Agency Response Letter GRAS Notice No. GRN 000422
CFSAN/Office of Food Additive Safety
August 31, 2012
John Husnik, Ph.D.
Functional Technologies Corporation
Suite 1500 - 885 West Georgia Street
Vancouver, British Columbia, V6C 3E8
Re: GRAS Notice No. GRN 000422
Dear Dr. Husnik:
The Food and Drug Administration (FDA) is responding to the notice, dated January 31, 2012, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on February 29, 2012, filed it on March 5, 2012, and designated it as GRAS Notice No. GRN 000422.
The subject of the notice is modified baker's yeast Saccharomyces cerevisiae (modified baker’s yeast). The notice informs FDA of the view of Functional Technologies Corporation (FTC) that modified baker's yeast is GRAS, through scientific procedures, for use to reduce acrylamide production in a variety of grain-based foods, vegetable-based food (potato), and coffee and coffee substitutes at a level of 0.5 to 5%.
FTC discusses the formation and effect of acrylamide in food. Acrylamide is produced during the cooking or processing of certain foods, particularly in foods high in carbohydrates and low in proteins. Acrylamide is predominately formed from free amino acids, mainly asparagine, and reducing sugars via the complex Maillard reaction. FTC intends to use modified baker’s yeast S. cerevisiae to prevent acrylamide formation in the notified food and beverage products.
FTC discusses the natural occurrence of S. cerevisiae and its use in foods. S. cerevisiae is a commensal organism that is normally found on the human body, in the air, and on many foods consumed by humans. S. cerevisiae strains have been used in the production of baked goods, wine, and beer for more than five thousand years. FTC states that the host strain used to develop modified baker’s yeast is an industrial S. cerevisiae strain that is widely used in the baking industry. The host strain was obtained directly as a commercial culture from a product manufacturer.
FTC discusses the development and characterization of modified baker’s yeast. The host strain was transformed with three copies of the S. cerevisiae ASP3 gene encoding for asparaginase. The resulting modified baker’s yeast overexpresses asparaginase. Sequencing analyses also confirmed that the inserted DNA sequences in modified baker’s yeast were all obtained from S. cerevisiae and that no foreign genetic material was incorporated into the yeast genome.
FTC describes the method of manufacture of modified baker’s yeast to be identical to that of commercial fresh or active dry yeast from S. cerevisiae described in the published literature. Pure yeast inoculum is grown initially as laboratory cultures under anaerobic conditions. Subsequent steps include aerobic fermentation in the presence of essential nutrients including molasses. The fermentation harvest is centrifuged to obtain yeast cream, followed by vacuum filtration. The filtered product is extruded and dried to obtain modified baker’s yeast. FTC notes that the modified baker’s yeast is produced under good manufacturing practice and using food grade materials.
FTC considers the intended use of modified baker’s yeast to be substitutional for typical baker’s yeast currently used in the baking, snack food, and other food industries. Therefore, the dietary exposure to modified baker’s yeast would be similar to that of typical baker’s yeast currently in use.
Standards of Identity
In the notice, FTC states its intention to use modified baker’s yeast in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of FTC’s notice that modified baker’s yeast is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing modified baker’s yeast. Accordingly, this response should not be construed to be a statement that foods that contain modified baker’s yeast, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by FTC, as well as other information available to FDA, the agency has no questions at this time regarding FTC’s conclusion that modified baker’s yeast is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of modified baker’s yeast. As always, it is the continuing responsibility of FTC to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000422, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition