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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000136

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. 000136 for further details

CFSAN/Office of Food Additive Safety

March 25, 2013

Natalie Weber
Pioneer Hi-Bred, a DuPont Business
DuPont Experimental Station, E353/305C
P.O. Box 80353
Wilmington, DE 19880-0353

Dear Ms. Weber:

This is in regard to Pioneer Hi-Bred’s (Pioneer) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on its bioengineered corn event 4114 (event 4114 corn). According to information Pioneer has provided, event 4114 corn is genetically engineered to express the Cry1F, Cry34Ab1, Cry35Ab1, and phosphinothricin N-acetyl transferase (PAT) proteins. Cry1F, Cry34Ab1, and Cry35Ab1 are intended to confer resistance to targeted Lepidopteran and Coleopteran pests and the PAT protein provides tolerance to the herbicide glufosinate-ammonium. All materials relevant to this notification have been placed in a file designated BNF 000136. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, Pioneer submitted a summary of its safety and nutritional assessment of event 4114 corn on December 22, 2011. Pioneer submitted additional information on June 12, 2012. These communications informed FDA of the steps taken by Pioneer 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 Pioneer has conducted, it is our understanding that Pioneer has concluded that food and feed derived from event 4114 corn are not materially different in composition, safety, and other relevant parameters from corn-derived food and feed currently on the market, and that event 4114 corn does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIP), which include both the active and inert ingredients. Event 4114 corn contains PIPs, which are within the purview of EPA. It is Pioneer’s responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from event 4114 corn.

Based on the information Pioneer has presented to FDA, we have no further questions concerning food and feed derived from event 4114 corn at this time. However, as you are aware, it is Pioneer’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 000136, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000136, is available for public review and copying at www.fda.gov/bioconinventory.

Sincerely yours,

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