Who Needs to Comply?
The Food Traceability List
Helping You Determine if FSMA 204 Applies to Your Organization
The Food Traceability List is a central part of the FDA’s Food Traceability Rule (FSMA 204). Businesses that manufacture, process, pack, or hold foods on the list are required to carry out additional traceability recordkeeping.
The Food Traceability List was compiled by the FDA and CDC, who identified a number of foods that were judged to be at higher risk of contamination. Foods on the list include certain cheeses, nut butters, shell eggs, fish & seafood, fresh produce, and ready-to-eat deli salads.
Additional recordkeeping responsibilities apply to:
- Foods specifically listed on the Food Traceability List.
- Foods that contain listed foods as ingredients, provided that they remain in the same form (e.g. fresh) as they appear on the list.
There are a number of exemptions, including revenue thresholds. To see if the rule applies to you, the FDA has created an online exemptions tool.
A Quick Snapshot
The FDA listed a total of 19 food types, which we have further divided into 6 broad categories.
This includes named fresh and fresh cut fruit, vegetables, leafy greens, herbs, and sprouts.
‘Shell egg’ means the egg of the domesticated chicken.
This includes finfish, smoked finfish, crustaceans, and molluscan shellfish (fresh, frozen, and previously frozen).
Excluding hard cheeses, frozen or previously frozen, shelf stable, or those that are aseptically processed and packaged.
Including, but not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters.
Includes all types of refrigerated ready-to-eat deli salads, including previously frozen salads. Does not include meat salads.
The Food Traceability List in Full
Fresh Produce
Cucumbers
Cucumbers Fresh [2]
Includes all varieties of fresh cucumbers.
Herbs Fresh
Herbs Fresh
Includes all types of fresh herbs.
Examples include, but are not limited to, parsley, cilantro, and basil.
Herbs listed in 21 CFR 112.2(a)(1), such as dill, are exempt from the requirements of the rule under 21 CFR 1.1305(e).
Leafy Greens
Leafy Greens
Includes all types of fresh leafy greens.
Examples include, but are not limited to, arugula, baby leaf, butter lettuce, chard, chicory, endive, escarole, green leaf, iceberg lettuce, kale, red leaf, pak choi/bok choi, Romaine, sorrel, spinach, and watercress.
Does not include whole head cabbages such as green cabbage, red cabbage, or savoy cabbage.
Does not include banana leaf, grape leaf, and leaves that are grown on trees.
Leafy greens listed in § 112.2(a)(1), such as collards, are exempt from the requirements of the rule under § 1.1305(e).
Leafy Greens (fresh cut)
Freshly Cut Leafy Greens [3]
Includes all types of fresh-cut leafy greens, including single and mixed greens.
Melons
Melons Fresh
Includes all types of fresh melons.
Examples include, but are not limited to, cantaloupe, honeydew, muskmelon, and watermelon.
Peppers
Peppers Fresh
Includes all varieties of fresh peppers.
Sprouts
Sprouts Fresh
Includes all varieties of fresh sprouts (irrespective of seed source), including single and mixed sprouts.
Examples include, but are not limited to, alfalfa sprouts, allium sprouts, bean sprouts, broccoli sprouts, clover sprouts, radish sprouts, alfalfa & radish sprouts, and other fresh sprouted grains, nuts, and seeds.
Tomatoes
Tomatoes Fresh
Includes all varieties of fresh tomatoes.
Tropical Tree Fruits
Tropical tree fruits (fresh)
Includes all types of fresh tropical tree fruit.
Examples include, but are not limited to, mango, papaya, mamey, guava, lychee, jackfruit, and starfruit.
Does not include non-tree fruits such as bananas, pineapple, dates, soursop, jujube, passionfruit, Loquat, pomegranate, and sapodilla. Does not include tree nuts such as coconut. Does not include pit fruits such as avocado.
Does not include citrus, such as orange, clementine, tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and pomelo. Tropical tree fruits listed in § 112.2(a)(1), such as figs, are exempt from the requirements of the rule under § 1.1305(e).
Vegetables
Vegetables other than leafy greens (fresh-cut)
Includes all types of fresh-cut vegetables other than leafy greens.
Vegetables listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e).
