Food Safety Modernization Act (FSMA) Traceability Rule (Section 204) Update

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Wesley Kline, PhD

The new traceability rule goes into effect January 20, 2026, for all operations. There will be no phase
in period as there has been for other parts of FSMA. The rule is not part of the Produce Safety Rule,
but part of FSMA. The Food and Drug Administration wants the ability to trace a produce item as
quickly as possible from a foodborne outbreak to the source.

Traceability Rule includes important new terms in § 1.1310:

  • Food Traceability List (FTL) means the list of foods for which additional traceability records
    are required to be maintained, as designated in accordance with section 204(d)(2) of the FDA
    Food Safety Modernization Act. The term “Food Traceability List” includes both the foods
    specifically listed and foods that contain listed foods as ingredients, provided that the listed food
    that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.

The full Food Traceability List can be found at: https://www.fda.gov/food/food-safety-modernizationact-
fsma/food-traceability-list.
The Traceability Rule includes a provision – § 1.1305(e) – stating that if produce is on the Rarely
Consumed Raw List, it is exempt from the Traceability Rule. Thus, produce items listed in the
Produce Safety Rule are exempt from the Traceability Rule.

The following were copied from the September 5, 2024, version of the Food Traceability List.
These items fall under the traceability rule unless noted as exempt. FDA will update the list when
appropriate.

  • Cucumbers – Includes all varieties of fresh cucumbers.
  • Herbs – 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 – 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).
  • Melons – Includes all types of fresh melons. Examples include, but are not limited to,
    cantaloupe, honeydew, muskmelon, and watermelon.
  • Peppers – Includes all varieties of fresh peppers.
  • Sprouts – 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 – Includes all varieties of fresh tomatoes.
  • Tropical tree fruits – 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, passion fruit,
    Loquat, pomegranate, sapodilla, and figs. 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).
  • 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).
  • 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).
  • Note: When a food is no longer in the fresh form (i.e., dried peppers, herbs, frozen spinach,
    etc.) then it is no longer on the list. The person changing the form would need to maintain
    receiving records only. Also, the information on finfish, crustaceans and molluscan shellfish are
    not included on this list but can be found at the website.
  • Critical Tracking Event (CTE) means an event in the supply chain of a food involving the harvesting,
    cooling, initial packing of a raw agricultural commodity
    Note: For farms, important CTEs are harvesting, cooling, and the initial packing of produce and must
    include the following if packing.
    – Who is purchasing the produce?
    – The commodity
    – Quantity (e.g., boxes, bins, pounds, etc.)
    – Location of the farm
  • Name of field, greenhouse, etc.
    – Date of harvest
    – Reference document type (P.O. invoice, etc.)
    – Reference document number
    – Must provide the above information including business name and phone number.
    Note: If the farm is exempt the packer must obtain the above information and assign a traceability
    lot code
  • Cooling means active temperature reduction of a raw agricultural commodity using hydrocooling,
    icing forced air cooling, vacuum cooling, or a similar process.
  • Transformation means an event in a food’s supply chain that involves manufacturing/processing
    a food or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or
    packing, when the output is a food on the Food Traceability List. Transformation does not
    include the initial packing of a food or activities preceding that event (e.g., harvesting, cooling).
  • Receiving means an event in a food’s supply chain in which someone receives a food other than a
    consumer after being transported (e.g., by truck or ship) from another location. Receiving includes
    receipt of an intra company shipment of food from one location at a particular street address of
    a firm to another location at a different street address of the firm.
  • Traceability lot means a batch or lot of food that has been initially packed (for raw agricultural
    commodities other than food obtained from a fishing vessel), received by the first land-based
    receiver (for food obtained from a fishing vessel), or transformed.
  • Traceability lot code means a descriptor, often alphanumeric, used to uniquely identify a
    traceability lot within the records of the traceability lot code source.
  • Initial packing means packing a raw agricultural commodity for the first time.
  • Key data element means information associated with a critical tracking event for which a record
    must be maintained and/or provided in accordance with this subpart.
  • Location description means key contact information for the location where a food is handled,
    specifically the business name, phone number, physical location address (or geographic
    coordinates), and city, state, and zip code for domestic locations and comparable information for
    foreign locations, including country.

Exemptions to the traceability rule

There are several exemptions that applies to farms. To see if your organization is exempt go to the FDA
Exemptions and Exclusions tool: https://collaboration.fda.gov/tefcv13.

