October 24, 2003

FDA Holds Grassroots Meetings to Discuss New Interim Final Rules

In addition to its already announced Satellite Downlink Public Meeting scheduled for October 28, 2003, FDA has now announced a series of domestic meetings to discuss its two new interim final regulations, issued on October 10, 2003, regarding Registration of Food Facilities and Prior Notice of Imported Food Shipments. The purpose of these meetings is to provide information on the rules to the public and to provide the public an opportunity to ask questions of clarification.

Grassroots Meetings:

Dates and locations: All meetings are from 9:00 am - 12:00 noon.

Wednesday, November 12, 2003 - DETROIT, MI
Marriott Detroit Metro Airport
30559 Flynn Road
Romulus, MI 48174

Friday, November 14, 2003 - LOS ANGELES, CA
Hilton Los Angeles Airport
5711 West Century Boulevard
Los Angeles, CA

Monday, November 17, 2003 - JAMAICA QUEENS, NY
LaGuardia Airport Marriott Hotel
Ditmars Blvd
East Elmhurst, NY 11369

Tuesday, November 18, 2003 - SAN ANTONIO, TX
Westin Riverwalk
420 West Market Street
San Antonio, TX 78205

Thursday, November 20, 2003 - MIAMI, FL
Marriott Miami Airport
1201 NW LeJeune Road
Miami, FL

Friday, November 21, 2003 - BALTIMORE, MD
Hyatt Regency
300 Light Street
Baltimore, MD

You may register online at http://www.cfsan.fda.gov/~dms/fsbtac15.html or by fax at (202) 479-6801. Submit meeting location, your name, title, firm name, address, telephone number, email address, and fax number at least 2 workdays before the particular meeting date. Space is limited, and registration will be closed at each site when maximum seating capacity for that site is reached (between 100-200 persons per site).

Additional information about the public meetings, contact information, and the provisions of the Bioterrorism Act under FDA's jurisdiction can be accessed at http://www.fda.gov/oc/bioterrorism/bioact.html. For general questions, contact FDA, CFSAN at 301-436-2277 or CFSAN-FSS@cfsan.fda.gov.

FY 2003 CFSAN Research Grants Awarded

In September 2003, CFSAN awarded cooperative agreement research funds to augment its food safety and food security research program. Applications competing for these awards were submitted in response to the Request for Applications (RFA) solicitation of June 25, 2003 (Federal Register, Volume 68, No. 122, Pages 37847-37850). Awards were granted in three technically distinct categories. Nevertheless, the applied focus of all categories is to enhance the ability of the Agency to detect non-traditional microbial, chemical, and toxin adulterants in food, dietary supplements, food additives, and cosmetics.

In granting these awards, CFSAN has sought projects composed of high scientific quality and promise that can complement the Center's existing intramural research program. By providing talents, capabilities, and resources that the Center does not immediately possess, these projects enhance the Center's overall research effort and thus enable it to acquire the scientific knowledge and tools needed for CFSAN/FDA to conduct its regulatory affairs intelligently and with a sound scientific basis.

Five new grants totaling $2,828,759 were funded. The grants cover the full cost of the awards, which are typically for 3 years.

Project 1 Title: Development of Waveguide Immunoassay for Yesinia pestis
Organization: University of Georgia Research Foundation Inc.
Principal Investigator: Dr. Michael P. Doyle
Total Award Amount: $600,000
Duration of Award: 3 years

A rapid, sensitive (100 to 1,000 cells/ml), and specific assay for the detection of Yersinia pestis in food and environmental samples will be developed. The assay will not require pre-enrichment procedures nor highly trained technical personnel to run. Because the fraction 1 (F1) antigen of Y. pestis is produced at 37°C but not at 26°C or less, it's usefulness as a target in many food and environmental samples is limited. Monoclonal antibodies specific for Y. pestis, but not against F1 will be produced and in turn be used individually and in combination on a multi-assay optical chip. Once an interferometric waveguide biosensor has been prepared, the immunoassay will be applied to the detection of the pathogen in contaminated milk, juice, and water samples. The use of immunobead capture and concentration of the pathogen will be investigated to optimize the sensitivity of the detection system.

Project 2 Title: Rapid Immunoassay Silver Amplification Test System
Organization: Cornell University - Department of Food Sciences
Principal Investigator: Dr. Joseph H. Hotchkiss
Total Award Amount: $546,470
Duration of Award: 3 years

The overall objective is the development of a highly sensitive and rapid test strip immunoassay-based method for detecting microbial agents and toxins in food. A simple swab of suspected material, after initial incubation with enzyme-conjugated antibody, will be used to apply tagged target sample to a test strip. Presumptive positive results will be indicated by development of a visual band in approximate proportion to the amount of target analyte. Due to a unique amplification technology, the method will require a maximum of 6 hours to complete and it will not require pre-enrichment amplification to detect 100 - 1,000 cells per gram of food. Collaboration with researchers from Eastman Kodak will facilitate the incorporation of specialized film coating, amplification systems, and chemistries into the development of a model rapid test strip detection system. Initially, this system will target E. coli O157:H7 as a model analyte, after which the feasibility of incorporating multiple target detectors on one strip will be investigated.

Project 3 Title: Rapid Food Screening for Biological Toxins on a Microchip
Organization: Naval Research Laboratory
Principal Investigator: Dr. Greg Earl Collins
Total Award Amount: $570,600
Duration of Award: 3 years

This project has two objectives. The development of a novel, compact microchip sensing system capable of monitoring for hazardous levels of staphylococcal enterotoxin B and the epsilon toxin of Clostridium perfringens; and the development of simplified extraction methods. The extraction methods will be designed to be compatible with a Lab-on-a-Chip sensing platform approach to the rapid screening of these and other biological toxins. This rapid screening approach utilizes a miniaturized capillary electrophoresis (CE) sensing platform. The Lab-on-a-Chip in combination with the potential use of strong colorimetric complexation agents will support sensitive and rapid separation and detection of the toxin analytes in extracts from a variety of food matrices.

Project 4 Title: Development of a PCR Device for Pathogen Detection
Organization: Cornell University - Material Research Laboratory
Principal Investigator: Dr. Carl A. Batt
First Year Award Amount: $599,954
Duration of Award: 3 years

Previous work by this group has resulted in the design and formatting of PCR-based assays for food-borne pathogens. They have begun the fabrication of key components for cell lysis and DNA purification in a microchip format, and the accompanying hardware necessary for delivering reagents and controlling the reaction temperatures. Through collaboration with Dynal Biotech, Inc., and the Department of the Army, which will supply expertise and reagents for target analyte separation by immunomagnetic separation, this technology will be adapted to the design of PCR-based protocols in a portable bread-board system that is directed at the detection of Bacillus anthracis, Yersinia pestis and Clostridium perfringens. During initial development and testing, Bacillus subtilis and Erwinia herbicola will be used as surrogates for B. anthracis and Y. pestis, respectively.

Project 5 Title: Rapid Screening of Foods for Toxins by TLC-Bioluminescence
Organization: ChromaDex Inc.
Principal Investigator: Dr. James D. McChesney
Total Award Amount: $512,095
Duration of Award: 2 years

A method for monitoring complex mixtures, such as food samples, will be developed that relies upon the direct coupling of bioluminescence to thin layer chromatography (TLC). By TLC, such samples can be separated into discreet substance zones on the TLC plate. Selective detection of toxic compounds is achieved using a kit based on a bacterial bioluminescence, such as that for Vibrio fischeri. Observed bioluminescence reflects the metabolic status of the cells and decreases for cells exposed to toxic substances. Thus, dark TLC-zones correlate well with the toxic components of the sample. The extremely fast response of the bioluminescence system allows identification of separated toxic compounds in mixtures within seconds. Detection in the picomol range is achievable with this approach and can be monitored and documented by video imaging or photography.