Assesment Food and Environmental Saftey of Genetically Engineered (GE) Food Crops

4/18/2017 1Plant Biotechnology

Defined by the World Health Organization (WHO), genetically modified (GM)
or genetically engineered (GE) foods are foods derived from organisms in which
genetic material has been altered in a way that does not occur naturally by
mating and/or natural recombination.
Genetically Modified Food (GM Food)

4/18/2017 Plant Biotechnology 3
Outline
Biotech Crop Highlights in 2015
Top 10 Commercially Available GM Crops
Regulation of GM Crops in India
Regulation of GM Foods in the U.S. & E.U.
Safety assessment approach for GM Food crops
Codex framework of the safety assessment of a food derived from G.M. Crops
Case Study
Selected G.E. crops at various stages of field testing in India
Summary

4/18/2017 4Plant Biotechnology http://www.isaaa.org/

Sr.
No.
Crop Trait (s) GM Events
1. Soybean (Glycine max L.) HT 36
2. Maize (Zea mays L.) IR/HT/NI 231
3. Cotton (Gossypium hirsutum L.) IR/HT 58
4. Canola (Brassica napus) HT/MS 39
5. Potato (Solanum tuberosum L.) IR/DR 47
6 Rice (Oryza sativa L.) IR/HT/NI 07
7. Papaya (Carica papaya) DR (PRSV) 04
8. Squash (Cucurbita pepo) DR (YMV) 03
9. Alfalfa (Medicago sativa) HT 05
10. Sugar Beet (Beta vulgaris) HT 03
Top 10 Commercially Available GM Crops

Biotech Crop Highlights in 2015
http://www.isaaa.org/

Cont. . . Biotech Crop Highlights in 2015
http://www.isaaa.org/

Government of India (GOI)
Department of
Biotechnology (DBT)
RDAC
Policy recommendations
RCGM
Monitoring Safety
Manual guidelines
IBSC
Implementation of guidelines
SBSC
Regulations of violations related to GMO’s
DLBSC
Monitoring safety regulations at district level
Ministry of
Environment &
Forest (MoEF)
GEAC
Permission & Approval of
GMO’s
Regulation of GM Crops in India
Choudhary, B. et. al.,
Plant Biotech Journal, 2014 (12)

Review to
prove
GMOs are
safe to eat
Review of
GMOs that
enhance pest
control to
prove they
are safe for
the
environment
Review of
all GMOs
to prove
they are
safe to
grow
After 13 YEARS and
$136 MILLION
(on average), the seed
variety is brought
to market
New GMO seed
variety
How a GM Seed Gets to Market in USA…?
www.FoodDialogues.com
EPA

http://sitn.hms.harvard.edu/flash/2015/sam
e-science-different-policies/
Regulation of GM foods in the U.S. & E.U.
Product based Process based

Safety assessment approach for GE crops
GM food safety assessment / Tools for trainers
FAO, 2008
Substantial equivalence

 The safety of foods produced from genetically modified (GM) organisms (GM)
organisms, GMOs or GM crops is mandated by most countries including the US, China
and countries who are members of the Codex Alimentarius Commission (CAC), an
international food standards program within the World Health Organization and the
Food and Agricultural Organization of the United Nations ( www.codexalimentarius.org ).
 International organizations like the Food and Agriculture Organization (FAO) of the
United Nations, the World Health Organization (WHO) and the Organization for
Economic Cooperation and Development (OECD) have been facilitating the
harmonization of food and feed risk assessment methodologies.
Goodman R.E., 2014
Journal of Huazhong Agricultural University, Vol. 33 No.6
International Organizations Involved in GM Food Risk Assessment

The Codex framework of the safety assessment of a food derived
from G.M. Crops
Koniga,A., et.al.,2004
Food and Chemical Toxicology

What is ‘Substantial equivalence’ ? : Key Element
 It is widely accepted that the best approach to begin the safety assessment of GM
food and feed is a comparative approach.
 According to this principle, if a new food or feed derived from a GM crop is shown to
be substantially equivalent to its conventional counterpart, then it is considered to be
as safe as the food or feed from the conventional crop, and the assessment then
focuses on the safety of the introduced traits (Codex Alimentarius, 2003b).
Garcia-Alonso M.
Collection of Biosafety Reviews Vol. 8 (2013):
Assessment of whole foods
Based on the principle of "substantial
equivalence”, i.e. as safe as the
conventional counterpart

