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FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
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The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.

The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.

“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.

The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.

Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.

Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:

For growers:

  • Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
  • Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
  • Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
  • Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
  • Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce

For the broader industry:

  • The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
  • All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
  • The adoption of best practices in supply chain traceability

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
Kevin Payne, Zest Labs
FST Soapbox

2019 Food Safety and Transparency Trends

By Kevin Payne
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Kevin Payne, Zest Labs

When it comes to addressing food safety, did the industry really make any progress in 2018? In 2019, what new approaches or technologies can be successfully applied to prevent problems before they occur and minimize the consumer risk, minimize the market impact, and speed up the identification, isolation and recall of contaminated products?

Field-packed produce offers a unique challenge to the fresh food supply chain, as it is not processed and is not required to adhere to an FDA mandated HACCP (Hazard Analysis and Critical Control Points) process. It has been a challenge for field-packed produce suppliers to proactively identify or prevent contaminated produce from entering the supply chain. As a result, during serious contamination incidents, the reaction is to pull and destroy all suspect product from store shelves and supply chain. Due to the lack of data isolating the source of the contamination, this is the safest approach, but it’s costing the industry millions of dollars. Ultimately, our inability to prevent or quickly isolate these events causes confusion among consumers who don’t know who to trust or what is safe to eat, resulting in a prolonged market impact.

In response to the latest E. coli outbreak involving romaine lettuce, the industry has proposed a voluntary item-level label that reflects the harvest location and date, to help identify safe product to the consumer. At best, this is a stop-gap solution, as it burdens the consumer to identify safe product.

I work in the fresh produce supply chain industry. When I go to the grocery store, I examine the produce, noting the brand and various other factors. I was aware of the romaine problem and the voluntary labeling program, so I knew what to look for. But I’m an exception. Most consumers don’t know romaine lettuce is grown during the summer and fall in northern California and further south during the winter in regions that include Arizona and Mexico. Most consumers don’t know what the “safe date” for harvest really means—nor should they be required to know this information. They look to the industry to manage this. If we buy a car or microwave oven that is found to be unsafe, the manufacturer and the government are responsible for identifying the problem and recalling the product. Yet, in the produce industry, that responsibility seems to be moving to the retailer and consumer.

It’s an unfair burden, as the retailer and consumer do not have the necessary information to make a definitive judgement regarding food safety. The responsibility needs to be shared across the entire fresh food supply chain. Records about the produce need to be shared and maintained from harvest to retail.

Will 2019 be the year that we realize we can address this challenge proactively to improve the safety of our fresh food?

We need a new approach that leverages innovative technology to provide a more reliable solution. For example, irrigation water is often identified as a culprit in spreading bacteria. Yet even with regular testing of irrigation water, the results do not currently guarantee food safety. We see emerging technology that will make regular testing more reliable, accurate and affordable to facilitate more proactive management of the water supply. This will be a critical part of an overall solution for proactive produce food safety.

Blockchain technology has been hailed as a savior of food safety and traceability. Early in 2018, it was all the rage, as various sources claimed that, by using blockchain, recall times could be cut from days or weeks to seconds. But was this an oversimplification? Perhaps so, as this early hype faded by the middle of the year amidst the various food safety outbreaks that went unresolved. Then last August, Gartner, a  market analyst firm, declared that blockchain had moved into the “trough of disillusionment” on its 2018 Hype Cycle for Emerging Technologies as a result of over-hyped expectations. The firm predicts that the technology may reach the “plateau of productivity” within the next decade. Can we wait another 10 years before being able to benefit from it? Should we?

We expect that blockchain trials will continue in 2019. But, while blockchain has shown promise in terms of being a secure and immutable data exchange, questions remain. What data about the produce will be entered into the blockchain? How is that data collected? Is the data validated? Bad, inaccurate or incomplete data makes blockchain relatively useless, or worse, as it undermines a trusted platform. Further, without broad agreement and adoption of data collection, blockchain can’t be successful.

For proactive management of food safety, we will also need to address both forward and backward supply chain traceability. One of the challenges realized from recent outbreaks is that it takes time to figure out what is happening. Identifying the source of the illness/outbreak isn’t easy. Once we identify a source (or multiple sources) of the contamination, blockchain—assuming that all of the necessary data has been collected—only helps to more quickly trace back produce to its origin. But, for growers, quickly understanding where all product shipped from a specific location or date is just as critical in understanding and minimizing consumer impact. Tracing product forward enables a grower to proactively inform retailers and restaurants that their product should be recalled.

