What is the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA), signed into law by President Barack Obama on January 4, 2011, is designed to ensure safety of the US food supply by shifting regulator focus from response activities to preventive activities.

Entities impacted

Mandates are imposed on entities, and individuals, who manufacture, process, pack, transport, distribute, receive or hold articles of food - though some farms and small businesses are exempt.

Key provisions of FSMA

Title I: Improves the capacity to prevent food safety problems
  • Expands regulatory authority to inspect all foods with reasonable probability to cause illness or death
  • Expands regulatory registration requirements and suspension powers
  • Requires many food facilities to conduct comprehensive hazard analysis
  • Regulatory authorization to collect fees related to re-inspections and recalls
  • Promulgation of regulations on the sanitary transportation of foods
  • Sanitary transportation of food
Title II: Improves capacity to detect and respond to food safety problems
  • Allocates government resources to food inspection based on risk profile
  • Increases frequency of both domestic and international facility inspections
  • Requires mandatory testing at accredited laboratories based on model standards
  • Improves tracking and tracing of food with enhanced recordkeeping requirements
  • Expands mandatory recall authority
Title III: Improves the safety of imported food
  • Requires US importers to conduct risk-based foreign supplier verification program
  • Establishes program for expedited review and importation of food certification
  • Authorizes government to refuse admission of foods not meeting certification requirements
  • Allocates increased resources for governmental inspections of foreign food facilities

Risks of noncompliance

  • Fines and penalties
  • Operation suspension
  • Mandatory recalls
  • Mandatory inspections
  • Reputational damage
  • Inability to import supply

How Baker Tilly’s Food and Beverage team can help

  • FSMA records compliance review
  • Implementation of risk analysis program
  • Review of current risk mitigation strategies