Case Description: The Regulatory Strategy for Stacked Soybean

Miguel Alvarez Arancedo Asociacin Semilleros Argentinos (ASA)

17 September 2012

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
Alfafa Looper (Rachiplusia nu) Bud Borer (Epinotia aporema)

Velvet Bean Caterpillar (Anticarsia gemmatalis)

Soybean Lopper (Pseudoplusia includens)

INTACTA RR2 PRO Trait Protection

Industry Launch Policies

CropLife International General Policy
CropLife International believes in access to the shared benefits of crop biotechnology. To help ensure the continued adoption of agricultural biotechnology globally and to continue to have products of agricultural biotechnology bring value to the marketplace, CropLife International supports actions that facilitate the flow of goods in commerce and minimize trade disruptions. CropLife International believes that henceforth individual member companies should, prior to commercialization meet applicable regulatory requirements in key countries identified in a market and trade assessment that have functioning regulatory systems and are likely to import the new biotechnology-derived plant products.

Soybean Trade Flows

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

Global Regulatory Submissions Bt/RR2Y Soybean

Country or Region
China EU Korea
Taiwan Japan Thailand Indonesia India Brazil
Argentina
Total Export Share* %

BRZ ARG
45 35 3.2
1.4 1.2 5.6 <1 <1

Regulatory Framework
Yes Yes

Bt soybean submission
May 2010 Feb-Mar. 2010 Nov. 2009 Dec. 2009Mar. 2010 Oct. 2009 Mar. 2011

Bt/RR2 submission
Aug. 2009 Oct.-Nov. 2011 July 2011 Dec. 2010; July 2012 Production Approval: Aug. 2010
Aug. 2012

28 28 1.5
<1 <1 <1 4.2 2.9

Oct. 2010*

Yes
(5 agencies)

Yes Yes
(3 agencies)

evolving evolving evolving YES YES

Oct. 2010 June 2009 Dec. 2010 Total 40+ submissions

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

Production Production

Additional submissions made to potential importing countries Australia/NZ; Canada; Colombia; Mexico; Philippines; Russia; Singapore, United States. Potential production countries Paraguay, Uruguay. 5

Industry Efforts to Achieve Synchrony and Avoid Potential Trade Disruption

Regulatory submissions made in rapid succession starting in targeted 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 regulatory requirements from key countries most likely to import biotechnology-derived plant products
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 countries Multiple 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
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Thank you