Learn the disconnect between regulatory traceability requirements & industry standards; how KDEs needed for recall resolution compare to those in FSMA 204; & ways to fortify your traceability system

1. Beyond Compliance
Webinar & Podcast Series for Process Manufacturers
The Traceability Disconnect
FSMA 204 vs the Industry
with Jennifer McEntire, Ph.D.
Chief Food Safety and Regulatory Officer, IFPA

2. ✔ Improve Yield
✔ Maximize Productivity
✔ Ensure Compliance
Plant Management Platform
BEYOND COMPLIANCE
The Sponsor

3. Casual but Professional Format
✔ Ask questions! (Q&A at end)
✔ Only panelists are displayed
✔ Recording link will be shared
✔ Audio issues: use call-in number
BEYOND COMPLIANCE
Helpful tips
Before We Get Started

4. Today’s Panelist
BEYOND COMPLIANCE
Jennifer McEntire, Ph.D.
Chief Food Safety and Regulatory Officer
Microbiologist with 20+ years of experience working in
Washington, DC area. Past roles include:
● Vice President of Science Operations at the Grocery
Manufacturers Association
● VP and Chief Science Officer at The Acheson Group
● Senior Staff Scientist and Director of Science & Technology
Projects at the Institute of Food Technologists
● Advisory Board Member of the Global Food Traceability
Center; On the technical committee of the Center for
Produce Safety
● PhD from Rutgers University in Food Safety; B.S. in Food
Science from the University of Delaware
Aaron Bolshaw
CMO

5. About IFPA
• Advocate
• Connect
• Guide
• …The global produce and floral
industries
• Represents all supply chain
points
5

6. IFPATraceability Expertise
Me (Jennifer McEntire) EdTreacy
UFPA/… IFT PMA/… industry
Food safety, generalist Supply chain, blockchain
All of food Produce/ PTI
6
Traceability takes a village!
It’s not “just” food safety, or IT, or supply chain etc.

7. Traceability is aTool
It’s NOT an answer
It’s NOT the solution
What problem are you trying to
solve?
Why follow product movement?
7

8. ManyValid Answers
•Marketing
•Authentication
•Supply chain efficiency
•Recall capabilities
•Regulatory compliance (more on this!)
•Technology can support all of these
8

9. 9
REGULATORY COMPLIANCE:
WHY?
FSMA 204

10. What Problems are Regulators Solving?
•Increase speed of recalls
– Limit opportunities for people to eat contaminated food
•Increase speed of tracebacks (during outbreak investigations)
– Figure out what’s causing illness, so a recall can be executed
•1 up/ 1 down (1 forward/ back) recordkeeping is already required.
– What’s the problem?
10

11. Recalls andTracebacks Are Different
Recall Traceback
Led by industry Led by FDA
Food is known Food is unknown
Adding “buffers” is protective Adding “buffers” causes confusion
“signal” gets diluted by the “noise”
11

12. Outbreak Investigation Process
• Dr. visit?
• Sample analysis
• Test “leftovers”
State/local
• Outbreak
identified
• What did people
eat?
CDC • Common source
of food
• What happened?
FDA
12

13. Outbreak Investigation Process
• Dr. visit?
• Sample analysis
• Test “leftovers”
• If available
State/local
• Outbreak
identified
• What did people
eat?
CDC • Common source of food
• Traceability records
• What happened?
FDA
13

14. Traceback
• Start where people
report eating/
purchasing food
• One up/down
requires going
through each step
14
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-inve
stigations/inspection-guides/guide-traceback-fresh-fruits-and-vegetables-im
plicated-epidemiological-investigations-april-2001

15. What Problem are we Solving?
15
Should we
revisit what’s
REALLY a
CRITICAL
Tracking Event?

16. Data Elements- My Opinion
16
For traceBACK
• Who- Company name
• What- granular product
identification, including lot number
• When- date/time is useful to
determine what happened; is it
needed toTRACE?
• Where – needed to investigate what
happened; is it needed toTRACE?
For traceFORWARD (recall)
• What- granular product
identification, including lot number,
as applicable
• The “who” is often what helps
make the “what” unique
• Any point in the supply chain should
be able to extract recalled product

17. FDA Proposed Rule
All CTEs
Tons of KDEs
Sure, technology systems can
manage this…
17

18. Recommendations
18
Don’t make adjustments based on
the proposed rule
Do expect lot number will be key
Final rule coming Nov 2022; compliance date
TBD
DO align on the problem you are
trying to solve
What needs to be proactively shared with
trading partners (what problem areTHEY trying
to solve) vs what needs to be shared upon
request (with investigators)?

19. ClosingThoughts
•Technology is there
•Processes might not be
•The supply chain is complex and continually evolving
– A minimalistic approach to product tracing may be more achievable
•Global supply chains necessitate the use of global standards
•Firms should be able to choose the technology(ies) that work for them AND
that integrate with supply chain partners
19

20. Resources
•Leafy GreensTraceability Pilots
– https://www.ift.org/leafygreens
•ProduceTraceability Initiative
– https://www.producetraceability.
org/
•Produce Industry traceability
challenges
•www.freshproduce.com
20
Let’s get creative

21. Questions?
Jennifer McEntire, Ph.D.
Chief Food Safety & Regulatory Officer
jmcentire@freshproduce.com

22. Q&A
BEYOND COMPLIANCE

23. White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
BEYOND COMPLIANCE
Webinar Replay: Are Your Food Safety KPIs Driving the Right Behaviors?
1/28/22: Chemophobia (FSMA Fridays)
2/4/22: How to Calculate the Financial Impact of OEE Improvements
2/16/22: Designing Internal Audits for both “Industry” and Gov’t Compliance
safetychain.com/resources/webinars-events/
More Resources at www.safetychain.com