Trait Moves
Asynchronous global approvals for new genetically engineered traits create a trade challenge for growers and agribusinesses.
Since the first biotech traits came on the market nearly two decades
ago, growers have been putting the technology to work and reaping the
benefits. The International Service for the Acquisition of Agri-Biotech Applications reports that biotech crops have decreased production costs and increased productivity valued at $116.9 billion. It’s no wonder more and more corn growers are choosing genetically engineered seeds. According to the U.S. Department of Agriculture (USDA), American growers planted 90 percent of their corn acres with genetically engineered hybrids last year, up from just 25 percent in 2000.
That relentless pace of adoption has made the U.S. the most efficient country in the world to grow corn. Everyone benefits from that efficiency: from producers, who can economically reduce production risks, to American consumers, who spend less than 10 percent of their disposable income on food, to exporters.
"It’s capitalism at its best," says Chuck Lee, head of corn for Syngenta.
But those gains in efficiency are at risk because some countries that import a portion of U.S. harvests don’t approve new biotech traits in the same time frame as most other nations where the technologies are grown or imported.
Asynchronous Approval
The first hurdle for approval comes in the country where a company develops the trait. In the U.S., for instance, the USDA must review and approve or deregulate a trait or biotech event. If the trait is insecticidal, the Environmental Protection Agency must approve it as well. Trait developers also voluntarily submit traits to the Food and Drug Administration (FDA) for its review. It’s a lengthy, expensive process, but one that’s also predictable and science-based. Companies like Syngenta know what information regulators expect and when agencies are likely to make a decision.
The next step is to seek approval in the countries that are most likely to import the harvested crops with the trait. That’s where the process becomes complicated, explains Lisa Zannoni, global head of regulatory and stewardship for Syngenta.
"There is no harmonization on format or data requirements," Zannoni says. "Every country adheres to its own timelines."
Mexico, for example, will allow companies to begin the import approval process for a new product once the FDA approves a trait; but China won’t begin its review until another country has granted cultivation approval.
Once the approval process begins, most countries have a predictable time frame for how long it will last. But in some countries, the clock stops when regulators ask questions and begins again when a company submits a response.
Not Just an American Problem
China’s rejection of U.S. grain shipments said to contain the Agrisure Viptera® trait (MIR 162) this winter garnered a great deal of media attention. But the problems caused by the world’s discordant approval processes affect all biotech companies and not just those in the U.S.
As companies increase their deployment of new biotech traits in Canada, Brazil and Argentina, these countries are also feeling the impacts of asynchronicity. Even China is beginning to consider what it means to be a production country as biotech rice nears commercialization.
The biotech industry and grower groups have been working to achieve review and approval harmonization for many years, but it was a lonely fight when the U.S. was virtually the only production country. Now that Brazil and Argentina have emerged as major production countries, the three leading corn-exporting countries are working together on market access and streamlining regulatory processes for biotechnology. MAIZALL, a strategic alliance formed by the U.S. Grains Council (USGC), the National Corn Growers Association (NCGA) and the leading corn producers' organizations in Argentina and Brazil, is an example of those efforts.
Right to Grow
Syngenta is hopeful that its participation with the USDA, other nations, producer organizations and other biotechnology companies will result in a streamlined global regulatory review process that has a predictable time frame and is based on science.
But progress comes slowly. Efforts to set a low-level presence threshold for genetically engineered traits that will enable importers to accept shipments containing a small amount of a not-yet-approved product began nearly a decade ago. Countries haven’t yet agreed on a globally accepted threshold.
In the meantime, Syngenta is using an innovative approach to help U.S. growers market grain from the company’s latest traited corn seed, Agrisure Duracade™, the cutting-edge corn rootworm (CRW) control technology that has been approved in the U.S. In February, Syngenta announced an agreement with Gavilon Grain, LLC, that provides grain marketing opportunities for farmers who choose to plant seed with the Agrisure Duracade trait. If a grower’s usual grain marketing outlet will not accept Agrisure Duracade grain, Gavilon will accept that corn at market price, while providing stewardship and distribution services for producers.
Many ag professionals have hailed the program as a model for how to make biotech traits available to U.S. farmers while protecting valuable export markets, at least until a more uniform review process is in place.
