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8 WWW.CEN-ONLINE.ORG JANUARY 25, 2010 NEWS OF THE WEEK M ONSANTO has won the first battle in what may be a long season of skirmishes with rival seed producer Pioneer Hi-Bred, a DuPont business. In May 2009, Monsanto filed a lawsuit to prevent Pioneer from combining traits for crop resistance to glyphosate, a common herbicide sold as Roundup by Monsanto. Pioneer had planned to create corn and soy- bean seeds containing both Monsanto’s Roundup Ready and its own Optimum GAT trait for herbicide tolerance. To do so, Monsanto contended, would violate Pioneer’s license for Roundup Ready seed technology. In what it described as a narrow ruling on the language of the license, the U.S. Dis- trict Court for the Eastern District of Mis- souri sided with Monsanto, saying Pioneer was not licensed to combine the two traits. But DuPont says it will pursue claims against Monsanto for antitrust and patent fraud. And it accuses Monsanto of preventing farmers from planting better seeds, claiming the combined traits provide 6% better yield than Roundup Ready alone. In part because Monsanto commands more than 90% of the U.S. market for genetically engineered soy- bean traits, the company has also attracted the atten- tion of the Department of Justice. In December 2009, DOJ opened an investigation into possible anticom- petitive business practices in the seed industry. Another likely reason for the scrutiny, analysts say, is that in 2014, Monsanto’s Roundup Ready soybeans will be the first genetically engineered crop to lose pat- ent protection. The company’s rivals are concerned Monsanto will try to block the launch of generic seeds. Monsanto has stated that the first-generation soybeans “would remain available after patent expiry and would be royalty-free to farmers beginning in the 2015 season.” Experts know of few precedents for challenges to intellectual property for genetically engineered traits. John E. Roberts, a stock analyst with Buckingham Research, sees an apt comparison in the computer world. If seeds are analogous to computer hardware, and traits are like computer software, he asks, “is this conceptually different than Europe’s investigation into Microsoft’s efforts to maintain Internet Explorer’s dominance on Windows machines?” As a result of that investigation, Microsoft agreed that European computers running the Windows oper- ating system would allow users to choose from a list of Internet browsers. —MELODY VOITH F DA ANNOUNCED on Jan. 15 that it has “some con- cern” about the potential health effects of the plas- tics chemical bisphenol A (BPA) in infants and chil- dren. But the agency said that more research is needed to fully assess the safety of the estrogen-like chemical. The announcement brings FDA in line with the Na- tional Toxicology Program, which said in 2008 that it has some concern that BPA may cause neurological effects in infants and children at current exposure levels. At that time, under the Bush Administration, FDA maintained that BPA in food and beverage containers is safe. “Some concern means, in part, that we need to know more,” FDA Commissioner Margaret Hamburg said dur- ing the Jan. 15 briefing. Over the next 18–24 months, FDA will work with NIH and other federal agencies to con- duct key research on the health effects of BPA, she noted. In the meantime, FDA is taking steps to reduce human exposure to BPA. For example, the agency is supporting efforts to replace BPA in infant formula cans and minimize the chemical in other food can lin- ings. FDA is also considering a more robust regulatory framework for BPA so that if new information becomes available, it can act quickly. FDA’s decision pleased some members of Congress, particularly those trying to reform chemical safety leg- islation. Henry A. Waxman (D-Calif.), chairman of the House Energy & Commerce Committee, called the an- nouncement “a very positive step that sets us back on a path of science-based decision-making.” Environmental and consumer health groups had mixed reactions. Some were disappointed with the an- nouncement, saying there is already enough scientific evidence to warrant a ban on BPA in food and beverage containers. Others called the announcement a victory for parents and children and a signal of a new era for health protection at FDA. The American Chemistry Council—a chemical industry trade group that includes BPA manufactur- ers—said that FDA’s announcement “confirms that exposure to BPA in food contact products has not been proven harmful to children or adults.” The trade group was disappointed, however, saying that “some of the recommendations are likely to worry consumers and are not well-founded.” —BRITT ERICKSON Soybeans with the Pioneer Hi-Bred Optimum GAT trait. SHUTTERSTOCK PIONEER HI-BRED FDA RAISES FLAG ON BISPHENOL A CHEMICAL SAFETY: Agency moves to collaborate with other federal partners on health effects research COURT RULING FAVORS MONSANTO SEED TRAITS: DuPont cannot combine its own herbicide tolerance with Monsanto’s FDA supports replacing or minimizing BPA in food can linings, but few alternatives exist.

