January 30, 2001

Bruce K. Bernard, Ph.D.
SRA International, Inc.
1920 L Street, N.W.
Suite 420
Washington, DC 20036

Re: GRAS Notice No. GRN 000055

Dear Dr. Bernard:

The Food and Drug Administration (FDA) is responding to the notice, dated August 7, 2000, that you submitted on behalf of Ajinomoto USA, 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)). FDA received this notice on August 8, 2000 and designated it as GRN No. 000055.

The subject of the notice is transglutaminase enzyme preparation (TGP) derived from a nontoxigenic and nonpathogenic strain of Streptoverticillium mobaraense. The notice informs FDA of the view of Ajinomoto that TGP is GRAS, through scientific procedures, for use as a protein cross-linking agent in the following food categories: pasta products at a level of 25 parts per million (ppm); bread products at a level of 15 ppm; pastry products (cakes, pies, doughnuts, etc.) at a level of 20 ppm; ready to eat cereal products at a level of 45 ppm; pizza dough at a level of 20 ppm; grain mixtures (burritos, tacos, etc.) at a level of 25 ppm.

In GRN 000055, Ajinomoto incorporates by reference its two previous GRAS notices (GRN 000004 and GRN 000029) regarding the use of TGP in processed seafood, processed cheeses, natural hard cheeses (domestic), cream cheese, refrigerated yogurt, frozen desserts, and vegetable protein dishes/vegeburgers/meat substitutes. In GRN 000004, Ajinomoto incorporates by reference Food Master File 000612 (FMF 000612), which is FDA's record of Ajinomoto's submission to the Food Safety and Inspection Service of the U.S. Department of Agriculture regarding the use of TGP as a protein cross-linking agent in processed low fat/low salt meat food products and poultry food products.

In its previous submissions, Ajinomoto described (1) published information about the identity and function of transglutaminase enzymes from a variety of sources; (2) published information about the source of TGP (S. mobaraense); (3) published information about the identity and function of TGP derived from S. mobaraense; (4) information about the method of manufacture, which is based on standard procedures for fermentation-derived enzyme preparations; (5) unpublished toxicity studies conducted with TGP; (6) the basis for its conclusion that certain biologically active substances, which could be present in TGP, are either absent or are unlikely to be biologically active under the proposed conditions of use; and (7) the results of quality control tests that were conducted on five representative lots of TGP. TGP meets the specifications in the Food Chemicals Codex (4th edition) and guidelines issued by the Joint Expert Committee on Food Additives (JECFA; a joint committee of the Food and Agriculture Organization/World Health Organization), and all substances used in the manufacture of TGP are food grade.

Based on the information provided by Ajinomoto, as well as the information in FMF 000612, GRN 000004, GRN 000029, and other information available to FDA, the agency has no questions at this time regarding Ajinomoto's conclusion that TGP derived from a nontoxigenic and nonpathogenic strain of Streptoverticillium mobaraense 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 TGP. As always, it is the continuing responsibility of Ajinomoto 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 Office of Premarket Approval's homepage on the Internet (at http://www.cfsan.fda.gov/~lrd/foodadd.html).

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