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 Retail pet stores are exempt 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 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 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 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 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 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 Site visits Voluntary Considered “Gold Standard” of industry Institution prepares program description and does self-assessment 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