From: Sara Madera [madera@texas.net] Sent: Tuesday, April 03, 2001 9:42 PM To: fdadockets@oc.fda.gov Subject: Genetically engineered food Dear FDA Commissioner, The proposed Food and Drug Administration (FDA) regulations fail to require labels or safety tests on genetically engineered (GE) food. The new rules continue to deny Americans the fundamental right to know what is in our food, while protecting the economic interests of biotech corporations. Labeling GE foods would protect the public from potential hazardous health effects such as food allergies and toxicity that can only be traced if GE foods can be identified. By refusing to require both labeling and mandatory pre-market safety testing of foods, the FDA puts consumers' health at risk, ignores possible environmental hazards, and fails to satisfy the overwhelming desire of American consumers to exercise freedom of choice in the marketplace. It is not enough to require that firms simply notify you of their intent to market a food produced with genetic engineering; this is no substitute for thorough pre-market safety testing. The proposed "voluntary labeling" guidelines will do nothing to inform consumers of the presence of genitally engineered ingredients in their food, because biotech companies and food manufacturers have vehemently opposed labeling in the past and will not voluntarily label their foods in the future. Therefore, I urge you to keep all genetically engineered ingredients and crops off the market unless or until: 1) Independent safety testing demonstrates they have no harmful effects on human health or the environment; 2)They are labeled to ensure consumers' right-to-know; and 3) The biotechnology corporations that produce them are held responsible for any harms they may cause. Growing numbers of responsible and informed farmers, scientists and concerned citizens disagree with genetic engineering, citing new hazards to our health and the environment. Blessed with the potential to help feed ourselves and a hungry world with wholesome foods from fertile soils, we are instead forging ahead with dangerous biotechnologies that much of the developed world and now even China are rejecting,. The New England Journal of Medicine has warned that " the allergenic potential of these newly introduced microbial proteins is uncertain, unpredictable and untestable. " GE foods may set off allergies, increase cancer risks, produce antibiotic-resistant pathogens, damage food quality, and produce dangerous toxins. Environmental hazards include increased use of toxic pesticides, damage to soil fertility, genetic pollution of adjoining farmlands, harm to Monarch butterflies and beneficial insects such as ladybugs, and the creation of "superpests", "superweeds," and virulent new plant viruses. Consumer polls show that 80-95% of Americans want genetically engineered food to be labeled. It is imperative for the health of our nation now and in the future, for the continued strength of our nation over generations to come, that you courageously take the major step of requiring stringent labeling and full disclosure. Such action requires the courage of conviction and an open mind unfettered by financial influence, but to do any less is to condemn millions to unknown and dangerous consequences. It amazes me that when blessed with such abundance, our nation is championing a process so dangerous and destructive, placing perceived profit over the health and welfare of our people and the sustainability of the environment that ultimately sustains us all. Sincerely, Mark Madera