New GM Products
Implications for Food Safety
and Environmental Risk Assessment:
SUGARCANE
Reinaldo M. Barata
Regulatory Affairs Manager
Sugarcane Technology Center
October 14th, 2013
CTC - Sugarcane Technology Center
CTC – Copersucar Technology Center
2011
1969
2004
Headquarter in Piracicaba
CTC – Sugarcane Technology
Center (non profit)
CTC S.A.
(for profit)
Business Plan
NEW TECHNOLOGIES
VARIETIES
Business Plan
VARIETIES
Conventional
Breeding
Conventional Breeding
The biggest sugarcane germoplasm collection in the world
Breeding Station
Camamu – BA (50ha)
CTC Varieties - Market Share
89 varieties with brands SP and CTC
including SP81-3250, second most cultivated in Brazil
13% of the area
CTC
28
SP
61
50% Market Share
NovoBusiness
Plano dePlan
Negócios
VARIETIES
Biotechnology
Transgeny and Molecular Markers
•
•
•
•
•
High Sugar
More Productivity
Drought Tolerance
Insect Resistance
Herbicide Tolerance
First GM
Sugarcane in Brazil
(1994)
Sugarcane - Geographical Distribution
1.8 billion ton
harvested in 2011
35° N
75%
world sugar
35° S
Tropical and Subtropical zone:
Fits for the exploitation of sugarcane
Sugarcane – Geographical Distribution and
Economic Importance
Main Producers in the world
15%
9.8 Mha
588 million tons
Brazil is the world’s leading sugar producer
and exporter:
- Sugar production: 38.2 million tons
- 25 % of global production
- 50 % of world exports
85%
In 2012/13, Brazilian ethanol production reached:
- 23.2 billion liters (6.1 billion gallons)
- Most of this production is absorbed by the
domestic market where it is sold as either pure
ethanol fuel or blended with gasoline
Commercial Sugarcane Cycle
Bud
Stalk pieces
used in planting
Beginning of
bud sprouting
and rooting
Tillering phase
Intense tillering
and begining of
maturation
Maturation: stalks
in optimal sucrose
concentration
1st harvest
100 ton/ha
2nd harvest
94 ton/ha
3rd harvest
83 ton/ha
4th harvest
76 ton/ha
5th harvest
70 ton/ha
Replanting with
news stalks is required
Industrial Processing in the Mill
(Sugar, Ethanol, Vinasse, Filtercake and Bagasse=Biomass)
Sugarcane Industrial Processing in an Average Mill
400
ton/h
100-150
ton
50/50
12 ton
Processing 10,000 tons a day of sugarcane:
•
•
•
•
•
208,000 l
2,500-3,000 ton of Bagasse
300 ton of Filtercake
600 ton of Sugar
400,000 liters of ethanol
5,200,000 liters of vinasse
24 ton
16,000 l
Industrial Processing in the distilleries
(Ethanol, Vinasse, Filtercake and Bagasse=Biomass)
300
ton/h
Distribution of mills and distilleries in Brazil
75 ton
100%
9 ton
312,000 L
24,000 L
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Field Trial with GM Sugarcane
1 hectare = 10,000 m2
Soccer Field with Sugarcane
100 tons in 1st harvesting
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Disposal: only 2 ways
COMMUNICATION N° 07 - OCTOBER 21st, 2010
National Technical Commission on Biosafety (CTNBio) stipulates the following
conditions for genetically modified sugar cane disposal:
“The biomass produced by experiments with GM sugar cane should be discarded in
distilleries or crushed and buried in graves in areas with CQB”
5m
6m
1st harvest
15 m
With CQB?
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Urgent: new Resolution for Disposal (additional ways)
300
ton/h
75 -100
ton
100%
9 ton
Without CQB!
Distilleries process 7,500 ton/day
GM Sugarcane – 100 ton (20 minutes)
• 8 m3 Ethanol
(1,5% of what is produced by day = 576 m3)
312,000 L
• 30 ton of bagasse
(1,5% of what is produced by day = 2,400 ton)
• 96 m3 of vinasse
(1,5% of what is produced by day = 7,500 m3)
24,000 L
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Urgent: New
new Resoltution
Resolution for
forDisposal
Disposal(additional
(additionalways)
ways)
Urgent: newperformed
Experiment
Resoltutionatf CTC
Bud
Is GM sugar coming to town?
Where are we with GM sugarcane?
Field Trials with GM Sugarcane in Brazil applied at CTNBio (1997-2013)
70 Field Trials
•
•
•
•
•
Insect Resistance
Herbicide Tolerance
Drought Tolerance
High Productivity
High Sugar
Is GM sugar coming to town?
Where are we with GM sugarcane?
Advanced GM Sugarcane Field Trial in World
USA: Texas A&M
Traits: Herbicide tolerance and Viral Control
Status: Preparing deregulation application
Indonesia: PT Perkebunan
Trait: Drought tolerance
Fase: Approved
Argentina: Chakra
Trait: Herbicide tolerance (glyphosate)
Status: Preparing deregulation application
Brazil: Is GM sugar coming to town?
Requirements for the Commercial Release GMO and their by products
Normative
Resolution n° 05
CTNBio*
Annex II
Annex III
Information
Related to the
GMO
Human and Animal
Health Risk
Assessment
*CTNBio
NATIONAL TECHNICAL
COMMISSION ON
BIOSAFETY
Annex IV
Environment Risk
Assessment
Gene Flow
Gene Flow
Sugar and garapa
Sugar and garapa
OECD recommendations
Overview of Problems
and Prospects
Brazil: Is GM sugar coming to town?
