Acting Division Director: Steven Foley, Ph.D.
Studies of SARS-CoV-2 NSP1 and Envelope Protein
Studies of SARS-CoV-2 NSP1 and Envelope Protein
Strategies to Meet Our Mission
Understand better the regulatory process to identify issues
Integrate research program into the FDA infrastructure
Contribute to the FDA/NCTR mission
Assess the needs of FDA
Conduct research critical to the FDA regulatory science mission
Expand our collaborative relationship with FDA product centers and Office of Regulatory Affairs
Focus research priorities in consultation with regulatory colleagues
Establish benchmarks of scientific excellence
Communicate research in plain language
Upgrade research facilities and infrastructure
Division Research Themes
The Division of Microbiology scientists engage in research addressing FDA issues with special emphasis on:
- Evaluating the impact of antimicrobial agents, food contaminants, food additives, nanomaterials, and FDA-regulated products on the microbiome.
- Developing methods to detect and characterize microbial contaminants in FDA-regulated products.
- Determining antimicrobial resistance and virulence mechanisms of foodborne and other pathogens.
- Conducting research to aid FDA in the areas of women's health, tobacco products, and nanotechnology.
- Improving risk assessments of FDA-regulated products, including the integration of systems biology approaches.
2020 Select Accomplishments
Food Safety and Virology: Antimicrobial Resistance and Virulence
- Developed and optimized genetic databases and matching algorithms to identify Salmonella enterica virulence factors and plasmid transfer genes from whole-genome sequence data that serves to improve the safety foods and feed. Genes.
- Researched the contributions of bacterial plasmids to spread antimicrobial resistance and how these plasmids can also contribute to increased virulence in bacterial pathogens. Poultry Science, BMC Microbiology, and Microbiology Resource Announcements.
- Developed spore preparation methods for Bacillus spp. which will aid in the establishment of standardized methods for sporicidal efficacy assessment that will support FDA’s regulation of drug compounding.
- Produced recombinant Coronavirus spike proteins that are important resources for ongoing the evaluation of viral-host cell interactions and facilitate the assessment of antibody-dependent enhancement which can lead to deleterious disease outcomes.
Microbiome and Biological Interactions
- Studied the effects of antimicrobial drug and drug residues to determine the impact on the human gastrointestinal tract microbiota composition and intestinal permeability. Higher exposures were found to lead to alterations of the microbiota and intestinal permeability. A review article describing the dynamics of antimicrobial residues in food on the microbiota and an update on evaluating the safety in toxicology risk assessments is available in the Journal of Veterinary Pharmacology and Therapeutics.
- Assessed the impact of exposure of xenobiotic compounds including arsenic, bisphenol AF and triclosan on the microbiome and host responses through National Toxicological Program funded efforts. These efforts are informing risk assessments of the test compounds. Toxicological Sciences.
- Evaluated the impact of sex-related differences on microbial dysbiosis, inflammatory responses and epithelial cell permeability following exposure to xenobiotic compounds. Frontiers in Pharmacology and International Journal of Molecular Sciences.
Microbial Contaminants Detection
- Identified enhanced methods for the detection of Burkholderia cepacia complex (BCC) in pharmaceutical-grade water and antiseptics. Improved detection of BCC in products is a key public health concern due to disease outbreaks in susceptible individuals and immunocompromised patients. Journal of Industrial Microbiology & Biotechnology.
- Developed methods for the detection of microbial contaminants in tattoo and permanent make-up inks and completed two surveys on the microorganisms present. Organisms that have the potential to be opportunistic bacterial pathogens were identified in some products. Letter in Applied Microbiology.
- Validated new sample preparation procedures for the detection of Salmonella in spices. This method with its increased sensitivity has been incorporated into the FDA Bacteriological Analytical Manual (BAM) Chapter 5.
2021 Select Research Projects
- A Recombinant Coronavirus Spike Protein to Generate Reagents, Study Cell Interactions and Antibody-Dependent Enhancement
- Assessment of the Role that the Microbiome May Play in the Toxicity of Xenobiotics
- Studies on the Intrinsic Structural Multidrug Efflux Pump Mechanisms on Antimicrobial Resistant Salmonella enterica and Their Role in Antimicrobial Resistance
- Detection of Microbial Contaminants, including Anaerobic Bacteria, in Tattoo Inks and other Related Products
- Assessment of the Interactions of Nanoscale Materials used in Sunscreens on the Skin Microbiome
- Nonclinical Modeling and Risk Assessment of FDA-Regulated Drug-Nanocrystals
- Multi-Omics Approach to Identify an Antimicrobial Resistance Marker of Staphylococcus aureus Associated with Antimicrobial-Coated Medical Devices in a Biofilm Reactor
- A Plasmid Analyses Toolbox: Approaches and Tools to Efficiently Assess Antimicrobial Resistance and Pathogenicity-Related Functions of Plasmids in Bacterial Pathogens
- Development of in vitro Vaginal Tract Models to Assess the Biotherapeutic Potential of Lactobacillus Toward Toxic Shock Syndrome Toxin-1 Producing Staphylococcus aureus
- Comparative Methods Study for the Detection of Burkholderia cepacia Complex from Non-Sterile Pharmaceutical Products
Resources for You
- NCTR Grand Rounds: "Studies of SARS-CoV-2 NSP1 and Envelope Protein" (Presentation recorded in Adobe Connect on March 11, 2021)
- Annual Report
- Meet the Principal Investigators
- National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
- (870) 543-7121