Doctorate Seminar

1. WELCOME 1

2. 2
Sheikh Aafreen Rehman
PhD (Entomology)
15-Ag(Entom) 2019-D
Regulation and biosafety concerns associated
with genetically modified crops in India
Division of Entomology,
Sher-e-Kashmir
University of Agricultural Sciences &
Technology of Kashmir
Faculty of Agriculture, Wadura-193201
Doctoral Credit seminar

3. Genetically modified crops
Crops improved by the incorporation of one or
more genes from another species by genetic
engineering techniques.
(Kolady et al., 2014)

4. History
1982
• First transgenic plant produced.
1986
• First field trails of genetically engineered plants
established.
1994
• Flavr savr tomato released.
1995
• Bt Potato approved.
2000
• Golden rice was developed.
2002
• Bt Cotton released in India.
2009
• GEAC recommended commercial release of
Bt brinjal

5. Global Area of Genetically modified crops
(2010- 2018)
Year Hectares (million)
2010 148.0
2011 160.0
2012 170.3
2013 175.2
2014 181.5
2015 179.7
2016 185.1
2017 189.8
2018 191.7
(ISAAA, 2018)

6. Country wise area of GM crops
Country AREA
(Million Hectare)
Biotech crops
USA 75.0 Soybean, Maize, Cotton, Alfalfa, and other biotech crops
Brazil 50.0 Soybean, Maize, Cotton
Argentina 23.6 Soybean, Maize , Cotton
Canada 13.1 Canola, Soybean, Maize and other biotech crops
India 11.4 Cotton
Paraguay 3.0 Soybean, Maize, Cotton
Pakistan 3.0 Maize, Cotton
China 2.8 Cotton, Papaya
South Africa 2.7 Cotton, Maize, Soybean
(ISAAA, 2018)

7. Status of GM Crops in India
( Gupta and Ahuja, 2016)
• Approved for commercial
cultivation
Bt Cotton
• Moratorium for environmental
release
Bt Brinjal
• Under various stages of field
trails
Mustard, Rice, Potato
Tomato, Pea,
Papaya, Maize
Tobacco and Cabbage.

8. Advantages of GM crops
Insect resistance
Virus tolerance
Nutrient enhancement
Yield increase
Herbicide tolerance
Drought resistance
Genetically
modified crops
(Mishra and Shukla, 2019

9. TransGenes
(Sharma et al., 2000)
Protease inhibitors
Endo-toxin gene from Bt
Alpha amylase inhibitors
Lectins
Enzymes

10. S
Endo-toxin gene fromBt
The gene responsible for producing endo-toxin is isolated from
Bacillus thuringiensis (Bt) and cloned into plants to develop resistance
to insects

11. Why to regulate GM crops?
• Pose no risk to food safety
• Environmental safety
• Agriculture productivity
Demonstration of potential benefits over
the conventional variety/hybrid
Generate quantitative biological,
ecological and agronomic supportive
data
Formulation of rules and guidelines to
achieve above objectives

12. Government rules for Genetically Modified crops
Regulatory framework
Rules 1989 under Environment
Protection Act (1986)
The Food Safety and Standards
Act, 2006
Biological Diversity Act, 2002
Plant Quarantine order, 2003
(Ahuja, 2018)

13. Rules, 1989 under Environment Protection Act,1986
1.
• Recombinant DNAAdvisory Committee (RDAC)
2.
• Review Committee on Genetic Manipulation (RCGM)
3.
• Genetic Engineering Approval Committee (GEAC)
4.
• Institutional Biosafety Committees (IBSC)
5.
• State Biosafety Coordination Committees (SBCC)
6. • District Level Committees (DLC).
(Ahuja, 2018)

14. Approval of new transgenic
crops
IBSC RCGM GEAC
Ongoing research
activities and small scale
field trials
Institute level research
Large-scale trials and
environmental release

15. REGULATORY MECHANISM
Government of India
Department of
biotechnology(DBT)
SBCC
GEAC
RCGM
Ministry of
environment, forestry
and climate change
IBSC
Applicant DLC
(Mishra and Shukla, 2019)

