ALAT Regulations and Compliance 2 — Questions and Answers
Question 1: Which federal agency enforces the Animal Welfare Act?
- FDA
- USDA-APHIS (Correct answer)
- EPA
- OSHA
Correct answer: USDA-APHIS
USDA-APHIS (Animal Care division) enforces the AWA through registration, unannounced inspections, and enforcement actions.
USDA-APHIS Animal Care conducts unannounced inspections of all registered research facilities. Violations result in citations and potentially fines, suspensions, or cease-and-desist orders.
Question 2: What is the minimum composition required for an IACUC?
- Two scientists and one vet
- At least five members including a veterinarian, scientist, non-scientist, and unaffiliated member (Correct answer)
- Any three employees
- One vet and one administrator
Correct answer: At least five members including a veterinarian, scientist, non-scientist, and unaffiliated member
The AWA requires at least five members: chairperson, attending veterinarian, practicing scientist, non-scientist, and one unaffiliated member.
IACUC composition ensures diverse perspectives. Required: chairperson, attending veterinarian, practicing scientist, non-scientist, and unaffiliated community representative. Many IACUCs have additional members.
Question 3: What is the Annual Report that research facilities must submit to USDA?
- A financial audit
- A report detailing animal numbers, species, pain categories, and alternatives searches (Correct answer)
- A list of publications
- An equipment inventory
Correct answer: A report detailing animal numbers, species, pain categories, and alternatives searches
The annual report documents animals used by species and pain/distress category (B through E), alternatives searches, and IACUC attestation.
APHIS Form 7023 requires reporting animals by pain category: Column B (held), C (minimal pain), D (pain with relief), E (pain without relief requiring justification). Reports are public record.
Question 4: What does the Guide for the Care and Use of Laboratory Animals represent?
- A legally enforceable federal regulation
- The primary reference standard used by AAALAC and PHS for evaluating programs (Correct answer)
- A textbook for vet schools only
- Guidelines for government facilities only
Correct answer: The primary reference standard used by AAALAC and PHS for evaluating programs
The Guide establishes the standards against which AAALAC evaluates programs and OLAW measures PHS Policy compliance.
The Guide (8th edition, 2011) has regulatory force because PHS Policy requires compliance for PHS-funded research, and AAALAC uses it as the primary evaluation standard.
Question 5: What is the significance of USDA pain and distress categories?
- They determine registration fees
- They classify pain levels requiring increasing justification and oversight (Correct answer)
- They rank animals by monetary value
- They indicate which species need no IACUC approval
Correct answer: They classify pain levels requiring increasing justification and oversight
Categories B through E classify the extent of pain or distress. Higher categories require more justification and welfare oversight.
Column B: held but not used. Column C: minimal pain. Column D: pain/distress with relief. Column E: unalleviated pain/distress requiring strong scientific justification and IACUC approval.
Question 6: Who has the authority to suspend an animal activity not conducted per approved protocol?
- Only the PI
- The IACUC by majority vote (Correct answer)
- Any technician without review
- Only the USDA inspector
Correct answer: The IACUC by majority vote
The IACUC can suspend any non-compliant animal activity by majority vote of a quorum after review.
IACUC suspension authority is established by both AWA and PHS Policy. The attending veterinarian can also intervene immediately in emergencies. Technicians have the right to report concerns with whistleblower protection.
ALAT Regulations and Compliance 2
Which federal agency enforces the Animal Welfare Act?