Laboratory Animal Care and Use

Laboratory Animal Welfare Act (1966)

President Johnson. Momentum from the Life Magazine photo essay depicting stolen pets in poor condition sold to labs for research.

IACUC Protocol Review

Two Methods of Review: 1. Full Committee Review (FCR) 2. Designated Member Review (DMR): All members receive the protocol and determine if it needs full committee review. If not, chairman assigns one or more reviewer. Three Actions of Full Committee Review 1. Approve 2. Require modifications to secure approval 3. Withhold approval

IACUC Review

Types of Review 1. Initial protocol review 2. Annual review 3. Triennial review (de novo) 4. amendments--modifications to original protocol

US Department of Agriculture

Unannounced annual inspections of animal care and use program: review any areas where animals are housed or used and all associated animal protocols and medical records. Annual reports of research facility and use submitted to the USDA. "USDA-covered species" refers to the "animals"as defined by AW

1966 Life Magazine

expose on "concentration camps for dogs"

1965 Sports Illustrated

"The Lost Pets that Stray to the Labs" Describes the disappearance of the infamous Dalmatian, Pepper

PHS Policy Requirements of Program of Animal Care and Use

1. Designation of an institutional official 2. Appointment of an Institutional Animal Care and Use Committee (IACUC) 3. Administrative support for the IACUC 4. Standard IACUC procedures 5. Arrangements for a veterinarian with authority and responsibility for animals 6. Adequate veterinary care 7. Formal or on-the-job training for personnel that care for or use animals 8. An occupational health and safety program for those who have animal contact 9. Maintenance of animal facilities 10. Provisions for animal care

IACUC Review Questions

1. How proposed use of animals benefit human or animal health 2. Experimental design and details of procedures proposed justification of species and numbers (stats) 3. Description of humane endpoints 4. Surgery details, anesthesia and analgesia (survival v. Non-survival; major v. minor surgery; multiple survival surgeries) 5. Use and handling of hazardous or toxic agents 6. Euthanasia methods 7. Housing, restraint, etc

AWR Requirements

1. Investigators to consider alternatives and document this for IACUC to review 2. Investigators to assure the IACUC that proposed use of animals is not unnecessarily duplicative

IACUC Semi-Annual Review

1. Monitor animal facilities and program of animal care and use to determine if they comply with AWA, AWR, and PHS Policy 2. Identify deficiencies, create a plan to correct deficiencies, ensure they are corrected 3. Communicate results to IO, with suggestions for improvements to program or facilities

Primary Roles of the IACUC

1. Review and approve animal use protocols 2. Monitor the animal care and use program by thoroughly reviewing the program and inspecting animal housing and use areas twice a year (semi-annual) 3. Review any animal welfare concerns 4. Suspend animal activities when warranted 5. Report to an institutional official IACUC functions as self-regulating body for animal research

Three Rs

1959 William Russell and Rex Burch Replacement: with non-animal models (or less sentiment) Reduction: of animal numbers Refinement: of technique to reduce pain / distress

USDA Pain Categories

Annual report to the USDA of species / number used in each pain category B: no pain distress (breeders, ordered but not used) C: procedures may cause no more than discomfort or mild and transient pain (behavior observation, injection) D: relieved pain / distress (surgery w/analgesia) E: unrelieved pain / distress (strong justification--intense scrutiny) US Principle IV: procedures that cause pain / distress in humans should be considered to cause pain / distress in animals

Animal Welfare Act (AWA)

Applies to institutions that: 1. Purchases or transports live animals in commerce 2. Receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments.

PHS Policy

Applies to those receiving PHS funds and covers all live vertebrates; overseen by the Office of Laboratory Welfare (OLAW)

IACUC Composition

Chair Veterinarian (with program responsibility and authority; also known as attending veterinarian) Practicing Scientist (experience in animal research) Non-scientist Unaffiliated member (community member)

Animal Welfare Act

Covers all warm blooded animals used for, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet.

Office of Laboratory Animal Welfare (OLAW)

Established to administer the PHS Policy Prior to accepting any PHS awarded funds the institution must have an Animal Welfare Assurance on file with OLAW: 1. Comply with PHS Policy, the Guide, and the Animal Welfare Act 2. Describe the animal program 3. Appoint an institutional official

USDA-Covered Species

Hamsters, guinea pigs, sheep, canines, pigs, rabbits, ferrets, non-human primates

Public Health Service Policy on Humane Care and Use of Laboratory Animals

Health Research Extension Act of 1985 instructed PHS to establish guidelines for animal research. Requires institutions receiving funds PHS provide acceptable standards of care for animals used in research. Incorporates the US Government Principles and requires institutions base their program of animal care and use on the guide. Animals are defined to include all live, vertebrate animals used in research, teaching, or testing.

Laboratory Animal Welfare Act (1966)

Minimum standards during the transport, handling and sales of "animals" and licensing and records requirements for dog and cat dealers and laboratories. Amended to include: 1. Establishment of the IACUC 2. Exercise for dogs and physiological well-being of NHPs 3. Requirements to minimize pain/distress and search for alternatives

IACUC Meetings

Required to meet at least two times per year

The Guide for the Care and Use of Laboratory Animals (8th edition)

PHS Policy --animal care and use program must be based on Guide standards Chapters of The Guide: Animal care and use program Environment, housing and management Veterinary care Physical plant

Animals Excluded from Animal Welfare Act

Birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency,or for improving the quality of food or fiber.

Animal Welfare Act

Federal law overseen by the US Dept. Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) [excluding birds, rats, and mice bred for research]

Safety in Animal and Lab Research

Regulated Waste: biohazards/infectious waste 1. Human and non-human primate blood, body fluid, tissues 2. Microbiological and pathological waste 3. Items contaminated with above 4. OPIM (Other potentially infectious materials) Lab/Institution responsibilities 1. Determine the existence of biohazard waste 2. Correct treatment and disposal of biohazard waste 3. Correct packaging and labeling to avoid exposure Special Considerations: Sharps (needles, scalpels, dissection pins) Regulated federally by Occupational Safety and Health Administration (OSHA)'s Bloodborne Pathogen Standards and by state regulations