Dr. Amita Prasad, Additional Secretary, Ministry of Environment, Forest and Climate Change
Government of India
Biosafety Capacity Building: Initiatives and Way Forward
GMOs and Biosafety Regulations
Significant advances have taken place in last three decades towards development of genetically modified organisms (GMOs).
GMOs and products thereof are being used for diverse applications in healthcare, agriculture, process industry etc.
Ensuring biosafety of GMOs and products thereof is commitment of the national governments.
National and international regulations are in place to deal with biosafety aspects.
India’s biosafety regulatory framework is based on “Rules for manufacture, use/import/ export & storage of hazardous micro organisms/ genetically engineered organisms or cells, 1989” notified under the Environment (Protection) Act, 1986
The Ministry of Environment, Forest and Climate Change is the nodal Ministry responsible for implementation of the Rules, 1989. The Department of Biotechnology and state governments are also involved.
The Rules are implemented through six statutory committees with Genetic Engineering Appraisal Committee as the apex committee.
Biosafety Regulatory Framework in India
As the genes are derived from various
organisms, concerns raised regarding safety of such organisms since the advent of technology in 1975 and guidelines/regulations put in place
First GMO derived product Insulin approved
in 1982 and first GM crop (tomato)approved in 1996 in USA
Applications in healthcare widely accepted, however biosafety concerns in applications in agriculture
Biosafety Concerns
Regulatory Approval of a GM crop
Comprehensive biosafety research data to demonstrate:
Food and feed safety Environmental safety Social and economic benefits
Safety Assessment Process • The development process of a GM crop is a step wise
process consisting of laboratory research, greenhouse studies, field trials and safety studies.
• Guidelines have been issued by DBT and MoEFCC to deal with various steps in this development process.
• International guidance available, prepared through years of deliberations and participation of many countries
• Food safety guidance notified by Codex Alimentarious (FAO/WHO) and Environmental Risk Assessment under the Cartagena Protocol on Biosafety.
• Socio-economic considerations are country specific and location specific; international discussions still underway.
Cartagena Protocol on
Biosafety
What is Cartagena Protocol on Biosafety (CPB)?
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another.
Key Features:
An agreement between different countries negotiated under the
Convention on Biological Diversity (CBD)
Adopted on 29 January 2000 after 4 years of intense
negotiations
Entry into force on 9 September 2003 and India ratified this
Protocol on September 11, 2003
Till date 170 countries have ratified this Protocol
Cartagena Protocol on Biosafety and Socio-economic Considerations
Article 26 of the Cartagena Protocol on Biosafety enables Parties to consider socio-economic considerations (SECs) in the decision making.
There have been series of online discussions, meetings and work by an Ad-hoc Technical Expert Group to deliberate on SECs.
These reports will be discussed in the forthcoming Eighth Conference of Parties Serving as Meeting of Parties (COPMOP-8) scheduled to be held in Mexico in December 2016.
Status of GM crops in India
Bt cotton is the only approved GM crop in India.
More than 20 crops are at various stages of field trials and safety assessment
More than 50 crops under research in both public and private sector.
Public Research – GM Crop Trials
Private Research – GM Crop Trials
Capacity Building on Biosafety
MoEFCC is actively engaged in Capacity building in biosafety using National and International resources
Several capacity building activities undertaken by
MoEFCC in association with other concerned Ministries like DBT, MoA, ICAR, Research Institutions, State Department of Agriculture, State Agricultural Universities etc.
MoEFCC is implementing UNEP/GEF supported
Phase-II Capacity Building Project on Biosafety since 2012.
Phase-II Biosafety Project: Key Points • Ministry of Environment, Forest and Climate
Change is the Nodal Ministry for Implementation of the Project
• The objective of the project is to strengthen biosafety management system in India
• Activities undertaken under four thrust areas: • Risk Assessment and Risk Management • Handling, Transport, Packaging and
Identification • Socio-economic considerations • Information dissemination and public
awareness
Thrust Areas
Risk Assessment
and Risk Management
Handling, Transport,
Packaging and Identification
Public Awareness
Socio-Economic Considerations
Workshops/ Trainings
Preparation of Outreach Materials
Development of Guidelines/ Manuals
Capacity Building
Stakeholder Involvement
Policy Makers Scientists & Researchers
Legal Experts & Economists
Enforcement Officials (Customs, Plant Quarantine Seed
Inspectors, Food Safety Inspectors, SBB)
Media/ farmers/ Students
Project Outcomes
Guidance on Environmental Risk Assessment have been adopted by the GEAC
Manuals and tools for trainers developed for monitoring, risk communication etc.
Baseline documents prepared on key topics relevant to the thrust areas
Training workshops organized for multiple stakeholders viz. members of regulatory committees, scientists, custom officials, state biodiversity boards, food safety inspectors, plant quarantine officials etc.
Way Forward
Activities to continue for dissemination of project outputs to stakeholders under the project.
Translation of outreach material into local languages for wider circulation.
Resource documents to be used for development of policies/guidelines in future.
Phase III project to be planned for continuing capacity building in biosafety
Thank You !!!
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