On July 6, FDA announced the availability of a final guidance for industry entitled “Hazard Analysis and Risk-Based Preventative Controls for Food for Animals.” The guidance is intended to help animal food facilities comply with the hazard analysis and risk-based preventative controls under Current Good Manufacturing Practices (CGMPs).

Animal food facilities currently must comply with the CGMPs found in 21 CFR § 507 unless an exemption applies. The recently issued guidance is intended to help animal food facilities develop a food safety plan in accordance with those regulations. Specifically, the guidance will assist industry:

  • Identify the biological, chemical, and physical agents that are reasonably foreseeable hazards in manufacturing, processing, packing and holding of animal food;
  • Understand the components of a food safety plan and the importance of those components;
  • Conduct a hazard analysis;
  • Identify preventative controls and understand how to apply controls;
  • Implement preventative control management components (i.e., monitoring and corrective actions); and
  • Understand and implement a food safety plan and maintain records associated with the plan.