Introduction
CFSAN Regulatory Codes
CFSAN Program Priority Codes: FY2000
Abbreviations
Project No. 1: Detection and quantitation of pathogens
Component 1: Develop methods to detect Salmonella
Component 2: Development of Simple Detection Methods for Bacillus cereus emetic toxin
Component 3: Development of Pathogen Detection Systems for Deployment into Food Safety Applications
Component 4: Development of tests for pathogen monitoring during processing of sprouts and other produce.
Component 5: SPR biosensor analysis of microbial toxins in food.
Component 6: Detection of Hepatitis A and other viruses from fruits and produce.
Component 7: NEW COMPONENT - Improve methods for the detection of Shigella
Component 8: NEW COMPONENT - Methods for determination of sublethal injury of pathogens in food processing.
Component 9: NEW COMPONENT- Automated Ribotyping of Food borne Pathogens
Component 10 Title /Description: NEW COMPONENT - DNA Microarray analysis of microbial pathogens in food.
Project No. 2: Molecular characterization of maverick strains of enterohemorrhagic Escherichia
coli
Component 1: <Single component project>
Project No. 3: Effects of environmental conditions, process operations, modified atmosphere
packaging and other parameters on the growth and survival of food borne pathogens on produce, particularly sprouted seeds,
and other minimally processed foods.
Component 1: Prevalence, growth and survival of toxigenic Bacillus and Staphylococcal spp. in sprouting
seeds. Determine the growth/survival of Staphylococcus aureus, Campylobacter and Listeria monocytogenes in
cilantro, lettuce and green peppers during storage under various atmospheres.
Component 2 - (previously component 3 in the FY 1999-2001 plan): Development of a more sensitive method for quantifying
L. monocytogenes
Component 3 - (previously component 5 in the FY 1999-2001 plan): Modeling thermal growth and thermal inactivation of
L. monocytogenes under modified atmospheres.
Component 4: Effect of Various Processing Parameters on the Levels of Food borne Pathogens in Minimally Processed
Foods
Project No. 4: Molecular Mechanisms for Pathogen Emergence
Component 1: <Single component project>
Project No. 5: Identification of Virulence Determinants in Salmonella enteritidis and
Vibrio species
Component 1: Identification and characterization of a novel toxin gene from Vibrio cholerae O1 vaccine strain.
Component 2: Purification and characterization of virulence factors, including toxins and proteases of
S. enteritidis and pathogenic Vibrio species.
Component 3: Cloning of the virulence genes from Vibrio parahaemolyticus (VP) and Salmonella enteritidis
(SE).
Component 4: Adherence and invasion mechanisms of vibrio species.
Project No. 6: Cyclospora and Related Parasitic Protozoa: Detection and Viability
Assessment
Component 1: Methods for the Detection of Cyclospora and Related Protozoa in Fresh Produce, Prepared Foods and
Environmental Samples.
Component 2: Develop animal and tissue culture models for propagation of Cyclospora cayetanensis outside of the
human host.
Component 3: Intervention strategies for the elimination of Cyclospora cayetanensis and related protozoan parasite
contaminants.
Project No. 7: Characterization of Pathogenic Aquatic Eucaryotes and their Toxins
Component 1: Alternative Methods to Mouse Bioassay for PbTx Regulatory Screening and confirmation of violative
shellfish.
Component 2: Identification of Molluscan Metabolites of Brevetoxins, determine critical levels/limits for NSP biotoxins
and metabolites in molluscan shellfish, and characterize brevetoxin absorption, metabolism and elimination in
shellfish.
Component 3: Preparation of ciguatoxin (CFP) standards and development of methods for determination in finfish.
Component 4: Development of guidance level for CFP.
Component 5: Characterization of okadaic acid (DSP) absorption, metabolism and elimination from shellfish and
Identification of molluscan metabolites of okadaic acid.
Project No. 8: Control of Viral and Bacteriological Pathogens in Seafood
Component 1: Methodology for detection and enumeration of pathogens in seafoods and environmental samples.
Component 2: Prevention of seafood borne illness through pathogen source identification and implementation of remediation
processes.
Project No. 9: Assessment of Technologies for Pathogen Reduction or Elimination
Component 1: Reduction of pathogens in fresh fruit juices
Component 2: Effect of chemical disinfection on microflora in fresh produce
Component 3: Effectiveness of Intervention Strategies to Control Biofilms
Component 4: Safety Assessment of Pulsed Electric Field Processing Technology
Component 5: Safety Assessment of High Frequency Ultrasound Technology
Component 6: Inactivation of Clostridium botulinum spores by high pressure processing
Component 7: UV Disinfection of Juices36
Component 8: Evaluation of Packaging Materials for Irradiated Pre-Packaged Foods.37
Component 9: Packaging integrity evaluation
Component 10: NEW COMPONENT -- Bacterial Pathogen Surrogate Evaluation
Component 11: NEW COMPONENT -- In-Shell Pasteurization of Eggs Utilizing Microwave and/or Ultrasonic Energy
Component 12: NEW COMPONENT -- Chemical changes of polymer additives during irradiation
Project No. 10: Mycotoxins
Component 1: Isolation and Identification of Mycotoxins
Component 2 Revised Component -- Isolate and Identify Molds from Foods and Fresh Produce.
