Historical Perspectives of Research Animal Protection Dr. Susan Wilson-Sanders

Participants in the Process Laboratory Animal Scientists Laboratory Animal Scientists Animal Care Panel Animal Care Panel AALAS AALAS AAALAC AAALAC ILAR ILAR Public Public Animal-centric organizations Animal-centric organizations Health care consumers Health care consumers Research community Research community Government Government Congress Congress USDA USDA HHS: PHS (NIH, FDA) HHS: PHS (NIH, FDA)

Laboratory Animal Scientists: Five “Founding Fathers” Dr. Robert J. Schroeder Dr. Robert J. Schroeder Dr. Nathan R. Brewer Dr. Nathan R. Brewer Dr. Elihu Bond Dr. Elihu Bond Dr. Robert J. Flynn Dr. Robert J. Flynn Dr. Bennet J. Cohen Dr. Bennet J. Cohen

Timeline Continued 1967 Name of the ACP changes to the American Association for laboratory Animal Science (AALAS) 1967 Name of the ACP changes to the American Association for laboratory Animal Science (AALAS)

The Public: Changing Attitudes

Animal-centric organizations

Public’s Involvement 1962Silent Spring, by Rachel Carson 1962Silent Spring, by Rachel Carson 1966LIFE magazine and Sports Ill articles 1966LIFE magazine and Sports Ill articles 1969 Greenpeace founded 1969 Greenpeace founded 1975Animal Liberation, by Peter Singer 1975Animal Liberation, by Peter Singer 1982The “Silver Spring Monkeys” 1982The “Silver Spring Monkeys” 1983University of Pennsylvania head injury studies 1983University of Pennsylvania head injury studies

Sports Illustrated Article

Life Magazine

RESEARCH INVOLVEMENT ACADEMIC FREEDOM

Government Involvement 1962NIH Contract –First Guide 1962NIH Contract –First Guide 1966Laboratory Animal Welfare Act (1970, 1976, 1985, 1990) 1966Laboratory Animal Welfare Act (1970, 1976, 1985, 1990) 1971NIH Policy 1971NIH Policy 1973Public Health Service Policy (1979) 1973Public Health Service Policy (1979) 1985PHS Act (Health Research Extension) 1985PHS Act (Health Research Extension)

1966 Laboratory Animal Welfare Act Housing Housing Feeding Feeding Watering Watering Sanitation Sanitation Shelter Separation of Species Ventilation Adequate Vet Care Preventing theft of dogs and cats Registration limited facilities with dogs/cats Holding areas only Only records of acquisition required Developed 8 areas of minimum standards

1970 Animal Welfare Act LAWA changed to AWA LAWA changed to AWA Extension into the laboratory Extension into the laboratory Report number of animals by pain categories Report number of animals by pain categories Require appropriate use of anesthetics Require appropriate use of anesthetics Included standards for animal transport Included standards for animal transport Include all warm blooded except those excluded by the Sec of Ag Include all warm blooded except those excluded by the Sec of Ag

TRANSPORT

1985 Animal Welfare Act Amendments Establishment of IACUC Establishment of IACUC Assign responsibility to Institutional Official Assign responsibility to Institutional Official Review of protocols Review of protocols Semiannual program review & inspection Semiannual program review & inspection Search for alternatives to painful procedures Search for alternatives to painful procedures Personnel qualifications Personnel qualifications Environmental enrichment for NHPs Environmental enrichment for NHPs Exercise for dogs Exercise for dogs

Animal Welfare Act Applies to any live or dead warm-blooded animal which is being used, or is intended for used for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. Applies to any live or dead warm-blooded animal which is being used, or is intended for used for research, teaching, testing, experimentation, or exhibition purposes, or as a pet.

Definition of Animals Includes: Includes: Wilds mammals used in field research and laboratory research Wilds mammals used in field research and laboratory research Farm mammals used in biomedical research Farm mammals used in biomedical research

Act Applies To: Horseshows (particularly Gaited, prevention of “soreing”. Horseshows (particularly Gaited, prevention of “soreing”. Dog/cat breeders with more than three breeding bitches or queens. Dog/cat breeders with more than three breeding bitches or queens.

