PAH -Sept 1997 - Food and Drug Administration

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National Center for Toxicological Research

Scientific Advisory Board Subcommittee
Program Review of the Division of
Microbiology

“Response to the Subcommittee Report”


Saeed A. Khan, Ph.D.

Division of Microbiology

National Center for Toxicological Research

US Food and Drug Administration

Jefferson, Arkansas

National Center for Toxicological Research
Advisory Board Site Visit Review Team





Science Advisory

BoardMember

Dr. Catherine W. Donnelly, Chair

Consultants To Advisory Board

Dr. Raul J. Cano

Dr. Thomas W. Federle

Dr. Mike G. Johnson

Dr. Susan F. Kotarski

Consumer

Representative

Dr. Robert E. Anderson

FDA Liaison Members


Dr. Peter H. Cooney (CBER)

Dr. Roger A. Jones (CVM)

Dr. Arthur J. Miller (CFSAN)

Dr. David G. White (CVM
)


Comments on the General
Recommendations


Strategic Planning


A New Philosophical
Paradigm


Leadership


Building Capacity


Public
Relations/Communications


Foodborne Pathogens, Food Safety
and Methods Development


Determination of the Role of
Intestinal Microflora In Activation
or Detoxification of Xenobiotics


Environmental Biotechnology

Comments on the Research Focal Areas


Use of Microorganisms as Models to
Predict the Metabolic Pathway by which
Drugs are Metabolized in Animals


Microbiologist Surveillance/Diagnostic
Support of Research

Comments on the Research Focal Areas
(Cont.)

Overview of the

Division of Microbiology

Saeed A. Khan, Ph.D.

Division of Microbiology

National Center for Toxicological Research

US Food and Drug Administration

Jefferson, Arkansas

Food and Drug Administration (FDA)


Department of Health and Human Services (DHHS)

Office of Operations

National Center for Toxicological Research

Office of the Director

Office of the Deputy Director for Research

Division of Genetic and

Reproductive Toxicology

Genetic
Toxicology Lab

Reproductive
Toxicology Lab

Division of Microbiology

Division of Chemistry

Division of
Biometry and

Risk Assessment

Division of
Biochemical
Toxicology

Division of
Molecular
Epidemiology

Division of
Neurotoxicology

The Division of Microbiology at the NCTR
serves a multipurpose function with
specialized expertise to perform
fundamental and applied research in
microbiology in areas of FDA’s
responsibility in toxicology. The Division
of Microbiology also responds to microbial
surveillance and diagnostic needs for
research projects within the NCTR and
FDA.

Mission

Division of Microbiology

Breeding Colony

Quarantine Facility

Primate colony

NTP Animal Studies

NON
-
NTP Animal Studies

Animal Husbandry Contractor

Diet Preparation Contractor

Environmental Health and


Program Assurance

Microbiology Division

Biochemical Toxicology Division

Chemistry Division

Genetic & Reproductive


Toxicology Division

Molecular Epidemiology Division

Neurotoxicology Division


FDA/Division of Microbiology

Research Collaboration

Center Surveillance

and


Research Support

Media

Preparation

Surveillance/Diagnostic Program

Environmental

Biotechnology

Intestinal

Microflora

Projects

Director

Microbial

Models in

Toxicology

Virology

Serology

Research Program

Bacteriology

Parasitology

Mycology

Food Safety


Research Program


Principal Investigators


Intern Program

Erickson, Bruce D., Ph.D.


Bunch, Sherita

Khan, Ashraf A., Ph.D.


Wynne, Rebecca

Khan, Saeed A., Ph.D.


Nawaz, Mohamed, Ph.D.


Technical Support

Pothuluri, Jairaj V., Ph.D.


Moody, Joanna D.

Rafii, Fatemeh, Ph.D.


Williams, Anna

Sutherland, John B., Ph.D.

Wang, Rong
-
Fu, Ph.D.

ORISE

Cha, Chang
-
Jun, Ph.D.

Kim, Seong
-
Jae, Ph.D.

Kim, Yong
-
Hak, Ph.D.

Nayak, Rajesh, Ph.D.

Administration

Cerniglia, Carl E., Ph.D.,


Director, Division of
Microbiology

Fleischer, Patricia

Malone, Sandra L
.

Surveillance/Diagnostic


Program


Campbell, Warren,


Program Leader

Camp, Marvin W.

Colvert, Ronald M.

Holland, Michael A.

Paine, Donald D.

Robertson, Latriana H.

Steele, Roger S.

Summage
-
West, Christine

Wagner, R. Doug, Ph.D. (PI)

Williams
-
Sims, Lillie M.




