[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Notices]
[Pages 49955-49957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25277]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service
[Docket No. PY-97-008]


Pasteurized Shell Eggs (Pasteurized In-shell Eggs)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: The purpose of this notice is to inform interested persons 
that the Agricultural Marketing Service (AMS) intends to approve the 
official identification of pasteurized shell eggs (in-shell eggs) on a 
tentative basis. Such shell eggs will be required to be subjected to a 
pasteurization process deemed acceptable to the Food and Drug 
Administration (FDA). Additionally, AMS advises all interested parties 
that it will not develop grade standards for pasteurized shell eggs at 
this time.

DATES: This tentative approval period begins September 24, 1997 and 
extends until AMS makes a final determination regarding the official 
identification of pasteurized shell eggs. Comments should be submitted 
on or before November 24, 1997.

ADDRESSES: Written comments may be sent to Douglas C. Bailey, Chief, 
Standardization Branch, Poultry Division, Agricultural Marketing 
Service, U.S. Department of Agriculture, Stop 0259, 1400 Independence 
Avenue, SW, Washington, DC 20250-0259. Comments may be inspected at 
this location between 8 a.m. and 4:00 p.m., Eastern time, Monday 
through Friday, except holidays. State that your comments refer to 
Docket No. PY-97-008.

COMMENTS: Commenters are invited to provide specific information during 
the comment period on the Agency's tentative approval to officially 
identify pasteurized shell eggs.

FOR FURTHER INFORMATION CONTACT: Rex A. Barnes, Chief, Grading Branch, 
Poultry Division, 202-720-3271.

[[Page 49956]]

SUPPLEMENTARY INFORMATION:

Background

    The Agricultural Marketing Act of 1946, as amended (AMA) (7 U.S.C. 
1621 et seq.), authorizes the Secretary of Agriculture to set standards 
for agricultural products and, on a voluntary basis, inspect and 
certify conformity of agricultural products to such standards to assist 
in their orderly marketing.
    The voluntary shell egg grading program (7 CFR Part 56) 
administered under the AMA provides that any interested party may make 
an application with USDA to determine the class, quality, quantity, 
condition, of shell eggs.
    Moreover, USDA may authorize the applicant to officially identify 
such commodities after they have been graded by a representative of the 
Secretary and meet the requirements of the authorizing regulations, 
standards, or specifications.

Grade Standards

    On June 18, 1996, the Agricultural Marketing Service (AMS) 
published a notice in the Federal Register (61 FR 30851) advising 
interested persons that grade standards currently applicable to shell 
eggs are not appropriate for pasteurized shell eggs. The notice also 
solicited comments on the need for USDA grade standards for pasteurized 
shell eggs. AMS received 5 comments during the comment period. Two 
commenters were not in favor of grade standards for pasteurized shell 
eggs and 3 commenters addressed issues that were outside the scope of 
the notice. AMS reviewed this issue and does not plan to develop grade 
standards for pasteurized shell eggs at this time.

