2 maa global llp meeting

8/13/2019 2 Maa Global Llp Meeting

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Case Description: The Regulatory

Strategy for Stacked Soybean

Miguel Alvarez Arancedo

Asociación Semilleros Argentinos (ASA)

17 September 2012

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Bt/RR2Y Soybeans Provide Combined Insect Protection

and Herbicide Tolerance

30 M Ha are infected by Lepidopteran pests in Brazil/Argentina – Primary target markets

Complete insect control demonstrated in multi-year field trials

Potential to reduce insecticide applications while showing significant yield protection

vs. current insecticides

Combined with RR2Y trait to provide excellent tolerance to glyphosate

Velvet Bean Caterpillar

( Anticarsia gemmatalis)

Soybean Lopper(Pseudoplusia includens)

Alfafa Looper

(Rachiplusia nu)

Bud Borer

(Epinotia aporema)

INTACTA RR2 PRO ™ Trait

Protection 2



CropLife International General Policy

CropLife International believes in access to the shared benefits ofcrop biotechnology. To help ensure the continued adoption ofagricultural biotechnology globally and to continue to have products

of agricultural biotechnology bring value to the marketplace, CropLifeInternational supports actions that facilitate the flow of goods incommerce and minimize trade disruptions. CropLife Internationalbelieves that henceforth individual member companies should, priorto commercialization meet applicable regulatory requirements in keycountries identified in a market and trade assessment that have

functioning regulatory systems and are likely to import the newbiotechnology-derived plant products.

Industry Launch Policies

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Soybean Trade Flows

Source: Food and Agribusiness Research & Advisory, Rabobank International (2009)



Global Regulatory Submissions

Bt/RR2Y Soybean

Countryor Region

Total Export Share* %

BRZ –

ARGRegulatory

Framework

Bt soybean

submission Bt/RR2submission

China 45 28 Yes Oct. 2010*

EU 35 28 Yes May 2010 Aug. 2009

Korea 3.2 1.5 Yes(5 agencies)

Feb-Mar. 2010 Oct.-Nov. 2011

Taiwan 1.4 <1 Yes Nov. 2009 July 2011

Japan 1.2 <1 Yes(3 agencies)

Dec. 2009-

Mar. 2010

Dec. 2010;

July 2012

Thailand 5.6 <1 evolving Oct. 2009 -

Indonesia <1 4.2 evolving Mar. 2011 -

India <1 2.9 evolving Oct. 2010

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Additional submissions made to potential importing countries Australia/NZ; Canada; Colombia; Mexico; Philippines;

Russia; Singapore, United States. Potential production countries Paraguay, Uruguay. Total –

40+ submissions

Brazil Production YES June 2009

Argentina Production YES Dec. 2010

Production

Approval:

Aug. 2010

Aug. 2012

* 2010 figures based on total export volume beans, meal, oil



Industry Efforts to Achieve Synchrony and

Avoid Potential Trade Disruption

Regulatory submissions made in rapid succession starting intargeted production geographies then key export markets with

functioning regulatory systems

Submissions to export markets made based on market assessment

and dialogue with value chain and Gov. for crop in question

Submissions comply with national data requirements –

based on

recent experience and, where possible, regulator feedback

Responses to regulatory questions are handled as quickly as

possible; Stack submissions made as soon as possible

Commercial introduction after meeting applicable regulatoryrequirements from key countries most likely to import

biotechnology-derived plant products

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The elements above are captured in various stewardship

policy statements (Excellence Through Stewardship, CLI, BIO)



Challenges to Synchronicity

Regulatory requirements shift and vary over time and within a country

Complexity and diversity of data requirements between countriesMultiple reviews occurring simultaneously in some markets;

Submissions and reviews may run sequentially (i.e., single then stack) within

a country; some countries require approvals in other markets

Emergence of new or evolving regulatory systems

Technical reviews and approvals impacted by politics

Bottom line – Predictability of review process varies significantly

Opportunities for Greater Synchrony

Assure adequate resources/training is available to achieve target review

timelines

Streamline processes and reduce redundancies; year round submissions;

worksharing or joint reviews; Parallel reviews

Harmonized data requirements; Mutual acceptance of data/data reviews 7



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Thank you

2 maa global llp meeting

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