[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31508-31509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10438]


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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 the 
extension of a temporary permit 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 
extension allows the applicant to continue to evaluate commercial 
viability of the products and to collect data on consumer acceptance of 
the products, in support of a petition to amend the standard of 
identity for cheese products. We also invite other interested parties 
to participate in the market test.

DATES: The new expiration date of the permit will be either the 
effective date of a final rule amending the standard of identity of 
cheese products that may result from the petition or 30 days after 
denial of the petition.

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: In accordance with Sec.  130.17 (21 CFR

[[Page 31509]]

130.17), we issued a temporary permit to Bongards Creameries, 250 Lake 
Drive East, Chanhassen, MN 55317, to market test products that deviate 
from the standards of identity for cheese products under Sec. Sec.  
133.167, 133.169, 133.170, and 133.173 (21 CFR 133.167, 133.169, 
133.170, and 133.173) (85 FR 80118, December 11, 2020). We issued the 
permit to facilitate market testing of products that deviate from the 
requirements of the standard of identity for cheese products issued 
under section 401 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 341). The permit covers limited interstate marketing tests of 
cheese products.
    The test products deviate from the standards of identity for cheese 
products under Sec. Sec.  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 test products meet all the requirements of the standard with 
the exception of this deviation.
    On December 22, 2022, the applicant asked us to extend the 
temporary permit so the applicant could have more time to market test 
the cheese products and gain additional consumer acceptance in support 
of the petition to amend the standard for cheese products. We find that 
it is in the interest of consumers to extend the permit for continued 
market testing of the cheese products to gain additional information on 
consumer expectations and acceptance. Therefore, under Sec.  130.17(i), 
we are extending the temporary permit granted to Bongards Creameries 
for temporary marketing of a maximum of 100 million pounds (45,359,237 
kilograms) of cheese products to provide continued market testing of 
the specified amount of product for the applicant on an annual basis. 
The new expiration date of the permit will be either the effective date 
of a final rule amending the standard of identity for cheese products 
that may result from the petition or 30 days after denial of the 
petition. All other conditions and terms of this permit remain the 
same.
    In addition, we invite interested persons to participate in the 
market test under the conditions of the permit, except for the 
designated area of distribution. Any person who wishes to participate 
in the extended market test must notify, in writing, the Branch Chief, 
Product Evaluation Labeling Branch, Division of Food Labeling and 
Standards, Office of Nutrition and Food Labeling, Center for Food 
Safety and Applied Nutrition, via [email protected]. The 
notification must describe the test products and the area of 
distribution, specify and justify the amount requested, and include 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) (see Sec.  130.17(c)). The information panels on the labels of 
the test products 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 21 CFR part 101.

    Dated: May 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10438 Filed 5-16-23; 8:45 am]
BILLING CODE 4164-01-P