Randy Fields, Repositrak
FST Soapbox

What Comes After FSMA?

By Randy Fields
No Comments
Randy Fields, Repositrak

The initial deadlines for Food Safety Modernization Act implementation are upon us, and while it will be a year or more before companies must comply with the regulations, now is an appropriate  time to consider the happens next with food safety in the United States. Packaging requirements, issues with imports, the move toward clean labels, updating facility auditing requirements, and a wide set of compliance issues will be near-term time-consuming issues for food safety directors and executives all the way up to the c-suite.

FSMA is the most impactful set of safety regulations to hit the grocery and restaurant industries since before World War II. But there are other elements of consumer protection that will quickly capture the attention of supermarket and foodservice executives after August, and smart companies are already looking ahead to ensure a competitive advantage.

Packaging requirements aren’t just limited to country of origin labeling. Consumers are demanding full transparency from manufacturers and the retailers from which they buy their food. Shoppers are demanding clear descriptions of what they’re eating and voicing their displeasure for companies that are not providing the details they want by buying competitive items. A quick look at the comparative sales of the big processed food companies during the last few years verifies this isn’t a fad.

Tainted imported food (for both humans and pets) nearly a decade ago was a key trigger for the legislation that ultimately became FSMA. While the act addresses record keeping and some elements of lab testing, there are still several issues to tackle, including third-party validation rules and the voluntary program for importers that provides for expedited review and entry of foods.

The move toward clean labels or reducing the number of ingredients in processed food is taking form in several different ways. For example, many manufacturers, particularly those that make products targeting young consumers, are eliminating high-fructose corn syrup from their product lines to address consumer concern about the impact the ingredient is having on obesity and other health issues.

Updating facility auditing requirements, at retail, foodservice and manufacturing operations, has been largely left to trade associations and the companies themselves. A single incident of foodborne illness or death linked to a store commissary, a restaurant or a processing facility is all it will take for consumers to demand government action to raise standards and increase inspections.

On compliance issues, FSMA requires companies to collect verification data of their supply chain’s adherence to regulations for up two years and have it accessible within 24 hours. Similar to Sarbanes-Oxley, CEOs are responsible for verifying the compliance of their supply chain under FSMA.  Given these risks, companies have started to automate their management of compliance documentation. Now forward-thinking companies are applying the same technology to ensure that information supplied by trading partners on products such as gluten-free goods or items containing nuts is frequently updated to avoid lapses that could lead to lawsuits and worse.

There certainly are a few different visions of the future of food safety. One commonality is that consumers will continue to demand an even safer food supply chain.  If companies don’t pursue this goal, legal action or governmental regulation will step in to encourage change.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

Creating a Food Safety Culture

By Deirdre Schlunegger
No Comments
Deirdre Schlunegger, CEO of STOP Foodborne Illness

Thanks to Walmart, I recently had the good fortune to attend a course titled “Creating a Food Safety Culture” at Michigan State University. Presented by Frank Yiannas, vice president of food safety for Walmart, the course was an invigorating gathering of food safety professionals and included striking conversations about culture, food safety, and behavior-based modalities. Frank even mentioned this blog in class, saying, “I am in” in reference to the Food Safety Culture Club. We found time for some fun in the evenings, which included a night out with “Sparty” the MSU mascot and a dinner at the Eli and Edythe Broad Art Museum on Campus. What a great time!

After introductions, Frank started the two-day class with a definition of culture. He presented it as defined by the Social & Behavioral Foundations of Public Health: “Culture is shared patterns of thought and behavior that characterize a social group, which are learned through socialization processes and persist through time.”

This launched a delivery and discussion of attributes of a food safety culture, diving deeper into each attribute. We learned about the Science of Influence and discussed a proposed divergence between the terms “accountability” and “responsibility”. Frank framed the presentation by contrasting Traditional verses Behavior-Based Food Safety Management. We thought about how the world, the food supply and food safety is changing. In the view of STOP Foodborne Illness, one thing remains the same: Food Safety only exists because humans can and have become ill from eating, which instigates a string of consequences, none of which are positive. And only humans can make a difference—OK, well, with the help of technology.

