FDA Archives

Guest Commentary: Is Your Traceability Solution Sophisticated Enough for Today’s Complex Food Supply Chains?

Food & Beverage Industry | By Tom Kozenski • 05/22/2012

The complexity of our food supply chain has increased exponentially over the past decade as evidenced by the enactment of the Food Safety Modernization Act (FSMA) in early 2011 and a list of recent food recalls. Three of a dozen or so recalled items in the last six weeks were from India, Vietnam and The Philippines (two kinds of fish and apricots). According to the FDA, an estimated 15 percent of our domestic food supply is imported—60 percent of fresh fruits and vegetables and 80 percent of seafood.

These were “simple” recalls that involved essentially single-ingredient items. But as you know, a tremendous amount of the foods we eat are like sub-prime mortgages—they’ve been sliced, diced, mixed, processed and re-portioned with ingredients that come from multiple suppliers and countries of origin, each with varying levels of quality assurance and local regulations. So in a jar of spaghetti sauce, you may have tomatoes from two (or more) different sources, oil from somewhere else—and don’t even get started on the spices!

What ties all this together is that the FSMA pushes the FDA to focus more on prevention rather than treatment and containment of food safety issues after the fact. And that change puts additional responsibility on food companies to be accountable for the 48 million people in the U.S. affected by foodborne illness each year.

The question is: Is your company capable of adequately shouldering that responsibility? Unfortunately, it’s very likely that you aren’t.

To effectively ensure food safety in such a complex environment, you need to be able to track all ingredients from the moment they enter the supply chain until items reach consumers’ hands.

But that’s just the beginning. A company’s traceability capabilities must cover transport and distribution in order to monitor key details such as temperature control for heat- and cold-sensitive items, and it must extend to and be accessible to suppliers and business partners. Otherwise, all you can track is what goes on within your own operation, and that’s not enough.

In other words, if you can provide a real-time, end-to-end record of the chain of custody, that’s great, but it needs to go further than that. You also need to be able to connect to partners’ solutions to incorporate their data and provide 360-degree visibility to everyone in your network as you move forward, monitoring quality assurance, or backward in the event of a recall.

The consequences of falling short in your traceability capabilities are obvious: the average cost of a product recall is $10 million. And the damage to your brand and overall reputation may be incalculable. Remember Peanut Corporation of America? Although that episode in 2008 may have involved intentional misconduct, the company went bankrupt, was connected to hundreds of cases of salmonella and prompted the recall of more than 2,000 other items that contained PCA products.

But let’s close on a happier note. The FSMA puts more responsibility on food companies, and that should help push the great number of companies lacking adequate traceability to get state-of-the-art systems and procedures in place to protect both their businesses and their customers.

And for one final positive example, consider seafood company John West. Based in the UK, its traceability begins on the high seas, recording the exact location and boat that catches its tuna. But the company goes beyond traceability as a safety and operational issue. It even offers a “Fish Finder” application to customers. By entering a code found on the lid of the can, consumers can tap into point-of-origin information to address concerns about sustainability and responsible sourcing of depleted tuna stocks. So this company shows how sophisticated traceability is not just good for business when it comes to food safety. From a public relations perspective, it can also be very, very good for business.

Tom Kozenski brings more than 42 years of supply chain technology and logistics experience to his role of Vice President of Product Marketing for RedPrairie, a global supply chain and retail technology provider. Kozenski is an active industry speaker on supply chain and retail technology topics who has presented at numerous supply chain conferences including PROMAT, CSCMP, WERC, DC Expo, FMI, NAW, APICS and Interlog.

Food Safety Modernization Act Increases Need for Electronic Track and Trace

Food & Beverage Industry | By Steve Banker • 02/28/2011

In January, the Food Safety Modernization Act (FSMA) was passed and signed into law. The bill increases the Food and Drug Administration’s authority over food recalls. It allows the FDA to require food producers to have safety plans and enhances the FDA’s ability to improve the safety of imported foods. The bill, however, does not include any funding provisions to implement the law, estimated at $1.4 billion over five years.

You can read more about the major provisions of this bill in this article (available to ARC clients only). But below are some of the major provisions that will impact logisticians in the food and beverage value chain.

The FDA Commissioner now has the authority to order a mandatory recall when the agency determines that there is a reasonable probability that a food poses a health hazard. Previously, the agency could only recommend voluntary recalls of food products resulting from possible outbreaks. The FDA would have to negotiate with the manufacturers of the recall and this delayed the recall process. The law allows the FDA to suspend the registration of a food facility associated with unsafe food, thereby preventing it from distributing food.
The Act expands on registration requirements first implemented by Congress in the 2002 Bioterrorism Act. The Bioterrorism Act required facilities that manufacture, process or pack food to register with the FDA, but exempted retail food establishments and farms. The new legislation only exempts family and smaller growers. Initially, however, these smaller companies are only exempt for one and two years after the law is implemented.
Imported foods will be inspected and subjected to the same standards in place for US foods. The FDA now has the authority to block foods from facilities or countries that refuse FDA inspections. The FDA will also increase its inspection of foreign facilities that produce foods imported into the US.
The FDA is required to establish, as appropriate, “a product tracing system to receive information that improves the capacity to effectively and rapidly track and trace food that is in the United States or offered for import into the United States.”

