From: Janean Nelson [jcats68@earthlink.com] Sent: Thursday, March 29, 2001 10:05 PM To: fdadockets@oc.fda.gov Subject: Docket 00N-1396 & Docket 00D-1598 Dear Sir or Madam, I am writing to comment on the above-captioned dockets. Science can be a wonderful way to improve our lives. But science is not infallible, because people are not infallible; remember Three Mile Island, Love Canal, and thalidomide babies? Radioactive sticks were claimed to have health benefits before it was discovered that exposure to radiation caused cancer. Science often has to admit after the fact that it has caused harm because of unanticipated consequences. The more powerful we become in our ability to manipulate nature, the more harmful the consequences can be. Radioactive sticks and thalidomide only harmed the individuals who used them, but nuclear reactions can harm whole populations. The people of Chernobyl would attest to that. The effects of Genetically-Engineered (GE) foods could be equally powerful. Cross-pollination could eliminate Non-GE food from the planet, resulting in effects that we cannot control, nor predict. A small number of mutant genes could have a population explosion and reproduce forever, causing unlimited and irreparable damage. According to biology professor Phillip Regal, a biotech company put genetic material from Brazil nuts into soybeans to make them more nutritious. But when tested on blood from people allergic to the nuts, the beans caused severe reactions, and the project was dropped. If those soybeans had gone to market, people would have died and never known why. In another case, the amino acid L-tryptophan that had been made by genetically engineered bacteria killed 39 people and crippled 1,500. Yet the FDA persists in acting as though GE foods are safe and science is infallible. Actually, not even science, just industry, whose motive is corporate profits, not the welfare of the populace. Why is the FDA backing industry on the issue of GE foods, even though adequate safety testing has not been performed? What can possibly be the justification for this passive and permissive attitude? Just because industry SAYS that GE foods are not harmful, you simply take their word for it? I protest this attitude on the part of the FDA, and demand that our rights as consumers be attended to. I want to see a ban on GE foods until such time as their safety has been tested. The FDA must require mandatory pre-market long-term health testing. GE products could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers. I want to see mandatory labelling for all GE foods that are allowed on the market. Without mandatory labeling, neither consumers nor health professionals will know if an allergic or toxic reaction was the result of a genetically engineered food. Consumers would be deprived of the critical knowledge needed to hold food producers liable should any of these novel products be hazardous. I want to see the FDA restored to a position of integrity by separating it from the industry it portends to regulate, and disallowing the "revolving door" that permits industry to write its own regulations on its own products. Sincerely, Janean Nelson Rockville, MD jcats68@earthlink.net