03. Animal Welfare Act (AWA - includes new bird info)

The first legislation in the US to protect animals? (hint: farm animals)

28 hour law (1873), which required farm animals be provided food, water and rest at least once every 28 hours during transit

Animals used in research were first protected by which federal legislation, what species were covered in this Act?

1966 called the Laboratory Animal Welfare Act (cats, dogs, nonhuman primates, rabbits, hamsters, and guinea pigs)

Dog and cat dealers (if the animals crossed state lines) and laboratories (if received federal funding or animals crossed state lines) were required to be licensed/registered and to provide identification for the animals.

Laboratory Animal Welfare Act authorize which entity ? Who specifically enforces the regulations?

Authorized USDA to develop and enforce these regulations

APHIS enforces the regulations

In 1970 The Laboratory Animal Welfare Act was amended to include what?

-The name was changed to Animal Welfare Act

-Scope expanded to include all warm-blooded animals used for teaching, exhibitions, and wholesale. Exempted were agricultural exhibitors and pet stores.

-In-state and interstate transported animals all now fell under USDA's oversight.

-Requirement for the appropriate use of anesthetics and other tranquillizing drugs during animal experiments. It covered care standards for animals during research.

-Required each animal facility to submit an annual report with assurance

The 1976 Animal Welfare Act amendment resulted from what public concern?

1976- added the key changes to standards of shipment and fighting

-It prohibited interstate promotion or shipment of animals for fighting venues.

-It also refined standards for transporting animals and expanded upon the definition of a "carrier" - (any enterprise transporting regulated animals) and required these transporters to be licensed.

-The 1976 amendment established standards for shipping containers, feed, water, rest, ventilation, temperature, and handling in order to promote better care for animals during their transport.

The 1985 Animal Welfare Act amendment was included in which Act?

-The Food Security Act of 1985

-Improved Standards for Laboratory Animals Act

-Include exercise requirements for dogs and psychological well being for non-human primates as a minimum standard

-Mandated the establishment of IACUCs to oversee animal care and use at registered institutions.

-IACUC is responsible for ensuring that alternatives to animal use were explored when experiments involved pain or suffering or were unnecessarily duplicative in nature.

-Creation of the Animal Welfare Information Center (AWIC).

When was the fourth amendment to the AWA passed by the Congress?

-The fourth amendment of the Act was the Pet Theft Act of 1990

-Established a 5 day holding period for dogs and cats held at pounds and shelters or research facilities (plus Saturday)

What other amendments to the AWA were passed by the Congress?

-2002 amendments to the Animal Welfare Act

-In 2002, an amendment to the AWA was added in the Farm Bill that redefined the term animal in the law to match the current definition in the regulations. This change means that the definition of animal in the AWA excludes "birds, mice of the genus Mus, and rats of the genus Rattus, bred for use in research" from the definition of animal.

Define an animal according to the AWA

-Any living or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit or any other warm-blooded animal which is being used for research, teaching, testing, experimentation or exhibition purposes or as a pet.

-Excludes:

Birds, rats (genus Rattus), mice (genus Mus) bred for use in research

Horses not used for research

Other farm animals used for food/fiber, improving animal nutrition, breeding, management, production efficiency

Amphibians, reptiles, fish, invertebrates

According to AWA, elementary/secondary school is not considered research facility (T or F)

True

According to AWA, what is excluded from dealers?*

- retail pet stores

-<$500 income & not selling animals other than dog, cat, wild

According to AWA, what is excluded from exhibitors?

- Retail pet stores

- Racing

- owner/household pet who derives less than substantial portion of income from a nonprimary source

- State and county fairs

- Livestock shows

- Rodeos

-falconry

-Purebred dog and cat shows, bird fancier shows

- intended to advocate for ag science

Who enforces regulations from PHS?

OLAW

What is the definition for animal based on PHS? What is excluded?

Animal: Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. also covers zebrafish immediate after hatch

Excludes

• non-vertebrate animals

• embryonated chicken eggs

•dead animals

Which entity wrote Guide?

ILAR

What is the definition for animal based on the Guide? What is excluded?

Animal: Any vertebrate animal (i.e., traditional laboratory animals, agricultural animals, wildlife, and aquatic species) produced for or used in research, testing, or teaching.

