By Prof. Akhilesk K. Tyagi - Indian National Science Academy

Seeds of Dialogue
Akhilesh K. Tyagi

Genetically Modified Food
• Humans have
been genetically
modifying plants
for a very long
time:
– Selective breeding
– Cross pollination
– hybridization

Per capita availability of food grains
186
197
189
208
191
199
kgs
140

Food Demand of India
Item
Production
2010 (in MT)
Demand
2020 (in MT)
Rice 95.32 122.1
Wheat 85.93 102.8
Coarse cereals 42.22 45.9
Pulses 18.09 27.8
Food grains 241.56 298.6

Why GM Crops?
‣ Protection against yield loss due to stress
‣ To improve nutrition/quality
‣ For post-harvest gain
‣ For more yield
‣ To create bio-factories
‣ Premium for quality
‣ Reduction in insecticide or fertilizer use

What are potential disadvantages of
growing GM Crops?
‣ Biosafety
‣ Environmental safety
‣ Economic value
‣ Option to choose
‣ Ethical issues

Who has grow them and how much?

Global Area of Biotech Crops, 1996 to 2012:
Industrial and Developing Countries (M Has, M Acres)
ISAAA
M Acres
445 180
395 160
346 140
296 120
Total
Industrial
Developing
247 100
198
80
148
60
99
40
49
20
0
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Source: Clive James, 2012

Global Area of Biotech Crops, 1996 to 2012:
By Crop (Million Hectares, Million Acres)
ISAAA
M Acres
198
173
148
124
99
74
49
25
0
90
80
70
60
50
40
30
20
10
0
Soybean
Maize
Cotton
Canola
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Source: Clive James, 2012

Global Area of Biotech Crops, 1996 to 2012:
By Trait (Million Hectares, Million Acres)
ISAAA
M Acres
297
247
198
148
99
120
100
80
60
40
Herbicide Tolerance
Insect Resistance (Bt)
Herbicide Tolerance/
Insect resistance
49
20
0
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Source: Clive James, 2012

Global Adoption Rates (%) for Principal
Biotech Crops (Million Hectares, Million Acres), 2012
ISAAA
M Acres
445
395
346
180
160
140
Conventional
Biotech
159
296
247
120
100
100
198
80
148
60
99
40
30
31
49
20
0
0
81%
Soybean
81%
Cotton
35%
Maize
30%
Canola
Source: Clive James, 2012

Biotech Crop Countries and Mega-Countries, 2012
ISAAA

ISAAA

Bt Cotton in India
‣ 10.8 million ha out of 12 million ha
‣ >6 million farmers
‣ 33 million bales
‣ 50% increase in yield
‣ 50% reduction in spray of insecticide
‣ 30% increase in income

Why Bttechnology in brinjal?
Adult
moth
Egg
3 days
Hatching
Achilles’
Heel
Entry
Or Bttechnology?
2 to 3 hours
9 to 14 days
Mature
Larva
Cocoon
Adult
emergence
7-9 days
Pupation
Farmer’s Dilemma: Repeated pesticides prays?

Some important transgenic crop plants developed / tested by
public research institutions in India
Crop Trait Institution
___________________________________________________________________________
1. Brinjal Insect resistance IVRI Varanasi, NRCPB, TNAU, UAS Dharwad
2. Chickpea Insect resistance Assam Agricultural University Jorhat,
BI, ICRISAT Hyderabad, NRCPB
3. Cotton Insect resistance Central Institute of Cotton Research, Nagpur
NBRI, UAS Dharwad
4. Groundnut Disease resistance ICRISAT, Hyderabad
5. Mustard Male sterility DUSC
6. Potato Disease resistance CPRI
7. Potato Cold-sweetening CPRI
8. Potato Protein quality NIPGR
9. Rice Insect resistance BI, CU, DRR, NRCPB
10. Rice Pro Vitamin A CU, DRR, IARI, TNAU
11. Rice High iron CU
12. Rice Abiotic stress BI, CU, ICGEB, MSSRF, DUSC
13. Rice Fungal disease CU, MKU, TNAU
14. Sorghum Insect resistance NRC for Sorghum, Hyderabad
15. Sugarcane Insect resistance Sugarcane Breeding Institute, Coimbatore
16. Tomato Slow ripening NIPGR, NRCPB
17. Tomato Virus resistance IARI
18. Tomato Edible vaccine DUSC

