Food

Biotechnology Consultation Agency Response Letter BNF 000148

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. 000148 for further details

Mark E. Groth
Regulatory Affairs Manager
Monsanto Company
800 North Lindbergh Blvd.
St. Louis, MO 63167

Dear Mr. Groth:

This letter addresses Monsanto Company’s (Monsanto’s) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered corn, MON 87419. According to information Monsanto has provided, MON 87419 corn is genetically engineered to express a dicamba mono-oxygenase (dmo) gene encoding a DMO protein and the phosphinothricin N-acetyltransferase (pat) gene encoding the PAT protein. The DMO protein is intended to confer tolerance to dicamba herbicide and the PAT protein is intended to confer tolerance to glufosinate ammonium herbicide. All materials relevant to this consultation have been placed in a file designated BNF 000148. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Monsanto submitted to FDA a summary of its safety and nutritional assessment of the genetically engineered corn, which FDA received on May 25, 2015. Monsanto submitted additional information, received by FDA on February 2, 2016. These communications informed FDA of the steps taken by Monsanto 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 Monsanto has conducted, it is our understanding that Monsanto has concluded that food and feed from MON 87419 corn are not materially different in composition, safety, and other relevant parameters from corn-derived food and feed currently on the market, and that genetically engineered MON 87419 corn does not raise issues that would require premarket review or approval by FDA.

It is Monsanto’s responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department of Agriculture, before marketing food or feed derived from MON 87419 corn.

Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 87419 corn at this time. However, as you are aware, it is Monsanto’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000148, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000148, is available for public review and copying at http://www.fda.gov/bioconinventory.

Sincerely yours,

Dennis M. Keefe, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

Page Last Updated: 12/14/2016
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