Food Safety & FSMA Compliance Category Guide

What Is FSMA and Food Safety Regulation?

The Food Safety Modernization Act (FSMA), signed in 2011, fundamentally changed food safety regulation in the United States by shifting focus from responding to contamination to preventing it. For dairy farms, FSMA interacts with the existing Pasteurized Milk Ordinance (PMO) framework that has long governed milk safety. Together, these regulations establish requirements for how dairy operations manage food safety risks.

The Pasteurized Milk Ordinance (PMO)

The PMO is the foundational regulation for Grade A milk production, updated every two years through the National Conference on Interstate Milk Shipments. Key requirements include:

Farm Construction and Equipment

• Milkhouse design, ventilation, and lighting requirements
• Milking equipment specifications and cleaning procedures
• Bulk tank cooling and capacity requirements
• Water supply quality and protection
• Waste disposal systems

Animal Health

• Freedom from diseases communicable to humans
• Tuberculosis and brucellosis testing requirements
• Drug residue prevention and testing
• General animal health and sanitation

Milk Quality Standards

• Bacteria count limits (Standard Plate Count)
• Somatic cell count limits
• Temperature requirements
• Drug residue testing requirements
• Added water/adulteration prohibition

FSMA Requirements for Dairy

Preventive Controls for Animal Food

If you manufacture, process, or pack animal feed (including mixing on-farm rations), you may be subject to FSMA's Preventive Controls for Animal Food rule. This requires hazard analysis and preventive controls to address identified risks in feed production.

Produce Safety Rule

If you grow covered produce (fruits and vegetables), the Produce Safety Rule applies. Of particular relevance: raw manure application must occur at least 120 days before harvest for produce in contact with soil, or 90 days for produce not in contact with soil.

FSMA and On-Farm Processing

If you process dairy products on farm (cheese, yogurt, ice cream), the Human Food Preventive Controls rule likely applies. This requires written food safety plans with hazard analysis, preventive controls, monitoring, corrective actions, and verification activities.

Building a Food Safety Culture

Standard Operating Procedures

Document procedures for milking, cleaning, animal treatment, and other activities that affect food safety. Written SOPs help ensure consistent practices and serve as training tools.

Record Keeping

Maintain records of cooling temperatures, cleaning activities, drug treatments, and other safety-relevant activities. Good records demonstrate compliance and help identify issues before they become problems.

Employee Training

Train all personnel on food safety procedures relevant to their roles. Document training activities. Regular refresher training helps maintain awareness and compliance.

Supplier Verification

For purchased inputs that could affect food safety (feed ingredients, cleaning chemicals), verify suppliers provide safe products. This may involve supplier questionnaires, certificates of analysis, or other verification activities.

Common Compliance Challenges

• Drug residues: Implement strict treatment protocols and withdrawal period tracking
• Cooling times: Ensure milk is cooled to 45°F within two hours, 40°F within four hours
• Cleaning verification: Monitor cleaning effectiveness through inspection and testing
• Water quality: Conduct required water testing and protect water sources
• Cross-contamination: Prevent contact between milk and potential contaminants

Resources for Compliance

• State dairy inspectors can explain specific requirements
• Extension services offer food safety training
• FDA provides FSMA guidance documents and training
• Industry organizations offer compliance assistance
• Third-party consultants can help develop food safety plans

Cost Considerations

Basic food safety compliance has minimal direct cost beyond good management practices. On-farm processing operations face more significant compliance costs for food safety plan development, training, testing, and documentation. Typical costs for developing a preventive controls food safety plan with professional assistance range from $3,000-15,000 depending on complexity.