4/18/2017 Plant Biotechnology 17Syngenta
Davis P. et.al., 2015
Syngenta Crop Protection AG (Syngenta) has developed MZIR098 Corn (maize; Zea
mays L.), a new cultivar that has been genetically modified to provide dual modes of
action for control of corn rootworm (Diabrotica spp.) and tolerate herbicides
containing glufosinate-ammonium.
Case Study

Description of the parent crop
 Corn belongs to the Poaceae family and likely originates from southern Mexico.
 It is cultivated extensively around the world, with the largest production in the
U.S., China, Brazil, and Argentina.
Syngenta

Description of the donor(s), transgene(s) and delivery process
 Recipient Corn Line - Syngenta inbred corn line, NP2222
- Well-suited to Agrobacterium-mediated transformation and
regeneration from tissue culture.
 Transformation method- Agrobacterium-mediated
 Incorporate the transgenes - eCry3.1Ab, mCry3A, and PAT-08
Syngenta

Cont. . .
 The native Cry3A from the soil bacterium Bacillus thuringiensis subsp. tenebrionis is
active against coleopteran pests.
 Effective in controlling three of the major rootworm pests of corn in the U.S.,
specifically:
 Diabrotica virgifera virgifera (western corn rootworm)
 D. longicornis barberi (northern corn rootworm)
 D. virgifera zeae Krysan (Mexican corn rootworm).
 The transgene PAT-08 was derived from the soil bacterium Streptomyces
viridochromogenes.
 PAT acetylates glufosinate-ammonium, thus inactivating it and conferring tolerance to
glufosinate-ammonium in herbicide products, and was used as the selectable marker in
development of MZIR098 corn.
 In addition, regulatory sequences from cauliflower mosaic virus, yellow leaf curling
virus, and A. tumefaciens were introduced during the production of MZIR098 corn.
Syngenta

Steps in the development of MZIR098 corn
Syngenta

Description of the gene product(s)
Syngenta
 Nucleotide sequence of the ecry3.1Ab gene in 5307 corn encoding the eCry3.1Ab
protein was confirmed by nucleotide sequencing of the insert.
 5307 corn is currently approved to support cultivation activities in the U.S. and
Canada.
1. eCry3.1Ab Protein Familiarity and History of Safe Exposure

Amino acid sequence alignment between eCry3.1Ab in
5307 corn and eCry3.1Ab in MZIR098 corn
Similar
amino acid
sequence
eCry3.1Ab in 5307
eCry3.1Ab in MZIR098
Syngenta

1.2 Levels of eCry3.1Ab Protein in MZIR098 Corn Tissues
Concentrations of eCry3.1Ab in MZIR098 corn tissue samples at several
growth stages, across four locations, on a dry-weight and fresh-weight basis
Syngenta

1.3 Identification and Characterization of the eCry3.1Ab Protein
Confirmed by peptide mass coverage analysis, apparent molecular weight, and
immunoreactivity.
Amino acid sequence identified by
peptide mass coverage analysis
85.9%
Syngenta

Western blot analysis of eCry3.1Ab and mCry3A as expressed in MZIR098 corn
eCry3.1Ab
mCry3A
eCry3.1Ab
&
mCry3A
Syngenta

2. mCry3A Protein Familiarity and History of Safe Exposure
mCry3A in MIR604 corn and mCry3A in
MZIR098 corn
Similar
amino
acid
sequence
Levels of mCry3A Protein in MZIR098
Corn Tissues
91.6%
Syngenta

3. PAT-08 Protein Familiarity and History of Safe Exposure
PAT-08 in Bt-11 corn and PAT-08 in
MZIR098 corn
Similar
amino
acid
sequence
Levels of PAT Protein in MZIR098 Corn
Tissues
96%
Syngenta

Cont. . .
Western blot analysis of PAT from MZIR098 corn
Syngenta

Description of the new GM crop
Syngenta
Satellite view of composition trial locations in the United States

Compositional Assessment of MZIR098 Corn Grain and Forage
 Identification of test, control, and reference corn varieties
 Field-trial locations for composition study
Syngenta

Compositional Analysis Results
1. Mineral composition
2. Starch composition

3. Vitamin composition
Conclusion from Compositional Analyses
These results indicate that the levels of the majority of nutritional components did not
differ between MZIR098 and near-isogenic, nontransgenic control corn, and that those
levels that did differ fell within ranges considered to be normal for conventional corn.

