[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Notices]
[Page 21031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007P-0150]


Iceberg Water Deviating From Identity Standard; Temporary Permit 
for Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
temporary permit has been issued to Canada Ice Enterprises, Inc., to 
market a product designated as ``80 degrees north 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 July 27, 2007.

FOR 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 Canada Ice 
Enterprises, Inc., P.O. Box 722, St. Anthony, NL A0K 4S0.
    This permit covers limited interstate marketing tests of products 
identified as ``80 degrees north Iceberg Water'' that deviate from the 
U.S. standard of identity for bottled water (Sec.  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 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 500,000 cases 
of 24 x 500 milliliter bottles and 500,000 cases of 12 x 1 liter 
bottles, totaling 1 million cases per year. The total fluid quantity 
covered by this application is 12 million liters (3,170,065 gallons). 
The test product will be manufactured for Canada Ice Enterprises, Inc., 
10 Cremilliare Rd., St. Anthony, NL Canada A0K 4S0. Canada Ice 
Enterprises, Inc., will distribute the test products throughout the 
United States. The information panel of the labels must bear nutrition 
labeling in accordance with 21 CFR 101.9. The bottled water must be 
manufactured in accordance with the quality standards in Sec.  
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 food is introduced or caused to be 
introduced into interstate commerce, but not later than (see DATES).

    Dated: April 20, 2007.
Barbara Schneeman,
Director, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. E7-8040 Filed 4-26-07; 8:45 am]
BILLING CODE 4160-01-S