Major Functions and Responsibilities
Performing fundamental and applied research to address critical issues in support of the FDA mission; research projects are based on expertise of staff and scientists from other Centers, regulatory agencies, academia, and industry.
Division Director: Carl Cerniglia, Ph.D.
Research Within the Division
The Division of Microbiology scientists engage in research addressing FDA issues with special emphasis on:
- Improving methods to detect, identify, and characterize foodborne pathogens.
- Determining antimicrobial resistance and virulence mechanisms of microbial pathogens.
- Using state-of-the-art molecular biological approaches to monitor interactions between the human microbiome and antimicrobial agents, nanomaterials, food contaminants, and FDA-regulated products.
- Conducting studies related to women's health.
- Improving environmental risk assessments of priority pollutants, including polycyclic aromatic hydrocarbons and drugs, by integrating systems biology approaches.
- Conducting research involving nanotechnology.
- Evaluating smokeless-tobacco products for toxicity from a microbiology perspective.
2018 Select Accomplishments
- Development and utilization of approaches for the evaluation of the plasmid-associated antimicrobial resistance and virulence in Salmonella
Study demonstrated that certain antimicrobial exposures impact plasmid transfer dynamics in a dose-dependent fashion. It also showed that plasmid-encoded factors likely contribute to infection under low-iron conditions as seen by the fact that iron acquisition systems were up-regulated during infection.
- Detection of microbial contaminants including pathogenic mycobacteria in tattoo inks
Investigators completed a survey of 85 unopened, sealed tattoo and permanent makeup inks purchased from 13 companies available in the US, for microbial contamination and found that 42 inks (49%) were contaminated with microorganisms, often with relatively high levels that includes Dermacoccus barathri and Roseomonas mucosa, which have been associated with skin infections.
- Conducted host-microbiome assessments to evaluate the effects of FDA-regulated products on the microbiome
One study analyzed the metabolic alterations in oral bacteria as a result of smokeless tobacco exposure and demonstrated with in vitro studies that STPs affected the growth and viability of some oral bacterial species in a concentration-dependent manner. Similarly, the investigators evaluated the effects of STPs on oral microbiota in a Syrian Golden hamster cheek pouch carcinogenesis model and found that the use of STPs tobacco significantly disrupted the oral microbiota.
Additionally, capability-building efforts to standardize sample collection and data analysis methodologies for gut microbiome and gut mucosa associated immune responses were undertaken. As part of these efforts, investigators established 16s rRNA gene sequencing approaches to facilitate assessment of: animal model species, sample anatomical collection sites, exposure vehicle, and toxicological relevance to human disease.
Also the effects of residue levels of antimicrobial agents on the intestinal microbiome were evaluated and it was found that higher concentration levels above established acceptable daily intake values impacted intestinal microbiome composition and intestinal barrier functions.
2019 Select Research Projects
- 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
- Evaluation of Methods Used to Measure Growth of Staphylococcus aureus and the Production of Toxic Shock Syndrome Toxin-1 as Influenced by Menstrual Tampons
- Evaluation of Potential Antimicrobial Resistance Selection in Human Intestinal Microbiota Following Long-Term Exposure to
Residual Concentrations of Antimicrobial Drugs as Part of Human Food Safety Assessment
- Drug-Delivery Nanoparticle Immunological Effects on Induction of Pro-Inflammatory Responses to Candida albicans in Mice
- Interaction of Nanoparticles with Gastrointestinal Tract
- Nonclinical Modeling and Risk Assessment of FDA-Regulated Drug-Nanocrystals
- Comparative Study to Evaluate Molecular Assays and Culture-Based Reference Methods for the Detection of Toxigenic Clostridium difficile and to Evaluate Storage Conditions on the Recovery of C. difficile in Clinical Stool Specimens
- Detection of Microbial Contaminants including Pathogenic Mycobacteria in Tattoo Inks
- Role of Plasmid-Encoded Factors in Salmonella enterica Virulence
- Exploration of Fecal Transplant Mechanisms: Differential Pro-Inflammatory Responses of Intestinal Epithelial and Dendritic Cells to Clostridium difficile and Commensal Bacteria
- Multi-Omics Approach to Identify an Antimicrobial Resistance Marker of Staphylococcus aureus Associated with Antimicrobial-Coated Medical Devices in a Biofilm Reactor
- Using In Vitro Continuous Culture of the Human Intestinal Microbiota to Evaluate Risk Associated with Bacterial Pathogen Contamination of Fecal Microbiota Transplantation Samples
- Comparative Methods Study for the Detection of Burkholderia cepacia Complex from Non-Sterile Pharmaceutical Products
- The Effect of Nanomaterials Used in Dentistry on Biofilm Formation and the Oral Microbiota
Resources for You
- National Center for Toxicological Research
Food and Drug Administration
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