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Page 1: COURT RULING FAVORS MONSANTO

8WWW.CEN-ONLINE.ORG JANUARY 25, 2010

NEWS OF THE WEEK

MONSANTO has won the first battle in what may be a long season of skirmishes with rival seed producer Pioneer Hi-Bred, a DuPont business.

In May 2009, Monsanto filed a lawsuit to prevent Pioneer from combining traits for crop resistance to glyphosate, a common herbicide sold as Roundup by Monsanto. Pioneer had planned to create corn and soy-

bean seeds containing both Monsanto’s Roundup Ready and its own Optimum GAT trait for herbicide tolerance. To do so, Monsanto contended, would violate Pioneer’s license for Roundup Ready seed technology.

In what it described as a narrow ruling on the language of the license, the U.S. Dis-trict Court for the Eastern District of Mis-souri sided with Monsanto, saying Pioneer was not licensed to combine the two traits.

But DuPont says it will pursue claims against Monsanto for antitrust and patent

fraud. And it accuses Monsanto of preventing farmers from planting better seeds, claiming the combined traits provide 6% better yield than Roundup Ready alone.

In part because Monsanto commands more than 90% of the U.S. market for genetically engineered soy-bean traits, the company has also attracted the atten-tion of the Department of Justice. In December 2009, DOJ opened an investigation into possible anticom-petitive business practices in the seed industry.

Another likely reason for the scrutiny, analysts say, is that in 2014, Monsanto’s Roundup Ready soybeans will be the first genetically engineered crop to lose pat-ent protection. The company’s rivals are concerned Monsanto will try to block the launch of generic seeds. Monsanto has stated that the first-generation soybeans “would remain available after patent expiry and would be royalty-free to farmers beginning in the 2015 season.”

Experts know of few precedents for challenges to intellectual property for genetically engineered traits. John E. Roberts, a stock analyst with Buckingham Research, sees an apt comparison in the computer world. If seeds are analogous to computer hardware, and traits are like computer software, he asks, “is this conceptually different than Europe’s investigation into Microsoft’s efforts to maintain Internet Explorer’s dominance on Windows machines?”

As a result of that investigation, Microsoft agreed that European computers running the Windows oper-ating system would allow users to choose from a list of Internet browsers. —MELODY VOITH

FDA ANNOUNCED on Jan. 15 that it has “some con-cern” about the potential health effects of the plas-tics chemical bisphenol A (BPA) in infants and chil-

dren. But the agency said that more research is needed to fully assess the safety of the estrogen-like chemical.

The announcement brings FDA in line with the Na-tional Toxicology Program, which said in 2008 that it has some concern that BPA may cause neurological effects in infants and children at current exposure levels. At that time, under the Bush Administration, FDA maintained that BPA in food and beverage containers is safe.

“Some concern means, in part, that we need to know more,” FDA Commissioner Margaret Hamburg said dur-ing the Jan. 15 briefing. Over the next 18–24 months, FDA will work with NIH and other federal agencies to con-duct key research on the health effects of BPA, she noted.

In the meantime, FDA is taking steps to reduce

human exposure to BPA. For example, the agency is supporting efforts to replace BPA in infant formula cans and minimize the chemical in other food can lin-ings. FDA is also considering a more robust regulatory framework for BPA so that if new information becomes available, it can act quickly.

FDA’s decision pleased some members of Congress, particularly those trying to reform chemical safety leg-islation. Henry A. Waxman (D-Calif.), chairman of the House Energy & Commerce Committee, called the an-nouncement “a very positive step that sets us back on a path of science-based decision-making.”

Environmental and consumer health groups had mixed reactions. Some were disappointed with the an-nouncement, saying there is already enough scientific evidence to warrant a ban on BPA in food and beverage containers. Others called the announcement a victory for parents and children and a signal of a new era for health protection at FDA.

The American Chemistry Council—a chemical industry trade group that includes BPA manufactur-ers—said that FDA’s announcement “confirms that exposure to BPA in food contact products has not been proven harmful to children or adults.” The trade group was disappointed, however, saying that “some of the recommendations are likely to worry consumers and are not well-founded.” —BRITT ERICKSON

Soybeans with the Pioneer Hi-Bred Optimum GAT trait.

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FDA RAISES FLAG ON BISPHENOL A

CHEMICAL SAFETY: Agency moves to collaborate with other federal

partners on health effects research

COURT RULING FAVORS MONSANTO

SEED TRAITS: DuPont cannot combine its own herbicide tolerance with Monsanto’s

FDA supports replacing or minimizing BPA in food can linings, but few alternatives exist.