How to Choose the Right FSMA 204 Traceability Solution

Understanding FSMA 204

In 2011, the U.S. Congress passed the Food Safety Modernization Act (FSMA), shifting the focus from responding to foodborne illness to preventing it. One key component of FSMA is Section 204(d), which directed the FDA to establish enhanced traceability recordkeeping requirements for certain high-risk foods.

This led to the FDA’s Food Traceability Rule, which mandates additional recordkeeping for those who manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL). The rule is part of the FDA’s New Era of Smarter Food Safety Blueprint and significantly expands upon existing regulations to improve food safety and traceability across the supply chain.

Why a Technology Partner Matters

Partnering with the right technology provider does more than ensure compliance—it also unlocks valuable insights and efficiencies that can enhance your brand’s trust and transparency.

However, sharing and managing traceability data across your supply chain can be complex. The rule applies broadly across food businesses—including importers—and allows non-covered entities, like brokers, to maintain records on behalf of those who are covered. A smart technology partner can help you navigate these nuances.

Key Features to Look for in a FSMA 204-Compliant Traceability Solution

Your solution should not only meet the requirements but also fit your operational needs. Look for:

• Full FSMA 204 Compliance, including all Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as outlined in the Code of Federal Regulations
• Support for GS1 Standards to ensure interoperability and global alignment
• A Critical Tracking Event Log accessible to you and your customers (where applicable)
• A secure portal for suppliers (and customers) to share and view traceability data
• Options for data capture beyond electronic methods, such as scanning, direct key entry, or CSV uploads
• Enterprise-grade robustness
• A well-documented API that integrates with legacy and modern systems (ERP, WMS, e-commerce, etc.)
• User-friendly features for partners with limited tech capabilities—your solution should work for every link in your supply chain

What to Look for in an Implementation Partner

Selecting the right partner to help implement your traceability solution is just as important as the technology itself. Your provider should:

1. Have team members who are knowledgeable about the FSMA 204 Rule (CFR)
   Ensure your provider has personnel who have read and fully understand the Food Safety Modernization Act Section 204 requirements.
2. Demonstrate expertise in GS1 standards
   Look for proven experience and a deep understanding of GS1 standards, as these are essential for compliant traceability systems.
3. Bring a track record of successful traceability solution implementation
   Your partner should have real-world experience in designing and deploying traceability systems similar to what your business requires.
4. Understand relevant guidance for items listed on the Food Traceability List (FTL)
   The right team should be familiar with FDA guidance documents specific to the items you handle.
5. Have experience working with industry groups and trade associations (including GS1)
   Participation in relevant industry groups indicates an understanding of best practices and regulatory trends.
6. Provide ongoing, dedicated customer support
   Ask important questions upfront:
   * Will you have dedicated implementation and support personnel assigned to your project?
   * Will those same people remain available post-GoLive?
   * Are they trained in FSMA 204 compliance?
   * Are they based in the U.S., or part of an offshore team you may never meet?
   
   Many vendors highlight their size—but what matters is whether they’ve allocated the right resources for your success.
   
7. Be financially stable with strong customer references
   Choose a partner with a solid financial foundation and a history of satisfied clients who can speak to their reliability and performance.

Red Flags to Watch Out For

When evaluating technology providers, stay vigilant for these common pitfalls:

• Pre-FSMA traceability ≠ FSMA 204 compliance: A company that offered traceability before FSMA 204 isn’t automatically compliant now. Make sure they can show specific FSMA 204 implementations and walk you through real use cases.
• One-trick vendors may be risky: Be cautious of companies that only offer FSMA 204 solutions. Given the evolving nature of the regulation, providers with a narrow focus may not be sustainable long-term.
• Don’t rely solely on press releases: A signed contract doesn’t guarantee a successful rollout. Ask for completed case studies, testimonials, and follow-through on promised capabilities.
• Beware of “Too Good to Be True” Pricing: Be cautious of low upfront quotes—these may hide additional costs such as transaction-based or per-case fees that can quickly add up. Always review the terms and conditions carefully to understand the full scope of fees, not just the initial price. Ask about protections against future price increases to avoid unexpected cost hikes.
  On the other hand, if a provider offers bundled pricing (multiple solutions in one package), make sure they clearly break down the cost specific to FSMA 204 functionality so you understand exactly what you’re paying for and what your costs may be should you decide to remove one of the solutions in the future.

Bottom Line: Choosing the right FSMA 204 traceability solution is not just about compliance—it’s about future-proofing your operations, building trust across your supply chain, and enabling data-driven decision-making. Vet your options carefully, ask the right questions, and select a partner that can guide you through the complexity with experience and reliability.

More Information on FSMA 204

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