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LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM
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LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

Dec 23, 2015

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Page 1: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

LATG:A Review of the

Animal Welfare Act

Created by

Marc S. Hulin, DVM, Dipl. ACLAM

Page 2: 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• 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

Page 3: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

History of AWA

• 1976 Amendment (PL#94-279):– carriers were covered & transportation

standards were set– expanded to cover Marine Mammals

Page 4: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 5: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 6: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 7: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 8: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 9: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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.

Page 10: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 11: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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.

Page 12: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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.

Page 13: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 14: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 15: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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.

Page 16: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

Subpart B- Registration

• Carriers, Intermediate handlers, and exhibitors must register with the Secretary of USDA

• Must be updated every 3 yrs.

Page 17: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 18: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 19: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 20: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 21: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 22: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 23: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 24: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 25: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 26: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 27: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 28: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 29: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 30: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 31: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 32: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 33: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 34: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 35: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 36: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 37: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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)

Page 38: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 39: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 40: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 41: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 42: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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.

Page 43: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 44: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 45: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 46: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 47: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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)

Page 48: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 49: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 50: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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

Page 51: LATG: A Review of the Animal Welfare Act Created by Marc S. Hulin, DVM, Dipl. ACLAM.

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