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?

Mechanism of Action of Bt Protein

Regulation of Genetically Modified Crops through Genetic Engineering Appraisal

Committee (GEAC)

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

Why are Confined Field Trial (CFT) Experiments Necessary

Conducting Confined Field Trials

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

Indian and Global Status of GM crops

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.

Public Research – GM Crop Trials

Private Research – GM Crop Trials

Cartagena Protocol on Biosafety Reducing the Environmental Risks of Modern Biotechnology

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

COP-MOP 8 is scheduled to be held in December 2016 in Mexico

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

Thank You !!!