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The Food Safety Modernization Act (FSMA) is an update on food safety laws in the United States that regulate the production and distribution of food. FSMA tackles the ongoing issue of foodborne illness, a significant public health burden that is largely preventable. The Food Safety Modernization Act is transforming the nation’s food safety system by shifting the focus of food safety from reactive measures to a preventative approach. FSMA is enforcing new proactive safety measures and increasing transparency throughout the food supply chain.

FSMA was signed into law by President Barack Obama in January 2011 and is being implemented by the FDA.

FSMA was set up in response to dramatic changes to the global food system and our understanding of foodborne illness, as well as the realization that foodborne illness is both a significant public health burden, and that it is largely preventable.

Approximately 48 million people get sick from a foodborne illness in the United States (1 in 6 people) every year, with 128,000 requiring hospitalisation and 3,000 deaths annually. This is according to the U.S. Centers for Disease Control and Prevention (CDC).

FSMA 204, known as the ‘FDA Food Traceability Rule’ or ‘FDA Food Traceability Final Rule’, is a section within the Food Safety Modernization Act that focuses on food traceability and establishing a foundation for end-to-end traceability. “FSMA 204” is informal shorthand for the FDA’s 2022 final rule, Requirements for Additional Traceability Records for Certain Foods, issued under Section 204(d) of the Food Safety Modernization Act (FSMA).

The FDA Food Traceability Rule sets additional food traceability recordkeeping responsibilities for businesses who manufacture, process, pack, or hold foods that are featured on the Food Traceability List. These foods include soft cheeses, shell eggs, fresh-cut fruits and vegetables, fish and seafood, nut butters and ready-to-eat deli salads. These recordkeeping requirements are beyond those outlined in existing regulations.

FSMA 204 aims to more quickly identify the source of an outbreak of a contaminated batch of food and allow more efficient recall, to prevent further spread.

The FDA states that their aim is always to ‘educate before they regulate’. Routine inspections are not due to begin until Jan 2027, but inspections may be carried out on a for cause basis, i.e. as needed, if an outbreak occurs. The FDA is still developing their compliance and enforcement strategy for failure to comply with FSMA 204. However, they have shared their likely strategy. Individuals will be given an opportunity to take corrective action and comply before any enforcement action is taken against them. What this means is the FDA will warn you that you are currently violating the requirements of the regulation and you will be given a chance to comply or face consequences. The FDA states that warnings will most likely be in the form of warning letters, notifying a business of their need to comply and giving the opportunity to voluntarily comply. 

The FDA does not have the authority to impose fines for noncompliance with FSMA 204 themselves. However, they do have the ability to bring civil and/or criminal action in federal court against non-cooperating individuals. Non-compliance with FSMA is considered committing a prohibited act. Other corrective actions that may be taken include refusal of admission to the United States, if the food product does not have the required records.

FSMA 204 is a highly-anticipated FDA requirement that impacts organizations throughout the entire domestic food supply chain and foreign companies producing food for the US. 

By mandating comprehensive food traceability requirements, the FDA Traceability Rule affects every level of the supply chain from farmers and suppliers to caterers and the hospitality sector.

The Food Traceability Rule has already come into effect.

However, the compliance date for all persons is July 20, 2028.

Businesses who manufacture, process, pack, or hold foods that are featured on the Food Traceability List. The rule does not apply to businesses that fall below certain revenue thresholds (average over the 3 previous years). 

Threshold include:

• Farms that generate less than $25,000 per annum.
• Food Businesses that generate less than $250,000 per annum.

The Food Traceability List is a central part of the FDA’s Food Traceability Rule (FSMA 204). FSMA 204 requires businesses who manufacture, process, pack, or hold foods on the list to carry out additional food traceability recordkeeping. These additional responsibilities are being brought in to allow for rapid identification and removal of contaminated foods. 

Foods on the list are judged to be at higher risk of contamination. This includes certain cheeses, eggs, nut butters, fresh produce, seafood, 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. 

FSMA 204 identifies certain foods for additional recordkeeping requirements. These foods are considered to be at a higher risk of contamination and are therefore being designated for additional recordkeeping so that the FDA can quickly identify the source of the contamination in the event of a foodborne disease outbreak. 

If an outbreak were to occur, the affected batch of food can be recalled more effectively to prevent further spread. The foods selected to be on the list were decided by the FDA and the Centers for Disease Control and Prevention (CDC). The factors considered in the risk ranking model determining whether a food is included in the list are:

• Frequency of outbreaks and occurrences of illnesses
• Severity of illness
• Likelihood of contamination
• The potential for pathogen growth, with consideration of shelf life
• Manufacturing process contamination probability and industry-wide intervention
• Consumption rate and amount consumed
• Cost of illness

Businesses manufacturing, processing, packing or holding foods included in the Food Traceability List must establish and maintain a food traceability plan. Your traceability plan must be continuously updated as needed to ensure the information provided reflects your current practices and ensure continuous compliance. Your previous traceability plan must be maintained for 2 years after you update your current plan. 

Required items in your traceability plan include:

• A description of the procedures you use to maintain the records you are required to keep, including the format and location of these records.
• A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold.
• A description of how you assign traceability lot codes to foods on the Food Traceability List.
• A statement identifying a point of contact for questions regarding your traceability plan and records.
• If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods. This map must show the location and name of each field in which you grow food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area. For aquaculture farms, the farm map must show the location and name of each container (e.g. pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.)

