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1
2
University of Agricultural and Horticultural
Sciences, Shivamogga
College of Horticulture, Mudigere.
ETHICALAND SAFETY ISSUES OF GM CROPS
BY:
MAHAMMED FAIZAN
MH2TAG0165
Dept. of genetics and
plant breeding
SEMINAR OUTLINE
introduction
Status of GM crops
Advantages and achievements
Methods of production of GM crops
Ethics
Studies on environmental safety
Studies on animal health
Safety measures
4
Conclusion
Genetic engineering
the group of applied techniques of genetics and
biotechnology used to cut up and join together genetic
material and especially DNA from one or more species of
organism and to introduce the result into an organism in
order to change one or more of its characteristics
5
GMO ??
Fig. 1. Acreage of GM crops world wide
Status of GM crops
6
Methods of production of GM crops
1. Direct Method
2. Indirect Method
a) Chemical Method
b) Electroporation Method
c) Particle bombardment
d) Microinjection
e) Others
7
 Improved nutritional quality
 Increased crop yield
 Insect resistance
 Disease resistance
 Herbicide resistance
 Salt tolerance
 Biopharmaceuticals
 Ability to grow plants in
harsh environments
Advantages
8
Achievements
Herbicide Resistance
Crop Trade name Gene Target Country Year
Alfalfa Roundup Ready cp4 epsps glyphosate USA 2005
Canola Liberty Link bar glufosinate USA 1995
Carnation Moonique surB sulfonylurea Colombia 2008
Chicory Seed Link bar glufosinate USA 1997
Cotton WideStrike cp4 epsps glyphosate Mexico 2005
Linseed CDC Triffid Flax als sulfonylurea Canada 1996
Maize Optimum Zm-hra sulfonylurea USA 2008
Rice Liberty Link bar glufosinate USA 1999
Soybean Liberty Link PAT glufosinate USA 1996
Sugarbeet InVigor cp4 epsps glyphosate USA 1998
Wheat Roundup Ready cp4 epsps glyphosate USA 2004
Table 1. herbicide resistant GM crops
9
Disease Resistance
Abiotic Stress Tolerance
10
Insect Resistance
Modified Product Quality
11
12
What are “Ethics”?
The act of defining what is morally right or wrong.
Two kinds of ethical arguments GMCs
1. Non-scientific base
2. Scientific base
13
Arenas of Ethical Discourse/Debate
• Intrinsic arguments
• Consequentialist arguments
• Rights/consent arguments
• Structural/ Procedural arguments
Jeffrey Burkhardt, IFAS, UF14
STUDIES ON ENVIRONMENTAL
15
Direct effects on non-target organisms
In May 1999, it was reported that
pollen from Bacillus thuringiensis
(Bt) insect resistant corn had a
negative impact on Monarch
butterfly larvae
This report raised concerns and
questions about potential risks to
Monarchs and perhaps other
non-target organisms
(Losey et al,1999, New York)16
Fig. 2. Survival and leaf consumption of second to third-instar monarch larvae on each of three
milkweed leaf treatments: leaves with no pollen (light blue), leaves treated with untransformed
corn pollen (green) and leaves dusted with pollen from Bt corn (dark blue). a, Mean (5s.e.m.)
survival based on the proportion of larvae surviving in five replicates of each treatment. b,
Mean (5s.e.m.) cumulative leaf consumption based on the total amount of leaf area consumed
per larva in five replicates of each treatment. The amount of leaf area consumed per larva in
each experimental unit was calculated for each time interval by dividing the amount of leaf
area consumed in that interval by the number of larvae alive during the time interval.
Cumulative consumption was calculated by summing the leaf area consumed per larva at each
interval. Colours of lines correspond to those of the bars in a.
(Losey et al,1999, New York)17
Protein
Transgenic
plant
Pest Natural enemy
Effects on natural
enemy
Bt (Cry1Ab) corn
Chilo partellus
(Lep: Crambidae)
Diaraetiella rapae
(Hym: Braconidae)
reduced survival owing
to host mortality,
smaller cocoons and
adults
Bt (Cry1Ac) cotton
Helicoverpa
armigera
(Lep: Noctuidae)
Microplitis mediator
(Hym: Braconidae)
wasp survival and
development negatively
affected
Bt (Cry1Ac) Broccoli P. xylostella
Diadegma insulare
(Hym:
Ichneumonidae)
no effect on parasitoid
when exposed by
Bt-resistant hosts
CpTI potato
Lacanobia
oleracea
(Lep: Noctuidae)
Eulophus pennicornis
(Hym:Eulophidae)
fewer hosts parasitized,
no effects on parasitoids
GNA sugarcane E. loftini P. pyralophagus
reduced size and
longevity of adult wasps
Table 2. Impacts of transgenic crops on parasitoids.
