Cedric de La Beaujardière
3153 Stelling Drive
Palo Alto, CA 94303
January 12, 2000
Commissioner Jane Henney,
Food and Drug Administration
5630 Fishers Lane
Room 1061 (HFA-305)
Rockville, MD 20852
RE: Docket No. 99N-4282
Dear Commissioner Henney,
On October 25, 1999 the Food and Drug Administration posted a notice in the Federal Register calling for the public to submit comments on bioengineered foods (Docket No. 99N-4282). As a concerned citizen, I am writing to ask that you require the labeling and thorough pre-market safety testing of genetically engineered foods.
Objections to genetically engineered foods arise from a broad spectrum of concerns, including concerns for personal health, the health of ecosystems, and religious and ethical beliefs. Recently, a Time Magazine poll showed that 81% of American consumers believe genetically engineered foods should be labeled. There is a significantly large enough number of people with concerns about genetically engineered foods to require thourough testing of any such foods before they are sold on the market, and clear labeling of such foods once they reach the market. We have an absolute right to know what is in the food that we are purchasing, as well as how it was produced. Those few consumers who do not care what they eat can simply ignore the labeling. But if genetically engineered foods are not labeled, then the majority of consumers who do care what the eat have no way of making informed food purchasing decisions.
Businesses which produce genetically engineered seeds and foods may fear that labeling their products as such will deter consumers from purchasing them. If such is the case, then these companies will have all the more incentive to prove to the public that their products are indeed safe, and this proof will require thorough testing, which is yet another reason to require rigorous pre-market testing.
The testing of genetically engineered foods should examine possible health effects on all segments of the population, including infants, the elderly, and the allergy-prone. These tests could be dangerous because these people may be more susceptible, but this is precisely the reason why such testing is necessary. In addition, testing should assure that there are no environmental impacts, so perhaps the Environmental Protection Agency should partner with the Food and Drug Administration to assure sufficient environmental impact testing. Finally, tests must be conducted away from nature, where unsafe seeds could escape into the environment, with disastrous and unforeseeable consequences.
"With each gene insertion there is the possibility that a nontoxic element in the food could become toxic and create a human health hazard. This remains the most probable explanation for the dozens of deaths and thousands of serious illness caused by a genetically engineered food supplement, L- tryptophan, several years ago.
"Food allergies are another major health concern with genetically engineered foods. Those with food allergies will often have no way of knowing what is in genetically engineered foods and therefore what foods to avoid. Health professionals are also concerned that the mass consumption of genetically engineered foods could make treating infections more difficult in that some genetically modified foods contain antibiotic resistant genes.
"In addition to health concerns, millions of Americans feel obligated to refrain from some or all genetically engineered foods based on their ethical and religious principles. Many Jews and Muslims need to avoid foods with substances from specific animals, while devout vegetarians want to avoid substances from any animal. Additionally, a considerable portion of the population is religiously motivated to avoid all genetically engineered foods."
(Source:
Your own "FDA scientists expressed several concerns about bioengineered foods, including allergenicity, toxicity and antibiotic resistance. For example, the Divisions of Food Chemistry and Technology and Contaminants Chemistry warned that premarket testing of genetically engineered foods should be conducted because 'some undesirable effects such as increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, increased capability of concentrating toxic substances from the environment (e.g., pesticides or heavy metals), and undesirable alterations in the levels of nutrients may escape breeders' attention unless genetically engineered plants are evaluated specifically for these changes.'"
(Source:
The FDA's Web site (
www.fda.gov/oc/biotech) states "Special labeling [of bioengineered foods] would be required if consumers need to be informed about a safety issue, such as the possible presence of an allergen that would not normally be found in the conventionally-grown product." As described above, there are significant personal health issues which individuals need to be aware, but with genetically engineered foods, safety concerns go beyond the health of the individual and include concerns for the health of the environment. Genetically engineered plants can have and have had unexpected detrimental impacts on the ecosystem, as in the case of the migrating Monarch butterflies which were devastated by pest-resistant corn. Genetically engineered plants will spread into nature and have unknowable effects on their ecosystems. Once they have spread into nature, it will be costly and probably impossible to remove them from nature. We may not currently know whether or not genetically engineered plants will harm the environment, but if and when we learn they are harmful, it will likely be too late to stop them. The damage will have been done and will continue to be done. This is one reason why people who are concerned for the health of our environment are justifiably worried about genetically engineered foods, and why labeling of genetically engineered foods is needed, so that people who question the foods' environmental safety can refuse to support their development.I am deeply concerned that the government does not require mandatory pre-market safety testing of genetically engineered foods. Without such requirements, we will have no way to know if new toxins or allergens are being introduced, or if levels of existing toxins in these new, novel foods are increased. Additionally, the effect of using of antibiotic resistant genes in the genetic engineering process remains unclear, and may pose a health risk by transferring such resistance to consumers.
Further, it is my understanding that the Food, Drug, and Cosmetic Act mandates that genetically engineered foods be subject to premarket safety testing and labeling. I support the Center for Food Safety and other organizations that have filed suit against the FDA to require the fulfillment of these legal obligations.
Thank you for providing this forum for concerned citizens, such as myself, to present our thoughts and feelings on this matter of requiring labeling and pre-market testing of genetically engineered foods. Please take action to ensure that I have the ability to make an educated choice about the foods that I eat.
Sincerely,
Cedric de La Beaujardière