A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food Safety

Presented by Tim Lombardo and Thomas Bell

September 24, 2025, 1pm (eastern)

The final Food Safety Modernization Act rule, the Food Traceability Rule – commonly referred to as FSMA 204 – will require enhanced recordkeeping for facilities handling foods that have a high risk of foodborne illness.

To comply with the law, manufacturers who are subject to the rule must:

• Maintain enhanced traceability records
• Develop traceability plans
• Provide records to the FDA in 24 hours

Compliance with the requirements was set for January 2026. However, the FDA has now delayed implementation by 30 months to allow more time for small grocers to comply without undue financial and logistical strain. Compliance is likely to become mandatory in mid-2028.

While the compliance date has shifted, it’s never too early to determine whether your facility is subject to the rule, and if so, to better understand the requirements.

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About the Presenters

Tim Lombardo

Tim is a widely regarded expert in food safety and microbiology with over 25 years of direct experience leading these programs at a variety of manufacturing facilities. Tim’s direct experience includes dairy, infant formula, baked goods, nuts and nut products, fruits and vegetables, meat and poultry, spices, color flavors and other ingredients and many others. He is a Lead Instructor through the Food Safety and Preventive Controls Alliance (FSPCA) in Preventive Controls for both Human and Animal Foods, is certified in Thermal / Aseptic Processing and Sterilization through the Better Process Control School and is a Lead Instructor for the HACCP Controls Alliance.

Prior to joining EAS, Mr. Lombardo was the Lead Staff Scientist at Eurofins where he oversaw microbiological harborage site investigations, facilitated Food Safety plan development and validation including Food Security, Food Defense/Intentional Adulteration and Food Fraud Plan Development. He also spent 17 years at Leprino Foods Company, in roles of increasing responsibility, culminating as the Corporate Manager of Sanitation where he provided corporate sanitation leadership and guidance to ten cheese and dairy ingredient manufacturing facilities, three of which manufactured infant formula ingredients. Additionally, he had responsibility for the firm’s Food Safety/Quality Systems including GMPs, HACCP, Environmental Monitoring, Pest Control, Foreign Material Control, Traceability, and Ingredient Monitoring at various plants.

Mr. Lombardo is a published author and international speaker. He is a member of the Institute for Food Technology (IFT), the International Association of Food Protection (IAFP) and is a member of the US Hemp Authority Technical Committee. He is also a combat Veteran, having served in Operation Desert Shield and Desert Storm.

Thomas Bell Ph.D.

EAS Independent Consultant, Thomas Bell, has a Ph.D. in Microbiology & Physiology from The Ohio State University’s College of Veterinary Medicine & College of Agriculture. His Master’s degree is in Microbiology & Nutrition. He is an expert in quality systems, compliance to standards and regulations, and prevention of microbial contamination through FSMA, GMP, HACCP and GFSI schemes in addition to 3D food printing and cell culturing for production of meat products.

Prior to consulting he oversaw Corporate Quality Assurance for Procter and Gamble, conducting risk management and compliance assessments to both industry and corporate standards for North American manufacturing operations and new international ventures. Also, at Procter and Gamble, he served as the Global Microbiologist under the Global Microbiology Organization where he developed and implemented operational standards and practices to mitigate product risk across multiple categories using standards of FDA cGMPs, HACCP and GFSI SQF. He has also worked as the Executive Director of Quality Assurance and Food Safety at Donatos where he established quality control procedures to validate product performance and audited supplier food safety and quality assurance programs ensuring food safety across store operations and in coordination with regulatory agencies. He was also worked with the Quality Systems, GMPs and HACCP systems for AIB International.