(Gatehouse et al., 2011)
18
Development of insect resistance
The use of Bt crops is that it will lead
to the development of insect resistance to
Bt toxins.
19
Gene flow
Accidental cross breeding between GMO plants and traditional
varieties.
Fig. 3. Gene flow
20
Strategies to prevent gene flow
1. Isolation zone - Devoid of vegetation
2. Trap crop - Use of non-transgenic variety
3. Male sterility -Inactive pollens
4. Chloroplast transformation -Gene construct introduced into chloroplast
5. Clean gene technology - Markerless GM
(Chawla,2009)
21
Increased weediness
• Weediness
• There are apprehensions about GM crops becoming weeds.
• development of superweeds
22
Changes in the soil ecology
• Many plants leak chemical compounds
into the soil through their roots
• There are concerns that transgenic plants
may leak different compounds than
conventional plants, As and unintended
sequence of their changed DNA
• The interaction between plants and solid
microorganisms is very complex.
23
Fig. 4. Potential sites of interaction between transgenes and soil microbial community. HT,
herbicide tolerance gene.
24
Genetic Contamination / Interbreeding
• Introduced GMOs may interbreed
with the wild-type or sexually
compatible relatives.
• The novel trait may disappear in wild
types unless it confers a selective
advantage to the recipient.
25
STUDIES ON ANIMAL HEALTH
26
Toxicity
• Any compound entering the
food supply is subject to specific
scrutiny for food safety.
• For example, a potentially toxic
transgenic product, such as Bt
toxin, must pass the same
standards for safety that are
applied to any biochemical
pesticide products.
27
(Aris and Leblanc, 2011, Canada)28
Maternal (n =30) Fetal cord (n =30) P valuea
GLYP
Number of detection
Range of detection (ng/ml)
Mean±SD
nd nd nc
AMPA
Number of detection
Range of detection (ng/ml)
Mean±SD (ng/ml)
nd nd nc
GLUF
Number of detection
Range of detection (ng/ml)
Mean±SD (ng/ml)
nd nd
nc
3-MPPA
Number of detection
Range of detection (ng/ml)
Mean±SD (ng/ml)
30/30 (100%)
21.9–417
120±87.0
30/30 (100%)
8.76–193
57.2±45.6
P <0.001
Cry1Ab
Number of detection
Range of detection (ng/ml)
Mean±SD (ng/ml)
28/30 (93%)
nd–1.50
0.19±0.30
24/30 (80%)
nd–0.14
0.04±0.04
P =0.002
nd, not detectable;
nc, not calculable
because not
detectable. Dataare
expressed asnumber
(n, %) of detection,
range and mean±SD
(ng/ml). a P values
were determined by
Wilcoxon matched
pairs test.
Table 3. Concentrations of GLYP, AMPA, GLUF, 3-MPPA and Cry1Ab protein in
maternal and fetal cord serum
(Aris and Leblanc, 2011, Canada)29
Table 4. Concentrations of GLYP, AMPA, GLUF, 3-MPPA and Cry1Ab protein in
serum of pregnant and nonpregnant women.
nd, not detectable; nc, not
calculable because not
detectable. Data are expressed
as number (n, %) of detection,
range and mean±SD (ng/ml). a
P values were determined by
Mann–Whitney test.
(Aris and Leblanc, 2011, Canada)30
Fig. 5. Chemicals were assessed using GC–MS. P values were determined by Mann–Whitney test in the comparison
of pregnant women to nonpregnant women (A–C). P values were determined by Wilcoxon matched pairs test
in the comparison of maternal to fetal samples (D). A P value of 0.05 was considered as significant.
Fig. 6. Levels of Cry1Ab toxin were assessed using an ELISA method. P values were determined by Mann–Whitney
test in the comparison of pregnant women to non pregnant women (A). P values were determined by
Wilcoxon matched pairs test in the comparison of maternal to fetal samples (B). A P value of 0.05 was
considered as significant.
(Aris and Leblanc, 2011, Canada)
Fig. 6Fig. 5
31
Allergenicity
• Another concern related to food safety
is the potential for genetically modified
food to introduce allergens into the food
Supply
• If the gene product is a known allergen,
then it will also be an allergen in a
transgenic plant.
Example- Brazil-nut allergen
Allergen databases: AgMoBiol, Central Science Lab, PROTALL,
SwissPort
32
(Julie et al., 1996, Nebraska)33
Fig. 7. Results of Radio allergosorbent Assays with Extractsof Non-transgenic Soybean
( ), Transgenic Soybean ( ), and Brazil Nut ( ).
Fig. 8. Results of SDS–PAGE and Autoradiography.
In Panel A, SDS–PAGE gels (gradient, 10 to 20 percent) were stained with Coomassie blue. Lane 1 shows the
molecular-weight standards; lane 2, non-transgenic-soybean extract; lane 3, transgenic-soybean extract; lane 4, Brazil-nut
extract; and lane 5, purified 2S albumin from the Brazil nut. Panels B, C, and D show autoradiographic results of IgE
binding. In Panel B, IgE in serum from a subject allergic to Brazil nuts bound to the 9-kd 2S albumin Brazil-nut protein (lane
4) and proteins of similar molecular weights in extracts from Brazil nut (lane 3) and transgenic soybean (lane 2), but did
not react with an extract of non-transgenic soybean (lane 1). In Panel C, IgE in serum from a subject allergic to Brazil nuts
bound to the 9-kd 2S albumin in Brazil-nut extract (lane 2) and to he 9-kd 2S albumin and 12-kd processed intermediate in
transgenic soybean (lane 1).
(Julie et al., 1996, Nebraska)
Fig. 7 Fig. 8
34
Fig. 9. Reactivity on Skin-Prick Testing to Extracts
of Transgenic Soybean, Non-transgenic
Soybean, and Brazil Nut in a Subject
Allergic to Brazil Nuts.
The dilutions are given in parentheses.
(Julie et al., 1996, Nebraska)
Fig. 9
35
Antibiotic resistance
• Marker gene could induce antibiotic resistance
• Would reduce effectiveness of antibiotics to fight other
diseases
• Conditions for HGT (horizontal gene transfer) :
1. DNA must be free from the cells
2. Integration depends on sequence homology
3. Acid environment of human stomach
4. HGT of nptII gene can occur 1 in 10 billion
5. Specificity of promoter
(Redenbaugh et al,1994)36
(Nielsen et al., 1998)
Fig. 10. Fate of DNA released into the soil environment. Most DNA released into soil is probably
rapidly degraded by exogenous nucleases released by microorganisms.
37
Eating of foreign DNA
• DNA present in all living things and eaten by humans
with every meal
• Broken down during digestion process
• Small amount absorbed in blood stream or excreted
• According to WHO amount of DNA ingested- 0.1 to 1
g/day (novel DNA represents 0.0001%)
(Chawla , 2009)
38
Fig. 11. Coverage of the tomato chloroplast in the IBD sample. Small gray dots indicate the
counts of alignments at individual nucleotide positions, darker shades are the result of
several overlapping points. The orange line is the smoothed coverage of the tomato
chloroplast, while the short gray dash indicates the average coverage level of the human
genome for the same sample.
(Spisak et al., 2013, Hungary)39
Biosafety
Protecting human & animal health and
environment from the possible adverse effects of
the products of modern biotechnology.
Only one crop approved
14 crops under various stages of contained field trials
Include brinjal, cotton, cabbage, groundnut, pigeon pea,
mustard, potato, sorghum, tomato, tobacco, rice, okra and
cauliflower
Traits include insect resistance, herbicide tolerance,
virus resistance, nutritional enhancement, salt tolerance,
fungal resistance
40
Codex Alimentarius commission (CAC)
• CAC is an inter governmental body concerned with
implementation of the joint FAO/WHO food standards
programme in order to protect the health of consumers
and the promote food trade by setting international
standards on food called Codex Standard.
41
Guidelines by Codex Alimentarius Commission
• Assessment of possible allergenicity
• Assessment of possible toxicity
• Compositional analysis of key components
• Food processing
• Nutritional modification
Safety assessment of GM foods comprise
42
Safety assessment approach for GM crops
Fig. 12. Safety assessment approach for GM crops
43
GM foods: Allergenicity; Toxicity
Allergy
It is a hypersensitive reaction initiated by immunologic
mechanisms caused by specific substances called
allergens.
Toxicity
• New proteins as a result of intended and Unintended
modification
Assessment
• Is the gene source allergenic?
