-- Victor Hugo
Dr. Richard A. Davis is a part-time faculty member of the Toxicology Program at the University of Medicine and Dentistry of New Jersey, School of Health Related Professions. He teaches lecture, laboratory, research and seminar courses in toxicology. He also is responsible for direction of the Toxicology Student Internship Program and participates in the development and conduct of continuing education courses for the professional community. Further information on the program can be found below under UMDNJ-SHRP and on the UMDNJ Website. Dr. Davis is also an adjunct faculty member at Georgian Court College and teaches a toxicology course as part of the Graduate Program in Biology. The course is a broad overview of adverse effects of chemicals on living organisms, underlying molecular mechanisms causing environmental damage by toxic substances, identification and testing of toxic substances, and safety evaluations related to environmental and industrial toxicology. The goal of the course is to give graduate students in biology a basic understanding of the methods used to assess adverse effects on all levels of biological systems.
Courses and lecture topics taught by Dr. Davis at UMDNJ include Regulatory Toxicology, Organ System Toxicity, Principles of Pharmacology for the Toxicologist, and Research in Toxicology . Each course is described below.
Regulatory Toxicology
Classroom presentations are included on federal, state and local governmental approaches and programs for controlling exposure to toxic chemicals. Identification of legislation and agencies involved in the regulation of chemical categories including food, drugs, cosmetics, pesticides, industrial chemicals, air and water pollutants and hazardous wastes. The use of toxicological data by regulators to assess safety and the impact of regulatory requirements on toxicology studies are discussed. Strategies for internet information access are presented.
Course Objectives
- Define terminology used.
- Identify major laws/regulations regulating the marketing of chemical products and the control of chemicals in the environment
- Identify agencies/authorities responsible for the enforcement of these laws/regulations
- Describe the goals and objectives of specific laws/regulations presented
- Identify the role that costs, health risks, societal concerns, economical impact and other modifying factors play in the process of regulating chemicals
- Describe how toxicological data is utilized/required in the chemical regulatory process
- Identify and access internet and other sources providing information on the toxicity and regulation of chemicals
Learning Objectives
UNIT I - Role of Toxicology in Safety Regulation
- Define what product safety and environmental laws utilize toxicology information
- Describe the federal regulation development process and the role of toxicologists
- List guideline setting organizations which supplement or complement federal product safety and environmental programs
UNIT II - Hazard Classification and Communication
- Know the ways regulatory agencies utilize hazard classification
- Describe how weight of evidence and strength of evidence are utilized to classify carcinogens
- Explain the difference between EPA, IARC and NTP carcinogen classification schemes
- Explain how hazard classification triggers hazard communication requirements
- Describe the various types of hazard communication documents
UNIT III - Safety Assessment
- Know the derivation of ADIs and RfDs
- Describe when and how safety factors are applied
- Explain how the Benchmark Dose is determined and utilized
- Describe the difference between safety assessment and risk assessment
UNIT IV - Risk Assessment
- Briefly define the four broad components of the risk assessment process.
- Describe the types of assumptions that can be made regarding inhalation, ingestion or dermal contact rates
- Explain how risk assessment is conducted for noncarcinogens and for carcinogens.
- Explain how risk assessment is conducted for genotoxic and non-genotoxic carcinogens
UNIT V - Food Additives
- Describe the FDA authorization to regulate food additives under the Food, Drug and Cosmetic Act (FDCA) and its amendments
- Name the three classes of indirect food additives that are subject to distinct regulatory standards
- Define GRAS substances and their status under FDCA
- Discuss the issues/conflicts associated with implementation of the Delaney Clause
UNIT VI - Drugs / Medical Devices
- Describe the FDA authorization to regulate drugs and medical devises under the Food, Drug and Cosmetic Act (FDCA) and its amendments
- List materials that are exempt from premarket approval under FDCA
- Describe the types of information required in an INDA and NDA
- Explain the four phases of testing utilized in development of a new prescription drug
UNIT VII - Chemicals / Consumer Products
- Describe the EPA authorization under the Toxic Substances Control Act (TSCA)
- List those materials that are specifically excluded from TSCA regulation
- List information that must be contained in a PMN
- Describe the "triggers" under which EPA may require new chemical testing
- Describe the procedures and standards for TSCA regulation of existing chemicals
- Explain the function of the Consumer Product Safety Commission
UNIT VIII - Pesticides
- Describe the EPA authorization under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and amendments
- List information that is required to register a pesticide
- Explain the difference between suspension and cancellation orders and describe the role of scientific advisory committees in these processes
- Discuss the rationale for exclusion of exported US pesticides from FIFRA coverage
- Describe the EPA authorization under the Food Quality Protection Act (FQPA)
- Explain how FQPA changed the safety requirements to register a pesticide
UNIT IX - Occupational Safety and Health
- Describe the OSHA authorization under the Occupational Safety and Health Act.
