Transcript Regulations, Policies, and Principles Governing the Care

Regulations, Policies, and Principles
Governing the Care and Use of
Laboratory Animals
Animal Welfare Act
• Passed in 1966
• 1st law that protected non-farm animals in the
U.S.
• Originally known as the Laboratory Animal
Welfare Act
Animal Welfare Act
• Amended in
– 1970, 1976, 1985, 1990, 2002, 2007, and 2008
• Requirements set forth under Regulations and
Standards in the Code of Federal Regulations
– Title 9, Chapter 1, Subchapter A – Animal Welfare
• USDA issues Animal Care Policies to clarify
intent
Animal Welfare Act
• Responsibility for administration and
enforcement delegated to the USDA’s Animal
and Plant Health Inspection Service (APHIS),
Animal Care
• USDA performs unannounced inspections at
least once a year
Animal Welfare Act
• Regulations apply to
– Animal research facilities
– Animal dealers and exhibitors
– Operators of animal auction sales
– Carriers and transporters of animals
• Retail pet stores are exempt
Animal Welfare Act
• Regulations describe
– Humane handling
– Care
– Identification
– Recordkeeping
– Treatment
– Transportation
Animal Welfare Act
• Mandatory minimal care standards were
developed for dogs, cats, guinea pigs, hamsters,
rabbits, nonhuman primates, and marine
mammals
• Standards include
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Feeding and watering
Sanitation
Lighting and ventilation
Shelter from extremes of weather
Separation of species
Adequate veterinary care
Animal Welfare Act
• Species regulated
– Dogs
– Cats
– Nonhuman primates
– Guinea pigs
– Hamsters
– Rabbits
– Other warm-blooded animals designated by the
Secretary of Agriculture
Animal Welfare Act
• Not covered by regulations
– Birds, mice, and rats specifically bred for research,
teaching, or testing
– Horses not used for research purposes
– Farm animals intended for use in improving
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Animal nutrition
Breeding
Management or production efficiency
Quality of food or fiber
Animal Welfare Act
• Original Act
– Known as the Laboratory Animal Welfare Act
– Protect owners of dogs and cats from theft of
their pets
– Ensure animals in research facilities were provided
humane care and treatment
– Only applied to animals being held before or after
actual research and testing
– Research facilities were required to register
Animal Welfare Act
• 1970 Amendment
– Given official title AWA
– Broadened coverage of law
– Standards of care extended to apply to animals
throughout their stay in the research facility
– Annual report
• Numbers of animals used or held
• If animals required or received anesthetics, analgesics,
or tranquilizers
Animal Welfare Act
• 1976 Amendment
– Redefined the regulation of animals during
transportation
– Combat the use of animals for fighting
Animal Welfare Act
• 1985 Amendment, Improved Standards for
Laboratory Animals Act
– Chief executive officer of each research facility
must appoint an Institutional Animal Care and Use
Committee (IACUC)
– Mandatory training of all personnel using animals
in research facilities
– Exercise standards for dogs
– Psychological well-being for nonhuman primates
– Established Animal Welfare Information Center
IACUC
• Must consist of 3 members
– DVM with experience in lab animal medicine
– One member who is not affiliated with the institution
(public member)
• Inspects all animal facilities and study areas once
every 6 months
• Reviews and approves all proposed activities
(protocols)
• Investigates concerns involving care and use of
research animals
IACUC
• Protocol must provide
– Species and approximate number of animals to be
used
– Rational and appropriateness of species/numbers
– Detailed description of animal use
– Description of procedures and drugs used to
assure that discomfort and pain will be limited
– Euthanasia method
IACUC
• DVM must be consulted when planning any procedure that
could cause pain to animals
• If procedure could cause pain, a written description is
required of methods and sources used to determine that
alternatives are not available
• Principal investigator must assure the work does not
unnecessarily duplicate previous experiments
• Survival surgery must be performed using aseptic
techniques
Animal Welfare Act
• 1990 Amendment, Protection of Pets
– Mandated that pounds and shelters hold a dog or
cat for a minimum period of 5 days before
euthanizing or releasing the animal
Animal Welfare Act
• 2002 Amendment, Farm Security and Rural
Investment Act
– Changed the definition of “animal”
• Specifically excluding birds, rats of the genus Rattus,
and mice of the genus Mus bred for research
– Addresses animal fighting
Animal Welfare Act
• 2007 Amendment, Animal Fighting Prohibition
Enforcement Act
– Violation punishable by up to 3 years in prison
– Felony to trade, sell or ship equipment used in
animal fighting or to promote an animal fighting
venture
Animal Welfare Act
• 2008 Amendment, Farm Bill
– Strengthens penalties for animal fighting activities
– Limits transport and resale of dogs unless they are
at least 6 months of age
