Rules and Regulations. Notice 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
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BILLING CODE 4164-01-P 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 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 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]
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Rules and Regulations
Notice 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
Cite21 CFR 101
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