Shawna Wagner, DNV GL
FST Soapbox

Did You Write “NONE” for Biological, Chemical and Physical Hazards in Your HACCP Plan?

By Shawna Wagner
No Comments
Shawna Wagner, DNV GL

Ok, ok I know what you are thinking, another article about HACCP. You have been HACCP certified since 1999 and doing this for years—why read this article? That golden sticker on your certificate does not last forever. Industry has changed, approaches to food safety have changed, and your HACCP plan should have evolved. Did it?

Biological, chemical, physical, biological, chemical, and physical hazards. If you are any part of the quality assurance or HACCP team, you can recite this in your sleep. Do you recite economical and radiological hazards? These are one of the most commonly missed items in a plant’s HACCP plan that I have witnessed when auditing. This, of course, applies only to plants that must comply with FSMA, but does it truly hurt to think about including it in all plants? I mean, we are all in this for food safety, right?!

In speaking about radiological hazards, most of the time I will have site management tell me that I am not by a power plant so there are not hazards to my operations. If you are a producer of vegetables and fruits, or a plant receiving these kinds of ingredients, water and even soil can be a home to radioactive hazards! Radioactive minerals are naturally occurring and unless you know where to start, items such as Cadmium may sneak up on you in unacceptable levels. Economical hazards are, in my opinion, a bit easier to research. When looking at economical hazards, we are basically trying to prevent intentional contamination to gain or profit. In more common terms, this is often referred to as food fraud. Olive oil, fish, and even spices have been known to be the victims of food fraud. There are plenty of informational sites out there to help get you started on writing your hazard analysis for food fraud, however some I have found you do have to pay for.

Another common non-conformance that I see missing in HACCP audits is what I would call inputs and outputs to the HACCP flow chart. Inputs are: Water, compressed air, ice and even steam. Outputs are: Waste, animal feed or by-products. This is not an all-inclusive list, but certainly these examples could bring a new level of hazards to your facility, especially if you did not include them in your hazard analysis. Even worse, if you did include them but decided to write in your hazard analysis that word…dare I even say it… “NONE”: You wrote “none” for biological, chemical, and physical hazards. More than likely you have a pre-requisite program, letter of guarantee, or something that controls these hazards, and you absolutely want to include these in your HACCP plan. Give yourself credit! Auditors and customers alike truly want to see that you have documented and given thought to each of your processing steps. Make sure you take that HACCP flow chart and walk around your facility to ensure you have captured the needed information that will give you the best chance of catching items that can be missed. The plan is only as strong as the time you put into it, which leads me to my next point: Your HACCP or Food Safety Team.

The notorious HACCP team. You have one, the head of the team is the QA manager, and you have team members to cover the multi-disciplinary basis. So, what’s the problem? Well, maybe none, but remember the comment about the golden sticker on your certificate? It’s the same thought process here. Your team must be continually updated and educated to keep up with the ever-changing world of food. That 1999 HACCP certificate is no longer valid in the eyes of some customers. I have seen many customers requiring that HACCP be retrained every five years. For the sites that must follow FSMA rules and regulations, have you completed your Preventative Controls Qualified Individual training? You should have, and who is their backup? It takes much planning and money to make this happen, but it is all a crucial step in maintaining food safety and your HACCP plan.

We all know that our programs and processes are not good for forever and that change is inevitable. There are always avenues for gathering information and accessing it. You must be willing to go out and get the resources that will place an upgrade on your food safety management system, as waiting for it can sometimes cause gaps and non-conformities. The big question is: Did you put in the hours?

Doug Sutton, Steritech
Retail Food Safety Forum

What Attracts Customers to Your Restaurant, and What Could Keep Them Away Forever?

By Doug Sutton
No Comments
Doug Sutton, Steritech

The most recent numbers from Black Box Intelligence reflect what has been an ongoing trend for the last several months—improving same store sales. Sounds like great news, right? It could be, if another key metric wasn’t trending in the wrong direction.

Traffic numbers in restaurants are on a very steady down slope. In the third quarter, traffic was down 1.3%, and in October, traffic slowed down by another 2.2%.

The bottom line: Fewer people are dining out, but they’re spending more money.

For now.

Earlier this year, a survey of 500+ consumers asked them several questions about their preferences and experiences when dining out, as well as how they are making their decisions. The results could help restaurant operators adjust their customer experience to help bring more traffic through the door.

Despite Low Traffic Numbers, Americans Still Dine Out Frequently

Consumers have a lot of choice when purchasing a prepared meal these days: Restaurants or prepared foods from a grocery store? Dine in or take out? Fast food, fast casual, or full-service dining? The list goes on and on.

Sixty percent of the above-mentioned survey takers had dined at a restaurant, whether sit-in or delivery, once a week or more frequently. Another 25% reported doing the same two to three times a month.

But there is stiff competition.

Nearly 70% of the same group has purchased prepared foods (pre-made sushi, fried chicken, sandwiches, etc.) at a grocery or convenience store in the last month, indicating that the convenience of prepared foods is taking root in American life. This is an increase from a similar survey conducted in 2016, when slightly more than 65% of respondents said they had purchased a prepared meal from these sources.

What Are Customers Really Looking for in a Restaurant?

It should come as no surprise, that the driving factor for choosing a restaurant is the quality of the food. Respondents of this survey were provided a list of 10 areas of food safety and operational items to choose from and asked them to choose up to five that matter to them most when choosing a restaurant. Food quality and taste was the frontrunner by far, but restaurant cleanliness was second.

The third item on the list might surprise people. It wasn’t speed of service, or order accuracy, or service quality—while they all do matter to customers, it’s their previous experience with a location or chain that matters most.

