The FDA's Food Traceability Final Rule
Course details
Self-Paced eLearning
49.00
30 Minutes
Dr. Gene Bartholomew
The FDA’s Food Traceability Final Rule is designed to improve food safety and outbreak response by requiring detailed traceability records for certain high-risk foods. This course covers the rule’s core components, including Critical Tracking Events (CTEs), Key Data Elements (KDEs), and Traceability Lot Codes (TLCs), along with guidance for developing a written Traceability Plan. By the end of the course, participants will be prepared to meet the January 2026 compliance deadline and apply traceability principles across their operations.
Benefits and Learning Objectives
- Describe the purpose and scope of the FDA’s Food Traceability Final Rule
- Identify foods listed on the Food Traceability List (FTL)
- Define and apply Critical Tracking Events (CTEs) and Key Data Elements (KDEs)
- Explain the role and assignment of Traceability Lot Codes (TLCs)
- Outline the required elements of a Traceability Plan
- Recognize exemptions and understand recordkeeping and reporting requirements
Agenda:
- Define validation and verification in food safety.
- Differentiate between validation and verification activities.
- Outline the steps for implementing effective processes.
- Review real-world examples in HACCP and sanitation programs.
- Examine regulatory requirements and their applications.
- Discuss the importance of scientific support in compliance efforts.
Who Should Attend?
- Food Safety Managers
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Supply Chain Managers
- Operations Managers
- Compliance Officers
- Logistics Coordinators
- Food Safety Consultants
- Internal Auditors
- Record keeping and Documentation Specialists
Registration and Payment
To register for this course, please visit our training portal.
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Vice President, Technical Services
IEH Laboratories & Consulting Group
Meet the Instructor
Dr. Gene Bartholomew
Dr. Gene Bartholomew joined IEH as Vice President of Technical Services in 2019. He earned an M.S. and Ph.D. in microbiology from Cornell University and a B.S. in biology from Bucknell University. Dr. Bartholomew began his professional career at International Paper in 1983 as a research scientist. During his 15 years there, he commercialized and validated an aseptic packaging system, managed a beverage pilot plant and its laboratory, started taste panel testing for the company, and advanced to manage several products, and development groups.
Dr. Bartholomew then joined Smithfield Foods Packaged Meats. He started in the John Morrell Group as the corporate director of food safety for 7 meat processing and slaughter facilities and 1 spice plant. He later took on the role of Senior Director of Corporate Food Safety, during which he was responsible for 14 meat processing plants and several FDA-regulated plants. Throughout his 20-year career at Smithfield, he led HACCP plan design and validation, thermal processing, regulatory compliance, sanitation, allergen control, and environmental pathogen monitoring. He also managed a corporate microbiology laboratory and its accreditation, has certifications in HACCP training, BRC, and SQF schemes, and is a Preventive Controls Qualified Individual.
Dr. Bartholomew was a founding member of the North American Meat Institute Listeria Control Workshop and has taught numerous courses to members of the food industry.
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Executive Vice President
IEH Laboratories & Consulting Group
Carol Cave
Ms. Carol Cave joined IEH as the Executive Vice President in 2024, bringing with her extensive expertise in regulatory affairs and consumer protection. She holds a B.S. in Consumer Economics from the University of Maryland.
Before joining IEH, Ms. Cave served as the Acting Associate Commissioner (ACRA) for the Office of Regulatory Affairs (ORA) at the Food and Drug Administration. In this role, she oversaw approximately 5000 ORA employees stationed across the U.S. and around the world.
Prior to her role as Acting ACRA, Ms. Cave served as Deputy Associate Commissioner, where she managed inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning.
Earlier in her career at the FDA, she served as the Assistant Commissioner of Import Operations, where she led the Office of Enforcement and Import Operations, ensuring FDA-regulated imported products comply with U.S. laws. Ms. Cave also led coordination efforts between the FDA and U.S. Customs and Border Protection, developing joint regulations, policies, procedures, and operations.
Before her tenure at the FDA, Ms. Cave was the Deputy Director of the Office of Compliance and Field Operations at the U.S. Consumer Product Safety Commission (CPSC). In this role, she collaborated with federal government agencies to identify potentially defective consumer products. With nearly 26 years at the CPSC, Ms. Cave held various leadership positions, including Director of State and Local Programs and Assistant Executive Director for the Office of Import Surveillance, ensuring the safety of consumer products nationwide.