Animal Welfare Act

Question 1

According to the AWA what is a farm animal?

Answer 1

1. Mink, Chinchilla, and Rabbit (if used for meat or fur)
2. Horses and Llamas (if used as pack animals)
3. Traditional farm animals

(P.21 AWA)

Question 2

What do the AWRs say about multiple major survival surgery?

Answer 2

The AWRs state that animals may not be used in these procedures unless:
- there is a scientific justification (eg. related components of the same study) provided by the PI in writing
- the MMSS are required as a routine veterinary procedure or to protect the health and well-being of the animal, as determined by the attending veterinarian
- under other special circumstances which have been approved by the Administrator of APHIS

Question 3

AWRs (9CFR Part 2, Subpart C, Section 2.32(c)(4)) states:

Answer 3

No facility employee, committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the [Animal Welfare] Act

Question 4

Why was the AWA created?

Answer 4

Regulation of animals and activities in this act are necessary to prevent and eliminate burdens upon commerce and to effectively regulate such commerce in animals and related activities:

• to ensure that animals intended for use in research facilities, for exhibition purposes, or for use as pets are provided humane care and treatment
• assure the humane treatment of animals during transportation in commerce
• to protect the owners of animals from the theft of their animals by preventing sale or use of stolen animals

Congress further finds that it is essential to regulate the transportation, purchase, sale, housing, care, handling, and treatment of animals by carriers or by persons / organizations engaged in using them for research, experimental, or exhibition purposes, or holding them for sale as pets or for any such purpose or use.

Question 5

What is the difference between the AWA and AWRs?

Answer 5

AWA is federal law
AWRs are the associated regulations that interpret the law into enforceable standards

USDA can amend existing regulations and/or create new regulations, but only Congress can change the actual law.

Question 6

What is Commerce according to the AWA?

Answer 6

Trade, traffic, transportation, or other commerce -

• between a place in a state and any place outside such state, or between points within the same state but through any place outside thereof, or within any territory, possession, or the District of Columbia
• which affects trade, traffic, transportation, or other commerce

Question 7

What is a Research Facility according to the AWA?

Answer 7

Any school (except elementary/secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments, and that

• purchases or transports live animals in commerce

OR

• receives funds under a grant, etc. from any part of the US government for the purpose of carrying out research, tests, or experiments

The Secretary may exempt any of these organizations that does not intend to use live dogs or cats, except those organizations which use substantial numbers of live animals for research purposes

Question 8

What is an animal according to the AWA?

Answer 8

Any live or dead dog, cat, monkey (NHP), guinea pig, hamster, rabbit or such other warm- blooded animal used (or intended for use) in research, exhibition, or as a pet. Also includes dogs used for hunting, security, or breeding purposes.

Excludes
- Birds, Rats (Rattus), Mice (Mus) bred for use in research
- horses not used for research purposes
- other farm animals used for food/fiber or for improving animal nutrition, breeding, management, production efficiency, or quality improvements of food/fiber

Question 9

What does the AWA include/exclude as an exhibitor?

Answer 9

• Includes anyone exhibiting animals for commerce purposes
• Includes zoos/carnivals/circuses (public/private profit or not)
• Excludes retail pet stores
• Excludes owners of common domesticated house pets who gets less than a substantial portion of income for exhibiting an animal that lives at the person’s residence
• Excludes sponsors/participants at fairs, ag shows, rodeos, purebred cat/dog shows, livestock shows

Question 10

Time period for disposal of dogs or cats by dealers or exhibitors

Answer 10

No sale or other disposal of a dog or cat within five business days after the acquisition of such animal (or as otherwise specified by the Secretary)

Question 11

Purchase of dogs or cats by research facilities prohibited except from authorized operators of auction sales and licensed dealers/exhibitors, also applies to who?

Answer 11

This also applies to US government facilities

Question 12

Recordkeeping Requirements according to the AWA?

Answer 12

Research facilities shall make and retain records related to the purchase, sale, transportation, identification, and previous ownership of live dogs and cats.

Question 13

Marking and ID of animals per the AWA?

