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APPROVAL & PLANTS: Monsanto and FDA move toward healthier GM soybean oil



                                  PART 1


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TITLE:   MONSANTO AND FDA MOVE TOWARD HEALTHIER GM SOYBEAN OIL

SOURCE:  Food Navigator, USA

AUTHOR:  Caroline Scott-Thomas

URL:     http://www.foodnavigator-usa.com/On-your-radar/Trans-and-saturated-fats/Monsanto-and-FDA-move-toward-healthier-GM-soybean-oil

DATE:    28.01.2011

SUMMARY: "Monsanto and the Food and Drug Administration have completed a biotechnology consultation process for a key component of the company?s high-oleic soybeans, the biotech giant has said. The company said completion of the consultation process is a significant first step toward commercialization of Monsanto?s Vistive Gold soybeans, which are low in trans and saturated fats, enabling food manufacturers to improve the health profile of foods made with soybean oil. [...] Monsanto?s Vistive Gold soybeans are subject to a number of further regulatory hurdles with both the FDA and the US Department of Agriculture before they can be fully commercialized."

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MONSANTO AND FDA MOVE TOWARD HEALTHIER GM SOYBEAN OIL

Monsanto and the Food and Drug Administration (FDA) have completed a biotechnology consultation process for a key component of the company?s high-oleic soybeans, the biotech giant has said.

The company said completion of the consultation process is a significant first step toward commercialization of Monsanto?s Vistive Gold soybeans, which are low in trans and saturated fats, enabling food manufacturers to improve the health profile of foods made with soybean oil. The crop represents one of the first to be developed through a combination of biotechnology and traditional breeding methods to provide health benefits for consumers.

Monsanto?s global technology lead for food quality traits Joe Cornelius said that the product has been developed with input from the food and nutrition industry. The soybeans have 60 percent less saturated fat than conventional soybean oil, and 70 percent less saturated fat than fry shortening, the company said.

?Vistive Gold soybeans will give farmers an opportunity to produce nutritionally improved soybean oil for food companies and consumers,? Cornelius said. ?Monsanto is continuing to provide innovations to the soybean oil market and help growers create additional value within the food supply chain.?

The Vistive Gold soybeans will be combined with the company?s Genuity Roundup Ready 2 Yield soybeans, to increase yield for farmers, as well as providing nutritionally improved oil.

There is a large body of evidence suggesting that trans fatty acids raise levels of LDL-cholesterol (so-called ?bad? cholesterol) and reduce levels of HDL-cholesterol (or ?good? cholesterol, and can influence other risk factors for cardiovascular disease. This has led to trans fat bans in many parts of the United States.

In the food industry this has been mirrored by an increase the in pressure on manufacturers to eliminate trans fat from their products. But food manufacturers have faced a number of technical difficulties in removing trans fat from their products, and some have expressed concern that trans fats could end up being replaced by saturated fats, which are nearly as unhealthy as the fats they replace, prompting companies to look for healthier replacements.

Trans fats formed by partial hydrogenation of vegetable oil are attractive to the food industry due to their extended shelf life, flavor and heat stability, and have displaced natural solid fats and liquid oils in many areas of food processing.

?Food companies continue to look for ways to eliminate trans fats and reduce saturated fat, and Vistive Gold soybean oil is an excellent option that is more economical, sustainable and nutritionally desirable than current solutions,? Cornelius said.

Monsanto?s Vistive Gold soybeans are subject to a number of further regulatory hurdles with both the FDA and the US Department of Agriculture before they can be fully commercialized.



                                  PART 2

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TITLE:   MONSANTO COMPLETES FDA CONSULTATION PROCESS FOR LOW-SATURATE, HIGH-OLEIC SOYBEANS, PAVING THE WAY FOR INTRODUCTION OF VISTIVE® GOLD SOYBEANS

SOURCE:  Monsanto, USA

AUTHOR:  Press Release

URL:     http://monsanto.mediaroom.com/Vistive-Gold-FDA-consultation-process-complete

DATE:    26.01.2011

SUMMARY: "The U.S. Food and Drug Administration notified Monsanto that the biotechnology consultation process for MON 87705, a key component of the company?s Vistive® Gold soybeans that produce a high-oleic, low-saturate, low-trans fat soybean oil, has been completed. [...] ?Vistive Gold soybeans will give farmers an opportunity to produce nutritionally improved soybean oil for food companies and consumers,? Cornelius said. ?Monsanto is continuing to provide innovations to the soybean oil market and help growers create additional value within the food supply chain.?"

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MONSANTO COMPLETES FDA CONSULTATION PROCESS FOR LOW-SATURATE, HIGH-OLEIC SOYBEANS, PAVING THE WAY FOR INTRODUCTION OF VISTIVE® GOLD SOYBEANS

ST. LOUIS, (Jan. 26, 2010) ? The U.S. Food and Drug Administration (FDA) notified Monsanto that the biotechnology consultation process for MON 87705, a key component of the company?s Vistive® Gold soybeans that produce a high-oleic, low-saturate, low-trans fat soybean oil, has been completed. Conclusion of the consultation with FDA completes one of the key regulatory steps to allow for full commercial introduction of Vistive Gold soybeans.

Vistive Gold soybeans, which contain the low-saturate, high-oleic trait will enable food companies to produce foods made with soybean oil to have lower saturated fat levels and maintain low levels of trans fat.

Consumers and farmers will benefit from this product, which was developed with input from the food and nutrition communities, said Joe Cornelius, Monsanto?s global technology lead for food quality traits.

?Vistive Gold soybeans will give farmers an opportunity to produce nutritionally improved soybean oil for food companies and consumers,? Cornelius said. ?Monsanto is continuing to provide innovations to the soybean oil market and help growers create additional value within the food supply chain.?

Vistive Gold soybeans represent one of the first crops developed through the combination of biotechnology and traditional breeding that enable farmers to help food companies bring direct health benefits to consumers. Vistive Gold soybeans have 85 percent less saturated fat than palm oil, 70 percent less saturated fat than fry shortening and 60 percent less saturated fat than conventional soybean oil.

Vistive Gold soybeans will be commercialized after receipt of appropriate regulatory approvals. The soybeans will be combined with Genuity® Roundup Ready 2 Yield® soybeans, giving farmers an increased yield opportunity in addition to providing the nutritionally improved oil.

?Food companies continue to look for ways to eliminate trans fats and reduce saturated fat, and Vistive Gold soybean oil is an excellent option that is more economical, sustainable and nutritionally desirable than current solutions,? Cornelius added.

Monsanto initiated the biotechnology consultation with FDA in November 2009. In May 2010, FDA issued a positive response letter to Monsanto?s Generally Recognized as Safe (GRAS) notification for the oil from these soybeans. The completion of the FDA consultation process supports the use of oil from Vistive Gold soybeans under the intended conditions of use, which enabled food companies to develop and evaluate foods that contain this nutritionally improved oil. Monsanto petitioned the U.S. Department of Agriculture for non-regulated status of high-oleic soybeans in June 2009. The petition is currently under review.

Monsanto has also made submissions for import approval in key export markets. Upon commercialization, food companies will be able to purchase this new food oil from Vistive Gold soybeans and sell food products prepared with this nutritionally improved oil.

To learn more about Vistive Gold, visit www.vistive gold.com.

About Monsanto Company

Monsanto Company is a leading global provider of technology-based solutions and agricultural products that improve farm productivity and food quality. Monsanto remains focused on enabling both small-holder and large-scale farmers to produce more from their land while conserving more of our world?s natural resources such as water and energy. To learn more about our business and our commitments, please visit: www.monsanto.com.