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The Deadline Is Fast Approaching – FDA and FSMA Food Regulations Explained

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In the background, words such as foodborne illness, recall, food poisoning, and others appear on a white background in black, red, and blue. A hand holds a magnifying glass, enlarging some of the words, including bacteria, sickness, and recall. Key Takeaways:

  • About 48 million people are victims of foodborne illnesses annually
  • Rule 204 expands FSMA by adding new foods to the food traceability list
  • It also lists new documentation and reporting requirements
  • The new regulations take effect in November 2022
  • Traceability requirements include all areas of the supply chain: growing, receiving, transformation, creation, and shipping

Food supply chain transparency to prevent illness is the ultimate goal

Current regulations set by the federal Food and Drug Administration (FDA) mean companies that process, pack, or hold foods must maintain traceability records for foods on their list. This makes it easier to track the movements of food quickly and efficiently through the supply chain to prevent or promptly quash the outbreak of a foodborne illness. The Food Safety Modernization Act (FSMA) regulates around 75% of the food supply in the U.S.

The FSMA regulates all companies that register with the FDA. This includes the entire supply chain from commercial farms to food processing operations. The FMSA became law in 2011, but the finalization of the regulations didn’t happen until 2015. 

To further protect consumers from contaminated food, foodborne illness, and other public safety and health issues, Rule 204(d) was created and takes effect in November 2022.

Section 204 expands recordkeeping requirements for certain foods that, per a risk-ranking model, are more likely to cause illness if mishandled, including commodity-hazard pairs. The new regulation requires companies to document particular key data elements for critical tracking events. 

This documentation will have to be provided within 24 hours in a specific format. In this article, you’ll find the new FDA and FSMA food regulations explained and how electronic data gathering is the only real option for compliance.

Do the new FMSA food regulations affect me?

As you learned, the FDA regulates approximately 75% of the food supply. The rest is regulated by other government agencies like the Department of Agriculture, which governs meat, poultry, and most dairy products. FMSA food regulations do not bind those who manufacture products regulated by these other agencies.

The FMSA covers commercial farms, packing operations, and food processing facilities – almost every company that must register with the FDA as a food manufacturing facility. Companies with a Hazard Analysis and Critical Control Points plan will have to update it to comply with the new FMSA regulations.

Supply chain visibility is the goal of the new FMSA rule. This requires real-time data and swift reporting capabilities. The rules apply not only to the foods on the Food Traceability List (FTL) but also to foods that use ingredients on the list. 

How the FDA developed the FTL

Foods on the FTL were determined through a risk-ranking model based on factors in Section 204. They then developed seven criteria:

  • The frequency of outbreaks and illness occurrences
  • Illness severity
  • Contamination likelihood
  • Pathogen growth potential, with consideration of shelf life
  • The probability of manufacturing process contamination and industry-wide intervention
  • Amount consumed and consumption rate
  • The cost of illness

Designed to be flexible, the model includes a wide range of contaminants and commodity-hazard pairs. Commodity-hazard pairs include E. coli in leafy greens and Salmonella in tomatoes. The new traceability list includes all soft cheeses, shell eggs, cucumbers, all fresh-cut fruits and vegetables, ready-to-eat deli salads, and tropical tree fruits. 

The FDA food traceability requirements

The FDA has defined a set of metrics. These key data elements (KDEs) correspond to events in the supply chain called critical tracking events (CTEs), which include growing, receiving, transformation, creation, and shipping. If you’re unsure which KDEs would apply to your operation, the FDA provides additional details on the specific records required.

Each step would require a traceability lot code (TLC), an alphanumeric descriptor used to identify a traceability lot. And for each CTE, different KDEs are defined:

  • Growing. The food grower must establish and keep records containing and linking the traceability lot code to the growing area coordinates. There are additional requirements for growers of sprouts.
  • Receiving. This event is defined as one in which food is received by a customer other than a consumer at a designated location after transport from another designated location. Some of the KDEs include location identifier and description, quantity, unit of measure, and the name of the transporter.
  • Transformation. Transformation is an event that changes a food, its packaging, and/or its label. This can mean combining ingredients or processing food. In this case, the food transformer would create and link a new traceability code that includes all the new information, including the quantity of food, what food was used, and the location and date the food was transformed.
  • Creation. Creating food involves manufacturing or processing exclusively using ingredients that are not on the FTL to produce or make food that is on the list. In this case, the TLC would link to location identifier and description, quantity, and unit of measure, as well as traceability product identifiers and product descriptions. 
  • Shipping. Shipping poses several risks to food safety, including deterioration or spoilage of ingredients because of delays, damage, breakage, and spills. Contamination with fungi and bacteria can often happen when food is transported at improper temperatures. The KDEs include many of the same requirements as the other supply chain steps.

However, shippers bear an extra burden: In addition to keeping records, they must send them to the immediate subsequent recipient. Farms have additional KDEs. In the case of an event of foodborne illness, the FDA may request all records. Among those records would be proof of temperature control during transit per Title 21.

Conforming to these new regulations means collecting and analyzing data, and when it comes to proof that food and food products were shipped at the right temperature, you’ll need a data logger that provides real-time information and produce the required reports on demand. 

Rule 204 is intended to build a fully transparent food supply chain. This requires real-time food safety data on demand, along with the ability to trace any one item across the entire supply chain. Approximately 48 million people fall victim to foodborne illnesses each year. These amped-up rules and supply chain visibility are additional tools to combat disease and death.

Marathon Products for FMSA Compliance

Marathon Products is a leading manufacturer and distributor of precision environmental monitoring devices for temperature, humidity, and vibration for the food and agricultural industries. 

All of our devices are 100% tested to ensure reliability, and we have a no-questions-asked return policy – that’s how reliable our products are. We have monitoring devices that answer the question of how to reduce food waste and loss and comply with all FDA Title 21 rules.  

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