PCR


DNA Sequencing


ELISA


Gene Cloning


Gene Isolation and


Manipulation


Hybridoma Technology


Monoclonal and


Polyclonal

Antibodies


Site
-
directed


Mutagenesis


Biodegradation
Methods


Isolation and Identification


of Chemical Intermediates



Gas liquid
Chromatography


High Performance Liquid


Chromatography


Semicontinuous


Culture System



Fermentation Facility


Microbial Bioassays


Tuberculocidal


Assays of Chemical


Germicides


Protein Purification


Techniques


Division

of

Microbiology

Staff Skills

and

Facilities


Anaerobic Bacteria


Culture and Detection


Bacteria Isolation and


Identification


Cellular Fatty Acids


Analysis (MIDI)


Diagnostic Surveillance of


Environmental Samples


Endo and Ecto
-
parasite


Identification


Fungal Isolation and


Identification


Media Preparation


Facility


Rapid Molecular Methods


in Detection of


Microorganisms


Virus Detection

NCTR

Microbiology







































Division of Microbiology

FDA Projects

CFSAN

3

ORA

6

CBER

CVM

10

CDRH

1

CDER





In Vitro

Model and Molecular Analysis of
Competitive Exclusion Products


Molecular Screening Methods for the
Determination of Vancomycin Resistance in
Selective Competitive Exclusion Products.


Studies on the Fluoroquinolone Resistance in
Campylobacter

sp. isolated from Poultry




Microbiology Division Research

Projects with the

Food Safety Initiative


Studies on Mechanism of Fluoroquinolones
Resistant
Salmonella

spp. Isolated from Poultry.


Screening Animal Feeds Using Molecular
Techniques for Proteins Derived from Mammalian
Tissue to Detect Possible Bovine Spongiform
Encephalopathy (BSE)


Molecular Methods to Identify and Quantitate
Human Foodborne Pathogens in the Animal
Production Environment.


Biodegradation of Veterinary Drug Residues.





Microbiology Division Research

Projects with the

Food Safety Initiative

Developed



Molecular techniques for detecting


(a) human intestinal microflora


(b) 13 different strains of food
-
borne pathogens


(c) animal pathogens and environmental isolates


Guidance document entitled “Assessing the effects
of antimicrobial residues in food on the human
intestinal microflora”


Alternative microbial methods for studying
metabolism of drugs

Recent Accomplishments

Developed



Bioluminescent assay to determine the
tuberculocidal activity of disinfectants


Developed multiplex PCR methods for the
determination of vancomycin resistance genes


Developed a cell
-
based model of colonization
resistance against Salmonella invasion


Developed a multiplex PCR method for the
detection of
Salmonella typhimurium

DT104.

Recent Accomplishments (Cont.)

Characterized



Microbial cytochrome P
-
450s and glutathione
transferase


Aerolysin toxins genes


Erythromycin resistance genes (erm) in
Staphylococcus

sp. isolated from chickens


Azoreductase and nitroreductase enzymes in
bacteria isolated from human intestinal tract


Fluoroquinolone resistant
Campylobacter

spp. from
poultry samples.

Recent Accomplishments (Cont.)

Recent Accomplishments (Cont.)


Characterized competitive exclusion products.


Completed method validation trial for the detection
of BSE


Determined the survival of
Shigella

on foods


Discovered an agent in oyster homogenates that is
lethal to
V. cholerae

and
V. vulnificus


Discovered new strains of bacteria and fungi that
degrade environmental pollutants


Elucidated novel biodegradation pathways for
xenobiotics

FY 2001 Plans


PI: Bruce Erickson, Ph.D.



Initiate a new chemostat experiment for testing



veterinary fluoroquinolones.



PI: Ashraf Khan, Ph.D.



Isolation and molecular characterization of



fluoroquinolone resistant
Salmonell
a spp. and



E. coli
from chicken and turkey litters.

FY 2001 Plans (Cont.)


PI: Saeed Khan, Ph.D.




Study the plasmid profile of vancomycin
-



resistant bacteria isolated from Competitive



Exclusion Products.





Genetic fingerprinting and strain typing of




vancomycin
-
resistant organisms isolated



from the CE product will be carried out by


pulse
-

field gel electrophoresis and molecular


probing.

FY 2001 Plans (Cont.)


PI: Mohamed Nawaz, Ph.D.




Correlate the environmental data with the




occurrence of fluoroquinolone resistance to




campylobacters.





Characterize all fluoroquinolone resistance




campylobacters at the molecular level



(PCR
-
RFLP, PFGE).


PI: Jairaj Pothuluri, Ph.D.



Determine the biodegradation rates and




metabolic

fate of the antibiotics used in




aquaculture.

FY 2001 Plans (Cont.)


PI: Fatemeh Rafii, Ph.D.




Detect specific bacteria from the human



intestinal tract involved in the conversion of



phytoestrogens

(daidzein and genistein) to



estrogenic and non estrogenic end products.





Evaluate the effect of fluoroquinolones on



resistance

development in anaerobic bacteria



from the human intestinal tract, mechanism of



resistance

development, impact on metabolic



activities and the dissemination of resistance to



bacterial pathogens.

FY 2001 Plans (Cont.)


PI: John Sutherland, Ph.D.




Identification of the metabolites produced from




norfloxacin and sarafloxacin by fungi grown on




poultry litter.





Isolation of new strains of fungi from litter in





poultry houses and screening them for the






biotransformation of veterinary fluoroquinolones.


PI: Robert Wagner, Ph.D.




Complete
in vitro

assay of competitive exclusion




products.

Strive for scientific excellence and
strengthen the relevance of the research
in the Division of Microbiology with the
mission of the Food and Drug
Administration. Maintain a world
-
class
research program to solve current issues
that face the FDA in the next millennium,
so the Agency can make sound science
-
based regulatory decisions on
microbiology.

Vision