and there have been some litigations in the U.S. that caused the industry to make sure information is presented properly, but the biggest factor is the lack of resources available to the various regulatory agencies to process the number of applications.”
There is no question there have been some delays with products reaching the market. This summer, Pioneer Hi-Bred updated the introduction timeline for Optimum GAT corn, because approvals in certain U.S. export markets are taking longer than originally expected. “Adjustments to the regulatory approval schedule are common,” said Paul Schickler, DuPont Vice-President and General Manager and Pioneer Hi-Bred President. “While we are disappointed in this administratively-driven schedule change, we are confident in our long-term prospects.”
The changed regulatory approval schedule will limit the introductory volumes of corn seed with the Optimum GAT trait
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to controlled releases in 2010 and 2011. Full-scale commercial introduction of the trait was originally set for 2010. The company completed regulatory submissions for the trait in corn to the U.S. Food and Drug Administration and USDA back in July of 2007, but is still waiting for approval. Recently Pioneer received full Canadian regulatory approval for Optimum GAT in corn and anticipates U.S. approval of the trait in corn in the coming months.
At the same time, Monsanto remains positive about its approval situation. “From our point of view, yes we would like things to move faster, however, we are not discouraged by the state of affairs,” says Hjelle.
And the company has set some pretty lofty goals, including a commitment to double yields in corn, cotton and soybeans by 2030, and deliver seven new high impact technologies, launching a technology every one to two years. The company’s HIT projects include drought-tolerant and nitrogen utilization corn; and broad-acre, higher-yielding corn and soybean. Only time will tell if these products hit the market on time, but as far as the company is concerned, it is poised to meet its goals.
Certainly Monsanto, along with partner Dow Agrosciences, are on track to launch SmartStax corn. The companies received registration from the U.S. Environmental Protection Agency and regulatory authorization from the Canadian Food Inspection Agency and remains on track for a 2010 commercial launch. In addition, Monsanto’s Roundup Ready 2 Yield trait for soybeans was successfully launched this year.
Part of the problem might be that the current regulatory system is meant for chemicals and has had to be adapted to biotech traits; therefore, some in the industry feel there might be some merit to exploring the development of a separate regulatory system that deals with just biotech traits. However, others feel this isn’t necessary as the biotech traits aren’t radically different and it’s just a matter of tweaking the system already in place.
“The process is working and we have no complaints, but we want to make sure the regulatory agencies have the resources they need in place,” says Hjelle. “Before there were just a few companies submitting biotech traits, but now there are more and more so the total work for regulatory agencies is greater then ever and I can’t imagine it won’t get worse. These agencies need to ensure they keep pace with the demand. The industry is growing and they need more resources.”
And that will take a commitment from the seed industry and the agencies. “We [the seed industry] need to continue the dialog with agencies on where our industry is going so they know what we need,” explains Hjelle. “And then it’s up to the agencies to make sure they have the resources they need based on that.”
While it’s easy to point a finger at the regulatory agencies for delays, Rowe says the industry also has an obligation to put forward the right information in every application to help speed the process along.
Hjelle attributes Monsanto’s success in commercialization of its traits to the fact that the company’s science program and regulatory department are kept together as one unit, a coordinated approach that ensures applications to the agencies are science based.
“Having the science together in a proper manner is critical,” explains Hjelle. “One question in the research can delay the
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