Watch the replay here: https://info.safetychain.com/needs-benefits-supply-chain-traceability Since the final FSMA 204 rule was established in late 2022, food manufacturers have been looking into what they'll need to meet the requirements before the deadline. In this presentation we explored the effects of FSMA 204 food traceability methods and import rules, the impact to domestic and foreign suppliers, and the many potential benefits data tracking has to keep consumers healthy while driving down costs. Food and Beverage Manufacturers, Producers, and Suppliers will learn: • What's needed to strengthen food safety systems for effective data gathering • How data tracing can lead to increased cost savings and productivity • Where the Food Traceability List (FTL) is changing hazard management • How to manage a culture of food safety to help maintain traceability and food safety FSMA requirements Presented by Dr. Liliana Casal-Wardle | Executive Sr. Director, Food Safety @ The Acheson Group

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Dr. Liliana Casal-Wardle
Executive Sr. Director,
Food Safety & Supply Chain Risk
The Need-to-Haves, Nice-to-Haves, and
Benefits of Supply Chain Traceability

2. ✔Monthly FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS
A global food safety and public
health consulting group made up
of seasoned industry experts
A digital plant management
platform to ensure quality,
maximize yield & optimize labor
Brought to you by:

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 Friday
Before We Get Started…
FSMA FRIDAYS

4. Meet Your FSMA Friday Speaker
FSMA FRIDAYS
Dr. Liliana Casal-Wardle
Executive Sr. Director, Food Safety & Supply Chain Risk
Dr. Casal-Wardle has over 25 years of food industry experience with
technical and global leadership roles managing supply chain food
safety and product quality.
Her specific areas of expertise include Supply Chain Food Safety, Food
Safety Culture, Food Science, Food Defense, Cleaning and Sanitation
practices, Environmental Microbiological Monitoring Programs, GFSI
requirements and Quality Assurance, amongst others.

5. FSMA FRIDAYS
FSMA FRIDAYS
FSMA: Regulatory Updates
What's New
The FDA issued a final guidance (2023 Final Guidance), seen below, and a separate new draft guidance (2023 Draft Guidance) to
replace the original 2017 draft guidance - Produce Safety Rule
The 2023 Final Guidance updates and finalizes the following sections of the original 2017 draft guidance:
● Cleaning and Sanitizing
● Agricultural Water in Sprout Operations
● Environmental Monitoring
● Recordkeeping

6. FSMA FRIDAYS
FSMA 204: The requirements of the Food Traceability Act
The Need-to-Haves, Nice-to-Haves, and Benefits of Supply Chain Traceability
The need-to-haves, nice-to-haves
Tools to manage traceability: Food safety Culture and data management
What We’ll Cover Today:

7. FSMA FRIDAYS
The Complex Supply Chain

8. FSMA FRIDAYS
Globalization Complexity

9. FSMA FRIDAYS
Supply Chain Trends & Challenges

10. FSMA FRIDAYS
Traceability is a Tool to Better Manage the Supply Chain

11. FSMA FRIDAYS
Regulatory Compliance
https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint
The New Era of Smarter Food Safety Blueprint is
centered around four core elements:
1. Tech-enabled Traceability
2. Smarter Tools and Approaches for Prevention
and Outbreak Response
3. New Business Models and Retail Modernization
4. Food Safety Culture

12. FSMA FRIDAYS
FSMA 204: Additional Traceability Records for Certain Foods
Applies to persons who manufacture,
process, pack, or hold foods that
appear on the FTL
Requirements:
Maintain records containing Key Data
Elements (KDEs) that are associated
with Critical Tracking Events (CTEs)
Provide information to the FDA
within 24 hours
Compliance date of January 20, 2026

13. FSMA FRIDAYS
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-bades receiving of a food obtained from a fishing vessel
● Shipping
● Receiving
● Transformation of the food

14. FSMA FRIDAYS
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

15. 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

16. FSMA FRIDAYS
Traceability Plan
● 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

17. FSMA FRIDAYS
Records Requirements
● Paper, electronic, or true copies allowed
● 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
● 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