Tentative Official Identification of Pasteurized Shell Eggs

    AMS has been requested to permit the official identification of 
pasteurized shell eggs (in-shell eggs). Pasteurized shell eggs are 
shell eggs of the domesticated chicken which have been subjected to a 
process to destroy harmful viable microorganisms. Such processes shall 
meet the criterion for pasteurization set forth by FDA.
    Since FDA is responsible for the definitions and standards or 
descriptions of foods such as eggs, shell egg processors must first 
receive FDA authorization to use the term ``pasteurized'' in 
conjunction with its shell egg labels. All such labeling must also 
comply with the Federal Food, Drug and Cosmetic Act; Fair Packaging and 
Labeling Act; and Nutrition Labeling and Education Act; and their 
associated regulations.
    The FDA criterion for pasteurization is a 5 log reduction in 
Salmonella count after introducing a mixture of Salmonella organisms 
containing Salmonella enteritidis into the intact egg. Processors must 
demonstrate the effectiveness of their pasteurization process by 
obtaining and providing FDA data which show that their process resulted 
in the required reduction in Salmonella count. An evaluation of the 
pasteurization process will include not only a review of the time/
temperature data necessary to achieve a 5 log reduction in Salmonella 
count, but will also include an evaluation of survival and growth of 
bacteria from eggs held for 30 days at 41  deg.F after pasteurization. 
Additionally, processors will also be required to demonstrate that 
product integrity can be ensured after pasteurization. This may be done 
by the marking and/or packaging of the pasteurized eggs to ensure that 
unpasteurized eggs are not substituted in the containers after 
processing.
    After processors have submitted appropriate data acceptable to FDA 
for use of the term ``pasteurized,'' AMS will consider their requests 
to permit official identification of the pasteurized shell eggs.
    Processors would be authorized to state that USDA certifies the 
shell eggs as pasteurized when a representative of the Secretary 
monitors the pasteurization process to ensure it is conducted in 
accordance with appropriate requirements. Additionally, processors 
would be authorized to officially identify pasteurized shell eggs with 
a shield-shaped certified as pasteurized symbol if the eggs certified 
as pasteurized were produced from eggs which had been officially graded 
and identified as U.S. Consumer Grade A or Grade AA. An official 
identification symbol that does not include the shield could also be 
developed to identify ungraded pasteurized shell eggs if there is 
sufficient interest in the use of such a symbol.
    AMS recognizes that appropriate investigation is needed before 
amending current regulations to establish an authority for a new 
official identification. As part of this investigation, AMS is 
tentatively authorizing the official identification of pasteurized 
shell eggs to determine industry and consumer acceptance of such a 
practice, and to permit the collection of other necessary data. Current 
regulations (7 CFR 56.3) provide AMS the flexibility needed to permit 
such experimentation. After AMS has evaluated the results of the 
tentative authorization of official identification for pasteurized 
shell eggs, it will determine if the current shell egg grading 
regulations should be amended, through notice and comment rulemaking, 
to include authorization to identify shell eggs as certified as 
pasteurized.

Tentative Requirements for Official Identification of Pasteurized Shell 
Eggs

    Identifying and Marking Products.
    Use of USDA Certified as Pasteurized Statement.
    1. During the tentative approval period, processors may state on 
labels, containers, or packaging material that USDA certifies shell 
eggs as pasteurized in accordance with the following requirements:
    a. Acceptance of the efficacy of the pasteurization process by FDA.
    b. Use of a grader to monitor the pasteurization process to ensure 
it is conducted in accordance with prescribed parameters.
    Use of USDA Certified as Pasteurized Official Identification 
Symbol.
    2. During the tentative approval period, processors may use the 
USDA official symbol certifying shell eggs as pasteurized on labels, 
containers, or packaging material in accordance with the following 
requirements:
    a. Acceptance of the efficacy of the pasteurization process by FDA.
    b. Use of a grader to monitor the pasteurization process to ensure 
it is conducted in accordance with prescribed parameters.
    c. Use of eggs officially graded and identified as U.S. Consumer 
Grade A or Grade AA to produce pasteurized shell eggs.
    Design of Certified as Pasteurized Official Identification Symbol 
for Graded Eggs.
    3. Except as otherwise authorized, the shield set forth in Figure 1 
containing the letters ``USDA'' shall be the official identification 
symbol to identify cartons of shell eggs which are officially graded 
and pasteurized. The shield shall be of sufficient size so that the 
print and other information contained therein is distinctly legible and 
in approximately the same proportion as shown in Figure 1.

BILLING CODE 3410-02-P

[[Page 49957]]

[GRAPHIC] [TIFF OMITTED] TN24SE97.020



BILLING CODE 3410-02-C
    Authority: 7 U.S.C. 1621 et seq.

    Dated: September 18, 1997.
Lon Hatamiya,
Administrator, Agricultural Marketing Service.
[FR Doc. 97-25277 Filed 9-23-97; 8:45 am]
BILLING CODE 3410-02-P