Frank shared the slide from the STOP Foodborne Illness website that portrays the faces of those who have perished, those with life-long consequences, and the survivors of foodborne illness. From the perspective of STOP Foodborne Illness, the most important food safety attribute is human life, and it must lead, be at the forefront, and be integrated into each and every attribute, goal and measurement so that the consequence is not serious illness or the loss of life.

Image courtesy of STOP Foodborne Illness
Image courtesy of STOP Foodborne Illness

Frank shared the quote from the 2003 Investigation Board of the Space Shuttle Columbia (the incident when the shuttle Columbia broke up upon returning to Earth, killing seven astronauts on board. The board cited cultural traits and organizational barriers that prevented effective communication and thus affected safety). “In our view, the NASA organizational culture had as much to do with this accident as the foam.” This certainly is relevant in food safety environments, and there is much to be learned.

This is just a snippet of the course—there is so much more to share, and just not enough room here. Hats off to Frank, to my colleagues, to Michigan State University, and to Walmart. I came home with many thoughts, ideas and planned actions to share with the staff, board and constituents of STOP Foodborne Illness. Let’s keep the conversation going and grow membership in the club!

Paul Dewsbury, B.Sc.
In the Food Lab

Is that Pricey Wine the Real Deal? Using IRMS to Detect Fraud

By Paul Dewsbury
1 Comment
Paul Dewsbury, B.Sc.

By Paul Dewsbury, B.Sc.

Upon conducting some online research to find a nice bottle of wine to bring to a party, I became distracted by a story about the world’s most expensive wine, priced at an eye-watering $195,000. With just a few clicks, I uncovered stories about auctioning a single bottle of wine for more than $300,000, and a case of 114 bottles selling for a record $1.6 million. Some of the reasons for the huge sums invested in pricey wines include rarity, social status of owner (aka famous), vintage, and perhaps most importantly, region and vineyard.

Ever the analytical chemist, I wondered, how do buyers identify whether that the extravagant bottle of wine they’re purchasing is the real thing? Perhaps the serious wine collectors out there could benefit from having an isotope ratio mass spectrometer (IRMS) in their cellar! But seriously, could IRMS play a role in authenticity testing?

Testing for Authenticity and Geographic Origin of Wine

Increasingly, fraud surrounding the provenance of wine has become a problem. Last year, a man was sentenced to 10 years in prison for selling millions of dollars of counterfeit wine. He not only created fake labels, but he also mixed and blended lower-priced wines to imitate the taste and character of rare and much more expensive wines.

An article published last year about the authenticity and geographic origin of wine discusses the results of investigating the stable isotope composition (C and O) of wine samples.1 The authors claim to have found significant isotope variations within samples from the same country as well as between samples from different countries.

¹³C and Simultaneous ¹⁸O and ²H Isotope Analysis in Ethanol with Thermo Scientific DELTA V Isotope Ratio Mass Spectrometers is also a useful resource, as it defines the configuration required for such testing. The method demonstrates excellent results and could be quite suitable for origin testing of wine. Isotopic analysis of wine has become a widespread tool to evaluate the quality, authenticity and origin of labeled products. This application note shows the ability and performance of the analysis of ethanol with combustion and with a high temperature carbon reduction technique in combination with a DELTA V IRMS. With this configuration, the ethanol can be analyzed for oxygen and carbon isotope composition. The analysis allows for the quantification of exogenous sugar added during the fermentation process, which is used to increase the alcohol content of the wine. This control is also needed for the detection of frauds, such as mislabeling regarding both ingredients and origin.

Most laboratories will seek alternative or complimentary techniques for authenticating wine. A few months ago, I blogged about using an ion chromatography method to verify the authenticity of your wine. I was also captivated by the poster, Related Seasonal and Geographical Differences in Wine from California’s Central Coast, which describes how a high performance liquid chromatography coupled to mass spectrometry (LC-MS) configuration was successfully implemented to analyze several wine varieties from different areas to show simultaneous detection and relative quantification of the wine’s components.

Wine authenticity is a fascinating subject, and I will leave you with this unbelievable but true story. In 1989, a bottle of 1787 Château Margaux from Thomas Jefferson’s wine collection was valued at more than $500,000 by its owner, William Sokolin, a New York wine merchant. At a dinner, it was accidentally knocked over and broke. What’s more,  the insurers paid $225,000 for the loss of the wine.

