[Federal Register: August 23, 2000 (Volume 65, Number 164)]
[Notices]
[Page 51324-51325]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au00-73]
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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: FDADockets@oc.fda.gov 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: wendy.buckler@cfsan.fda.gov. 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:
robert.brackett@cfsan.fda.gov
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