• Expression level of introduced gene
• Unintended effect
• Digestibility and heat stability
44
(Séralini et al., 2011, France)45
plants Pesticide contained Name of event Species Duration Main observations
Soybean Roundup herbicide mCP4 EPSPS Mouse 240 days
Ultrastructural
histochemistry
disturbed
Soybean Roundup herbicide mCP4 EPSPS Rat 91 days Weight problems
Maize Roundup herbicide NK603 Rat 90 days Controversial results
Maize mCry1Ab insecticide MON810 Rat 90 days Controversial results
Maize
mCry3Bb1
insecticide
MON863 Rat 90 days Controversial results
Maize mBt insecticide not indicated Rat
Multigeneratio
nal (F3)
Histopathological,
biochemical, organ
weights alterations
Table 5. Review of the longest chronic or subchronic toxicity studies in mammals fed with
commercialized GM soybean and maize representing more than 80% of edible GMOs
(Séralini et al., 2011, France)46
All parameters measured in
vivo in GMO toxicity studies
Measured by organ (%)/Total
(694-698)
Disturbed in each organ (%)/Total
disrupted parameters (approximately
9%)
sex Females Males Females Males
Liver 22.9 22.9 30.8 26.1
Kidney 23.7 23.7 26.4 43.5
Bone marrow 29.5 29.5 29.7 22.8
Total for 3 tissues 76.1 76.1 86.9 92.4
Table 6. Meta-analysis of statistical differences with appropriate controls in feeding
trials
(Séralini et al., 2011, France)47
GM Labelling
• proper labelling represents the
“GM” word along with additional
information on changed
characteristics & the external source
of the inserted genes.
• Why is it necessary to label GM
food?
It is not about health issue
rather, it is about consumer rights to
make an informed choice on GM.
48
Fig. 13. Brazilian GMF and international hazard symbols. Brazilian GMF symbol (the letter "T" in the
center of a yellow triangle with black outline - center), biohazard symbol (top left side), radiation
hazard symbol (top right side), toxic hazard symbol (bottom right side), and warning hazard
symbol (bottom left side), displaying the similarity between them that can promote
miscommunication in food labeling.
Fig. 14. Radura is the international symbol for food that has been treated with ionizing radiation
(Borges et al., 2018)49
Scope of the Cartagena Protocol
The Cartagena Protocol on Biosafety is an international treaty that
seeks to protect biological diversity from the risks posed by living
modified organisms (LMOs), also often referred to as genetically
modified organisms (GMOs), which are a product of modern
biotechnology.
The Protocol is a supplementary agreement to the Convention on
Biological Diversity.
50
Rules, 1989
There are six competent authorities as per the rules:
• Recombinant DNA Advisory Committee (RDAC)
• Review Committee on Genetic Manipulation
(RCGM)
• Genetic Engineering Approval Committee (GEAC)
• Institutional Biosafety Committees (IBSC)
• State Biosafety Coordination Committees (SBCC)
• District Level Committees (DLC).
51
Protocol for release of transgenic crops
Fig. 15. Safety assessment approach for GM crops
52
53
Conclusion
54
55

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Ethical and bio-safety issues related to GM crops

  • 1. 1
  • 2. 2
  • 3. University of Agricultural and Horticultural Sciences, Shivamogga College of Horticulture, Mudigere. ETHICALAND SAFETY ISSUES OF GM CROPS BY: MAHAMMED FAIZAN MH2TAG0165 Dept. of genetics and plant breeding
  • 4. SEMINAR OUTLINE introduction Status of GM crops Advantages and achievements Methods of production of GM crops Ethics Studies on environmental safety Studies on animal health Safety measures 4 Conclusion
  • 5. Genetic engineering the group of applied techniques of genetics and biotechnology used to cut up and join together genetic material and especially DNA from one or more species of organism and to introduce the result into an organism in order to change one or more of its characteristics 5 GMO ??
