When I was in high school, I enjoyed (or perhaps I should say I was obsessed with) sports. Back in the day, I played the "Big 3" (baseball, basketball, and football) and occasionally played tennis, ping pong, and golf. It did not matter which sport I was playing; I simply loved to compete. I chased the thrill of victory and accepted the moments of defeat, which were much more frequent than the victories and served as a motivator to improve.

In sports, the greatest success stories almost always involve overcoming adversity:

• Jim Abbott, born without a right arm, became a successful Major League Baseball pitcher, defying the odds.
• Jackie Robinson faced violent racism and death threats while breaking the color barrier as the first African American to play Major League Baseball in the modern era.
• Kerri Strug, with an injured ankle, landed her final vault on one foot, helping the U.S. women's gymnastics team secure its first-ever team gold medal in gymnastics (she was carried off the podium afterward).
• Micheal Jordan played 44 minutes and contributed 38 points, 7 rebounds, 5 assists, 3 steals, and 1 block to lead the Chicago Bulls to victory in game 5 of the NBA playoffs in 1997 while working through flu-like symptoms before and during the game.
• Bethany Hamilton, after losing her left arm at age 13 in a shark attack, went on to become a professional surfer, winning national and international competitions.

There are countless examples of teams and individuals overcoming adversity to achieve success, and this applies to the business world, too. Research Steve Jobs, Howard Schultz, Nelson Mandela, and Sara Blakely, for a few examples.

As food safety professionals, it is important not to let adversity get in our way when it comes to ensuring food safety and protecting public health.

In an era when regulatory agencies face budgetary constraints and an ever-growing scope of responsibility, the burden of food safety oversight is increasingly shifting from the public sector to the private sector. Nowhere is this shift more evident than in supplier compliance with the Food Safety Modernization Act (FSMA), particularly under 21 CFR Part 117 Subpart G, which governs supply chain preventive controls.

As U.S. Food and Drug Administration (FDA) resources tighten and inspection cadence becomes less predictable, food manufacturers, distributors, and retail operators must take a more proactive and risk-based approach to managing their suppliers, to protect public health and their brands. "Trust but verify" now has a different meaning—verification must be robust, data-driven, and documented.

The Current Compliance Landscape

The FSMA rule on supply chain programs requires receiving facilities to approve suppliers, conduct appropriate verification activities, and ensure that suppliers are controlling identified hazards. Yet, many suppliers, particularly small or international businesses, still lag behind in FSMA readiness. Some reasons include:

• Lack of PCQI-led hazard analyses
• Incomplete or generic food safety plans
• Inadequate allergen and sanitation controls
• Limited traceability infrastructure (especially under FSMA 204).

Meanwhile, FDA inspections under the Preventive Controls Rule remain targeted but infrequent, particularly for lower-risk foods or smaller importers. As a result, noncompliance may go undetected until a recall or outbreak forces it into the spotlight.

The Risk: When Supplier Compliance Falters

For operators that rely on suppliers with unknown compliance, the risks are significant:

• Undetected hazards (e.g., allergens, Salmonella in spices, Listeria in ready-to-eat [RTE] produce)
• Supply chain interruptions due to non-conforming product and/or recalls
• Brand damage from association with foodborne illness outbreaks
• Regulatory liability, especially if verification obligations are unmet.

Unknown compliance is often considered higher risk than known, high-risk, non-compliant situations. With known, high-risk, non-compliance, appropriate mitigation plans can be established, which is not the case for unknown-compliance risk situations, when risk can turn into reality at any time.

What Can Be Done? A Practical Mitigation Roadmap

Despite resource constraints, companies can take several targeted, risk-based actions to strengthen supplier oversight and meet FSMA obligations:

1. Risk Rank Your Suppliers

Develop a risk matrix based on:

• Ingredient risk (biological, chemical, physical hazards)
• Product use (raw agriculture, RTE vs. fully cooked)
• Volume and frequency of use
• Supplier geography and past performance.

Use this analysis to determine the depth and frequency of verification needed.

