FSMA 204: Initial Packing CTE’s and KDE’s

The FDA Final Rule on FSMA Section 204 published in November 2022 adds the requirement to capture and record Critical Tracking Events or CTE’s. The FDA defines a “Critical Tracking Event” to mean an event in the food supply chain involving the harvesting, pre-packing cooling, and initial packing of a Raw Agricultural Commodity (RAC), which applies to any food, “…not obtained from a fishing vessel, shipping, receiving, or transformation of the food.”

In prior blogs we looked at the overall CTE requirements and explored harvesting and cooling CTE’s. Today we will deep dive into Initial Packing and the associated Key Data Elements (KDE’s) for that event.

For produce, as the event name implies, “Initial Packing” means the first packing of a RAC.

Under the final rule, lot-based recording keeping is not required at harvest or any other point before initial packing. While this information is not required, most growers have already assigned some form of unique lot identifier that tracks the seeds, processes and application of nutrients or pesticides associated with growing the commodity in the given lot. It is likely wise to store this data for later use.

The Initial Packing of a Raw Agricultural Commodity (RAC), is where the FDA states the lot traceability code gets assigned. Most produce companies will not need to alter their current lot traceability assignment process. However, they will need to add this data to the initial packing event and pass it through for use in subsequent Critical Tracking Events. It needs to follow the product through the supply chain.

Under section 1.1330 of the final rule the initial packer must maintain records including:

·         The commodity and variety (if applicable) of the received RAC
·         The date the RAC was received
·         The unit of measure and the quantity of the RAC received
·         The farm and location description or reference identifier from where the commodity was harvested
·         The field or growing area name
·         The business name and phone number of the company that harvested the product, regardless of ownership
·         The date of harvest
·         The pre-packing cooling location
·         The date the product was cooled
·         The traceability lot code assigned
·         The description of the packed food
·         The quantity and unit of measure of the packed food
·         The description of the packing location
·         The initial packing date
·         The reference document type and number

If you are packing sprouts, except for soil or substrate sprouts harvested with roots, there are additional required records:

·         The location description for the grower of seeds for sprouting and date of seed harvesting, if available

·         The description of the location for the seed conditioner or processor, the associated seed lot code and date of conditioning or processing
·         The description of the location of the seed packing, and repacking, the date of packing and repacking, if applicable, and any associated seed lot code assigned by the seed packing house
·         The description of the location of the seed supplier and any seed lot code assigned by the sprouter
·         A description of the seeds, including the taxonomic name, growing specifications, type of packing and any antimicrobial treatments applied to the seeds
·         The date and of receipt of the seeds by the spouter and the reference document type and number

The FDA clarified that if there is a transformation of a RAC prior to its initial packing, for example cutting whole apples into slices before packing, the entity that slices the apples is required to create and keep the Initial Packing records KDE’s instead of the Transformation CTE KDE’s.

The data associated with FSMA 204’s critical tracking events are what enables traceability and therefore the improvement in food safety we all desire. The number of data points is not huge compared to some other industries, but enabling their acquisition and reporting is challenging, mostly since it is a new requirement. It also may require a significant investment in both hardware and software. Nevertheless, understanding the data requirements is crucial and easiest when tackled one bite at a time.

FSMA 204: Critical Tracking Events (CTE’s) and Key Data Elements (KDE’s) for Harvesting and Cooling

When the FDA released the Final Rule on FSMA Section 204 in November one of the biggest changes was the addition of the requirement to capture and record Critical Tracking Events or CTE’s. The FDA defines a CTE as 

    “Critical Tracking Event to mean an event in the supply chain of a food involving the
    harvesting, cooling (before initial packing), initial packing of a RAC other than a food obtained
    from a fishing vessel, … shipping, receiving, or transformation of the food.”

Each of these were defined in further detail in our previous blog post. Here we will explore the Key Data Elements (KDE’s) associated with each of the Critical Tracking Events.

Harvesting and Cooling KDE’s

If you grow  food on the FDA's Food Traceability List (FTL) you must maintain records that link the items harvested to the geo coordinates of where that food came from. In produce, this is being referred to as the field map. While the grower must maintain this information, the packer of products on the FTL list is required to maintain a refence to the harvest location field map and link that to packed products traceability lot code. This traceability lot code is commonly referred to as the pack lot. The reference to the harvest location can be a web link to the farm map, or other references such as the grower’s name and block ID that uniquely identifies where the product came from.

The packer must also keep records of the harvesting and cooling of the product on the FTL, as these records need to be available in case of a foodborne illness outbreak investigation. Specific record keeping requirements by entity include:

The Harvester:

· The name of the field, including geo coordinates from where the product was harvested

· The commodity

· The variety (if applicable)

· The quantity and unit of measure

· The date of harvest

· Reference document type and number (such as the harvest order number)

· The business name and phone number

The Cooler:

· The location where product was cooled

· The commodity

· The variety (if applicable)

· The quantity and unit of measure

· The date of cooling

· The location description from the farm that harvested the product

· Reference document type and number (such as the harvest order number)

· The business name and phone number

The Harvester does not need to provide the Farm Map directly to the Packer, if they provide a reference document or web link that does have the actual farm map and geo coordinates.

Demystifying FSMA Section 204: What FSMA means for you.

On Nov. 15 the FDA released the Final Rule on FSMA Section 204, which contains the long-awaited regulations on record keeping for products on the Food Traceability List.

For those already doing case traceability (PTI), you are half-way there. The new additional information requirements include the introduction of Critical Tracking Events and corresponding Key Data Elements, and the need for a written Traceability Plan. The high-level summary is below with details available on the FDA website under FSMA.

Critical Tracking Events for produce include the following:

• Harvesting: “…activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities from the place they are grown or raised and preparing them for use as food.”
• Receiving: “…an event in a food’s supply chain in which a food is received by someone other than a consumer after being transported (e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.
• Cooling:  ”…active temperature reduction of a raw agricultural commodity using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.”
• Initial Packing: ”…packing a raw agricultural commodity, other than a food obtained from a fishing vessel, for the first time.
• Transformation:”… an event in a food’s supply chain that involves manufacturing/processing or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List. Transformation does not include the initial packing of a food or activities preceding that event
• Shipping: “an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.”

The Key Data Elements have some specifics by CTE, but the common elements include: the location of activity, the commodity and variety if applicable, date, reference document. At the Initial Packing, Traceability Lot Code and the product description must be included.

A written Traceability Plan is required for all items on the FTL must include a description of the procedures you use to maintain the required records, including the format and the location of the records. This plan must include the following:

• A description of the procedures you use to identify foods on the FTL that you manufacture, process, pack or hold.
• A description of how you assign traceability lot codes to foods on the FTL, if applicable.
• A statement identifying a point of contact for questions regarding your traceability plan and records.
• If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods. The farm map must show the location and name of each field in which you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area. This information only need to be provided to the initial packer, and can be a web link if applicable.
• You have to update your traceability plan as needed to ensure that the information reflects your current practices and to ensure compliance with the rule.
• You must retain your previous traceability plan for two years after you update the plan.

Realizing some retailers, distributors and grower-shippers have not implemented case traceability and even those who have will need to add capabilities to capture and report for these requirements. The FDA will start enforcing these new mandates in January 2026.

RedLine Solutions Wins Ivanti Innovation Award 2020

 Author: Todd Baggett - CEO of RedLine Solutions

We are honored to have received the Innovation Award for Ivanti’s 2020 Supply Chain Partner of the Year. Over the past 24 years we have helped hundreds of companies acquire, implement, and manage thousands of mobile devices in the supply chain. The Wavelink products and our partnership with Ivanti have enabled us to bring value through both software and professional service that really impact our manufacturing, distribution, and logistics customers.

RedLine Solutions CEO Todd Baggett

We use Ivanti to modernize our client’s telnet applications, provide a secure browsing environment and restrict access to specific approved applications, and manage devices across work groups and geography. We even embed some of Ivanti’s products into our own Supply Chain Applications to allow rendering on multiple device sizes and screen configurations while simplifying our development efforts.

Joe Wilson, Vice President of Global Sales, Ivanti Supply Chain stated that recipients are "experts in mission-critical device management, wireless infrastructure management, terminal emulation, voice enabling, or mobile application development." Read more in their blog here.

© RedLine Solutions Inc. 2021. Unauthorized use and/or duplication of this material without express and written permission from this site’s owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to RedLine Solutions and there is the inclusion of a link to www.traceabilitynerd.com. All rights reserved. RedLine Solutions name and logo, referred to in this document, are trademarks of RedLine Solutions Inc.

Improving Traceability in the New Era of Food Safety

In July, the FDA announced the New Era of  Smarter Food Safety, a new approach to food safety that leverages “technology and other tools to create a safer and more digital, traceable food system.” The FDA focus is on four elements for reducing foodborne illness: tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization and food safety culture.”

According to the FDA, when it comes to food traceability, “many in the food system still utilize a largely paper-based system of taking one step forward to identify where the food has gone and one step back to identify the source. The use of new and evolving digital technologies envisioned in the New Era of Smarter Food Safety will play a pivotal role in tracing the origin of a contaminated food to its source in minutes, or even seconds, instead of days or weeks.”

And, of course, the COVID-19 pandemic has accelerated interest in digital technologies, including those that will improve food traceability.

Meeting Traceability Challenges

Food traceability isn’t just an industry concern. As Zebra’s recent Food Safety Supply Chain Vision Study found, both consumers and industry decision makers are concerned about the source, quality and safety of their food. Nearly 70% of decision makers say the industry is well equipped to manage food traceability and transparency, but only 35% of consumers agree. 

Recent product recalls and food safety incidents, new FDA food safety goals, the Produce Traceability Initiative (PTI), an industry-led program designed to help the industry adopt electronic traceability across the supply chain—as well as new food safety threats posed by the COVID-19 pandemic—are among many factors driving the need for new and improved traceability solutions.

The Zebra study found that nearly all (90%) of industry decision makers acknowledge that investments in traceability-focused solutions will provide them with a competitive advantage, by enabling them to meet consumer expectations.

Food Safety Scanning Solutions

Most (90%) of the industry decision maker respondents to the Zebra study say they expect to use rugged barcode scanners and other mobile technology within the next five years to digitally manage and track food products and related information.

Zebra’s ultra-rugged handheld scanners can help food manufacturers and warehousing operations achieve food traceability goals by creating a complete record of every product as it moves through each step in the facility. The Zebra 3600 line of ultra-rugged scanners, for example, is a new class of handheld scanner built to deliver the unstoppable performance required by today’s demanding environments.

Integrated with RedLine’s produce software, Zebra scanners can help you achieve fast and accurate barcode capture and meet end-to-end product traceability requirements. Redline Solutions’ industry-leading management, inventory and traceability solution provides a practical inventory control tool for produce growers, shippers and distributors. Our software suite enables fast, accurate, electronic collection of all product movements and transactions—updating our current system with real-time data, while providing your staff with actionable information that enables them to be more accurate, productive and efficient.

If you are a grower, shipper or distributor of fresh produce, our software will enable you to easily manage your fresh produce inventory and orders, from receipt through shipment, including the management of bins, cases and pallets, pack lines, label printing, order management, shipment processing and more.

With Zebra handheld scanners and Redline produce software, we can help you improve staff productivity in your facility and the web UI can be securely accessed by you from anywhere.

End-to-end traceability starts here. Find out how Zebra’s series of ultra-rugged handheld scanners—integrated with RedLine’s industry-leading management, inventory and traceability solution—can help you achieve unparalleled, end-to-end visibility and unheralded productivity. 

© RedLine Solutions Inc. 2020. Unauthorized use and/or duplication of this material without express and written permission from this site’s owner is strictly prohibited. This blog was written and provided to RedLine Solutions by Zebra Technologies and any excerpts and links may be used, provided that full and clear credit is given to RedLine Solutions, Zebra Technologies and there is the inclusion of a link to www.traceabilitynerd.com. All rights reserved. RedLine Solutions name and logo, referred to in this document, are trademarks of RedLine Solutions Inc.

Why the Move to Cloud Services is a Smart One!

Moving to the Cloud is a Smart Move for Many Reasons

America’s mainstream business move to the Cloud has been growing steadily over the past four years, and with good reason. Early on there was a lot of fear surrounding the security of having your company information in the cloud, yet today’s reality is that cloud service providers have the expertise to ensure that not only your data is safe, that it backed-up and can be securely accessed from any locations. You can also operate with hybrid models (cloud and on-premise) are often used which can give you the best of both worlds.

The cloud is no longer just about that hard disk in the sky. In fact, many of the high value cloud services are less about storage and more about computing, communicating, and securing your business data.

From a computing standpoint some interesting stats bear this out:

• 83% of enterprise workloads will be in the cloud by the end of 2020
• 94% of enterprises already use a cloud service
• 30% of all IT budgets are allocated to cloud computing

Taking a Fresh look At Cloud Services

In-house computing can be expensive and small to mid-size businesses may be dependent on one or two individuals, without whom your business would grind to a halt. Furthermore, the team you have is often spread thin between implementing that new system, supporting for your users, and maintaining your infrastructure. One problem can have a cascading effect of delaying multiple projects, adding expense, and leading to employee burnout.

Buying an in-house phone system is already a thing of the past. Cloud-based telecom is the wave of the present and not going away any time soon. Employee desk phones are antiquated, with the rise of mobility, now the phone number follows the employee whether they are at their desk, in the facility or off-site. Products like Microsoft Teams integrate online meeting software and collaboration with people within your organization as well as partners, contractors, and customers as co-collaborators in a secure environment.

If you have fifty phone lines or more, either desk phones or mobile, there is a good chance you could cut your monthly bill by 25-30%. In fact, some of the companies we represent will perform an audit for free and take their payment as a percentage of the savings they identify for you.

Do you know someone in a company hacked by ransomware? Unknown assailants have infiltrated your organization via an unsecured public IP address or a Phishing email and now have your data encrypted, you’re locked out, and for a few hundred thousand dollars of Bit Coins they will maybe release it back to you. Cloud services can protect you from these scenarios, giving you access to military-grade software defense systems to not only protect you, but identify the vulnerable areas in your organization and address challenges before they occur.

The Cloud is here to stay, and you don’t have to get into an airplane to find it. RedLine Solutions has launched RedLine Cloud Solutions, a new group of cloud-savvy professionals representing the most successful cloud service providers in the industry.

We work with you to understand your business needs and introduce you to our cloud partners that specialize in these services. You work directly with the provider on the pricing, the support, and the implementation and we work with them to make sure you’re happy. The best news is that there are no up-front costs. These cloud services are offered as a monthly, ‘As-A-Service’ subscription fee. Contact your RedLine sales representative or sales@redlinecloudservices.com today for a free 30-minute consultation.

Author: Todd Baggett - CEO of RedLine Solutions

© RedLine Solutions Inc. 2020. Unauthorized use and/or duplication of this material without express and written permission from this site’s owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to RedLine Solutions and there is the inclusion of a link to www.traceabilitynerd.com. All rights reserved. RedLine Solutions name and logo, referred to in this document, are trademarks of RedLine Solutions Inc.

Caring Resources for Challenging Times

The Covid-19 virus pandemic has changed our lives in numerous ways.  Anyone following the daily news has been inundated with constant updates on the problems. So much so, I am limiting the amount of news I watch. Instead I’m turning my thoughts to solutions. I do this by spending time to stimulate my body with exercise, trying to eat in healthy ways, and turning my attention to counter-balancing all the negativity. I am also feeding my mind with daily positive content, uplifting messages, and things like music that bring me joy.

This has been helpful in keeping me focused on the fact that we are in a temporary situation- but nonetheless we all feel pressures. As I thought about the various needs of our families, co-workers, and community an idea came to me; by putting together a web page that aggregated resources we could serve our community. I assembled a team of employees and requested resources from them and my friends and family. We set our intention and shifted our focus from business to building a web page that would serve a higher purpose. The content includes links for supplemental resources for homeschooling, making face masks, online meeting resources, and various mental health links. We also included some religious, spiritual, art and inspirational resources.

Caring about people is part of who I am, it is an important part of the culture at RedLine Solutions. Today I am pleased to announce the launch of our Caring Resources web page.

I am clear that this page is not all encompassing, may not adequately represent our diversity, and is light in content. I am also clear that its purpose is to provide valuable resources on a variety of topics many of us can use now.  Perhaps more importantly, it might inspire you to search for resources to answer the questions you may be facing. I am partial to classic rock music and found many of the links here. If you love country, R&B, classical or other, I hope you will look for the music you enjoy. Our Care Team’s job is not over, in fact we are just getting started. If you have resources in any of these topic areas or would like to comment or make a suggestion, please email the topic and links to icare@redlinesolutions.com. We will be meeting weekly to review suggestions and screen content to ensure it follows our purpose, then prioritize for our web developer to add items to the page.

As we go through this difficult time we can focus on the challenges and disappointments of today or focus on using the resources available to us and do our best to focus on a better tomorrow.

Together we will get through this pandemic and hopefully come out on the other side with more empathy, kindness, and appreciation for all we have taken for granted.

We hope you find our Caring Resources page to be helpful and look forward to your comments and suggestions.

Wishing you health and happiness,

Todd Baggett

About the author Todd Baggett:

Todd is the President and CEO of RedLine Solutions; a company that provides produce  traceability and inventory solutions. He is the author of “Produce Traceability for Dummies”, and has served as the Co-Chair of the PTI Technical Working Group since 2011.

© RedLine Solutions Inc. 2020. Unauthorized use and/or duplication of this material without express and written permission from this site’s owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to RedLine Solutions and there is the inclusion of a link to www.traceabilitynerd.com. All rights reserved. RedLine Solutions name and logo, referred to in this document, are trademarks of RedLine Solutions Inc.