From: sdss [sdss@earthlink.net] Sent: Sunday, March 25, 2001 3:13 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 Genetically Engineered Products MUST be Labeled and Tested for Safety. The Public Has a Right to Know, and a Right to Freedom of Choice. It's unconscionable to flood the market with GE food without informing the public that this food IS genetically engineered and without informing the public of the lack of long-term safety testing of GE food, and of the possible hazards of consuming such food. The most unconscionable is the fact that there are GE ingredients in baby food! What can the members of the FDA be thinking? Whatever happened to the Bill of Rights? How would they feel if someone made their baby or their child an unknowing guinea pig to a dubious experiment without their knowledge? How do they plan to answer the public if/when it's proven that this genetically engineered food causes who knows what kind of problems? With drugs and other mistakes, they could recall the offending item. But with GE products that option isn't a choice. Once the GE product is created, it can't be recalled. It could continue to wreak havoc with the environment and all the inhabitants of the Earth. The members of the FDA seem to forget that the FDA was created to protect and serve the public and not just special interest groups. The members of the FDA seem to forget that members of the government are not in business for vast profits, but are public servants, and are already better paid than the average citizen. The proposed rules do not require mandatory pre-market safety testing or environmental review. The proposed rules do not require mandatory labeling of GE foods, and restrict voluntary labeling of non-GE foods. Producers of organic food have a right to label their good wholesome food as such, to ensure safety to those people who wish to avoid eating GE food. The proposed rules require only a mere letter of notification prior to the marketing of a GE food, and fail to ensure public access to adequate information for independent review. The proposed rules are only supported by the GE food industry, and are opposed by consumer groups. The FDA MUST require mandatory comprehensive pre-market environmental review before a GE food is introduced into the market. Unlike conventional pollutants, where a given amount of pollutant causes a limited amount of damage, a small number of mutant genes could have a population explosion and reproduce forever, causing unlimited and irreparable damage. The FDA MUST require mandatory comprehensive pre-market long-term health testing. GE food products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. The FDA MUST require mandatory labeling of GE products. Without mandatory labeling, neither consumers nor health professionals will know if an allergic or toxic reaction was the result of a genetically engineered food. Consumers would be deprived of the critical knowledge needed to hold food producers liable should any of these GE foods prove hazardous. The FDA MUST end its cozy relationship with the industries it purports to be regulating. It is well known that people have been allowed to work for a biotech company, then work for the FDA writing the regulatory rules on that company's product, then go back to working for the company again. It has been shown that ninety-two percent of FDA advisory committee meetings had at least one conflict of interest. I urge you to read the following truths about GMOs, look into your consciousneses, and take appropriate action to protect the Americann public, to provide for the rights and freedom of choice on which this country was founded, by the mandatory labeling and testing of all GE foods. Sincerely, Elaine M. Stauffer P.O. Box 7321 Colorado Springs, CO 80933-7321 The Truth About GMOs Right now a debate is raging in the United States about genetically modified organisms (GMOs) in our food. The biotech industry claims that GMOs will save the environment and solve the hunger crisis. But Greenpeace considers GMOs a threat to the planet, and organizations like Christian Aid and the Institute for Food and Development Policy say GMOs are likely to increase world hunger. How can you make sense of this tricky subject? Read on to find out the truth behind the genetic engineering myths. MYTH #1: Genetic engineering is merely an extension of traditional breeding. REALITY: Genetic engineering is a new technology that has been developed to overcome the limitations of traditional breeding. Traditional breeders have never been capable of crossing fish genes with strawberries. But genetically engineered "fishberries" are already in the field. With genetic engineering, these types of new organisms can be created and released into the environment. Food and Drug Administration scientists stated that genetic engineering is different from traditional breeding, and so are the risks. Despite this warning, the FDA continues to assert that GMOs are not different and don't require special regulations. MYTH #2: GMOs can make foods better, more nutritious, longer lasting and better-tasting. REALITY: The reason for almost all of the 70 million acres of GMO crops grown in this country today has nothing to do with nutrition, flavor or any other consumer benefit. There is little benefit aside from the financial gains reaped by the firms producing GMOs. Nearly all of the GMO corn, soy, potatoes and cotton grown in the United States have been genetically altered so that they can withstand more chemicals or produce their own insecticides. MYTH #3: GMO crops