Which regulatory framework governs compliance during USDA inspections?

• A. 21 CFR Part 11
• B. 9 CFR Parts 1-3
• C. 40 CFR Part 60
• D. 42 CFR Part 2

Answer: (B)

The checks during USDA inspections are governed by the regulations that implement the Animal Welfare Act, found in 9 CFR Parts 1 through 3. These parts establish the framework for which institutions must register, what licenses are required for personnel, and how enforcement and compliance are carried out. During an inspection, USDA inspectors verify that facilities and programs meet the Act’s humane care and use standards, maintain proper records, and follow approved oversight processes, all within the rules set out in these sections.

Other options don’t fit because they pertain to different regulatory systems: 21 CFR Part 11 covers electronic records and signatures under FDA rules; 40 CFR Part 60 deals with air emission standards under EPA regulations; and 42 CFR Part 2 governs confidentiality of substance use disorder treatment records. None of these regulate USDA inspections of animal facilities.