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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.

Key FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. FSMA final rules include:

      • 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).
      • 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.
      • 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.
      • Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
      • Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
      • Accredited Third-Party Certification Rule: Crated a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.

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 Data Carrier Requirements: FDA Guidance & GS1 Standards

Posted on by rfxadmin

We’ve recently talked about Food Safety Modernization Act (FSMA) traceability requirements and GS1 standards and the FSMA traceability lot code. Today, we’re covering FSMA 204 data carrier requirements: FDA guidance and — once again — GS1 standards, including incorporating the mandated traceability lot code into compliant barcodes.

Like our previous post, we’re basing much of this discussion on GS1’s March 1, 2023, industry guidance document, “Application of GS1 System of Standards to Support FSMA 204.” For an in-depth description of GS1 data carriers, check out our “Understanding GS1 Barcodes in the Global Supply Chain” article.

Data carriers: a quick definition for context

A building block for traceability in any supply chain, data carriers enable product information to be quickly and accurately captured, stored, shared, and leveraged for business needs. Companies can mark their entire product hierarchy — from individual items and inner packs to cases/boxes and pallets — with data carriers, which include barcodes (e.g., linear, 2D DataMatrix codes, and QR codes).

Do GS1 barcodes meet FSMA 204 data carrier requirements?

The short answer is “yes.”

However, FSMA does not mandate the use data carriers to provide product information and the FDA does not say what data must be present to meet the FSMA traceability requirements. This is stated clearly in Federal Register Response 524, in which the FDA says that “firms may use product labels to provide the information required [our emphasis] to their supply chain partners if that suits their business practices.”

In the context of this question, suggestions for “product labels” included twist ties, bags, food-grade stickers, and traditional-type labels on produce or customer order forms. For GS1, product labels mean data carriers, primarily barcodes.

What does GS1 say about FSMA 204 data carriers?

In its guidance document, GS1 says this about the FSMA 204 data carrier requirements (or lack thereof):

“Data carriers are not required to meet the requirements of the Final Rule. For this reason, there is no clear prescription of what data must be present in a data carrier to fulfill traceability for the Final Rule. Instead, companies must evaluate what data will enable rapid access to the necessary information in the event the FDA requests their records.”

GS1 explains three types of data carriers that might have applications for the FSMA 204:

      1. GS1 Element String (1D and 2D), which can contain the primary identifier (e.g., Global Trade Item Number, or GTIN) and attribute data (e.g., lot/batch number, expiration date, sell-by date, net weight)
      2. GS1 Digital Link URI (2D), a web-compatible format that can contain the primary identifier and attribute data
      3. Electronic Product Code Uniform Resource Identifier (EPC URI), which can contain the primary identifier with a serial number plus attribute data for use in RFID tags, primarily UHF passive tags (also called RAIN RFID).

Using GS1 barcodes as a FSMA 204 data carrier

Below are some examples of how GS1 barcodes might look when used as FSMA 204 data carriers. (We’re not going to get into RAIN RFID today.)

Specifically, we want to illustrate how these barcodes could meet the FSMA traceability lot code requirement, which GS1 says a GTIN + batch/lot numbers would satisfy. (Read our article here for more about the traceability lot code.) In the illustrative images below, we’ve highlighted the GS1 Application Identifiers (AIs) for GTIN (01), lot/batch number (10), and expiration date (17). AIs tell systems what information is being interacted with and enable them to process that information accordingly.

GS1-128. GS1-128 is a 1D barcode that can be up to 6.5 inches long and have up to 48 data characters. In terms of FSMA 204 data carriers, GS1 includes an “important” note that “1D barcodes cannot be removed until all stakeholders expected to scan the barcode are fully capable of interacting with 2D barcodes. This means that both a 1D and 2D barcode would be required during any transition period.”

GS1 DataMatrix. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 identification keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.

GS1 DataMatrix + GS1 Digital Link URI. The GS1 Digital Link URI essentially turns data carriers into web links. GS1 says that “scanning capabilities are not widely available for GS1 Digital Link URI in general distribution,” so companies would  have to update their systems in order to process these barcodes and the data they contain.

GS1 QR Code + GS1 Digital Link URI. Like GS1 DataMatrix codes, GS1 QR codes are omnidirectional and support attributes and all GS1 ID keys; however, they can hold 7,089 numbers or 4,296 alphanumeric characters. Some mobile device cameras cannot process DataMatrix codes, so GS1 says QR Codes are “the current preference for engagement through mobile devices.”

GS1 Barcodes FSMA 204 data carrier

Final thoughts

Let’s repeat what we said in our post about GS1 and FSMA traceability requirements:

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

Food companies are already using GS1 barcodes; adapting them as FSMA 204 data carriers or “product labels” makes good sense. GTINs, batch/lot numbers, Serialized Shipping Container Code (SSCC) data, and other information can be encoded into GS1-128, GS1 DataMatrix, GS1 QR code barcode configurations, as well as Electronic Product Code-enabled RAIN RFID tags and labels.

Contact us today if you’d like to learn more about using a barcode as a FSMA 204 data carrier, how to integrate data capture technology into you FSMA 204 compliance strategy, and everything else you need to have in place by the January 2026 deadline. A short talk with one of our supply chain experts will get you going in the right direction or help you course-correct if you feel like you’ve been treading water with your FSMA initiatives.

And if you’re interested in learning how we’ve put more than 1.5 billion of barcodes on as many products to help a major berry producer control product safety and quality, click here.

Read more about FSMA:

Understanding FSMA 204 Data Carrier: FDA Guidance and GS1 Standards

Posted on by rfxadmin

People have been asking us about the Food Safety Modernization Act (FSMA), so we’ve recently written about the Final Rule, the Food Traceability List, and the FSMA traceability lot code. Now we’re going to cover what GS1 is saying about the FSMA traceability requirements.

It’s a timely — and important — topic for the food industry. About two weeks ago, GS1 published an industry guidance document about applying its standards to support FSMA 204. Among other things, the 62-page paper “defines the recommendations for product and location identification, structured product descriptions, and recording common industry defined events to support the additional traceability records required in the Final Rule.”

Today, we’re looking at three things:

      1. What the FDA says about complying with FSMA traceability requirements
      2. GS1 standards for identification
      3. GS1 standards and the FSMA traceability lot code

Caveats and context

GS1 says its guidance document, which was developed by its US FSMA 204 Workgroup, “does not provide any guidance or advice regarding regulatory compliance.”

It also states that the “guideline reflects current industry understanding of the Additional Traceability Records for Certain Foods. Those requirements, and the statutes and regulations affecting them, are subject to change and may evolve in a manner this guideline cannot anticipate.”

Keep these statements in mind as you’re reading. Also know that the purpose of this blog post is to summarize what GS1 is saying about its standards and FSMA traceability requirements, not to advise on or advocate for the use of GS1 standards for FSMA compliance.

Of course, if you do want to get into specifics of ensuring you’re FSMA-compliant, contact us today and start that conversation with one of our supply chain experts.

Last, we’re going to be getting into technical aspects of GS1 standards, including Application Identifiers, identification keys, and barcodes. We’ll explain everything, but read our “Understanding GS1 Barcodes in the Global Supply Chain“ article for more detailed information.

What does the FDA say about complying with FSMA traceability requirements?

The answer is pretty simple: The FDA does not provide concrete guidance about how to meet FSMA traceability requirements; instead, it speaks in general terms. For example:

      • In Federal Register Final Rule Response 507 to a question about “requiring the use of globally unique product identifiers” — including GS1 identifiers — the Agency says, “we are not making this a requirement under the final rule.”
      • In Federal Register Final Rule Response 516 to a question about GS1 Serial Shipping Container Codes (SSCCs), the Agency says, “we encourage the use of any tools that will improve a firm’s procedures for traceability and support the maintenance and sharing of the required traceability records under the final rule.”
      • Though it does mention the GS1 Global Trade Item Number (GTIN) in a response about the traceability lot code, it says “firms are not required to use GTIN or any other particular coding system or technology.”

In this regulatory context, let’s see what GS1 says about using its standards for the FSMA traceability requirements.

GS1 standards for identification

GS1 says food companies can use GTINs, SSCCs, and Global Location Numbers (GLNs) for the FSMA traceability requirements.

      • GTINs identify individual products. They can be linked to key data elements (KDEs) in a database; food companies wouldn’t need to maintain required information in a separate location. (See our simple explanation of KDEs here.)
      • SSCCs identify single logistics units (e.g., pallets). They can be paired with the mandated FSMA traceability lot codes to improve traceability.
      • GLNs identify the “who” and “where” of a product/company. They would provide required company and location identification.

GS1 standards and the FSMA traceability lot code

Though the FDA does not commit to a standard for the traceability lot code, it does indicate some options. For example:

      • In Final Rule Response 324, the Agency says there are “industry-supported traceability initiatives [to use] a combination of a globally unique product identifier, firm-assigned internal lot code, and standard date code [that] could be used as a traceability lot code.”
      • In Response 361, it says “a traceability lot code may include a product identifier such as a GTIN and/or an internal lot code (provided the definition of ‘traceability lot code’ in § 1.1310 is met).”

GS1 says a GTIN plus batch/lot numbers would meet the FSMA traceability lot code requirements. Here’s a step-by-step explanation of why it would work:

      • GS1 uses Application Identifiers (AI) to indicate identification keys, attribute information, and secondary information.
      • There are 12 identification keys, including GTINs, SSCCs, and GLNs. Every identification key also has an AI. (Read our article about GS1 barcodes for a more thorough explanation of identification keys.)
      • The GTIN AI is 01 and “uniquely identifies [a] trade item.” It can be 8, 12, 13, or 14 digits long.
      • The batch/lot number is AI 10 and “identifies a group of the same product, all of which were manufactured under identical conditions to support traceability and other use cases.” It can be up to 20 characters (letters, numerals, and a defined subset of special characters).
      • The batch/lot number must be expressed in conjunction with a GTIN (AI 01) because it is a product attribute.

Final thoughts about FSMA Traceability Requirements

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

It also reinforces a point we’ve been making for quite some time: Companies that see regulations as a chance to lead in their industry and create business value will win the day, and companies that think only about the mechanics of compliance will likely miss these opportunities.

So, like we said above, if you want to talk turkey about ensuring you’re FSMA-compliant, contact us today to start the conversation. In about 15 minutes, one of our supply chain experts can show you Antares Vision Group’s solutions for the food industry and how rfxcel technology drives them.

Also check back next week. We’ll continue this discussion with a piece about data carriers — 1D and 2D barcodes, QR Codes, RFID tags — and what the FDA and GS1 is saying about their role in FSMA traceability requirements. Last but not least, click here to learn how we barcoded more than 1.5 billion products help a major berry producer control product safety and quality.

Read more about FSMA:

 

What is the FSMA Traceability Lot Code and Who Must Comply?

Posted on by rfxadmin

If you read our blog (and we know you do), you’re up to speed on the fundamentals of Food Safety Modernization Act (FSMA) Section 204, including the Food Traceability List (FTL) and the food traceability “Final Rule.” Today, we’re looking at an important part of the regulations — the FSMA traceability lot code — and who must comply.

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.”

The FSMA traceability lot code in action: CTEs and KDEs

To fully understand the FSMA traceability lot code, 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 the FSMA traceability lot code

This is a lot to digest. Online tools are fine, but the better 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: What the Food Industry Needs to Know Today

Posted on by rfxadmin

U.S. regulators want a more robust, technology-driven approach to traceability and safety in the food supply chain. Their strategy has several components, but the FSMA traceability requirements published in November 2022 should be top-of-mind for the food industry in the United States and elsewhere.

Let’s take a look at the Food Safety Modernization Act (FSMA) and FSMA traceability requirements. Even though the compliance deadline is about three years away, now is the time to start planning your strategy.

FSMA implementation and goals

The Food and Drug Administration (FDA) is the primary implementing regulatory agency of FSMA, a law that seeks to transform the United States’ food safety system “by shifting the focus from responding to foodborne illness to preventing it.” It focuses on five areas:

    1. Preventive controls
    2. Inspection and compliance
    3. Imported food safety
    4. Response (i.e., recalls)
    5. Enhanced partnerships

In terms of FSMA traceability, the regulations address the “need for rapid and effective tracking and tracing of foods.”

FSMA Section 204 and the three pillars of FSMA traceability

Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:

    1. Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
    2. Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
    3. Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

Today, we’re going to focus on Nos. 2 and 3, which concern the FDA’s Food Traceability List and the Final Rule on Requirements for Additional Traceability Records for Certain Foods (“Final Rule”).

The Food Traceability List and the Final Rule

The Food Traceability List (FTL) was developed with input from a 2014 Request for Comments and for Scientific Data and Information in the Federal Register, members of the FDA and the Centers for Disease Control and Prevention, and external subject matter experts. It includes “high-risk foods” such as leafy greens, shell eggs, crustaceans (e.g., shrimp, crab, lobster), and finfish (e.g., cod, tuna, salmon).

In September 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods.” Known as the “Food Traceability Proposed Rule” or “Proposed Rule,” it defined additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FTL.

After making modifications and holding a period for public comments, The FDA in November 2022 announced the Final Rule on Requirements for Additional Traceability Records for Certain Foods.

The gist of the Final Rule and FSMA traceability is that businesses are responsible for establishing and maintaining records of critical tracking events (CTEs) and associated key data elements (KDEs).

CTEs are typically events that occur during growing and processing (e.g., harvesting, initial packing, and shipping). KDEs provide the granular details for FSMA traceability, such as time, location, unit measurements, and a company’s contact information.

The information companies must keep and share with their partners depends on the type of supply chain activities they perform with respect to food(s) on the FTL. The activities encompass the entire food supply chain, from harvesting or production, to processing, distribution, and receipt at a retail location or other point of service.

The FDA says this “framework forms the foundation for effective and efficient tracing and clearly communicates the information that FDA needs to perform such tracing.”

Final thoughts

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.

Read more about FSMA:

 

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.

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