[Federal Register: October 7, 2004 (Volume 69, Number 194)]
[Proposed Rules]
[Page 60108-60110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc04-16]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Parts 16 and 118
 
[Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504]
RIN 0910-AC14
 
 
Egg Safety; Proposed Rule for Prevention of Salmonella
Enteritidis in Shell Eggs During Production; Public Meetings
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Notification of public meetings.
 
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SUMMARY: The Food and Drug Administration (FDA) is announcing a series
of public meetings to discuss the proposed rule for prevention of
Salmonella Enteritidis (SE) in shell eggs during production. On
September 22, 2004, FDA published in the Federal Register a proposed
rule for egg safety national standards. The purpose of these meetings
is to solicit public comments
 
[[Page 60109]]
 
on the proposed rule and provide the public an opportunity to ask
questions.
 
DATES: Meetings will be held on October 28, 2004, in College Park, MD;
on November 9, 2004, in Chicago, IL and on November 16, 2004, in Los
Angeles, CA from 9 a.m. to 1 p.m. and registration will begin at 8 a.m.
    FDA provided 90 days for submission of comments on the September
22, 2004 proposal. Written and electronic comments are due by December
21, 2004, and should be submitted in the manner prescribed in the
ADDRESSES section of this document.
 
ADDRESSES: The following are a list of the upcoming meeting locations:
    1. Thursday, October 28, 2004, Harvey W. Wiley Federal Building,
Auditorium, 5100 Paint Branch Pkwy., College Park, MD.
    2. Tuesday, November 9, 2004, Chicago Marriott Downtown Magnificent
Mile, 540 North Michigan Ave., Chicago, IL.
    3. Tuesday, November 16, 2004, Los Angeles Airport Marriott, 5855
West Century Blvd., Los Angeles, CA.
     You may submit comments, identified by [Docket Nos. 1996P-0418,
1997P-0197, 1998P-0203, and 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 Nos. 1996P-
0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN number 0910-AC14]
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, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name and
Docket Nos. or Regulatory Information Number (RIN) 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 ADDRESSES
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 docket number(s), found in brackets in the heading of
this document, 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: Marion V. Allen, Center for Food
Safety and Applied Nutrition (HFS-32), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2428, FAX 301-
436-2605, e-mail: marion.allen@fda.hhs.gov for general questions only
about the meeting.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    In the Federal Register of September 22, 2004 (69 FR 56823), FDA
proposed to establish measures to prevent SE contamination of shell
eggs during egg production. The motivation for this proposal is a farm-
to-table risk assessment of SE in eggs which identified implementation
of on-farm prevention measures as a very important step that could
reduce the occurrence of SE infections from eggs. While voluntary
quality assurance (QA) programs for egg production have led to
meaningful reductions in SE illnesses, these programs are not always
uniformly administered or uniformly comprehensive in their prevention
measures.
    Moreover, the most recent data from the Centers for Disease Control
and Prevention (CDC) show that SE illnesses have essentially remained
steady for the past several years. CDC estimated that 118,000 illnesses
were caused by consumption of SE-contaminated eggs in 2001.
Accordingly, FDA believes that further actions to improve egg safety,
building upon the safe consumer handling labeling and egg refrigeration
at retail rule of 2000, are the most effective way to achieve our
public health goals of a 50 percent reduction in overall salmonellosis
and a 50 percent reduction in SE outbreaks by 2010.
    The proposed rule for SE prevention measures includes:
    Provisions for procurement of chicks and pullets;
    <bullet> A biosecurity program;
    <bullet> A pest and rodent control program;
    <bullet> Cleaning and disinfection of poultry houses that have had
an environmental sample or egg test positive for SE before new laying
hens are added to the house;
    <bullet> Refrigerated storage of eggs at the farm;
    <bullet> Producer testing of the environment for SE in poultry
houses, if the environmental test is positive, FDA proposes that egg
testing for SE be undertaken, and that, if an egg test is positive, the
eggs be diverted from the table egg market;
    <bullet> Identification of a person responsible for SE prevention
at each farm;
    <bullet> Recordkeeping requirements for environmental and egg
sampling and testing and for egg diversion; and
    <bullet> Exemptions: the proposed rule would not apply to producers
who sell all of their eggs directly to consumers or producers with
fewer than 3,000 laying hens. In addition, if a producer has 3,000 or
more laying hens and all eggs at a farm are to be given a treatment
that will achieve at least a 5-log destruction of SE or processed into
egg products, then only the proposed refrigeration requirements would
apply.
    The proposed rule and fact sheet are available on FDA's Web site
at: http://www.cfsan.fda.gov/dms/fs-eggs6.html and http://www.fda.gov/OHRMS/DOCKETS/98fr/1996p-0418-npr0002.pdf.
 
II. Registration
 
    Please submit your registration information (including name, title,
firm name, address, telephone number, e-mail address, and fax number)
at least 7 business days before the meeting date. We encourage you to
register online at http://www.cfsan.fda.gov/dms/egg0904.html, or by fax
at 202-479-6801. We will accept registration on-site. Space is limited,
and registration will be closed at each site when maximum seating
capacity for that site is reached. If you need special accommodations
due to a disability, including a sign language interpreter, please
notify the contact person as listed under FOR FURTHER INFORMATION
CONTACT in this announcement at least 7 business days in advance of the
meeting. All participants must present a valid photo ID when entering a
federal building and parking facility.
    Attendees are encouraged to present their comments, concerns, and
recommendations regarding the proposed rule at the public meeting.
Attendees wishing to make a presentation will be allowed 5 minutes
each. Please indicate when registering if you wish to make a
presentation. Individuals and organizations that do not pre-register to
make a presentation may have the opportunity to speak if time permits.
While oral presentations from specific individuals and organizations
will be limited during the public meeting, the written comments
submitted as part of the administrative record may contain a discussion
of any issues of concern. All relevant data and documentation should be
submitted with the written comments.
 
[[Page 60110]]
 
III. Transcripts
 
    A transcript of the proceedings from these public meetings, as well
as all information and data submitted voluntarily to FDA during the
public meetings, will become part of the administrative record and will
be available to the public under 21 CFR 20.111 from FDA's Division of
Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852 at a cost of 10 cents per page. Summaries of the public
meetings will also be available for public examination at FDA's
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
 
    Dated: September 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22476 Filed 10-4-04; 2:49 pm]
 
BILLING CODE 4160-01-S

Fact Sheet: FDA's Proposed Regulation: Prevention of Salmonella Enteritidis in Shell Eggs During Production September 20, 2004

Registration Information: Domestic Outreach Public Meetings Egg Safety - Proposed Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production October 7, 2004

Proposed Rule: Prevention of Salmonella Enteritidis in Shell Eggs During Production September 22, 2004