When Customers Want Answers about a Restaurant, They Go Online

Social media and online reviews are playing an increasingly important role in how customers share their experiences with restaurants. The news about social media and online review sites is good for restaurants. If you’re doing a good job with your customer experience, your customers are willing to talk about it.

Respondents were extremely likely to use social media to share a restaurant experience on a social media platform such as Facebook, Twitter, or Instagram: 58%, said they would be very or somewhat likely to share a restaurant experience on social media. Even better news? Among those who fell into these two categories, nearly two-thirds say they are more likely to share a positive experience than a negative one.

The same holds true for online restaurant review sites, such as Yelp! And OpenTable. While fewer customers say they are very or somewhat likely to share their experience on an online restaurant review site, 49% of those who use review sites once again say that a positive experience is more likely to garner a review than a negative one. A full 66% of those who would be likely to use an online review site are likely to post a positive experience over a negative one.

Especially in the case of online restaurant review sites, this is important. Why? Because nearly three-quarters of respondents sometimes or often use restaurant review sites to help select where they will dine. Among those respondents, the online review carries significant weight in making their decision. Nearly 25% say online reviews are extremely or very influential in their dining decisions, while another 41% qualified them as moderately influential.

Delivery Problems and Who Customers Blame

Most restaurant operators know that there are big dollars to be had in the delivery space. But, the results of this survey indicate that restaurants have a bit of work to do.

Well over half (58.9%) of those surveyed had ordered food for delivery in the six months before the survey. Of those, nearly 30% experienced a problem with their order: Food being cold, wrong food, took too long to deliver the food, etc.

Here’s the important takeaway for restaurants offering delivery: Whether you manage delivery yourself or use a third-party delivery service, customers that experience problems place the fault squarely on the restaurant. Among those that experienced a delivery problem, 79.55% say the restaurant was to blame. That’s important because with third-party delivery service, the restaurant does lose some control over time it takes to deliver, food security, and more.

Foodborne Illness Outbreaks Have a Long-term Effect on Revenue

A 2018 study from the Johns Hopkins Bloomberg School of Public Health put a price tag on foodborne illness outbreaks for restaurants: Anywhere from $4,000 up to $1.9 million wrapped up in “lost revenue, fines, lawsuits, legal fees, insurance premium increases, inspection costs and staff retraining.”

The survey results discussed in this article show that the effects of a foodborne illness outbreak could linger for much longer than anyone truly realizes.

Nearly 30% of respondents said they would never eat at that location if they knew a foodborne illness outbreak had happened there; 24% said they would stay away for between one to six months, and another 18% said they would stay away for six months to a year.

The responses get more dramatic when chain restaurants have foodborne illness incidents. When asked if they would avoid eating at other locations in the chain if a single location was involved in an outbreak, more than 31% said yes, and a whopping 50% say maybe. The majority of respondents would give the chain a second shot, however. Only 19% say they’d never eat at any location in the chain again; more than half (over 58%) report that they would only stay away for between one month and one year.

If multiple locations of a chain are involved, the percentage of respondents that would avoid eating at other locations in the chain more than doubled to more than 68%. The bulk of those who would stop eating at other locations in the chain (31%) say they’d never eat at the chain again, while another 18.5% would avoid the chain for longer than a year. Another 23% say they’d stay away for six months to one year.

Customer Experience Investments Can Reap Big Rewards

This survey revealed plenty of other details about what customers are looking for—what cleanliness factors drive them crazy, what they think of health department scores (and which groups are really paying attention), what really turns them off when they read it in a review—but the real takeaway is this: Restaurants willing to invest in customer experience and a culture of food safety will reap the rewards from customers.

Mahni Ghorashi, Clear Labs
FST Soapbox

Why the Food Safety Industry Needs the Cloud

By Mahni Ghorashi
1 Comment
Mahni Ghorashi, Clear Labs

Cloud computing and storage, the breakthrough technology that once dominated headlines, conferences and CIOs’ strategic plans, is now commonplace in most industries. That is not to discount the journey it took to get here, though. This easy acceptance wasn’t always the case, and in fact, some of the world’s most important industries are lagging behind.

Food safety is one such industry that stands to gain the most from adopting cloud technology but continues to rely heavily on manual processes, paperwork, and cumbersome on-premise databases. These methods are seen as fail-safe, proven by history to be effective enough and compatible with the overarching goals of the industry. We’re suffering from the age-old adage: If it isn’t broken, we don’t need to fix it.

While the food safety industry has good reasons for taking a more conservative approach to new technology, I’d argue that the most pressing risk to our industry is the failure to invest in innovation. In our own attempts to avoid risk, we’re actually exposing ourselves to far greater losses both in protecting consumers and new opportunities.

A Path Forward For Food Safety

The food safety industry is changing, and changing rapidly. However, despite advances, the industry still faces major challenges. We’ve seen more than 200 recalls just this year. An average recall costs $10 million dollars in direct costs alone. On average, it takes 57 days to recall food, according to a report by the Office of Inspector General.

At the same time, we’re beginning to generate more data than ever, with technologies like blockchain and next-generation sequencing coming online in a big way. We’re about to experience a data explosion arguably bigger than in any other industry. A single NGS test can give industry officials hundreds of millions of data points per analysis, and routine pathogen tests are happening at high volumes around the clock.

This amount of data cannot be contained in the spreadsheets and on-premise databases of today.

The hesitation to adopt cloud-computing is not unfounded, given the initial fear around outages and security, and a disbelief that the technology could ever be as reliable and secure as their existing systems. And the hesitation is even more understandable when you consider that food and beverage is the third-most hacked industry. The damage from these breaches can be extensive, with reports that 70% of hacked food and beverage companies go out of business within a year of an attack. There is a substantial cost for lax security or prolonged outages.

Clearly, any solution has to be comprehensive, and our justifications for switching systems have to be all the more clear. But we cannot as an industry sit idle.