16.  No person shall import, export, transport, manufacture, process,
use or sell any GMOs, substances or cells except with the approval
of the GEAC.
 Use of pathogenic organisms or GMOs or cells for research purpose
shall be allowed under the Notification, 1989 of the EPA, 1986.
 Any person operating or using GMOs for scale up or pilot operations
shall have to obtain permission from GEAC.
 For purpose of education, experiments on GMOs IBSC can look
after, as per the guidelines of the Government of India.
 Deliberate or unintentional release of GMOs not allowed.
 GEAC carries out supervision through SBCC, DLC or any authorized
person.
Summarization of approvals and prohibitions under Rules
1989:

17.  If orders are not complied, SBCC/DLC may take suitable
measures at the expenses of the person who is responsible.
 In case of immediate interventions to prevent any damage,
SBCC and DLC can take suitable measures and the expenses
incurred will be recovered from the person responsible.
 All approvals shall be for a period of 4 years at first instance
renewable for 2 years at a time.
 GEAC shall have powers to revoke approvals in case of:
i. Any new information on harmful effects of GMOs
ii. GMOs cause such damage to the environment as could not be
envisaged when approval was given.

18. Other relevant rules and policies:
Act/Rules Implemented by Activities covered
Plant Quarantine
(Regulation For Import Into
India) Order 2003
Ministry of Agriculture &
Farmers Welfare
Covers regulation of import of
germplasm/ GMOs/transgenic
plant material for research
purpose.
Biological Diversity Act,
2002
National Biodiversity
Authority
Regulates the use of biological
resources including genes used
for improving crops and livestock
through genetic intervention
The Food Safety and
Standards Act, 2006
Food Safety and Standards
Authority of India
Regulates manufacture, storage,
distribution, sale and import of
food which includes GM food.
(MoEF&CC, 2017)

19. OVERVIEW OF MINISTRIES AND DEPARTMENTS
INVOLVED IN REGULATION OF GM FOOD

20. Ministry of
Environment and
Forest
• Secretariat of the
Genetic Engineering
Approval Committee
• Approval for
manufacture, sale,
import and export of all
GMOs and products
Department of
Biotechnology
• Secretariat of the
Review Committee on
Genetically
Modification
• Interacts with the
Institutional Biosafety
Committees (IBSCs) set
up in all organizations
undertaking activities
involves GMOs
Department of Health
in the Ministry of
Health and Family
Welfare
• Responsible for
implementation of the
PFAAct.

21. Indian Council
of Medical
Research
• Apex body in India
for the formulation,
coordination and
promotion of
biomedical
research.
• Advisory body for
MoHFW (Ministry
of Health and
Family Welfare) on
various issues
including GM
foods.
Ministry of
Agriculture
• Nodal ministry for
agriculture growth
in the country.
• Comprises of
Department of
Agriculture and
Cooperation,
Department of
Agricultural
Research &
Education/ Indian
Council of
Agricultural
Research (ICAR)
and Department of
Animal Husbandry
& Dairying.
Ministry of
Commerce and
Industry
• Responsible for the
formulation of the
Export and Import
(EXIM) Policy in
the country.
• Implements a
legislation
prescribing a
system of quality
control and
inspection for both
export/import.
Ministry of Food
Processing
Industries
• Responsible for the
formulation of
policy for the
healthy growth of
the food processing
industries and
provides
developmental
support to these
industries.
• Licensing authority
for processed fruits
and vegetable
industries.

22. Lack of adequate
protocol for risk
assessment
Detailed safeguards
as embodied in the
Cartagena protocol
yet to be incorporated
Lack of infrastructure
for risk assessment.
Instructions and conditions
for use on labelling and
packaging of products
containing GMOs yet to be
specified
Shortage of skilled
personal from
laboratory researchers
to extension service
officers.
Limitations of
Regulatory system
in India
(Mishra and Shukla, 2019

23. Biosafety
Protecting human & animal health and environment from the
possible adverse effects of the products of modern
biotechnology

