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Traceability in the Food Supply Chain

Traceability has always been an important part of the food supply chain. It helps ensure food safety, speeds recalls and investigations, and makes the food supply chain faster and more efficient. In recent years, however, there has been a stronger push for traceability from regulators and consumers alike.

Regulators, notably the U.S. Food and Drug Administration, have developed new traceability requirements for food products, including rules governing specific types of food (i.e., those that are more prone to contamination), guidance for stakeholders to collect more data at every node of the food supply chain, and modern, digital systems to optimize safety and efficiency and aid recall management.

Similarly, consumers are demanding more information about the foods they eat. They want a demonstrable provenance of what they’re taking home to their families, “on-demand data” that demonstrates that foods are exactly what companies say they are. And if they don’t get this, they’re only too happy to take their business somewhere else — and let other people know that Brand XYZ isn’t living up their expectations of quality and transparency.

Every stakeholder in the food supply chain, from manufacturers and processors to distributors and retailers, has to think about traceability. If they don’t, they’re risking problems with regulators, alienating consumers, damaging their brand reputations, and, ultimately, putting their business in jeopardy.

This rfxcel white paper covers the fundamentals of traceability in the food supply chain. It describes how critical tracking events (CTEs) and key data elements (KDEs) build “digital assets” that can be traced (and tracked) from farm to fork. It takes an in-depth look at the FDA’s initiatives to modernize the U.S. food supply chain using digital technology, including the Food Safety Modernization Act (FSMA), the “New Era of Smarter Food Safety,” the “Food Traceability List,” and the pending “Requirements for Additional Traceability Records for Certain Foods,” also known as the Proposed Rule. It also describes the many benefits of food traceability, which include better consumer engagement and brand protection.

 

Food Traceability Data: Not Just for Compliance Anymore

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.

Food Traceability Regulations in the United States: A Timeline

The U.S. Food and Drug Administration (FDA) is orchestrating the construction of a more robust, technology-driven approach to food traceability and safety. And it’s happening as the food industry is undergoing major change, including scores of new foods being introduced to the market, rising consumer demand for more information about the food they buy, the development of more sophisticated production and delivery methods, and a growing push for digitization of the supply chain.

As regulations in the United States continue to evolve, manufacturers, wholesalers, distributors, and retailers need to keep a finger on the pulse of the latest developments. Today, we’ll help with a quick rundown of what’s happened with food traceability over the last year.

Food traceability regulations in the United States: 2020-present

On September 23, 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods” on its Food Traceability List. Referred to as the “Food Traceability Proposed Rule,” it’s part of the FDA’s New Era of Smarter Food Safety Blueprint and aims to standardize the data elements and information required to rapidly and accurately identify foods that may be causing illness. It defines additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List, which must establish and maintain records containing key data elements (KDEs) associated with specific critical tracking events (CTEs).

In January 2021, the FDA made clarifying modifications to the Food Traceability List and published a detailed FAQ that answered commonly asked questions that emerged following the announcement of the Proposed Rule. In February 2021, the comments period for the modifications closed. The FDA has until November 2022 to finalize it.

More about the New Era of Smarter Food Safety Blueprint

These initiatives are part of the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it envisions a modern approach to ensuring food safety through digital, tech-enabled traceability.

The New Era of Smarter Food Safety Blueprint, announced in July 2020, outlines the FDA’s methodology for achieving its traceability and safety goals. It’s based on the following four pillars, which leverage a range of technologies, analytics, business models, modernization, and values as its building blocks:

1. Tech-enabled food traceability

A supply chain that includes paper-based recordkeeping and yields insufficient data makes it difficult to track and trace foods rapidly. Fast, accurate food traceability is essential to safeguarding consumers’ health — and your brand reputation and bottom line.

For example, modernized food traceability that leverages the latest technologies and integrates expanding data streams empowers supply chain stakeholders to identify an outbreak and trace a contaminated food product’s origin within minutes — or even seconds — and be proactive about getting the product off of shelves.

2. Smarter tools and approaches for prevention and outbreak response

In addition to better food traceability, the FDA wants to ensure the root cause of an outbreak or contamination can be easily identified to support a prevention-based approach. To do this, stakeholders need to incorporate new knowledge while continuously assessing how they can make processes and communications more effective and efficient. As more data becomes available, the use of predictive analytics tools becomes increasingly important to predict when a significant food event may occur. With this information, manufacturers can prevent a contaminated food products from entering the supply chain or target efforts to remove a potentially contaminated product from the market.

