Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -16

Accepted - Volume 9

Comment Record
Commentor Dr. Philip L. Bereano Date/Time 2003-01-06 19:20:06
Organization Washington Biotechnology Action Council
Category Consumer Group

Comments for FDA General
1. General Comments The Washington Biotechnology Action Council is a 13 year old non-profit citizens' organization which has been acting locally, nationally, and internationally to raise public interest perspectives on gentic engineering issues. We know that the US regulatory system for GE organisms is terribly flawed--patch-work in coverage, logically faulty in operation (such as the notion of substantial equivalence) and skewed to promoting short-term corporate profitability over consumer health and safety. It has even been criticized by mainstream agencies and scientists (see, for example, Wolfenbarger, L.L., and P.R. Phifer, The ecological risks and benefits of genetically engineered plants. Science 290:2088-2093, 2000). However, even from your own perspective, the idea of growing pharmaceuticals in plants in open fields, subject to the vagaries of wind, weather, insects and birds, should be absurd. Corn pollen, for example, can flow up to 20 miles, although the proposed policy would only apply to 1 mile buffers. Outflow of pollen to non-engineered organisms, and horizontal gene flow to unrelated ones are no longer cautionary warnings of NGOs; they are the stuff of scientific papers published in the open literature. Thus, it is inevitable that such practices would lead to contamination of the food supply and the inadvertent medication of unsuspecting persons. Such a situation would violate the international norms relating to the protection of human subjects, etc. as people would become objects in an experimental activity without informed voluntary consent. The Starlink situation also shows that liability issues would be significant. Not only would the corporations be at risk for damages, but the agencies such as FDA might be sued for nonfeasance. Finally, the FDA's deference to corporate claims of confidential business information has gone so far as to nullify any claims of democratic transparency the US regulatory system might like to claim. We must restore citizen oversight of the FDA's regulatory function, which means that much more of the relevant information must be made publicly available. Open-field testing of biopharm crops must be banned. Sincerely, Washington Biotechnology Action Council Dr. Philip L. Bereano Vice-President

EC -16