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Appendix F Food Safety Research at Intramural and Extramural U.S. Food and Drug Administration Research Centers, by Topic TABLE F-1 Intramural Research Centers Topic Project Center for Food Safety and Applied Nutrition (CFSAN) Additives Development of Methodology to Detect and Quantitate Intermediates and Unsulfonated Impurities in Certifiable Color Additives Use of Migration Models for Indirect Food Additive Approval Allergens Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food The Detection of Food Allergens Using Rapid Immunology– Based Detection Devices Direct Detection, Confirmation, and Measurement of Allergens in Food Matrices Effects of Cleaning on Removal of Allergenic Foods from Food-Contact Surfaces Food Allergen Research Prevalence of Self-Reported Food Allergy in American Adults and Use of Food Labels Filth and Spoilage Assessment of Seafood Decomposition with Electronic Sensors Evaluation of the 2-Day Hydrophobic Grid Membrane Filter, Simplate Yeast and Mold Color Indicator, and Petrifilm Dry Dehydratable Film Methods for the Enumeration of Fungi from Foods Filth and Extraneous Materials in Foods continued 

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 ENHANCING FOOD SAFETY TABLE F-1 Continued Topic Project Food Defense: Control Chemical and Thermal Inactivation of Ricin Thermal Characterization of Botulinum Neurotoxin Using Scanning Differential Calorimetry Food Defense: Detection Counter Terrorism for Proteinaceous Toxins: Ricin, Clostridium botulinum, and Staphylococcal enterotoxin B Detection of Clostridium botulinum Neurotoxins in Foods The Detection of Proteinaceous Toxins and Biomarkers of Select Agents Using Multianalyte (Multiplex) and Agent Specific Technologies Determination of the Characteristics in Foods of Bacillus anthracis in Comparison to Other Bacillus Species Development of Rapid, Multiplexed Methods for Detection and Confirmation of Protein Toxins and Allergens in Food Using Matrix Assisted Laser Desorption/Ionization and Electrospray Mass Spectrometry Isolation and Identification of Non-Traditional Pathogens from Food Foodborne Pathogens: Alternative Molecular Subtyping Methods for Microbial Detection, General Foodborne Pathogens The Application of Deoxyribonucleic Acid (DNA) Microarray Technology in Bacterial Identification Using Different Food Matrices and the Detection of DNA Hybridization Constructs Using Infrared Spectroscopy The Application of Interferometric Biosensor Technology to the Analysis of Food Matrices for Multiple Bacterial and Viral Pathogens, Allergens, and Toxins Characterization of the Zinc-Containing Metalloprotease Encoded by zpx and Development of a Species-Specific Detection Method for Enterobacter sakazakii Development and Validation of Methods for Species Identification of Potentially Hazardous Fish Species Based on DNA Bar-Coding Development of Liquid Chromatography/Mass Spectrometry Protein Profiling as a Tool for Bacterial Differentiation Diagnostic Methodology for Foodborne Illness (Bacteria and Virus) Evaluation of Bioluminex Test Methods and Application to the Analysis of Foods Evaluation of Direct Analysis in Real Time Ionization and Application to the Analysis of Foods and Food Contact Substances Infrared Detection of Label-Free DNA Hybridization on a Microarray Platform for Use in the Identification of Virulence Genes in Foodborne Microorganisms Molecular Applications for Identifying Microbial Pathogens in the Post-9/11 Era

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 APPENDIX F TABLE F-1 Continued Topic Project Prevalence of Pathogens in Imported Product Pulsed-Field Gel Electrophoresis (PFGE) of Microbial Foodborne Pathogens Surface Plasmon Resonance Detection of Foodborne Pathogens and Toxins Use of Gas Chromatography-Flame Ionization Detector and Gas Chromatography-Mass Spectrometry (GC-MS) for Identification and Classification of Foodborne Bacteria and Spores Foodborne Pathogens: Genomic Analysis of Cyclopsora cayetenensis and Emerging Pathogens Cryptosporidium spp: Methods Development for Viability and Molecular Epidemiological Applications Identification and Analyses of Invasion Gene Targets for Use as Diagnostic Probes to Detect Virulent Enterobacter sakazakii Molecular Characterization of Foodborne Pathogens and the Development of Virulence Factor Foodborne Pathogens: Effects of Food Processing on Viruses in Foods Foodborne Viruses Microarray Based Identification of Foodborne Viruses Viral Survival During Produce Processing and Storage: Determined by Cellar Infectivity and Real-Time Polymerase Chain Reaction (PCR) Foodborne Pathogens: Development of a Method to Enrich and Detect Salmonella Gram-Negative Bacterial enteritidis in Whole Eggs Pathogens (E. coli, Ecology and Control of Salmonella Newport on Tomatoes Salmonella, Shigella, Genetic and Phenotypic Differentiation of Salmonella Yersina) enteritidis Strains Derived from Poultry Genetic Factors Regulating Salmonella Stress Response Identification of Shigella Species by GC-MS/MS and Two- Dimensional Gas Chromatography-Time of Flight Modification of Shigella Isolation and Detection Methods Molecular Characterization of Atypical Strains of Enterohemorrhagic Escherichia coli Molecular Evolution of Enteric Pathogens Recurrent Multistate Outbreak of Salmonella Newport Associated with Tomatoes from Contaminated Fields A Systems Approach to Minimize E. coli O157:H7 Food Safety Hazards Associated with Fresh and Fresh-Cut Leafy Greens Thermal Resistance of Yersinia Species in Milk and Other Liquids Related to Food Composition Foodborne Pathogens: Comparative Genomic Analysis of Listeria monocytogenes for Survival in Food Processing Environments L. monocytogenes Effect of Solids Levels on the Thermal Resistance of Listeria Species continued

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 ENHANCING FOOD SAFETY TABLE F-1 Continued Topic Project Efficacy of Mitigation Techniques Against Listeria monocytogenes on Seafood and Seafood Processing Surfaces Growth Modeling and Assessment of Technologies for Pathogen Reduction or Elimination of Listeria monocytogenes Identification and Characterization of Factors Associated with the Virulence of Listeria monocytogenes Involved in Human Gastroenteritis Optimization and Validation of Real Time PCR Most Probable Number Enumeration of Foodborne Listeria monocytogenes Foodborne Pathogens: Decontamination of Dry Ingredients Processing Inactivation of Clostridium botulinum Spores Using High Pressure Processing Post-Harvest Practices to Enhance the Safety of Fresh Tomatoes Validation of Microwave Pasteurization of Multiple Shell Eggs Foodborne Pathogens: Development of a Risk-Ranking Framework to Evaluate Risk Assessment Potential High-Threat Microorganisms, Toxins, and Chemicals in Food Development of Bacterial Pathogenesis Models Using Ceanorhabditis elegans as Host Organism to Study Bacterial Virulence and Host Defense Factors Framework for Establishing Extended Shelf-Life Processes Using the Food Safety Objective Approach Joint U.S. Food and Drug Administration (FDA)/Health Canada Public Health Risk Assessment of Listeria monocytogenes in Cheese Risk Assessment for the Public Health Impact of Highly Pathogenic Avian Influenza Virus in Poultry Meat, Shell Eggs, and Egg Products Risk Assessment to Determine Potential of Chronic Wasting Disease in Infected Cervids as a Human Health Risk Foodborne Pathogens: Biomarkers of Neurotoxic Shellfish Poisoning Seafood Toxins Ciguatera Fish Poisoning Detection Methods for Paralytic Shellfish Poisoning Toxins Development of Conjugates of Saxitoxins for the Production of Antibodies An Intervention Analysis for the Reduction of Exposure to Methylmercury from the Consumption of Seafood by Women of Child-Bearing Age Mussel-Associated Azaspiracid Intoxication in the United States Neurotoxic Shellfish Poisoning Non-Traditional Vectors for Paralytic Shellfish Poisoning

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 APPENDIX F TABLE F-1 Continued Topic Project Paralytic Shellfish Poisoning: Link Between Surface Algal Blooms and Deep Water Shellfish Toxicity in Federal Waters Foodborne Pathogens: Indicator Microorganisms and Viruses in Shellfish in Harvest Surveys Waters Microbiological Survey of Raw Oysters Collected at Retail Across the United States Survey of U.S. Raw Milk Supply for Pathogens Toxicology: Detection Analysis of Total Mercury in Foods by Compton Suppression Instrumental Neutron Activation Analysis Determination of the Thyroid-Interactive Anions Iodide, Perchlorate, and Thiocyanate in Food Development of Tuna Reference Material for Toxic Elements Impact of Processing on Detection of Melamine and Cyanuric Acid Methodology for Determination of Volatile Contaminants in Foods Two-Dimensional Gas Chromatography and Time-of-Flight Mass Spectrometry for the Determination of Pesticides and Persistent Organic Pollutants in Foods Validating the Predictive Performance of Caenorhabditis elegans as an Animal Model for Toxicity Testing Toxicology: Mechanisms Cellular and Cytokine Biomarkers for Infectious and Inflammatory Models Denaturation/Renaturation Kinetics of Staphylococcal Enterotoxin in Acidic Foods Evaluation of the Mass Transfer Properties of Perfluoro Chemicals from Paper Food Packaging Hepatotoxicity—Role of Gender, Species and Inflammation on In Vitro and In Vivo Biomarkers of Liver Toxicity Interaction of Combined Exposure to the Microbial Toxin Lipopolysaccharide (and Deficient or Graded Dietary Vitamin D Level Toxicology: Monitoring Acrylamide Testing at CFSAN: Exploratory Survey Results Aquaculture Drugs and Chemicals FDA Toxicity Databases and Real-Time Data Entry FDA’s Total Diet Study: Dietary Intake of Perchlorate and Iodine Health Care Provider Survey—re the Methylmercury Advisory continued

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 ENHANCING FOOD SAFETY TABLE F-1 Continued Topic Project Center for Veterinary Medicine (CVM) Animal Feed Safety Antimicrobial Susceptibility of Native Enterococcus faecium from Chickens Given Feed Containing Virginiamycin Detecting Animal Tissues in Feed and Feed Ingredients Evaluation of Two Commercial Lateral-Flow Test Kits That Detect Animal Proteins in Finished Animal Feed Validation of a PCR-Based Method for the Detection of Various Rendered Materials in Feedstuffs Using a Forensic DNA Extraction Kit Compliance* Develop Needed Enforcement Methods for Drug Residues Evaluate Screening Test Performance Perform Method Trials to Determine Drug Residues from Unapproved Uses Use Tissue-Fluid Correlations to Predict Drug Residue Levels in Edible Tissues from Food-Producing Animals Premarket Drug Review: The Clonal Spread of Multidrug-Resistant Non-Typhi Antimicrobial Resistance Salmonella Serotypes Mechanisms Determine Microbial Ecology of Antibiotic Resistance Development and Dissemination in the Food Animal Production Environment Genetic Diversity and Antimicrobial Susceptibility Profiles Among Staphylococcus aureus Isolated from Bovine Mastitis Interrogate Salmonella Diversity Using a Novel 35 Genome Salmonella Species Microarray—A Critical Path Study Use Molecular and Biochemical Methods to Determine the Animal Origin of Foodborne Bacterial Pathogens Premarket Drug Review: Broth Microdilution Susceptibility Testing of Campylobacter Microbiological Methods jejuni and the Determination of Quality Control Ranges for 14 Antimicrobial Agents Conduct Molecular Characterization of Foodborne Bacterial Pathogens Isolated from Animals and Retail Meats by Microarray Technology Develop Antimicrobial Susceptibility Testing Methods and Interpretive Criteria for Aquatic Animal Microflora Develop Standardized In Vitro Antimicrobial Susceptibility Testing Methods for Bacterial Pathogens Salmonella Resistant to Extended-Spectrum Cephalosporins: Prevalence and Epidemiology

