Tag Archives: Listeria

Make Your Data More Meaningful

By Maria Fontanazza
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Data can be a very powerful tool, but only if it is used in an effective manner. It needs to be easily consumable and understood by all levels within an organization. “It’s great to collect information, but if you don’t do something with it, you’re not doing yourself, your facility or your employees any favors,” says Holly Mockus, product manager at Alchemy Systems. “It can really trip you up during a regulatory inspection to have all of this information that you haven’t looked at, tracked, trended or reacted to.”

As FSMA places more importance on documentation and record keeping, FDA-regulated facilities will need to not only capture information but also translate data into easily digestible content for management and employees in order to drive continuous improvement. In a discussion with Food Safety Tech, Mockus shares some key points on how companies can transform their data from numbers and statistics into meaningful and actionable information.

  1. Collect meaningful data from the start. From the beginning of the data collection process, be mindful of exactly what outcome the organization wants to achieve. Having an understanding that the data will be measured and acted upon encourages facilities to avoid gathering information just for the sake of collecting it.
  2. Involve the employees who actually collect the data. Data is more meaningful when employees understand why they’re gathering information and are involved in the process from the beginning.
  3. React to the data. If the information reveals a good or bad trend, or that a process or procedure is out of spec, take action. In addition, document how the business reacted to the issue and the corrections that were put in place.
  4. Close the loop for continuous improvement. Establish a closed loop for data collection, focusing on how gaps were addressed, with an emphasis on continuously improving on the process.
  5. Really examine the data collected. Whether collected for a product, process or equipment line, sit down and take a close look at the data. This exercise is intended to reveal redundancies across departments and help reduce record keeping tasks.

Food Safety Tech: How do companies transform data into a meaningful tool for management?

Mockus: That’s such a challenge for us. It should be easily consumable, especially for management and the higher ups in organizations, because they don’t have as much time to sit down and digest a 20-page document that’s full of numbers and statistics. Work towards to summarizing the information in a way that allows executives and plant managers to look at a graph and know instantly what it means; they don’t need to get into the nitty-gritty. Simplifying the scientific data, whether environmental sampling, quality assurance data, or microtesting in general, and taking it down to base a level so that the non-scientist can understand it—I think that’s something we have to work on, especially for those coming under more regulation. Keep in mind that people who look at the tracking and trending [might not] understand graphs and scientific terms.

A lot of people put the data into a graphic format—it doesn’t have to be a line graph or pie chart, it can be a red, yellow, green [indicator] or a scale of justice. Look at the graphics that are meaningful to your specific organization and use those. Be creative, but keep it simple.

FST: When companies set metrics, how can they ensure that those metrics are taking them in the right direction from a food safety perspective?

Mockus: Especially when you have metrics that are tied to performance for a manufacturing facility, you want to be careful how you set them and how you reward them. For example, if your metric for environmental testing is very low or at zero, you’re encouraging your workforce not to find those Listeria niches or areas in which Salmonella can grow, because you’re telling them that they have to be at a zero rate to be incentivized. It’s more about measuring the outcomes of the activities—are we finding the niches and eliminating them so we don’t have those issues versus saying we want to be at “zero”? [It’s important] to work with upper management so that they understand the consequences of their expectations and the incentive programs that they put in place.

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

Listeria Puts a Spook in Halloween

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

It’s that time of year again: A time when Americans, both young and old, enjoy decorating pumpkins, dressing up in outrageous costumes, visiting houses haunted with ghosts and goblins, and consuming way too much sugar. And then there’s the classic favorite, the caramel apple. I’ve never been a huge fan of the sticky treat, but many Americans just can’t get enough it.

This year’s Food Safety Consortium conference features “Preventing Listeria Workshop: A Practical Workshop on Food Safety Controls” on Tuesday, November 17. REGISTER HERE. Last year caramel apples received a huge amount of negative press as a result of a deadly Listeria outbreak that was traced back to prepackaged caramel apples from Bidart Bros (Bakersfield, CA). In February of this year, the CDC closed its investigation, and provided the final stats: 7 dead and 34 hospitalizations throughout 12 states.

