00-21632. Salmonella Enteritidis Research Public Meeting

AGENCY:

Food and Drug Administration, HHS

ACTION:

Notice.

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: [e-mail] 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 [phone] or e-mail: [e-mail]. 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 [phone] or e-mail: [e-mail]

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

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.