Microbiology 501

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Microbiology 501

• Laws, Regulations and Policies that impact the
  Care and Use of Animals

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1832 oil of animal experimentation
Francois Magendie, 1783-1855
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Claude Bernard in his Laboratory
Claude Bernard 1813-1878
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1876 Cruelty to Animals Act

• Registration of laboratories
• Record keeping
• Terminal anesthesia (Exceptions)
• Licensing of researcher investigators

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The Life magazine article - 1965
The Pepper incident - 1965
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The Laboratory Animal Welfare Act - 1966
The Animal Welfare Act -1970
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ALF Break-in - Univ. of Penn. Head Trauma Lab.

• Head Injury Lab. - Dr. Thomas Gennarelli
• Development of baboon model to study the
  functional and anatomic effects of head injury
• ALF Break-in of May 28, 1984
• vandalized computer electronic equipment
• stole videotape documenting studies
• tapes provided to PETA, edited provided to
  media

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ALF Break-in - Univ. of Penn. Head Trauma Lab.
(cont)

• Violations of Animal Welfare Act
• inadequate levels of anesthesia
• non-sterile surgery
• inadequate levels of lab sanitaition
• insensitivity of personnel

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The Laboratory Animal Welfare Act - 1966
The Animal Welfare Act -1970
Improved Standards for Laboratory Animals Act -
1985
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Legislative Issues and Regulations

• Federal Regulations of immediate interest,
  include
• Animal Welfare Act
• Public Health Service Policy
• GLP Regulations

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Legal Requirements

• Animal Welfare Act
• Administered by the US Department of Agriculture
• Public Health Service Policy on the Humane Care
  and Use of Laboratory Animals
• Administered by OLAW of NIH

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Federal and State Regulations

• United States Department of Agriculture (USDA)
• Registered as a research facility
• Unannounced site visits
• Public Health Service (PHS)
• Submit annual reports and updates in compliance
  with Animal Welfare Assurance statement
• Necessary for NIH research funding

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Animal Welfare Act

• Created in 1966
• Amended in 1970, 1976, 1985, 1990
• Regulates the use of all warm-blooded vertebrates
  in research except birds, rats and mice bred
  exclusively for research, and farm animals used
  or intended for food or fiber.
• Covers all wild mammals, even wild rats and mice.
• Facilities must record their yearly animal
  inventory and use on a special form (APHIS Form
  7023) and submit it to the USDA by the first day
  of December.

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APHIS Form 7023
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Requirements of the Animal Welfare Act

• Register with the USDA
• Maintain individual records on the source and use
  of dogs and cats by using identification tattoo
  or tag
• Submit a count by species of the number of
  animals involved in projects by pain category C,
  D, or E.
• House species separately, and provide appropriate
  floor area and environmental controls for each
  animal.

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Categories of Animal Use

• USDA
• Category C - Pain and/or distress no greater than
  an injection.
• Category D - Pain and/or distress fully
  alleviated with analgesics/anesthetics.
• Category E - Pain and/or distress not fully
  alleviated with analgesics/anesthetics.
• Category D or E
• Specific agents and dosages and routes
• Consideration of alternatives

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Requirements of the Animal Welfare Act

• Minimum standards for husbandry, care, and
  treatment of animals
• Provide adequate veterinary care
• Minimum standards for transportation
• proper shipping containers
• Adequate food and water
• maintain proper temperatures

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Requirements of the Animal Welfare Act (1985)

• Training for scientists, animal technicians, and
  others using animals
• Exercise of dogs
• Provide for the psychological well-being of
  non-human primates
• Require anesthetics, analgesics and/or
  tranquilizers be administered if a procedure is
  likely to cause more than momentary pain, unless
  otherwise scientifically justified

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Requirements of the Animal Welfare Act (1985)

• Prohibiting the performance of more than one
  major survival surgical procedure on an animal
  unless scientifically justified
• Consideration of alternatives to experiments
  likely cause to pain and distress
• Establish an IACUC to assess animal care and use
  and minimization of animal pain and distress
• Inspection of facilities by the IACUC

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Compliance

• USDA inspectors conduct unannounced site visits
  to the research facilities
• USDA has the authority to stop research at an
  institution that does not treat its animals in
  accordance with the law
• Records of USDA inspections are available to the
  general public under the Freedom of Information
  Act (FOIA)

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

• Office of Laboratory Animal Welfare (OLAW,
  formerly OPRR)
• Institutional official must send a letter called
  an Animal Welfare Assurance Statement
• Lists every branch and major component of the
  institution
• Lines of authority for administering the research
  program and ensuring compliance

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PHS Policy Animal Welfare Assurance Statement
(cont.)

• The qualifications, authority and responsibility
  of the veterinarian(s) who participate in the
  program
• The membership of the IACUC
• Description of the review procedures for animal
  use protocols
• An outline of training instruction offered to
  scientists, animal technicians, etc.
• Description of the animal facility, including
  gross square footage, species housed, and average
  daily inventory of animals

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

• The letter is a promise from the institution that
  it will conduct all animal research in accordance
  with the Guide for the Care and Use of Laboratory
  Animals, the Public Health Service Policy, and
  any other applicable animal welfare laws and
  regulations

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The Guide
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The Guide...

• Standard used to assess PHS Policy and AAALAC
  International
• Covers all vertebrate animals
• Does not cover animals used for food and fiber
  researchGuide for the Care and Use of
  Agricultural Animals in Agricultural Research and
  Teaching

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Segments of The Guide...

