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Points of View

The full collection of our monthly series of Points of View where Intelleflex asks industry experts their point of view on cold chain issues
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April 2013

Food recalls have been prominent in recent news stories. What key steps should grocers and growers take to protect consumers and their brands from recalls? Intelleflex, asks experts from the legal, academic and business communities their to-the-point opinions on food recalls:

  • Melanie Neumann, J.D., Sr. Director, Food & Import Safety, Leavitt Partners
  • Melissa Germaine, Associate Director Cold Chain Research at Georgia Tech
  • Dr. John Ryan, Food Safety and Quality Expert at Ryan Systems
  • Mike Nicometo, Founder and Food Quality Consultant, FreshXperts

“The first key recall risk reduction strategy is having proper preventive controls in place to reduce the risk of causing a recall in the first place.  The second key strategy is to have a robust recall and crisis management plan to guide you through the process of handling a recall should one occur. One last important take-away: documentation is more critical than ever.  If there is one message I try to communicate to our clients it is that in the eyes of the regulators “if it isn’t documented it didn’t happen.”
Melanie Neumann, JD, MS Sr director, food and import safety, Leavitt Partners

“Few consumers select their produce based on brand, therefore a food recall on a particular growers produce will affect all growers of that item. It is in the benefit of the entire industry to work together to minimize food recalls as consumer confidence can be greatly diminished regardless of brand.  Utilizing an effective traceability system will help growers and grocers trace contamination directly to the source since most consumers will not know the brand they ate that caused the illness.”
Melissa Germain, associate director cold chain research, Georgia Tech and director of the Academic Cold Chain Forum

“For those not yet convinced that the food world is in the middle of dynamic change, an attitude adjustment is in order.  Rather than living in a state of arrogant denial, a more humble approach might be taken.  Invite the local FDA, city or even food safety experts into the operation and give them a few hours to point out what might bother them during a recall or stop order.  Let the chips fall where they may then remain idle or set some management priorities.”
Dr JohnRyan, president, Ryan Systems

“Posting real time supply chain data to shared databases provides visibility for “install recall” plus real time metrics to improve logistics. Consider how credit card transactions involving different buyers, vendors, products, currencies and cultures happen in near real time using common data transaction exchange.  Studies have shown the ROI of real time supply chain visibility, where “instant and total recall” is a free by-product –not just added cost.  Our industry needs a common transaction layer with real time logistics information.”
Mike Nicometo, founder, FreshXperts

“For recalls, retailers and growers also need to think in terms of shopper loyalty, brand reputation, consumer liability and public safety. One study showed a recall costs $10 million plus brand damage and lost sales. It’s essential to automate the recall process with electronic traceability records so tainted product can be identified and destroyed in hours versus days or weeks.”
Kevin Payne, senior director of marketing, Intelleflex

 

March 2013

What is your reaction to the proposed rules recently published for the FSMA and their potential impact on growers and grocery retailers?

Jennifer McEntire, PhD, Sr Director, Food & Import Safety, Leavitt Partners
After much anticipation, it’s nice to finally see where the FDA is headed and what they expect of industry. With so many exemptions, we’ll need to see which growers wind up being subject to the Produce Safety Rule. With these grower exemptions, retailers may shoulder more responsibility and need increased supply chain visibility to ensure that produce is being grown with food safety in mind. FSMA is not going to protect companies against the brand risk they face everyday. Hopefully, the risk of food-borne illness to consumers will decrease, but this will not happen overnight, and each company still needs to evaluate and manage supply chain risks, because plaintiffs’ attorneys don’t care that the rules are not yet final.

Melissa Germain, Associate Director Cold Chain Research at Georgia Tech and Director of the Academic Cold Chain Forum
The FSMA created legislation that outlined practices the industry should have been doing anyway. It has always been, and will always be, in the best interest of the food industry to ensure food safety. No one benefits from food recalls and food borne illness outbreaks. For example, in 1998 tomatoes were initially linked to Salmonella outbreaks. Later it was determined that other products such as peppers from Mexico were the culprit. But it was too late. U.S. and imported tomato growers lost significant business. The act rewards companies and growers who have always had food safety as their first priority while giving others more of a regulator push to do the right thing. The entire industry can benefit by maintaining consumer confidence.

Dr John Ryan, President, Ryan Systems
Based on bio-contaminant and pesticide levels normally found on farms, the proposed FSMA rules are extremely lax and insufficient. There is ample evidence that has gone unreported by the FDA regarding high levels of contaminants that are allowed to move through the supply chain to retailers and consumers. There is a lack of FDA supported development for high speed, low cost testing technology. With no FSMA, established traceability rules, recall requirements and the concept of preventive planning are insufficient at best. Kevin Payne, Senior Director of Marketing, Intelleflex Initial feedback on the proposed FSMA rules seems to be positive, but there appear to be gaps or undefined  areas relating to temperature-sensitive goods and traceability requirements for the cold chain. Retailers, in particular, need to realize that, even though most of the rules don’t apply directly to them, they still have an implied responsibility to their shoppers to ensure the quality and safety of the foods they sell.

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January 2013 – 
In terms of produce quality and traceability, what’s the most significant thing you expect to see happen in 2013?
 

Due to the lack of aggressive food safety implementation on the part of supply chain members and the delayed FSMA implementation, I suspect the most significant issue to arise this year will be a number of large scale food recalls.The industry appears to be in as much of a muddled state as the food side of the FDA.Until governmental expertise and industry reluctance work together in this way, what else should we expect?
Dr John Ryan, president, Ryan Systems

Consumers will begin to place more demands on the retailer as they strive to obtain more information about their products. They will want to know more about the origin of foods as well as the expected shelf life. A retailer has begun to offer guaranteed vase life for fresh cut flowers, this guarantee will become expected in other perishable products.
Dr Jean-Pierre Emond, director of Cold Chain Research, Georgia Tech

Without doubt I see the emergence of Intelligent RTI’s in the fresh produce sector.The marriage of technology and a reusable platform is the answer to the question, “This is great, but how am I going to pay for it?” which is the number one barrier to implementation for these essential initiatives. Once that door opens, the possibilities are endless for improving this supply chain.

Kaley Parkinson, national sales manager, Supply Chain Technology, Rehrig Pacific Co

The rollout of the FSMA –and related increased public awareness around food safety and quality –will require growers and retailers to fundamentally rethink their cold chains. They need to proactivelymanage and monitor quality and safety to prevent issues and implement electronic traceability to improve response to recalls.  In 2013, grocers and food service providers will begin mandating that their growers and suppliers provide complete electronic records  –at the pallet level –utilizing new solutions including RFID, The Cloud, and intelligent RTIs and containers.
Kevin Payne, senior director of marketing, Intelleflex

Social media is potentially a useful tool to improve public awareness of food safety issues and disseminate knowledge about food risk. The flip side is instant broadcasting of any failures by food companies with huge implications for brand values. Traceability and monitoring is no longer optional insurance, but a critical aspect of the food distribution chain. Food logistics providers are in the vanguard with this service but need to push its benefits hard.

Dean Stiles, editor, Global Cold Chain News

November 2012:  Pharmaceuticals and package-level temperature monitoring

How does package-level temperature monitoring reduce risk against customers’ claims and provide a business management tool for improving operations?

Unlike foods, where temperature abuse is visibly evident, pharmaceutical products rarely show signs of temperature excursions. Package-level temperature monitoring may be beneficial for some specialty drug products that carry a high value and high risk to the customer if it’s potency is reduced. The monitoring may be more critical in business units that have less control of the transportation process and conditions, such as mail order pharmacies.
Dr Jean-Pierre Emond, Director Cold Chain Research, Georgia Tech

Too many operators see legislative or customer-driven standards in the cold chain solely as a cost that has to be met rather than an opportunity to enhance service. The cost of installing the hardware and software to meet base standards can rarely be recovered and meeting minimal standards offers little benefit to marketing the business. More imaginative application of the same hardware and software means carriers can market added-value services that potentially provide better margins.
Dean Stiles, Editor, Global Cold Chain News

Package-level monitoring can help reduce risk in two very significant ways.   First, today’s technology provides active monitoring of shipments in transit.  This allows immediate actions to be taken and contingencies triggered to prevent excursions in “live” shipments before they occur.  Secondly, from a perspective of initiating permanent solutions, package-level monitoring provides a true data record that, over many shipments, can be used to analyze non-compliant routes and initiate permanent corrective actions.
Bob Koplowitz, Global Director of Vertical Industries, Expeditors

Customer claims result from both real and perceived temperature excursions.  Temperature monitoring, at the package level, provides 100% data driven decisions about product condition upon receipt.  This data based confirmation eliminates false claims and, when qualified packaging is used, reduces the high costs associated with handling false claims.  With qualified distribution systems in place, any temperature excursions can be traced and will provide ongoing insight into process failures.  This insight allows for constant visibility and correction which increases patient safety and improves operational efficiency.
Jamie Chasteen, Product Development Manager,Cold Chain Technologies

Of all the potential risk factors that can exist within any supply chain, actually knowing that the drug that is being delivered within the package is compliant to its biological structure and protocol is by far one of the most important, if not the most important, specifically when it comes to cold chain. The bottom line for any company that wants to avoid potential law suits is to insure that quality and efficacy are maintained throughout the shipping processas this could be the one shot to save, or maintain a patient’s life.
Peter Norton, Senior Cold Chain Consultant, Intelleflex

October 2012 – Food Safety

What is the first step that the industry should take to improve food safety and traceability in the light of concerns about food safety in the cold chain?

Most people take food safety for granted. But, with the trend of buying ready-to-eat foods at a wide variety of sale points, extra precaution should be made as temperature maintenance plays a critical role in the safety of food. Utilizing temperature monitoring during the entire distribution process can provide crucial temperature data during storage, transportation and while on display. Reliable temperature monitoring allows for proactive approaches rather than reacting to problems that previously occurred. By resolving issues before they become a serious problem, you can avoid loss of product as well as the loss of customer loyalty and safety.
Dr Jean-Pierre Emond, director of cold chain research, Georgia Tech

An integrated food safety system combining traceability and food safety data would reduce risks, shorten recall times and provide inter-operation communications along the supply chain. Food safety data can be used to rank suppliers and handling operations. Low scoring operations would equate to high risk. During a recall, high risk operations would be the first required to provide traceability information thus allowing recall specialists the opportunity to quickly locate, test and dispose of adulterated food.
Dr John Ryan, president, Ryan Systems

Prevention and traceability are the two cornerstones that must be implemented and practiced by all players from field to fork. End-to-end food handling, storage and preparation practices that emphasize best practices for food safety are the best way to insure that a cold chain product is clean, fresh and safely consumable. Tracking and tracing of food products and related supply chain components is necessary if a food safety situation occurs that requires audit or trace-back.
Jack Sparn, chief innovation officer, iGPS

The cold chain role with food safety is primarily ensuring that perishable food items are stored within established temperature ranges. Technology helps by monitoring temperatures throughout the cold chain and providing alerts for any excursions. New technology allows us to implement monitoring at the pallet level affordably without disrupting work flow. Automated data capture of product moving in the supply chain provides a single data store enabling an instant recall in the event of a problem, versus getting all supply chain stakeholders to report where the product came from, what they had and where they shipped it.
Mike Nicometo, founder, FreshXperts

Traceability is a good starting point for food safety, but it needs to be implemented across a product’s full supply chain to be effective. Simply reporting “one up” and “one down” relationships makes recalls difficult and time consuming, as multiple hops need to be traversed to collect complete data. Manual collection of product data at each site, either by invoice or bar code, has a high enough data entry error rate that it is not suitable for food safety and traceability. The industry needs a solution that captures the full supply chain history automatically and at every touch point – that would deliver actionable traceability data.
Peter Mehring, president and chief executive, Intelleflex

September 2012 – Pharmaceuticals
Now that studies have shown RFID is safe for use with biologics, how will this impact the cold chain?

The use of RFID in cold chain monitoring brings significant benefits for the pharmaceutical industry. First, you do not need to open a container in order to read the temperature inside which eliminates the potential of exposing products to the environment while keeping the integrity of the container. Second, monitoring the temperature of each shipment at any location in your distribution system may bring important information about potential “unknown” breaks in the cold chain that weren’t previously identified. The third benefit allows for corrective actions to be made during transit rather than be confronted with the problem at reception.

Dr. Jean-Pierre Emond, Director Cold Chain Research, Georgia Tech
Biologics products are expected to drive 60% of the revenue for Big Pharma in 2012 and beyond. This switch in products, their cost and cold chain handling challenges will force the manufacturers to develop new Supply Chain strategies. At Excellis Health, we believe companies will need to evaluate and deploy technologies to track and trace these products through their supply chain. RFID tracking technologies are industrial strength and ready to support this mission. The benefits to manufacturers will be product visibility, integrity and quality.

Greg Cathcart, CEO, Excellis Health
The recent findings means biologic serialization and traceability initiatives can confidently evaluate the use of RFID at any packaging level.   Companies in this position should ensure that all layers of their traceability solution, including data management, reporting, and authentication, are designed to unlock the full value of the richer and more real-time data which RFID and other sensor monitoring technologies can provide.

Scott Pugh, Director of Strategic Business Development, Verify Brand, LLC
I anticipate companies will study their supply chains and gather sufficient data so that they can answer regulatory questions on safety and efficacy. At the same time the FDA has promoted RFID as a means of securing the supply chain, they also expect companies to have data that shows the product is unaffected by exposure. So while I expect adoption of the technology, I also expect it initially to be measured.  The primary reason for adopting this technology is patient safety.

Larry Sweeney, Chief Operating Officer, DDN Dohmen
Pending ePedigree laws in California are likely to require a combination of RFID and 2D barcoding systems with RFID being suggested for use at the package or pallet level and 2D barcodes being used at the item level. Because the study confirms RFID’s inherent safety, it will enable technology companies, pharmaceutical manufacturers, shippers, 3PLs and health care providers to move forward more aggressively on developing solutions for ePedigree and documenting the safe and authentic shipments of biopharmaceutical products.

Peter Norton, Senior Cold Chain Consultant, Intelleflex

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August 2012: What is the weakest link in the cold chain?

As product moves through the cold chain, it is transferred from one type of transportation to another or from a transporting unit into an inventory location where it is held until the next transfer. There is abundant data available to show that the greatest temperature variation generally occurs not during transportation or in the inventory location, but during the transfer point between the two. Such variation indicates lack of control over the shipment.
Dr John Ryan, President, Ryan Systems

Any step in the cold chain could become the weakest link. If a portion of the supply change incurs temperature damage, it makes the cold chain initiatives before and after irrelevant, as one step could ruin the product and/or dramatically reduce quality and shelf life. If all handlers during the cold chain process were educated about the end result of temperature damage, they may be more vigilant on maintaining the proper cold chain, as they would better understand their impact.
Dr Jean-Pierre Emond, Director of Cold Chain Research, Georgia Tech

The weakest link could happen because employees managing the product don••t understand the importance of the cold chain. As a result, product from the field can end up waiting athigh temperaturesuntil someone is available to get it ready for the precooler. And, when there••s a high volume of product, it affects perception of when product is sufficiently precooled, and the product doesn’t reach the ideal storage temperature. It••s essential that all of the people managing your product understand the importance of the cold chain and its impact on quality and your brand.
Steve Dean, General Manager, ProWare Services

The single biggest threat to delivered quality and freshness is  the “cut to cool” link from harvest to pre-cool. Because the product is losing shelf life much faster at higher temperatures, for every hourduring the “cut to cool” link, the product is losing up to a full day of shelf life. In a 15 day supply chain, you can easily lose 4 to 8 days due to delays in gettingthe product properly pre-cooled! The only way to know where problems are in a given cool chain is to measure the complete cool chain, including the post harvest „cut to cool••time.
Mike Nicometo, Founder, FreshXperts

Pallet-level temperature monitoring and management throughout the supply chain is essential for ensuring the delivered freshness of produce. Simple room-level monitoring for pre-cooling results in inconsistent pallet-level temperatures, directly resulting in reduced shelf life. Because of the wide variation of produce temperature coming in from the field, it is critical that each individual pallet’s temperature be properly managed to ensure the product is sufficiently chilled. Since there are no visible indicators when removing pallets from pre-cool, actual pallet-level temperature monitoring is the only method to ensure reliable pre-cool results.
Peter Mehring, president and chief executive, Intelleflex

For more information:
Intelleflex
Tel: +1-877-694-3539
info@intelleflex.com
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