Scientific Advisory Panel

FIFRA Scientific Advisory Panel
Open Meeting, March 31-April 1, 2009

Scientific Issues Associated with Designating a Prion as a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods

Environmental Protection Agency Conference Center
Lobby Level, One Potomac Yard (South Bldg.),
2777 Crystal Dr., Arlington, VA 22202

FIFRA SAP Website: https://www.epa.gov/scipoly/sap/
Docket Number EPA-HQ-OPP-2008-0859
OPP Docket Telephone: 703-305-5805

FIFRA SAP Session Chair

Steven G. Heeringa, Ph.D.
Research Scientist & Director for Statistical Design
University of Michigan Institute for Social Research
Ann Arbor, MI

Designated Federal Official

Myrta R. Christian, M.S.
US Environmental Protection Agency
Office of Science Coordination & Policy
FIFRA Scientific Advisory Panel
EPA East Building, MC 7201M
1200 Pennsylvania Avenue, NW
Washington, DC  20460
Tel:  202-564-8450, Fax:  202-564-8382, Christian.myrta@epa.gov

FIFRA Scientific Advisory Panel Members

John R. Bucher, Ph.D., DABT
Associate Director
Environmental Toxicology Program
National Institute of Environmental Health Sciences
Research Triangle Park, NC

Janice E. Chambers, Ph.D., DABT, ATS
William L. Giles Distinguished Professor
Director, Center for Environmental Health Sciences
College of Veterinary Medicine
Mississippi State University
Mississippi State, MS

Kirby C. Donnelly, Ph.D.
Professor and Head
Department of Environmental and Occupational Health
School of Rural Public Health
Texas A&M University System Health Science Center
College Station, TX

Carey N. Pope, Ph.D.
Professor, Head & Sitlington Chair of Toxicology
Department of Physiological Sciences
Oklahoma State University College of Veterinary Medicine
Stillwater, OK

Kenneth M. Portier, Ph.D.
Program Director, Statistics
American Cancer Society
National Home Office
Atlanta, GA

Daniel Schlenk, Ph.D.
Professor of Aquatic Ecotoxicology & Environmental Toxicology
Department of Environmental Sciences
University of California, Riverside
Riverside, CA

FQPA Science Review Board Members

Jason C. Bartz, Ph.D.
Assistant Professor
Department of Medical Microbiology & Immunology
Creighton University School of Medicine
Omaha, Nebraska 

Dr. Jason C. Bartz is an Assistant Professor in the Department of Medical Microbiology and Immunology in the School of Medicine at Creighton University where he conducts research on prion diseases.  Dr. Bartz received a Ph.D. in veterinary science from the University of Wisconsin where he focused on interspecies transmission and adaptation of prions to new host species.  Dr. Bartz has over 15 years of experience in prion disease research and is currently investigating the biology of prion strains.  Specifically, Dr. Bartz is interested in the mechanisms of strain-specific routes of neuroinvasion, prion strain targeting in the central nervous system and prion strain interference.  Dr. Bartz has been an advisor to panels of the National Institutes of Health and the Department of Defense. 

Byron Caughey, Ph.D.
Senior Investigator & Chief - TSE/Prion Biochemistry Section
Laboratory of Persistent Viral Diseases
NIH/NIAID Rocky Mountain Laboratories
Hamilton, Montana 

Dr. Byron Caughey is a Senior Investigator and Chief of the TSE/prion Biochemistry Section of the Laboratory of Persistent Viral Diseases, Rocky Mountain Laboratories, National Institute for Allergy and Infectious Diseases, National Institutes of Health in Hamilton, Montana. Dr. Caughey got his Ph.D. in Biochemistry from the University of Wisconsin-Madison in 1985. In 1986, after post-doctoral studies in neurochemistry at Duke University, he began TSE/prion research at Rocky Mountain Laboratories. Dr. Caughey has published extensively in the TSE/prion field on biochemical, biophysical, cell biological, diagnostic and therapeutic aspects of TSE/prion diseases. He has served on journal editorial boards and is currently a senior editor for the Journal of Virology. He has been a member of institutional scientific review committees for the Institute for Animal Health (UK) and the NIDDK (NIH), and chaired the TSEs Review Panel for the 2006 USDA Scientific Quality Review. He has been an ad hoc reviewer for numerous granting agencies and is currently a member of the scientific advisory boards of the funding agencies PrioNet Canada and Alberta Prion Research Institute.