Blockchain currently does not directly support this forward tracing, but can be augmented to do so. But blockchain can maintain a food safety data item, or items, that could quickly and reliably communicate product status at the pallet-level, providing instant food safety status to the current product owner, even if they didn’t have direct contact with the grower. As such, a hybrid blockchain approach, as espoused by ChainLink Research, is optimal for forward and backward traceability.

Equally important, we need to fully digitize the supply chain to enable blockchain. To make comprehensive data collection feasible, we need to automate data collection by utilizing IoT sensors at the pallet level, to properly reflect how distribution takes place through the supply chain. We need reliable data collection to properly reflect the location and condition of product distributed through a multi-tier distribution network. That level of product data visibility enables proactive management for food safety as well as quality and freshness— well beyond the current trailer-level monitoring that only monitors transit temperatures with no benefit to managing food safety. Effective data capture will define the next generation of fresh food management, as it embraces proactive food safety, quality and freshness management.

Goals for This Year

For 2019, our goals should be to embrace new approaches and technology that:

  1. Identify food contamination at its source and prevent contaminated food from ever entering the supply chain. We need to focus on developing new technologies that make this feasible and cost effective.
  2. Accurately and consistently track product condition and authenticity of fresh produce from the time it is harvested until it is delivered. IoT sensors and proactive fresh food supply chain management solutions provide this capability.
  3.  Make it cost-effective and practical for growers, suppliers and grocers to use solutions to improve the entire fresh food supply chain. If we make the process burdensome or without a reasonable ROI, implementation will lag, and the problems will persist. But if we demonstrate that these solutions offer value across the fresh food supply chain—through reduced waste and improved operational efficiency—growers, suppliers, shippers and grocers will embrace them.
Steve Ardagh, Eagle Protect
FST Soapbox

Glove Polymers: The Unregulated Food Safety Threat

By Steve Ardagh
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Steve Ardagh, Eagle Protect

Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.1

Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.

Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.2

There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.

As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!

References

  1. Bhutta, M. and Santhakumar, A. (March 2016). In Good Hands. Tackling labor rights concerns in the manufacture of medical gloves. British Medical Association. Retrieved from https://www.bma.org.uk/collective-voice/influence/international/global-justice/fair-medical-trade/medical-gloves-report.
  2. Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report

The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.

Chelle Hartzer, Orkin
Bug Bytes

Not-So-Fantastic Pests and Where to Find Them

By Chelle Hartzer
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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.

FDA

FDA Restaurant Study Finds Employees Not Properly Washing Hands or Keeping Foods to Temp

By Food Safety Tech Staff
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FDA

Yesterday FDA released the initial phase of its findings of a 10-year nationwide study that looks at the relationship between food safety management systems, certified food protection managers, and the occurrence of risk factors and food safety behaviors/practices, and how this contributes to foodborne illness outbreaks in retail establishments. This first phase collected data from 2013–2014; subsequent data collection will be from 2017 and 2021. The entire span of the study is 2013–2023.

The data collected and used in the 84-page “Report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full Service Restaurants, 2013-2014” will be used as a baseline to evaluate trends in the occurrence of risk factors during the 2017 and 2021 data collection periods. Key findings in the report include the following:

  • Food safety management systems are important!
  • Restaurants had the most effective control over ensuring there is no bare hand contact with RTE foods as well as cooking raw animal foods (including meat, poultry and eggs) to the required temperature
  • Unsafe food behaviors in fast food and full-service restaurants. Improvement needed in:
    • Employee hand washing (knowing when and how to do it)
    • Proper temperature control of foods that require refrigeration to limit pathogen growth

Study results will be used to help advise retail food safety initiative and policies, industry partnerships and specific intervention strategies that target foodborne illness risk factors. It will also aid in providing technical assistance to state, local and other regulatory professionals. FDA put together a factsheet with highlights of the study.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Five Steps to Creating a Successful Validation Study

By Gabriela Lopez-Velasco, Ph.D.
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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.

Chris Keith, FlexXray
FST Soapbox

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

By Chris Keith
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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.

Y-strainer, water filtration

Food Safety: Why Water Filtration is Important

By Tim McFall
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Y-strainer, water filtration

Food and beverage processing requires a lot of water. Whether it’s steam in the preparation or cleaning of dishes and flatware, or as an ingredient in food or beverages, water comes into contact with just about every edible or drinkable item in the food industry. That means the quality of the water used in food preparation or service must be monitored and managed to ensure not only that it tastes good, but also that it is safe for employees and customers.

Making sure water is safe to consume often requires the installation of a water filtration system. The quality of tap water greatly varies depending on where you are located. In some areas, there are higher levels of sediment, chemicals or organic matter in the water, which means that there is a likelihood that not only is the water not ideal for consumption, but it’s also damaging to equipment. Filtration systems will improve the lifespan of equipment that uses water.

