[Federal Register Volume 69, Number 236 (Thursday, December 9, 2004)]
[Notices]
[Pages 71418-71419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26996]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P-0519]


Cottage Cheese 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 Wells' Dairy, Inc., to market test 
cottage cheese that deviates from the U.S. standard of identity for 
cottage cheese. 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 March 9, 2005.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, 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 Wells' Dairy, 
Inc., 1 Blue Bunny Dr., P.O. Box 1310, Le Mars, IA 51031.
    The permit covers limited interstate marketing tests of these 
products:
1. Blue Bunny Brand
    <bullet> ``Cottage cheese, 4% milkfat, homestyle, large curd'' 24 
ounces (oz);
    <bullet> ``Cottage cheese, 4% milkfat, original, small curd'' 32 
oz;
    <bullet> ``Cottage cheese, 4% milkfat, original, small curd'' 24 
oz;
    <bullet> ``Cottage cheese, 4% milkfat, original, small curd'' 12 
oz;
    <bullet> ``Cottage cheese, 2% milkfat, reduced fat'' 24 oz;
    <bullet> ``Cottage cheese, 2% milkfat, reduced fat'' 12 oz;
    <bullet> ``Cottage cheese, 1% milkfat, lowfat'' 24 oz;
    <bullet> ``Cottage cheese, 1% milkfat, lowfat'' 12 oz; and
    <bullet> ``Cottage cheese, Health Smart, fat free'' 24 oz.
2. Great Value Brand
    <bullet> ``Cottage cheese, 4% milkfat, large curd'' 24 oz;
    <bullet> ``Cottage cheese, 4% milkfat, large curd'' 16 oz;
    <bullet> ``Cottage cheese, 4% milkfat, small curd'' 24 oz;
    <bullet> ``Cottage cheese, 4% milkfat, small curd'' 16 oz;
    <bullet> ``Cottage cheese, 1% milkfat, lowfat, small curd'' 24 oz;
    <bullet> ``Cottage cheese, 1% milkfat, lowfat, small curd'' 16 oz; 
and
    <bullet> ``Cottage cheese, fat free, small curd'' 24 oz.
3. ShurFresh Brand
    <bullet> ``Cottage cheese, 4% milkfat, small curd'' 24 oz.
    These cottage cheese products may deviate from the U.S. standard of 
identity for cottage cheese (21 CFR 133.128) in that the products are 
formulated using fluid ultrafiltered (UF) skim milk. Fluid UF skim milk 
is obtained by subjecting skim milk to a physical separation process 
called ultrafiltration using a membrane with a pore size of 10,000 
Daltons molecular weight cutoff, resulting in the partial loss of 
lactose, minerals, water-soluble vitamins, and water present in skim 
milk. The casein-to-whey protein ratio of skim milk is not altered 
during the ultrafiltration process. The moisture content of fluid UF 
skim milk so obtained is about 80 percent. Fluid UF skim milk is added 
to skim milk at a level needed to increase the total solids of the 
cheese milk by 5 to 25 percent. The physical, chemical, and sensory 
properties characteristic of cottage cheese are not altered in the test 
product. The fluid UF skim milk will be declared in the ingredient 
statement of the finished cottage cheese as ``ultrafiltered skim 
milk.'' The test product meets all the requirements of the standard 
with the exception of the use of fluid UF skim milk. 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.
    This permit provides for the temporary marketing of a total of 15 
million pounds (6.8 million kilograms) of the test product. The test 
products will be manufactured by Wells' Dairy,

[[Page 71419]]

Inc., at 12th and Lincoln Sts. SW., Le Mars, IA 51031. The test 
products will be distributed by Wells' Dairy, Inc., throughout the 
States of Iowa, Minnesota, Wisconsin, Missouri, Nebraska, Oklahoma, 
Kansas, South Dakota, North Dakota, Arkansas, and Colorado. Each of the 
ingredients used in the food must be declared on the labels as required 
by the applicable sections of part 101 (21 CFR part 101). The 
information panel of the labels will bear nutrition labeling in 
accordance with Sec.  101.9. 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 March 9, 2005.

    Dated: November 29, 2004.
Barbara Schneeman,
Director, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. 04-26996 Filed 12-8-04; 8:45 am]
BILLING CODE 4160-01-S