3. New business models and retail modernization

As the industry continues to find new ways to produce and distribute food, the FDA is seeking to explore new approaches in ensuring food traceability and safety. This includes:

  • Educating supply chain actors on the importance of food safety issues
  • Adapting FDA oversight to ensure the safety of novel ingredients, new foods, and new food production methods
  • Advancing the safety of foods sold in traditional retail establishments
4. Food safety culture

The FDA wants to encourage an environment of support for a stronger food safety culture on farms, in food facilities, and in homes. If the food industry does not commit to embracing food traceability and safety, real improvements will be difficult to achieve.

Final thoughts

We can be certain of two things when it comes to food traceability regulations in the United States: they’re going to keep evolving and they’re not going away. The good news is advancements in technology are making it profoundly easier — and even more affordable — to ensure food traceability across the entire supply chain. Yes, the FDA’s proposed requirements technically apply only to items on the Food Traceability List, but the Agency is encouraging voluntary adoption of these practices industry-wide. Savvy food companies will see this as an opportunity to get involved early and be part of the process, helping to set the industry’s regulatory course while going a long way to secure their own business.

rfxcel can help you comply with U.S. food traceability regulations today, tomorrow — always. From raw ingredients to finished goods, our rfxcel Traceability System (rTS) offers end-to-end food supply chain traceability and visibility. Our rfxcel Integrated Monitoring (rIM) is a real-time traceability and supply chain visibility solution that helps you remotely monitor products in transit And our MobileTraceability app brings the power of rTS to every node of your operations, including places that have traditionally been “blind spots.” Contact us today to arrange a demo.

DSCSA 2023: Understanding DSCSA Authorized Trading Partners, Part 2

Welcome to Part 2 of our discussion about DSCSA authorized trading partners. The 10-year rollout of the U.S. Drug Supply Chain Security Act — the DSCSA — is scheduled to conclude on November 27, 2023, so now’s a good time to take stock of where we are and what to expect over the coming months.

As we said in Part 1, everybody’s talking about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers. From now until November 2023, it’s really all about ensuring these supply chain actors are ready to comply with the regulations.

Remember, under the DSCSA, authorized trading partners may engage in transactions only with other authorized trading partners. In other words, if you’re not a DSCSA authorized trading partner, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

Below, we finish our discussion of DSCSA authorized trading partners by defining who qualifies as a repackager, a 3PL, and a dispenser.

Repackagers

Repackagers own or operate an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.

Generally, dispensers (specifically pharmacies) are not considered repackagers. By this definition, a dispenser/pharmacy only packs and labels a product for dispensation to a person who has a valid prescription for that product; they do not do “bulk” repackaging.

Repackagers are considered trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, another repackager, a wholesale distributor, or a dispenser. To be a DSCSA authorized trading partner, repackagers, like manufacturers, must be registered with the U.S. Food and Drug Administration (FDA) in accordance with Section 510 of the Food, Drug, and Cosmetics Act (FD&C Act), “§360. Registration of producers of drugs or devices.”

3PLs

The DSCSA defines a 3PL as an “entity that provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”

3PLs are considered trading partners if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. Returns processors and reverse logistics providers are considered 3PLs. There are two reasons for this:

  1. They provide other logistics services for other trading partners in a facility they own, rent, or lease.
  2. They do not take ownership of the product and do not direct the sale or disposition of the product.

Generally, brokers, solution providers, common carriers, and logistics or administrative services contractors are not considered 3PLs because they don’t provide or coordinate warehousing and don’t accept or transfer direct possession of the product. These stakeholders do not have to be licensed.

To be a DSCSA authorized trading partner, 3PLs must have a valid license under state law or FD&C Act Section 584(a)(1), “National Standards for Third-Party Logistics Providers,” in accordance with Section 582(a)(7), “Requirements, Third-party logistics provider licenses”, as amended by the DSCSA and in compliance with reporting requirements under Section 584(b).

Dispensers

To be considered a dispenser, you must meet one of three criteria:

  1. You’re a retail pharmacy, a hospital pharmacy, or a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor.
  2. You’re a person legally authorized to dispense or administer prescription drugs.
  3. You’re an affiliated warehouse or distribution center of a dispenser under common ownership and control that does not act as a wholesale distributor.

A dispenser is considered a trading partner if they accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or another dispenser. To be a DSCSA authorized trading partner, a dispenser must have a valid state license.

Generally, veterinarians are not considered dispensers, per FD&C Act Section 512(a)(5).

Final thoughts

The table below summarizes everything we’ve laid out above and in Part 1 of our DSCSA authorized trading partners series. It’s adapted from an August 2017 FDA publication.

As you’re reading, remember that all of our stakeholders are considered to be trading partners if they accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be an DSCSA authorized trading partner, however, they must meet the criteria explained in the table.

There’s one last installment of our “DSCSA 2023” series coming soon. In it, we’ll talk about the key requirements for 2023 and the future of traceability in the pharma supply chain. While you’re waiting for that, take a moment to check out our webinars, white papers, pharmaceutical compliance solutions, and other resources about the DSCSA. If you feel inspired, contact us to schedule a demo to see our solutions in action.

DSCSA Authorized Trading Partners

DSCSA Authorized Trading Partners

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

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

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

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

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

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

Meat traceability is more essential than ever

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

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

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

Final thoughts

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

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

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

Modernizing Food Recall Management

“Recall” is the one word food companies never want to hear. But recalls are a fact of life, so it’s the wise manufacturer, wholesaler, and retailer that prepares for the inevitable. What does it take to have fast, effective food recall management? The short answer is that you need to modernize your supply chain so you can act quickly based on high-quality data. Let’s take a look.

“Modernize” is today’s food and beverage buzzword

The Food Safety Modernization Act (FSMA) has been in effect for almost a decade, so modernizing the food and beverage supply chain isn’t a new idea. Designed to improve the security and safety of the U.S. food supply, FSMA focused on preventing food-borne pathogens across the food system. It also encouraged companies to be proactive instead of reactive when it comes to food safety — including how they deal with food recall management.

Now, the U.S. Food and Drug Administration (FDA) has ratcheted up its food safety efforts. On April 30, 2019, it announced the New Era of Smarter Food Safety, which it describes as “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” To be rolled out over the next decade, it’s “also about simpler, more effective, and modern approaches and processes.”

In other words, more modernization that builds on FSMA. The “ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses.”

Then, in July 2020, the Administration released the “New Era of Smarter Safety Blueprint” that

“ … outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize our approach to food safety.”

The Blueprint also includes a Food Traceability Proposed Rule (formal title: “Requirements for Additional Traceability Records for Certain Foods.”) It would implement Section 204(d) of FSMA, with requirements to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.” The list includes fruits and vegetables, fish, shellfish, cheeses, nut butters, eggs, herbs, and ready-to-eat salads.

What does modernization mean for food recall management?

It’s clear that FSMA and the New Era of Smarter Food Safety have recalls in mind when they mandate modernization or propose procedures to attain it. However, with or without the influence of regulations, rules, blueprints, and lists, modernization boils down to two things for food recall management: digitization and traceability.

A digital supply chain with end-to-end traceability delivers speed and high-quality data, the most crucial aspects of food recall management. Digitization — eliminating the physical paper trail in favor of a cloud-based management system — enables end-to-end traceability, and end-to-end traceability means you have rich, actionable data available in real time so you can find products quickly, make informed decisions, and act with authority and assuredness.

Digitization and traceability also expediate food recall management because they allow you to easily share information with your trading partners and regulators. If you’re a manufacturer or wholesaler, you’ll keep retailers up to date so they can take the recalled product off the shelves. Consumers benefit too, because they’ll get recall alerts and know to return the product or dispose of it as instructed.

Modernizing food recall management also helps mitigate the very things that can trigger a recall in the first place, such as poor visibility into the supply chain, lack of accountability, or an insufficient safety culture. Indeed, it’s up to companies to fix such shortcomings internally through training and establishing safety protocols, but digitization and traceability will carry and facilitate safety across the entire supply chain.

For instance, you can attach critical tracking events (CTEs) and key data elements (KDEs) to every product’s digital profile, creating an indelible provenance you can trace up and down the supply chain. You’ll see where a product has been, where it is (or is supposed to be), and where it’s going. During a recall, you can “reach into” your supply chain and extract the product quickly.

Final thoughts

As we move into 2021, F&B companies have absolutely no excuses to put off modernizing their supply chains and recall management systems. A poorly handled recall can result in catastrophic financial loss and cause irreparable damage to your reputation. And companies that don’t modernize will likely find themselves pursued by regulators, ostracized by trading partners, shunned by consumers, and, ultimately, out of business.

rfxcel can help. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

For example, our Serialization Processing (rSP) solution assigns every product a unique digital ID that lets you locate affected products quickly, remove them from circulation, and record and verify that every recalled item was destroyed. Furthermore, rSP generates last-mile data that helps you identify the source of outbreaks and their scope for better consumer safety efforts.

Coupled with rSP, our Raw Materials Traceability (rRM) and Finished Goods Traceability (rFG) solutions build a digital supply chain that aids food recall management by maintaining a validated, traceable pedigree for every product. Track the transformation of raw materials into finished goods with total forward and backward traceability. Track lot to unit or unit to lot all the way to the consumer. Attach key data to every critical tracking event digitally. And if there’s a recall, see how exposed you are and respond rapidly by notifying affected customers and trading partners and changing the disposition of all units/lots to “RECALL” to prevent them from being included in any ship event. You can also use your data to aid investigations.

Contact us today to speak with one of our F&B supply chain experts. They’ll give you a short rTS demo that will show you how an rfxcel digital supply chain with end-to-end traceability will modernize your operations and optimize your food recall management.