Import of Genetically Modified (GM) Food, Feed, Genetically Modified Organisms (GMOs), and Living Modified Organisms (LMOs) into India: Legal and Regulatory Framework.

[YAGAY andSUN]

The importation of Genetically Modified Organisms (GMOs), Living Modified Organisms (LMOs), and Genetically Modified (GM) food and feed into India is governed by a stringent regulatory framework to safeguard human health, biodiversity, and the environment. This process ensures that any GMOs or LMOs entering India are thoroughly assessed for potential risks before they are allowed into the country. Below is an in-depth look at the legal and regulatory framework, requirements and procedures, and the role of the Genetic Engineering Approval Committee (GEAC).

Legal and Regulatory Framework

1. Environmental Protection Act, 1986:
   • This act provides the legal basis for regulating activities that could impact the environment, including the introduction of GMOs. The Act is broad in its focus, addressing issues such as environmental pollution, waste management, and ecosystem health, which includes the regulation of genetically modified organisms.
2. Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Engineered Micro Organisms or Cells (1989):
   • These rules were issued under the Environmental Protection Act, 1986 and govern the importation of GMOs and their use in India. They set standards for safe handling, storage, and transport of GMOs, including food and feed.
3. The Genetic Engineering Appraisal Committee (GEAC):
   • GEAC is the apex body responsible for evaluating and approving the release, import, and commercialization of GMOs in India. It is a part of the Ministry of Environment, Forest and Climate Change (MoEFCC).
   • GEAC's primary role is to assess the environmental risks associated with GMOs and LMOs before they can be allowed for importation or use in India. This includes approving GM seeds for agricultural use and evaluating any genetically modified food and feed.
4. Food Safety and Standards Authority of India (FSSAI):
   • FSSAI, established under the Food Safety and Standards Act, 2006, is responsible for regulating the safety and quality of food products in India, including GM food.
   • The FSSAI plays a key role in ensuring that GM food is safe for consumption by humans and animals. Before GM food can be marketed in India, it must undergo rigorous safety evaluations conducted by the FSSAI.
5. The Biodiversity Act, 2002:
   • This Act, through its provisions under the National Biodiversity Authority (NBA), focuses on preserving India's biodiversity and regulating the use of biological resources. It also plays a role in ensuring that the importation of GMOs does not negatively affect India’s genetic resources and ecosystems.

Requirements and Procedure for Import

1. Risk Assessment:
   • All GMOs, including GM food and feed, must undergo a detailed risk assessment to evaluate their potential impact on human health, animal health, and the environment. This assessment is conducted by experts from various departments, including the GEAC and the FSSAI.
   • Risk assessments include evaluating the possible effects of genetic modifications, such as allergenicity, toxicity, unintended gene flow, and ecological impacts.
2. Import Permission:
   • Any individual or organization wishing to import GMOs, GM food, or GM feed into India must obtain prior permission from the GEAC.
   • The GEAC evaluates the application based on scientific data and risk assessments. The process is transparent, and all decisions are made based on scientific evidence and safety standards.
3. Import Authorization:
   • Import authorization must be obtained through the Ministry of Environment, Forests, and Climate Change (MoEFCC) for environmental safety, and through the FSSAI for food safety concerns. The importation of GMOs, GM food, and feed is only allowed once these authorities issue their clearance.
   • Importers must submit detailed documentation about the GMOs being imported, including scientific data on their safety, origin, and proposed use.

Permissions and No Objection Certificates (NOC)

1. GEAC Approval:
   • GEAC’s approval is the cornerstone for importing GMOs into India. The committee evaluates the scientific evidence regarding the safety of GMOs and LMOs in terms of potential risks to human health, animal health, and the environment.
   • GEAC approval is a requirement for the importation of GM food/feed and genetically modified crops, which need to be evaluated and authorized before they can be allowed entry.
2. FSSAI Approval for GM Food:
   • For GM food and feed, approval must also be obtained from the FSSAI, ensuring that the GM products meet food safety standards.
   • Importers must provide a detailed risk assessment, including testing data on allergenicity, toxicity, and any other food safety concerns related to the GM product.
3. No Objection Certificate (NOC):
   • In some cases, a No Objection Certificate (NOC) may be required from relevant authorities like the National Biodiversity Authority (NBA) if the product involves biodiversity concerns.
   • The NOC indicates that there are no objections from the relevant authorities regarding the importation of the GMO, typically after the product has been assessed for environmental or biodiversity risks.

Role of the Genetic Engineering Approval Committee (GEAC)

The GEAC plays a central role in regulating the importation and use of GMOs and LMOs in India. It is tasked with:

1. Review and Approval: The GEAC reviews and approves all applications for the import of GMOs, including food, feed, and crops, based on scientific data, including risk assessments on health and environmental safety.
2. Monitoring and Evaluation: The committee also monitors ongoing GM-related activities, including field trials, imports, and commercialization, ensuring that they comply with established safety standards.
3. Public Consultation: In some cases, GEAC may conduct public consultations before approving certain GMOs to ensure transparency and address public concerns related to safety and ethical issues.
4. Regulatory Coordination: The GEAC works with other regulatory bodies like the FSSAI, MoEFCC, and NBA to ensure a coordinated approach to the regulation of GMOs and LMOs.

Conclusion

The import of Genetically Modified Organisms (GMOs), Living Modified Organisms (LMOs), and GM food and feed into India is tightly regulated to ensure environmental protection, food safety, and biodiversity preservation. The process involves several stages, including risk assessments, approvals from relevant regulatory bodies (like GEAC and FSSAI), and obtaining permissions and No Objection Certificates (NOCs).

India’s regulatory framework is designed to balance the need for scientific innovation and agricultural progress with the protection of human health, the environment, and the country’s rich biodiversity. The Genetic Engineering Approval Committee (GEAC) plays a pivotal role in overseeing the approval and regulation of GMOs, ensuring that imports are safe and align with India's environmental and agricultural policies.

This regulatory process ensures that GMOs are subject to rigorous scrutiny before they enter the country, giving the public confidence in the safety and efficacy of imported genetically modified food and crops. As global biotechnology advances, India’s regulatory framework will continue to evolve to address emerging challenges in genetic modification while safeguarding the nation's agricultural and ecological integrity.