Tag Archives: recalls

magnifying glass

Avoiding Total Recalls: Regulatory Labeling for the Food and Beverage Industry

By Josh Roffman
No Comments
magnifying glass

In recent memory, no time has more effectively demonstrated the challenges facing the food and beverage industry than spring 2018. In addition to a widely publicized recall of romaine lettuce, several other companies have instituted noteworthy product recalls. For example:

While demoralizing for food and beverage manufacturers, these recalls may also be an unavoidable part of doing business. Plants are grown outdoors, livestock lives outdoors, and no method of sterilization or disinfection is perfect. This is why regulations exist, such as FSMA or EU 1169, so that when recalls do occur, companies can efficiently find and eliminate their contaminated products, and then find the point in the supply chain where the contaminants were introduced.

Despite their necessity, food labeling and packaging regulations represent a huge challenge for food and beverage (F&B) manufacturers—and these challenges don’t exist in a vacuum. The labeling and packaging process is already a huge challenge, which includes customer requirements such as branding, cultural and linguistic localization, 2-D barcodes, and more. How can F&B companies enmesh their regulatory requirements with these existing challenges without adding to the complexity and expense of the entire undertaking?

Challenges of the Regulatory Environment

Since 2011, FSMA has been changing the way that F&B manufacturers produce, package, ship and sell food. In a departure with previous tradition, government inspectors no longer form the first line of defense against contaminated or mislabeled food. Rather, food producers and manufacturers themselves must bear the responsibility to implement procedures that prevent foodborne illness.

In short, FSMA will force F&B manufacturers to implement full transparency and traceability within their supply chains. Artwork and product labeling must be used to support these endeavors—ideally, one would be able to scan the barcode on a food package to instantly determine its origin as well as the chain of distributors that it passed through in order to reach your hands. Right now, the industry standard is well below this benchmark.

Right now, a seven-day timeline is the best-case scenario for traceability throughout the F&B supply chain. Although the endpoints of the supply chain—grocery stores and restaurants—may use modern digital records, you’ll find growers and transportation companies still using Excel and paper records.

In the meantime, a new European Union regulation known as EU 1169 went into effect in December 2016. It made a number of changes to food labeling laws, creating a uniform standard for nutritional facts information. Manufacturers must meet minimum standards for legibility, attain a minimum font size, and notify consumers about potential allergens.

Purely by coincidence, a new FDA food labeling law has also recently gone into effect. Announced in May 2016, this rule will update serving sizes found on most food packaging, alert consumers to added sugars, and more. Although these rules were originally slated to take effect in 2018, they’ve been delayed to 2020 for companies with more than $10 million in revenue, and delayed to 2021 for smaller F&B manufacturers.

To encapsulate, F&B manufacturers must now adjust to the following factors:

  • The FDA is becoming much more serious about preventing foodborne illnesses
  • To this extent, it’s begun to demand instant traceability from F&B manufacturers
  • In addition, the EU will force manufacturers to update their nutritional labeling
  • Manufacturers must update their nutritional labels in the United States as well—but differently

Barcodes and labeling already pose a complicated challenge for manufacturers, causing product recalls and packaging write-offs. Putting additional regulation on top of that solves problems in one sense, by making recalls less likely, but also creates problems in another sense—by putting pressure on artwork and labeling departments that are already overworked. After all, regulations alone aren’t the only sources of change and challenge when it comes to labeling and packaging.

Other Stressors on Labeling and Packaging within F&B Manufacturers

Changing consumer tastes, changing marketing methods, and changing technologies all play their role in adding stress to the job of labeling and packaging within the F&B manufacturing industry.

  • New Branding Needs. Packaging drives 36% of purchase decisions, which means that new and eye-catching label designs are always a must. Good design is subjective, however, and tastes change. For example, most Americans are now driven towards brands that are driven towards social and environmental causes. In other words, many F&B manufacturers may soon reorient their product artwork design to reflect this new concern.
  • International Expansion. If EU 1169 is a concern for you, it probably means that you’re selling into countries where English isn’t the only language. It’s easy to make missteps in this realm. For example, it’s possible to accidentally approve poorly translated copy, or to approve copy that’s in the wrong language entirely.
  • New Technologies. In addition to the UPC, many brands are now incorporating 2-D barcodes (such as QR codes), which provide product information when scanned by a smartphone. Although these codes are supposed to provide more information to consumers, only 34% of consumers actually scanned them as of 2014. The challenge for the labeling department is to make these codes more useful and user-friendly.

