Agency Additional
Correspondence Letter
GRAS Notice No. GRN 000062

Peter Gray, Ph.D.
Bernàrd Technologies, Inc.
75 East Wacker Drive, Suite 500
Chicago, IL 60601

Re: GRAS Notice No. GRN 000062

Dear Dr. Gray:

The Food and Drug Administration (FDA) is responding to your correspondence dated May 30, 2003, that you sent regarding additional uses for the subject of GRAS Notice No. GRN 000062. Bernàrd Technologies, Inc. (BTI) submitted GRN 000062 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 GRN 000062 on December 4, 2000, and designated it as GRAS Notice No. GRN 000062.

The subject of GRN 000062 is chlorine dioxide generated from particles (less than 30 micrometers) composed of sodium polyphosphate, magnesium sulfate, sodium silicate and sodium chlorite that are incorporated into low density polyethylene (LDPE) food-packaging films, at levels not exceeding 17.5 micrograms chlorite/in² of finished package film. In the remainder of this letter, we refer to the chlorine dioxide generated in this manner as "the ingredient;" we refer to the particles that are less than 30 micrometers and are composed of sodium polyphosphate, magnesium sulfate, sodium silicate and sodium chlorite as "the particles." The particles are blended with the LDPE film for the purpose of delivering a controlled, time-released dose of the ingredient to food in order to extend its shelf life. The ingredient migrates out of the package and extends the shelf life of the food by exerting an antimicrobial effect on spoilage bacteria in or on the packaged food.

In GRN000062, BTI informed FDA of its view that the ingredient is GRAS, through scientific procedures, for the following uses:

1. For packaging meats, poultry and seafood that will be cooked prior to being consumed, and
2. For packaging fresh fruits and vegetables and foods in transit or storage from producers to processors, or institutional users, that will be washed with a potable water rinse and further processed before being consumed.

In GRN 000062, BTI concluded that there would be no exposure to chlorite or chlorine dioxide from their proposed use of the ingredient. BTI based its conclusion on generally available information about the decomposition of chlorite to chloride in solution and during cooking, and the removal of residues of sodium chlorite by washing. In a letter dated June 19, 2001, FDA informed BTI that the agency had no questions at that time about BTI's conclusion that the subject of GRN000062 is GRAS under the intended conditions of use.

Your May 30, 2003 letter informs FDA of the view of BTI that the ingredient is GRAS, through scientific procedures, for the following additional uses:

1. For fresh pasta products that will be cooked prior to being consumed, and
2. For prepared dough products that will be baked, or otherwise cooked, prior to being consumed.

In the May 30, 2003 letter, BTI informs FDA of its view that these additional uses, like those in GRN 000062, result in no residues of chlorite or chlorine dioxide because the foods will be cooked prior to consumption.

Based on the information provided by BTI, as well as the information in GRN 000062 and other information available to FDA, the agency has no questions at this time regarding BTI's conclusion that the ingredient that is the subject of GRN 000062 is GRAS under the intended conditions of use (i.e., for use in fresh pasta and in prepared dough products). The agency has not, however, made its own determination regarding the GRAS status of the subject use of the ingredient. As always, it is the continuing responsibility of BTI 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) and proposed 21 CFR 170.36(c)(1), a copy of the text of this letter, as well as an updated copy of the intended conditions of use of the ingredient, 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. Acting Director Office of Food Additive Safety Center for Food Safety      and Applied Nutrition