[Federal Register Volume 65, Number 164 (Wednesday, August 23, 2000)]
[Notices]
[Pages 51324-51325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1460]


Salmonella Enteritidis Research Public Meeting

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) in cooperation with the 
Food Safety and Inspection Service (FSIS) and the Agricultural Research 
Service of the United States Department of Agriculture is announcing a 
public meeting to assess the current status of scientific research 
required to make decisions about Salmonella Enteritidis (SE) in egg 
preventative controls, surveillance, and education based on the Egg 
Safety Action Plan (Objective 7). This public meeting will provide an 
opportunity to identify the existing primary research gaps and what 
mechanism should be used to address such research gaps (e.g., awarding 
of competitive research grants, targeted contracting of research).

DATES: The meeting will be held on Friday, September 8, 2000, from 8:30 
a.m. to 5 p.m. Registration and written notices of participation will 
be accepted beginning August 23, 2000. Submit written comments no later 
than October 10, 2000.

ADDRESSES: The meeting will be held at the Holiday Inn Crowne Plaza, 
1325 Virginia Ave., Atlanta, GA.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. You may also send comments to the Dockets Management Branch 
at the following e-mail address: [email protected] or on the FDA 
website at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Transcripts and summaries of the meeting will be 
available for examination at the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: To register for the meeting: Wendy S. 
Buckler, Center for Food Safety and Applied Nutrition (HFS-300), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-
2923, FAX 202-205-4422 or e-mail: [email protected]. When 
registering please provide name, title, firm name, address, telephone, 
and fax number. When registering, please indicate if you would like to 
make a presentation during the meeting. Time allotted for each 
presentation will be approximately 5 minutes for each participant, but 
will depend on the number of people participating.
    There is no registration fee for this public meeting, but advance 
registration is suggested. Interested persons are encouraged to 
register early because space may be limited.
    For general information regarding the meeting or the Egg Safety 
Action Plan: Robert E. Brackett, Center for Food Safety and Applied 
Nutrition (HFS-300), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, 202-205-4064, FAX 202-205-4422 or e-mail: 
[email protected]

SUPPLEMENTARY INFORMATION:

I. Background

    The President's Council on Food Safety issued a directive entitled 
``Egg Safety from Production to Consumption: An Action Plan to 
Eliminate Salmonella Enteritidis Illness Due to Eggs'' (Egg Safety 
Action Plan) to address this public health issue. A primary objective 
of the Egg Safety Action Plan is to promote research that will help 
eliminate SE illnesses associated with consumption of eggs by the year 
2010. The purpose of this public meeting is to assess the current 
status of scientific research as specified in Objective 7 of the Egg 
Safety Action Plan. All discussion and presentations will focus on one 
or more of the items outlined in this objective. Objective 7 from the 
Egg Safety Action Plan states:

Objective 7:

    Ensure adequate, current information is available to make decisions 
about SE preventive controls, surveillance, and education based on 
sound science.
    7.1. Conduct research to develop and evaluate on-farm intervention 
strategies or technologies, including:
    7.1.1. Forced molting and other stress factors
    7.1.2. Vaccines and immunomodulators
    7.1.3. Competitive exclusion
    7.1.4. Ion air scrubbers in hatcheries

Timeline: By Fiscal Year (FY) 2005

    7.2. Conduct research to provide additional information about 
commercial processing technologies and practices
    7.2.1. In-shell pasteurization of eggs
    7.2.2. Rapid cooling before and after processing
    7.2.3. Continuous rewashing
    7.2.4. Repackaging

[[Page 51325]]

    7.2.5. Pasteurization of egg products with additives

Timeline: By FY 2003

    7.3. Conduct research to improve testing methodologies for SE on 
the farm and in eggs, including the identification of virulence factors 
and development of rapid tests, screening tests, sampling protocols, 
and molecular for subtyping SE isolates.

Timeline: By FY 2005

    7.4. Conduct research to understand the ecology and epidemiology of 
SE in the hen and farm environment, including:
    7.4.1. Sources of SE in the environment
    7.4.2. Mechanism of colonizing the layer house
    7.4.3. Factors affecting infection of the hen and contamination of 
the egg
    7.4.4. Characteristics of SE that promote infection in hens and 
humans
    7.4.5. Biochemical characteristics of SE strains causing variations 
in virulence
    7.4.6. Immunological and other factors in humans that affect 
infectivity
    7.4.7. Risk factors associated with the on-farm presence of SE 
isolates

Timeline: By October 2008

II. Public Dockets and Submission

    The agency has established public dockets to which comments may be 
submitted. All comments must include the docket number found in 
brackets in the heading of this document. Submit written comments in 
duplicate to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

III. Meeting Summary and Transcript

    A summary of the public meeting may be requested in writing from 
the Dockets Management Branch (address above) approximately 30 business 
days after the meeting at a cost of 10 cents per page. The summary of 
the public meeting will be available for public examination at the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
    A transcript of the public meeting will be prepared. Copies of the 
transcript may be requested in writing from the Freedom of Information 
Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 
12A-16, Rockville, MD 20857, approximately 15 working days after the 
meeting at a cost of 10 cents per page. The transcript of the public 
meeting and submitted comments will be available for public examination 
at the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: August 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21632 Filed 8-21-00; 12:48 pm]
BILLING CODE 4160-01-F