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 APPENDIX F TABLE F-1 Continued Topic Project Postmarket Approval and Characterize Antimicrobial Resistance Among Bacteria Isolated Monitoring: Analysis of from Retail Meats Survey Data Characterize Antimicrobial Resistance Among Historical Isolates of Foodborne Pathogens Characterize Antimicrobial Resistance Mechanisms of Animal Bacterial Pathogens Determine the Prevalence of Pathogenic Escherichia coli Recovered from National Antimicrobial Resistance Monitoring System (NARMS) Retail Meats DNA Fingerprinting of Foodborne Pathogens by PFGE (in conjunction with PulseNet) Genotyping of Campylobacter coli Isolated from Humans and Retail Meats Using Multilocus Sequence Typing and PFGE Molecular Serotyping of Salmonella spp by Using the Luminex Multianalyte Profiling (xMAP) Technology Survey Susceptibility of Foodborne Pathogens from Humans, Food, and Animals in Mexico Use of Tissue-Fluid Correlations to Estimate Gentamicin Residues in Kidney Tissue of Holstein Steers Postmarket Approval Center for Veterinary Medicine (CVM) Participation in the and Monitoring: Survey NARMS Program Programs CVM Participation in PulseNet Targeted Surveys as Needed Veterinary Drug Residues National Center for Toxicological Research (NCTR) Antimicrobial Resistance Antimicrobial Resistance Genetics of “Emerging” Salmonella enterica Serovar Javiana Phenotypes Involved in Clinical and Food-Related Outbreaks Beta-Lactamase Resistance in enterococci Heteroresistance to Vancomycin and Novel Point Mutations in Tn1546 of Enterococcus faecium ATCC 51559 Molecular Characterization of Multidrug-Resistant Enterococcus spp from Poultry and Dairy Farms: Detection of Virulence and Vancomycin Resistance Gene Markers by PCR Substitutions of Amino Acids in Alpha-Helix-4 of Gyrase A Confer Fluoroquinolone Resistance on Clostridium perfringens continued

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00 ENHANCING FOOD SAFETY TABLE F-1 Continued Topic Project Methods Development Biostatistical Modeling for Food Protection Plan Development of Public Toxicogenomics Software for Microarray Data Management and Analysis Evaluation of Certain Food Additives and Contaminants Genotoxic Effects of Acrylamide and Glycidamide in Mouse Lymphoma Cells In Vitro Antimicrobial Susceptibility, Genetic Diversity and Prevalence of Uridine Diphosphate-Glucose 4-Epimerase Gene in Campylobacter coli and Campylobacter jejuni from Turkey Production Facilities Innovative, Static, and Dynamic Chemical Sensors for Food Safety—Litmus Cooperative Research and Development Agreement Integrating Time-Course Microarray Gene Expression Profiles with Cytotoxicity for Identification of Biomarkers in Primary Rat Hepatocytes Exposed to Cadmium Isolation and Characterization of Tetracycline-Resistant Citrobacter spp from Catfish Mold2, Molecular Descriptors from Two-Dimensional Structures for Chemoinformatics and Toxicoinformatics Molecular Characterization of Salmonella spp and Vibrio spp Isolated from Seafood and Development of Microarray Detection Method Molecular Typing Methodologies for Microbial Source Tracking and Epidemiological Investigations of Gram- Negative Bacterial Foodborne Pathogens Physiologically-Based Pharmacokinetic/Pharmacodynamic Model for Acrylamide and Its Metabolites in Mice, Rats, and Humans Rapid Bacterial Identification with Subspecies-Level Specificity Real-Time PCR Assays for Ricin and Related Potential Bioterrorism Agents in Foods The Survivability of Bacillus anthracis (Sterne Strain) in Processed Liquid Eggs Other Chemical Inactivation of Protein Toxins on Food Contact Surfaces Effect of Egg White Addition to Milk and Ground Beef on the Survival of Sterne Strain of Bacillus anthracis, Salmonella enterococci, and Staphylococci at Different Temperatures Laboratory Studies in Melamine and Cyanuric Acid Biochemical Toxicology Mechanistic Evaluation of the Induction of Lymphoproliferation and Apoptosis Inhibition by Probiotic Bacteria in Mice Infected with Salmonella enterica