The food safety industry has an opportunity to learn from those who have gone before us and build a stronger, more robust cloud infrastructure.

We’re starting to see this shift take place – some of the top poultry manufacturers have already made the leap into cloud computing. They and others will prove that the value of making the move far outweighs the risk.

Quality Control and Consistency

Right now, it’s not uncommon for food safety employees to record their observations via paper and pencil. In a best-case scenario, these professionals are forced into spreadsheets with limited interoperability. In either scenario, there are huge amounts of friction when it comes to sharing information and, in fact, data can easily be lost as inboxes fill, software crashes, or papers get buried in the shuffle.

By enabling instantaneous data sharing, the cloud makes collaboration across an organization easily accessible for the first time. This, in turn, boosts productivity and also guarantees a higher degree of consistency in both process and results.

Employees can instantly share results, communicate across departments, and easily control permissions and access to information, allowing others to iterate on or apply their findings in real time.

Speed Across an Organization

The drive to increase efficiency actually underwrites the entire food safety industry. Experts are constantly asking how we can be faster at assessing risk, managing recalls, and generally running a business. These questions are only becoming more important as the threat of foodborne illness continues to rise.

The cloud enables greater speed in tracking food information inside and outside of the lab. Perhaps more than any other tool, cloud technology is going to allow the food safety industry to more quickly and effectively manage recalls.

Technology that allows companies to immediately update information company-wide without the burden or drag of an unwieldy IT infrastructure is valuable. Technology that gives you easily interpretable results, so that you can make quick decisions for the good of public health safety is valuable.

Cloud technology enables both. You could easily process terabytes worth of data and spit out easy, comprehensible results that would have otherwise taken days or weeks to produce.

This ability, which on its own is attractive, is especially important as you get into more complicated pathogen tests. For example, with traditional serotyping, a substantial portion of calls are subjective. The speed of cloud computing can take away some of that guesswork.

Dramatic Cost Savings

Not only does the cloud offer a faster system for storing and accessing information, but it also offers cheaper infrastructure, usually an offshoot of its speed. A survey of more than 1,000 IT professionals found that 88% of cloud users pointed to cost savings and 56% agreed that cloud services had helped them boost profits. Additionally, the absolute cost of the cloud is continuing to drop, improving margins.

With the cost savings enabled by the cloud, the food safety lab no longer has to stay a cost center. Adopting cloud technologies can create more wiggle room in a company’s budget and free up resources for ambitious experiments, new product development, and other activities that contribute to the bottom line of the organization.

Security and Regulatory Advancements

The cloud also allows companies to more easily cooperate with HAACP and FSMA regulations. With all of this organizational data easily available and updated in real time, organizations can ensure they’re keeping pace with regulatory requirements by easily producing traceability records and managing compliance requirements across multiple locations and vendors, for example.

While better, more transparent data management company-wide has always been the draw of cloud, the technology has been crippled by simultaneous concerns about security. Food safety executives feel stuck between wanting to comply with best practices and needing to protect sensitive and valuable information.

Fortunately, food safety has waited long enough. Even as recently as 2015, cloud breaches of major organizations’ databases were still making headlines. However, the technology has come a long way in a short time. Cloud providers are beginning to implement automatic checks of systems to analyze threats and identify their severity.

These advancements speak to the food safety industry’s primary pain points, security and speed. By solving for both, the cloud has reached a maturity worthy of the food safety industry.

The Future: Data Pollination

Finally, the cloud makes it much easier to share data across departments, organizations, and even entire industries.

We’re entering an era of data pollination. What I mean by that is there an opportunity to mesh food safety data (genomic data, label information, etc.) with other forms of data—human microbiome data, for instance, to create “personalized” food, enabling consumers to eat ideal foods based on their genetic makeup. While this trend has already taken off, it could be further improved and better validated by bringing food and genetic data out of their silos.

On the opposite end of the production line, data pollination could also help farmers, who have huge amounts of data at their fingertips, understand how they can play a larger role in food safety. If data can enable farmers to produce bigger yields, data can also certainly help farmers prevent any environmental causes of food safety on the farm itself.

Bringing together the data from the entire lifecycle of food—from farmer to consumer—can only be a good thing, powered by the cloud.

Conclusion

The food industry should not look at the task of updating their infrastructure to the cloud as a burden or an extra cost—it’s an investment and when done right, it can provide far greater returns. We have the advantage of late adoption and learning from the implementation mistakes and successes.

This isn’t just incremental improvement territory—we’re talking about making a quantum leap forward in our industry.

Karen Everstine, Decernis
FST Soapbox

Food Fraud Quick Bites: Recent Notable Incidents

By Karen Everstine, Ph.D.
No Comments
Karen Everstine, Decernis

We developed a system that tracks food fraud records using four categories: Incidents, inference records, surveillance records and method records. Food fraud incidents are documented occurrences of fraud that include contextual information about location, perpetrators, timeframe, geographic location and other characteristics. In many ways, incidents are the gold standard of food fraud records. However, there have been unsubstantiated reports of food fraud that were subsequently discredited (such as the “plastic rice” scandal of a few years ago). For this reason, for every incident we capture, we assign a “weight of evidence” classification to provide our assessment of the strength of the evidence. For example, incidents reported directly by regulatory agencies with supporting documentation will generally be assigned a “high” weight of evidence classification.

We also work diligently to avoid “double counting” food fraud incidents, although at times this can be challenging. Incidents may be reported in multiple media outlets and, at times, the reports may not include enough information to determine if it is a new report or related to an issue already reported. We cross-reference the dates and locations of reports, along with information about the ingredients and adulterants, to help ensure that isolated food fraud cases are reported as one incident.