Golden rice -Vitamin A deficiency
Ingo Potrykus
co inventor
Problem : Rice is major Staple and does not contain
Provitamin A
Consequences: 400 million rice eating poor suffer from
vitamin A deficiency ; 6000 die per day and 500, 000
become blind every year
Answer : Biofortification : improvement of the
micronutrient content of the crops on genetic basis
Golden rice contains genes introduced
through genetic engineering required to
activate the biochemical pathway leading to
accumulation of
pro-vitamin A
Indian Rice lines with 8- 25 µg/ gram of
rice produced by breeding and ready for
field testing
Lines with 16µg/ gram of rice are enough
to meet 50 percent of RDA
25µg/gram
8µg/gram

Development of GM potatoes with enhanced nutritive value
by tuber-specific expression of a seed protein AmA1
(Amaranth Albumin 1)
•up to 60% increase in total protein content in seven
genotypic backgrounds suitable for cultivation in
different agro-climatic regions.
•the concentrations of several essential amino acids
were increased significant in transgenic tubers.
•enhanced photosynthetic activity with a concomitant
increase in total biomass.
•a moderate increase in tuber yield.
•field performance and safety evaluation indicate that
the transgenic potatoes are suitable for commercial
cultivation.
______________________________________________
______
Thus, introduction of AmA1 is expected to provide a basis for
commercial production of nutritive value added crops

Enhancement of fruit shelf life by silencing N-glycan processing
enzymes (alpha-mannosidase and beta-hexosaminidase)
Climacteric fruit (tomato)
Ethylene is necessary for ripening
Non-climacteric fruit (capsicum)
Ethylene is not necessary for ripening
Control RNAi-α-Man RNAi-β-Hex
Vec control
RNAi-α-Man
RNAi-β-Hex
Days
20 10
Days
15
5
10
RNAi mediated silencing of α-man and β-hex genes together to
enhance shelf-life of fruits
Not I
CaMV 35S promoter
Kpn I
EcoR I
Xho I
PDK intron
Xba I
Bam HI
Hind III
Cla I
Not I
OCS terminator
subcloned into pART27 and
transformed to tomato
Hex Man
Sense direction
cloning
Hex Man
Antisense direction
cloning
RNAi Cassette in pHANNIBAL
α-man and β-hex
suppressed
transgenic plants

Grain Yield: UBI:OsSAP1 lines under water-deficit Stress
160
Soil moisture- 8-9%
Number of filled grains
140
120
100
80
60
40
20
0
WT-US WT-Str S10-US S10-Str
WT (US) WT (Str) S-10 (US) S-10 (Str)

GMOs approved so far in India
Agriculture
Healthcare
(Recombinant
Therapeutics)
Bt Cotton from Monsanto, USA
Bt Cottonfrom IIT, Kharagpur
Bt CottonCtt fromf Biocentury,Bit ChinaChi
Bt Cotton from Metahelix, Bangalore
Bt Cotton from CICR, Nagpur
A Total of 20 products including
‐Human insulin for diabetes
‐Hepatitis B Vaccine
‐Human growth hormone
‐Streptokinase for acute myocardial infraction
‐Teriparatide(Forteo) for Osteoporosis
‐Platelet Derived Growth Factor (PDGF) for Bone
marrow induction & Osteoblastsproliferation
‐Follicle Stimulating Hormone for reproductive
disorders

Who regulates them and how?

Guiding Principles for International
Regulatory Systems
‣ Substantial Equivalence
‣ Principle of Familiarity
‣ Generally Regarded as Safe (GRAS)
‣ Cartagena Protocol on Biosafety
‣ International Plant Protection Convention
‣ Codex Alimentarius
‣ Agreement as the Application of Sanitary and Phyto-sanitary
Measures
‣ Agreement as Technical Barriers of Trade
‣ Agreement on Trade related Aspects of Intellectual Property
Rights
‣ United Nations Convention on Biological Diversity

Indian Regulatory System
‣ To ensure that GM crops pose no risk to food safety,
environmental safety and agriculture productivity
‣ To demonstrate potential benefits over the conventional
variety/hybrid in terms of economic benefit to the farmer
and/or the environment
‣ To generate quantitative biological, ecological and agronomic
supportive data
‣ Rules and guidelines formulated to achieve above objectives