Answer 13

All animals delivered for transportation, transported, purchased, or sold, in commerce, by a dealer or exhibitor shall be marked or identified, provided that only live dogs or cats need to be so marked or identified by a research facility

Question 14

Species specific call outs from the AWA regarding adequate care for animals

Answer 14

1. Provision of exercise for dogs (per AV devised program)
2. Provision of a physical environment adequate to promote the psychological well being of primates

Question 15

Items to consider as requirements for ensuring standards for animal welfare in research facilities according to the AW

Answer 15

1. Animal care, treatment, and practices that minimize animal pain and distress including appropriate use of analgesics, anesthetics, tranquilizing drugs, or euthanasia:
   
   • PI considers alternatives to painful/distressful procedures
   • for procedures which may cause pain, a DVM should be consulting in planning the procedures, for the use of tranquilizers, analgesics, and anesthetics, as well as pre- and post surgical care. No paralytics without anesthesia, and withholding of pain / stress relieving measures shall be for the minimum duration of time.
   • No animal used in more than one major operative procedures with recovery unless scientifically necessary.
   • Exceptions to these standards must be specified in writing and explained and on file with the IACUC

Question 16

According to the AWA, what information is a research facility required to present upon inspection and at least annually?

Answer 16

• Report that the provisions of the AWA are being followed and that professionally acceptable standard governing the care, treatment, and use of animals are being followed by the research facility during actual research/experimentation. This is done via providing:

1. Info on procedures likely to produce pain or distress in any animal and assurances demonstrating that the PI considered alternatives.
2. Satisfactory assurances that such facility is adhering to the standards within this section
3. Explanation for any deviation from the standards within this section

Question 17

AWA requirements for veterinary certificate, contents, exceptions

Answer 17

No dogs or cats or other classes of animals designated by the Secretary shall be delivered without a certificate issued by the veterinarian that animal has been inspected and found to be of good health no longer than 10 days before delivery.

The Secretary may provide exceptions under the regulations for animals shipped to research facilities which require animals not eligible for such certification.

Minimum ages may be established for transportation of animals

Question 18

What does the AWA say about C.O.D. arrangements for animal transportation?

Answer 18

Not allowed, unless the provider of such animals guarantees in writing the payment of transportation charges for any animal not claimed within 48 hours. This promised payment must also include any additional costs incurred (return transport charges, cost of care, feeding, storage of such animals).

Question 19

What is a class A licensee?

Answer 19

A dealer (breeder) whose business involving animals consists only of animals bred and raised on the premises in a closed or stable colony and those animals acquired for the sole purpose of maintaining or enhancing the breeding colony.

“Purpose-bred dealer”

Question 20

What is a class B licensee?

Answer 20

A dealer whose business includes the purchase and/or resale of any animal.

Includes brokers and operators of auction sales as such individuals negotiate or arrange for the purchase, sale, or transport of animals in commerce.

“Random-source dealer”

Question 21

What is a class C licensee?

Answer 21

An exhibitor whose business involves the showing or displaying of animals to the public. May buy or sell animals as a minor part of the business in order to maintain or add to the animal collection.

Question 22

How often must an institution’s registration with USDA be updated, and who must receive it?

Answer 22

AWA 2.30 -
Update registration every 3 years (complete a new official form provided by AC Regional Director)

Must be filed with AC Regional Director

Question 23

How long does a research institution have to notify the AC Regional Director of a change in the name, address, ownership, or other change in operations that affect the institution’s status as a research facility?

Answer 23

Within 10 days after making such change

Question 24

(Legacy) A research facility which has not used, handled, or transported animals for a period of at least 2 years may be placed in what status?

Answer 24

Inactive. Must inform AC Reg Director at least 10 days in advance before using, handling, or transporting animals again.

This is no longer the case, as USDA now only has registered or unregistered research facilities. (Jan 12, 2022)

Question 25

What is the process for cancelling a research facility’s registration?

Answer 25

Make a written request to AC Regional Director

Question 26

Functions of the IACUC according to AWRs?

Answer 26

Review, at least once every 6 months the research facility’s program for humane care and use of animals.

Inspect, at least once every 6 months, all of the research facility’s animal facilities including animal study areas (not including areas containing free-living wild animals in their natural habitat)

Prepare reports of these evaluations and submit these reports to the IO. The IACUC may determine the best means of conducting evaluations of the research facility’s programs and facilities. No committee member wishing to participate in any evaluation may be excluded.

The reports shall be reviewed and signed by a majority of the IACUC members and must include any minority views. Shall be made available to USDA-APHIS and federal funding agencies for inspection and copying upon request.