  • 6. Fig. 1. Acreage of GM crops world wide Status of GM crops 6
  • 7. Methods of production of GM crops 1. Direct Method 2. Indirect Method a) Chemical Method b) Electroporation Method c) Particle bombardment d) Microinjection e) Others 7
  • 8.  Improved nutritional quality  Increased crop yield  Insect resistance  Disease resistance  Herbicide resistance  Salt tolerance  Biopharmaceuticals  Ability to grow plants in harsh environments Advantages 8
  • 9. Achievements Herbicide Resistance Crop Trade name Gene Target Country Year Alfalfa Roundup Ready cp4 epsps glyphosate USA 2005 Canola Liberty Link bar glufosinate USA 1995 Carnation Moonique surB sulfonylurea Colombia 2008 Chicory Seed Link bar glufosinate USA 1997 Cotton WideStrike cp4 epsps glyphosate Mexico 2005 Linseed CDC Triffid Flax als sulfonylurea Canada 1996 Maize Optimum Zm-hra sulfonylurea USA 2008 Rice Liberty Link bar glufosinate USA 1999 Soybean Liberty Link PAT glufosinate USA 1996 Sugarbeet InVigor cp4 epsps glyphosate USA 1998 Wheat Roundup Ready cp4 epsps glyphosate USA 2004 Table 1. herbicide resistant GM crops 9
  • 12. 12
  • 13. What are “Ethics”? The act of defining what is morally right or wrong. Two kinds of ethical arguments GMCs 1. Non-scientific base 2. Scientific base 13
  • 14. Arenas of Ethical Discourse/Debate • Intrinsic arguments • Consequentialist arguments • Rights/consent arguments • Structural/ Procedural arguments Jeffrey Burkhardt, IFAS, UF14
  • 16. Direct effects on non-target organisms In May 1999, it was reported that pollen from Bacillus thuringiensis (Bt) insect resistant corn had a negative impact on Monarch butterfly larvae This report raised concerns and questions about potential risks to Monarchs and perhaps other non-target organisms (Losey et al,1999, New York)16
  • 17. Fig. 2. Survival and leaf consumption of second to third-instar monarch larvae on each of three milkweed leaf treatments: leaves with no pollen (light blue), leaves treated with untransformed corn pollen (green) and leaves dusted with pollen from Bt corn (dark blue). a, Mean (5s.e.m.) survival based on the proportion of larvae surviving in five replicates of each treatment. b, Mean (5s.e.m.) cumulative leaf consumption based on the total amount of leaf area consumed per larva in five replicates of each treatment. The amount of leaf area consumed per larva in each experimental unit was calculated for each time interval by dividing the amount of leaf area consumed in that interval by the number of larvae alive during the time interval. Cumulative consumption was calculated by summing the leaf area consumed per larva at each interval. Colours of lines correspond to those of the bars in a. (Losey et al,1999, New York)17
  • 18. Protein Transgenic plant Pest Natural enemy Effects on natural enemy Bt (Cry1Ab) corn Chilo partellus (Lep: Crambidae) Diaraetiella rapae (Hym: Braconidae) reduced survival owing to host mortality, smaller cocoons and adults Bt (Cry1Ac) cotton Helicoverpa armigera (Lep: Noctuidae) Microplitis mediator (Hym: Braconidae) wasp survival and development negatively affected Bt (Cry1Ac) Broccoli P. xylostella Diadegma insulare (Hym: Ichneumonidae) no effect on parasitoid when exposed by Bt-resistant hosts CpTI potato Lacanobia oleracea (Lep: Noctuidae) Eulophus pennicornis (Hym:Eulophidae) fewer hosts parasitized, no effects on parasitoids GNA sugarcane E. loftini P. pyralophagus reduced size and longevity of adult wasps Table 2. Impacts of transgenic crops on parasitoids. (Gatehouse et al., 2011) 18
  • 19. Development of insect resistance The use of Bt crops is that it will lead to the development of insect resistance to Bt toxins. 19
  • 20. Gene flow Accidental cross breeding between GMO plants and traditional varieties. Fig. 3. Gene flow 20
  • 21. Strategies to prevent gene flow 1. Isolation zone - Devoid of vegetation 2. Trap crop - Use of non-transgenic variety 3. Male sterility -Inactive pollens 4. Chloroplast transformation -Gene construct introduced into chloroplast 5. Clean gene technology - Markerless GM (Chawla,2009) 21
  • 22. Increased weediness • Weediness • There are apprehensions about GM crops becoming weeds. • development of superweeds 22
  • 23. Changes in the soil ecology • Many plants leak chemical compounds into the soil through their roots • There are concerns that transgenic plants may leak different compounds than conventional plants, As and unintended sequence of their changed DNA • The interaction between plants and solid microorganisms is very complex. 23
