FDA Issues FSMA Guidance For Feed Facilities

The U.S. Food and Drug Administration (FDA) on July 6 released a final guidance document to provide information to animal food facilities on developing and implementing animal food safety plans.

The document -- Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals -- is intended to assist animal food facilities in complying with the Food Safety Modernization Act (FSMA)-related rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” published on Sept. 17, 2015, and specifically provides information on how to:

• Identify the biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food.
• Understand the components of a food safety plan and the importance of each component.
• Conduct a hazard analysis and develop a food safety plan for the animal food produced.
• Identify preventive controls for biological, chemical, and physical hazards requiring a preventive control and understand how to apply those preventive controls.
• Implement preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation).
• Understand and implement the food safety plan as well as all recordkeeping requirements associated with the food safety plan.

NGFA previously provided comments on the draft version of GFI #245 issued by the FDA in January 2018 for stakeholder feedback. In response to feedback received, some significant changes made in the final guidance include:

• Removal of Appendix E: “Aid to Identifying Animal Food Hazards” and further clarification that not all the hazard examples in the guidance are applicable to all animal food or all facilities.
• Examples of when a facility may or may not be required to reanalyze its food safety plan.
• Additional information, resources, and examples of certain hazards in animal food, including information on animal food recalls that occurred since the draft guidance published.