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FSMA Resource Center

Navigating FSMA Compliance: Your Ultimate Resource for Food Safety Modernization Act Guidance










What is the FMSA Final Rule?


The Food Safety Modernization Action (FSMA) was signed into law in 2011. Section 204, the Food Traceability Rule, was drafted to identify the foods for which additional traceability records are required to protect public health. It is called the “final rule,” because the FDA started working on a draft list in 2014 and published the final Food Traceability List (FTL) on November 15, 2022. The objective of section 204 of FSMA is to reduce foodborne illnesses and deaths by expediting the identification and requiring removal of potentially contaminated food from the market.

What is FSMA Section 204?


Section 204 of FSMA establishes additional traceability recordkeeping requirements for commercial farms, packing operations and food processing facilities. While all foods are required to be traceable, certain high-risk foods must adhere to a higher standard. This higher standard dictates that specific information about the food, known as Key Data Elements (KDEs), must be recorded as the food travels through the supply chain. KDE records must be retrieved within 24 hours if there is a request by the FDA or another regulatory authority. Exemptions include home gardeners, food preservers and direct-to-consumer sales at restaurants, retail food establishments and farmers’ markets.

What foods require additional Traceability records?

For the complete list, click here.


  • Certain Cheeses
  • Shell Eggs
  • Nut Butters
  • Cucumbers (fresh)
  • Herbs (fresh)
  • Leafy Greens (fresh)
  • Leafy Greens (fresh-cut)
  • Melons (fresh)
  • Peppers (fresh)
  • Sprouts (fresh)
  • Tomatoes (fresh
  • Tropical Tree Fruits (fresh)
  • Fruits (fresh)
  • Vegetables (other than leafy greens fresh-cut)
  • Finfish (fresh and frozen)
  • Smoked Finfish (refrigerated and frozen)
  • Crustaceans (fresh and frozen)
  • Molluscan shellfish, bivalves (fresh and frozen)
  • Ready to Eat Deli Salads (refrigerated)

How long do I have once the FDA requests the information?

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Upon request by the FDA, all records must be made available to an authorized FDA representative, upon request, within 24 hours (or within some reasonable time to which FDA has agreed) after the request, along with any information needed to understand these records.

How long do the records need to be kept?


In most cases, records containing the information required under the final rule must be maintained for two years from when the records were created or obtained. Records maintained by a retail food establishment or restaurant for food purchased directly from a farm must be maintained for 180 days. A previous traceability plan must be retained for two years after the plan has been updated. The traceability plan must be updated as needed to ensure that the information provided reflects the current practices and to ensure compliance with the requirements.

What traceability records are required?


You must maintain and provide specific information associated with different events in the food supply chain to supply chain partners and link that information to a traceability lot code. The rule identifies the following events in the food supply chain as the Critical Tracking Events (CTEs) for which traceability records containing Key Data Elements (KDEs) are required to be maintained and provided:

  • Harvesting
  • Cooling (before initial packing)
  • Initial packing of a RAC (other than food obtained from a fishing vessel)
  • First land-based receiving (of food obtained from a fishing vessel)
  • Shipping
  • Receiving
  • Transformation of a food

Traceability lot codes are central to the rule’s operation. They are used to identify food(s) as they move through the supply chain and maintain other records relating to their activities. At each CTE, required records must include the traceability lot code and KDE linked to the relevant traceability lot. In addition to records of certain CTEs, entities subject to the rule must establish and maintain a traceability plan. The traceability plan contains information related to an entity’s traceability procedures and operations and is intended to help regulators understand the records they review. The traceability plan must include the following:

  • A description of the procedures used to maintain the required records
  • A description of the procedures used to identify foods on the FTL that an entity manufactures, processes, packs, or holds. For farms, this includes any foods on the FTL that the farm grows.
  • A description of how traceability lot codes are assigned (if applicable);
  • A point of contact for questions regarding your traceability plan and records; and
  • For farms that grow or raise food on the FTL, a farm map shows the areas where the food is grown or raised. The farm map must show the location and name of each field (or other growing area) where the food on the FTL is grown, including geographic coordinates and any additional information needed to identify the location of each field or growing site.
  • For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) where the seafood on the FTL is raised, including geographic coordinates and any other information needed to identify the location of each container.

What is the deadline?


Section 204 of FSMA went into effect in January 2023. However, the FDA has given companies until January 20, 2026, to become fully compliant.

What are the penalties if I cannot provide the information?


The violation of any recordkeeping requirement under section 204 of FSMA is prohibited. However, depending on the nature of the violation, the FDA intends to allow individuals and firms to take prompt and voluntary corrective action before enforcement action is initiated. If compliance is not met (by one or multiple entities) voluntarily, the FDA can bring civil and criminal activities to prosecute violators, holding them responsible. While the FDA does not have the authority to impose fines for violations of section 204 of FSMA, these prosecutions open the way for private actions.

What could be some of the possible advantages offered by FSMA 204?


FSMA 204's Final Rule, though limited to specific foods, offers a multitude of benefits, leading to groundbreaking developments in the field of traceability recordkeeping. This first-ever standardized model opens up possibilities for industries to embrace digital, tech-based traceability systems now and in the future. Not only does this improve consumer safety by rapidly identifying contamination sources, but it also narrows the range of product recalls and minimizes the risk of illness or death.

By bolstering traceability, we can expedite the root cause investigations to understand contamination sources and prevent future outbreaks. So, what's in it for you? Here's a snapshot of the many benefits of the Final Rule:

  • A decrease in foodborne illnesses and deaths
  • Swift identification and isolation of contamination sources
  • Rapid removal of contaminated food from the market
  • Limited recall scopes, reducing disruption and financial burden
  • Harmonized information for ease of access and understanding
  • Quicker establishment of linkages along the supply chain
  • Seamless alignment with existing industry approaches
  • Enhanced ability to perform root cause investigations and learn from past outbreaks

Mastering Traceability

Worried about the extensive and meticulous nature of traceability? Imagine encountering an audit or product recall without these fundamental guidelines. Traceability requires a calculated and systematic method. It may be time-consuming and financially demanding, yet technology can lighten this load with instantaneous electronic data capture, reducing mistakes and digitizing your crucial records.

There's a sea of information to deal with, and managing it with traditional pen and paper is far from efficient. To truly master traceability and be ready for audits and recalls, connect with us for more insights.