Cows being fed

FSMA and Animal Food: What You Need to Know

Matthew Passannante
February 18, 2020

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eBook: 10 Components of a Strong Good Manufacturing Program

Good Manufacturing Practices (GMPs) serve as the basis of all food safety programs, and if they're not well-established, the food safety system will fail. GMPs are required before any advanced programs like Hazard Analysis and Critical Control Points (HACCP) can be implemented. Download our eBook to ensure your food safety program is sound.

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The Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA) includes Preventive Controls for Animal Food. Facilities must establish a food safety plan containing an analysis of hazards and determine which need to be controlled via risk-based preventative controls. 

What are the key requirements?

1.  Implement Current Good Manufacturing Practices (CGMPs) 

  • Processors already implementing safety requirements for human food and supply by-products for animal foods do not need to perform additional preventive controls, except to prevent contamination. 

  • If the human food facility processes by-products for animal food use, it must process the by-product in compliance with CGMPs. 

  • When further processing the by-product, facilities can choose to follow either human food or animal food CGMPs. 

  • The facility needs to determine whether there are any hazards and if they require a preventive control. 

2. Implement a Food Safety System

  • Hazard analysis:  Hazard identification considers known or reasonably foreseeable biological, chemical, and physical hazards. If preventive controls are revealed, the facility must implement written preventive controls for each hazard.

  • Preventive controls: Preventive controls guard against adulteration, and are tailored to address hazards within a facility's specific manufacturing processes. The rule includes the following preventive controls: 

    • Process controls: Procedures to ensure control over operational processes such as cooking, refrigerating, and acidifying foods.

    • Sanitation controls Procedures, processes, and practices to ensure sanitary conditions within the facility to prevent hazards stemming from environmental pathogens or employees handling animal food.

    • Other Controls: Controls to ensure hazards requiring a preventive control will be minimized or prevented. 

  • Oversight and management of preventive controls: To ensure the effectiveness of controls.

    • Monitoring: Consistently perform procedures to validate preventive controls.

    • Corrections: Steps to correct a minor or isolated food production problem.

    • Corrective actions: Actions to fix a problem implementing a preventive control.

    • Verification: Operational preventive controls validated by the food safety plan. Product testing and environmental monitoring can be required.

  • Recall plan: For every facility that produces animal food with a hazard requiring a preventive control. 

3. Supply-chain Programs: 

  • A risk-based supply-chain program is needed if its hazard analysis identifies a hazard requiring a preventive control applied in the facility's supply chain.

    • Manufacturers do not need a supply-chain program if they control the hazard in their facility.

    • Ensuring approved suppliers deliver raw materials and other ingredients 

    • Documentation and review of supplier verification activities 

4. The Definition of a 'Farm':

  • Definition: Operations meeting the definition of 'farm' are not subject to the Preventive Controls for Animal Food rule. 

  • Primary Production Farm: An operation devoted to crop growth or harvesting, or to raise animals. Farms and harvesters that pack or store raw foods and feed mills are subject to the Preventive Controls for Animal Food rule, an operation devoted to raising animals is not. 

  • Secondary Activities Farm: An off-site harvesting, packing, or raw storage facility, majority-owned by the Primary Production Farm supplying the raw materials.  

5. Feed Mills are not covered: 

  • Fully integrated Feed Mills are not subject to the Preventive Controls for Animal Food final rule.

  • The FDA is concerned as feed mills manufacture significant amounts of animal food. They intend to publish a proposed rule to require some feed mill operations to implement CGMPs established by the Preventive Controls for Animal Food. 

The published list of Preventive Controls for Animal Food key requirements can be found here

TraceGains has a robust suite of solutions to help food, beverage, and dietary supplement manufacturers maintain compliance with CGMPs while streamlining and automating business processes throughout operations. For more information, download our eBook "Ten Components of a Strong Good Manufacturing Program" here

FSMA CGMP
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