- Explain the difference between an OSHA Standard and a TLV
- Describe the process used by ACGIH to establish TLVs and STELs
- Explain the difference between air monitoring and biological monitoring to control workplace exposure
- Know how to convert air concentrations from ppm to mg/m3 and when to use these concentration units
UNIT X - Air and Water Pollution
- Name the four categories of Clean Air Act (CAA) regulatory programs
- Name the six pollutants covered by the National Ambient Air Quality Standards (NAAQS) Program
- Describe the EPA authorization under the Safe Drinking Water Act (SDWA) and amendments
- Describe how MCLGs are set for noncarcinogens and for carcinogens
- Describe the role that costs play, versus health and risk reduction benefits, in the establishment of an MCL
- Identify the research to be conducted to identify groups within the general population that may be at greater risk to adverse health effects from exposure to contaminants in drinking water.
- State the objectives and goals of the Clean Water Act (CWA) and the purpose of the NPDES permit program
UNIT XI - Hazardous Waste
- Describe the goals and objectives of The Resource Conservation and Recovery Act (RCRA) and amendments
- Define "hazardous waste" under RCRA and each of the four characteristics that these materials may exhibit
- Explain the RCRA "mixture rule" and how it is applied
- Describe the most important provisions of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) and the SARA amendments
- Define "hazardous substance' under CERCLA
- List the criteria used by the EPA to develop the NPL
- Describe the major events in the remedial action process of a site after NPL listing
- Discuss the issues/factors involved in determining the appropriate level of site cleanup
UNIT XII - Emergency Response / Right-to-Know
- Identify and explain the various emergency response exposure levels
- Describe the purpose of the NJ Worker and Community Right-to-Know Act
- Describe labeling requirements for containers containing chemicals
- List the characteristics of a chemical hazard
- Describe the relationship between the MSDS and hazardous substance information
- Compare and contrast the MSDS and Hazardous Substance Fact Sheet for a chemical
Organ System Toxicity
Classroom instruction in organ and physiologic system dysfunction following exposure to toxic agents with emphasis on diagnostic techniques. Selected topics include: genotoxicity; carcinogenicity; teratology, toxicity of the central nervous; reproductive, respiratory and hematological systems; hepatic, renal, dermal and ocular toxicity.
Course Objctives
- Define terminology used
- Review the normal physiology and anatomy of the target organ or system
- Describe clinical, functional, biochemical or morphological changes, which occur in the target organ or system following exposure to representative toxic agents
- Identify factors characteristic of the organ or system, which modify the outcome following exposure to toxic agents, e.g., genetic predisposition, biochemical repair mechanisms, metabolizing capabilities, etc
Learning Objectives
UNIT I - Genetic Toxicity
- Describe the method of transmission of genetic information
- Define the terms mutagenesis, clastogenesis, and aneuploidization
- Describe three tests used to determine gene (or chromosome) mutation
- Describe three factors, which modify expression of gene (or chromosome) information following mutation
UNIT II - Carcinogenicity
- Describe four types of biological responses accepted as indications of carcinogenicity
- Explain the difference between genotoxic and epigenetic carcinogens
- Explain the difference between a primary carcinogen, co-carcinogen and promoter
- Describe the role of metabolism and DNA repair processes in modifying the effectiveness of a carcinogen
- Describe tests used to determine the carcinogenicity of chemicals
UNIT III - Reproductive Toxicity
- Describe functional barriers that alter the penetration of toxicants into testis or ovaries
- Describe the capacity of spermatogenic and oogenic cells to metabolize toxic compounds and to repair DNA damage
- Describe three tests used to assess male (female) reproductive damage
- Describe the protocol of a multigeneration study and explain the value of information gained by such a study
UNIT IV - Renal Toxicity
- Explain why renal function renders the kidney particularly sensitive to chemical toxicity
- Describe the consequences of chemical damage to each of the following: glomerulus, distal and proximal tubules, and loop of Henle
- Describe three ways by which the kidney can compensate for toxic damage
UNIT V - Developmental Toxicology
- Define congenital defect
- Describe the developmental sequence of embryonic and fetal growth
- Explain how timing of exposure affects observed teratogenic effects
- Describe three examples of how an agent can produce teratogenic effects by either direct or indirect mechanisms
- Describe guidelines for teratogenicity testing in animals
- Explain limitations in extrapolating results of teratogenicity studies in animals to human exposures
UNIT VI - Neurotoxicity
- List three anatomic features of the CNS, which contribute to its functional barrier against toxicants
- Describe the factors, which account for regional variation in response of the CNS to toxicants
- Discuss the role of CNS structural redundancy in its adaptability to the expression of toxicity
- Describe tests to measure sensory, motor, and integrative toxicities
- List four anatomic sites of a neuron, which can be damaged by toxins
UNIT VII - Hepatotoxicity
- List three types of intracellular injuries produced by hepatotoxins and describe the biochemical / functional consequences
- List three factors which alter the outcome following exposure to hepatotoxic agents
- Describe tests to measure hepatotoxicity
UNIT VIII - Respiratory System Toxicity
- Describe factors, which determine the regional distribution of toxic effects in the respiratory tract
- Describe the affect of anatomy and particle size on the respiratory deposition of aerosols
- Explain what role diffusion plays in the uptake of toxicants by the lungs
- Describe tests to measure sensory, motor, and integrative toxicities
- Describe tests to measure respiratory system toxicity
IX - Dermal / Ocular Toxicity
- Explain the difference between tests for dermal irritation and dermal sensitization
- Describe the pathologic changes, which are monitored to indicate irritation to the skin or eye
- Describe the animal tests commonly utilized to detect skin and eye irritation caused by chemicals
UNIT X - Hematologic Toxicity
- Describe three tests, which are used to determine toxicity to the bone marrow
- Explain how changes in formation and degradation of blood cells can impact hematologic parameters
- For each of the formed elements of blood (excluding lymphocytes) describe a qualitative or functional change which is indicative of exposure to hematopoietic toxins
UNIT XI - Immunotoxicity
- Explain the outcome of deficiencies in the humoral or cellular components of the immune system produced by toxin exposure
- Describe one in vitro and two in vivo tests of toxicity to a) humoral, and b) cell-mediated components of the immune system
Principles of Pharmacology for Toxicologists
Lecture (43 hours) and laboratory (50 hours) course introducing fundamental pharmacologic principles applied to toxicology including receptor concept, dose-response relationship, fate of chemicals in the body, kinetics, factors influencing toxic response, and methods of toxicity testing. At the completion of this course, the student will be able to analyze the relationship between toxic chemical exposure and biological effects using basic principles and concepts. A team of faculty members presents lectures for this course. Only topics covered by Dr. Davis are shown below
Course Objectives
- Identify the basic principles that govern the relationship between toxic chemical exposure and biological effects produced
- Explain the occurrence of unexpected relationships in terms of altered chemical properties or biological mechanisms
- Perform selected toxicity tests and collect data
- Analyze and interpret experimental data using basic principles
Labratory Exercises:
- Introduction to Animal Handling, Injection Techniques, Collection of Specimens
- Establishing a Dose-Response Curve
- Metabolic Enzyme Induction/Inhibition
- Plasma Kinetics
- Skin Sensitization
- Reproduction/Teratology
Lecture Learning Objectives:
UNIT III - Factors Affecting Absorption, Distribution and Excretion
- List the major routes of chemical exposure / administration
- Discuss factors that affect the degree of chemical absorption
- Explain the transfer of chemicals into the major body compartments based on chemical and physical principles
- Describe the effect that binding to body components has on chemical distribution
- Describe the factors that influence the route of excretion of chemicals
UNIT V - Pharmacokinetics
- Explain how absorption, distribution, metabolism and excretion processes affect the time course of chemical in the body
- Explain how the time course of a chemical in the body relates to the expression of chemical action
- Discuss why plasma is used to monitor concentrations of chemicals in the body
- Explain one- and two-compartment kinetic models and draw a graphic representation of each
- Define half-life and determine half-life from graphical information
- Define volume of distribution and determine from graphical information
- Discuss the effect of multiple chemical exposure on time course of chemical in the body
UNIT VII - Allergic Sensitization
- Explain the difference between sensitization and hypersensitivity reactions
- Describe the immune mechanism responsible for sensitization reactions
- List the four types of possible allergic responses
- Explain the time course of occurrence of sensitization type reactions
- List some common manifestations of sensitization type reactions
UNIT IX - General Toxicity Testing
- Describe the role of the EPA and FDA in the regulation of toxicity testing
- List four objectives of toxicity testing
- Discuss the factors involved in selection of species and numbers of animals used in testing
- Discuss the rationale for the choice of a particular route of chemical administration
- Describe the procedures utilized to establish the dosage range in acute toxicity testing
- List the types of effects that may be observed or elicited during acute toxicity studies
- Explain why prolonged and chronic testing studies are performed
- Describe the basis of selected laboratory procedures utilized during prolonged toxicity testing
- Explain the purpose of pathological examination in toxicity testing
UNIT X - Special Toxicity Tests
- List the types of special toxicity tests
- Discuss the rationale for selection of individual tests based on general test results
UNIT XI - Good Laboratory Practice
- Describe what types of studies must comply with Good Laboratory Practice (GLP) Regulations
- List the responsibilities of various laboratory personnel in conducting a GLP study
- Explain the documentation requirements for data obtained under a GLP study
Research in Toxicology I
Independent study in toxicology under faculty supervision. Includes instruction in experimental design and methodologies and techniques of literature review and submission of a written proposal. The student will develop and refine organizational, problem solving and critical thinking skills through supervised, independent study of a toxicology research topic of appropriate scope culminating in the preparation of a written research proposal. Content of individual student experiences will vary depending on the interest of the supervising faculty member and project selected.
Course Objectives
Under faculty supervision the student will:
- Define concisely and realistically what the selected research project intends to accomplish and/or what hypothesis is to be tested
- Conduct a systematic review of the research literature (published and unpublished) to establish a background of information on the topic
- Critically evaluate existing knowledge on the topic
- Identify an experimental approach, including statistical procedures, which will be utilized to conduct the project
- Prepare a written proposal for the research project including the aim, background, experimental design/methods, references and schedule of proposed activities to be implemented during seven weeks in RESEARCH IN TOXICOLOGY II
Research in Toxicology II
According to the written proposal developed in RESEARCH IN TOXICOLOGY I, the student will develop and refine organizational, problem solving and critical thinking skills by completing a supervised, independent study of a toxicology research topic. Research will be conducted, data will be analyzed and a written report will be prepared. Content of individual student experiences will vary depending on the interest of the supervising faculty member and project selected.
Course Objectives
Under faculty supervision the student will:
- Establish and maintain effective communication with faculty sponsor and laboratory personnel
- Organize activities in a timely, systematic and efficient manner
- Conduct experimental procedures according to established protocols and applicable regulations
- Develop an appropriate level of proficiency with techniques utilized
- Demonstrate initiative in anticipating and/or solving problems
- Maintain an up-to-date laboratory notebook according to Good Laboratory Practice regulations and facility procedures
- Critically evaluate the accuracy and precision of results obtained (as applicable)
- Analyze data according to appropriate statistical methods
- Prepare a written report including specific aim, background, experimental design/methods, results obtained, discussion/conclusion and reference sections and which accurately and concisely reflects the research activities conducted
UMDNJ - SHRP Baccalaureate Program in Toxicology
The University of Medicine and Dentistry of New Jersey (UMDNJ) - School of Health Related Professions (SHRP) Toxicology Program is one of a handful in the nation and the first in New Jersey that provides baccalaureate level education in toxicology. The Program combines pre-professional and professional training to provide a strong foundation in the basic and biomedical sciences, as well as a well-rounded general education.
The Program is affiliated with the following academic institutions in New Jersey, which provide the pre-professional education phase of the Program:
- Bloomfield College
- College of St. Elizabeth
- Fairleigh Dickinson University
- Felician College
- Jersey City State College
- Monmouth University
- Ramapo College of New Jersey
- Rutgers University
- Saint Peters College
These institutions offer a wide variety of academic environments from which students complete at least 90 semester hours of pre-professional education, including required basic science courses in Cell Biology, Anatomy and Physiology, General Chemistry, Organic Chemistry, Analytical Chemistry, Biochemistry, Physics, Calculus, and Statistics.
The professional phase of the Program is completed at UMDNJ - SHRP. As New Jerseys' primary provider of health profession education, research and service, UMDNJ is uniquely qualified to offer this training. Conveniently located on the UMDNJ Newark campus are the faculty, research and clinical resources of SHRP, New Jersey Medical School, New Jersey Dental School, Graduate School of Biomedical Sciences, University Hospital, and George Smith Health Sciences Library.
The professional curriculum of 37 semester hours commences in June and runs for fifteen months. It incorporates on and off campus internship experiences, which compliment classroom instruction in toxicology. Students receive hands-on training using up-to-date equipment and the latest techniques at clinical, forensic and industrial toxicology laboratories and conduct supervised research projects. Emphasis is placed on development of critical thinking, communication skills, and informed, independent judgment. Students who complete the Program are awarded a baccalaureate degree (B.S. in Clinical Laboratory Sciences, toxicology major) jointly by UMDNJ and their affiliated academic institution. This approach provides graduates with maximum future growth potential and flexibility in employment opportunities.
A brief description of the major UMDNJ - SHRP professional courses follows, in the general order in which they are completed:
- Toxic Agents Instruction in the major classes of toxic agents, emphasizing the role of chemical and/or physical properties in producing characteristic toxicity and factors that modify toxicity (3 credits)
- Organ System Toxicity Instruction in organ and physiologic system dysfunction following exposure to toxic agents with emphasis on diagnostic techniques (3 credits)
- Principles of Pharmacology for the Toxicologist Instruction and laboratory in fundamental principles of toxicology including receptor theory, dose-response relationship, fate of chemicals in the body, kinetics and factors influencing toxic responses. Emphasis on design and interpretation of toxicity tests with conduct and analysis of selected tests (4 credits)
- Pathology for Toxicologists Instruction in the basic concepts of disease mechanisms particularly as they relate to injury from toxic agents. Emphasis on gross and microscopic examination of tissue samples from mammalian species commonly used in toxicological studies (4 credits)
- Clinical Toxicology Instruction and laboratory in the application of analytical methods for the identification and quantitation of drugs and exogenous chemicals in human body tissues and fluids (3 credits)
- Forensic Toxicology Instruction in the medico-legal aspects of drug and exogenous chemical involvement in human fatalities (1 credit)
- Clinical Toxicology Internship Directed experiential learning in a clinical toxicology laboratory including specimen handling and analysis, reporting and documentation requirements, and quality control (3 credits)
- Forensic Toxicology Internship Directed experiential learning in analytical techniques to identify exogenous chemicals in selected forensic specimens, including procedures for sample collection, handling, documentation and data reporting. Chain of evidence and correlation of analytical results with autopsy findings are presented in a case study approach (1 credit)
- Regulatory Toxicology Instruction in federal, state and local governmental programs for controlling exposure to toxic chemicals. Identification of legislation and agencies regulating foods, drugs, cosmetics, pesticides, industrial chemicals, air and water pollutants and hazardous wastes. The use of toxicology data by regulators in safety evaluation and risk assessment and the impact of regulatory requirements on toxicology studies are discussed. Strategies for computerized information access are presented (3 credits)
- Research in Toxicology I and II Independent study in toxicology under faculty supervision. Instruction in literature review techniques, experimental design, data interpretation and reporting. Development of a written research proposal, followed by conduct of the proposed research project (6 credits)
- Toxicology Seminar Student presentation and discussion of current articles in the toxicology literature as well as results of student research projects. Practice in oral, written and poster presentations (2 credits)
- Industrial Internship Instruction, demonstration and practice in the application of testing procedures or hazard evaluation methods to determine the safety of industrial products. A variety of techniques and responsibilities are covered including animal testing, pathology assessment, data processing and compliance with federal regulation. Student interest and Sponsor facility function determine individual internship content (4 credits)
