[Federal Register Volume 69, Number 110 (Tuesday, June 8, 2004)]
[Notices]
[Pages 32009-32010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003P-0296]


Romano Cheese for Manufacturing 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 Kerry, Inc., Eau Galle Cheese 
Factory, First District Association, and Mullins Cheese, Inc., jointly 
to market test romano cheese for manufacturing that deviates from the 
U.S. standard of identity for romano cheese Sec.  133.183 (21 CFR 
133.183). The purpose of the temporary permit is to allow the 
coapplicants 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 holders introduced or caused the introduction of the test 
product into interstate commerce, but not later than September 8, 2004.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Center for Food Safety 
and

[[Page 32010]]

Applied Nutrition (HFS-820), 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) 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 jointly to Kerry, Inc., 352 East Grand Ave., Beloit, WI 53511; 
Eau Galle Cheese Factory, N6765 State Hwy., Durand, WI 54736; First 
District Association, 101 South Swift Ave., Litchfield, MN 55355; and 
Mullins Cheese, Inc., 598 Seagull Dr., Mosinee, WI 54455.
    The permit covers limited interstate marketing tests of products 
identified as ``Romano cheese for manufacturing made from cow's milk.'' 
These products may deviate from the U.S. standard of identity for 
romano cheese (Sec.  133.183) in two ways. First, the product is 
formulated using an enzyme technology that fully cures the cheese in 2 
months rather than 5 months and, second, the product is intended only 
for further manufacturing into food ingredients. Except for these two 
deviations, the test product meets all the requirements of the 
standard. The purpose of the temporary permit is to allow the 
coapplicants to measure consumer acceptance of the product, identify 
mass production problems, and assess commercial feasibility.
    FDA previously issued a temporary permit jointly to Kerry, Inc., 
Eau Galle Cheese Factory, and First District Association to market test 
this product, i.e., romano cheese for manufacturing made from cow's 
milk (68 FR 46198, August 5, 2003). In accordance with the provisions 
of Sec.  130.17(b), the permit required the permit holders to introduce 
or cause the introduction of the test product into interstate commerce 
no later than November 5, 2003. Because the permit holders did not 
introduce or cause the introduction of the test product into interstate 
commerce within the assigned time period, that permit was terminated.
    The current permit provides for the temporary marketing of a total 
of 9 million pounds (4.1 million kilograms) of the test product. The 
test product will be manufactured by Eau Galle Cheese Factory, N6765 
State Hwy., Durand, WI 54736; First District Association, 101 South 
Swift Ave., Litchfield, MN 55355; and Mullins Cheese, Inc., 598 Seagull 
Dr., Mosinee, WI 54455. The test product then will be shipped to Kerry, 
Inc., plants in Wisconsin and Minnesota, where it will be further 
manufactured into food ingredients. The food ingredients will be 
distributed by Kerry, Inc., throughout the United States. Each of the 
ingredients used in the test product must be declared on the labels of 
the test product as required by the applicable sections of 21 CFR part 
101. The permit is effective for 15 months, beginning on the date the 
permit holders introduced or caused the introduction of the product 
into interstate commerce, but not later than September 8, 2004.

    Dated: May 25, 2004.
Laura Tarantino,
Acting Director, Office of Nutritional Products, Labeling, and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. 04-12842 Filed 6-7-04; 8:45 am]
BILLING CODE 4160-01-S