[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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov.
 
Follow the instructions for submitting comments.
    <bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
 
Follow the instructions for submitting comments on the agency Web site.
    <bullet> E-mail: fdadockets@oc.fda.gov. Include Docket No. 2000N-
0504 in the subject line of your e-mail message.
    <bullet> FAX: 301-827-6870.
    <bullet> 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://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://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?
    <bullet> 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?
    <bullet> 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?
    <bullet> 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?
    <bullet> Is vaccination used as a preventive measure, if so, when
and how?
    <bullet> What cleaning and disinfecting practices are common?
    <bullet> 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

Prevention of Salmonella Enteritidis in Shell Eggs During Production; Proposed Rule September 22, 2004 Federal Register

Reopening of Comment Period - May 10, 2005 Federal Register