Understand how the FDA's final version of the Food Traceability Rule helps identify food-borne illness outbreaks and impacts your business.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
The Finalized FDA Food Traceability Rule:
What it Means for your Business
Dr. Ben Miller
VP, Public Health & Regulatory Affairs
Eric Edmunds, JD
Food Safety Director

2. Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. ✔Only panelist microphones are on
✔Ask questions! (Q&A at end)
✔Recording link will be shared
✔Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started…
FSMA FRIDAYS

4. Meet Your FSMA Friday Speakers
FSMA FRIDAYS
Dr. Ben Miller
VP, Public Health & Regulatory Affairs
Dr. Ben Miller has nearly 20 years of
experience in food safety regulation,
epidemiology, outbreak investigation
and response, and public health.
Eric Edmunds, JD
Food Safety Director
Eric is a food industry expert on food safety,
risk management, regulatory compliance,
and operational excellence. He regularly
works along the farm to fork continuum to
help address food safety and regulatory
concerns for his clients.

5. FSMA FRIDAYS
FSMA FRIDAYS
Regulatory Updates
● FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell
Culture Technology
● Manufactured Food Regulatory Program Standards 2022 Updates
● Proposed Regulatory Framework to Reduce Salmonella Illnesses Attributable to Poultry
● GAO recommends FDA should have more authority over food contact substances
● Release of Annual Report for 2020 on the Sources of Foodborne Illness by the Interagency
Food Safety Analytics Collaboration
Eric Edmunds, JD Dr. Ben Miller

6. FSMA FRIDAYS
Agenda: The Finalized FDA Food Traceability Rule
• Timeline for rule, compliance dates, enforcement
• Food Traceability List (FTL)
• Exemptions
• Key terms
• Traceability Plan requirements
• Record requirements
• Record maintenance and availability

7. FSMA FRIDAYS
• Establishes the “Food Traceability List” (FTL)
Features: Food Traceability Rule
• Applies to: persons who manufacture, process, pack, or hold foods that
appear on the food traceability list
• Maintain records containing Key Data Elements (KDEs)
• That are associated with specific Critical Tracking Events (CTEs)
• Provide information to the FDA within 24 hours or within some reasonable time to
which the FDA has agreed
• Compliance date of January 20, 2026 for all persons subject to the rule
• FDA Webinar: December 7, 2022

8. FSMA FRIDAYS
Food Traceability List (FTL)
• Cheeses, other than hard cheeses
• Shell eggs
• Nut butters
• Cucumbers (fresh)
• Herbs (fresh)
• Leafy greens (fresh)
• Melons (fresh)
• Peppers (fresh)
• Sprouts (fresh)
• Tomatoes (fresh)
• Tropical tree fruits (fresh)
• Fruits (fresh-cut)
• Vegetables other than leafy
greens (fresh-cut)
• Finfish (fresh and frozen)
• Smoked finfish (refrigerated
and frozen)
• Crustaceans (fresh and frozen)
• Molluscan shellfish, bivalves
(fresh and frozen)
• Ready-to-eat deli salads
(refrigerated)

9. FSMA FRIDAYS
Exemptions
• Farms (size of farm, contractual agreements, type of food)
• Foods receiving certain types of processing (i.e., kill step)
• Produce that is rarely consumed raw
• USDA regulated foods
• Commingled Raw Agricultural Commodities (RAC)
(excludes fruits and vegetables covered by Produce Safety Rule)
• Small retail food establishments and restaurants
• Retail food establishments and restaurants
(size of establishment, source of food)

10. FSMA FRIDAYS
Exemptions cont.
• Farm to school and farm to institution programs
• Owners, operators, or agents in charge of fishing vessels
• Transporters
• Nonprofit food establishments
• Food for personal consumption
• Persons who hold food on behalf of specific individual consumers
• Food for research or evaluation

11. FSMA FRIDAYS
Key Terms
Critical Tracking Event (CTE)
An event in the supply chain of a food involving the:
• harvesting,
• cooling (before initial packing),
• initial packing of a RAC other than food obtained from a fishing vessel,
• first land-based receiving of a food obtained from a fishing vessel
• shipping
• receiving
• transformation of the food

12. FSMA FRIDAYS
Key Terms cont.
Key Data Element (KDE)
Information associated with a critical tracking event for which a record
must be maintained and/or provided in accordance with this subpart
• Traceability lot codes
• Product descriptions, quantities, units of measure
• Dates the food was received, shipped, harvested, cooled,
packed, transformed
• Location description for where activities occurred
• Reference document types and reference document numbers
Specific KDE’s vary depending on the specific CTE

13. FSMA FRIDAYS
Traceability Lot Code
• A descriptor, often alphanumeric, used to uniquely identify a
traceability lot within the records of the traceability lot code source
Traceability Lot Code Source
• The place where a food was assigned a traceability lot
Key Terms cont.
When must these be assigned?
• When you initially pack a RAC (when not obtained from a fishing vessel)
• When you perform the first land-based receiving of food from a fishing vessel
• When you transform a food

14. FSMA FRIDAYS
Traceability Plan
• Description of the procedures you use to maintain required records,
including the format and location of those records
• Description of the procedures you use to identify foods on the FTL that
you manufacture, process, pack, or hold
• Description of how you assign traceability lot codes
• Point of contact for questions about your traceability plan and records

15. FSMA FRIDAYS
Traceability Plan cont.
• If you grow or raise a food on the FTL (other than eggs), a farm map
showing the areas in which you grow or raise such foods
• Must show the location and name of each field/growing
area/aquaculture container, including geographic coordinates
and other information needed to identify the location
• Must be updated as needed to reflect current practices
• Previous traceability plans must be retained for 2 years
after any update

16. FSMA FRIDAYS
• Must be made available to the FDA within 24 hours of a request, or
within some reasonable time to which the FDA has agreed
• Request requires submission of additional information needed to
understand the records
Record Requirements
• When necessary to help FDA prevent or mitigate a foodborne illness
outbreak, or to assist in the implementation of a recall, or to otherwise
address a threat to the public health
• Must provide information in an electronic sortable spreadsheet
• There are exceptions for farms, retail establishments, and others based on annual
value of food sold and held, and religious beliefs
• Paper, electronic, or true copies allowed

17. FSMA FRIDAYS
Summary: The Finalized FDA Food Traceability Rule
• Compliance date is January 20, 2026
• Lots of potential exemptions based on company size/type, and
product type
• Tool available to help stakeholders determine if exemption applies
• FDA will “educate before and while we regulate”
• Specific KDEs apply to each of the CTEs
• 24 hour turnaround time for record requests
FSMA FRIDAYS
Eric Edmunds, JD Dr. Ben Miller

18. FSMA FRIDAY
Questions?
Eric Edmunds, JD
Food Safety Director
Dr. Ben Miller
VP, Public Health & Regulatory Affairs

19. ✔ FSMA Friday Session Recordings & Content Library
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