Genetically Modified (GM) Crops

Why in the News? The Supreme Court recently delivered a split verdict on the validity of the Union Government's decision to approve the environmental release of genetically modified (GM) mustard crops in 2022.

Details of the Split Verdict:

• Judge 1: Found the approval by the Genetic Engineering Appraisal Committee (GEAC) in 2022 to be "vitiated" (defective) and contrary to the principle of public interest. This judge highlighted that the Food Safety and Standards Authority of India (FSSAI) had not conducted any health impact studies on GM mustard.
• Judge 2: Held that the approval was valid but issued directives for stricter monitoring by the Union Government. This judge also mandated that the Union Government should evolve a national policy on GM crops in consultation with all stakeholders, including states, farmers, and other relevant groups.

What is Genetic Modification?

• Definition: Genetic modification involves altering an organism's DNA by either changing an existing section of DNA or introducing a new gene altogether.
• Process: In plants, genetic modification involves inserting a foreign gene (transgene) into the plant’s own genetic material. This gene could be introduced from another plant, an animal, or a microorganism.

About GM Mustard Crop (DMH-11):

• Development: DMH-11 is developed by the Centre for Genetic Manipulation of Crop Plants (Delhi University) and represents a significant step toward the commercialization of India’s first GM food crop.
• Current Status: GM mustard has not yet been released for commercial cultivation.
• Genetic Background: DMH-11 is produced by crossing two mustard varieties, ‘Varuna’ and East European ‘Early Heera-2’. This crossing process is challenging in conventional breeding because mustard is self-pollinating, meaning its pollen fertilizes the same plant. To overcome this, the barnase and barstar genes from the soil bacterium Bacillus amyloliquefaciens have been introduced to facilitate cross-breeding.

Implications of the Verdict:

• Policy Development: The Supreme Court’s directions for a national policy reflect the need for comprehensive regulation and stakeholder consultation regarding GM crops.
• Health and Safety: Ongoing concerns about health impacts and environmental safety are central to the debate on GM crop approval and commercialization.

Genetically Modified (GM) Crops in India: Current Status and History

1. Bt-Cotton:

• Introduction: Bt-Cotton was the first GM crop approved for commercial cultivation in India, starting in 2002.
• Purpose: It was engineered to protect against bollworm infestation, a major pest affecting cotton crops.
• Adoption: By 2018-19, Bt-Cotton constituted 95% of the total cotton planted in India, reflecting its widespread acceptance and use among Indian farmers.
• Impact: The introduction of Bt-Cotton has been credited with increasing cotton yields and reducing the need for chemical insecticides, thereby benefiting both productivity and the environment.

2. Bt-Brinjal:

• Approval and Moratorium: Bt-Brinjal received clearance from the Genetic Engineering Appraisal Committee (GEAC) for commercial cultivation in 2009. However, it faced strong public opposition and was put under a 10-year moratorium by the Technical Expert Committee (TEC).
• Recent Developments: In response to evolving agricultural needs and ongoing research, GEAC has permitted field trials of two new varieties of Bt-Brinjal—Janak and BSS-793—across eight states between 2020 and 2023. These trials aim to assess the performance and safety of these new varieties before considering broader approval.

Regulatory Framework of GM Crops in India

1. Food Safety and Standards Act, 2006:

• Overview: Prohibits the import, manufacture, use, or sale of GM food without the approval of the Food Safety and Standards Authority of India (FSSAI).
• Purpose: Ensures that GM foods meet safety standards before they enter the market.

2. Review Committee on Genetic Manipulation (RCGM):

• Affiliation: Operates under the Department of Biotechnology (DBT).
• Role: Monitors and evaluates research and development projects involving GM organisms. It ensures that research complies with regulatory guidelines and safety measures.

3. State Biotechnology Coordination Committee (SBCC):

• Function: Reviews safety and control measures in institutions handling GMOs. It provides oversight and coordination at the state level.

4. District Level Committee (DLC):

• Responsibilities: Inspects and investigates compliance with regulatory guidelines at the district level. Reports findings to the SBCC or Genetic Engineering Appraisal Committee (GEAC).

5. GM Crop Approval Process:

• Procedure: Approval is granted on a case-by-case basis after thorough scientific evaluation of health and environmental safety, following guidelines under the Environment (Protection) Act, 1986.

Concerns about GM Crops

1. Human Health:

• Herbicide Use: GM crops often rely on herbicides like glyphosate, which has been classified as a "probable carcinogen" by the World Health Organization (WHO) in 2015. Concerns about its long-term health effects persist.