Kenneth D. Clinkenbeard, D.V.M., Ph.D.
Professor & Coordinator,
  Veterinary Biomedical Sciences Graduate Program
Department of Veterinary Pathobiology
College of Veterinary Medicine
Oklahoma State University
Stillwater, Oklahoma 

Dr. Kenneth D. Clinkenbeard is Professor of Veterinary Pathobiology and coordinator of the Veterinary Biomedical Sciences Graduate Program at the College of Veterinary Medicine, Oklahoma State University where he teaches graduate and veterinary students and conducts research in the areas of infectious disease pathogenesis and ecology. Ken earned his PhD degree at The Johns Hopkins University School of Medicine in physiological chemistry in Albert Lehninger’s department studying enzymology and was a NIH postdoctoral fellow under Nobel prize winner Dr. Edwin G. Krebs at the University of California at Davis, where he also earned his DVM degree. Dr. Clinkenbeard has over thirty-five years experience working with infectious diseases including disseminate histoplasmosis in dogs and cats; shipping fever, pinkeye, and E coli O157:H7 in cattle; tularemia and plague in wildlife; and chronic wasting disease in cervids. Recently, he has along with his collaborators from DNA Solutions, Inc. developed an in vitro model for detection and study of chronic wasting disease using an immortalized whitetail deer cell line developed in his laboratory under Phase II Small Business Innovative Research funding from the DoD.

Christina Egan, Ph.D.                                       
Director, Biodefense Laboratory
Wadsworth Center
New York State Department of Health
Albany, New York

Dr. Christina Egan is the Director of the Biodefense Laboratory at the Wadsworth Center, New York State Department of Health (NYSDOH). Dr. Egan has been with the NYSDOH since 1999 joining the Wadsworth Center as a New York State Emerging Infectious Disease fellow and then as a research scientist and member of the Bioterrorism Response Team which was responsible for the analysis of environmental and clinical specimens for anthrax in 2001. Dr. Egan has 10 years experience working with biological pathogens and high containment laboratories and has obtained specialized certification as a C.B.S.P (Certified Biosafety Professional) through the National Registry of Microbiologists. She has been involved in the development of new diagnostic assays designed to test clinical specimens and environmental samples for bacterial, toxins, and viral agents and oversees the validation process of these molecular assays.  Additionally, she has been involved with the development and presentation of many training courses for laboratorians, first responders, Civil Support Teams, and members of the law enforcement community in New York State.  She has participated on a number of different federal, state, and scientific panels and committees such as Association of Analytical Communities Biothreat Methods Committee to create standards for biothreat detection method and the EPA Science Advisory Board.  She has numerous publications and book chapters related to the development of diagnostic assays for biothreat assays and other issues related to public health preparedness and is an Assistant Professor in the SUNY School of Public Health, Departments of Biomedical Sciences and Environmental Health Sciences.

Kurt Giles, D. Phil.
Assistant Adjunct Professor
Department of Neurology
Institute for Neurodegenerative Diseases
University of California at San Francisco
San Francisco, California 

Dr. Kurt Giles is an Assistant Adjunct Professor at the University of California San Francisco (UCSF).  He is director of the transgenics core and a senior scientist at the Institute for Neurodegenerative Diseases (directed by Nobel laureate Dr Stanley B. Prusiner).  Kurt received his Ph.D. in pharmacology from Oxford University, United
Kingdom, where he used biochemical tools to determine abnormally functioning proteins
in Alzheimer’s disease.  This was followed by post-doctoral research at the Weizmann
Institute of Science, Israel, where he expanded on these studies focusing on protein
structure analysis. Kurt has held faculty positions at the Weizmann Institute and at
Oxford University prior to moving to UCSF.  He has taught undergraduate and graduate
courses, and given workshops in many countries, and serves on the editorial board of the
journal Biochemistry and Molecular Biology Education.  He is also involved in education
outreach with High Schools. Kurt has over 15 years experience in neurodegenerative
disease research, and he uses transgenic mouse models to understand the molecular basis
of various neurodegenerative diseases.  He is an expert in prion diseases, where his
research encompasses determining the molecular basis for transmission of prion strains
between species, understanding the endogenous function of the prion protein, and
devising methods to inactivate prions.  He has also pioneered the use of survival analysis
techniques to more rigorously quantify prion inactivation.  Kurt has published widely on
the use of transgenic mouse models to measure prion infectivity, and on the inactivation
of prions.