How is Filtration Used in the Food Processing Industry?

Water filtration systems are typically used on any type of food processing equipment that uses water. This can include everything from the machinery in large food processing plants to smaller equipment in restaurants and school cafeterias.

When equipment or machinery that use water is run, over time it will develop a build up of scale (mineral deposits), which can lead to equipment breakdowns, malfunctions or even contamination of the food or beverage that is being processed. Using water filtration systems on food processing equipment will help prevent the scale build-up as it filters the water that is used in the equipment.

Water filtration removes sediment, chemicals, minerals and organic matter from water, improving the taste and smell, and safely eliminating contaminants that may be dangerous for the people who will consume the products being processed.

Which Areas are At Risk in Food Processing?

There is a presumption of both quality and safety in the American food and beverage industry by consumers. That is due to, in large part, the fact that there are standards and regulations by which food and beverage processes must abide. The quality burden often rests on the machinery or equipment that are used in processes. Thus, the need for water filtration systems is more than simply wanting to provide consumers with quality products—it is also crucial for the continued operation of manufacturers.

Improved water quality has highlighted filtration in recent years, and rightfully so. Water is a prevalent ingredient, cooking method and means of cleaning. Additionally, air power is used to operate pneumatic machinery, move food products, and sometimes add texture to those products. Water (liquid or steam) and air can easily transfer microbials or other contaminants into the food products, packaging or surfaces on which food comes into contact.

While every process is different depending on the equipment being used, there are generally three areas in the food and beverage process where filtration is critical:

  1. Prefiltration: In areas of the facility where water, air or steam sources are first brought in or are generated.
  2. Intermediate filtration: During the process when water, air and steam move through piping or other equipment prior to making direct contact with food or a surface in which food comes into contact.
  3. Final filtration: At the end of processing, where there is a last opportunity to manage surviving contaminants.

How Strainers Help Water Filtration Systems

One of the most common ways food and beverage processers ensure that there are no unwanted solids in the water or equipment they use is by installing sanitary strainers in the water piping in the above-mentioned areas. One such type of strainer is the y-strainer.

Click on page 2 to read the rest of this article.

Karen Everstine, Decernis
Food Fraud Quick Bites

A Look at the Latest Targets

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Recent food fraud news includes the seizure of a million bags of fraudulently labeled and expired rice in Kenya, fraudulent spices found in a warehouse in India, and a U.S. grocery store chain sued for selling manuka honey that wasn’t 100% manuka. In Spain, tuna intended for canning was dyed and diverted to be sold as fresh and in China, 8,000 bottles of counterfeit wine were seized by the local food and drug administration. In Greece, 17 teenagers became ill after drinking alcoholic beverages containing methanol. Recently published journal articles on detection methods have looked at adulteration of honey with sugar syrups, meat adulteration with other species, authentication of products containing truffles, and Arabica coffee authenticity. One group of researchers evaluated a method to authenticate the botanical and geographic origin of hops.

Vanilla prices have been high, increasing the incentive to substitute natural vanilla extracts with similar flavors. A search of the Food Fraud Database shows a range of fraudulent adulterants associated with vanilla extract: Coumarin, ethyl maltol, ethyl vanillin, maltol, vanillic alcohol, and vanillin (natural or synthetic). Recently published authentication methods include GC-VUV and analysis of stable isotopes of carbon and hydrogen (with GC-IRMS).

In 2004 (another period of high vanilla prices), a company that sourced vanilla beans from Indonesia for use in manufacturing vanilla extract identified mercury contamination in two lots of beans they had received. Mercury was presumably added to increase the weight of the beans. The company quarantined all beans and products that had been manufactured from them. They also had to shut down flavor production to clean and decontaminate the processing equipment.

Due to their high value and physical form (they are often sold in ground or liquid extract form), herbs and spices have a long history of fraudulent adulteration. Many countries have publicly reported being affected by food fraud in herbs and spices over the past 10 years.

Food Fraud incidents, spices
Incidents of food fraud reported in the Food Fraud Database for the past ten years in the category “Herbs, Spices, and Seasonings” (68 total).1

Mitigation measures for products at high risk for fraud include putting in place raw material specifications that include authenticity criteria, implementing analytical surveillance, establishing strong supplier relationships and audit programs, and increasing supply chain transparency.

Resource

  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.
X-ray systems

Production and Inspection: What to Do When Contamination Occurs

By Chris Keith
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X-ray systems

As much as food manufacturers take precautions to avoid all types of contaminants, there can still come a moment when you realize that your best efforts have failed. Maybe you find a broken blade or a missing wire during a sanitation break, but the product has already gone through your inline inspection machines—and nothing was detected.

