Document ID: FDA-2011-D-0398-0008
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Questions and Answers Regarding Final Rule: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation
Posted Date: 2012-08-21T04:00Z

[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Rules and Regulations]
[Pages 50372-50373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20383]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 118

[Docket No. FDA-2011-D-0398]

Guidance for Industry: Questions and Answers Regarding the Final 
Rule, Prevention of Salmonella Enteritidis in Shell Eggs During 
Production, Storage, and Transportation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance entitled ``Guidance for Industry: Questions 
and Answers Regarding the Final Rule, Prevention of Salmonella 
Enteritidis in Shell Eggs During Production, Storage, and 
Transportation.'' The guidance contains questions we have received on 
the final rule since its publication and responses to those questions, 
and is intended to assist egg producers and other persons who are 
covered by the final rule.

[[Page 50373]]

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Plant and Dairy Food Safety/Office of Food Safety, 
Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety 
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1493.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2009 (74 FR 33030), we issued a 
final rule requiring shell egg producers to implement measures to 
prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm 
and from further growth during storage and transportation, and 
requiring these producers to maintain records concerning their 
compliance with the final rule and to register with FDA. This final 
rule became effective September 8, 2009. In the Federal Register of 
July 13, 2011 (76 FR 41157), we made available a draft guidance 
entitled ``Questions and Answers Regarding the Final Rule, Prevention 
of Salmonella Enteritidis in Shell Eggs During Production, Storage, and 
Transportation'' and gave interested parties an opportunity to submit 
comments by September 12, 2011. We have reviewed and evaluated these 
comments and have modified the guidance where appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents our 
current thinking on how to interpret the requirements in the final 
rule, including questions and answers on compliance dates; coverage; 
definitions; SE prevention measures; sampling and testing for SE; 
registration; and compliance and enforcement. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternate approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 118.5, 118.6, 118.10, and 118.11 
have been approved under OMB control number 0910-0660.

III. Comments

    Interested persons may submit written comments regarding this 
document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Always 
access an FDA document using the FDA Web site listed previously to find 
the most current version of the guidance.

    Dated: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20383 Filed 8-20-12; 8:45 am]
BILLING CODE 4160-01-P