And to get back to where I started—I went to the supermarket and picked up a cheap bottle of wine. I don’t think anyone was the wiser, either.

References

1. Horacek, M., Papesch, W., Ogrinc, N., Magdas, A., Wunderlin, D., and
Misurovic, A. (2014). Control of Authenticity and Geographic Origin of Austrian, Slovenian,Romanian, Montenegrin and Argentinean wine, Geophysical Research Abstracts, 14. Retrieved from: http://www.josephinum.at/fileadmin/content/BLT/Puplikationen/1444-00_E.pdf.

Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group
Beltway Beat

Market Withdrawal Vs. Recall: What’s the Difference?

By Peyman Fatemi, Melanie J. Neumann
3 Comments
Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group

Determining whether to initiate a market withdrawal or recall procedure depends on the situation and unfortunately, is not always a clear-cut decision. Whether due to a lack of insights into the intricacies of recall management nuances o r because you simply cannot please everyone all the time, even using the best judgment can still cause upset. Take, for example, the 2013 Chobani yogurt incident: Let’s look at some of the facts surrounding the case.

The Chobani Market Withdrawal

On August 31, 2013, Chobani initiated a market withdrawal of yogurt due to “quality concerns surrounding certain products, which were experiencing swelling or bloating.” On September 3, the company stated that the issue was caused by a type of mold “commonly found in the dairy environment”.

Although the mold (Mucor circ inelloides) was not considered to be a disease-causing foodborne microorganism and “should not pose a health risk to most consumers” (according to Chobani’s blog), the company moved from a voluntary market withd rawal of the product to a voluntary recall on September 5.

Chobani seemed to be following protocol on withdrawals and recalls, and it was providing daily updates to consumers on its blog, but it did not escape negative publicity. In fact, foodborne illness lawyer Bill Marler, who dedicated nine of his own blogs to the incident, stated, “This probably ranks near the top in a mismanaged recall/market withdraw/PR disaster that I have seen in 20 years.” And directed questions to Chobani, including: “Why did you at first try to quietly ‘withdraw’ the product instead of issuing a ‘recall?’”

Market Withdrawals vs. Recalls

So, when should you initiate a market withdrawal and when might does it need to be elevated it to a voluntary recall (and if so, at what recall class)? In addition, at what point does FDA escalate it to a mandatory recall? Or, when should you voluntarily inform FDA yourself?

Chobani’s issue was not an isolated case. There are several theories about why its recall received so much negative publicity. Was the company slow to initially respond? Could it have stayed on top of social media monitoring more proactively? Did it take too long to determine the need to elevate from a market withdrawal to a recall? Some would say yes. Others would say the company made the best decision it could with the facts it had at the time it had to make the decision. Whatever the reason—understanding the nuances between market withdrawals and recalls will help.

Since each case will be unique, there isn’t a hard-and-fast answer without discussing the particulars of each situation, but we can provide you with more information about withdrawals and recalls – so that your first reaction and call are, if nothing else, at least a bit less frantic.
FDA’s definitions:

• Market withdrawal: When a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation.
• Recalls: Actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
Class I: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II: Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Class III: Use of or exposure to a violative product is not likely to cause adverse health consequences.

In the Chobani case, an initial assessment showed that “common mold” was a quality issue that did not violate food safety regulations or require a recall, so the company initiated a market withdrawal. However, as more people who consumed the yogurt allegedly became ill, the incident was escalated (although no confirmed link was established) and was eventually classified by FDA as a Class II recall.

Your company needs to ask this type of question when a product is found to be defective in any way. Not only which of the above definitions does it fit at this time, but also whether it is likely that the consequences could be more severe. Using Chobani as the example, perhaps the fact that containers were bulging and exploding would indicate that there was a component in the product that could potentially make people sick? You need to constantly reassess the situation and consider if a status or actions must change.