Now here we are, at the height of the season for apples and sweet treats, and concerns over Listeria in caramel apples are back in the media. The good news is that industry is proceeding with caution. The Wall Street Journal reports that Kroger Co. is taking unrefrigerated caramel apples off its store shelves following a recent study that cited a higher likelihood of Listeria growth on the products when at room temperature versus under refrigeration. Published by the American Society of Microbiology, the study, “Growth of Listeria monocytogenes within a Caramel-Coated Apple Microenvironment”, found that “insertion of a stick into the apple accelerates the transfer of juice from the interior of the apple to its surface, creating a microenvironment at the apple-caramel interface where L. monocytogenes can rapidly grow to levels sufficient to cause disease when stored at room temperature”. The researchers also advise that consumers purchase refrigerated apples or eat them fresh.

Although representatives from Kroger said they think the risk of Listeria contamination is minimal, they decided to take a cautionary approach. It’s reassuring to see companies step up and take proactive tactics to mitigating risks, especially when it involves protecting consumers against another potentially deadly outbreak.

Jim Hammel, vice president, customer success at Sample6
In the Food Lab

Using Software for Environmental Tracking and Data Visibility

By Jim Hammel
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Jim Hammel, vice president, customer success at Sample6

There is growing evidence that a strong environmental program is critical to identifying potential issues before they threaten product. This data must be captured regularly based on a robust environmental sampling plan and then analyzed in order to take advantage of the results. However, without the proper tools, this is challenging, time consuming and ineffective.

How Software Strengthens a Sampling Program

The most critical component of an environmental sampling plan is zone coverage. Many sampling plans exclude zone 1, direct food contact, because this implicates the finished product and may lead to a test-and-hold situation. However, at minimum, zones 2-4 should be covered in a sampling plan. In addition, it is important to randomize test points and schedules. Sanitation crews are held to rigorous standards, but it is human nature to complete repetitive tasks in the same manner. By randomizing which test points are tested—by day, time and operator—quality teams are more likely to identify potential areas of concern. Randomization is a challenging task to complete manually but a routine task for software.

Using Software for Environmental Tracking and Data Visibility
Using software enables environmental tracking and provides and data visibility. Image courtesy of Dietz & Watson

In addition, ensuring test-point coverage is a key component to sampling plans. An interval for test-point coverage is typically included in environmental sampling plans. It is up to quality teams to ensure that their sampling programs are consistent with these business rules. When this is tracked in an Excel spreadsheet, randomization is typically sacrificed to ensure test-point coverage. This is tracked in a large table with dates on one axis and test points on the other. The challenges to this approach include randomization, analysis and management of more than one test-point coverage interval. Business rules of this nature can be easily managed through software algorithms. In fact, the task of creating a schedule according to a series of business rules is not unlike a macro.

Lastly, robust sampling programs include detailed remediation and response plans in the event of a positive or presumed positive test result. The details on these plans are reviewed internally to ensure that the issues have been adequately addressed. Documentation that each step has been completed in a timely manner is absolutely essential in today’s regulated food production environment. Remediation records may be requested in a government or supplier food safety audit. Emails, meeting notes, pictures and cleaning records can certainly be kept in file drawers, but the more accessible this information is, the more likely it will be used. Approval processes and business workflows have been automated in a variety of software tools. Everything from sales to expense reports has sought support from software to ensure that their workflows are executed consistently and with traceability. Software can support food safety efforts in this way as well.

Dos and Don’ts of Data Analysis

The next challenge in environmental monitoring is the volume of data generated and the tools required for effective analysis. A robust environmental sampling program for Listeria can range from 10 to 15 samples per week per line—often much more. Each test result includes metadata such as sample location, day and time, sample collector and result. In a plant with 10 lines, there are 150 test results per week, or 7,800 test results per year. When compiling results for the past three years, the numbers reach nearly a quarter of million just for pathogen testing. Routine testing such as yeast, mold and Enterobacteriaceae should also be considered in the analysis. The sheer volume of the data can be challenging in a spreadsheet but routine in a database.

