Historical Perspectives of Historical Perspectives of Research Animal Research Animal

ProtectionProtection

Dr. Susan Wilson-SandersDr. Susan Wilson-Sanders

Participants in the ProcessParticipants in the Process Laboratory Animal ScientistsLaboratory Animal Scientists

Animal Care PanelAnimal Care Panel AALASAALAS AAALACAAALAC ILARILAR

PublicPublic Animal-centric organizationsAnimal-centric organizations Health care consumersHealth care consumers

Research communityResearch community

GovernmentGovernment CongressCongress USDAUSDA HHS: PHS (NIH, FDA)HHS: PHS (NIH, FDA)

Laboratory Animal Scientists:Laboratory Animal Scientists: Five “Founding Fathers Five “Founding Fathers””

Dr. Robert J. Dr. Robert J. SchroederSchroeder

Dr. Nathan R. Dr. Nathan R. BrewerBrewer

Dr. Elihu BondDr. Elihu Bond Dr. Robert J. FlynnDr. Robert J. Flynn Dr. Bennet J. CohenDr. Bennet J. Cohen

Timeline ContinuedTimeline Continued

19671967 Name of the ACP changes to the Name of the ACP changes to the American Association for laboratory American Association for laboratory

Animal Science (AALAS)Animal Science (AALAS)

The Public:The Public: Changing Attitudes Changing Attitudes

Animal-centric organizationsAnimal-centric organizations

Public’s InvolvementPublic’s Involvement

19621962Silent SpringSilent Spring, by Rachel Carson, by Rachel Carson19661966LIFE magazine and Sports Ill LIFE magazine and Sports Ill

articlesarticles1969 1969 Greenpeace foundedGreenpeace founded19751975Animal LiberationAnimal Liberation, by Peter Singer, by Peter Singer19821982The “Silver Spring Monkeys”The “Silver Spring Monkeys”19831983University of Pennsylvania head University of Pennsylvania head

injury studies injury studies

Sports Illustrated ArticleSports Illustrated Article

Life MagazineLife Magazine

Life MagazineLife Magazine

RESEARCH INVOLVEMENTRESEARCH INVOLVEMENT

ACADEMIC FREEDOMACADEMIC FREEDOM

Government InvolvementGovernment Involvement

19621962 NIH Contract –First NIH Contract –First GuideGuide

19661966 Laboratory Animal Laboratory Animal Welfare Act (1970, Welfare Act (1970, 1976, 1985, 1990)1976, 1985, 1990)

19711971 NIH PolicyNIH Policy 19731973 Public Health Public Health

Service Policy Service Policy (1979)(1979)

19851985 PHS Act (Health PHS Act (Health Research Extension)Research Extension)

1966 Laboratory Animal Welfare Act1966 Laboratory Animal Welfare Act

HousingHousing FeedingFeeding WateringWatering SanitationSanitation

ShelterShelter Separation of Separation of

SpeciesSpecies VentilationVentilation Adequate Vet CareAdequate Vet Care

Preventing theft of dogs and catsRegistration limited facilities with dogs/catsHolding areas onlyOnly records of acquisition requiredDeveloped 8 areas of minimum standards

1970 Animal Welfare Act1970 Animal Welfare Act LAWA changed to AWALAWA changed to AWA Extension into the laboratoryExtension into the laboratory Report number of animals Report number of animals

by pain categoriesby pain categories Require appropriate use of Require appropriate use of

anestheticsanesthetics Included standards for Included standards for

animal transportanimal transport Include all warm blooded Include all warm blooded

except those excluded by except those excluded by the Sec of Agthe Sec of Ag

TT

RR

AA

NN

SS

PP

OO

RR

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1985 Animal Welfare Act 1985 Animal Welfare Act AmendmentsAmendments

Establishment of IACUCEstablishment of IACUC Assign responsibility to Institutional OfficialAssign responsibility to Institutional Official Review of protocolsReview of protocols Semiannual program review & inspectionSemiannual program review & inspection Search for alternatives to painful Search for alternatives to painful

proceduresprocedures Personnel qualificationsPersonnel qualifications Environmental enrichment for NHPsEnvironmental enrichment for NHPs Exercise for dogsExercise for dogs

Animal Welfare ActAnimal Welfare Act

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

Definition of AnimalsDefinition of Animals

Includes:Includes: Wilds mammals used Wilds mammals used

in field research and in field research and laboratory researchlaboratory research

Farm mammals used Farm mammals used in biomedical researchin biomedical research

Act Applies To:Act Applies To:

Horseshows (particularly Gaited, Horseshows (particularly Gaited, prevention of “soreing”.prevention of “soreing”.