Additionally, you need to consider your brand reputation. No one really wants to go to the regulators and fess up to a mistake that may not become an issue. But, it’s kind of like telling Mom you accidentally spilled your red Kool-Aid on the carpet before she sees it. If immediately targeted, that stain just may come out – and she may even consider your scrubbing of the carpet and promise to NEVER again take red Kool-Aid into the living room as “corrective action” enough. But if it sits for a day and she finds it herself while you remain quiet, it could be permanent, her trust in you soiled, and the punishment more severe than if you would have just told her in the first place.

When in doubt, if you address the potential “stain” on your product and brand head on, admit to your error, be upfront about the cause – and what you are doing to correct it – to both FDA and your customers, FDA is likely to work with you on your situation, and your customers will forgive you and continue to buy your product once they know the issue has been corrected. Understanding the differences between market withdrawals and recalls will be key to possibly avoiding a “spill” in the first place.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Feeding the Fear and The Battle to Regain Consumer Trust

By Maria Fontanazza
No Comments
Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

When it comes to educating consumers, the process of building trust goes beyond providing research and scientific information. Consumers respond to having connections and shared values related to food safety, the treatment of animals, and nutrition. However, today’s crowd-sourcing environment has served to both enlighten and distribute information that isn’t always fully understood by consumers.

As food companies are facing increasing pressure for transparency, they’re grappling with more effective ways to communicate what’s in their products. “That’s a healthy part of the marketplace, and there’s nothing wrong with food companies responding to consumer demands,” says Jayson Lusk, Regents Professor and Willard Sparks Endowed Chair in the Department of Agricultural Economics at Oklahoma State University. In many cases, when companies provide more information about certain ingredients, it puts them in a difficult position. “Often, many consumers are not in a position to evaluate or understand why an ingredient is used or evaluate the safety risks, so there are all kinds of biases that consumers have; [for example,] if it sounds like a chemical name, it must be deadly. There are all kinds of misinformation on the Internet about various food ingredients that consumers have easy access to.”

Just giving stats and scientific information isn’t always the most effective route. “People don’t tend to respond to just scientific information. That’s unfortunate,” says Lusk. “The research shows people are more persuaded by stories, by a better understanding of why farmers or food processors might be interested in using a particular ingredient.”

Issues surrounding artificial additives, antibiotics and GMOs are particularly contentious, and marketing and advertising play a big role in shaping public perception. Take, for example, gluten-free orange juice. Most natural juices (not juice drinks) are free of gluten, but labeling them as such opens the door to new markets (or maybe it just confuses people more). “One of the big challenges for a lot of food companies, especially big companies that have multiple brands appealing to different segments, is that on the one hand, they defend the use of certain ingredients [for example, genetically modified organisms],” says Lusk. “At the same time, they offer brands that make claims that say they don’t have those ingredients and make all efforts to make sure we aren’t selling you these things.”

This dichotomy can be perceived as a lack of integrity, because it undermines the message of trust that food companies want to convey to the market. Companies need to explain why they’re using certain ingredients in a product and the impact it has on safety and nutrition. And consumers need to understand that either the addition of or absence of certain ingredients can lead to higher prices. Many consumers are willing to pay a premium for products that are labeled as organic or non-GMO, but many consumers still want food to be affordable.

This year companies are being particularly aggressive in announcing their moves to remove additives or antibiotics, or provide GMO-free menus, but the question remains as to whether this will have a positive impact on the bottom line, as well as whether consumers really understand the implications. In April, Chipotle publicized that it was the first U.S. restaurant chain to use only non-GMO ingredients. However, if you read the fine print, you’ll learn that its tortillas still use additives, and the soft drinks that the chain sells may contain sweeteners from GMO corn. Panera stated its plans for removing artificial additives from its menus by the end of 2016. Kraft’s famous Macaroni & Cheese will no longer have that eerie glow, as the company is nixing artificial flavors and dyes, including Yellow No. 5 and 6. Walmart just voiced its new position on responsible use of antibiotics in farm animals, and so did President Obama—at least in Federal cafeterias.

And in an effort to put the kibosh on the “big is bad” mentality, Hormel has put down $775 million to pick up Applegate Farms, a producer of organic meats. Rest assured, as Applegate tells its irate consumers on its Facebook page, its products will “continue to work toward transparency in labeling” and its “standards and products won’t be changed”. Applegate is doing the right thing. It is engaging with consumers, whether or not it likes what they have to say, and it’s doing so in a non-defensive way.

