Acting Division Director: Steven Foley, Ph.D.
Deputy Director: Steven Foley, Ph.D.
About the Division
Serve a multipurpose function including 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; determining antimicrobial resistance and virulence mechanisms; conducting research to aid FDA in the areas of women's health, tobacco products, and nanotechnology; and improving risk assessments.
- Engaging colleagues at FDA product centers early in the research-design phase to assess the feasibility and interest in the research.
- Increased participation on FDA workgroups and timely dissemination of research results to stakeholders in product centers.
- Identify opportunities for increased support for training programs to facilitate research advancement.
Strategies to Meet Our Mission
Understand the regulatory process to identify issues
Integrate research program into the FDA infrastructure
Communicate research in plain language
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
Upgrade research facilities and infrastructure
Studies of SARS-CoV-2 NSP1 and Envelope Protein
2021 Select Accomplishments
Food Safety and Virology: Antimicrobial Resistance and Virulence
- Assessed the contributions of bacterial plasmids to increased virulence and antimicrobial resistance in bacterial pathogens and evaluated factors that lead to dissemination of plasmids between bacteria, which could lead to more difficult-to-treat infections (Frontiers in Microbiology, Microbiology and Molecular Biology Review).
- Produced and purified coronavirus spike proteins that serve as important resources for ongoing efforts to examine the interactions of the virus and host cells, and further used computational approaches to predict the impact of spike protein-structure changes on the binding of the proteins to cell surface receptors (Frontiers in Artificial Intelligence).
- Carried out studies in partnership with the University of Arkansas at Little Rock to assess the antimicrobial properties of nanostructured aluminum foil surfaces. There are potential applications for nanostructured food-contact surfaces to minimize spoilage and the growth of foodborne pathogens (Nanotechnology, MRS Advances).
Microbiome and Biological Interactions
- Assessed the impact of the exposure of antimicrobial drug residues on the human gastrointestinal (GI) microbiota composition and intestinal permeability. Higher exposures contributed to alterations of the microbiota and intestinal permeability (Antibiotics).
- Continued studies on the 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 exposure to different nanomaterials on the GI tract and the microbiome. There are limited studies available describing the potential impact of nanomaterials on microbial dysbiosis, inflammatory responses, and epithelial cell permeability following exposure to these types of compounds (NanoImpact, Research Square, International Journal of Molecular Sciences).
Microbial Contaminants Detection
- Developed and evaluated a simple gene-amplification method for the detection of Burkholderia cepacia complex (BCC) in pharmaceutical products. Improved and widely accessible detection methods for BCC are important to limit patient exposure to BCC pathogens that have been linked to multiple disease outbreaks (Pathogens).
- Assessed the impact of different storage conditions of fecal specimens and the corresponding ability to detect the important pathogen Clostridioides difficile, which is the cause of difficult-to-treat infections in many patients. The ability to make an accurate diagnosis is key to developing effective treatment strategies for the infections (Pathogens).
- Used sequencing methods to characterize potential bacterial pathogens for both veterinary and human patients (Microbiology Resource Announcements – October 2021 and November 2021, Canadian Journal of Microbiology).
Studies of SARS-CoV-2 NSP1 and Envelope Protein
2022 Select Research Projects
A Recombinant Coronavirus Spike Protein to Generate Reagents, Study Cell Interactions and Antibody-Dependent Enhancement
Discovery of Intracellular and Extracellular Signaling Pathways and Mechanisms Contributing to Complement Activation and Coagulopathies Associated with Coronavirus Infections
Assessment of the Role that the Microbiome May Play in the Toxicity of Xenobiotics
Multi-Lab Validation of Isolation and Identification of Nontuberculous Mycobacteria Associated with Tattoo-Related Skin Infections
Detection of Microbial Contaminants, Including Anaerobic Bacteria, in Tattoo Inks and Other Related Products
Establishing Standardized Methods for Sporicidal Efficacy Assessment and Building Up an Efficacy Database of Sporicidal Products to Support FDA’s Regulation on Drug Compounding
Evaluation of Antimicrobial, Antibiofilm and Cytotoxicity Activity of Nanoparticles (Se, V) and Nanostructured Surfaces (Ti, Cu) and Transcriptomic and Proteomic Response of Multidrug Resistant Bacteria
Evaluation of Tools to Efficiently Assess Antimicrobial Resistance and Pathogenicity-Related Functions of Plasmids in Bacterial Pathogens
Evaluation of In Vitro Vaginal Tract Models to Assess the Biotherapeutic Potential of Lactobacillus Toward Toxic Shock Syndrome Toxin-1 Producing Staphylococcus aureus
Metagenomic Analyses for the Detection of Microorganisms in Non-Sterile Pharmaceutical Products
Resources for You
- Division of Microbiology Fact Sheet
- 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
- About the National Center for Toxicological Research
- National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
- (870) 543-7121