Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -78

Accepted - Volume 9

Comment Record
Commentor Mrs. Beth Burrows Date/Time 2003-02-07 13:48:55
Organization The Edmonds Institute
Category Other

Comments for FDA General
1. General Comments Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Regarding: DOCKET NO. O2D-0324 These comments are submitted on behalf of the Edmonds Institute, a public interest, non-profit, 501(c)(3) organization concerned with issues related to environment and technology. After the recent Starlink incident, the recent ProdiGene field trial incidents, and the recent bioengineered piglets incident, much evidence has accumulated to remind us that even the most sincere of human intentions, the strictest of Industry or academic oversight, and the best of government regulations cannot prevent human beings from making mistakes, miscommunications from occurring, and genes of concern from going astray. These experiences, taken together with the facts that other methods exist for the production of pharmaceuticals and pose fewer potential hazards to the food chain (and hence to human health) than does out-of-doors biopharming, lead the Edmonds Institute to recommend: (1) that no food or feed crop ever be used as host for biopharming anywhere, (2) that no biopharming of any crop - food/feed or non-food/feed - be permitted out-of-doors, and (3) that a scientific committee be convened to determine mandatory adequate standards of containment for the use of non-food/feed crops in indoor biopharming. With regret, the Institute further notes that voluntary compliance mechanisms generally do not work and that tests to detect the presence of unwanted genes - while useful for the enforcement of standards - generally do not prevent problems but only confirm the existence of problems. Hence, the Institute finds that mandatory standards of containment must be the goal. We thank you for this opportunity to comment. Sincerely, Beth Burrows President/Director for The Edmonds Institute 20319-92nd Avenue West Edmonds, Washington 98020 USA phone: 425-775-5383 email: website: President/Director The Edmonds Institute 20319-92nd Avenue West Edmonds, Washington 98020 USA phone: 425-775-5383 email: website:

EC -78