Hyderabad: Genetic Engineering Appraisal Committee (GEAC), which operates under the aegis of the ministry of environment, forest and climate change (MoEF&CC), has cleared the import of genetically engineered (GM)yeast for ethanol production with city-based Danisco (India) Pvt. Ltd. among the applicants. The approval, covering the active dried yeast strain of ‘Saccharomyces cerevisiae’, comes with stringent biosafety conditions, including mandatory emergency response protocols to prevent accidental release into the environment.Danisco has applied for permission to import and market 2,000 metric tonnes of Synerxia Jade active dried yeast annually from the United States. The proposal was first examined during the 148th GEAC meeting, where the committee advised strict adherence to zero discharge of the yeast strain during import, transport, storage, and handling. Firms intending to use the imported yeast were also directed to seek separate approvals for large-scale manufacturing under the 2017 Regulations and Guidelines for Recombinant DNA Research and Bio-containment.Subsequent deliberations by GEAC and the Review Committee on Genetic Manipulation (RCGM) focused on environmental safety. The 151st GEAC meeting called for a standard risk assessment and risk management plan (RARMP) covering storage, distribution, repacking, disposal, and decontamination. The plan, finalised in late 2024 and reviewed by RCGM in early 2025, was later forwarded to GEAC for adoption. Acting on RCGM’s recommendations, the committee endorsed Danisco’s application recently with compliance conditions.The approval requires Danisco to follow RARMP in full, with oversight by Institutional Biosafety Committees (IBSCs). The company must submit IBSC-approved emergency action plans before importing the yeast and provide 16s and 18s RNA sequencing reports for the first five batches to detect adventitious microbial presence.The imported strain is restricted to ethanol production, and any alternate use would need fresh GEAC clearance. Access to the yeast must remain limited to trained personnel, with secure storage and inventory tracking in place. Packaging must include triple containment and withstand transport pressures, while consignments must be clearly labelled as genetically modified organisms.In case of accidental release, the applicant would be responsible for site decontamination and must notify IBSC within three days. Transport records must capture details of quantity, container numbers, expiry dates, and transporter information. Annual compliance reports have to be submitted to GEAC. The approval was granted for a limited period of four years under the 1989 Rules framed under the Environment Protection Act.
