Food Safety Modernization Act (FSMA)

Scope

The FSMA makes prevention a shared responsibility across the entire supply chain. It’s implemented through several foundational rules:

• Preventive Controls for Human Food
• Preventive Controls for Animal Food
• Produce Safety Rule
• Foreign Supplier Verification Program (FSVP)
• Accredited Third-Party Certification
• Sanitary Transportation Rule
• Intentional Adulteration (Food Defense)
• Food Traceability
• Laboratory Accreditation for Analyses of Foods (LAAF)
• Pre-Harvest Agricultural Water

Regulatory citations

• Food Safety Modernization Act (FSMA)
  • 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
  • 21 CFR Part 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
  • 21 CFR Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
  • 21 CFR Part 1, Subpart L, Foreign Supplier Verification Programs (FSVP) for Food Importers
  • 21 CFR Part 1, Subpart M, Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
  • 21 CFR Part 1, Subpart O, Sanitary Transportation of Human and Animal Food
  • 21 CFR Part 121, Mitigation Strategies to Protect Food Against Intentional Adulteration [Food Defense]
  • 21 CFR Part 1, Subpart S, Additional Traceability Records for Certain Foods (Food Traceability Rule)
  • 21 CFR Part 1, Subpart R, Laboratory Accreditation for Analyses of Foods (LAAF)
  • 21 CFR Part 112, Subpart E, Agricultural Water

Key definitions

• Accredited Third-Party Certification: FDA-recognized auditors for voluntary audits and certifications.
• Food and Drug Administration (FDA): The FDA regulates all food and food ingredients introduced into or offered for sale in the U.S. except for meat, poultry, catfish, and egg products (liquid, dried, or frozen), which are regulated by the U.S. Department of Agriculture, or USDA.
• Food Safety Modernization Act (FSMA): Implemented in 2011 to focus on preventing foodborne illness and provide authority to oversee and enforce food supply chains. Enforcement includes preventative controls for human and animal food, food production and growth, global supply chains, vulnerability protection, and sanitary transportation.
• Food Traceability: FDA requires additional recordkeeping for certain foods so they can easily be traced through every step of the supply chain. The Food Traceability List (FTL) identifies the foods for which additional traceability records are required.
• Foreign Supplier Verification Program (FSVP): Importers must verify foreign suppliers meet FDA standards.
• Intentional Adulteration (Food Defense): Covered facilities must evaluate and control vulnerabilities to intentional contamination.
• Laboratory Accreditation for Analyses of Foods (LAAF): An FDA-run accreditation program that ensures certain food testing is performed by high-quality, accredited laboratories, improving the accuracy, reliability, and oversight of testing results.
• Pre-Harvest Agricultural Water: A major FSMA revision in 2024 that updated how farms manage and evaluate water used during growing activities for covered produce (except sprouts).
• Preventive controls: Proactive measures taken to ensure food safety. Under FSMA, they are part of a required food safety plan.
• Preventive Controls for Animal Food: Hazard analysis and risk-based controls in facilities that process animal food.
• Preventive Controls for Human Food: Hazard analysis and risk-based controls in facilities that process food for human consumption.
• Produce Safety Rule: Standards for growing, harvesting, packing, and storing produce.
• Sanitary Transportation Rule: Prescribes sanitary transportation practices that ensure human and animal food transported by vehicle or rail is protected from adulteration.

Summary of requirements

FSMA requires establishments covered by FDA regulations to:

• Develop and follow a food safety plan.
• Identify potential hazards in their processes.
• Implement, monitor, and verify preventive controls to stop contamination.
• Maintain documentation for all implementation, monitoring, and verification activities.
• Take corrective actions when needed.
• Provide employee training regarding all aspects of safe food handling and preparation.