Beyond this, companies need to really study their consumers, understand their patterns, and learn how to educate them in a meaningful way—beyond a simple label.

I try to avoid food with a lot of extra…crap. But sometimes I’m just too tired (or hungry) to pay attention to every detail on the label. And sometimes I eat that red velvet cupcake at a party and, after examining my florescent tongue in the bathroom mirror, I think, shoot—how much dye was in that??? And maybe I like the idea of slicing an apple that doesn’t turn brown. Then again…maybe I don’t.

Truth is, I’m just not sure yet.

Maria Fontanazza
Editor-in-Chief

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Panera Throws Down the Gauntlet by Removing Artificial Additives

By Dr. David Acheson
No Comments
Dr. David Acheson is the Founder and CEO of The Acheson Group

Earlier this month, Panera announced its intention to remove “artificial additives by publishing a list of artificial colors, flavors, sweeteners and preservatives that it has eliminated or intends to remove from its [menus] by the end of 2016.” The company’s position wasn’t a response to consumer demand but rather the latest step in its Food Policy of holding itself accountable.

Whether you think Panera’s move is good or unnecessary; whether or not your company plans to start removing additives (or GMOs), it’s important to understand that the food industry is truly driven by consumers. And consumers are all-to-often driven by consumer group and media hype, or by trends they don’t truly understand. It is just as important to understand that whether you are a foodservice provider, retailer, or anyone upstream in the supply chain, this movement impacts you.

Panera commented, “We are not scientists”. However, the company did consult with third-party scientists and experts to create a list of “common artificial additives” with a goal to “unengineer” its food menu and remove artificial additives “that have become prevalent across the industry’s supply chain.” Interestingly enough, Panera never directly states that these additives are bad—they’re just “artificial”. Panera did, however, allow others to say it for them in a series of quotes contained in the company’s press release.

According to the release, “The artificial additives on the No No List will be removed across the Company’s food menu, from bakery to soups to salads and sandwiches. The list also includes substances like high fructose corn syrup and artificial trans fats. There are more than 150 ingredients that will be impacted.”

Don’t believe all 150 ingredients are bad? Your product uses only “a little” high fructose corn syrup? You need to use an ingredient on EWG’s “dirty dozen” list (among the 150 to be discontinued)? You use antibiotics for your poultry? Too bad. If you want to supply Panera (or Chipotle or Whole Foods, etc.), you’ll be left with the option either following their limitations or not supplying them at all. Panera touts itself as the first national restaurant company to publicly share a comprehensive list of ingredients to be removed, but it’s not the first to begin banning ingredients. And with the vocal nature of the consumer groups and the media, it certainly won’t be the last.

If you are a retailer or foodservice provider yourself, be aware that Panera has just thrown down the gauntlet. Will you pick it up and join the fight? Will you publicly share your own list of ingredients in a very transparent way … can you? Now that one company has “shared,” we have to believe it’s going to start a wave of disclosure, either as a competitive tool or in response to public demand—or both.

What if you believe in “engineering”? You know your ingredients are beneficially engineered for health, productivity, or to feed the world in 2050. What are your options if you don’t intend to give into the pressure? You can try to fight transparency with transparency focused on science and communication. Consumers want to know what is in their food, and they have a right to know. They also have a right to understand what is in their food and why, but it is up to industry to be communicating that. But, and it is a huge but, there are many consumer organizations that strive to keep the general consumer off balance and continuing to not trust what the science is telling us. Those battles are very hard to fight let alone win. As soon as the food industry points out that “ingredients” are safe and approved for use, the consumer reaction is one of lack of trust.

Just as we are beginning to see global food safety standards being set (e.g., GFSI, FSMA, etc.), manufacturers and suppliers are being handed a whole new array of “clean” requirements (bringing new audits?) that varies from customer to customer. This adds to the complexity of food production. And if we are not careful, these changes will introduce risks to the food. As we use less preservatives and salt, the obvious concern is that the microbes will simply move in and grow.