4th January 2011 – Food Safety Modernization Act (FSMA) signed into law, providing the Food and Drug Administration (FDA) the authority and responsibility of monitoring food production.

21st November 2022 — FDA published the Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule).

20th July 2028 — The original date for compliance was Tuesday, January 20, 2026. However, in March of 2025, the FDA announced a 30 month extension, pushing the new deadline to July 20th, 2028.

In the event of a foodborne disease outbreak, an electronic sortable spreadsheet must be provided to the FDA within 24 hours of request (or within a reasonable timeframe decided by the FDA). 

Records containing the information required for compliance with FSMA 204 must be maintained as either paper or electronic records, or as true copies. They must be clearly legible and stored in a way as to prevent deterioration or loss.

The FDA defines food traceability as the ability to track a food product and its ingredients throughout the entire food supply chain, both backward and forward.

Food traceability involves maintaining documentation at each step of the supply chain from production and processing, to holding and distributing. Effective tracing of food enables faster identification and removal of affected food products, reducing the public’s potential exposure to contaminated food products.

Food traceability software is software that enables you to track a food product through your supply chain and ensure you have full visibility over where it has come from and where it is being used within your products/recipes.

In the event of an outbreak of a foodborne illness, the ingredients of a dish/product can be quickly and effectively traced back to their source and recalled.

Food recall management software is software that allows you to more efficiently and effectively carry out a product recall. Product recalls are carried out when an outbreak of a foodborne illness occurs and a food in your supply chain is contaminated.

A traceability management system allows you to have all of your data ready and waiting when you need it. You can easily identify the ingredients used within a food product and track each of their origins, allowing you to identify the root cause in an outbreak.

FSMA 204 will enable the FDA to trace food more effectively and carry out faster and more efficient food recalls.

According to the CDC every year 48 million people get sick from a foodborne illness in the United States, with 128,000 requiring hospitalisation and 3,000 deaths.

The Food Traceability Final Rule aka FSMA 204 aims to mitigate and contain the impact of future outbreaks by more quickly identifying and recalling affected batches. This has the potential to reduce the incidences of foodborne illnesses and save thousands of lives in the United States each year.  

References: 

CDC

Traceability Lot Codes FDA

Tracking and Tracing of Food

A core part of the Food Traceability Rule is the assignment of a Traceability Lot Code. This is a unique identifier that is like a serial number or social security number for food. This unique descriptor, which typically contains both letters and numbers, is used to uniquely identify and track a specific batch of food through the supply chain. The traceability lot code stays with a food product through the entire global food supply chain and links it to its initial lot, batch or source. 

Attaching a traceability lot code to food allows the FDA to quickly identify the source of the food if an outbreak occurs, skipping entire steps in the supply chain. It also enables the FDA to quickly determine the appropriate scope of a recall and prevent further infection. Traceability lot codes allow for greater harmonisation, while allowing firms the flexibility to integrate the requirements into their existing tracing systems. 

A traceability lot code is much like a social security number for food. It provides a unique identifier that allows the food to be traced back through the entire supply chain to its origin. For this reason, it is important that it stays the same. However, there are a number of instances where a new lot code will need to be assigned. 

A TLC is first assigned when it is first being packaged at its source, in most cases; the farm. In the case of seafood, the TLC is first assigned when it is collected from the fishing boat. 

All businesses that need to comply with FSMA will assign lot codes at the start of the supply chain. However, there are businesses such as farms that generate less than $25,000 per year that are exempt. If you purchase food from these sources, they will not come with TLCs preassigned. In these cases, you must assign a lot code yourself. 

The only time you would assign a new lot code to a food that already has one is when that food is being transformed. Transformation refers to a significant change in the food. In most cases, this occurs when a food is combined with other foods in a recipe. When this occurs, the new recipe must be assigned its own TLC, which must link back to the original TLCs of all of the ingredients within it. 

This system allows food to be efficiently and effectively traced back through the entire global supply chain. 

FSMA 204 requires organizations to keep a record of a number of crucial stages along the food supply chain. These are known as Critical Tracking Events (CTEs) and include 7 key stages. 

1. Harvesting: Removing foods from the place they were grown.
2. Cooling: Temperature reduction of a raw agricultural commodity.
3. Initial Packing: Packaging a commodity for the first time.
4. First Land-Based Receiver (from a shipping vessel).
5. Shipping: From one part of the supply chain to another. 
6. Receiving: Someone receiving a product at another location. 
7. Transformation: Manufacturing/processing or changing a food.

The FDA has provided a complete breakdown of each critical tracking event and the recordkeeping requirements at each stage in this incredibly helpful, 11-page slide deck.

Key Data Elements (KDEs) refers to the traceability data that an organization is required to maintain and provide to their supply chain partners. These key data elements are related to the 7 most crucial stages of the food supply chain. This data will vary depending on the supply chain activity. 

A core part of the Food Traceability Rule is the assignment of a Traceability Lot Code. This is a unique identifier that follows a food product through the global supply chain and links it to its initial lot, batch or source. This allows the FDA to quickly identify the source of the food if an outbreak occurs. 

The FDA has provided a complete breakdown of the Key Data Elements required at each stage of the food supply chain. These stages are also known as the ‘Key Tracking Events’. They include harvesting, cooling, initial packing, first land-based receiver, shipping, receiving, and transformation. Full details can be found here.