Food safety

Food Traceability Rule Guide: How to Meet FSMA 204 Compliance in 8 Steps

Discover the 8 practical steps you can start taking today to get compliant with the Food Traceability Final Rule.


Discover the 8 practical steps you can start taking today to get compliant with the Food Traceability Final Rule.

In January 2011, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law. Now, the FSMA 204 final rule on food traceability has many businesses needing to adapt and update their food safety management systems.

The FSMA contains many sections but in this article, we'll cover Section 204(d), which outlines additional traceability record-keeping requirements for certain foods.

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Key requirements for the FSMA 204 traceability final rule, include the food traceability list, enhanced recordkeeping, standardized traceability system, and food traceability plan.

Food traceability refers to a business's ability to track the movement of food materials throughout the supply chain until they become finished products. In the context of FSMA 204, the traceability rule includes:

  • Food Traceability List: Defines foods requiring enhanced recordkeeping and applies to both listed foods and those containing listed ingredients, provided they maintain the form specified on the FTL (e.g., fresh).
  • Standardized food traceability system: Uses the FTL and Key Data Elements (KDEs) for consistent and accurate monitoring of specific foods across the supply chain.
  • Enhanced recordkeeping requirements: Mandates detailed documentation of Critical Tracking Events (CTEs) for foods under regulation, ensuring a thorough audit trail.
  • Food traceability plan: Requires companies to create and follow a traceability plan detailing the procedures for new recordkeeping rules, including assigning and documenting traceability lot codes along with other identifiers to trace food shipments within the supply chain.

    So let’s get into the what, why, when, and who of FSMA 204.

Key points covered:

  1. FSMA 204, also known as the Food Traceability Rule, applies to businesses that need to keep additional traceability records if they hold, process, pack, or manufacture foods that are specifically on the Food Traceability List.
  2. FSMA 204 doesn't mandate food businesses to fulfill these new requirements digitally (i.e., with electronic records). However, it will be easier and more reliable than paper-based records.
  3. To comply with FSMA 204 requirements, you must ensure that your food traceability system allows you to support critical tracking events and key data elements, traceability lot codes, a traceability plan, as well the ability to provide data to the FDA with 24 hours.
  4. The FDA will review the food traceability list every five years.
  5. The Food Traceability List outlined in FSMA 204 includes shell eggs, nut butters, specific types of cheeses, various produce, and a range of seafood.
  6. The FSMA 204 rule went into effect on January 20, 2023. However, the compliance date for food businesses is Tuesday, January 20, 2026.
  7. FoodDocs can support your business's traceability efforts and FSMA 204 compliance with an easy-to-use system that tracks ingredient and product movement.

 

What is FSMA 204? 

FSMA 204, also known as the Food Traceability Rule, is Section 204 of the Food Safety Modernization Act, which requires the FDA to identify foods that require additional recordkeeping to protect public health.

Get your FSMA 204 Compliance eBook

 

Why was FSMA 204 written into law?

FSMA 204 was written into law for many reasons, one of the primary ones being to more effectively minimize and mitigate food safety hazards (e.g., E. coli and Salmonella). In particular, these additional recordkeeping requirements are intended to identify and remove potentially contaminated food from the market even faster, resulting in fewer foodborne illnesses and worse, deaths.

Who does FSMA 204 apply to?

FSMA 204 applies to businesses that need to keep additional traceability records if they hold, process, pack, or manufacture foods that are specifically on the Food Traceability List. Additional record-keeping requirements include maintaining Key Data Elements and Critical Tracking Events and being able to forward these records to the Food and Drug Administration (FDA), ideally within 24 hours.

When is the FSMA 204 compliance date?

The FSMA 204 compliance date is Tuesday, January 20, 2026. It originally came into effect in January 2023, two months after the traceability final rule was published.

When does FSMA 204 enforcement start?

The FDA recognizes that food businesses will need to implement or update their traceability plans. This is something that should not and cannot happen overnight.

It's important to note that the FDA website states:

"We generally note that, while we aren’t initiating routine inspections until 2027, we may do inspections for compliance with the Food Traceability Rule on a for-cause basis, such as during an outbreak investigation, once the compliance date of January 20, 2026, is reached."

What key will terms help to standardize our understanding of FSMA 204?

Before we dive deeper into FSMA 204 compliance, let’s level set about the traceability rule terms and acronyms that we’ll be seeing a lot.

  • Food Traceability List (FTL): A catalog of specific food items that require enhanced recordkeeping as stipulated by FSMA 204.
  • Critical Tracking Events (CTE): A pivotal point within the food supply chain where capturing and documenting key information is essential.
  • Key Data Elements (KDEs): Essential data associated with each CTE that businesses must maintain and disclose to partners in the supply chain and the FDA.
  • Raw Agricultural Commodity: Typically refers to unprocessed fruits or vegetables.
  • Retail Food Establishment: Locations such as stores or restaurants where food is sold directly to the public.
  • Traceability Lot Code (TLC): A distinctive code allocated to a specific batch of food to facilitate its traceability throughout the supply chain, especially during recalls.
  • TLC Source: The initial location or facility where a food batch is assigned its traceability lot code.

Standardized FSMA 204 terms food businesses need to know including food traceability list, critical tracking events, key data elements, traceability lot code, and more.

What's on the FSMA 204 food traceability list?

The idea of a designated high-risk foods list goes back to 2014 when, as required by the FSMA law, the FDA requested comments, scientific data, and information help them implement one.

Today, the food traceability list we have is a result of thorough analyses of outbreak investigations and recall data over time. The amount and frequency of outbreaks and recalls helped to determine which foods — from cheeses to popular produce — appear on the food traceability list as outlined in FSMA Section 204.

Food Traceability List items and descriptions

FTL

Description

Cheese (made from pasteurized milk), fresh soft or soft unripened

Includes soft unripened/fresh soft cheeses. Doesn't include cheeses that are frozen or previously frozen, shelf stable at ambient temperature, or aseptically processed and packaged.

Cheese (made from pasteurized milk), soft ripened or semi-soft

Includes soft ripened/semi-soft cheeses. Doesn't include cheeses that are frozen or previously frozen, shelf stable at ambient temperature, or aseptically processed and packaged.

Cheese (made from unpasteurized milk), other than hard cheese

Includes all cheeses made with unpasteurized milk, other than hard cheeses. Doesn't include cheeses that are frozen or previously frozen, shelf stable at ambient temperature, or aseptically processed and packaged.

Shell eggs

Shell egg means the egg of the domesticated chicken.

Nut butters

Includes all types of tree nut and peanut butters. Includes all forms of nut butters, including shelf stable, refrigerated, frozen, and previously frozen products. Doesn't include soy or seed butters.

Fresh cucumbers

Includes all varieties of fresh cucumbers.

Fresh herbs

Includes all types of fresh herbs. Herbs listed in 21 CFR 112.2(a)(1) are exempt.

Fresh Leafy greens (fresh)

Includes all types of fresh leafy greens. Doesn't include whole-head cabbages such as green cabbage, red cabbage, or savoy cabbage. Doesn't include banana leaves, grape leaves, and leaves that are grown on trees. Leafy greens listed in § 112.2(a)(1) are exempt.

Fresh leafy greens

Includes all types of fresh-cut leafy greens, including single and mixed greens.

Fresh melons

Includes all types of fresh melons.

Fresh peppers

Includes all varieties of fresh peppers.

Fresh sprouts

Includes all varieties of fresh sprouts (irrespective of seed source), including single and mixed sprouts.

Fresh tomatoes

Includes all varieties of fresh tomatoes.

Fresh fruits from tropical trees

Includes all types of fresh tropical tree fruit. Doesn't include non-tree fruits, tree nuts, pit fruits, or citrus.

Fresh-cut fruits

Includes all types of fresh-cut fruits. Fruits listed in § 112.2(a)(1) are exempt.

Fresh-cut vegetables other than leafy greens

Includes all types of fresh-cut vegetables other than leafy greens. Vegetables listed in § 112.2(a)(1) are exempt.

Finfish, histamine-producing species (fresh, frozen, and previously frozen)

Includes all histamine-producing species of finfish.

Finfish, species potentially contaminated with ciguatoxin (fresh, frozen, and previously frozen)

Includes all finfish species potentially contaminated with ciguatoxin.

Finfish, species not associated with histamine or ciguatoxin (fresh, frozen, and previously frozen)

Includes all species of finfish not associated with histamine or ciguatoxin. Siluriformes fish are not included.

Smoked finfish (refrigerated, frozen, and previously frozen)

Includes all types of smoked finfish, including cold smoked finfish and hot smoked finfish.

Crustaceans (fresh, frozen, and previously frozen)

Includes all crustacean species.

Molluscan shellfish, bivalves (fresh, frozen, and previously frozen)

Includes all species of bivalve mollusks. Doesn't include scallop adductor muscle. Raw bivalve molluscan shellfish that are (1) covered by the requirements of the National Shellfish Sanitation Program; (2) subject to the requirements of 21 CFR part 123, subpart C, and 21 CFR 1240.60; or (3) covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish are exempt.

Refrigerated ready-to-eat deli salads

Includes all types of refrigerated ready-to-eat deli salads, including ready-to-eat deli salads that are frozen at some point in the supply chain before retail. Doesn't include meat salads.

Download the FSMA Food Traceability List PDF

 

In her Food Safety Fridays talk for the ISFQN community, Radojka Barycki, Owner and CEO of RDR Global Partners, shared that the FDA will review the food traceability list every five years. Since the FTL was updated in 2022, the food industry can expect an updated list of foods for inclusion sometime in 2027.

Now that you’re aware of what’s included in the Food Traceability List, you’ve got to know your CTEs and KDEs, which help to form the foundation for more safe and holistic food traceability throughout the entire supply chain.

You can see the original comprehensive list with more in-depth examples of food on the FDA's Food Traceability List page.

What are Critical Tracking Events?

Critical Tracking Events are important aspects of a food item's journey that help to decrease likelihood of contamination and reduce risk of foodborne diseases.

There are 7 critical tracking events which include:

  1. Harvesting: Activities performed at farms to remove and prepare raw agricultural commodities for food use, including both growing and raising processes.
  2. Cooling (before Initial Packing): The process of actively reducing the temperature of a raw agricultural commodity using methods such as hydro-cooling, icing (excluding seafood), forced air, or vacuum cooling.
  3. Initial Packing (raw agricultural commodities aka RACs): The first packing of a raw agricultural commodity, excluding seafood from fishing vessels, into containers for further handling or transport.
  4. First Land-Based Receiver: The first business entity on land to take possession of food directly from a fishing vessel.
  5. Shipping: The act of arranging food for transport from one location to another, which includes intracompany shipments to different addresses but not direct sales or donations to consumers.
  6. Receiving: The act of accepting food shipments at a new location, including intracompany transfers, but not direct consumer deliveries.
  7. Transformation: Involves significantly altering the food through processes like manufacturing, commingling, repacking, or relabeling, specifically when the result is a food on the Food Traceability List.

A flow chart of Critical Tracking Events as outlined in FSMA 204.

What are Key Data Elements?

Key Data Elements are different pieces of data that are determined by the specific CTEs which businesses have to keep track of. These details should answer the who (parties involved), what (activities that occurred to the food item), when (date of the event), and where (location).

Different key data elements are required for each critical tracking event. But some common KDEs include:

  • Location description of the food for where it was either harvested, cooled, packed, shipped, etc. (other than a transporter)
  • Commodity (and variety of food, if relevant)
  • Food quantity and unit of measurement
  • Location description for the location from which you shipped the food
  • Traceability lot code you assigned or traceability lot code source
  • Date of harvesting/cooling/initial packing/landing/shipping/receiving/transformation completion
  • Reference document type and number

For exact details and wording of what key data elements are needed for each critical tracking event, reference the FDA USDA's CTE and KDE document. (Yes, that was a lot of acronyms...)

What are Traceability Lot Codes?

Traceability Lot Codes or TLCs are unique identifiers (usually alphanumeric) assigned to items on the food traceability list to increase supply chain transparency You must assign a TLC to a food on the Food Traceability List (FTL) when you:

  • Initially pack a RAC (excluding foods obtained from fishing vessels)
  • Perform the first land-based receiving of food obtained from a fishing vessel
  • Transform a food

Examples of traceability lot codes.

What records are necessary to keep when shipping or receiving food on the Food Traceability List?

Attribute

Details

1: Traceability lot code

Consensus on using GTIN alongside a Lot Code

2: Quantity & unit of measure

Examples include 1 case, 10 reusable containers, 100 storage tanks, 1000 pounds

3: Product description

Details such as product name, brand, type of commodity, variety, and packaging specifics including size or style, and types of seafood

4: Location description for receiver

Details like business name, contact number, full address including city, state, zip, and country

5: Location description for source

Includes business name, contact information, and complete address with city, state, zip, and country

6: Date

Records the date of when the food was either shipped or received

7: Traceability Lot Code Source (TLC Source)


Traceability Lot Code Source Reference (TLC Source Reference)

The location where a food item was given its traceability lot code, noting the company's address, city, state, zip, and contact.


An alternative method to detail the location for the TLC Source, potentially including a web address, FFRN, DUNS, or GLN, with accessibility mandated by the FDA.

8: Reference documents

Includes any business document or record that holds key data elements for an event, such as BOL, PO, ASN, work orders, invoices, receipts, etc.

§ 1.1340: Shippers must provide (via electronic, paper, or another written method) all details specified in this section to the next direct recipient (excluding transporters) of any shipped traceability lot.

A table outlining the traceability records that companies must keep when shipping or receiving items on the FSMA 204 food traceability list.

What types of food businesses are exempt from the FSMA 204 rule?

A number of businesses are exempt from food traceability with either full exemptions, partial exemptions, or full and partial exemptions. You can find the exact answer to “What foods and persons are exempt from this subpart?” in Section 1.1305 in the Code of Federal Regulations.

Here’s a high-level overview of the business types that fall under these exemption categories:

Full exemptions

  • Small producers: Certain producers of small scale are fully exempt
  • Direct-to-consumer farms: Farms selling or donating food directly to consumers
  • Low-risk produce: Produce typically not consumed raw
  • Seafood: Raw bivalve molluscan shellfish
  • USDA-regulated entities: Entities that manufacture, process, pack, or hold foods regulated by USDA
  • Transport entities: Companies that transport food
  • Nonprofit organizations: Nonprofit food service establishments
  • Personal use: Individuals who handle food for personal consumption
  • Research food: Food designated for research or educational purposes

Partial exemptions

  • Mixed commodities: Commingled raw agricultural commodities
  • Small food services: Small retail food outlets and eateries
  • Direct purchase restaurants: Restaurants buying directly from farms
  • Cross-purchasing retailers: Retail food entities buying from other retail locations
  • Educational programs: Farm to school and other institutional programs
  • Fishing vessels: Individuals or entities managing fishing operations

It’s important to note that exemptions aren't always clear-cut. Sometimes, a company might not need to keep certain records for some types of food but will need to keep them for others.

Also, a company might be exempt from some rules at one stage of moving food from place to place, but later stages could still require following those rules. This shows how some foods that usually don't need detailed records might still need them when they reach someone else down the line.

Want to see whether or not your business is exempt from FSMA 204 regulations, use the FDA’s Exemptions to the Food Traceability Rule interactive flow chart.

(If you’d like, try the exemption tool above to clarify if you will have to seek FSMA 204 compliance before jumping into the steps below.)

8 Steps to get compliant with FSMA 204

Below, we’ll get into the practical steps you can start taking to ensure your food business is ready for FSMA 204 compliance in time for January 20, 2026:

  1. Create an FSMA 204 compliance team
  2. Get familiar with FSMA 204 requirements
  3. Establish the scope of implementation
  4. Assess your operation’s traceability and data compatibility
  5. Conduct internal gap and risk assessments
  6. Implement the FSMA 204 compliance plan
  7. Assign traceability tasks and start tracking
  8. Prioritize continuous improvement

1. Create an FSMA 204 compliance team

To ensure your business aligns with FSMA 204 regulations, start by forming a compliance team. This group should be composed of key personnel who understand the complexities of your food operations.

Including a mix of roles, such as operations managers, quality assurance specialists, and IT staff, is beneficial to cover all aspects of the compliance process. Importantly, the team should be led by a Preventive Controls Qualified Individual (PCQI), who brings essential knowledge of FSMA requirements.

When assembling your team, consider the scope of your operations and the specific needs related to FSMA 204 compliance, such as traceability and preventive controls, ensuring each member is clear on their roles and responsibilities. In a typical food business, for example, an FSMA 204 compliance team could look like this:

Role

Responsibilities

Operations Manager

Manages the integration of traceability systems and ensures all processes comply with FSMA 204 requirements.

Quality Assurance Specialist

Develops and maintains preventive controls, conducts hazard analyses, and ensures the food safety plan meets regulatory standards.

IT Staff

Implements and maintains technology solutions to support traceability and record-keeping required by FSMA 204.

PCQI (Preventive Controls Qualified Individual)

Leads the development, implementation, and review of the food safety plan; trains team members on compliance-related tasks.

This structured approach will not only facilitate smoother implementation but also enhance ongoing compliance efforts. If you’ve already got a PCQI to generally maintain FSMA compliance, you’ll be off to a good start.

2. Get familiar with FSMA 204 requirements

Knowledge is power and knowing what the food traceability rule expects of you will make the compliance journey much easier. Start by reviewing the official final rule and lean on resources like the one you’re reading now. Build a comprehensive resource list that includes eBooks, webinars, and presentations from the FDA and other experts to deepen your understanding.

Here’s a starter list:

Also, refer back to the glossary section earlier in this article to familiarize yourself with key terms like FTL, CTE, KDE, and TLC, ensuring that all team members have a solid foundation in the terminology and requirements of FSMA 204.

3. Establish the scope of implementation

Understanding the traceability rule's impact on your specific business operations is crucial. Take these steps to help determine the scope of FSMA 204 compliance:

  • Begin by reviewing the Food Traceability List to identify which of your products or ingredients are affected.
  • Document your current traceability processes to determine how you manage and track these FTL items.
  • Next, develop or refine your strategy for capturing the necessary data, such as lot or batch numbers, dates, and quantities.

Essentially, assess your existing food traceability program to ensure it meets the transparency and safety requirements throughout your supply chain.

4. Assess your operation’s traceability and data compatibility

Start by pinpointing your company's role in the supply chain to understand your specific responsibilities under FSMA 204. Do you hold, process, pack, or manufacture foods? Is it a combination?

Examine your current systems for tracking and managing traceability data to see how well they align with FSMA requirements. Check how you currently receive, or plan to receive, traceability data from your suppliers.

Get your 3-in-1 Traceability Logs Bundle

to help with FSMA 204 compliance

 

Engage in discussions with your customers, trading partners, and technology providers to gather insights on their FSMA 204 compliance strategies. In addition to creating an FSMA compliance statement of your own, request to see your supplier’s statement to make sure their food safety compliance goals align with your company’s.

Evaluate whether your trading partners are prepared for FSMA compliance, ensuring that all links in your supply chain are ready to meet these regulatory requirements. You can start with your approved suppliers list and based on their FSMA compliance (or lack thereof), you can decide whether you’ll need to source new ones.

This holistic approach will help you identify any gaps in your current system and facilitate a smoother transition to full FSMA 204 compliance.

5. Conduct internal gap and risk assessments

Compare your current systems to FSMA 204 requirements to uncover any discrepancies. Common gaps might include inadequate data capture capabilities or insufficient traceability measures for items on the Food Traceability List.

Review the impact of these gaps on your systems, hardware, and operational procedures.

  • Systems: Non-compliant systems may lead to inefficient tracking and reporting, potentially causing delays in identifying and addressing food safety issues.
  • Hardware: Inadequate hardware could fail to support new software requirements for data logging and real-time tracking, limiting your ability to maintain continuous oversight.
  • Operational procedures: Gaps might result in flawed procedures that do not ensure all key data elements are captured, leading to incomplete records that could jeopardize both compliance and responses to food safety incidents.

You should also assess potential risks in your traceability system, such as the vulnerabilities of a paper-based system versus the benefits of adopting food traceability software. Searching through piles of paper for specific food safety monitoring records when the FDA gives you just 24 hours to provide the recall data becomes a lot more stressful and difficult. With digital traceability logs, you can share the information with the FDA in seconds.

6. Implement the FSMA 204 compliance plan

To effectively implement your FSMA 204 compliance plan:

  • Start by identifying the Critical Tracking Events that pertain to your operations.
  • Establish a system for consistently collecting and managing Key Data Elements associated with these CTEs.
  • Standardize your Traceability Lot Code system to ensure uniformity across all products and processes.
  • Develop FSMA 204-specific Standard Operating Procedures (SOPs) to guide your team's daily activities.
  • Provide comprehensive training for your team, which could include in-person sessions, video courses, or step-by-step instructions integrated within your software applications.

7. Assign traceability tasks and start tracking

For effective traceability management, assign role-based traceability tasks using your chosen system — paper-based or digital. Here's a list of typical traceability monitoring tasks in a food business:

  • Logging incoming raw materials with batch numbers and source details.
  • Tracking processing and packaging activities with time or temperature stamps.
  • Recording storage conditions and durations.
  • Documenting shipments with destination and carrier information.

Managing these tasks with a paper system can be challenging due to the manual effort required, the potential for human error, and difficulties in quickly accessing specific data during audits or inspections.

Transitioning to a digital traceability system offers significant benefits, such as real-time data updates, improved accuracy, and easier access to traceability records, enhancing overall food safety compliance and operational efficiency.

8. Prioritize continuous improvement

Regularly monitor and review your food traceability program and FSMA 204 compliance, establishing a review cadence that aligns with your business operations.

Incorporate training sessions and mock audits as part of this ongoing process to keep your team sharp and prepared. You can use the FSMA compliance checklist and place a particular focus on the final Recall section.

Be prepared to re-assess your compliance strategies, particularly when significant operational changes occur or when new regulations are introduced, such as the FDA's updates to the Food Traceability List every five years. This approach ensures that your compliance measures evolve and improve continuously, staying effective and relevant.

January 2026 seems far away, but in the context of food safety and the change management inevitably involved in implementing a plan and system that works for your team, it will approach faster than you think.

Getting buy-in at every level of the business, sourcing new or better compliant suppliers, and making other necessary changes in your organization can take several months or even over a year.

And why wouldn't you? If you're a business that's directly impacted by FSMA Rule 204, getting compliant will help to:

  • Protect your customers from a foodborne illness outbreak
  • Reduce the risk of financial loss
  • Ensure compliance with regulations
  • Protect your business's brand reputation

FSMA 204 Food Traceability List

Look at that, those four bullet points create an apt acronym: PREP. And on that note...


How do you choose the right FSMA 204 food traceability software?

Regarding having what you need, many businesses choose to digitize their food safety system. Leveraging the right food safety software will help your team:

  • Meet and maintain compliance with the standards of your choice
  • Complete monitoring and traceability logs with less human error
  • Safely store and gain instant access to food safety records at all times

Regardless of what food traceability software you choose, make sure it's able to support the specifics outlined earlier in FSMA Section 204's key features: critical tracking events and key data elements, traceability lot codes, traceability plan, as well as additional requirements.

How FoodDocs helps you manage FSMA 204 compliance

Would you like to make traceability logging and recall management easier? FoodDocs’ software is built so you can log your traceability within seconds, saving time on repetitive activities and making the whole traceability process easy to trace in case of a recall.

  • Intuitive and simple: FoodDocs' traceability system is easy to use and applies to all traceability needs.
  • Quick and efficient logging: Create traceability logs within seconds to save time and effort on repetitive activities.
  • Easy recall management: Instantly access detailed recall information about products and ingredients to ensure quick and effective responses.

Two-in-one traceability log txt

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Using FoodDocs' smart Food Safety Management System equipped with an all-in-one effective Traceability System fulfills your production and traceability needs.

In addition to the most critical and primary features of a food safety management platform, our smart software features a Traceability System with the following benefits:

Traceability System for accurate tracking of ingredient and product movement

You can create traceability logs with just three clicks. Enter all product information, including:

  1. Product name
  2. Ingredients
  3. Batch number/ Production dates
  4. Target amount
  5. Expiry date

All essential information needed to track the movement of your ingredients and products and for recalls is conveniently presented in one custom food traceability software.

Managers can attach monitoring tasks to traceability information, such as cooling temperature or dispatch records, to further support record-keeping. They can also attach receiving temperature tasks to ingredients using the monitoring feature and, based on batch numbers, still access relevant traceability data.

Traceability_full flow

In case of a recall or inspection, you can find historical traceability logs in seconds using the advanced search filter. This will give you instant access to information based on entry date, expiry date, product batch, and ingredient batch data. And if you want to further analyze specific batches of food information, simply download the data as a CSV or XSLS file.

Traceability-2

While food safety teams can log traceability information on desktop, logs are much easier to complete with the FoodDocs mobile app — available on both Apple iOS and Android.

BOOK A DEMO  

Digital recipe book for organizing all recipes and instructions

Ensure that all of your recipes are organized in cloud storage with the help of our Digital Recipe Book. With this feature, you can log all recipe information, including the following, to our system:

  1. Recipe name
  2. Ingredient amounts
  3. Preparation steps
  4. Allergen information
  5. Shelf-life information
  6. Image of the final product

Digital_recipe_book

The information logged into our Digital Recipe Book is also used to automatically calculate how much food you're preparing and the expiration dates of products.

Use this smart solution to ensure food handlers have access to proper food preparation and reference for the correct business processes.

Track shelf-life automatically based on information provided in recipes

Once you log individual product or ingredient shelf-life information in our Digital Recipe Book, you can receive intuitive alerts about shelf-life reminders.

With this feature, you can access accurate data for labels and ensure that all food ingredients and products are optimized before spoilage to reduce food waste.

FoodDocs mobile app preview of the shelf-life date tracker to improve food traceability.

With the help of our comprehensive food traceability software system, you can be confident that all ingredient and product information is well-organized and can be accessed easily in case of future recall events or inspections.

Whether you're holding, manufacturing, processing or packing items on the Food Traceability List, you can gain a competitive advantage by using food traceability software. Give FoodDocs' a try with a 14-day free trial and take your next step toward FSMA 204 compliance.

Food Traceability FoodDocs

Frequently asked questions about FSMA 204, the food traceability rule

What are the recent developments of FSMA 204?

A group of U.S. politicians recently introduced legislation called the Food Traceability Enhancement Act. It proposes implementation changes which aim to “strengthen compliance” with the Food Traceability Final Rule.

If the bill ends up passing, it would lessen the TLC and record-keeping requirements for restaurants, food retailers, and warehouse facilities. Specifically, these types of businesses would no longer be required to maintain TLC data nor send the data to supply chain partners or to the Secretary of the U.S. Department of Health and Human Services (the Secretary).

Another change, in particular, includes delaying the compliance date to at least two years after the completion of the pilot projects, of which the bill proposes nine or more that the Secretary would have to conduct.

The proposed pilot projects would seek to gauge the effectiveness of foodborne illness investigations without available traceability lot code data, as well as evaluate low-cost food traceability technologies.

For more information about the Food Traceability Enhancement Act, here's the official proposed bill.

What are the 4 key features of the Food Traceability Final Rule?

The FDA outlines four key features of FSMA 204:

1. Critical tracking events and key data elements

CTEs and KDEs help to form the foundation for more safe and holistic food traceability throughout the entire supply chain.

In the context of the FDA's Food Traceability List (which we include in full below), Critical Tracking Events are important aspects of a food item's journey that help to decrease likelihood of contamination and reduce risk of foodborne diseases.

Critical tracking events include:

  • Harvesting
  • Cooling (before Initial Packing)
  • Initial Packing (raw agricultural commodities aka RACs)
  • First Land-Based Receiver
  • Shipping
  • Receiving
  • Transformation

Key Data Elements are different pieces of data that are determined by the specific CTEs which businesses have to keep track of.

Different key data elements are required for each critical tracking event. But some common KDEs include:

  • Location description of the food for where it was, e.g., harvested, cooled, packed, shipped, etc. (other than a transporter)
  • Commodity (and variety of food, if relevant)
  • Food quantity and unit of measurement
  • Location description for the location from which you shipped the food
  • Traceability lot code you assigned or traceability lot code source
  • Date of harvesting/cooling/initial packing/landing/shipping/receiving/transformation completion
  • Reference document type and number

For exact details and wording of what key data elements are needed for each critical tracking event, reference the FDA USDA's CTE and KDE document. (Yes, that was a lot of acronyms...)

Historically, the FDA has defined "traceability" as the point at which you receive raw materials to the time you process and ship a food product. But in light of continued recalls and a need for faster identification when it comes to the source of contamination, the FDA's addition to the FSMA makes it clear that the traditional one-step-forward, one-step-backward record-keeping rule is insufficient for accomplishing true food traceability.

That's why, in order to go more than one step forward or backward, the FDA is placing greater emphasis on stricter documentation and record-keeping of those critical tracking events.

2. Traceability Lot Codes (TLCs)

To increase supply chain transparency, a TLC, usually alphanumeric, is a unique identifier assigned to items on the food traceability list. You must assign a TLC to a food on the Food Traceability List (FTL) when you:

  • Initially pack a RAC (excluding foods obtained from fishing vessels)
  • Perform the first land-based receiving of food obtained from a fishing vessel
  • Transform a food

FSMA 204 Traceability

3. Traceability plan details

As a business that's subject to FSMA 204 requirements, your traceability plan must include details covering:

  • Procedures for maintaining traceability records (including format and location)
  • Procedures for identifying FTL items that you hold, manufacture, process, or pack
  • Procedures for assigning traceability lot codes to those FTL items
  • Information outlining your point of contact for company traceability-related questions
  • Maps that detail where you grow or raise food, e.g., the name and location of each field or container (if you're a farm that doesn't produce eggs)

4. Additional FSMA 204 requirements

FSMA 204 also requires that businesses must:

  • Maintain their chain of traceability records on paper or digitally, so long as records are legible
  • Make those records available to the FDA within 24 hours of a request (or within a reasonable time agreed upon with the FDA)
  • Provide the FDA with an electronic sortable spreadsheet containing relevant traceability information within the same timeframe to assist the FDA during an outbreak, recall, or other public health threat (unless exempt)

How does GS1 impact FSMA 204 compliance?

GS1 plays a crucial role in FSMA 204 compliance by offering standardized tools and guidelines that align with the FSMA 204 Final Rule's requirements. Here's an in-depth look at how GS1 aids in compliance:

  1. Formation of the GS1 US FSMA 204 workgroup: GS1 US created a team of industry experts dedicated to formulating guidelines for applying GS1 Standards to fulfill FSMA 204 requirements. This joint initiative highlights the importance of collaboration in improving traceability and compliance.

  2. Guidance document: The GS1 US Application of the GS1 System of Standards to Support FSMA 204 is an essential resource. It details best practices for implementing GS1 Standards to improve the scalability, precision, and interoperability of traceability programs, thereby directly supporting FSMA 204 compliance.

  3. Mapping of standards to FSMA 204 requirements: GS1 US has effectively demonstrated how its standards align with the Key Data Elements (KDEs) and Critical Tracking Events (CTEs) mandated by FSMA 204. This involves utilizing Global Location Numbers (GLN), the Global Data Synchronization Network (GDSN), the Global Data Model (GDM), Electronic Data Interchange (EDI) with Advanced Ship Notice (ASN), and Electronic Product Code Information Services (EPCIS). Each of these elements is crucial for supplying the necessary data and support to monitor a product’s lifecycle within the supply chain.

  4. Support for emerging technologies: GS1 Standards promote the creation and adoption of advanced traceability systems by improving data sharing efficiency and minimizing data entry errors across various platforms. For instance, EPCIS enhances the detailing of CTEs from harvest to sale, ensuring a unified and precise account of supply chain events.

  5. Continued collaboration with the FDA: GS1 US maintains a close partnership with the FDA to guarantee that communication and educational materials about GS1 Standards are accessible and understandable, which is essential for achieving industry-wide compliance with FSMA 204.

What is the FSMA 204 not?

In an effort to improve food supply chain visibility and transparency, FSMA 204 mandates the what, i.e., improved record-keeping and reporting of traceability lot codes. But what FSMA 204 does not do is mandate the how. Specifically, it doesn't require food businesses to fulfill these new requirements in a particular way (i.e., paper records vs electronic records).

However, given that the FDA requires you to submit traceability data with 24 hours (unless you establish another agreed upon timeline), paper records could pose more challenges that prevent you from doing it in time, such as:

  • Damaged records due to tears, creases, or stains
  • Misplaced records due to loose or disorganized filing
  • Illegible or incorrect traceability logs due to human error

Frank Yiannis, former FDA Deputy Commissioner, also notes monitoring records that the Traceability Rule doesn't require, including:

  • Certified compliances
  • Climate data
  • Collateralized debt obligations
  • Costing data
  • Inventory utilization (e.g., warehouse optimization, storage scheduling)
  • Positional data (i.e., geographic coordinates)

What are the recent FSMA 204 developments?

As of May 2024, a group of U.S. politicians recently introduced legislation called the Food Traceability Enhancement Act. It proposes implementation changes which aim to “strengthen compliance” with the Food Traceability Final Rule.

If the bill ends up passing, it would lessen the TLC and record-keeping requirements for restaurants, food retailers, and warehouse facilities. Specifically, these types of businesses would no longer be required to maintain TLC data nor send the data to supply chain partners or to the Secretary of the U.S. Department of Health and Human Services (the Secretary).

Another change, in particular, includes delaying the compliance date to at least two years after the completion of the pilot projects, of which the bill proposes nine or more that the Secretary would have to conduct.

The proposed pilot projects would seek to gauge the effectiveness of foodborne illness investigations without available traceability lot code data, as well as evaluate low-cost food traceability technologies.

For more information about the Food Traceability Enhancement Act, here's the official proposed bill.

How do food safety workers feel about FSMA 204?

The sentiment among food safety workers isn't the most positive. There are many people who are unsure of how to properly move forward, and not for lack of trying. The IFSQN forum saw a recent topic titled "Is anyone else struggling with the FSMA204 Final Rule regulations?"

People who responded shared legitimate concerns, such as:

  • "We are struggling with our GDST (Global Dialogue on Seafood Traceability) and syncing it to our current ERP and feels like we're doing it blind."
  • "I also forecast we'll have some struggles with our smaller farms and packing houses to sort through whatever hodgepodge they come up with for sending the KDEs to us."
  • "I really struggle to figure out how to get out of the weeds and have some traction to this data while higher-ups are demanding implementation plans and presentations... we are just not there yet."

This is not a one-dimensional issue. It involves management, the state of food safety technology, those who are writing and enforcing FSMA 204, and more.

These concerns are exactly why, if at this moment, regardless of whether or not the FSMA 204 compliance date gets delayed, you know that you're food traceability plan is non-existent or not where it needs to be, our message is this: do not wait.

In the Episode 97 of Don't Eat Poop! A Food Safety Podcast, hosts Matt and Francine discussed the challenges of the FSMA 204 rollout with Andrew Kennedy.

Kennedy used to work in the FDA and was one of the key people involved in writing the FDA's Traceability Rule. In comparing the traceability rule to GFSI's initial introduction, he said:

No one complains about it anymore because at first when GFSI was rolled out, it was a big deal and people complained and it was hard, but now it's just how people do business... 

So I think that's where traceability will be in five, six years, where it will just be how people ship product. And if you don't do traceability, you'll be an outlier.

So I think the transition happens quickly. There's like a tipping point where you go from no one does traceability to everyone does traceability. And then if you want access to markets, you have to do it.

What are 3 important questions you need to ask if you want to meet FSMA 204 compliance on time?

  1. Do we understand how FSMA 204 applies to our food business? Determine whether or not you're a packer, processor, holder, or manufacturer of anything on the Food Traceability List. Get crystal clear on the critical tracking events and accompanying key data elements you need to track and keep records of on an ongoing basis.
  2. Do we know how we're going to meet FSMA 204 traceability requirements? Align on your business's method of record-keeping (i.e., will you be keeping paper or digital food safety records?). Check if your traceability plan currently covers what's required by the updated law, or if your business needs to adjust its processes and tools to, for example, provide the FDA with traceability records within 24 hours.
  3. Do we have what we need in order to successfully be FSMA 204 compliant? Based on your answers to questions one and two, examine where gaps or questions still exist. You might determine that you need an FSMA 204 consultant, or that your existing paper-based records pose too high a risk to your compliance.

 

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