Deviations from AWR standards must be documented and explained, and deficiencies categorized as minor or major, with a schedule and plan to correct the deficiency.

Review, and if warranted, investigate concerns regarding the care and use of animals at the research facility resulting from public reports / reports of non-compliance received from lab or facility personnel

Make recommendations to the IO regarding any aspect of the research facility’s animal program, facilities or personnel training

Review and approve, require modifications in, or withhold approval of proposed significant changes regarding the care of use of animals in ongoing activities.

Be authorized to suspend an activity involving animals

Question 27

According to the AWRs what records must a research facility maintain?

Answer 27

Minutes of IACUC meetings, incl. attendance records, committee activities, committee deliberations

Records of proposed activities and proposed significant changes, whether IACUC approval was given or withheld

Records of semi-annual IACUC reports and recommendations

For each live dog or cat obtained/held/transported:
- name and address of the person from whom the animal was obtained,
- USDA license or registration of source person (if they have one),
- vehicle license number and State, and Driver’s License number and State of the person if they don’t have a USDA license or registration
- date of acquisition
- official USDA tag number or tattoo assigned to each dog or cat
- description of each dog or cat including species and breed/type, sex, DOB or approximate age, color and any distictive markings
- any ID or mark assigned to each dog or cat by the research facility
- if obtained from a non licensed/registered individual nor a pound/shelter, the research facility needs a certification that the animals were born and raised on the person’s premises and that the person has sold fewer than 25 dogs and/or cats that year

For any disposition of a live dog or cat:
- name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of
- date of transportation, sale, euthanasia or other disposition
- method of transportation, including name of initial carrier or intermediate handler, or if a privately owned vehicle is used, the name of the owner of the vehicle.

APHIS forms 7001 (interstate and international certificate of health exam) and 7005 (record of acquisition and dogs and cats on hand) are forms which may be used to keep and maintain this requested info on dogs and cats

Question 28

What specific records must be retained by an institution regarding dogs and cats?

Answer 28

For each live dog or cat obtained/held/transported:
- name and address of the person from whom the animal was obtained,
- USDA license or registration of source person (if they have one),
- vehicle license number and State, and Driver’s License number and State of the person if they don’t have a USDA license or registration
- date of acquisition
- official USDA tag number or tattoo assigned to each dog or cat
- description of each dog or cat including species and breed/type, sex, DOB or approximate age, color and any distictive markings
- any ID or mark assigned to each dog or cat by the research facility
- if obtained from a non licensed/registered individual nor a pound/shelter, the research facility needs a certification that the animals were born and raised on the person’s premises and that the person has sold fewer than 25 dogs and/or cats that year

For any disposition of a live dog or cat:
- name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of
- date of transportation, sale, euthanasia or other disposition
- method of transportation, including name of initial carrier or intermediate handler, or if a privately owned vehicle is used, the name of the owner of the vehicle.

APHIS forms 7001 (interstate and international certificate of health exam) and 7005 (record of acquisition and dogs and cats on hand) are forms which may be used to keep and maintain this requested info on dogs and cats

The above information must accompany each shipment of a dog or cat sold or disposed of by a research facility. The facility must also retain a copy of these records as well.

Question 29

What are the required components of an annual report according to the AWRs?

Answer 29

Must be submitted on or before December 1 of each calendar year, signed and certified by the CEO/IO and covers the previous federal fiscal year.

It shall:

Assure that professionally acceptable standards were followed by the research facility

Assure that each principal investigator has considered alternatives to painful procedures

The sure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the PI and approved by the IACUC. Any such exceptions must be attached with an explanation as well as the species and number of animals affected.

The locations of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for those purposes must be stated

State the common names and numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain relieving drugs. (Routine procedures such as injections, tattooing, blood sampling would be reported here) (Pain Category C)

State the common names and the number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic analgesic or tranquilizing drugs were used (Pain Category D)

State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate pain relief would have adversely affected the procedures, results, or interpretation of the procedures. An accompanying explanation of the pain or distress causing procedures and the reasons for withholding the pain relieving drugs must be attached (Pain Category E)

State the common names and numbers of animals being bred, conditioned, or held for use in research activities but not yet used for such purposes (Pain Category B)

Question 30

Identification of dogs and cats

Answer 30

At the time of delivery for transportation, purchase, sale, disposal, or acquisition, all live dogs or cats must be identified in one of the following ways:

• By the official tag or tattoo which it was fixed to the animal at the time it was acquired by the research facility
• By a tag, tattoo, or collar, applied to the dog or cat by the research facility and which individually identifies the dog or cat by number.