2. Biodiversity Loss:

• Herbicide Tolerance: GM crops with herbicide-tolerant traits may affect all vegetation in and around fields where these crops are grown. This could disrupt mixed farming practices and lead to reduced biodiversity.

3. Contamination:

• Gene Flow: There is a risk of gene flow from GM crops to wild and weedy relatives, non-GM crops, and organic farming systems. Instances of transgene escape have been reported, such as in GM canola and wheat in Canada.

4. Impact on Pollinators:

• Herbicide Overuse: Herbicide use can reduce the availability of pollen and nectar for pollinators like honeybees. This can affect biodiversity and ecosystem health, as seen with the decline of monarch butterflies in the USA.

5. Corporate Control:

• Seed Market: High corporate concentration in the seed market can lead to increased prices and reduced choices for farmers, which may impact their economic well-being.

6. Income Loss:

• Price Fluctuations: Instances like the sharp decline in farm-gate prices of Bt Cotton after bumper crops can result in significant income losses for farmers, affecting their financial stability.

Way Forward

1. Research and Development:

• Investment: Increase public investment in R&D to develop new seed varieties that are more resilient and have minimal environmental impact. Focus on sustainability and reduced harm to ecosystems.

2. Regulatory Information Requirements:

• Plant Description: Provide detailed information about the plant’s biology and the nature of its genetic modification.
• Health Assessments: Assess potential allergenicity and toxicity of GM crops.
• Protein Expression: Evaluate the expression of new proteins introduced through genetic modification.

3. Parliamentary Standing Committee Recommendations:

• Field Trials: Conduct field trials in controlled environments and in consultation with agricultural universities to ensure safety and effectiveness.
• GEAC Leadership: Appoint an expert from the field of biotechnology as the head of GEAC to ensure informed decision-making based on scientific data.
• Bt Cotton Evaluation: Undertake comprehensive studies to assess the success and impact of Bt Cotton, including its economic effects on farmers and its environmental implications.

About GEAC

• Established: Under the Ministry of Environment, Forest and Climate Change (MoEFCC), the GEAC is the apex body responsible for evaluating and approving the environmental release of genetically modified (GM) organisms and products in India.
• Purpose: Ensures that GM crops and other GM organisms do not pose a threat to the environment or public health before they are released for commercial use.

Functions:

• Approval of GM Crops:
• Evaluation: Assesses the safety and environmental impact of GM crops and organisms based on data provided by developers and other scientific research.
• Recommendations: Provides approvals for field trials, environmental release, and commercial cultivation based on thorough scientific evaluation.
• Regulatory Compliance:
• Monitoring: Ensures compliance with regulatory guidelines and environmental protection standards during the research and development phase of GM crops.
• Inspection: Oversees inspections and investigations to ensure adherence to safety protocols and guidelines.
• Public Consultation and Stakeholder Engagement:
• Consultation: Engages with various stakeholders, including scientists, environmentalists, farmers, and the public, to gather inputs and address concerns related to GM crops.
• Transparency: Strives to maintain transparency in decision-making processes and provides information on approvals and evaluations to the public.

Approval Process:

• Application Submission:
• Developers submit applications for environmental release and commercialization of GM crops, including data on safety, efficacy, and environmental impact.
• Scientific Evaluation:
• Expert Panels: GEAC reviews applications through expert panels that assess the data and provide recommendations.
• Risk Assessment: Conducts risk assessments related to health, environmental impact, and ecological balance.
• Decision-Making:
• Approval: Based on expert recommendations and risk assessments, GEAC grants approval for field trials, environmental release, and commercialization.
• Conditions: May impose specific conditions to mitigate risks and ensure safety.

Key Regulatory Frameworks and Guidelines:

• Environmental Protection Act, 1986: Provides the overarching legal framework for environmental protection, including the regulation of GM organisms.
• Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells (1989): Details the procedures and safety measures for GMOs.

Recent Developments:

• Court Directions: Recent judicial rulings, such as the split verdict on GM mustard, have prompted calls for more stringent guidelines and the evolution of national policies on GM crops.
• Policy Updates: The Supreme Court has directed the Union Government to formulate a national policy regarding GM crops in consultation with all stakeholders, including states, farmers, and scientific experts.

Challenges and Criticisms:

• Scientific Scrutiny: Ensuring robust scientific scrutiny and addressing concerns related to the potential health and environmental impacts of GM crops.
• Public Perception: Balancing scientific assessments with public concerns and ensuring transparent communication about GM crop safety.