Don’t rely on unmanageable spreadsheets. Analysis should look for trends in the data as well as compliance to the program. Completing this task in spreadsheets requires that the data be properly formatted. Further, the database-like structure that would enable analysis is often inconsistent with the table format used for sample schedule generation. In addition, this task is time consuming, manual and error prone; therefore, the frequency of analysis may be reduced.

Don’t take an analog approach to floor plans and risk it being outdated. Particularly for environmental data, it is important to understand the proximity of test points and their results. This allows managers to look for patterns or workflow trends that may be impacting results. This task typically requires mapping the test points and their results to a floor plan. Many plants keep a copy of the floor plan and recent findings posted on the wall.

Do use the tools available. In today’s data-rich food production environment, successful data analysis must be automated.

Answering the Call for Communication

Lastly, for an environmental monitoring program to be effective, communication is critical. The members of the quality team need to know what specific tasks are expected of each of them and when. Sanitation workers need to know what areas require their timely response. Executives need visibility into the results and actions underway so that they can support their teams and make critical food safety decisions. While these tasks can be completed manually, it is ripe for automation and new tools are streamlining the communication process.

Food safety managers and quality teams are working diligently with their sanitation teams to keep their plants and product safe.  However, they need to leverage the available tools needed to do their jobs efficiently and effectively. New software tools designed for the food safety industry are changing the way the industry handles safety initiatives. In particular, sampling program, data analysis and communication tools are ripe for automation. Take advantage of technologies and tools already in use in business today so you are prepared to manage the food safety challenges of tomorrow.

3M Molecular detection assay for Listeria

Molecular Detection Assay for Listeria Promises Faster Results

By Food Safety Tech Staff
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3M Molecular detection assay for Listeria

A molecular detection assay for Listeria monocytogenes has been approved by the AOAC Performance Test Methods

3M Molecular detection assay for Listeria
The new test was developed in response to customer engagement and a desire to work with food processors to protect the world’s food supply, says 3M Food Safety.

(PTM) program. Developed by 3M Food Safety, the assay is based on isothermal DNA amplification and bioluminescence detection technologies. With a streamlined workflow that is 30% faster than the first generation assay, the new test is designed to provide expedited, simple and more accurate real-time pathogen detection.

Obtaining AOAC PTM status involved a thorough independent lab examination of the test method’s ability to accurately detect Listeria monocytogenes within a variety of foods. During the validation study, analyzed food samples included beef hot dogs, queso fresco cheese, vanilla ice cream, 4 % milk fat cottage cheese, 3% chocolate whole milk, romaine lettuce, bagged raw spinach, cold smoked salmon, deli turkey, raw chicken, cantaloupe, and various environmental surfaces (plastic, stainless steel, concrete). Achieving AOAC PTM approval certifies that the test kit is equivalent or better than standard reference methods, according to 3M Food Safety.

Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

Food Safety Testing Must Live Up to Higher Expectations

By Maria Fontanazza
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Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.

Key trends:

  • Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
  • Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
  • The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.

Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?

Tim Curran, CEO of Sample6, pathogen detection
Tim Curran, CEO of Sample6

Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].

Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.

Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.

“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.

These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.

Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.

Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.

Michael Koeris, Ph.D., founder and vice president of operations, Sample6, pathogen detection
Michael Koeris, Ph.D., founder and vice president of operations

Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.

FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?

Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.

Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.

Jim Godsey, vice president of research & development, Sample6, pathogen detection
Jim Godsey, vice president of research & development

There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.

FST: How do you expect the final FSMA rules and implementation process will impact industry?

Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.

FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.

Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.

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

How the Blue Bell 483 Inspection Reports Affect Us

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

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

Point 1

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

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

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

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

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

Point 2

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

  • Determination of the pathogenicity of the coliform isolates.

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

Point 3

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

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

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

Point 4

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

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

Point 5

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

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

Conclusion

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

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

Listeria Invasion – How is it Creeping into Our Beloved Foods?

By Traci Slowinski
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As a result of several recent high-profile Listeria-related recalls, interest in the foodborne pathogen is increasing and food processors must take preventive measures to keep it out of facilities.

Listeria monocytogenes is a gram-positive bacteria. It has 13 serotypes, three of which have been associated with the vast majority of foodborne infections (called listeriosis). Although it is not a leading cause of foodborne illness, it is among the leading causes of death from foodborne illness. This hardy pathogen is salt tolerant, thrives in cold, moist environments and can grow under refrigeration temperatures. Listeria is found throughout our environment including in soil, water, sewage, decaying vegetation and even some animals. Its presence has most often been identified in foods such as raw or under-pasteurized milk, smoked fish, deli meats, soft cheeses and raw vegetables.

For a healthy individual, Listeria may cause mild symptoms or have no effect at all. Fever, muscle aches, nausea, vomiting and diarrhea are common signs of infection. For the e  immunocompromised (the very young or old, pregnant women, or adults with weakened immune systems), symptoms can be more severe and include septicemia and meningitis; in pregnant women, it can cause miscarriage. Symptom-onset ranges from a few hours to two–three days, with durations lasting from days to several weeks, depending on the severity of infection.

Keep Listeria Out of Your Plant

The first line of defense against Listeria contamination is to keep it out of a facility, but that may not always be possible, thus a Listeria prevention plan should be integrated into a company’s food safety program, considering the following areas:

    • Employees—can be brought in on shoes and clothing, or through infected workers. Prevention includes:
      • Good Manufacturing Practices
        • Personnel Hygiene—proper hand washing, wearing clean clothes and shoes, wearing proper hair restraints
        • Employee Illness Policy—restriction/exclusion of ill employees
    • Raw Materials—introduction into the environment from raw ingredients (milk, fish, seafood, produce), pallets, cardboard, packaging material. Prevention includes:
      • Supply Chain Management
        • Supplier Approval Program—having strategic partners that ensure only safe, high-quality raw materials
        • Ingredient Management—requesting COAs, letters of guarantee, allergen control
        • Receiving/Storage Procedures—completing incoming inspections, proper nonconforming material handling
    • Processing Aids—harborage in ice, brine solutions, improperly filtered compressed air and HVAC units. Prevention includes:
      • Sanitation Program—proper cleaning/sanitizing of equipment
      • Preventative Maintenance—regular replacement/maintenance on filters/motors
      • Water, Air, and Steam—utilizing potable water, properly filtered air, properly treated steam
    • Equipment Design—contamination of conveyor belts, filling and packaging equipment, slicers/dicers, ice makers, hoses, equipment framework, condensate drip pans, maintenance tools, trash cans, tools for cleaning equipment (brushes and scouring pads). Prevention includes:
      • Sanitary Equipment Design – ensuring that all equipment can be broken down as far as possible and properly cleaned and sanitized to remove dirt, debris and micro-organisms
    • Process Flow—not maintaining segregation of high vs. low risk, clean vs. dirty. Prevention includes:
      • Separation of high-risk vs low-risk areas through time, space or physical barriers
      • Proper garb (smocks, hair restraints, captive shoe policy) and sanitary measures (hand wash and sanitize, shoe sanitizer) to reduce introduction into high-risk areas
      • Proper personnel flow or movement to prevent cross-contamination
    • Plant Environment—common pathogen harborage areas. Prevention includes:
      • Floors/Drains – splash back, biofilms
      • Overhead Structures – condensate, dust/debris
      • Waste Areas – trash buildup
      • Wash Areas – standing water
    • Sanitation Program—insufficient cleaning/sanitizing to remove pathogens. Prevention includes:
      • SSOP’s – comprehensive sanitation SOPs with special focus on hard-to-clean areas and equipment.
      • Drain Cleaning—proper frequency, chemicals and procedures
      • Clean-In-Place Systems—accessibility to hard-to-reach areas
      • Sanitizing Agents—quaternary ammonium compounds, peroxyacetic acid sanitizers (for biofilms)
    • Environmental Monitoring Program—tool to identify gaps and risk used improperly resulting in missed problems. Prevention includes:
      • Robust Sampling Plan—identify zones and sampling areas
      • Effective Track & Trend Tool—identify gaps or risk that require corrective/preventive action
      • Timely Corrective Action— ensure proper follow-up on any issues that arise

First Person: The Listeria Experience and Lessons Learned

The above list is by no means exhaustive when it comes to all the areas you need to consider when completing a gap analysis within your facility. Listeria can be very insidious, and you will need to be ever-vigilant to ensure it does not take hold in your environment. Believe me, I have been there when it has.

Once upon a time, I worked for a Ready-to-Eat processing plant. We had robust food safety and quality assurance programs. We employed two microbiologists and had a good environmental monitoring program. The sanitation team did a thorough job of cleaning and sanitizing every night, and we completed preoperational sanitation inspections (including ATP testing) every morning.

Then we had a Listeria recall.

It started out small. One sample tested by FDA came back positive. Then another…and another. More intensive environmental testing found Listeria in the plant—in the drains, in the hard to reach areas of the old slicers and MAP packaging equipment, and even in the production room cooling units.

After many, many hours of cleaning, sanitizing, testing and retesting, we determined that the current layout of the facility would never allow for complete elimination of the Listeria. We had one big production room where raw material was brought in and broken down, fed into the processing lines and assembled, and lastly, finished product was placed into the packaging, which then went into cases and onto wooden pallets. There was no separation of high-risk areas from low risk.

So, what did we do? We set up a temporary location for production (which was a major project in and of itself), redesigned the process flow, shut down the plant, and remodeled our production area.

Highlights of the redesign included:

      • Building a cleanroom for the production area. We walled off the raw material handling area by the receiving warehouse, enclosed the packaging area by the shipping warehouse, and made the room that housed the processing lines a cleanroom/high-risk room. Entry into the room required appropriate garb (clean smocks, hair restraints, gloves, captive shoes), use of the hands-free hand wash and sanitizer, and a pass through the boot sanitizer. The temperature of the room was reduced from 50oF to 38oF to discourage pathogen growth.
      • Setting up a raw material handling room. A separate “dirty” area was built to break down raw material components and remove them from their packaging (corrugate cases, plastic wrap). Raw material was then fed through a wall opening where a UV light was mounted to “sanitize” the outside of the material. This helped to reduce the introduction of cardboard packaging and wood pallets into the cleanroom and drive down any pathogens that might be on the surface of the raw material.
      • Adding a packaging room. All sealed, packaged finished product passed through a wall opening into the packaging room where it was boxed up and placed on pallets. This also helped to reduce the introduction of cardboard and wood into the clean room.

The new process flow allowed for employees to move from the “clean” processing room to the raw material or packaging rooms without any extra precautions, but they were required to go back through the clean room procedures prior to going back to the processing area. Raw material and packaging employees were excluded from the cleanroom to minimize potential of contamination from personnel flow.

We also reevaluated our Hazard Analysis and Critical Control Points (HACCP), Sanitation Standard Operating Procedures (SSOPs), and Sanitation and Environmental Monitoring (EM) programs to ensure all potential risk was identified and addressed either through the new facility design or other control measures. One key takeaway was to use the EM program to identify gaps and areas of opportunity rather than to just try to prove that everything is fine. We learned that having a comprehensive EM program that can capture all the necessary data points, analyze trends and drive corrective action helped our team use the program to drive food safety and continuous improvement. It wasn’t good enough to just have an EM program in place; we needed to use the data to address gaps and mitigate identified risks.

Conclusion

Foodborne pathogens are one of the biggest risks to the safety of our foods. Listeria poses a threat to a number of food categories (dairy, protein, and produce) and should be highlighted as a significant hazard to be assessed when developing and implementing your food safety programs. Using risk-based preventive controls within your facility will help prevent adverse events related to Listeria.

Why Everyone Should Care About Food Safety

By Matt Shipman
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Food safety poses a global health problem. According to the World Health Organization, contaminated food can cause more than 200 diseases – and food- and water-borne diseases that cause diarrhea are estimated to kill two million people each year worldwide.

And food safety is not just someone else’s problem.

“Foodborne illnesses are a significant problem in the United States, with massive impacts on public health and the economy,” says Ben Chapman, a food safety expert and researcher at NC State. And the numbers back Chapman up.

According to a 2012 report from researchers at the Emerging Pathogens Institute, Resources For the Future, and the U.S. Department of Agriculture’s Economic Research Service, foodborne illness is estimated to cost the U.S. more than $14 billion annually. (The estimate takes into account factors such as medical costs and productivity losses.)

And a 2011 report from the U.S. Centers for Disease Control and Prevention (CDC) reported an estimated 9.4 million episodes of foodborne illness each year in the U.S. from known pathogens. An additional 38.4 million cases are estimated to come from unspecified or unknown pathogens. In total, foodborne illnesses are thought to contribute to 48 million illnesses annually – resulting in more than 128,000 hospitalizations and 3,000 deaths. It is, in short, a big deal.

So what are these foodborne illnesses? And how much damage does each of them cause? In advance of World Health Day, we wanted to explain a handful of the relevant pathogens implicated in foodborne illness.

Campylobacter fetus bacteria Image credit: CDC.  Obtained via Wikimedia Commons.  Click for more information.
Campylobacter fetus bacteria
Image credit: CDC.
Obtained via Wikimedia Commons.

Campylobacter

Campylobacter is a genus of bacteria, many of which can cause an illness called campylobacteriosis in humans, with symptoms including diarrhea and abdominal pain. People can contract campylobacteriosis from undercooked chicken, from cross-contamination via raw chicken, or from drinking unpasteurized milk.

According to the 2012 paper, campylobacteriosis affects 845,000 people annually in the U.S., costing the nation an estimated $1.747 billion every year and leading to 8,463 hospitalizations.

Listeria monocytogenes

This is a bacterium that causes listeriosis, which is characterized by fever, muscle aches, and sometimes by gastrointestinal problems, such as diarrhea. Listeriosis can be contracted from an incredibly broad range of foods.

According to the 2012 study, listeriosis costs the U.S. $2.577 billion annually, despite the fact that there are only 1,591 illnesses per year. But 1,455 of those illnesses require hospitalization – and 255 result in death.

Norovirus

Noroviruses are the most common cause of foodborne illness in the U.S., affecting an estimated 19-21 million people each year. Symptoms range from vomiting and diarrhea to fever and headache. Transmission comes from ingesting infected feces or vomit particles – for example, by touching a contaminated surface and then touching food or touching your mouth.

According to the 2012 study, noroviruses cost the U.S. $2 billion per year, with more than 14,000 hospitalizations and approximately 150 deaths annually. NC State is a leader in norovirus research, and home to NoroCORE – the Norovirus Collaborative for Outreach, Research, and Education. NoroCORE pulls together norovirus research from 18 institutions, with funding from the U.S. Department of Agriculture.

Salmonella enteritidis Image credit: U.S. Department of Agriculture.  Obtained via Wikimedia Commons.
Salmonella enteritidis
Image credit: U.S. Department of Agriculture.
Obtained via Wikimedia Commons.

Salmonella enterica

This is one species of the pathogen that has myriad of subspecies and types – more than 1,400 of which are known to cause human illness. Infection with Salmonella species causes salmonellosis, with symptoms including diarrhea, fever, and cramping. Salmonellosis can be contracted from a variety of sources, ranging from poultry to peanut butter to mangoes.

According to the 2012 study, the subspecies within S. enterica alone costs the U.S. $3.3 billion each year, causing more than one million hospitalizations and almost 400 deaths annually.

What are researchers doing about this?

The four pathogens listed above are just a few of the rogue’s gallery of bacteria and viruses that can cause foodborne illness. But researchers are constantly learning more about these health risks.

“New technology and new research on pathogens, practices and prevention are improving our ability to identify and address foodborne illness,” Chapman says. “The field is really opening up. It’s an exciting time to be involved in food safety research.”

Between now and April 7, we’re planning to publish a series of posts on various aspects of food safety – what we know, what we don’t know, and what we’re working on. We also hope to offer insights to help folks lower the risk of contracting foodborne illnesses. We hope you’ll learn something new.

Note: This article originally appeared on NC State News, and has been published here with permission. You can find all of NCSU’s posts related to food safety here.

