From: Pradella, Josephine J [PradeJ@mail01.dnr.state.wi.us] Sent: Monday, February 05, 2001 12:22 PM To: 'fdadockets@oc.fda.gov' Cc: 'action201@sustainableagriculture.net' Subject: Docket Numbers 00n-1396 and 00D-1598 This is an electronic version of a hard copy of comments I've put in the mail. FDA Commissioner, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 February 5, 2001 RE: Docket Numbers 00N-1396 and 00D-1598 Dear Commissioner, The new FDA rule on genetically engineered (GE) foods does not offer enough protection. I strongly urge the FDA to : 1. Require mandatory pre-market safety testing. GE foods could be toxic, cause allergic responses, have lower nutritional value, and compromise immune responses in consumers; 2. Require mandatory pre-market environmental review. GE crops and goods could cause unforseen and irreparable damage to the environment; 3. Require mandatory labeling of GE foods. Without mandatory labeling, neither consumers nor health professionals will know if an allergic or toxic reaction was the result of a GE food. Consumers will also be deprived of the critical knowledge they need to hold food producers liable should any of these novel foods prove hazardous; FDA's "Notification" policy is not in the best interest of consumers since it ignores strong scientific evidence of numerous potential health and environmental risks of GE foods. A more proactive rule is needed to protect public health and the environment and provide more consumer information. Sincerely, Josie Pradella Wisconsin Sustainable Futures Network 4803 Buckeye Rd. #2 Madison, WI 53716-2219