Nancy J. Hanson, Ph.D.
Associate Professor
Department of Medical Microbiology
Director of Molecular Biology
Center for Research in Anti-Infectives and Biotechnology
Creighton University School of Medicine
Omaha, Nebraska 

Dr. Nancy D. Hanson is an Associate Professor and Director of Molecular Biology for the Center for Research in Anti-Infectives and Biotechnology in the Department of Medical Microbiology and Immunology at Creighton University. Dr. Hanson received her PhD in Medical Microbiology from the University of Nebraska Medical Center. She joined the faculty of Creighton University in 1995. Dr. Hanson has an active research laboratory and has trained several Master and PhD level students. Her area of expertise involves the study of molecular mechanisms of antibiotic resistance in Gram-negative organisms such as E. coli, K. pneumoniae, Salmonella spp. and Pseudomonas aeruginosa. Her research explores two aspects of antibiotic resistance mechanisms: 1) the regulation of the genes involved in resistance and 2) the development of PCR-based diagnostic tests that can be used by clinical laboratories to detect resistance genes in clinical isolates. Dr. Hanson has served as an ad-hoc grant reviewer for National Institutes of Health study sections, the Wellcome Trust, and the British Society for Antimicrobial Chemotherapy. Dr. Hanson has been the invited speaker for the Australian Society of Microbiology, General Society for Microbiology held in Edinburgh Scotland, the American Society of Microbiology and the Interscience Conference on Antimicrobial Agents and Chemotherapy. She serves as an ad-hoc reviewer for 12 scientific journals. Dr. Hanson has also been involved in the Fulbright mentoring program training recipients of the fellowship from countries such as Nigeria and Egypt. In 2007, Dr. Hanson was awarded researcher of the year by the Nebraska Chapter of the Cystic Fibrosis Foundation for her work on P. aeruginosa infecting patients with cystic fibrosis.

Corinne I. Lasmezas, D.V.M., Ph.D.
Professor, Department of Infectology
The Scripps Research Institute, Scripps Florida
Jupiter, Florida 

Dr. Corinne I. Lasmézas is Professor at the Department of Infectology of The Scripps Research Institute, Scripps Florida where she directs a research laboratory focusing on the study of prion diseases. Corinne Lasmézas has a Doctorate of Veterinary Medicine from the University of Toulouse, France, and a Ph.D. in Neurosciences from the University Pierre&Marie Curie in Paris, France. She has over fifteen years of experience in the study of prion diseases. Her research in France has contributed to demonstrate the transmissibility to humans of bovine spongiform encephalopathy by showing the similarity of this prion strain with that of the human variant Creutzfeldt-Jakob Disease. She has established a non-human primate model for the study of the pathogenesis and iatrogenic risk from the bovine prion. She has studied prion pathogenesis in rodent models, including the involvement of the lymphoreticular system, the relationship between infectivity and the misfolded prion protein, prion therapy and the interaction of the prion protein with cell surface proteins. Since 2005 Corinne Lasmézas continues her research in the USA at the newly created Department of Infectology of the Scripps Research Institute located in Jupiter, Florida, where her group focuses on the mechanisms of neurodegeneration in prion diseases, the search for a therapy, and a better understanding of the molecular mechanisms underlying prion replication and the strain phenomenon. She serves as a scientific reviewer for research programs and journals, and is a member of several advisory panels in Europe for issues related to ruminant and human prion diseases including the iatrogenic risk linked to human derived medicinal products.

Laura Manuelidis, M.D.
Professor & Head of Neuropathology
Department of Surgery
Yale University School of Medicine
New Haven, Connecticut 

Dr. Laura Manuelidis is a Professor and Head of the Section of Neuropathology in the Department of Surgery  at Yale, as well as on the interdepartmental faculty of Virology and Neuroscience. She received her MD at Yale and trained in both pathology and neuropathology. Major research contributions have been the discovery and sequencing of alpha satellite DNA and retroviral LINES in the 1970s, with the development of non-isotopic in-situ methods for defining chromosome and nuclear structure at high resolution. She also has done broad diagnostic work as Chief of the Neuropathology service for many years, and has been deeply involved in Creutzfeldt-Jakob disease (CJD) research. The first small animal models of CJD were developed at Yale in the 1970s and these have been fundamental for pathogenesis and infectivity studies. Recent tissue culture models of various CJD and a variety of distinct scrapie agent strains have simplified the study of these agents, including variant CJD (vCJD). The vCJD human isolate is derived from the "mad cow disease" agent (UK BSE). Dr. Manuelidis has been a consultant for the NIH, FDA, NATO, the Wellcome Trust, SEAC and the USDA and continues to participate in editorial boards and activities.

Suzette A. Priola, Ph.D.
Senior Investigator & Chief - TSE/Prion Molecular Biology Section
Laboratory of Persistent Viral Diseases
NIH/NIAID Rocky Mountain Laboratories
Hamilton, Montana 

Dr. Suzette A. Priola is a Senior Investigator and Chief of the TSE/Prion Molecular Biology Section in the Laboratory of Persistent Viral Diseases at the National Institutes of Health’s Rocky Mountain Laboratories.  She obtained her PhD in Microbiology and Immunology from the University of California, Los Angeles and specializes in infectious diseases of the central nervous system.  She has over 18 years of research experience in the field of prion diseases during which time her laboratory has identified novel prion disease inhibitors and studied multiple different aspects of prion pathogenesis including how prions infect cells and the molecular basis of prion species barriers and strains.  She was a member of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathy (TSE) Advisory Committee for five years and Chair for almost three years.  She has served as a consultant to both the FDA’s Center for Biologics Evaluation and Research and the World Health Organization (WHO) and was a member of the National Prion Research Program administered by the Department of Defense’s Congressionally Directed Medical Research Programs.  She has been an editorial board member at the Journal of Biological Chemistry and is currently on the editorial board of the journal Virology.