Excludes

• Ag animals used in production

• Ag research or teaching

• Wildlife or aquatic species studies in natural settings

•Invertebrates used in research

Which animal use/species is covered by the Animal Welfare Regulations?

a. Research to improve Coturnix coturnix japonicum egg production

b. Testing botulinum toxin potency in Mus musculus

c. Exterminating a wild Rattus norvegicus in your garage

d. Antibody production technique research in Gallus gallus domesticus

e. Use of Peromyscus leucopus as a model in research on aging

E. white footed mouse

Based on AWA, how many IACUC members are required? What role?*

3 members (chair, DVM, non-affiliate)

Based on PHS, how many IACUC members are required? What role?*

5 members (DVM, scientist, nonscientist, non-affiliate)

Based on Guide, how many IACUC members are required? What role?*

4 roles (DVM, scientist, non-scientist, non-affiliate)

Which two regulations require reviewing facility and program once every 6 months?

PHS and AWA

How often should the facility and program be reviewed based on the Guide?*

• Review program and facility annually

• Annual protocol update, triennial review

What are the responsibilities of IACUC inspection and frequency?

-Must conduct semiannual inspection of all study areas and animal facilities

-Retain inspection reports for 3 YEARS

-IACUC reviews training (facility is responsible for providing training)

Humane practices

Reduce pain/distress

Using National Ag Library (prevent duplication)

How to report deficiencies

What are the dealer licenses class based on AWA?

-Class A ain't from anywhere else Breeder

Animals are bred and raised on the premises, or acquired to maintain the colony

-Class B broker Dealer

Animals are purchased and/or/resold

i.e. brokers, auction operators (usually do not hold animals in any facilities)

-Class C Exhibitor

Animals for show or display to the public (may buy or sell to add to collection)

Circuses, zoos, animal acts, educational exhibits

Requires licensing of dealers and exhibitors and registration of research facilities

How often does USDA inspection occurs?

USDA inspects facilities annually

What does APHIS stand for?

Animal and Plant Health Inspection Service

When can APHIS perform an inspection?

7 AM to 7 PM Monday through Friday except on Federal holidays

Define the term "field study"

Study conducted on free-living wild animals in natural habitat

excludes any invasive procedure, anything that harms, or alters behavior of animal

Define a study area based on AWA

Any building, room, area or enclosure outside a core facility in which animals are housed for > 12 hours.

Define a satellite facility based on PHS

Any building, room, area or enclosure outside a core facility in which animals are housed for > 24 hours.

When are rabbits, chinchilla, or mink considered to be farm animals and therefore not covered under the AWA?

When they are raised for meat or fur

What defines an indoor housing facility?

Temperature within limits of species

Humidity 30-70%

Rapidly eliminates odors

Continuous connection: roof, floor, walls

At least one door for entry/exit, covered windows

What is a primary enclosure?

A structure or device used to restrict an animal to a limited amount of space.

What is a major operative procedure?

If a body cavity is penetrated and exposed or if it produces permanent impairment of physical or physiological functions.

How is a painful procedure defined by the AWA?

Anything that would reasonably be expected to cause more than momentary pain or distress in a human being, in excess of that caused by an injection or other minor procedure.

Define a research facility based on AWA

Any school, institution, organization, or person that uses live animals in research, tests, or experiments -AND-

Purchases or transports live animals -OR-

Receives funds under a grant, award, loan, contract

What are the exemptions from research facility based on AWA?

Excludes primary and secondary schools

May exempt facilities if they do not use live dogs/cats, and use only a small number of other animals

Define Institutional Official (IO)

Individual authorized to legally commit on behalf of the research facility

According to the AWA, what is a quorum of an IACUC?*

A majority of the members.

According to the AWA, who is responsible for appointing the IACUC?

CEO of research facility

According to the AWA, who is required to be members of the IACUC?

3 members are required. Two of which are the veterinarian and non-affiliated member.

What does sanitize mean?

To make physically clean and to remove and destroy to the maximum degree that is practical, agents injurious to health

Who is the Secretary referred to in the AWA?

The Secretary of Agriculture

When is an animal considered weaned?

Any animal that is accustomed to taking solid food, without nursing for a period of at least 5 days

Dog or cat obtained from animal pounds or shelters, auction, or from any person who did not breed and raise them on their premises

Random source

Who is exempt from obtaining a license?*

-Retail pet stores

-Any person selling that derives no more than $500 gross income from sales per year (except wild/exotic, dog/cat)

-Any person selling fewer than 25 dogs and/or cats per year to a research facility (born/raised on the premises)

-Any person who arranges for transportation or transports animals for shows, grooming, medical treatment, food, or fiber

-Any person maintaining a total of 4 or less breeding females on premises & only sells offspring for pets or exhibition

-food/fiber animals

-maintains 8 or fewer animals for exhibition

-personal use

-NEW - selling <200g pet birds equal to or <250g OR 8 pet birds > 250g

-Anyone with equal to or <4 raptors for exhibition & holds a valid permit from USFWS

A voluntary license, issued to any person selling fewer than 25 dogs or cats that are bred on the premises for research or teaching purposes, is what class?