Does it ever end? Not if you consider the implications of a comment by Michael Jacobson, executive director of the Center for Science in the Public Interest, in a USA Today article that a greater nutritional problem with Panera’s menu items are their high-calorie counts, “wide use of white flour and excessive use of sugar.” Even if the additive-GMO-artificial ingredient issue gets solved or blows over, there will always be a new health-nutrition-safety-quality-trending issue or fad developing just over the horizon.

It seems you can’t win for losing, so your best bet is to do what you believe is best for your customer and your business, communicate what and why you do what you do, be as transparent as is practical, and keep an eye on the horizon for the next wave. Panera has done this; it has put its flag in the sand in order to enhance its brand and its business. There will be some in the food industry that look at these changes as a threat or a mistake. However, the reality is that it is the way of the future. Food companies make money by selling food, and consumers are the ones that ultimately put the money in the system that keeps it all going. So ignore consumers at your peril, but a huge challenge for much of the industry is that, at the retail and food service end it is easy to make quick changes – but in the manufacturing end it is often neither easy nor fast, and it will be costly.

Randy Fields, Repositrak
FST Soapbox

Despite FSMA Exemptions, Compliance Will Not Be Optional For Small Suppliers

By Randy Fields
No Comments
Randy Fields, Repositrak

The product recall at Blue Bell Creameries earlier this year is yet another example of food safety issues negatively impacting food marketers, growers, processers and manufacturers. We all remember the Peanut Corporation of America’s salmonella outbreak in 2008 and the Jensen Farms listeria outbreak in 2011. Salmonella-tainted eggs in 2010, E. coli in strawberries in 2011, and listeria in caramel apples last Halloween combined with dozens of others during the last six years, have sickened thousands and killed dozens of people.

The brand reputation impact from the incidents at Peanut Corporation of America and Jensen Farms was terminal—both companies went bankrupt. The effect on Blue Bell, while likely not fatal, is expected by industry experts to be substantial and include loss of revenue and market share. The company has already announced plans to lay off more than 1,000 workers as a result of the recall.

In addition, growers saw cantaloupe consumption take a nosedive after the Jensen Farms listeria outbreak, which was one of the worst foodborne illness outbreaks in U.S. history in terms of number of deaths. They are only now seeing sales levels return to those before the incident. And because the farm itself went out of business, personal injury lawyers went after the companies that sold the disease-ridden cantaloupes—the retailers. By virtue of last year’s out-of-court settlement by Walmart on the Jensen Farms lawsuit, both suppliers and retailers are now responsible for everything they sell.

Enter the Food Safety Modernization Act, signed in 2011 and about to begin finalization in August. FSMA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection. Add these records to the business relationship records that retailers and suppliers should already be maintaining (including indemnifications and certificates of insurance that help manage brand risk), and you’d think our risk of foodborne illness is about be eradicated.

Although FSMA represents the most sweeping change to our food safety laws in the last 70 years, it may not have the greatest impact where the supply chain is most vulnerable. Today the largest suppliers that sell the majority of our food have very sophisticated systems to ensure safe food production and transportation. This group will have the easiest path to compliance with FSMA, and they most likely already hold themselves to a higher standard. It’s actually the smaller suppliers, which likely do not have the available resources or sophistication to comply with FSMA requirements, that will be exempt from certain documentation under FSMA based on their size. This group of suppliers is growing rapidly to meet consumer desire for fresh food that is locally grown and produced. Unfortunately for them, it’s only a matter of time before wholesalers and retailers decide that the risk is too great to continue to do business with these small suppliers.

The good news is that technology exists that can help small suppliers reduce risk in their extended supply chains. Affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation. Suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall. This move to automation will help all suppliers not only meet the demands of FSMA, but also establish a base for retailer and consumer demands for transparency in the supply chain going forward.

Having a comprehensive food safety system is quickly becoming a competitive advantage. Retailers and consumers are looking for those suppliers that have an unblemished safety record and are transparent about their safety processes, so the time is now for small suppliers to hold themselves to a higher standard than FSMA requires for future business opportunities. The stakes are just too high for retailers and wholesalers to not verify that everything they sell to consumers is produced and transported safely.

