Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (referred to as the ‘Rules, 1989’) under the Environment (Protection) Act, 1986. These regulations govern various aspects including research and large-scale applications involving Genetically Modified Organisms (GMOs) and their derived products across India. Additionally, the rules extend to the utilization of hazardous microorganisms, regardless of genetic modification, which pose risks to both animals and plants due to their pathogenic nature.
These rules shall apply in the following specific scenarios:
a. Sale, offers for sale, storage for the purpose of sale, offers, and any form of handling, whether with or without consideration.
b. Exportation and importation of genetically engineered cells or organisms.
c. Production, manufacturing, processing, storage, import, drawing off, packaging, and repackaging of Genetically Engineered Products.
d. Production, manufacturing, etc., of drugs, pharmaceuticals, foodstuffs, distilleries, tanneries, etc., that utilize microorganisms or genetically engineered microorganisms in any capacity.
COMPETENT AUTHORITIES
Recombinant DNA Advisory Committee (RDAC):
- The RDAC operates within the Department of Biotechnology and is tasked with reviewing biotechnological advancements at both national and international levels.
- It recommends appropriate safety regulations for India concerning recombinant research, use, and applications.
Review Committee on Genetic Manipulation (RCGM):
- The RCGM, also functioning within the Department of Biotechnology, oversees safety aspects related to ongoing research projects involving genetically engineered organisms or hazardous microorganisms.
- It comprises representatives from various organizations, including the Department of Biotechnology, Indian Council of Medical Research, Indian Council of Agricultural Research, Council of Scientific and Industrial Research, and independent experts.
- The RCGM establishes guidelines for regulatory procedures regarding activities involving genetically engineered organisms, ensuring environmental safety.
- It reviews ongoing projects to ensure compliance with containment conditions and precautionary measures.
Institutional Biosafety Committee (IBSC):
- The IBSC is formed by entities handling microorganisms or genetically engineered organisms, such as research institutions.
- It consists of the head of the institution, scientists specializing in DNA work, a medical expert, and a nominee from the Department of Biotechnology.
- The IBSC collaborates with the occupier to develop on-site emergency plans in accordance with RCGM guidelines, ensuring preparedness for emergencies.
- Copies of these plans are made available to relevant committees and authorities.
Genetic Engineering Approval Committee (GEAC):
- Operating under the Department of Environment, Forest, and Wildlife, the GEAC is responsible for approving activities involving large-scale use of hazardous microorganisms and recombinants in research and industrial production from an environmental perspective.
- It also approves proposals for the release of genetically engineered organisms and products into the environment, including experimental field trials.
The microorganisms listed in the schedule are categorized as follows:
i. Bacterial agents:
ii. Fungal Agents:
iii. Parasitic Agents
iv. Viral, Rickettsial, and Chlamydial Agents:
v. Special Category
Permission and approval from the Genetic Engineering Approval Committee (GEAC) are required for the production, sale, import, or use of substances and products containing genetically engineered organisms, cells, or microorganisms.
SUPERVISION
- The Genetic Engineering Approval Committee has the authority to oversee the implementation of the terms and conditions specified in the approvals it grants.
- This supervision can be conducted by the Genetic Engineering Approval Committee either through the State Biotechnology Coordination Committee, the State Pollution Control Boards, District Level Committees, or through any authorized individual.
PENALTIES
- Failure to comply with an order may result in the District Level Committee or State Biotechnology Co-ordination Committee taking corrective actions at the expense of the responsible individual.
- In situations demanding urgent intervention to prevent harm to the environment, nature, or health, the District Level Committee or State Biotechnology Coordination Committee may take necessary actions without issuing prior orders or notices. The incurred expenses will be the responsibility of the party causing the damage.
- The State Biotechnology Co-ordination Committee or District Level Committee may collect samples for a thorough examination of organisms and cells.
- The State Biotechnology Co-ordination Committee or District Level Committee is authorized to seek assistance from any other government authority to carry out its directives.
FAQs Regarding Rules for Hazardous Micro-Organisms/Genetically Engineered Organisms 1989
1. What do the Rules for Hazardous Microorganisms/Genetically Engineered Organisms 1989 entail?
A: These rules, established under the Environment (Protection) Act, 1986, regulate various aspects related to the manufacture, use, import, export, and storage of hazardous microorganisms, genetically engineered organisms, or cells. They cover research and large-scale applications involving Genetically Modified Organisms (GMOs) and their products, as well as hazardous microorganisms that pose risks to animals and plants.
2. In what specific scenarios do these rules apply?
A: These rules apply in scenarios involving the sale, offers for sale, storage for sale, offers, and handling of genetically engineered cells or organisms, as well as their exportation/importation. They also govern the production, manufacturing, processing, storage, import, packaging, and repackaging of Genetically Engineered Products, along with activities in industries such as drugs, pharmaceuticals, foodstuffs, distilleries, and tanneries utilizing microorganisms or genetically engineered microorganisms.
3. Who are the competent authorities overseeing the implementation of these rules?
A: The competent authorities include:
- Recombinant DNA Advisory Committee (RDAC)
- Review Committee on Genetic Manipulation (RCGM)
- Institutional Biosafety Committee (IBSC)
- Genetic Engineering Approval Committee (GEAC)
4. How are microorganisms classified under these rules?
A: Microorganisms listed in the schedule are categorized into bacterial agents, fungal agents, parasitic agents, viral, rickettsial, and chlamydial agents, and a special category.
5. What permissions and approvals are required for substances containing genetically engineered organisms or cells?
A: Permission and approval from the Genetic Engineering Approval Committee (GEAC) are necessary for the production, sale, import, or use of substances and products containing genetically engineered organisms, cells, or microorganisms.
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