00-22950. 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 Industries Corp. to market test a product designated as “Borealis 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, in support of a petition to amend the standard of identity for bottled water.

DATES:

This permit is effective for 15 months, beginning on the date the food is introduced or caused to be introduced into interstate commerce, but not later than December 6, 2000.

FOR FURTHER INFORMATION CONTACT:

Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS-822), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561.

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 Industries Corp., 16 Forest Rd., suite 200, P.O. Box 8251, St. John's, Newfoundland, Canada, A1B 3N4.

The permit covers limited interstate marketing tests of products identified as “iceberg water” that deviate from the U.S. standard of identity for bottled water (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. Because test preferences vary by area, along with social and environmental differences, the purpose of this permit is to test the product throughout the United States.

Under this temporary permit, the bottled water will be test marketed as “Borealis Iceberg Water.”

This permit provides for the temporary marketing of 150,000 cases of the 24 x 350 milliliters (ml), 150,000 cases of the 12 x 1 liters (L), and another 100,000 cases of the 24 x 500 ml giving 400,000 cases in total. The total fluid weight of the test product will be 1,124,024 gallons or 4,260,000 L). The test product will be manufactured at Iceberg Industries Corp. Water Bottling Plant, Daniel's Point, Trepassy, Newfoundland, Canada, A0A 4B0. The product will be distributed by Iceberg Industries in the United States.

The information panel of the labels will bear nutrition labeling in accordance with 21 CFR 101.9. Each of the ingredients used in the food must be declared on the labels as required by the applicable sections of 21 CFR part 101. This permit is effective for 15 months, beginning on the date the food is introduced or caused to be introduced into interstate commerce, but not later than December 6, 2000.

Dated: August 23, 2000.

Christine J. Lewis,

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