Food fraud, Decernia
Food fraud incidents since 1980. (Source: Decernis Food Fraud Database)

Incidents we have captured in the past two months include $14 million of counterfeit wine discovered in China, which was reportedly based on a tip off. The Carabinieri and ICQRF in Italy discovered wines with added flavorings and other additives. The Guardia di Finanza in Italy also seized adulterated extra virgin olive oil. Counterfeit liquor was discovered in Russia and bootleg liquor containing methanol caused deaths in Malaysia.

Expired (possibly rotting) eggs intended to be powdered and used in food production were discarded by regulatory authorities in India. A customer in China reported that expired carrots were being re-labeled with new dates. Adulterated milk was discovered in Pakistan. In Kenya, reports surfaced of sodium metabisulfite being used on meat to enhance its appearance. Finally, in the United States, two companies were indicted for importing giant squid and selling it domestically as octopus (which usually has a higher retail price) over a period of three years. A review of these reports illustrates how challenging it can be to collect and standardize food fraud information, especially when it is reported in media sources.

Chelle Hartzer, Orkin
Bug Bytes

Not-So-Fantastic Pests and Where to Find Them

By Chelle Hartzer
No Comments
Chelle Hartzer, Orkin

Although no two food processing facilities face the exact same pest pressure, there are a few common pests you’re likely to spot. Depending on the type of pests in the surrounding area, different spaces in a building will be more at-risk for an infestation. Pests will feed on and contaminate product, and get into equipment, if undeterred. And considering many pests can be a potential health and safety threat, prevention is important to help protect your bottom line.

Instead of reacting to pest issues, adjust your integrated pest management (IPM) program to take a proactive approach to preventing the following six common pests.

Rodents

Some of the most clever and resilient creatures in the pest world, rodents are a versatile threat to food products. Usually brown or gray, mice and rats can compress their bodies to fit through holes and gaps the size of a dime and a quarter, respectively. Once inside, they reproduce rapidly. A single rat or mouse can produce more than 32 offspring per year. In addition, they can use their sharp teeth to gnaw through packaging and leave urine and feces droppings everywhere they go. All of this makes them an absolute terror once indoors. They’re smart enough to know hiding from humans is their best option, and they’ll even learn from unsuccessful trapping attempts.

Cockroaches

These notorious crawling insects are contaminators, too. Roaches love to get into dirty areas and run all over food contact surfaces, equipment and products, potentially dropping off disease-inducing pathogens on everything they touch. Cockroaches can fit through tiny gaps by flattening their bodies, making them tough (but not impossible!) to keep out. They tend to avoid coming out in the open during daytime hours, as they prefer to hide in the dark. If you spot one running around during the day, then it may be a sign of a larger infestation behind the scenes.

Flies

When flies detect a potential food source, they’re going to head straight for it. Stringent sanitation is the best way to minimize attractants, and keeping doors and other openings closed can help, too. Preventing flies is important, because they’re twice as filthy as cockroaches. In fact, more than 100 pathogens are associated with the housefly alone. These pathogens are transferred when the fly lands on a surface, contaminating the area. If flies are a threat, you should have fly lights placed strategically to reduce the population and monitor where they’re coming from.

Indian Meal Moths

This tiny insect feeds on a wide range of raw and finished goods, and leaves behind frass (insect droppings) that that can lead to major loss of products. If you don’t see the pest itself, which can be reddish-brown and silver-grey in color, you may notice the silk webbing spun by larvae. When someone notices this, immediate action is necessary, as it means the moths are reproducing and may be spreading amongst products in close proximity.

Sawtoothed Grain Beetle

Unable to penetrate most packaging, sawtoothed grain beetles hunt for holes in packaging, which can be one millimeter in diameter, and lay eggs near the opening. Larvae then squeeze through the hole once hatched and begin feeding on product! Although they prefer processed food products like bran, chocolate and oatmeal, they’ll feed on just about anything they can get into. About three millimeters in length, these beetles love moldy, damp conditions, so minimize those attractants as much as possible.

Ants

Everybody has seen or been around ants before, but are you aware that they carry bacteria on their bodies capable of contaminating food? What starts with a few foragers can escalate quickly, as ants leave behind an invisible chemical trail leading other ants straight to a food source. Ants will feed on just about anything depending on the species, so identification is key. Generally only a few millimeters in length and ranging in color from black to red, ants can establish colonies under a building’s foundation, on lawns or in out-of-sight locations indoors.

Watch Out for High-Risk Areas

Understanding the biology of pests helps us to understand what they’re looking for and where they’re most likely to be hiding. Generally speaking, pests are attracted to places able to provide them with the three things they need to survive: Food, water and shelter.

Food doesn’t necessarily mean actual food products of course, as some pests—like cockroaches, flies and ants—will feed on any organic matter they can find. Remember, that includes garbage!

But taking out the trash and ensuring dumpsters are far away from the building aren’t the only ways to reduce pests. Quite the contrary, pests have a myriad of different hiding spots that should be checked by facility staff and a pest management professional regularly.

For starters, don’t overlook the break room. It’s easy to forget to take out the trash, which should be done at least daily depending on waste output. Break rooms also frequently have sinks with drains where food buildup can cause odors that are attractive to pests. Drain flies love this! Wipe down countertops and sweep/vacuum/mop daily to ensure larger food crumbs and debris are taken care of, and make sure your staff knows to clean up any spills immediately. Don’t forget those vending machines—when was the last time they were moved and cleaned underneath and behind?

Equipment can be a hot spot for pests, too. Insects, especially stored product pests, will hide beneath and behind heavy machinery. Pests don’t want to be exposed out in the open, so they’ll hide in small gaps and crevices. And if there is food waste or moisture present, watch out! Those attractants will prove irresistible if allowed to linger for too long, so make sure your cleaning schedule includes sanitation in and around equipment. Never overlook those hard-to-reach areas, or pests will make you pay.

Speaking of hard-to-reach areas, walls are often popular harborage areas for pests. Rodents are perhaps the most dangerous, as they pose a health and safety threat to employees and can contaminate product. Worse still, wiring in walls looks like roots to rodents. They’ll often chew through and create sparks—a potential fire hazard. Rodents are just one of many pests happy to live in your walls, so contact a professional if you notice activity.

Even once food is produced, packaged and stored, pests are still a threat! Stored product pests, like the Indian meal moth and sawtoothed grain beetle, can get into packaged products and live in it. They’ll feed and contaminate the product, then move onto the next, proving costly when large batches have to be thrown out. Thankfully, there are monitoring devices like pheromone traps to help identify where these begin to pop up, but again, you’ll want a professional’s help to ensure these tools are effective.

Don’t wait for pest sightings to occur before taking action. The best approach to pest prevention is a proactive one, and there’s not an insect or animal alive who can outsmart a trained pest management professional. Lingering issues will prove costly with time, as a product infestation or plant shutdown would be a painful hit on your business’s bottom line. Instead, create a plan that accounts for these pests and high-risk areas around your building, and you’ll be able to rest easier knowing you’re prepared for pest invaders.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Five Steps to Creating a Successful Validation Study

By Gabriela Lopez-Velasco, Ph.D.
No Comments
Gabriela Lopez, 3M Food Safety

Manufacturing large volumes of food product that must be safe for human consumption with finite resources is, simply put, a demanding responsibility. For many food brands, having dedicated production lines is not always an option, so lines are often shared amongst a variety of food products. A potential problem arises when products containing allergenic foods are manufactured on the same equipment as other products, and those allergenic foods are not meant to be declared in the product label. As a result, residues of the first product manufactured may move to the next product. Known as direct cross-contact contamination, this issue can have a severe adverse impact on allergic consumers.

Cross-contact contamination can occur at various stages of production, but it’s direct food cross-contact in shared production lines that is often found as a particularly significant food safety hazard. Addressing cross-contact through effective cleaning procedures is one of the most critical allergen management activities in establishing preventive controls and minimizing the potential of unintentional presence of food allergens. Allergen cleaning validation enables food manufacturers to evaluate that their cleaning procedure is adequate when it comes to removing ingredients from direct food contact surfaces.

Cleaning validation consists of generating data to demonstrate that allergenic foods are removed from direct food contact areas to a pre-defined acceptable level. A basic cleaning validation design consists of determining the residual level or presence of allergenic food before cleaning (baseline), and then assessing the level of the allergenic food after cleaning.

If the cleaning procedure exists in several steps (i.e., more than one rinse or purge, as with dry cleaning) additional testing to assess the level of allergens between cleaning stages and in the final product can also be incorporated. It is important to remember that a single validation study may not be applicable for an entire site operation. Different production lines within a food production site may require an individualized validation analysis. This determination will depend on the cleaning process as well as the formulation of the products being manufactured.

There are five important considerations for establishing a successful validation study:

  1. Set up a team and assign a leader to carry out the design of the validation. Involving relevant personnel with knowledge in the product formulation, manufacturing process, equipment design and cleaning and sanitation regimes may provide valuable insight to identify processes that should be included in the validation. It may also bring to light critical sampling points in the equipment that should be considered.
  2. Determine the scope of the study. This is where you describe and justify which equipment, utensils, cleaning regime and production processes will be validated. It may be wise to group different processes or select the worst-case scenario. For example, you might choose to focus on food production equipment regarded as hard to clean or equipment that contains the highest concentration of the allergenic food.
  3. Design a sampling plan. This is a critical prerequisite before starting a validation study. The plan should be clearly defined, with critical sampling points and locations prescribed to challenge the effectiveness of the cleaning regime and to find evidence of allergenic food presence. In both open equipment and equipment that will be dismantled as part of the cleaning regime, it is important to select sites where food can get trapped, as well as other sites that are hard to clean. Also consider other surfaces that can be a source of direct cross-contact like protective clothing and utensils. For clean-in-place (CIP) systems, wash water should be collected from the onset of cleaning and then at intervals leading up to the final rinse water. This helps to demonstrate that allergen food levels are diminishing, thereby validating the use of CIP analysis as a verification method. Note that it is important to consider that the sampling plan for the validation should also reflect the sampling plan that will be used during routine verification. Support from a statistician may facilitate the decision to define how many samples and type of samples (swabs, CIP or final product) should be collected for the validation and how many cleaning runs should be performed to demonstrate validity.
  4. Select a method of analysis. Validation and verification involve the use of a specific method to detect allergenic foods. The selected method should be validated as well, an undertaking most often done by the commercial supplier. Then it should be verified by the food processor that the method is fit for purpose, such that the allergenic food will be recovered and detected under the conditions in which samples are routinely collected. This ensures there will not be interference due to the food itself or due to cleaning chemicals. There are a variety of different analytical methods; most are based in technologies designed to detect proteins. Enzyme-linked immunosorbent assays (ELISA) and immune-based lateral flow devices (LFDs) offer detection of specific protein targets (i.e., egg proteins, milk proteins, peanut proteins) and are ideal for a validation study. ELISA can provide quantitative data from pre-cleaning, at various intervals during the cleaning process, at post-cleaning and at final product, offering a measurable level of the allergenic food during the cleaning process. Rapid detection through LFDs also allows food processors to assess the presence or absence of a specific protein or group of proteins, but different from ELISA, the result is only qualitative. In either case, these rapid tests may be used for both validation and routine verification. In addition, there are non-specific tests that can detect total protein that may be selected for a cleaning validation study. These tests do not provide specific information about the allergen to be managed, and thus may be more suitable for routine verification. During a cleaning validation study, it is important to include the test that will be utilized for verification and ensure it is also fit for purpose and detects the allergenic food to an appropriate pre-defined sensitivity. This is particularly important if the test is different from the analytical method chosen for cleaning validation.
  5. Establish acceptance criteria. Proteins from allergenic foods may cause an adverse reaction at very low levels. To date, there are very few regions in the world in which threshold or permitted levels for allergens in food are established. Each individual food manufacturer should define a criterion to establish when a surface is clean from allergens after routine cleaning. The limits that are set up should be practical but also measurable and verifiable, thus it is important to define a level with knowledge of the sampling and analytical method selected. The sensitivity of the analytical methods currently available may be used as a criterion to verify that levels of an allergen are under control if they fall below the limit of detection of the analytical method.

