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INTRODUCTION TO FSMA

Guide to FSMA Compliance

THE COMPLIANCE DATE IS JANUARY 20, 2026, FOR ALL COMPANIES COVERED BY THE RULE.

The Food Safety Modernization Act (FSMA) represents the most significant overhaul of food safety laws in over 70 years. Signed into law by President Obama in 2011, FSMA shifts the focus from responding to foodborne illnesses to preventing them. This guide provides an overview of FSMA, its requirements, and the steps businesses need to take to ensure compliance.

Key Components of FSMA

INSPECTION AND COMPLIANCE
  • Increased FDA Inspections.
  • The FDA has greater authority to conduct inspections of food facilities to ensure compliance with safety standards.
  • Record-Keeping Requirements.
  • Businesses must maintain detailed records of their food safety practices and make them available to the FDA upon request.
PREVENTIVE CONTROLS
  • Increased FDA Inspections.
    The FDA has greater authority to conduct inspections of food facilities to ensure compliance with safety standards.
  • Record-Keeping Requirements.
    Businesses must maintain detailed records of their food safety practices and make them available to the FDA upon request.
IMPORTED FOOD SAFETY
  • Increased FDA Inspections.
    The FDA has greater authority to conduct inspections of food facilities to ensure compliance with safety standards.
  • Record-Keeping Requirements.
    Businesses must maintain detailed records of their food safety practices and make them available to the FDA upon request.
RESPONSE
  • Mandatory Recall Authority.
  • The FDA can mandate recalls of contaminated food products.
  • Administrative Detention.
  • The FDA can detain products that are suspected of violating safety standards.
ENHANCED PARTNERSHIPS
  • Collaboration with State and Local Authorities.
  • The FDA works closely with state and local agencies to improve food safety standards.
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Traceability is a fundamental component of FSMA, playing a vital role in preventing food safety issues, enabling efficient recall processes, and ensuring compliance with regulatory requirements. Traceability refers to the ability to track the production, processing, and distribution of food products throughout the entire supply chain.
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Impact on Businesses

Specifically, from a traceability perspective, businesses must establish and maintain records of the immediate previous sources and immediate subsequent recipients of food, making it easier to trace products through the supply chain.
MANUFACTURER

Food Manufacturers and Processors: Must adhere to preventive controls and good manufacturing practices.

IMPORTER

Importers: Required to ensure that their foreign suppliers meet U.S. safety standards.

FARM

Importers: Required to ensure that their foreign suppliers meet U.S. safety standards.

TRANSPORTER

Importers: Required to ensure that their foreign suppliers meet U.S. safety standards.

Key impacts include

COMPLIANCE

Compliance Costs: Implementing preventive controls and maintaining records can incur significant costs.

OPERATIONAL CHANGES

Operational Changes: Businesses may need to alter their processes to meet FSMA standards.

SUPPLY CHAIN PARTNERS

Supply Chain Management: Ensuring that suppliers and partners also comply with FSMA regulations.

Benefits of FSMA Compliance

IMPROVED FOOD SAFETY:
Enhanced measures to prevent contamination and foodborne illnesses.

CONSUMER TRUST:
Demonstrating a commitment to food safety can enhance brand reputation.

MARKET ACCESS:
Compliance ensures continued access to the U.S. market and can open up new opportunities.

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Steps to Achieve FSMA Compliance

1
CONDUCT A GAP
ANALYSIS:
  • Identify current practices and compare them against FSMA requirements.
  • Highlight areas needing improvement.
2
DEVELOP A FOOD SAFETY PLAN:
  • Create a written plan that includes hazard analysis, preventive controls, monitoring procedures, and corrective actions.
3
IMPLEMENT PREVENTIVE CONTROLS:
  • Put in place measures to prevent food safety hazards identified in your analysis
4
TRAIN EMPLOYEES:
  • Ensure all staff are trained on FSMA requirements and the specifi c controls relevant to their roles.
5
MAINTAIN RECORDS:
  • Keep detailed records of your food safety practices, monitoring activities, and corrective actions.
6
STAY INFORMED:
  • Regularly review updates from the FDA and adjust your practices as necessary.

FOR A MORE DETAILED LOOK AT FSMA REGULATIONS AND STEP-BY-STEP INSTRUCTIONS ON ACHIEVING COMPLIANCE — CALL US!

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Expert Guidance

Navigating FSMA compliance can be complex. Our consultancy specializes in helping businesses like yours achieve compliance efficiently and effectively from Traceability perspective.

WE OFFER:

  • Regulatory Guidance: Expert advice on understanding and meeting FSMA traceability requirements.
  • Technology Solutions: Implementation of advanced track and trace systems to ensure compliance and improve supply chain visibility.
  • Customized Support: Tailored solutions to fit your specific business needs.

Ulrich Schild

Sales Director

ulrich.schild@3keys.com

Why Choose Us?

3keys is well known in serialization and Track & Trace consulting, having successfully implemented international projects for multiple industries, such as pharmaceuticals, tobacco, and FMCG (the food industry). 3keys is an expert in implementing Track & Trace, whether for legal compliance or brand protection.

CONTACT US TO LEARN MORE AND SCHEDULE A DEMO.

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Key definitions

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CRITICAL TRACKING EVENTS (CTES)

Under the Food Safety Modernization Act (FSMA) 204, Critical Tracking Events (CTEs) are specific points in the supply chain where data must be collected to ensure the traceability of food products. These events help in tracking the journey of food from the source to the consumer, which is crucial in managing and mitigating foodborne illness outbreaks.

FOOD TRACEABILITY LIST (FTL)

The Food Traceability List (FTL) under the Food Safety Modernization Act (FSMA) Rule 204 pertains to a list of foods identifi ed by the U.S. Food and Drug Administration (FDA) as high-risk under the FSMA's Additional Traceability Records for Certain Foods requirement. These foods require more rigorous record-keeping to enhance traceability from farm to table, helping to quickly and effi ciently identify the source of a foodborne illness outbreak.

FOOD TRACEABILITY LIST (FTL)

The Food Traceability List (FTL) under the Food Safety Modernization Act (FSMA) Rule 204 pertains to a list of foods identifi ed by the U.S. Food and Drug Administration (FDA) as high-risk under the FSMA's Additional Traceability Records for Certain Foods requirement. These foods require more rigorous record-keeping to enhance traceability from farm to table, helping to quickly and effi ciently identify the source of a foodborne illness outbreak.