Fruits
Fruits (fresh-cut)
Includes all types of fresh-cut fruits.
Fruits listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e).
Does not include citrus, such as orange, clementine, tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and pomelo. Tropical tree fruits listed in § 112.2(a)(1), such as figs, are exempt from the requirements of the rule under § 1.1305(e).
Cheeses
Cheeses, other than hard cheeses, specifically:
Cheese (made from pasteurized milk), fresh soft or soft unripened
Includes soft unripened/fresh soft cheeses.
Examples include, but are not limited to, cottage, chevre, cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna.
Does not include cheeses that are frozen or previously frozen, shelf stable at ambient temperature, or aseptically processed and packaged.
Cheese (made from pasteurized milk), soft ripened or semi-soft
Includes soft ripened/semi-soft cheeses.
Examples include, but are not limited to, brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, monterey jack, and muenster.
Does not include cheeses that are frozen or previously frozen, shelf stable at ambient temperature, or aseptically processed and packaged.
Cheese (made from unpasteurized milk), other than hard cheese [1]
Includes all cheeses made with unpasteurized milk, other than hard cheeses.
Does not include cheeses that are frozen or previously frozen, shelf stable at ambient temperature, or aseptically
Eggs
Shell Eggs
Shell Eggs (White and Brown)
Shell egg means the egg of the domesticated chicken.
Nut Butters
Nut Butters
Nut Butters
Includes all types of tree nut and peanut butters. Includes all forms of nut butters, including shelf stable, refrigerated, frozen, and previously frozen products.
Examples include, but are not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters.
Does not include soy or seed butters.
Fish and Seafood
Finfish (fresh, frozen, and previously frozen), specifically:
Finfish, histamine-producing species
Includes all histamine-producing species of finfish.
Examples include, but are not limited to, tuna, mahi mahi, mackerel, amberjack, jack, swordfish, and yellowtail.
Finfish, species potentially contaminated with ciguatoxin
Includes all finfish species potentially contaminated with ciguatoxin.
Examples include, but are not limited to, grouper, barracuda, and snapper.
Smoked finfish
Smoked finfish (refrigerated, frozen, and previously frozen)
Includes all types of smoked finfish, including cold smoked finfish and hot smoked finfish.[6]
Crustaceans
Crustaceans (fresh, frozen, and previously frozen)
Includes all crustacean species.
Examples include, but are not limited to, shrimp, crab, lobster, and crayfish.
Molluscan Shellfish
Molluscan shellfish, bivalves (fresh, frozen, and previously frozen) [7]
Includes all species of bivalve mollusks.
Examples include, but are not limited to, oysters, clams, and mussels.
Does not include scallop adductor muscle. Raw bivalve molluscan shellfish that are (1) covered by the requirements of the National Shellfish Sanitation Program; (2) subject to the requirements of 21 CFR part 123, subpart C, and 21 CFR 1240.60; or (3) covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish are exempt from the requirements of the rule under § 1.1305(f).
Ready-to-eat Deli
Ready-to-Eat Deli
Ready-to-Eat Deli Salads (refrigerated)
Includes all types of refrigerated ready-to-eat deli salads, including ready-to-eat deli salads that are frozen at some point in the supply chain prior to retail.
Examples include, but are not limited to, egg salad, potato salad, pasta salad, and seafood salad.
Does not include meat salads.
Appendix
[2] The designation “fresh” does not include previously frozen forms of the food.
[3] The designation “fresh-cut” does not include previously frozen forms of the food.
[4] For a more comprehensive list, see Chapter 3 of the Fish and Fishery Products Hazards and Controls Guidance.
[5] Data for catfish were excluded from the Risk-Ranking Model because Siluriformes fish (such as catfish) are primarily regulated by the U.S. Department of Agriculture.
[6] “Smoked finfish” refers to a finfish product that meets the definition of a smoked or smoke-flavored fishery product in 21 CFR 123.3(s).
[7] Under 21 CFR 123.3(h), molluscan shellfish means any edible species of fresh or frozen oysters, clams, mussels, or scallops, or edible portions of such species, except when the product consists entirely of the shucked adductor muscle.
Note: Foods for animals are not included in the current risk-ranking model and are not included on the FTL, and therefore not covered by the final rule.
