Ministry of Environment, Forest and Climate Change
Government of India
Overview of Biosafety Activities
Mandate of MoEFCC
Regulation of Genetically Modified Organisms (GMOs) and products thereof in India
Implementation of Cartagena Protocol on Biosafety (CPB) and Nagoya- Kuala Lumpur Supplementary Protocol on Liability and Redress to the CPB
Capacity Building in Biosafety
Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology
and its products.
Biosafety
Source: bch.cbd.int/protocol
WHAT ARE GMOs/LMOs?
A genetically modified organism (GMO) is an organism whose genetic material has been altered (introduced or silenced) using genetic engineering techniques, also known as recombinant DNA technology
GMOs are also referred as genetically engineered organisms (GEO) or living modified organisms (LMOs)
Transgenic organisms, a subset of GMOs, are organisms which have inserted DNA that originated in a different species.
• Basic biological research
• Medical biotechnology
– Vaccines
– diagnostics …
• Pharmaceuticals
– antibiotics, insulin, growth hormone ,therapeutics,
– Monoclonal Antibodies
• Enzymes for food manufacture
– Rennet for cheese production
• Agriculture
– New plant cultivars
Where are GMOs used today?
GENETIC ENGINEERING: WHAT IS UNIQUE?
A GE plant carries new
gene(s)
New gene(s) can be Introduced into a plant from
any source -bacteria, virus, fungi, animals - thus overcoming taxonomic or
reproductive barrier
A Big Breakthrough!
Novel Products
TRADITIONAL PLANT BREEDING
DNA is a strand of genes, much like a strand of pearls. Traditional plant breeding combines many genes at once.
Desired Gene
X
Many genes are transferred
Donor Plant Commercial Plant Variety
New Plant Variety
+
A single gene is transferred
Desired Gene
Commercial Plant Variety
Improved Commercial Plant
Variety
PLANT BIOTECHNOLOGY
Using plant biotechnology, you can add a single gene to the strand.
Desired Gene
Donor
Biotechnology is an Extension of Traditional Plant Breeding
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
These include food safety issues and environmental safety issues
Biosafety Concerns
Bt: Abbreviation for Bacillus thuringiensis, a ubiquitous soil bacterium that can produce insecticidal proteins
Bt-Plant: It contains the gene(s) from Bacillus thuringiensis introduced into it through genetic engineering
Example :What is Bt & Bt-Plant?
Biosafety Regulatory Framework
Rules, 1989 notified under the Environment Protection Act, 1986
India’s biosafety regulatory setup consists of six committees at the apex, which derive their authority from Rules, 1989
1. Recombinant DNA Advisory Committee (RDAC)
2. Institutional Biosafety Committee (IBSC)
3. Review Committee on Genetic Manipulation (RCGM)
4. Genetic Engineering Appraisal Committee (GEAC)
5. State Biotechnology Coordination Committee (SBCC)
6. District Level Coordination Committee (DLCC)
Scope of Rules 1989
All activities involving research and development of products containing GMOs /LMOs including transgenic crops, pharma products, industrial products, food and foodstuffs.
Field trials /clinical trials
Deliberate/unintentional release
Import/Export/ Manufacture
Genetic Engineering Appraisal Committee (GEAC)
GEAC established under MoEFCC is the Apex body notified under Rules 1989 to accord approval of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle.
Approval of proposals relating to release of GMOs and products into the environment including experimental field trials (Biosafety Research Level trial-I and II known as BRL-I and BRL-II).
To permit the use of GMOs and products thereof for commercial applications
To adopt procedures for restriction or prohibition, production, sale, import & use of GMOs both for research and applications under EPA
To authorize large scale production and release of GMOs and products thereof into the environment.
Composition of GEAC (i) Chairman – Additional / Special Secretary, MoEFCC
Co-Chairman – Representative of Department of Bio-technology
Vice-Chairman – Joint Secretary, MoEFCC
(ii) Members: Representatives of concerned Agencies and Departments, namely, Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy.
(iii) Expert Members : Director General-Indian Council of Agricultural Research, Director General – Indian Council of Medical Research, Director General – Council of Scientific and Industrial Research, Director General-Health Services, Plant Protection Adviser, Directorate of Plant Protection, Quarantine and Storage, Chairman, Central Pollution Control Board and three outside experts in individual capacity.
(iv) Member Secretary : An official of the Ministry of Environment, Forest and Climate Change.
