[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:
    <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 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?
    <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?
 
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

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