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Re: DewDiligence post# 61

Sunday, 12/06/2009 11:46:13 AM

Sunday, December 06, 2009 11:46:13 AM

Post# of 877
Re: What the heck does this mean?

Optimum GAT soybeans are expected to be commercialized about two to three years later than the anticipated 2011 introduction [i.e. 2013-2014 (maybe)] due to changes in regulatory policy in key import markets and increasing complexity in managing grain stewardship. [What the heck does this mean?]

Dew, the meaning of the the above statement was addressed to some extent in the Q&A of the Dec 4 CC. (see below).... Searching under “stewardship” at the Pioneer website suggests that this term is used to designate the ethical and quality control procedures associated with a biotechnology product from its conception to its discontinuance... As such in the context above, managing grain stewardship probably just means that bringing Optimum GAT to market is a complicated process that takes time.

<Q – Kevin McCarthy>: Yes, good morning. In your press release, you cited changes in regulatory policy in key import markets as a reason why the Optimum GAT soybean product will be delayed by two to three years. Can you elaborate on what you were referring to there? Is it related to Japan, Europe, China, other countries, and what have been the changes that have caused this deferral?

<A – Paul Schickler>: That’s a good question because as you know, regulatory practices and regulations in some areas are nonexistent or evolving and changing. So that’s sort of the situation that we and others in the industry face. Specifically, regarding Optimum GAT soybean, the issue comes down to a couple of countries that are key export markets for growers in the United States and Canada. We adhere to industry practices and standards to make sure that export approvals for key countries are achieved before cultivation in the United States and Canada occurs. And in the case of soybeans, there’s two on that list that are critical – one is China, the other is Europe. In China’s case, what we have is a situation where Pioneer is the first company to bring a stacked trait to the market. And as a result, in addition to the individual trait components needing approval, subsequent to that the stacked combination also requires approval. So that adds to the timeline. Secondly, in Europe, another key market, we have a challenging, changing and unpredictable environment there. I think everyone is familiar with that situation. But the nuance here is that the requirements or the importance of Europe in soybeans is much different than what it is for corn. Thus, the export market of Europe is very critical and important to U.S. and Canadian growers. And for that reason, import approval in European countries by both EFSA and the European Commission needs to be accomplished before cultivation can occur in the United States and Canada. Those regulations in Europe continue to ebb and flow, and recent changes put that timeline back somewhat.


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