Component 3: Development and validation of analytical methods
Component 4: Effects of Processing on Mycotoxins
Component 5: In-vitro and In-vivo Studies to Determine the Immunotoxic, Neurotoxic, and Developmental
Toxicity of Selected Mycotoxins
Component 6: Toxicological Study of Selected Fusarium Toxins (e.g., Deoxynivalenol, Acetyl Derivatives of
Deoxynivalenol, and Zearalenone)
Component 7: Studies of Fumonisins
Component 8: Biochemical and Immunologic Endpoints in Toxicological Studies with Rats Exposed to Aflatoxin B1
and Aflatoxin B1 in Combination with Selected Mycotoxins
Project No. 11: Virulence Assessment and Molecular Pathogenesis of Salmonella spp. and
Shigella
Component 1: Studies to identify new virulence genes functionally involved in Salmonella exocytosis using green
fluorescent protein (GFP) gene insertions to monitor gene expression.
Component 2: Template preparation from samples analyzed using DNA based rapid methods.
Component 3: Development of a diarrhea animal model in healthy and chronically ill animals.
Component 4: Examine the role small, cryptic plasmids in the transfer of Salmonella virulence genes.
Component 5: NEW COMPONENT -- The role of host factors in establishing a Salmonella infection.
Project No. 12: Minimizing Biogenic Amine Formation in Seafoods and other Commodities
Component 1: Shipboard and Dockside Handling of Scombrotoxic Susceptible Seafood
Component 2: Compare techniques for detecting scombrotoxic fish and determine the consquences of gaseous and chemical
treatments prior to storage.
Component 3: Investigate the roles of specific decomposition metabolites in consumer illnesses from scombroid and
non-scombroid fish. Determine the types of illness and relationship to compositions of samples.
Project No. 13: Survival of Food Pathogens during the 60-Day Aging Period of Hard Cheeses Made
from Unpasteurized Milk
Component 1: <single component project>
Project No. 14: Pathway Analysis: Assessment of Pathogen Transmission Capacities of
Disease-Carrying Insects
Component 1: Layer house phase
Component 2: Fly colony phase
Project No. 15: Effects of a Variety of Stress Factors on the Immune Systems of Poult
and Subsequent Infection of Shell Eggs by Salmonella Enteritidis
Project No. 16: Levels of Vibrio vulnificus and Vibrio parahaemolyticus
Retail Seafood (Shell Oysters)
Component 1: <single component project>
Project No. 17: Development of Gastroenteritis Animal Models and Biomarkers for Foodborne
Pathogens to Serve as Surrogate Models for Human Disease
Component 1: Molecular pathogenesis and dose response to enteropathogenic Campylobacter, Escherichia coli and
Vibrio parahaemolyticus using animal models of gastrointestinal disease.
Component 2: Immunologic biomarkers of exposure to Staphylococcal enterotoxins
Component 3: The role of food matrix in dose response and susceptibility to food-borne pathogens
Component 4: Biomarkers and surrogate endpoints for dose response to L. moncytogenes and
V. parahaemolyticus
Project No. 18: Developing alternative modeling tools for assessing dose response and severity
Component 1: Developing Formal Modeling Techniques for Drawing Inferences from Data
Component 2: Monetary Values of Illnesses from Different Hazards
Component 3: Development of a Physiologically based Pharmacokinetic (PBPK) Model for Microbial Endotoxin,
Lipopolysaccharide (LPS).
Appendices - Table of Contents
Appendix A: Risk Assessments and Related Activities
Project Title: Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Molluscan Shellfish
Project Title: Risk Assessment on the Public Health Impact of Foodborne Listeria monocytogenes
Project Title: Food Safety Risk Analysis Clearinghouse
Appendix B: FDA/CFSAN/FSI Funded Cooperative Research Agreements
Research Grants Awarded
Renewed Research Grant Awards
Project Title: Apple Cider Safety Research Project
Project Title: Criteria for the Intensive Investigation of Outbreaks of Foodborne Illness as a Method to Acquire Data for
Use in Quantative Microbial Risk Assessment
Appendix C: CFSAN-FSI Funded FY 2001-2002 Intramural Grant Awards for Technical Support
Appendix D: Specialized Scientific Equipment and Instrumentation Support
Appendix E: FDA/CFSAN Priority Research Needs