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LATG: A Review of the Animal Welfare Act. Created by Marc S. Hulin, DVM, Dipl. ACLAM. History of AWA. Laboratory Animal Welfare Act of 1966 (PL# 89-544): designed to stop “pet napping” applied to dog & cats dealers; research facilities that used dogs and cats

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latg a review of the animal welfare act

LATG:A Review of theAnimal Welfare Act

Created by

Marc S. Hulin, DVM, Dipl. ACLAM

history of awa
History of AWA
  • Laboratory Animal Welfare Act of 1966 (PL# 89-544):
    • designed to stop “pet napping”
    • applied to dog & cats dealers; research facilities that used dogs and cats
  • Animal Welfare Act (PL# 91-579) amended in 1970:
    • expanded to cover hamsters, guinea pigs, rabbits, NHP & other warm-blooded species
    • cover animals while on study
    • cover use in teaching and exhibition
history of awa3
History of AWA
  • 1976 Amendment (PL#94-279):
    • carriers were covered & transportation standards were set
    • expanded to cover Marine Mammals
history of awa4
History of AWA
  • Food Security Act of 1985 (PL# 99-198):
    • aka “Improved Standards for Laboratory Animals”
    • mandated training of all personnel using animals in research
    • defined duties & composition of the IACUC
    • developed standards for exercise of dogs & psychological well-being of NHP
    • defined one major operative procedure only: unless scientifically justified or vet. procedure
    • established Animal Welfare Information Center (AWIC) to prevent unnecessary duplication
history of awa5
History of AWA
  • Protection of Pets-1990 Amendment:
    • attached to Food, Agriculture, Conservation and Trade Act (PL # 101-624)
    • mandated a minimum holding period of 5 days for pounds and shelters before providing any live cat or dog to a “Class B” dealer
aphis awa
APHIS & AWA
  • Animal and Plant Health Inspection Service (APHIS):
    • enforcement of the standards and regulations of the AWA
  • Regulatory Enforcement and Animal Care (REAC):
    • group within APHIS that administers Federal laws concerning transportation, sale, and handling of animals used in lab research
    • NOTE: USDA inspections are unannounced and conducted annually
part 1 definition of terms
Part 1- Definition of Terms
  • Animal:
    • any live or dead dog, cat, NHP, guinea pig, hamster, rabbit or any other warm-blooded animal intended for use in research
    • term excludes: birds, rats of the genus Rattus and mice of the genus Mus bred for research
    • also excludes horses not used for research purposes and other farm animals intended for use as food or fiber
part 1 definition of terms8
Part 1- Definition of Terms
  • Class “A” dealer (purpose bred):
    • breed and raise animals in a closed or stable colony
  • Class “B” dealer (random source):
    • purchase and/or resale of any animal for the purpose of research
  • Class “C” dealer (exhibitor):
    • showing or displaying of animals to the public
part 1 definition of terms9
Part 1- Definition of Terms
  • Field study:
    • study conducted on free-living wild animals in their natural habitat; which does not involve invasive procedures, and which does not harm or materially alter the behavior of the animals under study
  • Institutional Official:
    • individual at a research facility who is authorized to legally commit on behalf of research facility that requirements of AWA will be met.
part 1 definition of terms10
Part 1- Definition of Terms
  • Major operative procedure:
    • any surgical procedure that penetrates and exposes a body cavity or any procedure which produces permanent impairment of physical or physiological functions
  • Painful procedure:
    • any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being
part 1 definition of terms11
Part 1- Definition of Terms
  • Random sources:
    • dogs & cats obtained from animal pounds or shelters, auction sales, or from any person who did not breed & raise them on his or her premises
  • Primary enclosures:
    • any structure or device used to restrict an animal or animals, such as a room, pen, or cage.
part 1 definition of terms12
Part 1- Definition of Terms
  • Study area:
    • any room, area, enclosure, or other containment outside of a main animal facility where animals are housed for more than 12 hours.
    • NOTE: PHS Policy defines as 24 hrs.
part 2 regulations
Part 2- Regulations
  • This part sets forth requirements for registration & licensing under the Act, adequate veterinary care, handling, holding, facilities, identification of animals, and recordkeeping
subpart a licensing
Subpart A- Licensing
  • Persons operating or desiring to operate as dealers, exhibitors, or operators of auction sales must be licensed
  • Exemptions:
    • retail pet stores
    • persons who derive no more than $500 gross annual income
    • persons who maintain no more than 3 breeding female dogs or cats & sell offspring for pets or exhibition
    • persons who sell fewer than 25 dogs and or cats annually for research, testing, or education
subpart a licensing15
Subpart A- Licensing
  • Exemptions (con’t):
    • persons who buy animals solely for their own use & do not sell or exhibit animals
  • License application: $10 fee
    • Applicants must demonstrate that their premises, facilities, vehicles, equipment are in compliance
    • licenses are valid for 1 yr.
    • 30 days prior to expiration must reapply and submit annual report with income or number of animals sold.
subpart b registration
Subpart B- Registration
  • Carriers, Intermediate handlers, and exhibitors must register with the Secretary of USDA
  • Must be updated every 3 yrs.
subpart c research facilities
Subpart C- Research Facilities
  • Research facilities, other than federal research facilities must register
  • Updated every 3 yrs.
  • An official who has legal authority to bind the parent organization must sign the registration form
subpart c research facilities18
Subpart C- Research Facilities
  • IACUC:
    • CEO must appoint IACUC members
    • Must consist of at least 3 people
      • Chairman
      • DVM with training or experience in lab animal science and medicine
      • Person not affiliated with the facility (not immediate family member)
    • If more than 3 members, no more than 3 members from same dept.
    • NOTE: PHS policy must have 5 members
subpart c research facilities19
Subpart C- Research Facilities
  • IACUC functions:
    • review animal care program & inspect animal facilities at least once every 6 months
    • prepare reports from the review & inspection
    • review & investigate public complaints about animal care
    • review & approve proposed activities or significant changes
    • suspend an activity involving animals
subpart c research facilities20
Subpart C- Research Facilities
  • Attending Veterinarian and Adequate Veterinary Care:
    • each facility must employ an attending veterinarian
    • part time or consultants must have a written program of veterinary care & regularly scheduled visits to the facility
subpart c research facilities21
Subpart C- Research Facilities
  • Recordkeeping Requirements:
    • Must maintain IACUC records
      • Meeting minutes
      • Proposed activities & significant changes
      • Semiannual reports
      • must keep for 3 yrs. after completion of project
    • Must keep records for live dogs and cats
      • Health certificate, Animal description, USDA #, date of acquisition, vendor info.
    • All records must be available for APHIS and federal agency inspection & copying (FOIA)
    • NOTE: PHS require 2 more: AWA & AAALAC, Int. accreditation
subpart c research facilities22
Subpart C- Research Facilities
  • Annual Report to USDA:
    • Must be submitted by Dec. 1 of each yr.; covers Oct. 1-Sept. 30 (federal fiscal yr.)
    • Considered alternatives to painful procedures
    • Assure adhering to the AWA
    • Common names and number of animals used in the following categories:
      • D or 0: no pain or distress
      • E or 1: pain or distress with appropriate drugs
      • F or 2: pain or distress without drugs; requires scientific justification
subpart c research facilities23
Subpart C- Research Facilities
  • Identification of dogs and cats:
    • Official tag:
      • “USDA”
      • Numbers and letters identifying the state and dealer
      • Numbers identifying the animal
    • Tags cannot be reused within a 5 yr. period
    • Lost tags must be replaced with new tag and number & must be recorded in records
    • Tags must be kept for 1 yr. period
subpart c research facilities24
Subpart C- Research Facilities
  • Identification of dogs and cats (con’t):
    • Tattoo
    • Collar
    • Unweaned puppies or kittens to not need individual identification if with dams
  • Health certificates:
    • Dog, Cat, or NHP transported from a research facility must be accompanied by health certificate issued by licensed, accredited vet.