These new techniques, regions and branding requirements pose challenges. Think about the possibility of approving the right logo for the wrong country, approving out-of-date artwork, or substituting an FDA-compliant label for one that should comply with EU-1199. These things will happen, and they will necessarily lead to recalls. Here’s the question: How do you structure your artwork and labeling departments to minimize these risks?

Minimize Risks with Standardized, Centralized Labeling and Artwork Management

The secret to producing compliant labeling with up-to-date branding and correct localization is to create a system that gives you as little choice as possible. In other words, you should not find yourself wandering through a nest of file folders wondering which asset is the most up-to-date or find yourself developing separate label templates for each separate region you sell into.

Instead, your labeling and packaging artwork should be able to integrate with other business applications and content libraries to ensure your accessing the correct, most up-to-date approved content and assets. In an ideal world, if you start creating a label and select “Spain” as your target market, your labeling solution would immediately retrieve the relevant content for that target market. With the right kind of integrated, dynamic, data-driven solution you can be confident that you’ll only be dealing with complete with approved Spanish-language content for your packaging and your labeling. You would have peace of mind that your solution would generate an EU 1199-compliant nutrition label template, auto-populated with the appropriate nutrition facts. Additionally, if this label is intended for food sold only by a particular supermarket chain, you would feel confident that your solution would retrieve all of the correct content, images and barcodes required for that brand.

Improve Traceability by Replacing Sources of Confusion with Sources of Truth

To ensure accuracy and consistency, your labeling solution should integrate with your “sources of truth,” namely your ERP systems, but also potentially including your manufacturing execution systems, warehouse management systems, and more. You should be able to leverage existing business processes and vital data sources to drive labeling—to avoid replication of data and potential error, and instead automate and streamline your processes.

Recalls may be a fact of life, but using the right labeling and packaging solution will let you narrow their scope—and trace contamination to its source within a much faster window. The fastest solve for this problem involves creating a true “closed loop” for artwork and labeling—a comprehensive, integrated and automated solution to provide accurate and consistent labeling.

Melanie Nuce, GS1 US
FST Soapbox

Blockchain: Separating Fact from Fiction

By Melanie Nuce
2 Comments
Melanie Nuce, GS1 US

Over the course of the past two years, blockchain has shown promise across nearly every industry—far beyond the confines of its cryptocurrency origins. The food industry is no exception, with key stakeholders like Walmart, Cargill, Tyson, Coca-Cola and Starbucks all announcing pilot programs this year.

 Melanie Nuce and other industry experts will participate in a blockchain panel discussion at this year’s Food Safety Supply Chain Conference | June 12–13, 2018 | Learn moreAlthough blockchain has tremendous potential to speed up food recalls and enable the information transparency that consumers demand, there are important building blocks that must be in place before planning a blockchain implementation. Test your blockchain knowledge with these statements below to see if you can separate fact from fiction. Armed with the right information, you’ll be able to better understand the value of blockchain and how it fits into an entire ecosystem of data sharing before jumping immediately to its application.

Blockchain is basically a shared database. This is true. While it’s no secret that shared databases have benefits, what makes blockchain special is that it is a distributed and immutable ledger. There is no single point of failure in a distributed ledger—it is a consensus of replicated and synchronized digital data geographically spread across multiple sites. This decentralized structure makes the data resilient to a technology or organizational failure.

Blockchain also supports “smart” supply chain contracts, meaning an automated execution of terms, conditions and business rules. Through this feature, trading partners can automatically enforce terms and conditions as previously defined, eliminating the errors and inefficiencies associated with the current manual processes based on legacy systems. A trading partner is prevented from writing a business transaction to the blockchain ledger that is outside of the rules specified in the smart contract. For retail grocery, this means far fewer item substitutions, more certainty around what is being shipped and when, and fewer discrepancies downstream.

GS1 US
Image courtesy of GS1 US

Blockchain will do for the supply chain what email did for communication. This is also true—but Rome wasn’t built in a day. It will take time for blockchain to become a ubiquitous technology on par with email, and it is likely another decade away. However, given the amount of pilot programs underway, and the commitment from technology providers like IBM, Microsoft, and SAP to develop blockchain enterprise programs, many industry analysts believe blockchain will breakthrough to start to solve business process challenges in the next three to five years.

Purchasing blockchain software is all you need to create a traceability program. This is completely false! Industry stakeholders already leverage GS1 Standards, which enable traceability by ensuring all trading partners communicate in a uniform manner. Standards ensure systems interoperability, and provide a singular approach to creating, sharing and maintaining product information that supports, at the very least, “one up/one down” visibility of the product’s movement through the distribution channel. The internal data and processes a company uses to track products is integrated into a larger system of external data exchange that takes place between trading partners. Blockchain represents an opportunity for traceability to move faster—smart contracts and immutable ledgers expedite the flow of data between supply chain partners.

Blockchain can reduce food recalls from weeks to minutes. This is true, but only with a food traceability program already in place. Traceability has been achievable without blockchain, and many leading retailers have a long history working with farmers, distributors and processors on effective food traceability programs in order to assure consumers of food safety. Product recalls are significantly faster with standards in place to help break down any barriers caused by proprietary numbering systems and manual business processes.

Ultimately, now is the time to stay educated on blockchain and follow its development closely to uncover its many opportunities.

For more details on blockchain in the food supply chain, attend the blockchain panel discussion at this year’s Food Safety Supply Chain Management Conference, on June 13 at 8:30. I will be joined by Kathleen Wybourn, Director, Food Safety Solutions, DNV Business Assurance, and Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University for a realistic discussion of blockchain’s ability to boost the food supply chain.

Steven Burton, Icicle Technologies
FST Soapbox

Food Recall Strategies: What You’re Missing (And What You’re Risking)

By Steven Burton
No Comments
Steven Burton, Icicle Technologies

You’ve heard the horror stories of product recalls: The Peanut Corporation of America in 2009, Blue Bell ice cream in 2015, and Darwin’s Raw Pet Foods this year. Beyond the nightmare scenario, the truth is that food recalls are common—even for companies that take food safety seriously, train effectively and keep excellent records. Yet all of these things, when done properly and efficiently, go a long way to reduce the impact and severity of a recall.

Unfortunately, many food manufacturers, although required to have a written recall plan, aren’t ready for the challenge. Without the proper systems in place, businesses needlessly risk their customers, reputation, revenue and future.

Risks Of Inadequate Recall Strategies

Resolving a recall can take years and potentially millions of dollars in fines, product shipping and disposal cost, production line downtime, lawsuits, and lost market share as consumers lose trust in the company. But there are two strategic errors that can amplify these consequences—and they both have to deal with traceability.

The first problem we frequently see is lot codes not being specific enough. Rather than breaking up production into discrete lot codes so the scope of recalls can be as limited as possible, some facilities just run the same lot code for many production runs. The record we have seen so far is three years! When a recall occurs,this results in a recall of massive scope that can easily bankrupt a company.

The second problem that is even more common is a lack of dynamic documentation. Assembling transactions using disconnected records from different departments can be time-consuming and error-prone. When you’re under pressure from regulators or auditors to connect the dots between an ingredient and customers through complex, multi-stage production processes using such a record system, it can cause stress and potential audit failures.

These two missing pieces make recalls larger, more time-consuming, and more expensive than necessary due to a lack of precise traceability. Let’s take a look at the two ways you can fill these gaps in your system and mitigate the consequences of recalls.

Get Specific with Ingredients, Suppliers and Lot Codes

Streamlining your product lines and packaging options lists is a straightforward way to reduce potential headaches in the event of a recall. The more products and packaging options with which you work, the more complex it will be to pinpoint and resolve food safety failures. Anyway, this type of housekeeping is beneficial as far too many companies have large lines where only a small subset of their products sell well at decent margins. Larger, more mature organizations tend to thin down their lines to optimize for profitability, and smaller companies can often benefit from doing the same.

The next strategy you can employ to mitigate the consequences of a recall is by being ultra-precise when it comes to your records and lot codes. The more narrowly you refine your lot coding system, the fewer items you’ll have to recall. Let’s look at a specific example of how this could have saved two companies millions of dollars.

In 2010, Hillandale Farms and Wright County Egg recalled about 550,000,000 eggs, one of the largest recalls in the history of the United States. Although the company was able to resolve the specific dates and facilities where the contaminated product originated, they had 53 million hens laying, so this level of resolution may not have been adequate enough. Had they implement traceability lot codes down to the hen house level, they may have been able to contain the recall.

Automate Your Traceability To Be Audit Ready, All The Time

The challenge of maintaining an overly broad product line or providing customized packages is that you create hundreds or thousands of variants in your products. When records are maintained manually, it becomes extremely difficult to manage recalls effectively. An Excel spreadsheet may keep a record of everything, but it’s certainly not dynamic or time-efficient when undertaking mass balance calculations.

The key here is to adopt software that you can incorporate into every department. Shipping, receiving, accounting, production—when all the records are kept in a central database, checking and updating those records becomes much easier. But the best systems don’t just centralize your collected data; they automate your data collection.

Dynamic documents automatically update each other. When a supplier changes, an ingredient lot gets swapped out, or products are shipped out, all the connected records for every department are automatically updated. No user mistakes, no failure to update the notes—just seamless, streamlined, auto-updating records.

There’s no better way to track complex production processes, control hazards, and collect all the necessary information necessary to breeze through audits than by using an automated system. With all your documentation interconnected, you don’t have to piece together the puzzle or play connect the dots—it’s all done for you, and that means you won’t waste millions on recalling products unnecessarily because you couldn’t pinpoint the exact path every ingredient took on the way to the customer.

Recalls are detrimental in every way, but they happen, so don’t get caught off guard. A little bit of proactive technology will go a long way in keeping your business afloat if you ever do face the nightmare of a recall.

Francine Shaw, Savvy Food Safety, Inc.
FST Soapbox

Foodborne Illnesses and Recalls on the Rise

By Francine L. Shaw
3 Comments
Francine Shaw, Savvy Food Safety, Inc.

The last word a manufacturer wants to hear is “recall”. During 2017, recalls involved everything from salad mix contaminated with a dead bat to hash browns infused with shredded golf balls.

Not all recalls are created equal. Both the USDA and the FDA have three classifications of recalls to indicate the relative degree of health hazard presented by the product being recalled:

  • Class I: A Class I recall is the most serious classification, involving a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.
  • Class II: A Class II recall involves a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.
  • Class III: A Class III recall involves a situation in which eating the food will not cause adverse health consequences.

During 2017, there were 456 recalls recorded in the United States. The number one reason for those recalls was undeclared allergens.

Identify the weak links in your supply chain: Attend the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MD | Learn moreFoodborne illnesses continue to be widespread, as well. In 2017, we saw Robin Hood flour contaminated with E.coli, Soygo yogurt with Listeria, tomatoes, cantaloupe, and ground turkey tainted with Salmonella, and even shredded coconut was responsible for causing a Salmonella outbreak in the United States and Canada. Foodborne illness outbreaks can happen at restaurants, corporate events, private parties, schools and cruise ships—anywhere and everywhere food is served.

Recalls and foodborne illnesses are 100% preventable. Incidents occur because of human error, and all it takes is one weak link to cause serious—and potentially fatal—problems. That’s it. One weak link can cause the traumatic deaths and/or illnesses of customers, and cost your company billions of dollars, loss of sales, plummeting stocks, negative media coverage and a severely damaged reputation.

When there’s a recall or a foodborne illness, products must be destroyed, which is lost revenue for manufacturers, retailers, restaurants, etc. Finding the source of the contamination can be a massive undertaking. The manufacturer may need to close all of their plants for cleaning until the source is identified, which adds up to a tremendous financial burden, and also requires significant time and effort. Class 1 recalls can cost hundreds of millions of dollars or more, to identify the source of contamination, recall products, sanitize facilities, and keep consumers safe.

It takes years for companies to establish a solid reputation, and food recalls and foodborne illness outbreaks can obliterate a brand’s reputation overnight. Consumers lose confidence much faster than they gain it, and bad news travels fast (especially in this time of social media where news spreads instantly and widely). And on top of that, there may be litigation as a result of the recall, incident or outbreak, which will result in attorney fees and potential settlements that could be very significant. If the risk of massive expense and bankruptcy isn’t enough, for the past few years, the U.S. District of Justice has been issuing fines and prison terms to company leaders involved in foodborne illnesses outbreaks and food recalls.

The government, media and general public are holding companies (and their leadership) accountable now, so you’d think that recalls and foodborne illness incidents would be on the decline but, unfortunately, that’s not the case. And with advancements in technology, why are we still having so many issues surrounding the safety of our food?

Many media outlets report that foodborne illnesses have been rising considerably in the past few years. However, according to the CDC, a study showed that the six most common foodborne illnesses have actually declined in frequency by 25% over the last two decades. Having said that, though, the severity of foodborne illness outbreaks seems to be increasing, and the number of outbreaks connected to produce has risen, as well. Some experts believe the increases may be due to better reporting processes rather than an actual increase in the number of foodborne illnesses.

There are various theories as to why foodborne illnesses may be getting worse. Some government agencies indicate it has to do with farming policies. The CDC disagrees. More widely accepted beliefs are the increase in popularity of organic produce—grown with manure rather than chemical fertilizer—which can transfer bacteria to the produce. Additionally, there’s debate that the use of antibiotics can cause bacteria that causes foodborne illnesses to become resistant.

