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FDA Critics Cite Food Safety Concerns

April 15, 2005

GM WATCH daily http://www.gmwatch.org
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EXCERPT: "If somebody was to submit a study like those presented to the FDA for peer review, it would be rejected flat out," said Doug Gurian-Sherman, a senior scientist at the nonprofit Center for Food Safety in Washington, D.C., and a onetime biotech safety reviewer with the Environmental Protection Agency.

Industry studies don't thoroughly explain how the study was done, which a peer review would demand, Mr. Gurian-Sherman said. And they often cite only summaries of data, not the raw data needed to verify the studies'
conclusions.
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Vioxx Recall Prompt Biotech Questions FDA Critics Cite Food Safety Concerns April 15, 2005

[Sidebar: Biotech Food Safety Research - see end]

By Robert Mullins, Newsdesk.org
http://www.newsdesk.org/archives/000173.php

Stymied by legal setbacks and a lack of public interest, critics of genetically engineered foods expressed impatience with the federal Food and Drug Administration for putting its regulatory foot down on pharmaceuticals such as Vioxx and Bextra, but keeping its hands off biotechnology.

While the FDA must approve pharmaceuticals before they are sold, and regulates them once they hit the market, it requires only voluntary consultations with food and biotech corporations about the safety of any genetically engineered foods they want to sell.

James Maryanski, biotechnology coordinator for the FDA's Center for Food Safety and Nutrition, said that this is consistent with the agency's mandate.

Medicines are newly created products combining different chemicals and other ingredients to treat diseases, and so must be pre-tested for possible side effects, he said, while genetically engineered food crops are still just plants, and therefore "substantially equivalent" to what's already on the market. "[T]he foods we eat today are all derived from crops we've had for centuries," Mr. Maryanski said.

Activists and medical researchers alike say that this attitude underestimates the complexity of genetic engineering.

"If we have problems because of drugs ... think of the problems of G.E. foods," said Steven Druker, executive director of the Alliance for Bio-Integrity of Fairfield, Iowa.

He said that modern genetic technology is dramatically different from traditional plant breeding, and can potentially create entirely new kinds of chemical and biological reactions.

The effects of these on humans are unknown, however, because the FDA does not require food corporations to conduct long-term safety testing, and has overlooked warnings about potential biotech food health risks from its own researchers.

"They have purposely tied their hands behind their back," said Druker, whose organization unsuccessfully sued the FDA to improve safety testing in 1998. He said the FDA is "statutorily mandated" to regulate biotech foods, and called for obligatory long-term safety testing, and labeling of any such products that do make it to grocery store shelves.

Currently, food corporations are only asked to participate in a voluntary consultation with the FDA prior to marketing a genetically engineered food product.

There have been 65 voluntary consultations between 1994 and March of this year, and an industry representative said businesses don't consider them optional.

"There is not a single biotech company that doesn't treat the process as mandatory," said Stephanie Chiles, spokeswoman for the Grocery Manufacturers of America, a trade organization for the $500 billion-a-year U.S. food
industry.

She said genetically engineered food safety should be based on the quality of the end product, not the process used to create it.

According to the GMA, 70 to 75 percent of the foods sold in the U.S. already contain genetically engineered ingredients.

Most of the letters to companies posted on the FDA's Web site approving a new biotech food product are brief:

"Based on the information Monsanto has presented to FDA, we have no further questions ... However, as you are aware, it is Monsanto's continued responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements," a January 2005 letter reads.

But the testing methods used by food corporations have drawn fire.

"If somebody was to submit a study like those presented to the FDA for peer review, it would be rejected flat out," said Doug Gurian-Sherman, a senior scientist at the nonprofit Center for Food Safety in Washington, D.C., and a onetime biotech safety reviewer with the Environmental Protection Agency. Industry studies don't thoroughly explain how the study was done, which a peer review would demand, Mr. Gurian-Sherman said. And they often cite only summaries of data, not the raw data needed to verify the studies'
conclusions.

Philip Regal, an ecology professor at the University of Minnesota-St. Paul, a longtime skeptic of the business side of genetic engineering, and one of the plaintiffs in the Alliance for Bio-Integrity's 1998 lawsuit against the FDA, said most of the testing conducted by food corporations was not necessarily for safety. "[T]hey throw around phrases like, 'This is the most intensively tested food in history.' This is probably true," he wrote in an e-mail correspondence, "but it is quite misleading because the testing was mostly for commercial properties" such as crop yield, and a plant's ability to handle different types of soil and climate.

Regal also said the FDA has a history of ignoring research that raises red flags about genetically engineered foods.

About 44,000 pages of internal FDA documents were made public as part of the Alliance for Bio-Integrity lawsuit, including memos that revealed dissent within the agency about biotech food safety.

For example, a 1993 memo from an FDA pathologist revealed that four of 20 female rats fed genetically engineered tomatoes developed stomach lesions.

In a control group fed only non-engineered tomatoes, no lesions were found. The research was conducted on the FlavrSavr tomato, introduced in 1994 by Calgene, a biotech firm since acquired by Monsanto. Production of FlavrSavr tomatoes ended in 1997.

According to the FDA's Maryanski, the critical memos were "a very small part" of all the documents produced by the agency as it was determining its policy on food produced through biotechnology.

"The fact that we have differences of opinion [within the agency] is a good thing," he said.

In September 2000, Federal District Judge Colleen Kollar-Kotelly found that FDA administrators were entitled to overrule their research staff.

While acknowledging considerable disagreement in the scientific community about genetic engineering and food safety, the judge also ruled that the agency was technically justified in assuming that there was scientific consensus that such foods were safe when it developed its policy of voluntary consultation.

The plaintiffs dropped their appeal, and according to Druker planned instead to challenge a new set of proposed regulations. But the FDA never moved forward with the new rules, leaving the plaintiffs with no new opportunity for legal action.

At the grassroots level, activists are also having trouble.

Only 27 percent of Americans polled in 2003 said they considered genetically engineered foods to be "basically safe," and 25 percent considered them "basically unsafe," according to a survey done for the Pew Initiative on Food and Biotechnology.

But when informed that a majority of the foods already on store shelves are made using some form of biotechnology, the belief that such products are safe rose to 44 percent, while the belief that they are unsafe dropped to 20 percent, the survey showed.

Additional reporting by Newsdesk.org staff.
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Genetically Engineered Food: Safety Research
April 15, 2005
http://www.newsdesk.org/archives/000174.php

Although the FDA does not conduct safety testing on genetically engineered foods, research is ongoing throughout the world, and not always free of
controversy. The following is a brief overview:

--Food-safety researcher Dr. Arpad Pusztai reported in 1998 that rats fed genetically engineered potatoes at a British lab developed immune system deficiencies and stunted growth. After announcing his findings, Pusztai was suspended by the lab at which he worked. Other independent researchers supported his conclusions.

--Reports of soy allergies in the United Kingdom rose by 50 percent in 1998 after soy milk from genetically engineered, pesticide-resistant crops was introduced there.

--StarLink corn, a genetically engineered ingredient that accidentally made it into the food supply was suspected as the cause of several severe allergic reaction cases in the U.S. in 2000, but a U.S Centers for Disease Control and Prevention study was inconclusive.

--Experimental studies have shown that genetically modified, antibiotic-resistant plant genes have been found in the intestines of human volunteers, according to a 2003 report from a global independent science panel.

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This GMO news service is underwritten by a generous grant from the Newman's Own Foundation, edited by Thomas Wittman and is a production of the Ecological Farming Association www.eco-farm.org <http://www.eco-farm.org/
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