(v) Co-opt: 13 Experts co-opted
STUDIES TO BE COMPLETED
Food & Feed Safety
Assessment
Environmental Risk
Assessment
Field
studies
Non-field
studies*
Field
studies
Non-field
studies*
Acute oral safety limit study
Pepsin digestibility assay
Protein thermal stability
Subchronic feeding study in rodents (if required)
Livestock feeding study (if required)
Molecular characterization
Inheritance of introduced trait
Stability of introduced trait
Expression of introduced protein(s)
Compositional analysis
Reproductive and survival biology
Impact on non-target organisms: Tier I testing
Impact on non-target organisms: Tier 2 testing
Staged completion of specific information and data requirements for the safety assessment of GE plants
*run concurrently with field trials
Environmental Loss of biodiversity Cross-pollination Emergence of super weeds and superbugs Potential increase in use of herbicides
Food safety Fear of unknown allergens Spread of anti-biotic resistance Inadequate regulation of new products Consumer choice and labeling Organic food safer
Food and farm security Need distribution, not just more
Technology fees
Small farmers are not benefitted
Socio-economic issues Corporations benefit, not those in need Products needed in developing countries are not being developed because the market is not profitable It is wrong to patent life
Specific to GM crops Common to all crops
Some Common Public Concerns
Bt-cotton - First and only GM crop approved in India (2002) for
commercial cultivation
Cultivated in more than 11.6 million hectares (2015)
Six Events and more than 1100 Bt cotton hybrids approved in India
Net economic benefit - $ 225/ha
Yield gain - 31%
Increase in profit – 88%
Reduction in pesticide sprays – 39%
India ranks Second in global cotton production and from a Cotton
importing country we became Cotton exporting country
Bt Cotton in India: Key Features
GEAC’s Approval for Commercial Release of Different Bt
Cotton Events in India, 2002 to 2012
No. Crop Gene(s) Event Developer Status Year of Approval
1. Cotton* cry1Ac MON-531 Mahyco/Monsanto
Commercialized 2002
2. Cotton* cry1Ac and cry2Ab2
MON-15985
Mahyco/Monsanto
Commercialized 2006
3. Cotton* cry1Ac Event-1 JK Agri-Genetics
Commercialized 2006
4. Cotton* Fused genes cry1Ab and cry1Ac
GFM Event Nath Seeds Commercialized 2006
5. Cotton** cy1Ac BNLA-601 UAS, Dharwad & CICR (ICAR)
Discontinued 2008
6. Cotton* Synthetic cry1C MLS-9124 Metahelix Life Sciences
Approved, Not placed to market yet
2009
*Bt cotton hybrid; **A hybrid and a variety of Event BNLA-601 discontinued since 2010
Bt Brinjal
Bt brinjal is created by inserting a crystal protein gene (Cry1Ac) from soil
bacteria Bacillus thuringenisus (Bt) and it is resistant to Fruit and Shoot Borer
(Leucinodes orbonalis).
Genetically modified brinjal event is termed Event EE 1.
In October 14, 2009, the GEAC recommended the approval of commercial
cultivation of Bt brinjal (eggplant).
On February 9, 2010, the MoEFCC announced a moratorium on the approval.
National Committee on Biosafety (NCB), Bangladesh has approved for limited
scale cultivation of Bt Brinjal by farmers (2013).
Hybrid Mustard GM mustard hybrid, DMH-11, containing barnase-barstar system has been
developed by University of Delhi, South Campus and funded by National Dairy Development Board. The barnase-barstar system is considered as an efficient system for hybrid seed production of high purity seed.
An effective method to obtain higher yields since hybrids recorded for more than 25% more yield than the best open-pollinated varieties. Laboratory and Field evaluation to assess the safety efficacy and stability of the introduced genes has been completed.
Biosafety dossier submitted by the applicant is under review by the Sub-Committee constituted by the GEAC.
GEAC has received representations both in favor and against release of GM Mustard. Special meeting scheduled on July 18, 2016 to hear the consensus from NGOs
Public comments would be invited by the GEAC after Sub-Committee review is complete.
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
Objective of the Protocol
To contribute to ensuring the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the biological diversity, taking also into account risks to human health
Applies to: Transboundary movement, transit, handling and use of all LMOs that
may have adverse effects on biodiversity, taking also into account risks to human health
Exclusion: Pharmaceuticals for humans that are addressed by other international
Agreements or organizations
As Parties to the Protocol have certain obligations for ensuring safe transfer of
LMOs as per various Articles of CPB
The objective of the Supplementary Protocol is to
contribute to the conservation and sustainable use of biological diversity by providing international rules and procedures for liability and redress in the event of damage resulting from LMOs.
Adopted on October 15, 2010 by the fifth
meeting of the COP-MOP, which took place in Nagoya, Japan
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety
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 (2012-2016) and nearing completion
Phase-II Biosafety Project: Key Points
• India has accessed US$ 3.0 million from GEF for the biosafety program with US$ 6.0 million from GOI as Co-Financing
• Ministry of Environment, Forest and Climate Change is the
Nodal Ministry for Implementation of the Project
• Project Time Frame: 4 years (2012-2016)
• National Project Director:
• National Project Coordinator: Focal Points
• National Steering Committee
• Project Management and Monitoring Committee Committees
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