[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80118-80119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2226]


Cheese Products 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 or we) is announcing 
that a temporary permit has been issued to Bongards Creameries (the 
applicant) to market test several pasteurized standardized cheeses that 
deviate from the U.S. standards of identity for cheese products. The 
temporary permit will allow the applicant to evaluate commercial 
viability of the products and to collect data on consumer acceptance of 
the products.

DATES: This permit is effective for 15 months, beginning on the date 
the applicant introduces or causes introduction of the test products 
into interstate commerce, but not later than March 11, 2021.

FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: We are giving notice that we have issued a 
temporary permit to Bongards Creameries. We are issuing the temporary 
permit in accordance with 21 CFR 130.17, which addresses temporary 
permits for interstate shipments of experimental packs of food varying 
from the requirements of standards of identity issued under section 401 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341).
    The permit covers interstate marketing test of several pasteurized 
standardized cheeses. The test products deviate from the standards of 
identity for cheese products under 21 CFR 133.167, 133.169, 133.170, 
and 133.173. For the purpose of this permit, natamycin, which is not 
permitted under the standards of identity for these cheese products, 
would be added as a mold inhibitor in the standardized cheeses. The 
inhibitor would be incorporated into blended and processed cheese just 
prior to pasteurization and further cast into slices (or packaging into 
loaves or other final forms as in the case of pasteurized process 
cheese spread). Natamycin, which is stable under typical thermal 
processing conditions for pasteurized cheeses, would be added directly 
to cheese blends just prior to pasteurization, as is done with other 
mold inhibitors such as sorbic acid, sodium propionate, and their 
approved variants. The final concentration of natamycin would not 
exceed 20 parts per million and would be effective at producing process 
and blended slices with a shelf life of up to 150 days before seeing 
mold growth.
    The purpose of the temporary permit is to allow the applicant to 
market test the products throughout the United States. The permit will 
allow the applicant to evaluate commercial viability of the products 
and to collect data on consumer acceptance of the products.
    This permit provides for the temporary marketing of a maximum of 
100 million pounds (45,359,237 kg) of the test products. The test 
products will be manufactured at the Bongards Creamery facilities 
located at 13200 County Rd. 51, Bongards, MN 55368, and 3001 Hwy. 45 
Bypass West, Humboldt, TN 38343.
    Bongards Creameries will produce, market test, and distribute the 
test products throughout the United States. The following sliced cheese 
products will be market tested: American Pasteurized Process Cheese, 
Reduced Fat and Reduced Sodium American Pasteurized Process Cheese, 
Restricted Melt American Pasteurized Process Cheese, American Swiss 
Pasteurized Process Cheese, White American Pasteurized Process Cheese, 
American with Jalapeno Pasteurized Process Cheese, Pasteurized Blended 
Cheddar Cheese, Pasteurized Reduced Fat Cheddar Cheese, Pasteurized 
Blended Swiss Cheese, Pasteurized Blended Pepper Jack Cheese, 
Pasteurized Blended Low-Moisture Part Skim Mozzarella Cheese, and 
Pasteurized Blended Provolone Cheese.
    In addition, the following products will be market tested for 
further manufacturing: Yellow Restricted Melt Process American Slice, 
Yellow Reduced Fat/Reduced Sodium Process American Slice, Yellow 
Reduced Sodium Process American Slice, and Yellow Process American 
Cheese Food Slice.
    Each ingredient 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 applicant introduces 
or causes the introduction of the test products into

[[Page 80119]]

interstate commerce, but not later than March 11, 2021.

    Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27197 Filed 12-10-20; 8:45 am]
BILLING CODE 4164-01-P


