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As different people within the agencies of the United States government are involved with making the decisions for the “Statement of Policy” of ‘Foods from Genetically Modified Plants’ for its permanence as a document in the Federal Register, the process of corrections and correspondence, go back and forth, and back and forth, between agencies. Dr. Linda Kahl, Compliance Officer the FDA, in an informal note, (no letterhead) to Dr. James Maryanski, (FDA Biotechnology Coordinator) expressed her concern about the ‘schizophrenic’ advice from other agencies on the subject. She starts out Jim Areas of Concern 1)

“The current document (particularly the section on scientific issues and the appendix) is very schizophrenic in regards to the objective.

2)

…some of this is provoked by conflicting comments from multiple sources on previous drafts.”

3)

“The recommended actions should be the same for cultivars developed by new and traditional methods, because it is the product and not the process that is regulated.”

4)

Other advice has been “Do you realize you are proposing regulations for an entire industry that has previously been virtually unregulated and has a history of safety” (i.e. traditional plant breeding.) Comments Reference 1) It is clear the doctor sees confusion by the responders not only about the scientific issues, but, to the ‘objective’ of the document, Reference 2) Abundance of conflicting comments from a range of regulatory sources. Reference 3) …recommended actions should be the same for new [genetically engineered], as the traditional methods of cultivars, because, it is ‘the product and not the process’ which is regulated. So the product will be regulated by unsubstantiated words on paper, rather than the process being determined by scientific evaluation where regulations are determined based on scientific findings. Traditional Plant Breeding (traditional methods):


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