Once a cleaning regime has been validated and documented, routine allergen cleaning verification should be performed as part of a monitoring program to demonstrate that the cleaning process in place is effective and that the risk of direct cross-contact is consequently being controlled. The validation should be repeated at defined intervals, often once a year. However, it is expected that a cleaning verification will be performed after each production run and cleaning procedure in order to reflect that the validated cleaning process is still effective. Cleaning verification, along with other allergen management activities, strengthens implemented food safety programs and helps to protect consumers.

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
No Comments
Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements

Karen Everstine, Decernis
FST Soapbox

Food Fraud Quick Bites: “Natural Flavor” Claims

By Karen Everstine, Ph.D.
No Comments
Karen Everstine, Decernis

The company that produces the very popular flavored sparkling water brand LaCroix is facing a class action lawsuit that alleges false claims of the product being “all natural.” The suit alleges that certain flavor chemicals used in the beverage are, in fact, artificial ingredients. These flavor chemicals include limonene, linalyl propionate (linalool propionate), linalool and ethyl butyrate (ethyl butanoate). While these flavor chemicals can be synthesized, they are naturally occurring chemical constituents and can therefore be derived from natural sources.

The safety of the beverages is not at issue; this is a labeling question. The suit states that linalool is “used in cockroach insecticide,” which is inflammatory and misleading. Chemical compounds, including those used as food ingredients, naturally have multiple applications and this does not have any bearing on the question of whether they are safe to use in foods.

Presumably, the labeling issue of whether these flavor chemicals were naturally or synthetically derived will be addressed as the suit progresses. This suit does, however, highlight some of the challenges we have in tracking food fraud information related to flavors.

Flavors are big business. Appealing flavors enabled LaCroix to make unsweetened sparkling water explode in popularity. If you have been on the Institute of Food Technologists Annual Meeting expo floor, you have seen the prominent displays and creative food samples offered up by the big flavor houses. It is a competitive business and very proprietary. The FDA labeling requirements for flavors allow them to be listed generally as “spice,” “natural flavor,” or “artificial flavor” (or a combination of those). This makes tracking and standardizing public records of food fraud related to flavors challenging.

Our data includes more than 60 of food fraud related to flavors represented as “natural.” Most of these records are linked to vanilla extract or various essential oils. However, we have also captured a handful of records that address misrepresentation of synthetic flavor chemicals as naturally-derived. This includes records for linalool and ethyl butyrate, among others such as vanillin and linalyl acetate. However, none of these records describe publicly reported incidents of fraud for naturally-derived flavor chemicals. The records are based on peer-reviewed publications aimed at method development for authentication of natural flavors.

Added value claims such as “natural” tend to increase food fraud risk because the costs of production can be so much higher. While an ingredient like vanilla extract is certainly one example of this, we do not tend to see the same level of evidence of food fraud potential for naturally-derived flavor chemicals in public records. When our users need to conduct a food fraud vulnerability assessment for a natural flavor that is a proprietary blend of flavor chemicals, we suggest that they incorporate information from the entire natural flavors group into their assessment. Given the proprietary nature of flavor blends and FDA labeling requirements, it is not feasible for us to track every individual flavor blend in our database.

Fortunately, given the importance of flavors to the food industry, flavor companies have a vested interest in preserving their client relationships and public reputation by ensuring flavors labeled as “natural” qualify for that label claim.

Resources

  1. The Decernis Food Fraud Database is a continuously updated collection of food fraud records curated specifically to support vulnerability assessments. Information is gathered from the scientific literature, regulatory reports, media publications, judicial records, and trade associations from around the world and is searchable by ingredient, adulterant, country, and hazard classification.
Chelle Hartzer, Orkin
Bug Bytes

Stored Product Insects Are Costly Consumers

By Chelle Hartzer
No Comments
Chelle Hartzer, Orkin

How much can pest issues cost? The truth is, it changes based on the pest, the size of the population and the prevalence throughout your food processing facility and products. If you want to protect your bottom line, you need to know which pests are the biggest threat and take steps to prevent them. Let’s focus on one major threat to food processing facilities: Stored product insects.

Believed by some pest control providers to be the costliest pests for food manufacturing and processing businesses, stored product insects can put a huge dent in your profits. What’s worse, these pests can be tough to discover by an untrained eye, and they’re incredibly difficult to control without the help of a pest management professional.

According to the USDA and the University of Wisconsin, “stored product pests can damage, contaminate, or consume as much as 10% of the total food produced in the U.S. alone, while in developing countries that rate has been estimated at 50% or more.”

That’s an astronomical figure for such small insects! Can you imagine the impact on your bottom line if 10% of your product was ruined?

For any business in need of an updated prevention plan, the first step is to review the current integrated pest management (IPM) program to ensure a proactive approach has been implemented to monitor for, and react quickly to, any pest issues around the facility. There’s no one-size-fits-all strategy for an IPM program; each program should be customized to meet the needs of the individual business. Different geography, construction and food products being produced can all create different pest pressures.