    • Health certificate must have date examined by vet.; not more than 10 days prior to transport
subpart c research facilities25
Subpart C- Research Facilities
  • Holding periods for dogs and cats:
    • Research facilities that obtain dogs or cats from sources other than dealers, exhibitors, and persons who are exempt from licensing regulations must hold the animal for 5 full days, not including the day of acquisition or time in transit
subpart h compliance with standards
Subpart H- Compliance with Standards
  • Holding period:
    • Any live cat or dog acquired by a dealer or exhibitor must be held for 5 full days, not including the day of acquisition or time in transit and must include at least one Saturday
    • This 5 days is for animals acquired from public pounds or shelters
    • Extended to 10 days if acquired from private or contract pounds or shelters
    • Pounds or shelters must hold for 5 days before releasing to Class “B” dealer
subpart h compliance with standards27
Subpart H- Compliance with Standards
  • Holding period (con’t):
    • Before selling a random source dog, a dealer must provide certification relating to:
      • background and registration of the dealer and animal
      • description of the animal
      • background of shelter were purchased
      • statement by shelter that held for at least 5 days
      • assurance that the dealer notified person, pound or shelter that the animal might be used for research or educational purposes
subpart h compliance with standards28
Subpart H- Compliance with Standards
  • Procurement of random source dogs and cats:
    • Class “B” dealers may obtain random source dogs and cat only from:
      • licensed dealers
      • state, county, or city-owned and operated pounds or shelters
      • another legally operated animal shelter
part 3 standards
Part 3- Standards
  • This sections specifies standards for the humane handling, care, treatment, and transportation of dogs, cats, guinea pigs, hamsters, rabbits, NHP, marine mammals, and other warm-blooded animals
  • NOTE: This section has a lot of common sense info. e.g., removal and disposal of waste must be regular and frequent or adequate potable water must be supplied for animals’ drinking needs
part 3 standards30
Part 3- Standards
  • Indoor facilities:
    • Dogs, Cats, NHP:
      • the ambient temp. must not fall below 45 F or rise above 85 F for more than 4 consecutive hours when animals are present
    • Guinea pigs and hamsters:
      • the ambient temp. must not fall below 60 F or exceed 85 F
    • Rabbits:
      • indoor facilities need not be heated
part 3 standards31
Part 3- Standards
  • Outdoor facilities:
    • Not suitable for guinea pigs and hamsters
    • Dogs and cats:
      • unknown acclimation status: do not keep outdoors if temp. is less than 50 F
    • Rabbits:
      • temp. > 90 F artificial cooling shall be provided (sprinkler system)
  • Shelter from cold weather:
    • Dogs and cats: below 50 F
    • Rabbits: below 40 F
    • NHP: below 45 F
part 3 standards32
Part 3- Standards
  • Primary enclosures:
    • Dogs, Cats, & NHP: must be structurally sound and maintained in good repair
      • contain & protect from injury
      • allow animals to remain dry & clean
      • easy access to food and water
      • protection from extreme cold and heat
      • surfaces to be cleaned/sanitized readily
    • Dogs & Cats:
      • innovative enclosure that do not precisely meet floor area and height may be used; must be approved by IACUC
part 3 standards33
Part 3- Standards
  • Cats:
    • must provide receptacle with clean litter
    • space requirements:
      • 24 in. high
      • < 8.8 lb or 4 kg must have 3.0 sq. ft.
      • > 8.8 lb or 4 kg must have 4.0 sq. ft.
      • queens with litters must have additional space
      • minimum floor space excludes food/water pan, but includes litter box
    • each primary enclosure must contain an elevated resting surface
    • no more than 12 adult cats may be housed in same primary enclosure
part 3 standards34
Part 3- Standards
  • Dogs:
    • Interior height must be at least 6 inches higher than the head of the tallest dog when it is in normal standing position
    • Minimum floor space:
      • Equal to the square of the sum of the length of the dog in inches (measured from the tip of the nose to the base of the tail) plus 6 inches, expressed in square feet (divide by 144).
      • Dog measuring 30 inches, would be 36 x 36/144 = 9 sq. ft.
      • NOTE: Differs from Guide (based on wt. of dog)
    • No more than 12 adult dogs in same enclosure
part 3 standards35
Part 3- Standards
  • Nonhuman primates:
    • Minimum space requirements must be met even if perches or swings are placed in the enclosure
    • based on typical wt. of species
    • ranges from Group 1-Group 6
    • Group 6 includes great apes < 50 kg and brachiating species
    • Great apes > 50kg must have additional space for normal postural adjustments
    • Smaller innovative enclosures may be used but must be approved by IACUC/Administrator
part 3 standards36
Part 3- Standards
  • Guinea pigs:
    • cage interior height: 7 inches
    • minimum floor space: 60 sq. in. < 350 gr and 101 sq. in. > 350 gr
  • Hamsters:
    • cage interior height: 6 inches
    • minimum floor space: see AWA
    • no other hamster may be kept in an enclosure with nursing female and litter
  • Rabbits:
    • minimum interior height: 14 in.