Regulation of GM Foods in India
‣ Under Environment Protection Act (1986), MoEf rules
formulated in 1989 created six competent authorities namely
RDAC, RCGM, IBSC; GEAC, SBCC, DLC; MEC for field trials under
RCGM and GEAC
‣ Recombinant DNA Safety Guidelines 1990, modified 1994
‣ DBT Revised Guidelines for Research on Transgenic Plants –
1998, also includes guidelines for toxicity & allergenecity
evaluation of transgenic seeds, plants & plant parts
‣ Safety Assessment of GM Food Crops -2007, modified 2009
‣ Guidelines for the Safety Assessment of Foods Derived from GE
plants – 2008
‣ Guidelines & SOPs for Confined Field Trials of Regulated
Genetically Engineered Plants – 2008
‣ Event Based Approval Mechanism (EBAM)- 2009

Consult : http://igmoris.nic.in
Indian GMO Research Information
Indian GMO Research Information System (IGMORIS) is a web
based database on activities involving the use of GMOs and
products thereof in India.
make available objective and realistic scientific information
relating to GMOs and products thereof under research, trials and
commercial use pertaining to agriculture, pharmaceuticals,
environment and industrial products to all stakeholders including
scientists, regulators, industry and the public in general.

Lessons learnt…..
Regulatory
Frame
work
PUBLIC
POLICY
Public
concerns
Science of
risk
assessment

METHODOL0GY ADOPTED BY DBT FOR
ESTABLISHMENT OF BRAI
Step 1
Review of the
structure and
governance of other
autonomous
agencies in India
Review of
international
models for the
regulation of
biotechnology
Review of India’s
international
obligations
pertinent to the
BRAI’s mandate
Step 2
Step 3
Step 4
Development of a model for the BRAI that addresses:
1. Scope of the regulatory mandate of the BRAI
2. Structure of the BRAI: programs and operations
3. Legal framework and other issues
Preparation of a preliminary establishment plan for the BRAI.
Stakeholder interviews to obtain feedback on the preliminary plan.
Preparation of a revised, draft plan incorporating stakeholder feedback.
Preparation of draft legislation for establishing the BRAI
Step 5
Consultative process with various stakeholders

KEY FEATURES OF BRAI BILL, 2011
The proposed statutory independent regulator that is
the Biotechnology Regulatory Authority of India (BRAI)
would be a nodal agency of the Government of India to
ensure comprehensive safety assessment of
organisms and products of modern biotechnology.
Commercialization of biotechnology products in
agriculture and healthcare would be subject to all
other laws whether Central or State, for the time being
in force and rules and regulations made thereunder.
The organizational plan of the Authority also provides
collaborative arrangements, co-ordination and
mechanisms with other existing regulatory agencies.

Conclusions
‣ GM Technologies is a ‘safe’ and ‘complementary’ option to
improve crop production
‣ Prioritization of trait, gene source and crops based as risk
benefit analysis is required
‣ Regulatory system should be independent, transparent,
rigorous, inclusive and science-driven
‣ Mission-mode approach is required to deliver benefits of GM
crops to farmers in India
‣ Policy on multiplication, procurement and distribution of GM
seed (variety/hybrid) is required
‣ Closer communication in policy makers, scientists, industry,
farmers and consumers required
‣ Post-release surveillance and risk-aversion strategy should be in
place

OPINIONS
‣ “…..GM technology, coupled with important developments in other areas,
should be used to increase the production of main food staples, improve
the efficiency of production, reduce the environmental impact of
agriculture, and provide access to food for small-scale farmers.” –the Royal Society
of London, the US National Academy of Sciences, the Brazilian Academy of Sciences, the Chinese Academy of Sciences, the Indian National Science
Academy, the Mexican Academy of Sciences, and the Third World Academy of Sciences, In Transgenic Plants and World Agriculture (2000),
Document made available by the Indian National Science Academy, New Delhi.
‣ “The affluent nations can afford to adopt elitist positions and pay more
for food produced by the so-called natural methods; the 1 billion
chronically poor and hungry people of this world cannot. New technology
will be their salvation, freeing them from obsolete, low-yielding, and
more costly production technology.” –Dr. Norman E. Borlaug (Nobel Prize Laureate for Peace 1970), Plant
Physiology (2000). 124, 487-490