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0 APPENDIX F TABLE F-1 Continued Topic Project Risk-Based Research Anaerobic Metabolism of 1-Amino-2-Naphthol-Based Azo Dyes (Sudan Dyes) by Human Intestinal Microflora Approaches in the Safety Evaluations of Veterinary Antimicrobial Agents in Food to Determine the Effects on the Human Intestinal Microflora Identification and Characterization of Class 1 Integron Resistance Gene Cassettes Among Salmonella Strains Isolated from Imported Seafood Influence of Erythromycin A on the Microbial Populations in Aquaculture Sediment Microcosms Surveillance Prevalence and Characterization of Salmonella enterica Serovar Weltevreden from Imported Seafood Probiotic Bacteria Are Antagonistic to Salmonella enterica and Campylobacter jejuni and Influence Host Lymphocyte Responses in Human Microbiota-Associated Immunodeficient and Immunocompetent Mice Office of Regulatory Affairs (ORA) Food Science and Liquid Chromatographic Analysis of Vitamin B6 in Technology Reconstituted Infant Formula: Collaborative Study Potential Use of DNA Barcodes in Regulatory Science: Applications of the Regulatory Fish Encyclopedia Foodborne Pathogens: Molecular Confirmation of Oyster as the Vector for General Hepatitis A in a 2005 Multistate Outbreak Recovery of Mycobacterium bois from Soft Fresh Cheese Originating in Mexico Foodborne Pathogens: Comparison of Salmonella enterica Serovar Heidelberg Gram-Negative Susceptibility Testing Results Bacterial Pathogens (Campylobacter, E. coli, Salmonella, Shigella, Yersina) *Compliance functions focus on methods development and validation, which includes incur- sion services as needed.

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0 ENHANCING FOOD SAFETY TABLE F-2 Extramural Research Centers Topic Project Joint Institute for Food Safety and Applied Nutrition (University of Maryland) Additives Predicting Exposure Estimates: Experimental Food Additive Partitioning Studies and Model Development Filth and Spoilage Moulds and Yeasts in Fruit Salads and Fruit Juices Food Defense: Control Studying Nisin and Sublancin to Strategize Protection of U.S. Food Supply from Bioterrorism Foodborne Pathogens: Enzymatic Degradation of Prion Surrogate Proteins General Plant-Derived Vaccines Against Diarrheal Diseases Public Health Impact and Cost-Effectiveness of Implementing Good Agricultural Practices in Tomato Farming Foodborne Pathogens: Campylobacter-Induced Interleukin-8 Secretion in Polarized Gram-Negative Human Intestinal Epithelial Cells Requires Campylobacter- Bacterial Pathogens Secreted Cytolethal Distending Toxin- and Toll-Like Receptor-Mediated Activation of NF-κB (Campylobacter, E. coli, Salmonella, Shigella, Detecting and Identifying Shigella in Foods Yersina) Reducing and Controlling Salmonella and E. coli in Crops Role of Efflux Pumps and Topoisomerase Mutations in Fluoroquinolone Resistance in Campylobacter jejuni and Campylobacter coli Foodborne Pathogens: Survival of Enterobacter sakazakii in a Dehydrated Powdered Processing Infant Formula Risk-Based Research Emotion Regarding a Food Crisis and Predicting Consumers’ Hesitancy to Eat the Food After the Crisis Evaluation of the ALERT (Assure, Look, Employees, Reports, Threat) Campaign Impact on Audience Attitudes and Behaviors of Risk Messages about Act of Bioterrorism on U.S. Food Supply Toxicology: Detection Characterizing and Predicting Drug Residues in Fish National Center for Food Safety and Technolog (Illinois Institute of Technology) Allergens Cleaning and Other Control and Validation Strategies to Prevent Allergen Cross-Contact in Food-Processing Operations—A Review Purification, Crystallization, and Preliminary X-Ray Characterization of Amandin, A Major Allergen in Almonds (Prunus dulcis)

