Biotechnology Consultation Agency Response Letter BNF No. 000101
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
January 16, 2009
Appalachian Fruit Research Station
Agricultural Research Service
United States Department of Agriculture
2217 Wiltshire Road
Kearneysville, West Virginia 25430-2771
Dear Dr. Scorza:
This is in regard to the consultation of the United States Department of Agriculture's Agricultural Research Service (USDA-ARS) with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition (CFSAN)) on genetically engineered plum line ARS-PLMC5-6 (C5). According to USDA-ARS, this new line is engineered to be resistant to plum pox virus by the introduction of the plum pox virus coat protein gene (ppv-cp). The neomycin phosphotransferase type II gene (nptII) and β-glucuronidase gene (uidA) were used as selectable markers. All materials relevant to this notification have been placed in a file designated BNF 0101. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation regarding this product to closure, USDA-ARS submitted a summary of its safety and nutritional assessment of the genetically engineered plum on January 12, 2007. USDA-ARS submitted additional information dated April 5, June 3, and June 12, 2007, and September 19, 2008. This communication informed the FDA of the steps taken by USDA-ARS 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 USDA-ARS has conducted, it is our understanding that USDA-ARS has concluded that plums derived from the new variety are not materially different in composition, safety, and other relevant parameters from plums currently on the market and that genetically engineered plum line C5 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 ppv-cp, nptII, and uidA genes to be part of the plant-incorporated protectant in plum line C5, 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 USDA-ARS to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food derived from plum line C5.
Based on the information USDA-ARS has presented to FDA, we have no further questions concerning plums from plum line C5 at this time. However, as you are aware, it is USDA-ARS's continued responsibility to ensure that those foods marketed by USDA-ARS are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition