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FSMA Rules: A Guide to FDA Food Safety Modernization Act Regulations

Posted on by rfxadmin

The Food Safety Modernization Act (FSMA) is transforming the food supply chain in the United States. Learn about FSMA requirements and how they affect the food industry.

Understanding the FDA Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA), signed into law in 2011, aims to reduce foodborne illness, protect the U.S. food supply, and ensure public health. The law gives the U.S. Food and Drug Administration (FDA) authority to regulate the production, processing, packing, and transport of food throughout the country.

The FDA has finalized nine major rules through FSMA that address different aspects of the food supply chain. FSMA covers both human and animal food, and the rules are designed to address issues such as traceability, sanitation, produce safety, and supplier verification.

7 FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. The food traceability final rule established additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). Additionally, there are seven main roles that the FDA implemented in the final FSMA rules.

      1. Preventive Controls for Human and Animal Food: Require food facilities to meet Current Good Manufacturing Practice (CGMP) requirements, conduct hazard analyses, and establish risk-based preventive controls.
      2. Produce Safety Rule: Established science-based standards for the production, packing, and storage of fruits and vegetables on farms in the U.S. and other countries.
      3. Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
      4. Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
      5. Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
      6. Protection Against Intentional Adulteration: Aims to address the probability of an outbreak due to potential food safety risks of intentional adulteration.
      7. Voluntary Qualified Importer Program (VQIP): fee-based program provided by the FDA FSMA to foreign food facilities that intend to import their products into the country.

Other rules concern protection against intentional adulteration of food and guidelines for the use of agricultural water.

Compliance strategies for FSMA

Navigating FSMA can be complicated, especially as rules are proposed, reviewed, and finalized. To implement effective compliance strategies, organizations should:

      • Review: Start by conducting a thorough review of FSMA requirements to understand which rules apply to your business.
      • Develop: Create a robust FSMA food safety plan that’s tailored to your operations, including hazard analysis and critical control points (HACCP).
      • Implement: Establish preventive controls and monitoring systems across the organization and have a plan in place for food recalls.
      • Verify: Use audits and validation procedures to ensure compliance.

Implementing FSMA’s Preventive Controls and Hazard Analysis

FSMA’s Preventive Controls for Human Food, finalized in 2015, was created to minimize and prevent hazards at food facilities. Key components of this rule include:

      • Current Good Manufacturing Practice (CGMP) revisions: FSMA updated FDA’s existing CGMP requirements to create binding requirements for employee education and training.
      • Food safety plans: The rule created new requirements for risk-based preventive controls and hazard analysis at food facilities, including sanitation practices and allergen controls.

Businesses covered under the Preventive Controls rule must perform a hazard analysis of their facilities and products, implement food safety practices, and provide ongoing monitoring and verification of all preventive controls.

Ensuring FSMA compliance in supply chain management

Even if you’re confident about your organization’s food safety practices, you need to know that your supply chain partners are holding themselves to the same standards. Establishing clear supplier approval and verification processes can help you thoroughly vet the growers, suppliers, processors, or distributors you work with.

By implementing traceability and documentation requirements, you’ll be able to track specific products and lots in real-time. As with your internal processes, conduct regular assessments to ensure suppliers and co-manufacturers are maintaining FSMA compliance.

Final thoughts: FSMA rules and regulations

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

We understand the importance of complying with FSMA and other regulations for the food and beverage industry. We have extensive experience delivering tailored traceability, visibility, and transparency solutions that not only help ensure compliance, but also create added value for operational efficiency, brand protection, and customer loyalty. Contact us today and one of our traceability experts will show you how it works.

And be sure to download our “Traceability in the Food Supply Chain” white paper, which explains the FSMA Food Traceability List and the Food Traceability Final Rule in detail.

FSMA 204 and Food Safety: Examining Compliance Requirements

Posted on by rfxadmin

The Food Safety Modernization Act (FSMA) is a sweeping set of regulations designed to revolutionize how we approach food safety in the United States. The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule” or “Final Rule”) implements FSMA Section 204. FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).

For the food industry, understanding and complying with FSMA 204 is not just a legal requirement: it’s a commitment to public health and safety. It also creates many value-add opportunities through leveraging supply chain traceability.

Let’s dive into the FSMA 204 rule and what it means for your business.

Understanding FSMA 204

FSMA’s overarching goal is to prevent foodborne illnesses; it has seven rules to govern food production and distribution. Section 204 focuses on enhancing the traceability of FTL food, ensuring that businesses can quickly identify and address potential safety issues. The rule emphasizes the need for detailed recordkeeping. It’s like a meticulous logbook of your food product’s journey from farm to table.

Specifically, FSMA 204 requires supply chain actors to maintain records of critical tracking events (CTEs) and associated key data elements (KDEs). Entities that manufacture, process, pack, or hold foods on the FTL (e.g., harvesters, packers, processors, and distributors) must maintain and share these electronic records. So it’s not a stretch to say that the Food Traceability Final Rule will affect almost everyone in the U.S. food supply chain.

Compliance Requirements

If you’re wondering whether FSMA 204 applies to you, consider the scope of your business. The rule primarily targets businesses that manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL). Some items on the FTL include:

    • Nut butters
    • Deli salads
    • Leafy greens
    • Melons
    • Shell eggs
    • Tropical tree fruits
    • Crustaceans
    • Cucumbers
    • Finfish
    • Other fresh produce

To comply, you need to register with the FDA, providing detailed information about your business and the specific food products you handle. While there are exemptions, most members of the food supply chain will have to comply with FSMA 204, which also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Compliance Measures

Compliance with FSMA Section 204 might sound daunting, but it’s achievable with the right approach. Start by thoroughly understanding the Final Rule and its requirements. Develop a system for meticulous traceability recordkeeping. Training your staff on food safety practices is also crucial.

The goal is to make food safety part of your company’s DNA; you can’t treat the FDA Food Safety Modernization Act as an afterthought or a box you have to check.

Navigating the Countdown to Compliance

Let’s take a closer look at the FSMA 204 timeline. Traditionally, the FDA has rolled out major regulations using a phased approach. For FSMA 204, however, the Agency has set a single firm compliance date: January 20, 2026.

Although that’s a little more than two years away, the time to start preparing is now. Don’t wait. Start your compliance process early, and use the time to refine and perfect your systems. That way, if you encounter any unexpected hurdles, you’ll have time to sort them out.

The Importance of Traceability

Traceability is at the heart of FSMA 204. By maintaining and sharing CTEs, KDEs, and detailed records of each food item’s journey, businesses can know where every product came from, where it is right now, where it’s going next, and its final destination. With this rich traceability data, they can swiftly address safety concerns, recall affected products, and provide critical information during investigations. Improving traceability can also mitigate brand damage due to recalls and help maintain consumer trust.

Common Challenges and Solutions

As you work to implement FSMA 204 into your business model, you could encounter one of these challenges:

    • Data challenges: Existing data-sharing strategies need to be supplemented with traceability data.
    • Trading partners challenges: If your partners don’t send required traceability data, it will affect your ability to maintain and send CTEs and KDEs across your supply chain.
    • Process challenges: Your system must be able to send and receive traceability data quickly and accurately. It must also be able to spot (and fix) errors and communicate effectively with your partners.
    • Technology challenges: Legacy supply chain systems may not be equipped to capture and organize traceability data.

Overcoming these hurdles requires a holistic approach. You must reevaluate your processes to ensure they promote compliance and, critically, collaborate with your partners to ensure you’ll be able to share all the required FSMA 204 data. Most important, you should determine if you need to replace or augment legacy tech with new solutions designed to modernize and simplify traceability.

Benefits of FSMA 204 Compliance

FSMA 204 compliance provides many, many benefits to your business, your trading partners, and the public. When you comply with FSMA 204, you help maximize traceability, food safety, and supply chain visibility. You also avoid penalties for non-compliance.

Implementing traceability technologies will also make your supply chain more efficient. You’ll gather robust item-level data insights about the flow of goods, which will help you to identify bottlenecks and “blind spots,” reduce spoilage, and even fight diversion, theft, and counterfeits. The more you know about your supply chain, the easier it will be to optimize it.

Complying with FSMA 204 requirements is also an opportunity to leverage rich traceability data to enhance your brand reputation, engage with consumers and build trust, and establish yourself as a leader in food safety. These benefits translate into customer loyalty and business growth.

Final Thoughts About FSMA 204 Compliance

The deadline to comply with FSMA traceability requirements is January 20, 2026. (That’s a Tuesday, if you’re wondering.) The FDA is giving the food industry the extra time because it wants all regulated businesses to come into compliance by the same date — and because it acknowledges that trading partners have to get their systems in place.

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

This is where Antares Vision Group can help. We offer a full-stack solution for the food industry. A “soup to nuts” solution, if you will. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

A Guide to Traceability Lot Codes and Food Safety

Posted on by rfxadmin

Traceability lot codes are small but mighty tools that help to ensure food safety. Today, we’re going to look at traceability lot codes, including how they promote safety in the food industry and the important role they play in the Food Safety Modernization Act (FMSA) Section 204 compliance and securing public health.

What Is a Lot Code?

A lot code is essentially a passport for food products. It’s a unique identifier, usually a sequence of numbers and letters, that identifies a specific batch of products that were manufactured (or harvested) under the same conditions and in the same location. Lot codes help track products through the entire supply chain and are vital for troubleshooting quality issues and speeding recalls. Lot codes are assigned to products by the manufacturer.

Whether it’s a pallet loaded with cases of olive oil, a box of cereal, or even a raw agricultural commodity (RAC), the lot code tells you where an item came from and when it was made. This is vital for traceability, helping manufacturers and regulators such as the FDA and USDA keep tabs on products as they move from field to factory to consumers.

Using lot codes not only helps food companies comply with traceability and food safety regulations — they also promote supply chain transparency as part of an indelible provenance that tells where a food came from, who handled it (e.g., harvesters, packers, shippers, and receivers), and its expiration date.

How to Read a Lot Code on a Product

Typically, a lot code includes information about the production date, batch number, and sometimes even the manufacturing line. For instance, a lot code reading “20210305” could mean the product was manufactured on March 5, 2021. If it says “2021030515,” it could mean the product’s expiration date is March 15, 2021. Other numbers can indicate a unique product ID or the name of the grower, producer, or manufacturer.

Role of Lot Codes in Traceability

In the journey from farm to fork, lot codes act like breadcrumbs. They enable traceability at every step, from production to first land-based receiving interactions and beyond. If there is a foodborne illness outbreak or other problem, stakeholders can trace goods back to their sources.

And as we said above, they help you comply with food regulations, including the Food Safety Modernization Act (FSMA), which mandates recordkeeping and traceability requirements for certain foods. More on that below.

Ensuring Food Safety Through Lot Codes

Traceability lot code requirements, such as those in FSMA 204, promote better food safety and transparency across the supply chain. One of the biggest benefits of traceability lot codes is that they help companies and investigators quickly pinpoint  the origins of foodborne illnesses.

If an issue occurs with one of your products, you can quickly determine which products have been affected and where they are in your supply chain or, if they’ve reached their final destination, what retail establishment they’re in. With this granular data, you can implement a focused recall strategy that protects consumers and public health while minimizing product loss. Such precision also helps protect your brand: You can communicate with consumers about the status of the recall, affected areas, and how to dispose of the recalled product.

Common Questions About Traceability Lot Codes

Let’s consider a few common questions about traceability lot codes.

Can a Lot Code Tell You Whether a Product Is Organic or Not?

Lot codes don’t directly convey this information; however, they can be used alongside other product details to let consumers know if a product is organic.

How Can Consumers Use Lot Codes?

Consumers can use lot codes to make informed decisions about the food they buy. They can check the lot code to determine whether their product is part of a recall. It’s also a handy way to gauge a product’s freshness.

Why Are Lot Codes Important for Food Safety?

Lot codes make tracking and tracing products faster, easier, and more accurate. If there’s a problem with a food item, such as a contamination issue, the codes help quickly identify which products are affected.

Consumer Awareness and Lot Codes

If you want to establish your brand as transparent and customer-centric, you should educate consumers about traceability lot codes. Teaching consumers how to read codes and learn what information they provide will empower them to make informed choices regarding the food products they buy.

The FSMA Traceability Lot Code

The Food and Drug Administration’s (FDA) Food Safety and Modernization Act (FSMA) is the primary set of regulatory requirements governing the use of a lot code on food products. FSMA rules outline when to put a lot code on food products, what traceability data you must retain, and more.

The FDA Food Safety Modernization Act requires you to track key data elements (KDEs) and critical tracking events (CTEs) for certain foods like shell eggs, butter, tree-borne fruits, and more. The final rule’s requirements have a compliance date of January 20, 2026. However, some aspects are already being enforced.

What is the FSMA Traceability Lot Code?

The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)

A traceability lot code must be assigned when any of the following occur:

      • Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
      • Performing the first land-based receiving of a food obtained from a fishing vessel
      • Transformation of a food

Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”

FSMA Traceability Lot Codes in Action: CTEs and KDEs

To fully understand FSMA traceability lot codes, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.

In broad terms:

      • CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
      • KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
      • Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).

A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.

Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).

Do You Have to Comply? Are You Exempt?

The Final Rule does have exceptions to the requirements we’ve discussed above.

Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”

Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.

However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.

Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.

Final Thoughts About Traceability Lot Codes

This is a lot of information to digest, especially the FSMA requirements. The best option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.

As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.

Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.

Read More About FSMA:

 

FSMA Traceability: A Comprehensive Guide for Food Industry Compliance

Posted on by rfxadmin

The Food Safety and Modernization Act (FSMA) is the most significant development in food industry traceability. One specific set of requirements in the law, the Final Rule on Requirements for Additional Traceability Records for Certain Foods, is reshaping and modernizing the approach to food safety and food supply chain data.

Whether you’re a grower, processor, distributor, or retailer in the food industry, understanding and implementing FSMA traceability is vital. Let’s walk through FSMA traceability requirements so you can adapt to the FDA’s Food Traceability Final Rule and ensure your compliance.

What Is FSMA Traceability?

FSMA traceability refers to the ability to track every step of a food product’s journey from farm to table, as required by the law. It’s primary goal is to help prevent and mitigate foodborne illnesses

FSMA traceability requirements center around creating, maintaining, and sharing a clear record of where food comes from, where it was, where it is now, where it’s going, and who’s handling it. 

Under FSMA, the Food Traceability Final Rule defines additional recordkeeping requirements all those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), which includes cheeses, shellfish, and certain fruits and vegetables. It provides you and your trading partners with clear guidance on what data you must keep and share as your products move across your supply chain.

The FDA’s Role in FSMA Traceability

The Food and Drug Administration plays a pivotal role in FSMA traceability: It sets FSMA traceability requirements, evaluates foods using a risk-ranking model, and holds stakeholders accountable for complying with the act. In addition to setting traceability recordkeeping requirements, the FDA also assesses penalties for non-compliance with the traceability program.

Compliance Requirements for Food Industry Professionals

FSMA 204 and other provisions of FSMA apply to:

  • Harvesters
  • Coolers
  • Packers
  • Processors
  • Distributors
  • Retail food establishments

The specific requirements for your business will vary based on your role in the food supply chain. Many requirements focus on initial packing and labeling; proper packaging and labeling promote FSMA traceability and streamline the flow of goods along the supply chain.

FSMA 204 also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Benefits of FSMA Traceability

Embracing traceability promotes better food safety and protects consumers from foodborne illnesses. If an issue arises with one of your products, you can use traceability data to quickly find where it came from and where it is now. This granular, read-time information expedites recalls and ensures that all affected products are removed from store shelves as quickly as possible.

From a business perspective, FSMA 204 helps you protect your brand image, as you can ensure the quality, integrity, and safety of food products. In addition to enhancing your reputation, you can use FSMA traceability to identify bottlenecks within the supply chain and eliminate waste.

Technology and Tools for FSMA Traceability

FSMA gives the FDA the authority to establish modern, science- and risk-based requirements, including all the traceability requirements in Section 204. 

The law dovetails with the Agency’s New Era of Smarter Food Safety, which is “a new approach to food safety, leveraging technology and other tools and approaches to create a safer and more digital, traceable food system.” It will the FDA identify ways to further its modernization goals and help ensure that the regulations evolve with the industry and available technology to reduce foodborne illness.

So, what we’re seeing with FSMA 204 is part of the FDA’s plan to secure the food supply chain using technology. FSMA traceability, anchored by requirements for food companies to record and share Critical Tracking Events (CTEs) and Key Data Elements (KDEs), is attainable with currently available digital supply chain technology. 

Other requirements, such as using traceability lot codes and having systems to share electronic sortable spreadsheets with traceability information to the FDA, are also part of a strategic approach to leveraging technology for FSMA compliance.

Food supply chain traceability software is the best road to meeting technological requirements and FSMA compliance. It’s also the best way to ensure you remain compliant and competitive as regulations, food trends, and consumer attitudes evolve. 

Common FSMA Traceability Challenges 

Challenges to complying with FSMA traceability regulations include the following:

  • Integrating traceability systems with existing processes: Adding any new tech tool to your established systems/process could disrupt operations, including interactions with trading partners.
  • Ensuring your partners are preparing: Traceability requires participation from everyone in the supply chain. Talking with your trading partners about FSMA readiness is vital to being ready to comply by the January 2026 deadline.
  • Training staff: You’ll need to educate and train staff on FSMA 204 compliance and the effect it will have on your business. Training is also necessary to create a culture of food safety in your organization.
  • Managing data: Complying with FSMA means you will be creating, sharing, accessing, and storing massive amounts of data. Your systems not only have to handle the volume — they must ensure the data is compliant.

Navigating the challenges requires a holistic approach. First and foremost, you need to get your team on board by being transparent about the regulations, how they will affect your daily operations, people’s roles and responsibilities, and what you are doing to prepare. 

The Importance of Data Security and Privacy

With so much sensitive data being generated, security and privacy are paramount. You need to make sure that your traceability data is protected from unauthorized access and breaches. This means investing in secure systems and being mindful of privacy laws and regulations.

Additionally, you must ensure that your partners are doing their part to promote data security. Remember, you’ll need to integrate some of your technologies with theirs to expedite the flow of traceability data. You don’t want to inadvertently create a blind spot or weak link in your data infrastructure by partnering with a vendor that does not take data security as seriously as you do.

Anticipating Regulatory Audits

Nobody wants to be audited, but everybody should be prepared. The key to passing an audit is to make food safety and FSMA compliance part of your company culture. If these are only afterthoughts or simply a box to check, the chances of failing an audit are much higher. In contrast, being proactive means an audit will essentially be a formality (and become an opportunity to stand out among competitors).

Final Thoughts: FSMA Traceability with rfxcel

Familiarizing yourself with FSMA traceability requirements will help you achieve and maintain compliance, improve food safety, and preserve your brand image. Prioritize compliance and implement effective traceability practices by partnering with rfxcel. We’ve been a leader in traceability (and compliance) technology for 20 years, and we will work with you to develop a solution suited to your needs.

Book a demo to learn more. We also invite you to explore our other FSMA resources.

Why FDA Food Traceability Regulations Are a Business Opportunity

Posted on by rfxadmin

It’s going to be a busy couple of years for the food industry as the Food and Drug Administration (FDA) formalizes key parts of its plan to modernize and further secure the U.S. food supply chain. The next milestone for FDA food traceability regulations is just four months away, so let’s take a look at the requirements — and why food companies should embrace them as an opportunity to improve their businesses.

But first, if you’re intrigued by the idea that opportunities are “hiding” in the FDA food traceability regulations, join us for our “Safety, Regulatory Compliance & Beyond: Leveraging Traceability to Optimize the Food & Beverage Supply Chain” webinar on Wednesday, August 10, at 1 p.m. EST. Our experts will break down the “whys” and “hows” of traceability, discuss the real-world applications and value-adds, and take your questions.

Recap of FDA food traceability regulations & upcoming deadlines

Here’s a quick rundown of what’s on the table and upcoming deadlines.

Food Safety Modernization Act (FSMA)

      • Signed into law on Jan. 4, 2011
      • Aims to ensure the food supply is safe by shifting the focus to preventing contamination rather than responding to it
      • Applies to human food as well as to food for animals, including pets

Proposed Rule (FSMA 204)

      • Establishes additional traceability recordkeeping requirements for people who manufacture, process, pack, or hold foods on the Food Traceability List
      • Food Traceability List contains foods with additional traceability recordkeeping requirements (see table below)
      • Stakeholders to establish and maintain records with key data elements (KDEs) associated with different critical tracking events (CTEs)

Key dates

      • Nov. 7, 2022: FDA to finalize and submit the Food Safety Modernization Act (FSMA) Proposed Rule to the Federal Register
      • January 2023: Proposed Rule goes into effect
      • Jan. 6, 2025: Deadline for full compliance

The FDA has also launched the New Era of Smarter Food Safety and an accompanying New Era of Smarter Food Safety Blueprint, which envision a modern approach to ensuring food safety through digital, tech-enabled traceability. Get more details in our blog here.

FDA food traceability regulations: What to know now and how to seize opportunities

This is really just a preview of our August 10 webinar about leveraging traceability. We’ll touch on a few key points below; sign up for the webinar to take a deep dive.

Just the facts

The FSMA 204 deadlines are set. You’ll have to be fully compliant in about two years, so the time to prepare is now.

The Food Traceability List is a living document. More and more food items are sure to be added over time.

The FDA is committed to modernizing and securing the U.S. food supply chain. Expect the Agency to continue promoting (and regulating) traceability in a digital supply chain. This includes improving recall management.

Where’s the opportunity?

End-to-end traceability makes everything better. With the right solution, you’ll not only be compliant — you’ll make your supply chain faster, leaner, and more cost-effective.

“1-up, 1-down” is useful, but antiquated. Today, 1-up, 1-down traceability is merely a facet of end-to-end traceability (and visibility and transparency) in a digital supply chain. The right solutions transform your supply chain into an ecosystem that optimizes operations and creates opportunity and value beyond the point of sale.

Serialization is the building block of compliance — and added value. Serialization turns every product into a “digital asset” that can be traced in real time from virtually any location, yielding practical benefits to your operations. But these digital assets can accomplish much, much more, including brand protection and consumer engagement.

Traceability enables precise, targeted recall management — which means better outcomes for your brand. We’ve all heard the statistic that the average food recall costs $10 million. With traceability, you can locate specific items quickly, identify where they came from (e.g., grower, warehouse), take clear, decisive action to remove only those items from circulation, and protect consumers and your reputation.

Traceability in a digital supply chain means less clutter — literally. Do you have nightmares about back rooms full of boxes stuffed with paperwork? Traceability turns your nightmare into an operational dream. Get rid of all the paper and gain the power to quickly dial up any document, any time, from any location, including from mobile devices.

Traceability and added value

Traceability is the key to keeping consumers happy and inspired. Consumers are thinking deeply about the things they buy — where they come from and what goes into making them. They also expect to interact with the brands they trust. We wrote way back in October 2020 that supply chain traceability was building a new kind of consumer kingdom; it was true then, it’s true today, and it will be true tomorrow.

The era of digital assets and smart products is here. Products are no longer just products. With serialization and traceability, products are gateways to experiences. They’re beacons to broadcast information. They are conduits for hyper-targeted and hyper-personalized consumer engagement.

Final thoughts

FDA food traceability regulations are center stage in FSMA, the Food Traceability Proposed Rule (FSMA 204), the Food Traceability List, and the New Era of Smarter Food Safety. The deadlines are coming and you should be preparing.

But now you know that savvy companies will see traceability as more than a compliance mandate from the government — they’ll see it as a technology that creates a universe of opportunities for their businesses and brands.

Companies that are thinking only about the mechanics of complying with FDA food traceability regulations will miss these opportunities to be proactive about ensuring food safety and quality, reducing  risks, protecting and building their brands, and leveraging every single product to connect with individual consumers in exciting, meaningful ways.

We don’t want you to miss these opportunities. To get started, sign up for our food traceability webinar to see how traceability works and how it delivers value.

Next, contact us to schedule a short demo of our food and beverage solutions, including our award-winning Traceability System and Mobile Traceability App. In about 15 minutes, our supply chain experts will show you how we create end-to-end traceability in a fully interoperable digital supply chain that’s visible anytime, anywhere.

Last, take a look at our other food traceability materials, some FDA links, and our shortened version of the Food Traceability List.

Our FSMA & Food Traceability Resources

Other FDA Resources

Food Traceability List

FDA Food Traceability List

Supply Chain Traceability Systems Make Your Business Better

Posted on by rfxadmin

One of the best ways to get more people to buy your products is to inspire consumer confidence. And one of the best ways to increase consumer confidence is to insist on airtight food safety protocols, which absolutely should include supply chain traceability systems.

Are there some areas where your food safety can improve? It’s always a good idea to periodically reflect on what you and your team are doing. This will allow you to improve on weak spots in your food supply chain. Supply chain traceability systems are a huge help.

Most important, the ability to trace everything in your supply chain ensures you are delivering safe food to your customers — and building consumer confidence. It also helps ensure compliance with regulations. So, if you don’t have traceability in your supply chain, you should consider implementing a system as soon as possible.

Let’s take a closer look at the benefits supply chain traceability systems can bring to your business.

What are supply chain traceability systems?

Supply chain traceability systems are a powerful tool for any industry. They give you the ability to know where your ingredients and finished products have been and where they’re going as they move through your supply chain, through the “life cycle” of your business. They are particularly helpful with maintaining product safety and minimizing and proactively managing issues that could harm your business, such as a recall.

Advantages of supply chain traceability

There’s no doubt supply chain traceability systems will save your company time, money, and effort. But what specifically can they do for you? Let’s look further into the benefits of implementing a food safety program with supply chain traceability.

Effective recall management

Supply chain traceability is a key part of recall management. The food industry is one of the most vulnerable to recalls. A recent example is Tyson Chicken. On July 3, 2021, the food giant had to recall almost 9 million pounds of ready-to-eat chicken in the United States. Thanks to supply chain traceability, however, Tyson could work quickly and effectively with the U.S. Department of Agriculture, pinpointing when the products were made and what labels were on the packaging, notifying consumers, and mitigating further troubles.

Needless to say, a recall of any size can hurt profitability and brand reputation. But supply chain traceability systems help manage damage. As we’ve discussed before, having the proper systems in place for effective recall management is paramount for protecting your business’ profitability and your brand reputation.

Regulatory compliance

Another advantage of implementing supply chain traceability systems is meeting regulatory requirements. The FDA keeps a watchful eye over food supply chain processes in the United States. And, with much of our food traveling far and wide before it reaches our plates, those processes require many moving parts. Being aware of where your food has been, where it is now, where it’s going, who is handling it, and how long it’s been in transit are all helpful metrics to keep your operation in compliance with the FDA and other regulatory agencies.

The FDA is pushing hard for more traceability standards, and consumers are more aware of where their food is coming from and demanding more information about what they eat. This is yet another reason why traceability is so important today.

Maximized efficiency

Being able to trace (and track) your products as they move through your supply chain also allows you to identify inefficiencies and bottlenecks. In other words, end-to-end traceability maximizes operational efficiency. It will enable you to see which processes are working well and which ones aren’t.

Supply chain traceability systems also help you cut costs. If you have rich data that quantifies that a particular process (or trading partner) is inefficient, you can take steps to improve it or remove it from your supply chain process.

Consumer engagement

Believe it or not, traceability will also help your sales. Customers love stories — and they’re demanding more information about the products they buy. Smart companies will use their supply chain traceability systems as part of their marketing, connecting with consumers by telling their story and sharing information about their products.

You see this all of the time in the food industry. In commercials, companies highlight how far their products have traveled and how much care goes into making, packaging, and shipping them. This kind of advertising paints a picture of the journey the products take to arrive in a customer’s home and emphasizes the qualities people want (e.g., salmon from Alaska or peaches from Georgia). Being able to “play up” the source and the journey will make your food products more appealing to shoppers.

Communicating with stakeholders

You always need to consider input from stakeholders. Supply chain traceability is an effective way to keep them happy. Making stakeholders aware of this information is known as supply chain transparency.

Supply chain transparency is an important part of your business. While food safety and quality are important, you also need to keep your trading partners in the loop. Any effective supply chain transparency plan has three main components.

The first component is the “what” of your supply chain traceability. What information are you going to share with your stakeholders? You’re also going to want to determine what format you’re going to use to display the information.

The next step is to decide the “who.” Who needs to see this information? Several different groups might need it, such as internal stakeholders, vendors, suppliers, clients, and consumers. You’ll also want to consider why they need to have it.

Last, you’ll want to consider the “when.” When are your people going to get this information? And how often?

You’ll also need to decide how often to update your information. Today, the trend is toward real-time updates. This is the ideal scenario, but it can be a challenge to attain. Supply chains involve a lot of moving parts and have many different nodes or tiers. Providing real-time updates in this complex framework requires efficient, streamlined operations utilizing supply chain traceability systems.

Supply chain mapping

Supply chain mapping — the process of mapping every tier of your supply chain with easy-to-follow imagery — is an effective way to keep all your stakeholders happy. A supply chain map doesn’t show every person involved in the process; instead, it shows all of the players within each tier of the supply chain.

One of the benefits of supply chain mapping is that it presents an opportunity for risk assessment. Seeing your supply chain clearly mapped out allows your management team to decide which areas need to be carefully monitored. You can also analyze your supply chain with a “bird’s-eye view” and decide if you need to make adjustments for greater efficiency.

Safer, healthier food

Today, grocery stores are full of food that’s touted as being locally sourced, sustainably caught, and so on. How can companies make and prove these claims? With end-to-end supply chain traceability data. Making these types of claims requires companies to make sure they are tracking the right metrics to support them. Companies also need to leverage the correct technology to support these initiatives.

Examples of how supply chain traceability systems work

How do companies achieve end-to-end supply chain traceability? Keeping track of your products and all the important metrics requires modern technology.

One of the ways companies are doing this is by putting QR codes and 2D Data Matrix codes on their packaging. These codes contain important information and can be scanned as products move through the supply chain. This allows vendors, suppliers, and people responsible for transport to “check the food in” at various points throughout the process and add important data, including critical tracking events (CTEs) and key data elements (KDEs).

Leveraging this technology is a critical aspect of today’s supply chain traceability systems. It helps companies keep track of where their products are at all times, throughout all nodes of the supply chain. For more information about it all works, download our new white paper, “Traceability in the Food Supply Chain.”

A quick word about blockchain

As technology moves forward, supply chain traceability systems also continue to evolve. One of the newest technologies with traceability applications is blockchain.

Most people probably associate blockchain with cryptocurrencies such as Bitcoin. One of the reasons Bitcoin is so valuable is because it can be traced across the internet via the blockchain. Investors and computer programmers can map each Bitcoin to its proper place on a global digital ledger.

This and other characteristics give blockchain tremendous functionality in a wide array of industries. For food in particular, blockchain can help companies achieve a “locked down” supply chain, providing indisputable, verified data and a level of security not possible with other technologies.

What do you think tracking food products in the same manner as cryptocurrency would do for supply chain traceability systems? It’s still in the early stages, but blockchain could revolutionize traceability. It’s a complicated subject, so we encourage you to download our white paper, “Blockchain-Based Supply Chain Traceability.”

Final thoughts

Supply chain traceability systems are an essential part of any business. But they’re especially important in the food industry. The safety and quality of your product is the most important part of your business. Consumers’ health depends on it. Your brand reputation depends on it. Your bottom line depends on it.

rfxcel can help. We have the software solutions you need for your business — for supply chain traceability, regulatory compliance, serialization, monitoring, and even vaccine track and trace.

Contact us today if you have any questions about supply chain traceability systems or would like to see a short demo of how our solutions can help you build your business, no matter what your business is.

 

Traceability in the Food Supply Chain

Posted on by rfxadmin

This white paper describes how traceability transforms food products into powerful “digital assets,” helps prevent common supply chain and business problems, and brings an array of benefits to all actors in the food supply chain. It examines the regulatory landscape in the United States, where the Food and Drug Administration has made food traceability one of its top priorities. We examine the Food Safety Modernization Act (FSMA), the Food Traceability List, and the Final Rule on Requirements for Additional Traceability Records for Certain Foods. We feel food companies and their trading partners everywhere can benefit from understanding these requirements and should see them as indicative of where the industry is headed in terms of regulations, technology, and consumer expectations.

 

Dairy Traceability in 2021: The FDA, the Industry, and the Future

Posted on by rfxadmin

It’s June, and it’s definitely ice cream season! It was 96°F (35°C) at our headquarters in Reno, Nevada, yesterday. Naturally, when we think of ice cream, we think about dairy traceability. Dairy traceability ensures consumer safety and keeps vital supply chains moving.

Most of our readers can probably assume that their food was manufactured, processed, transported, and stored safely and in accordance with quality standards and safety regulations. But the World Health Organization estimates that 600 million people are sickened from contaminated food products every year — and as many as 420,000 die. Dairy products are among the biggest culprits, as they can carry pathogens that cause foodborne illnesses.

The implications are significant. And they illustrate why dairy traceability is so important. Let’s take a look at where we are with dairy traceability in 2021.

Dairy traceability: the industry perspective

Dairy traceability has been on the industry’s radar for quite some time. For example, the Innovation Center for U.S. Dairy has been an advocate since at least 2009, when its Globalization Report noted that traceability was, in so many words, the future of the dairy supply chain.

In 2013, the Center published Guidance for Dairy Product Enhanced Traceability. Now in its third iteration (July 2020), it addresses much of what the FDA wants, including establishing and maintaining records with key data elements (KDEs) associated with critical tracking events (CTEs). There’s also a 21-point Dairy Traceability Checklist that manufacturers can use to evaluate if they follow enhanced dairy traceability best practices.

Last, the Center created the U.S. Dairy Traceability Commitment, “designed by processors, for processors, to increase global competitiveness, help satisfy future requirements of the Food Safety Modernization Act (FSMA) and, in the rare event of a safety issue, quickly isolate products to protect public health and prevent brand damage.”

Dairy traceability: the FDA perspective

Traceability — including dairy traceability — and modernization have also been on the FDA’s radar. We’ve written about this before, so we won’t drill down into the details today. In a nutshell:

The new requirements, also known as the Food Traceability Proposed Rule, apply to many popular cheeses, including brie, camembert, feta, mozzarella, Monterey Jack, cottage cheese, ricotta, and queso fresco.

Dairy traceability in 2021

Just about a year after the FDA announced its New Era of Smarter Food Safety Blueprint and the Innovation Center for U.S. Dairy updated its Guidance for Dairy Product Enhanced Traceability, it’s clear the dairy industry and the FDA are trying to get on the same page.

Generally, the industry has been receptive to the FDA’s efforts. The International Dairy Foods Association, for example, supports the New Era of Smarter Food Safety Blueprint. Still, many in the industry say the Food Traceability Proposed Rule isn’t necessary because supply chain stakeholders have been modernizing and building traceability systems without a government mandate.

With that in mind, the International Dairy Foods Association submitted comments to the FDA asking it to revise the recordkeeping requirements, arguing that doing so would support more widespread adoption of dairy traceability across the industry, to the ultimate benefit of the public. The Association is also working with the FDA to ensure dairy manufacturers have the proper direction and tools that support more efficient food safety practices and dairy traceability protocols.

Final thoughts

This quick sketch of dairy traceability makes two things clear. First, the FDA is all-in on modernization and traceability. Second, the industry understands the need for dairy traceability and has shown its willingness to commit to maintaining a modern, traceable supply chain.

In this environment, rfxcel’s traceability solutions will help dairy companies in any market modernize their food safety protocols, facilitate end-to-end traceability in a digital supply chain, comply with evolving regulations, and maintain trust with customers. Contact us for more information about how we can help, and check back soon for more about traceability in the food supply chain.

 

Food Traceability Data: Not Just for Compliance Anymore

Posted on by rfxadmin

As the Food and Drug Administration (FDA) continues to evolve its traceability and modernization initiatives across the U.S. food supply chain, the need for more accurate food traceability data is more important than ever.

Foundationally, the FDA’s initiatives require companies to have digital traceability systems in place that facilitate greater food safety. But food traceability data means more than ensuring you’re complying with regulations: It offers significant business value. Let’s take a look.

FDA’s food traceability initiatives: a refresher

In 2011, Congress enacted the Food Safety Modernization Act (FSMA) to regulate the way foods are grown, harvested, and processed in the United States. The law transforms the nation’s food safety system from an after-the-fact response to foodborne illness to a proactive posture aimed at prevention.

To address the rapid and effective tracking and tracing outlined in FSMA, the FDA in April 2019 launched the New Era of Smarter Food Safety, a tech-enabled approach to food traceability to ensure food safety, and the New Era of Smarter Safety Blueprint (July 2020), which outlined the Agency’s vision for how to get there and included the Food Traceability Proposed Rule, which defines specific traceability recordkeeping requirements for foods on its Food Traceability List.

Food traceability data delivers benefits beyond mere compliance

Although food traceability data serves as the cornerstone of effective recall management and outbreak prevention as required by the FDA, it means much more than compliance. Here are three ways food traceability data can drive business value to support sustainable growth.

Create operational efficiencies

Food traceability data yields complete, real-time visibility into operations across every node in the supply chain. This empowers food companies to take immediate action, solve problems, coordinate with partners and regulators, and keep things moving.

For example, by tracking a product’s ingredients from harvest through production through the last mile to delivery, you can quickly trace raw materials backward and forward, pinpoint supply chain weaknesses or trouble spots, and strengthen your recall program and minimize the impact of recalls. And with a traceability system that allows you to monitor products anywhere in transit, you can collect data on environmental conditions, track the location of all your deliveries, and set precise parameters for alerts.

This food traceability data allows you to proactively protect your shipments, safeguard their environmental integrity, track their position on land, sea, and air, and intervene immediately should something seem awry, such as a spike in temperature or a route diversion. Add critical tracking events (CTEs) and other information (e.g., quality inspections) to the process and you’ve got an indelible product provenance from farm to table.

Build consumer engagement and trust

These days, consumers are more attuned than ever to family health and finances. They want to know more about what they’re eating, such as ingredients, how food is raised or grown, and the safety and environmental practices used to produce it. They want to feel good about what they eat and where they are spending their money. By supplying information that meets this demand, you build trust and loyalty and build a community of customers who will advocate for your products.

The simple truth is that food traceability data creates tremendous opportunities to communicate with consumers and nurture more committed relationships. You can back your claims and prove your product is what you say it is.

Protect your brand

This dovetails with consumer engagement and trust. With modernized, secure, and compliant food traceability protocols, you can better collaborate with partners and authorities if there’s a recall. In this scenario, you’re not only protecting consumers from a health hazard — you’re safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about the foods they consume, you create a strong brand image that conveys trust, credibility, and reliability. You can even use your food traceability data as a core differentiator in your value proposition messaging.

Final thoughts

Food traceability data has always been important, but the FDA has clearly put it center stage with FSMA, the New Era of Smarter Food Safety, the Food Traceability Proposed Rule, and the Food Traceability List.

Do not expect this to change.

rfxcel believes industry leaders will see traceability as an investment in their businesses and brands, not a compliance mandate from the government. If fact, savvy companies will know the FDA’s initiatives are an opportunity to be involved in shaping the future of the U.S. food supply chain. Keep an eye out this summer for more from rfxcel about how you can tap into the FDA’s initiatives to help lead the transformation of the U.S. food supply chain. As we said above, this is a moment of opportunity for the food industry. Don’t miss the boat.

In the meantime, take a look at our solutions for food and beverage:

Contact us today for more information and to schedule a short demo of our food traceability solutions. Get started now and take advantage of all the opportunities food traceability data can create for you.

Exploring Meat Traceability in the Food Supply Chain: Getting to Know Your Protein

Posted on by rfxadmin

Today’s consumers demand transparency, particularly when it comes to the meat they consume. They want more information about how and where the livestock was raised and processed — not just from a nutritional standpoint, but also with regard to food safety practices, animal care practices, environmental impact, and worker safety. Put simply, they want meat traceability.

Consumers are making an emotional connection to the foods they buy and consume; they want to feel good about where their money is going and what they are putting into their bodies. While this trend has been growing over the past several years, it has gained significant traction recently. Add the pandemic into the mix, and you’ve got an even greater demand for transparency amid an environment driven by heightened health and financial concerns.

The supply chain saw significant disruption during the pandemic, as high infection rates in processing plants led to a marked curtail in operations in pork, beef, and poultry plants—and in some cases, plant closures. In fact, roughly 65 percent of meat processing plants experienced outbreaks and 20 percent were forced to temporarily suspend operations, which, in a consolidated meat industry, had a ripple effect across the country. As the outbreaks played out publicly, consumers grew even warier of the origins of their meats.

Adding more complexity to the issue, bad weather over the past year meant smaller corn and soybean harvests, making it harder and more expensive for cattle, hog, and poultry farmers to feed their herds. The last time the industry saw such high grain prices was during the 2012 U.S. drought.

As meat supplies diminished, consumer demand grew, with more people stuck inside and forced to cook and eat at home. The result: price inflation at the grocery stores, making it more expensive for consumers to feed their families. As they pay more for the foods that nourish their families and read headlines about the pandemic’s effects on the food supply chain, their demand for transparency has only become greater.

Meat traceability is more essential than ever

As we usher in a new era in food safety, meat traceability is no longer a “nice-to-have” — it’s essential. With increasing consumer demand for more information about where their protein is coming from, clear documentation from the farm to the end product is a must.

The Global Food Traceability Center defines traceability as the “ability to access any or all information relating to a food under consideration, throughout its entire life cycle, by means of recorded identifications.” This goes beyond the information itself; it’s about linking the information throughout the supply chain and ensuring coordinated processes and end-to-end meat traceability.

The good news is that tech-enabled meat traceability doesn’t have to be complicated, and its benefits are vast and powerful. From increased meat quality, improved food safety, and fewer product recalls to better inventory tracking and superior customer service, traceability delivers a range of benefits that go far beyond simply responding to consumers’ demand for information. With visibility across the entire supply chain, manufacturers can document and link the production, processing, and distribution chain of their protein products, which results in greater organizational efficiencies, reduced market and operational risks, a stronger competitive advantage, and a better brand image.

Final thoughts

While challenges continue to emerge amid a rapidly evolving global landscape, brands have an opportunity to tell a story that evokes a positive emotion and inspires a purchase. Consumers want to know that their meats were produced ethically and safely, and, of course, pose no risk to themselves or their families. As more and more people scan labels and packages for information about where their food came from and how it was made, transparency will play an increasingly crucial role in a meat producer’s brand image. It really comes down to trust: If consumers don’t trust your brand, they’ll be more than happy to buy another company’s product. Meat traceability satiates a consumer’s need for information, which builds trust with your brand.

From farm to table, rfxcel’s food supply chain solutions have you covered. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end meat traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

Offering the most complete and flexible raw materials and meat traceability solution for food and beverage, we’ll help you to optimize your supply chain operations while catering to the consumers’ increasing demand for information about the meats they consume.

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