Agency Response Letter GRAS Notice No. GRN 000261
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CFSAN/Office of Food Additive Safety
February 03, 2009
Gary L. Yingling
Kirkpatrick & Lockhart Preston Gates Ellis LLP
1601 K Street NW
Washington, DC 20006-1600
Re: GRAS Notice No. GRN 000261
Dear Mr. Yingling:
The Food and Drug Administration (FDA) is responding to the notice, dated August 13, 2008, that you submitted on behalf of Grain Millers, Inc. (Grain Millers), 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 September 18, 2008, filed it on September 22, 2008, and designated it as GRAS Notice No. GRN 000261.
The subject of the notice is oat hull fiber. The notice informs FDA of the view of Grain Millers that oat hull fiber is GRAS, through scientific procedures, for use (1) as an ingredient in bread/pizza crust, cookies/crackers/bars, cereal (hot and cold), baby food cereal, and snacks (fried and baked) at levels ranging from 5 percent to 14 percent by weight; (2) as an ingredient in breaders and batters applied in coating onto meat and poultry at levels ranging from 2 percent by weight of the total food system (breaded or coated meats) to 5 percent by weight of the dry coating system (breader and batter); and (3) as an extender in meat products at levels ranging from 3 percent to 5 percent.
Grain Millers describes the identity and composition of oat hull fiber. Oat hulls are a component of whole grain oats that contain a high level of insoluble fiber in the form of celluloses and hemicelluloses. Oat hull fiber is a cream to natural oatmeal colored powder obtained from oat hulls that have been treated to break down the crystalline nature of the cell walls. The powder has an insoluble fiber content of approximately 89 percent on a dry weight basis, a mean particle size of 43 microns, and a water holding capacity of 318 percent.
Oat hull fiber is produced from pre-qualified, cleaned oat hulls. Pre-qualification consists of selection of the oat hull on the basis of color, odor, moisture content, multiple residue analysis, mycotoxin content, and heavy metal content. Cleaning consists of rendering the oat hulls free from other oat grain components (e.g., groat fragments, trichomes) through mechanical detachers, gravity separators, sieves, and air classifiers. The pre-qualified, cleaned oat hulls are treated with heat and shear conditions, with specified moisture content for specific time periods, and reduced to powder form. The notifier states that this process is conducted in the absence of chemical processing aids.
The notifier provides specifications for food-grade oat hull fiber with target levels for total dietary fiber (85 percent) as well as insoluble fiber (not less than 84.5 percent, as is) and soluble fiber (0.5 percent). Specifications also include (1) physical/chemical target levels for absorption, protein, fat, fat acidity, enzyme activity, ash, and pH; and (2) limitations on pesticide chemical, heavy metal, and microbial residues.
The notifier estimates that oat hull fiber will be consumed at a rate of between 2 - 5 grams per 50 gram serving for a total dietary consumption of 21 - 28 grams per day.
Grain Millers describes the composition of the whole oat kernel as a mixture of non-starchy polysaccharides (principally celluloses and hemicelluloses) as well as proteins, starch, lipids, vitamins, minerals, and phytonutrients. Grain Millers references published results of compositional analyses showing that, although the proportionality of the oat kernel components differs among the parts of the kernel, the oat kernel components are common throughout various parts of the kernel, including the oat groat, bran, and hull. On the basis of the similarity of the composition of the oat hull with that of other edible oat tissues (groat and bran), the notifier concludes that data supporting the safety of oat groat and bran tissues supports the safety of oat hull fiber for use as a food ingredient.
Grain Millers further states that components found in the unprocessed oat hull are generally preserved during processing, with the exception of the cellulosic and hemicellulosic tissues. The crystalline structures of these tissues are broken down by the heat and shear conditions of Grain Millers' hydrothermal and mechanical processing method, making them more water absorbent. Grain Millers concludes that this difference does not affect its conclusion that the use of oat hull fiber as an ingredient in food is GRAS.
Standards of Identity
In the notice, Grain Millers states its intention to use oat hull fiber 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 oat hull fiber and in describing the information that Grain Millers relies on to conclude that oat hull fiber is GRAS under the conditions of its intended use, Grain Millers raises a potential issue under these labeling provisions of the FFDCA. This issue consists of nutrient content claims described in Grain Millers' notice related to increased fiber content and reduced calorie content. If products that contain oat hull fiber bear any claims on the label or in labeling, such claims are the purview of the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition. The Office of Food Additive Safety 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 oat hull fiber on the label or in labeling.
Use in Meat and Poultry Products
During its evaluation of GRN 000261, FDA consulted with the Risk Management Division of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat and poultry 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 advised that binders are regulated under the Federal Meat Inspection Act based on efficacy of use in meat products, including standardized meat products. FSIS advised that although Grain Millers' notice does not provide any data to support Grain Millers' assertion that the oat hull fiber is suitable for use as a binder in meat products, FSIS has already accepted the use of oat fiber as a binder in various meat products (e.g., frankfurters, sausages, patties, loaves) where binders are permitted and in whole muscle meat products at a level not to exceed 3.5 percent of the product formulation. Therefore, FSIS would not object to the use of oat hull fiber as a binder in various non-standardized comminuted meat products, provided that it does not exceed 3.5 percent of the product formulation.
FSIS advised that Grain Millers' notice does not provide any data to support Grain Millers' assertion that the oat hull fiber is suitable for use on poultry products, so FSIS cannot accept the use of oat hull fiber in poultry products at this time.
FSIS requested that FDA advise Grain Millers to seek regulatory guidance from FSIS, Risk Management Division, about the use of oat hull fiber in meat and poultry products. Grain Millers should direct such an inquiry to Dr. John Hicks, Risk Management Division, Office of Policy, Program, and Development, Food Safety and Inspection Service, 1400 Independence Ave., S.W., Room 3549, South Agriculture Building, Washington, DC 20250-3700. The telephone number for that office is (202) 205-0210 and the telefax number is (202) 720-0582.
Section 301(ll) of the FFDCA
The Food and Drug Administration Amendments Act of 2007 that 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 Grain Millers' notice that oat hull fiber is GRAS for use in select foods, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing oat hull fiber. Accordingly, this response should not be construed to be a statement that foods that contain oat hull fiber, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Grain Millers, as well as other information available to FDA, the agency has no questions at this time regarding Grain Millers' conclusion that oat hull fiber 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 oat hull fiber. As always, it is the continuing responsibility of Grain Millers 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 000261, as well as a copy of the information in this notice that conforms to the information in the proposed 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.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. John Hicks, Jr. DVM, MPH
Risk Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture
1400 Independence Avenue., S.W., Room 3549, South Agriculture Building
Washington, DC 20250-3700