According to another study conducted by CEBR on the impact of pests on the global food supply, disruptions caused by pest infestations resulted in $9.6 billion in operating costs in the countries surveyed and 84% of U.S. businesses reported a net impact on revenue due to pest infestation across a five-year period. Diving deeper, 28% of food manufacturers and processors reported pest-related costs associated with contamination of raw materials leading to replacement costs.

In other words, having stored product insects around is expensive. If there were ever any doubts about the value of a proactive IPM program, these statistics prove it. So, let’s take a closer look at how you can work to protect your business against stored product insect—some of the most likely and costly invaders.

Types of Stored Product Insects

The term stored product insect covers a range of insect species that can be broken up into three main subcategories: External feeders, internal developers and secondary feeders. Each category has its own distinct characteristics, which are important to know for detection and proper identification.

External Feeders

This group develops on the outside of products, including damaged grains and processed foods. As they feed, they damage product and leave behind frass (insect droppings) as they make their way through.

Some of the most common external feeders include Indian meal moths and flour beetles.

Adult Indian meal moths are roughly 9 mm long and have a wingspan of 14–20 mm. The front wings on the adults are bicolored, with two main tones: Reddish-brown at the wing tip and silver-grey at the base. If you don’t see the pest itself, you may notice a messy silk webbing spun by the larvae.

Red and confused flour beetles, two of the most common beetle species, are 3–4 mm in length and also have a reddish-brown color. They’re rectangular-shaped beetles and can often be found in grain bins infested with internal developers. This is because flour beetles like to feed on the kernels other stored product insects, like borers, have already broken up. They can also be found in processing lines and finished products.

Internal Feeders

Internal feeders lay eggs inside or outside of kernels of grain but develop entirely inside those kernels. As they develop, they hollow out the kernel, then the adults can go on to damage other kernels.

Some of the most commonly encountered internal developers are lesser grain borers and rice, maize and granary weevils. Weevils measure about 5 mm in length and are usually brown in color with a distinct elongated “snout.” Lesser grain borers, the most common internal feeder across the United States infesting wheat, are a bit smaller and don’t have the snout that weevils do. Both weevils and lesser grain borers have pitted patterns on their bodies, and all can fly except the granary weevil. As the larvae and pupae develop inside grain kernels, damage becomes especially evident when the adult chews out and leaves a distinctive perfectly round hole.

Secondary Feeders

This group typically eats from the outside in and feeds on the mold and fungus that can grow on out-of-condition grain and damp product.

Two of the most common secondary feeders are the foreign grain beetle and sawtoothed grain beetle. Foreign grain beetles love mold, and resemble flour beetles in size and color. To tell them apart, look for two “bumps” on the top corners of the thorax. Eliminating molds and damp conditions that facilitate mold growth is generally enough to help prevent infestations from secondary feeders.

Sawtoothed grain beetles can feed on many types of products and while they can’t physically penetrate packaging, the adults will find holes less than 1 mm in diameter, lay eggs, and the larvae will squeeze through the tiny openings to get to the product. They prefer processed food products like bran, chocolate, oatmeal and even pet foods, but will feed on whatever they can access. Sawtoothed grain beetles are smaller than flour beetles (3 mm) and have distinctive “teeth” on the margins of the thorax.

Prevention, Monitoring & Detection, and Removal

The best way to protect a facility from stored product insects is to employ numerous different tactics. Specifically, it’s important to proactively mitigate pest attractants, monitor for activity in key areas around the facility, and establish thresholds and action plans when pests are detected.

First and foremost, educate all employees about the pests most common around your facility and what to do should they spot one. Your pest sighting log is a great tool, but only if people use it! Have a clear escalation plan for any pest issues spotted. In addition, create a sanitation schedule to ensure all areas and equipment are cleaned to remove food and moisture buildup attractive to pests on a regular basis. While you can’t possibly eliminate all food (you are of course storing and processing food!), the aim is to minimize the amount and the access these insects have to that food source.

Next, make sure all incoming shipments and packages are inspected closely in a sealed off unloading area away from other products. Make sure employees know to check for signs of damage, especially holes caused by boring pests. Taking the time to inspect anything entering your facility in this way will give you a chance to spot pests before they have the chance to spread to your other products. Use the first-in, first-out (FIFO) approach for all goods to ensure older product doesn’t sit. The longer product sits, the more chance it can be infested and it may start deteriorating, and this is especially attractive to stored product insects.

For ongoing monitoring, talk to a pest management professional about deploying pheromone traps strategically around your facility. Pheromone traps are the best tool to monitor for stored product insects, as they will give you an idea of which pests are present, in what numbers, where they are, and they can help you track trends in pest activity over time. If any stored product insects are ever spotted, contact your pest management professional immediately. If there’s a chance of having stored product insects on your product, you absolutely should have pheromone trap monitoring in place.

The Total Cost of Stored Product Pest Problems

The impact of pest issues caused by stored product insects isn’t limited to the cost of paused operations and replacing contaminated product. These pests are tough to spot, and could be passed along to partners further down the supply chain. Naturally this could hurt the trust between supply chain partners, which is never a good thing!

If your facility gets a reputation of having problems with stored product insects, it’s going to hurt your brand—and that’s going to be another knock to your bottom line. Stored product insects can spread quickly between products placed closely together. So, if pests are mistakenly shipped to a partner’s facility or a store and then on to a customer, now THEY are going to have to deal with stored product insects, too. Being proactive is the best approach, and careful documentation can help you and your supply chain partners track pest issues to the source so they can be resolved quickly and minimize the impact on profits.

It becomes easy to see stored product insects can cause both short-term and long-term effects on the profitability of a business. Don’t let that be your facility and your reputation! Be proactive and partner with a pest management provider to help ensure your facility operations run smoothly and your customers stay happy.

