February 16, 2010

Division of Dockets Management,
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane Room 1061
Rockville, MD 20852


DOCKET NUMBER: FDA-2010-P-0081-0001/CP

This Petition is being submitted to the Food and Drug Administration for the purpose of requesting a review of the section of the Statement of Policy: Foods Derived from New Plant Varieties 57 Fed. Reg. 22984 1992 [Docket No. 92N-0139] which states: “VI Labeling…The Agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concerns than foods developed by traditional plant breeding.”

We believe that genetically engineered food should have been labeled initially in 1992, and while we understand the Food and Drug Administration has built over time a series of policies based on the decision not to label, we think recent evidence supports our position in revising these conclusions which would initiate labeling.

In May 29, 1992, the Food and Drug Administration studied information to show how genetically engineered food may “differ from other foods in any meaningful or uniform way.” I will attempt to document how genetically engineered foods “differ from other foods in any meaningful or uniform way” that has occurred in the over sixteen years since the initial statement of policy was published.

It appears that the decision to not label genetically engineered food was a marriage between agribusiness (including herbicide manufacturers like Monsanto) and government officials for purely political reasons; i.e. to increase profits and control seed stock, solve trade imbalances, subsidize crops and advance science. None of this had anything to do with the “different and greater safety concerns” about genetically engineered food, or does it address the public interest and consumer confidence in our food supply.


1) How then does genetically engineered food “differ from other foods in any meaningful or uniform way?”

a) First of all, there could be no more dramatic difference than altering the DNA of a plant. Wide spread and unpredictable changes occur when doing DNA manipulation of plant varieties. We know these changes have a different effect on the body as a result of gene altering procedures. We know altered DNA creates new allergic reactions. We know Bt-toxin is more concentrated…..and that genetically engineered crops have much higher residue of toxic herbicide.

b) Second, genetic engineering is radically different from natural breeding. In contrast to the statements of biotech advocates, Food and Drug Administration scientists and others affirm that genetic modification is not just an extension of the conventional breeding techniques that have been used by farmers for millennia. Genetic engineering transfers genes across natural species barriers, using imprecise laboratory techniques that bear no resemblance to natural breeding. Furthermore, the technology is based on outdated concepts of how genes and cells work. Gene insertion is done by shooting genes from a “gene gun” into a plate of cells or by using bacteria to invade the cell with foreign DNA. The altered cell is then cloned into a plant. These processes create massive collateral damage, causing mutations in hundreds or thousand of locations throughout the plant’s DNA. Natural genes can be deleted or permanently turned on or off, and hundreds may change their levels of expression. [This information is from the book Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, by Jeffrey Smith, published in 2007 as a result of a two-year collaboration with more than 30 scientists.]

c) Third, Monsanto holds a patent on their genetically engineered corn, soy, cotton, and canola seed. They must “differ’ significantly since they have patented those differences!


1) A “different safety concern” is the concern by farmers that their crops may become contaminated by genetically engineered plants and the consumer’s food supply may become contaminated.

a) Many public health and consumer groups are concerned that genetically modified crops have already contaminated native and related species, and that transgenic seeds are spreading nationwide, creating an adventitious presence in the food supply. In California, voters in four (4) counties: Mendocino, Marin, Santa Cruz and Trinity; have gone to the ballot box to ban the growing of genetically engineered crops. The “different safety concern” is obvious – people don’t trust growing and eating food which is genetically engineered and has not had long term safety testing.

b) A number of court cases - the most recent involving sugar beets - have highlighted the need for an Environmental Impact Statement before growing genetically engineered crops. A 2007 federal court ruled that the USDA broke the law by approving genetically engineered alfalfa without an Environmental Impact Statement. In 2009, the 9th Circuit Court of Appeals upheld the decision, ruling that the planting of GE alfalfa can cause potentially irreversible harm to organic and conventional crops.

c) Ecological effects must be considered as well. Since 99% of genetically engineered crops tolerate and/or produce insecticides, bee colony collapse disorder and a large number of butterfly deaths may be related to genetically engineered crops. This could be the gravest danger – eliminating the earth’s pollinators.


The greatest safety concern of all, the harm and damage to human health and life itself.

a. Deadly epidemic caused by genetically engineered food supplement. One hundred (100) Americans were killed by L-tryptophan, a contaminated food supplement in the 1980’s. It caused sickness in another 4,000 to 8,000 American citizens. It took years to detect, even though the symptoms were unique, acute and speedy. The Food and Drug Administration needs an approval process that does long term testing, prior to any use of genetically engineered products.

b. Consumer concern about genetically engineered food in Europe reached its peak in 1999; in less than a week all major food manufacturers removed genetically engineered ingredients from their products. United States manufacturers currently “label” for export to Europe. Most industrialized nations in the world such as the European Union, Australia and Japan regulate genetically engineered foods to protect human health and the environment, and ensure the free movement of safe products. Food safety (or lack of) in the United States has led to an epidemic of unsafe foods. Illnesses such as cancer have the highest incidence of occurrence in the United States.

c. Study proves three Monsanto corn varieties pose health hazard. The International Journal of Biological Sciences has just completed a study which demonstrates the toxicity of three (3) genetically engineered corn varieties (MON810, MON863, and NK603) which are in considerable use in the United States. To cite Gilles-Eric Seralini, a member of the Commission for Biotechnology Reevaluation, and a molecular biologist at the University of Caen: “For the first time in the world, we have proven that genetically engineered foods are neither sufficiently healthy or proper to be commercialized. Each time, for all three genetically modified organisms, the kidneys and liver which are the main organs that react to a chemical food poisoning, had problems.” By problems, the study pointed to a build up of abnormal structural changes in various organs, which included the liver, spleen, and pancreas, as well as different levels of damage to heart, adrenal glands, and the haematopoietic system.