Recalls may occur for a variety of reasons. Products may be pushed beyond their shelf life by the manufacturer, or maybe the design and development around the product was insufficient (equipment, building, etc.). Is the manufacturing facility designed in a manner that can prevent contamination—structurally and hygienically? Maybe the production quality control checks failed. Did the manufacturer conduct an adequate food safety risk assessment prior to launching the new product? Profit margins are often thin—did financial incentives prevent the company from implementing a thorough food safety program?

Getting back to the basics of food safety would reduce recalls and foodborne illnesses significantly. Manufacturers must be certain about food safety as well as the integrity of the ingredients they use. They need to be honest with themselves and understand the risks of the ingredients, processes and finished products that they are handling.

Human error is a given. It’s the corporation’s responsibility to minimize the risk. Implement ongoing food safety education and training for all employees, explaining the proper food safety protocols and processes. Develop internal auditing systems, using innovative digital tools. Get rid of the pen and paper forms, where it’s more likely for errors to occur and for pencil whipping to happen. Digital solutions provide more effective internal auditing, meticulousness in corrective action systems including root cause analysis, allergen management, and controls relating to packing product into the correct packaging format—all fundamental to keeping foods, consumers and businesses healthy and safe.

Tim Birmingham, Almond Board of California
In the Food Lab

10 Years, 0 Salmonella Outbreaks

By Tim Birmingham
No Comments
Tim Birmingham, Almond Board of California

Almond Board of California (ABC) tackled food safety head-on in the wake of emerging Salmonella concerns in the early 2000s. Conventional wisdom of the time suggested that low-moisture foods like almonds presented a minimal threat, but rather than simply accepting this, ABC engaged in research to better understand the risks. The resulting best practices and groundbreaking mandatory pasteurization program developed by ABC remain the gold standard for other sectors—and drive continued food safety and quality efforts for California Almonds.

In 2017, ABC marked the 10-year anniversary of its mandatory almond pasteurization program – and, most importantly, 10 years free of Salmonella recalls and outbreaks attributed to California Almonds. The almond industry is proud of its unified efforts over the last decade, as well as the food safety record we’ve been able to achieve. However, the work to protect and improve food safety and quality continues. Looking back at our initiatives and successes reminds us of how important this work is and drives our exploration of what’s next.

Understanding and Addressing the Risk

Outbreaks of Salmonella in 2001 and 2004 raised questions and concerns about food safety and quality across industries. For California Almonds, one of the biggest challenges was determining the true level of risk. The easy answer seemed to be that risk should be low, that, based on accepted conventions of the time, pathogens should not be able to grow in almonds and other low-moisture foods. However, ABC investigated further and quickly realized that the pathogen could present a problem. The organization decided to take action and tackle Salmonella and other potential threats.

In collaboration with food safety experts and research partners, ABC began research in 2001 to better understand the prevalence and concentration of contamination in almonds, conducted in tandem with efforts to develop strategies for contamination control. ABC was able to gather enough survey data over the course of several years to show that Salmonella was indeed present in about 1% of the almonds tested at very low concentrations. This data was fed into ABC’s risk assessment work, which enabled identification of appropriate performance criteria for ensuring consumer safety (>4-log reduction).

At the same time, ABC also worked to identify effective processing technologies and the best means of validating them. A technical expert review panel was assembled to help ABC develop a plan, assess research needs, establish standards and create guidelines for the industry. Extensive work went into determining how to validate equipment, including the determination of an appropriate surrogate (non-pathogenic microorganisms) that could be used in lieu of Salmonella in the plant. Concurrently, researchers worked to determine the specific time and temperature combinations needed for a >4-log (and 5-log) reduction for a range of pasteurization processes, including oil roasting, blanching and dry roasting, some steam processes and PPO processing. ABC and partners invested significant time and effort into this research, which culminated in the development of the groundbreaking mandatory pasteurization program for Salmonella reduction, and validation guidelines.

Process Implementation and Ongoing Education

Voluntary compliance with the pasteurization program began in 2004, well in advance of September 2007, when it became mandatory. By that time, pasteurization was established as the industry norm and laying the groundwork for ongoing food quality and safety efforts. Today, ABC has more than 1 billion pounds of validated pasteurization capacity for processes that maintain the raw characteristics of almonds, including steam, moist heat and propylene oxide (PPO). It also has close to 1 billion pounds of validated capacity for processes such as dry roasting, oil roasting and blanching. All reduce the level of potential contamination in almonds without diminishing the product’s quality, nutritional value or sensory qualities (taste and crunch).

ABC also developed a comprehensive round of updates to recommended food safety practices, creating a powerful program with tools that help growers and processors achieve their desired results. These tools include Good Agricultural Practices, Good Manufacturing Practices, HACCP guidelines and Pathogen Environmental Monitoring resources.

In total, ABC has made a $5 million investment in food quality and safety research and validated more than 200 treatment processes, to date. It remains committed to this mission, maintaining close connections with the scientific and regulatory communities to stay current on food safety in the broader context as well as issues specific to California Almonds. All relevant insights and information are disseminated to growers and processors in the form of clear, practical resources, including print publications and digital communications, and workshops and one-on-one field trainings.

What’s Next: Research, Tech and Regulatory Practices

The mandatory pasteurization program is now well established, but it isn’t static – ABC continues to stay on top of the latest methods, regulations and needs impacting California Almonds. Industry investment continues to increase, particularly in processes that maintain the raw characteristics of the product. And, while much information regarding processes and technologies are company-specific and confidential, equipment manufacturers continue evolving and growing their offerings, with a particular focus on maximizing almond quality and throughput.

On the regulatory side, FSMA continues to roll out for growers and processors. ABC helps growers and other stakeholders understand which rules apply, what actions to take to ensure compliance and when specific requirements come into effect for different operations, with FSMA-related resources, Preventative Controls and Produce Safety trainings and timely information available online. Many processors and non-farm huller/shellers started 2018 already meeting FSMA Preventive Control requirements, but the number of impacted orchards and huller/shellers expanded in January as the Produce Safety rule came into effect. At this point, the almond industry and the larger community of food and beverage industries have had time to assess the impact on their stakeholders and take action to ensure FSMA compliance.

FSMA reflects the evolving role of FDA in ensuring food safety. Traditionally, FDA has taken a reactive approach to food safety. The agency now has the authority to investigate farms and facilities regularly to ensure food safety regulations are followed. For the first time, growers and huller/shellers falling under the farm definition may be audited by FDA or FDA-designated agencies. While some growers may choose the exemption option, ABC encourages almond growers to understand the rule’s requirements and develop food safety plans appropriate to their farms. It will be new and uncertain territory for some, but with the FDA’s proactive approach, staying ahead of the curve on food safety and quality will be beneficial.

Currently, almonds are the only tree nut with a mandatory pasteurization program and defined performance criteria accepted by FDA. They have paved the way for validation of other tree nuts, and those industries should also consider implementing appropriate preventive controls for Salmonella. ABC’s work can be considered a road map for other nuts and low-moisture foods, but what works for almonds will not always work for other foods. Research specific to each type of nut needs to be conducted to uncover pathogen prevalence and concentration, as well as pathogen/surrogate resistance to various processes. We will continue to be proactive, as well, evaluating current practices and engaging in research to improve how we understand and control microbial contamination in almonds.

Even with a track record to take pride in, the responsibility and work of food quality and safety never end. We will continue to update and evolve programs, not only as a function of compliance, but to protect the almond customers who support us every day.

Recall

FDA Food Recalls Up Nearly 93% Since 2012

By Food Safety Tech Staff
1 Comment
Recall

Over the past five years, the food and beverage industry has seen a big increase in the units recalled—a 92.7% spike in FDA recalls and an 83.4% increase in recalled pounds by USDA since 2012, according to Stericycle’s quarterly recall index. The firm cites technological advances in food testing, factory farming and more automation in food production as the main contributors to the high numbers.

During Q4 2017, bacterial contamination and undeclared allergens led the pack in food recall causes. According to Stericycle, back in 2012, about 28% of FDA food recalls were a result of bacterial contamination, while undeclared allergens accounted for 35% of pounds of food recalled by USDA. During Q4 2017, 44% of food recalls (based on units) were from bacterial contamination, followed by undeclared allergens (31%), mislabeling (13%), and quality (10%). Among the top categories for recalls were prepared foods (20%, nuts and seeds (16%), produce (15%) and baked goods (12%). In addition, nearly 50% of the USDA recalled pounds were a result of lack of inspection.

Lance Roberie, D.L. Newslow
FST Soapbox

Can You Defend Your Food Safety Plan?

By Lance Roberie
1 Comment
Lance Roberie, D.L. Newslow

As a food safety plan manager, do you ever get asked these questions regarding your food safety plan: What was your thought process for making this decision? Why do you do it this way? How do you answer this?

And, do you ever answer with one of the following statements:

  • I’m not sure? What do you mean?
  • That’s the way it has always been.
  • Our customer asked us to do it that way.
  • That’s what our last auditor recommended.
  • We make a low-risk product.

If this is one of your answers, defending your food safety plan may be a challenge. There is a major shift taking place in the world of food safety. With the implementation of FSMA Preventive Controls, the widespread adoption of GFSI audits, along with advanced technologies such as rapid pathogen and allergen detection, whole genome sequencing, and transparency efforts such as Blockchain, as well as with the increasing use of social media and access of information via the internet, food industry professionals are more educated and informed than ever before and ready to challenge your every move. As a food safety plan manager, you and your team must be ready! Being prepared to defend your food safety plan can be the difference between a recall and a routine audit. If you cannot fully explain the reasoning behind your decision-making, then how will you be able to prove that you are in complete control and are being proactive against food safety hazards? It will not be easy.

You must be ready to defend each and every part of your food safety plan. You must be able to defend questions and challenges with certainty and facts. Every decision made in your hazard analysis should be written down and backed with factual evidence whenever possible. Even the “none identified” areas should be backed by strong reasoning if no other factual evidence is available. You can use the data that you collect daily to help justify your decisions. Data collected from your prerequisite programs (ATP swab results, allergen cleaning validations, GMP audit findings, pest control trends, etc.) and food safety plan (CCP’s, validations, verifications) is all support for your decisions. Have this on file and ready to review when necessary.

If something looks out of the ordinary in your plan, make sure you can fully explain it and can back it with solid justification. If not, auditors, regulators, customers, etc. may start to become suspicious, which can lead to unwanted questions. You will then oftentimes start to get suggestions for change based on others’ individual expertise. Regulators may make “strong suggestions” for changes, for instance, and some people will just go along with it to avoid the pushback or because they simply don’t have a better solution. If this happens, soon your plan is no longer yours—it’s everyone’s. Some of these suggestions may be good, but is it really the right change for your plan? If not, it will often make the plan less rational and often difficult to defend.

The following are tips to help you avoid this situation.

  1. Meet with your food safety team regularly. Go through each part of your food safety plan and figure out how to answer the “why’s”. Why are things done this way? Why did we decide if this hazard was significant or not? Have annual reviews to make sure your plan is still functioning as originally intended and review new industry trends to be proactive regarding new potential hazards.
  2. Write a process narrative. Writing a process narrative documenting what happens at each step of your process and explaining your “thought process” for making decisions is a great support tool. It gives your team a chance to elaborate on the “justification” column in the hazard analysis, providing more decision-making details without crowding the hazard analysis form.
  3. Gather supporting documents. Scientific studies, guidance documents, expert opinions, etc. are vital pieces to have in your supporting documents library. Make sure it is appropriate for your individual products and the documents are from reputable sources, such as FDA, USDA, universities, process authorities, etc. Oh, and don’t forget about history! A reputable supplier with a long track record of safe product, a low history of recalls for the products you produce, etc. can help justify your decision-making.
  4. Conduct Internal Audits. Having an internal audit schedule and well-trained internal auditors help with finding inconsistencies within your program and allow you to make corrections before outside parties find these issues.
  5. Prepare. Have a “mock audit” and prepare for questions that are commonly asked during audits. Practice your answers and make sure you have supporting evidence when needed. Stay up-to-date with industry trends, especially common audit non-conformances.
  6. Be organized. It’s great to have all the supporting documents that you need, but if you cannot find them, then you just as well have nothing.
  7. Be confident. People, especially experienced auditors and inspectors, can quickly sense fear and lack of confidence. This often prompts more questions. Knowledge is power, and knowledge also builds confidence. Simply put, the more knowledgeable you are about your food safety plan, the more confident you will be when someone is trying to test you.
  8. Continuously Improve. It’s understandable that mistakes will be made. However, the next logical question you will be asked is: What did you do about it? Remember, for every nonconformance you find in your system, there should be a correction or corrective and preventive action to address it. It must not simply restate the problem, but legitimately correct the issue. This will give regulators, auditors, customers and anyone else looking at your system confidence that you are in control and can provide a consistently safe product.
Scott Gottlieb, M.D., FDA

FDA’s Gottlieb Says Some Food Recall Practices Raise Significant Concerns

By Food Safety Tech Staff
No Comments
Scott Gottlieb, M.D., FDA

Following the Office of Inspector General’s (OIG) final issuance of its report on FDA food recall practices, FDA Commissioner Scott Gottlieb, M.D., is voicing concern. The OIG report looked at FDA food recall practices from October 1, 2012 to May 4, 2015. Its findings are obvious in the report’s title: The Food And Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply.

“Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always (1) evaluate health hazards in a timely manner, (2) issue audit check assignments at the appropriate level, (3) complete audit checks in accordance with its procedures, (4) collect timely and complete status reports from firms that have issued recalls, (5) track key recall data in the RES [Recall Enterprise System], and (6) maintain accurate recall data in the RES,” according to the OIG report.

Food Safety Tech first reported on the draft findings in June 2016 when the OIG said the FDA recall initiation process was not efficient or effective. Although Gottlieb noted that the agency took action after the draft was released, “we still have more work to do,” he said in an FDA statement.

One of the action steps for 2018 is that FDA will issue guidance on recall communications in the first half of the year. The agency is also looking at situations in which it can assist consumers in getting information about the stores and food service locations that may have sold or distributed recalled food, as well as the company that supplied the product.

“Much work remains to be done if we’re going to provide the highest assurance of safety.” – Scott Gottlieb, FDA

Gottlieb stated that the agency will be revealing more early this year about policy steps it will be taking to improve food safety oversight and how the recall process is implemented. FDA is also examining how it can expedite the timeliness and scope of information provided to consumers about food recalls.

Julie McGill

Make Your Food Chain Recall Ready At The 2017 Food Safety Consortium

By Julie McGill
No Comments
Julie McGill

As we reflect back on 2017, food recalls continued to dominate our headlines even after the implementation of FSMA. Our industry has taken corrective actions to limit risk. We want to protect consumers as well as our brands, limiting the financial and reputational damage that a recall can inflict on a company. We, along with consumers, are also more aware and in tune with the news due to social media and the 24-hour news cycle. It may appear that there are more recalls, but I would argue that the industry is more proactive and more accountable by submitting itself to voluntary recalls. Without a doubt, the food industry is under increased pressure.

Looking forward to 2018, we are reminded that it was 25 years since the E. coli outbreak at Jack in the Box. It was a monumental turning point in food safety that sparked the industry to modernize and examine processes. Since then, the food industry as a whole has come a long way. During my 16 years at GS1 US, working on programs such as the Foodservice GS1 US Standards Initiative, I saw food companies embrace global standards to increase efficiencies and build a foundation for traceability and supply chain visibility. Now adding Blockchain, Smart Labels, and IoT data to the technology mix will continue to advance the modernization of the food industry.

The good news for our industry is that consumers are patronizing companies that are embracing transparency as a strategic business strategy and these are the companies who are winning the market share as a result.

As stewards of our industry, we will always review our processes, continue to train and educate our employees and adopt better ways of guarding the supply chain. One way to become better at protecting the food chain and the public is exchanging ideas with our peers. We are stronger together.

That is why I am excited to bring together a diverse group of industry leaders for this year’s Food Safety Consortium to discuss this very topic. Titled, Is Your Food Chain Recall Ready?, I will be joined on Thursday, November 30th at 2:30pm CST by Jessica Jones, sr. specialist of Supplier Quality & Safety at Chick-Fil-A; Barbara Hullick, senior director of Food Safety at Produce Alliance and Bryan Cohn, vice president of Operations at Seal the Seasons.

During this panel session, we will discuss:

  • Best practices for FSMA compliance before, during and after a recall.
  • Best practices to execute precise, data-driven and timely recalls and stock withdrawals.
  • Establish and execute a process for escalation and post-recall audit reporting.
  • Work and communicate with suppliers and distributors on “what if” scenarios and what they can expect when quality issues arise.
  • Create a food safety culture which works in concert with legal, marketing and other internal teams.

I hope you will join us in person at the Renaissance Schaumburg Convention Center Hotel for the entire conference but if not, join us virtually! Registration details can be found on the Food Safety Consortium website.

Dollar

Trends and Real Cost of Product Recalls

By Food Safety Tech Staff
1 Comment
Dollar

Last year, nearly 550 food products were recalled in the United States. Nearly half of those recalls were a result of biological contamination, a whopping 65% of which was due to Listeria monocytogenes, according to Rentokil. The company recently released an infographic about the cost of a product recall, pulling out some of the key trends in food product recalls in the United States and the United Kingdom. Next to biological contamination, mislabeling continues to be a large issue.

Rentokil Product Recalls 2016
The Cost of a Product Recall in the Food Industry. Infographic courtesy of Rentokil.