[Federal Register Volume 66, Number 174 (Friday, September 7, 2001)]
[Notices]
[Page 46803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98N-1230, 96P-0418, and 97P-0197]


Small Entity Compliance Guide: ``Food Labeling: Safe Handling 
Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held 
for Retail Distribution;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide (SECG) for a final rule 
that published in the Federal Register of December 5, 2000 (65 FR 
76092), entitled ``Food Labeling: Safe Handling Statements, Labeling of 
Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution.'' 
The SECG is intended to set forth the requirements of that final rule 
in plain language and to help small businesses understand the 
regulation.

DATES: Submit written or electronic comments on this SECG at any time.

ADDRESSES: Submit written comments concerning this SECG to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Submit written requests for 
single copies of the SECG to the Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 200 C St., Washington, 
DC 20204, 202-205-4561. Send one self-adhesive address label to assist 
that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT:
    For the labeling provisions: Geraldine A. June, Center for Food 
Safety and Applied Nutrition (HFS-822), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4168.
    For refrigeration provisions: Nancy S. Bufano, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-401-2022.

SUPPLEMENTARY INFORMATION:

I. Background

    To reduce the risk of illness and death from consumption of eggs 
contaminated with Salmonella enteritidis (SE), FDA published in the 
Federal Register of July 6, 1999 (64 FR 36492), a proposed rule 
requiring the labeling of shell eggs with a safe handling statement and 
the refrigeration of shell eggs at retail. FDA published the final rule 
in the Federal Register of December 5, 2000 (65 FR 76092).
    FDA examined the economic implications of that final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and 
determined that the final rule would have a significant economic impact 
on a substantial number of small entities.
    In compliance with section 212 of the Small Business Regulatory 
Fairness Act (Public Law 104-121), FDA made available (via the 
Internet) a SECG stating in plain language the requirements of this 
regulation.
    FDA is issuing this SECG as level 2 guidance consistent with FDAs 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the agency's current thinking on the subject. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the SECG entitled ``Food Labeling: Safe Handling 
Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held 
for Retail Distribution'' to the Dockets Management Branch (address 
above). Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Copies of the SECG may also be viewed on a personal computer with 
access to the Internet. Center for Food Safety and Applied Nutrition's 
home page includes the SECG and can be found at http://
www.cfsan.fda.gov/dms/eggsguid.html.

    Dated: August 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22482 Filed 9-6-01; 8:45 am]
BILLING CODE 4160-01-S