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

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

Whats coming next? More hectares, more countries and more farmers
240 200 160 120 200 MM hectares 40 countries 20 MM growers

160 MM hectares 29 countries 16.7 MM growers

80
40 0 1996 1997 1998 1999 2000 2002 2003 2004 2005 2006 2007 2009 2010

2011

2012

2013

2014

2001

2008

Source: ISAAA

2015
3

Whats coming next?

More GM products
120
90 60

30
0 2008 2015
In 2015, 120 events are expected to be commercialized
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Sources: Agrilife-JRC

Whats coming next? More GM crops

Today
Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation

5 years
Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation Rice - Bean Potato - Eggplant Plum

>5 years
Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation Rice - Bean Potato - Eggplant Plum
Sugar cane - Wheat Tomato - Cassava Cabbage - Okra Cauliflower Mustard - Peanut Sweet pepper

Commercial GM crops Commercial and regulatory pipeline

R&D pipeline

Sources: CropLife, Agrilife-JRC

Whats coming next? More GM traits

Today
Herbicide tolerance Insect resistance Virus resistance

5 years
Herbicide tolerance Insect resistance Virus resistance

>5 years
Herbicide tolerance Insect resistance Virus resistance

Commercial GM traits Commercial and regulatory pipeline

Drought tolerance Higher yielding Crop composition (beta-carotene, fatty acids, starch, lignin)

Drought tolerance Higher yield Crop composition (beta-carotene, fatty acids, starch, lignin)
Stress tolerance Nitrogen use Improved feed Increased ethanol Fungal resistance Nematode resistance Disease resistance

R&D pipeline

Sources: CropLife, Agrilife-JRC

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
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3 maize 1 soybean 1 cotton

Whats coming next?

BR

ARG

8 maize 1 soybean 2 cotton

More and faster commercial approvals in exporter countries

18 maize 5 soybean 12 cotton 1 bean 20 maize 4 soybean 3 cotton

BR

2007
ARG

2012
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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

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Why synchronicity is so important?

Food & feed exporters
New technology Product launch

Supply

More and better food Same price Sustainability

Demand

Food & feed importers

Synchronous approvals
Regulatory approvals

Regulatory approvals

Political will Gov/industry coordinated efforts Proactive farming and agribusiness sectors

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Why asynchronicity is so disruptive?

Food & feed exporters
New technology Product launch

Supply

More and better food same price sustainability

Demand

Food & feed importers

Asynchronous approvals + Zero tolerance for LLP

Regulatory approvals

Regulatory approvals

Despite Political will Gov/industry coordinated efforts Proactive farming and agribusiness sectors

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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

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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

Plant Development

Seed Production

Seed Marketing & Distribution

Crop Production

Crop Utilization Product Discontinuation

Gene Discovery

Timing of submissions

Working with Government and other stakeholders to encourage national solutions to avoid trade disruption due to LLP in seed and FFP
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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).

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PY

1 soybean 1 others 20 maize 4 soybean 3 others

18 maize 5 soybean 13 others

BR

ARG

7 maize 1 soybean

Synchronicity is already in the agenda of LATAM countries

MEX 54 maize 11 soybean 41 others

UY

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)
COL 27 maize 5 soybean 9 others

Approvals for FFP in Mexico and Colombia

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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

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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.
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Thank you for your attention!

Juan.kiekebusch@syngenta.com

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