Animal Science 101 Study Notes

Course Rules and Information

  • Instructor: Dr. Beltaire, DVM, DACT
  • Course Title: Animal Science 101 (AnSci 101)
  • University: UMass
  • Policy on Course Materials:
    • Students are prohibited from posting, publishing, or selling course materials (e.g., PowerPoint notes, review sheets, exam questions).
    • Violations considered against university policies and federal copyright laws.
  • Exam Date: Exam #2 scheduled for Tuesday, 10/21, from 10:00 AM to 11:15 AM in Bartlett 65.
  • Materials to Bring: Bring a #2 pencil and your Spire ID.

Ethical Considerations of Animal Research

Why Use Animals for Research & Education?

  • Questions addressed:
    • Applicability of results from animal models to humans.
    • Availability of alternatives to animal research.
  • Topics discussed include:
    • Knowledge gained from animal research.
    • Protection measures for laboratory animals in research and education.

Case Studies and Historical Context

Notable Incidents Leading to Regulation

  • 1937: A Tennessee drug company marketed a sulfa drug containing ethylene glycol, leading to 71 adult and 34 child fatalities.
  • 1933: p-phenylenediamine caused severe reactions in humans, including skin issues and death.
    • Regulatory Response:
    • 1906: Pure Food and Drugs Act established to regulate food, drink, and drugs in interstate commerce to prevent misbranding and adulteration.
    • 1938: Federal Food, Drug, and Cosmetic Act further regulated food and drug safety, including requiring pre-market animal testing.
    • The FDA was formed to protect public health via the oversight of drugs, food, and cosmetics.

Animal Research Purposes

  • Understanding Biological Functions:
    • Whole-body system interactions, biology of diseases, testing diagnostics and treatments.
  • Training:
    • Training clinicians and scientists (e.g., MD, DVM).

Safety Testing Methods

Types of Tests Conducted

  • Eye and Skin Irritation Tests (Draize Test):

    • Aimed to predict toxicity through single exposure.

  • Acute Toxicity Tests:

    • Determine the lethal dose where 50% of test animals die (LD50_{50}).

  • Chronic Toxicity Tests:

    • Assess long-term exposure effects (up to 1 year and beyond).

  • Carcinogenicity Tests:

    • Long-term exposure to identify potential human carcinogens.

  • Developmental & Reproductive Toxicity Tests:

    • Evaluate potential infertility, miscarriage, and birth defect risks.

  • Mutagenicity Tests:

    • Assess genetic material changes in cells.

Clinical Trial Phases

  • Phase 0: First-in-man early trial assessing target engagement.
  • Phase I: Initial safety evaluations, dosage ranges, and side effects in a small volunteer population (10-15).
  • Phase II: Efficacy exploration while maintaining safety.
  • Phase III: Final confirmation of safety and efficacy in larger populations (1,000-3,000 subjects).
  • Phase IV: Post-marketing studies exploring alternative uses of the drug.

Animal Research Contributions

Benefits Derived from Animal Research

For Humans:
  1. Vaccines
  2. Antibiotics
  3. Anesthetics & Analgesics
  4. Chemotherapy
  5. Organ Transplants
  6. Surgical Procedures
  7. Insulin for Diabetics
  8. High Blood Pressure Medications
  9. Cataract Surgery
  10. Allergy Treatments
  11. Arthritis Treatments
  12. MS & MD Treatments
  13. Dental Treatments
  14. Joint Replacements
For Animals:
  1. Vaccines
  2. Antibiotics
  3. Anesthetics & Analgesics
  4. Chemotherapy
  5. Organ Transplants
  6. Surgical Procedures
  7. Parasite Treatments
  8. Artificial Insemination
  9. Embryo Transfer
  10. Improved Pet Nutrition
  11. Treatments for Pet Heart Disease
  12. Joint Replacements for Hip Dysplasia
  13. Genetic Research for Purebred Diseases

Legislative Framework for Animal Welfare

Animal Welfare Act (AWA)

  • Introduced: 1966, with multiple amendments.
  • Scope: Covers treatment of certain warm-blooded animals in various settings (research, breeding, etc.).
    • Exclusions include:
    • Rats, mice, birds bred for research
    • Farm animals in production
    • Horses in non-research settings
    • Cold-blooded species
    • Invertebrates
  • Enforcement: Governed by the USDA - Animal and Plant Health Inspection Service (APHIS).
  • Annual Reporting: Research facilities must report animal use statistics by December 1st to ensure compliance.

Animal Use Statistics (FY 2024)

  • Reported Animals and Categories:
    • Class B: Not used in research
    • Class C: Used, no pain involved
    • Class D: Used, pain minimized with drugs
    • Class E: Used, pain not minimized
  • Statistical Data: Detailed breakdown of species used, including guinea pigs, rabbits, and non-human primates.

Health Research Extension Act (HREA) of 1985

  • Mandates humane treatment of vertebrates used in research funded by public health service grants.
  • Institutional Animal Care and Use Committee (IACUC) must oversee facilities receiving federal funding.

Institutional Oversight and Protocols

Overview of IACUC Responsibilities:

  1. Regular facility inspections.
  2. Ensure animals receive proper care.
  3. Review animal use protocols before beginning research.
  4. Submit reports to institutional officials.

Protocol Requirements:

  • Comprehensive documentation about experiments, including:
    • Personnel training, animal species selection, justification for animal number, housing, care, anesthesia, and euthanasia methods.

Choosing an Animal Model

  1. Scientifically accurate and interpretable results.
  2. Review historical data relevance.
  3. Biological hazards to research staff.
  4. Economical acquisition and housing.
  5. Special characteristics suiting planned studies.

Advances in Animal Research Alternatives

Alternatives to Animal Testing

  • FDA Modernization Act 2.0 (Dec 29, 2022): Allows for nonclinical tests and alternatives (e.g., cell-based assays, computer models).
  • Importance of alternatives in research:
    1. Microorganisms
    2. Cell and Tissue Cultures
    3. Mathematical/Computer Models
    4. Organ Chips: Mimic 3D tissue structures.
    5. Microphysiological Systems: Utilize living human organ cells lined within microfluidic channels.

Certification and Professional Standards

American Association for Laboratory Animal Science (AALAS)

  • Sets professional standards and certification for lab animal technicians at three levels:
    1. Assistant Lab Animal Technician (ALAT)
    2. Lab Animal Technician (LAT)
    3. Lab Animal Technologist (LATg)

Certification Requirements

  • ALAT: Varies based on previous experience or degree qualifications.
  • LAT: Similar, requiring three years of experience or relevant degrees.
  • LATg: Requires more extensive experience, usually 5 years or more.

Environmental Enrichment in Laboratory Animal Management

Importance of Environmental Enrichment

  • To improve animal well-being and enhance scientific outcomes:
    • Provides sensory and motor stimulation.
    • Helps in decreasing stress and fighting among cage mates.
    • Promotes better reproductive outcomes and health.
    • Enhances cognitive engagement.
  • Requirements include social housing, proper structures, and enrichment materials.