Guidance 152 is concerned with the potential impact on human health of all uses of all classes of antimicrobial new animal drugs intended for use in which animals?

• A. Food producing animals
• B. Pets
• C. Wildlife
• D. Laboratory

Answer: (A)

Guidance 152 focuses on how antimicrobial new animal drugs could affect human health through the use of those drugs in animals whose edible products may reach people. The key point is that residues in meat, milk, or eggs—and the associated risks of allergic reactions, toxicity, or contributing to antimicrobial resistance—drive the safety evaluation, withdrawal times, and residue limits for these drugs. Therefore, the guidance is specifically concerned with food-producing animals because they are the source of products consumed by humans. Uses in pets, wildlife, or laboratory animals don’t translate into the same direct food-safety exposure pathway, so they aren’t the primary focus of this guidance.