Chimpanzee Health Improvement,
Maintenance and Protection Act
• CHIMP Act of 2000
– Created a sanctuary retirement system for
chimpanzees previously used in medical research
– Only applied to chimpanzees used in studies
supported by federal government
– Chimp Haven in Louisiana selected as sanctuary
Office of Laboratory Animal Welfare
and Public Health Service Policy
• PHS comprised of multiple organizations
including
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National Institutes of Health
Food and Drug Administration
Centers for Disease Control and Prevention
Health Resources and Services Administration
Alcohol, Drug Abuse and Mental Health Administration
Office of Laboratory Animal Welfare
and Public Health Service Policy
• PHS Policy
– Relates to use of animals in research and other
activities that are supported by federal monies
– Extends to all vertebrates not just warm-blooded
– Staff who are engaged in research activities with
PHS funds must receive instruction in responsible
conduct of research
Office of Laboratory Animal Welfare
and Public Health Service Policy
• PHS Policy
– Institutions must submit an assurance to OLAW
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Describing program of animal care
US Government Principles and Guide are followed
Names, position titles, credentials of IACUC members
IACUC must consist of 5 members
– Institutions must establish mechanism to review
animal facilities and procedures
– Accreditation by Association for Assessment and
Accreditation of Laboratory Animal Care is suggested
Good Laboratory Practice Regulations
• Framework for performing product safety
studies
– Food and Drug Administration
– Environmental Protection Agency
• Important components
– Quality assurance
– Adherence to standard operating procedures
– Extensive recordkeeping
Guide for the Care and Use of
Laboratory Animals
• Prepared by Institute of Laboratory Animal
Research for NIH in 1963 and periodically
updated
• Assists institutions caring for and using
animals
• Makes recommendations for humane animal
care and use
Guide for the Care and Use of
Laboratory Animals
• Outlines and references major components of the
animal care and use program
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Institutional policies and responsibilities
Animal environment
Housing
Management
Veterinary medical care
Physical plant
Personnel qualifications and training
Occupational health and safety of personnel
Preventative medicine
Surgery
Guide for the Care and Use of
Laboratory Animals
• Programs must adhere to
– US Government Principles
– PHS Policy
– Other applicable regulations
• Emphasizes use of performance-oriented
standards
– Directs user to achieve a goal
– Does not specify method to reach the goal
Guide for the Care and Use of Agricultural
Animals in Research and Teaching
• Supplements laws, regulations and policies
and the “Guide”
– Animals used in agricultural research or teaching
• Guidelines for husbandry, veterinary care,
facility construction and maintenance
• Not intended to pertain to animals produced
on farms and ranches
Occupational Health and Safety
• Anyone working directly with animals or are in
the vicinity of equipment and facilities are
potentially exposed to hazards
• Hazards
– Physical (lifting, animal bites, needle sticks)
– Biologic (infectious agents)
– Chemical (carcinogens, cleaning chemicals)
– Other (allergens)
Occupational Health and Safety
• Institution must establish and maintain an
occupational health and safety program
• Control and prevention are key to success
– Health questionnaires, physical exams, reporting
– Use of personal protective equipment (PPE)
– Development of standard operating procedures
– Training
Association for Assessment and
Accreditation of Laboratory Animal
Care International (AAALAC)
• Nonprofit organization
• Supported by prestigious member organizations
• Promotes the humane treatment of animals in
science through
– High standards of animal care and use
– Well-being through assessment and accreditation
AAALAC International
• AAALAC accreditation
– Voluntary
– Considered “Gold Standard” of industry
• Institution prepares program description and does selfassessment
• Site visits
– Occur once every 3 years
– Done by council members and consultants
AAALAC International
• Site visit
– Three documents are used in evaluation of animal
care and use program
• Guide for the Care and Use of Laboratory Animals
• Guide for the Care and Use of Agricultural Animals in
Research and Teaching
• European Convention for the Protection of Vertebrate
Animals Used for Experimental and Other Scientific
Purposes
Animal Welfare Information Center
• Part of the National Agricultural Library
• Mandated by 1985 AWA amendment
• Information
– Improved research methods
– Alternatives
– Literature searches
– Employee training
State Regulations
• All 50 states and the District of Columbia have
laws that protect animals
• Most animal laws deal with
– Prevention of cruel treatment
– Provision of food and water
– Provision of shelter and protection from extreme
weather