Agency Response Letter GRAS Notice No. GRN 000342
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CFSAN/Office of Food Additive Safety
December 23, 2010
Mark L. Itzkoff
Olsson Frank Weeda Terman Bode Matz PC
1400 16th St, NW
Washington, DC 20036
Re: GRAS Notice No. GRN 000342
Dear Mr. Itzkoff:
The Food and Drug Administration (FDA) is responding to the notice, dated May 19, 2010, that you submitted on behalf of J. Rettenmaier USA LP (Rettenmaier) 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 May 26, 2010, filed it on May 27, 2010, and designated it as GRAS Notice No. GRN 000342
The subject of the notice is oat hull fiber. The notice informs FDA of the view of Rettenmaier that oat hull fiber is GRAS, through scientific procedures, for use as an ingredient in comminuted meat products and in both whole muscle and comminuted poultry products at levels consistent with current good manufacturing practice.
Rettenmaier describes the identity and composition of oat hull fiber. Oat hull fiber is a tan to off-white powder obtained from oat hulls. Oat hull fiber contains approximately 85 percent total dietary fiber, consisting of cellulose (70 percent), hemicellulose (25 percent), and lignin (maximum 5 percent).
Rettenmaier describes the method of manufacture of oat hull fiber as a series of physical processes. Oat hull fiber is produced from oat hulls that have been prescreened for fines and groats. The prescreened oat hulls are mixed with hot water and sodium hydroxide in a temperature-controlled retention tank. Rettenmaier indicates that sodium hydroxide is added to reduce the level of microorganisms that may be present on the oat hulls. After approximately one hour, the mixture is further diluted with water and citric acid is added to adjust the pH. The mixture is passed through a filter to remove waste water and then pressed, dried, ground and sieved. The notifier states that oat hull fiber is manufactured using current good manufacturing practice and that the processing aids used in the manufacturing process are all of food-grade quality as specified in the 5th Edition of the Food Chemicals Codex.
The notifier provides specifications for food-grade oat hull fiber. Rettenmaier reports physical specifications for appearance, pH (5 – 7), and moisture (maximum 8 percent). Rettenmaier reports chemical specifications for ash (maximum 5 percent), total dietary fiber (greater than 85 percent), insoluble fiber (greater than 78 percent) and soluble fiber (less than 6 percent). Specifications also include limitations on heavy metals (lead, arsenic, and cadmium) and microorganisms (aerobic plate count, yeasts and molds, Salmonella, and Clostridium perfringens). Rettenmaier provides analytical results from five manufacturing lots in support of the ability of its method of manufacture to produce oat hull fiber that meets the specifications.
The notifier calculates estimated daily intakes for both the ingredient oat hull fiber and for fiber from consumption of the ingredient, based on (1) the intended use of oat hull fiber at levels of 3.5 percent in comminuted meat products and in both whole muscle and comminuted poultry products and (2) food consumption survey data from the United States Department of Agriculture’s Continuing Survey of Food Intakes by Individuals. Rettenmaier estimates that the intended use of oat hull fiber will result in mean and 90th percentile intakes of 3.4 grams per person per day (g/p/d) and 6.8 g/p/d, respectively. As oat hull fiber contains approximately 85 percent fiber, the estimated mean and 90th percentile intakes of fiber are 3 g/p/d and 6 g/p/d, respectively. Rettenmaier notes that the Institute of Medicine established recommended intake levels for dietary fiber of 38 g/p/d for men and 25 g/p/d for women in 2001.
Rettenmaier discusses the safety of oats in general and of oat hull fiber as an ingredient in food specifically. Rettenmaier summarizes the history of consumption of oat kernel tissues, specifically oat groat and bran. The notifier describes the composition of the whole oat kernel, noting that the oat kernel fiber components (e.g., celluloses, hemicelluloses, pentosans) are common throughout various parts of the kernel, although their proportionality in these parts differs. On the basis of the similarity of the composition of the oat hull with that of other edible oat tissues commonly consumed in the diet (groat and bran), the notifier concludes that the safety data of oat groat and bran tissues are applicable to oat hull fiber for use as a food ingredient. Rettenmaier states that it conducted a comprehensive search of the scientific literature for safety and toxicity information on oat fiber, oat hull fiber and other related fibers. The notifier discusses published animal and human studies of oat and other fibers, noting that no evidence of significant adverse effects related to oat fiber was observed in these studies. Based on the available information in the scientific literature and the compositional similarity between oat hull and other edible oat tissues that are commonly consumed in the diet, Rettenmaier concludes that the use of oat hull fiber is GRAS under the intended conditions of use.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000342, 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 has determined that Olsson Frank Weeda Terman Bode Matz PC has provided sufficient data on behalf of Rettenmaier to support that oat hull fiber is suitable for use as a binder in poultry products. Data was provided for both whole muscle and comminuted poultry products that demonstrated an increase in cooking yield. Further, a summary was provided of the organoleptic testing done by the company. The summary stated that oat hull fiber containing products were found to be equivalent when compared against the control non-fiber formulations. Company panelists also determined that most poultry products containing oat hull fiber had qualities that were superior to the control products with regards to texture and juiciness. Therefore, FSIS has no objection to the use of oat hull fiber as a binder at up to 3.5 percent of the product formula in whole muscle and comminuted poultry products that provide for the use of ingredients of this type. The use of oat hull fiber as a binder in various comminuted meat products is listed in FSIS Directive 7120.1 “Safe and Suitable Ingredients Used in the Production of Meat and Poultry Products.”1
With regard to labeling, FSIS does not permit the term “fiber” to be used as nomenclature for ingredients used in meat and poultry products. FSIS suggests “isolated oat hull product” as a suitable name for the ingredient.
FSIS requested that FDA advise Rettenmaier to seek regulatory guidance from FSIS, Risk and Innovations Management Division, about the use of oat hull fiber in meat and poultry products. Rettenmaier should direct such an inquiry to Ms. Valeria Jefferson, Acting Director, Risk and Innovations Management Division, Office of Policy and Program Development, Food Safety and Inspection Service, George Washington Carver Center (GWCC), 5601 Sunnyside Avenue, Mail STOP 5271, Beltsville, MD 20705-5271.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (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 Rettenmaier’s notice that oat hull fiber is GRAS for the intended uses, 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 Rettenmaier, as well as other information available to FDA, the agency has no questions at this time regarding Rettenmaier’s 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 Rettenmaier 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 000342, 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 http://www.fda.gov/grasnoticeinventory.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Ms. Valeria Jefferson
Risk and Innovations Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
George Washington Carver Center (GWCC)
5601 Sunnyside Avenue, Mail STOP 5271
Beltsville, MD 20705-5271
1See FDA’s response letter to GRAS Notice No. GRN 000261, dated February 3, 2009.