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How Japan approves traits

Agriculture.com Staff 05/22/2007 @ 10:30am

Japan has been a reliable approver of traits in hybrids and varieties.

However, Japan's approval process does take time. In some cases, this has caused seed companies to delay marketing hybrids and varieties with traits.

Dow AgroSciences and Pioneer Hi-Bred International went down to wire with its Herculex RW and Herculex Xtra products in 2006. Although they had received U.S. approval in 2005, Japanese approval had not been granted going into the 2006 growing season.

"We were really touch and go with Japanese approval, right down to the wire, but we did not put any seed into grower's hands until we had (Japanese) approval," says Garry Hamlin, Dow AgroSciences spokesman. Japanese approval occurred in early April 2006.

In November 2003, Monsanto received U.S. approval to plant YieldGard Plus, a trait stack resistant to European corn borer and corn rootworm.

Later that winter, Monsanto was uncertain if it would have Japanese approval for YieldGard Plus in time for the 2004 growing season, says Tami Craig Schilling, director, public affairs for Monsanto.

Monsanto then decided not to launch YieldGard Plus in 2004. "We decided we would build the production, but we would not deliver anything (to farmers) until we knew if we had approval from Japan or not," she adds.

They agreed to abide by the National Corn Growers Association's (NCGA) Know Before You Grow program, which requests seed companies obtain full foreign approval before marketing new traits. However, Monsanto used -- with NCGA's blessing -- YieldGard Plus in a farmer demonstration program where they compared the trait with conventional corn and insecticide systems to selected U.S. farmers in 1,800 trials, says Schilling.

On this limited basis, Monsanto was able to track and channel the grain for domestic use. In the meantime, Japan granted final approval to YieldGard Plus in June 2004, which enabled farmers to market the corn where they wanted at harvest.

The Japanese approval process consists of three separate components -- feed, food and environmental approvals. All are separate processes, says Paul Bertels, NCGA director of biotechnology & economic analysis.

An expert government committee for each area evaluates each application and sends a recommendation to an upper committee. Typically, the upper committee accepts the expert committee's report. After this process, a 30-day public commentary period follows, after which approval typically follows. Approval must occur in feed, food and environmental areas before Japan gives final approval.

More on the Agrisure RW situation:

Japan has been a reliable approver of traits in hybrids and varieties.

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