"We need a globally aligned review process to provide everyone in the value chain with the incentive to develop or plant the latest trait technologies," Lee says. "The risk of continuing on the current course is that the innovation needed to maximize the quality and yield of American crops will slow, and that could have a ripple effect on food security around the world."
That relentless pace of adoption has made the U.S. the most efficient country in the world to grow corn. Everyone benefits from that efficiency: from producers, who can economically reduce production risks, to American consumers, who spend less than 10 percent of their disposable income on food, to exporters.
"It’s capitalism at its best," says Chuck Lee, head of corn for Syngenta.
But those gains in efficiency are at risk because some countries that import a portion of U.S. harvests don’t approve new biotech traits in the same time frame as most other nations where the technologies are grown or imported.
Asynchronous Approval
The first hurdle for approval comes in the country where a company develops the trait. In the U.S., for instance, the USDA must review and approve or deregulate a trait or biotech event. If the trait is insecticidal, the Environmental Protection Agency must approve it as well. Trait developers also voluntarily submit traits to the Food and Drug Administration (FDA) for its review. It’s a lengthy, expensive process, but one that’s also predictable and science-based. Companies like Syngenta know what information regulators expect and when agencies are likely to make a decision.
The next step is to seek approval in the countries that are most likely to import the harvested crops with the trait. That’s where the process becomes complicated, explains Lisa Zannoni, global head of regulatory and stewardship for Syngenta.
"There is no harmonization on format or data requirements," Zannoni says. "Every country adheres to its own timelines."
Mexico, for example, will allow companies to begin the import approval process for a new product once the FDA approves a trait; but China won’t begin its review until another country has granted cultivation approval.
Once the approval process begins, most countries have a predictable time frame for how long it will last. But in some countries, the clock stops when regulators ask questions and begins again when a company submits a response.
Not Just an American Problem
China’s rejection of U.S. grain shipments said to contain the Agrisure Viptera® trait (MIR 162) this winter garnered a great deal of media attention. But the problems caused by the world’s discordant approval processes affect all biotech companies and not just those in the U.S.
As companies increase their deployment of new biotech traits in Canada, Brazil and Argentina, these countries are also feeling the impacts of asynchronicity. Even China is beginning to consider what it means to be a production country as biotech rice nears commercialization.
The biotech industry and grower groups have been working to achieve review and approval harmonization for many years, but it was a lonely fight when the U.S. was virtually the only production country. Now that Brazil and Argentina have emerged as major production countries, the three leading corn-exporting countries are working together on market access and streamlining regulatory processes for biotechnology. MAIZALL, a strategic alliance formed by the U.S. Grains Council (USGC), the National Corn Growers Association (NCGA) and the leading corn producers' organizations in Argentina and Brazil, is an example of those efforts.
Right to Grow
Syngenta is hopeful that its participation with the USDA, other nations, producer organizations and other biotechnology companies will result in a streamlined global regulatory review process that has a predictable time frame and is based on science.
But progress comes slowly. Efforts to set a low-level presence threshold for genetically engineered traits that will enable importers to accept shipments containing a small amount of a not-yet-approved product began nearly a decade ago. Countries haven’t yet agreed on a globally accepted threshold.
"It’s just not an easy process," Zannoni says. "Governments must answer to their own citizens while balancing trade with public acceptance of the technology." Still, she is optimistic that governments can resolve the issues, especially as the major production countries work together."We need a globally aligned review process to provide everyone in the value chain with the incentive to develop or plant the latest trait technologies."
In the meantime, Syngenta is using an innovative approach to help U.S. growers market grain from the company’s latest traited corn seed, Agrisure Duracade™, the cutting-edge corn rootworm (CRW) control technology that has been approved in the U.S. In February, Syngenta announced an agreement with Gavilon Grain, LLC, that provides grain marketing opportunities for farmers who choose to plant seed with the Agrisure Duracade trait. If a grower’s usual grain marketing outlet will not accept Agrisure Duracade grain, Gavilon will accept that corn at market price, while providing stewardship and distribution services for producers.
Many ag professionals have hailed the program as a model for how to make biotech traits available to U.S. farmers while protecting valuable export markets, at least until a more uniform review process is in place.
"We need a globally aligned review process to provide everyone in the value chain with the incentive to develop or plant the latest trait technologies," Lee says. "The risk of continuing on the current course is that the innovation needed to maximize the quality and yield of American crops will slow, and that could have a ripple effect on food security around the world."
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