Montana’s United States Senator, Jon Tester states….. “Unlabeled GMO’s in our food works against what I have learned in my 30 years as a family farmer. Agriculture should be sustainable, food should be healthy and safe, and people deserve to know what they’re eating.” ……. (From the forward to Genetic Roulette, the Documented Health Risks of Eating Genetically Engineered Foods by Jeffrey M. Smith. There is nothing more important in modern society than “the right to know,” for without that information, citizens cannot exercise their “freedom of choice,” and isn’t that what it is all about: “FREEDOM!” It has been alleged that the Food and Drug Administration and the Department of Agriculture intentionally withheld “labeling” for fear the public would be “concerned.” Labeling will occur, not “if,” but when. Already the Department of Agriculture is debating the labeling of “cloned” meat and poultry. Cloning, which simply replicates the DNA, is much less risky than the genetically engineered plant varieties, which transfer genes across natural species barriers, and injects bacteria and virus into the cells. Section 5…Federal Trade Commission…Unfair and Deceptive Acts and Practices…..By withholding information and not properly labeling genetically engineered foods, the government has practiced “unfair and deceptive acts” against the American people and the Federal Trade Commission should act to correct these practices. ________________________________________________________


The Truth in Labeling Coalition, Executive Committee: Chris Wege, President,…Nancy Casady, Vice President…Derek Casady, Vice President…Peter Bellonci, Treasurer… Anne Dietrich, Administrative Director; Mayor Ed Malloy, Fairfield, Iowa; American Organic Seed, Austrade, Inc., Cedar Circle Farms, Eden Foods, Food Democracy Now!, Frontier Natural Products Co-op, Institute for Agriculture and Trade Policy, Lundberg Family Farms, Mary’s Gone Crackers, The Natural Grocery Company, New Pioneer Food Co-op, Now Foods, Ocean Beach People’s Organic Food Co-op, Oregon Physicians for Social Responsibility, Organic & Non-GMO Report, Organic Consumers Association, Organic Valley, Radiance Dairy, Sacramento Natural Foods, Straus Family Creamery, United Natural Foods International, Vantage Organics, Whole Soy & Co.…..The American Public Health Association, …The American Nurses Association…. The British Medical Association… Organic Seed Alliance, Uprising Organic Farm, Uprising Seed, South Central Farmers Coop, Albert Lea Seed House, Karen Klimnock, Jason West, Ashsha East, Marshall Friedman, Morgan Dickerson, Ruth Duemler, Dave and Sandy Robinson, Lisa Holub, New Leaf Natural Grocery, Inc., PCC Natural Markets, Rodale Institute, Campbells Nutrition, Northland Organic Foods Corp., Rainbow Light Nutritional Systems, Inc., Bruach na-Greine Farm, Donna Prizgintas, Howard Vlieger, Dr. David Pimentael, One Backyard Consulting, Cornucopia Institute, East End Coop, Guayaki SRP, Inc., Yoxagoi Orchards, Dancing Crow Vineyards, LLC; Abundance Cooperative Market, Artichoke Food Coop, Eagle Rock Food Coop, River City Coop, Daily Groceries Coop, West Michigan Cooperative, Sunseed Food Coop, Indiana Chapter of the American College of Physicians Health and Public Policy Committee, Iowa Farmers Union, Briar Patch Coop, Certified Organic Arkansas Farmer Market, Uprising Organic Farm, Uprising Seed, South Central Farmers Coop, Organic Seed Alliance, Abundance Co-op Market, Berkshire Co-op Market, Food and Water Watch, Weston A. Price Foundation, Ashland Food Coop.

The action of this petition will not have any further environmental impact.

The undersigned submits this petition under any relevant statutory sections of the Federal Food, Drug and Cosmetic Act of the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR10.30, to petitioner which are unfavorable to the petition.

Jim Bates Former Member of Congress, on behalf of the Truth in Labeling Coalition

17822 Highway 67 Ramona, California 92065

Telephone 760-613-9730 E-Mail: surveyresearch@juno.com


The following documents are being included for the record:

1) President Obama’s signed campaign statement to support mandatory labeling of genetically engineered food.

2) California Democratic Party Resolution Number SAC09.68 to Secure the Labeling of Genetically Engineered Food.

3) Citizens’ Resolution to Secure the Mandatory Labeling of Genetically Engineered Food