Biosafety in India

What is biosafety? What are the rules and regulations governing it? Why is it important to comply with biosafety regulations? The biosafety rules and regulations are governed by various authorities to ensure the safe handling, storage, transport, and disposal of biological materials that pose potential risks to human health, animals, plants, or the environment. Read here to learn more.

Biosafety refers to the set of practices, safety measures, and guidelines implemented to ensure the safe handling, containment, and manipulation of biological materials, particularly those that may pose risks to human health, animals, plants, or the environment.

The primary objective of biosafety is to prevent accidental exposure, release, or dissemination of hazardous biological agents, including infectious microorganisms and genetically modified organisms (GMOs).

Biosafety

Biosafety measures are crucial in various settings, such as laboratories, healthcare facilities, agricultural research, and biotechnological industries.

The level of biosafety precautions depends on the nature of the biological materials being handled and the potential risks associated with them.

The key components of Biosafety are:

Biosafety Levels (BSL)

Biosafety levels categorize laboratories based on the degree of risk associated with the biological materials being handled. The levels range from BSL-1 (basic containment) to BSL-4 (maximum containment).

Each level has specific requirements for laboratory design, equipment, and procedures to minimize the risk of exposure.

	BSL-1 (Basic Level)	BSL-2 (Moderate Level)	BSL-3 (High Level)	BSL-4 (Maximum Level)
Agents	Generally non-pathogenic microorganisms.	Associated with human disease, but with low individual risk.	Indigenous or exotic agents cause serious diseases.	Dangerous and exotic agents cause severe diseases.
Laboratory Practices	Basic hygiene practices. Standard aseptic techniques.	BSL-1 practices plus additional precautions. Limited access to the lab. Use of personal protective equipment (PPE).	BSL-2 practices plus additional precautions. Controlled access. Use of specialized equipment and procedures.	BSL-3 practices plus additional precautions. Full-body, air-supplied suits. Strict protocols and procedures.
Facility Requirements	Open bench workspaces. Limited access restrictions.	Controlled access. Biosafety cabinets for certain procedures.	Separate building or isolated zone. Directional airflow. Controlled access points.	Isolated facility. Strict access controls. Multiple layers of containment.

Other important components of biosafety

Personal Protective Equipment (PPE)

• The use of appropriate PPE, including gloves, laboratory coats, masks, and eye protection, is essential to prevent contact with infectious materials. The type of PPE depends on the biosafety level and the specific activities being conducted.

Engineering Controls

• Laboratories and facilities implement engineering controls, such as biological safety cabinets, fume hoods, and containment systems, to provide physical barriers and prevent the release of hazardous agents.

Standard Operating Procedures (SOPs)

• SOPs outline specific procedures and protocols for the safe handling, storage, and disposal of biological materials. They guide laboratory personnel in carrying out activities in a safe and controlled manner.

Training and Education

• Proper training of laboratory personnel is essential to ensure awareness of biosafety protocols and adherence to safe practices. Training includes understanding the risks associated with biological materials and the proper use of equipment.

Waste Management

• Proper disposal of biological waste is a critical aspect of biosafety. It involves the segregation, collection, and disposal of waste according to established guidelines to prevent the spread of infectious agents.

Decontamination Procedures

• Laboratories implement decontamination procedures to sterilize equipment, surfaces, and waste. This helps in minimizing the risk of contamination and accidental release.

Risk Assessment

• Before conducting any work involving biological materials, a risk assessment is performed to evaluate the potential hazards and determine the appropriate biosafety measures.

Access Controls

• Restricted access to laboratories and specific work areas ensures that only authorized personnel with proper training and awareness of biosafety protocols enter these areas.

Regulatory Compliance

• Laboratories and facilities must comply with national and international regulations and guidelines related to biosafety. This includes obtaining necessary approvals and certifications for handling hazardous biological materials.

Emergency Response Plans

• Preparedness for emergencies, including accidental spills or exposures, is crucial. Laboratories must have emergency response plans in place to address unforeseen situations promptly.

Read: Biomedical Waste Management

Biosafety rules and regulations in India

The primary regulatory framework for biosafety in India includes guidelines from the Ministry of Environment, Forest and Climate Change (MoEFCC) and the Department of Biotechnology (DBT).

The Environment (Protection) Act, 1986:

• The Environment (Protection) Act is a comprehensive legislation that empowers the central government to take measures to protect and improve the quality of the environment. It provides the legal basis for regulating activities involving the release of hazardous substances.

The Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms, Genetically Engineered Organisms, or Cells, 1989 (1989 Rules):

• Also known as the “Rules for Handling GMOs (Genetically Modified Organisms),” these guidelines were introduced under the Environment (Protection) Act. They cover activities related to the research, development, production, marketing, and use of organisms and products derived from modern biotechnology.

The Biological Diversity Act, 2002:

• This Act aims to conserve biological diversity, promote sustainable use, and ensure the fair and equitable sharing of benefits arising from the use of biological resources. It establishes the National Biodiversity Authority (NBA) to regulate access to biological resources and associated traditional knowledge.