Bug Bytes

Tis the Season for Mosquitoes. Take Preventative Action to Protect Your Facility

By Maria Fontanazza
No Comments

With the heat of summer quickly upon us, food processors should take measures to keep their facilities free of pests that can both harm workers and lead to contamination.

Memorial Day is the unofficial start of summer, a time when we can look forward to more relaxing days sitting by the pool, just enjoying life. But the season also welcomes the unwelcome: more bugs and other little critters.  It is during this time of year that food processers should be extra vigilant about inspecting their facilities to ensure that pests do not become a problem.

While small in size, mosquitoes can be big in nuisance. Ron Harrison, Ph.D., director of technical services at Orkin, LLC, offers a few steps that companies should take to prepare for the season to both protect workers from potentially serious disease transmission such as West Nile Virus or chikungunya virus, and keep mosquitoes from contaminating a food processing facility.

1.    Inspection. Conduct a thorough survey of the perimeter or outside of your building. Have your pest control professional or entomologist look for the presence of natural breeding sites and how they can be eliminated. For example, if there is standing water, how can it be drained? Can it be moved as opposed to remain standing? Growth regulators can also be used to inhibit the developing larvae.

2.    Secure your building. Make sure all screens are in place and that your heating and air system is in proper working order. Check the pressure of your building. If you have positive air pressure with a door open, it pushes air out; if you have negative air pressure, it sucks air in, so a mosquito or any type of bug could be sitting on the outside and get sucked inside.

3.    Use residual products. Mosquitos can be blown in from long distances. Using good residual products on vegetation and shrubs on the outside of your building can help reduce the population. In addition, make sure any dense landscaping is pruned to reduce the harboring sites where mosquitoes might live.

Harrison adds that the prevalence of mosquitos tends to be worse based on the location of a facility. This is where making sure your building is tightly sealed, from the cracks to the positive air pressure in entranceways, is important. “The biggest reason we struggle is that the building or processing plant is built in a swampy area, which is a haven for bugs,” he says. Other factors, including the color of the building (light-colored buildings) and the presence of excessive lighting, can attract more insects.
 
Now is the time for food processing facility managers to take action and inspect their facility. “Mosquitos are just now starting. In another two or three weeks, it’s going to get serious,” says Harrison. “Preventative activity means that later on in the season when they are bad, your processing plant won’t have problems because you took proactive steps.”

Deirdre Schlunegger, STOP Foodborne Illness
Food Safety Culture Club

Join the Club

By Deirdre Schlunegger
No Comments
Deirdre Schlunegger, STOP Foodborne Illness
 
Deirdre Schlunegger, CEO of STOP Foodborne Illness 

What is the Food Safety Culture Club and what does it mean?  Long before it was trending, STOP Foodborne Illness was talking about and cultivating food safety culture. We intimately know and share the compelling reasons, along with the “Why” behind food safety. Statistics without stories are not compelling. By hearing the stories and seeing the faces of those who have been ill or who have lost loved ones, the reason for a food safety culture is remembered—and these memories may translate into everyday food safety practices. Everyone has a role in food safety but for some, the only role was to become ill.  Think about cantaloupe, peanut butter, ice cream, pre-washed greens, candy apples and more.

Why should you care?  We are all consumers; we all have children, parents, friends and loved ones who we do not want to become ill from a preventable illness. No one wants for individuals to contract a foodborne illness.

So here we are, on a journey towards creating strong food safety culture in the lives of business leaders, the food industry, employees handling food, and in our schools and homes. I recently attended several conferences that had themes and program titles related to “A Food Safety Culture”. We know it is critical for leaders to embrace the culture, model safe and best practices, and we know it is important to share the reasons why.

In this column, I will talk about summer food safety, back to school food safety, the importance of hand washing, and many other Food Safety Culture Club topics.  

You are a significant contributor in keeping food safe; you make a difference.

STOP Foodborne Illness is a national nonprofit organization dedicated to preventing illness and death from foodborne illness by advocating for sound public policy, building public awareness, and assisting those impacted by foodborne illness. Contact STOP Foodborne Illness if you are interested in having one of the staff members or board members speak at your training.

