Biotechnology Consultation Agency Response Letter BNF 000130
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
See FDA's memo on BNF No. 000130 for further details
CFSAN/Office of Food Additive Safety
July 2, 2014
Angela McKean, M.S.
Regulatory Affairs Manager
BASF Plant Science L.P.
26 Davis Drive
Research Triangle Park, NC 27709
Dear Ms. McKean:
This letter addresses BASF Plant Science Company GmbH's (BASF) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition (CFSAN)) on the genetically engineered starch potato, AM04-1020 (AM04-1020 potato). According to information that BASF has provided, AM04-1020 potato is genetically engineered to reduce the levels of amylose, thus resulting in starch composed predominantly of amylopectin (also referred to as "amylopectin-type" starch). All materials relevant to this consultation have been placed in a file designated BNF 000130. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation to closure, BASF submitted a summary of its safety and nutritional assessment of the genetically engineered starch potato on March 30, 2011. BASF submitted additional information on November 11, 2011, and on February 1 and July 18, 2013. These communications informed FDA of the steps taken by BASF 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 BASF has conducted, it is our understanding that BASF has concluded that its amylopectin-type starch potato variety, AM04-1020 potato, and the foods and feeds derived from it are as safe as the parental variety Kuras and comparable to other conventional starch potato varieties. We also understand that BASF has concluded that, except for reduced amylose levels, the AM04-1020 potato is not materially different in composition or other relevant parameters from starch potato varieties now grown and used for commercial starch production and other food and feed uses. The genetically engineered AM04-1020 potato does not raise issues that would require premarket review or approval by FDA.
BASF states that its rationale for developing AM04-1020 potato is the need of the starch industry for pure amylopectin starch. Because unmodified potato starch contains both amylopectin and amylose, the starch industry uses potato starch that has been chemically modified to suppress the functional properties associated with amylose. According to BASF, AM04-1020 potato starch has the characteristics and functionality of amylopectin-type starch; consequently, AM04-1020 potato starch can be used in place of chemically modified potato starch in a variety of food processing applications. While the anticipated use of AM04-1020 potato starch by food processing industries is similar to that of other starch potato varieties, potato starch may also be marketed as a retail food product to consumers. If a company intends to market AM04-1020 potato starch as a retail product, it should consider potential labeling issues. It is the company's responsibility to ensure that labeling for products it introduces into the food supply is truthful and not misleading.
It is BASF’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 AM04-1020 potato.
Based on the information BASF has presented to FDA, we have no further questions concerning food and feed derived from AM04-1020 potato at this time. However, as you are aware, it is BASF’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 000130, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000130, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition