Food Safety Modernization Act Archives

New Food Safety Regulations Impact Truckers

Regulations | By Steve Banker • 09/20/2016

The U.S. Food & Drug Administration (FDA) is, step by step, implementing new rules based on the Food Safety Modernization Act (FSMA). The goal of these efforts is “to protect foods from farm to table.” The rules fall most heavily on food manufacturers, but they also impact truckers. The deadline for the section of the regulations known as the Preventive Controls for Human Food began this week.

I turned to Jon Sampson to explain these regulations to me. Mr. Sampson is the Executive Director, Agricultural and Food Transporters Conference (AFTC), of the American Trucking Associations (ATA).

The ATA has played an active role in advocating for truckers, and the final versions of these rulings are not as onerous as what was initially proposed. Frozen food transport, for example, is exempt. Carriers under $500,000 in annual revenues are exempt. And when it comes to documentation, carriers in temperature controlled supply chains were initially going to be required to provide temperature documents to the FDA. Now they are only required to keep documents that prove that they have a process in place to provide these documents when requested by the shippers.

But most importantly, the responsibility for compliance has fallen mainly on manufacturer shippers who bear greater responsibility for record keeping and training. But, that does not mean these rules only minimally impact carriers. Nothing could be further from the truth. Because these shippers are also liable for the decisions they make, they protect themselves, according to Mr. Sampson, by “asking more of their carriers. This is particularly true when transportation contracts come up for renegotiation.” So for example, even though carriers under $500,000 in revenues are exempt from these regulations, shippers concerned about liability are apt to require the same things of these small carriers that they would of larger carriers.

The premise behind putting most of the responsibility on manufacturers is that the manufacturer understands how to keep their products safe better than anyone else in that product’s value chain. It is up to the shipper to specify a checklist for carriers, and carriers to carry out those instructions. The checklist can include making sure refrigeration equipment is running properly, that the requested temperature settings are in place, that the trailer has been cleaned to their specifications, and that drivers have receive what they deem to be the appropriate training.

So for example, one shipper may require that the temperature in the trailer be checked upon loading, and again 200 miles later when it is unloaded. A different shipper may require that the temperature be monitored every 10 minutes by a telematics device connected to sensing equipment in the trailer. What a shipper is requiring of a carrier should also be based upon knowledge of how that carrier operates on that lane. So, for example, a full truckload shipment traveling a short distance might only require checking the temperature at origin and destination. But a less-than-truckload carrier that stops and opens the trailer door 15 times before the food gets to its destination would require more robust monitoring.

It is also up to the manufacturer to decide if truckers need to archive documents proving they have done what they agreed to do. The shipper might decide that those documents only need to be provided in the event of a recall. Or, the shipper might decide to require the carrier to provide documents to the manufacturer or the consignee when the goods are delivered. Or, if they are being super careful, the shipper might require the pertinent documents be electronically uploaded to the manufacturer’s traceability database at several steps along the delivery process.

The communication of shipper requirements is made more complex by the intermediaries that exist in transportation. It may be that a shipper relies a broker to find a carrier. In this instance, the shipper’s requirements must be communicated to the broker who then communicates to the carrier. The FSMA requirements treat brokers and 3PLs the same as shippers.

Even something like how a truck should be cleaned can end up having a great amount of complexity. “A trucker hauling barley out of a field may only be required to broom out the trailer,” according to Mr. Sampson. “But if the barley shipment follows a shipment of peanuts,” which cause allergies for many, “a disinfectant may be required before picking up the barley.” Based on these kinds of issues, another shipper requirement may be that the carrier be able to document the products hauled by the trailer that will carry their load over the past three or four moves.

For the transport of unprocessed meat, a number of different chemicals, or even gas treatments may be required. To eliminate all of the germs, manufacturers need to understand, and then specify, what kinds of disinfectants will kill the types of bacteria that can degrade their food products. Further, each treatment may require a different water temperature be used in the cleaning process to insure one hundred percent of the bacteria are killed. And truckers need to be alert to whether the chemicals specified by manufacturers will damage their trailers. “A chemical used on in a plant with a concrete floor may be fine for the shipper,” Mr. Sampson said, “but cause damage to a trailer.” ATA’s Technology and Maintenance Council (TMC) has formed a trailer washing group tasked with understanding what kinds of treatments could damage trailers.

Clearly, this makes life more complicated for many food carriers. Potentially a trucker with 20 different food shipper clients will be subject to 20 sets of shipper requirements. How should they respond to this? One possibility, according to Mr. Sampson, is to be a carrier with robust safety standard operating procedures and then be able to sell shippers on the robustness of your process. That way the carrier does not have to do as many distinctly different things for each shipper.

But Tom McLeod, the President of McLeod Software, pointed out that better software also becomes increasingly critical to help truckers deal with the variability of shipper requirements. McLeod Software is a provider of transportation management software solutions to the trucking and freight brokerage industry. “Some receivers,” Mr. McLeod said, “may want a report ready at the point of delivery that contains the driver’s training certification, a temperature profile, information on how the truck was precooled and how the trailer’s temperature was maintained, the trailer’s wash ticket, and all of this before they accept delivery.” What is needed are flexible software solutions, solutions with workflows that can extend to encompass multiple parties, and software that is mobility enabled.

Mr. McLeod warns that if carriers have not started getting ready for these regulations, they are already well behind where they need to be. “Carriers will need more than 6 months to get compliant.”

Guest Commentary: Achieving Agility in the Food Supply Chain

Food & Beverage Industry | By Eric Lamphier • 01/24/2013

Supplying the nation with food is the most critical of functions, but one that comes with layer upon layer of complexity. In many ways, the supply chain of supermarkets and independent merchants is similar to those of any other retailer. Suppliers are spread around the country and the globe, and driven by customer demand for local, independent products, retailers must work with small, local farmers as well as with large multi-national suppliers.

However, two key factors exist that make the food supply chain more complex. The first is that every product, albeit to varying degrees, is a time bomb. From the second it’s picked, caught or made, it has a finite lifespan. Seasonal trends can have a similar impact on fashion or fast moving consumer goods supply chains, but at least last season’s coats can go on the sale rack. Out of date milk cannot be dealt with in the same way, so it must be made available to the customer as quickly as possible. The result is a far more expansive supply chain network that becomes difficult to manage efficiently.

The second factor is regulatory compliance. With the Food Safety Modernization Act (FSMA) demanding compliance down to the finest detail, farmers, manufacturers and retailers must have very strict tracking processes in place.

Stopping the rot – getting produce to the customer on time
The clock starts ticking the second a pea is picked, a potato pulled or a fish netted. The customer demands the freshest food, which means getting produce from farmer to retailer to customer within ever decreasing time frames.

Greater speed of delivery does not come from simply trying to do things faster, it also comes from creating a more agile supply chain. Farmers need to be able to get goods into the supply chain right away, which requires easy-to-use labeling, scanning and shipping devices to ensure that products are accurately logged and enter the supply chain quickly and efficiently.

It’s then the responsibility of the retailer to create the best transport route to the store shelf. This can only be achieved by gaining an understanding of stores’ and customers’ requirements and the ability to make quick decisions on what produce goes where.

Matching store or customer need with stock availability is a fundamental skill of good retailing, but having to make those decisions in time frames of minutes, or hours at most, is one of the defining characteristics that make the food supply chain different from others.

Retailers have responded to these demands and put in place multiple distribution centers close to the source. This ensures that produce is fresh when it hits the shelves, but also creates a new challenge: managing it. To achieve this, it’s essential for operations managers to have clear visibility of all products, all the time.

Fresh food, rubber stamped
One of the reasons that the ability to monitor across all of these sites from a single interface is important is regulatory compliance. Goods must be tracked from farm to customer to ensure quality of produce on the shelves. This puts responsibility on farmers and manufacturers to time stamp and label all goods appropriately, but also means that the more visibility retailers have of the transit of these goods, the better. This means knowing exactly where products are, when and for how long – including when they’re in the back of a refrigerated vehicle, in a warehouse or on a shelf.

The reason that this is growing in importance from a commercial standpoint is that retailers are committing to print the source of their produce on every packet.

Online shopping highlights supply chain weaknesses
In the rapidly changing retail environment, supply chain inefficiencies will be exacerbated by the continued growth of online shopping and home delivery. The importance of removing those inefficiencies is demonstrated by a number of recent research, including a Bain study indicating that online grocery shoppers end up buying more frequently and spending more money in each transaction as they come to rely on the service over time.

Many food home delivery services are going through a major transition as critical mass approaches – consolidating picking into dedicated distribution centers away from low volume store-based operations. However, while the enthusiasm to address these new challenges is important, recent high profile failures highlight the risks of investing in too much costly, fixed, inflexible automation. To achieve the goals of a multi-channel enterprise, agility is a higher priority than optimization to solve today’s problems in such a fast moving sector.

Some of the characteristics of agility in the supply chain include being able to cross stock over between different distribution lines, as well as adjusting supply chain processes in real-time to adapt to changing circumstances and requirements.

Achieving Agility
There are several key considerations for the food supply chain that will ensure that this multi-channel challenge is met and overcome with a profitable outcome. The first is to have a single Order Management system. If this can’t be easily achieved, an integration technology that can at least aggregate information from multiple systems to give a single view of each channel is essential. Without this, the supply chain will slow down and the capability to ship the most appropriate stock does not exist.

