resource documents for the country. These guidelines and SOPs are expected to speed up development of plant varieties and to reduce the time of approval. The statement also said new plant varieties with improved traits would contribute towards increasing farmer's income.
Overall, this regulatory streamlining will bring transformational change in product development and commercialisation and thereby will contribute to agenda for Atmanirbhar Bharat of the government of India. This has also paved the way for India as emerging global power in Genome Edited Plants based technology and its applications, the statement noted.