  • Sales less than 25,000 on three-year average adjusted for inflation (2020)
  • Food sold or donated directly to consumers.
  • Food packaged on the farm to prevent contamination the packaged product must be
    completely enclosed and be labeled with name and complete address and phone number.
    Clamshells or vented containers are not exempt since there is possibility of contamination.
  • Food delivered directly to restaurants, schools, institutions or under USDA food programs.
  • Commercial processing that reduces public health risk. If shipping produce that will be
    heat treated must have a written agreement (effective date, printed name, and
    signatures) that this will happen.
  • Product changed so not on Food Traceability List. Exempt if the receiver maintains the
    records required in §1.1345.
    Other groups that are exempt include:
  • Small establishment with sales less than $250,000 on three-year average (adjusted for
    inflation based on 2020) but must maintain name and address of the farm for 180 days
    when receiving produce.
  • Nonprofit establishments
  • Transporters
  • Holding food for specific individual consumer, but not involved in sales (hotel staff, office
    staff, etc.)
    Note: Food hubs are not exempt, but USDA feeding programs are exempt

Partial Exemptions:

  • Restaurant and Retail Food Establishment purchasing directly from the farm (produced
    and packaged on farm)
    – Record of name and address of the farm and must be maintained for 180 days.
  • Farm to school or institutions
    – Must maintain name and address of the farm for 180 days.
  • Restaurant or Retail Food Establishment – Sales directly to consumer if annual
    monetary value of sales of food products is greater than total sales purchases from
    another on an ad hoc basis.
    – Name of Product purchased date, name, and address.

Businesses including farms that fall under the traceability rule must have a written plan which
includes:

  • How you maintain records including format and location of records
  • Procedure used to identify foods on FTL.
  • Description of how traceability lot codes are created (if packing produce)
  • Point of contact for the traceability plan (need not be a person’s name)
  • For farms, a farm map showing where foods are grown.
    – Location and name of each field, including GPS and other necessary location
    information.

When shipping produce, the shipper must provide to the purchaser:

  • Traceability lot code
  • Quantity (cases, boxes, etc.)
  • Product description
  • Receiver of lot
  • Location from where shipped.
  • Date shipped.

When receiving produce that is on the Food Traceability List the receiver must have the

  • Traceability lot code
  • Quantity and unit of measure (box, RPC, etc.)
  • Product description of food
  • Location description of immediate previous source
  • Location description where food was received.
  • Date received.
  • Location description of traceability lot code source or reference
  • Reference document type and reference document number

When transforming (commingling, repacking, or relabeling) the organization must maintain
the original

  • Traceability lot code
  • Description of the food
  • Quantity and unit of measure from each lot
  • Food transformed.
  • Assign a new traceability lot code.
  • Where transformed food
  • Date completed.
  • Product description for food
  • Quantity and unit of measure (cases, RPC, etc.)
  • Reference document type and number
  • If not previously packed must have records required at packing

Maintaining Records
The records can be in paper if the operation meets the following criteria if not, they must be in an
electronic format.

  • Paper only
    – Farm with sales (raw agricultural commodities) less than $250,000 3-year
    average adjusted for inflation (2020)
    – Retail food establishment $1 million 3-year average (food sold)
    – Persons other than farm with food sales of $1 million on 3-year average (2020)
    – For religious belief
  • Third party may establish and maintain records if available within 24 hrs.
  • Do not need to keep one set of records but must indicate the format and location.
  • Can store records offsite if available in 24 hrs.
  • Retain for 2 years from when created or obtained.

Related Documents

  • FDA Final Traceability Rule: https://www.fda.gov/food/food-safety-modernization-actfsma/
    fsma-final-rule-requirements-additional-traceability-records-certain-foods
  • FDA Food Traceability List: https://www.fda.gov/food/food-safety-modernization-actfsma/
    food-traceability-list#List
  • FDA Exemptions and Exclusions tool: https://collaboration.fda.gov/tefcv13
  • FDA Small Entity Compliance Guide; https://www.fda.gov/food/food-safetymodernization-
    act-fsma/fsma-rules-guidance-industry
  • Small Entity Compliance Guide: Requirements for Additional Traceability Records for
    Certain Foods: What You Need to Know About the FDA Regulation | FDA