[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]



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.


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 

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 
     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 Nos. 1996P-
0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN number 0910-AC14] 
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, 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://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 ADDRESSES 
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 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.


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 
    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;
     A biosecurity program;
     A pest and rodent control program;
     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;
     Refrigerated storage of eggs at the farm;
     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;
     Identification of a person responsible for SE prevention 
at each farm;
     Recordkeeping requirements for environmental and egg 
sampling and testing and for egg diversion; and
     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 
    The proposed rule and fact sheet are available on FDA's Web site 
at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/fs-eggs6.html and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/OHRMS/DOCKETS/98fr/1996p-0418-npr0002.pdf.II.

    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]