Diapositiva 1

1
SECOND INTERNATIONAL MEETING ON LOW LEVEL
PRESENCE Rosario, September 17, 2012
Current situation and causes of asynchronous
approvals Efforts to avoid trade issues Juan
Kiekebusch, Argentine Seed Association
2
Current status of GM crops (2011)
Soybean - Maize Cotton - Canola Alfalfa - Sugar
beet Papaya -Squash Poplar - Carnation
Herbicide tolerance Insect resistance Virus
resistance - Color
29 countries, 16.7 MM growers, 160 mi hectares
Source ISAAA
3
Whats coming next?
More hectares, more countries and more farmers
160 MM hectares 29 countries 16.7 MM growers
200 MM hectares 40 countries 20 MM growers
Source ISAAA
4
Whats coming next?
More GM products
In 2015, 120 events are expected to be
commercialized
Sources Agrilife-JRC
5
Whats coming next?
More GM crops
Today
5 years
gt5 years
Soybean - Maize Cotton - Canola Alfalfa - Sugar
beet Papaya -Squash Poplar - Carnation
Soybean - Maize Cotton - Canola Alfalfa - Sugar
beet Papaya -Squash Poplar - Carnation
Soybean - Maize Cotton - Canola Alfalfa - Sugar
beet Papaya -Squash Poplar - Carnation
Commercial GM crops
Commercial and regulatory pipeline
Rice - Bean Potato - Eggplant Plum
Rice - Bean Potato - Eggplant Plum
Sugar cane - Wheat Tomato - Cassava Cabbage -
Okra Cauliflower Mustard - Peanut Sweet pepper
R D pipeline
Sources CropLife, Agrilife-JRC
6
Whats coming next?
More GM traits
Today
5 years
gt5 years
Herbicide tolerance Insect resistance Virus
resistance
Herbicide tolerance Insect resistance Virus
resistance
Herbicide tolerance Insect resistance Virus
resistance
Commercial GM traits
Drought tolerance Higher yielding Crop
composition (beta-carotene, fatty acids, starch,
lignin)
Drought tolerance Higher yield Crop composition
(beta-carotene, fatty acids, starch, lignin)
Commercial and regulatory pipeline
Stress tolerance Nitrogen use Improved
feed Increased ethanol Fungal resistance Nematode
resistance Disease resistance
R D pipeline
Sources CropLife, Agrilife-JRC
7
Whats coming next?
More developers and countries of origin

• Some examples of local developments in the
  commercial or regulatory pipeline
• Soybean imidazolinone tolerance (EMBRAPA/BASF -
  Brazil)
• Bean virus resistance (EMBRAPA Brazil)
• Plum virus resistance (USDA/ARS US)
• Rice beta carotene, Golden Rice (IRRI -
  Philippines)
• Eggplant insect resistance (Maharashtra Hyb
  Seeds Co India)
• Maize crop composition, phytase (CAAS China)
• Potato virus resistance (Tecnoplant
  Argentina)

Most likely isolated/foreign approvals with
authorization only sought in cultivation markets
Sources CropLife, Agrilife-JRC
8
Whats coming next?
More and faster commercial approvals in exporter
countries
2007
2012
9
More cultivation More products More crops More
traits More local developments More and faster
approvals in exporter countries
More burden on regulatory agencies worldwide

• Differences in regulatory processes and times
• High regulatory costs

More asynchronous approvals
10
Why synchronicity is so important?
Supply
Demand
Food feed exporters
Food feed importers
New technology
Synchronous approvals
Political will ? Gov/industry coordinated
efforts ? Proactive farming and agribusiness
sectors ?
11
Why asynchronicity is so disruptive?
Supply
Demand
Food feed exporters
Food feed importers
New technology
Asynchronous approvals Zero tolerance for LLP
DELAYED
Despite Political will ? Gov/industry
coordinated efforts ? Proactive farming and
agribusiness sectors ?
12
Asynchronous approvals and zero tolerance
policies for LLP cause trade disruptions and
delays in commercialization and accessing new
technologies

• Synchronize approvals
• Implement pragmatic LLP policies

13
What is industry doing?

• Stewardship - the responsible management of the
  biotech products across the full life cycle,
  including the implementation of appropriate
  programs and processes to manage product
  integrity, product launch and commercialization
  activities
• Timing of submissions
• Working with Government and other stakeholders to
  encourage national solutions to avoid trade
  disruption due to LLP in seed and FFP

14
How Governments could help minimize trade
disruptions?

• Continue transparency in regulatory requirements
• Predictability in timelines for decision-making
• Working at bilateral and regional level to
  synchronize approvals and develop practical LLP
  policies (mutual recognition of approvals or risk
  assessments can be an important step forward).
  

15
Synchronicity is already in the agenda of LATAM
countries
2012
Approvals for commercial planting in Mercosur
countries
(at least 5 new maize and 1 soybean events are in
the advanced regulatory pipeline in Paraguay and
Uruguay)
16

• Conclusions
• Modern biotechnology is here to stay and is
  crucial to respond to the global demand for food
  and feed.
• Despite developers efforts to obtain timely
  approvals in major markets, asynchronous
  approvals will increase.
• Despite stewardship, best management practices
  and quality control systems, LLP 0 is not
  possible to reach.
• Both asynchronous approvals and zero tolerance
  policies cause trade disruptions and delays in
  commercialization and accessing new technologies.
• Pragmatic LLP policies are needed to minimize
  trade disruptions, rapidly and safely respond to
  LLP incidents and establish clear rules for the
  industry activities.
• A joint effort by importer and exporter countries
  is crucial to achieve synchronous approvals, as
  the ultimate goal to really avoid trade
  disruptions

17
A final thought
Argentina produces now enough food to feed 400
million people 10 times its population and
the global population growth and food demand will
make Argentina increase that to 650 million by
2020. To do so, Argentina needs to introduce new
technologies allowing sustainable and
high-intensity crop production, with
biotechnology being essential for both
sustainability and intensification. Importer
countries should support the adoption of such new
technologies to benefit both importer and
exporter countries, assuring food supply.
Synchronization of GMO approvals will be a big
step forward in achieving this objective.
18
Thank you for your attention! Juan.kiekebusch_at_syn
genta.com