Agency Response Letter
GRAS Notice No. GRN 000147

Robert G. Hibbert
McDermott, Will & Emery
600 13th Street, N.W.
Washington, DC 20005-3096

Re: GRAS Notice No. GRN 000147

Dear Mr. Hibbert:

The Food and Drug Administration (FDA) is responding to the notice, dated March 3, 2004, 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 March 8, 2004, filed it on March 10, 2004, and designated it as GRAS Notice No. GRN 000147.

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

The extracted fish protein is intended for use as a binding agent, to decrease volume shrinkage and to increase water content while maintaining protein content in the final cooked product. The extract derived from a particular fish species would be added to fresh or frozen seafood of the same species by needle injection into fillets, static soaking, or vacuum tumbling. According to the notifier, the intended use is self-limiting because extracts with protein concentrations greater than 18% (w/w, at pH 3.2 using citric acid) may impart a sour taste to the finished product. The notifier states that a typical use would be 10% addition by weight to the seafood product of an 8% protein solution.

The extracted fish protein consists of myofibrillar and sarcoplasmic proteins from fish 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 fish 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 citric acid. The final extract is a thin syrup-like product expected to have a protein content between 5 and 12% and a moisture content range between 88-95%. Citric acid in the final product would be present at approximately 0.1% to 0.14%. 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.

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 fish protein extract 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 fish protein extract. 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,    /s/ Laura M. Tarantino, Ph.D. Director Office of Food Additive Safety Center for Food Safety      and Applied Nutrition