Slide 1: Going All-In for Food and All-Out for Those Who Produce It
“GOING ALL-IN FOR FOOD AND ALL-OUT FOR THOSE WHO PRODUCE IT” Shawn Stevens stevens@foodindustrycounsel.com 920.698.2561
Slide 2: FSMA 204 Food Traceability - We're Past the Point of Waiting
FSMA 204 FOOD TRACEABILITY - WE'RE PAST THE POINT OF WAITING - «BivFoodIndustry
Slide 3: FSMA Traceability Rule Key Dates
January 20, 2026 November 15, 2022 November 28, 2023 December 1, 2024 December 31, 2025
Slide 4: FSMA Food Traceability - 24 Months
FSMA 204 FOOD TRACEABILITY - WE'RE PAST THE POINT OF WAITING - DYN =r 24 MONTHS
Slide 5: FoodIndustry
FoodIndustry
Slide 6: FDA's New Era of Smarter Food Safety
FDA's New Era of Smarter Food Safety “Yeah ... | did that.” FoodIndustry
Slide 7: www.foodrecallreporter.com
www.foodrecallreporter.com
Slide 8: www.foodrecallreporter.com
www.foodrecallreporter.com
Slide 9: FDA's New Era of Smarter Food Safety
FDA's New Era of Smarter Food Safety Tech-enabled Traceability Smarter Tools and Approaches for Prevention and Outbreak Response HW FoodIndustry
Slide 10: FDA's New Era of Smarter Food Safety
FDA's New Era of Smarter Food Safety Tech-enabled Traceability Smarter Tools and Approaches for Prevention and Outhreak Response «@yyFoodIndustry
Slide 11: FDA's New Era of Smarter Food Safety
FDA's New Era of Smarter Food Safety Tech-enabled Traceability Outbreak Response «@yyFoodIndustry
Slide 12: FDA's New Era of Smarter Food Safety
FDA's New Era of Smarter Food Safety Tech-enabled Traceability Outbreak Response 9@mlkanm BH he* «BivFoodIndustry
Slide 13: What Foods Does the Rule Apply To?
WHAT FOODS DOES THE RULE APPLY TO? FOODS ON THE TRACEABILITY LIST [FTLI Frequency of outbreaks and occurrence of illnesses (C1) FSMA Factor (i) Severity of illness (C2) Likelihood of contamination (C3) ++] FSMA Factor (v) FSMA Factor (ii) Growth potential, with consideration of shelf life (C4) FSMA
Slide 14: www.foodrecallreporter.com
www.foodrecallreporter.com
Slide 15: What Foods Does the Rule Apply To? Foods on the Traceability List
WHAT FOODS DOES THE RULE APPLY T0> FOODS ON THE TRACEABILITY LIST IFTLI Cheese (other than hard cheeses) Smoked Finfish Shell eggs Crustations Nut Butter Molluscan shellfish, Bivalves Cucumbers Ready-to-eat deli salads g Herbs (fresh) Leafy Greens (including fresh-cut) Melons (fresh) Peppers (fresh)
Slide 16: Who Does the Rule Apply To?
WHO DOES THE RULE APPLY TO? Persons who manufacture, process, pack, or hold foods that appear on the FTL HW FoodIndustry
Slide 17: FDA final rule link
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
Slide 18: FDA final rule link
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
Slide 19: FDA final rule link
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
Slide 20: FDA final rule link
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
Slide 21: Who Does the Rule Apply To?
WHO DOES THE RULE APPLY TO? is the product, ingredient in the he product Does the processing product, on the Food PX, Subjected toa Yee» result in a food not ves—of processing s listed on the Food \ Traceability List? | | fk / Subject to all, { requirements of \ the Traceability / Rule No he pr a ki
Slide 22: What Needs To Be Done? Lot Traceability Code
WHAT NEEDS T0 BE DONE? LOT TRACEABILITY CODE Must be assigned by: (1) the initial packer; (2) the FLBR (fishing vessel); or (3) any transformer (01)04562135785133 (17)140704 (10) DE-456 GS1-128 Example 475123C 6-digit code + letter to represent grower/manufacturing location BFCA179A152023213 Ltt tt
Slide 23: What Needs To Be Done?
WHAT NEEDS T0 BE DONE? Receiving; and Transforming (when the finished product is still a product on the FTL) FoodIndustry
Slide 24: What Needs To Be Done? Key Data Elements
WHAT NEEDS T0 BE DONE? KEY DATA ELEMENTS IKDEs] Traceability Lot Code Source (TLCS) [Place assigning Lot Code (Location description)] Traceability Lot Code Source Reference (TLCSR) lie., FDA Registration Number] Product Description {Brand name, commodity, and variety} iy FoodIndustry
Slide 25: What Needs To Be Done?
WHAT NEEDS T0 BE DONE? Location Description (farm) Name or description of field/growing area Harvest date Brand, commodity, and variety Quantity Location description for immediate subsequent recipient FoodIndustry
Slide 26: Location Description
Location Description The key contact information for the location where a food is handled, specifically the business name, phone number, physical location address or geographic coordinates, the city, State, and Zip code for domestic locations and comparable information for foreign locations includin
Slide 27: What Needs To Be Done?
WHAT NEEDS T0 BE DONE? Location Description (farm) [Name or description of field/growing area] Harvest date Brand, commodity, and variety Quantity Cooling location FoodIndustry
Slide 28: Location Description (farm)
Location Description (farm) [Name or description of field/growing area] Harvest Date Brand, Commodity, Variety Quantity Date Received Cooling Location Cooling Date Location description of where food packed (TLC Source/TLC source Reference) Traceability Lot Code you assigned Date of initial packing L
Slide 29: What Needs To Be Done? Initial Packing KDEs
WHAT NEEDS T0 BE DONE? Initial Packing KDEs Reference document type and reference document number Reference document is defined as “a business transaction document, record, or message, in electronic or paper form, that may contain some or all of the key data elements for a critical tracking event in
Slide 30: Traceability lot code for the food
Traceability lot code for the food Quantity and unit of measure of the food Product description for the food Location description for the immediate subsequent recipient (other than a transporter) of the food Location description for the location from which you shipped the food Date you shipped the f
Slide 31: What Needs To Be Done?
WHAT NEEDS T0 BE DONE? New traceability lot code for the food Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference Date transformation was completed Product description for the food Quantity a
Slide 32: FDA download link
https://www.fda.gov/media/163132/download?attachment
Slide 33: Traceability Plan
Traceability Plan Description of the procedures you use to maintain the required records, including the format and location of the 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 cod
Slide 34: What Needs To Be Done? Examples
WHAT NEEDS TO BE DONE? Examples ply Chain Example: Cucumber: BiyFoodindustry
Slide 35: What Needs To Be Done?
WHAT NEEDS T0 BE DONE? ot . — ply Cnain &Xal ByFoodIndustry
Slide 36: Supply Chain Example: Deli salad using FTL ingredients
Supply Chain Example: Deli salad using FTL ingredients and FD, non-FTL ingredients 'n this scenario, a deli salad is made with fresh-cut celery and fresh-cut onions, both of which are on the FTL, as well as other non-FTL ingredients. Since deli salads are on the FTL, the processor would need to main
Slide 37: FSMA Rule Key Dates
January 20, 2026 November 15, 2022 November 28, 2023 December 1, 2024 December 31, 2025
Slide 38: Shawn Stevens contact
Shawn Stevens stevens@foodindustrycounsel.com 920.698.2561