Tag Archives: FSMA 204

Why now is the time to prepare for FSMA 204

By Geoff Olsen
No Comments

In recent years, food recalls have become a concern for the food and beverage (F&B) industry, with regulatory bodies tightening oversight as the number of recall-related incidents continues to rise. The F&B industry is no stranger to recalls, but recent trends indicate a steady increase in frequency, with the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) issuing 313 recalls in 2023, an 8% increase from the previous year. This uptick can be attributed to various factors, including the detection of undeclared allergens, which made up almost half of food recalls last year, and contamination by harmful bacteria such as Listeria, Salmonella, and E. coli.

Consumers are taking notice of these continuous food recalls as a new Gallup poll revealed that Americans’ perspective of the grocery industry has turned negative due to inflation and food safety concerns. It also showed that, for the first time, Americans have more negative views (47%) than positive (33%) of the grocery industry. The growing number of recalls, plus consumer concerns, has intensified calls for stricter compliance and enhanced traceability within the food supply chain.

Major Changes Are Coming

These recalls have become a persistent public health problem, with over 1,100 Americans falling ill from foodborne illnesses linked to recalled products. However, significant steps are being taken to address these concerns in the next few years. To reduce the number of foodborne illnesses, the FDA introduced the Food Safety Modernization Act (FSMA) 204, a regulation requiring F&B businesses to provide detailed traceability information within 24 hours of a recall. Starting in January 2026, this rule will focus on tracking food inputs from suppliers, enabling companies to pinpoint the source of contamination more efficiently.

FSMA 204 will bring major changes to the F&B industry by enhancing traceability requirements for high-risk foods. The rule mandates that companies must improve tracking across the supply chain to ensure key data points are recorded at critical stages of food production, processing, and distribution. This means F&B businesses must implement more stringent record-keeping processes, invest in technology for real-time tracking, and increase collaboration with suppliers to ensure compliance.

However, many organizations aren’t prepared to undergo the data process transformations needed to align with this new traceability rule. Below are a few actionable steps companies can take to prepare their supply chains for FSMA 204:

Investing in Solutions to Streamline Reporting

Despite the wide scale impact FSMA 204 will have across the F&B industry, a main challenge for companies will be updating and investing in new systems and processes to comply with the rule. FSMA 204 mandates that F&B companies provide detailed, accurate traceability data within a 24-hour window during a recall, which requires modern technology capable of handling real-time information. Many existing systems are outdated or not equipped to meet this new level of compliance. As a result, suppliers will need to adopt new software, train staff, and overhaul data management processes. These changes are certain to be time-consuming and raise operational costs. The complexity of this process, especially in a global and multifaceted supply chain, can be overwhelming without the right tools in place.

In addition, suppliers face the challenge of integrating these new systems with their broader supply chain networks. Ensuring seamless communication between suppliers, manufacturers, and retailers is essential for meeting the strict reporting timelines under FSMA 204. The coordination required to share and track data effectively across multiple partners adds an additional layer of complexity. Suppliers must also ensure their traceability solutions are scalable to accommodate future growth and evolving regulations, all while maintaining business continuity and protecting their bottom line.

Investing in scalable technology not only ensures compliance but also enhances business resilience. It provides better visibility into the supply chain, helping businesses respond quickly to disruptions, recall situations, or emerging food safety threats. Furthermore, these solutions enable businesses to streamline their data-sharing processes with trading partners, improving collaboration and reducing the time and resources spent manually documenting transactions.

While this can be costly, investing in robust technology systems and implementing effective food safety quality programs for employees provides the benefit of demonstrating a commitment to food safety and helps ensure smoother operations.

A few solutions suppliers can consider include advanced technologies like supply chain control towers and blockchain. These solutions provide real-time insights into inventory, orders, and potential disruptions, allowing companies to trace food origins and pinpoint contamination sources quickly. Supply chain control towers centralize data collection, management, and analysis, streamlining reporting processes, while blockchain offers a secure, tamper-proof record that ensures data consistency and transparency across all participants in the supply chain. By leveraging these technologies, suppliers can enhance traceability, reduce contamination risks, and build greater consumer trust.

Enhancing Data Consistency

Data consistency works in tandem with the integration of new technologies. The success of any traceability system under FSMA 204 relies on the consistency and accuracy of data collected throughout the supply chain. However, one of the most significant challenges businesses face is ensuring that data is recorded uniformly across different suppliers and systems. Inconsistent or incomplete data can lead to gaps in traceability, making it difficult to track products effectively or respond quickly to a recall. With the new regulation requiring detailed traceability information within 24 hours of a recall, any discrepancies or gaps in data could lead to delays in identifying contamination sources.

To ensure data consistency, suppliers can implement standardized data collection practices and utilize integrated technologies, such as supply chain control towers and blockchain. By implementing uniform data entry protocols across the entire supply chain, suppliers can avoid errors, discrepancies, and miscommunication that often result from inconsistent or fragmented data. Standardization helps streamline reporting and ensures that all parties—from suppliers to distributors—are working from the same set of accurate, reliable information.

Bringing Employees Along on the Journey

Investing in technology and ensuring data consistency are vital steps in preparing for FSMA 204, but they are only part of the equation. For these initiatives to succeed, businesses must also invest in their employees through training and education. Compliance with FSMA 204 requires everyone involved in the food supply chain to understand their role in the traceability process and the importance of accurate data reporting.

Training programs can be implemented at all levels of the organization to educate employees on the new traceability requirements and how they affect day-to-day operations. This includes not only teaching staff how to use new software solutions but also fostering a culture of accountability and food safety awareness, including setting up conversations with employees at every stage of the supply chain. Employees must understand that even minor data collection or reporting lapses can have significant consequences, from costly recalls to legal penalties and damage to brand reputation.

Continuous education is also key to keeping up with the evolving regulatory landscape. As food safety regulations change and new technologies emerge, businesses must keep their teams informed and updated. This can be achieved through regular workshops, webinars, or online courses that keep employees engaged and equipped with the latest knowledge.

The Cost of Non-Compliance

Failure to comply with FSMA 204 can lead to serious consequences for both suppliers and retailers. The FDA has the authority to enforce various penalties, including civil or criminal actions in federal court. It’s important to remember that this rule is considered mandatory, and parties will be under real pressure from the government if they don’t take the necessary steps to ensure the traceability requirements under this act. Non-compliance can lead to legal repercussions for both companies and suppliers in the form of lawsuits and litigation. In addition, the FDA has the authority to impose significant fines, sanctions, and criminal penalties for non-compliance.

Suppliers that are unable to meet FSMA 204 requirements may also face financial loss and damage to the company’s reputation as retailers and manufacturers may decide to switch to more reliable partners. Compliance penalties can also result in lost sales and brand damage that can impact consumers’ decisions.

Operationally, non-compliance with FSMA 204 can disrupt supply chain processes, leading to delays in identifying and resolving contamination issues. The inability to quickly trace food inputs can result in prolonged and costly recalls. Furthermore, non-compliance can strain relationships with trading partners who rely on accurate traceability data for product safety.

Preparing for FSMA 204 requires a multifaceted approach that combines technology, data standardization, and employee engagement. By investing in solutions that streamline reporting, enhance data consistency, and bring employees along through training and education, F&B companies can position themselves for success. These actions will help ensure compliance with FSMA 204 and lead to more efficient, transparent, and resilient supply chains, ultimately improving food safety for consumers.

It’s Five O’Clock Somewhere! Episode 3 Recording: Partnership for Food Traceability

No Comments

Watch this recorded webinar where host Rick Biros as he welcomes Dr. Ben Miller from The Acheson Group and Eric Marshall from Leavitt Partners on the “It’s Five o’clock Somewhere” webinar. They’ll unpack the FDA’s FSMA 204 Traceability Rule and explore how the groundbreaking Partnership for Food Traceability (PFT) is leading the way in helping companies and regulators prepare for the new rule.

Analyzing the Most Common Food Safety Issues in Cold Storage: How to Avoid Them & Prepare for the Future Frozen Food Supply Chain

No Comments

Watch this webinar recording and learn key food safety elements and details of FDA’s final Food Traceability rule and its implications for frozen foods. Panelists will reveal new research findings and never-before-seen audit data, share ongoing global efforts toward scale transitions in the frozen food supply chain, particularly as it relates to sustainability and energy-use, and discuss potential operational impacts in cold storage facilities.

Spreadsheets, food safety documentation

Survey Says… 48% of F&B Suppliers Rely on Spreadsheets

By Food Safety Tech Staff
No Comments
Spreadsheets, food safety documentation

From June 24, 2024 through July 15, 2024, TraceGains conducted an online survey of 483 food
and beverage industry suppliers to better understand supplier readiness and drivers for change and found
most suppliers stuck in the past, unprepared for change with legacy processes despite a
willingness and understanding on the benefits for modernizing.

To quantify the problem, a new report “Old Habits, New Challenges: The Critical Need for
Modernization in Food and Beverage Supply Chains” found nearly half (48%) of all suppliers
commonly rely on legacy approaches to manage communications with F&B buyers.

These legacy approaches hinder efficiency, with more than two-thirds (71%) of respondents
admitting these methods often cause issues such as data entry errors (39%) and
miscommunication (32%), negatively impacting their ability to operate effectively.

As the regulatory landscape becomes more complex, manual processes will be pushed to the
edge. In fact, compliance with regulatory change made the top-3 list of reasons
suppliers want to modernize their software. Requirements such as the U.S. Food Safety
Modernization Act (FSMA) Rule for Traceability (204), set to take effect in January 2026, will
impose stricter traceability requirements for certain food materials. And, in Europe existing
mandates such as the Corporate Sustainability Due Diligence Directive (CSDDD) already
require time-based sustainability reporting, adding further compliance challenges.

Sustainability continues to be a priority for almost all suppliers, with nine in ten (89%) saying it’s
at least somewhat important for new technologies to align with their company’s corporate
sustainability objectives.

Cost, however, remains the largest factor influencing software purchasing decisions, with 77%
of suppliers citing it as their top consideration, followed by ease of implementation (65%) and
customer support (56%).

Enhancing Food Safety: The Impact of FSMA’s Traceability Rule on the Supply Chain

By Jacob Olson
No Comments

The FDA’s Food Safety Modernization Act (FSMA) is designed to enhance food safety by establishing and regulating traceability requirements. The act mandates that all parties in the supply chain share critical information to address potential food safety issues. This article discusses FSMA requirements for comprehensive recordkeeping, including defining Critical Tracking Events (CTEs) and Key Data Elements (KDEs). It highlights the crucial role of Electronic Data Interchange (EDI) in meeting compliance and optimizing food traceability. EDI automates data exchange, improves visibility, simplifies compliance, and enables rapid outbreak response. By investing in EDI technology, organizations can establish a strong foundation for complying with FSMA regulations and ensuring food safety.

The Food & Drug Administration’s (FDA) final ruling for the Food Safety Modernization Act has introduced new stringent regulations that organizations who manufacture, process, pack, or hold foods must follow. The final rule mandates that all parties in the supply chain, from suppliers to retailers, share critical information to promptly address potential food safety issues. This ruling underscores the critical role of technology in maintaining compliance and ensuring safety throughout the food supply chain.

The latest FSMA updates require comprehensive recordkeeping for businesses involved in food production and distribution. Companies must now document key data elements (KDEs) tied to critical tracking events (CTEs) in the food supply chain. This includes manufacturing, processing, packing, and distribution activities for foods listed on the Food Traceability List (FTL). Organizations must provide this data to the FDA within a timely manner and in compliance with accepted standards.

Defining Critical Tracking Events (CTEs)

Critical Tracking Events (CTEs) are key checkpoints that mark the movement of food products from their origin to the retailer or consumer. These milestones offer visibility into the product’s journey through the supply chain. CTEs represent significant points in the food supply chain where specific actions occur, such as:

  • Receiving raw materials from suppliers
  • Processing and manufacturing food products
  • Packaging and labeling items for distribution
  • Shipping products to distribution centers
  • Receiving products by retailers or food service establishments
  • Selling products to consumers

Defining Key Data Elements (KDEs)

The FDA identifies Key Data Elements (KDEs) as crucial details linked to specific CTEs. This information provides essential insights into food products and their journey through the supply chain. KDEs may include:

  • Product Identifiers: Lot numbers, batch numbers, and serial numbers
  • Key Data Attributes: Ingredients, packaging materials, production and expiration dates, storage conditions
  • Chain of Custody: Records of entities handling and transporting products
  • Contact Information: Details of organizations responsible for food safety and emergency responses

Record Keeping Requirements

FSMA’s updated guidelines include specific requirements for the format and duration of recordkeeping. These records must also be available within 24 hours of an FDA inquiry and must be preserved for at least two years. The FDA mandates documentation be preserved in its original format and readily searchable electronically. Consequently, your organization must establish protocols for recordkeeping, product identification, and traceability lot code allocation.

Role of Electronic Data Interchange in Food Traceability

Electronic Data Interchange (EDI) is vital for meeting FSMA compliance and recording critical information such as CTEs and KDEs. EDI automates the exchange of traceability data by integrating with and extracting information from enterprise resource planning (ERP) or warehouse management system (WMS) solutions. EDI can ensure accuracy in KDEs to adhere to critical and time sensitive regulations. EDI also reduces potential manual data entry errors and ensures timely data management. Your suppliers and customers will have different levels of technical aptitude so remember; all types of EDI can be leveraged to achieve these outcomes, including traditional X12 EDI, EDIFACT EDI, and TRADACOMS EDI, along with other electronic data like APIs, JSON or XML, Flat Files, Spreadsheets, and web portals.

This technology streamlines the management of lot information, including its reception, translation, and distribution, and even enables direct integration of lot numbers into ERP systems. This integrated approach enables compliance and benefits all supply chain stakeholders by providing critical data for swift responses to any FDA inquiries regarding food traceability and safety.

EDI is crucial for optimizing food traceability within the supply chain by facilitating the accurate and efficient collection of KDEs and CTEs through the following:

  • Automation: EDI automates data exchanges, reducing manual input errors and facilitating efficient data management. It ensures precise tracking of food products with details such as purchase orders, invoices, and shipment notices.
  • Visibility: EDI is the foundation to providing real-time insights into product movement across the supply chain. Coupled with a modern integration platform, this enables businesses to track products from their origin to the end consumer.
  • Compliance: EDI simplifies compliance with food safety regulations by enabling the electronic recording and transmission of critical traceability data, streamlining the audit process.

Benefits of EDI Technology in Achieving FSMA Compliance

EDI offers several advantages beyond enhancing food traceability. It also positions your organization to proactively adapt to evolving regulatory landscapes. By investing in a modern, scalable EDI platform, you can establish a strong foundation for complying with upcoming FSMA regulations. To meet FSMA requirements, businesses need adaptable processes and procedures supported by technology that seamlessly integrates and automates critical data exchange. EDI integration specifically contributes to FSMA compliance by enabling:

  • Rapid Outbreak Response: EDI facilitates the quick exchange of standardized documents, simplifying the tracking of food movement and enabling a swift response to contamination outbreaks.
  • Efficient Recordkeeping: EDI automates the generation, storage, and sharing of electronic records, ensuring data accuracy and accessibility.
  • Improved Supplier and Customer Management: EDI supports real-time communication with suppliers, customers, carriers, and the other key components of your supply chain, enhancing management and simplifying compliance.
  • Risk Management: EDI integrates with other systems to enable data-driven risk assessments, monitoring critical control points, shelf life, and temperature controls to mitigate foodborne hazards.
  • Audit Readiness: EDI simplifies the capture, retrieval, and presentation of records, ensuring companies are always prepared for FDA inspections and can demonstrate compliance.

The cornerstone of food traceability under FSMA hinges on accurately identifying and documenting CTEs and KDEs. These regulations mandate electronically accessible and readily searchable records, underscoring the need for automated B2B integration technologies like EDI. EDI systems optimize data collection, minimizing errors and ensure real-time access to critical information. By automating these processes, EDI not only facilitates compliance but also enhances operational efficiency and responsiveness to potential food safety incidents.

The FSMA food traceability rules represent a pivotal advancement in safeguarding the food supply chain. By enforcing meticulous recordkeeping and rapid data retrieval, the regulation empowers authorities to swiftly identify and address food safety risks, protecting public health. Implementing advanced technologies such as EDI is essential for both compliance and operational excellence. These systems automate data sharing, improve transparency, and foster a connected supply chain all leading to improved business partner relationships, increasing revenue, and higher profitability.

As the industry navigates these rigorous standards, embracing technology will not only ensure compliance but also cultivate a more resilient and responsive food system capable of effectively managing food safety challenges.

Food Safety Supply Chain Virtual Event

No Comments

Supply chain risks have a significant impact on food safety and quality. Maintaining communication, approving new suppliers in times of geopolitical conflict and product shortages, and conforming to the coming FSMA Traceability Final Rule are among the inherent challenges now facing supply chain managers and food safety professionals.

Matthew Taylor

Are You Ready? Preparing for FSMA 204

By Matthew Taylor
No Comments
Matthew Taylor

With millions of people in the U.S. getting sick each year from foodborne illness, the FDA is continuing to transform the nation’s food safety system with more stringent rules and regulations. In 2011, the Food Safety Modernization Act (FSMA) was signed into law, and consequently, several rules have been finalized to implement the act and ensure food safety across different points in the global supply chain.

The FDA’s Requirements for Additional Traceability Records for Certain Foods, also known as the Food Traceability Final Rule or FSMA 204, establishes additional recordkeeping requirements for entities that manufacture, process, pack or hold foods on the Food Traceability List. The list includes specific foods, such as specific cheeses, eggs, cucumbers, herbs, leafy greens and more, for which extra recordkeeping requirements are reasonable and necessary to protect public health.

