Biotechnology Consultation Agency Response Letter BNF No. 000100

Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties

See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties

See FDA's memo on BNF No. 000100 for further details

CFSAN/Office of Food Additive Safety
December 24, 2008

Michael J. Davis, Ph.D.
Professor, Institute of Food and Agricultural Sciences
University of Florida
Citrus Research and Education Center
700 Experiment Station Road
Lake Alfred, Florida 33850-1299

Dear Dr. Davis:

This is in regard to the consultation of the University of Florida's Citrus Research and Education Center (University of Florida) with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered papaya line X17-2. According to the University of Florida, this new line is genetically engineered to be resistant to papaya ringspot virus by the introduction of the papaya ring spot virus coat protein gene (psrv-cp). The neomycin phosphotransferase type II gene (nptII) was used as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 0100. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, the University of Florida submitted a summary of its safety and nutritional assessment of the genetically engineered papaya on September 19, 2007. The University of Florida submitted additional information dated February 15, and September 19, 2008. These communications informed the FDA of the steps taken by the University of Florida to ensure that this product complies with the legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment the University of Florida has conducted, it is our understanding that the University of Florida has concluded that papayas derived from the new variety are not materially different in composition, safety, and other relevant parameters from papayas currently on the market and that genetically engineered papaya line X17-2 does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants, which include both the active and inert ingredients. EPA considers the recombinant DNA construct containing the prsv-cp and nptII genes to be part of the plant-incorporated protectant in papaya line X17-2, and therefore EPA is reviewing the information related to the safety of the recombinant DNA construct and resulting expression products. It is the responsibility of the University of Florida to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food derived from papaya line X17-2.

Based on the information the University of Florida has presented to FDA, we have no further questions concerning papayas derived from papaya line X17-2 at this time. However, as you are aware, it is the University of Florida's continued responsibility to ensure that the foods marketed by the University of Florida are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

Sincerely yours,

Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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