[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Proposed Rules]               
[Page 24490-24491]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-9]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2000N-0504] (formerly Docket No. 00N-0504)

 
Prevention of Salmonella Enteritidis in Shell Eggs During 
Production; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until June 
9, 2005, the comment period for the agency's proposed rule entitled 
``Prevention of Salmonella Enteritidis in Shell Eggs During 
Production'' that published in the Federal Register of September 22, 
2004 (69 FR 56824). FDA is reopening the comment period to receive 
comments and other information regarding industry practices and 
programs that prevent Salmonella Enteritidis (SE)-monitored chicks from 
becoming infected by SE during the period of pullet rearing until 
placement into laying hen houses.

DATES: Submit written or electronic comments by June 9, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2000N-
0504, by any of the following methods:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2000N-
0504 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number or regulatory information number for this rulemaking. 
All comments received will be posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
, including any personal 

information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

and insert the relevant docket number, 2000N-0504, into the ``Search'' 
box and follow the prompts and/or go to the Division of Dockets 
Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lou Carson, Center for Food Safety and 
Applied Nutrition (HFS-032), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-2130.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 22, 2004 (69 FR 56824), FDA 
proposed regulations that would require egg safety measures to prevent 
the contamination of shell eggs with SE during egg production. The 
proposal would reduce SE prevalence in the egg production environment 
and consequently in the eggs themselves. The proposed SE prevention 
measures include: (1) Provisions for procurement of chicks and pullets, 
(2) a biosecurity program, (3) a pest and rodent control program, (4) 
cleaning and disinfection of poultry houses that have had an 
environmental sample or egg test positive for SE, and (5) refrigerated 
storage of eggs at the farm. In addition, the proposal would require 
that producers test the environment for SE in poultry houses. If the 
environmental test is positive, the proposal would require that egg 
testing for SE be undertaken, and that if an egg test is positive, eggs 
be diverted from the table egg market to a technology or process that 
achieves at least a 5-log destruction of SE for shell eggs, or to 
processing in accordance with the Egg

[[Page 24491]]

Products Inspection Act. The proposed rule had a 90-day comment period, 
which ended December 21, 2004. To discuss the proposed rule and solicit 
comments from interested stakeholders, FDA held three public meetings 
in 2004: October 28 in College Park, MD; November 9 in Chicago, IL; and 
November 16 in Los Angeles, CA.

II. Request for Comments

    Based on comments received in response to the proposal, FDA is 
seeking further comment and information on industry practices and 
programs that prevent SE-monitored chicks from being infected by SE 
during the period of pullet rearing until placement into laying hen 
houses. Specifically, FDA seeks additional comment and supportive data 
or other information on the following questions:
    1. How many pullet growing facilities are there in the United 
States? What is the range in the number of houses on those facilities?
     What percentage of pullet growers are under programs or 
have practices aimed at preventing SE-monitored chicks from becoming 
infected by SE during the period of pullet rearing until placement into 
layer hen houses?
     Do State or regional Egg Quality Assurance Programs 
include provisions to prevent SE-monitored chicks from becoming 
infected by SE during the period of pullet rearing until placement into 
layer hen houses? How effective have the pullet programs (whatever the 
programs entail--cleaning, testing, etc.) been in reducing the 
prevalence of SE in layer flocks? How is effectiveness measured?
    2. During pullet rearing, what programs or industry practices are 
currently taken to prevent SE-monitored chicks from becoming infected 
by SE during the period of pullet rearing until placement into layer 
hen houses?
     Are pullets, or their environment, tested for SE between 
the time they are procured as chicks and the time they enter layer 
houses? If so, when? When tested, approximately how often do pullets or 
pullet environments test positive? What happens after a positive test?
     Is vaccination used as a preventive measure, if so, when 
and how?
     What cleaning and disinfecting practices are common?
     Are measures taken to reduce the prevalence of rodents and 
pests in the pullet rearing houses?

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
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.

    Dated: May 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9327 Filed 5-9-05; 8:45 am]

BILLING CODE 4160-01-S