From: Nancy Sawyer [nsawyer@together.net] Sent: Saturday, March 24, 2001 8:40 PM To: fdadockets@oc.fda.gov Cc: smith45@together.net Subject: Docker 00N-1396 & Docket 00D-1598 To Whom It May Concern, Regarding your proposed rules on genetically engineered foods, I believe that they are seriously flawed and need to be completely rewritten. At the very least, the rules need to require mandatory labeling of all GE foods and certainly not restrict voluntary labeling. All food additives and ingredients are currently listed on package labels by law. Since GE foods always contain genes that have been artificially incorporated into the crop, all GMO derived foods are inherently different from conventional food products. The FDA's failure to acknowledge this one simple fact lies at the heart of the inadequacey of the rules that have been proposed. Labeling is a health issue. One reason is because of the increased risk of allergic reaction that is possible when foreign genes are incorporated into traditional food crops. The consumer has a right to know what is in the products they buy. Without labels, a consumer will not know whether the gene from a nut has been transfered into a tomato, for example, making it life threatening for the individual allergic to nuts. The proposed rules need to require an environmental review of GMO's prior to being planted in test plots and prior to being marketed. The rules also need to require safety testing before a GM food product is released onto the market. These requirements are needed simply because every widespread application of modern science has become notorious for unforeseen harmful side effects. Coal-powered machinery brought smog, noise and physical danger. The chemical industries have created building materials, paints, glues, fertilizers, herbicides, pesticides, preservatives and plastics, all of which have led to the global pollution of our soil, water and air along with a host of health issues. Nuclear power brought fear of annihilation, pollution of the environment by radioactive waste, and a global wave of concern for safe use of this technology. As technology advances, it utilizes more powerful laws of nature, and we find that it takes longer for natural processes to repair damage due to side effects. If we stop using coal in open fires then smog can dissipate within a month. If we stop creating chemicals it will take years, sometimes many decades, for nature to breakdown existing pollutants. If we shut down all nuclear reactors it will take thousands of years for our radioactive waste to become harmless. With genetic engineering we are manipulating the most fundamental level of living organisms. An act that potentially influences life on earth forever. This makes GMO's and food products obtained from them potentially more dangerous than nuclear waste. GM foods should not be approved until we have a firm grasp on how nature can be restored to normalcy following the release of genetic pollution. In the early days of every applied technology, there are disasters. Medicines have proven to be poisons, bridges have collapsed, steering mechanisms have failed, nuclear reactors have gotten out of control. As a technology matures, disasters are fewer. This indicates that test plans eventually cover most eventualities. But it takes a while to iron out the wrinkles and make a new technology safe. In the case of nuclear technology, the goal of safety has proved so elusive that responsible governments are trying to put the whole technology on ice. But whether a technology flies or dies, the basis of its safety program is applied experience carefully accumulated over time. In the case of GMO's, the technology is so new and the potential effects so far-reaching, there simply has not been time to accumulate sufficient applied experience. This makes it impossible to justify any broad claim of safety. Of great concern is the fact that genetic engineers use enzymes isolated from microorganisms to cut and combine segments of DNA. These enzymes make it possible to put foreign genes into viruses and bacteria plasmids. Viruses and plasmids are parasitic DNA vectors. They can infect cells and multiply in them. They can insert themselves into the DNA of the host cell. In short, genetic engineers have created new vectors to carry genes of their choosing to a wide variety of host organisms. Unfortunately, genetically engineered vectors have three seriously undesirable features: 1 - They carry genes for antibiotic resistance. 2 - They are designed to bread down species barriers so that they can shuttle genes between a wide range of species. 3 - They are derived from viruses, plasmids and mobile genetic elements known to cause tumors and cancers. This means that these vectors could contribute significantly to horizontal gene transfer, thereby changing the dynamics in the global gene pool. They could provide bacteria with antibiotic resistance genes, aggravating an already all too common health problem. Although genetic engineers cripple disease-causing functions to make the vectors "safe," it is possible that the vectors will be able to restore those missing disease-causing DNA segments and become a serious health hazard. This view is shared by scientists A.E. Greene and R. F. Allison who authored "Recombination between viral DNA and transgenic plant transcripts" in the journal Science. (1994): 263: 1423-1425 Since the combination and passage of parent DNA to the child is not a predictable process, and since the overall possibilities for horizontal gene transfer are not known, nobody can accurately predict the effect of new DNA on existing ecological communities. Given the dynamism of the global gene pool, it seems naive to imagine that creating super-vectors and changing the DNA in millions of acres of crops will not have serious environmental, health and safety repercussions. Adding genetically engineered DNA to the gene pool could lead to herbicide-tolerant weeds, antibiotic resistant bacteria, and new dominant varieties of plants, with cascading consequences for ecosystems. The possible extent of damage is profoundly worrisome, and it is therefore possible that genetic engineering, which violates the very laws of nature irreversibly altering the chemical basis of life for all future generations may well be the greatest threat in history to life on earth. Exhaustive environmental, health and safety testing must be required for all genetically modified organisms. In addition, the proposed rules need to include provisions to assure the liability of corporations responsible for any environmental, economic or health damages caused by their genetically modified organisms or crops harvested from GMO's. As a certified organic grower and beekeeper, I am well aware of the danger of genetic contamination of my crops and the harmful health effects that have been scientifically shown to occur to honeybees exposed to GE pollen. Unfortunately, my options to protect my bees and crops are limited due to inadequate safeguards taken on the part of GMO proponents and because so little is known about this new technology. If my crops are decertified or my honeybees die prematurely due to GMO's, there needs to be a measure of liability on the part of the manufacturers of this technology that is both economic and criminal. In science, safety cannot be assumed. It must be proven. The reality is that genetic engineering is too new and potentially too hazardous for any of us - consumers, scientists, farmers, government officials, or corporate executives to be in a hurry to take GMO's out of the labs and put them onto our dinner tables. The bottom line is that no one knows if these foods are really safe for us or the environment in the long run. Without out knowledge or consent, we have all become subjects in a highly controversial experiment. As I stated in the beginning of this message, at the very least, genetically engineered foods must be labeled so that consumers can choose for themselves whether they will eat them or not. Thank you for your time and consideration in this matter. Ross Conrad PO Box 443 Middlebury, Vermont 05753