This is the freak-out moment that no plant manager or quality assurance manager wants to have. Knowing that there’s possible contamination of your food product (and not knowing where that contaminant might be) creates a hailstorm of possibilities that your plant works hard to avoid. And you’re probably wondering how this could have happened in the first place.

X-ray systems
In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.

Understanding How Contaminants Get Past Detection

To prevent physical contamination from occurring, it’s important to understand the reasons why it happens. In-house inspection systems often fail to detect contaminants for the following reasons:

  • The equipment isn’t calibrated to detect contaminants to a small enough degree, or the contaminants are materials that aren’t easily detected by the in-house machinery (glass, rubber, plastic, etc.)
  • The machines aren’t constantly monitored
  • The speed of the production line doesn’t allow for detecting small particles

Metal detectors are the most commonly used inline inspection devices in food manufacturing, and they depend on an interference in the signal to indicate there is metal contamination in the product.
Despite the fact that technology has progressed to deliver fewer false positives, the machines can still be deceived by moisture, high salt contents and dense products that could provide interference in the signal. When that continues to occur, it’s common for manufacturers to recalibrate the machine to get fewer false positives—but that also decreases its effectiveness.

Another limitation of the metal detector is that, as the name indicates, it can only find metal. That means contaminants like plastic, glass, rubber and bone won’t be found through a metal detector, but will hopefully be discovered through some other means before the product is shipped out.

Oftentimes, contamination or suspected physical contamination is discovered when a product, such as cheese or yogurt, goes through a filtration system, or when a piece of machinery is inspected during a sanitation break.
If the machinery is found to be missing a part, such as a bolt or a rubber gasket, the manufacturer then has to backtrack to the machinery’s last inspection and determine how much, if any, of the product manufactured during that time has been contaminated.

X-ray inspection
X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. In this image, you can see foreign material detected in canned goods.

What To Do When Contamination Occurs

Once a food manufacturer discovers that it may have a physical contamination problem, it must make a decision on how to handle the situation. Options come down to four basic choices, each of which comes with its own risks and benefits.

Option 1: Dispose of the full production run

The one advantage of disposing of a full production run is that it entirely eliminates the possibility of the contaminated product reaching consumers.

However, this is an expensive solution, as the manufacturer has to pay for the cost of disposal in a certified landfill and absorbs the cost of packaging, labor and ingredients. It also presents the risk of lost revenue by having a product temporarily out of stock.

Option 2: Shut down your production lines for re-inspection/re-work

Running the product through inline inspections a second time may result in finding the physical contaminant, but there’s also a risk that the contaminant won’t be found—and now the company has lost money through overtime pay and lost productivity.

If the inspection equipment was not sensitive enough to find the contaminant the first time around, it may not find it the second time, which puts the manufacturer back at square one. The advantage to this method is that the manufacturer maintains complete accountability and control over the process, although it may not yield the desired results.

Option 3: Risk it and ship the product to retailers

There’s always a chance that a missing bolt didn’t make its way into the product. Sometimes, if a metal detector goes off and the manufacturer can’t find any contaminants upon closer examination, they will choose to ship the product and take their chances.

The advantage for them is that, on the front end, this is the least expensive option—or it could be the costliest choice of all if a consumer finds a physical contaminant in their food. In fact, the average cost of a food recall is estimated at $10 million; lawsuits may push that cost even higher and result in a business being closed for good.

Option 4: Use third-party X-ray inspection

X-ray inspection is the most effective way to find physical contaminants. In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.

When a food manufacturer has a contamination issue, it can have the bracketed product inspected by a third-party X-ray inspection company and only dispose the affected food, allowing the rest of the product to be distributed. This option allows the manufacturer to maintain inventory and keep food deliveries on schedule while still eliminating the problem of contamination.

X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. When X-ray beams are directed through a food product, the rays lose some of their energy, but will lose even more energy in areas that have a physical contaminant. So when those images are interpreted on a monitor, the areas that have a physical contaminant in them will show up as a darker shade of gray.
This allows the workers monitoring machines to immediately identify any foreign particles that are in the food, regardless of the type of material.

Detection is Key to Avoiding Contamination Issues

Handling contamination properly is vital to every food manufacturing company. It affects the bottom line and the future of the company, and just one case of a physical contaminant reaching the consumer is enough to sideline food companies of any size. As X-ray technology continues to evolve, it remains an effective and efficient form of food inspection.

Educating plant managers and quality managers on what to do if inline inspection machines fail to detect contaminants should include information on how X-ray technology can be a food company’s first line of defense. While physical contaminants can’t always be avoided, they can be detected—and the future of your company may depend on it.