Food Safety Modernization Act (FSMA)

Food Safety Modernization Act (FSMA)

Each year, food-borne illness strikes approximately 48 million Americans (1 in 6), according to the Center for Disease Control (CDC). On January 4, 2011, the U.S. government took aims to improve the safety of the U.S. food supply chain by signing the most significant food legislation in over 70 years—the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA).

Prevention Is Key

FSMA shifts the focus from responding to contamination to preventing it by strengthening the food safety system. The act directs the FDA to build a new system of food safety oversight that applies the best available science. The better the system handles producing, processing, transporting, and preparing foods, the safer our food supply will be.

The legislation includes the following major provisions to prevent food safety issues:

  • Food facilities must have a written preventive controls plan that outlines potential food safety risks and the steps to prevent or significantly minimize them.
  • FDA must establish science-based preventive controls for safely producing and harvesting fruits and vegetables, factoring in manmade and naturally occurring hazards.
  • FDA must implement and continue to increase the frequency of inspections (e.g., high-risk domestic facilities receive an initial inspection within the next five years and at least every three years thereafter).
  • FSMA gives the FDA new enforcement authority (without court orders) to issue recalls, suspend distribution, and open access for any record it seeks based on probable cause.

The Cornerstones of Compliance

FSMA impacts every aspect of the U.S. food system, from farmers to manufacturers to importers. To comply with FSMA, food companies essentially need to demonstrate that they have the following in place:

  • A written food safety plan meeting the food risk level of the site or company
  • Preventive controls based on science-based risk assessments
  • Records to demonstrate that the written food safety plan is being followed
  • A traceability system
  • A foreign supplier verification program (if the facility processes foods using ingredients sourced from overseas)

The real cornerstone of FSMA is the written food safety plan, which requires conducting a food safety assessment of the facility, identifying food safety hazards, and then developing and implementing critical control points (CCPs) to manage those hazards.

FSMA Plan-Do-Check-Act Cycle

FSMA Plan Do Check Act CycleFSMA Compliance Value Strategies

High Level

  • Establish expense change impacts
  • Complete a compliance review and valuation of all plants and equipment based on validation requirements
  • Determine project cost bills of material for plant and equipment upgrades and high-level project plans
  • Assess product specification compliance and risks
  • Assess supplier and supply chain impacts
  • Consider plant and product SKU rationalization

Mid Level

  • Assess and document compliance and needs
  • Determine HR and qualified resources
  • Establish plant contingency plans
  • Determine alternative process options
  • Expand supplier qualification for backups
  • Conduct detailed review of product compliance

Short Term

  • Conduct a FSMA SWOT analysis
  • Determine short-term vulnerabilities
  • Develop food safety/compliance business plan from commitment to audit
  • Communicate compliance principles and goals with customers
  • Create short-term compliance goals and objectives