[Federal Register: June 27, 2002 (Volume 67, Number 124)]
[Notices]               
[Page 43325-43326]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn02-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-1439]

 
Iceberg Water Deviating From Identity Standard; Extension of 
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 the 
extension of a temporary permit issued to Iceberg Industries Corp., to 
market test products designated as ``Borealis Iceberg Water,'' a name 
not otherwise permissible under the U.S. standard of identity for 
bottled water. The extension will allow the permit holder to continue 
to collect data on consumer acceptance of products while the agency 
takes action on a petition to amend the

[[Page 43326]]

standard of identity for bottled water, which was submitted by the 
permit holder.

DATES: The new expiration date of the permit will be either the 
effective date of a final rule amending the standard of identity for 
bottled water that may result from the permit holder's petition or 30 
days after denial of the petition, whichever the case may be.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food 
Safety and Applied Nutrition (HFS-822), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION: In accordance with Sec. 130.17 (21 CFR 
130.17), FDA issued a temporary permit to Iceberg Industries Corp., 16 
Forest Rd., suite 300, St. John's, Newfoundland, Canada, A1C 2B9, to 
market test products identified as ``iceberg water'' a name that is not 
permitted under the U.S. standard of identity for bottled water in 
Sec. 165.110 (21 CFR 165.110) (65 FR 54283, September 7, 2000). The 
agency issued the permit to facilitate market testing of products whose 
labeling differs from the requirements of the standard of identity for 
bottled water issued under section 401 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 341). The permit covers limited interstate 
market testing of products that deviate from the standard for bottled 
water in Sec. 165.110 in that they are identified as ``iceberg water'' 
rather than as ``bottled water'' or one of the other names specified in 
Sec. 165.110(a)(2). The test product meets all the requirements of the 
standard with the exception of this deviation.
    On September 28, 2001, Iceberg Industries Corp. requested that its 
temporary permit be extended to allow for additional time for the 
market testing of its products under the permit in order to gain 
additional information in support of its petition. The petitioner 
requests FDA to amend the standard of identity for bottled water to 
provide for a new kind of bottled water, ``iceberg water,'' and to 
require icebergs in a marine environment as its source.
    The agency finds that it is in the interest of consumers to issue 
an extension of the time period for the market testing of products 
identified as iceberg water to gain information on consumer 
expectations and acceptance. FDA is inviting interested persons to 
participate in the market test under the conditions that apply to 
Iceberg Industries Corp. (e.g., the composition of the test product), 
except for the designated area of distribution. Any person who wishes 
to participate in the extended market test must notify, in writing, the 
Team Leader, Conventional Foods Team, Division of Standards and 
Labeling Regulations, Office of Nutritional Products, Labeling and 
Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-
822), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740. The notification must include a description of the test 
products to be distributed, justification for the amount requested, the 
area of distribution, and the labeling that will be used for the test 
product (i.e., a draft label for each size of container and each brand 
of product to be market tested). The information panel of the label 
must bear nutrition labeling in accordance with 21 CFR 101.9. Each of 
the ingredients used in the food must be declared on the label as 
required by the applicable sections of 21 CFR part 101.
    Therefore, under the provisions of Sec. 130.17(i), FDA is extending 
the temporary permit granted to Iceberg Industries Corp., 16 Forest 
Rd., suite 300, St. John's, Newfoundland, Canada, A1C 2B9 to provide 
for continued market testing on an annual basis 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 products will bear the name ``Borealis Iceberg 
Water.'' FDA is extending the expiration date of the permit so that the 
permit expires either on the effective date of a final rule amending 
the standard of identity for bottled water that may result from the 
permit holder's petition or 30 days after denial of the petition, 
whichever the case may be. All other conditions and terms of this 
permit remain the same.

    Dated: June 18, 2002.
Christine Taylor,
Director, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. 02-16291 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S