Food

Agency Response Letter GRAS Notice No. GRN 000306

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CFSAN/Office of Food Additive Safety

April 7, 2010

Raymond C. Dobert, Ph.D.
Monsanto Company
800 N. Lindbergh Blvd.
Saint Louis, MO 63167

Re: GRAS Notice No. GRN 000306

Dear Dr. Dobert:

The Food and Drug Administration (FDA) is responding to the notice, dated October 14, 2009, 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 October 20, 2009, filed it on October 20, 2009, and designated it as GRAS Notice No. GRN 000306.

The subject of the notice is soybean oil with reduced palmitic and linolenic acids and increased oleic acid (soybean oil-RP/RL/IO). The notice informs FDA of the view of Monsanto Company (Monsanto) that soybean oil-RP/RL/IO is GRAS, through scientific procedures, as a food ingredient for frying and spraying applications in a variety of food products including meat, poultry, and fish dishes (commercial and restaurant), fried eggs (commercial and restaurant), French fries, potato chips and puffs, creamy salad dressings, salty snacks, and grain mixture dishes.

21 CFR 101.4 states that all ingredients must be declared by their common or usual name. In addition, 21 CFR 102.5 outlines general principles to use when establishing common or usual names for nonstandardized foods. Our use of “soybean oil-RP/RL/IO” in this letter should not be considered an endorsement or recommendation of that term as an appropriate common or usual name for the purpose of declaring the substance in the ingredient statement of foods that contain that ingredient. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition.

As part of its notice, Monsanto includes the report of a panel of individuals (Monsanto’s GRAS panel) who evaluated the data and information that are the basis for Monsanto’s GRAS determination. Monsanto considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Monsanto’s GRAS panel evaluated estimates of dietary exposure, method of production, and product specifications as well as published and unpublished studies. Based on this review, Monsanto’s GRAS panel concluded that soybean oil-RP/RL/IO that meets its established food-grade specifications is GRAS under the conditions of its intended use.

Monsanto describes the identity of soybean oil-RP/RL/IO. The oil is obtained from soybean varieties that have been developed through a combination of bioengineering techniques and traditional breeding. Monsanto states that soybean oil-RP/RL/IO contains the same major fatty acids as conventional soybean oil, but at different levels. The fatty acid profile of soybean oil-RP/RL/IO is similar to other high oleic vegetable oils such as high oleic sunflower, high oleic safflower, and high oleic canola oils as well as commercial vegetable oil such as olive oil. Monsanto states that soybean oil-RP/RL/IO has the following composition: oleic acid (55–85 percent), linoleic acid (8–30 percent), palmitic acid (less than 4 percent), stearic acid (less than 4 percent), and linolenic acid (less than 4 percent).

Monsanto discusses the biosynthetic pathway of fatty acids in the soybean varieties used to produce soybean oil-RP/RL/IO. Using bioengineering techniques to alter the biosynthetic pathway of fatty acids, Monsanto introduced segments of the endogenous soybean genes FATB-1A and FAD2-1A(1) configured to suppress expression of their respective protein products. Monsanto also developed altered fatty acid profile varieties of soybean using two known mutations in the Fad3-1b and Fad3-1c genes(2) and traditional breeding techniques. Finally, Monsanto used traditional breeding to cross the bioengineered varieties with the varieties developed through breeding to develop the varieties of soybean that produce the subject of GRN 000306, that is, soybean oil-RP/RL/IO.

Monsanto states that soybean oil-RP/RL/IO is produced using conventional industry standard processing methods with food-grade material and processing agents consistent with current good manufacturing practices. Briefly, the soybean meat is first mechanically separated from the hulls and the resulting meat is flaked and extracted with hexane solvent to yield crude soybean oil and soybean meal. The crude oil is degummed and bleached, and further purified through filtration and steam distillation. Anti-oxidants, primarily TBHQ, are added at the end of processing to inhibit oxidation of the oil.

Monsanto states that soybean oil-RP/RL/IO is stable when stored at either room temperature (25 degrees Celsius) or elevated temperature (40 degrees Celsius) for 30 days, with respect to iodine values, peroxide values, and fatty acid content.

Monsanto provides specifications for soybean oil-RP/RL/IO, and compares these to the specifications set forth in the Food Chemicals Codex Sixth Edition, for conventional soybean oil. Specifications include fatty acid composition, stability, and limits for: free fatty acids (0.1 percent), lead (0.1 milligrams/kilogram), peroxide value (10 milliequivalents/kilogram), unsaponifiable matter (1.5 percent), and water (0.1 percent).

