Lab Animal; Regulations and Guidelines

To provide ethical standards for animal research

• All warm blooded vertebrates except birds, purpose bred mice or rats, or animals used for food or fiber.
• Also covers horses and farm animals used in biomedical research

United States Department of Agriculture

Animal Plant and Health Inspection Service - Veterinary Medical Officer (APHIS - VMO)

• Registration with USDA 
• Inspections by Animal Plant and Health Inspection Service - Veterinary Medical Officer (APHIS - VMO)   
• The Guide for the Care and Use of Laboratory Animals
• AVMA Guidelines for Euthanasia 
• Institutional animal care and use committee (IACUC)

American Veterinary Medical Association (AVMA)

Composed of veterinarian responsible for animal program, scientists that use animals & community member with no ties to institution other than being IACUC member. Requires minimum of 3 people.

• Personnel qualifications 
• Veterinary care
• Recordkeeping
• Annual Report submitted to USDA
• Access for inspector
• Individual identification of dogs & cats/Small animals can be ID'd in groups

• Housing and care requirements for each warm-blooded vertebrate species
• Transportation requirements 
• Special provisions for exercise of doqs and (psychological) enrichment of monkeys

To provide ethical standards of care

Animal Welfare Act for ALL

• All warm blooded vertebrates
• Agricultural animals for biomedical research 
• Cold blooded vertebrates like birds, fish
• Purpose bred mice and rats
• Agriculture animals used for food, fiber or agricultural research
• Invertebrates

Office of Laboratory Animal Welfare (OLAW)

Animal Welfare Assurance Statement

• Describes the lines of authority 
• Defines role, responsibilities, and composition of the IACUC
• Assures compliance with National Institute of Health (NIH) standards
• Records and reporting requirements
• Training requirements

• National Institute of Health (NIH) Office of Laboratory Animal Welfare (OLAW)
• Institutional Animal Care and Use Committee (IACUC)
• NIH funding can be taken away

• OLAW enforcement 
• Submit Animal Welfare Assurance Statement  
• IACUC compliance 
• Follow The Guide for the Care and Use of Laboratory Animals 
• Follow AVMA Guidelines on Euthanasia
• Follow the nine US Government Principles for the Utilization and Care of Vertebrate Animals, Used in Testing, Research and Training

Anyone receiving federal money for research using vertebrate animals

• I - Laws, Policies, Guidelines - Must follow the AWA guidelines for transportation, care and use of animals & other applicable laws, guidelines and policies
• II - Justification - Research must justify the purpose, model system is best to answer scientific question, and the research methods will provide valid results.
• III - Species Selection and Quantity - Animal selected must be appropriate species and use minimum number to obtain valid results
• IV - Proper Use of Animals - utilize methods that avoid or minimize discomfort, distress and pain
• V - Painful Procedures - should be performed with appropriate sedation, analgesia and/or anesthesia
• VI - Unrelieved Pain or Distress - if can't be relieved should be euthanized at end or during procedure
• VII - Environment and Well-being - provide appropriate living conditions for species
• VIII - Personnel - qualified and trained 
• IX - Exceptions - require IACUC review

To provide guidelines for the ethical care and use for animals in research.

All live vertebrate animals

• Institutional responsibilities
• Professional standards for Environment, Animal husbandry and Animal facilities (includes temperature, humidity, air exchange etc)

• Acceptable  Ex CO₂, barbituates, captive bolt
• Conditional acceptable (must be justified by IACUC) Ex: cervical dislocation w/o anes
• Unacceptable - Ex potassium chloride w/o anes

• 1. Review and approval of protocols
• 2. Assess program and facilities semi-annually
• 3. Review of concerns regarding the care and use of animals
• 4. Authority to suspend activities

• Voluntary peer review group accreditation
• Federal policies and laws
• Site facility review with 1) accreditation 2) provisional accreditation 3) accreditation withdrawn. Every 3 years must have another site review.

• Pharmacy and Biochemical Research
• Non-clinical Research trials

• Purpose - More stringent guidelines than clinical research. To provide consistency, reproducibility and reliability. 
• Standards - According to Food and Drug Administration (FDA) & Environmental Protection Agency (EPA) standards