18. FSMA FRIDAYS
(FSMA) section 204 (21 U.S. Code § 2223): FDA is required to designate high-risk foods for
which additional recordkeeping requirements are appropriate and necessary to protect
the public health
Risk-Ranking Model for Food Tracing ( RRM-FT) a data-driven science-based decision
support tool to assist the Agency in the process of designating a Food Traceability List
Efforts focus on foods contaminated with biological or acute chemical toxins which
present an immediate public health risk
Developed a model of seven criteria for scoring commodity-hazard pairs using
seven criteria based on FSMA statutory factors
Food Traceability List

19. FSMA FRIDAYS
● The known safety risks of a particular food, history and severity of foodborne illness
outbreaks (CDC data)
● The likelihood of high potential risk for microbiological or chemical contamination
of support the growth of pathogenic microorganisms (nature or processes)
● Point in the manufacturing process of the food where contamination is most likely
to occur
● The likelihood of contamination and steps taken during the manufacturing
process to prevent contamination
● The likelihood that consuming a particular food will result in a foodborne illness
● The likely of known severity, including health and economic impacts of a
foodborne illness
FSMA Statutory Factors

20. FSMA FRIDAYS
FSMA 204: Criteria for Risk Ranking Model
Food Traceability List
The model scores commodity-hazard pairs according to information relevant for seven criteria:

21. FSMA FRIDAYS
Tools for Compliance
https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint
The New Era of Smarter Food Safety Blueprint is
centered around four core elements:
1. Tech-enabled Traceability
2. Smarter Tools and Approaches for Prevention
and Outbreak Response
3. New Business Models and Retail Modernization
4. Food Safety Culture

22. FSMA FRIDAYS
Support and educate the members of your supply chain
Communicate: Share best practices and ask about opportunities on traceability
Establish shared simulation exercises to assess compliance and effectiveness
Leadership by example
Recognition and incentives
Managing Behaviors Within the Supply Chain

23. FSMA FRIDAYS
Strive for Consistency and be Change Ready
● Provide tools for data management and verify its effectiveness
● Establish direct or indirect KPIs that can give trends for consistency on traceability
● Share trends of data with the workforce and partners
● Find out what is working and what is not
● Manage failure as a learning experience
● Near misses are learning experiences and KPIs for success
● Be adaptable: share your successes and learnings with your supply chain partners
● Global cultures have unique social markers: find common denominators
● Establish verification practices through audit and record reviews

24. FSMA FRIDAYS
Maturity of Food Safety Culture in the Supply Chain
● Key stakeholders
● Cross-functional teams
● CEO and Senior Leaders
Procurement
Food safety and Quality
Product Development
Logistics: Distribution and Transportation
Sales
Marketing
Build a community of leaders, enablers, and partners
Learn from each other and
share successes and failures
Key KPIs: External partner
performance scorecard
Success relies on:
Ongoing data
sharing and
review
Enhanced
communication
Shared tools
for continuous
improvement
Rewards and
recognition
Verification
Assessment of maturity of food safety culture

25. FSMA FRIDAYS
FSMA 204: Digital Tools
● Agile communication of real-time data among all participants of the supply chain
● Easily accessible capabilities for trending of results and verifications of effectiveness
● Results and trends can easily become visual aids that are used for education, training, recognition
and continuous improvement
The Rule does not establish a requirement for digital tools for compliance, BUT…
There are multiple benefits for companies that leverage digital tools throughout the supply chain

26. FSMA FRIDAYS
Traceability: A “nice-to-have” or a “must”?

27. FSMA FRIDAYS
Key Takeaways
FSMA 204: Compliance with regulation by January 20, 2026
Data gathering allows companies to strengthen food safety systems: Protect the Health of Consumers
The investment on data tracing might bring added benefits on cost saving and enhanced productivity
FSMA 204 will expand traceability models globally
Watch cascade impact on import requirements such as FSVP
FTL will drive changes in management of hazards for a large number of product categories

28. FSMA FRIDAY
Questions?
Dr. Liliana Casal-Wardle
Executive Sr. Director, Food Safety & Supply Chain Risk
The Need-to-Haves, Nice-to-Haves, and
Benefits of Supply Chain Traceability

29. FSMA FRIDAYS
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