Unifying processes to gain visibility of the entire supply chain is essential. As many deliveries – for example for bread and milk – have to go direct to store from the manufacturer, coordinating the entire delivery cycle requires the integration of an extensive web of manufacturers, delivery vehicles and stores’ own stock management systems.

Eric Lamphier joined Manhattan Associates in 1997 and is currently the senior director of product management for Manhattan’s Warehouse Management for Open Systems (WMOS) solution. Lamphier has worked in various roles in Manhattan’s Professional Services Organization, supporting and overseeing the design and implementation of Warehouse Management solutions for customers across target verticals. He earned a Bachelor of Science degree in chemical engineering and an MBA from Clarkson University.

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.

The Farm-to-Fork Supply Chain

Food & Beverage Industry | By Steve Banker • 08/29/2011

When it comes to following supply chain processes and technologies, the supply chain that extends from a food manufacturer’s factory to retail stores has always gotten a disproportionate share of attention. This is natural because large food & beverage and consumer goods companies were the first to use warehouse and transportation management systems, are heavy users of advanced supply chain planning applications, and are leading the way toward demand-driven supply chains based on the use of demand signal repositories.

I grew up in Indiana making summer money detasseling seed corn. Not surprisingly, I also find the farm supply chain interesting. But this supply chain gets far less attention. I was talking to a logistics manager for a feed supplier that delivers products right to the farm. His company needs to achieve flawless transportation execution, which involves more than just showing up on time. Their trucks drive right up a farmer’s driveway and they need to make sure they use the correct driveway – the one that leads to the barn, not the house. The farmer’s wife gets testy if a truck knocks down her shrubbery or flattens her flower beds. The truck drivers also need to know which bins to fill with feed, since there are apt to be several available. In short, fulfillment execution is about delivering the right product, using the correct process, in order to meet the farmer’s expectations, and each farmer has slightly different requirements.

And then there is Monsanto. It has been demonized as a company that produces genetically-modified soybean, corn and cotton seed products. But I consider Monsanto one of the best examples of a company using product development to differentiate its product. I put them right up there with Apple in the area of product differentiation. The company’s trick was to develop a herbicide, Round Up, that only works when used with its seed. In parts of the world where farmers use this combination of seed and herbicide, Monsanto is the clear winner in the marketplace because its products generate higher yields.

My complaint about Monsanto stems from its overzealous use of litigation. The company sues organic farmers or dealers if their organic seed becomes contaminated with Monsanto’s patented biotech seed germplasm based on the legal claim that these farmers or dealers are using its seed without paying required royalties.

Fonterra is also a very interesting company. Fonterra is a leading multinational dairy company owned by 13,000 New Zealand dairy farmers. It is also the world’s largest exporter of dairy products. Fonterra has an innovative supply/demand planning process. This process is complicated because as a cooperative Fonterra is contractually obligated to take all of the milk its farmers produce. The company cannot cut production to balance to demand. Fonterra forecasts how much milk it will produce based on where it rains, using GIS (global informaton systems) and satellite maps to determine the latter. The more it rains, the more grass will grow, the more milk cows will produce. Once it has forecast the supply, the company turns fresh milk into inventory by figuring out how much cheese and powdered milk it can profitably sell over a multi-year period. Having the supply/demand plans in place allows Fonterra to optimally move the milk to the correct production facilities.

Leading growers are using GIS and GPS to figure out which parts of their massive farms should be planted with which crops based on soil books, slopes, frost free zones, and other parameters. This improves yields while reducing fertilizer, fuel, and seed costs.

I had hoped, based on the passage of the Food Safety Act in the US this past January, that farm-to-fork traceability and food safety would make big advances in the near future. As I’ve written in the past, despite scientific and technological advancements in so many areas, such as plant safety, mine safety, driving safety, and disease control, we’re really not improving the safety of our food supply. But after reading the traceability portion of the Food Safety Act a while back, I was very disappointed.

It is technologically feasible to have end-to-end, farm-to-fork traceability using case-level barcode/RFID tracking with product and location codes developed by GS1. If products need to be recalled, then multiple companies could access a database “in the cloud” to quickly trace back to the source of the problem. And of course, when this end-to-end visibility exists, the supply chain can be optimized in new and exciting ways.

However, the corporate interests won. The food safety bill only includes one step up/one step back traceability by the different players in this supply chain. In short, timely recalls will be impossible. For a non-legalese based explanation of the statute, the consulting firm Leavitt Partners provides a good explanation in an article titled “Product Tracking: Impact of FSMA.”

But the farm supply chain will always interest me. You can take a Hoosier out of farm country, but you can’t take the farm out of a Hoosier.

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.

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