[Federal Register: June 8, 2005 (Volume 70, Number 109)]
[Proposed Rules]               
[Page 33404-33405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn05-42]                         

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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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 
25, 2005, the comment period for the document that appeared in the 
Federal Register of May 10, 2005 (70 FR

[[Page 33405]]

24490). In the document, FDA reopened the comment period until June 9, 
2005, 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 
reopened the comment period to receive comment 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. 
The agency is taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit written or electronic comments by July 25, 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 May 10, 2005, FDA reopened the comment 
period until June 9, 2005, 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. FDA reopened the comment period to receive comment and other 
information regarding industry practices and programs that prevent SE-
monitored chicks from becoming infected by SE during the period of 
pullet rearing until placement into laying hen houses. Specifically, 
FDA requested 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?
    Interested persons were given until June 9, 2005, to submit 
comments and supportive data or other information.
    The agency has received requests for an extension of the reopened 
comment period. The requests conveyed concern that the current 30-day 
comment period does not allow sufficient time to develop meaningful 
responses for submission.
    FDA has considered the requests for additional time to submit 
comments and is extending the reopened comment period for an additional 
45 days, until July 25, 2005. The agency believes that a 45-day 
extension allows adequate time for interested persons to submit 
comments without significantly delaying the agency's progress in 
publishing a final rule. However, the agency does not anticipate 
granting any further extensions of the reopened comment period.

II. 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: June 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11407 Filed 6-7-05; 8:45 am]

BILLING CODE 4160-01-S