Class A

All the following must be inspected for obtaining a license

Animals

Facilities

Vehicles

Equipment

Other premises used for the business

A licensee must file for license changes with how many days notice? Who must they notify?

- AC regional director

-90 days notice to obtain new license for changes in name, address, ownership, location, type of activity, or number of animals increases, or 3yr license expires, acquires animal that are group 5 or group 6 NHPs, hyenes, wild/exotic canids, big cats ,bears, or megaherbivores

-if you have bird on 3/23/23 - continue to operate under that license until it's expiration date

Demonstrating compliance - initial application

- inspected by APHIS (during business hours or other mutually agreeable time)

What can you do after initial application if you fail inspection?

- if fails inspection, 2 additional chances to become compliant (request re-inspection within 60 days of first for both inspections)

What happens if you fail the two inspections after the first initial failed inspection?

- If fail third inspection, OR fails to schedule re-inspect within 60 days, OR fails to submit timely appeal w/in 7 days cannot reapply for 6 months

- Appeal for a failed 3rd inspection must be received by the Deputy Admin within 7 days of applicant receipt of the failed third inspection report (must be WRITTEN statement contesting the inspection findings and include any documentation or other info in support of appeal)

- Deputy administrator will response with written response within 7 days of receiving appeal

The license for the facility may be transferred to a new owner. T/F

False - The license is issued to a specific person for a specific premises and does not transfer to a different person or location.

No person shall have more than one license

If initial license application is denied, how long until you can reapply?

- can request expedited hearing w/in 30d, but if denial is upheld:

-One year from final order

How often does a license need to be renewed?

License is issued for 3 years (reapply within 90 days of expiration, form 7003)

When can the DA give a temp license? how long does the license last?

-for 120d after 3yr expires IF applicant submits appropriate app form before expiration date of past license and application has no non-compliances

-If its expired/terminated - must follow procedure for new applicants

When must you appeal inspection report if you don't like it?

A written statement contesting the inspection findings must be received by the Deputy Admin within 21 days of the date the licensee received the inspection report

Can an employee of licensees who have had their license revoked by licensed as a carrier, IH, dealer, exhibitor or research facility during the licensees suspension/revocation?

Yes, but ONLY if they were not responsible nor did they participate in the cat that causes the suspension/revocation

Other than research facilities, who is required to register?

Carriers, intermediate handlers, exhibitors not required to be licensed

How often must registration of research facility be renewed?

Every 3 years

A research facility registrant must notify the Deputy Administrator by certified mail of which changes within 10 days?

Name

Address

Ownership

Change in status

A research facility registrant may be placed in an inactive status after ...... (time period) of not using, handling, or transporting animals.

2 years

Notify AC Regional Director in writing _____ before resuming activities after being on inactive status. What form specifically needs to be filled out for research facilities?

10 days, 7011A

How does a registrant request to cancel a license (going out of business or ceasing to function)?

He or she must make a written request to the Deputy Administrator.

What kind of facility is exempt from registering with the Secretary?

Federal research facilities

What is the notification of change form?

APHIS 7033

Each research facility must register with the Secretary for the state in which the facility is located and registration must be updated every ____ years?

3 years

How many IACUC members?

IF >3 members, no more than __ members may be from same admin unit

3 members: Chairman, DVM (training, authority), non-affiliate (not family)

• If >3 members: NMT 3 members from same admin unit

What is the minimum number of IACUC members required on a subcommittee performing a program review / inspection?

Two (and may add ad hoc consultants)

The inspection report must be reviewed and signed by a majority of IACUC members and updated once every 6 months based on AWA? T/F

True (must include minority views)

Functions of the IACUC (AWA)

Program review every ___ months

Facility inspection every ____months

Prepare and submit reports to ____*

6 months

6 months

IO

Review, investigate concerns involving the care and use of animals

Make recommendations to IO

Review and approve, require modifications, or withhold approval of activities or significant changes

Suspend an activity if needed

What areas are subject to inspection by IACUC based on AWA?

All study areas, not field areas

Who decides what a significant deficiency is based on AWA?

