2010-27518. Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Iceberg Canada Corp., to market test a product designated as “GLACE Rare Iceberg Water” that deviates from the U.S. standard of identity for bottled water. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility.

DATES:

This permit is effective for 15 months, beginning on the date the permit holder introduces or causes the introduction of the test product into interstate commerce, but not later than February 1, 2011.

FURTHER INFORMATION CONTACT:

Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 130.17 concerning temporary permits to facilitate market testing of foods deviating from the requirements of the standards of identity issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), FDA is giving notice that a temporary permit has been issued to Iceberg Canada Corp., 5335 J. Armand Bombardier, St-Hubert (Quebec), Canada J3Z 1G4.

This permit covers limited interstate marketing tests of products identified as “GLACE Rare Iceberg Water” that deviate from the U.S. standard of identity for bottled water (§ 165.110 (21 CFR 165.110)) in that the source of the water is an iceberg. The test product meets all the requirements of the standard with the exception of the source definition. The purpose of this temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility.

This permit provides for the temporary marketing of 153,090 cases of the 24 x 250 milliliter bottles and 515,900 cases of the 12 x 700 milliliter bottles totaling 668,990 cases. The total fluid quantity covered by this application is 5,252,100 liters (1,387,458 gallons). The test product will be manufactured for Iceberg Canada Corp., 5335 J. Armand Bombardier, St-Hubert (Quebec), Canada J3Z 1 G4. Iceberg Canada Corp. will distribute the test products throughout the United States. The information panel of the labels will bear nutrition labeling in accordance with 21 CFR 101.9. The bottled water must be manufactured in accordance with the quality standards in § 165.110(b) and the requirements for processing and bottling of bottled drinking water in 21 CFR part 129. This permit is effective for 15 months, beginning on the date the permit holder introduces or causes the introduction of the product into interstate commerce, but not later than (see DATES).

Dated: October 26, 2010.

Barbara Schneeman,

Director, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition.