FSMA Regulation 204 Has Come Into Effect

In November 2022, the US Food and Drug Administration (FDA) issued its final ruling on the Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) under the Food Safety Modernization Act (FSMA) Section 204(d).

Commonly known as FSMA 204, this regulation is a key component of the FDA’s New Era of Smarter Food Safety Blueprint. It is also the result of sweeping reforms in the United States regarding food safety under the FSMA, which was passed by Congress in December 2010 and signed into law by President Barack Obama in January 2011. However, it took several years for the FDA to finalize the FSMA’s regulations and how compliance would be enforced.

What does this mean for agrifood companies, including producers, processors, distributors, retail chains, restaurants, etc.? Let’s take a closer look at the FSMA framework and what FSMA 204 means for their businesses.

FSMA Regulation 204 Has Come Into Effect

WHY WAS THE FOOD SAFETY MODERNIZATION ACT CREATED?

The Food Safety Modernization Act (FSMA) was originally drafted to transform the US food safety system so that it could prevent foodborne illnesses that can harm humans and animals—rather than reactively respond to their devastating consequences.

According to the World Health Organization (WHO), unsafe food causes 600 million cases of foodborne disease and 420 000 deaths every year—40% of those being children under the age of 5. In addition, the WHO estimates that 33 million years of healthy lives are lost globally and annually because people eat contaminated food, which can be caused by bacteria, viruses, parasites, prions, or chemicals.

Apart from their catastrophic effects on human life, the WHO purports that foodborne illnesses hold back socioeconomic development by straining healthcare systems and preventing countries’ economies, trade and tourism from flourishing.

And foodborne illnesses are not relegated to developing nations. The United States Centers for Disease Control and Prevention (CDC) gauges that 48 million Americans get sick on a yearly basis, with 128 000 being hospitalized and 3000 dying. Legislators in the United States government decided to implement regulations, under the FSMA, to prevent foodborne illnesses and ensure that the responsibility for safety in the US food supply chain is shared among all stakeholders.

HOW IS FSMA 204 PART OF THE FOOD SAFETY MODERNIZATION ACT?

While the Food Safety Modernization Act covers an expansive array of rules and guidance programs, the FDA’s final rule on FSMA 204 this past November legally established traceability recordkeeping requirements for businesses that manufacture, process, pack, hold or distribute foods that are part of the Food Traceability List (FTL).

WHAT ARE THE FOODS INCLUDED IN THE FDA’S FOOD TRACEABILITY LIST?

The FDA’s Food Traceability List is applicable to certain foods as well as products that contain the listed foods as ingredients. Foods on the FTL include:

Cheeses
Nut butters
Fresh herbs
Leafy greens
Several types of fresh fruits
Finfish, crustaceans, molluscan shellfish
And other types of foods like ready-to-eat deli salads, shell eggs, etc.

You can find a complete list of FTL-listed foods here on the FDA’s website. If you’re interested in exploring the exemptions to the FSMA’s Food Traceability Rule, you can take this quick quiz.

HOW DOES THE FSMA WORK?

This means that agri-food companies that are subject to the rule must maintain up-to-date records on Critical Tracking Events (CTEs). These events are rules that oversee Harvesting, Cooling, Initial Packing, First Land-Based Receivers, Shipping, Receiving and Transformation.

Each CTE has a host of key data elements (KDEs) that supply chain partners are obliged to track in real time and report to the FDA, if required, within 24 hours in the event of a foodborne illness outbreak, recall or other public health threat.

It is essential to keep in mind that, depending on the nature of your business, you may need to capture multiple KDEs from different CTEs. For example, suppose you are a transformer. In that case, you may have to record receiving, transformation and shipping KDEs, since you take physical possession of a product, transform it using other ingredients, and then ship it to the next destination, like a grocery store chain or distributor that caters to restaurants.

The FDA put together three examples of how CTEs and KDEs have to be monitored and recorded for supply chains dealing with food on the Food Traceability List:

FSMA 204 example with produce

FSMA 204 example seafood

FSMA 204 example with cheese

WHAT DOES THE FSMA 204 MEAN FOR SUPPLY CHAIN ACTORS IN 2023 AND BEYOND?

The FSMA Rule 204 is slated to come into effect in January 2023, 60 days after the final rule was published in November 2022. The compliance deadline is scheduled for January 23, 2026.

The FDA is giving companies three years to develop a series of plans that affect their entire supply chains

When applicable, safety standards for growing, harvesting, packing and storing produce

Preventative controls for human food or preventive controls for animal food that pinpoint potential hazards that could cause foodborne illnesses and detail process, sanitation and transportation controls to mitigate—or ideally prevent—them

Recall action plan that enables a company to respond to the FDA’s 24-hour reporting criteria as well as swiftly carry out tracebacks to stop further distribution of contaminated foodstuffs and identify the cause

Third-party Certification Plan to prepare companies to be evaluated and accredited by third-party auditors

Foreign Supplier Verification Program that importing companies can use to demonstrate that their international supply chain partners comply with the FDA’s regulations

Food Defense Program to protect food products from intentional acts of adulteration and/or tampering

In addition, companies in the food industry will have to implement a traceability plan, which includes the procedures used to maintain records of foods on the FTL.

Inevitably, to keep these records updated and centralized for on-demand access, businesses will need to integrate an end-to-end food traceability solution that tracks and traces a food item from farm to fork, regardless if the data to be captured is electronic or paper-based.

DOES MY BUSINESS REALLY HAVE TO COMPLY WITH THE FSMA 204?

In a nutshell, yes. If a company doesn’t adhere to the requirements surrounding traceability, preventive controls, produce safety, and certification and supplier verification programs, the FDA will carry out a series of actions, depending on the violation.

Advisory letters are likely to be the first step. However, the FDA can order administrative detention (forced recall) and collect fees associated with the recall.

The FDA can issue injunctions to seize food products that have been proven to be the cause or have contributed to a foodborne illness. Extended audits and an increase in inspections may occur.

Finally, the FDA has the power to suspend the registration of food facilities if auditors deem that a company or facility has the capability of causing a serious adverse health event.

These repercussions are on top of the risks of lawsuits, damage to the brand’s reputation, and loss of both competitiveness and market share.

FSMA 204 will completely transform a food business’ supply chain as it becomes digitalized and connected through each stage. But it is paramount that companies start preparing today as the 2026 deadline looms. What’s more: it is very plausible that other foods will be added to the FTL. Preparing your organization today can have a substantial positive impact on your operations tomorrow.

Are you interested in learning more about OPTEL’s approach to FSMA 204 compliance?

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