India is currently in the process of formulating gene editing regulations in agriculture. The draft guidelines put forward by the Department of Biotechnology (DBT) are with the Genetic Engineering Approval Committee (GEAC) for approval. Since gene editing allows breeders to make changes similar to those made by conventional breeding, the edited plant is indistinguishable from traditionally bred plants. Therefore, edited plants should be exempted from complex regulations, Ram Kaundinya, director general, Federation of Seed Industry of India (FSII) tells Telangana Today in an interview.
Commercialisation
Gene editing technology allows small modifications in the genome that can emulate natural mutations observed in nature. It allows breeders to make precise, specific changes in a short time and single generation compared to prolonged breeding cycles associated with conventional breeding. Globally, a few gene edited products have been commercialised. A lot many crops with enhanced consumer and processing traits are in the pipeline.
Regulatory scenario
Regulations are based on associated risk levels and since these crops are similar to traditional ones, these should be treated as traditionally bred products with no additional data requirements. Globally too, most nations have exempted the non-novel plants developed by gene editing from any regulations. Edited crops with novel changes like insertion of foreign DNA only are being regulated as Genetically Modified crops.
Monitoring right use
The proposed regulations include a reasonable level of regulatory oversight, especially during product development. The Indian regulatory bodies at institution level as well as national level are suitably equipped to monitor the use of the technology. Research-based Indian industry has a well-established stewardship process to evaluate, monitor and deploy technology.
Global scenario
Globally, most nations have exempted the edited crops with small, precise modifications and only regulate the edits with foreign DNA insertions. This is true for the US, Canada, Japan, Russia and Latin American nations. India can play a leadership role, especially in South Asia. This would also help in smoother trade across the region. Currently, India is a leader in skill, competency and infrastructure required for harnessing the technology, but a science-based predictable regulatory system will establish its leadership role in the region.
Application areas
Multiple Indian public sector labs and institutes are in the process of developing gene edited crops. These include Vitamin A rich banana, improved rice, millets and mustard crops. Globally a robust pipeline of gene edited products exists- high oleic acid soybean, non-browning mushrooms, GABA (gamma-aminobutyric acid) tomatoes that have been commercialised and many more like- waxy corn, non- browning potato and apples, vitamin A rich sweet potato, high yielding berries and tomatoes, improved camelina, alfalfa, cassava crops are in the pipeline.
Role of FSII
FSII is working with multiple stakeholders in India including DBT and shares the global best practices and industry’s perspective on regulations of gene edited crops so as to harness the technology to the fullest for the benefit of farmers, consumers and sustainable agriculture. The simplicity, economics and efficiency of the technology makes it usable by the small and medium sized industry, thereby giving a major boost to innovation as well as improvement of local crops and traits. Our member companies collaborate with academic institutions, ICAR and CGIAR labs to support research.
Research focus
We expect biotech research to spread far and wide instead of being concentrated in high investment hubs, as had been the case for GM. The easy availability of genome sequence information, the ease of gene editing and the short time required to come up with the final product will democratise the technology. More supportive regulations will encourage investment and innovation in the field.
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