June 22, 1998

Bruce K. Bernard, Ph.D.
SRA International, Inc.
1850 M Street, N. W.
Suite 290
Washington, DC 20036

Re: GRAS Notice No. GRN 000004
Docket No. 98S-0104

Dear Dr. Bernard:

This is in response to your GRAS notice dated March 3, 1998, which was received by the Food and Drug Administration (FDA) on March 4, 1998. This request was submitted to FDA on behalf of Ajinomoto U.S.A., Inc. (Ajinomoto) in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997). FDA designated your notice as GRAS Notice No. GRN 000004.

Your notice states that Ajinomoto has determined that transglutaminase enzyme preparation (TGP) derived from a nontoxigenic and nonpathogenic strain of Streptoverticillium mobaraense is generally recognized as safe (GRAS) for use as a cross-linking agent in processed seafood at levels up to 65 parts per million (ppm). Your notice reports that TGP is derived from a nonpathogenic and nontoxigenic strain of Streptoverticillium mobaraense, an actinomycete, that is a descendant of an isolate from a soil sample collected in Nishiharu-cho, Aichi Perfecture, Japan. This producing strain was derived through conventional mutagenesis by exposure to chemical mutagens. Transglutaminase is an enzyme that forms cross-links between the -carboxyamide group of protein- or peptide-bound glutamine residues and a primary amine of lysine residues, producing a bond that cross-links proteins. The ability of transglutaminase to cross-link proteins in foods increases binding in processed seafood products and can, thereby, improve the food's gelling characteristics.

Your notice describes the manufacturing process for TGP. Your notice states that all substances used in the manufacture of TGP are food grade, and the final enzyme preparation meets the specifications in the Food Chemicals Codex (3rd edition) and guidelines of the FAO-WHO Joint Expert Committee on Food Additives. You also note that Ajinomoto examined TGP for the presence of biologically active substances and concluded 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.

Your notice states that the basis for the GRAS determination is through experience based on scientific procedures. Based on the information provided by Ajinomoto, as well as the information in GRN00004 and other information available to FDA, the agency has no questions at this time regarding the conclusion of Ajinomoto that TGP is GRAS under the proposed 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 your continuing responsibility to ensure that food ingredients that you market 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 this letter has been made available for public review and copying at the agency's Dockets Management Branch (Docket No. 98S-0104). As mentioned in our letter dated March 10, 1998, which acknowledged receipt of your GRAS notice, a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1) is likewise available in Docket No. 98S-0103.

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