Food allergies
Assessment strategy for allergenicity
 Source of the protein
 Amino acid sequence homology (FASTA or BLASTP)
 Pepsin degestion
 Specific serum screening
GM food safety assessment / Tools for trainers
FAO, 2008
IgE cross-reactivity between the newly expressed protein and a known allergen should
be considered a possibility when there is more than 35% identity in a segment of 80 or
more amino acids (FAO/WHO, 2001).
Allergenic

Allergen databases on the Internet
Koniga,A., et.al.,2004
Food and Chemical Toxicology

 Gene Flow
Tripsacum dactyloides
The chance of natural introgression of genes from corn
to Tripsacum was ‘extremely remote’ and that no other
species in the continental U.S. would interbreed with
commercial corn.
Environmental Saftey of MZIR098 Corn
 Effects of eCry3.1Ab and mCry3A on Nontarget Organisms
As assessments of the risk to nontarget species have been performed for the eCry3.1Ab
and mCry3A proteins expressed in 5307 and MIR604 corn, and because the eCry3.1Ab
and mCry3A proteins expressed in 5307 and MIR604 corn are the same as those
expressed in MZIR098 corn, the environmental assessments for 5307 and MIR604 corn
inform the assessment of MZIR098 corn.
Syngenta

 Laboratory and field investigations confirmed that there were no changes in grain,
pollen, plant phenotypic, or compositional parameters suggestive of increased plant pest
risk or increased susceptibility of MZIR098 corn to plant disease or other pests.
 Well-characterized modes of action, physicochemical properties, and a history of safe
use demonstrate that the eCry3.1Ab, mCry3A, and PAT proteins present in MZIR098 corn
present no risk of harm to humans or livestock that consume corn products.
 Compositional assessments of grain and forage from multiple U.S. field sites
demonstrated that MZIR098 corn is nutritionally and compositionally equivalent to, and
as safe and nutritious as, conventional corn.
 Corn does not possess weedy properties or outcross to wild relatives in the U.S.; these
properties have not been altered in MZIR098 corn.
Conclusions:

4/18/2017 Plant Biotechnology
38
Labeling of G.M. Food & Their Products
PLU Code (Price Look-Up Code)
& 3
 Europe - Strict labeling
 USA - Voluntarily Labeling
IFPS PLU codes, 2015

Selected G.E. crops at various stages of field testing in India
IR: Insect Resistant HT: Herbicide Tolerance VR: Virus Resistance FR: Fungal Resistance
AP: Agronomic Performance DR: Drought Tolerance
Sr. No. Crop Trait (s) Attributes Institutions
1. Brinjal/Eggplant IR Fruit and shoot borer NRCPB/ICAR, Bejo Sheetal,
Ankur Seeds & Rasi Seed
2. Chickpea IR Pod borer resistance AAU, DBT & Sungro Seeds
3. Cotton IR/HT Stacked insect resistant &
herbicide tolerant
Mahyco & Monsanto
4. Cotton IR/HT Triple gene insect
resistant & herbicide
tolerant
Monsanto
5. Corn IR/HT Stacked insect resistant &
herbicide tolerant
Pioneer, Monsanto, Syngenta
& Metahelix
6. Groundnut VR/FR Groundnut rosette virus,
Aspergillus flavus &
Aflatoxin
ICRISAT
Clive J. 2015
ISAAA Brief

Sr. No. Crop Trait (s) Attributes Institutions
7. Mustard AP Heterosis exploitation University of Delhi & South
Asia
8. Pigeon pea IR Pod borer resistance ICRISAT
9. Potato DR Late blight resistance CPRI, ICAR, ABSP-II & USAID
10. Rice IR Insect resistance Mahyco, Rasi Seed, Metahelix,
Bayer, Pioneer, JK Agrigenetics
& Bioseeds
11. Rice NUE Nitrogen use efficiency Mahyco
12. Sugarcane AP Drought tolerant SRI & UPCSUR
IR: Insect Resistant HT: Herbicide Tolerance VR: Virus Resistance FR: Fungal Resistance
AP: Agronomic Performance DR: Drought Tolerance
Clive J. 2015
ISAAA Brief
Cont. . .