Definition Excludes Production farm animals Production farm animals Laboratory rats and mice Laboratory rats and mice Birds, bred for or used in research (new in 2004) Birds, bred for or used in research (new in 2004)

Animal Welfare Act The Act is administered by the U. S. Department of Agriculture. At least once a year, unannounced inspections of all registered facilities are conducted by USDA veterinarians. These inspectors have the authority to review all housing areas, laboratories and offices where animals or records pertaining to animals are kept. The Act is administered by the U. S. Department of Agriculture. At least once a year, unannounced inspections of all registered facilities are conducted by USDA veterinarians. These inspectors have the authority to review all housing areas, laboratories and offices where animals or records pertaining to animals are kept.

Animal Welfare Act Fines and penalties are levied for violating the act Fines and penalties are levied for violating the act

AWA Establishes the Institutional Animal Care and Use Committee (IACUC) as the internal regulatory authority for each Research Facility Establishes the Institutional Animal Care and Use Committee (IACUC) as the internal regulatory authority for each Research Facility

1971 NIH Policy Institution had to have Assurance Institution had to have Assurance AAALAC AAALAC Local Committee Local Committee Annual Inspections Annual Inspections Compliance with AWA Compliance with AWA Follow Guide Follow Guide

1985 PHS Policy Health Research Extension Act Health Research Extension Act More detailed Assurance More detailed Assurance IO ultimately responsible IO ultimately responsible CEO appoints IACUC members CEO appoints IACUC members Minimum of 5 IACUC members: Minimum of 5 IACUC members: DVM program authority DVM program authority Once practicing scientist Once practicing scientist One community member One community member Protocol Review Protocol Review Semiannual reports of program review Semiannual reports of program review Detailed training program description Detailed training program description

Public Health Service Policy The Public Health Service Policy on the Care and Use of Laboratory Animals is a Congressionally mandated Act in the same way the AWA is, but applies only to vertebrate animals used in PHS funded research. Such research includes that performed by the National Institutes of Health (NIH), National Cancer Institute (NCI) and other branches of the PHS. The Public Health Service Policy on the Care and Use of Laboratory Animals is a Congressionally mandated Act in the same way the AWA is, but applies only to vertebrate animals used in PHS funded research. Such research includes that performed by the National Institutes of Health (NIH), National Cancer Institute (NCI) and other branches of the PHS.

PHS Policy Under the PHS Policy farm animals, birds, laboratory rodents, fish, amphibians, and reptiles, as well as all other vertebrates, would be covered, as long as the study was funded by PHS. Under the PHS Policy farm animals, birds, laboratory rodents, fish, amphibians, and reptiles, as well as all other vertebrates, would be covered, as long as the study was funded by PHS.

PHS Policy In 1966, a panel of experts commissioned by the PHS wrote the Guide for the Care and Use of Laboratory Animals, which has become the primary reference in the United States for animal care and use programs. In 1966, a panel of experts commissioned by the PHS wrote the Guide for the Care and Use of Laboratory Animals, which has become the primary reference in the United States for animal care and use programs.

PHS Policy The Policy addresses concerns for the welfare of PEOPLE, as well as animals. The Policy addresses concerns for the welfare of PEOPLE, as well as animals. Requirement that each Institution have an Occupational Health Program to protect humans against animal hazards. Requirement that each Institution have an Occupational Health Program to protect humans against animal hazards.

PHS Policy No routine inspections; however, NIH inspects several institutions per year checking for compliance with the Guide and Policy No routine inspections; however, NIH inspects several institutions per year checking for compliance with the Guide and Policy Major violations? Loss of all PHS funding to the institution Major violations? Loss of all PHS funding to the institution

PHS Policy Requires each institution have an IACUC, which is the local authority over the animal care and use program Requires each institution have an IACUC, which is the local authority over the animal care and use program

“Animals” at the UA ALL VERTEBRATES animals, regardless of use are covered. ALL VERTEBRATES animals, regardless of use are covered.

Other Federal Laws Affecting Animal Research Good Laboratory Practices Act—Requires to meet standards of PHS Policy and AWA Good Laboratory Practices Act—Requires to meet standards of PHS Policy and AWA Animal Enterprise Protection Act Animal Enterprise Protection Act Controlled Substances Act Controlled Substances Act Patriot Act Patriot Act

Federal and State Wildlife Protection Laws

Non-Regulatory Policies Affecting Research

Association for Assessment and Accreditation of Laboratory Care International

AAALAC Considered the Gold Standard for animal care Considered the Gold Standard for animal care AAALAC uses AWA, PHS and other sources as guides AAALAC uses AWA, PHS and other sources as guides Applies to all animals used by the institution Applies to all animals used by the institution

AVMA Panel on Euthanasia