IACUC and IO

What is usually considered a significant deficiency?

threats to health/safety of animals only

Time period to report this failure to a plan or schedule for fixing significant deficiencies that remain uncorrected is?*

15 business days

AWA-Failure to adhere to a plan or schedule for fixing significant deficiencies that remain uncorrected must be reported in writing by the __________, through the ___________, to ______________ AND ____________.

IACUC, IO, APHIS and Federal funding agencies

AWA - Major survival surgeries must be performed where? What species are excluded from this?

-designated facilities using aseptic techniques

-rodents and birds

AWA - Minor, rodent, and bird surgeries must be performed how?

using aseptic technique, designated facility not required

The limit for number of major survival surgeries on one animal is ____. What are the exceptions?

One

-unless scientifically justified and approved by the IACUC, required for health by AV, case by case determined by admin of AHPIS

A designated reviewer of a protocol has the authority to do the following:

Approve the activities

Require modifications of the activities

Request full Committee review

can't do what?

Designated review: can't withhold approval

If a full committee review is not requested, at least ___ IACUC member(s) designated by the chairman shall perform the review?

one

A protocol that is going before the committee in full review can be approved under what conditions?

Convened meeting

Quorum of the IACUC

Approval vote of a majority of the quorum present

How often must continuing review of approved activities occur?

Every 3 years in line with 21st Century Cures

Does the Chairman of the Committee have the authority to suspend any activity that is not being conducted in the manner approved?

No - An activity may be suspended only after a full committee review and majority vote.

-IO reports to aphis and federal funding agency

How often must protocols be re-reviewed by IACUC?

3 years

Proposed significant changes in ongoing activities can be reviewed/approved by officials in research facility. Officials cannot approve what?

activities if they have not been approved by IACUC

A proposal to make a significant change to ongoing activity involving animals must contain what?

● Identification of species & approximate # of animals to be used

● Rationale for species and number of animals used

● Description of use

● Description of procedures to assure discomfort and pain will be limited

Description of any euthanasia method used

Who is responsible for ensuring all personnel involved in animal care are properly qualified?*

The research facility

Name the areas in which training and instruction must be provided to research personnel.

-Humane methods of animal maintenance and experimentation (including basic needs, handling, aseptic surgical methods, pre/post op care),

-The need to limit the use of animals or minimize distress,

-Proper use of anesthetics and analgesics,

-How to report animal misuse, and how to access information on methods and alternatives to animal use.

-How to use AWIC

The duties of the attending veterinarian:

-Be a voting member of the IACUC (can appoint another DVM)

-Have the appropriate authority to ensure the adequate veterinary care of all animals

-Daily observation of all animals

-Guidance to the principal investigators and other research personnel

What specifically is not the responsibility of the AV?

training

Part-time veterinarians for research facilities (as well as exhibitors/dealers) need to have what?

Written program of veterinary care (APHIS 7002)

What must be included in IACUC records?

1) Meeting minutes (attendance, activities, committee deliberations)

2) Proposed animal activities, significant changes, IACUC approval given or nah

3) Semiannual IACUC reports, recommendations, minority views

Each live dog or cat purchase must have the following information in the record:

1) Name/address of source

2) USDA license/registration number

3) Vehicle license number/State, driver’s license number/State (if not registered/licensed)

4) Date of acquisition

5) USDA tag number or tattoo

6) Description (species, breed, sex, age, color/markings)

7) Identification given by facility

8) Certify animals born on premise and person sold <25 dogs/cats (if not licensed/registered and not a shelter)

When transporting/selling/disposing dogs or cats, what info must be included?

1) Name and address of recipient

2) Date of transportation/sale/euthanasia

3) Method of transportation, name of initial carrier/IH or name of person who used POV (privately owned vehicle)

4) APHIS 7001 (health cert form)

5) APHIS 7005 or 7006 form (acquisition or disposition form respectively)

Who keeps a copy of the records?

1 copy goes with shipment/disposition & one stays with research facility

How many years to keep records of disposition of dog/cat (transported/sold and to whom, euthanized, method of transportation)?*

Keep records for 3 years or 3 years after completion of project (whichever is longer)

When is this record governed under the freedom of information act?

when it contains photos, reports, or summaries of trade secrets or commercial/financial info

The annual report should be submitted on or before _____, and covers the previous fiscal year.*

December 1 (covers OCT 1- SEP 30), signed by CEO/IO; no minority views. Form 7023

The annual report to the USDA should contain the following information*

-Location of all facilities where animals were housed and used for teaching or research

-Common names and numbers of animals used in one of three pain categories, common name and number of animals being bred

-Summary of all exceptions

-Signed by the CEO or IO (not IACUC)