Rules for Hazardous Microorganisms

Let us begin with a basic but crucial question:

If genetic engineering can improve agriculture, medicine and industry, why does it need strict regulation?

The answer lies in biosafety. A genetically engineered organism, if released irresponsibly, can:

• Disrupt ecosystems
• Harm human and animal health
• Cause irreversible environmental damage

To prevent such risks, India notified the Rules for Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989, commonly referred to as “Rules 1989.”

🎯 Objective of Rules 1989

The primary aim of Rules 1989 is to ensure biosafety, i.e.,

• Protection of the environment
• Protection of nature and biodiversity
• Protection of human and animal health

This is done in connection with the application of gene technology and hazardous microorganisms.

📌 In simple words:
Scientific innovation is allowed, but only with safety, oversight and accountability.

📜 Legal Basis

• The Rules are notified under the Environment (Protection) Act, 1986
• They apply to → Research, Field trials, Large-scale applications, Seed production, Environmental release of GMOs

🧪 Scope of Rules 1989

The Rules regulate:

• Use of hazardous microorganisms
• Research and development involving genetically modified organisms (GMOs)
• Field trials of genetically engineered crops
• Large-scale production and commercial use
• Import, export, transport and disposal of GMOs

They also clearly define authorities, their composition, and functions, ensuring that regulation is not arbitrary.

🏛️ Institutional Framework: The Six Committees

To implement these rules effectively, a multi-tier regulatory structure has been created. Each committee operates at a different level, ensuring checks and balances.

1️⃣ Recombinant DNA Advisory Committee (RDAC)

🔍 Nature:

• Advisory body

🎯 Function:

• Recommends safety guidelines
• Advises on biosafety policies related to recombinant DNA research and applications

📌 Think of RDAC as the policy thinker and guideline framer.

2️⃣ Review Committee on Genetic Manipulation (RCGM)

🏢 Established under:

• Department of Biotechnology
• Ministry of Science and Technology

🎯 Function:

• Monitors safety aspects of ongoing research projects
• Reviews laboratory research and contained field trials

📌 Key role:
RCGM acts as a scientific watchdog during the research phase, before environmental release.

3️⃣ Genetic Engineering Appraisal Committee (GEAC)

🏛️ Status:

• Statutory body
• Constituted under Rules 1989
• Located in the Ministry of Environment, Forest and Climate Change

🎯 Function:

• Appraises proposals for:
  • Large-scale use
  • Environmental release
  • Commercialisation of GMOs
• Grants or rejects approvals based on risk assessment

📌 Important:
👉 GEAC is the apex decision-making authority on GMOs in India.

4️⃣ State Biotechnology Coordination Committee (SBCC)

📍 Level:

• State level

🎯 Powers:

• Inspect facilities
• Investigate violations
• Take punitive action for non-compliance with Rules 1989

📌 Role:
SBCC ensures that central biosafety norms are enforced on the ground.

5️⃣ District Level Committees (DLCs)

📍 Level:

• District level

🎯 Function:

• Monitor installations using:
  • GMOs
  • Hazardous microorganisms
• Ensure compliance with safety norms during actual application in the environment

📌 DLCs are the last-mile enforcement agencies.

6️⃣ Institutional Biosafety Committee (IBSC)

📍 Level:

• Institutional (laboratory / university / research institute)

🎯 Function:

• Reviews research projects involving → Recombinant DNA, RNA interference (RNAi), Pathogens, Human biological materials, Transgenic animals

📌 First line of defence:
No GMO research begins without IBSC scrutiny.

🔁 How the System Works (In Simple Flow)

1. IBSC – clears research at the institution
2. RCGM – monitors safety during research & trials
3. GEAC – approves environmental release / commercial use
4. SBCC & DLCs – enforce and monitor compliance at state & district levels
5. RDAC – continuously refines safety guidelines

📌 This creates a layered biosafety architecture, reducing risk at every stage.