Monsanto notes that replacement of currently used food oils with soybean oil-RP/RL/IO, under the intended conditions of use, would not change the total daily intake of fat in the diet. Use of soybean oil-RP/RL/IO would result in an increase in dietary exposure to oleic acid of approximately ten percent, and a decrease in palmitic and linoleic acids, each of approximately ten percent.

In discussing the safety of soybean oil-RP/RL/IO, Monsanto notes that the percentages of fatty acids are very similar to other commercial vegetable oils that have been consumed over many generations and the biological pathways for oils (digestion, absorption, metabolism and excretion) are well-defined. Monsanto discusses a published rodent study where high oleic (70%) soybean is consumed over 90 days and is as nutritious and wholesome as common soybean. Monsanto discusses another published rodent study where ethyl oleate (the ethyl ester of oleic acid) shows no safety issues at a daily intake equal to ten percent of the diet. Monsanto discusses several published epidemiology studies regarding dietary oleic acid intake and notes that many individual populations around the world have diets with higher oleic acid content than what is currently intended for usage in GRN 000306. Finally, Monsanto discusses the issue of allergenicity and why soybean oil-RP/RL/IO will not provide an increased risk for allergenicity.

Standards of Identity

In the notice, Monsanto states its intention to use soybean oil-RP/RL/IO 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.

Potential Labeling Issues

Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. In describing the intended use of soybean oil-RP/RL/IO and in describing the information that Monsanto relies on to conclude that soybean oil-RP/RL/IO is GRAS under the conditions of its intended use, Monsanto raises a potential issue under these labeling provisions of the FFDCA. If products that contain soybean oil-RP/RL/IO bear any claims on the label or in labeling, such claims are the purview of ONLDS. The Office of Food Additive Safety (OFAS) neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about soybean oil-RP/RL/IO on the label or in labeling.

Allergen Labeling

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the FFDCA to require that the label of a food that is or contains an ingredient that bears or contains a “major food allergen” declare the presence of the allergen (section 403(w)). FALCPA defines a “major food allergen” as one of eight foods or food groups (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein derived from one of those foods. Issues associated with labeling food are the responsibility of ONLDS.

Use in Meat, Poultry, and Egg Products

During its evaluation of GRN 000306, FDA consulted with the Risk and Innovations Management Division of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.

FSIS requested that FDA advise Monsanto to seek regulatory guidance from FSIS, Risk and Innovations Management Division (RIMD), about the use of soybean oil-RP/RL/IO in meat and poultry products. Monsanto should direct such an inquiry to Dr. John M. Hicks, Jr., RIMD, Office of Policy and Program Development, Food Safety and Inspection Service, United States Department of Agriculture, George Washington Carver Center (GWCC), 5601 Sunnyside Ave., Mailstop 5271, Beltsville, MD 20705-5271. The telephone number for that office is (301) 504-0884 and the telefax number is (301) 504-0876.

Section 301(ll) of the FFDCA

The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, 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 Monsanto’s notice that soybean oil-RP/RL/IO is GRAS for use in a variety of food products including meat, poultry, and fish dishes (commercial and restaurant), fried eggs (commercial and restaurant), French fries, potato chips and puffs, creamy salad dressings, salty snacks, and grain mixture dishes, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing soybean oil-RP/RL/IO. Accordingly, this response should not be construed to be a statement that foods that contain soybean oil-RP/RL/IO, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Based on the information provided by Monsanto, as well as other information available to FDA, the agency has no questions at this time regarding Monsanto’s conclusion that soybean oil-RP/RL/IO) 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 soybean oil-RP/RL/IO. As always, it is the continuing responsibility of Monsanto 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 000306, 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 via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.

Sincerely,

Mitchell A. Cheeseman, Ph.D.
Acting Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: John M. Hicks, Jr. DVM, MPH
Risk and Innovations Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
United States Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Ave., Mailstop 5271
Beltsville, MD 20705-5271


(1)FAD2 (delta-12 desaturase) facilitates the conversion of oleic acid (C18:1) to linoleic acid (C18:2) in the endoplasmic reticulum. FATB (acyl-ACP-thioesterase) allows the release of palmitic acid (C16:0) and stearic acid (C18:0) from the plastid into the cytoplasm.

(2)Fad3-1c and Fad3-1b encode delta-15 desaturases that catalyzes the production of alpha-linolenic acid.

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