Chapter 2: Animal Research Environment
PHS
Who does IO submit their reports to?
Animal Welfare Act (AWA)
Requires that minimum standards of care and treatment be provided for covered animals bred for commercial sale, used in research, transported commercially or exhibited to the public.
All vertebrates, including rats, mice, and birds, farm animals, wildlife, and aquatic animals.
What animals are covered under The US Government Principles?
Replacement, Reduction, Refinement
What are the 3 R's?
Refinement
refine a procedure to reduce pain and distress or to minimize the number of potentially painful procedures animals undergo.
Standard Operating Procedures (SOPs)
Written instructions approved by management and used to perform a routine activity.
OLAW
What agency oversees The PHS & US Government Principles policy?
Warm-blooded animals (live or dead) Except: birds, rats and mice bred for research and agricultural animals used for food or fiber
What animals are covered under The AWA and AWR?
APHIS (Animal and Plant Health Inspection Service)
conduct an unannounced semi-annual inspection and issues a public report for which any violation must be corrected.
Replacement
consider non-animal alternatives and substitue lower forms of vertebrate or an invertebrate model whenever possible.
Bioetchics
social and moral issues concerning work with live animals for research and the applications of that research.
The US Government Principles
Presents overreaching principles for the humane care of animals in these activities and in the relevance of animal use to the good of society. Covers humane transportation, minimization of discomfort, appropriate husbandry, and methods of Euthanasia.
1) Train personell and keep training on file 2) Establish Quality Assurance (QA) unite solely to monitor compliance 3) Write SOP's for all husbandry and scientific procedures
What 3 things do you need to meet EPA GLP regulations?
Animal and Plant Inspection Service (APHIS) & USDA
What agencies oversee The AWA and AWR?
ALL live vertebrates (including birds, rats, and mice)
What animals are covered under PHS?
USDA
Can stop the research if violations are not corrected in a timely manner.
Good Laboratory Practices (GLP)
validate and document the process by which safety tests are conducted in such a way that the process can be reconstructed if needed.
Procedural SOPs
Address procedures specific to each study (ex: mouse breeding SOP, Blood collection SOP)
Institutional SOPs
Describe "the way things are done here" (ex: general housekeeping & husbandry chores)
The Guide
Document to assist institutions in caring for and using animals in research.
IACUC
Ensures animal care facilities confirm to AWR and that all research programs are in compliance with all applicable laws, regulations, policies and guidelines. Oversees and evaluates animal care & use programs.
The Guide
Provides guidelines and standards for a variety of areas in animal research.
Animal Welfare Regulations (AWR)
Published each year in the code of federal regulations and define the roles of different individuals in the animal facility.
Public Health Service Policy (PHS)
Requires all federal grant recipients to comply with US Government principles, the AWA, and The Guide. It also requires that institutes have an IACUC and Occupational Health and Safety Program.
Office of Laboratory Animal Welfare (OLAW)
Responsible for the general administration and coordination of PHS policy.
1) Appropriate transportation & husbandry 2) Design & performance of procedures on the basis of relevance to human/animal health, advancement of knowledge, or good of society 3) Use of appropriate species, quality and number 4) Avoid or minimize distress, discomfort and pain 5) Use of appropriate sedation, analgesia and anesthesia 6) Establishment of humane endpoints 7) Adequate vet care & appropriate living conditions 8) Close supervision of qualifies & experienced personnel 9) Consideration of alternatives to reduce or replace animals
What are "The Guides" guidelines?
1) The Guide for the Care and Use of Laboratory Animals 2) Animal Welfare Act and Animal Welfare Regulations 3) Public Health Service Policy on Humane Care and Use of Laboratory Animals 4) U.S Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training 5) American Veterinary Medical Association Guidelines for the Euthanasia of Animals
What are the 5 most important regulations and guidelines?
1) The Animal Welfare Act & Animal Welfare Regulation 2) The Institutional Animal Care & Use Committee 3) The Public Health Science Policy (PHS) 4) The US Government Principles 5) The Good Laboratory Practices (GLP) 6) Standard Operating Procedures (SOP)
What are the 6 federal regulations?
The Guide; in 1963
What did The Animal Care Panel (later became AALAS) publish and when?
1) Pesticides 2) Toxic substances
What do EPA GLP's include?
1) Drug testing 2) Food coloring additives 3) medical devices or biologics
What do FDA GLP's include?
1) Personnel qualifications 2) Occupational Health and Safety 3) Animal environment, housing & management 4) Veterinary care 5) Animal procurement & transportation 6) Surgical & Postsurgical Care 7) Alleviation of pain/distress 8) Euthanasia 9) Physical plant design & construction
What does The Guide describe standards for?
Anti-cruelty laws extended to include human treatment of lab animals.
What happened in the 20th century?
19th century; for the "more effectual prevention of animal cruelty
When did NY pass a law and what for?
1873; directed at meat packing industry
When was the 1st federal law passed to protect from animal cruelty and who was it directed at?
1641; in Massachusetts
When was the earliest law passed to protect from cruelty in the U.S?
The Institutional Official (IO)
Who does The IACUC report to?
1) 1 Chair person 2) 2 Other Members: 1 public member & 1 scientist
Who makes up The IACUC?
Animal and non-animal research and safety studies that are funded by the FDA and EPA.
Who or what does the GLP apply to?
National Research Council (NRC) & Institute of Laboratory Animal Research (ILAR)
Who oversees "The Guide"
AWA
Who provides more specific standards, The AWA or AWR?
AAALAC International
a private, non-profit organization that promotes the humane treatment of lab animals and accredits lab animal research programs. Committee evaluates how well guidelines are followed.
euthanasia
act of humanely killing animals by methods that induce rapid unconsciousness and death without pain or distress.
Reduction
only minimum number of animals needed to obtain valid information