Pasteurized Shell Eggs (Pasteurized In-shell Eggs)

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.

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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

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[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