Dog/cat breeders with more than three Dog/cat breeders with more than three breeding bitches or queens.breeding bitches or queens.

Definition ExcludesDefinition Excludes

Production farm animalsProduction farm animals Laboratory rats and Laboratory rats and

micemice Birds, bred for or used in Birds, bred for or used in

research (new in 2004)research (new in 2004)

Animal Welfare ActAnimal Welfare Act

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

Animal Welfare ActAnimal Welfare Act

Fines and penalties Fines and penalties are levied for violating are levied for violating the actthe act

AWAAWAEstablishes the Institutional Animal Care Establishes the Institutional Animal Care

and Use Committee (IACUC) as the internal and Use Committee (IACUC) as the internal regulatory authority for each Research regulatory authority for each Research FacilityFacility

1971 NIH Policy1971 NIH Policy

Institution had to have Institution had to have AssuranceAssurance AAALACAAALAC Local CommitteeLocal Committee

Annual InspectionsAnnual Inspections Compliance with AWACompliance with AWA Follow Follow GuideGuide

1985 PHS Policy1985 PHS Policy Health Research Extension ActHealth Research Extension Act More detailed AssuranceMore detailed Assurance IO ultimately responsibleIO ultimately responsible CEO appoints IACUC membersCEO appoints IACUC members Minimum of 5 IACUC members:Minimum of 5 IACUC members:

DVM program authorityDVM program authority Once practicing scientistOnce practicing scientist One community member One community member

Protocol ReviewProtocol Review Semiannual reports of program Semiannual reports of program

reviewreview Detailed training program Detailed training program

descriptiondescription

Public Health Service PolicyPublic Health Service Policy The Public Health Service Policy on the Care The Public Health Service Policy on the Care

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

PHS PolicyPHS Policy

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

PHS PolicyPHS Policy

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

PHS PolicyPHS Policy

The Policy addresses The Policy addresses concerns for the welfare concerns for the welfare of PEOPLE, as well as of PEOPLE, as well as animals.animals.

Requirement that each Requirement that each Institution have an Institution have an Occupational Health Occupational Health Program to protect Program to protect humans against animal humans against animal hazards.hazards.

PHS PolicyPHS PolicyNo routine inspections; however, NIH No routine inspections; however, NIH

inspects several institutions per year inspects several institutions per year checking for compliance with the Guide checking for compliance with the Guide and Policyand Policy

Major violations? Major violations? Loss of all PHS funding Loss of all PHS funding to the institutionto the institution

PHS PolicyPHS Policy

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

““Animals” at the UA Animals” at the UA

ALL VERTEBRATES ALL VERTEBRATES animals, regardless of animals, regardless of use are covered.use are covered.

Other Federal Laws Affecting Animal Other Federal Laws Affecting Animal ResearchResearch

Good Laboratory Practices Act—Requires Good Laboratory Practices Act—Requires to meet standards of PHS Policy and AWAto meet standards of PHS Policy and AWA

Animal Enterprise Protection ActAnimal Enterprise Protection ActControlled Substances ActControlled Substances ActPatriot ActPatriot Act

Federal and State Wildlife Federal and State Wildlife Protection LawsProtection Laws

Non-Regulatory Policies Affecting Non-Regulatory Policies Affecting ResearchResearch

Association for Assessment and Association for Assessment and Accreditation of Laboratory Care Accreditation of Laboratory Care

InternationalInternational

AAALACAAALAC

Considered the Gold Considered the Gold Standard for animal Standard for animal carecare

AAALAC uses AWA, AAALAC uses AWA, PHS and other PHS and other sources as guidessources as guides

Applies to all animals Applies to all animals used by the institutionused by the institution

AVMA Panel on EuthanasiaAVMA Panel on Euthanasia