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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):

Through cross breeding existing varieties, the breeder aims to re-shuffle the plants' genetic material to produce new varieties that may have useful characteristics, so As a general rule, conventional breeding develops new plant varieties by the process of selection Approx 40% of the genetic material is reorganized in the resulting hybrid plant and seeks to achieve expression of genetic material which is already present within a species From these new plants, the breeder uses a slow process of selection to work out which are useful and which are not.

Genetic Engineering: This insertion process through the cell wall does not occur in nature. A gene "gun", a bacterial "truck" or a chemical or electrical treatment inserts the genetic material into the host plant cell.

With the help of genetic elements in the construct, this genetic material inserts itself into the chromosomes of the host plant.

A "promoter" gene from a virus is used to make the inserted gene express itself.

Traditional Plant Breeding (traditional methods) vs Genetic Engineering This process alone, involving a gene gun or a comparable technique, and a promoter, is profoundly different from conventional breeding, even if the primary goal is only to insert genetic material from the same species. (By Michael K. Hansen, Ph.D.Research Associate) Consumer Policy Institute/Consumers Union Reference 4) “Do you realize you are proposing regulations for an entire industry that has previously been virtually unregulated and has a history of safety�

Once again, as we reference the above definitions of: Traditional Plant Breeding (traditional methods), and Genetic Engineering, the meaning and differences are clear. The industries, farmers, throughout time have had a safe history. They are able to observe, while in the fields, the soil before planting, the seeds for planting, the plants as they grow, and the grain or fruit at harvest. They are able to distinguish what seeds are needed for each season and which seeds to save. There was no need for micro-management as regulations.

Farmers are not able to go to their fields and determine cellular and genetic changes within the plant. They are unable to have the foresight of the binding

of important minerals and vitamins. They are not able to tell what amino acids have reformed with other amino acids within the gene to make a man-made protein. They are not able to see which hereditary and evolutionary-switches are being turned on or off, or what recombination of genetic information created exists within the gene.

Coordinated Framework for Regulation of Biotechnology. ACTION: Announcement of policy; notice for public comment. The current system was delineated under the (United States Federal Register), June 26, 1986.

Currently January 8, 1992 Dr. Linda Kahl, FDA Compliance Officer continues to voice her concerns: “The June 1986 Coordinated Framework seems to be unconcerned with traditional methods and no apologies for discussing only biotechnology. It is very concerned with making it clear that no new legislation is needed. It notes that the framework seeks to distinguish those organisms which need review and those that do not. So why can’t the current appendix deal only with new biotechnology? Why try to make it appear that we are discussing all modified crops?”

“I believe that there are at least two situations relative to this document in which it is trying to fit a square peg into a round hole. The first square peg in a round hole is that the document is trying to force an ultimate conclusion that…

Continued on document 18953 …there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices. This is because of the mandate to regulate the product, not the process.

This a clear concise indicator of the intent of the responses to follow a mandate, an obligation handed down by an inter-governmental body

an obligation handed down by an inter-governmental body

Comments from: Dr. Linda Kahl, FDA Compliance Officer Comments to: Dr. James Maryanski, FDA Biotechnology Coordinator Concerning: Federal Register document "Statement of Policy: Foods from Genetically Modified Plants."

Document 18952 Dated January 8, 1992.

Information for this article is extracted from documentation provided by ALLIANCE FOR BIO-INTEGRITY Preserving the Safety of Our Food, the Health of Our Environment, and the Harmony of Our Relationship with Nature 2040 Pearl Lane #2, Fairfield, Iowa 52556 (206) 888-4852 info@biointegrity.org www.biointegrity.org Steven M. Druker, J.D. Executive Director In May 1998 the Alliance for Bio-Integrity led a group of public interest organizations, life scientists, and religious leaders in filing a lawsuit against the U.S. Food and Drug Administration (FDA) to gain mandatory safety testing and labeling of genetically engineered (GE) foods. During the discovery process, the agency was required to provide plaintiffs copies of over 44,000 pages of internal records. Photocopies of 24 documents from these files are in a numbered list for viewing and printing on our website (www.biointegrity.org).