24. BIOSAFETY CONCERNS
ENVIRONMENTAL SAFETY
FOOD SAFETY TO HUMAN AND ANIMAL HEALTH
ETHICAL ISSUES

26. Direct effects on non
target organisms
Development of resistance in
insects
Gene flow

27. Effect of Bt. corn on monarchs
pollen
Bt. corn Milk weed
Larvae feeding on Milk
weed dusted with bt pollen
Bt. pollen
(Losey , 2018)

28. GM crops may also have negative impacts on bees
Bees will potentially go
malnourished and die of illness
When the flower pollen becomes genetically
modified or sterile, the bees will potentially go
malnourished
Effect of GM Crops on bees
The genetic modification of the plant leads to the
concurrent genetic modification of the flower pollen
(Amos, 2019)

29. INSECT RESISTANCE
• In March 2010 Monsanto India declared the Bt cotton with
the single protein Cry1Ac, has developed resistance to
pink bollworm (Pectinophora gossypiella).
• Resistance was confirmed in four districts in Gujarat -
Amreli, Bhavnagar, Junagarh and Rajkot.
• Fakrukdin et al., (2002) reported the resistance
development in Helicoverpa armigera to Cry1Ac toxin
• Resistance confirmed in the entire South Indian Cotton
Ecosystem.

30. Increased weediness
Loss of
Biodiversity/reduction of
cultivars
Changes in the soil ecology
(Keese, 2018)

31. Competition with Natural
Species
Increased Selection Pressure on
Target and Non target Organisms
Genetic
Contamination/Interbreeding
(Keese, 2018)

32. Impossibility of Follow-up
Once the GMOs have been
introduced into the environment
and some problems arise, it is
impossible to eliminate them.

34. Toxicity in Animals
Allergenecity in humans

35. Animal morbidity
 Sheep, goat and cattle morbidity were reported from Andhra
Pradesh, Maharashtra, Punjab, Haryana after feeding on bt cotton
 Animal Husbandry Department of AP asks farmers not to graze
animals on Bt Cotton – “as yet unidentified toxin” causing morbidity
 AP government writes to centre not to permit the Bt cotton till
proven safe
(Shukla, 2017)

36. Animal Husbandry Dept.’s Advisory
Media Announcement
It has come to our notice that in several blocks of the district, animals
are falling sick after grazing on Bt Cotton fields.After harvesting
cotton completely from the fields, there is a long tradition in the
district of grazing animals in those cotton fields. However, because Bt
Cotton is being grown in large tracts and because of a yet-unidentified
toxic material in these plants, it has come to our notice that animals
which are grazing on these fields are exhibiting symptoms like shivers,
convulsions, running nose, bloat, bloody diarrhea etc., and are dying.
Therefore, we appeal to farmers not to graze their animals on Bt
Cotton fields.We request farmer brethren to please do approach the
approach the nearest veterinary doctor and get treatment, if any
animal has grazed on such fields accidentally.
Sd/- MVenkataswamy
Joint Director Animal Husbandry Dept Adilabad.

37.  Soybeans are deficient in sulphur containing amino acids such as
methionine and cysteine.
 Seeds of the brazil nut are rich in methionine.
 The 2S albumin gene from the seeds of the Brazil nut (Bertholletia
excelsa) is encoding for sulfur-rich proteins such as methionine and
cysteine
 2S albumin gene was introduced into soybeans through
recombinant-DNA techniques as a strategy for improving the
nutritional quality of soybeans
 But 2S albumin gene proved to be a major allergen causing allergies
to the people consuming GM Soybean
Brazil nut allergy in Soybean
(Julie et al.,1996)

38. Ethical issues
Unacceptable intervention in Gods
creation violating barriers in
natural world
(Labra et al., 2011)

39. Case studies

40. GM Soybean
Gene inserted
Results
Mice were fed diet containing 14% GTS
from the ages of 1 to 8 months
EPSPS-CP4 for
glyphosate tolerance
Differences found at ultra
microscopic level
Body weight, pancreas and liver
macroscopic appearance was
same between control and GTS
fed mice
Irregular shaped nuclei, high number of
nuclear pores, zymogen granular size
smaller
(Malatesta et al.,2002)

41. Other studies of Safety assessment performed with GM Soybean
Inserted gene/ Trait Model animal Effects Refrences
CP4-EPSPS glyphosate-
tolerant
Broiler Differences in organ weights Hammond et al.(2018)
CP4-EPSPS glyphosate-
tolerant
Salmon Decreased spleen and distal
intestine somatic index
Hemre et al.(2005)
CP4-EPSPS glyphosate-
tolerant
Rabbit Increased LDH in Kidney and heart Tudisco et al.(2006)
CP4-EPSPS glyphosate-
tolerant
Rat Zymogen granule depletion Magena- Gomez et al.
(2008)
CP4-EPSPS glyphosate-
tolerant
Salmon Inflammation in intestine and
increased kidney isozyme activity
Bakke-McKellep et
al.(2017)
CP4-EPSPS glyphosate-
tolerant
Mouse Kidney and pituitary lesions Harrison et al.(1996)

42. GM Maize
Gene inserted
Evaluated parameters
Rats were fed for 90 days with diet
containing 11% MON 863
Cry 3 Bb1, resistance to corn root
worm(MON 863)
Elevated white blood cell count,
lymphocyte count, basophiles,
Slight increase in Glucose levels
in female
Overall health, body weight gain,
food consumption, clinical
pathology parameters and
microscopic apperance of tissues
(Hammond et al.,2002)
Results

43. Other studies of Safety assessment performed with GM Maize
Inserted gene/ Trait Model animal Effects Refrence
Cry 1 Ab, resistance to
European corn
borer(MON 810)
Salmon Change in White blood cell level
associated with immune
response
Sagstad et al.(2007)
CP4-EPSPS glyphosate-
tolerant
Cows No differences among
conventional and GM diets
Barriere et al.(2001)
CP4-EPSPS glyphosate-
tolerant
Chicken No differences among
conventional and GM diets
Yonemochi et al.
(2002)
Cry 1 Ab, resistance to
European corn
borer(MON 810)
Chicken No differences among
conventional and GM diets
Barriere et al.(2001)

44. Studies of Safety assessment performed with other GM crops
GM crop Inserted gene/ Trait Model animal Effects Refrences
Potato GNA lectin insect resistant Rat Gastric mucosa
proliferation, thinner
ceacal mucosa
Ewen and Pusztai
(2017)
Potato Cry 1, Insect resistant Mouse Abnormally large
enterocytes,
hypertrophied and
multinucleated
Fares and El-
Sayed.(2008)
Peas Amylase inhibitor Rat Decrease of nutritional
level at higher
inclusion level
Pusztai etal. (2009)
Sweet pepper Coat protein, resistant to
cucumber mosaic virus
Rat No differences among
conventional and GM
diets
Chen et al. (2003)
Rice Cry 1 Ab, insect resistant Salmon Reduced white blood
cells, protein and
adrenal levels
Schroder et al.(2007)
Rice PHA-E lectin, insect
resistant
Rat Increased weight of
small intestine,
stomach and pancreas
Poulsen et al.(2007)

45. CONCLUSION
 The use of genetically modified organisms is important in order to
meet increasing demands and improve existing conditions prevalent
in our environment.
 Monitoring and detection methods are vital for risk assessment and
management to control the negative environmental and health
impacts.
 The biosafety regulatory frameworks should be sufficiently
stringent in order to protect against genuine ascertainable risks.
 Social, economic, and ethical issues needs to be taken care of.

46. Future Prospective of GM Crops
 Regulation of GM Crops deals with a trans scientific problem, that is, the
resolution of the problems is beyond the competence of the scientific system.
 Public perception and acceptance are dependent on trust and whether the
products or processes benefit them as citizens and consumers.
 To take proper accounts of uncertainties and public concern would help to
capture the benefits, minimize the risk, and provide goals for future
development and use of genetic engineering.
 Judgment about risks should not be based on the method modification (classical
or modern) but on the quality of the final product.
 Encouragement of new monitoring and detection methods and tools is
therefore vital for assessment, control of environmental, and health impacts as
well as collection of ecological knowledge of relevance to future releases