biosafety activities of moefcc

1. Assignment
Subject : Breeding Designer Crops (GPB822)
Presented by: Mr. Indranil Bhattacharjee
Student I.D. No.: 17PHGPB102
Presented to : Prof. (Dr.) B.G.Suresh
Sam Higginbottom University of Agriculture, Technology &
Sciences
Allahabad-211007
Overview of Bio-safety Activities of Ministry of
Environment, Forest and Climate Change
Government of India

2. 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

3. Biosafety
‘Biosafety is a term used to describe efforts to
reduce and eliminate the potential risks
resulting from biotechnology and its products.’
Source: bch.cbd.int/protocol

4. 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.

5. Where are GMOs used
today?
,
•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

6. GENETIC ENGINEERING: WHAT IS UNIQUE?

7. Biotechnology is an Extension of Traditional Plant
Breeding

8. Biosafety Concerns
1. 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
2. First GMO derived product Insulin approved in 1982
and first GM crop (tomato)approved in 1996 in USA
3. Applications in healthcare widely accepted, however
biosafety concerns in applications in agriculture
4. These include food safety issues and environmental
safety issues

9. Example : What is Bt & Bt-Plant?
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

10. Mechanism of Action of Bt Protein

11. 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)

13. 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

14. 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.

15. 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

17. Why are Confined Field Trial (CFT) Experiments
Necessary

19. Conducting Confined Field Trials

20. Staged completion of specific information and data
requirements for the safety assessment of GE plants

21. Some Common Public
Concerns

22. Indian and Global Status of GM crops
Bt Cotton in India: Key Features
 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

24. 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).

25. 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.

31. 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

32. 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

33. COP-MOP 8 was held in December 2016 in Mexico

34. Nagoya – Kuala Lumpur
Supplementary Protocol on
Liability and Redress to the
Cartagena Protocol on
Biosafety
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

35. 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

36. 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)

40. Thank You