eliminate the need for farm chemicals and are necessary for environmentally sustainable farming. REALITY: The most widely grown GMO crops actually require the use of chemical herbicides. For example, Monsanto created Roundup-Ready (RR) soy, corn, canola and cotton specifically so farmers would continue to buy Roundup, the company's best-selling chemical weed killer, which is sold with RR seeds. Instead of reducing chemical use, one study of more than 8,000 university-based field trials found that farmers who plant RR soy use two to five times more herbicide than non-GMO farmers who use integrated weed-control methods. GMOs may be the greatest threat to sustainable agriculture on the planet. Many organic farmers rely on a natural bacterial spray to control certain crop pests. The advent of genetically modified, insect-resistant crops is likely to lead to insects that are immune to this natural insect control. When this biological pesticide is rendered ineffective, other farmers will turn to increasingly toxic chemicals to deal with the "superbugs" created by GMOs. Meanwhile, organic farmers will be out of options. MYTH #4: The Government ensures that genetic engineering is safe for the environment and human health. REALITY: Neither the FDA, the Department of Agriculture (USDA), nor the Environmental Protection Agency (EPA) has done any long-term testing of GMOs in food or the environment. The FDA has acknowledged that it has not established any regulation specific to bioengineered food. Biotech companies are on the honor system. They have virtually no requirements to show that this new technology is safe. FDA scientists and doctors warned that GMO foods could have new and different risks such as hidden allergens, increased plant-toxin levels and the potential to hasten the spread of antibiotic-resistant disease. The USDA has reviewed more than 5,000 applications for biotech crop field trials without denying a single one. USDA officials say they will start long-term studies of GMO crops, but the agency has not required any pre-market or pre-release assessment. Studies conducted after our environment and food supply have been contaminated will be too late. MYTH #5: There is no scientific evidence that GMOs harm people or the environment. REALITY: There is no long-term study showing that GMOs are safe, yet the biotech industry and the government have allowed our environment and our families to become test subjects in these experiments. Doctors and scientists around the world have warned that GMO foods may cause unexpected health consequences that may take years to develop. Laboratory and field evidence shows that GMOs can harm beneficial insects, damage soil and transfer genes in the environment, modified, contaminating neighboring crops and potentially creating uncontrollable weeds. Already GMO canola in Canada has become resistant to three different herbicides becoming a problem weed in other fields. MYTH #6: GMOs are necessary to feed the developing world's growing population. REALITY: In 1998, African scientists at a United Nations conference strongly objected to Monsanto's promotional GMO campaign that used photos of starving African children under the headline "Let the Harvest Begin." These scientists, who represented many of the nations affected by poverty and hunger, said gene technologies would undermine the nations' capacities to feed themselves by destroying established diversity, local knowledge and sustainable agricultural systems. Genetic engineering could actually lead to an increase in hunger and starvation. Biotech companies are still eagerly pursuing a genetic engineering technique named "terminator" technology that would render a crop's seed sterile, making it impossible for farmers to save seed for replanting. Half the world's farmers rely on saved seed to produce food that 1.4 billion people rely on for daily nutrition. 1. Rissler, Jane and Mellon, Margaret. The Ecological Risks of Engineered Crops (Cambridge: MIT Press, 1996, 4-5.) 2. Discovery documents from the lawsuit Alliance for Bio-Integrity et al v Shalala, May 1998. Center for Food Safety, 666 Pennsylvania Ave, SE, Washington DC, 202-547-9359. 3. Benbrook, Charles. "Evidence of the Magnitude of the Roundup Ready Soybean Yield Drag from University-Based Varietal Trials in 1998," Ag BioTech InfoNet Technical Paper Number 1, July 13, 1999. http://www.biotech-info.net/herbicide-tolerance.html. 4. Statement of James Maryanski, FDA Biotechnology Coordinator, Before the Senate Committee on Agriculture, Nutrition and Forestry, October 7, 1999. 5. Discovery documents from the lawsuit Alliance for Bio-Integrity et al v Shalala, May 1998. Center for Food Safety, 666 Pennsylvania Ave, SE, Washington DC, 202-547-9359. 6. Sally McCammon, USDA, "Regulating Products of Biotechnology," Economic Perspectives, US Department of State, vol 4, #4, October 1999. 7. See British Medical Association, "The Impact of Gene Modification on Agriculture, Food and Health: An Interim Statement," May 1999; Patrice Courvalin, "Transgenic Plants and Antibiotics," La Recherche, May 1998; Rebecca Goldburg and Gabrielle Tjaden, "Are Bt Plants Safe to Eat," January 1991 Global Pesticide Campaigner. 8. Mary MacArthur, Triple-Resistant canola weeds found in Alberta, Western Producer, February 10, 2000. 9. "Let Nature's Harvest Continue!" African Counter Statement to Monsanto, at the 5th Extraordinary Session of the FAQ Commission on Genetic Resources, June 12, 1998. 10. Peter Rosset, "Why Genetically Altered Food Won't Conquer Hunger," New York Times, September 1, 1999.