Chris Keith, FlexXray
FST Soapbox

What Should I Do if I Have a Foreign Material Problem?

By Chris Keith
No Comments
Chris Keith, FlexXray

Imagine this: While cleaning a slicing machine during a sanitation break, one of your employees discovered a piece of harp wire was missing from the machine. The meat that had been sliced since the cutting machine’s last inspection had already been added to your product, and the product had been packaged. It had already passed through your company’s inline inspection machines without any foreign contaminants being detected.

You enjoy a spotless reputation in the food industry and know that if consumers lose faith in the product, it will suffer significant damage to both its reputation and its bottom line. So what do you do now?

Here’s a look at four different scenarios and how each one can affect a respected food manufacturer.

Option 1: Dispose of the Full Production Run

Disposing of a full production run will give your company complete confidence that the contaminant issue is resolved and will never reach the public. However, you have to take into consideration the full cost and implications of such a move, such as:

Where to dispose of the contaminated product. The FDA has specific rules about disposing of contaminated food products, but those guidelines can be affected by local, state and even federal regulations. Among the disposal options are landfills, rendering or incineration. You must find the proper facility, arrange the safe transportation of the product and procure all the required permits for the disposal.

Food waste. With 40% of the food produced in the United States going to waste, and 50 million Americans not knowing where their next meal will come from, you don’t want to add to the problem.

Product out of stock. Having your product out of stock will be costly. In addition to the lost sales, there’s a chance that consumers will turn to another brand—and not return to buying your product.

Cost of reproduction. To re-run the entire product line, you will essentially double your costs. You will have to pay for the cost of the products used, as well as pay for new packaging and all labor costs.

Option 2: Rework the Product In-House

You can use your own resources and inline equipment to try and troubleshoot the problem. Running the product through the metal detector to look for the harp wire could salvage most of the product, and would give your company the ability to supervise the entire process. That way, if you find the metal, you’d know firsthand that the contaminated product is out of production and won’t reach consumers.

But there are some expensive downsides to this approach. Among the factors that your company must consider are:

Loss of productivity. Both from the standpoint of equipment utilization and the productivity of employees, reworking the product would be costly to the company. You would have to have to slow the production line and manually re-run all the product through the metal detector to look for the missing wire.

Increased labor costs. You would have to pay overtime to your employees and keep your standard production line running while it re-runs the product and looks for the suspected contamination.

Limitations of their inspection equipment. Your results are only as good as the equipment you are using, and there’s always a risk that the metal detector that missed it the first time won’t find it the second time, either.

It seems like a bit of a gamble; if the metal detector catches it the second time around, then it could be worth it. If the product is re-run and no contaminants are found, however, your company is back where it started and must decide how to move forward.

Option 3: Risk It and Ship the Product to Retailers

Since the metal wasn’t detected by the company’s inline inspection system, you cannot be absolutely sure the metal is in the product. You only know that a broken piece of harp wire is missing; it’s unclear whether that wire made it into the food.

The least expensive option—but also the riskiest—is to go ahead and ship the product, hoping that the missing wire didn’t make it into the food and, therefore, never gets discovered by consumers.

There’s a chance that the metal detector was right, the wire isn’t in the food, and things will be fine. However, if the risky gamble doesn’t go in your favor, the consequences could be severe and this becomes the most expensive option of all. Among the risks the company faces are the following.

Costly recall. Food recalls are always expensive. According to a study from the Food Marketing Institute and the Grocery Manufacturers Association, the average recall runs up a $10 million tab in direct costs alone.

This includes the cost of notifying the supply chain and consumers, retrieving the product, storage, disposal and additional labor costs associated with having to perform all of these actions.

Possible litigation. Food recalls often are accompanied by lawsuits, and if the metal wire is eaten by a customer and causes injury, you could be held liable for everything from medical bills to time lost from work due to pain and suffering.

Bad publicity and lost sales. In today’s 24/7 news world and with the power of social networking, news of a food recall can reach consumers at lightning speed. This equates directly to lost sales and can have a negative impact on your brand reputation and market value.

A recent Harris Interactive Poll found that 55% of consumers would switch brands temporarily after a recall, and 15% would never buy the product again. What’s more, 21% said they would avoid buying any other products made by that manufacturer.

Option 4: Use an X-ray Inspection Service

A fourth option can help avoid lawsuits, recalls and bad publicity, while at the same time sidestepping unnecessary waste and the costs associated with disposing of an entire production run or reworking it internally.

You can have your product shipped to an X-ray inspection facility, or use an X-ray inspection rental service.

A contaminant removal service and professional catalog reporting with full traceability could also ensure that the specific contaminant was located and removed, and you would have the confidence that the problem had been resolved as the product reached consumers. There are several other advantages to using a company that offers this type of solution as well, including:

Reduced waste. Because the only product being thrown away would be the product that was contaminated, there would be minimal waste. This is the only option that allows you to recover the rest of the product, with the certainty that it has been inspected and is safe for its customers.

Advanced detection capabilities. You can be confident in inspection process using custom technology that enables the detection of foreign particles down to 0.8 mm or smaller. In addition to metal, such systems can also detect product clumps, glass particles, stones, bone, rubber, plastic, wood, gasket materials, container defects and missing components.

This type of solution far exceeds the capabilities of inline inspection machines, and, because it can run a single pallet an hour, instead of the average 10,000 pounds an hour, and thus it spends more time focusing on what is passing through the machine to ensure no contaminants pass through.

Final Thoughts

When it comes to the quality of your product, it’s better not to take any chances. When you put your product line in the hands of a third-party X-ray food inspection company, you know you will get results since food safety is our specialty — and it’s what they do, all day, every day.