USDA Policies 11-20

Question 1

What example does USDA use as “momentary pain”?

Answer 1

injection or other minor procedure (policy 11)

Question 2

According to USDA, is terminal surgery considered something that may cause pain?

Answer 2

yes, policy 11

Question 3

What 3 examples are given in USDA Policy 11 that may cause pain/distress?

Answer 3

surgery, CFA, ocular or dermal toxicity testing

Question 4

When is thermal stimuli considered to potentially cause distress according to USDA Policy 11?

Answer 4

if it is inescapable, also electric shock

Question 5

What other examples does USDA list as potentially causing distress?

Answer 5

forced exercise, infectious or inflammatory models, paralysis or immobility in a conscious animal

Question 6

What examples does USDA provide as causing both pain and distress potentially?

Answer 6

irradiation, inhalation toxicity, tumor growth

Question 7

Which methods are not considered alternatives to painful or distressful procedures?

Answer 7

those that do no permit goals of the research to be accomplished (policy 12)

Question 8

What does USDA recommend as the best way to search for alternatives?

Answer 8

database search, one is rarely adequate

Question 9

What other sources of alternatives can be used in lieu of database searches?

Answer 9

info from consultants, conferences, colloquia

Question 10

What information should be provided to the IACUC if alternate sources of database searches are performed?

Answer 10

consultants name, date and content of consult and qualifications of consultant

Question 11

When database searches are used to look for alternatives, what information should be reported?

Answer 11

name of database, date of search, time period covered, search strategy

Question 12

What does AWIC stand for?

Answer 12

Animal Welfare Information Center

Question 13

Why was the AWIC established?

Answer 13

to provide information on alternatives to painful, distressful and animal procedures

Question 14

if animal testing is mandated, what information should be provided to the IACUC?

Answer 14

citation for mandate, guidelines from the requiring agency in case alternatives have been allowed

Question 15

How often should alternatives to animal, painful, and distressful procedures be considered?

Answer 15

minimum q3 years with denovo review that is required by PHS. (policy 12)

Question 16

If a facility wants to use microchips to identify animals, what is required according to USDA policy 13

Answer 16

place in standard location, scanner readily available to APHIS, records kept, if sold to another facility they must have scanner

Question 17

What records are required for microchipped animals?

Answer 17

microchip no., location on animal, name of microchip manuf.

Question 18

Licensees that wish to use tattoos to identify their animals, must contact which entity?

Answer 18

Animal Care Regional Office

Question 19

Identification codes for tattooing of regulated species must contain what information?

Answer 19

State and type of business. I.e. Maryland Class A dealer = MDAA - MDAZZ.

Question 20

Does USDA or the facility or dealer choose the unique animal identifier in addition to the code with the type of business and state?

Answer 20

facility or dealer

Question 21

What are the exceptions that allowe puppies

Answer 21

they are maintained as distinct litters where they were born, enclosure is labeled with all required information until they are sold or 16+wks age

Question 22

If a company sells surgically modified guinea pigs for auditory research, must they be registered?

Answer 22

yes, that is considered research

Question 23

Can a vendor selling surgically modificed guinea pigs for an auditory research project do so without IACUC approval?

Answer 23

yes, it is considered necessary for a single research project. IACUC approval of the project is needed, but no USDA exemption.

Question 24

Is some type of identification required for animals that have undergone major surgery for protocol purpsoes? Veterinary purposes?

Answer 24

yes for research, no for veterinary

Question 25

if animals are needed in separate studies, both of which require major procedures who is responsible for submitting a request to USDA?

Answer 25

IO

Question 26

When the IO submits a major procedure exemption to USDA, who in USDA is contacted?

Answer 26

Animal Care Regional Director receives submission and forwards to the Animal Care Deputy Administrator

Question 27

What form is used to submit the annual report to USDA?

Answer 27

Form 7023

Question 28

If the IO submits a request for exemption to major procedure requirements, is IACUC approval required before or after the submission to USDA is sent?

Answer 28

before, the submitted request for exemption should containe an assurance that the IACUC has approved the exemption for multiple major surgeries

Question 29

Once USDA has approved an exemption for multiple major surgeries, does the IACUC review it?

Answer 29

yes, annually and it should go on the annual report to NIH Director

Question 30

Which regulatory document requires an IACUC Chair on the committee?

Answer 30

AWRs but NOT the AWA

Question 31

What is USDA’s stance on having one person fulfill multiple roles on the IACUC?

Answer 31

They strongly discourage it due to potential for conflict of interest (PHS and Ag Guide allow it)

Question 32

Describe IO vs. CEO

Answer 32

CEO is highest ranking official at an institution (PHS), IO is legally authorized to commit on behalf of facility that requirements of regulations are met and enforce policies across depts (USDA and PHS). IO per The Guide=person bears ultimate responsibility for program

Question 33

A registered research facility would like their nonaffiliated member to be an individual that works with mice at another local facility, is this ok with USDA?

Answer 33

no, they recommend nonaffiliated members not be laboratory animal users (The Guide also says this

Question 34

Can nonaffiliated members of the IACUC be compensated for their work?

Answer 34

Yes, if the amount is not a significant source of income or affects their voting (policy 15 and The Guide)

Question 35

When can IACUC members review their own protocol?

Answer 35

never (PHS, policy 15 and AWRs)

Question 36

What does FASS stand for?

Answer 36

Federation of Animal Science Societies

Question 37

Livestock are used for training in various procedures, when are they considered regulated by USDA vs. exempt?

Answer 37

Medical or Veterinary procedures for diagnostics, surgery etc are regulated, farm management procedures like hoof trimming, breeding etc are exempt

Question 38

Which farm animal exhibits are regulated by USDA?

Answer 38

if they also have nonag animals, if they are at a nonag location, if main reason is for public contact or photo ops (petting zoo etc). Exempt includes: advancing ag knowledge, livestock shows, educational settings regarding farm life, incidental exhibition (ie people drive by a farm to view animals)

Question 39

When are health certificates NOT required for dog, cat, NHP transport?

Answer 39

if it is intrastate AND in private vehicle (policy 18)

Question 40

what is the only recommended way to trap praire dogs according to USDA

Answer 40

humane traps that do not injure and are checked frequent enough to allow animal access to food and water

Question 41

A vendor selling dead animals or animal parts is required to be licensed under what circumstances according to USDA Policy 20?

Answer 41

euthanizes the animal to be sold, acquires dead dog or cat from unlicensed source. Exempt: acquires dead animal (other than dog or cat) for sale, dead dog or cat is acquired from licensed source or govnt pound or shelter.