Summary
 Over the last two decades, individual governments and intergovernmental
organizations have designed strategies and protocols for safety assessment of foods/ feed
derived from GM crops, (FAO/WHO, CAC, OECD etc).
 All GM crops that have been approved for commercialization and entered the agri-food
chain have undergone extensive testing.
 The corner stone of the safety assessment of novel foods, including foods derived from
GM crops, is the concept of substantial equivalence.
 Challenges in the use of animal models for testing whole foods include the importance
of ensuring nutritional balance when diets contain high proportions of novel foods or
food extracts.
 Advances in molecular biology, toxicology, biochemistry, and nutrition will provide
novel biomarkers and methodologies, which could be developed into new safety
assessment tools.

References :
Kramer, C., Brune, P., McDonald, J., Nesbitt, M., Sauve, A. and Storck‐Weyhermueller, S.,
(2016). Evolution of risk assessment strategies for food and feed uses of stacked GM
events. Plant biotechnology journal, 14 . pp.1899-1913
James, Clive. (2015). 20th Anniversary (1996 to 2015) of the Global Commercialization of
Biotech Crops and Biotech Crop Highlights in 2015. ISAAA Brief No. 51. ISAAA: Ithaca, NY.
Goodman, R.E., (2014). Biosafety: evaluation and regulation of genetically modified (GM)
crops in the United States.
Garcia-Alonso, M., (2013). Safety assessment of food and feed derived from GM crops:
using problem formulation to ensure “fit for purpose” risk assessments. Collect Biosafety
Rev, 8 (2013), pp.72-101.
GM food safety assessment tools for trainers, Food and Agriculture Organization of the
United Nations Rome, 2008.
Arora, N. and Mishra, A., (2011). Safety assessment of genetically modified food crops.
Indian J Allergy Asthma Immunol, 25(2), pp.53-60.

Li, Y., (2012). Gene deletor: a new tool to address gene flow and food safety concerns
over transgenic crop plants. Frontiers in biology, 7(6), pp.557-565.
König, A., Cockburn, A., Crevel, R.W.R., Debruyne, E., Grafstroem, R., Hammerling, U.,
Kimber, I., Knudsen, I., Kuiper, H.A., Peijnenburg, A.A.C.M. and Penninks, A.H., (2004).
Assessment of the safety of foods derived from genetically modified (GM) crops. Food
and Chemical Toxicology, 42(7), pp.1047-1088.
Choudhary, B., Gheysen, G., Buysse, J., Meer, P. and Burssens, S., (2014). Regulatory
options for genetically modified crops in India. Plant biotechnology journal, 12(2), pp.135-
146.
Davis, K. P. (2015) Request for an extension of determination of nonregulated status for
insect-resistant and herbicide-tolerant event MZIR098 corn. Syngenta Seeds, Inc. CR019-
USDA-1
References :

http://www.thedailystar.net/country/Bangla
desh-to-release-3-more-GM-brinjal-varieties-
1380223
http://www.isa
aa.org/
Online Resources

https://www.aphis.usda.gov/aphis/our
focus/biotechnology/SA_Environment
al_Documents
https://www.aphis.usda.gov/br
s/biotech_ea_permits.html
Permits with
Environmental
Assessments
as of March 27,
2017

http://gmo-crl.jrc.ec.europa.eu/gmomethods/
The EU Database of Reference
Methods for GMO Analysis
provides comprehensive
information of fully validated
GMO detection methods. Novel
GMO detection methods could be
validated by European Network of
GMO Laboratories (ENGL)
advisory group via submission.
Reference Methods for GMO Analysis

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