  • 24. Fig. 4. Potential sites of interaction between transgenes and soil microbial community. HT, herbicide tolerance gene. 24
  • 25. Genetic Contamination / Interbreeding • Introduced GMOs may interbreed with the wild-type or sexually compatible relatives. • The novel trait may disappear in wild types unless it confers a selective advantage to the recipient. 25
  • 26. STUDIES ON ANIMAL HEALTH 26
  • 27. Toxicity • Any compound entering the food supply is subject to specific scrutiny for food safety. • For example, a potentially toxic transgenic product, such as Bt toxin, must pass the same standards for safety that are applied to any biochemical pesticide products. 27
  • 28. (Aris and Leblanc, 2011, Canada)28
  • 29. Maternal (n =30) Fetal cord (n =30) P valuea GLYP Number of detection Range of detection (ng/ml) Mean±SD nd nd nc AMPA Number of detection Range of detection (ng/ml) Mean±SD (ng/ml) nd nd nc GLUF Number of detection Range of detection (ng/ml) Mean±SD (ng/ml) nd nd nc 3-MPPA Number of detection Range of detection (ng/ml) Mean±SD (ng/ml) 30/30 (100%) 21.9–417 120±87.0 30/30 (100%) 8.76–193 57.2±45.6 P <0.001 Cry1Ab Number of detection Range of detection (ng/ml) Mean±SD (ng/ml) 28/30 (93%) nd–1.50 0.19±0.30 24/30 (80%) nd–0.14 0.04±0.04 P =0.002 nd, not detectable; nc, not calculable because not detectable. Dataare expressed asnumber (n, %) of detection, range and mean±SD (ng/ml). a P values were determined by Wilcoxon matched pairs test. Table 3. Concentrations of GLYP, AMPA, GLUF, 3-MPPA and Cry1Ab protein in maternal and fetal cord serum (Aris and Leblanc, 2011, Canada)29
  • 30. Table 4. Concentrations of GLYP, AMPA, GLUF, 3-MPPA and Cry1Ab protein in serum of pregnant and nonpregnant women. nd, not detectable; nc, not calculable because not detectable. Data are expressed as number (n, %) of detection, range and mean±SD (ng/ml). a P values were determined by Mann–Whitney test. (Aris and Leblanc, 2011, Canada)30
  • 31. Fig. 5. Chemicals were assessed using GC–MS. P values were determined by Mann–Whitney test in the comparison of pregnant women to nonpregnant women (A–C). P values were determined by Wilcoxon matched pairs test in the comparison of maternal to fetal samples (D). A P value of 0.05 was considered as significant. Fig. 6. Levels of Cry1Ab toxin were assessed using an ELISA method. P values were determined by Mann–Whitney test in the comparison of pregnant women to non pregnant women (A). P values were determined by Wilcoxon matched pairs test in the comparison of maternal to fetal samples (B). A P value of 0.05 was considered as significant. (Aris and Leblanc, 2011, Canada) Fig. 6Fig. 5 31
  • 32. Allergenicity • Another concern related to food safety is the potential for genetically modified food to introduce allergens into the food Supply • If the gene product is a known allergen, then it will also be an allergen in a transgenic plant. Example- Brazil-nut allergen Allergen databases: AgMoBiol, Central Science Lab, PROTALL, SwissPort 32
  • 33. (Julie et al., 1996, Nebraska)33
  • 34. Fig. 7. Results of Radio allergosorbent Assays with Extractsof Non-transgenic Soybean ( ), Transgenic Soybean ( ), and Brazil Nut ( ). Fig. 8. Results of SDS–PAGE and Autoradiography. In Panel A, SDS–PAGE gels (gradient, 10 to 20 percent) were stained with Coomassie blue. Lane 1 shows the molecular-weight standards; lane 2, non-transgenic-soybean extract; lane 3, transgenic-soybean extract; lane 4, Brazil-nut extract; and lane 5, purified 2S albumin from the Brazil nut. Panels B, C, and D show autoradiographic results of IgE binding. In Panel B, IgE in serum from a subject allergic to Brazil nuts bound to the 9-kd 2S albumin Brazil-nut protein (lane 4) and proteins of similar molecular weights in extracts from Brazil nut (lane 3) and transgenic soybean (lane 2), but did not react with an extract of non-transgenic soybean (lane 1). In Panel C, IgE in serum from a subject allergic to Brazil nuts bound to the 9-kd 2S albumin in Brazil-nut extract (lane 2) and to he 9-kd 2S albumin and 12-kd processed intermediate in transgenic soybean (lane 1). (Julie et al., 1996, Nebraska) Fig. 7 Fig. 8 34
  • 35. Fig. 9. Reactivity on Skin-Prick Testing to Extracts of Transgenic Soybean, Non-transgenic Soybean, and Brazil Nut in a Subject Allergic to Brazil Nuts. The dilutions are given in parentheses. (Julie et al., 1996, Nebraska) Fig. 9 35
  • 36. Antibiotic resistance • Marker gene could induce antibiotic resistance • Would reduce effectiveness of antibiotics to fight other diseases • Conditions for HGT (horizontal gene transfer) : 1. DNA must be free from the cells 2. Integration depends on sequence homology 3. Acid environment of human stomach 4. HGT of nptII gene can occur 1 in 10 billion 5. Specificity of promoter (Redenbaugh et al,1994)36
  • 37. (Nielsen et al., 1998) Fig. 10. Fate of DNA released into the soil environment. Most DNA released into soil is probably rapidly degraded by exogenous nucleases released by microorganisms. 37
  • 38. Eating of foreign DNA • DNA present in all living things and eaten by humans with every meal • Broken down during digestion process • Small amount absorbed in blood stream or excreted • According to WHO amount of DNA ingested- 0.1 to 1 g/day (novel DNA represents 0.0001%) (Chawla , 2009) 38
  • 39. Fig. 11. Coverage of the tomato chloroplast in the IBD sample. Small gray dots indicate the counts of alignments at individual nucleotide positions, darker shades are the result of several overlapping points. The orange line is the smoothed coverage of the tomato chloroplast, while the short gray dash indicates the average coverage level of the human genome for the same sample. (Spisak et al., 2013, Hungary)39
  • 40. Biosafety Protecting human & animal health and environment from the possible adverse effects of the products of modern biotechnology. Only one crop approved 14 crops under various stages of contained field trials Include brinjal, cotton, cabbage, groundnut, pigeon pea, mustard, potato, sorghum, tomato, tobacco, rice, okra and cauliflower Traits include insect resistance, herbicide tolerance, virus resistance, nutritional enhancement, salt tolerance, fungal resistance 40
  • 41. Codex Alimentarius commission (CAC) • CAC is an inter governmental body concerned with implementation of the joint FAO/WHO food standards programme in order to protect the health of consumers and the promote food trade by setting international standards on food called Codex Standard. 41
  • 42. Guidelines by Codex Alimentarius Commission • Assessment of possible allergenicity • Assessment of possible toxicity • Compositional analysis of key components • Food processing • Nutritional modification Safety assessment of GM foods comprise 42
  • 43. Safety assessment approach for GM crops Fig. 12. Safety assessment approach for GM crops 43
  • 44. GM foods: Allergenicity; Toxicity Allergy It is a hypersensitive reaction initiated by immunologic mechanisms caused by specific substances called allergens. Toxicity • New proteins as a result of intended and Unintended modification Assessment • Is the gene source allergenic? • Expression level of introduced gene • Unintended effect • Digestibility and heat stability 44
  • 45. (Séralini et al., 2011, France)45
  • 46. plants Pesticide contained Name of event Species Duration Main observations Soybean Roundup herbicide mCP4 EPSPS Mouse 240 days Ultrastructural histochemistry disturbed Soybean Roundup herbicide mCP4 EPSPS Rat 91 days Weight problems Maize Roundup herbicide NK603 Rat 90 days Controversial results Maize mCry1Ab insecticide MON810 Rat 90 days Controversial results Maize mCry3Bb1 insecticide MON863 Rat 90 days Controversial results Maize mBt insecticide not indicated Rat Multigeneratio nal (F3) Histopathological, biochemical, organ weights alterations Table 5. Review of the longest chronic or subchronic toxicity studies in mammals fed with commercialized GM soybean and maize representing more than 80% of edible GMOs (Séralini et al., 2011, France)46
  • 47. All parameters measured in vivo in GMO toxicity studies Measured by organ (%)/Total (694-698) Disturbed in each organ (%)/Total disrupted parameters (approximately 9%) sex Females Males Females Males Liver 22.9 22.9 30.8 26.1 Kidney 23.7 23.7 26.4 43.5 Bone marrow 29.5 29.5 29.7 22.8 Total for 3 tissues 76.1 76.1 86.9 92.4 Table 6. Meta-analysis of statistical differences with appropriate controls in feeding trials (Séralini et al., 2011, France)47
  • 48. GM Labelling • proper labelling represents the “GM” word along with additional information on changed characteristics & the external source of the inserted genes. • Why is it necessary to label GM food? It is not about health issue rather, it is about consumer rights to make an informed choice on GM. 48