2. Define/Standardize Supplier Approval Criteria

For example, consider requiring all food suppliers to provide:

• Documentation to verify that an active GFSI or equivalent food safety system is in place
• FSMA-compliant food safety plan (PCQI-led), upon request
• Certificates of analysis (COAs) or microbial testing, upon request
• Foreign supplier verification program (FSVP) documentation for imports
• Recall response logs or mock recall documentation, when appropriate.

When resources allow, conduct virtual or in-person audits for high-risk or critical-path suppliers.

3. Do Not Just Collect Documents—Challenge Them

Ask for:

• Real hazard analyses (not boilerplate statements)
• Validation studies for kill steps or sanitation
• Environmental monitoring data, especially for RTE foods.

4. Lean On Shared Schemes—Verify and Audit with a Purpose

While GFSI certifications (e.g., SQF, BRCGS) provide a solid baseline, they do not replace FSMA-required hazard-specific verification. Ensure that your program does not rely solely on certificates. Design internal or third-party audits that evaluate actual FSMA preventive control compliance—not just general Good Manufacturing Practices (GMPs).

5. Build Cross-Functional Ownership

Procurement, operations, and R&D should understand how food safety risk ties into supplier decisions.

6. Invest in Digital Solutions

• Explore artificial intelligence (AI) solutions to streamline data analysis and enable real-time insights to act quickly
• Digitize your traceability records up and down the supply chain. Do not wait for the government deadline. Do it because it is the right thing to do for your business and public health.

A Call to Industry Action

The evolving regulatory environment makes one thing clear: food safety must be industry-led. In the face of limited government oversight and growing complexity, companies that proactively manage supplier risk will not only avoid liability—they will also build consumer trust, resilient operations, and long-term competitive advantage.

Who wants to be the next Jim Abbott, Jackie Robinson, Michael Jordan, Bethany Hamilton, or Kerri Shrug? Let this moment be a wake-up call to action: supplier verification is not a one-time audit—it is an ongoing commitment to accountability, transparency, and continuous improvement. The tools exist, and the data is available. What remains is the will to act.

Additional Reading

1. U.S. Food and Drug Administration (FDA). "Inspection Observations." Current as of January 13, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations.
2. U.S. Government Accountability Office (GAO). "Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues." GAO-18-760. 2018
3. GAO. "FDA's Food Recall Process and Foreign Supplier Oversight." GAO-21-235. 2021
4. Food Safety Preventive Controls Alliance (FSPCA). "Preventive Controls for Human Food Training Overview." 2023. https://www.ifsh.iit.edu/fspca.
5. FDA. "Warning Letters." Current as of October 7, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.
6. FDA. "Recalls, Market Withdrawals, & Safety Alerts." Current as of October 9, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.
7. FDA. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. Current as of August 6, 2025. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.
8. International Fresh Produce Association (IFPA). "FSMA 204 Resources." 2025. https://www.freshproduce.com/resources/supply-chain-management/fsma-204-resources/.
9. Centers for Disease Control and Prevention (CDC). (2022). April 4, 2022. "Listeria Outbreak Linked to Packaged Salads Produced by Dole—Investigation Details." https://archive.cdc.gov/www_cdc_gov/listeria/outbreaks/packaged-salad-mix-12-21/details.html.
10. Code of Federal Regulations. "21 CFR Part 117 Subpart G—Supply-Chain Program." https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-G.
11. SQFI. "Approved Supplier Program: Edition 9 Guidance Document." April 2021. https://www.sqfi.com/docs/sqfilibraries/code-documents/guidance-documents/approved-supplier-program-guidance-document.pdf?sfvrsn=32be41bf_9.
12. FDA. "New Era of Smarter Food Safety Blueprint." Current as of March 5, 2024. https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint.
13. Yiannas, F. Food Safety Culture: Creating a Behavior-Based Food Safety Management System. 2nd Ed. Springer, 2021.
14. FDA. Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. January 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food.

Steve Lutes, M.B.A. is a former Global Vice President of Food Safety and Quality Assurance for a major restaurant brand and now advises food companies on FSMA compliance, supplier risk management, and food safety culture through Active Food Safety LLC.