    • minimum floor space: see AWA
part 3 standards37
Part 3- Standards
  • Environmental enhancement to promote psychological well-being:
    • dealers, exhibitors, and research facilities must follow and document a plan for EE and must be directed by attending veterinarian
    • The plan must address:
      • Social grouping (conspecifics)
      • Environmental enrichment: species typical activity
      • Special considerations: juveniles, psychological distress
      • Restraint devices: must not be used unless required by protocol (restraint > 12 hrs. must give 1 hr. unrestrained daily)
part 3 standards38
Part 3- Standards
  • Environmental enhancement to promote psychological well-being (con’t):
    • exemptions:
      • Veterinarian may exempt animals for reasons of health, condition, or well-being
      • IACUC may exempt for scientific reasons
      • Records of exemptions must be made available to USDA and federal agencies
part 3 standards39
Part 3- Standards
  • Dog Exercise Program:
    • dealers, exhibitors, and research facilities must have appropriate documented plan to provide dogs with the opportunity for exercise
    • must be approved by attending veterinarian
    • plan must have written standard procedure
dog exercise program
Dog Exercise Program
  • All dogs individually housed with less than 2 times required floor space must be provided regular opportunity for exercise
  • Dogs that are group housed do not require additional opportunity for exercise if floor space is equal to at least 100% of the required floor for each individual dog
dog exercise program41
Dog Exercise Program
  • Exemptions:
    • Attending veterinarian decision for reasons of health, condition, or well-being
      • exemption must be documented and reviewed at least every 30 days
    • Scientific reasons
      • must be documented in IACUC approved protocol
animal health husbandry
Animal Health & Husbandry
  • Feeding:
    • animal must be fed at least once daily
    • food containers for all species must be sanitized at least every 2 wks.
  • Watering:
    • if potable water is not accessible at all times, potable liquids must be offered at least twice daily for at least 1 hr. each time
    • water receptacles sanitized at least every 2 wks.
animal health husbandry43
Animal Health & Husbandry
  • Sanitation:
    • effective program for control of insects, ectoparasites, and vermin shall be maintained
    • dogs, cats, and nonhuman primates:
      • excreta and food waste must be removed from primary enclosures daily
      • enclosures should be sanitized at least every 2 wks.
      • Hard surfaces can be cleaned by cage washer, live steam under pressure, or detergent and disinfectant
animal health husbandry44
Animal Health & Husbandry
  • Guinea pigs and hamsters:
    • enclosures must be cleaned and sanitized at least every 2 wks.
  • Rabbits:
    • enclosures must be cleaned and sanitized at least every 30 days
    • underlying pans or troughs shall be cleaned at least once a week
transportation standards
Transportation Standards
  • Carriers and intermediate handlers may not accept animals for transportation more than 4 hrs. before departure
  • Must be accompanied by health certificate signed by vet. within 10 days of shipment
  • Temperature of terminal facility must be lower than 45 F for more than 4 hrs. when animals are present
transportation standards46
Transportation Standards
  • Primary enclosures used to transport live animals:
    • Interior must be free of any protrusions
    • Openings must be easily accessible for emergencies
    • adequate handholds for lifting must be located on exterior
    • Enclosures: must have words “Live Animals” or “Wild Animals” printed in letters at least 1 inch high on top and one side
transportation standards47
Transportation Standards
  • Food and water requirements (must be affixed to outside of enclosure):
    • Dogs, cats, NHP:
      • must be offered water and food within 4 hrs. of transportation
      • water must be offered at least every 12 hrs.
      • NHP > 1 yr., dogs and cats > 16 wks must be fed at least once every 24 hrs.
      • NHP < 1 yr., dogs and cats < 16 wks must be fed at least once every 12 hrs.
    • Guinea pigs, hamster, and rabbits:
      • animals in transit for more than 6 hrs. must have access to food and water or type of food to satisfy their needs during transit (Transgel)
transportation standards48
Transportation Standards
  • Guinea pigs, hamster, and rabbits:
    • Maximum allowable number of animals which can be transported in one enclosure:
      • Guinea pigs: 15
      • Rabbits: 15
      • Hamsters: 50
transportation standards49
Transportation Standards
  • Care in Transit:
    • Surface Transportation:
      • Animals must be observed at least every 4 hrs. to assure proper ventilation, temperature, or physical distress
    • Air Transportation:
      • Animals must be observed at least every 4 hrs. if the animal cargo area is accessible during flight. If not, must be observed during loading and unloading
terminal facilities
Terminal Facilities
  • Ventilation and Temperature:
    • Dogs, Cats, NHP (same for primary conveyances):
      • ventilation must be provided by windows, doors, vents, etc.
      • auxiliary ventilation must be used when the temp. > 85 F in holding area
      • ambient temp. must not exceed 85 F nor fall below 45 F for more than 4 consecutive hrs. when animals are present
    • Duration:
      • must not be held at terminal facility for more than 24 hrs. if consignee cannot be notified, but 48 hrs. if fails to take physical possession
terminal facilities51
Terminal Facilities
  • Ventilation and Temperature:
    • Guinea pigs, hamsters, rabbits, other warm blooded animals (same for primary conveyances):
      • ventilation must be provided by windows, doors, vents, etc.
      • auxiliary ventilation must be used when the temp. > 75 F in holding area
      • ambient temp. must not exceed 85 F nor fall below 45 F for more than 4 consecutive hrs. when animals are present