ALAT Regulations and Compliance 5 — Questions and Answers
Question 1: Under the Animal Welfare Act, which federal agency is responsible for inspecting research facilities that use regulated animals?
- FDA
- USDA APHIS (Correct answer)
- NIH OLAW
- EPA
Correct answer: USDA APHIS
USDA APHIS (Animal and Plant Health Inspection Service) conducts unannounced inspections of AWA-regulated research facilities.
Question 2: The 'three Rs' framework in animal research stands for which of the following?
- Reduce, Refine, Replace (Correct answer)
- Report, Record, Review
- Regulate, Research, Respond
- Restrict, Reuse, Reassign
Correct answer: Reduce, Refine, Replace
The three Rs—Replace, Reduce, and Refine—are guiding principles for minimizing animal use and suffering in research.
Question 3: An IACUC must include which of the following members at minimum?
- A veterinarian, a scientist, a non-scientist, and a non-affiliated member (Correct answer)
- A veterinarian, two scientists, and a statistician
- A facility director, a veterinarian, and an ethicist
- Two veterinarians and a community representative
Correct answer: A veterinarian, a scientist, a non-scientist, and a non-affiliated member
Federal regulations require an IACUC to include at minimum a veterinarian, a practicing scientist, a non-scientist, and a member unaffiliated with the institution.
Question 4: Which document must a research facility file with USDA APHIS annually under the Animal Welfare Act?
- Institutional Animal Care and Use Protocol
- Annual Report of Research Facility (Correct answer)
- Assurance of Compliance
- Occupational Health and Safety Plan
Correct answer: Annual Report of Research Facility
Registered research facilities must submit an Annual Report to USDA APHIS detailing animal usage and pain/distress classifications.
Question 5: Pain and distress categories in USDA annual reports are classified using which system?
- Categories I through V
- Columns B, C, D, and E (Correct answer)
- Levels 1 through 4
- Classes Alpha through Delta
Correct answer: Columns B, C, D, and E
USDA annual reports use Columns B, C, D, and E to classify animals by the level of pain, distress, or use of pain-relieving drugs.
Question 6: Which federal law specifically requires institutions receiving PHS funding to establish an animal care and use program consistent with the Guide for the Care and Use of Laboratory Animals?
- Animal Welfare Act
- Public Health Service Policy (Correct answer)
- Laboratory Animal Welfare Act
- Federal Research Protection Act
Correct answer: Public Health Service Policy
The PHS Policy on Humane Care and Use of Laboratory Animals requires PHS-funded institutions to follow the Guide and maintain an Animal Welfare Assurance with NIH OLAW.
Question 7: If an ALAT observes that a colleague is not following an approved IACUC protocol during a procedure, what is the most appropriate immediate action?
- Complete the procedure first, then report it at the next staff meeting
- Report the deviation to the supervisor or veterinarian promptly (Correct answer)
- Ignore it if the animals appear healthy
- Document it only in personal notes
Correct answer: Report the deviation to the supervisor or veterinarian promptly
Protocol deviations must be reported promptly to a supervisor or veterinarian so corrective action and required IACUC reporting can occur.
ALAT Regulations and Compliance 5
Under the Animal Welfare Act, which federal agency is responsible for inspecting research facilities that use regulated animals?