Agency Response Letter GRAS Notice No. GRN 000310
CFSAN/Office of Food Additive Safety
November 6, 2010
Olsson Frank Weeda Terman Bode Matz PC
1400 16th Street NW
Washington, DC 20036
Re: GRAS Notice No. GRN 000310
Dear Mr. Itzkoff:
This letter corrects our letter in response to GRAS Notice No. GRN 000310 dated June 10, 2010. The purpose of this revised letter is to clarify the types of poultry products in which J. Rettenmaier USA LP (Rettenmaier) intends for potato fiber to be used. In the letter dated June 10, 2010, one product category was incorrectly stated as “whole cuts of chicken” rather than “whole muscle poultry products”; this was an inadvertent, propagated error. In addition, the section entitled “Use in Products under USDA Jurisdiction” has been changed to better reflect the current status of Food Safety and Inspection Service’s (FSIS’) regulations. Also, to reflect a recent change in personnel at the United States Department of Agriculture (USDA), we have updated the contact information for the Risk and Innovations Management Division within FSIS.
The Food and Drug Administration (FDA) is responding to the notice, dated December 17, 2009, 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 December 22, 2009, filed it on December 24, 2009, and designated it as GRAS Notice No. GRN 000310.
The subject of the notice is potato fiber. The notice informs FDA of the view of Rettenmaier that potato fiber is GRAS, through scientific procedures, for use to improve the texture, stability, and oil/water binding capacity of whole muscle poultry products and comminuted meat and poultry products at a maximum level of 3.5 percent in the final product.
Rettenmaier describes the identity, composition, and method of manufacture of potato fiber. Rettenmaier states that potato fiber is manufactured through a series of physical processes that begin with potatoes that are washed and ground in water. Rettenmaier states that the water is removed, and the remaining mixture is blended to form a uniform mixture that is then dried and passed through a sieve to yield the powder product. Rettenmaier notes that there are no chemical extractions or treatments involved in the manufacturing of potato fiber. Rettenmaier states that potato fiber is a free-flowing, off-white, light tan powder that has a pH of 5-7. Rettenmaier states that potato fiber is identical to the fiber portion of potatoes and is composed primarily of cellulose, hemicellulose, starch, and resistant starch. Rettenmaier provides specifications for the appearance and proximate composition of potato fiber. Rettenmaier states that potato fiber is composed of approximately 72 percent total dietary fiber: 12 percent resistant starch (the portion of dietary starch that escapes digestion in the small intestine), 54 percent insoluble fiber, and 6 percent soluble fiber.
Rettenmaier states that potato fiber is intended to be used at levels consistent with current good manufacturing practices, typically up to 3.5 percent in whole muscle poultry products and in comminuted meat and poultry products. Rettenmaier states that the use of potato fiber in these products is self-limiting because unacceptable taste and texture characteristics result when recommended levels (which are identical to the intended use levels provided in this notice) are exceeded. Rettenmaier states that potato fiber will be used in whole muscle poultry products and in comminuted meat and poultry products as an aid to improve the texture and stability of the food products and to increase moisture binding and retention of complex polysaccharides.
Rettenmaier estimates that based on the USDA survey data, the dietary intake of potato fiber from poultry would be 3.4 gram per person per day (g/p/d) at the mean and 6.8 g/p/d at the 90th percentile. Rettenmaier estimates that based on USDA survey data, the dietary intake of potato fiber from sausage would be 1.5 g/p/d at the mean and 2.8 g/p/d at the 90th percentile. Rettenmaier states that since poultry and meats, such as sausage, are unlikely to be consumed together, the estimated daily intake for poultry consumption can be used to accurately reflect the maximum amount of potato fiber consumed.1
Rettenmaier discusses a number of published studies conducted in rats, pigs, and humans, in which the physiological effects of potato fiber and starch are investigated. Rettenmaier reports that no adverse effects were observed in rats and pigs that consumed potato fiber and starch at levels up to 7500 milligram per kilogram body weight per day (mg/kg bw/d). Additionally, Rettenmaier cites human studies in which there were no serious adverse effects as a result of humans consuming potato fiber and starch at levels up to 20 g/p/d. Rettenmaier also notes the long history of human consumption of cooked potatoes, including the fiber portion.
Rettenmaier discusses the naturally-occurring glycoalkaloid content as well as the allergenic potential of potato fiber. Rettenmaier states that potatoes are known to contain glycoalkaloids and that an upper limit for glycoalkaloid content of 20 milligram (mg) per 100 g of potato is generally accepted. Rettenmaier states that the estimated daily intake of glycoalkaloids from the intended uses of potato fiber is 0.75 mg and is thus considered to be safe. Regarding allergenic potential, Rettenmaier states that given the extraction process employed during the potato fiber manufacturing process, the potential allergenicity of potato fiber should be the same or less than that of ordinary cooked potatoes. Based on their findings that neither potato fiber nor any of its constituents pose any toxicological hazards or safety concerns at the intended use levels, as well as on published toxicology studies and other articles relating to the safety of their potato fiber product, Rettenmaier concludes that the use of potato fiber under the intended conditions of use is GRAS.
Standards of Identity
In the notice, Rettenmaier states its intention to use potato 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.
Use in Products under USDA Jurisdiction
During its evaluation of GRAS Notice No. GRN 000310, FDA consulted with the Risk and Innovations Management Division, Office of Policy and Program Development, Food Safety and Inspection Service of the USDA (RIMD/OPPD/FSIS/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 advises that Rettenmaier has provided sufficient data to support their assertion that potato fiber is suitable as a binder in whole muscle poultry products and in comminuted meat and poultry products in which binders are permitted. Therefore, FSIS would not object to the use of potato fiber as a binder in whole muscle poultry products and in comminuted meat and poultry products in which binders are permitted, provided that it does not exceed 3.5 percent of the product formulation.
FSIS also advises that the ingredient will need to be declared on the labeling of meat and poultry products containing it as “isolated potato product.”
FSIS requested that FDA advise Rettenmaier to seek regulatory guidance from RIMD/OPPD/FSIS/USDA about the use of potato fiber in meat and poultry products. Rettenmaier should direct such an inquiry to Ms. Valeria Jefferson, Risk and Innovations Management Division, Office of Policy and Program Development, Food Safety and Inspection Service, 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 potato fiber is GRAS for use to improve the texture, stability, and oil/water binding capacity of whole muscle poultry products and comminuted meat and poultry products at a maximum level of 3.5 percent in the final product, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing potato fiber. Accordingly, this response should not be construed to be a statement that foods that contain potato 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 potato 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 potato 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 GRAS Notice No. GRN 000310, 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.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Valeria Jefferson, MPA
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
1Using National Health and Nutrition Examination Survey consumption data from 2003-2006, FDA calculates that if potato fiber is used at a level of 3.5 percent, the dietary intake of potato fiber from comminuted meats would be 2.2 g/p/d at the mean and 4.3 g/p/d at the 90th percentile.