Agency Response Letter
GRAS Notice No. GRN 000168

Robert G. Hibbert
McDermott, Will & Emery
600 Thirteenth Street, N.W.
Washington, D.C. 20005-3096

Re: GRAS Notice No. GRN 000168

Dear Mr. Hibbert:

The Food and Drug Administration (FDA) is responding to the notice, dated May 18, 2005, that you submitted on behalf of Proteus Industries, Inc. (Proteus), 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 20, 2005, filed it on May 24, 2005, and designated it as GRAS Notice No. GRN 000168. FDA received an amendment transmitting supplemental material, dated September 14, 2005, that Proteus also submitted directly to the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA).

The subject of the notice is poultry protein. The notice informs FDA of the view of Proteus that poultry protein is GRAS, through scientific procedures, for use in finished poultry products of the same species as the extracted poultry protein.

The poultry protein is intended for use as a water binding agent and as a coating to increase moisture retention and to reduce fat absorption in the final cooked product. The extract derived from a particular poultry species would be added to fresh or frozen poultry of the same species (1) as a protein coating (only) by dip; (2) applied as a portion of the batter (only); or (3) as a portion of the batter and coating (together). Proteus states that the actual range of poultry protein that is applied when delivered as a solution is 0.06 - 0.80 percent when used as a protein coating (only); 0.04 - 0.14 percent when used as a batter (only); and 0.11 - 0.89 percent when used in both the batter and coating (together).

The poultry protein consists of proteins from poultry muscle tissue. According to Proteus, the protein and amino acid profile of the extract is similar to that of the original muscle tissue. The extract is derived from poultry muscle through an acid solubilization process. The starting material is homogenized with cold water to form a slurry that is acidified using citric acid or some other food-grade acidulant. Many of the muscle proteins are insoluble at neutral pH but soluble at acid pH. Centrifugation and pre-filtration are used to remove lipid and other contaminants. The resulting solution is subjected to ultrafiltration to concentrate the protein and remove the acidulant The final extract is a thin syrup-like product with a protein content between 5 and 12 percent and a moisture content between 88 and 95 percent. The acidulant in the final product would be present at approximately 0.1 percent to 0.14 percent. Salt may be added back to the protein solution at a level not to exceed the original tissue salt level.

The notifier states that there is extensive evidence in the peer-reviewed literature demonstrating a consensus on the safety of acid-solubilized proteins from both fish and mammalian tissues, and provides a number of citations to that effect.

During its evaluation of GRN 000168, OFAS consulted with FSIS regarding the use of poultry protein in finished poultry products of the same species as the extracted poultry protein. Based on the information submitted by Proteus (1) in the original GRAS notice and (2) in supplemental material dated September 14, 2005, FSIS has no objections to the use of poultry protein in the production of poultry products of the same kind, e.g., the use of chicken protein as a coating of a breaded fritter provided the ingredient and product identity are appropriately declared on the labeling. If you have any additional questions, you should direct your inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program, and Employee Development, Food Safety and Inspection Service, 1400 Independence Avenue, S.W., Suite 602, Annex, Washington, DC 20250-3700. The telephone number for that office is (202) 205-0279 and the telefax number is (202) 205-3625.

Based on the information provided by Proteus, as well as other information available to FDA, the agency has no questions at this time regarding Proteus' conclusion that poultry protein is GRAS when produced as described and used under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of poultry protein. As always, it is the continuing responsibility of Proteus 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, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,

Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program and Employee Development
Food Safety and Inspection Service
1400 Independence Ave., SW, Suite 602, Annex
Washington, DC 20250-3700