All official tag or tattoo numbers shall be correctly listed in the records of purchase/acquisition/disposal/sale

Unweaned puppies or kittens need not be individually identified while housed in the same primary enclosure as the dam, who is individually identified.

Question 31

Requirements for dog/cat tag materials and dimensions

Answer 31

Made of durable alloy such as brass, bronze, or steel, or of durable plastic. Aluminum of a sufficient thickness to assure the tag is durable and legible may also be used.

Tag maybe circular in shape and not less than 1.25 inches diameter

Tag may instead be oblong and flat in shape and not less than 2 inches x 0.75 inches and riveted to an acceptable collar.

Question 32

What information is required on a dog or cat tag?

Answer 32

Info must be embossed or stamped, legible and easy to read:

• The letters USDA
• Numbers identifying the state and dealer/exhibitor/research facility (such as 39-AB)
• Numbers identifying the animal

Tags shall be serially numbered and applied to dogs/cats in as close to consecutive numerical order as possible.

No tag number shall be used to identify more than one animal or shall be reused within a 5-year period.

Question 33

Guidance on the use and application of tags to dogs or cats

Answer 33

Each research facility shall be held accountable for all official tags acquired. In the event an official tag is lost from an animal while in the possession of a research facility, The facility shall make a diligent effort to locate and reapply the tag to the proper animal. If the last tag is not located, the research facility shall affix another official tag to the animal and record the tag number on the official records.

When a dog or cat with an official tag arrives at a research facility, the facility may continue to use that tag to identify the dog or cat or the tag may be replaced with another official tag produced by the research facility.

Where a dog or cat which is identified by an official tag as euthanized, or dies from other causes, the research facility shall remove and retain the tag for the required period (All official tags removed entertained by a research facility shelby-held until called for by an APHIS official or for a period of one year)

When official tags are removed from animals for disposal, the tags must be disposable so as to preclude their reuse for animal ID (such as in the case of the receiving facility replacing the tag with another tag after receipt)

Question 34

Which species require a research facility to execute and issue a health certificate by a licensed veterinarian accompanying an animal delivered to an intermediate handler or carrier for transportation?

Answer 34

Dogs, cats, NHPs

Question 35

Guidance from the AWRs regarding holding animals for a research facility.

Answer 35

Prior approval must be provided by the AC Regional Director

The person holding the animals must agree in writing to comply with the regulations of the AWRs and allow inspection of the premises by an APHIS official during business hours.

The animals must remain under total control and responsibility of the research facility.

The IO must agree in writing that the holding person/premises are a recognized animal site under its research facility registration (use APHIS form 7009 for approval)

The holding person or promises must either be directly included in the research facility’s contingency plan or must develop its own contingency plan

Question 36

What is the holding period for research facilities obtaining dogs and cats from sources other than dealers, exhibitors, and exempt persons?

Answer 36

5 full days, not including the day of acquisition. This excludes time in transit.

This period must elapse before an animal may be used by the facility.

Question 37

Contingency Plan Details [update]

Question 38

Temperature requirements for dogs and cats according to the AWRs?

Answer 38

Ambient temp must be above 50°F/10°C for animals not acclimated to lower temps, for short haired or other cold-intolerant breeds, sick, aged, or young animals except as approved by AV.

Dry bedding, solid resting boards, other methods of conservation of body heat must be provided when temps below 50’F/10’C.

Ambient temp must not fall below 45’F/7.2’C and must not rise above 85’F/29.5’C for more than 4 consecutive hours.

If at or above 85’F, additional ventilation such as fans, blowers, A/C must be provided

Question 39

What are necessary components of shelter for outdoor - houses dogs and cats?

Answer 39

Shelter must consist of a roof, four sides, and a floor.

Must provide the dogs and cats with adequate protection and shelter from the cold and heat

Must provide the dogs and cats with protection from the direct raise of the Sun and the direct effect of wind, rain, or snow

Must be provided with a windbreak and rain break at the entrance

Must contain clean, dry, bedding material If the ambient temperature is below 50°F, additional clean / dry bedding is required when the temperature is 35°F or lower