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GMO and the FDA

From the website of Beth H. Harrison, PhD and author of Shedding Light on Genetically Engineered Food: In its 1992 Statement of Food Policy, the FDA asserted: “Ultimately, it is the food producer who is responsible for assuring safety.” But wait! According to biotech-giant Monsanto’s former director of corporate communications, “Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job.” So, if neither the U.S. government nor the U.S. food producers are responsible for the safety of genetically modified food, who is? “The FDA has placed the interest of a handful of biotechnology companies ahead of their responsibility to protect public health. By failing to require testing and labeling of genetically engineered foods, the agency has made consumers unknowing guinea pigs for potentially harmful, unregulated food substances.” - Andrew Kimbrell, executive director of Center for Food Safety Sure enough, in April 2011, the FDA moved to allow Monsanto to perform their own environmental impact study on the very GMOs it has been responsible for developing.


In that same month, the leading scientific journal Science Direct published a study showing a significant conflict of interest in so-called “research” done on the health risks and nutritional assessment of genetically modified products. Speaking of conflict of interest… • Michael Taylor, former Monsanto Vice President, is the FDA Deputy Commissioner for Foods. • Roger Beachy, former director of the Monsanto-funded Danforth Plant Science Center, is the director of the USDA National Institute of Food and Agriculture. • Islam Siddiqui, Vice President of the Monsanto and Dupont-funded pesticide-promoting lobbying group, CropLife, is the Agriculture Negotiator for the US Trade Representative. • Rajiv Shah, former agricultural-development director for the pro-biotech Gates Foundation (a frequent Monsanto partner), served as Obama’s USDA Under Secretary for Research Education and Economics and Chief Scientist and is currently the head of USAID. • Elena Kagan, who took Monsanto’s side against organic farmers in the Roundup Ready alfalfa case, is an Associate Justice of the Supreme Court. • Ramona Romero, former corporate counsel to DuPont, is the General Legal Counsel of the United States Department of Agriculture. The Institute of Responsible Technology summarizes the situation in the following FAQs from their “GMO Basics” page: Q. Hasn’t the FDA said that GM foods are safe? The biotech industry claims that the FDA has thoroughly evaluated GM foods and found them safe. This is untrue. The FDA does not require safety studies. Instead, if the makers of the GM foods claim that they are safe, the agency has no further questions. Q. Didn’t the scientists at the FDA study GM foods themselves? No. The FDA relies solely on information supplied by the biotech companies. Q. What kind of information did the companies provide? Calgene, the makers of the first GM crop, the FlavrSavr tomato, was the only company to submit detailed raw data from animal feeding studies to the FDA. The rest provide only summaries and conclusions. Industry research can be rigged; data often is omitted or distorted. In the FlavrSavr tests, lab rats refused to eat the tomatoes and had to be force-fed. Several developed stomach lesions, and seven of forty died within two weeks. Still, the tomato was approved, but has since been taken off the market. Q. Based on the information that was supplied, did the FDA scientist have concerns? Agency scientists and even independent scientists did warn that GM foods might create toxins, allergies, nutritional problems, and new diseases that might be difficult to identify. Internal FDA memos reveal that the scientists urged their superiors to require long-term safety testing to catch these hard-to-detect side effects. Q. What did the FDA do about these concerns? Nothing was done that would protect consumers. In fact, in the case of genetically modified bovine growth hormone, some FDA scientists who expressed concerns were harassed, stripped of responsibilities, or fired. The remaining whistleblowers had to write an anonymous letter to Congress complaining of fraud and conflict of interest at the agency Q. How could the government approve dangerous foods? A close examination reveals that industry manipulation and political collusion – not sound science – was the driving force. The FDA official in charge ignored all warnings of the FDA staff scientists. The official, a former outside attorney for Monsanto, was a political appointee specifically to a new FDA post on GM policy, and left shortly after to become vice president at Monsanto. Q. Why aren’t foods with GMOs at least labeled here? The same political influence and money that got them past the FDA has prevented any labeling laws from being passed. Although President Obama had indicated support for labeling laws during his campaign, he has allowed a whole host of genetically engineered crops to come to market in just this year alone, including RoundUp resistant Alfalfa (the fourth most widely grown crop in the US, inherent in livestock feed for industrial and sustainable farming alike), Kentucky Bluegrass, and sugar beets. Q. So do the biotech companies always get everything they want? Up until recently the biotech companies have fallen far short of their goals due to consumer resistance. The GM potatoes and tomatoes were taken off the market, and other GM crops, although approved, were never commercialized. Concerned consumers in Europe were able to get major companies to commit to eliminate GMOs within one week. This was done with

only a small percentage of the overall population. Businesses do not want to lose even a portion of their customer base. Everyone can vote with his or her pocketbook! As early as 1998, the biotech industry tried to get the USDA to let GM products pass as organic. During the public comment period, the Department received over 275,000 irate letters of protest from citizens, a public response unprecedented in the USDA’s history. Thanks to this public protest, GM products cannot be labeled organic in the USA.

This graphic may explain how the biotech industry manages to get what they want… (click to enlarge) A New Loophole… Up until now, what little “regulation” that existed was based on the fact that genetic engineering used a bacteria or virus to artificially insert the genetic code for RoundUp into a plant. The FDA’s ability to control (albeit minimally) was tied to the use of a virus or bacteria. But science recently found a sobering loophole: genetic modifications can now be inserted into the plant’s DNA using metal particles. Without the bacteria or virus present, the FDA has lost what little ground it had to regulate the process. The result? Kentucky Bluegrass is inherently a naturally invasive grass. Once it became genetically engineered to withstand RoundUp, it’s become even more resistant to control, and its parent company, Scotts Miracle-Gro, has become equally resistant to control under current regulatory standards. No surprise, Monsanto has a similar regulation-free process for genetically modified soybeans waiting in the wings… Read the related articles on The Scientist, and also on Nature.

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FDA Corruption  

“The FDA has placed the interest of a handful of biotechnology companies ahead of their responsibility to protect public health. By failing...

FDA Corruption  

“The FDA has placed the interest of a handful of biotechnology companies ahead of their responsibility to protect public health. By failing...