Juergen A. Richt, DVM, Ph.D.
Regents Distinguished Professor
Kansas State University
College of Veterinary Medicine
Diagnostic Medicine/Pathobiology
Manhattan, Kansas

Dr. Jürgen A. Richt, DVM, PhD, is the Regents Distinguished Professor at the College of Veterinary Medicine at Kansas State University in Manhattan, KS.  He received his DVM from the University of München, Germany, and his PhD in Virology from the University of Giessen, Germany.  Dr. Richt has been working in the area of emerging zoonotic diseases for more than 20 years. In his early research years, Dr. Richt focused on the immunopathogenesis and molecular biology of Borna Disease Virus (BDV). After his move to the United States, Dr. Richt’s work focused on influenza virus infections in animals, especially swine, and on animal transmissible spongiform encephalopathies (TSEs) or prion diseases.  Dr. Richt has published more than 90 peer-reviewed manuscripts in his area of expertise. He is one of the Editors for the journal Virus Genes and on the Editorial Board of numerous other journals. His research program is funded by the NIH and the CDC. He was recently appointed to the Scientific Advisory Board of OIE, Paris, France.

Lynne Sehulster, Ph.D.
Health Scientist
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, Georgia 

Dr. Lynne Sehulster is a Health Scientist in the Division of Healthcare Quality Promotion (DHQP) within the National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) at the Centers for Disease Control and Prevention (CDC).  She has been at CDC for 12 years.  She received her MS and PhD in Microbiology from Rutgers, the State University of New Jersey, and has her certificate as a Microbiologist with the American Society of Clinical Pathologists (M[ASCP]).  Prior to coming to CDC, she completed a postdoctoral assignment in the Department of Virology and Epidemiology at Baylor College of Medicine in Houston doing laboratory research in hepatitis B virus inactivation.  She subsequently served as an infectious disease epidemiologist for 15 years at the Texas Department of Health (currently known as the Texas Department of State Health Services).  While in Texas she was the state health department’s point of contact for viral hepatitis and influenza epidemiology and surveillance activities.  Her current areas of expertise at CDC focus on environmental infection control, transmission of infectious diseases, and microbial inactivation.  She advises the agency, health care professionals, and the public on issues concerning indoor environmental cleaning, sterilization and disinfection, prion inactivation and risk assessment, and environmental management of emerging diseases.  She also provides perspective to CDC on regulated medical waste and other healthcare facility issues such as laundry and environmental services.  She is the coordinator of and contributor to the CDC/HICPAC “Guidelines for Environmental Infection Control in Health-Care Facilities” that was released in 2003.

Claudio Soto, Ph.D.
Professor, Department of Neurology
University of Texas Medical  School at Houston
Houston, Texas 

Dr. Claudio Soto is the Director of the George and Cynthia Mitchell Center for Neurodegenerative Diseases and Professor on the Departments of Neurology, Neuroscience & Cell Biology and Biochemistry & Molecular Biology at the University of Texas Medical Branch in Galveston. Dr. Soto holds the Green Distinguished University Chair in Neuroscience, the largest endowed professorship in the University of Texas. Currently he is also the Founder, Vice-President and Chief Scientific Officer of AMPRION Inc. He received his PhD in biochemistry and molecular biology from the University of Chile in 1993 and was a postdoctoral fellow at the Catholic University of Chile and at the New York University School of Medicine, where he became an assistant professor of research in 1995. Between 1999-2003, Dr Soto was Senior Scientist, Chairman of the Department of Molecular Neuropathology and Senior Executive Scientific Advisor for Neurobiology at Serono International in Switzerland.   For the past 13 years, he and his colleagues have engaged in research into the molecular basis of neurodegenerative diseases associated to the misfolding and brain accumulation of proteins, particularly focusing in Alzheimer’s and prion-related disorders. His work has led to the development of novel strategies for treatment and diagnosis of these diseases. He has published more than 90 peer review scientific publications and contributed to more than 15 books, including one written entirely by Dr. Soto. Many of his studies have been published in the most prestigious scientific journals (including Cell, Nature, Science, Nature medicine, EMBO Journal, etc) and several of them have produced a large impact in the scientific community.