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[Federal Register Volume 90, Number 1 (Thursday, January 2, 2025)]
[Notices]
[Pages 109-110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1991-P-0355]

Liquid Eggs Deviating From the Standard of Identity; Revocation 
of Temporary Permit for Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 110]]

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
revocation of the temporary permit issued to M.G. Waldbaum Co., a 
subsidiary of Michael Foods Egg Co., to market test ``ultrapasteurized 
liquid whole eggs'' and ``ultrapasteurized liquid whole eggs with 
citric acid'' because the need for the temporary permit no longer 
exists.

DATES: This permit is revoked as of January 2, 2025.

FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Nutrition Center of 
Excellence, Human Foods Program, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371; or Jessica Ritsick, 
Office of Policy, Regulations, and Information, Human Foods Program, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-2378.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 21, 1989 (54 
FR 30612), we issued a notice announcing that we had issued a temporary 
permit to Crystal Foods, Inc., 6465 Wayzata Blvd., Minneapolis, MN 
55426, a subsidiary of Michael Foods, Inc., to market test experimental 
packs of ``ultrapasteurized liquid whole eggs'' and ``ultrapasteurized 
liquid whole eggs with citric acid,'' which we stated deviate from the 
standard of identity for liquid eggs at Sec.  160.115 (21 CFR 160.115) 
because they were processed with increased heat treatment and aseptic 
processing and packaging. We refer to the temporary permit holder as 
``the company'' throughout this notice. The temporary permit allowed 
the company to measure consumer acceptance of the product, identify 
mass production problems, and assess commercial feasibility (Id.). In 
February 1991, FDA combined the original docket for the temporary 
permit (FDA-1989-P-0168) with other related dockets for the company 
into what is now docket number FDA-1991-P-0355.
    After issuance of the temporary permit, the company requested, and 
FDA granted, several revisions:
     July 11, 1990 (55 FR 28456)--FDA amended the temporary 
permit to provide for package sizes larger than the designated 2.27 
kilograms (5 pounds) to provide a broader base for data collection on 
consumer acceptance of the test products.
     September 20, 1990 (55 FR 38753)--FDA extended the 
temporary permit so the company could continue experimental market 
testing of the products and continue gathering data in support of its 
petition to amend the standard of identity for liquid eggs at Sec.  
160.115. As part of the extension, FDA invited interested persons to 
participate in the market test under the conditions in the temporary 
permit, except for the designated area of distribution. We have no 
records that show that any interested persons notified us of their 
intent to participate in the market test, as required under Sec.  
130.17(i) (21 CFR 130.17(i)).
     March 22, 1991 (56 FR 12206)--FDA amended the temporary 
permit to allow the test products to be packaged in aseptic packages 
ranging in size from 42.5 grams (1.5 ounces) to 1 kilogram (2.2 
pounds). Additionally, as requested by the company, we changed the name 
and address of the permit holder from Crystal Foods, Inc., Minneapolis, 
MN 55426, to M.G. Waldbaum Co., Wakefield, NE 68784.
    In the time since the temporary permit was originally issued, FDA 
has concluded that the temporary permit is not necessary, because the 
standard of identity in Sec.  160.115 provides for the treatment 
process used by the company under the temporary permit. Our regulation, 
at Sec.  160.115(a), states that liquid eggs must be pasteurized or 
otherwise treated to destroy all viable Salmonella microorganisms. The 
specific process used by the company under the temporary permit--
increased heat treatment and aseptic processing and packaging--is 
consistent with Sec.  160.115(a). Specifically, the standard of 
identity for liquid eggs permits other treatments that destroy all 
viable Salmonella microorganisms. As such, we have concluded that the 
temporary permit is not necessary to market liquid eggs using the 
company's process, consistent with the standard of identity.
    In addition, in April 2024, FDA contacted the company via email 
regarding the current use of its temporary permit. The company did not 
object to FDA revoking the temporary permit under Sec.  130.17(g)(3).
    Therefore, under Sec.  130.17(g)(3), we are revoking the company's 
temporary permit because the need for it no longer exists.

    Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31470 Filed 12-31-24; 8:45 am]
BILLING CODE 4164-01-P
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