Notifying the rules for manufacture, use, import, export and storage of genetically-engineered “organism of cells”, the Ministry of Environment on Wednesday said plants under SDN1 and SDN2 categories are exempted from concerned biosafety regulations, potentially helping in faster development of new varieties. However, such genome-edited plants will have to follow other applicable laws/acts/rules.
In its order, the Ministry of Environment, Forest and Climate Change said that Department of Biotechnology and Department of Agriculture Research and Education had recommended that the “SDN1 and SDN2 Genome Edited Products free from exogenous introduced DNA be exempted from biosafety assessment.”
It is a recognition of the potential of genome editing technology in agriculture, said Bhagirath Choudhary, head of Jodhpur-based South Asia Biotechnology Centre. The notification paves a path for Department of Biotechnology to approve and notify the guidelines on Genome Edited Plants, which was pending since early 2020.
States feedback
The delay in the exemption was mainly due to the Ministry of Environment’s decision in September 2021 to seek feedback from the States, even as scientists were against taking such a path as they had feared that it could further delay the process and might even derail it, sources said.
In essence, it’s really not an exemption per se, but this policy decision would allow an exit of SDN1/SDN2 categories of genome-edited plants free from transgene/foreign gene from the GMO regulatory system, he said.
The Ministry of Environment had taken a similar decision in 2006 on the recommendation of Dr Mashelkar Committee to allow exit of rDNA pharma products from the GMO regulatory system, said Choudhary.
The limited benefit of this policy decision is that genome edited SDN1/SDN2 category plants will be absolved from the cumbersome GMO regulatory system after evaluation of molecular data by IBSC/RCGM under EPA Rules 1989 and subsequently under the Seed Act, a unique dual regulatory system ensuring biosafety and benefits of technology for the welfare of small growers, added Choudhary.
Experts said while genetically modified (GM) crops are objected to as genes of others are mixed in developing new varieties, in the case of genome-editing, it is just a process of correcting some bad elements and therefore does not find any opposition.
There are some varieties of crops like paddy and banana that have been developed using the genome-editing technology and once the guidelines are issued, it will pave the way for their commercial release, said Kailash Bansal, Secretary of National Academy of Agricultural Sciences (NAAS).
“It will not only help increase food production, but also ensure environmental sustainability. Crops can be developed with better water use efficiency,” Bansal said.
In March last year, National Academy of Agricultural Sciences (NAAS), Trust for Advancement in Agricultural Sciences (TAAS), Tata Institute for Genetics and Society (TIGS), Biotech Consortium India Ltd (BCIL), Biotechnology Industry Research Assistance Council (BIRAC) and Mohali-based National Agri-Food Biotechnology Institute (NABI) had unanimously agreed on this technology’s induction for the betterment of the farm sector.