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0 APPENDIX F TABLE F-2 Continued Topic Project Filth and Spoilage Factors Affecting Mycotoxin Production in Fruits Minimum Leak Size Determination, Under Laboratory and Commercial Conditions, for Bacterial Entry into Polymeric Trays Used for Shelf-Stable Food Packaging Stability of Picrotoxin During Yogurt Manufacture and Storage Food Defense: Detection Detection and Decontamination Methods for Food Defense Foodborne Pathogens: Rapid Tests for Pathogenic Microbes in Food-Producing Detection, General Animals Foodborne Pathogens: Inactivation of Hepatitis A Virus, Poliovirus and a Norovirus Foodborne Viruses Surrogate by High-Pressure Processing Foodborne Pathogens: Multi-Virulence-Locus Sequence Typing Identifies Single Nucleotide Polymorphisms Which Differentiate Epidemic L. monocytogenes Clones and Outbreak Strains of Listeria monocytogenes Foodborne Pathogens: Modeling the Inactivation of Bacterial Spores Processing New Kinetic Models for Inactivation of Bacterial Spores Western Institute for Food Safety and Security (WIFSS, University of California, Davis) Foodborne Pathogens: U.S. Food and Drug Administration Rapid Response Teams General (to Enhance, Complement, Develop, and Improve State Manufactured Food Protection Regulatory and Surveillance Programs) Food Safety Risks and Mitigation Strategies for Feral Swine (Sus scrofa) Near Agriculture Fields Foodborne Pathogens: Escherichia coli O157:H7 in Feral Swine Near Spinach Fields Gram-Negative Bacterial and Cattle, Central California Coast Pathogens (E. coli, Incidence and Tracking of Escherichia coli O157:H7 in a Salmonella, Shigella, Major Produce Production Region in California Yersina) A Multi-State Outbreak of Escherichia coli O157:H7 Linked to Consumption of Beef Tacos at a Fast-Food Restaurant Chain Salmonella in Almonds Funded by WIFSS Foodborne Pathogens: Attachment, Uptake, Dissemination and Inactivation of General Foodborne Enteric Caliciviruses in Vegetables Fresh Express—Determining the Environmental Factors Contributing to the Extended Survival or Regrowth of Foodborne Pathogens in Composting Systems continued

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0 ENHANCING FOOD SAFETY TABLE F-2 Continued Topic Project Survival and Transmission of Pathogenic Viruses in an Agricultural Environment Foodborne Pathogens: Ecology and Epidemiology of E. coli O157:H7 in Fresh Gram-Negative Bacterial Produce Production Regions of the Central California Coast Pathogens (E. coli, Effect of Wilting and Tissue Infiltration on the Behavior of Salmonella, Shigella, E. coli O157:H7 on Leaf Lettuce Directly After Harvest Yersina) Evaluation of Growth Kinetics of E. coli O157:H7 on Bagged Spinach, Crisp Head Lettuce, and Romaine Lettuce in Relation to Consumption Decisions Based on Visual Quality and Off-Odors Infiltration of Edible Plants by E. coli O157:H7