Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -94

Accepted - Volume 9

Comment Record
Commentor Mr. James Wyerman Date/Time 2003-02-07 18:28:58
Organization 20/20 Vision
Category Other

Comments for FDA General
1. General Comments To whom it may concern: 20/20 Vision would like to address its concerns regarding Docket No. 02D-0324, specifically calling on the FDA to ban open-field testing of crops engineered to contain pharmaceuticals and industrial chemicals. We are submitting these comments due to several concerns. One is that the FDA’s proposed regulations to prevent contamination do not go far enough in addressing the issue. Corn pollen is known to travel as far as 20 miles, yet the new FDA guidance would require one mile between genetically engineered variants and non-modified crops. Corn is especially risky because it readily cross-pollinates and hybridization between two different species is also likely to occur. Many of the compounds grown are kept secret, so a farmer would not know whether his fields were contaminated. 20/20 Vision is particularly concerned about the possible environmental risks of contamination because once an engineered variant is released to the native environment, scientists say it will be almost impossible to get it out. It is simply impossible to completely guarantee no contamination whatsoever. Another concern is that recent contamination incidents have demonstrated the inability of the US regulatory system to properly address the contamination issue and protect the food supply. Genetically engineered corn remaining from a previous harvest sprouted in a soybean field in Nebraska and contaminated 500,000 bushels of soybeans. In another incident in Iowa, GE corn escaped from open fields and contaminated hundreds of acres of non-GE Iowa corn—possibly pollinating grain intended for human consumption. In addition, we are extremely concerned about the potential human health effects of contamination. Some industrial enzymes in corn such as trypsin and antitrypsin are known allergens. Trichosanthin, a potent abortion-inducing drug has been introduced into tobacco by means of an engineered virus, which is also known to infect tomatoes, peppers and other tobacco relatives. If these crops contaminate the food supply, individuals could unwittingly be consuming these and other chemicals such as insulin and heart medicine. . It is for these reasons that 20/20 Vision calls for the FDA to ban all open-field testing of these crops. Testing should continue in a contained and controlled environment as opposed to in the open air. In the meanwhile, we demand the FDA to strengthen the guidance and put in place greater distances, at least 20 miles, to isolate such crops from the food supply. Thank you for your time and consideration. We look forward to hearing your reply.

EC -94