FDA FSMA petfood HARPC

The Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food (21 CFR Part 507) applies to pet food manufacturing. HARPC (Hazard Analysis and Risk-Based Preventive Controls) requirements: (1) hazard analysis identifying known or reasonably foreseeable hazards (biological, chemical, physical, radiological); (2) preventive controls for hazards requiring them (sanitation controls, allergen controls, supplier controls, etc.); (3) supply chain verification for high-risk ingredients (e.g., imported rendered animal proteins); (4) recall plan per 21 CFR 507.38; (5) PCQI (Preventive Controls Qualified Individual) responsible for implementation. Compliance dates: small facilities (> $1M revenue) since 2018; very small (< $1M, > $250K) since 2019. FDA inspectors now conduct routine HARPC audits of pet food facilities. The 2024 enforcement focus: supply chain controls for imported ingredients, particularly from Southeast Asia.