A provision of the FSMA also requires companies to enhance their track and trace capabilities – rapidly tracing back from where a product was received and tracking forwards to where it was sent. This will create massive amounts of information that companies will have to manage and integrate to provide complete traceability across the supply chain.

The Bioterrorism Act included a “one step forward, one step back” traceability records requirement. The main difference is that the new law requires the FDA to run pilot tests that cover the entire supply chain, including farms and restaurants, and make a recommendation to Congress shortly thereafter. Our analysts in this area – Janice Abel, John Blanchard, and Tom Fiske – believe that the FDA will most likely recommend to Congress the utilization of electronic track and trace systems that can track the food genealogy throughout the supply chain.

Of course, track and trace for the purpose of recalls is a bit like opening the barn door after the horse has left. When track and trace encompasses the complete supply chain, these technologies can be extended to allow consumers to use cell phones to capture information about the food product. Consumers can learn where the produce was grown, who grew it, expiration dates, and if the food was recalled. Shoppers can scan the sticker with their smartphones or go to the website and enter the number from the sticker to track the path the food has taken and other information the farmer chooses to share, such as the harvest date. All of this information could be available almost immediately.

More control over fresh fruits and vegetables will have a positive impact on food safety. It also offers a major opportunity for Supply Chain Execution and AutoID vendors to provide new solutions that will fulfill the emerging dictates of this new legislation.

Preventing Counterfeiting in the Pharmaceutical Industry

Pharma & Life Sciences | By Steve Banker • 04/21/2010

When supply chain folks think about anti-counterfeiting in the pharmaceutical supply chain, we naturally think about bar codes and RFID. Those technologies have a role to play, but the requirements go far beyond the simple tracking that occurs in many other supply chains.

My colleagues Janice Abel and John Blanchard have written an ARC Insight (available to ARC clients only) on preventing counterfeiting in the pharmaceutical industry that documents the breadth of this problem, outlines global anti-counterfeiting regulatory initiatives, and delineates the various anti-counterfeiting technologies and the primary vendors who supply them.

What I found interesting was the role of non-scan-based technologies. As my colleagues wrote:

The FDA also issued draft guidance on July 13, 2009 covering the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to counterfeit and to make it easier to identify the genuine version of the drug. PCIDs, inactive ingredients that can be detected and authenticated to deter counterfeiting, are added to coatings, capsule shells, encapsulated particles, or tablet layers of solid oral dosage forms (SODFs) for on-dose protection. PCIDs for SODFs include inks, molecular taggants, pigments, and flavors. The guidance recommends using PCIDs listed in the FDA’s Inactive Ingredient Guide, adding the smallest amount possible and placing them on SODFs so that they do not interact with the API or interfere with the drug release.

Inert substances that are combined with active ingredients in a drug are known as excipients. The kinds of excipients described above are used for covert identification, as opposed to bar codes and RFID tags that are typically not covert. Because of the complexity of the excipient industry, the FDA determined that a paper trail would provide the fastest and least-disruptive approach to tracking chain of custody through the supply chain.

Ideally, however, the excipient approach should be combined with technologies that aid in tracking drugs through a multi-tiered supply chain, from the factory all the way to a drug store’s shelves. Here RFID and bar coding are used to support serialization, ePedigrees, and track and trace. ePedigrees are an electronic record that contains information about each transaction that results in a change of ownership of a given dangerous drug, from sale by a manufacturer through acquisition and sale by one or more wholesalers or retailers. The pedigree needs to be created and maintained in an interoperable electronic system, ensuring genealogy throughout all stages of distribution.

End-to-end tracking and tracing goes even further than ePedigrees. In addition to tracking the changes in ownership, tracking involves knowing the physical location of a product throughout the supply chain at all times, as well as the time spent at each location, environmental storage conditions, and packaging hierarchies that answer questions such as: How many bottles in a case? How many cases on a pallet? What are the dimensions of each of those units? And how does the packaging hierarchy change at each step of the supply chain.

Creating ePedigrees and performing detailed track and trace requires serialization—i.e., a unique serial number for every unit or item produced that can be used to track and trace the product across the supply chain.

ARC is conducting a multi-industry anti-counterfeiting web survey. If you are interested in this topic, please take a few minutes to fill out the survey.

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