Requirements for the Commercial Release GMO and their by products
Normative
Resolution n° 05
*CTNBio
NATIONAL TECHNICAL
COMMISSION ON
BIOSAFETY
CTNBio*
Annex II
Information Related
to the GMO
Annex III
Human and Animal
Health Risk
Assessment
Annex IV
Environment Risk
Assessment
- Centers of Origin and Diversity - Genetic Constitution
- Gene Flow
Requirements for the Commercial Release GMO and their by products
Sugarcane Evolution and Domestication
Saccharum Complex Teory
3
2
1
In Brazil, sugarcane is
considered an exotic crop
and non-invasive plant.
S. officinarum
100 years ago
Java Island
S. officinarum
Nobilization
S. spontaneum
Saccharum interspecific hybrids
S. Spontaneum Recombinants
Requirements for the Commercial Release GMO and their by products
Sugarcane Gene Flow
Besides being exotic:
•
•
•
•
Pollen has low viability in normal conditions
Requires very specific conditions to flower
Sexual reproduction (Northeast Region of Brazil)
There no known wild relatives in Brazil
Recent studies:
some botanists have classified some Brazilian native
plants from Erianthus genus as belonging to the
Saccharum genus
Dr. Giancarlo Conde Xavier de Oliveira
(ESALQ/USP)
Deadline: 2016/2017
S. angustifolium
S. asperum
S. villosum
Brazi: Is GM sugar coming to town?
Requirements for the Commercial Release GMO and their by products
*CTNBio
NATIONAL TECHNICAL
COMMISSION ON
BIOSAFETY
Normative
Resolution n° 05
CTNBio*
Annex III
Annex II
Information Related
to the GMO
Human and Animal
Health Risk
Assessment
Annex IV
Environment Risk
Assessment
Compositional Analysis
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Compositional Analysis – OECD
food
SECTION IV- SUGGESTED CONSTITUENTS TO BE ANALYSED
RELATED TO FOOD USE
The key constituents suggested to be analysed in sugarcane
intended for human consumption are shown.
SECTION V - SUGGESTED CONSTITUENTS TO BE ANALYSED
RELATED TO FEED USE
The key constituents suggested to be analysed in sugarcane
intended for animal consumption are shown below. Acid
detergent fibre (ADF) and neutral detergent fibre (NDF) are
relevant analytes particularly for ruminant feed.
feed
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Compositional Analysis – Baseline Data
food
An important component of demonstrating that the products of
GM sugarcane varieties are substantially equivalent to
conventional varieties is whether the nutritional composition falls
within the range of compositions that are currently found in
production
The science-based regulatory assessment relies on good baseline
data on the biology of conventional varieties for comparison with
the new modified varieties to identify any potential changes.
feed
Dr. Giancarlo Conde Xavier de Oliveira
(ESALQ/USP)
Deadline: 2017/2018
Safety of GM sugarcane products
Investigation of Residual DNAs and proteins in Sugar
from Sugarcane
Sugarcane Industrial Processing in a Mill
Raw Juice
WT
GM Sugarcane Agro
nptII
GM Sugarcane biolistics
nptII
Leaf, Fibre, Juice, Syrup, Filter Mud, Molasses, Sugar
The composition of sucrose, glucose and frutose in juice
and raw sugar were indistinguishable
Safety of GM sugarcane products
Sugarcane Artisanal Processing
Rapadura, Muscovado Sugar and Sugarcane Syrup
DNA:
+
Protein: +
DNA:
+
Protein: +
1
1
3
2
4
2
3
4
DNA:
Protein: -
DNA:
Protein: -
DNA:
Protein: -
DNA:
Protein: -
Cachaça
Regulation of (GM) Sugarcane in Brazil
Recommended Reference
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Sugarcane Additional Issues
-
Introduced trait is not easily transfered to other varieties by the breeding programs (around 10
years)
Cane growers need different varieties of sugarcane for different environmental conditions
New Events with same/similar constructs = shall pass through a Simplified Analysis by CTNBio.
Normative Resolution n° 05 (CTNBio*)
Requirements for the Commercial Release GMO and their
byproducts
*NATIONAL BIOSAFETY TECHNICAL COMMISSION
CHAPTER I
PRELIMINARY AND GENERAL PROVISIONS
Article 3. GMOs containing the same genetic
construction used in a GMO of the same species, for
which a technical opinion favorable to commercial
release in Brazil has already been issued, shall be
subject to a simplified analysis for release thereof, at
the discretion of CTNBio.
Suggestions: all data from risk assessment of the
first variety approved should be used with the
inclusion of the following data:
1- Molecular characterization of the GMO related
to: (1) the number of copies inserted, and (2) the
location of insertion into the genome, where
possible, (3) flanking sequences, where possible;
2 – Compositional analysis;
3 - Determination of the expression level(s) of the
product of the gene inserted in the receptor
organism.
GM Sugarcane Regulation in Brazil
Overview of Problems and Prospects
Sugarcane Additional Issues
-
Introduced trait is not easily transfered to other varieties by the breeding programs (around 10
years)
Cane growers need different varieties of sugarcane for different environmental conditions
New Events with same/similar constructs = shall pass through a Simplified Analysis by CTNBio.
Argentina
Thanks!
Reinaldo Barata
[email protected]