Citations:

  1. Batz, Michael B., Sandra Hoffmann, and J. Glenn Morris, Jr. “Ranking the Disease Burden of 14 Pathogens in Food Sources in the United States Using Attribution Data from Outbreak Investigations and Expert Elicitation” Journal of Food Protection, Vol. 75, No. 7, 2012, Pages 1278–1291. doi:10.4315/0362-028X.JFP-11-418
  2. Scallan, Elaine, et al. “Foodborne Illness Acquired in the United States—Major Pathogens” Emerg Infect Dis, Vol. 17, No. 1, 2011. doi:10.3201/eid1701.P11101

 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Implementing an Effective Listeria Control Plan for Dairy Products

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In the last three years, there have been four major foodborne illness outbreaks caused by Listeria monocytogenes in dairy products (Oasis fresh curd cheese; Roos raw hard cheese; Crave Brothers pasteurized farmstead cheese; and Frescolina Marte pasteurized ricotta cheese). Before 2012, there have been multiple outbreaks due to raw and pasteurized Mexican-style soft cheeses and in pasteurized milk in 2007.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology LaboratoriesDr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories , recently spoke about Implementing an effective Listeria control plan for Dairy Products in a recent presentation. He described the pathogen as “a gram-positive bacteria, which is facultatively anaerobic, psychotrophic (can even multiply at refrigeration temperatures – though at slower rates), sensitive to heat processing, even found in healthy cows, raw milk and dairy processing environments, and can survive most cheese ripening processes.”

Though, listeriosis, the infection caused when a person is infected with LM, is relatively rare – only affecting about 1600 individuals a year – it has a high mortality rate, highest among foodborne illnesses, especially among high-risk individuals.

Dr. Marshall listed some of the contributing factors to a LM outbreak:

  • Inadequate thermal processing
  • Refrigeration temperature being too high
  • Inadequate product flow through processing plant
  • Inadequate personal hygiene
  • Product shelf-life too long
  • Inadequate cleaning and sanitation
  • Inadequate environmental monitoring and control
  • Inadequate end product testing

Thermal processing is a time-temperature process, and it can be inadequate if either the temperature is too low, or the process time is too short.

It is common knowledge that whether it’s during transportation, or at retail or at homes, often temperature of food storage is not adequately maintained. Dr. Marshall said that as high as 55 percent of household units and 32 of retail store units had refrigeration temperatures of greater than 9 °C. “And once you get past that temperature threshold of 10 °C, the bacteria reaches maximum population level within six days (average shelf life).”

Inadequate cleaning & sanitation is another major cause for LM contamination and this is often the battle between production & sanitation. Floor drains are a common culprit, responsible for 63 percent incidence of LM. Dr. Marshall also referred to other sources of inoculation that you are not getting effective control of such as filler heads and high pressure water sprays or air sprays, which can aerosolize bacteria and spread the contamination to other surfaces.

Inadequate product flow is usually due to the failure to segregate pasteurized product form raw product or the failure to segregate employees working in raw vs. pasteurized locations. Address this by mapping out product and employee flow (along with equipment) and look for areas where cross contamination can occur, advises Dr. Marshall, who cautions facilities to monitor and control the following direct food contact surfaces that can be cross-contaminated:

  • Fillers
  • Packaging stems
  • Conveyors
  • Chilling solutions
  • Slicers, dicers, shredders, blenders, hoops, molds
  • Collators, assemblers
  • Product movement items, such as racks, bins, tubs and buckets
  • Spiral coolers, blast freezers
  • Hand tools, gloves, aprons

Inadequate personal hygiene is another contributing factor and this can include clothing such as outerwear and gloves. Maintenance personnel should be thorough in their hand-washing and it’s recommended they use alcohol based wipes after hand-washing.

Address the issue of shelf-life being too long by determining the shelf life based on food safety, and not food quality. Also, run LM challenge test in each product, Dr. Marshall advises.

Eurofins-LM-in-Dairy-webinar-March2015

FDA, in their Preventive Controls rule proposed under the Food Safety Modernization Act, has a section on Environmental Monitoring, based on the rationale that that poor control of the environment can lead to LM cross contamination of finished product, explains Dr. Marshall, adding that inadequate environmental monitoring and control is a key component for LM contamination.

“Invest your testing dollars to find hot spots in your facility and ensure the control mechanisms are working every day,” he says, asking companies to “detect and control hot spots, measure effectiveness of general cleaning and sanitation programs, and test for Listeria species.”

Dr. Marshall asks, “If I were LM and wanted to hide, where would that be? Would it be on an easy to clean surface such as the floor, or would it be in a nook or cranny where it’s hard to reach and clean?” He lists the following as areas that commonly harbor the pathogen and advises extra caution and creativity to clean these spots:

  • Equipment framework – nuts, bolts, open tubing, spot welds
  • Floors and drains – standing water
  • Walls
  • Ceilings, overhead equipment, catwalks, pipes
  • Condensate
  • Exposed, wet insulation around pipes and walls
  • Fork lifts, trolleys
  • Cleaning tools – sponges, brushes, scrubbers
  • Maintenance tools
  • Conveyors, belts and rollers (need to be broken down and cleaned regularly)
  • Control panels and switches
  • Rubber seals (especially if they have cracks)
  • Trash cans
  • Air fillers
  • Motor/ pump housings
  • Cracked hoses
  • Ice makers

End product testing is an effective way for testing for LM, but Dr. Marshall points out that there are often arguments against this. “Companies often argue that their HACCP plan is working, their kill step is effective and that they have a history of doing end product testing, and they haven’t had any positive results so far. But this is not a convincing enough argument.” End product testing can address the failure to monitor and control high risk ingredients, and is very useful to detect gross contamination events. It should be used to assess risk of rework, and also test for LM, not just Listeria, Dr. Marshall advises.

Hear more about building an effective control plan for Listeria in your dairy processing environment, by listening to this archived webinar recording, presented by Eurofins.

Apple Recall – Here are 5 Fruits and Veggies at Greater Risk

“Fresh fruits and vegetables are probably the biggest source of foodborne illness today in North America, and that’s because they’re fresh — we don’t cook them — so anything that comes into contact has the potential to contaminate.”

A Listeria outreak in apples has killed seven people and hospitalized 31, according the Centers for Disease Control and Prevention, which has trace the outbreak to Bidart Bros. apple-packing plant in California.

While apples are the second most popular fruit in America, according the Agricultural Marketing Resource Center, outbreaks linked to apples are rare, due to the natural hard surface of the fruit, which, prevents bacteria from entering the fruit, says Doug Powell, PhD, a former professor of food safety in the U.S. and Canada who publishes barfblog.com.

In a Yahoo! Health article, Amy Rushlow quotes Prof. Powell: “Fresh fruits and vegetables are probably the biggest source of foodborne illness today in North America, and that’s because they’re fresh — we don’t cook them — so anything that comes into contact has the potential to contaminate.” Powell especially sounds caution about the following five fruits and vegetables, which have been linked to a significant number of foodborne illness outbreaks over the past years:

1. Sprouts: A 2011 outbreak in Germany killed more than 50 people and sickened more than 4,000. In late 2014, more than 100 Americans became ill after eating sprouts tainted with E. coli. Sprouts are particularly prone to bacteria because they germinate in a high-temperature, high-moisture environment — the same environment where germs thrive. The CDC recommends that pregnant women, children, older adults, and people with weak immune systems avoid eating raw sprouts. Cooking sprouts destroys harmful bacteria.

2. Cantaloupe: Cantaloupes’ porous rinds allow bacteria to enter the fruit. In addition, the fields where cantaloupes are grown are often flooded, resulting in the fruits sitting in water that may have come downstream from a livestock operation.”

3. Leafy greens: Bacteria becomes trapped on the inner leaves as the head is forming, and leafy greens are difficult to wash effectively. Over the past several years in the U.S., bags of romaine lettuce, prepackaged salad mix, spinach, and spring mix have all been linked to E. coli outbreaks.

4. Tomatoes: There are several ways for germs to enter the fruit of the tomato, including via groundwater or through the water tomatoes are plunged into to give them a little shine.

5. Garnishes, such as green onions, cilantro, and parsley: Green onions and other herbs and vegetables used as garnishes are at high risk for outbreaks because we typically don’t cook them.

However, Powell advises that while there is no one measure that will keep you completely safe, a few small steps can add up such as rinsing fresh produce, and cooking then when you can.

Source: Yahoo! Health