Insects playing a crucial role in many ecosystems and some insects are also harmful to humans, animals, and crops. By transmitting deadly diseases they impose a huge burden on health worldwide. Insects are also responsible for severe economic losses through damage to crops and livestock. Additionally, some insects can be a nuisance in homes and public spaces, such as bed bugs and cockroaches. As a result, it is important to control insect populations to prevent these negative impacts and ensure the safety and well-being of humans. With the advent and rapid development of biotechnological tools like genetic engineering (GE), we can reduce or replace populations of insect pests or disease transmitting vectors. In the last two decades, several GE methods like RIDL (Release of Insects with Dominant Lethal Gene), Homing Endonuclease Gene (HEG), Wolbachia based control, CRISPR-Cas, MEDEA (Maternal Effect Dominant Embryonic Arrest) based Gene drive and RNAi have been tested for population suppression of vector and or insect pests. For conducting research on GE insects, different countries have developed their own guidelines. In India, Department of Biotechnology, Government of India, released "Guidelines and SOPs’ for Research on Genetically Engineered Insects, 2023" to keep pace with global research on GE insects.
These guidelines and standard operating procedures (SOPs) are intended to provide guidance on regulatory requirements and data requirements of genetic engineering research on insects under containment conditions (e.g., laboratory, cages, net houses and greenhouses.). Earlier, DBT constituted an expert committee for this purpose. With input from members of the Review Committee on Genetic Manipulation (RCGM), numerous other experts, these guidelines and standard operating procedures have been developed through extensive deliberation. These rules are anticipated to speed up GE insect research in containment settings given the growing significance of genetic engineering in insect research for a number of uses, including pest control, the decrease of disease transmission, and ecological studies.
The research and development of GE insects proposed in the new guideline is in accordance to the prescribed steps mentioned in WHO’s Guidance framework for testing genetically modified mosquitoes.
Phase 1 studies have been categorised into categories I, II, III and IV experiments. These studies are conducted in a containment facility. Each categories explains the insect group, insects infected with or suspected to be infected with microorganisms that cause animal and/or human diseases, appropriate containment facility, and requirement for prior approvals.
Phase 2 studies are called as semi-field trial/ testing, e.g. large sized cages/net house/greenhouse that are placed in open fields which simulate the actual environmental conditions.
Phase 3 and Phase 4 are considered confined field trails. Phase 3 comprises studies to be done in confined field conditions, wherein deployment/release of GE insects is done under natural conditions (confined) to evaluate their performance. Phase 4 is post-release monitoring, which includes both general surveillance to find unintended negative effects and case-specific monitoring to confirm or deny risks found during the pre-release environmental risk assessment. The Genetic Engineering Appraisal Committee (GEAC) and other regulatory bodies approvals are necessary for confined field trials. The guidelines also highlight the strategies of GE insect safety assessment.
For Phase 1 and Phase 2 trials of GE insects in India, there are new SOPs available containing information for all parties on application submission, containment requirements, important parameters to be studied, and relevant regulatory compliance.
The present guidelines and SOPs provide researchers with the regulatory pathway for import, export, transfer, and receipt, as well as for conducting research on GE insects.
For details and complete guidelines click below link:
Dr. P.R. Shashank is a Scientist at the Division of Entomology, ICAR-Indian Agricultural Research Institute, New Delhi 110012, India.
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