All About the FDA’s FSMA 204: Food Traceability

On September 21, 2020, the Food and Drug Administration (FDA) finally released their proposal for achieving traceability within the farm-to-table food system. This piece of legislation belongs to section 204 of the Food Safety Modernization Act (FSMA) formed in 2011, which has been highlighted as a great achievement as the agency moves forward with its New era of Smarter Food Safety initiative.

The initiative aims to provide better transparency for the sake of consumer protection within the food industry. In other words, the goal is to make food traceability as quick and simple and possible.

That means if you’re in the food industry, the new FSMA section 204 may apply to you. To learn more about the legislation and the requirements your business may have to meet and how to prepare your team, keep reading.

What Exactly Is FSMA Section 204?

The FSMA section 204 in plain and simple terms elevates the transparency and enhancement for food traceability and record-keeping. According to the FDA, this is to “help establish clear tracing of a food product’s source when needed to address food safety risks.”

Under this section of the legislation, the rules outline potential changes that could eventually enable end-to-end food traceability throughout the entire industry. As of right now, the rules and regulations are rather limited to the foods that are at the highest risk for foodborne illness outbreaks.

Under the proposed rule designated for the inclusion of the food traceability list, FSMA section 204 applies to anyone within the industry who manufactures, processes, packs, or holds food. The entire purpose behind section 204 is to mitigate or prevent any foodborne illness outbreaks and enable those within the industry to address credible threats of any serious adverse health consequences — including death.

More on the Benefits of Food Traceability

The goal is to revolutionize food safety and illness prevention for consumer protection. By the technological use of Critical Tracking Events (CTEs) and Key Data Elements (KDEs), the food industry will be able to build more transparency within the food system to reveal any vulnerabilities and get to the root cause much quicker.

Of course, by adding these regulations there are benefits beyond consumer protection. Food transparency also benefits any stakeholders in the industry. In addition to preventing serious illness or worse, death, having a transparent food system will allow for more targeted and low-impact approaches to solving general food safety issues.

For example, once the availability of traceability records is set up and put into action, it can help limit the number of recalls in most instances by identifying the issue and its root cause. This will allow the entire supply chain within the food industry to keep contaminated foods from reaching store shelves and restaurant tables before the event erupts into a bigger issue.

This is something that will also allow many food brands, markets, and the hospitality industry to save face with their consumers by avoiding large, blanketed alerts to the public.

The Food Traceability List

As mentioned earlier, the new requirements set up by the FSMA section 204 will apply primarily to any foods that are considered to be at high risk for contamination and foodborne illnesses.

Any of the food or food products listed below will be subject to enhanced traceability requirements unless they’re exempt under the rules and regulations of the legislation:

• Cheeses (except for hard cheeses)
• Eggs (raw, in their shells)
• All types of nut butter
• Cucumbers
• Fresh herbs
• All leafy greens, including fresh-cut leafy greens
• All melons
• All peppers
• All types of sprouts
• All types of tomatoes
• All tropical tree fruits
• All fresh and fresh-cut fruits and vegetables
• All types of Finfish, including smoked finfish. However, this does not include Siluriformes fish, such as catfish
• All crustacean species, such as shrimp, crab, lobster, crayfish, and so on
• Mollusks and any other bivalves, i.e., clams and muscles
• Ready-to-eat deli salads

Additional Requirements and Exemptions

In addition to defining the KDEs and the CTEs required for record creation, section 204 has also laid out standards for record-keeping and broader records requirements. As mentioned these requirements and regulations apply to those within the food industry who manufacture, pack, or hold foods to maintain the new traceability program records.

Those requirements would include:

• A detailed description of any relevant reference records
• A list of any foods found on the food traceability list involved in shipping
• A detailed description of how the traceability lot codes are assigned
• Any other information needed to understand the data provided within the required records

These record requirements are what enable third parties to navigate, track, and understand the traceability data collected from the CTEs. In addition to these requirements, it’s also mandated that all records must be properly documented and stored to ensure that they can be easily read and are protected from deterioration and other hazards.

Electronic record-keeping is not yet the standard under FSMA section 204, however, the FDA will require that records be made available within 24 hours of being requested. In certain cases, they will also be expected to be typed up in an electronic spreadsheet, should a request needing assistance during an outbreak, recall, or other public health crisis occur.

Therefore, most businesses will likely need to keep electronic documents in addition to their paper documents as backup and for easier access during the request timeframes.

When it comes to exemptions, these are limited to certain products and individuals. Exemptions may or may not apply to you and your business if your operation is found to be below a certain profit or production threshold.

Another instance would be if your products are sold directly to the public via venues such as farmer’s markets. This type of exemption only applies if you’ve taken certain processing procedures to reduce any foodborne illness risks or if the end-product is rarely (or not at all) consumed raw.

Blockchain for Safety and Traceability

Legacy supply chains have their own set of unique challenges. These challenges include the antiquated, paper-based processes in which result timeliness, soiled networks, difficult data sharing, a complete lack of transparency. Legacy supply chains also tend to have a single point of failure which tends to end in human error and potential fraud which only costs more time and money. These errors often happen due to the over-reliance on intermediaries, brokers, geographical distance, language barriers and currency conversions that all make basic communication within the supply chain susceptible to error.

Through the implementation of blockchain technology into supply chain systems there are specific benefits that come as a result of its implementation. Paper-based processes are digitized so that means the data is securely stored and everything along the chain can become more efficently managed and tracked. Through the implementation of blockchain, transparency within the supply chain becomes second to none, with the ability to track and trace products from the source to the end consumer, giving stakeholders and consumers the ability to authenticate products. Specific products that are perishable or subject to fraud can now be secured through the ability blockchain gives with real-time auditability. And lastly blockchain within the supply chain allows for greater decentralization and increased security.

Bottom line — blockchain-based track and trace solutions — powerful and outstanding for supporting the anticipated 204(d) track and trace, digital record-keeping, and compliance responsiveness requirements.

You can learn more about the exemption requirements here.