USDA

Question 1

USDA Requirements for Continuing Review

Answer 1

Complete re-review of the project at least once every three years.

Formerly no less often than annually.

[Add citation here]

Question 2

USDA Regulations on Scientific Value

Answer 2

1. Rationale for… and… appropriateness of the species and numbers of animals [2.31(e)(2)]
2. Activities do not unnecessarily duplicate previous experiments [2.31(d)(ii)(iii)]
3. Procedures… for the conduct of scientifically valuable research [2.31(e)(4)]

Question 3

USDA IACUC Composition Rules

Answer 3

Minimum of 3 people (chairperson + 2 others)

Must contain:
Veterinarian with program authority
Non-affiliated member

No more than three individuals from one administrative unit, wherever possible (whenever the committee consists of more than three members).

Each committee shall be appointed by the chief executive officer of the research facility

Question 4

USDA Policy #11

Answer 4

Painful Procedures

Question 5

USDA Policy #3

Answer 5

Veterinary Care
(July 2007)

Question 6

USDA Policy #12

Answer 6

Consideration of Alternatives to Painful / Distressful Procedures
(June 2000)

Question 7

USDA Policy #14

Answer 7

Major Survival Surgery, Single vs. Multiple Procedures
(April 1997)

Question 8

USDA Policy #15

Answer 8

IACUC Membership
(March 2006)

Question 9

USDA Policy #17

Answer 9

Annual Report for Research Facilities
(August 2006)

Question 10

USDA Policy #26

Answer 10

Regulation of Agricultural Animals
(Nov 1998)

Question 11

USDA Policy #28

Answer 11

Licensing Sales of Dead Animals
(Sept 1999)

Question 12

USDA Policy #29

Answer 12

Farm Animals Used for Non-agricultural Purposes
(Feb 2000)

Question 13

USDA Policy #22

Answer 13

Necropsy Requirements
(Oct 1998)

Question 14

Per USDA, how often must an IACUC meet?

Answer 14

Not addressed

Question 15

What is the USDA’s definition of an ANIMAL?

Answer 15

Includes any live or dead warm-blooded animal excluding:
- Birds
- Rats of genus Rattus bred for use in research
- Mice of genus Mus bred for use in research
- Horses not used for research purposes
- Farm Animals, including livestock and poultry, used or intended for use as food or fiber or in agricultural research
- Fish
- Invertebrates

Question 16

Who owns the USDA license?

Answer 16

USDA licenses are granted to a specific person for a specific property.
They do not transfer ownership or properties.

Question 17

What species of animals are covered by the USDA?

Answer 17

Any warm blooded animal to be used by a “research facility” in “activities”, as defined previously, except birds, rats (Rattus), mice (Mus) bred for use in research, and horses or other farm animals used or intended for use as food or fiber.

Question 18

USDA Requirements for Inspecting Specific Locations Semi-annually

Answer 18

Must inspect anywhere an animal is held for more than 12 hours

Question 19

What document is the basis for semi-annual review from the USDA standpoint?

Answer 19

Title 9, Chapter 1, Subchapter A - Animal Welfare

Question 20

Which regulations require IACUC members to be presend for the semi-annual inspection and how many?

Answer 20

USDA AWRs require 2 IACUC members (and no IACUC member wishing to participate may be excluded)

Question 21

AWRs (sec 2.32c) require what training?

Answer 21

1. Humane methods of animal maintenance & experimentation
2. The concept, availability & use of research or testing methods that limit the use of animals or minimize distress
3. Proper use of anesthetics, analgesics, and tranquilizers
4. Methods whereby deficiencies can be reported
5. Utilization of services available to provide information on:
   a) methods of animal care and use
   b) alternatives to use of live animals
   c) unnecessary duplication of research involving animals
   d) intent and requirements of the AWA

Question 22

Which regulations (PHS or USDA) require you to consider alternatives to procedures that may cause more than momentary or slight pain or distress?

Answer 22

USDA AWRs

These require that investigators consider alternatives to procedures that may cause more than momentary or slight pain or distress and provide a written narrative of the methods used and sources consulted to determine availability of alternatives.
Animal Care Policy 12 provides guidance on the requirements for the written narrative

Question 23

USDA requirements on reporting are essentially the same as those for PHS with three exceptions:

Answer 23

1. The AWRs include additional reporting requirements if the schedule and plan for correcting a deficiency are not followed.
   - Failure to correct a significant deficiency in accordance with the specified schedule and plan must be reported in writing within 15 business days by the IACUC, through the IO, to APHIS and any federal agency funding the activity.
2. USDA requires that reports be reviewed and signed by a majority of IACUC members.
3. USDA does not require the identification of facilities accredited by AAALAC.