Genetically Modified Crops — Tech Evolutions

Entry	Year	Description	Impact
Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells	1989	These rules, notified under the Environment (Protection) Act, 1986, form the primary legal framework for regulating GMOs in India. They establish the multi-tier regulatory system, including GEAC, RCGM, and IBSCs, and define the procedures for research, field trials, and commercial release of GM organisms.	Created the foundational regulatory structure for all activities involving GMOs, including GM crops, ensuring biosafety and environmental protection. It mandates a rigorous approval process for any environmental release or large-scale use of genetically engineered organisms.
Food Safety and Standards (Genetically Modified Foods) Regulations	2021	Notified by the FSSAI, these regulations specifically address the safety assessment and labeling of genetically modified foods and food ingredients in India. They mandate prior approval from the FSSAI for manufacturing, selling, or importing GM food products.	Strengthened the regulatory oversight for GM foods, ensuring their safety for human consumption and providing a framework for labeling. It clarifies the FSSAI's role in the post-harvest regulation of GM food products, complementing GEAC's role in environmental release.
Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Crops	1998, 2008 (updated)	Issued by the Department of Biotechnology (DBT), these guidelines provide detailed scientific protocols and methodologies for conducting research, biosafety assessments, and toxicity/allergenicity evaluations of transgenic crops. They are crucial for researchers and regulatory bodies.	Standardized the scientific procedures for GM crop research and safety assessment, ensuring consistency and rigor in data generation. They serve as a technical backbone for the regulatory decisions made by RCGM and GEAC.
Exemption of SDN1 and SDN2 Gene-Edited Plants from Biosafety Regulations	2022	The MoEFCC issued an office memorandum clarifying that certain gene-edited organisms (SDN1 and SDN2 categories, which do not involve foreign DNA insertion) are exempt from the stringent biosafety regulations applicable to transgenic GMOs under the 1989 Rules.	Aimed to accelerate research and development in gene-editing technologies like CRISPR by reducing regulatory hurdles for specific types of gene-edited plants. This distinction recognizes the precision and potentially lower risk profile of certain gene-editing techniques compared to traditional genetic modification.