• Institutional Policies
• IACUC compliance requirements
• Qualifications of animal care personnel
• Occupational Health Program
• Personal Hygiene
• Proper restraint
• Optimal surgical procedures

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Segments of The Guide...

• Laboratory Animal Management
• Recommended cage sizes and construction
• Equipment, food, bedding, water, sanitation, pest
  control, record keeping etc.
• Environmental considerations
• Macroenvironment-the room
• Microenvironment-the cage

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Segments of The Guide...

• Veterinary Care
• Animal selection, procurement, and health
  maintenance
• Procedures for quarantine, separation of species,
  anesthesia, health monitoring, and euthanasia
• Discusses disease recognition, control, and
  prevention

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Segments of The Guide...

• Physical Plant
• Proper construction of animal facility
• Floors, walls, ceilings, storage areas,
  laboratories, surgical suites, animal room
  locations, and corridor traffic

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Regulation of Animals at Research Institutions
Farm Animals Used in Food Fiber Research
Cats
Hamsters
Dogs
Rabbits
Guinea Pigs
Laboratory Rodents
Primates
Farm Animals
Wild Animals in Captivity
Birds
Guide for the Care and Use of Laboratory Animals
Covers all animals in facilities receiving PHS
funds
Animal Welfare Act Covers these animals when used
in medical research, education testing
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Association for Assessment of Accreditation of
Laboratory Animal Care, International (AAALAC
International)

• Voluntary, external review program
• Apply for membership
• Facility description
• Procedures
• Programs
• Research animal use

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AAALAC

• Yearly written report is submitted
• Inspected every 3 years
• Categories
• No major deficiencies, full accreditation
• Major deficiencies, correctable, deferred
• Revoked if deficiencies cant be corrected in a
  24-month period

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Food and Drug Administration (FDA)

• The Food, Drug and Cosmetic Act of 1938, as
  amended in 1962, requires that the effectiveness
  of a drug, food additive or device must be
  demonstrated by evidence that consists of
  thorough, well-controlled investigations.

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Good Laboratory Practices (GLPs)

• Write Standard Operating Procedures (SOPs) for
  all husbandry and scientific procedures
• Adequately train personnel and maintain a current
  job file on each employee
• Provide proper daily care, husbandry, and
  veterinary treatment
• House each species separately
• Requires extensive recordkeeping
• Keep all supporting documentation for a minimum
  of 2 years after completion of the project

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Importation and Transportation Regulations

• USDA Specific Regulations
• California
• Permit to import Xenopus sp..
• Health Certificate
• Dogs, Cats, and Nonhuman primates
• Rabies
• Dogs and Cats

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State Regulations

• Animal anti-cruelty laws
• State inspection programs
• Laws that prohibit release of impounded animals
  to research institutions

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Institutional Responsibilities

• Establish lines of authority responsibility
• Establish disseminate institutional policy
• Annual reports to USDA OLAW
• Provide appropriate facilities for housing and
  care
• Occupational health program
• Ensure personnel involved in care use of
  animals are qualified to perform assigned duties

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Consequences of Noncompliance

• REVOCATION OF ASSURANCE AND LOSS OF PHS SUPPORT
  FOR ENTIRE INSTITUTION

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Institutional Animal Care and Use Committee
(IACUC)

• Reviews and approves animal use protocols and
  modifications to protocols
• Reviews semiannually institutional animal
  facilities and program
• Investigates concerns about the care and use of
  animals
• Suspends activities noncompliant with the AWA
  and/or PHS Policy

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Institutional Animal Care and Use Committee
(IACUC)

• Membership is dictated by the PHS and USDA and
  appointed by the IO
• Minimum of three (AWA) or five (PHS) members
• Veterinarian with training or experience in
  laboratory animal medicine
• Practicing scientist with experience in research
  involving animals
• Nonscientist
• Nonaffiliated or community member

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IACUC Responsibilities

• Review new ongoing animal activities
• Ensure scientific relevance of proposal
• Program review facility inspection every 6 mos.
• Submit report to Institutional Official
• Reviewed signed by majority of members
• Must include any minority views
• Plan of action where deficiencies noted
• Review investigate concerns involving care
  use of animals

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How to Report Concerns about Animal Care or Use
at MSU

• Persons may contact (anonymously, if so desired)
  the Animal Resources Center (x6803) or the IACUC
  Chair (x2030) to report concerns regarding the
  care and use of laboratory animals.
• Forms are also available in all animal areas for
  anonymous submission.

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Animal Use Protocol Reviews

• Protocols are reviewed within the following
  guidelines
• USDA Animal Welfare Regulations
• PHS Policy
• Guide for the Care and Use of Laboratory Animals
• Relevant Institutional Polices

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Facility Inspections and Program Review

• Conducted at least every 6 months
• Findings are reported to the Institutional
  Official
• Part of institutional records
• Semi-annual review of research program policies
  and procedures

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Attending VeterinarianResponsibilities

• Direct housing, feeding and care of animals
• Voting member of IACUC
• Ensure provision of adequate veterinary care
• Programs to prevent, control, diagnose and treat
  diseases and injuries
• Appropriate pre- and post-procedural care in
  accordance with vet. medical and nursing
  practices
• Emergency, weekend, holiday care
• Daily observations and reporting mechanism
• Guidance and advice to investigators

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