The rule was finalized by the FDA on November 15, 2022. It will be enforced beginning January 20, 2026, with routine inspections anticipated to start in 2027, meaning businesses must prepare now to comply with the new requirements.

The goals are to identify and remove potentially contaminated food from the market more quickly, and as a result, prevent the spread of foodborne illnesses and/or fatalities.

Understanding the Food Traceability List

The FDA’s identified foods can be found on the Food Traceability List (FTL). FSMA 204 uses an established set of metrics known as Key Data Elements (KDEs) that relate to various supply chain occurrences known as Critical Tracking Occurrences (CTEs). The CTEs are:

  • Harvesting
  • Cooling
  • Initial Packing (applies to Raw Agricultural Commodities not obtained from a fishing vessel)
  • First Land-Based Receiver (applies only to seafood)
  • Shipping
  • Receiving
  • Transformation

If an entity uses any of the above CTEs for any food on the FTL, as well as food that uses an ingredient that remains in the same form (e.g. fresh) on the list, it must comply with the additional recordkeeping requirements.

Preparing for FSMA 204

FSMA 204 became operative in January 2023, 60 days after the publication of the final rule in November 2022. While businesses have three years to become fully compliant (until January 20, 2026), starting the process early is highly recommended as several of the requirements, such as having an established food traceability system, take both time and effort. Meeting the deadline can be extremely challenging if preparations are put off until just before the compliance date.

To prepare for FSMA 204, first, take the time to thoroughly review and understand the rule. Carefully read through the FTL and its overview of ingredients and finished products. Then, make sure that you understand any exemptions that apply to your business.

The next step should be to consult the FDA’s reference guide on CTEs and KDEs to determine which KDEs you must record. Various sets of KDEs may need to be recorded depending on your specific business activities. For example, a food processor could fall under the categories of receiver, transformer, and shipper since it physically acquires products from a supplier, then combines, repackages, relabels, or otherwise transforms the food before shipping it to clients.

In addition to capturing the KDEs, businesses should:

  • Create and maintain a traceability plan.
  • Maintain records in the form of either the original printed records, electronic records, or true copies. (Records must be legible and stored to prevent loss or deterioration.)
  • Ensure traceability records are sent to the FDA within 24 hours of their request (or within a reasonable time to which the FDA has agreed), including any information required to comprehend the data or records. When required to assist during an outbreak, recall or other public health danger, you must deliver an electronic sortable spreadsheet containing pertinent traceability data to the FDA within 24 hours of a request (or within a reasonable timeframe to which the FDA has consented).

Traceability Plan Must-Haves

The food traceability plan should include all procedures used to maintain traceability records, including detailing the format and location of these records in the business. It should also include procedures used to identify foods on the FTL and the subsequent CTEs.

Other key items to include are a process on how traceability lot codes are assigned, points of contact for questions on the traceability system and its records, and supporting documents such as a farm map that indicates the location of the growers or raisers of the food on the FTL (other than eggs). The map must include the position and name of each field or growing area, as well as other details required to pinpoint the sites. 

Next Steps

Preparing for FSMA 204 and meeting the requirements can be overwhelming. Several third-party organizations are offering support services. Additionally, the FDA has several resources located on its website, including Frequently Asked Questions, a webinar recording and more.

For businesses unsure about how the rule applies to them and their products, NSF offers an Initial Scoping Workshop that includes a virtual session, which involves reviewing the ingredients and finished products compared to the FTL, a document check (e.g. of the traceability plan), confirmation that all relevant stakeholders have been captured, and access to a video recording explaining the principles of FSMA 204’s traceability requirements. A recommendation will also be made if a FSMA 204 Readiness Assessment is needed.

Businesses who already know their products fall under the FTL can opt to start with a full FSMA 204 Readiness Assessment, which ensures you have taken all the steps necessary and helps you identify any corrective actions/controls needed to ensure compliance with the rule.

Effectively communicating the food traceability plan and coaching supply chain partners on new processes is a critical component to meeting compliance. Label harmonization must be completed to properly track and secure the required information from suppliers.

Though paper records are permitted under the rule, businesses should consider leveraging technology to assist them with complying with the requirements. Consider investing in a platform that can automate data gathering and securely save information so it can be easily retrieved if needed. On-demand traceback and trace forward features are especially important, as in the event of an investigation or recall, immediate product tracing capabilities are essential.

While FSMA 204 will require entities across the food industry to comply with the new requirements, it will contribute to a stronger and more resilient global food supply chain.