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

How the Blue Bell 483 Inspection Reports Affect Us

By Dr. David Acheson
No Comments
Dr. David Acheson is the Founder and CEO of The Acheson Group

FDA has released the 483 Inspectional Observation reports involving the Blue Bell facilities following the recent Listeria outbreaks in ice cream. While most of the information contained in a 483 is not a big surprise to a typical food safety expert, I was still struck by some of the observations. Below are extracted sections within the 483 language that raised some questions in my mind.

Point 1

“Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination… Plant Environmental Program was used as an indicator determining whether the cleaning and sanitation program was effective. However this sampli ng program failed to include the following:

  • Sampling food contact surfaces.
  • Determination of the Listeria spp. associated with the presumptive positive results.
  • Root cause analysis of why the cleaning and sanitizing treatments were inadequate in controlling the occurrences of microbiological contamination.”

Q: Does this mean that FDA expects us to do zone 1 testing on a routine basis?
A: Based on this 483 – the answer is yes. But, if so, when should this be done? Is post clean up and pre-start up adequate? I sure hope so!

Q: Does this mean whenever we identify Listeria spp. we need to get it typed to determine the type of Listeria?
A: Based on this 483, the FDA will write you up if you simply stop at Listeria spp.

Q: Does this mean that every time we have a positive finding, we must document a root cause analysis?
A: Maybe…or is it only when we have multiple positives?

Point 2

“You also stated the results of your daily total coliform sampling on finished product, in process product, and raw ingredients added post pasteurization were used as an indicator in determining whether the cleaning and sanitation program was effective. However, this sampling program failed to include the following:

  • Determination of the pathogenicity of the coliform isolates.

Q: Does this mean when we find coliforms in finished product, or in ingredients being added post lethality or with in-process product, we need to determine if any of the coliforms would be considered to be pathogens?
A: The answer would appear to be yes.

Point 3

“Failure to store cleaned and sanitized portable equipment in a location and a manner which protects food-contact surfaces from contamination.”

This observation was related to equipment that was being stored in a basement area uncovered and unprotected, and that same equipment would be re-cleaned and sanitized prior to use.

Q: If you are storing equipment that has a food-contact surface, should the food-contact surface area be fully covered and protected, even if you will clean and sanitize it prior to production?
A: Based on this observation, the answer is yes. When you store equipment you will later use and if it has a food contact surface, make sure you cover and protect that surface during storage.

Point 4

“All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, you do not have cleaning and sanitizing procedures for employee shoes worn into the sanitary food production areas of the firm to ensure that any potential contamination risks are minimized.”

Q: Does this mean that, at all entries to a sanitary or RTE area, there needs to be a process for cleaning and sanitizing footwear?
A: While this is certainly a common industry practice, it appears to now be a requirement.

Point 5

“The design of equipment does not allow proper cleaning and maintenance. Specifically wooden pallets which are porous and not easily cleanable are used throughout your firm to store and transport raw ingredients, finished product, and packaging materials. The wood pallets were observed in different stages of damage and disrepair while they were being used in the kitchen, warehouse, freezer, production, and mixing areas. The top platform, bottom, and corners of the pallets were broken, discolored, and soiled. The wood pallets were also observed to be saturated from being used in the wet processing areas and were observed as having black mold-like residues and red stains.”

Q: Is FDA declaring war on wood pallets?
A: Certainly wood pallets are known to be a potential problem, but FDA is making it clear that you should not use wood pallets if they are damaged, discolored or soiled – even to store packaging materials or containers of food that will subsequently be used in production.

Conclusion

There are always opportunities to learn from others’ 483s, however, the above 483 extractions a little alarming. Not many companies will speciate Listeria spp., they will treat a Listeria finding as though it were LM and act accordingly. But based on these 483s, FDA could issue a 483 if you don’t speciate your Listeria spp. They could issue a 483 if you don’t test your coliforms in finished product or raw ingredients being used in finished product to see if any are pathogenic.

The language in the Blue Bell 483s is sending a strong prevention message to the food industry. It is also clearly using FSMA-like approaches. I see some of the observations in these 483s as being grenades that FDA has lobbed out – and it will be interesting to see if they have pulled out the pins as FSMA continues to roll out and FDA kicks up its inspections of food safety plans and preventive controls a notch. My message to the industry is this: Watch out and learn from others’ mistakes.