The Cartagena Protocol on Biosafety:

• India is a signatory to the Cartagena Protocol, an international treaty that addresses the safe handling, transport, and transfer of living-modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biodiversity.

Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008:

• Issued by the Ministry of Health and Family Welfare, these guidelines provide a framework for the safety assessment of foods derived from genetically modified plants. They include procedures for risk assessment and approval for commercial release.

The Institutional Biosafety Committee (IBSC) Guidelines, 2007:

• These guidelines, issued by the Department of Biotechnology, outline the responsibilities and functions of Institutional Biosafety Committees. IBSCs are required to review and monitor activities involving genetically engineered organisms.

The Department of Biotechnology (DBT) Guidelines on Research in Transgenic Plants:

• These guidelines provide a regulatory framework for research involving transgenic plants, ensuring the safe and ethical conduct of such research activities.

The Ministry of Environment, Forest and Climate Change (MoEFCC) Guidelines on Handling, Storage, Transportation, and Disposal of Bio-Medical Waste:

• These guidelines address the safe management of biomedical waste, including waste generated from healthcare facilities that may contain potentially hazardous biological materials.

Institutional Biosafety Committee (IBSC) Approval:

• Any institution or organization involved in activities related to genetically engineered organisms or biotechnology is required to establish an IBSC and obtain approval for their activities.

Review and Monitoring:

• Regulatory bodies, including the Genetic Engineering Approval Committee (GEAC), are responsible for reviewing and monitoring activities involving genetically modified organisms (GMOs) to ensure compliance with biosafety guidelines.

Biosafety laboratories:

• Department of Health Research (DHR), Ministry of Health and Family Welfare has different Central Sector Schemes through which several BSL-3 and BSL-4 facilities have been sanctioned/established.
• Under the Scheme ‘Setting-up of a nationwide network of laboratories for managing epidemics and national calamities’, eleven BSL-3 facilities have been sanctioned/established at different Regional Viral Research and Diagnostic Laboratories (VRDLs).
• Under the Scheme ‘Pradhan Mantri-Ayushman Bharat Health Infrastructure Mission’ (PM-ABHIM), two BSL-4 facilities, nine BSL-3 facilities, and four Mobile BSL-3 units have been sanctioned/established.

Cartagena Protocol on Biosafety

The Cartagena Protocol on Biosafety is an international agreement under the Convention on Biological Diversity (CBD) aimed at ensuring the safe handling, transfer, and use of living-modified organisms (LMOs) resulting from modern biotechnology. Adopted in 2000 and effective in 2003, the Protocol’s primary goal is to protect biodiversity and human health from the potential risks posed by LMOs, particularly when they are transported across borders.

Key Objectives and Principles of the Cartagena Protocol:

1. Precautionary Principle:
   • The Protocol emphasizes a precautionary approach, which allows countries to take preventive actions against LMOs if there is a perceived risk to biodiversity or human health, even if there is a lack of scientific certainty.
2. Advance Informed Agreement (AIA):
   • AIA is a fundamental procedure within the Protocol, requiring exporters to notify importing countries in advance if they are shipping LMOs intended for environmental release (such as genetically modified crops). Importing countries can then assess the risks and make informed decisions regarding import approval.
3. Biosafety Clearing-House (BCH):
   • The BCH is an online platform established by the Protocol to facilitate the exchange of information on LMOs, including risk assessments, national regulations, and other biosafety-related data. This helps countries make informed decisions and promotes transparency.
4. Risk Assessment and Management:
   • The Protocol encourages countries to conduct comprehensive risk assessments of LMOs to understand their potential environmental and health impacts. These assessments help in crafting appropriate management measures for safe use.
5. Capacity Building:
   • Recognizing the varying levels of expertise among countries, the Protocol supports capacity-building initiatives to help developing nations strengthen their biosafety regulations, risk assessment capabilities, and overall biotechnology management

Conclusion

Biosafety measures are dynamic and evolve based on advancements in research and technology. Adhering to biosafety guidelines is essential not only in research and healthcare settings but also in industries where biological materials are manipulated to ensure the well-being of both workers and the environment.

Institutions, researchers, and entities involved in biotechnological activities need to adhere to these regulations to ensure the safe and responsible use of biological materials in India. Compliance helps prevent potential risks to human health, the environment, and biodiversity.

Frequently Asked Questions (FAQs)

Q. What do you mean by biosafety?

Ans: The term “biosafety” refers to the use of specific practices, safety equipment, and specially designed buildings to ensure that workers, the community, and the environment are protected from accidental exposure or unintentional release of infectious agents, toxins, and other biological hazards.

Q. What are the 4 types of biosafety?

Ans: The four biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4, with BSL-4 being the highest (maximum) level of containment. There are additional specific rules and designations for animal research (ABSL), agricultural research (BSL-Ag), and other types of research.

-Article by Swathi Satish