• Performed reproductive and carcinogenicity studies on aspartame for industry
• Performed reproductive and carcinogenicity studies on cyclamate for industry
• Performed reproductive and carcinogenicity studies on tobacco smoking for FDA
• Prepared various presentations in support of safety studies performed at Exxon Toxicology Laboratory for FDA
• Participated in GRAS review of several  chemicals
• Submitted a variety of food contact notifications for industry
• Submitted several 510Ks in support of sterilizing medical devices for hospitals
• Consult on all aspects of obtaining and using GRAS status
• Conducted audits of manufacturing plants for compliance with GMP regulations
• Assisted with calculations of dietary estimates for carcinogenic contaminants

Resume

Employment History

    1989--Present           President/Principal Scientist, BioTox, Lutherville, MD
    1984--1989               Director, Toxicology Laboratory, Exxon Biomedical Sciences,
                                        Inc, East Millstone, NJ
    1979--1984               Associate Director, Toxicology Laboratory, Exxon Biomedical
                                       Science, Inc., East Millstone, NJ
    1975--1979               Senior Staff Toxicologist, Toxicology Department, Hazleton/
                                       Covance, Vienna VA  
    1973--1975               Staff Toxicologist, Toxicology Department, Hazleton/Covance,
                                        Vienna, VA
    1971--1972               Corpsman 2nd Class, US Navy, Anatomical Pathology, National
                                        Naval Medical Center, Bethesda, MD 
    1968--1970               Corps, US Navy, Vietnam Era Assignments

Education/Certification
   
    Fellow, Academy of Toxicology of Sciences
    Ph.D., Genetic Toxicology, George Washington University, Washington, DC
    M.S., Biochemical Genetics, George Washington University, Washington, DC 

•  Completed coursework toward M.S. in Ethology, University of Missouri
•  Graduate School of Science, Columbia, MO

    B.A., Liberal Arts, Syracuse University, Syracuse, NY

Academic Appointments

    1985--Present          Adjunct Professor of Industrial Toxicology, University of Texas
                                       Medical Branch, Galveston, TX
    1996                          Center for Professional Advancement, Developmental and
                                       Reproductive Toxicology, Course Co-Director, New
                                       Brunswick, NJ
    2005--Present          Adjunct Assistant Professor of Toxicology, Lecturer in Genetic
                                       Toxicology, University of Medicine & Dentistry of New Jersey
                                       (UMDNJ), New Brunswick, NJ
  
Professional Experience

    Consulting Services--President, BioTox (1989--Present)

• Develop and create toxicity profiles for attorneys and industrial clients
• Direct genetic toxicology programs and data analysis for regulatory submission
• Direct reproduction/developmental toxicology programs and data analysis for regulatory submissions
• Design and conduct safety assessment programs for pharmaceuticals, commodity chemicals, consumer products and agrichemicals
• Develop and implement numerous Ecotox profiles for an oil company
• Provide toxicological reviews of petrochemicals for EPA
• Develop plan testing and creat OECD SIDS and SIAR Dossiers
• Prepare 510ks for submission to FDA
• Prepare Food Contact Notification Submissions since the re-organization of the program in 2002
• Assisted with Task Force Coordination and Representation and chaired the Isopropanol & Acetone Toxicology Research Task Groups (TRTGs) as Chemistry Council of America (CCA)
• Task Force Manager for Acetophenone
• Provide Expert Witness Testimony in court; Dataa Review or court and depositions in General and Genetic Toxicology for over 10 clients
• Provide in-depth toxicology laboratory facility reviews
• Conduct protocol evaluation and preclinical and clinical study monitoring for a consumer product company
• Create new and revise existing MSDSs and labels for various clients worldwide
• Develop regulatory submissions for new and existing materials for most of the international regulatory authorities, principally the EPA, FDA, EU, NICNAS and Japanese MHW, and represent the technical aspects of those submissions to the regulatory authority
• Prepare Safe Harbor NSRL-Like Values for Proposition 65 Labeling

Exxon Toxicology Laboratory--Laboratory Director/Associate Director (1979--1989)

• Staff of approximately 140 including 15 Ph.D.'s and 25 contract emplohyees
• 10 Department Managers
• Completed all reviews of the laboratory facility including trial testing of the 100,000 square foot facility which conducted 95% of Exxon Corporation toxicology testing program
• Developed and managed safety and risk programs for new petroleum products as needed for Research & Development
• Initiated, marketed and maintained a $3 million plus thrird party testing program with pharmaceutical, agricultural, and food products firms
• Provided guidance for new products/formulations for review by FDA, EPA, DOT and for international agencies such as the European Economic Community (EEC) and CONCAWE (Conservation of Clean Air and Watder in Europe--the oil companies' European organization for environment, health and safety)
• Acted as primary interface between Exxon scientific staff and Exxon laboratory staff and was the primary contact with all third party clients
• Provided toxicology guidance to various Exxon businesses, assisted in the development of risk assessment activities for occupational exposures, anddeveloped occupational exposure guidelines now in use at Exxon
• Direct report departments included all phases of mammalian and environmental toxicology including acute, subchronic, chronic, genetic reproduction, and developmental projects
• Direct stewardship responsibilities included deployment of manpower, fiscal budgets, project assignments, staff training, and future direction of the laboratory
• Functioned as the principal investigator for various toxicology programs that included acute, subchronic, chronic and oncogenicity, developmental and reproduction and environmental studies
• Represented Exxon in various trade organizations and industry consortia including Chemical Manufacturers Association (CMA--now ACC--American Chemistry Council), Johns Hopkins Center for the Advance of Alternatives to Animal Testing (CAAT), Chemical Specialties Manufacturers Association (CSMA) and American Council on Science and Health (ACSH)Reproductive and Developmental Effects Subcommittee--chaired several of these committees

Hazelton/Covance--Staff/Senior Staff Toxicologist (1973--1979)

• Staff of 25; 3 professional managters
• Expanded responsibilites t6o include ong term carcinogenicity and mutagenicity studeis
• Personally directed about 125 scientific projects (scientific and fiscal responsibility)
• Responsible for staff training and review and hiring new employees
• Study Director for Aspartame Project
• Study Director of Cyclamate Project
• Study Director for FDA Dog Smoking Studies
• Set up the genetic toxicology department including staffing, testing protocols and created a new department reporting to the Vice President of Toxicology Operations
• Responsible for the implementation of GLP in mammalian and genetic toxicology laboratories

US Navy--Corpsman/Lab Technician (1968-1972)

• Clinical activities associated with Corpsman duties
• Clinical blood drawing, clinical chemistry laboratory assignments
• Assigned to set up and manage US Navy Cytogenetics Laboratory at Bethesda Naval Hospital

Professional Society Memberships

• Member, American College of Toxicology, 1979--Present
• Member, American Society for Testing and Materials, 1979--1989
• Member, Genetic Toxicology Association, 1979--Present
• Member, Mid-Atlantic Society of Toxicology, 1982--1990
• Member, Society of Toxicology, 1983--Present
• Member, Roundtable of Toxicology Consultants, 1995--Present
• Member, Environmental Mutagen Society, 1974--Present
• Member, American Association for the Advancement of Science, 975--Present
• Member, Sigma Xi Honor Society, George Washington University Chapter, 1979--Present
• Member,  New York Academy of Science, 1975--Present
• Member, Dermal Clinical Evaluation Society (Charter Member), 1983--1992
• Member, Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), 2000--2003

Professional Society Activities

• Mid-Atlantic Chapter--Society of Toxicology, Program Committee, 1982--1983
• Society of Toxicology, Member, Placement Committee, 1984--1988 (appointed)
• Society of Toxicology, Member, Regulatory Affairs and Legislative Activities Committee, 1995--Present
• American College of Toxicology, Member, Nominating Committee, 1997--1999 (elected)
• American College of Toxicology, Councilor, 1998--2001 (elected)
• American College of Toxicology, Animals in Research--Committee Chair, 2000--2002 (appointed)
• American College of Toxicology, Treasurer, 2002--Present (elected
• Roundtable ot Toxicology Consultants, Secretary, 2000--2003 (elected)
• Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) Board of Trustees, 2000--2003 (appointed)

Editorial Responsibility

• Reviewer, Teratogenesis, Carcinogenesis and Mutagenesis, 1984--1989
• Editorial Board, Journal of Applied Toxicology, 1998--Present
• Book Review Editor, International Journal of Toxicology, 1999--Present
• Reviewer, Regulatory Pharmacology and Toxicology, 2002--Present
• Reviewer, Human and Experimental Toxicology, 2005--Present

Publications

• 6 Chapters
• 1 Book Editorship
• 22 Major Publications
• 40+ Abstracts and Posters

Industrial Panels and Committees

• Cancer Center of the University of Texas, Appointed to faculty of an annual course entitled "Principles and Practices of Genetic Toxicology" in Galveston, 1979-1983
• ASTM, Chair, Medical and Toxicology Subcommittee, 1979--1983
• American Chemistry Council (ACC), Expert Representative to the OECD Genetic Toxicology Expert Review Panel, 1992--1995
• Exxon Biomedical Sciences, Inc., Chairperson, Animal Welfare Committee, 1980--1983
• Serves as a Reviewer for grant applications for National March of Dimes/Birth Defects, 1980--Present
• Served on a Symposium Planning Committee for the Central New Jersey Chapter of March of Dimes.  Symposium entitled "Chemicals and our Environment, the Mother, the Fetus, and the Child.  Implications for the Health Care Worker", in New Brunswick, NJ, March 1, 1985
• Appointed University of Medical & Dental Schools of New Jersey (UMDNJ Safety Committee, New Brunswick, NJ, 1986-1988
• American Chemistry Council (ACC), Member, Phthalate Esters CHEMSTAR Task Group for Exxon, 1986--1989
• Johns Hopkins Center for the Advancement of Alternatives to Animal Testing (CAAT), Exxon Representative, 1986--1989
• American Industrial Hygiene Council (AIHC), Reproductive and Developmental Effects Subcommittee, Exxon Representative, 1986--1989
• Chemical Specialties manufacturers Association (CSMA), Exxon Representative, 1987--1989
• American Chemistry Council (ACC), Member, Butadiene CHEMSTAR Toxicity Research Task Group for BP, 1991--1996
• American Chemistry Council (ACC), Chair, Ispropanol Toxicology Research Group for BP, 1994--1997
• Acrylonitrile Group, Member, Health and Safety Subcommittee for BP, 1991--1996
• American Chemistry Council (ACC), Member, Neurotoxicity Work Group for BP, 1992--1994
  
• American Chemistry Council (ACC), Member, Oxo Process Panel, 1992--1994
• Acetophenone Task Force, Chair, 1997--2002

Government Panels and Presentations

• Testified before the Subcommittee on Environmental Mutagenesis at the National Institutes of Health on March 28, 1977:  Topic:  "Monitoring XYY Nondisjunction in Human Males"
• Testified at the First Annual NIOSH Scientific Symposium on April 17, 1978 in Cincinnati, Ohio:  Topic: "Toxicity of Low Concentration Long-term Exposure to an Airborne Mixture of Nitrous Oxide and Halothane"
• Testified at an NIH Workshop on the Assessment of Reproductive Hazards in the Workplace:  Topic:  "YFF Sperm Test"
• Testified at an NIH Workshop on Systems to Detect Induction of Aneuploidy by Environmental Mutagens on November 5, 1978 in Savannah, Georgia:  Topic:  "Detection of Mutations in Humans"
• Testified at the US Department o Labor Seminar Genetic/Reproductive Toxicology on September 15, 1979 in Washington:  Topic:  "DBCP and Teratogenicity"
• Testified before a US EPA FIFRA Meeting--Intent to Suspend Registration of Pesticide Products Containing Dibromochloropropane (DBCP):  Topic:  "Genetic Toxicity Consideration with DBCP".  Published in the Federal Register, Volume 44, No. 219, Friday, November 9, 1979, pp. 145-146
• Appointed to the Dominant Lethal Committee of the US EPA Gene-Tox Program, 1978-1983
• Served as a consultant to the Department of Health and Human Services to review grant applications, 1980--2003
• Appointed to the Energy Health Science Review Panel for the US EPA, 1984-1988
• Served as a consultant to the National Toxicology Program Board of Scientific Counselors to review proposals, 1982-1990
• Serve as a Peer Reviewer for Gran Applications for ATSDR, 1993--Present