  • 49. Fig. 13. Brazilian GMF and international hazard symbols. Brazilian GMF symbol (the letter "T" in the center of a yellow triangle with black outline - center), biohazard symbol (top left side), radiation hazard symbol (top right side), toxic hazard symbol (bottom right side), and warning hazard symbol (bottom left side), displaying the similarity between them that can promote miscommunication in food labeling. Fig. 14. Radura is the international symbol for food that has been treated with ionizing radiation (Borges et al., 2018)49
  • 50. Scope of the Cartagena Protocol The Cartagena Protocol on Biosafety is an international treaty that seeks to protect biological diversity from the risks posed by living modified organisms (LMOs), also often referred to as genetically modified organisms (GMOs), which are a product of modern biotechnology. The Protocol is a supplementary agreement to the Convention on Biological Diversity. 50
  • 51. Rules, 1989 There are six competent authorities as per the rules: • Recombinant DNA Advisory Committee (RDAC) • Review Committee on Genetic Manipulation (RCGM) • Genetic Engineering Approval Committee (GEAC) • Institutional Biosafety Committees (IBSC) • State Biosafety Coordination Committees (SBCC) • District Level Committees (DLC). 51
  • 52. Protocol for release of transgenic crops Fig. 15. Safety assessment approach for GM crops 52
  • 53. 53
  • 55. 55

Editor's Notes

  1. Biotechnology is at the intersection of science and ethics. Technological developments are shaped by an ethical vision, which in turn is shaped by available technology. Much in biotechnology can be celebrated for how it benefits humanity. But technology can have a darker side. Biotechnology can produce unanticipated consequences that cause harm or dehumanise people. The ethical implications of proposed developments must be carefully examined. The ethical assessment of new technologies, including biotechnology, requires a different approach to ethics. some of the ethical dilemmas that have arisen as a result of the development and deployment of transgenic crop plants. The potential for transgenic crops to alleviate human hunger and the possible effects on human health and environment will discussed.
  2. EPSPS- blocks amino acid synthesis by inhibition of 5-enolpyruvylshikamte-3-phosphate synthase
  3. GROWING NON HOST CROP FOR MONARCH BUTTERFLY
  4. REFUGE CROPING SYSTEM
  5. Distraction local resource ecological disturbance
  6. Super weeds
  7. Toxins through root exudates
  8. However, tolerance abilities of wild types may also develop, thus altering the native species’ ecological relationship and behavior. Genetic erosion and genetic pollution.
  9. when a Brazil nut albumin was expressed in soybean to boost methionine content
  10. • It was found that serum from Brazil nut allergic subjects reacted with the transgenic soybean extracts
  11. a publication by the Organization for Economic Cooperation and Development (OECD), called "Recombinant DNA Safety Considerations," became the first intergovernmental document to address issues surrounding the use of GMOs.
  12. The task force : Principles of risk analysis of food Derived from modern biotechnology. Guideline for the conduct of food safety Assessment for food produced Guideline for the conduct food safety Assessment of foods derived from rDNA plants.
  13. GM foods: need for safety assessment Expressed proteins generally not a part of regular food supply Food complex mixtures e.g. nutrients, anti-nutrients and natural toxins Directly enter human system Assume different forms Involve storage, processing, transportation
  14. Coclusion- Taxotest approach Long term test Acute toxicity approach Transcriptomics and proteomics methods
  15. Protocols for Food and Feed Safety Assessment of GE crops (DBT, ministry of science and technology, GOI) I. Acute Oral Safety Limit Study In Rats and Mice II. Sub-chronic Feeding Study In Rodents III. Protein Thermal Stability IV. Pepsin Digestibility Assay V. Livestock Feeding Study
  16. Being ethical in a scientific way. Improvement in safety assessment of gm foods.
  17. Eugenics, tribalism, bioterrorism, codan-code, agrananism Genetically Modified crops are one of the best sources for solving the problems revolving around agriculture management. Production of GM crops for trait specific enhancement may lead to better crop production and human health concern. Based on the report the GM crops are known to show some drawbacks like adverse impact on environment and human health. By, proper biosafety protocol on production and registration of GM crops can be introduced into the environment with meager effects.
  18. Thanx for spending your most precious time.